throbber
111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008992608B2
`
`c12) United States Patent
`Haug et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,992,608 B2
`Mar.31,2015
`
`(54) EVERTING HEART VALVE
`Inventors: Ulrich R. Haug, Campbell, CA (US);
`(75)
`Hans F. Valencia, Berkeley, CA (US);
`Robert A. Geshlider, San Francisco, CA
`(US); Tom Saul, El Granada, CA (US);
`Amr Salahieh, Saratoga, CA (US);
`Dwight P. Morejohn, Davis, CA (US);
`Kenneth J. Michlitsch, Livermore, CA
`(US)
`Assignee: Sadra Medical, Inc., Los Gatos, CA
`(US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 88 days.
`(21) Appl. No.: 12/492,512
`Jun.26,2009
`(22) Filed:
`Prior Publication Data
`(65)
`
`(73)
`
`( *)
`
`Notice:
`
`Oct. 22, 2009
`US 2009/0264997 Al
`Related U.S. Application Data
`
`(51)
`
`(60) Division of application No. 12/269,213, filed on Nov.
`12, 2008, now Pat. No. 8,668,733, which is a
`continuation of application No. 10/870,340, filed on
`Jun. 16, 2004, now Pat. No. 7,780,725.
`Int. Cl.
`A61F 2124
`(52) U.S. Cl.
`CPC ............. A61F 212418 (2013.01); A61F 212433
`(2013.01); A61F 212436 (2013.01); A61F
`212439 (2013.01);
`
`(2006.01)
`
`(Continued)
`
`(58) Field of Classification Search
`CPC ................ A61F 2/2412; A61F 2/2427; A61F
`2220/0016; A61F 2/24; A61F 2/2454; A61F
`2/07
`USPC ................................................ 623/1.11-1.54
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`15,192 A
`
`6/1856 Peale
`
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`
`6/1954 Lord
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`CN
`DE
`
`3/2002
`1338951 A
`3/1997
`19532846
`(Continued)
`
`OTHER PUBLICATIONS
`
`Paul eta!.; U.S. Appl. No. 12/578,463 entitled "Medical Devices and
`Delivery Systems for Delivering Medical Devices," filed Oct. 13,
`2009.
`
`(Continued)
`
`Primary Examiner- David Isabella
`Assistant Examiner- Ann Schillinger
`(74) Attorney, Agent, or Firm- Vidas, Arrett & Steinkraus,
`P.A.
`
`(57)
`
`ABSTRACT
`
`The present invention provides methods and apparatus for
`endovascularly replacing a patient's heart valve. The appara(cid:173)
`tus includes a replacement valve and an expandable anchor
`configured for endovascular delivery to a vicinity of the
`patient's heart valve. In some embodiments, the replacement
`valve is adapted to wrap about the anchor, for example, by
`everting during endovascular deployment. In some embodi(cid:173)
`ments, the replacement valve is not connected to expandable
`portions of the anchor. In some embodiments, the anchor is
`configured for active foreshortening during endovascular
`deployment. In some embodiments, the anchor includes
`expandable lip and skirt regions for engaging the patient's
`heart valve during deployment. In some embodiments, the
`anchor comprises a braid fabricated from a single strand of
`wire. In some embodiments, the apparatus includes a lock
`configured to maintain anchor expansion. The invention also
`includes methods for endovascularly replacing a patient's
`heart valve. In some embodiments, the method includes the
`steps of endovascularly delivering a replacement valve and an
`expandable anchor to a vicinity of the heart valve, wrapping at
`least a portion of the replacement valve about the anchor, and
`expanding the anchor to a deployed configuration.
`
`9 Claims, 63 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1001, p. 1 of 83
`
`

`
`US 8,992,608 B2
`Page 2
`
`(52) U.S. Cl.
`CPC ... A61F 2220/0016 (2013.01); A61F 2220/005
`(2013.01); A61F 2220/0058 (2013.01); A61F
`2220/0075 (2013.01); A61F 2230/005
`(2013.01); A61F 2230/0054 (2013.01); A61F
`2230/0065 (2013.01); A61F 2230/0078
`(2013.01)
`USPC ......................................................... 623/2.38
`
`(56)
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1001, p. 2 of 83
`
`

`
`US 8,992,608 B2
`Page 3
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`

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`9/2005 Pai et al.
`9/2005 Stacchino et a!.
`9/2005 Realyvasquez
`9/2005 Forster
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`9/2005 Cribier
`9/2005 Forster eta!.
`9/2005 Sharkawy et a!.
`9/2005 Freyman
`10/2005 Case eta!.
`10/2005 Macoviak
`10/2005 Nugent et al.
`10/2005 Bergheim
`10/2005 White
`1112005 Verhoeven eta!.
`1112005 Cribier
`1112005 Lambrecht et al.
`12/2005 Bates
`12/2005 Haug et al.
`12/2005 Boudjemline
`112006 Spenser et a!.
`112006 Spenser et a!.
`112006 Gunderson
`3/2006 Salahieh et a!.
`7/2006 Schwanunenthal et a!.
`7/2006 Levine eta!.
`7/2006 Realyvasquez et a!.
`8/2006 Salahieh et a!.
`8/2006 Navia eta!.
`1112006 Salahieh et a!.
`1112006 Schwanunenthal et a!.
`1112006 Thill eta!.
`12/2006 Fawzi eta!.
`12/2006 Rowe eta!.
`112007 Salahieh et a!.
`112007 Salahieh et a!.
`112007 Herrmann et a!.
`3/2007 Pryor
`3/2007 Salahieh et a!.
`5/2007 Salahieh et a!.
`5/2007 Salahieh et a!.
`7/2007 Haug et al.
`7/2007 Dreher eta!.
`8/2007 Salahieh et a!.
`10/2007 Salahieh et a!.
`12/2007 Gurskis et a!.
`112008 Cribier
`2/2008 Gelbart et a!.
`4/2008 Wilson eta!.
`5/2008 Salahieh et a!.
`8/2008 Salahieh et a!.
`8/2008 Antocci et a!.
`8/2008 Lamphere et a!.
`9/2008 Lamphere et a!.
`9/2008 Salahieh et a!.
`10/2008 Straubinger et a!.
`10/2008 Iobbi
`1112008 Pulnev eta!.
`112009 Goetz eta!.
`112009 Thielen et a!.
`212009 Salahieh et a!.
`3/2009 Salahieh et a!.
`4/2009 Keidar eta!.
`7/2009 Kveen eta!.
`9/2009 Figulla eta!.
`10/2009 Byrd
`10/2009 Salahieh et a!.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1001, p. 6 of 83
`
`

`
`US 8,992,608 B2
`Page 7
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2009/0299462 A1
`2010/0049313 A1
`2010/0094399 A1
`2010/0121434 A1
`2010/0191326 A1
`2010/0219092 A1
`2010/0280495 A1
`201110257735 A1
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`
`12/2009 Fawzi eta!.
`2/2010 Alon eta!.
`4/2010 Dorn eta!.
`5/2010 Paul eta!.
`7/2010 Alkhatib
`9/2010 Salahieh et a!.
`1112010 Paul eta!.
`10/2011 Salahieh et a!.
`112012 Haug eta!.
`212012 Salahieh et a!.
`212012 Salahieh et a!.
`3/2012 Salahieh et a!.
`4/2012 Haug eta!.
`12/2012 Haug eta!.
`112013 Gregg eta!.
`112013 Lee et al.
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`112014 Zhou eta!.
`4/2014 Salahieh et a!.
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`5/2014 Salahieh et a!.
`5/2014 Salahieh et a!.
`8/2014 Salahieh et a!.
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`DE
`DE
`DE
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP

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