Natural tissue heart valves and methods of making same

Description: TECHNICAL FIELD [Detailed description of the invention]

Natural tissue heart valve and how to make it Field of invention The present invention relates to a tissue-type artificial heart valve and an improved method for manufacturing such a valve. .. Background of the invention Artificial heart valves are used to replace damaged or diseased heart valves Has been done. In vertebrates, it is a hollow muscular organ with the following four pump chambers: : Left and right atrium and left and right ventricle, each with its own one-way valve To. Natural heart valves are named aortic valve, mitral (or bicuspid) valve, tricuspid valve and pulmonary valve. It is attached. Artificial heart valves replace any of these naturally occurring valves Can be used for. Two main types of heart valve alternatives or artificial aids are known Has been done. One is a mechanical prosthesis, which provides unidirectional blood flow. Use a swivel mechanical stopper. The other is a histological or "bioartificial" valve , It is constructed with a natural tissue valve leaflet that functions much like a natural human heart valve, Flexible heart valve lobules (which are placed relative to each other or called commissures) It mimics the natural action of (joining between adjacent tissue junctions). Each type Artificial valves have their own advantages and disadvantages. Mechanical heart valves work much like rigid mechanical check valves, so they are sturdy and long. Surviving for a period of time, but valve transplant patients, for the rest of their lives to prevent coagulation It is necessary to use a blood diluent. They also accompany each heartbeat There is a clicking sound when the mechanical plug is placed on the valve structure. In contrast, the tissue valve is small The leaves are flexible, silent and do not require the use of blood diluents. However However, the processes that occur naturally in the human body are particularly high stress areas of this valve (eg For example, the commissural junction between the valve leaflets and the peripheral leaflet attachment points of the outer edges of each leaflet. Or at the "cusps"), a bite that attacks and stiffens this leaflet for a long time. Or there is a risk of "calcification". In addition, these valves are a constant machine in the body. Receives stress due to mechanical action. Therefore, these valves wear out over a long period of time and are removed. Need to change. Tissue heart valves are also extremely difficult and time consuming to manufacture. It takes. Both mechanical and histological valves have been in the dynamic environment of the heart of a living patient for years. Although it must be manufactured to strict standards and tolerances in order to function, the machine Mechanical alternative valves can be mass-produced by using mechanized processes and standard parts. To. In contrast, tissue-type prosthetic valves are hand-crafted by well-trained and skilled assemblers. Will be built. Typically, a tissue-type prosthesis has two or three flexible natural tissue lobules. By sewing the part to a nearly circular support wireframe or stent Assembled. This wireframe or stent has dimensions for this valve leaflet Assembled to provide a stable support structure, this structure has a certain degree of It provides controlled flexibility and reduces stress on the lobular tissue during valve closure. this The biocompatible cloth coating on the wireframe or stent is this lobular commissure and A suture bond point is given to the apex. Similarly, this wireframe or stainless steel A cloth-covered suture ring can be attached to the patient's heart during the surgical valve replacement procedure. At an appropriate position within, an adhesive site for sewing this valve structure is provided. The histological artificial heart valve is an absolute support for its usefulness in 15 years of clinical trials. Proved to be successful. These days, their use causes less blood cell damage Machines to reduce the risk of concomitant coagulation without the use of comb blood diluents It has been proposed in conjunction with mechanical artificial hearts and mechanical left ventricular assist devices (LVADs). Therefore, an organization that can be adapted for use with such mechanical pumping systems. There is a need for a type artificial heart valve. The need that arose for this suitability , One of the drawbacks associated with histological artificial heart valves-ie, time consuming and painstaking It highlights the manual assembly process. Consistent with stable functioning valve leaflets Skilled and experienced assembly work to provide high quality histological artificial heart valve The contractor carefully wraps and sew each leaflet and valve part and is approved for dimensions. Must be a proper valve assembly. Changes in tissue thickness, extensibility and sutures To this end, each finished valve assembly is fine-tuned using additional handicraft techniques to achieve this. Proper joining of the valve leaflets and long functional life must be guaranteed. With the result Shi To meet the growing demand and increasing range of use for these valuable devices In addition, manufacturers of tissue-type artificial heart valves are faced with new challenges. Therefore, lessons learned in clinical trials (especially, in line with doctors' developing practice) Reduces stress on the valve leaflets while maintaining the desired structural and functional features An improved histological artificial heart valve with the addition of (to let) is still in need. In addition, a natural intracardiac or mechanical pump (eg, artificial heart or ventricular assist device) There is a high need for improved histological prosthetic heart valves that can be adapted for use in a variety of locations in waiting. In addition, it is easy to meet the growing demand for these devices. And there is a need for a histological heart valve that is more stable and easier to manufacture than existing valves. Existing. Abstract of the invention In order to achieve the above-mentioned objectives and correct the shortcomings of the prior art, the present specification herein. , New tissue heart valve structures and their parts, and easy to assemble them The method is disclosed. The improved tissue heart valve of the present invention is easily suitable for different future applications. Assembled to include standardized lobular subassemblies that can be modified to fit Be done. With similar importance, these lobular subassemblies have a tensile load, This valve assembly is evenly distributed along the entire circumference of the leaflet tip to reduce stress points. Significantly improve the long-term function of. An additional advantage of the present invention is less work. Due to the simplified manufacturing method using the degree and subassembly, this tissue valve supporter The stability and suitability of the assembly is achieved. This manufacturing protocol varies Combined with branched compatibility manufacturing technology for the manufacture of tissue heart valves with end-use Can be absorbed. In addition, these improved assembly techniques are effective in the overall manufacturing process. Being efficient and improving the consistency of tissue valves so manufactured, at the same time after assembly Reduces the need for fine-tuning and quality control operations. According to one aspect of the invention, the histological artificial heart valve is dimensionally stable and pre-aligned. Tissue lobule subassembly, nearly circular wire foam and nearly circular support stem Including This wire foam is this pre-aligned tissue leaflet subascen It has a bottom surface that is sized to accommodate yellowtail in a constant meshing connection. This support The holding stent is placed in contact with this pre-aligned tissue lobule subassembly. It has a sized top surface that is fixed so that it is of this wire foam It is fixedly arranged by meshing with the bottom surface. According to this configuration, a typical tissue valve contains multiple tissue lobules, which , At their tips, they are mounted together according to the template, and are dimensionally stable. A legally consistent mating leaflet subassembly is formed. Then essentially a single work As such, each leaflet of this subassembly is with a cloth-coated wire foam. Aligned and evenly from the tip of one wire foam commissure, of this leaflet tip Around the perimeter, to the tip of the adjacent wire foam commissure, to the cloth-coated wire foam Sewn individually. As a result, the sewn stitches are for aligned staplers Acting like a peg, all of them are equally of each pre-aligned joint leaflet It receives a load force that acts along the entire circumference of the tip. Tissue so formed-Wai Yafoam structural assembly evenly distributes stress from commissure to commissure across all leaflet tips The placement reduces stress and potential fatigue in this lobular suture. This Improved dimensionally stable and stress-reduced assembly prefabricated Effectively attached to the top of a cloth-coated stent, these lobules can be distorted or their This without interfering with the relative alignment and the resulting junction of their meshing edges This tissue lobule on the load distribution sheet formed by the top of the cloth-coated stent Clamp and fix the tip. This stent is secured to this assembly and the commissure of this stent is this small Extends to the corresponding commissure of the leaf / wire foam assembly. This stent Elgil itself has a surgically acceptable metal ring (eg, a cloth cover cut) Formed from an internal polyester film support fixed to oy® metal reinforcement) It can be folded and sewn around this support and reinforcement joint. Alternatively, it has an Elgiloy outer band and a laminated polyester film support. Instead, the two stent layers are both poly with moderately flexible commissural posts. It can be an ester layer or a single piece stent. Either stent configuration For valve structures that extend from commissure to commissure and are evenly distributed around each leaflet To provide support and dimensional stability. Due to this assembly methodology, this leaflet The uniformly sutured tissue of the head is sandwiched between this wire foam and the stent. This allows this load force to be more evenly distributed around the mounting site. this Tissue lobules undergo smaller, evenly distributed stresses during manipulation, so they Is less likely to cause distortion during use. Therefore, due to this uniform distribution of mounting force, this A more stable and long-lived functional seal or junction of these leaflets is obtained. Many additional benefits are obtained from the present invention and the stent configurations used therein. .. For example, for each major area of this stent, its flexibility is optimized or Can be customized. If desired, this junction tissue lobular commissure goes to the tissue at closure. Some warping to reduce stress in the valve or to fine-tune the operation of this valve Can be manufactured somewhat flexibly to allow for. Similarly, its overall valve structure The radial fastness of the base of the structure is increased to maintain the roundness and shape of this valve. Can be lowered or lowered. Unlike rigid mechanical valves, this stent radiates, not as a rigid heart valve. It acts as a support that is stable in shape but flexible in the axial direction. This valve leaflet Join and mesh with each other before mounting directly on the base of this cloth-coated wire foam Or because they are dimensionally pre-aligned along the sealing edges of the present invention. By using the teaching, the rigid structure becomes unnecessary. As a result, the whole of this valve Sealed surface in three dimensions, without the volatility previously encountered in traditional tissue valve configurations Can be aligned at once. In addition to eliminating the need for post-assembly adjustments, this pre-alignment This provides consistency and simplicity in the manufacture of this valve structure. further, This wire foam uses a uniform suture from the commissure tip to the commissure tip to make this small Acts as a template for suturing the leaf apex to this valve subassembly .. This results in a dimensionally consistent structure, which was previously available. It can work with this stent in a uniform manner that did not occur. This leaflet wire foam Due to the consistent dimensional integrity of the subassembly, this stent provides stress relaxation support. It can now act as a clamp, which also serves as a leaflet in this valve structure. Fix the head to give additional stability and stress distribution. If desired, this step A deformable cloth sheet with a single-fold or double-fold covering cloth on the top of the A stent lip with is obtained, which assists in the distribution of load at this lobular apex. And And easy to sew the stent to the tissue lobule wire foam subassembly To do. One of ordinary skill in the art can attach this stent to this tissue lobular wire foam. Overhanging of this valve subassembly, without stiffening its desired axial flexibility. Understand that it acts to stabilize the post. This new configuration method Eliminates the need for a separate commissure post in this tissue leaflet commissure and also this wire Eliminating multiple textures and fabric layers at the ohm commissural post, resulting in uniformity in valve manufacturing And add consistency, and eliminate multiple assembly steps. As a result, valve manufacturing has improved Not only will it be easier and more efficient. This stent also acts as a compatible structural interface and this tissue-wire four The stent structure subassembly depends on the intended valve placement and operating environment. , Can be attached to various pressing structures. For example, this tissue-wire foam Using a support stent fixed to the structural assembly, the resulting valve assembly Can be mounted, for example, on suture rings, flanges or conduits, depending on the desired valve application To. To form a conduit valve, this suture ring is also the inflow of this stent. Can be attached directly to the base, and the transplant surgeon will sew this valve in place on the heart. be able to. Alternatively, use this valve for artificial hearts and left ventricular assist devices (LVADs) When used, the inflow of this stent should act as a mechanical mount. , A more rigid flange can be installed. In some situations it is hoped that a conduit valve will be formed It may be better, here to replace the missing part of the patient's aorta or person A flexible or rigid conduit is required to work with the industrial blood pump device. This In such situations, the inflow of this stent may be fitted with an inlet duct, which is desired. If you like, you can install an outflow duct inside or outside this valve wire foam. To. Unlike conventional tissue heart valves, the present invention has different types of main valve components. Can be standardized for valves or valve applications, providing flexibility and suitability for use To. This manufacturing and structural consistency also improves quality control, and this valve Provides reproducibility and stability in the formation of. It also makes final assembly easy And this then gives high production speed without sacrificing consistent product quality Eh. More specifically, as part of the flexibility of the present invention, this stent can be used in a variety of generals. It is designed to accommodate different styles of mounting of this valve for future applications. The new configuration that enables this universal application is this dimensionally stable and pre-aligned. Obtained from a stent that provides perfect uniform support for the wire foam / leaflet subassembly Be done. Due to this compatibility, the valves of the present invention can function in a variety of applications. , Rather than standard soft suture rings, relatively rigid flanges or conduit acene Includes the use of temporary prosthetic heart valves within a circulation support system using yellowtail. is there Or, the present invention also includes a soft scallop suture ring for positioning the aortic valve. As an artificial valve with a soft flat suture ring for positioning the mitral valve, Incorporates proximity and distal ducts worn at both inflow and outflow valve ends It can function as a conduit valve. This outflow duct provides blood flow if desired It can be curved to improve. Within the artificial heart system, the valves of the present invention Blood from this heart while maintaining the patient until the donor heart is positioned and successfully transplanted It imitates the dynamic pumping action. In this application, blood inflow and outflow effects Both can be adjusted according to the present invention. Other objects and advantages of the present invention, along with the accompanying drawings, are described below. It will be apparent to those skilled in the art to which it belongs. A brief description of the drawing FIG. 1 is an exploded perspective view of a typical heart valve of the present invention, with standardized components and alternatives. The assembly relationship of the valve mounting structure is illustrated; FIG. 2 is a balance of typical lobules used in the production of the tissue heart valve of the present invention. It is a perspective view which illustrates the process of cutting according to a rate; Figure 3 shows the first pre-alignment of the leaflets of the valve subassembly to the template. The phase process is illustrated; Figure 4 shows an additional step in the pre-alignment of the valve leaflet subassembly; Fig. 5 shows a typical mounting process of the pre-aligned leaflets on the tip of the wire foam commissure. It is an enlarged view showing; Figure 6 shows the subsequent pre-attachment of a typical leaflet tip to the wire foam of Figure 5. It is a perspective view showing; Figure 7 illustrates the uniform attachment of the peripheral cusps of the leaflets to the cloth-coated wire foam. It is a perspective view; FIG. 8 is an enlarged view of a pair of mounting leaflet tabs of FIG. 7 with wire foam commissures. Illustrates uniform attachment of the tip to the tip; FIG. 9 shows a representative tissue lobe-wire foam to a representative stent of the present invention. It is a perspective view illustrating the mounting of structural subassemblies; FIG. 10 is an enlarged view of a pair of leaflet tabs in FIG. 9, in which the leaflet apex is clogged. The process of adding a stent to the wire foam at the tip of the commissure is shown while fixing the stent. Shows; FIG. 11 is an enlargement of one of the commissural tips of the tissue-wireform structural assembly of FIG. The figure illustrates the clamp fixation of the lobules with a stent; Figure 12 shows the final assembly of a typical tissue-wire foam structural assembly on a stent. It is a perspective view which illustrates the landing process; FIG. 13 is an enlarged view taken out by the circle 13 of FIG. 12, and shows an additional typical mounting method. Shows; FIG. 14 is an enlarged view taken out by the circle 14 of FIG. 12, and shows an additional typical mounting method. Shows; FIG. 15 is a perspective view illustrating a typical mounting process of the tissue leaflet tab at the commissural tip. Is; FIG. 16 is similar to FIG. 15 and illustrates the alternative mounting process; FIG. 17 shows a typical multi-piece formed from the flexible support and accompanying reinforcement of the present invention. It is an exploded perspective view which illustrates the stent; FIG. 18 is a perspective view illustrating the attachment of the support to the reinforcement of FIG. 17; FIG. 19 is a perspective view illustrating the initial process of covering the stent component of FIG. 18 with a cloth. is there; FIG. 20 is an enlarged view of the top of FIG. 19, which is an additional work when attaching the cloth to the stent part. Illustrated; Figure 21 shows the additional steps of assembling the suture tabs for attaching the cloth to the stent part. It is a perspective view shown; FIG. 22 is an enlarged view of a portion of FIG. 20 and illustrates the subsequent assembly process; FIG. 23 is an enlarged cross-sectional view taken at line 23-23 of FIG. 22; FIG. 24 is similar to FIG. 22 and illustrates the additional assembly process; FIG. 25 is a perspective view of the cloth-coated stent of FIG. 18 and illustrates the cloth-mounted lip. ; FIG. 26 is an enlarged cross-sectional view taken out along lines 26-26 of FIG. 25, which is a typical stent. Illustrates additional aspects of assembly assembly; FIG. 27 is a perspective view illustrating an initial component of a typical suture ring of the present invention. ; FIG. 28 is an enlarged cross-sectional view illustrating a typical suture ring assembly phase; FIG. 29 is a perspective view illustrating the additional features of a typical suture ring assembly. is there; FIG. 30 is an enlarged cross-sectional view of a portion of FIG. 29, with additional assembly of the suture ring assembly. Illustrates the situation; Figure 31 illustrates the additional aspects of a typical finished suture ring assembly. Large cross section; Figure 32 shows the positioning and assembly of the suture ring and lobular subassembly configuration. It is an exploded perspective view showing the standing; FIG. 33 illustrates the process of mounting the additional suture ring lobule subassembly at the apex. It is a visual view; FIG. 34 is a bottom perspective view illustrating yet another typical suture ring mounting process. is there; FIG. 35 illustrates a typical attachment of an outflow conduit to a typical valve of the present invention. It is a perspective view; FIG. 36 is an enlarged cross-sectional view illustrating the additional steps of conduit mounting; FIG. 37 is a cross-sectional view similar to FIG. 36, illustrating the characteristics of alternative conduit mounting; And FIG. 38 is an exploded perspective view illustrating an additional valve mounting alternative method of the present invention. Detailed description of the invention Referencing the drawings in more detail, Figure 1 shows the improved conformity tissue valve 50, its individual. Parts and their alternative configuration (these were manufactured according to the teachings of the present invention) It is an exploded view which is shown. Valve 50 is a pre-aligned and standardized leaflet sub-assen Includes yellowtail 52, cloth coated wire foam 54 and supporting stent 56. Details below Pre-aligned leaflet subassembly 52 and cloth coating during assembly of valve 50, as described in. The earfoam 54 is first assembled according to the present invention and has a tissue-wire foam. Structural assembly 58 (see Figures 2-9) is formed. Then the structural assembly 58 , Fixed to the stent 56 to form the assembly valve 50. As shown in Figure 1, the valve 50 has several useful alternatives for a variety of end applications. It is uniquely constructed so that a replacement valve can be manufactured. For example, the desired application is heaven If it is a heart valve replacement, then valve 50 is continuously sewn into place in the heart. It can be attached to a relatively soft suture ring 60 (not shown). Or Valve 50 should be used with a left ventricular assist device (LVAD) or mechanical cardiac pump If so, the valve 50 can be attached to a suitable rigid mechanical flange 62. further For both natural and mechanical applications where it is desirable to incorporate conduits, the valve 50 It may be attached to either the inflow conduit 64 and / or the outflow conduit 66. Tissue-Manufacture of wire foam structural assemblies In the disclosure of the present invention, the representative valve 50 is described as a three leaflet or tricuspid valve. ing. However, those skilled in the art will appreciate that the valve 50 has two leaflets, depending on future applications. Or understand that it may be configured to have any desired leaflet shape. .. The first step in assembling the tissue valve 50 is to attach the tissue leaflets 68 to each other and consistently dimension. It is to form a combined and standardized leaflet subassembly. Tissue leaflet Typically formed from pericardial tissue, porcine tissue or similar tissue obtained from donor organs This tissue is stored or "fixed" before being used in assembling the valve. To. Those skilled in the art will appreciate that the dimensions of the leaflet subassembly 52 are the intended end use of the finishing valve. And understand that it varies depending on the positioning and dimensional requirements that accompany it. However However, pre-alignment and suturing according to the teachings of the present invention simplifies the manufacture of the valve 50. Not only works to align all meshing or mounting surfaces of the valve at once To. This is to ensure correct joining of this leaflet at the meshing edge of the leaflet. Eliminates part alignment and dimensional changes and also tissue lobules after final assembly of this valve Significantly reduces the need to adjust parts. Now referring to Figure 2 here, the desired number of tissue leaflets 68 (in this example, 3 leaflets) Part) is obtained from a natural tissue known in the art, and each leaflet part 68 is tempered. Cut to a suitable desired shape and size for the intended valve application using G69. , Nearly linear or linear joint meshing edges 70 with opposed ends 71, 72 and Contours a nearly arched peripheral cusp 73 extending in the meantime. Further identify Then, each leaflet 68 is placed on the cutting plate 74, and then selected on the leaflet 68. Place the template 69. Tissue 75 extending beyond the boundaries of template 69 Is then cut using a sharp razor blade 76 or similar cutting instrument. The characteristic of pericardial tissue is that one surface is smoother than the opposite surface. Therefore, slip The non-clear surface is used as the meshing surface at the edge 70 with the adjacent leaflet edge 70. It is desirable to confirm this. After cutting out the leaflet part 68 and checking the meshing surface, Preliminary two leaflets 68a, 68b, together with template 69, as shown in FIG. Engage in rows or together. Two leaflets 68a, 68b, then at one end 71, together Attached to or sutured to form the first of multiple pairs of aligned mesh lobular ends .. For example, the leaflets 68a and 68b have guide slots 82 at one end of template 69. At the indicated position, a needle "through two threads", that is, a ring of thread 80 ( Or, use the "folded") part to insert the threaded needle 78 and push it through. Temp Rate 69 may then be removed, with needle 78 above the apex of leaflets 68a, 68b. Move to, then thread back into the loop and pull tight. Of course, the scope and teachings of the present invention Alternatively, another mounting method or suture may be used. Typical 3-leaflet valve The opposite ends 72 of the first two leaflets 68a and 68b are sewn together at this point. There is no. Referring to FIG. 4, the third leaflet 68c is again tricuspid using template 69. In the form of, it is pre-aligned and attached to the other two leaflets 68a and 68b. Especially the third small The leaf 68c meshes with the template 69, and the first two leaflets 68a and 68b are respectively. The unsutured ends 72 are unfolded and then each of the third lobules 68c adapted to the template. Align with the opposite ends 71, 72. Again, as a guide, the guide for template 69 Using slot 82, a needle with two threads threaded with thread 80 is inserted into three leaflets 68a, 68b, 68c. Insert into each unsuture pair and pair the ends of this lobe as shown. Fix to. This template may then be removed for each suture , Move the needle 78 above the apex of the leaflets 68a, 68b, 68c and thread it back through this loop. And pull hard to make a leaflet subassembly 52 with three leaflet meshing ends. Build. With reference to FIGS. 5 and 6, the leaflet subassembly 52 is attached to the back of the wire foam 54. Alternatively, it is preferably mounted on the bottom 83. A typical wire foam 54 has a cloth edge 84. Is a wire reinforced fabric with, substantially one to the shape of the leaflet subassembly structure 52 It is shaped in a compelling style. In the embodiment shown here, wire foam 54 Is approximately circular in shape and has sinusoidal undulations, which are leaflet meshing It defines a plurality of commissural tips 86 corresponding to a pair of terminals. Wire foam 54 cloth Contains the perimeter cloth edge 84, which is sutured or for the lobular subassembly 52 Served as a mounting surface. A typical wire foam 54 has three protruding mating points. Containing the ends 86, these include the leaflets 68a, b and of the pre-aligned leaflet subassembly 522. And c. Accepts each of the three pairs at the end of the meshing. A pair of leaflets at the end of the leaflet subassembly 52, the commissural tip of the wire foam 54 A typical method for mounting on one of the 86 is shown in FIG. Equipped with a ring-shaped thread 80 Needle 78 (not shown) was used to sew these leaflet ends together, but leaflets Insert from part 68 (indicated by the dotted line) through the inner edge of the cloth edge 84 (indicated by 87) and connect. The top surface of the fruit and meshing leaflets 68 is brought into contact with and fixed to the wire foam 54. This needle Is then reinserted from under the cloth edge 84 through the outer edge (indicated by 88'), and the first lock KU 89 (preferably a single lock suture) is made with thread 80. This locking process Repeatedly with a second lock 90 (preferably a double lock suture) as indicated by 88 " Can be done. Finally, this needle is placed from below the cloth edge 84 to its middle (indicated by 91). Insert and pull this thread under the first and second locks 89, 90 under the cloth edge 84 And pull to hide and protect during the rest of the assembly process. The excess thread is then cut Throw away. This method was applied to the meshed leaflets 68a, 68b, of subassembly 52. Each pair of aligned mesh leaflet ends fitted with 68c of wire foam 54 Repeat to secure to each commissural tip 86. Therefore, the wire foam 54 , Additional permanent to place this leaflet commissure in its final position relative to each other Acts as a template. As an additional advantage of the present invention, this manufacturing method In addition, this joined valve small before attaching the leaflet apex to the wire foam. Stabilize the leaves against each other. Therefore, there is no unevenness along this leaflet edge. The entire peripheral lobular apex, from the tip of one commissure to the next, to generate mounting stress It is possible to wear it evenly. Now see here in Figures 6 and 7, wire the representative leaflet subassembly 52 The next typical step for fixing to foam 54 is the peripheral cusp 92 of each leaflet 68. It may be attached to the cloth edge 84. In that regard, wire foam the leaflet tip 92 Pull along the wire foam 54 to temporarily secure it in place on the 54 Periodically spaced knots 94 (ie, potentially unfinished knots) .. For each leaflet tip 92, three draw knots 94 can be made, one in the center of this tip. , There are two refraction points with this commissure, which is during mounting on the wire foam 54, Helps to stabilize this apex in place and evenly. Temporarily fixed lobular apex 92 was then preferred, as shown in Figures 7 and 8. Or start at the center position 98 of each leaflet tip 92, using a double-threaded "in / out" suture 96 It extends to the tip of each commissure 86 and is attached to the wire foam cloth edge 84. Mating tip 86 At about 1 mm from, these threads are preferably as described above. , Lock, fill, and cut. Therefore, the conventional tissue valve (where the leaflets) Are individually worn and the sutures around the apex end in front of the tip of the commissure, potentially The method of the present invention is uniform from the commissural tip to the commissural tip. A novel tissue valve with a single suture and a stably aligned joint lobular meshing edge Produce an assembly. Tissue on Supporting Stent-Attachment of Wire Foam Structural Assembly For the purpose of further explanation, once this assembled structure-wire foam structure assembly When the membrane (which is confirmed by reference number 58) is manufactured as described above, The assembly 58 is then mounted on a support or stent 56. Figures 9, 10 and Referring to 11, Tissue-Wire Foam Structure Assembly 58, First, Stent 56 Between the top surface 99 of the wire (see FIG. 1) and the bottom surface of the wire foam 54, the peripheral cusp of the leaflet 68 On the correspondingly configured stent 56 in a manner that clamps the edges evenly. It is fixed. This assembly method also distributes the stress and load of leaflets 68. However, it contributes to its functional long life. In addition, pre-alignment and wire of leaflet 68 By mounting on foam 54, it is possible to align the dimensions of all valves 50 at once. , And the use of separate commissure posts eliminates the dimensional variation that can occur with conventional valves. Su. In particular, the stent 56 is sized to mesh or rest with the shape of the assembly 58. And the assembly 58 is the underside of each commissural tip 86 of the wire foam 54. Stent 5 so that it meshes with the top surface of the corresponding complementary stent commissure tip 100 It is meshed with 6. Aperture formed by joining meshing leaflets 68 Part 102 meshes tissue-wire foam structural assembly 58 with stent 56 Be careful to ensure that it does not distort in the meantime. Similarly, the leaflet 68 is evenly distributed. Make sure the lamp is fixed and remains evenly taut throughout this process Be careful to guarantee. Once the wire foam assembly 58 meshes with the stent 56, the wire four Bottom bend of each leaflet tip 92 to temporarily secure the assembly 58 to the stent 56 A temporary pin 104 can be inserted into the wire portion. Stent 56 and assembly 58, then Then, as shown in FIGS. 10 and 11, they are fixed together. Assembly 58 to stent 56 The suture begins at the top of the commissure tip 86. In particular, a needle with two threads (not shown), 10 As indicated by 5', pass through the stent commissural tip 100 and release adjacent pairs of lobules 68 From between the tab ends 106, 108, as indicated by 109 ", of the wire foam assembly 58 Insert through the cloth edge 84. This needle is then inserted through a looped thread , Form a single lock 110. The double lock 112 is then formed and the double lock 112 is formed. Stent this needle at 105 "in the manner described above, such as pulling the needle from under the cloth edge 84. Insert through the ream tip and through the cloth edge 84 at 109 ". The cloth edge as shown at 113. The excess thread coming out of part 84 may then be cut off and discarded. Wire four The same procedure can be performed for the remaining commissural tips 86 of the assembly 58. With the result Shi The wire foam commissure tip 86 is uniformly compatible with the stent commissure tip 100. With reference to FIGS. 9 and 12-14, the typical mounting procedure is double as described above. Threaded needle, stent 56 near the top of stent commissure tip 100, as indicated by 114' Through the tissue leaflet 68 and through the cloth edge 84 of the wire foam 54, as indicated by 115'. It can be completed by inserting it through. This needle is then placed on the edge of the cloth at 115 ". Thread, insert in reverse fashion through stent tip 100 at 114 ", and this double thread Pass through the wheel 115. With reference to FIG. 14, this suture is followed by the stent 56 and the wa. Along the meshing edge of the earfoam assembly 58, the next wire foam assembly Perform up to 86, 100 commissure tips of yellowtail and stent. See FIG. A single lock 118 and a double lock 120 can be formed near the top of the tip 86. , The thread is under the cloth edge 84 of the wire foam assembly 58, as described above. Can be buried in. The suture described here is at any stent commissure tip 100 Being able to start, and in and out sutures 116, around the stent 56, clockwise It can be seen that it can be carried out in either the counterclockwise direction. When the in-and-out suture 116 around the stent 56 is completed, each pair of play in the tissue lobule 68 The detached tab ends 106, 108 need to be fixed to each stent tip 100. Figure 15 With reference to and 16, two representative alternatives are offered to carry out this task. It is being served. With reference to FIG. 15, the first typical alternative is to match tab ends 106, 108. The shape is such that the connection 122 is formed. In particular, tab ends 106 and 108 , When folded towards each other, the end edges of each tab end 106, 108 bite uniformly A linear centerline that fits and preferably descends vertically from the commissure tip 100 Cut to form. Two leaflet tab ends 106, 108, then suture 124 Sew together with. With reference to FIG. 16, a second representative gene for fixing the leaflet tab ends 106, 108. The alternative method is that the tab ends 106 and 108 mesh uniformly and either side of the commissural tip 100. Above, such as forming a coplanar joint 126 with the cloth edge 84 of the wire foam 54. To make it into a shape. In particular, the leaflet tab ends 106 and 108 are the ends of the tabs 106 and 108, respectively. The edges should be sized to fit the cloth edge 84 of this wire foam in the same plane. Can be cut out like this. The leaflet tab ends 106, 108 are then illustrated. Sew on the cloth edge 84 of the wire foam 54 using such a suture 128. Like that The alternative coplanar joint 126 formed in is from the butt joint 122 of the first alternative method. Also gives a somewhat flat commissure, so the coplanar junction 126 has a smaller valve More desirable when needed. However, by both typical methods, this These commutations enable uniform and reliable distribution of the load on the lobules of this tissue. Typical stent assembly From the above description, the stent 56 meshes with and supports the wire foam assembly 58. It can be seen that it is configured to have a structure suitable for this. On that point The typical structure of the stent 56 is now described here with reference to FIG. Those skilled in the art Understand that the representative stents described herein have a multi-piece structure. .. However, providing a single piece stent is within the scope of the present invention. Be considered. However, the multi-piece stent assembly shown is its commissure. Provides radial stability for this stent while maintaining the desired axial flexibility of the post It may be easy to measure or fine-tune. No. 1 in the assembly of a typical stent 56 One step is the internal support member 130 and the external support member 132 (these are meshed together). When, in general, stainless steel that ultimately matches the shape of the wireform assembly 58 To form the shape of G56) is to be assembled. In a typical embodiment, inside The support member 130 is the three upright posts 134 (these are relative to the stent commissure tip 100). Served as a support structure). The external support member 132 is also an internal support The post 136 corresponding to the post 134 of the member 130 can be included. However, post 1 36 is cut out and therefore does not match the height of the post 134 of the internal support member 130. Inside The parts and external support members 130, 132 are metal or plastic, depending on the desired properties of the valve 50. Can be made from rustic material. Multiple on the internal support member 130, along the perimeter of the member 130 and on the post 134. Sewing hole 138 is arranged. The external support member 132 is a post 136 cut out from each of the external support members 132. On top, it includes at least one sewing hole 139, which is each post of the internal support member 130. Corresponds to each of the sewing holes 138 on 134. The inner diameter of the external support member 132 is the internal support portion. The size is adjusted so as to form a sliding fit with the outer diameter of the material 130. In the internal support member 130, the sewing holes 139 of the external support member 132 are the respective points of the internal support member 130. It is arranged in the external support member 132 so as to be aligned with the sewing hole 138 on the strike 134. These 2 The individual members then insert the previously described double-threaded needle into the alignment holes 138, 139. By doing so, they are sewn together. As shown in FIG. 18, each of the alignment holes 138 and 139. The thread 140 inserted into it is then threaded through the terminal loop 142 and tightened. This thread Then, for example, it may be locked using a draw knot (not shown), which is A knot that can slide along this thread so that it touches these supporting members. Therefore Post 134 of the internal support member 130, from its base to its top, to a greater extent Stretches to, and the external support member 132 increases the radial stability of the internal support member 130 The cut-out post 130 is attached to the base of the post 134 of the internal support member 130. Gives rigidity. Now referring to FIG. 19, once the internal and external support members 130 and 132 are sewn together. Combined, the coated fabric 144 (preferably made from woven polyester), Cut to form a cylindrical tube to cover the combination support members 130, 132 .. Those skilled in the art can equally apply this coating to single-piece stent assemblies. Understand that. The cover cloth 144 includes two crease lines 146, 148, the first of which is The one 146 folds the edge of the cloth 144 and folds (this is the post of the internal support member 130). It is formed by forming (accepting 134). In a typical embodiment, the first Between the crease line 146 and the top edge 149 of each post 134 (see Figures 17 and 18) It is 1mm to 1.5mm. The second crease line 148 is below the combined support members 130, 132. Positioned to coincide with edge 150 (see Figure 18). Referring to FIG. 20, a thread is attached to fix the covering cloth 144 to the support members 130 and 132. A digit needle passes through the cloth 144, through one hole 151 of the internal member post 134, and through the cloth 144. Even if you insert it through two layers and then back to cloth 144 through the same hole 151 through cloth 144 Good. The needle can then be passed through the loop to form the first lock 152. This threader The process can be carried out up to two more times. The excess thread is then cut off. Follow the same procedure for each of the three posts 134 on the internal support member 130. Can be done. Then, as shown in FIG. 21, the next typical step is to attach the covering cloth 144 to the internal support portion. Sew on the inner and outer support members 130, 132 along the upper edge 137 of the material 130 Including. First of all, the lower edge 154 of the cloth 144 has a second crease line 148 as its support. Support along crease line 148 so as to define the bottom or bottom of the holding member structure Can be folded inside the materials 130 and 132. Due to this folding, the support member 13 A double layer fabric 144 (including external and internal fabric layers 156, 158) wrapping 0, 132 is obtained. Next Then, using a needle with a single thread, this layered cloth is attached to the upper edges 153 of the support members 130 and 132. Sew together at 155 along the curved part of. The suture 155 is preferably reverse stitched. This is to insert this needle, for example, to the right to a certain sewing length, and then It is achieved by sewing back to the left at the same distance. However, suture 155 Does not extend to the top 149 of the post 134, between the top 149 of the post 134 and the anastomosis 155 Leaves a space of about 1 mm. After sewing the upper edge 153 of the support members 130 and 132 , Cloth 144, then at 156 along the lower edge 150 of the support members 130, 132, and so on. It can be sewn with a formula. The final suture is then to tie a draw knot More locked, this is to ensure that this suture locks in place, 3 It may be carried out up to once. Now, referring to FIGS. 21 to 26, the cloth 144 just attached to the support members 130 and 132. To match the shape of the support members 130, 132, and if desired, a gas bucket Cut out to give a sewn edge. To achieve this, an external cloth Layer 157 is approximately 5 m above its top edge and above the top edge 153 of the internal support member 130. Can be sliced downward to a distance of m ~ 6 mm. In a similar fashion, the inner fabric layer 158 is Approximately 2 mm to 3 m above the bottom of the slice in the outer fabric layer 157 from the top edge of the Can be sliced downwards up to a distance of m. These slices are next to the internal member 130 It is made in the middle position between the tangent posts 134, but downwards from each other, as shown by 160. It is intended to be aligned. Next, the outer cloth layer 157 is started from the bottom of the slice portion formed on the outer cloth layer 157. , Cut along the upper edge 153 of the internal support member 130. This representative fruit of the present invention In an embodiment, this cutout is such that the contour of the cloth 144 is below the upper edge 153 of the support member 130. The post 134 of the support member 130 extends upward at a distance of approximately 4 nm to 5 mm from the curved portion. of Approximately 2 mm to 3 mm above part of the support member 130 in the area at or near the base Approximately 0.5 mm above the top 149 of the post 134 of the support member 130, extending at a distance of It is carried out in a manner that extends at a distance of ~ 2 mm. As shown in FIG. 22, the inner fabric layer 158 is then the top 1 of the post 134 of the inner member 130. Folded over 49, and the style described above for the upper fold of cloth 144 Then, using a threaded needle to sew through the sewing hole 151 in the post 134, the post 134 Is stuck to. However, after applying these locking sutures, this needle It is passed under this cloth so that it exits from the top of the post 134. Next, a series of cutting operations can be performed. Refer to Figures 22 and 23, the inner cloth In the folding portion 162 of the layer 158, the lower edge portion 164 of the folding portion 162 is a hole 151 of the post 134. Cut around the entire circumference of this cloth so that it is about 1 mm to 1.5 mm from the suture. Is done. The folding portion 168 of the outer fabric layer 157 is the top 149 of the post 134 of the internal support member 130. Folded on top. The remaining edge of the folded portion 162 of the inner cloth layer 158 is cut first. It is further cut so that it is flush with the edge of the removed inner cloth layer 158. With respect to the unfolded portion of the inner fabric layer 158, this layer was cut off earlier at its edges. Cut out in a manner that extends approximately 2 mm beyond the edge of the outer fabric layer 157. .. The extension of the inner fabric layer 158 beyond the outer fabric layer 157 is the mounting surface and mounting on this stent. Provided is a desirable material for forming a landing or sutured surface. Each cutting operation starts from the central region between the posts 134 of the internal support member 130, Conducted to the top 149 of post 134. Inner cloth layer 158, outer cloth folding part 168, outer The arrangement of the fabric layer 157 and the internal fabric folds 162 is shown in the enlarged cross section of FIG. .. The remaining typical process of completing the assembly of the stent 56 is to fold these fabric layers. Suture with to form a sewn edge 169 around the stent 56. See Figure 24 The inner fabric layer 158 is then folded around the post 134 and surrounds the post 134. Is sewn like. More specifically, the folded outer cloth layer 157 is sewn into the hole 151. The thread that was inserted earlier through the top of the post 134 when connected through is now here, To hold the inner fabric layer 158 in place at the top of the post 134, the top of the post 134 Used to form the first and second locks 172 in the section. Typical inner cloth layer 1 Secure 58 further downwards around post 134, approximately 8 mm from the top of post 134. To do so, a whip stitch 174 may be used. Bottom of post 134 When it reaches the part, it forms the first and second locks and cuts off this thread. Up The suturing operation is performed on each of the three posts 134. However For the last of the posts 134 to be sewn, form the first and second locks 172 Instead of cutting the thread after it is done, on the residual edges of the support members 130, 132 between the posts 134 Uncut thread 176 can be used to perform suturing of the fabric along. In that regard, referring to FIGS. 25 and 26, the inner cloth layer 158 is the outer cloth layer 157. Folded up and holds the folded layer in place on this support member Alternate sutures are applied to form a sewn edge 169 on the g. Support members 130,13 After completing the suture around the rest of 2, this thread is used for the first and second b. A hook suture can be formed and excess thread is cut off to complete the assembly stent 56. Assembling a typical suture ring If the valve 50 is intended to be used as an alternative to the natural heart valve, this valve structure The use of a soft suture ring 60 is considered when completing the. For example, Figure 27 See the representative ring washer or "remey" 180 provided It is preferably made from non-woven polyester. Also, Remei 180 A silicone sponge waffle ring 182 for meshing with is also provided. To that point Thus, the ring 182 has a wall lip 184 arranged along the inner circumference 185 of the Remei 180. It is configured as follows. Lip 184 is contoured to include three recesses 186, which are Corresponds to the lower curved surface between each commissure on the valve 50. Remei 180 is Remei 180 Place it on the waffle ring 182 so as to surround the wall lip 184. This makes it soft A relatively flexible but stable suture ring integrated structure is produced, which is described below. Covered with a cloth as described, the corresponding stitch between the natural tissue of the heart and the artificial tissue valve 50 Functions as a possible interface. As shown in FIG. 28, before mounting the Remei 180 on the waffle ring 182, the Remei 180 times. A cloth 188 extending from the inner circumference 185 to the outer circumference 189 is placed there. Remei 180, next Then, on the waffle ring 182, the cloth 188 is sandwiched between the waffle ring 182 and the Remei 180. Put it on. Cloth 188 extends beyond the outer periphery 189 of Remei 180, as shown in FIG. Arrange so that it extends at a distance of 190 from 3 mm to 5 mm. Remei 180, Cloth 188 and Waffle ring 182, then using, for example, in-and-out suture 192, around Remei 180 Sew around the enclosure. A typical suture is preferably the outer periphery of the Remei 180. It is located at a distance of 194, approximately 1 mm from part 189. If desired, the same as the first suture line A second suture line (not shown) may be added at the same position, with each suture on the second suture line being the first. It is located between the sutures of one suture line. The resulting suture 192 was then combined with a continuous suture line. And appear. In addition, as shown in FIG. 29, the cloth 188 and the waffle ring 182 are both exposed. Reverse stitching in the space between the wall lip 184 of the ring 182 and the Remei 180 to secure it to 195 may be applied, and this space is shown by 196 in Fig. 28. Referring to FIG. 30, cloth 188 is a structural assembly of Remei 180 and waffle ring 182. It can be attached to the recess 186 of the cell, for example, at one corner 198 of the recess 186 (cloth 188 and (Through ring 182), insert a single-threaded needle, then double-pull knot into corner 198 And fix it to this thread. The cloth 188 is then ejected to secure it to the contour of the recess 186. Insertion suture 200 can be used. The same method can be followed for each recess 186. The excess cloth is then cut off to the outer edge of the Remei 180, as indicated by 201. Further referring to FIG. 31, the outer 202 of the cloth 188 is then the outer turn of the Remei 180. Fold it back and store it under the Remei 180 between the Remei 180 and the waffle ring 182. Can be taken. Due to the flexibility of the ring 182, the ring 182 is deformed and the outer 202 of the cloth 188 Fits with. A needle with a single thread to secure the folding cloth 188 under the Remei 180 Alternate sutures 204 can be used. After completing the suture around the entire circumference of Remei 180, suture Double knots can be used to secure the finish suture ring. Attaching a suture ring to a typical valve With reference to FIGS. 32 and 33, the suture ring 60 or alternative structure (eg, flange 6). 2 (see Figure 1)) is attached to the valve 50 by the recess 186 of the suture ring 60 below the valve 50. It is aligned with the descending cusp 206 and then meshed together. More specifically The valve 50 corresponds to the cloth edge 84 of the wire foam 58 at the bottom of each cusp on the valve 50. Suture at the recess 186 so that it is substantially flush with the top surface of the suture ring 60. Place on ring 60. Note this arrangement so that the tissue lobules 68 are not twisted or wrinkled. I mean. Valve 50 uses a needle 208 to facilitate this procedure, suture ring 60 Temporarily pin it to a suitable position on the top. As shown in FIG. 34, the assembly of the pinned valve 50 and suture ring 60 is Turned over, the suture ring 60 is the mating edge of the ring 60 edge 209 and the valve 50. Can be sutured to valve 50 along. More specifically, in a typical embodiment, suturing A single threaded needle can be used to sew the ring 60 to this stented fabric To. To facilitate this suturing process, these pieces were placed with an additional needle 208. , Temporarily but surely hold it in place. Opposite of ring 60 and valve 50 The sides can be sewn together in a similar fashion. Mounting a valve on the outflow conduit With reference to Figures 35-37, in certain applications, valve 50, outflow conduit as shown by 66. It is desirable to attach it to. For example, in patients who need aortic valve replacement, the aortic Some themselves are damaged or sick as they also need to be replaced It may be. Therefore, in line with the teachings of the present invention, its applicability tissue valve structure The structure can be modified to include an outflow conduit 66 that acts in place of the injured aorta. Ah Or, in some future mechanical pump applications, the conforming tissue valves of the present invention are this. It may be provided with an outflow conduit that facilitates connection with the mechanical pump structure. either In the alternative of, this can be achieved as shown in Figures 35 and 36, in this case the outflow guide. The tube 66 can be attached to the wire foam 54 when the tissue lobule 68 is fixed. Special In reference to FIG. 36, the conduit 66 is opposite to the tissue lobule 68, for example by suturing. It may be fixed to the side surface of the wire foam 54 of. Alternatively, as shown in FIG. 37, the conduit 66 is sutured and secured to wire foam 54 on the same side as tissue lobule 68, or You may put it between them. The third option is finishing as a subsequent suturing process. A conduit 66 may simply be secured around a valve (not shown). Valve 50 is curved Can be attached to the outflow conduit, either with or without curvature. Alternative shape for the inflow side of the valve FIG. 38 illustrates another representative alternative option available for improving and mounting the valve 50. ing. For example, as mentioned above, it is desirable to use valve 50 as a conduit valve. When, the suture ring 60 can be attached to the valve 50, as described above. Or a person For applications such as engineering hearts and left ventricular assist devices (LVADs), the suture ring 60 is always It is not necessary; therefore, the lower end of the stent 56 valve with an artificial heart or LVAD. It can be mounted on the flange 62 used when mounting. Yet other alternative fits include applications where the inflow conduit 64 is desirable. This In such applications, the inflow conduit 64 can be attached directly to the stent 56 of the valve 50. More specific The inflow conduit 64 is configured to have a stepped perimeter 210, which is stainless. Gently meshes with the outer circumference (or inner circumference) of G56 and sew it there. be able to. In this configuration, for example, in artificial heart or LVAD applications, suture phosphorus The g60 can be attached to the inflow conduit 64 rather than the valve 50. Conclusion Considering the above description of the valve 50 of a typical embodiment and its components, the present invention Ming meets the need for an improved histological artificial heart valve, where the desired structure Stress on valve leaflet 68 is reduced while maintaining superior and functional features .. In addition, the valve 50 will be used in various positions within the natural heart or with a mechanical pump. Can be adapted to sea urchin. In addition, the valve 50 is simple and has a more consistent style than existing valves. It can be easily manufactured. The standardized lobular subassembly 52 of the present invention is suitable for different future applications. As such, it can be easily improved. Of similar importance, these leaflet structure subassemblies Li 52 evenly distributes the tensile load along the entire circumference of the leaflet apex 92 to reduce stress points. Eliminate and significantly improve the long-term function of this valve 50. As an additional advantage of the present invention With a simplified manufacturing method that uses fewer steps and subassemblies Thus, the stability and suitability of this tissue valve subassembly is achieved. This manufacturing Rotocol is a branched suitable for the production of tissue heart valves with a variety of end uses. Can be incorporated into compatibility manufacturing technology. In addition, these improved assembly technologies are integrated Efficient manufacturing process, improve the consistency of tissue valves so manufactured, and simultaneously In addition, it reduces the need for post-assembly fine-tuning and quality control operations. Multiple tissue lobules 68 mounted together as described are dimensionally stable and dimensionally Form a consistent mating leaflet subassembly 52. In addition, the wire foam 54 is pointed The suture 96 used to attach the head 92 acts like an aligned stapler All of them are equally applied to the entire circumference of the apex 92 of each pre-aligned junction lobule 68. Receives a load force that acts along. Tissue Obtained-Wire Foam Structure Assembly 5 8 is the result of evenly distributing the stress from commissure to commissure to all leaflet apex 92. Reduces stress and potential fatigue in lobular sutures. In addition, Tissue-Wire The ohm structure assembly 58 distorts the leaflets 68 and their relative alignment and so Attached to cloth-coated stent 56 without interfering with the resulting junction of their meshing edges it can. The stent 56 assembled according to the present invention is from commissure to commissure, each small of the valve structure 50. Provides evenly distributed support and dimensional stability to leaf 68. This assembly According to the methodology, the uniformly sutured tissue of the leaflet tip 92 is formed with wire foam 54 and steer. It is sandwiched between the and 56, which allows this load force to be applied around this mounting site. Can be evenly distributed. Leaflet 68 receives lower and evenly distributed stress during operation The leaflet 68 is less likely to be distorted during use. Therefore, one of this wearing power Such distribution results in a more stable and long-lived functional closure or junction of leaflet 68. Be done. In addition, for each major region of stent 56, its flexibility is optimized or scrapped. Can be customized. If desired, the mating tissue lobular commissure 86 responds to tissue at closure. Allows for some warpage to reduce force or to fine-tune the operation of the valve 50 Can be manufactured to be somewhat flexible. Similarly, the basis of its overall valve structure Radial fastness of the part is increased or decreased to maintain the roundness and shape of the valve 50. You can do it. Unlike rigid mechanical valves, the stent 56 is a rigid heart valve. It acts as a support that is radially stable but axially flexible. Leaflet 68 are joined and meshed with each other before being directly attached to the cloth coated wire foam 54. Or because they are dimensionally pre-aligned along the sealed edge 70, the present invention By using the teaching, the rigid structure becomes unnecessary. As a result, the overall valve 50 The sealing surface is one in three dimensions, without the volatility previously encountered in traditional tissue-type valve configurations. Can be aligned every time. In addition to eliminating the need for post-assembly adjustments, this pre-alignment This provides consistency and simplicity in the manufacture of the valve 50. In addition, wire The ohm 54 uses a uniform suture from the commissural tip 86 to the commissural tip 86 to squeeze the leaflet tip 92. It acts as a template for suturing to this valve subassembly. to this A more dimensionally consistent structure is produced, which was previously unobtainable. Can work with the stent 56 in a uniform fashion. Leaflet wire foam subassembly Due to the consistent dimensional integrity of 58, the stent 56 can be used as a stress relaxation support clamp. Being able to function, this also fixes and adds the lobular apex 92 within the valve 50 Gives stability and stress distribution. Single on top 99 of stent 56, if desired A stainless steel with a deformable cloth sheet provided with a folded or double-folded covering cloth 144 A trip was obtained, which assisted in the distribution of load around the leaflet tip 92, and Tent 56 Tissue-Easy to sew to wire foam structure subassembly 58 To. Those skilled in the art attach the stent 56 to the tissue-wire foam structure subassembly 58. This valve sub-assembler does not stiffen its desired axial flexibility. Understand that it acts to stabilize the protruding commissural posts. This new structure The method of growth eliminates the need for a separate commissure post in this tissue leaflet commissure, and also Eliminate multiple textures and fabric layers in Earfoam Coupling 86, resulting in uniformity in valve manufacturing And add consistency, and eliminate multiple assembly steps. As a result, valve manufacturing has changed Not only is it good, it's easy and efficient. Stent 56 also acts as a compatible structural interface and this tissue-wire foam- The stent structure subassembly is the intended valve placement and operating environment (soft suture phosphorus) Depends on (including 60, mechanical flange 62, inflow conduit 64 and outflow conduit 66), It can be attached to various additional structures. Unlike traditional tissue heart valves, books The invention allows the main valve components to be standardized for different types of valves or valve applications. , The flexibility and compatibility of use is obtained. This manufacturing and structural consistency It also improves quality control and provides reproducibility and stability in the formation of this valve. Eh. It also simplifies final assembly, which in turn sacrifices consistent product quality. Gives high production speed without sacrificing. As part of the flexibility of the present invention, the stent 56 is a valve for a variety of future applications. It can be designed to accommodate 50 different styles of wear. This universal use is possible The new configuration is dimensionally stable and pre-aligned wire foam / leaflet sub-a Obtained from stent 56, which provides complete uniform support for Swertia japonica 58. This suitability Because of this, the valve 50 can function in a variety of applications, with standard soft suture rings. Circulation support system with relatively rigid flange or conduit assembly Includes use of temporary prosthetic heart valves within. Alternatively, valve 50 positions the aortic valve Soft to determine Soft scallop suture ring or soft to position mitral valve As an artificial valve with a quality flat suture ring, or at the end of the inflow valve and the end of the outflow valve In function as a conduit valve by incorporating proximity and distal conduits fitted on both Wear. This outflow duct can have a curved shape to improve blood flow, if desired. To. Within the artificial heart system, valve 50 positions and successfully transplants the donor heart. Until, while maintaining the patient, it resembles this hemodynamic pumping action of the heart. This In this application, both inflow and outflow of blood can be regulated by the valve 50. Numerous changes, adaptations and modifications that fall within the expertise of those skilled in the art from the detailed description above. It is clear that good exists. However, it does not deviate from the advanced aspects of the present invention. All of these changes are within the scope of the invention, which is limited only by the appended claims. It is intended to be considered.