(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property
`Organization
`International Bureau
`
`111111111111110111111111111111111111101011111111111111111111111111111011111111111111111
`
`(43) International Publication Date
`3 November 2005 (03.11.2005) (cid:9)
`
`PCT
`
`(10) International Publication Number
`WO 2005/102015 A2
`
`(51) International Patent Classification: (cid:9)
`
`Not classified
`
`(21) International Application Number:
`PCT/US2005/013746
`
`(22) International Filing Date: 22 April 2005 (22.04.2005)
`
`(25) Filing Language: (cid:9)
`
`(26) Publication Language: (cid:9)
`
`English
`
`English
`
`(30) Priority Data:
`60/565,118 (cid:9)
`
`23 April 2004 (23.04.2004) US
`
`(71) Applicant (for all designated States except US): 3F
`THERAPEUTICS, INC. [US/US]; 20412 James Bay
`Circle, Lake Forest, California 92630 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): BERGHEIM,
`Bjarne [NO/US]; 27722 Deputy Circle, Laguna Hills,
`California 92653 (US). DUMONTELLE, Jeffrey
`[US/US]; 5731 Sierra Cielo Road, Irvine, California 92612
`
`(US). MYERS, Keith [US/US]; 25291 Dayton Drive,
`Lake Forest, California 92630 (US).
`
`(74) Agent: NOLL, Rebekka; JONES DAY, 555 West Fifth
`Street, Suite 4600, Los Angeles, California 90013-1025
`(US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KM, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA,
`MD, MG, MK, MN, MW, MX, MZ, NA, NI, NO, NZ, OM,
`PG, PH, PL, VT, RO, RU, SC, SD, SE, SG, SK, SL, SM, SY,
`TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU,
`ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HU, IE, IS, IT, LT, LU, MC, NE PL, PT, RO,
`
`[Continued on next page]
`
`(54) Title: IMPLANTABLE PROSTHETIC VALVE
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`kr)
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`(57) Abstract: The present invention provides valve prostheses adapted to be initially crimped in a narrow configuration suitable
`for catheterization through body ducts to a target location and adapted to be deployed by state in the target location.
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`Edwards Lifesciences Corporation, et al., Exhibit 1059, p. 1 of 37
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`WO 2005/102015 A2 HINIMIHMONIIMMOMEHIHMIONMEMEREMMIll
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`SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN,
`GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`without international search report and to be republished
`upon receipt of that report
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`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes and Abbreviations" appearing w the begin-
`ning of each regular issue of the PCT Gazette.
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`DESCRIPTION
`Implantable Prosthetic Valve
`This application claims the benefit of U.S. Provisional Application No.
`60/565,118, filed April 23, 2004.
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`5 (cid:9)
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`Field of the Invention
`The present invention relates to implantable devices. More specifically, the
`present invention relates to heart valve prosthetic devices for cardiac implantation.
`The present invention may also be utilized in other body cavities, vessels, or
`ducts.
`
`10 Background of the Invention
`The transport of vital fluids in the human body is largely regulated by
`valves. Physiological valves are designed to prevent the backflow of bodily fluids,
`such as blood, lymph, urine, bile, etc., thereby keeping the body's fluid dynamics
`unidirectional for proper homeostasis. For example, venous valves maintain the
`15 upward flow of blood, particularly from the lower extremities, back toward the
`heart, while lymphatic valves prevent the backflow of lymph within the lymph
`vessels, particularly those of the limbs.
`Because of their common function, valves share certain anatomical
`features despite variations in relative size. The cardiac valves are among the
`20 largest valves in the body with diameters that may exceed 30 mm, while valves of
`the smaller veins may have diameters no larger than a fraction of a millimeter.
`Regardless of their size, however, many physiological valves are situated in
`specialized anatomical structures known as sinuses. Valve sinuses can be
`described as dilations or bulges in the vessel wall that houses the valve. The
`25 geometry of the sinus has a function in the operation and fluid dynamics of the
`valve. One function is to guide fluid flow so as to create eddy currents that
`prevent the valve leaflets from adhering to the wall of the vessel at the peak of
`flow velocity, such as during systole. Another function of the sinus geometry is to
`generate currents that facilitate the precise closing of the leaflets at the beginning
`30 of backflow pressure. The sinus geometry is also important in reducing the stress
`exerted by differential fluid flow pressure on the valve leaflets or cusps as they
`open and close.
`Thus, for example, the eddy currents occurring within the sinuses of
`Valsalva in the natural aortic root have been shown to be important in creating
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`smooth, gradual and gentle closure of the aortic valve at the end of systole. Blood
`is permitted to travel along the curved contour of the sinus and onto the valve
`leaflets to effect their closure, thereby reducing the pressure that would otherwise
`be exerted by direct fluid flow onto the valve leaflets. The sinuses of Valsalva also
`5 contain the coronary ostia, which are outflow openings of the arteries that feed the
`heart muscle. When valve sinuses contain such outflow openings, they serve the
`additional purpose of providing blood flow to such vessels throughout the cardiac
`cycle.
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`When valves exhibit abnormal anatomy and function as a result of valve
`disease or injury, the unidirectional flow of the physiological fluid they are
`designed to regulate is disrupted, resulting in increased hydrostatic pressure. For
`example, venous valvular dysfunction leads to blood flowing back and pooling in
`the lower legs, resulting in pain, swelling and edema, changes in skin color, and
`Lymphatic valve
`skin ulcerations that can be extremely difficult to treat. (cid:9)
`insufficiency can result in lymphedema with tissue fibrosis and gross distention of
`the affected body part. Cardiac valvular disease may lead to pulmonary
`hypertension and edema, atrial fibrillation, and right heart failure in the case of
`mitral and tricuspid valve stenosis; or pulmonary congestion, left ventricular
`contractile impairment and congestive heart failure in the case of mitral
`regurgitation and aortic stenosis. (cid:9) Regardless of their etiology, all valvular
`diseases result in either stenosis, in which the valve does not open properly,
`impeding fluid flow across it and causing a rise in fluid pressure, or
`insufficiency/regurgitation, in which the valve does not close properly and the fluid
`leaks back across the valve, creating backflow. Some valves are afflicted with
`both stenosis and insufficiency, in which case the valve neither opens fully nor
`closes completely.
`Because of the potential severity of the clinical consequences of valve
`disease, valve replacement surgery is becoming a widely used medical
`procedure, described and illustrated in numerous books and articles. When
`30 replacement of a valve is necessary, the diseased or abnormal valve is typically
`cut out and replaced with either a mechanical or tissue valve. A conventional
`heart valve replacement surgery involves accessing the heart in a patient's
`thoracic cavity through a longitudinal incision in the chest. For example, a median
`sternotomy requires cutting through the sternum and forcing the two opposite
`35 halves of the rib cage to be spread apart, allowing access to the thoracic cavity
`and the heart within. The patient is then placed on cardiopulmonary bypass,
`which involves stopping the heart to permit access to the internal chambers. Such
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`open heart surgery is particularly invasive and involves a lengthy and difficult
`recovery period. Reducing or eliminating the time a patient spends in surgery is
`thus a goal of foremost clinical priority.
`One strategy for reducing the time spent in surgery is to eliminate or reduce
`5 the need for suturing a replacement valve into position. Toward this end, valve
`assemblies that allow implantation with minimal or no sutures would be greatly
`advantageous. Attaching a valve such as a tissue valve to a support structure
`such as a stent may enable a valve assembly that allows implantation with
`minimal or no sutures. It is important that such valve constructs are configured
`10 such that the tissue leaflets or the support valve don't come into contact with the
`support structure, either during the collapsed or expanded state, or both in order
`to prevent abrasion. Such contactis capable of contributing undesired stress on
`the valve leaflet. Moreover, it is advantageous that such support structures are
`configured to properly support a tissue valve having a scalloped inflow annulus
`15 such as that disclosed in the U.S. patent application serial number 09/772,526
`which is incorporated by reference herein in its entirety.
`Accordingly, there is a need for a valve replacement system comprising a
`collapsible and expandable valve assembly that is capable of being secured into
`position with minimal or no suturing; facilitating an anatomically optimal position of
`20 the valve; maintaining an open pathway for other vessel openings of vessels that
`may be located in the valvular sinuses; and minimizing or reducing stress to the
`tissue valve leaflets. The valves of the present invention may comprise a plurality
`of joined leaflets with a corresponding number of commissural tabs. Generally,
`however, the desired valve will contain two to four leaflets and commissural tabs.
`Examples of other suitable valves are disclosed in U.S. Patent Applications
`09/772,526, 09/853,463, 09/924,970, 10/121,208, 10/122,035, 10/153,286,
`10/153,290, the disclosures of all of which are incorporated by reference in their
`entirety herein. Likewise, the systems and methods disclosed in U.S. Patent
`Application 10/831,770, filed April 23, 2004, are fully incorporated by reference
`30 herein.
`As mentioned above, an open-heart valve replacement is a long tedious
`procedure. For implantation of a bioprosthetic valve in the aortic position, a
`surgeon typically opens the aorta and excises the native valve. The surgeon then
`inserts the prosthetic valve through the opening in the aortic wall and secures the
`prosthesis at the junction of the aorta and the left ventricle. The inflow annulus of
`the valve faces the left ventricle and, relative to the surgeon's perspective, may be
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`termed the distal annulus, while the outflow annulus of the valve faces the aorta
`and may be termed the proximal annulus.
`An alternative procedure for approaching the left atrium and the aortic or
`mitrel valve is by intravascular catherization from a femoral vein through the
`5 cardiac septum, which separates the right atrium and the left atrium. Yet another
`alternative for approaching the left atrium and the aortic or mitral valve is by
`intravascular catherization from a femoral artery up through aortic valve.
`Andersen et al. in U.S. Pat. No. 6,582,462, entire contents of which are
`incorporated herein by reference, discloses a valve prosthesis for implantation in a
`body channel having an inner wall, the prosthesis comprising a radially collapsible
`and expandable cylindrical stent, the stent including a cylindrical support means
`having a cylinder surface; and a collapsible and expandable valve having
`commissural points, the valve mounted to the stent at the commissural points,
`wherein the stent and valve are configured to be implanted in the body by way of
`catheterization. It is one aspect of the present invention to utilize a balloon
`expandable stent coupled with a tissue valve. An alternative embodiment in the
`present invention to utilizing a balloon expandable stent is to utilize a self-
`expandable stent. Yet another alternative embodiment of the present invention to
`utilizing a balloon expandable stent is to utilize a stent that may be expanded with
`20 mechanical means.
`Sterman et al. in U.S. Pat. No. 6,283,127, entire contents of which are
`incorporated herein by reference, discloses a device system and methods
`facilitating intervention within the heart or great vessels without the need for a
`median sternotomy or other form of gross thoracotomy, substantially reducing
`25 trauma, risk of complication, recovery time, and pain for the patient. Using the
`device systems and methods of the invention, surgical procedures may be
`performed through percutaneous penetrations within intercostal spaces of the
`patient's rib cage, without cutting, removing, or significantly displacing any of the
`patient's ribs or sternum. The device systems and methods are particularly well
`adapted for heart valve repair and replacement, facilitating visualization within the
`patient's thoracic cavity, repair or removal of the patient's natural valve, and, if
`necessary, attachment of a replacement valve in the natural valve position.
`Haluck in U.S. Pat. No. 6,685,724, entire contents of which are
`incorporated herein by reference, discloses a surgical instrument for use in
`35 performing endoscopic procedures having a handle and an elongate tubular
`member having a proximal end coupled with the handle for being disposed
`externally of the anatomical cavity and a distal end for being disposed within the
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`anatomical cavity. The distal end further includes a pair of opposed, relatively
`movable jaws that form a grasping portion operable by manipulation of the handle
`to releasably grasp a releasable trocar. The releasable trocar has a
`complementarily shaped shank, a relatively sharp tip and may include a pair of
`5 blunt-edge tissue separators that project outwardly from the outer surface of the
`trocar.
`Endoscopic and minimally invasive medical procedures, such as
`laparoscopy, have become widely accepted for surgery and illness diagnosis. This
`is due to reduced trauma to the patient and reduced hospitalization time. Other
`10 techniques exist for creating a working space within the body cavity. At the
`beginning of most laparoscopic cases, a small incision is made, followed by a
`small (about 1 cm) port in the remaining layers of the tissue wall so as to gain
`access to the cavity.
`Hunsberger in U.S. Pat. No. 6,613,063, entire contents of which are
`15 incorporated herein by reference, discloses a trocar assembly which includes a
`shank having a distal end and a proximal end, and a planar piercing blade having
`two substantially flat faces and a cutting contour, where the piercing blade is
`integrally attached to the distal end of the shank. The shank tapers inwardly
`towards the opposed flat faces of the piercing blade.
`Further, McFarlane in U.S. Pat. No. 6,478,806, entire contents of which are
`incorporated herein by reference, discloses a tissue penetrating instrument of the
`type used in the medical field and which may or may not be embodied in the form
`of an obturator associated with a trocar assembly, wherein the instrument includes
`an elongated shaft having a penetrating tip mounted on one end thereof. The
`25 penetrating tip includes a base secured to the one end of the shaft and a distal
`extremity spaced longitudinally outward from the base and formed into an apex
`which may be defined by a point or other configuration specifically structured to
`facilitate penetration or puncturing of bodily tissue.
`Spenser et al. disclose in US patent applications 09/975,750, 10/270,252,
`30 and 10/637,882, entire contents of which are incorporated herein by reference,
`disclose and implantable prosthetic valve that comprises a support sent to be
`initially crimped in a narrow configuration suitable for catherization through the
`body duct to a target location.
`Key features of any valve where sutures to hold the replacement valve into
`position are to be eliminated or reduced are: durability, low-pressure gradient
`across the valve, sufficient seal around the valve to prevent perivalvular leak, and
`prevent migration. Therefore, it would be desirable to provide an implantable
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`valve that with features that aim to increase durability, reduce pressure gradient
`across the valve, and provide an adequate seal around the valve and prevent
`migration.
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`Summary of the Invention
`The present invention provides a valve prosthesis that in one embodiment
`comprises a support stent, comprised of a deployable construction adapted to be
`initially crimped in a narrow configuration suitable for catherization through the
`body ducts to a target location and adapted to be deployed by exerting
`substantially radial forces from within by means of a deployment device to a
`deployed state in the target location, the support stent provided with a plurality of
`longitudinally rigid support beams of fixed length; and a valve assembly
`comprising a flexible conduit having an inlet end and an outlet, made of pliant
`material attached to the support beams providing collapsible slack portions of the
`conduit at the outlet, whereby when flow is allowed to pass through the valve
`prosthesis device from the inlet to the outlet the valve assembly is kept in an open
`position whereas a reverse flow is prevented as the collapsible slack portions of
`the valve assembly collapse inwardly providing blockage to the reverse flow.
`In another embodiment of the present invention, the support stent
`comprises an annular frame.
`In yet another embodiment of the present invention, the support stent is
`made out of stainless steel.
`In yet another embodiment of the present invention, said valve assembly
`has a tricuspid configuration.
`In yet another embodiment of the present invention, said valve assemblyis
`25 made from biocompatible material.
`In yet another embodiment of the present invention, the valve assembly is
`made from pericardial tissue, or other biological tissue.
`In yet another embodiment of the present invention, said valve assembly is
`made from biocompatible polymers.
`In yet another embodiment of the present invention, the valve 'assembly is
`made from materials selected from the group consisting of polyurethane and
`polyethylene terphthalane.
`In yet another embodiment of the present invention, the valve assembly
`comprises a main body made from polyethylene terphthalane and leaflets made
`35 from polyurethane.
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`Edwards Lifesciences Corporation, et al., Exhibit 1059, p. 8 of 37
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`In yet another embodiment of the present invention, said support stent is
`made from nickel titanium alloys.
`In yet another embodiment of the present invention, the support beams are
`substantially equidistant and substantially parallel so as to provide anchorage for
`5 the valve assembly.
`In yet another embodiment of the present invention, the support beams are
`provided with bores so as to allow stitching or tying of the valve assembly to the
`beams.
`In yet another embodiment of the present invention, the support beams are
`10 not provided with bores so as to allow extra rigidity to the valve support structures.
`In yet another embodiment of the present invention, the support beams are
`chemically adhered to the support stent.
`In yet another embodiment of the present invention, said valve assembly is
`riveted to the support beams.
`In yet another embodiment of the present invention, said beams are
`manufactured by injection using a mold, or by machining.
`In yet another embodiment of the present invention, said valve assembly is
`rolled over the support stent at the inlet.
`In yet another embodiment of the present invention, said valve device is
`20 manufactured using forging or dipping techniques.
`In yet another embodiment of the present invention, said valve assembly
`leaflets are longer than needed to exactly close the outlet, thus when they are in
`the collapsed state substantial portions of the leaflets fall on each other creating
`better sealing.
`In yet another embodiment of the present invention, said valve assembly is
`made from coils of a polymer, coated by a coating layer of same polymer.
`In yet another embodiment of the present invention, said polymer is
`polyurethane.
`In yet another embodiment of the present invention, the support stent is
`30 provided with heavy metal markers so as to enable tracking and determining the
`valve device position and orientation.
`In yet another embodiment of the present invention, the heavy metal
`markers are selected from gold, platinum, iridium, tantalum, cobalt, chrome, and
`titanium alloys.
`In yet another embodiment of the present invention, the valve assembly
`leaflets are provided with radio-opaque materials at the outlet so as to help
`tracking the valve device operation in vivo.
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`In yet another embodiment of the present invention, said radio0opque
`material comprises gold thread.
`In yet another embodiment of the present invention, the diameter of said
`support stent when fully deployed is in the range of from about 15 to about 33mm.
`In yet another embodiment of the present invention, the diameter of said
`support stent may be expanded from about 4 to about 25mm.
`In yet another embodiment of the present invention, the diameter of said
`support stent may be expanded from about 10mm to about 25mm.
`In yet another embodiment of the present invention, the support beams are
`10 provided with bores and wherein the valve assembly is attached to the support
`beams by means of U-shaped rigid members that are fastened to the valve
`assembly and that are provided with extruding portions that fit into matching bores
`on the support beams.
`In yet another embodiment of the present invention, the support beams
`15 comprise rigid support beams in the form of frame construction, and the valve
`assembly pliant material is inserted through a gap in the frame and a fastening rod
`is inserted through a pocket formed between the pliant material and the frame and
`holds the valve in position.
`In yet another embodiment of the present invention, the main body of the
`20 valve assembly is made from coiled wire coated with coating material.
`In yet another embodiment of the present invention, the coiled wire and the
`coating material is made from polyurethane.
`In yet another embodiment of the present invention, a strengthening wire is
`interlaced in the valve assembly at the outlet of the conduit so as to define a fault
`25 line about which the collapsible slack portion of the valve assembly may flap.
`In yet another embodiment of the present invention, the strengthening wire
`is made from nickel titanium alloy.
`In yet another embodiment of the present invention, there is provided a
`valve prosthesis device suitable for implantation in body ducts, the device
`30 comprising a main conduit body having an inlet and an outlet and pliant leaflets
`attached at the outlet so that when a flow passes through the conduit from the
`inlet to the outlet the leaflets are in an open position allowing the flow to exit the
`outlet, and when the flow is reversed the leaflets collapse so as to block the outlet,
`wherein the main body is made from polyethylene terphtalate and collapsible
`35 leaflets are made from polyurethane.
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`In yet another embodiment of the present invention, support beams made
`from polyurethane are provided on the main body and wherein the leaflets are
`attached to the main body at the support beams.
`In yet another embodiment of the present invention, said support beams
`5 are chemically adhered to the main body.
`In yet another embodiment of the present invention, there is provided a
`valve prosthesis device suitable for implantation in body ducts, the device
`comprising:
`
`A support stent, comprised of a deployable construction adapted to
`be initially crimped in a narrow configuration suitable for catherization through the
`body duct to a target location and adapted to be deployed by exerting
`substantially radial force from within by means of a deployment device to a
`deployed state in the target location, the support stent provided with a plurality of
`longitudinally rigid support beams of fixed length;
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`A valve assembly comprising a flexible conduit having an inlet and
`an outlet, made of pliant material attached to the support beams providing
`collapsible slack portions of the conduit at the outlet; and
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`Substantially equidistant rigid support beams interlaced or attached
`to the slack portion of the valve assembly material, arranged longitudinally
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`In yet another embodiment of the present invention, the multiple plates are
`adapted to move simultaneously by means of a lever and transmission.
`In yet another embodiment of the present invention, there is provided a
`method for deploying an implantable prosthesis valve device at the natural aortic
`25 valve position at the entrance to the left ventricle of a myocardium of a patient, the
`method comprising the steps of:
`
`(a) providing a balloon catheter having a proximal end and a distal
`end, having a first and second independently inflatable portions, the first inflatable
`portion located at the distal end of the catheter and the second inflatable portion
`adjacently behind the first inflatable portion;
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`(b) providing a guiding tool for guiding the balloon catheter in the
`vasculature of the patient;
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`(c) providing a deployable implantable valve prosthesis device
`adapted to be mounted on the second inflatable portion of the balloon catheter;
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`(d) guiding the balloon catheter through the patient's aorta using the
`guiding tool, the valve device mounted over the second inflatable portion of the
`balloon catheter until the first inflatable portion of the balloon catheter is inserted
`into the left ventricle, whereas the second inflatable portion of the balloon catheter
`is positioned at the natural aortic valve position;
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`(e) inflating the first inflatable portion of the balloon catheter so as to
`substantially block blood flow through the natural aortic valve and anchor the
`distal end of the balloon catheter in position;
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`(f) inflating the second inflatable portion of the balloon catheter so as
`10 to deploy the implantable prosthesis valve device in position at the natural aortic
`valve positions;
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`(g) deflating the first and second inflatable portions of the balloon
`catheter; and
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`' (h) retracting the balloon catheter and removing it from the patient's
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`15 body.
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`In yet another embodiment of the present invention, the guiding tool
`compromises a guide wire.
`In some further embodiments, the present invention provides a method for
`deploying an implantable prosthesis valve device at the natural aortic valve
`20 position at the entrance to the left ventricle of the myocardium of a patient, the
`method comprising the steps of:
`
`(a) providing a balloon catheter having a proximal end a distal end,
`having a first and second independently inflatable portions, the first inflatable
`portion located at the distal end of the catheter and the second inflatable portion
`adjacently behind the first inflatable portion;
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`25 (cid:9)
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`(b)providing a guiding tool for guiding the balloon catheter in the
`vasculature of the patient;
`
`providing a deployable implantable valve prosthesis device adapted
`to be mounted on the first inflatable portion of the balloon catheter, and a
`30 deployable annular stent device adapted to be mounted over the second inflatable
`portion of the balloon catheter, the deployable implantable valve prosthesis device
`and the deployable annular stent kept at a predetermined distance apart;
`
`(d) guiding the balloon catheter through the patient's aorta using the
`guiding tool, the valve device mounted over the first inflatable portion of the
`
`Edwards Lifesciences Corporation, et al., Exhibit 1059, p. 12 of 37
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`(cid:9)
`(cid:9)
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`11
`balloon catheter and the deployable annular stent mounted over the second
`inflatable portion of the balloon catheter, until the first inflatable portion of the
`balloon catheter is positioned at the natural aortic valve position;
`
`(e) inflating the second inflatable portion of the balloon catheter so
`5 that the deployable stent device is deployed within the aorta thus anchoring the
`deployable annular stent and the coupled valve device in position;
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`(cid:9) (cid:9)
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`10 (cid:9)
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`(f) inflating the first inflatable portion of the balloon catheter so as to
`deploy the implantable prosthesis valve device in position at the natural aortic
`valve position;
`
`(g) deflating the first and second inflatable portions of the balloon
`catheter; and
`
`(h) retracting the balloon catheter and removing it from the patient's
`
`body.
`
`It is one object of the valve device described in the present invention to
`15 presents a novel means of attaching a tissue valve to a support structure. The
`means of attaching the valve to the support structure may increase the durability
`of the valve, reduce the pressure gradient across the valve, provide a seal, around
`the valve to prevent perivalvular leak, and prevent migration. The valves of the
`present invention may comprise a plurality of joined leaflets with a corresponding
`20 number of commissural tabs. Generally, however, the desired valve will contain
`two to four leaflets and commissural tabs.
`In an embodiment of the present invention, the valves are similar to the
`valves disclosed in U.S. Patent Applications 09/772,526, 09/853,463, 09/924,970,
`10/121,208, 10/122,035, 10/153,286, 10/153,290, the disclosures of all of which
`25 are incorporated by reference in their entirety herein. The diameter of the valves
`described in these applications may be equal or less than the orifice diameter of
`the support structure of the valve.
`In yet another embodiment of the present invention, the valves described in
`U.S. Patent Applications 09/772,526, 09/853,463, 09/924,970, 10/121,208,
`10/122,035, 10/153,286, 10/153,290, the valves are sized such that the effective
`valve diameter is 1-5mm less than the diameter of the orifice of the support
`structures of the valve. This size will help prevent the valve leaflets from hitting
`the support structure.
`In yet another embodiment of the present invention, the valves are made of
`35 equine pericardium.
`
`30
`
`Edwards Lifesciences Corporation, et al., Exhibit 1059, p. 13 of 37
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`(cid:9)
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`WO 2005/102015 (cid:9)
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`PCT/US2005/013746
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`10 (cid:9)
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`12
`In yet another embodiment of the present invention, a cuff (e.g. cloth)
`portion of the valve assembly is wrapped around the support stent at the inlet.
`This may enhance stability of the stent, but further, the cuff portion described in
`the current invention may be used for attaching sutures. Most importantly, the cuff
`5 portion of the present invention is intended to reduce perivalvular leak around the
`valve. Using such a cuff to c