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`W 0 03/04 7 468 A 1
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`1111111111111111111111111111111111111111111111111111111111111111111111111111111111111
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`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.
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 2 of 115
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`IMPLANTABLE PROSTHETIC VALVE
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`FIELD OF THE INVENTION
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`The present invention relates to implantable devices. More particularly, it relates
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`to a valve prosthesis for cardiac implantation or for implantation in other body ducts.
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`BACKGROUND OF THE INVENTION
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`There are several known prosthetic valves that have been previously described.
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`U.S. Patent No. 5,411,552 (Andersen et al.), entitled VALVE PROSTHESIS FOR
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`IMPLANTATION IN THE BODY AND CATHETER FOR IMPLANTING SUCH
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`VALVE PROSTHESIS, discloses a valve prosthesis comprising a stent made from an
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`expandable cylinder-shaped thread structure comprising several spaced apices. The
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`elastically collapsible valve is mounted on the stent with the commissural points of the
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`valve secured to the projecting apices, which prevents the valve from turning inside out.
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`Deployment of the valve can be achieved by using an inflatable balloon which in its
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`deflated state is used to carry about it the valve structure to its position and, when
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`inflated, deploys the stent in position to its final size. See, also, U.S. Patent No.
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`6,168,614 (Andersen et al.) entitled VALVE PROSTHESIS FOR IMPLANTATION IN
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`THE BODY and U.S. Patent No. 5,840,081 (Andersen et al.), entitled SYSTEM AND
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`METHOD FOR IMPLANTING CARDIAC VALVES.
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`In PCTIEP97/07337 (Letac, Cribier et al.), published as WO 98/29057, entitled
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`VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS, there is
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`disclosed a valve prosthesis comprising a collapsible valve structure and an expandable
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`frame on which the valve structure is mounted. The valve structure is composed of a
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`valvular tissue compatible with the human body and blood, the valvular tissue being
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`sufficiently supple and resistant to allow the valve structure to be deformed from a closed
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`state to an opened state. The valvular tissue forms a continuous surface and is provided
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`with guiding means formed or incorporated within, the guiding means creating stiffened
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`zones which induce the valve structure to follow a patterned movement in its expansion to
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`its opened state and in its turning back to its closed state. The valve structure can be
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 3 of 115
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`extended to an internal cover which is fastened to the lower part of the valve structure to
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`prevent regurgitation.
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`There are severallmown methods currently used for replacing aortic valves and
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`several types of artificial prosthetic devices. Mechanical valves are commonly used in
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`several different designs (single and double flap) manufactured by well-lmown companies
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`such as St. Jude, Medtronic, Sulzer, and others. Some of the main disadvantages of these
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`devices are: a need for permanent treatment of anticoagulants, noisy operation, and a need
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`for a large-scale operation to implant.
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`There is a wide range ofbiologicallybased valves made of natural valves or
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`composed of biological materials such as pericardia! tissue. These too are made and
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`marketed by well-known companies such as Edwards Lifesciences, Medtronic, Sulzer,
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`Sorin, and others.
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`Polymer valves are new and are not yet in use, but several companies are in the
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`process of developing such products. A new type of prosthesis is being considered, based
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`on artificial polymer materials such as polyurethane ..
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`The present invention introduces several novel structural designs for implantable
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`valves. An aspect of the present invention deals with the possibility of implanting the
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`valve percutaneously, i.e., inserting the valve assembly on a delivery device similar to a
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`catheter, then implanting the valve at the desired location via a large blood vessel such as
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`the femoral artery, in a procedure similar to other known interventional cardiovascular
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`procedures. The percutaneous deployment procedure and device has an impact on the
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`product design in several parameters, some of which are explained hereinafter.
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`The percutaneous implantation of medical devices and particularly prosthetic
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`valves is a preferred surgical procedure for it involves making a very small perforation in
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`the patient's skin (usually in the groin or armpit area) under local anesthetic and sedation,
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`as opposed to a large chest surgery incision, which requires general anesthesia, opening a
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 4 of 115
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`large portion of the chest, and cardiopulmonary bypass. This percutaneous procedure is
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`therefore considered safer.
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`The present invention provides a series of new concepts in the field of aortic
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`valves and other human valves.
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`SUMMARY OF THE INVENTION
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`It is therefore thus provided, in accordance with a preferred embodiment of the
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`present invention, a valve prosthesis device suitable for implantation in body ducts, the
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`device comprising:
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`a support stent, comprised of a deployable construction adapted to be initially
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`crimped in a narrow configuration suitable for catheterization through the body duct to a
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`target location and adapted to be deployed by exerting substantially radial forces from
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`within by means of a deployment device to a deployed state in the target location, the
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`support stent provided with a plurality of longitudinally rigid support beams of fixed
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`length; and
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`a valve assembly comprising a flexible conduit having an inlet end and an outlet,
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`made of pliant material attached to the support beams providing collapsible slack portions
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`of the conduit at the outlet,
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`whereby when flow is allowed to pass through the valve prosthesis device from
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`the inlet to the outlet the valve assembly is kept in an open position, whereas a reverse
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`flow is prevented as the collapsible slack portions of the valve assembly collapse
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`inwardly providing blockage to the reverse flow.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support stent comprises an annular frame.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly has a tricuspid configuration.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly is made from biocompatible material.
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 5 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the valve assembly is made from pericardia! tissue, or other biological tissue.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly is made from biocompatible polymers.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the valve assembly is made from materials selected from the group consisting
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`of polyurethane and polyethylene terephthalate (PET).
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly comprises a main body made from PET (polyethylene
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`terephthalate) and leaflets made from polyurethane.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said support stent is made from nickel titanium.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams are substantially equidistant and substantially parallel so as
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`to provide anchorage for the valve assembly.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams are provided with bores so as to allow stitching or tying of
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`the valve assembly to the beams.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams are chemically adhered to the support stent.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly is riveted to the support beams.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly is stitched to the support beams.
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`Furthermore, in accordance with another preferred embodiment ofthe present
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`invention, said beams are manufactured by injection using a mold, or by machining.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly is rolled over the support stent at the inlet.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve device is manufactured using forging or dipping techniques.
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 6 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly leaflets are longer than needed to exactly close the outlet,
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`thus when they are in the collapsed state substantial portions of the leaflets fall on each
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`other creating better sealing.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said valve assembly is made from coils of a polymer, coated by a coating layer
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`of same polymer.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said polymer is polyurethane.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support stent is provided with heavy metal markers so as to enable tracking
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`and determining the valve device position and orientation.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the heavy metal markers are selected from gold, platinum, iridium, or tantalum.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the valve assembly leaflets are provided with radio-opaque material at the
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`outlet, so as to help tracking the valve device operation in vivo.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said radio-opaque material comprises gold thread.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the diameter of said support stent, when fully deployed is in the range of from
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`about 19 to about 25 mm.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the diameter of said support stent may be expanded from about 4 to about 25
`mm.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams are provided with bores and wherein the valve assembly is
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`attached to the support beams by means ofU-shaped rigid members that are fastened to
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 7 of 115
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`the valve assembly and that are provided with extruding portions that fit into matching
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`bores on the support beams.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams comprise rigid support beams in the form of frame
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`construction, and the valve assembly pliant material is inserted through a gap in the frame
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`and a fastening rod is inserted through a pocket formed between the pliant material and
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`the frame and holds the valve in position.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the main body of the valve assembly is made from coiled wire coated with
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`coating material.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the coiled wire and the coating material is made from polyurethane.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, a strengthening wire is interlaced in the valve assembly at the outlet of the
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`conduit so as to define a fault line about which the collapsible slack portion of the valve
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`assembly may :flap.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the strengthening wire is made from nickel titanium alloy.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, there is provided a valve prosthesis device suitable for implantation in body
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`ducts, the device comprising a main conduit body having an inlet and an outlet and pliant
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`leaflets attached at the outlet so that when a flow passes through the conduit from the inlet
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`to the outlet the leaflets are in an open position allowing the flow to exit the outlet, and
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`when the flow is reversed the leaflets collapse so as to block the outlet, wherein the main
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`body is made from PET and collapsible leaflets are made form polyurethane.
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 8 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, support beams made from polyurethane are provided on the main body and
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`wherein the leaflets are attached to the main body at the support beams.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, said support beams are chemically adhered to the main body.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, there is provided a valve prosthesis device suitable for implantation in body
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`ducts, the device comprising:
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`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
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`within by means of a deployment device to a deployed state in the target location, the
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`support stent provided with a plurality of longitudinally rigid support beams of fixed
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`length;
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`a valve assembly comprising a flexible conduit having an inlet end and an outlet,
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`made of pliant material attached to the support beams providing collapsible slack portions
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`of the conduit at the outlet; and
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`substantially equidistant rigid support beams interlaced or attached to the slack
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`portion of the valve assembly material, arranged longitudinally.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, there is provided a crimping device for crimping the valve device described
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`above or in Claim 1, the crimping device comprising a plurality of adjustable plates that
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`resemble a typical SLR (Single Lens Reflex) camera variable restrictor, each provided
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`with a blade, that are equally dispersed in a radial symmetry but each plate moves along a
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`line passing off an opening in the center, all plates equidistant from that center opening.
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 9 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the multiple plates are adapted to move simultaneously by means of a lever and
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`transmission.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, there is provided a method for deploying an implantable prosthetic valve
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`device from the retrograde approach (approaching the aortic valve from the descending
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`aorta) or from the antegrade approach (approaching the aortic valve from the left ventricle
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`after performing a trans-septal puncture) at the natural aortic valve position at the
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`entrance to the left ventricle of a myocardium of a patient, the method comprising the
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`steps of:
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`(a)
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`providing a balloon catheter having a proximal end and a distal end, having
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`a first and second independently inflatable portions, the first inflatable portion located at
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`the distal end of the catheter and the second inflatable portion adjacently behind the first
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`inflatable portion;
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`(b)
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`providing a guiding tool for guiding the balloon catheter in the vasculature
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`of the patient;
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`(c)
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`providing a deployable implantable valve prosthesis device adapted to be
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`mounted on the second inflatable portion of the balloon catheter;
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`(d)
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`for the retrograde approach, guiding the balloon catheter through the
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`patient's aorta using the guiding tool, the valve device mounted over the second inflatable
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`portion of the balloon catheter until the first inflatable portion of the balloon catheter is
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`inserted into the left ventricle, whereas the second inflatable portion of the balloon
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`catheter is positioned at the natural aortic valve position;
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`(e)
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`for the antegrade approach, guiding the balloon catheter through the
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`patient's greater veins, right atrium, left atrium, and left ventricle using the guiding tool,
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`the valve device mounted over the second inflatable portion of the balloon catheter until
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`the first inflatable portion of the balloon catheter is inserted into the left ventricle,
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 10 of 115
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`whereas the second inflatable portion of the balloon catheter is positioned at the natural
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`aortic valve position;
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`(f)
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`inflating the first inflatable portion of the balloon catheter so as to
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`substantially block blood flow through the natural aortic valve and anchor the distal end
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`of the balloon catheter in position;
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`(g)
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`inflating the second inflatable portion of the balloon catheter so as to
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`deploy the implantable prosthetic valve device in position at the natural aortic valve
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`position;
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`(h)
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`deflating the first and second inflatable portions of the balloon catheter;
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`and
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`(i)
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`retracting the balloon catheter and removing it from the patient's body.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the guiding tool comprises a guide wire.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, there is provided a method for deploying an implantable prosthetic valve
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`device at the natural aortic valve position at the entrance to the left ventricle of a
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`myocardium of a patient, the method comprising the steps of:
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`(a)
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`providing a balloon catheter having a proximal end and a distal end, having
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`a first and second independently inflatable portions, the first inflatable portion located at
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`the distal end of the catheter and the second inflatable portion adjacently behind the first
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`inflatable portion;
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`(b)
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`providing a guiding tool for guiding the balloon catheter in the vasculature
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`of the patient;
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`(c)
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`providing a deployable implantable valve prosthesis device adapted to be
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`mounted on the first inflatable portion of the balloon catheter, and a deployable annular
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`stent device adapted to be mounted over the second inflatable portion of the balloon
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 11 of 115
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`catheter, the deployable implantable valve prosthesis device and the deployable annular
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`stent kept at a predetermined distant apart;
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`(d)
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`guiding the balloon catheter through the patient's aorta using the guiding
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`tool, the valve device mounted over the first inflatable portion of the balloon catheter and
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`the deployable annular stent mounted over the second inflatable portion of the balloon
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`catheter, until the first inflatable portion of the balloon catheter is positioned at the natural
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`aortic valve position;
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`(e)
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`inflating the second inflatable portion of the balloon catheter so that the
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`deployable stent device is deployed within the aorta thus anchoring the deployable
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`annular stent and the coupled valve device in position;
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`(f)
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`inflating the first inflatable portion of the balloon catheter so as to deploy
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`the implantable prosthetic valve device in position at the natural aortic valve position;
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`(g)
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`deflating the first and second inflatable portions of the balloon catheter;
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`and
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`(h)
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`retracting the balloon catheter and removing it from the patient's body.
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`Furthermore, in accordance with another preferred embodiment of the
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`present invention, a valve prosthesis device suitable for implantation in body ducts
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`comprises:
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`an expandable support frame, the support frame provided with a plurality of
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`longitudinally rigid support beams of fixed length; and
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`a valve assembly comprising a flexible conduit having an inlet end and an outlet,
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`made of pliant material attached to the support beams providing collapsible slack portions
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`of the conduit at the outlet,
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`whereby when flow is allowed to pass through the valve prosthesis device from
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`the inlet to the outlet the valve assembly is kept in an open position, whereas a reverse
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 12 of 115
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`flow is prevented as the collapsible slack portions of the valve assembly collapse
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`inwardly providing blockage to the reverse flow.
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`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
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`within by means of a deployment device to a deployed state in the target location.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams have aU-shaped cross section.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, a holder is used to secure the plaint material to the support beams.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support frame comprises three segments that form a circular assembly
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`when assembled.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams point inwardly with respect to a central longitudinal axis of
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`the device.
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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 a restricting tapered housing, for housing it
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`in a crimped state.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, hooks are provided to secure the device in position after it is deployed.
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the support beams comprise longitudinal bars having a narrow slit used as the
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`ยท commissural attachment so that extensions the pliant material are tightly inserted through
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`it.
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`Edwards Lifesciences Corporation, et al. Exhibit 1104, Page 13 of 115
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`Furthermore, in accordance with another preferred embodiment of the present
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`invention, the extensions of the pliant material are wrapped about rigid bars serving as
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`anchorage means.
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`Furthermore, in accordance with another preferred embodiment of the present
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`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 1104, Page 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
`
`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 1104, Page 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
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`invention, the device is incorporated with an angioplasty balloon.
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`Finally, in accordance with another preferred embodiment of the present
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`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
`
`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 1104, Page 16 of 115
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`Figure 4 depicts implantable valve deployment in a natural aortic valve position in
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`accordance with the present invention;
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`Figure 5 demonstrates manufacturing a polyurethane implantable valve using a
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`dipping technique according with the present invention;
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`Figures 6a to 6e illustrate manufacturing of an implantable valve by forging
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`according to the present invention;
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`Figures 7a and 7b demonstrate composite valve, which has polyurethane (PU)
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`leaflets and PET tubular-crown shaped construction, according to the present invention;
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`Figures 8a and 8b depict a manufacture process of a composite valve made of
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`flexible PU leaflets, rigid PU construction for mounting and a PET tubular end;
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`Figures 9 to 9i demonstrate different methods of attachment between the valve and
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`stent according to the present invention;
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`Figure 10 illustrates a dipping mandrel with an extra portion, which improves the
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`sealing ability of the valve, according to the present invention;
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`Figures lla to llc illustrate a valve mounted on a stent with an extra support,
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`which improves the force distribution on the valve material and facilitates prolonged
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`durability of the valve, according to the present invention;
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`Figures 12a to 12c depict a valve with rigid supports according to the present
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`invention, located substantially in the center of its leaflets. This design allows the valve
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`leaflets to perform without outer support;
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`Figures 13a to 13c illustrate the manufacturing of a reinforced PU tube composed
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`of strong fiber from PU, PET or other and a softer PU coating, for serving as the
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`supporting structure;
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`Figures 14a to 14c demonstrate incorporation of heavy metal markers on the stent,
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`according to the present invention. These markers allow orientation control while
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`positioning the device at the required location;
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`Figures 15a to 15c demonstrate a valve with radio-opaque coating, according to
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`the present invention, which allows imaging of the valve motion under angiogram;
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`Figures 16a to 16c illustrate a procedure, which helps in accurate positioning the
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`valve device with respect to the longitudinal orientation;
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`Figures 17a and 17b describe a valve device according to the present invention,
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`comprising one valve assembly mounted on a stent and an additional portion with a stent
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`only. This allows placing the device in a way that coronaries are not blocked,
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`longitudinal positioning thus becomes less sensitive and the extra stent decreases the risk
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`of device migration within the vasculature;
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`Figures 18a and 18b demonstrate a crimping device according to the present
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`invention, which can crimp a valve device in the operating theater as part of the
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`implantation procedure;
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`Figures 19a to 19c depict a crimping machine according to the present invention,
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`similar to the one described in figure 18 with a different mechanical method;
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`Figures 20a and 20b demonstrate a valve according to the present invention, made
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`of a tube mounted on a stent. During systole the tube is fully open and during diastole the
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`tube collapses according to the mounting geometry providing tight sealing;
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`Figure 21 depicts a stent structure according to the present invention, with built-in
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`mounting portions of constant length, whi