System for replacing a deficient native heart valve

p00001Implantable Prosthetic Device

p00002The present invention relates to implantable devices. More particularly, it refers to a valve prosthesis for cardiac implantation or for implantation in other body ducts.

p00003Background of the invention

p00004There are several known prosthetic valves that have been previously described. United States Patent No.

p000055,411,552 (Andersen et al.), Entitled VALVE PROSTHESIS FOR IMPLANTATION IN THE BODY AND CATHETERFOR IMPLANTING SUCH VALVE PROSTHESIS [VALVE PROSTHESIS FOR IMPLEMENTATION IN THE BODY AND CATHETER TO IMPLEMENT SUCH VALVE PROSTHESIS] that includes a valve prosthesis that includes a prosthetic valve an intravascular cannula made from a braided structure in the form of an expandable cylinder comprising several spaced apices. The elastically collapsible valve is mounted on the intravascular cannula having the valve commissure points secured to the projected apices, which prevents the valve from turning inwards. The deployment of the valve can be achieved through the use of an inflatable balloon that in its deflated state is used to bring the valve structure around it to its position and, when inflated, deploys the intravascular cannula in position to its final size. See, also, U.S. Patent No. 6,168,614 (Andersen et al.) Entitled VALVE PROSTHESIS FOR IMPLANTATION IN THE BODY [VALVE PROSTHESIS FOR IMPLEMENTATION IN THE BODY] and U.S. Patent No.

p000065,840,081 (Andersen et al.) Entitled SYSTEM AND METHOD FOR IMPLANTING CARDIAC VALVES [SYSTEM AND METHOD FOR IMPLANTING CARDIAC VALVES].

p00007In PCT / EP97 / 07337 (Letac, Cribier et al.) Published as WO 98/29057, entitled ALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS [VALVE PROSTHESIS FOR IMPLEMENTATION IN BODY CHANNELS], 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 flexible and resistant to allow the valve structure to be deformed from a closed state to an open state. The valvular tissue forms a continuous surface and is provided with guiding means formed and incorporated therein, the guiding means creating hardened areas that induce the valve structure to follow a pattern of movement in its expansion to its open state and in Your return to your closed state. The valve structure may extend to an internal liner that is secured to the bottom of the valve structure to prevent regurgitation.

p00008There are several known methods currently used to replace aortic valves and various types of artificial prosthetic devices. Mechanical valves are commonly used in different designs (single and double lamella) manufactured by well-known companies such as St. Jude, Medtronic, Sulzer and others. Some of the main disadvantages of these devices are: the need for permanent treatment with anticoagulants, noisy operation and the need for a large-scale operation for implantation.

p00009There is a wide range of biological-based valves made from natural valves or composed of biological materials such as pericardial tissue. These are also manufactured and marketed by well-known companies such as Edwards Lifesciences, Medtronic, Sulzer, Sorin and others.

p00010Polymeric valves are new and 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 polymeric materials such as polyurethane.

p00011The present invention introduces several novel structural designs for implantable valves. One aspect of the present invention relates to the possibility of implanting the valve pericutually, that is, by inserting the valve assembly over a delivery device similar to a catheter, then implanting the valve at the desired location through a vessel. large blood such as the femoral artery, in a procedure similar to other known cardiovascular intervention procedures. The percutaneous deployment procedure and device affects the design of the product in several parameters, some of which are explained later in this document.

p00012Percutaneous implantation of medical devices and particularly prosthetic valves is a preferred surgical procedure that involves performing a very small perforation in the patient's skin (usually in the groin or armpit area) under local anesthesia and sedation, as opposed to a incision by large thoracic surgery, which requires general anesthesia, opening a large portion of the chest, and a cardiopulmonary bypass. This percutaneous procedure is therefore considered safer.

p00013The present invention provides a series of new concepts in the field of aortic valves and other human valves.

p00014WO 01/49213 A2 describes an implantable valve prosthesis comprising a body member of the intravascular cannula having lumenal and ablumenal surfaces thereof and a central annular opening along a longitudinal central axis of the body member of the intravascular cannula; a graft member that covers at least a portion of at least one of the lumenal and ablumenal surfaces of the intravascular cannula body member; at least one deflection arm projecting from the body member of the intravascular cannula and into the central annular opening of the body member of the intravascular cannula; and at least one valve leaf member coupled to the at least one deflection arm and towards at least a part of the graft member, the at least one valve leaf member assuming a position, for a differential pressure of zero through of the prosthesis, which occludes the central annular opening of the body member of the intravascular cannula.

p00015In addition, WO 01/76510 A2 describes an expandable heart valve. The cardiac valve includes a plastic expandable annular base having a plurality of vertical commissure posts. A flexible tubular member is provided that includes a prosthetic section and a fabric section, the prosthetic section being connected to the commissure posts, and defining lamellae therebetween, and the tissue section being attached to the annular base.

p00016Document FR 2 815 844 A1 describes a tubular support for replacing a heart valve percutaneously.

p00017Summary of the invention

p00018The underlying technical problem is solved by the implantable prosthetic device percutaneously according to claim 1.

p00019In one example, a valve prosthesis device suitable for implantation in body ducts comprises:

p00020an intravascular support cannula, comprising a deployable construction adapted to be initially folded in a narrow configuration suitable for catheterization through the body duct to an objective location and adapted to be deployed exerting substantially radial forces from within by means of a deployment device to a state of deployment in the target location, provided with the intravascular support cannula with a plurality of rigid longitudinally fixed support bars of fixed length; and

p00021a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of a flexible material bonded to the support bars providing collapsible flaccid portions of the conduit to the outlet,

p00022whereby when the flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is held in an open position, while avoiding an inverse flow since the collapsible flaccid portions of the Valve assembly collapses inward providing reverse flow blockage.

p00023Additionally, in accordance with the present invention, the intravascular support cannula may comprise an annular frame.

p00024Additionally, according to the present invention, said valve assembly has a tricuspid configuration.

p00025Additionally, in a reference example, said valve assembly may be made of a biocompatible material.

p00026Additionally, according to the present invention, said valve assembly is made of pericardial tissue.

p00027Additionally, in a reference example, said valve assembly may be made of biocompatible polymers.

p00028Additionally, in a reference example, the valve assembly is made of materials selected from the group consisting of polyurethane and polyethylene terephthalate (PET).

p00029Additionally, in a reference example, said valve assembly comprises a main body made of PET (polyethylene terephthalate) and lamellae made of polyurethane.

p00030Additionally, according to another preferred embodiment of the present invention, said intravascular support cannula is made of nickel titanium.

p00031Additionally, in one example, the support bars are substantially equidistant and substantially parallel in such a way as to provide anchoring to the valve assembly.

p00032Additionally, in one example, the support bars may be provided with perforations such that they allow the valve assembly to be sewn or attached to the bars.

p00033Additionally, in one example, the support bars are chemically bonded to the intravascular support cannula.

p00034Additionally, in one example, said valve assembly is riveted to the support bars.

p00035Additionally, in one example, said valve assembly is sewn to the support bars.

p00036Additionally, in one example, said bars are manufactured by injection using a mold, or by machining.

p00037fifteen Additionally, according to another preferred embodiment of the present invention, said valve assembly is wound on the intravascular support cannula at the inlet.

p00038Additionally, said valve device can be manufactured using forging or pickling techniques.

p00039Additionally, in accordance with another preferred embodiment of the present invention, said leaflets of the valve assembly are longer than necessary to close the outlet exactly so that when substantial portions of the leaflets fall into one another in the collapsed state creating one sealed better.

p0004025 Additionally, in a reference example, said valve assembly is made of spirals of a polymer, coated by a coating layer of the same polymer.

p00041Additionally, in a reference example, said polymer is polyurethane.

p00042Additionally, in accordance with another preferred embodiment of the present invention, the intravascular support cannula may be provided with heavy metal markers in such a way as to allow monitoring and determination of the position of the valve device and its orientation.

p00043Additionally, according to another preferred embodiment of the present invention, heavy metal markers 35 are selected from gold, platinum, iridium or tantalum.

p00044Additionally, in accordance with another preferred embodiment of the present invention, the leaflets of the valve assembly may be provided with radiopaque material at the outlet, such that they assist in monitoring the operation of the valve device in vivo.

p00045Additionally, according to another preferred embodiment of the present invention, said radiopaque material comprises gold strands.

p00046Furthermore, according to another preferred embodiment of the present invention, the diameter of said intravascular support cannula 45, when fully deployed, is in the range of about 19 to about 25 mm.

p00047In addition, according to another preferred embodiment of the present invention, the diameter of said intravascular support cannula can be expanded from about 19 to about 25 mm.

p00048Additionally, in one example, the support bars are provided with perforations and where the valve assembly is attached to the support bars by means of rigid U-shaped members that are secured to the valve assembly and which are provided with protruding portions that fit the matching holes of the support bars.

p0004955 Additionally, in one example, the support bars comprise rigid support bars in the frame construction form, and the flexible material of the valve assembly can be inserted through a gap in the frame and a securing rod is inserted through of a pocket formed between the flexible material and the frame and keeps the valve in position.

p00050Additionally, in one example, the main body of the valve assembly is made from a spiral wire coated with coating material.

p00051Additionally, in one example, the spiral wire and the coating material are made of polyurethane. Additionally, in one example, the reinforcing wire is intertwined in the valve assembly at the outlet of the

p00052conduit such that it defines a dislocation line around which the collapsible flaccid portion of the valve assembly can flutter.

p00053Additionally, in one example, the reinforcing wire is made of nickel titanium alloy.

p00054Additionally, in a reference example, a valve prosthesis device is provided, suitable for implantation in body ducts, the device comprising a main duct body having an inlet and outlet and flexible lamellae attached to the outlet in such a manner. that when a flow passes through the conduit from the entrance to the exit the lamellae are in an open position allowing the flow to exit through the exit, and when the flow is inverse the lamellae collapse in such a way that they block the outlet, where the main body is made of PET and the collapsible lamellae are made of polyurethane.

p00055Additionally, in the reference example, the support bars made of polyurethane are provided on the main body and where the lamellae are attached to the main body on the support bars.

p00056Additionally, in the reference example, said support bars are chemically bonded to the main body.

p00057Additionally, in one example, a valve prosthesis device suitable for implantation in body ducts is provided comprising:

p00058an intravascular support cannula, composed of a deployable construction adapted to be initially folded in a narrow configuration suitable for catheterization through the body duct to an objective location and adapted to be deployed exerting substantially radial forces from within by means of a deployment device to a state of deployment in the target location, provided with the intravascular support cannula with a plurality of rigid longitudinally fixed support bars of fixed length;

p00059a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of flexible material bonded to the support bars providing collapsible flaccid portions of the conduit to the outlet; and

p00060Rigid support bars substantially equidistant intertwined or attached to the flaccid portion of the valve assembly material, arranged longitudinally.

p00061Additionally, in one example a folding device is provided for folding the valve device described above or in Claim 1, the folding device comprising a plurality of adjustable plates reminiscent of the typical SLR camera variable restrictor (Single Reflex Lens) , each provided with a sheet, which are dispersed equivalently in a radial symmetry but moving each plate along a line that passes over an opening in the center, all the plates equidistant from that central opening.

p00062Additionally, in one example, the multiple plates are adapted to move simultaneously by means of a lever and transmission.

p00063Additionally, in one example, a method is provided for deploying an implantable prosthetic valve device from the posterior approach (approaching the aortic valve from the descending aorta), or from the anterior approach (approaching the aortic valve from the left ventricle after perform a trans-septal puncture) in the natural position of the aortic valve at the entrance of the left ventricle of a patient's myocardium, comprising the method of the stages of:

<dl><dt>(to)</dt><dd> providing a balloon catheter having a proximal end and a distal end, having a first and second independently inflatable portions, located the first inflatable portion at the distal end of the catheter and the second inflatable portion adjacently behind the first inflatable portion; </dd></dl>

<dl><dt>(b) </dt><dd>provide a guide tool to guide the balloon catheter in the patient's vasculature; </dd></dl>

<dl><dt>(c) </dt><dd>providing a deployable implantable valve prosthesis device adapted to be mounted on the second inflatable portion of the balloon catheter; </dd></dl>

<dl><dt>(d) </dt><dd>for subsequent approach, guide the balloon catheter through the patient's aorta using the guide tool, mounted the valve device on the second inflatable portion of the balloon catheter until the first inflatable portion of the balloon catheter is inserted into the left ventricle, while the second inflatable portion of the balloon catheter is positioned in the natural position of the aortic valve; </dd></dl>

<dl><dt>(and) </dt><dd>For the previous approach, guide the balloon catheter through the patient's larger veins, right atrium, left atrium, and left ventricle using the guiding tool, mounted the device </dd></dl>

p00064valve on the second inflatable portion of the balloon catheter until the first inflatable portion of the balloon catheter is inserted into the left ventricle,

p00065(f) while the second inflatable portion of the balloon catheter is positioned in the natural position of the aortic valve 5;

<dl><dt>(g) </dt><dd>inflate the first inflatable portion of the balloon catheter so that it substantially blocks the flow of blood through the natural aortic valve and anchors the distal end of the balloon catheter in position; </dd></dl>

<dl><dt>(h) </dt><dd>inflate the second inflatable portion of the balloon catheter such that it deploys the implantable prosthetic valve device in position in the natural position of the aortic valve; </dd></dl>

<dl><dt>(i) </dt><dd>deflate the first and second inflatable portions of the balloon catheter; and</dd></dl>

p00066fifteen (j) retract the balloon catheter and remove it from the patient's body.

p00067Additionally, in one example, the guide tool may comprise a guide wire.

p00068Additionally, in one example, a method is provided for deploying an implantable prosthetic valve device in the natural position of the aortic valve at the entrance of the left ventricle of a patient's myocardium, the method comprising the steps of:

p00069(a) provide a balloon catheter having a proximal end and a distal end, having a first and

p00070second independently inflatable portions, located the first inflatable portion at the distal end of the catheter and the second inflatable portion adjacently behind the first inflatable portion;

<dl><dt>(b) </dt><dd>provide a guide tool to guide the balloon catheter in the patient's vasculature; </dd></dl>

<dl><dt>(c) </dt><dd>providing a deployable implantable valve prosthesis device adapted to be mounted on the first inflatable portion of the balloon catheter, and a deployable annular intravascular cannula device adapted to be mounted on the second inflatable portion of the balloon catheter, the valve prosthesis device being maintained implantable deployable and the intravascular cannula deployable separated by a predetermined distance; </dd></dl>

p0007135 (d) guiding the balloon catheter through the patient's aorta using the guiding tool, mounted the valve device on the first inflatable portion of the balloon catheter and mounted the deployable annular intravascular cannula on the second inflatable portion of the catheter. balloon, until the first inflatable portion of the balloon catheter is positioned in the natural position of the aortic valve;

p00072(e) inflating the second inflatable portion of the balloon catheter such that the deployable intravascular cannula device is deployed within the aorta thereby anchoring the deployable annular intravascular cannula and the valve device engaged in position;

p00073(f) inflating the first inflatable portion of the balloon catheter such that it deploys the implantable prosthetic valve device 45 in position in the natural position of the aortic valve;

p00074(g) deflate the first and second inflatable portions of the balloon catheter;

p00075and

p00076(h) retract the balloon catheter and remove it from the patient's body.

p00077Additionally, in one example, a valve prosthesis device suitable for implantation in body ducts comprises:

p0007855 an expandable support frame, the expandable support frame being provided with a plurality of longitudinally fixed rigid support bars of fixed length; and

p00079a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of a flexible material bonded to the support bars providing collapsible flaccid portions of the conduit to the outlet,

p00080whereby when the flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is held in an open position, while preventing a reverse flow set

p0008165 that the collapsible flaccid portions of the valve assembly collapse inwards providing blockage to the reverse flow.

p00082Additionally in one example, the support frame comprises a deployable construction adapted to be initially folded in a narrow configuration suitable for catheterization through the body duct to an objective location and adapted to be deployed by exerting substantially radial forces from within by means of a device from deployment to a deployment state at the target location.

p00083Additionally, in one example, the support bars may have a U-shaped cross section.

p00084Additionally, in one example, a support is used to secure the foldable material to the support bars.

p00085Additionally, in one example, the support frame comprises three segments that form a circular assembly when assembled.

p00086Additionally, in one example, the support bars may point inwardly with respect to a central longitudinal axis of the device.

p00087Additionally, in one example, the device is additionally provided with a tapered restrictive housing, to accommodate it in a folded state.

p00088Additionally, in one example, hooks are provided to secure the device in position after it is deployed.

p00089Additionally, in one example, the support bars comprise longitudinal bars that have a narrow groove used as a corner joint so that the extensions of the collapsible material are inserted tightly therethrough.

p00090Additionally, in one example, the extensions of the folding material can be wrapped through rigid bars that serve as anchoring means.

p00091Additionally, in one example, the extensions of the folding material are sutured together in the rigid bars.

p00092Additionally, in one example, a lower portion of the folding material is attached to the inlet.

p00093Additionally, in one example, each of the support bars is provided with a rounded tip, forming a loop through which the foldable material is inserted.

p00094Additionally, in one example, the flexible material is provided with longitudinal bars attached to the flexible material in positions assigned for attachment to the support frame, in order to avoid localized stresses arising from the forming.

p00095Additionally, in one example, the device is additionally provided with longitudinal bars having protrusions that are inserted into perforations of the folded material, a PET sheet and through perforations provided on the support bars.

p00096Additionally, in one example, where the flexible material is sutured leaving the flaccid portions free of sutures.

p00097Additionally, in one example, a connecting member with a split portion is used to connect the lamellae of the folding material to the support bars, the split connecting member comprising the folding material in position.

p00098Additionally, in one example, a portion of the connecting member may be perpendicular to the divided portion.

p00099Additionally, in one example, the support frame is provided with metal members coupled to the intravascular cannula and rigid members can be positioned on two opposite sides of metal member and held against each other supporting the portion of the foldable material between them, sutured, wrapped in metallic members with PET.

p00100Additionally, in the reference example, the device may additionally be provided with springs in order to reduce wear of the foldable material.

p00101Additionally, in the reference example, the spring is provided with a spiral.

p00102Additionally, in the reference example, the spring is made of stainless steel.

p00103Additionally, in the reference example, the spring is attached to grooves provided on the frames of

p00104support. Additionally, in one example, the folding material is sutured to the support frame forming pockets. Additionally, in one example, the tie rods are provided on the support of the intravascular cannula to a

p00105portion of the intravascular cannula near the outlet, on which the folding material is coupled, and where the folding material is circumferentially attached to an inlet, leaving the long folding material.

p00106Additionally, in one example, the output is tapered with respect to the input. Additionally, in one example, the support frame at the exit is wider in diameter than the folded material That forms the exit.

p00107Additionally, in one example, the folding material is reinforced with PET.

p00108Additionally, in one example, the support frame is a tube that has an internal wall, which has lines sinusoidal folds, where the foldable material is sutured to the inner wall of the tube along suture lines. Additionally, in one example, an additional piece of PET is added below the suture lines. Additionally, in one example, the device carries an angioplasty balloon. Finally, in one example, the balloon has a central longitudinal axis that runs along a flow path through

p00109of the device, and a perimeter, the balloon comprising four inflatable portions, a portion located along a central axis and the other three located on the perimeter, the flexible material being distributed in the form of lamellae around the perimeter.

p00110Brief description of the figures

p00111To better understand the present invention and appreciate its practical applications, the following Figures are provided and referenced hereafter. It is 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.

p00112Figure 1 illustrates an implantable prosthetic tricuspid valve suitable for percutaneous deployment using

p00113an intravascular cannula or similar deployment medium, in its deployed-inflated position; Figure 2 depicts an implantable valve mounted on a deployable intravascular cannula with a Inflatable balloon;

p00114Figure 3 illustrates an implantable valve mounted on an intravascular cannula with an inflatable balloon, in a folded position;

p00115Figure 4 depicts the deployment of an implantable valve in a natural position of the aortic valve; Figure 5 demonstrates the manufacture of an implantable polyurethane valve using a technique of pickling

p00116Figures 6a to 6e illustrate the manufacture of an implantable forged valve;

p00117Figures 7a and 7b demonstrate the composite material for the valve, which has polyurethane (PU) lamellae and PET crown shaped construction; Figures 8a and 8b represent a method of manufacturing a valve complex made of lamellae

p00118flexible PU, a rigid PU construction for mounting and a tubular end in PET; Figures 9 to 9i demonstrate different methods of union between the valve and the intravascular cannula; Figure 10 illustrates a pickling mandrel with an extra portion, which improves sealing stability.

p00119from valvule;

p00120Figures 11a to 11c illustrate a valve mounted on an intravascular cannula with an extra support, which improves the distribution of forces on the valve material and facilitates the prolonged durability of the valve; Figures 12a to 12c represent a valve with rigid supports located substantially in the center of

p00121Your lamellae This design allows the valve flaps to operate without external support; Figures 13a to 13c illustrate the manufacture of a reinforced PU tube composed of a strong PU, PET or other fiber and a softer PU coating, to serve as a support structure;

p00122Figures 14a to 14c demonstrate the incorporation of heavy metal markers on the intravascular cannula 5. These markers allow orientation control while positioning the device in the required location;

p00123Figures 15a to 15c show a valve with a radio-opaque coating which allows images of the movement of the valve to be taken on an angiogram;

p00124Figures 16a to 16c illustrate a procedure, which helps the exact positioning of the valve device with respect to the longitudinal orientation;

p00125Figures 17a and 17b describe a valve device comprising a valve assembly mounted on

p00126fifteen an intravascular cannula and an additional portion with an intravascular cannula only. This allows the device to be placed in a way that the coronary arteries are not blocked, thus achieving that the longitudinal positioning is less sensitive and the extra intravascular cannula decreases the risk of migration of the device through the vasculature;

p00127Figures 18a and 18b demonstrate a folding device, which can fold a valve device into the operating room as part of the implantation procedure;

p00128Figures 19a to 19c graphically represent a folding machine, similar to that described in Figure 18, with a different mechanical method;

p0012925 Figures 20a and 20b show a valve, made of a tube mounted on an intravascular cannula. During systole, the tube opens completely and, during diastole, the tube collapses according to the mounting geometry that provides a tight seal;

p00130Figure 21 depicts the structure of an intravascular cannula, with built-in mounting portions of constant length, which allows valve mounting;

p00131Figure 22 depicts another valve assembly having dilated supports;

p0013235 Figures 23a to 23e graphically represent steps of a method for manufacturing an implantable prosthetic valve;

p00133Figures 24a to 24c illustrate a support frame of an implantable prosthetic valve having means for mounting valve leaflets that can form a tricuspid valve. Figure 24a represents an isometric view of the frame, and Figure 24b represents a cross-sectional view of the means for mounting a valve foil in detail, provided with a valve foil. Figure 24c represents additional details of the joining means for the joining method;

p00134Figures 25a to 25d illustrate an implantable prosthetic valve. Figures 25a and 25b represent a view

p00135Four. Five isometric and a top view of the valve assembly, respectively, and Figures 25b and 25d illustrate top views of two optional constructions for the mounting means of the lamellae;

p00136Figures 26a to 26c illustrate a tricuspid valve provided with a self-expanding frame. Figure 26a is the valve in its fully expanded diameter, Figure 26b is a tapered tool that helps insert the valve into an introduction tube, and Figure 26c shows the valve assembly within a restriction tube, ready to be inserted into an introduction sleeve;

p00137Figure 27 illustrates an isometric view of an implantable prosthetic valve having hooks designed to anchor the valve assembly to body ducts;

p0013855 Figure 28 illustrates a partial view of an implantable prosthetic valve. The commissure junction is shown in detail;

p00139Figures 29a and 29b illustrate an isometric view and a top cross-sectional view, respectively, of a joint of the valve frame to the lamellae;

p00140Figures 30a to 30c illustrate in isometric view, a cross-sectional view and a flattened view, respectively, of a joint of a valve frame to the lamellae. Figure 30c is a side view illustrating two pieces of the pericardium before attachment to the frame;

p0014165 Figures 31a and 31b illustrate an exploded view and an isometric view, respectively, of a commissure joint representing the joint technique;

p00142Figures 32a to 32c illustrate an isometric view of a junction between lamellae and the frame;

p001435 Figures 33a to 33d illustrate different views and portions of a joint between a pericardium and a frame, demonstrating another method of attachment;

p00144Figures 34a to 34c illustrate an isometric view of a joint between a pericardium and a valve demonstrating another method of attachment. In Figures 34b and 34c, an unfolded portion and the folded portion are shown, respectively;

p00145Figures 35a to 35c illustrate isometric and transverse top views, respectively, of joining techniques between a pericardium sheet and a valve frame;

p00146fifteen Figures 36a and 36b illustrate an isometric view of a commissure assembly demonstrating a method of forming one;

p00147Figures 37a to 37c illustrate a commissure assembly, where the connecting rod functions as a flexible support and has integral means of attachment to the frame. Figure 37b is an isometric view of the connection bar;

p00148Figures 38a to 38g illustrate isometric views of flexible commissure supports and the method of attaching them to a pericardium and a frame and valve;

p0014925 Figures 39a to 39b illustrate an isometric view of a commissure joint demonstrating the attachment of the pericardium to the support by means of a shaped compression member;

p00150Figures 40a to 40c illustrate an isometric view of a bicuspid valve mounted on a frame. Figures 40b and 40c represent 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;

p00151Figures 41a to 41d illustrate isometric views of an implantable prosthetic tricuspid valve;

p00152Figures 42a and 42b illustrate an isometric view of an implantable prosthetic valve having a different commissure junction. Figure 42b represents the joint in detail;

p00153Figures 43 a and 43b illustrate an isometric view of an implantable prosthetic valve. Figure 43a represents the corner that is presuturated in a tapered shape;

p00154Figures 44a to 44c illustrate an isometric view of an implantable prosthetic valve with additional PET parts used to seal and protect the pericardium;

p00155Figures 45a to 45d illustrate an isometric view of an implantable prosthetic valve having lamellae sutured in a preformed PET tube and optional lamellae-tube joints in detail;

p00156Four. Five Figures 46a and 46b illustrate an exploded view and an upper cross-sectional view of an implantable prosthetic valve assembly;

p00157Figures 47a to 47c illustrate a side cross-sectional view of an inflatable balloon. The balloon is a part of an implantable prosthetic valve delivery system. Figures 47b and 47c are transverse top views in the inflated and deflated positions, respectively; and

p00158Figures 48a and 48b illustrate a side view in partial cross-section and a top cross-sectional view of an inflatable balloon.

55 Detailed description of the invention

p00159A main aspect is the introduction of several novel designs for an implantable prosthetic valve. Another aspect is the description of various manufacturing methods for implantable prosthetic valves according to the present invention. An additional aspect is the provision of new deployment and positioning techniques suitable for the valve.

p00160Basically the implantable prosthetic valve comprises a valve assembly with lamellae, preferably tricuspid but not limited to tricuspid valves only, consisting of a conduit having an end of 65 inlet and an outlet, made of a foldable material arranged in such a way that it presents collapsible walls at the exit. The valve assembly is mounted on a support structure that has an adapted intravascular cannula

p00161to position itself in an objective location within the body duct and to deploy the valve assembly through the use of deployment means, such as a balloon catheter or similar devices. In suitable embodiments for safe and convenient percutaneous positioning and deployment the annular frame can be positioned in two positions, a folded position where the cross section of the passage of the presented conduit

p001625 It is small so as to allow the device to move towards its target location, and an unfolded position where the frame extends radially by forces exerted from within (by means of deployment) so that support is provided against the wall of the body duct , secure the valve in position and open by itself to allow flow through the conduit.

p00163The valve assembly is made of pericardial tissue. Homologous biological valves need an occasional replacement (usually after 5 to 14 years) and this is a consideration that the surgeon must take into account when selecting the appropriate valve implant according to the type of patient. Mechanical valves, which have better durability qualities, carry the associated risk of long-term anticoagulation treatment.

p00164fifteen The frame can be made of shape memory alloys such as nickel titanium (nickel titanium shape memory alloys, or NiTi, as sold, for example, under the trade name of Nitinol), or other biocompatible metals. The implantable valve percutaneously must be suitable for folding in a narrow configuration to position and expand to a wider deployed configuration so that it is anchored in position at the desired target location.

p00165The intravascular support cannula is annular.

p00166The fabrication of the implantable prosthetic valve can be done by various methods, using pericardium.

p0016725 The attachment of the valve assembly to the intravascular support cannula can be achieved in several ways, such as sewing it to several anchor points on the intravascular support frame or cannula, or riveting it, with pins, adhering, or welding it, to provide a set Valve that is cast or molded onto the support intravascular frame or cannula, or using any other suitable form of joint.

p00168To prevent leaks from the entrance it is optionally possible to wind part of the flaccid wall of the entrance over the edge of the frame such that it has a rolled portion similar to a sleeve at the entrance.

p00169Additionally, floating supports can be added to enhance the stability of the device and prevent it from turning inwards.

p0017035 An important aspect of certain embodiments of the present invention is the provision of rigid support bars incorporated into the intravascular support cannula that retains its longitudinal dimension while the full support intravascular cannula can extend longitudinally or laterally.

p00171The 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 given solely for the purpose of understanding the present invention and presenting some of the preferred embodiments of the present invention, but this in no way limits the scope of the present invention as defined in the appended claims. .

p00172Four. Five Reference is now made to Figure 1, which illustrates a general tricuspid implantable prosthetic valve 20 suitable for percutaneous deployment using an expandable intravascular cannula or similar deployment means, shown in its deployed position. A valve assembly 28 comprises a conduit having an inlet 24 and an outlet 26, the outer walls consisting of collapsible collapsible material 29 which is arranged to collapse into a tricuspid arrangement. The valve assembly 28 is connected to an intravascular annular support cannula 22, the one of this Figure being a network-shaped frame designed to adapt to the homogeneous folding so that it has a narrow configuration and is radially deployable to a degree such that occupy the step in the target location for implantation in a body duct. The support bars 23 are provided on an intravascular annular support cannula 22 to provide anchorage to the assembly of

p0017355 valve 28. The support bars 23 are optionally provided with perforations 25 to allow sewing of the valve assembly28 to the support bars 23 by means of strands, wires, or other joining means.

p00174In Figure 1, a turned portion 21 of the valve assembly 28 is wrapped around the support intravascular cannula 22 at the inlet 24 to enhance stability. Preferably the turned portion 21 of the valve material 28 is attached to the support bars 23.

p00175Note that the entire valve structure is adapted to fold radially and expand radially, and this leads to ease of navigation through narrow passages in the vasculature during device positioning and proper deployment in the final location. This is made possible by the

p0017665 provision of a collapsible support intravascular cannula structure. However, the support bars remain constant in length at all times and are therefore suitable to serve as an anchor for the

p00177folding valve assembly. The valve assembly is attached to the support intravascular cannula on the support bars, and due to its constant length there is no need for elongation material since the junction points (25) remain at constant distances regardless of the position of the device Valve (folded or unfolded). This is an important aspect since it means that the manufacturer of the valve device can ensure that the valve assembly is secured and adjusted to the intravascular support cannula at all times. In implantable valve devices of the prior art the complete support structure changes its dimensions from its first initial folded position and the final deployed position, and that means that in the union of the valve assembly to the support structure these changes of dimensions and leaving elongation material in such a way that by deploying the device the valve assembly does not tear or deform. In the valve device there is no relative movement between the valve assembly and the support bars (along the central longitudinal axis of the device). As a result, the valve device acquires greater durability and is capable of withstanding the harsh conditions prevailing within the vasculature and especially the millions of tension cycles applied by blood pressure.

p00178The fixed attachment of the valve assembly to the support intravascular cannula in the valve device results in greater stability, enhanced safety, better sealing and consequently a longer life span. The design of the invention valve device leads to longitudinal strength and stiffness while its collapsible support structure results in radial flexibility.

p00179Figure 2 depicts an implantable valve 30 mounted on a deployable intravascular cannula 32. The valve assembly 34 is attached to the deployable intravascular cannula 32 (dotted lines) along three substantially equidistant and substantially parallel support rods 40 of constant length, which are part of the intravascular cannula 32. The connection of the valve assembly 34 to the intravascular cannula 32 is facilitated by the support bars 40 to which the valve assembly 34 is sewn with strands or fibers 46 (through perforations 42 of the support bars 40). The outlet plates 38, which are a flaccid portion of the valve assembly, hang inward, and the entire device is carried by an inflatable balloon 48, which serves as a deployment device. A portion of the valve assembly 34 in an inlet zone 45 is optionally wound on the support intravascular cannula 32 at the inlet, constituting a rolled sleeve, which enhances the sealing of the device at the valve inlet.

p00180Figure 3 demonstrates an implantable valve mounted on an intravascular cannula 50 with an inflatable balloon 52, in a folded position. The intravascular support cannula 50 initially folds around the balloon 52 in such a way that it has a narrow cross-section and is thus suitable for percutaneous catheterization and deployment.

p00181Figure 4 depicts a deployment of an implantable valve in a natural position of the aortic valve. The implantable valve is advanced while mounted on the balloon 52 until it reaches the desired target location 54 in a body duct, for example the aorta 56. The balloon is inflated and the support intravascular cannula 50 expands radially to take its position. .

p00182Figure 5 demonstrates the manufacture of a polyurethane valve in a pickling technique. A tubular portion 60 is provided with a pickling mandrel 60 with surfaces 64 corresponding to the flaps of the collapsible valve to be manufactured. The mandrel 60 is immersed in a dissolved polyurethane bath 66 and coated with a polyurethane coating in the form of the desired valve. Then, after the polyurethane coating has hardened sufficiently, the entire valve of the mandrel 60 is removed.

p00183Figures 6a to 6e illustrate the manufacture of an implantable forged valve. A suitable tubularly shaped material 74 is fitted tightly in a tubular portion 68 of the mandrel 67, covering the cusp portion 69. Flexible inserts 76 are pressed on the mandrel 67, forging the tubular material to the shape of the mandrel

p0018480. A tapered ring 70 holds the flexible inserts in place while the entire mold is placed in a heated oven set at a desired temperature, which is below the melting point of the material. Figure 6e illustrates a cross-sectional side view of the mandrel and a cross-sectional portion of the mold. The mold is made to press inward on the mandrel, which is coated with the valve material. As a result the material takes the desired shape. The materials used may vary, for example, polyurethane (PU), polyethylene terephthalate (PET) or any other suitable material that can be formed by heating.

p00185Figures 7a and 7b demonstrate a method for manufacturing a complex valve, which has PU lamellae and PET tubular construction with a crown shape. PU is a material with excellent fatigue resistance but is sensitive to tearing. The PU is reinforced with the PET crown to allow a secure connection to an intravascular cannula by means of sewing, riveting or any other method of joining. A PET crown 86 is placed on a mandrel 87, which is then (rotated and) immersed in a dissolved PU container. The manufactured device is a valve assembly having lamellae 88 composed of pure PU, and therefore resistant to fatigue, and a main body made of PET with protuberant joint portions 90 suitable for constructing the joint in the PU.

p00186Figures 8a and 8b demonstrate a method for manufacturing a complex valve, which is based on flexible PU 92 in

p00187what has to do with the valve body, rigid PU support bars 94 that serve for the joint area and portions 96 of PET sleeve for the inlet valve. The need for a rigid joint portion (support bars 94) is explained by the tendency of the fatigue-resistant flexible material to tear as explained. The advantage of rigid PU support bars is that they chemically adhere to the main body, and this improves the overall durability of the valve due to the reduction of internal forces and friction in the joint area especially in the joint between the Two different materials. The valve is stripped by the method mentioned with reference to Figure 5, and the rigid PU support bar 94 is created by injection in mold, machining or any other suitable form. The rigid PU support bar 94 is placed in the valve and then immersed in the dissolved PU container. This is done while the valve is positioned on the mandrel (not shown). This method provides the ability to compose various materials in a single body and thereby obtain the advantage of the various properties of the materials when they are needed in different areas of the prosthesis.

p00188Figures 9 to 9i demonstrate different methods of attachment between a valve assembly and the intravascular support cannulas. A valve assembly 99 shown in Figure 9 is incorporated into the valve 100 shown in the Figure. 9a, where an intravascular support cannula 102 is connected to a valve assembly 99 through a support beam 106. A detail is shown in Figure 9b where, in cross section, it can be seen that the layer 108 is an optional internal support made of stainless steel or rigid polymeric material, the valve assembly 99 comprises a PET layer 105 coated with a layer of PU 104, with the external support bar 106. The connector 107 is a connector wire made of a strong material, such as stainless steel. Figure 9c illustrates an alternative arrangement for joining by means of a rivet 109, and in Figure 9d the joint is achieved by a suture 110.

p00189Figures 9e to 9g show a joining method comprising rigid shaped members 116, preferably made of metal, which tightly hold the PU 118 valve material by engaging in a U-shaped nest of PU 120 and which are attached to an intravascular cannula 122 by protuberant portions 124 provided in the rigid U-shaped member 116, which fit into the perforations 126 of the support bar 128 of the intravascular cannula 122. Figures 9h and 9i show another method of attachment, where rigid support bars are provided in the form of frame constructions 132, and the foldable material of the valve assembly 135 made of a tubular material is inserted through a gap of 137 in the frame. After insertion, an adjustment bar 133 is inserted through the pocket formed between the folding material and the frame and holds the valve in position.

p00190Figure 10 illustrates a pickling mandrel 139 with an extension portion 141, which improves the sealing capacity of the valve. Since the valve is attached to a collapsible intravascular cannula and is itself collapsible, it is difficult to determine the exact shape of the valve after folding and unfolding. It is of greater importance that the sealing is achieved. By adding extension 141, the lamellae become longer than necessary to close the exit exactly, and therefore when they are in a collapsed state, substantial portions of the lamellae fall on top of each other creating a better seal.

p00191Figures 11a to 11c illustrate a valve assembly mounted on a support intravascular cannula 144 with interlocking reinforcement wire 146, which improves the distribution of forces 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 base of the tricuspid valve 148, also has the ability to be folded 150 to a small diameter, together with the intravascular cannula, the valve and the balloon, as shown in Figure 11b. The forces applied to the edge of the valve 148 when in the working position are applied to the joining points, making the joint line longer reducing the force on each joint point. In this support method the valve is sutured 152 connected to the complete line of extra support wire 146. This wire can be made of stainless steel, nickel titanium alloy such as nitinol, or polymeric material. The support suture causes the valve assembly to dislocate along the dislocation lines while the valve material flexes more easily, thus ensuring proper operation of the valve flaps (lamellae). Optionally, the valve assembly shown in Figures 11a to 11c can be mounted on an intravascular support cannula such as that described herein or similar support structures. The reinforcing wire is intertwined in the valve assembly at the outlet of the conduit such that it defines a dislocation line around which the collapsible flaccid portion 154 of the valve assembly can flutter.

p00192Figures 12a to 12c represent a valve device provided with an intravascular cannula 159 and substantially equidistant rigid support bars 160, interwoven or attached to the flaccid portion of the valve assembly material 161, arranged longitudinally. This design allows the valve flaps to operate without external support. The support on the standard valves is made by attaching the top edge of the cusp to a rigid body, so that it reacts to the load as a suspension bridge. In this new design, collapse prevention is achieved in a similar way to an Indian store, that is, the rigid supports rest on one another 162 when the valve is closed but does not interfere with opening 164 when the valve is opened.

p00193Figures 13a to 13c illustrate the manufacture of a valve assembly. Initially a braided line of polyurethane 170 is fed from a supply of PU 172 and wound around a cylindrical drum 174 to form

p00194a spiral 176. Then, the drum 174 with the spiral 176 is immersed in a bath of PU 177, and a second layer 178 of the PU covers the spiral 176, making it a stronger construction capable of withstanding tearing forces both laterally and in others. addresses. By incorporating two different types of materials - such as PU and PET - greater durability and resistance to valve assembly can be generated. This material is an alternative material that can be used in the forging method shown in Figure 6.

p00195Figures 14 to 14c demonstrate the incorporation of heavy metal markers on the intravascular cannula, markers that allow observation and therefore the orientation adjustment when the device is placed in the required location. Heavy metals are radiopaque, that is, they are conspicuous about an angioscopic image, which is a two-dimensional image. Since the ostia of the coronary arteries 237 and 238 are located near the typical location of the valve deployment and must remain open, it is extremely important to ensure that the deployed valve assembly is not blocking a coronary ostium. In some cases the intravascular cannula is lower than the ostium and in these cases it will remain open, but in some cases as shown in these Figures it is necessary to ensure that the portion 239 of the intravascular cannula that is connecting the valve support 235 is opposite to coronary ostia, and in that way the blood supply is preserved through the shoring of the intravascular cannula. Two metal markers 232 are attached on the side of the outlet, a marker 230 on the side of the entrance. It is possible to adjust the angioscopic view to the plane of the left coronary as shown in Figure 14b and anatomically locate the other accordingly. If the two upper markers 232 are located in the two-dimensional radiographic image, one on top of the other, and the lower marker 230 on the opposite side, there is assurance that the coronaries are open to blood flow as seen in Figure 14c. Gold, platinum, iridium or tantalum are suitable biocompatible materials for the markers described above.

p00196Figures 15a to 15c illustrate a valve with a portion of radiopaque material 267 such as a gold strand at the sealing edge. When a valve is implanted, it is very important to have clear indications of how the valve works in vivo. Pressure measurements, flow visualization and doppler are used. However, it is also possible to examine the valve by ultrasound methods, observing the opening and closing of the valve cusps on a monitor. Figure 15b is an angiographic image 268 of the open valve, while image 169 of Figure 15c is the closed position as seen in the angiogram.

p00197Figures 16a to 16c illustrate a procedure, which helps to place the device in the longitudinal position. It is very important to place the device in the correct longitudinal position, since if it is too deep in the left ventricle it can interfere with the function of the mitral valve by improper closure or function of the valve. If it is positioned too high it can migrate, it can escape through the sinus cavities, which are located around it, and / or can block the coronaries. It is a necessary task to position the valve prosthesis in a narrow target location. A method of lateral orientation is shown in Figure 14, and Figures 16a to 16c illustrate a longitudinal positioning. The valve device (the valve assembly and the intravascular support cannula) is placed on an inflatable balloon catheter, comprising independently inflatable double chambers 303, 305, and inserted into the left ventricle 302 in the folded position and guided on a guide stylet or guide wire 300. The balloon, which is larger than the annular diameter when inflated, is inflated in the left ventricle 302, and then slightly pulled back from the entire device. The balloon is supported on the inner part of the ring 303, allowing the positioning of the device in the exact desired position. In addition, it temporarily blocks blood flow, and that improves the ability to hold the device in place while it is inflating. The next stage is to inflate the second balloon 305, which deploys the valve device in the desired location.

p00198The method of deploying a prosthetic valve device in the natural position of the aortic valve at the entrance of the left ventricle of a myocardium of a patient, as depicted in Figures 16a, 16b and 16c, comprises the steps of:

<dl><dt>(to)</dt><dd> providing a balloon catheter having a proximal end and a distal end, having a first and second independently inflatable portions, located the first inflatable portion at the distal end of the catheter and the second inflatable portion adjacently behind the first inflatable portion; </dd></dl>

<dl><dt>(b) </dt><dd>provide a guide tool to guide the balloon catheter in the patient's vasculature; </dd></dl>

<dl><dt>(c) </dt><dd>provide a deployable implantable valve prosthesis device adapted to be mounted on the second inflatable portion of the balloon catheter, </dd></dl>

<dl><dt>(d) </dt><dd>guide the balloon catheter through the patient's aorta using the guide tool, mounted the valve device on the second inflatable portion of the balloon catheter until the first inflatable portion of the balloon catheter is inserted into the left ventricle, while that the second inflatable portion of the balloon catheter is positioned in the natural position of the aortic valve; </dd></dl>

<dl><dt>(and) </dt><dd>inflate the first inflatable portion of the balloon catheter so that it substantially blocks the flow of blood through the natural aortic valve and anchors the distal end of the balloon catheter in position; </dd></dl>

<dl><dt>(F) </dt><dd>inflate the second inflatable portion of the balloon catheter such that it deploys the implantable prosthetic valve device in position in the natural position of the aortic valve; </dd></dl>

<dl><dt>(g) </dt><dd>deflate the first and second inflatable portions of the balloon catheter; and</dd></dl>

<dl><dt>(h) </dt><dd>retract the balloon catheter and remove it from the patient's body. </dd></dl>

p00199Figure 17 describes a positioning of the valve device 310 of the invention using an additional deployable intravascular cannula 320. Several problems may occur while the intravascular cannula and the valve are deployed at the location of the aortic valve: coronary blockage may occur which is dangerous if the diameter of the intravascular cannula is similar to that of the coronary aortic roots 309. Secondly, the migration of the entire device can also take place, which is a dangerous possibility, and there is the problematic challenge of accurately positioning the valve device that is very difficult to achieve, as already explained. This new special device designed with an inflatable balloon of double diameter and a double intravascular cannula design allows the placement of the device in such a way that the coronaries will not be blocked due to a safety difference that is maintained between the diameters, the longitudinal placement It is less sensitive due to the smaller diameter which ensures that overexpansion of the valve prosthesis is avoided. The distal intravascular cannula 320, which does not contain the valve, expands in the ascending aorta, while the proximal intravascular cannula 310 is simultaneously placed in the annular position. This method of placement represents a minor challenge thanks to the smaller diameter of the proximal intravascular cannula 310 which ensures that the mitral valve will not be deformed due to overexpansion since its dimensions are maintained, and the additional intravascular cannula decreases the risk of migration Of the device. It is safer to overdilate in the aorta which is not valid for the ring.

p00200The method of deploying an implantable prosthetic valve device in the natural position of the aortic valve at the entrance of the left ventricle of a patient's myocardium, as depicted in Figures 17a and 17b, comprises the steps of:

<dl><dt>(to)</dt><dd> providing a balloon catheter having a proximal end and a distal end, having a first and second independently inflatable portions, located the first inflatable portion at the distal end of the catheter and the second inflatable portion adjacently behind the first inflatable portion; </dd></dl>

<dl><dt>(b) </dt><dd>provide a guide tool to guide the balloon catheter in the patient's vasculature; </dd></dl>

<dl><dt>(c) </dt><dd>providing a deployable implantable valve prosthesis device adapted to be mounted on the first inflatable portion of the balloon catheter, and a deployable annular intravascular cannula device adapted to be mounted on the second inflatable portion of the balloon catheter, the valve prosthesis device being maintained implantable deployable and the intravascular cannula deployable separated by a predetermined distance; </dd></dl>

<dl><dt>(d) </dt><dd>guide the balloon catheter through the patient's aorta using the guide tool, mounted the valve device on the first inflatable portion of the balloon catheter and mounted the deployable annular intravascular cannula on the second inflatable portion of the balloon catheter, up to that the first inflatable portion of the balloon catheter is positioned in the natural position of the aortic valve; </dd></dl>

<dl><dt>(and) </dt><dd>inflating the second inflatable portion of the balloon catheter such that the deployable intravascular cannula device is deployed within the aorta thereby anchoring the deployable annular intravascular cannula and the valve device engaged in position; </dd></dl>

<dl><dt>(F) </dt><dd>inflate the first inflatable portion of the balloon catheter such that it deploys the implantable prosthetic valve device in position in the natural position of the aortic valve; </dd></dl>

<dl><dt>(g) </dt><dd>deflate the first and second inflatable portions of the balloon catheter; and</dd></dl>

<dl><dt>(h) </dt><dd>retract the balloon catheter and remove it from the patient's body. Figures 18a and 18b illustrate an accessory folding device that is adapted to fold a valve device in the operating room as part of the implantation procedure. The folding device 330 comprises several adjustable plates that recall a typical SLR camera variable restrictor. It is composed of simultaneously movable plates 332 each provided with a sheet 334, which are homogeneously dispersed in a radial symmetry but each plate moves along a line passing through an opening in the center, all equidistant plates of that central opening 336. Initially (see Figure 18a) the plates are separated providing an opening large enough to position the implantable valve within that opening. When the plates are brought towards the center (see Figure 18b), the opening 336 is reduced in size but still retains the annular shape, and this facilitates the folding of the valve frame to a small dimension suitable for percutaneous positioning. </dd></dl>

p00201Figure 19a depicts a folding method for the intravascular cannula of support of the valve prosthesis device of the present invention, whereby the intravascular cannula 340 is folded, that is, compressed or rolled. A folding device 343 is shown in Figure 19b, which comprises a body having an annular vacuum in which an expanded intravascular cannula is positioned. The lever 346 is connected to the end 347 of the intravascular cannula and as it is stretched from the lever, the intravascular cannula is wound or compressed around the axis 345 in a compressed position 349 (Figure 19c).

p00202Figures 20a and 20b represent a valve made of a single tube mounted on an intravascular cannula.

p00203352 During the systole period the tube is fully open and during the diastole period the tube collapses according to the mounting geometry 357 and reaches the seal.

p00204Figure 21 describes a newly designed support intravascular cannula 360 in its open position. Three of the longitudinal struts 362 are complete and thick and always remain at their constant original size, serving as an anchor support. Each of these shoring 362 is provided with a plurality of perforations 364, which are subsequently used to mount the valve assembly (not shown) and attach it to the intravascular cannula 360. Between the struts 362 a net type construction is provided, which can be folded to a narrow state and can be deployed again to a wider state.

p00205Figure 22 illustrates another implantable prosthetic valve. It comprises a metal tube 370, which has three portions with a thicker wall 371 than in the rest of the tube 370, these areas that form the longitudinal columns 372 in the construction, after the tube is cut into its final shape. The advantage of such construction is in its superior resistance to bending, in specific required portions of the construction, with minimal interference on the folded volume of the entire construction.

p00206Figure 23a to 23c represents a method for manufacturing an artificial or biological folding valve device. A piece of textile material 370 (Figure 23a) is immersed in PU to create a portion that is formed later in valve slides 371 (Figure 23b). This composite material 371 is then attached to an additional piece of textile such as PET 372 by means of seams, sutures or other joining technique 373 (Figure 23c). The resulting textile 375 is cut along the seam line 373 leaving enough material to subsequently suture the valve assembly to the support construction. A tubular shape is then formed and sewn 374 (Figure 23d). The tubular valve is then attached to a support construction 380 by suturing the lower part around the valve 379 tightly to prevent leakage, and around the textile cutting line 376 (Figure 23e). This open wall structure 378 allows blood to flow to the coronary arteries. The valve is placed further 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 trimming the textile 372 with the shaped cut 376, and thereby creating a valve with an external tubular shape. The realization of Figures 23a to 23c is easy to manufacture since it is generally flattened throughout most of the production process and only in the final stage of mounting on the support intravascular cannula is it given a three-dimensional shape .

p00207Reference is now made to Figure 24a illustrating a framework of an implantable prosthetic valve having means for mounting the valve slides that can form a tricuspid valve. Figure 24a represents an isometric view of the frame and Figure 24b represents a detailed cross-sectional view of the means for mounting the valve flaps 430. A frame 420, which is suitable for folding and expanding, has three support bars 422 for mounting the lamellae positioned substantially symmetrically around the circumference of the frame. Frame 420 is shown in Figure 24a in its deployed state. The support bar 422 has a "U" shaped side cross section, or profile (clearly shown in Figure 24b) that is designed to join a corner of the valve structure. The "U" shape can be produced by extrusion, wire cutting or by welding the "U" profile to the shoring of the frame 421 at the junction points 424. The support bar 422 is provided with a series of perforations 425 positioned along its back wall. The perforations 425 are designed to sew the valve assembly by threads, wires or other joining means.

p00208Figure 24b is a detailed cross-sectional view of one of the support bars 422. Two pericardium lamellae 430 are inserted through a U-shaped or fork-shaped support 428 that compresses and restricts the lamellae in the U-shaped profile. The lamellae 430 are folded on both sides of the support bar 422. When the support 428 is compressed towards the support bar 422, the lamellae 430 are retained between the support 428 and the support bar 422 such that the lamellae are held in place. Figure 24c is an exploded view of the support, the bar 426 has a series of compatible perforations for attachment to the frames of the support bar 422, the joint being reached by suture 423 or any other suture means. This method of joining allows the lamellae to be attached to the frame without piercing it with sutures and needles. It is also important that the lamellae are held firmly in place by the support 428 so that it has no relative movement with respect to the rigid frame; therefore wear is avoided due to movement. The lamellae that are made of pericardium are known to better withstand internal movements and tensions and less against movement wear against hard or sharp rigid bodies.

p00209It is noted again that the complete valve structure is adapted to be radially folded and radially expanded. This feature imparts to the valve the ability and ease of navigating through narrow passages in the vasculature during device positioning. After the 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 connecting means (the height of the valve) remains constant at all times; Thus, it is to serve as an anchor for the folding valve assembly. The lamellae are attached to the support frame in the joining means, and due to their constant length there is no need for elongation material since these joining points that remain at constant distances regardless of the position of the valve assembly (folded or unfolded) ). This is an important feature, which means that the manufacturer of the valve device must ensure that the valve assembly is secured and fixed to the support frame at all times. In implantable valve devices of the prior art, the complete support structure changes its dimensions from its first initial folded position to its final deployed position and this means that at the junction of the valve flaps to the support structure they must be held in Consider these changes in dimension and leave elongation material so that when the device is deployed, the valve assembly does not tear or deform. In the valve device there is no relative movement between the valve lamellae and the support bars (along the central longitudinal axis of the device). As a result, the valve device acquires greater durability and is capable of withstanding the harsh conditions prevailing within the vasculature and especially the millions of tension cycles applied by blood pressure.

p00210The fixed connection of the valve leaflets to the support frame in the valve assembly device gives it greater stability, enhanced safety, better sealing and consequently longer service life. The design of the invention valve device provides longitudinal strength and stiffness while its collapsible support structure provides radial flexibility.

p00211Figures 25a to 25d illustrate another implantable prosthetic valve. Figures 25a and 25b represent an isometric view and a top view of the valve assembly, respectively, and Figures 25b and 25d illustrate top views of two optional constructions for the mounting means of the lamellae. The pericardium lamellae 430 is mounted on a folding support frame 432. The frame is preferably made of three segments that form a circular support frame when assembled (Figure 25b). The pericardium slides 430 are attached to the deployable support frame 432 along three substantially equidistant and substantially parallel bars 440, which are integral parts of the support frame 432. The lamellae 430 are attached to the support frame 432 in the support bars 440 by suturing the lamellae 446 to the support bars 440 through the perforations 442 in the bars. The frame segments, preferably made of stainless steel, are preformed 432 and can be shaped in different ways. Figure 25c illustrates support frame segments 432a having bars 435a pointing inwards. Figure 25d illustrates support frame segments 432b having bars 435b pointing outward. The advantages of this technique are the possibility of manufacturing the frame segments from sheets (as opposed to tubes) and the ease of assembling the frame fragments with the pericardial lamellae.

p00212Figures 26a to 26c illustrate another tricuspid valve provided with a self-expanding frame. Figure 26a is an isometric view of an implantable prosthetic valve 430 mounted on a self-expanding frame 445. The implantable prosthetic valve 430 composed of three valve leaflets and is mounted on a self-expanding frame 445 such that each leaflet extends along an equidistant portion of the frame and is sutured on both sides opposite to substantially equidistant and substantially parallel bars 440 . Using a tapered tube 448 the complete assembly is folded inside a restriction tube 449. Figure 26b shows the folded valve assembly 447 in its final folded diameter ready for insertion into the body. After insertion into the desired location in the body, the valve is released from the restriction tube and since it is made of self-expanding material (for example an alloy with shape memory), it expands back to its original diameter and is anchored in the place. In order to reduce the diameter of the device from its fully expanded diameter to its folded diameter, a special tapered tube shown in Figure 26c is used.

p00213Figure 27 illustrates another isometric view of an implantable prosthetic valve having hooks designed to anchor the valve assembly to body ducts. An implantable prosthetic valve 450 is placed in a natural position of the aortic valve 452. The implantable prosthetic valve 450 preferably comprises three lamellae 430 mounted on a metal support frame 455. The lower part of the support frame 455 is provided with joining means, preferably with hooks 453. The hooks 453 ensure that the valve assembly remains in place after deployment, and cannot migrate to another position.

p00214Figure 28 illustrates a partial view of another implantable prosthetic valve. The union of commissure is shown in detail. This Figure demonstrates a joining technique that is used in order to join pericardium slides 430 to a metal frame 420. A longitudinal bar 456 having a narrow groove 457 is used as a commissure joint such that the extensions 463 of the pericardium foil 430 are inserted tightly through the groove 457. Pericardium extensions 463 that extend beyond the groove 457 are wrapped around a rigid bar 458 that acts as an anchoring means. Every two extensions that originate from

p00215two sides of the groove 457 are sutured to each other by a suture 459 next to the rigid bar 458 opposite the groove. An additional suture 462 joins the lower circumference of the support frame 420 to the lamella 420 in order to obtain a seal. The advantages of the described joint is that no sutures or suture holes are applied in the working area of ​​the lamella, there are no concentrated tension points similar to the tension points caused by the suture, and the distribution of forces is at length of the longitudinal bar 456. The narrow passage that is maintained through the groove 457 forces the lamellae so that they are static with respect to the support such that abrasion is reduced.

p00216The embodiments that will be shown hereinafter are optional joint configurations between the lamellae and the support frame.

p00217Figures 29a and 29b illustrate an isometric view and a top cross-sectional view, respectively, of a connection assembly of a valve frame to the lamellae. The joint is similar in principle to the joint shown in Figure 28, however, the longitudinal bar 456 is additionally provided with an additional tip 465 which is attached to the longitudinal bar 456 such that it establishes an integral part. The tip 465 is rounded to ensure that the lamellae will not be subjected to abrasion or cutting through sharp corners. In the cross-sectional view shown in Figure 29b, adjacent lamellae 460 can be compressed together and the main protection objective is clearly shown.

p00218Figures 30a to 30c illustrate in isometric view, a cross-sectional view and a flattened view, respectively, of a joint of a valve frame to the lamellae. Using the method shown in Figures 30a to 30c, the pericardial lamellae are precut to the desired shape 430 and subsequently provided with longitudinal bars 470 that are sutured to the lamellae creating a longitudinal pinching effect (Figure 30c). This allows the distribution of forces along the entire length of the joining means as opposed to the concentration of the tensions in the holes of the sutures. In Figures 30a and 30b, an additional rigid portion 458 has been added, which creates a rounded end, which prevents the lamellae from being drastically bent at the junction point portions of the frame 420. The connection to the frame 420 is brought to out using sutures 459.

p00219Figures 31a and 31b illustrate an exploded view and an isometric view, respectively, of a commissure joint representing the joint technique. A method for assembling pericardium lamellae 430 to a frame 420 is demonstrated. A rigid bar 476 provided with integrated protrusions 478 is inserted through the perforations 479 that are precut into the pericardium lamellae 430. The integral protrusions 478 pass through a PET textile sheet 475 (interwoven polyester), and finally, through perforations 442 that are provided in the longitudinal bar 440 (the joining means) of the frame 420. After mounting the pieces, as shown in Figure 31b, the pieces are assembled tightly and the protrusions of the bar 478 are joined to the bar 440 by welding, riveting or any other technique. PET sheet 475 is folded and sutured tightly around bar 476 using suture 472.

p00220Figures 32a to 32c illustrate the isometric view of a junction between lamellae and the frame. An optional method of joining is demonstrated, in which a pericardium lamella 430 and bars 480 are sutured in an area as far away as possible from the working area of ​​the lamellae. The pericardium is first sutured using a suture 484 to bar 480 as seen in Figure 32b, and then folded and compressed. In order to firmly hold the pericardium lamellae in place between the bars 480, an integral connecting member 482 connects the two bars, allowing the folded portions of the bars to be in parallel position, the lamellae being fixed in the middle. Then, an additional suture 483 connects the bottom side of the bar to the lamellae so that while the valve is working, the lamellae do not withstand high stresses.

p00221Figures 33a to 33d illustrate different views of portions of a joint between a pericardium and a frame demonstrating another method of attachment. A connection member 490 (shown in the deployed position in Figure 33d) is used to connect two pericardium lamellae 492 in the commissure line. After connecting with each other, pericardium slides 492 are connected to frame bar 480. Here again, the principle of compressing the lamellae between two folded portions of bars 491 of the connecting member 490 and adjusting them using suture 484 without punctures in the work areas of the pericardium is applied. However, the connection means 490 is provided with a portion 493 that is positioned perpendicular to the two bent portions of the bars 491 that hold the two lamellae together. Portion 493 is the bar connecting member 480 of the frame. In Figure 33a, the junction point 495 between the portions of the connection member 491 is placed at the top (outlet) of the frame such that a rigid connection to the frame is achieved. In Figure 33b, the junction point 495 is positioned at the bottom (inlet) of the frame such that the junction point also functions as a spring. A broader explanation of the benefits of springs at the commissures is discussed and demonstrated with respect to Figures 37 to 39.

p00222Figures 34a to 34c illustrate an isometric view of a joint between a pericardium and a valve demonstrating another method of attachment. A deployed portion and the folded portion, respectively, are shown in Figures 34b and 34c. An optional design for the union between the frame and the lamellae is represented. A connection member 480 (clearly shown in Figure 34b) is generated in a flat configuration using a laser cut. The connecting member 480, which is a part of the frame attachment means, bends and then is ready

p00223for set with the lamellae. The connection member 480 comprises the main body as well as the connection bar 497 and a flexible element 498 which gives the commissure flexibility. The lamellae 430 are braided through corresponding holes 481 in the structured connection member 480 and then sutured using a suture 482.

p00224Reference is now made to Figures 35a, 35b, and 35c illustrating isometric and cross-sectional views, respectively, of joining techniques between a pericardium sheet and a valve frame. Figures 35b and 35c represent different techniques of commissure joints: in Figure 35b two pieces of pericardium foils 500 are wrapped around a metal member 505 that is connected to a frame 501. The rigid members 503 are positioned from both sides of the metal members 505 and then fit together and are connected by a suture 502. All metal parts are wrapped by PET 508 textile in order to avoid direct contact between the pieces. Metallic and delicate lamellae of pericardium. The advantage of this structure is that after adjusting the suture, the entire corner is static without relative movement between the portions. This improves the resistance of the valve assembly to abrasion. In addition, there are no needle holes or sutures in the work area. Figure 35c represents a similar structure, however there is no use of rigid side bars. After wrapping the metal member 505 with pericardium foils 500, a piece of PET 508 is used to adjust it to a tight beam. In this case, the suture line 502 is the boundary of the work area so that it should be designed so that the stresses are in the best possible distribution.

p00225Figures 36a and 36b focus on the connection of the commissure assembly to the protrusion of the frame 509, which is an integral part of the frame and is the basis for the commissure joint. This example shows the use of four rigid longitudinal bars 503 connected by a suture 502.

p00226Figures 37a to 37c illustrate a commissure assembly where the connecting rod functions as a flexible support and has integral means of attachment to the frame. Figure 37b is an isometric view of the connection bar. The connecting bar 520 is flexible and comprises a resilient material shaped in a "U" shape. The connecting rod 520 is a part of the commissure assembly 527 shown in Figure 37a. The connecting bar 520 is provided with protruding elements 521 that act as attachment means to the frame bar 480. The protruding elements are designed for insertion into the corresponding holes 442 of the bar

p00227480. It is optional to provide bars 527 that are an integral part of the "U" shaped member and replace suture 526 that connects the pericardium foil and the connecting bar to each other, which is shown in Figure 37a. Figure 37c represents another method for attaching flexible connection bar 520 to frame 480 by welding 523. Here the pericardium lamella 500 are attached to the connecting bar 520 by means of suture 526 inserted through a PET textile 508 and two connecting bars 503, which together create a tight beam.

p00228Figures 38a to 38g illustrate isometric views of flexible commissures supports and methods for attaching them to a pericardium and a frame or valve. Figures 38a to 38c demonstrate the incorporation of different design options of commissure springs. The main purpose of a commissure spring is to reduce the impact applied to pericardium lamellae when the valve lamellae are closed. If the structure is rigid in nature, high tension will be applied each time the valve is closed. If a spring is added to the structure, the spring will withstand the highest portion of the impact, thus reducing the tension applied to the lamellae during the time the valve is closed. In Figure 38a, a simple stainless steel spring 530 is connected to the frame bar 480 by sewing a portion of the spring into flanges with groove 538 as shown in more detail in Figures 38e and 38f. In Figure 38b, there is a similar spring 530 with lamellae 500 connected thereto by one of the joining methods, the commissure support 530 itself is connected to the frame bar 480 by spot welding, laser welding or other means of Union. Figure 38c represents a similar spring 534 having an additional spiral. The purpose of such a spiral is to reduce the tension in the spring and withstand the fatigue requirements, which in the case of heart valves are at least 200 million cycles.

p00229Figure 38d illustrates an isometric view of a flexible commissure support demonstrating the attachment of the pericardium to the support. Figures 38e to 38g are the details of the attachment to the frame. A commissure spring of a different design 539 comprises a stainless steel wire of a small diameter with respect to the springs described in Figures 38a to 38c. An advantage of this structure is the distribution of tensions between the spring and the ability to form a structure, which can be folded to a smaller diameter. Another advantage of this structure is that there are no open edges of the spring, which can be dangerous during operation; the open edges are protected in the frame bar as shown in Figures 38e to 38g, which show possible methods of joining the spring to the frame. In Figure 38e, a cut-out flat frame bar 480 has recesses for folding the spring 536. Figure 38F shows the pre-bending of the recesses 527 and Figure 38g shows the legs of the spring 539 firmly assembled in the recesses 538.

p00230Figure 39a illustrates a commissure assembly technique using a shaped compression member 511. The compression member 511 holds the pericardium lamellae 500 firmly while pressing them on the pivot points 513. A radial edge 514 is made with in order to protect the pericardium from abrasion. The complete assembly is held tightly within the compression member 516. The commissure assembly is connected to the frame by a protrusion member 518, which fits into the perforations in the frame bar 480. Figure 39b is an isometric view of the same detail.

p00231Figures 40a to 40c illustrate an isometric view of a bicuspid valve mounted on a frame. Figures 40b and 40c represent 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 folding frame 540, two pericardium slides 545, a PET skirt 543 and a connection suture 547. The important point of this drawing is in the pocket shape of the pericardium foil best shown in Figures 40b and 40c. One of the main objectives in the design of the valve, in general, is to distribute the tensions in a homogeneous way between the pericardium material and the joint areas. The design of the pericardium foil as a pocket helps in the distribution of the tensions along the suture line 547; the pericardium sheet 545 is sutured to the PET skirt 543 along the connection suture 547. The PET skirt 543 is sutured to the circumference of the folding frame 540 on the lower side 549 and on the upper 542 using one of the commissure junctions described here before observing other embodiments. When hydrodynamic pressure is applied to the lamellae 545, the lamellae will be located in the center 546 of the frame 540 so that the valve assembly is sealed. The shape of the lamellae in the valve assembly is determined by the surrounding conditions, which in this case are the suture lines. Suture lines can be designed to have an optimal shape with respect to stress distribution according to geometric constraints.

p00232Reference is now made to Figures 41a to 41d illustrating isometric views of a tricuspid implant prosthesis valve. Figure 41a illustrates valve assembly 553 in an open state. The valve assembly 553 comprises a frame 555 (rigid or flexible), pericardium slides 550 and bar 551. It is emphasized that in the embodiment shown, the objective is to distribute the tensions of the commissure arrangement in an optimal manner. Pericardium lamellae 550 are attached to bars 551 which acts as joining means. The joining means are positioned in the upper third of the valve; The lower circumference is attached to the frame in order to obtain a complete seal. The middle part of the pericardium is left elongated. The pre-cut pericardium is cut into dimensions larger than the frame; for example, the height of the pericardium sheet is greater than the height of the frame, for example, if the height of the frame is 15 mm, the pericardium will be cut at a height of 18 mm so that a flaccid portion is established in the middle area of ​​the valve assembly 553. Figure 41b represents the valve assembly in a closed state. The flaccid portion of the pericardium collapses in half while creating a small pocket shape 554, which helps in the distribution of tensions. Figure 41c shows the detailed commissure and the short bar joint as well as the sealing area of ​​the circumference in the lower portion of the pericardium assembly. It is shown in the Figures that the bars 551, which are relatively short, allow a firm bond of the upper portion of the flaccid commissure portion in the middle, and a good sealing surface in the lower portion 556.

p00233Reference is now made to Figures 42a and 42b illustrating an isometric view of an implantable prosthetic valve having a different commissure joint. Figure 42b represents the joint in detail. A similar valve assembly is illustrated in Figure 42a, while the short bar is arranged such that it is similar to the structure shown in Figure 28 and described hereinbefore. The relatively short bars 559 act as attachment means to the frame bar 558. Suture 557 joins short bars 559 to a member 558, the suture can be made of an elastic material such that it adds flexibility to the corners and gives the Valve set the benefits already explained here.

p00234Reference is now made to Figures 43a and 43b illustrating an isometric view of an implantable prosthetic valve. Figure 43a represents commissures that are presuturated in a tapered shape. The valve assembly shown in Figure 43a comprises a frame 560, pericardium slides 563 and joining means 561. The pericardium slides 563 are shown in an open state such that an open valve assembly is established while the dotted lines 565 show the valve in a closed sealing state. The union to the commissures can be carried out using one of the explained techniques. Specifically for the embodiment shown in Figures 43a and 43b, the point of interest is in the formation of a tapered valve in which the joining means is in the form of long bars 561 that are attached to the pericardium in an angular shape in opposition to the parallel union. By joining the bars in an angular shape when the pericardium is flattened, a tapered tube is created when it is incorporated into the three-dimensional shape. When the complete prosthetic valve is inflated by a balloon, the pericardium sheet, in the upper circumference of the frame, is stretched and the frame expands to full diameter. After deflating the balloon, the frame remains in its expanded size but the pericardium lamellae recover their pre-stretched shape. This procedure creates a permanent separation distance 562 between pericardium slides 563 and frame 560. This is of the greatest importance for the protection of the pericardium against abrasion against the frame.

p00235Reference is now made to Figures 44a to 44c illustrating an isometric view of an implantable prosthetic valve with additional PET parts used to seal and protect the pericardium. The implantable valve assembly illustrated recalls the valve shown in Figure 43, however it is emphasized that the union of the pericardium slides 570 to the frame 575, have the use of PET. Figure 44c shows in a cross-sectional view the way in which the PET is assembled to the pericardium and the frame so as to protect the pericardium from wear. PET 571 and 572 are used to connect pericardium lamella 570 to frame 575, in turn they are assembled between the lamellae and the frame. A suture 577 connects the pericardium sheet 570 in the middle of the two PET layers, while the inner layer of PET 572 is short and the outer layer is longer. Suture of

p00236576 bottom joint, connects the three layers, the lamellae and both layers of Py col frame and forms a strong sealing line. An upper suture 578 connects the outer layer of PET 571 to the frame 575. When the valve assembly is closed and the pericardium lamellae approach each other at the top of the assembly, there is a tendency of the lower joint to move and rotate around of a junction point 577. The upper suture line 578 keeps the outer PET layer tight and avoids a part of this rotational movement, which quickly causes an abrasion failure.

p00237Figures 45a to 45d illustrate an isometric view of an implantable prosthetic valve having lamellae sutured in a preformed PET tube and optional lamellae-tube joints in detail. A technique for mounting 580 pericardium slides to a preformed PET 585 tube is shown. The tube is shaped such that it has a fold 586 with a substantially sinusoidal pattern 586 that is similar to the optimal connection line of the valve slides in the natural valve. This shape allows the pericardium lamellae to be sutured inside the PET tube. Preferred suture techniques are shown in the cross-sectional views of the PET tubes in Figures 45b, 45c and 45d. In general, in order to protect the pericardium lamellae from tearing, an additional piece 583 of PET is added below the suture lines. Similar variations are shown in Figures 45c and 45d.

p00238Reference is now made to Figure 46a illustrating an exploded view of an assembled prosthetic valve assembly where the lamellae are mounted on a pre-cut and preformed tube and the valve outlet is cut in the form of a commissure. Figure 46a is a view of the joint. A preformed PET 590 tube is cut to have a substantially sinusoidal shape 596 and then folded in order to provide a suture area. Pericardium foil 593 is precut and assembled to PET tube 590 by means of suture 502. In this case, as in the previous case, an additional PET or pericardium protective layer 594 is added. Figure 46b is a cross section of the joint detail after being tightened.

p00239Figures 47a to 47c illustrate a side cross-sectional view of an inflatable balloon. The balloon is a part of an implantable prosthetic valve delivery system. Figures 47b and 47c are transverse top views in the inflated and deflated positions, respectively. The specially designed balloon shown in the Figures preferably comprises four inflatable members, three substantially identical and symmetrical sections 600 and a central section 602. Pericardium lamellae 612 are positioned between sections 600 and separate them. A frame 610 surrounds the inflatable members and a balloon shaft 619 that is positioned in the center of the administration system while a commissure connection 613 connects the pericardium slides 612 to the frame 610. The inflatable balloon sections 600 are positioned between the frame 600 and the pericardium lamellae 612 such that when the inflatable members inflate, they push the lamellae 612 towards each other and the frame 610 such that a completely closed position is established . This technique preserves the lamellae better since there is no contact between the lamellae and the frame apart from the commissure connection. The conservation of the lamellae is improved even in inflation times as well as after inflating the valve and establishing a closed position. Figure 47a clearly shows the fourth inflatable member of the balloon, central section 602. Through the central section 602, the inlet 617 of the valve is inflated while the inflated center section ensures that the entire valve is fully inflated to a shape substantially round. Figure 47c shows the assembly in a folded position. Frame 610 is folded and sections 600 are deflated. 612 pericardium slides are also shown in folded configuration.

p00240Figures 48a and 48b illustrate a side view in partial cross-section and a top cross-sectional view of an inflatable balloon. The inflatable balloon comprises a central inflatable balloon 620 and three protective sheets 622. In the lateral cross-section shown in Figure 48b, the parts of the inflated assembly 652 are clearly shown, the protective sheets 622 protect the pericardium lamellae 624 preventing are pushed against the 625 frame when the device is inflated. The advantage of this provision lies in the protection of pericardium lamellae.

p00241Implantable prosthetic valves according to the present invention are relatively easy to manufacture since they are generally flat throughout the entire production process and only at the final stage of assembly of the other elements of the valve assembly on the support frame. , a three-dimensional form is established.

p00242A typical size of an aortic prosthetic valve ranges from about 19 to about 25 mm in diameter. A maximum catheter size inserted into the femoral artery should not be 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 according to the present invention have the ability to change shape and size for administration purposes and are therefore novel. These designed valves require manufacturing methods and technical improvements and inventions, some of which are described herein.

p00243As mentioned earlier, the material from which the valve is made can be either biological or artificial. In any case, new technologies are required to create such a valve.

p00244To attach the valve to the body, the blood vessels determine the size during administration, and the requirements for it to work efficiently, and must be mounted on a collapsible construction that can be folded to a small size, expanded to a larger size, and strong enough to act as a support for the function of the valve. This construction, which is somehow similar to a “cannula

p002455 Large intravascular ”can be made of different materials such as nitinol, biocompatible stainless steel, polymeric material or a combination of all. The special requirements of the intravascular cannula are described herein.

p00246Mounting the valve on a collapsible intravascular cannula is a new field of problems. 10 new solutions for this problem are described herein.

p00247Another main aspect of the valve design is its attachment to the body.

p00248In the traditional procedure the valve is sutured in place by a complicated suture procedure. In the case of the percutaneous procedure, there is no direct access to the implantation site, therefore different binding techniques are required.

p00249Another new problem discussed in this document is the administration procedure that is new and unique. The positioning of the device in the body in an exact location and orientation requires special methods of marking and measuring the device and the surgical site as described herein.

p00250Artificial polymer valves require special treatments and special conditions during storage, as well as a special sterilization procedure. One of the consequences of storage treatment 25 is the need to fold the valve during the implantation procedure. A series of devices and inventions that allow the folding procedure have been described herein.

p00251It should be clear that the description of the embodiments and attached Figures defined in this specification serve only a better understanding of the invention, without limiting its scope as covered by the following claims.

p00252It 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 the embodiments described above, which would continue to be covered by the following claims.