PL243171B1 - Balloon expandable heart valve frame and a method of producing a balloon expandable heart valve frame - Google Patents

Abstract

The subject of the application is a balloon-expandable heart valve frame made of a sheet of metal or metal alloys, having a span multi-row structure with a part with smaller cells and a part with larger cells, the frame (2) is characterized in that it is made of at least one sheet of metal or metal alloy material with a fixed, directional, anisotropic crystal structure, given by the direction of the fibers formed during the plastic processing to which the sheet/sheets have been subjected, the sheet/sheets optionally being two-layer or three-layer, each layer having a predetermined directional anisotropic crystalline structure, and wherein the frame structure, where the sheet/sheets join, is provided with flat lay tabs (3) and opposing tab receiving means (4), which together form permanent joints arranged in multiple rows such that one joint is assigned to one row of spans in the frame structure. The invention also relates to a method of manufacturing the described heart valve frame.

Description

Description of the invention

The present invention relates to a balloon-expandable openwork heart valve frame and a method of manufacturing a balloon-expandable openwork heart valve frame to serve as a support for attaching the valve, the entire system being used to replace a native heart valve.

In more detail, the invention relates to a method of manufacturing a valve frame, i.e. a frame (stent) for attaching valve leaflets, with the whole system of frame with valve leaflets (prosthesis) dedicated to minimally invasive procedures, e.g. intravascular by means of intravascular catheter systems inserted into the patient's body percutaneously.

Currently, invasive surgical procedures of heart valve replacement are abandoned and minimally invasive endovascular methods are improved, which are faster, safer, do not require general anesthesia and shorten the convalescence period. In addition, the patient selection criteria for minimally invasive methods are much more lenient than those used for surgical procedures. Therefore, these methods can be used in patients excluded from surgery due to high risk.

Such methods include methods based on self-expanding frame constructions, in which the frame is made of materials with shape memory, and the second group of methods - based on expandable frames on the balloon, in which the frame initially clamped on the balloon by inflating it assumes the expected unfolded shape.

These two groups of methods have their advantages and disadvantages. Systems with a self-expanding frame require high precision, because the self-opening of the valve frame makes it difficult to correct its position. The elasticity of the shape memory material can also cause uncontrolled vibrations and shifts during implantation. The self-expanding valve frame may react minimally, i.e. contract and expand, with heart beats, which may affect the valve leaflets embedded inside the frame, whose functions may be disturbed, and the entire system may adversely affect the surrounding tissue through micromovements. Another disadvantage of valves using self-expanding frames is the lower radial force. The frame of the valve must guarantee its proper pressing against the surrounding tissue and maintaining the correct position during the operation of the valve in the long term. Therefore, the radial force of the valve frame must be higher than, for example, in typical endovascular stents. Expansion frames on the balloon allow for higher radial force. Placing markers at various locations on the valve frame allows better control of the position of the valve during implantation. Balloon-expandable valves are shorter than self-expanding valves, which reduces the risk of occlusion and obstructing access to coronary vessels.

Both types of valve frames have a collapsed, smaller diameter position for delivery in an endovascular system and an unfolded, larger diameter position when seated, implanted in their intended position. Thus, in addition to the requirements outlined above, the valve frame must be capable of having a small diameter in the collapsed position, i.e. clamped on the balloon in the case of an expandable frame on the balloon.

Heart valve frames made of metal or metal alloys, typically balloon expandable, are known from, for example, US5411552A, US5855601A, EP1057460A1, EP1330213A, and WO2006127756A2.

Heart valve frames made of metal or metal-containing alloys with a span openwork structure are also known from publications CN107212950A, US2018200054A1, US2018185146A1, US2018177595A1, US2015112421A1, WO2013191005A1, WO2006 026912A1, however, there is no disclosure of a frame structure constructed of a sheet or sheets of fixed, directional crystalline structure, and connecting these sheets by hooks and hook receiving means.

From the European patent application EP0975280A1 there is known a stent cut from a metal sheet, which is rolled into a cylindrical form, with the longitudinal edges of the element cut out of the sheet overlapping, which strengthens the structure of the stent in this section. The overlapping edges of the sheet may be joined by gluing or welding, as well as by riveting at several points, as shown in Figures 2 and 2A. The surfaces of the stent beyond the marginal junction may be cut in different patterns, e.g. linear segments joined by transverse spans. Such a construction causes thickening of the stent in the area of joining the edges of the sheet.

US patent application US2003055495A1 discloses a heart valve frame structure cut from a metal/metal alloy sheet, the frame having specially formed seaming edge fasteners to join the sheet into a cylindrical form at the implantation site.

The fasteners are not permanently joined and allow for adjusting the diameter of the frame through a series of slots created around its perimeter that form a fastener. The frame is delivered to the patient's body in a rolled form, which allows its diameter to be significantly reduced during delivery to the final destination.

A similar structure of the heart valve frame is known from the publication of the international patent application WO02076348A1.

The described publications do not indicate an advantageous improvement in the physical properties of the valve stent frame by being able to specifically select metal sheets or metal alloys with a particular internal crystalline structure.

The present invention relates to a balloon-expandable openwork heart valve frame made of at least one sheet of metal or metal-containing alloys, having a spanned, multi-row structure with a smaller cell part and a larger cell part, characterized in that the frame is made of sheet or sheets of metal or metal-containing alloys with a fixed, directional crystalline structure, given by the direction of the fibers formed during the plastic processing to which the sheet or sheets have been subjected, the sheet being either a single-layer, or possibly two-layer or three-layer, and each layer has a predetermined, directional crystalline structure, and wherein the frame structure, where the sheet or sheets join, is provided with flat tabs and opposing tab receiving means which together form permanent joints arranged in multiple rows such that one joint is assigned to one row of spans in the frame structure.

Preferably, the side of the sheet that forms or the sides of the sheets that form the annular perimeter of the frame are at an angle of 0°-85° to the fixed directional crystal structure of the sheet or sheets.

Preferably, the permanent joints made of hooks and hook receiving means are offset relative to each other, the next one relative to the previous one, in the same circumferential direction relative to the frame axis, preferably set on the frame perimeter on a diagonal line to the frame axis, or in an arc, or in a spiral to the axis of the frame.

Preferably, the frame is provided with valve board fasteners, preferably three such fasteners, which are equidistant from each other around the circumference of the frame, preferably the fasteners are provided with pairs of opposing protrusions, preferably from 2 to 20 protrusions, which preferably they are inclined relative to the axis of the fastener by an angle in the range of 5 to 60°.

Preferably, part of the protrusions is deflected towards one edge of the frame and part of the protrusions is deflected towards the opposite, other edge of the frame and, preferably, the protrusions are provided with thickenings at their ends.

Preferably, in the frame, the width (a) of the frame arms that enclose the larger frame cells, at the edge of the frame, is at least 10% greater than the width (Y) of the arms (Y) in the inner part of the frame with smaller cells, and/or the width (e) of the frame arms that close the smaller cells of the frame at the edge of the frame opposite the smaller cells is at least 10% larger than the arms (Y) in the inner part of the frame with the smaller cells.

The invention also relates to a method of manufacturing a balloon-expandable openwork heart valve frame, characterized in that it comprises the steps of:

a) more than one sheet made of metal or metal-containing alloys is delivered with a fixed, directional crystalline structure, given by the direction of the fibers formed during the plastic processing to which the sheets have been subjected, the sheets being single-layer or possibly two-layer or three-layer, and each layer has said predetermined crystalline structure, b1) cutting on opposite edges of the sheets, predetermined as frame joining edges, tabs and corresponding tab receiving means,

c) the sheets obtained in step b1 are folded into a cylindrical shape and the edges of the sheets provided with catches are permanently joined with the opposite edges provided with means for accepting the catches, the edges being joined along the contact line, and in a frame made of more than one sheet, preferably two, three or four sheets, single-ply or multi-ply, the successive sheets are connected side by side so as to form successive parts around the perimeter of the frame and a joint is formed between all the parts based on hooks and hook receiving means, and then,

d) the entire openwork pattern of the valve frame is cut out.

Preferably, the sides of the sheets that form the annular perimeter of the frame are at an angle of 0°-85° to a fixed crystalline structure given by the flow direction of the metal or metal-containing alloys.

Preferably, on the opposite edges of the sheets, defined as the frame connection edges, the catches and the corresponding means for accepting the catches are cut out in successive rows of spans in a diagonal or spiral line, or along an arc, in relation to the axis of symmetry of the frame to be produced, so that the joints, which is formed by the hooks and the hook receiving means are positioned on the surface of the frame in a diagonal or spiral line or in an arc.

Preferably, before and/or after and/or between the individual steps of the method for manufacturing the frame, an additional step or steps of heat and/or plastic treatment are applied.

The invention also relates to a method of manufacturing a balloon-expandable openwork heart valve frame, characterized in that it comprises the steps of:

a) a sheet made of metal or metal-containing alloys is provided with a fixed, directional crystalline structure, given by the direction of the fibers formed during plastic processing to which the sheet has been subjected, the sheet being single-layer or possibly two-layer or three-layer, and each layer has the said a predetermined crystal structure, b2) cut out on opposite edges of the sheet, predetermined as frame joining edges, tabs and corresponding tab receiving means along with the entire openwork pattern of the valve frame,

c) the sheet obtained in step b2) is rolled up into a cylindrical shape and permanently connected, the edge of the sheet provided with hooks with the opposite edge provided with means for accepting hooks, the joining of the edges being made along their contact line.

Preferably, the side of the sheet that forms the annular perimeter of the frame is at an angle of 0°-85° to a fixed crystalline structure given by the flow direction of the metal or metal-containing alloys.

Preferably, on the opposite edges of the sheet, defined as the frame joining edges, the catches and the corresponding means for accepting the catches are cut out in successive rows of spans in a diagonal or spiral line, or in an arc, in relation to the axis of symmetry of the frame to be produced, so that the joints, which is formed by the hooks and the hook receiving means are positioned on the surface of the frame in a diagonal or spiral line or in an arc.

Preferably, before and/or after and/or between the individual steps of the method for manufacturing the frame, an additional step or steps of heat and/or plastic treatment are applied.

The subject of the invention in an exemplary embodiment is shown in the drawing, in which Fig. 1 shows a general diagram of the method of manufacturing a penstock frame from a metal sheet or metal alloy in two variants, with the final product being an annular valve frame, Fig. 2 shows an enlarged fragment the penstock frame with multi-row hooks and the corresponding hook accepting means in a disconnected position, Fig. 3 shows a fragment of the penstock frame in Fig. 2 with the hooks in a position connected with the hook accepting means, Fig. 4 shows an enlarged fragment of the frame with marked widths of individual spans or elements of the penstock frame pattern, Fig. 5 shows a fragment of the frame and an enlarged view of several types of hooks in the penstock frame, Fig. 6 shows an example of a ready-made valve frame with joints made of hooks and fasteners for attaching the valve board, with the area marked "S" in Fig. 7 shows an enlarged area of "S" in Fig. 6 as part of a frame with an exemplary arrangement of markers in the form of black dots, Fig. Figure 9 shows an enlarged view of one exemplary retainer for securing the valve body.

In figures 2, 3, 4, 5, 7, 8, 9 only a section of the frame is shown, which is indicated by the wavy lines at the edges of the drawings. An overall at least partly annular frame according to the invention is shown in Fig. 1 and Fig. 6.

The method according to the invention, schematically shown in Fig. 1, consists in providing a raw material in the form of specially prepared sheets of metal or metal alloys, which sheets, by subjecting the raw material to a specific treatment, show the anisotropy of the crystal structure of the starting material, obtained by the appropriate orientation of the crystal structure when making the stock. This effect of the ordered, linear crystal structure of the metal (metal alloy) throughout the sheet from which the frame is made follows the direction of the fibers formed during the forming process. Such anisotropic ordering of the structure in a sheet of metal or metal alloy in which the fibers are arranged linearly can be achieved by any known forming methods such as cold rolling, with or without additional heat treatment.

Preferably, in the method according to the invention, rectangular or square sheets with sizes determined for the size of the target stent frame are used, or it is also possible to use sheets with an allowance on the sheet margins, so that only when cutting out the frame or cutting out the hooks or cutting out the span structure, they are given the desired dimensions ( length and width).

In the method shown in Fig. 1, sheet 1A can be used, in which the longer side of the blank coincides with the direction of the fibers formed during plastic working, sheet 1B, in which the longer side of the blank is transverse to the direction of fibers formed during plastic working, or sheet 1C in which the longer side of the stock is at an angle of 5°-85° to the direction of the fibers formed during plastic processing. Preferably, a sheet of type 1A or 1C is used, i.e. sheets in which the side of the sheet, which forms the annular perimeter of the frame, coincides with the direction of the fibers formed during plastic working or is at an angle of 5°-85° to the direction of the fibers formed in during plastic processing. In other words, sheets are preferred in which the side of the sheet that forms the annular perimeter of the frame is at an angle of 0°-85° to the direction of the fibers formed during the forming process, preferably in the range of 0°-60° or °-45°, or preferably close to 0°, or between 0° and 30°, preferably 0° to 20° or 0° to 10°, or close to 45° and between 35° up to 55°. Such orientation of the crystal structure in the sheet allows the use of anisotropy of the material structure in order to modify the mechanical properties of the valve frame, and in particular to increase its radial (radial) strength. Particularly preferred is the use of sheet types 1A and 1C. The use of sheet 1A in the method according to the invention, in which, after cutting out the profile (pattern) of the valve frame, the linear arrangement of the crystal structure in accordance with the direction of the fibers formed during its processing, runs in the transverse direction (at an angle of 90°) in relation to the axis of symmetry of the valve frame , is particularly advantageous due to the radial force of the finished product. The use of sheet 1C, in which the linear order of the crystalline structure of the metal (metal alloy) runs obliquely in relation to the axis of the finished valve frame cut from the tube, i.e. at an angle of 5° to 85° to this axis, is also advantageous due to the the resulting frame, i.e. increased radial force.

Type 1B sheets are the closest in their crystalline structure to the structure of typical frames cut from a ready-made metal tube. A crystalline order of this type is less favorable in terms of radial strength. However, due to the presence of a strong deformation of the material formed in the rolling process, the mechanical properties of the structure oriented in this way will differ from the mechanical properties of the material obtained by conventional methods by which metal pipes are produced.

In another variant of the invention, it is also possible to use a sheet in the form of a laminate resulting from the imposition and connection of two, three or four sheets, each of which has an anisotropic crystal structure, different from the others, e.g. using two sheets with a cross-flow direction of the material. A multi-layer sheet (preferably two-layer) constructed in this way will make it possible to use the anisotropies of the mechanical properties of individual layers of the material to improve the mechanical properties of the final product: the valve frame. With respect to such a laminate, for the purposes of the invention, each layer thereof is arranged linearly with respect to its crystalline structure, and preferably in these combined layers it is oriented either perpendicularly to the axis of the frame or at an angle ranging from 5°-85° to this axis. Preferably, the multi-layer sheet is a two-layer sheet and the layers are cross-aligned, i.e. each layer has an ordered, linear skew crystal structure with respect to the frame axis, but the linear structure in one layer with respect to the other layer differs by 90° or 45°, or ranges from 10 to 80°.

The method according to the invention, according to the scheme shown in Fig. 1, can be carried out in the first variant (left side of Fig. 1) so that from a sheet, i.e. from blank 1A or 1B or 1C, or from a multilayer sheet obtained from at least two such sheets , hooks and technical means accepting these hooks are cut out on the opposite edges (stage 1D), then the blank is rolled up and the edges are permanently connected to the hooks with opposite edges containing means for accepting hooks (step 1F) to form a ring or at least partially annular form, and then in the next stage (1H) an openwork pattern of the frame is cut out, constituting the final product - the valve frame.

In the second variant of the method according to the invention (right side of Fig. 1), in the first step 1E, the entire outline of the valve frame is cut out from the sheet, i.e. its openwork structure together with catches and means for receiving catches located on the opposite edge to these catches. In the second stage 1G, the cut outline of the frame is rolled up, the catches are fastened, and then their permanent connection is made, which leads to the final product - the valve frame.

In another variant of the invention, it is possible to carry out the first or second method with the modification that more than one sheet of material is used, e.g. between them a joint is formed based on juxtaposed tabs and tab receiving means. Thus, when the frame is made of two sheets, two lines of hook joints - hook receiving means are formed around the circumference of the frame, and in the case of three sheets of raw material, three lines of joints of hook - hook receiving means are formed around the perimeter of the frame.

The particular technologies used in said steps are known to those skilled in the art. Any known techniques may be used. Known cutting techniques, e.g. laser cutting, are used to cut the product from a sheet of metal. Permanent joining of metals in the place where the catches are joined with means accepting the catches is carried out by means of known methods, e.g. welding, welding, gluing.

Between each of the above-described method steps, it is possible to perform a heat treatment in the individual variants. Another intermediate treatment, obvious to those skilled in the art, is also possible, e.g. purification of semi-finished products.

The edges with the catches are joined with the opposite edges, i.e. with the means accepting the catches, maintaining one plane of the product, i.e. the elements from the opposite edges are connected face to face, without overlapping the sheet elements anywhere. In this way, a single layer of the raw material - the sheet - is preserved in the place where the sheet is joined. There may be minimal addition of binder material resulting from the gluing or welding process of the tabs being used, but the joint formed is substantially either the same thickness as the rest of the frame or only slightly different from the thickness of other areas of the frame structure.

Cutting out the hooks in successive rows of frame spans is preferably carried out diagonally with respect to the axis of symmetry of the final frame. The frame has a multi-row structure, i.e. it consists of rows of spans surrounding the rows of cells (eyes) and each row of spans is assigned a catch and corresponding catch receiving means. The hooks are therefore also in the form of multiple rows and are in the form of protruding protrusions, shaped in a manner adapted to the shape of the means for receiving these protrusions. The catches cooperate with the means for accepting the catches, i.e. the catches and the means for accepting the catches are mutually adjusted in shape to cause the effect of hooking, hooking of individual rows of frame spans. The joint formed by the catches and means for accepting the catches joins each row of spans. In order to maintain the minimum profile of the frame and to obtain maximum good physical properties of the frame, the said joints are successively shifted relative to each other around the perimeter of the frame, so that the joint from the first row of spans (on the first edge of the frame) is the farthest away from the joint from the last row of spans (on the second edge of the frame). frames). Such a relative offset of successive adjacent joints may be arranged such that adjacent joints form a diagonal line with respect to the axis of the frame, or are arranged in an arc or in a helical line on the outer surface of the frame. In an exemplary implementation of the method according to the invention, sheets obtained by cold rolling made of cobalt and chromium alloys, 0.4-0.5 mm thick, were used, the frame was made in two variants shown in Fig. 1, in which the cutting steps were carried out by and the joining of the fasteners and the fastener receiving means was carried out by welding or soldering. In the next implementation, a frame was made of one sheet with a two-layer structure, with a cross arrangement of the crystal structure of the layers.

The frame of the valve according to the invention is manufactured, i.e. it contains in its structure a sheet or sheets connected in a cylindrical shape, from which the frame pattern 2 is cut out, so that it has an openwork (mesh) structure consisting of two areas, an area with smaller cells 5 located at one end of the frame 2 and an area with larger cells 6 located at the opposite end of the frame 2, the structure of the frame 2 consisting of several rows of bays which in the inner area, with the smaller cells 5 of the frame 2, form X nodes, so that four Y arms (connectors) are derived from each of them, and the smaller cells 5 of this area have the shape of a regular polygon. The rows of smaller cells 5 in adjacent rows are offset by half a cell relative to the axis of the frame 2, so that the nodes X in every second row of these nodes are located in one line along the frame 2 (one above the other). The area with smaller cells 5 in the row at the edge of frame 2 ends with peaks V, which are formed by pairs of Y arms derived from nodes X in the row adjacent to the edge row of smaller cells 5. The area with larger cells 6 is adjacent to the area with smaller cells 5 and is formed in such a way that from the tops U of the arms Y in the row surrounding the smaller cells 5 in the last row (ending the area of small cells 5) parallel brackets Z are led out, passing on the edge of the frame 2 through connectors W into the arms ending the frame 2 with tops analogous to peaks V at the opposite end of the frame 2. The larger cells 6 of the frame 2 are in the shape of a regular polygon, the lower two sides and the upper two sides of which are formed by adjacent pairs of Y arms, and the longer, two opposite sides, parallel to the axis of the frame 2, are formed by Z-brackets. The Z-brackets in the frame 2 are substantially parallel to each other. The length of the larger cells 6 is at least 10% greater than the length of the smaller cells 5, said sizes being assessed in the expanded position of the frame 2 relative to the axis of symmetry of the frame 2.

Individual elements of the span structure of the frame 2 with the formula shown in part in Fig. 2 may have different widths, as shown in detail in Fig. 4, where the widths of the arms Y and the brackets Z in the individual rows of the penstock frame 2 spans are indicated. The width d of the arms Y is equal to the width c of the arms Y in the adjacent row of arms (in the opposite arms surrounding the smaller cell 5 of the mesh structure), the width of the arms b in the extreme row surrounding the larger cells 6 from the side of the smaller cells 5, may be larger by approx. 30% of the width c or equal to 1 to 1.2 times the width c, similarly the width f of the support Z located in the region of the larger cells 6 may be greater than 5% to 30% of the width c or equal to 1 to 1, 2 times the width of the span c, and the width a and e of the arms Y from the extreme rows, located on the opposite edges ending the frame 2, is greater by 10% to 150% of the width c or is equal to 1.2 to 2 times the width c. distribution of the width of the individual elements of the frame 2 pattern, it was ensured that the appropriate geometry of the frame 2 was obtained during the expansion of the frame 2 with the valve on the balloon, it was ensured that the appropriate radial force and stiffness in the upper part of the frame 2 needed to hold the commissions of the fixed valve were obtained.

Frame 2, based on the above construction, may also have a different form, i.e. a different number of rows, spans, their different size, it can also have a different mesh shape, e.g. /or transverse to the axis of the frame 2. The constructions of valve frames known from the state of the art dedicated to implantation in the balloon dilatation procedure and stent structures can be used to produce the frame 2 in accordance with the invention. It is obvious to the skilled person that the cut structure of the frame 2 in the collapsed, balloon-clamped state should provide a minimum size of the prosthesis, i.e. the cut pieces of the patterns of the frame 2 in the folded position adhere to each other so that the compressed structure forms a cylindrical shape of minimum diameter, and expands easily and expands in the transverse direction caused by inflation of the balloon. The frame 2 is cut from a sheet or sheets of material forming (forming) a ring shape when assembled, however, when expanding the frame 2 on the balloon, it is possible to obtain a modified shape of the frame 2, which may be cup-shaped on one side or have a widened form at both ends, etc.

Frame 2, apart from the span structure described above, according to the invention is provided with catches 3 and, on the side in contact with these catches 3, with means for receiving catches 4. in fig. 3 in a joined position, which then creates a permanent joint 7. The hooks 3 are shaped in the form of protrusions protruding beyond the outline of the frame 2, provided with concave and convex elements from the side that is to be hooked to the analogous elements of the hooks receiving means 4 Once the hooks 3 and the hook receiving means 4 are put together, they interlock to provide the application of the force holding the closed, cylindrical form of the frame 2. The number of hook assemblies 3 and hook receiving means 4 used corresponds to the number of rows of spans forming the outline of the frame 2.

Fig. 5 shows several examples of hooks 3-3A, 3B, 3C, 3D, 3E, which are used in a multi-row system in the frame 2. The simplest form of the hook 3 used may be the form of a single hook 3D or 3E mounted on the tab of the hook 3, which the reverse representation of this hook in the form of hook receiving means 4 corresponds to this. Such construction of the joint 7 is to ensure mutual engagement of these elements. The hooks 3 can also be in the form of a more complex broken line 3A, teeth, eg triple teeth 3C or a double hook, and also in the form of convex rounded forms 3B. Further modifications to the shapes of the fasteners 3 will be obvious to the person skilled in the art, which correspond to the patterned fastener receiving means 4 ("puzzle" principle). The arrangement of such a joint 7 works on the principle of concave and convex elements, holding each other in position when the frame 2 has its final cylindrical shape. The hooks 3 used make it possible to obtain the appropriate geometry of the frame 2 and to position the opposite ends of the profile relative to each other while making their permanent connection. The geometry of the hook 3 has a positive effect on the strength of the joint 7 by mechanically blocking the possibility of displacement of the opposite ends of the valve frame 2 outline relative to each other.

The frame 2 according to the invention also includes fastening elements 8 intended for fastening the commissures - places where the leaflets forming the valve come together, the fastening elements 8 being located in the frame 2 in such a way that they replace some of the brackets Z forming, together with the four arms Y, larger cells 6 of the frame 2. Consequently, it is essential that the entire structure is stable and symmetrical due to the symmetry of the acting forces. Preferably, if there are 2-9, 12, 15 or 18 Z-brackets in the frame, three of which are replaced by the arm rest fixing elements 8, the remaining 6, 9, 12 or 15 Z-brackets are symmetrically arranged between the three arm rest fitting elements 8.

An advantage of the use of the branched fastening element 8 for securing the commissures is the ease of suturing in the valve/valve material fastening step. Due to the presence of the first protrusions 18 for attaching the thread to the sutures and symmetrically positioned, on the opposite side of the fastening element 8, the second protrusions 19 for attaching the thread to the sutures, the fastening - sewing of the valve is facilitated. The fastening element 8 for fastening the commissions comprises at least two protrusions 18, 19 arranged oppositely. Holes 20, which are provided with the fastening element 8 for fastening the commissions, can also be used for fixing the penstock. The oblique inclination of the protrusions 18, 19 towards one or the other edge of the frame 2, with at least some of the protrusions directed towards the edges closing the larger cells 6 of the frame 2, generates tensioning and pulling forces on the commission, which has a positive effect on its tightness and durability fastenings. The inclination of the protrusions 18, 19 with respect to the axis of the fastening element 8 (shown in Fig. 9, where the axis extends vertically along the fastening element 8 through the openings 20) may be in the range of 5° to 80°, preferably 5° to 60°. Since no part of the valve leaflet is folded outside the frame 2, and only threads/stitches are present on the outside of the frame 2, the solution advantageously reduces the diameter of the valve frame 2 clamped on the balloon and protects the leaflet material at the place of commissure formation against possible damage during inserting the frame 2 into the implantation site.

As shown in Fig. 8, in the simplest variant of the invention (variant 8A), the fastening element 8 comprises simple oblique protrusions 18, 19 and holes 20, which are also used for fastening threads/stitches or are places for markers. In the version 8B, the fixing element 8 for attaching commissioned cases additionally includes lower protrusions directed opposite to the other protrusions, towards the other edge of the frame 2, in order to additionally prevent the seams from slipping. In versions 8C and 8D, the projections 18, 19 are provided with widened ends or with thickening at the ends to prevent the threads/stitches from slipping off. Version 8E presents another variant of the fastening element 8 for fastening commissars, devoid of central holes.

Fig. 7 shows possible locations for the placement of radiographic markers in the frame 2 of the valve. Such markers may indicate clinically significant positions of the frame 2 and valve elements, e.g. the marker 9 of the fastening element 8 indicates the location of the commissure attachment, the V peak markers 10, 17 indicate the two extreme ends of the valve frame 2. The markers 11 of the Z-brackets indicate the placement space of the valve and distinguish the position of the Z-brackets from the fixing elements 8 for securing the commissures (where there are two markers). The X-node markers 12 together with the Y-arm markers 13, 14, 15, 16 make it possible to assess the position of the entire area with the smaller cells 5 of the frame 2. The markers can be circular, oval or polygonal in shape. Depending on the location on the frame 2, they may differ in size. Markers can be placed on each row of spans or every 2nd, 3rd, 4th or every 6th span.

Claims (17)

1. A balloon-expandable openwork heart valve frame made of at least one sheet of metal or metal-containing alloys, having a spanned, multi-row structure with a part with smaller cells and a part with larger cells, characterized in that the frame (2) is made of sheet or sheets of metal or metal-containing alloys with a fixed, directional crystalline structure, given by the direction of the fibers formed during the plastic processing to which the sheet or sheets have been subjected, the sheet being either a single-layer or possibly two-layer or three-layer, and each layer has a predetermined, directional crystalline structure, and wherein the frame structure (2), where the sheet or sheets are joined, is provided with flat tabs (3) and opposing tab receiving means (4), which together form permanent joints (7 ) arranged in multiple rows, so that one joint (7) is assigned to one row of spans in the frame structure (2). 2. A frame as claimed in claim The sheet according to claim 1, characterized in that the side of the sheet that forms or the sides of the sheets that form the annular perimeter of the frame (2) are at an angle of 0°-85° to the fixed directional crystalline structure of the sheet or sheets. 3. A frame according to claim Characterized in that the permanent joints (7) formed by the catches (3) and the means for accepting the catches (4) are offset relative to each other, next to the previous one, in the same circumferential direction relative to the axis of the frame (2), they are preferably positioned around the circumference of the frame (2) on a diagonal line to the axis of the frame (2) or in an arc or spirally to the axis of the frame (2). 4. A frame as claimed in claim The device according to claim 1 or 2 or 3, characterized in that it is provided with fastening elements (8) of the valve body, preferably three such fastening elements (8), which are placed at equal distances from each other on the circumference of the frame (2). 5. A frame according to any one of claims from 1 to 4, characterized in that the fastening elements (8) are provided with pairs of opposite projections (18, 19), preferably from 2 to 20 projections (18, 19). 6. A frame according to any one of claims from 1 to 5, characterized in that the protrusions (18, 19) are inclined relative to the axis of the fastening element (8) by an angle in the range of 5 to 60°. 7. A frame as claimed in claim 6, characterized in that part of the protrusions (18, 19) is deflected towards one edge of the frame (2), and part of the protrusions (18, 19) is deflected towards the opposite, other edge of the frame (2). 8. A frame according to any one of claims 1 to 8. from 1 to 7, characterized in that the projections (18, 19) are provided with thickenings at the ends. 9. A frame according to any one of claims from 1 to 8, characterized in that the width (a) of the arms of the frame (2) that close the larger cells (6) of the frame (2) at the edge of the frame (2) is at least 10% greater than the arms (Y) in the inner part of the frame (2), with smaller cells (5) and/or the width (e) of the frame arms (2) that close the smaller cells (5) of the frame (2) at the edge of the frame (2) opposite to the smaller cells ( 5), is at least 10% larger than the arms (Y) in the inner part of the frame (2), with smaller cells (5). 10. A method of manufacturing a balloon-expandable openwork heart valve frame comprising the steps of: - a) more than one sheet of metal or metal-containing alloys is supplied with a fixed, directional crystalline structure, given by the direction of the fibers formed during the plastic processing to which the sheets have been subjected, the sheets being single-layer or optionally two-layer or three-layer , and each layer has said fixed crystal structure, - b1) on the opposite edges of the sheets, defined as the joining edges of the frame (2), the catches (3) and the corresponding catch receiving means (4) are cut out, - c) the sheets obtained in step b1) are folded into a cylindrical shape and the edges of the sheets provided with catches (3) are permanently joined with the opposite edges provided with means for accepting the catches (4), the edges being joined along the contact line, and in a frame (2) made of more than one sheet, preferably two, three or four sheets, single-ply or multi-ply, the successive sheets are joined next to each other so that they form successive parts around the circumference of the frame (2) and a joint is formed between all the parts (7) based on the hooks (3) and the hook receiving means (4) and then, - d) the entire openwork pattern of the valve frame (2) is cut out. 11. The method of claim 10, characterized in that the sides of the sheets that form the annular perimeter of the frame (2) are at an angle of 0°-85° to the fixed crystalline structure given by the flow direction of the metal or metal-containing alloys. 12. The method of claim 10 or 11, characterized in that on the opposite edges of the sheets, defined as the edges of the frame connection (2), the catches (3) and the corresponding means for receiving the catches (4) are cut out in successive rows of spans in a diagonal or spiral line or in an arc , in relation to the axis of symmetry of the frame (2) to be produced, so that the joints (7), which are formed from the catches (3) and the means for accepting the catches (4), are positioned on the surface of the frame (2) in an oblique or spiral line, or in an arc. 13. The method of claim A method according to claim 10 or 11 or 12, characterized in that before and/or after and/or between the individual steps of the method for manufacturing the frame (2), a heat treatment and/or plastic treatment step or steps are additionally applied. 14. A method of manufacturing a balloon-expandable openwork heart valve frame comprising the steps of: - a) a sheet made of metal or metal-containing alloys is supplied with a fixed, directional crystalline structure, given by the direction of the fibers formed during plastic processing to which the sheet has been subjected, the sheet being single-layer or possibly two-layer or three-layer, each layer having said fixed crystal structure, - b2) on the opposite edges of the sheet, defined as the joining edges of the frame (2), the catches (3) and the corresponding means for accepting the catches (4) are cut out together with the entire openwork pattern of the valve frame (2), - c) the sheet obtained in step b2) is rolled up into a cylindrical shape and the edge of the sheet provided with catches (3) is permanently joined with the opposite edge provided with means for accepting the catches (4), the edges being joined along their contact line. 15. The method of claim 14, characterized in that the side of the sheet that forms the annular perimeter of the frame (2) is at an angle of 0°-85° to the fixed crystalline structure given by the flow direction of the metal or metal-containing alloys. 16. The method of claim 14 or 15, characterized in that on the opposite edges of the sheet, defined as the edges of the frame connection (2), the catches (3) and the corresponding means for receiving the catches (4) are cut in successive rows of spans along a diagonal or spiral line or along an arc , in relation to the axis of symmetry of the frame (2) to be produced, so that the joints (7), which are formed from the catches (3) and the means for accepting the catches (4), are positioned on the surface of the frame (2) in an oblique or spiral line, or in an arc. 17. The method of claim A method according to claim 14 or 15 or 16, characterized in that before and/or after and/or between the individual steps of the method for manufacturing the frame (2), a step or steps of heat treatment and/or plastic treatment are additionally applied.