US0083O8797B2
`
`(12) United States Patent
`Paniagua et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,308,797 B2
`Nov. 13, 2012
`
`(54) PERCUTANEOUSLY IMPLANTABLE
`REPLACEMENT HEART VALVE DEVICE
`AND METHOD OF MAKING SAME
`
`(75) Inventors: David Paniagua, Houston, TX (US);
`Eduardo Induni, Alajuela (CR); Carlos
`Mejia, Houston, TX (US); Francisco
`Lopez-Jimenez, Rochester, MN (US);
`R. David Fish, Houston, TX (US)
`(73) Assignee: Colibri Heart Valve, LLC, Broomfield,
`CO (US)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1467 days.
`(21) Appl. No.: 10/887,688
`
`(22) Filed:
`
`Jul. 10, 2004
`
`(65)
`
`Prior Publication Data
`US 2005/O11391.0 A1
`May 26, 2005
`
`Related U.S. Application Data
`(63) Continuation-in-part of application No. 10/037,266,
`filed on Jan. 4, 2002, now abandoned.
`(51) Int. Cl
`A. iF M24
`623/214
`(52) U.S. Cl
`(58) Field of Classification Search ................. 623/124,
`623/126,900, 2.1-2.19
`See application file for complete search history.
`
`(2006.01)
`
`(56)
`
`References Cited
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`(Continued)
`Primary Examiner — Christopher Koharski
`Assistant Examiner — Cheryl Miller
`(74) Attorney, Agent, or Firm — Fox Rothschild LLP. Mark
`L. Yaskanin
`
`ABSTRACT
`(57)
`The present invention comprises a percutaneously implant
`able replacement heart Valve device and a method of making
`same. The replacement heart valve device comprises a stent
`member made of stainless steel or self-expanding nitinol, a
`biological tissue artificial valve means disposed within the
`inner space of the stent member. An implantation and delivery
`system having a central part which consists of a flexible
`hollow tube catheter that allows a metallic wire guide to be
`advanced inside it. The endovascular stented-valve is a glut
`araldehyde fixed bovine pericardium which has two or three
`cusps that open distally to permit unidirectional blood flow.
`The present invention also comprises a novel method of mak
`ing a replacement heart valve by taking a rectangular frag
`ment of bovine pericardium treating, drying, folding and
`rehydrating it in such a way that forms a two- or three-leaflet/
`cusp valve with the leaflets/cusps formed by folding, thereby
`eliminating the extent of Suturing required, providing
`improved durability and function.
`
`17 Claims, 12 Drawing Sheets
`
`Edwards Lifesciences Corporation, et al. Exhibit 1021, p. 1 of 25
`
`

`

`US 8,308,797 B2
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`Edwards Lifesciences Corporation, et al. Exhibit 1021, p. 5 of 25
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`1.
`PERCUTANEOUSLY MPLANTABLE
`REPLACEMENT HEART VALVE DEVICE
`AND METHOD OF MAKING SAME
`
`CONTINUITY INFORMATION
`
`This application is a continuation in part of U.S. non
`provisional patent application Ser. No. 10/037,266 filed on
`Jan. 4, 2002. The Applicants hereby claim the benefit under
`35 U.S.C. S 120 based on said application.
`
`10
`
`BACKGROUND OF THE INVENTION
`
`2
`has filled, the left ventricle contracts, causing a rapid rise in
`the left ventricular cavitary pressure. This causes the mitral
`valve to close while the aortic valve opens, allowing the
`oxygenated blood to be ejected from the left ventricle into the
`aorta. The chordae tendineae of the mitral valve prevent the
`mitral leaflets from prolapsing back into the left atrium when
`the left ventricular chamber contracts.
`The three leaflets, chordae tendineae, and papillary
`muscles of the tricuspid valve function in a similar manner, in
`response to the filling of the right ventricle and its Subsequent
`contraction. The cusps of the aortic valve also respond pas
`sively to pressure differentials between the left ventricle and
`the aorta. When the left ventricle contracts, the aortic valve
`cusps open to allow the flow of oxygenated blood from the left
`ventricle into the aorta. When the left ventricle relaxes, the
`aortic valve cusps reapproximate to prevent the blood which
`has entered the aorta from leaking (regurgitating) back into
`the left ventricle. The pulmonary valve cusps respond pas
`sively in the same manner in response to relaxation and con
`traction of the right ventricle in moving de-oxygenated blood
`into the pulmonary artery and thence to the lungs for re
`oxygenation. Neither of these semilunar Valves has associ
`ated chordae tendineae or papillary muscles.
`Problems that can develop with heart valves consist of
`Stenosis, in which a valve does not open properly, and/or
`insufficiency, also called regurgitation, in which a valve does
`not close properly. In addition to Stenosis and insufficiency of
`heart Valves, heart valves may need to be Surgically repaired
`or replaced due to certain types of bacterial or fungal infec
`tions in which the valve may continue to function normally,
`but nevertheless harbors an overgrowth of bacteria (vegeta
`tion) on the leaflets of the valve that may embolize and lodge
`downstream in a vital artery. If such vegetations are on the
`valves of the left side (i.e.