PATENT ABSTRACT
A prosthetic heart valve comprises a radially crimpable and radially expandable, net-like, annular support frame and a valve assembly disposed therein, the valve assembly comprising a conduit tapering from an inlet towards an outlet thereof. Some embodiments or the support frame comprise a proximal portion and a distal portion, a diameter of the proximal portion smaller than a diameter of the distal portion. The proximal portion is dimensioned for deployment in an annulus of a native aortic valve and a distal portion for deployment in an ascending aorta. Some embodiments of the conduit comprise a support construction with a three-cusp, crown-shaped cut line, the support construction sutured to the support frame around a bottom portion thereof and around the cut line. A method for using the prosthetic heart valve to replace a defective native aortic valve uses a minimally invasive procedure.

PATENT DESCRIPTION
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/529,909, filed Jun. 21, 2012, now U.S. Pat. No. 8,632,586, which is a continuation of U.S. patent application Ser. No. 13/168,016, filed Jun. 24, 2011, which is a continuation of U.S. patent application Ser. No. 11/692,889, filed Mar. 28, 2007, which is a continuation of U.S. patent application Ser. No. 10/637,882, filed Aug. 8, 2003, now U.S. Pat. No. 7,510,575, which is a divisional of U.S. patent application Ser. No. 10/270,252, filed Oct. 11, 2002, now U.S. Pat. No. 6,730,118, which is a continuation-in-part of U.S. patent application Ser. No. 09/975,750, filed Oct. 11, 2001, now U.S. Pat. No. 6,893,460, the disclosures all of which are incorporated by reference in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    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 
       [0003]    There are several known prosthetic valves that have been previously described. U.S. Pat. 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. Pat. No. 6,168,614 (Andersen et al.) entitled VALVE PROSTHESIS FOR IMPLANTATION IN THE BODY and U.S. Pat. No. 5,840,081 (Andersen et al.), entitled SYSTEM AND METHOD FOR IMPLANTING CARDIAC VALVES. 
         [0004]    In PCT/EP97/07337 (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 extended to an internal cover which is fastened to the lower part of the valve structure to prevent regurgitation. 
         [0005]    There are several known 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-known 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. 
         [0006]    There is a wide range of biologically based valves made of natural valves or composed of biological materials such as pericardial tissue. These too are made and marketed by well-known companies such as Edwards Lifesciences, Medtronic, Sulzer, Sorin, and others. 
         [0007]    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. 
         [0008]    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. 
         [0009]    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&#39;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 large portion of the chest, and cardiopulmonary bypass. This percutaneous procedure is therefore considered safer. 
         [0010]    The present invention provides a series of new concepts in the field of aortic valves and other human valves. 
       SUMMARY OF THE INVENTION 
       [0011]    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: 
         [0012]    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 
         [0013]    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, 
         [0014]    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. 
         [0015]    Furthermore, in accordance with another preferred embodiment of the present invention, the support stent comprises an annular frame. 
         [0016]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve assembly has a tricuspid configuration. 
         [0017]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve assembly is made from biocompatible material. 
         [0018]    Furthermore, in accordance with another preferred embodiment of the present invention, the valve assembly is made from pericardial tissue, or other biological tissue. 
         [0019]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve assembly is made from biocompatible polymers. 
         [0020]    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). 
         [0021]    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. 
         [0022]    Furthermore, in accordance with another preferred embodiment of the present invention, said support stent is made from nickel titanium. 
         [0023]    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. 
         [0024]    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. 
         [0025]    Furthermore, in accordance with another preferred embodiment of the present invention, the support beams are chemically adhered to the support stent. 
         [0026]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve assembly is riveted to the support beams. 
         [0027]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve assembly is stitched to the support beams. 
         [0028]    Furthermore, in accordance with another preferred embodiment of the present invention, said beams are manufactured by injection using a mold, or by machining. 
         [0029]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve assembly is rolled over the support stent at the inlet. 
         [0030]    Furthermore, in accordance with another preferred embodiment of the present invention, said valve device is manufactured using forging or dipping techniques. 
         [0031]    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. 
         [0032]    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. 
         [0033]    Furthermore, in accordance with another preferred embodiment of the present invention, said polymer is polyurethane. 
         [0034]    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. 
         [0035]    Furthermore, in accordance with another preferred embodiment of the present invention, the heavy metal markers are selected from gold, platinum, iridium, or tantalum. 
         [0036]    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. 
         [0037]    Furthermore, in accordance with another preferred embodiment of the present invention, said radio-opaque material comprises gold thread. 
         [0038]    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. 
         [0039]    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. 
         [0040]    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 of U-shaped rigid members that are fastened to the valve assembly and that are provided with extruding portions that fit into matching bores on the support beams. 
         [0041]    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. 
         [0042]    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. 
         [0043]    Furthermore, in accordance with another preferred embodiment of the present invention, the coiled wire and the coating material is made from polyurethane. 
         [0044]    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. 
         [0045]    Furthermore, in accordance with another preferred embodiment of the present invention, the strengthening wire is made from nickel titanium alloy. 
         [0046]    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. 
         [0047]    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. 
         [0048]    Furthermore, in accordance with another preferred embodiment of the present invention, said support beams are chemically adhered to the main body. 
         [0049]    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: 
         [0050]    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; 
         [0051]    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 
         [0052]    substantially equidistant rigid support beams interlaced or attached to the slack portion of the valve assembly material, arranged longitudinally. 
         [0053]    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. 
         [0054]    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. 
         [0055]    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: 
         [0056]    (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; 
         [0057]    (b) providing a guiding tool for guiding the balloon catheter in the vasculature of the patient; 
         [0058]    (c) providing a deployable implantable valve prosthesis device adapted to be mounted on the second inflatable portion of the balloon catheter; 
         [0059]    (d) for the retrograde approach, guiding the balloon catheter through the patient&#39;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; 
         [0060]    (e) for the antegrade approach, guiding the balloon catheter through the patient&#39;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, whereas the second inflatable portion of the balloon catheter is positioned at the natural aortic valve position; 
         [0061]    (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; 
         [0062]    (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; 
         [0063]    (h) deflating the first and second inflatable portions of the balloon catheter; and 
         [0064]    (i) retracting the balloon catheter and removing it from the patient&#39;s body. 
         [0065]    Furthermore, in accordance with another preferred embodiment of the present invention, the guiding tool comprises a guide wire. 
         [0066]    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: 
         [0067]    (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; 
         [0068]    (b) providing a guiding tool for guiding the balloon catheter in the vasculature of the patient; 
         [0069]    (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 catheter, the deployable implantable valve prosthesis device and the deployable annular stent kept at a predetermined distant apart; 
         [0070]    (d) guiding the balloon catheter through the patient&#39;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; 
         [0071]    (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; 
         [0072]    (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; 
         [0073]    (g) deflating the first and second inflatable portions of the balloon catheter; and 
         [0074]    (h) retracting the balloon catheter and removing it from the patient&#39;s body. 
         [0075]    Furthermore, in accordance with another preferred embodiment of the present invention, a valve prosthesis device suitable for implantation in body ducts comprises: 
         [0076]    an expandable support frame, the support frame provided with a plurality of longitudinally rigid support beams of fixed length; and 
         [0077]    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, 
         [0078]    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. 
         [0079]    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. 
         [0080]    Furthermore, in accordance with another preferred embodiment of the present invention, the support beams have a U-shaped cross section. 
         [0081]    Furthermore, in accordance with another preferred embodiment of the present invention, a holder is used to secure the plaint material to the support beams. 
         [0082]    Furthermore, in accordance with another preferred embodiment of the present invention, the support frame comprises three segments that form a circular assembly when assembled. 
         [0083]    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. 
         [0084]    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. 
         [0085]    Furthermore, in accordance with another preferred embodiment of the present invention, hooks are provided to secure the device in position after it is deployed. 
         [0086]    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. 
         [0087]    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. 
         [0088]    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. 
         [0089]    Furthermore, in accordance with another preferred embodiment of the present invention, a bottom portion of the pliant material is attached to the inlet. 
         [0090]    Furthermore, in accordance with another preferred embodiment of the present invention, the support beams are each provided with a rounded pole, forming a loop through which the pliant material is inserted. 
         [0091]    Furthermore, in accordance with another preferred embodiment of the present invention, the pliant material is provided with longitudinal bars attached to the pliant material at positions assigned for attachment to the support frame, in order to prevent localized stress from forming. 
         [0092]    Furthermore, in accordance with another preferred embodiment of the present invention, the device is further provided with longitudinal bars having protrusions that are inserted in bores in the pliant material, a sheet of PET and through bores provided on the support beams. 
         [0093]    Furthermore, in accordance with another preferred embodiment of the present invention, pliant material is sutured leaving the slack portions free of sutures. 
         [0094]    Furthermore, in accordance with another preferred embodiment of the present invention, a connecting member with a split portion is used to connect leaflets of the pliant material to the support beams, the split connecting member compressing the pliant material in position. 
         [0095]    Furthermore, in accordance with another preferred embodiment of the present invention, a portion of the connecting member is perpendicular to the split portion. 
         [0096]    Furthermore, in accordance with another preferred embodiment of the present invention, the support frame is provided with metallic members coupled to the stent and rigid members are positioned on two opposite sides of the metallic member and held against each other holding portion of the pliant material between them, sutured, the metallic members wrapped with PET. 
         [0097]    Furthermore, in accordance with another preferred embodiment of the present invention, the device is further provided with spring in order to reduce wear of the pliant material. 
         [0098]    Furthermore, in accordance with another preferred embodiment of the present invention, the spring is provided with a spiral. 
         [0099]    Furthermore, in accordance with another preferred embodiment of the present invention, the spring is made from stainless steel. 
         [0100]    Furthermore, in accordance with another preferred embodiment of the present invention, the spring is attached to slots provided on the support frames. 
         [0101]    Furthermore, in accordance with another preferred embodiment of the present invention, the pliant material is sutured to the support frame forming pockets. 
         [0102]    Furthermore, in accordance with another preferred embodiment of the present invention, attachment bars are provided on the stent support at a portion of the stent close to the outlet, onto which the pliant material is coupled, and wherein the pliant material is attached circumferentially to the inlet, leaving slack pliant material. 
         [0103]    Furthermore, in accordance with another preferred embodiment of the present invention, the outlet is tapered with respect to the inlet. 
         [0104]    Furthermore, in accordance with another preferred embodiment of the present invention, the support frame at the outlet is wider in diameter than the pliant material forming the outlet. 
         [0105]    Furthermore, in accordance with another preferred embodiment of the present invention, the pliant material is reinforced using PET. 
         [0106]    Furthermore, in accordance with another preferred embodiment of the present invention, the support frame is a tube having an inner wall, having sinusoidal fold lines, wherein the pliant material is sutured to the inner wall of the tube along suture lines. 
         [0107]    Furthermore, in accordance with another preferred embodiment of the present invention, additional piece of PET is added below the suture lines. 
         [0108]    Furthermore, in accordance with another preferred embodiment of the present invention, the device is incorporated with an angioplasty balloon. 
         [0109]    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 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. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0110]    To better understand the present invention and appreciate its practical applications, the following Figures are provided and referenced hereafter. It should be noted that the Figures are given as examples only and in no way limit the scope of the invention as defined in the appended claims. 
           [0111]      FIG. 1  illustrates an implantable prosthetic tricuspid valve in accordance with a preferred embodiment of the present invention, suitable for percutaneous deployment using a stent or similar deploying means, in its deployed-inflated position; 
           [0112]      FIG. 2  depicts an implantable valve according to the present invention mounted over a deploying stent with an inflatable balloon; 
           [0113]      FIG. 3  illustrates an implantable valve according to the present invention mounted over a stent with an inflatable balloon, in a crimped position; 
           [0114]      FIG. 4  depicts implantable valve deployment in a natural aortic valve position in accordance with the present invention; 
           [0115]      FIG. 5  demonstrates manufacturing a polyurethane implantable valve using a dipping technique according with the present invention; 
           [0116]      FIGS. 6   a  to  6   e  illustrate manufacturing of an implantable valve by forging according to the present invention; 
           [0117]      FIGS. 7   a  and  7   b  demonstrate composite valve, which has polyurethane (PU) leaflets and PET tubular-crown shaped construction, according to the present invention; 
           [0118]      FIGS. 8   a  and  8   b  depict a manufacture process of a composite valve made of flexible PU leaflets, rigid PU construction for mounting and a PET tubular end; 
           [0119]      FIGS. 9 to 9   i  demonstrate different methods of attachment between the valve and stent according to the present invention; 
           [0120]      FIG. 10  illustrates a dipping mandrel with an extra portion, which improves the sealing ability of the valve, according to the present invention; 
           [0121]      FIGS. 11   a  to  11   c  illustrate a valve mounted on a stent with an extra support, which improves the force distribution on the valve material and facilitates prolonged durability of the valve, according to the present invention; 
           [0122]      FIGS. 12   a  to  12   c  depict a valve with rigid supports according to the present invention, located substantially in the center of its leaflets. This design allows the valve leaflets to perform without outer support; 
           [0123]      FIGS. 13   a  to  13   c  illustrate the manufacturing of a reinforced PU tube composed of strong fiber from PU, PET or other and a softer PU coating, for serving as the supporting structure; 
           [0124]      FIGS. 14 and 14   a  to  14   c  demonstrate incorporation of heavy metal markers on the stent, according to the present invention. These markers allow orientation control while positioning the device at the required location; 
           [0125]      FIGS. 15   a  to  15   c  demonstrate a valve with radio-opaque coating, according to the present invention, which allows imaging of the valve motion under angiogram; 
           [0126]      FIGS. 16   a  to  16   c  illustrate a procedure, which helps in accurate positioning the valve device with respect to the longitudinal orientation; 
           [0127]      FIGS. 17   a  and  17   b  describe a valve device according to the present invention, comprising one valve assembly mounted on a stent and an additional portion with a stent only. This allows placing the device in a way that coronaries are not blocked, longitudinal positioning thus becomes less sensitive and the extra stent decreases the risk of device migration within the vasculature; 
           [0128]      FIGS. 18   a  and  18   b  demonstrate a crimping device according to the present invention, which can crimp a valve device in the operating theater as part of the implantation procedure; 
           [0129]      FIGS. 19   a  to  19   c  depict a crimping machine according to the present invention, similar to the one described in  FIG. 18  with a different mechanical method; 
           [0130]      FIGS. 20   a  and  20   b  demonstrate a valve according to the present invention, made of a tube mounted on a stent. During systole the tube is fully open and during diastole the tube collapses according to the mounting geometry providing tight sealing; 
           [0131]      FIG. 21  depicts a stent structure according to the present invention, with built-in mounting portions of constant length, which allow valve mounting; 
           [0132]      FIG. 22  depicts yet another preferred embodiment a valve assembly in accordance with the present invention, having dilated supports; 
           [0133]      FIGS. 23   a  to  23   e  depict stages in a method of manufacturing an implantable prosthetic valve in accordance with another preferred embodiment of the present invention; 
           [0134]      FIGS. 24   a  to  24   c  illustrate a support frame of an implantable prosthetic valve having means for mounting valve leaflets in accordance with a preferred embodiment of the present invention that can form a tricuspid valve.  FIG. 24   a  depicts an isometric view of the frame, and  FIG. 24   b  depicts a cross-sectional view of the means for mounting a valve leaflet in details, provided with a valve leaflet.  FIG. 24   c  depicts further details of attachment means for the attachment method; 
           [0135]      FIGS. 25   a  to  25   d  illustrate an implantable prosthetic valve in accordance with another preferred embodiment of the present invention.  FIGS. 25   a  and  25   b  depict an isometric view and an upper view of the valve assembly, respectively, and  FIGS. 25   c  and  25   d  illustrate upper views of two optional constructions for the means for mounting leaflets; 
           [0136]      FIGS. 26   a  to  26   c  illustrate a tricuspid valve in accordance with yet another preferred embodiment of the present invention, provided with a self-expandable frame.  FIG. 26   a  is the valve in its fully expanded diameter,  FIG. 26   b  is a tapered tool which assists in inserting the valve into an introducing tube, and  FIG. 26   c  shows the valve assembly inside a restriction tube, ready to be inserted into a introducing sheath; 
           [0137]      FIG. 27  illustrates an isometric view of an implantable prosthetic valve in accordance with another preferred embodiment of the present invention having hooks designated to anchor the valve assembly to body ducts; 
           [0138]      FIG. 28  illustrates a partial view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention. The commissural attachment is showed in details; 
           [0139]      FIGS. 29   a  and  29   b  illustrate an isometric view and an upper cross-sectional view, respectively, of an attachment assembly of a valve&#39;s frame to leaflets in accordance with a preferred embodiment of the present invention; 
           [0140]      FIGS. 30   a  to  30   c  illustrate an isometric view, a cross-sectional view and a flattened view, respectively, of an attachment assembly of a valves frame to leaflets in accordance with another preferred embodiment of the present invention.  FIG. 30   c  is a side view showing two pieces of pericardium before the attachment to the frame; 
           [0141]      FIGS. 31   a  and  31   b  illustrate an exploded view and an isometric view, respectively, of a commissural attachment in accordance with a preferred embodiment of the present invention depicting the attachment technique; 
           [0142]      FIGS. 32   a  through  32   c  illustrate an isometric view of an attachment between leaflets and the frame in accordance with yet another preferred embodiment of the present invention; 
           [0143]      FIGS. 33   a  to  33   d  illustrate different views and portions of an attachment between a pericardium and a frame in accordance with yet another preferred embodiment of the present invention, demonstrating another method of attachment in accordance with the preferred embodiment; 
           [0144]      FIGS. 34   a  to  34   c  illustrate an isometric view of an attachment between a pericardium and a valve in accordance with yet another preferred embodiment of the present invention demonstrating another method of attachment. In  FIGS. 34   b  and  34   c , a deployed portion and the folded portion, respectively, are shown; 
           [0145]      FIGS. 35   a  to  35   c  illustrate an isometric and cross-sectional upper views, respectively, of attachment techniques between a pericardium leaflet and a valve&#39;s frame in accordance with another preferred embodiment of the present invention; 
           [0146]      FIGS. 36   a  and  35   b  illustrate an isometric view of a commissural assembly in accordance with a preferred embodiment of the present invention demonstrating a method of forming one; 
           [0147]      FIGS. 37   a  to  37   c  illustrates a commissural assembly in accordance with another preferred embodiment of the present invention, where the connecting bar functions as a flexible support and has integral attachment means to the frame.  FIG. 37   b  is an isometric view of the connecting bar; 
           [0148]      FIGS. 38   a  to  38   g  illustrate isometric views of flexible commissural supports and the method of attaching them to a pericardium and a frame and valve in accordance with preferred embodiments of the present invention; 
           [0149]      FIGS. 39   a  and  39   b  illustrate an isometric view of a commissural attachment in accordance with yet another preferred embodiment of the present invention, demonstrating the attachment of the pericardium to the support by means of a shaped compressing member; 
           [0150]      FIGS. 40   a  to  40   c  illustrate an isometric view of a bicuspid valve mounted on a frame in accordance with yet another preferred embodiment of the present invention.  FIGS. 40   b  and  40   c  depicts a cross-sectional side view and an isometric view, respectively, of the pericardium that is sutured to a PET tube in the form of pockets; 
           [0151]      FIGS. 41   a  to  41   d  illustrate isometric views of an implantable prosthesis tricuspid valve in accordance with yet another preferred embodiment of the present invention; 
           [0152]      FIGS. 42   a  and  42   b  illustrate an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention, having a different commissural attachment.  FIG. 42   b  depicts the attachment in details; 
           [0153]      FIGS. 43   a  and  43   b  illustrate an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention.  FIG. 43   a  depicts the commissure that are pre-sutured in a tapered shape; 
           [0154]      FIGS. 44   a  to  44   c  illustrate an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention, with additional pieces of PET used for sealing and protecting the pericardium; 
           [0155]      FIGS. 45   a  to  45   d  illustrate an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention, having leaflets sutured to a pre-shaped PET tube and optional leaflet-tube attachments in details; 
           [0156]      FIGS. 46   a  and  46   b  illustrate an exploded view and an upper cross-sectional view of an implantable prosthetic valve assembly in accordance with yet another preferred embodiment of the present invention; 
           [0157]      FIGS. 47   a  to  47   c  illustrate a partial cross-sectional side view of an inflating balloon in accordance with a preferred embodiment of the present invention. The balloon is a part of an implantable prosthetic valve delivery system.  FIGS. 47   b  and  47   c  are cross sectional upper views in the inflated and deflated positions, respectively; and 
           [0158]      FIGS. 48   a  and  48   b  illustrate a partial cross-sectional side view and an upper cross-sectional view of an inflating balloon in accordance with another preferred embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0159]    A main aspect of the present invention is the introduction of several novel designs for an implantable prosthetic valve. Another aspect of the present invention is the disclosure of several manufacturing methods for implantable prosthetic valves in accordance with the present invention. A further aspect of the present invention is the provision of novel deployment and positioning techniques suitable for the valve of the present invention. 
         [0160]    Basically the implantable prosthetic valve of the present invention comprises a leafed-valve assembly, preferably tricuspid but not limited to tricuspid valves only, consisting of a conduit having an inlet end and an outlet, made of pliant material arranged so as to present collapsible walls at the outlet. The valve assembly is mounted on a support structure such as a stent adapted to be positioned at a target location within the body duct and deploy the valve assembly by the use of deploying means, such as a balloon catheter or similar devices. In embodiments suitable for safe and convenient percutaneous positioning and deployment the annular frame is able to be posed in two positions, a crimped position where the conduit passage cross-section presented is small so as to permit advancing the device towards its target location, and a deployed position where the frame is radial extended by forces exerted from within (by deploying means) so as to provide support against the body duct wall, secure the valve in position and open itself so as to allow flow through the conduit. 
         [0161]    The valve assembly can be made from biological matter, such as a natural tissue, pericardial tissue or other biological tissue. Alternatively, the valve assembly may be made form biocompatible polymers or similar materials. Homograph biological valves need occasional replacement (usually within 5 to 14 years), and this is a consideration the surgeon must take into account when selecting the proper valve implant according to the patient type. Mechanical valves, which have better durability qualities, carry the associated risk of long-term anticoagulation treatment. 
         [0162]    The frame can be made from shape memory alloys such as nickel titanium (nickel titanium shape memory alloys, or NiTi, as marketed, for example, under the brand name Nitinol), or other biocompatible metals. The percutaneously implantable embodiment of the implantable valve of the present invention has to be suitable for crimping into a narrow configuration for positioning and expandable to a wider, deployed configuration so as to anchor in position in the desired target location. 
         [0163]    The support stent is preferably annular, but may be provided in other shapes too, depending on the cross-section shape of the desired target location passage. 
         [0164]    Manufacturing of the implantable prosthetic valve of the present invention can be done in various methods, by using pericardium or, for example, by using artificial materials made by dipping, injection, electrospinning, rotation, ironing, or pressing. 
         [0165]    The attachment of the valve assembly to the support stent can be accomplished in several ways, such as by sewing it to several anchoring points on the support frame or stent, or riveting it, pinning it, adhering it, or welding it, to provide a valve assembly that is cast or molded over the support frame or stent, or use any other suitable way of attachment. 
         [0166]    To prevent leakage from the inlet it is optionally possible to roll up some slack wall of the inlet over the edge of the frame so as to present rolled-up sleeve-like portion at the inlet. 
         [0167]    Furthermore, floating supports may be added to enhance the stability of the device and prevent it from turning inside out. 
         [0168]    An important aspect of certain embodiments of the present invention is the provision of rigid support beams incorporated with the support stent that retains its longitudinal dimension while the entire support stent may be longitudinally or laterally extended. 
         [0169]    The aforementioned embodiments as well as other embodiments, manufacturing methods, different designs and different types of devices are discussed and explained below with reference to the accompanying drawings. Note that the drawings are only given for the purpose of understanding the present invention and presenting some preferred embodiments of the present invention, but this does in no way limit the scope of the present invention as defined in the appended claims. 
         [0170]    Reference is now made to  FIG. 1 , which illustrates a general tricuspid implantable prosthetic valve  20  in accordance with a preferred embodiment of the present invention, suitable for percutaneous deployment using an expandable stent or similar deploying means, shown in its deployed position. A valve assembly  28  comprises a conduit having an inlet  24  and an outlet  26 , the outlet walls consisting of collapsible pliant material  29  that is arranged to collapse in a tricuspid arrangement. The valve assembly  28  is attached to an annular support stent  22 , the one in this figure being a net-like frame designed to be adapted to crimp evenly so as to present a narrow configuration and be radially deployable so as to extend to occupy the passage at the target location for implantation in a body duct. Support beams  23  are provided on annular support stent  22  to provide anchorage to valve assembly  28 . Support beams  23  are optionally provided with bores  25  to allow stitching of valve assembly  28  to support beams  23  by thread, wires, or other attachment means. 
         [0171]    In the embodiment shown in  FIG. 1 , a cuff portion  21  of the valve assembly  28  is wrapped around support stent  22  at inlet  24  to enhance the stability. Preferably cuff portion  21  of valve material  28  is attached to support beams  23 . 
         [0172]    Note that the entire valve structure is adapted to be radially crimped and radially expanded, and this lends to provide ease of navigation through narrow passages in the vasculature during positioning of the device and adequate deployment on the final location. This is made possible by the provision of a collapsible support stent structure. However, the support beams remain at all times constant at their length and thus are suitable for serving as the pliable valve assembly&#39;s anchorage. The valve assembly is attached to the support stent at the support beams, and due to their constant length there is no need for slack material as the attachment points ( 25 ) remain at constant distances regardless of the position of the valve device (crimped or deployed). This is an important feature for this means that the manufacturer of the valve device can make sure the valve assembly is secured and fastened to the support stent at all times. In prior art implantable valve devices the entire support structure changes its dimensions from its initial first crimped position and final deployed position, and this means that in the attachment of the valve assembly to the support structure one must take into consideration these dimension changes and leave slack material so that upon deployment of the device the valve assembly does not tear or deform. In the valve device of the present invention there is no relative movement between the valve assembly and the support beams (along the longitudinal central axis of the device). As a result, the valve device of the present invention acquires greater durability and is capable of withstanding the harsh conditions prevailing within the vasculature and especially the millions of cycles of stress applied by the blood pressure. 
         [0173]    The fixed attachment of the valve assembly to the support stent in the valve device of the present invention results in greater stability, enhanced safety, better sealing and consequently longer lifespan. The novel design of the valve device of the present invention leads to longitudinal strength and rigidity whereas its collapsible support structure results in radial flexibility. 
         [0174]      FIG. 2  depicts an implantable valve  30  mounted on a deployable stent  32 . The valve assembly  34  is attached to the deployable support stent  32  (dotted lines) along three substantially equidistant and substantially parallel support beams  40  of constant length, which are part of stent  32 . The attachment of valve assembly  34  to stent  32  is facilitated by the support beams  40  to which valve assembly  34  is stitched with thread or fiber  46  (through bores  42  of support beams  40 ). Outlet leafs  38 , which are a slack portion of the valve assembly, dangle inwardly, and the whole device is carried by an inflatable balloon  48 , which serves as the deploying device. A portion of the valve assembly  34  at an inlet zone  45  is optionally rolled over support stent  32  at the inlet, making up a rolled sleeve, which enhances the sealing of the device at the valve inlet. 
         [0175]      FIG. 3  demonstrates an implantable valve mounted to a stent  50  with an inflatable balloon  52 , in a crimped position. The support stent  50  is initially crimped about the balloon  52  so that is presents a narrow cross-section and is thus suitable for percutaneous catheterization and deployment. 
         [0176]      FIG. 4  depicts an implantable valve deployment in a natural aortic valve position. The implantable valve is advanced while mounted over the balloon  52  until it reaches the desired target location  54  in a body duct, for example, aorta  56 . The balloon is inflated and the support stent  50  expands radially to take up its position. 
         [0177]      FIG. 5  demonstrates the manufacture of a polyurethane valve in a dipping technique. A dipping mandrel  60  is provided with a tubular portion  62  with surfaces  64  that correspond to the collapsible valve leaflets to be manufactured. Mandrel  60  is dipped into a dissolved polyurethane bath  66  and is coated with a polyurethane coating in the desired form of the valve. Then, after the polyurethane coating has hardened sufficiently, the completed valve is removed from mandrel  60 . 
         [0178]      FIGS. 6   a  to  6   e  illustrate manufacturing an implantable valve by forging. A suitable tubularly shaped material  74  is placed tightly on a tubular portion  68  of mandrel  67 , covering the cusp portion  69 . Flexible inserts  76  are pressed to mandrel  67 , forging the tubular material to mandrel shape  80 . A tapered ring  70  holds the flexible inserts in place as the whole mold is placed in a hot oven regulated to a desired temperature, which is lower than the material&#39;s melting point.  FIG. 6   e  illustrates a sectional side view of the mandrel and a cross cut portion of the mold. The mold is made to press inwardly on the mandrel, which is covered with the valve material. As a result the material takes up the desired shape. The materials used can vary, for example, polyurethane (PU), polyethylene terphthalate (PET), or any other suitable material, which may be formed by heating. 
         [0179]      FIGS. 7   a  and  7   b  demonstrate a method of manufacturing a composite valve, which has PU leaflets and PET tubular construction with a crown shape. PU is an excellent fatigue resistant material but is sensitive to tear. The PU is reinforced by the PET crown to allow safe attachment to a stent by means of stitching, riveting, or any other suitable attachment method. A PET crown  86  is placed on a mandrel  87 , which is then (turned and) dipped in a container of dissolved PU. The manufactured device is a valve assembly having leaflets  88  composed of pure PU, and thus fatigue resistant, and a main body made of PET with protruding attachment portions  90  suitable for attachment built in the PU. 
         [0180]      FIGS. 8   a  and  8   b  demonstrate a method of manufacturing a composite valve, which is based on flexible PU  92  for as the main body of the valve, rigid PU support beams  94  serving for the attachment area, and PET sleeve  96  portions for the valve inlet. The need for a rigid portion for attachment (support beams  94 ) is explained by the tendency of the flexible, fatigue resistant material to tear as already explained. The advantage of the stiff PU support beams is that they are chemically adhered to the main body, and this improves the overall durability of the valve due to reduction of inner forces and friction in the attachment area specially attachment between two different materials. The valve is dipped in the method mentioned with reference to  FIG. 5 , and the rigid PU support beam  94  is created by way of mold injection, machining or any other suitable way. The rigid PU support beam  94  is placed on the valve and then dipped into the container of dissolved PU. This is done while the valve is positioned on the mandrel (not shown). This method provides the ability to composite several materials into one body and, by that, gain the advantage of the various properties of the materials as they are needed in different areas of the prosthesis. 
         [0181]      FIGS. 9 to 9   i  demonstrate different methods of attachment between a valve assembly and the support stents. A valve assembly  99  shown in  FIG. 9  is incorporated into valve  100  shown in  FIG. 9   a , where a support stent  102  is attached to valve assembly  99  through support beam  106 . A detail is shown in  FIG. 9   b , where, in cross-section, it can be seen that layer  108  is an optional inner support made of stainless steel or rigid polymeric material, valve assembly  99  comprises a PET layer  105  coated with a PU layer  104 , with the outer support beam  106 . Connector  107  is a connecting wire made of a strong material, such as stainless steel.  FIG. 9   c  illustrates an alternative arrangement for attachment by a rivet  109 , and in  FIG. 9   d  the attachment is achieved by a suture  110 . 
         [0182]      FIGS. 9   e  to  9   g  show an attachment method comprising shaped rigid members  116 , preferably made from metal, which tightly hold the PU valve material  118  by fitting in between a PU U-shaped nest  120  and are attached to a stent  122  by extruding portions  124  that are provided on U-shaped rigid member  116 , which fit the bores  126  of the support beam  128  of the stent  122 .  FIGS. 9   h  and  9   i  show another attachment method, where rigid support beams in the form of frame construction  132  are provided, and the valve assembly pliant material  135  made of a tubular material is inserted through a gap  137  in the frame. After insertion, a fastening rod  133  is inserted through the pocket formed between the pliant material and the frame and holds the valve in position. 
         [0183]      FIG. 10  illustrates a dipping mandrel  139  with an extending portion  141 , which improves the sealing ability of the valve. Since the valve is attached to a collapsible stent and is itself collapsible, it is difficult to determine the exact shape of the valve after crimping and deploying. It is of major importance that sealing will be achieved. By adding the extension  141  the leaflets are made longer than needed to exactly close the outlet, and therefore when they are in the collapsed state, substantial portions of the leaflets fall on each other creating better sealing. 
         [0184]      FIGS. 11   a  to  11   c  illustrate a valve assembly mounted on a support stent  144  with interlaced strengthening wire  146 , which improves the force distribution on the valve material and facilitates prolonged durability of the valve. The support is in the form of a wire, which has a crown shape as the shape of the three cusp valve base  148 , it also has the ability to be crimped  150  to a small diameter, together with the stent, valve and balloon, as shown in  FIG. 11   b . The forces applied to the valve edge  148  while working, are applied to the attachment points, by making the attachment line longer we reduce the force on each attachment point. In this support method the valve is attached by suturing  152  the entire line to the extra support wire  146 . This wire can be made of stainless steel, nickel titanium alloy such as nitinol, or polymeric material. The support suture renders the valve assembly default fault lines where the valve material more readily flexes, thus ensuring proper operation of the valve flaps (leaflets). Optionally the valve assembly shown in  FIGS. 11   a  to  11   c  can be mounted on a support stent such as the one described herein or similar supporting structures. The 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  154  of the valve assembly may flap. 
         [0185]      FIGS. 12   a  to  12   c  depict a valve device provided with a stent  159  and substantially equidistant rigid support beams  160 , interlaced or attached to the slack portion of the valve assembly material  161 , arranged longitudinally. This design allows the valve leaflets to perform without outer support. The support in standard valves is by tying the upper edge of the cusp to a rigid embodiment, so that it reacts to the load as a suspension bridge. In this new design the prevention of collapsing is achieved similar to an Indian tent, i.e., the rigid supports lean on each other  162  when the valve is closed but do not interfere in opening  164  when the valve is open. 
         [0186]      FIGS. 13   a  to  13   c  illustrate the manufacturing of a valve assembly in accordance with another preferred embodiment of the present invention. At first a polyurethane thread line  170  is fed from a PU supply  172 , and coiled around a cylindrical drum  174  to form coil  176 . Then, drum  174  with coil  176  is dipped in a PU bath  177 , and a second layer  178  of the PU coats coil  176 , making it a stronger construction capable of withstanding tearing forces both laterally and in other directions. Incorporating two different types of materials—such as PU and PET—may render greater durability and endurance to the valve assembly. This material is an alternative material to be used in the forging method shown in  FIG. 6 . 
         [0187]      FIGS. 14 to 14   c  demonstrate the incorporation of heavy metal markers on the stent, which markers allow observation and thereby adjustment of orientation while placing the device in the required location. Heavy metals are radiopaque, that is, they are conspicuous on an angioscopic image, which is a two-dimensional image. Since the coronary artery ostia  237  and  238  are located near the typical valve deployment location and must stay open, it is extremely important to make sure that the deployed valve assembly is not blocking a coronary ostium. In some cases the stent is lower than the ostium and in those cases it will stay open, but in some cases as shown in these figures it is necessary to make sure that the stent portion  239  that is connecting the valve supports  235  is opposite the coronary ostia, and in that way the blood supply is preserved through the stent struts. Two heavy metal markers  232  are attached at the outlet side, one marker  230  at the inlet side. It is possible to adjust the angiogscopic view to the plane of the left coronary as shown in  FIG. 14   b  and anatomically locate the other accordingly. If the two upper markers  232  are placed in the radiographic two dimensional image, one on top of the other, and the low marker  230  on the opposite side, we make sure that the coronaries are open to blood flow as seen in  FIG. 14   c . Gold, platinum, iridium or tantalum are all biocompatible materials suitable for the markers described above. 
         [0188]      FIGS. 15   a  to  15   c  illustrate a valve with a portion of radio-opaque material  267  such as a thread of gold at the sealing edge. When a valve is implanted, it is very important to have clear indications of how the valve is functioning in vivo; pressure measurements, flow visualization, and doppler measurements are utilized. It is also possible to examine the valve by ultrasound methods, however, observing the opening and closing of the valve cusps on a monitor.  FIG. 15   b  is an angiographic image  268  of the open valve, while image  169  in  FIG. 15   c  is the closed position as seen on the angiogram. 
         [0189]      FIGS. 16   a  to  16   c  illustrate a procedure, which helps in placing the device in the longitudinal position. It is very important to place the device in the correct longitudinal position, for if it is too deep in the left ventricle it may interfere with the mitral valve function by improper closing or function of the valve. If it is positioned too high it may migrate, it may leak via the sinus cavities, which are located around it, and/or it may block the coronaries. It is a necessary task to position the valve prosthesis in a narrow target location. In  FIG. 14  a method of lateral orientation placement is shown, and  FIGS. 16   a  to  16   c  illustrate a longitudinal positioning. The valve device (the valve assembly and the support stent) is placed on an inflatable balloon catheter, comprising double independently inflatable chambers  303 ,  305 , and is inserted into the left ventricle  302  in the crimped position and guided over a guiding stylet or guide wire  300 . The balloon, which is larger than the annulus diameter when inflated, is inflated in the left ventricle  302 , and then the whole device is pulled slightly backwards. The balloon is supported on the inner part of the annulus  303 , allowing positioning of the device in the exact desired position. In addition, it temporarily blocks the blood flow, and that improves the ability to hold the device in place while inflating it. The next step is inflating the second balloon  305 , which deploys the valve device in the desired location. 
         [0190]    The 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, as depicted in  FIGS. 16   a ,  16   b  and  16   c , comprises the steps of: 
         [0191]    (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; 
         [0192]    (b) providing a guiding tool for guiding the balloon catheter in the vasculature of the patient; 
         [0193]    (c) providing a deployable implantable valve prosthesis device adapted to be mounted on the second inflatable portion of the balloon catheter 
         [0194]    (d) guiding the balloon catheter through the patient&#39;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; 
         [0195]    (e) inflating the first inflatable portion of the balloon catheter so as to substantially block blood flow through the natural aortic valve and anchor the distal end of the balloon catheter in position; 
         [0196]    (f) 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; 
         [0197]    (g) deflating the first and second inflatable portions of the balloon catheter; and 
         [0198]    (h) retracting the balloon catheter and removing it from the patient&#39;s body. 
         [0199]      FIGS. 17   a  and  17   b  describes a positioning of a valve device  310  using an additional deployable stent  320 . There are several problems that may be encountered while deploying the stent and valve in the aortic valve location: blockage of coronaries may occur that is dangerous if the diameter of the stent is similar to that of the coronaries aortic root  309 . Secondly, migration of the whole device may also occur, which is a dangerous possibility, and there is the problematic challenge of exact positioning of the valve device that is very difficult to accomplish, as already explained. The newly special designed device with a double diameter inflatable balloon and double stent design allows placement of the device in a way that coronaries will not be blocked because of a safe difference that is kept between the diameters, longitudinal placing is less sensitive because of the small diameter which ensures prevents over expansion of the valved prosthesis. The distal stent  320 , which contains no valve, is expanded into the ascending aorta, while the proximal stent  310  is placed simultaneously in the annular position. This placement method is less challenging due to the smaller diameter of the proximal stent  310  which ensures that the mitral valve is not deformed by over-expansion as the dimensions are preserved, and the additional stent decreases the risk of device migration. It is safer to over dilate in the aorta, which is not true for the annulus. 
         [0200]    The 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, as depicted in  FIGS. 17   a  and  17   b , comprises the steps of: 
         [0201]    (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; 
         [0202]    (b) providing a guiding tool for guiding the balloon catheter in the vasculature of the patient; 
         [0203]    (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 catheter, the deployable implantable valve prosthesis device and the deployable annular stent kept at a predetermined distant apart; 
         [0204]    (d) guiding the balloon catheter through the patient&#39;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; 
         [0205]    (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; 
         [0206]    (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; 
         [0207]    (g) deflating the first and second inflatable portions of the balloon catheter; and 
         [0208]    (h) retracting the balloon catheter and removing it from the patient&#39;s body. 
         [0209]      FIGS. 18   a  and  18   b  illustrate an accessory crimping device that is adapted to crimp a valve device in the operating theater as part of the implantation procedure. The crimping device  330  comprises several adjustable plates that resemble a typical SLR camera variable restrictor. It is comprised of simultaneously movable plates  332  each provided with a blade  334 , 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  336 . Initially (see  FIG. 18   a ) the plates are drawn apart providing a large enough opening for the implantable valve to be positioned within that opening. When the plates are drawn towards the center (see  FIG. 18   b ), the opening  336  reduces in size but still retains the annular shape, and this facilitates the crimping of the valve frame to a small dimension suitable for percutaneous positioning. 
         [0210]      FIG. 19   a  depicts a crimping method for the support stent of the valve prosthesis device of the present invention, whereby stent  340  is crimped, that is, compressed or curled. In  FIG. 19   b  a crimping device  343  is shown, comprising a body having an annular void in which an expanded stent is positioned. Lever  346  is connected to the end  347  of the stent and as the lever is pulled the stent is curled or compressed about axle  345  into a compressed position  349  ( FIG. 19   c ). 
         [0211]      FIGS. 20   a  and  20   b  depict a valve made of a simple tube mounted to a stent  352 . During systole period the tube is fully open and during diastole period the tube collapses according to the mounting geometry  357  and achieves sealing. 
         [0212]      FIG. 21  describes a newly designed support stent  360  in its open position. Three of the longitudinal struts  362  are full and thick and always stay with their original constant size, serving as anchoring support. Each of these struts  362  is provided with a plurality of bores  364 , which are later used for mounting the valve assembly (not shown) and tying it to stent  360 . Between struts  362  a web-like construction is provided, which is capable of being crimped to a narrow state and capable of being deployed again to a wider state. 
         [0213]      FIG. 22  illustrates another preferred embodiment of an implantable prosthetic valve according to the present invention. It comprises a metal tube  370 , having three portions with a thicker wall  371  than in the rest of the tube  370 , these areas form the longitudinal columns  372  in the construction, after the tube is cut to its final form. The advantage of such a construction is in its superior bending strength, in specific required portions of the construction, with minimal interference to the crimped volume of the whole construction. 
         [0214]      FIGS. 23   a  to  23   c  depict a new method of manufacturing an artificial or biological crimpable valve device. A piece of fabric material  370  ( FIG. 23   a ), is dipped in PU to create a portion which is later formed into valve leaflets  371  ( FIG. 23   b ). This composite material  371  is then attached to an additional piece of fabric such as PET  372  by means of stitching, suturing or other attaching technique  373  ( FIG. 23   c ). The resulting fabric  375  is cut along stitching line  373  leaving enough material to later suture the valve assembly to the support construction. It is then formed to a tubular shape and stitched  374  ( FIG. 23   d ). The tubular valve is then attached to a support construction  380  by suturing the bottom part around the valve  379  tightly to prevent leakage, and around the cut fabric line  376  ( FIG. 23   e ). This open wall structure  378  allows blood flow to the coronary arteries. The valve is later placed with the coronary artery between the support columns  385 . Additional variations of this can be made by replacing the composite material  371 / 370  with a biological patch such as a suitable pericardium patch. In some cases it is possible to make the same valve without cutting the fabric  372  with the shaped cut  376 , and by that create a valve with an outer tubular shape. The embodiment of  FIGS. 23   a  to  23   c  is easy to manufacture as it is generally flat throughout most of the production process and only at the final stage of mounting on the support stent is it given a three-dimensional form. 
         [0215]    Reference is now made to  FIG. 24   a  illustrating a frame of an implantable prosthetic valve having means for mounting valve leaflets in accordance with a preferred embodiment of the present invention that can form a tricuspid valve.  FIG. 24   a  depicts an isometric view of the frame and  FIG. 24   b  depicts a cross sectional view of the means for mounting valve leaflets  430  in detail. A frame  420 , which is suitable for crimping and expanding, has three support beams  422  for mounting leaflets positioned substantially symmetrically about the circumference of the frame. Frame  420  is shown in  FIG. 24   a  in its deployed state. Support beam  422  has a “U” shaped lateral cross section, or profile (shown clearly in  FIG. 24   b ) that is designed to attach to a commissure of the valve structure. The “U” shape can be produced by extrusion, wire cutting or by welding the “U” profile to the frame&#39;s struts  421  at junction points  424 . Support beam  422  is provided with a series of bores  425  positioned along its back wall. Bores  425  are designated for stitching the valve assembly by threads, wires, or other attaching means. 
         [0216]      FIG. 24   b  is a detailed cross-sectional view of one of the support beam  422 . Two pericardial leaflets  430  are inserted through a U-shaped, or forked holder  428  that compresses and restricts the leaflets in the U-shaped profile. Leaflets  430  are folded to both sides of the support beam  422 . When holder  428  is compressed toward the support beam  422 , leaflets  430  are caught in-between holder  428  and support beam  422  so that the leaflets are kept in place.  FIG. 24   c  is an exploded view of the holder, bar  426  has a series of bores compatible for attachment to the frames support beam  422 , attachment being achieved by suture  423  or any other attachment means. This attachment method allows attaching the leaflets to the frame without puncturing it with sutures and needles. It is also important that the leaflets are firmly held in place by the holder  428  so that it has no relative movement in respect to the rigid frame; hence avoiding wear due to movements. Leaflets that are made from pericardium are known to better withstand inner movements and stresses and less to wear by movement against rigid, hard or sharp bodies. 
         [0217]    It is noted again that the entire valve structure is adapted to be radially crimped and radially expanded. This feature imparts the valve with the ability and ease to navigate through narrow passages in the vasculature during positioning of the device. After final positioning of the valve, the valve is deployed. This is made possible by the provision of a collapsible support frame structure. However, the length of the attaching means (the height of the valve) remains at all times constant; thus suitable for serving as the pliable valve assembly&#39;s anchorage. The leaflets are attached to the support frame at the attaching means, and due to their constant length there is no need for slack material as these attachment points that remain at constant distances regardless of the position of the valve assembly (crimped or deployed). This is an important feature for this means that the manufacturer of the valve device can make sure the valve assembly is secured and fastened to the support frame at all times. In prior art implantable valve devices, the entire support structure changes its dimensions from its initial first crimped position to final deployed position and this means that in the attachment of the valve leaflets to the support structure one must take into consideration these dimension changes and leave slack material so that upon deployment of the device, the valve assembly does not tear or deform. In the valve device of the present invention there is no relative movement between the valve leaflets and the support beams (along the longitudinal central axis of the device). As a result, the valve device of the present invention acquires greater durability and is capable of withstanding the harsh conditions prevailing within the vasculature and especially the millions of cycles of stress applied by the blood pressure. 
         [0218]    The fixed attachment of the valve leaflets to the support frame in the valve assembly device of the present invention renders it greater stability, enhanced safety, better sealing and consequently longer lifespan. The novel design of the valve device of the present invention renders it longitudinal strength and rigidity whereas its collapsible support structure renders it radial flexibility. 
         [0219]      FIGS. 25   a  to  25   d  illustrate an implantable prosthetic valve in accordance with another preferred embodiment of the present invention.  FIGS. 25   a  and  25   b  depict an isometric view and an upper view of the valve assembly, respectively and  FIGS. 25   c  and  25   d  illustrate upper views of two optional constructions for the means for mounting leaflets. Pericardial leaflets  430  are mounted on a deployable support frame  432 . The frame is preferably made of three segments that form a circular support frame when assembled ( FIG. 25   b ). Pericardial leaflets  430  are attached to deployable support frame  432  along three substantially equidistant and substantially parallel beams  440 , which are integral parts of support frame  432 . Leaflets  430  are attached to support frame  32  at support beams  440  by suturing  446  leaflets  446  to support beams  440  through bores  442  in beams. The frame segments that are preferably made from stainless steel are pre-shaped  432  and can be formed in different ways.  FIG. 25   c  illustrates support frame segments  432   a  having beams  435   a  pointing inwardly.  FIG. 25   d  illustrates support frame segments  432   b  having beams  435   b  that are outwardly pointing. The advantages of this technique are the possibility to manufacture the frame segments from sheets (as opposed to tube) and the ease of assembly of the frame segments with the pericardial leaflets. 
         [0220]      FIGS. 26   a  to  26   c  illustrate a tricuspid valve in accordance with yet another preferred embodiment of the present invention, provided with a self-expandable frame.  FIG. 26   a  is an isometric view of an implantable prosthetic valve  430  mounted on a self-expandable frame  445 . Implantable prosthetic valve  430  comprised of three valve leaflets is mounted on self-expandable frame  445  so that each leaflet extends along an equidistant portion of the frame and is sutured at both opposite sides to substantially equidistant and substantially parallel beams  440 . By using a tapered tube  448  the whole assembly is crimped into a restriction tube  449 .  FIG. 26   b  shows the crimped valve assembly  447  in its final crimped diameter ready for insertion to the body. After insertion into the desired location in the body the valve is released from the restriction tube and as it is made of self expandable material (like a shape-memory alloy), it expands back to the original diameter and is anchored in place. In order to reduce the diameter of the device from its fully expanded diameter to its crimped diameter a special tapered tube is used, shown in  FIG. 26   c.    
         [0221]      FIG. 27  illustrates an isometric view of an implantable prosthetic valve in accordance with another preferred embodiment of the present invention having hooks designated to anchor the valve assembly to body ducts. An implantable prosthetic valve  450  is placed in a natural aortic valve position  452 . Implantable prosthetic valve  450  comprises preferably three leaflets  430  mounted on a metallic support frame  455 . The lower part of support frame  455  is provided with attachment means, preferably with hooks  453 . Hooks  453  assures that the valve assembly stays in place after deployment, and cannot migrate to another position. 
         [0222]      FIG. 28  illustrates a partial view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention. The commissural attachment is shown in details. This figure demonstrates an attachment technique that is used in order to attach pericardium leaflet  430  to a metallic frame  420 . A longitudinal bar  456  having a narrow slit  457  is used as the commissural attachment so that extensions  463  of pericardium leaflet  430  are tightly inserted through slit  457 . Pericardium extensions  463  that are extended beyond slit  457  are wrapped about a rigid bar  458  that acts as an anchoring means. Every two extensions originating from two sides of slit  457  are sutured to each other by a suture  459  at the side of rigid bar  458  opposite the slit. An additional suture  462  attaches the bottom circumference of support frame  420  to leaflet  420  in order to obtain sealing. The advantages of the described attachment are that no sutures or suture holes are applied in the leaflet working area, there are no concentrated stress points similar to stress point caused by suturing, and the force distribution is along the longitudinal bar  456 . The narrow passage that is maintained through slit  457  forces the leaflets to be static in respect to the support so as to reduce abrasion. 
         [0223]    The embodiments that will be shown herein after are optional configurations of attachment between the leaflets and the support frame. 
         [0224]      FIGS. 29   a  and  29   b  illustrate an isometric view and an upper cross sectional view, respectively, of an attachment assembly of a valve&#39;s frame to leaflets in accordance with a preferred embodiment of the present invention. The attachment is similar in principle to the attachment shown in  FIG. 28 , however, longitudinal bar  456  is further provided with an additional pole  465  that is attached to longitudinal bar  456  so as to establish an integral part. Pole  465  is rounded so as to make sure the leaflets will not be abraded or cut by sharp corners. In the cross sectional view shown in  FIG. 29   b , adjacent leaflets  460  can be seen compressed together and the main protection goal is clearly shown. 
         [0225]      FIGS. 30   a  to  30   c  illustrate an isometric view, a cross-sectional view and a flatten view, respectively, of an attachment assembly of a valves frame to leaflets in accordance with another preferred embodiment of the present invention. Using the method demonstrated in  FIGS. 30   a  to  30   c , the pericardial leaflets are pre-cut to the desired shape  430  and are provided with longitudinal bars  470  that are sutured to the leaflets creating a longitudinal clamping effect ( FIG. 30   c ). This allows distribution of forces along the whole length of the attachment means as opposed to concentrating the stresses in suture holes. In  FIGS. 30   a  and  30   b , an additional rigid portion  458  is added, creating a round ending, which prevents the leaflets from being bent drastically at the attachment point to portions of the frame  420 . The attachment to frame  420  is performed using sutures  459 . 
         [0226]      FIGS. 31   a  and  31   b  illustrate an exploded view and an isometric view, respectively, of a commissural attachment in accordance with a preferred embodiment of the present invention depicting the attachment technique. A method of assembling pericardial leaflets  430  to a frame  420  is demonstrated. A rigid bar  476  provided with integral protrusions  478  is inserted through bores  479  that are pre-cut in pericardial leaflets  430 . Integral protrusions  478  pass through a sheet of preferably PET (braided polyester) fabric  475 , and finally through bores  442  that are provided in longitudinal bar  440  (the attachment means) of frame  420 . After the assembling of the parts, as shown in  FIG. 31   b , the parts are tightly assembled and bar protrusions  478  are attached to bar  440  by welding, riveting or any other technique. The PET sheet  475  is folded and sutured tightly around bar  476  using suture  472 . 
         [0227]      FIGS. 32   a  to  32   c  illustrate an isometric view of an attachment between leaflets and the frame in accordance with yet another preferred embodiment of the present invention. An optional method of attachment is demonstrated, in which a pericardium leaflet  430  and bars  480  are sutured in an area as far as possible from the working area of the leaflets. The pericardium is first sutured using a suture  484  to bar  480  as seen in  FIG. 32   b , and then folded and compressed. In order to firmly hold the pericardial leaflets in place between bars  480 , an integral connecting member  482  connects the two bars, allowing the bent portions of the bars to be in parallel position, with the leaflets caught in between. Then, an additional suture  483  connects the bottom side of the bar to the leaflets so that while the valve is working, the leaflets do not bear high stresses. 
         [0228]      FIGS. 33   a  to  33   d  illustrate different views of portions of an attachment between a pericardium and a frame in accordance with yet another preferred embodiment of the present invention, demonstrating another method of attachment in accordance with the preferred embodiment. A connecting member  490  (shown in a deployed position in  FIG. 33   d ) is used to connect two pericardial leaflets  492  at the line of the commissurel. After being connected between them, pericardial leaflets  492  are being connected to frame bar  480 . Here again, the principal of compressing the leaflets between two bent portions bars  491  of connecting member  490  and tightening them using suture  484  without punctures in the working areas of the pericardium is applied. However, connecting member  490  is provided with a portion  493  that is positioned perpendicular to the two bent portions bars  491  that holds the two leaflets together. Portion  493  is the connecting member to frame&#39;s bar  480 . In  FIG. 33   a , the junction point  495  between the portions of connecting member  491  is placed at the upper part (outlet) of the frame so as to achieve a rigid connection to the frame. In  FIG. 33   b , junction point  495  is placed at the bottom part (inlet) of the frame so that the junction point also functions as a spring. Comprehensive explanation of the benefits of springs in commissures is discussed and shown in respect with  FIGS. 37 to 39 . 
         [0229]      FIGS. 34   a  to  34   c  illustrate an isometric view of an attachment between a pericardium and a valve in accordance with yet another preferred embodiment of the present invention demonstrating another method of attachment. In  FIGS. 34   b  and  34   c , a deployed portion and the folded portion, respectively, are shown. An optional design for the attachment between the frame and the leaflets is depicted. A connecting member  480  (shown clearly in  FIG. 34   b ) is being produced into a flat configuration using laser-cutting. Connecting member  480 , which is a part of the frame&#39;s attachment means, is bent and then is ready for assembly with the leaflets. Connecting member  480  comprises the main body as well as a connection bar  497  and a flexible element  498  allowing flexibility to the commissural. Leaflets  430  are threaded through corresponding holes  481  in the structured connecting member  480  and are sutured using a suture  482 . 
         [0230]    Reference is now made to  FIGS. 35   a ,  35   b , and  35   c  illustrating isometric and cross-sectional upper views, respectively, of attachment techniques between a pericardium leaflet and a valve&#39;s frame in accordance with other preferred embodiments of the present invention.  FIGS. 35   b  and  35   c  depict different techniques of commissural attachments: in  FIG. 35   b  two pieces of pericardial leaflets  500  are wrapped around a metallic member  505  that is connected to a frame  501 . Rigid members  503  are positioned from both sides of metallic member  505  and then tightened together and connected by a suture  502 . All metallic pieces are wrapped by PET fabric  508  in order to avoid direct contact between the metallic pieces and the delicate pericardial leaflets. The advantage of this structure is that after tightening the suture, the whole commissure becomes static with no relative movement between the portions. This improves the valve assembly&#39;s resistance to abrasion. In addition, there are no needle holes or sutures in the working area.  FIG. 35   c  depicts a similar structure, however, there is no use of rigid sidebars. After wrapping the metallic member  505  with pericardial leaflets  500 , a piece of PET  508  is used for tightening it to a tight bundle. In this case, the suture line  502  is the borderline of the working area so it should be designed so that stresses are in the best possible distribution. 
         [0231]      FIGS. 36   a  and  35   b  focus on the connection of the commissural assembly to frame&#39;s protrusion  509 , which is an integral part of the frame and is the basis for the commissural attachment. This example shows the use of four rigid longitudinal bars  503  connected by a suture  502 . 
         [0232]      FIGS. 37   a  to  37   c  illustrate a commissural assembly in accordance with another preferred embodiment of the present invention, where the connecting bar functions as a flexible support and has integral attachment means to the frame.  FIG. 37   b  is an isometric view of the connecting bar. Connecting bar  520  is flexible and comprises a resilient material shaped in a “U” shape. Connecting bar  520  is a part of commissural assembly  527  shown in  FIG. 37   a . Connecting bar  520  is provided with protruding elements  521  that are acting as the means of attachment to the frame&#39;s bar  480 . Protruding elements are designated to be inserted in corresponding bores  442  in bar  480 . It is optional to provide rods  527  which are integral parts of the “U” shaped member and replace the suture  526  that connects the pericardium leaflet and the connecting bar together, which is shown in  FIG. 37   a .  FIG. 37   c  depicts another method of attaching the flexible connecting bar  520  to the frame  480  by means of welding  523 . Here the pericardial leaflets  500  are attached to the connecting bar  520  by suture  526  inserted through a PET fabric  508  and two connecting bars  503 , which together create a tight bundle. 
         [0233]      FIGS. 38   a  to  38   g  illustrate isometric views of flexible commissural supports and the method of attaching them to a pericardium and a frame a valve in accordance with preferred embodiments of the present invention.  FIGS. 38   a  to  38   c  demonstrate incorporation of different design options of commissural springs. The main purpose of a commissural spring is to reduce the impact applied to the pericardial leaflets when the valve leaflets are closed. If the structure is of a rigid nature, high stress will be applied each time the valve closes. If a spring is added to the structure, the spring will bear the highest portion of the impact, thus reducing the stress applied to the leaflets during the time the valve is closed. In  FIG. 38   a , a simple stainless steel spring  530  is connected to frame&#39;s bar  480  by threading a portion of the spring into slots  538  as shown in more detail in  FIGS. 38   e  and  38   f . In  FIG. 38   b , there is a similar spring  530  with leaflets  500  connected to it by one of the attachment methods, the commissural support itself  530  is connected to the frame&#39;s bar  480  by spot welding, laser welding or other attachment means.  FIG. 38   c  depicts a similar spring  534  having an additional spiral. The purpose of such a spiral is to reduce stress in the spring and to allow the fatigue requirements, which in the case of heart valves are of at least 200 million cycles. 
         [0234]      FIG. 38   d  illustrates an isometric view of a flexible commissural support in accordance with yet another preferred embodiment of the present invention, demonstrating the attachment of the pericardium to the support.  FIGS. 38   e  to  38   g  are the details of the attachment to the frame. A commissural spring of a different design  539  comprises a stainless steel wire of a small diameter in respect with the springs described in  FIGS. 38   a  to  38   c . One advantage of this structure is the distribution of stresses in the spring and the ability to form a structure, which can be crimped to a small diameter. Another advantage in this structure is that there are no open edges of the spring, which can be dangerous when operated; the open edges are protected in the frame&#39;s bar as shown in  FIGS. 38   e  to  38   g , which show possible attachment methods of the spring to the frame. In  FIG. 38   e , a frame&#39;s flat bar  480  has slots  531  cut to form slot tabs  538  for crimping the spring  530 .  FIG. 38   f  shows pre-bending of the slots  527  and  FIG. 38   g  shows the spring legs  539  assembled firmly into the slot tabs  538 . 
         [0235]      FIG. 39   a  illustrates a technique of commissural assembly using a shaped compressing member  511 . The compression member  511  holds pericardial leaflets  500  firmly while pressing it in the pivot points  513 . A radial edge  514  is made in order to protect the pericardium from abrasion. The whole assembly is held tightly inside the compressing member  516 . The commissural assembly is connected to the frame by protrusion member  518 , which fit bores in the frames bar  480 .  FIG. 39   b  is an isometric view of the same detail. 
         [0236]      FIGS. 40   a  to  40   c  illustrate an isometric view of a bicuspid valve mounted on a frame in accordance with yet another preferred embodiment of the present invention.  FIGS. 40   b  and  40   c  depict a cross-sectional side view and an isometric view, respectively, of the pericardium that is sutured to a PET tube in the form of pockets. The valve assembly (in this case bicuspid) comprises a crimpable frame  540 , two pericardial leaflets  545 , a PET skirt  543  and a connecting suture  547 . The focus in this drawing is on the pocket shape of the pericardium leaflet shown best in  FIGS. 40   b  and  40   c . One of the main goals in valve design, in general, is to distribute the stresses in a homogenous way in the pericardium material and the attachment areas. The design of the pericardium leaflet as a pocket assists in distributing the stresses along suture line  547 ; pericardium leaflet  545  is sutured to PET skirt  543  along connecting suture  547 . PET skirt  543  is sutured to the circumference of crimpable frame  540  at the bottom side  549  and at the top  542  using one of the commissural attachments that are described herein before regarding other embodiments. When hydrodynamic pressure is applied on leaflets  545 , the leaflets will meet in the center  546  of frame  540  so as to seal the valve assembly. The shape of the leaflets in the valve assembly is determined by the boundary conditions, which in this case are the suture lines. The suture lines can be designed to have an optimal shape regarding the stress distribution in accordance with geometrical restrictions. 
         [0237]    Reference is now made to  FIGS. 41   a  to  41   d  illustrating isometric views of an implantable prosthesis tricuspid valve in accordance with yet another preferred embodiment of the present invention.  FIG. 41   a  illustrates valve assembly  553  in an open state. Valve assembly  553  comprises a frame  555  (rigid or crimpable), pericardial leaflets  550  and bars  551 . It is emphasized that in the shown embodiment, the goal is to distribute the stresses on the commissural arrangement in an optimal way. Pericardial leaflets  550  are attached to bars  551  that act as attachment means. The attachment means are positioned at the top third of the valve; the bottom circumference is attached to the frame in order to obtain full sealing. The middle part of the pericardium is left slack. The pre-cut pericardium is cut in greater dimensions than the frame; e.g., the height of the pericardium leaflet is greater than the height of the frame, for example, if the frame height is 15 mm, the pericardium will be cut to a height of 18 mm so as to establish a slack portion in the middle area of the valve assembly  553 .  FIG. 41   b  depicts the valve assembly in a closed state. The slack portion of the pericardium collapses toward the middle while creating a small pocket shape  554 , which assists in the stress distribution.  FIG. 41   c  shows the detailed commissural and the short bar attachment as well as the circumference sealing area at the bottom portion of the pericardium assembly. It is shown in the figures that bars  551 , which are relatively short, allow firm attachment of the top portion of the commissural, slack portion in the middle, and a good sealing surface at the bottom portion  556 . 
         [0238]    Reference is now made to  FIGS. 42   a  and  42   b  illustrating an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention, having a different commissural attachment.  FIG. 42   b  depicts the attachment in details. In the embodiment shown in  FIG. 42   a , similar valve assembly is illustrated, while the short bar is arranged in a manner that is similar to the structure shown in  FIG. 28  and described herein before. Relatively short bars  559  act as the attachment means to the frame bar  558 . Suture  557  attaches short bars  559  to a member  558 , the suture can be made from an elastic material so that to add flexibility to the commissures and to render the valve assembly the benefits already explained herein. 
         [0239]    Reference is now made to  FIGS. 43   a  and  43   b  illustrating an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention.  FIG. 43   a  depicts commissures that are pre-sutured in a tapered shape. The valve assembly shown in  FIG. 43   a  comprises a frame  560 , pericardial leaflets  563 , and attachment means  561 . Pericardial leaflets  563  are shown to be in an open state so as to establish an open valve assembly while dashed lines  565  show the valve in a closed sealed state. The attachment to the commissures can be performed using one of the explained techniques. Specifically to the embodiment shown in  FIGS. 43   a  and  43   b , the focus is on the formation of a tapered valve in which the attachment means is in the shape of long bars  561  that are attached to the pericardium in an angular way in apposition to the parallel attachment. Attaching the bars in an angular way when the pericardium is flattened will create a tapered tube when built up to the three dimensional shape. When the whole prosthetic valve is inflated by a balloon, the pericardium leaflet, at the top circumference of the frame, is stretched and the frame is expanded to the full diameter. After deflating the balloon, the frame stays in its expended size but the pericardial leaflets regains their pre-stretched shape. This process creates a permanent clearance distance  562  between the pericardial leaflets  563  and frame  560 . This is of major importance in the protection of the pericardium from abrading against the frame. 
         [0240]    Reference is now made to  FIGS. 44   a  to  44   c  illustrating an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention, with additional pieces of PET used for sealing and protecting the pericardium. The illustrated implantable valve assembly resembles the valve shown in  FIG. 43 , however, it is emphasized that in the attachment of the pericardial leaflets  570  to frame  575 , there is use of PET.  FIG. 44   c  shows in a cross-sectional view, the way the PET is assembled to the pericardium and the frame in a manner that protects the pericardium against wear. PET  571  and  572  are used for connecting pericardial leaflets  570  to frame  575 , while they are assembled in between the leaflets and the frame. A suture  577  connects pericardium leaflet  570  in between two layers of PET, while the inner layer of PET  572  is short and the outer layer is longer. Bottom attachment suture  576 , connects the three layers, the leaflet and both PET layers to the frame and forms a strong sealing line. An upper suture  578  connects the outer PET layer  571  to frame  575 . When the valve assembly closes and the pericardial leaflets come closer to each other at the top of the assembly, there is a tendency of the bottom attachment to move and rotate about an attachment point  577 . Upper suture line  578  keeps the outer PET layer tight and prevents a part of this rotational movement, which can rapidly cause an abrasion failure. 
         [0241]      FIGS. 45   a  to  45   d  illustrate an isometric view of an implantable prosthetic valve in accordance with yet another preferred embodiment of the present invention, having leaflets sutured to a pre-shaped PET tube and optional leaflet-tube attachments in details. A novel technique of mounting pericardial leaflets  580  to a pre shaped PET tube  585  is shown. The tube is shaped so as to have a folding  586  with substantially sinusoid pattern  586  that is similar to the optimal connection line of valve leaflets in the natural valve. This shape allows the pericardial leaflets to be sutured to the interior of the PET tube. The preferred suturing techniques are shown in the cross sectional views of PET tubes in  FIGS. 45   b ,  45   c , and  45   d . Generally, in order to protect the pericardial leaflets from tearing, an additional piece  583  of PET is added below the suture lines. Similar variations are shown in  FIGS. 45   c  and  45   d.    
         [0242]    Reference is now made to  FIG. 46   a  illustrating an exploded view of an implantable prosthetic valve assembly in accordance with yet another preferred embodiment of the present invention, where the leaflets are mounted on a pre-cut and pre-shaped tube and the outlet of the valve is cut in a commissural shape.  FIG. 46   a  is view of the attachment. A pre-shaped PET tube  590  is cut to have substantially sinusoidal shape  596  and then bent in order to provide a suturing area. The pericardium leaflet  593  is pre-cut and assembled to PET tube  590  by means of suturing  502 . In this case as well as in the former case, an additional protective layer of PET or pericardium  594  is added.  FIG. 46   b  is a cross-section of the attachment detail after being tightened 
         [0243]      FIGS. 47   a  to  47   c  illustrate a partial cross-sectional side view of an inflating balloon in accordance with a preferred embodiment of the present invention. The balloon is a part of an implantable prosthetic valve delivery system.  FIGS. 47   b  and  47   c  are cross sectional upper views in the inflated and deflated positions, respectively. The specially designed balloon shown in the figures preferably comprises four inflating members, three substantially identical and symmetrical sections  600  and a central section  602 . Pericardial leaflets  612  are positioned between sections  600  and separate them. A frame  610  circles the inflating members and a balloon shaft  619  that is positioned in the center of the delivery system while a commissural connection  613  connects pericardial leaflets  612  to frame  610 . The inflated balloon sections  600  are placed between frame  610  and pericardial leaflets  612  so that when the inflating members are inflated, they push leaflets  612  toward each other and frame  610  so as to establish a fully closed position. This technique better preserves the leaflets since there is no contact between the leaflets and the frame besides in the commissural connection. The preservation of the leaflets is even improved in times of inflation as well as after inflating the valve and establishing a closed position. In  FIG. 47   a  the fourth inflating member of the balloon, central section  602  is clearly shown. Through central section  602 , the inlet  617  of the valve is inflated while the inflated central section assures that the whole valve is fully inflated to substantially round shape.  FIG. 47   c  shows the assembly in a crimped position. Frame  610  is crimped and sections  600  are deflated. Pericardial leaflets  612  are also shown in a crimped configuration. 
         [0244]      FIGS. 48   a  and  48   b  illustrate a partial cross-sectional side view and an upper cross sectional view of an inflating balloon in accordance with another preferred embodiment of the present invention. The inflating balloon comprises of a central inflating balloon  620  and three protection sheets  622 . In the lateral cross-section shown in  FIG. 48   b , the parts of inflated assembly  625  are clearly shown, protection sheets  622  protects the pericardial leaflets  624  from being pushed against the frame  625  when the device is inflated. The advantage of this arrangement is in the protection of the pericardial leaflets. 
         [0245]    The preferred embodiments representing an implantable prosthetic valve in accordance with the present invention are relatively easy to manufacture as they are generally flat throughout most of the production process and only at the final stage of mounting the other elements of the valve assembly on the support frame, a three dimensional form is established. 
         [0246]    A typical size of an aortic prosthetic valve is from about 19 to about 25 mm in diameter. A maximal size of a catheter inserted into the femoral artery should be no more than 8 mm in diameter. The present invention introduces a device, which has the ability to change its diameter from about 4 mm to about 25 mm. Artificial valves are not new; however, artificial valves in accordance with the present invention posses the ability to change shape and size for the purpose of delivery and as such are novel. These newly designed valves require new manufacturing methods and technical inventions and improvements, some of which were described herein. 
         [0247]    As mentioned earlier, the material of which the valve is made from can be either biological or artificial. In any case new technologies are needed to create such a valve. 
         [0248]    To attach the valve to the body, the blood vessels determine the size during delivery, and the requirements for it to work efficiently, there is a need to mount it on a collapsible construction which can be crimped to a small size, be expanded to a larger size, and be strong enough to act as a support for the valve function. This construction, which is in somewhat similar to a large “stent”, can be made of different materials such as Nitinol, biocompatible stainless steel, polymeric material or a combination of all. Special requirement for the stent are a subject of some of the embodiments discussed herein. 
         [0249]    The mounting of the valve onto a collapsible stent is a new field of problems. New solutions to this problem are described herein. 
         [0250]    Another major aspect of the design of the valve of the present invention is the attachment to the body. 
         [0251]    In the traditional procedure the valve is sutured in place by a complicated suturing procedure. In the case of the percutaneous procedure there is no direct access to the implantation site therefore different attachment techniques are needed. 
         [0252]    Another new problem that is dealt herein is the delivery procedure, which is new and unique. Positioning of the device in the body in an accurate location and orientation requires special marking and measuring methods of the device and surgical site as was disclosed herein. 
         [0253]    Artificial polymer valves require special treatment and special conditions when kept on a shelf, as well as a special sterilization procedure. One of the consequences of the shelf treatment is the need to crimp the valve during the implantation procedure. A series of devices and inventions to allow the crimping procedure are disclosed herein. 
         [0254]    It should be clear that the description of the embodiments and attached Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope as covered by the following claims. 
         [0255]    It should also be clear that a person skilled in the art, after reading the present specification could make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the following claims.