WO2017103830A1

WO2017103830A1 - Single tissue leaflets of a prosthetic valve

Info

Publication number: WO2017103830A1
Application number: PCT/IB2016/057642
Authority: WO
Inventors: Harshad Amrutlal PARMAR; Deveshkumar Kothwala MAHENDRALAL; Nilay Mohanlal LAD
Original assignee: Meril Life Sciences Pvt Ltd
Priority date: 2015-12-15
Filing date: 2016-12-15
Publication date: 2017-06-22
Also published as: EP3310267A1; EP3310267A4

Abstract

A prosthetic heart valve having a plurality of leaflets formed from a single continuous tissue is disclosed. The leaflets made from a single continuous tissue are seated in a support frame having plurality of expandable cells. Semi-circular arcs of the leaflets are attached to a bottom row of the support frame while attachment nodes of rectangular cross-sections of the tissue are attached to commissures of the support frame. The tissue at the attachment nodes can be sutured to the support frame with leaflet sutures being positioned outside the support frame.

Description

SINGLE TISSUE LEAFLETS OF A PROSTHETIC VALVE

FIELD

[001] The present disclosure relates to embodiments of a prosthetic heart valve specifically, the present disclosure relates to leaflets of the prosthetic heart valve. BACKGROUND

[002] Prosthetic cardiac valves have been used for many years to treat cardiac valvular disorders. The native heart valves (such as the aortic, pulmonary and mitral valves) serve critical functions in assuring forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital, inflammatory or infectious conditions. Such damage to the valves can result in serious cardiovascular compromise or death. For many years, the definitive treatment for such disorders was surgical repair or replacement of the valve during open heart surgery, but such surgeries are prone to many complications.

[003] More recently, a transvascular technique has been developed for introducing and implanting a prosthetic heart valve using a flexible catheter in a manner that is less invasive than open heart surgery. In one embodiment of this technique, a prosthetic valve is mounted in a crimped state on the end portion of a flexible catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The valve near the catheter tip is then expanded to its functional size at the site of the defective native valve such as by inflating a balloon on which the valve is mounted. Alternatively, in accordance with another embodiment, the valve can have a resilient, self-expanding stent or support frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter.

[004] Either of the two embodiments of valves incorporates a support frame or stent that is typically a tubular structure and a plurality of leaflets. Typically, three leaflets made up of three individual pieces of tissue, are used which are seated in the support frame such that they form cusps in the support frame. The leaflets are stitched together and attached to the support frame at one end and have other end unattached to the support frame. The unattached ends are pushed open to permit blood flow but return to closed configuration to seal and prevent backflow of blood.

[005] Due to three joints being sutured, chances of peravalvular blood leakage through joints are high. Further, due to more stitching, chances of tissue tear at/around stitching points increase. [006] There thus, remains a need for an improved leaflet arrangement to be used in stent or support frames.

SUMMARY

[007] Certain embodiments of the present disclosure provide a prosthetic heart valve having a plurality of leaflets formed from a single continuous tissue. The tissue has a top rectangular cross- section followed by a plurality of semi-circular arcs at the bottom. Each of the semi-circular arcs corresponds to an inflow end of a leaflet of the plurality of leaflets. The rectangular cross-section includes a plurality of attachment nodes such that each attachment node extends from a junction of two consecutive semi-circular arcs of the plurality of semi-circular arcs across the width of the rectangular cross-section.

[008] In some embodiments, a support frame seating the plurality of leaflets is provided. The support frame includes a plurality of rows of expandable cells. The semi-circular arcs of the leaflets are attached to a bottom row of the support frame while the attachment nodes of the rectangular cross- section are attached to commissures of the support frame provided in the top row. The tissue at the attachment nodes can be sutured to the support frame with leaflet sutures being positioned outside the support frame. Further, the commissures are made of polymer that provides higher flexibility to commissures and reduces high stress on the tissue at the attachment nodes. In some embodiments radiopaque markers are attached to one of the first two rows of the support frame for fluroscopy.

[009] The foregoing and other features and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.

[0011] FIG. 1A is a perspective view of a support frame for a prosthetic valve according to an embodiment of the present disclosure. [0012] FIG. IB is a front view of the support frame of the valve of FIG. 1A according to an embodiment of the present disclosure.

[0013] FIG 1C is an enlarged view of commissures in the support frame of FIG. 1A.

[0014] FIG ID is a perspective view of a support frame for a prosthetic valve according to an embodiment of the present disclosure.

[0015] FIG. IE is an enlarged view of commissures in the support frame of FIG. ID.

[0016] FIG. 2 depicts an exemplary leaflet tissue.

[0017] FIG. 3 illustrates an exemplary embodiment of a prosthetic valve depicting details of outflow end portions of the leaflets according to an embodiment of the present disclosure. [0018] FIG. 4 illustrates an exemplary embodiment of a prosthetic valve depicting details of inflow end portions of the leaflets according to an embodiment of the present disclosure.

[0019] FIG. 5 illustrates a perspective view of the prosthetic valve with leaflets seated in the support frame.

[0020] FIG. 6 illustrates a manufacturing process of the prosthetic valve according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0021] Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment," "in an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean "one or more but not all embodiments" unless expressly specified otherwise. The terms "including," "comprising," "having," and variations thereof mean "including but not limited to" unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms "a," "an," and "the" also refer to "one or more" unless expressly specified otherwise.

[0022] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.

[0023] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments as set forth hereinafter. [0024] Disclosed embodiments of an improved radially expandable and compressible support frame having a plurality of leaflets made of a single continuous tissue can be used with any prosthetic valve, such as a prosthetic aortic heart valve. Embodiments of the leaflets made of a single continuous tissue advantageously reduce the stitching process, thereby reducing wear and tear of the tissue. By using a single continuous tissue, the multi-leaflets arrangement has only one sutured joint instead of multiple joints as known in conventional arts. This tremendously reduces the chances of peravalvular blood leakage through joints and tearing of tissue from the stitching points which increases the life of the prosthetic valve after implantation.

[0025] FIG. 1A shows one exemplary embodiment of a support frame 100. The support frame 100 may comprise a plurality of strut members 105 interconnected to each other to form a mesh structure; having an inflow end 110 and an outflow end 115. Further, the support frame 100 may include a plurality of link members 120 that may connect four strut members 105. The plurality of strut members 105 and link members 120 may be arranged to form repeating diamond-shaped, expandable cells 125. The strut members 105 and link members 120 may be welded or otherwise secured to each other so as to form a mesh structure. In some embodiments, the support frame 100 can be formed as a single, integral body. For example, in some embodiments, the support frame 100 is laser cut from a metal tubing as a single piece. While the support frame 100 is illustrated as a cylindrical tube with uniform diameter (FIG. IB), it is possible that the support frame may bulge at the center while tapering inwardly at the ends or may taper inwardly from an end to a reduced diameter section at the center.

[0026] The support frame 100 can comprise a suitable ductile material, such as cobalt nickel chromium. [0027] In an embodiment, there may be multiple rows of diamond-shaped, expandable cells 125, although more or fewer rows of cells are also possible. For example, in one embodiment the support frame 100 (as illustrated in 1A) may include two rows of diamond-shaped, expandable cells 125 with a first row 130 positioned adjacent to the inflow end 110 and formed of substantially identical cells 125 around the entire circumference of the support frame 100. A second row 135 also made of substantially identical cells 125 may be positioned on top of the first row 130 with the free end of the second row 135 positioned adjacent to the outflow end 115.

[0028] In another example, the support frame 100 (as illustrated in ID) includes three rows of diamond-shaped, expandable cells. A plurality of first rows 155 and 160 is positioned towards the inflow end 110 and are formed of substantially identical cells around the entire circumference of the support frame 100. A second row 135 also made of substantially identical cells is positioned adjacent to the row 160 of the first rows with the free end of the second row 135 positioned adjacent to the outflow end 115. In an embodiment, the maximal diameter of the cells in first two rows 155 and 160 is less than the maximal diameter of the cells of the second row 135.

[0029] In one embodiment, the support frame 155 includes one or more cavity 170 for attaching radiopaque markers. The markers provide for better vision ability under fluoroscopy. The markers enable a surgeon to correctly position a stent at the site where it is to be deployed. The cavity 170 may be provided on one or more link members 120 of the first and/or second rows of expandable cells. For example, as depicted in FIG. ID, row 155 includes a plurality of cavities 170 for attaching radiopaque markers. A radiopaque marker is deposited at least partially by an interference fit within the cavity 170. Alternately, a radiopaque marker is laser welded or micro-welded to the corresponding cavity 170. The radiopaque marker may be of different shapes like rectangular, oval, etc. Also, the height of the marker may vary as per the diameter of the cavity 170 and may range from 0.80 to 1.30 mm. The radiopaque marker may have a width of 0.40 mm and thickness of 0.36 mm. The radiopaque markers can be made of for example, Platinumiridium, Tantalum, Gold, Platinum, etc. In an embodiment, multiple radiopaque markers may be deposited in multiple cavities 170 on spaced apart link members 120 of one or more rows (first or second). [0030] The commissures 140 may be provided on respective link members 120 of the support frame 100. The commissures 140 may include an elongated body 145 with three holes 150 provided therein (FIG. 1A). The elongated body 145 may be rectangular planar in shape and contain holes/slots 150 placed along/around a central axis. The holes may be circular, spherical, tapering, etc. in shape. There may be more or fewer holes 150 in the commissures 140 as required. For example, the commissure 140 may be provided with an elongated slot 150 extending along the length of the same (FIG. IE). In an embodiment, the commissures 140 may be made from a polymer, for example, PET i.e. Polyethylene terephthalate. The use of polymer highly increases the flexibility of the commissures 140 and reduces significantly the stress developed on the folds of the leaflets, thereby, minimizing wear and tear of the leaflets and/or degradation of the collagen of the tissue.

[0031] The multiple leaflets, say three, are made of a single continuous tissue (described in FIG. 2) and attached to the respective commissures 140 provided on the support frame 100 of a prosthetic valve. In embodiments of a prosthetic valve with more or fewer leaflets, corresponding number of commissures are provided in the support frame. [0032] The strut members 105 are made of a suitable shape memory material, such as cobalt chromium, nickel titanium alloy known as Nitinol, etc. that allow the valve to be compressed to a reduced diameter for delivery in a delivery apparatus and then causes the valve to expand to its functional size inside the patient's body when deployed from the delivery apparatus.

[0033] The prosthetic valve of the present disclosure is a balloon-expandable valve that is adapted to be crimped onto an inflatable balloon of a delivery apparatus and expanded to its functional size by inflation of the balloon. The diameter of the prosthetic valve may be selected based upon requirement.

[0034] FIG. 2 is an exemplary diagram of a single continuous tissue 200 which is adapted to form multiple leaflets of a prosthetic valve. Though in the figure, tissue 200 is contoured for three leaflets as an exemplary embodiment, the tissue 200 may be contoured for fewer or more leaflets. The tissue 200 may be an elongated continuous tissue having a rectangular cross-section 205 followed by a plurality of semicircular arcs 210. The rectangular cross-section 205 has a free end 220 while the end opposite to the free end 220 sits on the top end of the semicircular arcs 210. The arcs 210 may be positioned towards the inflow end 110 of the support frame once the tissue 200 is sutured to the support frame 100. The tissue 200 is depicted to have three arcs corresponding to three leaflets to be deployed in a prosthetic valve; however, based upon the number of required leaflets, more or fewer arcs may be formed in the tissue 200. [0035] In the rectangular cross-section 205, two attachment nodes 215 are provided. The attachment nodes 215 extend from the junction of two arcs 210 upwards across the width of the rectangular cross-section 205 towards the free end 220. The attachment nodes 215 may also be considered to correspond to conventional sutured connections between two leaflets. The attachment nodes 215 may be small rectangular or square segments identified on the tissue 200. The tissue segment corresponding to the attachment nodes 215 is attached to the commissures 140 when the tissue is placed in the support frame. Once the attachment nodes 215 are attached to the commissures 140, the tissue folds about the longitudinal axis A-A' to form leaflet cusps as explained in FIG. 3.

[0036] The free ends 225 of the tissue 200 may be sutured together once the tissue 200 is seated inside the support frame 100 and thereafter, the tissue may be attached to the respective commissure 140. The multiple leaflets formed from the tissue 200 of the present disclosure need to be sutured only once at the two free ends 225 unlike conventional arts in which every two leaflet tissues have to be sutured together to form a continuous leaflet assembly. This use of single continuous tissue 200 thereby reduces the total tissue material required to form three leaflets. Further, the ingrain and fibrous structure of the tissue 200 remains the same across the entire cross-section of the tissue 200 which acts as an added advantage for the leaflets as the leaflets are formed of same ingrain and fibrous structure. Once sutured, the three leaflets of the tissue act as a valve that regulates the flow of blood through the valve.

[0037] The tissue 200 can comprise any suitable biological material (e.g., pericardial tissue, such as bovine, porcine, canine, or equine pericardium), other biological membranes, bio-compatible synthetic materials and fabrics.

[0038] FIG. 3 illustrates an exemplary embodiment of a prosthetic valve 300 depicting details of outflow end portions of the leaflets 305. The valve 300 is provided with the support frame 100, a plurality of leaflets 305 seated in the support frame 100 and a skirt 310 (better evident in FIGS. 4 and 5). The plural leaflets 305 of the valve 300 have respective inflow end portions (not shown) and outflow end portions 315. The inflow end portions of the leaflets 305 correspond to arcs 210 of the tissue 200 (further explained in FIG. 4) of which the leaflets 305 are made while the outflow end portions 315 correspond to the rectangular cross-section 205 of the tissue 200. The inflow end portions of the leaflets 305 can be secured to the inside of the support frame 100 near the inflow end portion 110 of the support frame as depicted by arrow 325. Suitable attachment methods for the inflow end portion of the leaflets can be used as known in the art. [0039] The attachment nodes 215 of the tissue 200 are attached to two commissures 140 while the ends 225 are sutured together at the third commissure 140. To attach the attachment nodes 215 to the respective commissures 140, the tissue is folded along the axis A-A' (shown in FIG. 2) such that the rectangular cross-section on either side of the axis A-A' are aligned together forming a fold. At the fold, a cloth may be placed on either side of the outside of the tissue and sutured to the commissure 140. For suturing, a cloth covered pin, a cloth covered Mylar insert, a thin polyester insert, or a small bar or pin made of metal and/or plastic may be used. The bars or pins can be of very small diameter and positioned outside of the support frame 100 so as not to limit the amount of crimping of the support frame 100 for delivery. It may be noted that one or more sutures can secure the cloth covering of the bar or pin to the cloth covering of the support frame 100.

[0040] At the third commissure 140, the ends 225 are sutured together and then, a cloth may be placed on the outer side of the sutured tissue. This assembly is then sutured to the commissure 140 as described above. It may be noted that as per the teachings of the present disclosure, it is not required to extend the leaflet through and outside a commissure hole 150 to attach the leaflet to the support frame 100. Rather, because the leaflets 305 are made of a single continuous tissue 200, at the point of attachment, the tissue is folded and attached to the inner side of the support frame 100. This reduces the amount of tissue required to make a leaflet and also the amount of suturing required to attach the leaflets 305 to the support frame 100. In fact, due to the novel arrangement, the thickness of the tissue can be reduced which may help in crimping the valve 300 further. At the center 320, the outflow end portions 315 converge.

[0041] The leaflet sutures can be positioned outside of the support frame 100 and outside of a cloth covered pin or insert, the leaflet sutures can be positioned far enough away from the high stress regions of the leaflets so as to be substantially shielded from the stresses applied to the leaflets during physiologic loading. This positioning can advantageously allow for use of a thinner leaflet material, which in turn can allow for a smaller crimped delivery diameter of the prosthetic valve 300.

[0042] FIG. 4 illustrates one embodiment of securing the inflow end portions of the leaflets 305 to the support frame 100. The prosthetic valve 300 may include an annular reinforcing skirt 310 that is secured to the inner surface of the support frame 100. The skirt 310 is sutured to one of the first rows 130 of strut members 105 on the inner surface of the support frame 100 along a suture line 405 that tracks the arcs 210 of the leaflets 305. The inflow end portion (namely, arcs 210) of the leaflets 305 can be secured to the support frame 100 by suturing the skirt 310 to strut members 105 of the lower section of the support frame 100 such that the skirt 310 is sandwiched between the support frame 100 and the arcs 210 of the leaflets 305. [0043] In some embodiments, the leaflet assembly can further include an inner reinforcing strip that is secured to the inner surfaces of the inflow end portions of the leaflets 305. The skirt 310 can comprise a suitable tear resistant fabric, such as PET or Dacron fabric. Further, the diameter of the skirt 310 is reduced. This ultimately reduces the crimp profile of the valve 300 on its delivery system and causes less trauma in an artery when the valve is introduced in the artery.

[0044] In some embodiments, at least a portion of the support frame 100 and/or portions of the leaflet can be covered with a cloth covering, such as Dacron, in order to facilitate leaflet attachment. For example, the cloth covered pin that the leaflet wrap around and/or the inflow end portion of the leaflets 305 can be sutured to a cloth covering surrounding the support frame 100. In some embodiments, the commissure 140 can be cloth covered to facilitate leaflet attachment. In some embodiments, the entire support frame 100 can be cloth covered.

[0045] FIG. 5 illustrates an exemplary perspective view of the valve 300 with the leaflets sutured to the frame 100. Further, the skirt is wrapped around the bottom part of the frame with substantially less crimp. [0046] The disclosed support frame and the overall prosthetic valve are radially compressible to a compressed state for delivery through the body to a deployment site and expandable to its functional size at the deployment site. Apparatuses particularly suited for percutaneous delivery and implantation of a self-expanding or balloon-expandable valve. Generally, the prosthetic valve can be implanted in a retrograde approach where the valve, mounted in a crimped state at the distal end of a delivery apparatus, is introduced into the body via, for example, the femoral artery and advanced through the aortic arch to the heart.

[0047] FIG. 6 illustrates a manufacturing process of the prosthetic valve. In the step 601, the scaffold/frame pattern is created on a tube for example, a metallic tube, by laser cutting. During laser cutting, the tube may be fed into a laser machine and a laser beam is directed and impinged onto the tube to cut desired scaffold/frame pattern/work on the support frame. For example, the frequency (Hz) of the laser beam may range from 9800-10000 Hz, the pulse width may range from 0.047 to 0.050 ms, the average power (W) may be 46.06 to 50.00 W and pressure of 10 to 12 bar of laser beam.

[0048] In the step 603, the support frame with scaffold/frame pattern is subjected to descaling to remove excess metal oxide. For descaling the support frame, ultrasonic vibration is applied in an acidic media for 360-450 minutes at a temperature range of 50°C - 60°C. In the descaling process, different types of acidic media may be used. For example, nitric acid (HN0₃) (69-72% cone.) (A. . Grade) and Hydro fluoric acid (HF) (40% cone.) (A.R. Grade) may be dissolved in the purified water in ratio of 18.0 ± 1 % & 6.0 ± 0.1 %. The descaled scaffold/frame may be then washed using purified water to remove any chemical residues.

[0049] In the step 605, annealing is performed to regain the mechanical properties of the support frame. The descaled support frame is loaded in a crucible and subjected to a thermal cycle inside the annealing furnace. The annealed support frame is then cooled under vacuum. A specific range of temperature and vacuum may be optimized for the same purpose. For example, thermal cycle is carried out at the higher temperature ranging from 1155±15 °C for 500 seconds.

[0050] In the step 607 to improve surface smoothness and to obtain final dimensions of the support frame electro polishing is performed. In this step, extra metal is removed from the surface of the support frame by passing of a current ranging from 1.8 to 2.3 (amp). During treatment with current, the support frame is immersed in an exemplary liquid medium namely, electrolyte (ethylene glycol (99%, A Grade):85%; sulphuric acid (98%, AR Grade):10%; hydrochloric acid (35.4%, AR Grade): 5%) along with cathode and heated to 45±5°C. The support frame is further connected to a power supply. The applied current controls the rate at which the metal ions from the support frame surface migrate through the liquid medium to the cathode. To obtain a bright spot free, mirror like surface finish and final scaffold/frame dimensions, the electro polishing process is carried out in three cycles. The radiopaque markers are then deposited on to the electro-polished scaffold/frame.

[0051] In the step 609, pre-cleaning of the support frame is performed for removing impurities. The support frame is cleaned using deionized water and subsequently air-dried using nitrogen gas. If the surface of support frame is free from any foreign contamination, the support frame is stored for transportation.

[0052] In the step 611, the prosthetic valve is assembled by stitching leaflets and skirt on to the support frame. Skirt can be secured to the inside of the support frame via a polyester suture. Leaflet structure can be attached to the skirt via a thin PET reinforcing strip (or sleeve), which enables secure suturing and protects the pericardial tissue of the leaflet structure from tears. In an embodiment, the leaflet structure can be sandwiched between the skirt and thin PET strip. Suture desirably tracks the curvature of the bottom edges of leaflet structure as described in diagrams above.

[0053] In the step 613, sterilization of the prosthetic valve is performed using liquid chemical sterilization. In an embodiment, the prosthetic valve is sterilized in two steps. Firstly, the prosthetic valve is treated with a liquid chemical germicide (LCG) inside an incubator with an optimized temperature range. One or more sterilization agents like formaldehyde, ethanol, tween 80, sodium phosphate dibasic (AR Grade) (Na2HP04), potassium phosphate monobasic (AR Grade) (KH2P04), glutraldehyde, sodium phosphate dibasic (AR Grade) (Na2HP04), potassium phosphate monobasic (AR Grade) (KH2P04), sodium chloride (NaCI), purified water, etc. may be used in this step. Finally, the processed prosthetic valve is rinsed to remove chemical residue using deionized water.

[0054] In the final step 615 of the manufacturing process of the prosthetic valve, the chemically sterilized prosthetic valve is packed in a jar. The jar may contain a storage solution like glutaraldehyde. The jar with prosthetic valve is then placed inside a thermocol box contacting ice bags to maintain a temperature of 10°C-25°C.

[0055] The prosthetic valve of the present disclosure provides relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific. Further, using single tissue leaflets allows good hemodynamic performance leading to optimal blood flow to increase human heart efficiency and activity.

[0056] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims.

Claims

WE CLAIM:

1. A prosthetic valve comprising: a plurality of leaflets formed from a single continuous tissue having a top rectangular cross-section followed by a plurality of semi-circular arcs at the bottom, each of the semicircular arcs corresponding to an inflow end portion of a leaflet of the plurality of leaflets, the rectangular cross-section comprising a plurality of attachment nodes, each attachment node extending from the junction of two consecutive semi-circular arcs of the plurality of semicircular arcs across the width of the rectangular cross-section.

The prosthetic valve of claim 1, wherein the plurality of leaflets have the same ingrain and fibrous structure.

The prosthetic valve of claim 1, further comprising a support frame including: i. a plurality of rows of diamond-shaped expandable cells adjacent to each other, each cell including multiple struts and link members; and ii. a plurality of commissures at one or more of the multiple link members of the diamond-shaped expandable cells.

4. The prosthetic valve of claim 3, wherein the frame comprises of cobalt chromium.

5. The prosthetic valve of claim 3, wherein the commissures comprises of a polymer including polyethylene terephthalate.

6. The prosthetic valve of claim 3, wherein the commissures comprises a plurality of holes on an elongated body.

7. The prosthetic valve of claim 3, further comprising a skirt attached to the inner surface of a bottom row of the plurality of rows of the support frame.

8. The prosthetic valve of claim 1, further comprising at least one leaflet suture securing the semicircular arcs and the attachment nodes to a support frame, the leaflet suture being positioned outside of the support frame.

9. The prosthetic valve of claim 1, wherein the tissue comprises of one or more of a biological material, a biological membrane, a bio-compatible synthetic material and/or a fabric.

0. A prosthetic valve com i. a support frame having a plurality of rows of expandable cells adjacent to each other, each cell provided with multiple struts and link members; ii. a plurality of commissures provided with one or more of the multiple link members of the expandable cells; and iii. a plurality of leaflets formed from a single continuous tissue having a top rectangular cross-section followed by a plurality of semi-circular arcs at the bottom, the semicircular arcs being attached to a bottom row of the plurality of rows forming inflow end portions of the plurality of leaflets, the rectangular cross-section comprising a plurality of attachment nodes such that each attachment node is attached to a corresponding commissure and forming an outflow end portion of the plurality of leaflets.