(12) United States Patent (cid:9)
`Haug et al. (cid:9)
`
`(54) EVERTING HEART VALVE
`
`(75) Inventors: Ulrich R. Haug, Campbell, CA (US);
`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)
`
`(73) Assignee: Sadra Medical, Inc., Los Gatos, CA
`(US)
`
`(* )
`
`Notice: (cid:9)
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1188 days.
`
`(21) Appl. No.: 10/870,340
`
`(22) Filed: (cid:9)
`
`Jun. 16, 2004
`
`(65)
`
`Prior Publication Data
`
`US 2005/0283231 Al (cid:9)
`
`Dec. 22, 2005
`
`(51)
`
`Int. Cl.
`A61F 2/06 (cid:9)
` 623/2.17
`(52) U.S. Cl. (cid:9)
` 623/1.1-2.1,
`(58) Field of Classification Search (cid:9)
`623/2.11-2.42; 128/898
`See application file for complete search history.
`
`(2006.01)
`
`(56)
`
`References Cited
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`(10) Patent No.: (cid:9)
`(45) Date of Patent: (cid:9)
`
`US 7,780,725 B2
`Aug. 24, 2010
`
`EP
`
`FOREIGN PATENT DOCUMENTS
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`(Continued)
`
`OTHER PUBLICATIONS
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`(Continued)
`
`Primary Examiner (cid:9) David Isabella
`Assistant Examiner (cid:9) Ann Schillinger
`(74) Attorney, Agent, or Firm (cid:9) Shay Glenn LLP
`
`(57) (cid:9)
`
`ABSTRACT
`
`The present invention provides methods and apparatus for
`endovascularly replacing a patient's heart valve. The appara-
`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-
`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.
`
`(Continued)
`
`31 Claims, 63 Drawing Sheets
`
`500
`
`522
`
`520
`526
`524
`
`Page 1 of 81
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-01293, U.S. Patent 8,992,608
`Exhibit 2010
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`US 7,780,725 B2
`Page 2
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`EP (cid:9)
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`EP (cid:9)
`WO (cid:9)
`WO (cid:9)
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`1000590 Al (cid:9)
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`WO 2004/023980 (cid:9)
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`WO 2005/084595 Al (cid:9)
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 1 of 63
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`US 7,780,725 B2
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`F/G. /A
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`F/G. 2A
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`U.S. Patent
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`Aug. 24, 2010 (cid:9)
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`Sheet 2 of 63
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`US 7,780,725 B2
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 3 of 63 (cid:9)
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`US 7,780,725 B2
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`F/G. 3A
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 4 of 63 (cid:9)
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`US 7,780,725 B2
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`F/G. 3B
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 5 of 63 (cid:9)
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`US 7,780,725 B2
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`30 (10
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`100
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`50 /12 (cid:9)
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`/10 60
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`F/G 4A
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`F/G 48
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`10
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`FIG 4C
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`Page 11 of 81
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 6 of 63 (cid:9)
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`US 7,780,725 B2
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`FIG 4D
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`30 37
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`/00
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`44
`45
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`FIG 4E
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`F/G 4F
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 7 of 63
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`US 7,780,725 B2
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`F/G. 5A
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`(cid:9)
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 8 of 63
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`US 7,780,725 B2
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`F/a 58
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`(cid:9)
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 9 of 63 (cid:9)
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`US 7,780,725 B2
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`FIG. 5C
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 10 of 63
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`US 7,780,725 B2
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`FIG. 50
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`Page 16 of 81
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 11 of 63 (cid:9)
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`US 7,780,725 B2
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`7100
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`A
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`LV
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`F/6. 5E
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`Page 17 of 81
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 12 of 63 (cid:9)
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`US 7,780,725 B2
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`F/6. 5F
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 13 of 63
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`US 7,780,725 B2
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`FIG 6A
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`Page 19 of 81
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 14 of 63 (cid:9)
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`US 7,780,725 B2
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`F/6 68
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 15 of 63 (cid:9)
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`US 7,780,725 B2
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`F/G 6C
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 16 of 63 (cid:9)
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`US 7,780,725 B2
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`F/6 6D
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`US 7,780,725 B2
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`30
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`F/G. 6E
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 18 of 63
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`US 7,780,725 B2
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`FIG. 6F
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`U.S. Patent (cid:9)
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`Aug. 24, 2010
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`Sheet 19 of 63 (cid:9)
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`US 7,780,725 B2
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`F/6 7
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`U.S. Patent (cid:9)
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`Aug. 24, 2010 (cid:9)
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`Sheet 20 of 63 (cid:9)
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