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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 1 of 2319
`
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`221
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`222
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`223
`
`FIG.2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 2 of 2319
`
`

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`FIG.3A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 3 of 2319
`
`

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`FIG.3B
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 4 of 2319
`
`

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`L
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 5 of 2319
`
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`200
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`FIG.5
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 6 of 2319
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 7 of 2319
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 7 of 2319
`
`

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`FIG. 7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 8 of 2319
`
`

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`450
`
`400
`
`460
`
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 9 of 2319
`
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`Fig. 9A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 10 of 2319
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 11 of 2319
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 12 of 2319
`
`

`

`PTO/AIN14 (08-12)
`Approved for use through 01/31/2014. 0MB 0651-0032
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`109978.10101
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`Application Number
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`Title of Invention
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`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
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`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF
`MAKING SAME
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`EFS Web 2.2.3
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 13 of 2319
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`PTO/AIN14 (08-12)
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`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
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`D Request Early Publication (Fee required at time of Request 37 CFR 1.219)
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 14 of 2319
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`PTO/AIN14 (08-12)
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`Application Data Sheet 37 CFR 1.76
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`Title of Invention
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`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 15 of 2319
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`

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`109978.10101
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`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 16 of 2319
`
`

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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 17 of 2319
`
`

`

`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE
`
`DEVICE AND METHOD OF MAKING SAME
`
`CONTINUITY INFORMATION
`
`[000 I] The present application is a continuation application of U.S. Patent Application
`
`No. 10/887,688 filed on July 10, 2004, now U.S. Patent No. 8,308,797, which is a continuation(cid:173)
`
`in-part application of U.S. Patent Application No. 10/037,266, filed on January 4, 2002 (now
`
`abandoned). Both applications of which are incorporated herein by reference in their entireties.
`
`BACKGROUND OF THE INVENTION
`
`[0002] Field of the Invention
`
`The present invention is in the field of heart valve replacement. More specifically, the
`
`present invention is directed to a method of making a percutaneously implantable replacement
`
`heart valve.
`
`[0003] 2. Description of Related Art
`
`There have been numerous efforts in the field of heart valve replacement to improve both
`
`the durability and effectiveness of replacement heart valves as well as the ease of implantation.
`
`A brief description of heart valves and heart function follows to provide relevant background for
`
`the present invention.
`
`[0004] There are four valves in the heart that serve to direct the flow of blood through the
`
`two sides of the heart in a forward direction. On the left (systemic) side of the heart are: 1) the
`
`mitral valve, located between the left atrium and the left ventricle, and 2) the aortic valve,
`
`located between the left ventricle and the aorta. These two valves direct oxygenated blood
`
`coming from the lungs through the left side of the heart into the aorta for distribution to the body.
`
`DNl 31005vl 11/13/12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 18 of 2319
`
`

`

`On the right (pulmonary) side of the heart are: 1) the tricuspid valve, located between the right
`
`atrium and the right ventricle, and 2) the pulmonary valve, located between the right ventricle
`
`and the pulmonary artery. These two valves direct de-oxygenated blood coming from the body
`
`through the right side of the heart into the pulmonary artery for distribution to the lungs, where it
`
`again becomes re-oxygenated to begin the circuit anew.
`
`[0005] Heart valves are passive structures that simply open and close in response to
`
`differential pressures on either side of the particular valve. They consist of moveable "leaflets"
`
`that are designed simply to open and close in response to differential pressures on either side of
`
`the valve's leaflets. The mitral valve has two leaflets and the tricuspid valve has three. The
`
`aortic and pulmonary valves are referred to as "semilunar valves" because of the unique
`
`appearance of their leaflets, which are more aptly termed "cusps" and are shaped somewhat like
`
`a half-moon. The aortic and pulmonary valves each have three cusps.
`
`[0006] In general, the components of heart valves include the valve annulus, which will
`
`remain as a roughly circular open ring after the leaflets of a diseased or damaged valve have
`
`been removed; leaflets or cusps; papillary muscles which are attached at their bases to the
`
`interior surface of the left or right ventricular wall; and multiple chordae tendineae, which couple
`
`the valve leaflets or cusps to the papillary muscles. There is no one-to-one chordal connection
`
`between the leaflets and the papillary muscles; instead, numerous chordae are present, and
`
`chordae from each papillary muscle attach to both of the valve leaflets.
`
`[0007] When the left ventricular wall relaxes so that the ventricular chamber enlarges and
`
`draws in blood, the leaflets of the mitral valve separate and the valve opens. Oxygenated blood
`
`flows in a downward direction through the valve, to fill the expanding ventricular cavity. Once
`
`the left ventricular cavity has filled, the left ventricle contracts, causing a rapid rise in the left
`
`DNl 31005vl 11/13/12
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 19 of 2319
`
`

`

`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.
`
`[0008] 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 passively 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 passively in the same manner in response to relaxation and contraction 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 associated chordae tendineae or papillary
`
`muscles.
`
`[0009] 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 infections in which
`
`the valve may continue to function normally, but nevertheless harbors an overgrowth of bacteria
`
`(vegetation) 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., the systemic circulation side) of
`
`the heart, embolization may occur, resulting in sudden loss of the blood supply to the affected
`
`DNl 31005vl 11/13/12
`
`3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 20 of 2319
`
`

`

`body organ and immediate malfunction of that organ. The organ most commonly affected by
`
`such embolization is the brain, in which case the patient suffers a stroke. Thus, surgical
`
`replacement of either the mitral or aortic valve (left-sided heart valves) may be necessary for this
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`problem even though neither stenosis nor insufficiency of either valve is present. Likewise,
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`bacterial or fungal vegetations on the tricuspid valve may embolize to the lungs resulting in a
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`lung abscess and therefore, may require replacement of the tricuspid valve even though no
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`tricuspid valve stenosis or insufficiency is present.
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`[0010] These problems are treated by surgical repair of valves, although often the valves
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`are too diseased to repair and must be replaced. If a heart valve must be replaced, there are
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`currently several options available, and the choice of a particular type of artificial valve depends
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`on factors such as the location of the valve, the age and other specifics of the patient, and the
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`surgeon's experiences and preferences. Currently in the United States over 100,000 defective
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`heart valves are replaced annually, at an approximate cost of $30-50,000 per procedure, and thus
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`it would be desirable if heart valves could be replaced using minimally invasive techniques and
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`without having to repeat the procedure within a matter of years due to the lack of durability of
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`the replacement heart valve. It would be especially advantageous if a defective heart valve could
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`be removed via an endovascular procedure, that is, a procedure where the invasion into the body
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`is through a blood vessel such as the femoral artery. The procedure is then carried out
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`percutaneously and transluminally using the vascular system to convey appropriate devices to the
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`position in the body wherein it is desired to carry out the desired procedure. An example of such
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`a procedure would be angioplasty, wherein a catheter carrying a small balloon at its distal end is
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`manipulated through the body's vessels to a point where there is a blockage in a vessel. The
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`DNl 31005vl 11/13/12
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`4
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 21 of 2319
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`balloon is expanded to create an opening in the blockage, and then the balloon is deflated and the
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`catheter and balloon are removed from the vessel.
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`[0011] Endovascular procedures have substantial benefits both from the standpoint of
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`health and safety as well as cost. Such procedures require minimal invasion of the human body,
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`and there is consequently considerable reduction and in some instances even elimination, of the
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`use of a general anesthesia and much shorter hospital stays.
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`[0012] Replacement heart valves can be categorized as either artificial mechanical
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`valves, transplanted valves and tissue valves. Replacement heart valves are designed to optimize
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`hemodynamic performance,
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`thrombogenicity and durability. Another factor
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`taken
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`into
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`consideration is the relative ease of surgical implantation.
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`[0013] Mechanical valves are typically constructed from nonbiological materials such as
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`plastics, metals and other artificial materials which, while durable, are expensive and prone to
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`blood clotting which increases the risk of an embolism. Anticoagulants taken to help against
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`blood clotting can further complicate the patient's health due to increased risks for hemorrhages.
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`[0014] Transplanted valves are natural valves taken from cadavers. These valves are
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`typically removed and frozen in liquid nitrogen, and are stored for later use. They are typically
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`fixed in glutaraldehyde to eliminate antigenicity and are sutured in place, typically with a stent.
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`[0015] Artificial tissue valves are valves constructed from animal tissue, such as bovine
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`or porcine tissue. Efforts have also been made at using tissue from the patient for which the
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`valve will be constructed.
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`[0016] Most tissue valves are constructed by sewing the leaflets of pig aortic valves to a
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`stent to hold the leaflets in proper position, or by constructing valve leaflets from the pericardial
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`sac of cows or pigs and sewing them to a stent. The porcine or bovine tissue is chemically
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`DNl 31005vl 11/13/12
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`5
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 22 of 2319
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`treated to alleviate any antigenicity. The pericardium is a membrane that surrounds the heart and
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`isolates it from the rest of the chest wall structures. The pericardium is a thin and very slippery,
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`which makes it difficult for suturing in a millimetricly precise way. The method of making the
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`replacement heart valve of the present invention solves this problem through a process that
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`includes drying and compressing the pericardium using photo-mechanical compression in such a
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`way that makes it possible to handle and fold the material more easily.
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`[0017] For example, one prior replacement heart valve requires each sculpted leaflet to
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`be trimmed in a way that forms an extended flap, which becomes a relatively narrow strand of
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`tissue near its tip. The tip of each pericardial tissue strand is sutured directly to a papillary
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`muscle, causing the strand to mimic a chordae tendineae. Each strand extends from the center of
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`a leaflet in the valve, and each strand is sutured directly to either an anterior and posterior
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`papillary muscle. This requires each leaflet to be positioned directly over a papillary muscle.
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`This effectively rotates the leaflets of the valve about 90 degrees as compared to the leaflets of a
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`native valve. The line of commissure between the leaflets, when they are pressed together during
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`systole, will bisect ( at a perpendicular angle) an imaginary line that crosses the peaks of the two
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`papillary muscles, instead of lying roughly along that line as occurs in a native valve.
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`[0018] A different approach to creating artificial tissue valves is described in U.S. Pat.
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`No. 5,163,955 to Calvin, et al. and U.S. Pat. Nos. 5,571,174 and 5,653,749 to Love. Using a
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`cutting die, the pericardial tissue is cut into a carefully defined geometric shape, treated with
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`glutaraldehyde, then clamped in a sandwich-fashion between two stent components. This creates
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`a tri-leaflet valve that resembles an aortic or pulmonary valve, having semilunar-type cusps
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`rather than atrioventricular-type leaflets.
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 23 of 2319
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`[0019] U.S. Pat. No. 3,671,979 to Moulopoulos describes an endovascularly inserted
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`conical shaped umbrella-like valve positioned and held in place by an elongated mounting
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`catheter at a supra-annular site to the aortic valve in a nearby arterial vessel. The conical end
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`points toward the malfunctioning aortic valve and the umbrella's distal ends open up against the
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`aorta wall with reverse blood flow, thereby preventing regurgitation.
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`[0020] U.S. Pat. No. 4,056,854 to Boretos describes an endovascularly inserted, catheter
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`mounted, supra-annular valve in which the circular frame abuts the wall of the artery and
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`attached flaps of flexible membrane extend distally in the vasculature. The flaps lie against the
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`artery wall during forward flow, and close inward towards the central catheter to prevent
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`regurgitation during reverse blood flow. The Boretos valve was designed to be positioned
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`against the artery wall during forward flow, as compared to the mid-center position of the
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`Moulopoulos valve, to reduce the stagnation of blood flow and consequent thrombus and
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`embolic formation expected from a valve at mid-center position.
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`[0021] The main advantage of tissue valves is that they do not cause blood clots to form
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`as readily as do the mechanical valves, and therefore, they do not absolutely require systemic
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`anticoagulation. The major disadvantage of tissue valves is that they lack the long-term
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`durability of mechanical valves. Tissue valves have a significant failure rate, usually within ten
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`years following implantation. One cause of these failures is believed to be the chemical
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`treatment of the animal tissue that prevents it from being antigenic to the patient. In addition, the
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`presence of extensive suturing prevents the artificial tissue valve from being anatomically
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`accurate in comparison to a normal heart valve, even in the aortic valve position.
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`[0022] A shortcoming of prior artificial tissue valves has been the inability to effectively
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`simulate the exact anatomy of a native heart valve. Although transplanted human or porcine
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`Edwards Lifesciences Corporation, et al. Exhibit 1017, p. 24 of 2319
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`aortic valves have the gross appearance of native aortic valves, the fixation process (freezing
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`with liquid nitrogen, and chemical treatment, respectively) alters the histologic characteristics of
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`the valve tissue. Porcine and bovine pericardi