A PROSTHETIC HEART VALVE

Abstract: In a prosthetic heart valve comprising a generally annular stent (2) and at least two obturators (3) mounted in the stent so as to be able to pivot between an open position and a closed position, the stent (2) is provided with at least one element (9) which projects inwardly of the stent itself, whilst each of the obturators (3) has recesses (8) which cooperate with the projecting element (9) of the stent (2) with clearance in a generally-hinged configuration which enables the obturators (3) to pivot between the open position and the closed position.

Description: A prosthetic heart valve The present invention relates to prosthetic heart valves and particularly to a prosthetic heart valve comprising a generally-annular stent intended to be traversed by the blood and at least two obturators mounted in the stent so as to be able to pivot between an open position, in which the obturators allow the blood to pass freely through the stent in a first direction, and a closed position, in which the obturators jointly prevent the blood from passing through the stent in the direction opposite the first direction. Prosthetic heart valves of the type specified above, which are usually provided with two obturators, are widely known in the art and are currently known as "bi-leaflet" or double semi-disc valves. Generally, in known prosthetic heart valves with several obturators, the pivoting of the obturators is achieved by the provision thereon of projecting formations which engage like pins in corresponding recesses provided in the wall of the orifice of the valve stent. A solution of this type is described, for example, in European patent application EP-A-0 338 179 in the name of the same Applicants. This document is, however published the 25.10.89 which is after the filing date of the application. Experiments and clinical tests carried out with known valves show that, whilst their performance can be considered generally satisfactory, they are still far from perfect from several points of view. For example, the articulation of the obturators by means of pins which cooperate with recesses provided in the stent of the prosthesis causes the fraction of blood which passes over the articulation zone, causing the so-called washing of the articulation itself, to follow a path which is removed or diverted from the main flow of blood through the prosthesis. Another possible disadvantage lies in the fact that the cross-section of the prosthesis stent usually has to be increased in the zones in which the recesses for engaging the pins of the obturator are situated, and forms a thickening (or shoulder) which reduces the cross-section available for the passage of blood through the prosthesis. There are usually two thickenings or shoulders of this type in a prosthesis including two obturators and this can reduce the useful cross-section for the blood flow significantly. Moreover, the region immediately downstream of the shoulders (in the direction of flow of the blood through the prosthesis) may constitute a region in which the blood is relatively stagnant and in which thrombogenic phenomena can arise more easily. Finally, in known solutions, the axes about which the obturators pivot, which are identified by the pins of the obturators and by the corresponding recesses provided in the stent, are in fixed positions. This means that the obturators continue to orient about the same axes throughout the entire useful life of the prosthesis. This means that certain parts of the prosthesis, and always the same parts, are subject to marked strain and are therefore potentially subject to wear and breakage. Moreover, the positions of the pivot axes of the obturators are decided univocally by the position in which the prosthesis is implanted, which is selected once and for all by the surgeon during implantation. It is, however, possible that the optimum position of the prosthesis from the point of view of its operation will vary with time. More specifically, the present invention relates to a prosthetic heart valve having the features called for in the pre-characterising portion of Claim 1, which is known, e.g. from EP-A-0 176 337 or EP-A-0 207 594. The object of the present invention is to provide a prosthetic heart valve of the type specified above, which is improved particularly as regards: the possibility of having a larger useful cross-section for the passage of blood through the prosthesis, the elimination of potential zones of stagnation of the blood, and the possibility of enabling the obturators to orient or rotate relative to the stent of the prosthesis. According to the present invention, this object is achieved by virtue of a prosthetic heart valve of the type specified above, having the further features called for in Claim 1. The invention will now be described, purely by way of non-limiting example, with reference to the appended drawings, in which: Figure 1 is a perspective view of a prosthetic heart valve according to the invention, Figure 2 is a cross-section taken on the line II-II of Figure 1, on an enlarged scale, Figure 3 is a perspective view of one of the elements illustrated in Figures 1 and 2, Figure 4 is a view on an enlarged scale, of the part of Figure 3 indicated by the arrow IV, and Figure 5 is a cross-section corresponding substantially to the cross-section of Figure 2, showing a first possible variant of the prosthetic valve according to the invention. In the drawings, a prosthetic heart valve intended to be used to replace a natural heart valve (for example the aortic valve or the mitral valve) which has suffered as a result of cardiac valve damage or of cardiopathy, is generally indicated 1. In accordance with a widely-known solution, the prosthesis 1 comprises: a generally annular-shaped stent which defines within it a passage for the blood, and a plurality of obturators (usually two) indicated 3 of generally eyelid or nail shape. The obturators 3 are mounted within the stent 2 so as to be pivotable between a closed position (shown in continuous outline in Figure 2) and an open position (shown in broken outline, also in Figure 2). For the purposes of the present description, it may be assumed that this pivoting takes place about respective lines approximately identifiable by the axes X₃ (see Figure 1). In their open position, the obturators 3 extend in positions almost perpendicular to the general plane of the stent 2 and thus enable the blood to flow freely through the prosthesis in a first direction (downwards with reference to the orientation of Figure 2). When the direction of the blood flow is reversed by the action of the heart muscle, the blood pressure itself automatically causes the obturators 3 to move into their closed position in which the obturators 3 jointly occlude the orifice of the prosthesis, preventing the blood from flowing in the opposite direction (upwards with reference to the orientation of Figure 2). The stent 2 is made from a rigid material, for example metal or a pyrolitic carbonaceous material, or a combination of the two (metal core covered with carbonaceous material, or carbonaceous material with a metal reinforcing structure). The stent 2 usually has a groove 4 in its outer surface for facilitating the assembly of a suture ring around the stent 2 which enables the prosthesis to be fixed to the annulus of the natural valve after its valve flaps have been removed. The cross-section of the suture ring R, which is made of a woven textile made from biocompatible thread (for example threads of the materials sold under the trade marks Dacron and Teflon) is illustrated schematically in broken outline in Figure 1 only. The obturators 3 may be constituted by a core (for example of graphite), covered with a layer of biocompatible carbonaceous material deposited by high-temperature pyrolisis (pyrocarbon) or by cathode spraying (sputtering). Alternatively the obturators 3 may be made entirely of carbonaceous material. Similar layers of biocompatible carbonaceous material may also be applied to the stent 2 and to the suture ring R, at least in the parts which will be exposed to the blood flow. The obturators 3 are generally eyelid-shaped (see Figure 3); each is seen to have two opposing vertices 5, between which extend the inner side 6 of the obturator (which will cooperate with the corresponding side of the other obturator in the closed position - Figures 2 and 5) and the outer side 7 of the same obturator (which will cooperate with the wall of the valve orifice in the closed position). The salient characteristic of the prosthetic valve according to the invention is that each obturator 3 has respective recesses 8, near its vertices 5, for cooperation with projecting elements (protuberances) 9 provided on the wall of the orifice of the prosthesis. The obturators 3 are mounted in the stent 2 so that the portions in which the recesses 8 are provided are arranged, so as to speak, astride the annular projection 9. In order to achieve this result, the obturators 8 may, in general, be arranged adjacent their final positions of assembly and then pressed slightly to cause their deformation and consequent snap-engagement with the projection 9. Alternatively, the same result can be achieved by action on the stent 2 (for example by its resilient deformation). In the embodiments to which Figures 1 to 5 relate, the projection 9 is constituted by an annular body of semicircular cross-section which projects from the inner wall of the stent 2 around its entire circumference. The projection 9 thus has two sides which face in opposite directions, towards the two axial ends of the stent 2 respectively. As can better be seen in the enlarged view of Figure 4, the recesses 8 are generally butterfly-shaped. Each recess 8 is thus seen to have two pairs of "diagonally opposite" sides 10, 11. The dimensions of the recesses 8 are such so as to achieve a hinged engagement with the projection 9, with sufficient clearance to enable the obturators 3 to pivot freely about the axes X₃ between their closed positions and their open positions. The relative positions and inclinations of the diagonally opposite sides or faces 10, 11 of the recesses are selected so that: the sides 10 are brought into contact with opposite sides (in an axial direction) of the projection 9 when each obturator 3 is in its closed position (relative position indicated A in Figure 4), and the other two sides 11 are brought into contact with the opposite sides of the projection 9 when the obturators 3 are in their open positions (relative position indicated B in Figure 4). The amplitude of the movement of the obturators 3 in pivoting between their open positions and their closed positions can therefore be determined univocally by the selection of corresponding inclinations of the sides or faces 10 and 11 of the recesses 8. The same end positions of the pivoting movement of the obturators 3 may, however, also be determined by other means, for example by means of abutments provided on the stent 2, or, particularly in the case of the closed position, by the shaping of the outer side 7 of each obturator 3 so that this side abuts the corresponding wall of the annular projection 9 precisely when the obturator 3 reaches the closed position. With the use of this solution in particular, the height of the stent 2 (that is, its axial extent in the direction of the blood flow) may be reduced to a minimum, in practice corresponding to the axial extent of the projection 9. This solution is shown schematically in Figure 5 which shows a prosthesis in which the stent 2 is practically reduced to a ring with a very small height, much less than the axial bulk (that is in the direction of the blood flow) of the obturators 3 in their closed position. This variant is particularly advantageous in terms of the reduction of the overall bulk of the prosthesis 1 and also as regards any traumatic effects which could be caused in that region of the annulus where the prosthesis 1 is sutured if the stent 2 were of excessive axial length. In the embodiments illustrated in Figures 1 to 5 it is implicitly assumed that the projecting element or protuberance 9 provided within the stent 2 extends continuously around the entire circumference of the stent 2, that is around the entire periphery of the prosthesis. This solution is particularly advantageous since it enables the obturators to rotate freely about the main axis of the stent 2 so that the angular positions of the respective pivot axes X₃ relative to the stent itself vary. The engagement between the recesses 8 and the projections 9 does in fact have sufficient clearance to enable the obturators to rotate around the periphery of the stent 2. Naturally this orienting movement does not cause the obturators 3 to be released from the stent 2 because of the mutual restraining action which the obturators 3 exert on each other. As stated above, the ability of the obturators 3 to rotate (with the change in the angular position of the pivot axes X₃ relative to the stent 2) has the advantage that it prevents certain operating forces from being applied constantly to the same region of the stent 2 and thus achieves a uniform distribution of the wear. In order to facilitate the orienting action, it is possible to provide the obturators 3 with a configuration, or shape, which is "fluidodynamically-asymmetric" relative to the blood flow duct defined by the stent 2. In other words, the obturators 3 may be provided (naturally in a concordant manner for the two obturators 3) with a generally asymmetric configuration similar to that of a propellor blade. This shaping operation (whose result is not obviously visible in the appended drawing for reasons of scale) can easily be achieved during the shaping of the graphite cores of the obturators 3, which are usually produced by cutting from a lump of graphite by means of numerically-controlled tools. By virtue of their generally blade-like configuration, when the obturators 3 are impinged upon by the blood flow (particularly at the beginning of the opening phase, that is when the direction of the blood flow is reversed and impinges on the extradotal faces - that is the convex face - of the obturators 3) the obturators tend to rotate slightly relative to the general plane of the prosthesis 1, with a slight angular displacement of the respective axes X₃ relative to the stent 2, as well as pivoting about these same axes X₃ towards the open position. The ability of the obturators 3 to rotate freely relative to the main axis of the prosthesis 1 is also advantageous since it enables the obturators 3 themselves to orient automatically into the position of least resistance to the blood flow, and thus to assume spontaneously the most effective position from the point of view of the operation of the prosthesis.

Claims: A prosthetic heart valve comprising a generally annular stent (2) intended to be traversed by the blood and at least two obturators (3) mounted in the stent (2) so as to be able to pivot between an open position in which the obturators (3) allow the blood to pass freely through the stent in a first direction, and a closed position, in which the obturators (3) jointly prevent the blood from passing through the stent in the direction opposite the first direction, wherein the stent (2) has at least one element (9) which projects inwardly of the stent itself, and each of the obturators (3) has recesses (8) which cooperate with the at least one projecting element (9) with clearance in a generally-hinged configuration, enabling the obturator (3) to pivot between the open position and the closed position, characterised in that the projecting element is in the form of an annular protuberance (9) extending around the entire circumference of the stent (2) so that the obturators (3) can orient relative to the stent (2) to vary the angular positions of their pivot axes (X₃) around the stent (2). A prosthetic valve according to Claim 1, characterised in that the projecting element (9) has opposite faces and the recesses (8) are generally butterfly-shaped with diagonally-opposite pairs of sides (10, 11); the sides of the pairs (10, 11) being able to cooperate with the opposite faces of the projecting element (9) to define at least one of the open and closed positions of the obturators (3). A prosthetic valve according to Claim 1 or Claim 2, characterised in that the obturators (3) are generally eyelid-shaped with two opposite vertices (5) and in that each obturator (3) has two of the said recesses (8) each provided near one of the two vertices (5). A prosthetic valve according to any one of Claims 1 to 3, characterised in that the obturators (3) are generally eyelid-shaped with two opposite vertices (5) and an outer edge (7) of the obturator extending between the two opposite vertices (5) and in that the coupling between the at least one projecting element (9) and the recesses (8) of the obturator is achieved in such a way that the outer edge (7) is brought into abutment with the projecting element (9) when the obturator (3) is in the closed position. A prosthetic valve according to Claim 1 or Claim 4, characterised in that the at least one projecting element (9) has a given dimension axially of the stent (2) and in that the stent (2) itself has axial dimensions corresponding substantially with the given dimension. A prosthetic valve according to any one of the preceding claims characterised in that it includes two obturators (3). A prosthetic valve according to Claim 1, characterised in that the obturators (3) have fluidodynamically-asymmetric shapes with respect to the duct for the blood flow defined by the stent (2) of the prosthesis, so that the blood flow in the duct can cause the obturators (3) to orient relative to the stent (2) so varying the angular positions of their pivot axes (X₃) around the stent.

Inventors: BONA, GIOACHINO, RINALDI, STEFANO, VALLANA, FRANCO
Applicants: SORIN BIOMEDICA S.P.A.
Application year: 1988
Main classification: A61F2
IPC codes: A61F2