I 1111111111111111 11111 111111111111111 IIIII 1111111111 111111111111111 IIII IIII
`US009125739B2
`
`c12) United States Patent
`Paniagua et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 9,125,739 B2
`Sep.8,2015
`
`(54) PERCUTANEOUS REPLACEMENT HEART
`VALVE ANDA DELIVERY AND
`IMPLANTATION SYSTEM
`
`(71) Applicant: Colibri Heart Valve LLC, Broomfield,
`CO (US)
`
`(72)
`
`Inventors: David Paniagua, Houston, TX (US); R.
`David Fish, Houston, TX (US)
`
`(73) Assignee: COLIBRI HEART VALVE LLC,
`Broomfield, CO (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by O days.
`
`EP
`EP
`
`(21) Appl. No.: 14/253,650
`
`(22) Filed:
`
`Apr. 15, 2014
`
`(58) Field of Classification Search
`CPC ............................. A61F 2/2412; A61F 2/2436
`USPC .............................. 623/1.24, 1.26, 2.12-2.19
`See application file for complete search history.
`
`(56)
`
`References Cited
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`(Continued)
`
`FOREIGN PATENT DOCUMENTS
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`1603493
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`2000115
`(Continued)
`
`OTHER PUBLICATIONS
`
`(65)
`
`Prior Publication Data
`
`US 2014/0228944 Al
`
`Aug. 14, 2014
`
`Cross-reference is made to U.S. Appl. No. 14/253,656, filed Apr. 15,
`2014, and its associated Preliminary Amendment.
`(Continued)
`
`(63)
`
`(51)
`
`(52)
`
`Related U.S. Application Data
`
`Continuation of application No. 13/675,665, filed on
`Nov. 13, 2012, which is a continuation of application
`No. 10/887,688, filed on Jul. 10, 2004, now Pat. No.
`is a continuation-in-part of
`8,308,797, which
`application No. 10/037,266, filed on Jan. 4, 2002, now
`abandoned.
`
`(2006.01)
`(2006.01)
`(2013.01)
`
`Int. Cl.
`A61F 2124
`A61B 8112
`A61F 2/95
`U.S. Cl.
`CPC ................. A61F 212412 (2013.01); A61B 8112
`(2013.01); A61F 2124 (2013.01); A61F 212415
`(2013.01); A61F 212418 (2013.01); A61F
`212427 (2013.01); A61F 212433 (2013.01);
`
`Primary Examiner - Thomas J Sweet
`Assistant Examiner - Cheryl Miller
`(74) Attorney, Agent, or Firm - Fox Rothschild LLP
`
`(57)
`
`ABSTRACT
`
`A method of making a replacement heart valve device
`whereby a fragment of biocompatible tissue material is
`treated and soaked in one or more alcohol solutions and a
`solution of glutaraldehyde. The dried biocompatible tissue
`material is folded and rehydrated in such a way that forms a
`two- or three-leaflet/cusp valve without affixing of separate
`cusps or leaflets or cutting slits into the biocompatible tissue
`material to form the cusps or leaflets. After the biocompatible
`tissue material is folded, it is affixed at one or more points on
`the outer surface to the inner cavity or a stent.
`
`(Continued)
`
`5 Claims, 12 Drawing Sheets
`
`400
`
`460
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1001, p. 1 of 26
`
`

`

`US 9,125,739 B2
`Page 2
`
`(52) U.S. Cl.
`CPC ............. A61F2/2436 (2013.01); A61F 212475
`(2013.01); A61F 2/2439 (2013.01); A61F
`2002/9534 (2013.01); A61F 2210/0014
`(2013.01); A61F 2220/0008 (2013.01); A61F
`2220/0016 (2013.01); A61F 2220/0075
`(2013.01); A61F 2230/0078 (2013.01); A61F
`2250/0039 (2013.01); YJ0S 623/917 (2013.01);
`Yl0T 29/49412 (2015.01)
`
`(56)
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`Edwards Lifesciences Corporation, et al. Exhibit 1001, p. 2 of 26
`
`

`

`US 9,125,739 B2
`Page 3
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`Edwards Lifesciences Corporation, et al. Exhibit 1001, p. 3 of 26
`
`

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