(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`1111111111111111111111111111111111111111111111111111111111111111111111111111111111111
`
`(43) International Publication Date
`12 June 2003 (12.06.2003)
`
`PCT
`
`(10) International Publication Number
`WO 03/047468 Al
`
`(51) International Patent Classification7:
`
`A61F 2/24
`
`(21) International Application Number: PCT/US02/32588
`
`(22) International Filing Date: 11 October 2002 (11.10.2002)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`09/975,750
`
`11 October 2001 (11.10.2001) US
`
`(71) Applicant (for all designated States except US): PERCU(cid:173)
`TANEOUS VALVE TECHNOLOGIES [US/US]; 2050
`Center Avenue, Suite 565, Fort Lee, NJ 07024 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): SPENSER, Ben(cid:173)
`jamin [IL/IL]; Havazelet St. 6, Caeserea (IL). BENICHU,
`Netanel [IL/IL]; Nir Etzion N.D., Hof-Carmel (IL).
`BASH, Assaf [IL/lL]; Hasseora St. 1, 37808 Givat Ada
`(IL). ZAKAI, Avraham [IL!IL]; Yair St.
`13, Zichon
`Yaacov (IL).
`
`(54) Title: IMPLANTABLE PROSTHETIC VALVE
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`-- ---i
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`iiiiiii
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`iiiiiiii ----
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`(74) Agent: DIPPERT, William, H.; Reed Smith LLP, 29th
`floor, 599 Lexington Avenue, New York, NY 10022 (US).
`
`(81) Designated States (national): AE, AG, AL, AM, AT, AU,
`AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU,
`CZ, DE, DK, DM, DZ, EC, EE, ES, Fl, GB, GD, GE, GH,
`GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC,
`LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW,
`MX, MZ, NO, NZ, OM, PH, PL, PT, RO, RU, SD, SE, SG,
`SI, SK, SL, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ,
`VN, YU, ZA, ZM, ZW.
`
`(84) Designated States (regional): ARIPO patent (GH, GM,
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW),
`Eurasian patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European patent (AT, BE, BG, CH, CY, CZ, DE, DK, EE,
`ES, Fl, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, SK,
`TR), OAPI patent (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`with international search report
`
`[Continued on next page]
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`QO
`\0
`~ (57) Abstract: A valve prosthesis device (20) is disclosed suitable for implantation in body ducts. The device comprises a support
`....... stent (22), comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheteri(cid:173)
`~ zation through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by
`-..... means of a deployment device ( 48) to a deployed state in the target location, and a valve assembly (28) comprising a flexible conduit
`
`a having an inlet end (24) and an outlet (26), made of pliant material (29) attached to the support beams (23) providing collapsible
`0 fixed length. 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.
`
`slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams (23) of
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.1 of 115
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`

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`W 0 03/04 7 468 A 1
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`1111111111111111111111111111111111111111111111111111111111111111111111111111111111111
`
`For two-letter codes and other abbreviations, refer to the "Guid(cid:173)
`ance Notes on Codes and Abbreviations" appearing at the begin(cid:173)
`ning of each regular issue of the PCT Gazette.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.2 of 115
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`IMPLANTABLE PROSTHETIC VALVE
`
`FIELD OF THE INVENTION
`
`The present invention relates to implantable devices. More particularly, it relates
`
`to a valve prosthesis for cardiac implantation or for implantation in other body ducts.
`
`BACKGROUND OF THE INVENTION
`
`There are several known prosthetic valves that have been previously described.
`
`U.S. Patent No. 5,411,552 (Andersen et al.), entitled VALVE PROSTHESIS FOR
`
`IMPLANTATION IN THE BODY AND CATHETER FOR IMPLANTING SUCH
`
`VALVE PROSTHESIS, discloses a valve prosthesis comprising a stent made from an
`
`expandable cylinder-shaped thread structure comprising several spaced apices. The
`
`elastically collapsible valve is mounted on the stent with the commissural points of the
`
`valve secured to the projecting apices, which prevents the valve from turning inside out.
`
`Deployment of the valve can be achieved by using an inflatable balloon which in its
`
`deflated state is used to carry about it the valve structure to its position and, when
`
`inflated, deploys the stent in position to its final size. See, also, U.S. Patent No.
`
`6,168,614 (Andersen et al.) entitled VALVE PROSTHESIS FOR IMPLANTATION IN
`
`THE BODY and U.S. Patent No. 5,840,081 (Andersen et al.), entitled SYSTEM AND
`
`METHOD FOR IMPLANTING CARDIAC VALVES.
`
`In PCTIEP97/07337 (Letac, Cribier et al.), published as WO 98/29057, entitled
`
`VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS, there is
`
`disclosed a valve prosthesis comprising a collapsible valve structure and an expandable
`
`frame on which the valve structure is mounted. The valve structure is composed of a
`
`valvular tissue compatible with the human body and blood, the valvular tissue being
`
`sufficiently supple and resistant to allow the valve structure to be deformed from a closed
`
`state to an opened state. The valvular tissue forms a continuous surface and is provided
`
`with guiding means formed or incorporated within, the guiding means creating stiffened
`
`zones which induce the valve structure to follow a patterned movement in its expansion to
`
`its opened state and in its turning back to its closed state. The valve structure can be
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.3 of 115
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`extended to an internal cover which is fastened to the lower part of the valve structure to
`
`prevent regurgitation.
`
`There are severallmown methods currently used for replacing aortic valves and
`
`several types of artificial prosthetic devices. Mechanical valves are commonly used in
`
`several different designs (single and double flap) manufactured by well-lmown companies
`
`such as St. Jude, Medtronic, Sulzer, and others. Some of the main disadvantages of these
`
`devices are: a need for permanent treatment of anticoagulants, noisy operation, and a need
`
`for a large-scale operation to implant.
`
`There is a wide range ofbiologicallybased valves made of natural valves or
`
`composed of biological materials such as pericardia! tissue. These too are made and
`
`marketed by well-known companies such as Edwards Lifesciences, Medtronic, Sulzer,
`
`Sorin, and others.
`
`Polymer valves are new and are not yet in use, but several companies are in the
`
`process of developing such products. A new type of prosthesis is being considered, based
`
`on artificial polymer materials such as polyurethane ..
`
`The present invention introduces several novel structural designs for implantable
`
`valves. An aspect of the present invention deals with the possibility of implanting the
`
`valve percutaneously, i.e., inserting the valve assembly on a delivery device similar to a
`
`catheter, then implanting the valve at the desired location via a large blood vessel such as
`
`the femoral artery, in a procedure similar to other known interventional cardiovascular
`
`procedures. The percutaneous deployment procedure and device has an impact on the
`
`product design in several parameters, some of which are explained hereinafter.
`
`The percutaneous implantation of medical devices and particularly prosthetic
`
`valves is a preferred surgical procedure for it involves making a very small perforation in
`
`the patient's skin (usually in the groin or armpit area) under local anesthetic and sedation,
`
`as opposed to a large chest surgery incision, which requires general anesthesia, opening a
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.4 of 115
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`large portion of the chest, and cardiopulmonary bypass. This percutaneous procedure is
`
`therefore considered safer.
`
`The present invention provides a series of new concepts in the field of aortic
`
`valves and other human valves.
`
`SUMMARY OF THE INVENTION
`
`It is therefore thus provided, in accordance with a preferred embodiment of the
`
`present invention, 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 catheterization through the body duct 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.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support stent comprises an annular frame.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly has a tricuspid configuration.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly is made from biocompatible material.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.5 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the valve assembly is made from pericardia! tissue, or other biological tissue.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly is made from biocompatible polymers.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the valve assembly is made from materials selected from the group consisting
`
`of polyurethane and polyethylene terephthalate (PET).
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly comprises a main body made from PET (polyethylene
`
`terephthalate) and leaflets made from polyurethane.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said support stent is made from nickel titanium.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams are substantially equidistant and substantially parallel so as
`
`to provide anchorage for the valve assembly.
`
`Furthermore, in accordance with another preferred 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.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams are chemically adhered to the support stent.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly is riveted to the support beams.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly is stitched to the support beams.
`
`Furthermore, in accordance with another preferred embodiment ofthe present
`
`invention, said beams are manufactured by injection using a mold, or by machining.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly is rolled over the support stent at the inlet.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve device is manufactured using forging or dipping techniques.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.6 of 115
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`Furthermore, in accordance with another preferred 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.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said valve assembly is made from coils of a polymer, coated by a coating layer
`
`of same polymer.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said polymer is polyurethane.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support stent is provided with heavy metal markers so as to enable tracking
`
`and determining the valve device position and orientation.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the heavy metal markers are selected from gold, platinum, iridium, or tantalum.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the valve assembly leaflets are provided with radio-opaque material at the
`
`outlet, so as to help tracking the valve device operation in vivo.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said radio-opaque material comprises gold thread.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the diameter of said support stent, when fully deployed is in the range of from
`
`about 19 to about 25 mm.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the diameter of said support stent may be expanded from about 4 to about 25
`mm.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams are provided with bores and wherein the valve assembly is
`
`attached to the support beams by means ofU-shaped rigid members that are fastened to
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.7 of 115
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`the valve assembly and that are provided with extruding portions that fit into matching
`
`bores on the support beams.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams 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.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the main body of the valve assembly is made from coiled wire coated with
`
`coating material.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the coiled wire and the coating material is made from polyurethane.
`
`Furthermore, in accordance with another preferred 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 line about which the collapsible slack portion of the valve
`
`assembly may :flap.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the strengthening wire is made from nickel titanium alloy.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, there is provided a valve prosthesis device suitable for implantation in body
`
`ducts, the device 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 PET and collapsible leaflets are made form polyurethane.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.8 of 115
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`Furthermore, in accordance with another preferred 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.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, said support beams are chemically adhered to the main body.
`
`Furthermore, in accordance with another preferred 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 catheterization through the body duct 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;
`
`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; and
`
`substantially equidistant rigid support beams interlaced or attached to the slack
`
`portion of the valve assembly material, arranged longitudinally.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, there is provided a crimping device for crimping the valve device described
`
`above or in Claim 1, the crimping device comprising a plurality of adjustable plates that
`
`resemble a typical SLR (Single Lens Reflex) camera variable restrictor, each provided
`
`with a blade, that are equally dispersed in a radial symmetry but each plate moves along a
`
`line passing off an opening in the center, all plates equidistant from that center opening.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.9 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the multiple plates are adapted to move simultaneously by means of a lever and
`
`transmission.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, there is provided a method for deploying an implantable prosthetic valve
`
`device from the retrograde approach (approaching the aortic valve from the descending
`
`aorta) or from the antegrade approach (approaching the aortic valve from the left ventricle
`
`after performing a trans-septal puncture) at the natural aortic 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;
`
`(b)
`
`providing a guiding tool for guiding the balloon catheter in the vasculature
`
`of the patient;
`
`(c)
`
`providing a deployable implantable valve prosthesis device adapted to be
`
`mounted on the second inflatable portion of the balloon catheter;
`
`(d)
`
`for the retrograde approach, 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;
`
`(e)
`
`for the antegrade approach, guiding the balloon catheter through the
`
`patient's greater veins, right atrium, left atrium, and left ventricle 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,
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.10 of 115
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`whereas the second inflatable portion of the balloon catheter is positioned at the natural
`
`aortic valve position;
`
`(f)
`
`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;
`
`(g)
`
`inflating the second inflatable portion of the balloon catheter so as to
`
`deploy the implantable prosthetic valve device in position at the natural aortic valve
`
`position;
`
`(h)
`
`deflating the first and second inflatable portions of the balloon catheter;
`
`and
`
`(i)
`
`retracting the balloon catheter and removing it from the patient's body.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the guiding tool comprises a guide wire.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, there is provided a method for deploying an implantable prosthetic valve
`
`device at the natural aortic 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;
`
`(b)
`
`providing a guiding tool for guiding the balloon catheter in the vasculature
`
`of the patient;
`
`(c)
`
`providing a deployable implantable valve prosthesis device adapted to be
`
`mounted on the first inflatable portion of the balloon catheter, and a deployable annular
`
`stent device adapted to be mounted over the second inflatable portion of the balloon
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.11 of 115
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`catheter, the deployable implantable valve prosthesis device and the deployable annular
`
`stent kept at a predetermined distant 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 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 that the
`
`deployable stent device is deployed within the aorta thus anchoring the deployable
`
`annular stent and the coupled valve device in position;
`
`(f)
`
`inflating the first inflatable portion of the balloon catheter so as to deploy
`
`the implantable prosthetic 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.
`
`Furthermore, in accordance with another preferred embodiment of the
`
`present invention, a valve prosthesis device suitable for implantation in body ducts
`
`comprises:
`
`an expandable support frame, the support frame 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
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.12 of 115
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`flow is prevented as the collapsible slack portions of the valve assembly collapse
`
`inwardly providing blockage to the reverse flow.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support frame comprises a deployable construction adapted to be initially
`
`crimped in a narrow configuration suitable for catheterization through the body duct 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.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams have aU-shaped cross section.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, a holder is used to secure the plaint material to the support beams.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support frame comprises three segments that form a circular assembly
`
`when assembled.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams point inwardly with respect to a central longitudinal axis of
`
`the device.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the device is further provided with a restricting tapered housing, for housing it
`
`in a crimped state.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, hooks are provided to secure the device in position after it is deployed.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the support beams comprise longitudinal bars having a narrow slit used as the
`
`· commissural attachment so that extensions the pliant material are tightly inserted through
`
`it.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.13 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the extensions of the pliant material are wrapped about rigid bars serving as
`
`anchorage means.
`
`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, extensions of the pliant material are sutured to each other at the rigid bars.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, a bottom portion of the pliant material is attached to the inlet.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams are each provided with a rounded pole, forming a loop
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`through which the pliant material is inserted.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the pliant material is provided with longitudinal bars attached to the pliant
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`material at positions assigned for attachment to the support frame, in order to prevent
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`localized stress from forming.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the device is further provided with longitudinal bars having protrusions that are
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`inserted in bores in the pliant material, a sheet of PET and through bores provided on the
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`support beams.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, pliant material is sutured leaving the slack portions free of sutures.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, a connecting member with a split portion is used to connect leaflets of the
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`pliant material to the support beams, the split connecting member compressing the pliant
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`material in position.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, a portion of the connecting member is perpendicular to the split portion.
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`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.14 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support :frame is provided with metallic members coupled to the stent and
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`rigid members are positioned on two opposite sides of the metallic member and held
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`against each other holding portion of the pliant material between them, sutured, the
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`metallic members wrapped with PET.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the device is further provided with spring in order to reduce wear of the pliant
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`material.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the spring is provided with a spiral.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the spring is made :from stainless steel.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the spring is attached to slots provided on the support :frames.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the pliant material is sutured to the support :frame forming pockets.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, attachment bars are provided on the stent support at a portion of the stent close
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`to the outlet, onto which the pliant material is coupled, and wherein the pliant material is
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`attached circumferentially to the inlet, leaving slack pliant material.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the outlet is tapered with respect to the inlet.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support frame at the outlet is wider in diameter than the pliant material
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`forming the outlet.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the pliant material is reinforced using PET.
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`Edwards Lifesciences Corporation, et al. Exhibit 1004, p.15 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support frame is a tube having an inner wall, having sinusoidal fold lines,
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`wherein the pliant material is sutured to the inner wall of the tube along suture lines.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, additional piece of PET is added below the suture lines.
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`Furthermore, in accordance with another preferred embodiment of the present
`
`invention, the device is incorporated with an angioplasty balloon.
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`Finally, in accordance with another preferred embodiment of the present
`
`invention, balloon has a central longitudinal axis that runs along a flow path through the
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`device, and a perimeter, the balloon comprising four inflatable portions, one portion
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`located along a central axis and the other three located on the perimeter, the pliant
`material in the form of leaflets is distributed about the perimeter.
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`BRIEF DESCRIPTION OF THE FIGURES
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`To better understand the present invention and appreciate its practical applications,
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`the following Figures are provided and referenced hereafter. It should be noted that the
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`Figures are given as examples only and in no way limit the scope of the invention as
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`defined in the appended claims.
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`Figure 1 illustrates an implantable prosthetic tricuspid valve in accordance with a
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`preferred embodiment of the present invention, suitable for percutaneous deployment
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`using a stentor similar deploying means, in its deployed-inflated position;
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`Figure 2 depicts an implantable valve according to the present invention mounted
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`over a deploying stent with an inflatable balloon;
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`Figure 3 illustrates an implantable valve according to the present invention
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`mounted over a stent with an inflatable balloon, in a crimped position;
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`Edwards Lifesciences Corporation, et al. Exhibit 100