FR2748653A1 - Prosthetic surgical heart valve - Google Patents

Abstract

The prosthesis has a peripheral annular support (2) for fixing into the aorta cavity and a valve (4) to selectively open and close the passage. The valve has an opening (12-12b,20-20b) to establish a blood circulation across the prosthesis when the valve is closed. The opening connects to one end of an intra-aortic bridge piece (14-14b,21-21b) extending to the interior of the aorta cavity. It extends between at least one coronary ostium (16a,b) and the valve opening so that the blood flow is preserved during the diastole in the bridge between the aortic cavity above the prosthesis and the coronary ostium after the prosthesis in implanted above the coronary ostium.

Description

AORTIC VALVE PROSTHESIS WITH CORONARY BRIDGE
INTRA-AORTIC AND SURGICAL INSTALLATION KIT
Implantable aortic valve prostheses replace the failed natural aortic valve which can be blocked or subject to regurgitation (retrograde leakage).

 There are essentially two categories of aortic valve prostheses. The so-called "mechanical" prostheses of the first category include one or more artificial valves (for example pyrolitic carbon disc (s)). Bioprostheses of the second category include valves of natural origin, generally from pork or veal. In all cases, these prostheses include a peripheral annular support provided with a hemocompatible textile sheath of suture to the aortic ring for fixing the prosthesis in the aortic cavity perpendicular to the blood flow, and a device (artificial or d 'natural origin) forming a valve, carried by the support in a central position, suitable for opening during systole of the left ventricle by allowing the ejection of blood out of the left ventricle, and for closing and closing the aorta avoiding regurgitation in the left ventricle during diastole.

The implantation of such prostheses and the associated surgical techniques are for example described in the book "CARDIAC SURGERY, Safeguards and
Pitfalls in Operation Technique ", Siavosh Khonsari, Aspen
Publishers, Inc., Rockville, Maryland, USA, 1988, especially pages 42-56, or in the book "CARDIAC SURGERY,
Morphology, diagnostic criteria, natural history, techniques, results and indications ", John W. kirklin et al, A WILEY MEDICAL PUBLICATION, JOHN WILEY & SONS, USA, 1986, in particular chap. 12, pp 373-429, and whose contents are incorporated by reference into the present application.

 The placement of these prostheses in the natural aortic ring is difficult, if not impossible in certain circumstances. However, it is necessary to preserve the irrigation of the coronaries during the diastole of the left ventricle, the valve being closed, which supposes that the ostia are above the valve.

 But the coronary ostia are located nearby above the aortic ring. Therefore, when the natural aortic ring is deteriorated (infection or significant calcification of the ring), you must either use a natural homograft valve involving a complete replacement of the aortic root with the aortic ring and the aortic valve, or implant a complete prosthesis of the aortic root, either to implant a valvular prosthesis above the coronary ostia and to perform long and multiple coronary bypasses (technique of DANIELSON). The first solution is subject to the scarcity of organ donations. With the first and second solutions, a reimplantation of the coronary ostia is essential.

 With the third solution, the proximal end of the left coronary artery masked by the pulmonary artery requires a long external bypass which is itself the source of many problems (in particular rapid deterioration over time by stenosis or aneurysm bypass).

 In addition, in the frequent case of patients who have already undergone one or more cardiac interventions, the above-mentioned solutions are all the more difficult to implement. In particular, the bypasses of the third solution are made delicate by the scar fibrosis surrounding the heart.

 These three solutions are time-consuming and require a heavy and complex surgical intervention.

 Furthermore, in the case where one of the coronary ostia, in particular the left coronary ostium, is abnormally close to the aortic ring, a prosthesis fixed on the ring risks blocking all or part of the coronary ostium.

 Similarly, the installation of such a prosthesis is difficult in children or when the aortic ring is small. As such, it should be noted that the diameter of the aortic ring is 30 to 50% smaller than the diameter of the ascending aorta. Thus, the rare attempts to treat the child are carried out according to the technique known as "Ross technique" consisting of implanting the patient's pulmonary valve (autograft) in place of the deficient aortic valve and implanting a new natural homograft valve ( organ donation) in the pulmonary position. In addition, the installation of a valve prosthesis on the aortic ring in children, prevents the growth of the aortic ring, which subsequently requires new interventions with extremely heavy surgical techniques.

 Consequently, the fitting of aortic valve prostheses can only be considered without heavy operation and without homograft only when the aortic ring is healthy, of sufficient size, in adults and when the coronary ostia are normally placed at a sufficient distance above of the aortic ring.

 The invention therefore aims to overcome these drawbacks by proposing an aortic valve prosthesis allowing a simple and reliable treatment of the aforementioned cases (aortic ring deteriorated, infected, highly calcified, or small; ostia too close to the aortic ring; treatment of multi-operated patients treatment of the child) under conditions similar to those corresponding to normal situations of fitting traditional aortic valve prostheses.

 More particularly, the invention aims to propose an aortic valve prosthesis which can be implanted above the coronary ostia, in the ascending aorta, without long and multiple bypasses, in particular without extra-aortic bypass of the left coronary, but which preserves the coronary irrigation during the diastole of the left ventricle.

 To do this, the invention relates to an aortic valve prosthesis comprising an annular peripheral support for fixing in the aortic cavity and a valve device, carried by the support, adapted to close during the diastole of the left ventricle and to open during systole of the left ventricle, characterized in that it comprises means defining at least one through orifice adapted to establish blood circulation through the prosthesis when the device forming the valve is closed, and to be connected to one end of an intra-aortic bypass extending inside the aortic cavity between at least one coronary ostium and the orifice, so that a blood circulation can be preserved, during diastole, in this intra-aortic bypass the aortic cavity extending above the prosthesis and the coronary ostium while the prosthesis is implanted above the coronary ostia.

 By "intra-aortic bypass" is meant throughout the present application any channel made by the practitioner in the aorta to establish a secondary blood circulation distinct from the main aortic circulation. Thus, this expression includes all the possible embodiments making it possible to establish this secondary circulation (artificial tube; portion of autograft, allograft or xenograft vein; artificial patch, autograft, allograft or xenograft attached to two longitudinal edges to the internal aortic wall for form a channel with it ...). By "intra-aortic bypass surgery" is meant an intra-aortic bypass that extends a coronary artery in the aorta from the coronary ostium. In addition, the term "prosthesis" includes both mechanical prostheses and bioprostheses.

 Thanks to the invention, the surgeon can easily implant the valve prosthesis in the ascending aorta above the coronary ostia, without having to set up an extra-arterial bypass of the left coronary (the proximal end of which is masked by pulmonary artery). The invention therefore opens access to the treatment of the most difficult cases of replacement of the aortic valve without requiring the complete replacement of the root of the ascending aorta and of the valve. In particular, the invention allows the simple fitting of an aortic valve prosthesis while the natural aortic ring cannot receive the prosthesis.

 It should also be noted that in the case of the child, the invention allows not only the fitting of a prosthesis, which was previously almost impossible given the small diameter of the aortic ring (conventionally less than 20 mm ), but also the simple subsequent change of the prosthesis after the patient has grown. In fact, growth will take place normally at the level of the aortic ring, in the aortic portion situated under the prosthesis, and in the aorta above the prosthesis. The aorta will then present a general shape of an hourglass. By cutting the aorta transversely immediately below and above the prosthesis, one can remove the prosthesis and put in place a new prosthesis of caliber corresponding to that of the aorta after growth. One can even after the end of growth, implant a valve prosthesis according to the traditional technique at the level of 1 aortic ring (below the coronary ostia).

 In addition, it is also possible thanks to the invention to implant in the aorta an oversized prosthesis after having enlarged the aorta radially using an enlargement patch. In this way, one can anticipate the patient's growth.

 In a method according to the invention for treating an aortic valve deficiency, a restorative aortic valve (in particular a prosthesis according to the invention) is therefore implanted above the coronary ostia. The method according to the invention is characterized in that at least one intra-aortic coronary bypass is carried out between at least one coronary ostium, in particular the left coronary ostium, and at least one corresponding through orifice formed through the aortic valve. restorative.

 Several embodiments of prostheses according to the invention can be provided according to the pathologies to be treated.

 According to certain embodiments, a prosthesis according to the invention comprises means defining an orifice passing through at least opposite the left coronary ostium, that is to say adapted to be connected to an intra-aortic bypass connecting the left coronary ostium at this orifice. The prosthesis according to the invention must in fact allow the intra-aortic bypass at least of the left coronary which poses the most problem of access from the outside.

 To do this, the orifice is placed relative to the valve device so as to allow it to be placed substantially in the axis above the left coronary ostium at least. In many cases, the angular position of the valve device around the main axis of the aorta is of little importance, so that the mere presence of an orifice is sufficient to allow the bypass, the orifice being positioned extemporaneously in the axis of the left coronary ostium by the surgeon.

Also in the embodiments where the orifice is placed in the central position of the device forming the valve, the intra-aortic bypass can be performed indifferently from the angular position given to the prosthesis around the axis of the aorta.

 On the other hand, in cases where the prosthesis, and in particular the valve-forming device, has an axial asymmetry and where its angular position around the axis of the aorta is of some importance, the means defining the through orifice are suitable for that it can be placed at least substantially in the axis of the left coronary ostium, that is to say in the same radial half-plane.

 According to other embodiments adapted to allow a double intra-aortic bypass (a bypass for each coronary), the prosthesis comprises means defining two through orifices adapted to be connected respectively to a bypass connecting each coronary ostium to each orifice.

 According to other embodiments, it is possible to provide only one orifice connected by a bypass to two intra-aortic bypasses towards the two coronary ostia. This orifice will therefore have a cross section whose area is at least substantially twice that of each ostium.

 Furthermore, it is possible to place at least one through hole on a non-peripheral part of the prosthesis, by incorporating it through the device forming the valve. For example, an orifice can be defined in the center of a bioprosthesis by a ring connected to the annular support by spokes, this ring being placed in the center of the bioprosthesis between three sigmoid valves of animal origin, the central ends of which are cut out at the shape of the ring in order to achieve a seal with it during the diastole.

 In the case of a mechanical prosthesis with disc (s), such a ring can also be provided fixed on a support for disc (s), with an orifice formed through a sealing disc or between sealing discs.

 Preferably and according to the invention, the prosthesis is characterized in that it comprises means adapted to define at least one orifice placed at least in the vicinity of the periphery of the prosthesis.

 Advantageously, according to the invention, and in the embodiments where the prosthesis comprises means defining two through orifices, said means are adapted to define two orifices spaced angularly about 1200 from one another, so as to be able to be focused above the two coronary ostia.

 In addition, advantageously and according to the invention, the prosthesis comprises a hemocompatible textile sheath adapted to allow suturing of a tubular or hemi-tubular intra-aortic bypass to the prosthesis.

 In certain embodiments, the prosthesis comprises at least one through orifice formed by said means entirely through a fixed peripheral part (that is to say immobile after implantation) of the prosthesis, for example through the annular peripheral support of the prosthesis. In this way, the intraaortic bypass associated with the orifice is of tubular type and can be carried out for example using a portion of the patient's saphenous vein (autograft tube), or using an artificial tube. of biocompatible and hemocompatible material. One end of the bypass tube is connected by extemporaneous suture around the coronary ostium and the other end is connected to the orifice of the prosthesis by a tight connection made either by suturing by the surgeon temporarily or in advance. These embodiments (orifice formed entirely through a part of the prosthesis and tubular bypass) of the invention are more particularly advantageous for the treatment of adults.

 In other embodiments, an orifice is formed partially by said means of the prosthesis, and partially by the aorta. Thus, such a through orifice may also result from the fact that the peripheral annular support of the prosthesis comprises at least one concave portion with concavity oriented towards the outside to define a through orifice with a portion of aortic wall facing after implantation. With these embodiments, an intraaortic bypass of the so-called hemi-tubular type is used, obtained by bonding a patch (artificial or autograft) against the aortic wall so as to produce, between the aortic wall and this patch, the orifice up to the coronary ostium, a channel for the coronary irrigation blood circulation. This patch is sutured by its lower end under the coronary ostium or at the natural aortic ring or at the base of the corresponding natural coronary sigmoid valve if it can be preserved.

The upper end of the patch is connected to said concave portion by a tight connection made either by suturing by the surgeon temporarily, or in advance.

To allow the extemporaneous suturing of the patch to said concave portion, the latter is advantageously provided with a hemocompatible textile sheath which covers it. In addition, the patch has two longitudinal edges sutured to the internal aortic wall. These embodiments (concave portion and hemi-tubular bypass patch) are more particularly advantageous for the treatment of children.

 Furthermore, said means defining at least one orifice can be the subject of several alternative embodiments.

 In a first variant, said means comprise at least one rigid segment of a core of the peripheral annular support, this segment being adapted to delimit entirely (segment forming a radial protuberance in which a through lumen is provided) or in part (shaped segment concave arch with concavity oriented towards the outside) a through hole. Thus, it is at least part of the annular friend of the peripheral annular support which is modified and adapted to form a through orifice.

 In a second variant, said means comprise at least one rigid reinforcement piece extending outside a peripheral core of a peripheral annular support in a sheath of hemocompatible suture textile surrounding the peripheral friend and the reinforcement by providing said orifice. Thus, said means comprise an insert (frame) adapted to form an orifice in whole (lumen) or in part (hoop shape).

 The invention also extends to a surgical kit for the placement of an aortic valve prosthesis, characterized in that it comprises a prosthesis according to the invention and means for performing at least one intra-aortic coronary bypass, between each orifice passing through the prosthesis and at least one coronary ostium, in particular at least one tube and / or at least one bypass patch adapted to this orifice. In one embodiment, the kit according to the invention comprises at least one bypass tube or patch previously rigidly associated with the prosthesis, so that the surgeon only has to suture the lower portion of the bypass (tube or patch ) and the prosthesis. In another embodiment, the kit is presented with the separate bypass of the prosthesis.

 The invention also extends to the method for fitting a prosthesis according to the invention and to the method for treating an aortic valve deficiency according to the invention.

 The invention further relates to a prosthesis, a kit, and a method, comprising in combination all or part of the features mentioned above or below.

Other characteristics, objects and advantages of the invention will emerge on reading the following description which refers to the accompanying drawings in which
FIG. 1 is a top view of a mechanical prosthesis according to the invention, comprising a through orifice for tubular intra-aortic coronary bypass, shown implanted in an aorta,
FIG. 2 is a top view of a mechanical prosthesis according to the invention, comprising two through orifices for tubular intraaortic coronary bypasses,
FIG. 3 is a top view of a mechanical prosthesis according to the invention, comprising a concave portion intended to form a through orifice for semi-tubular intra-aortic bypass grafting,
FIG. 4 is a top view of a mechanical prosthesis according to the invention, comprising two concave portions intended to form two through orifices for hemitubular intra-aortic bypass coronaries,
- Figure 5 is a top view of a bioprosthesis according to the invention, comprising a through hole for tubular intra-aortic coronary bypass of the left coronary and a concave portion intended to form a through orifice for hemi-tubular intraaortic coronary bypass of the right coronary,
- Figure 6 is a sectional view along the broken line VI-VI of Figure 1, showing a prosthesis implanted with a tubular intraaortic coronary bypass of the left coronary and a traditional tubular extra-aortic bypass of the right coronary, shown during the systole of the left ventricle,
FIG. 7 is a view similar to FIG. 6, representing the diastole of the left ventricle,
FIG. 8 is a view in axial aortic section showing an example of implantation of a prosthesis according to the invention in accordance with the embodiment of FIG. 2 with tubular intraaortic coronary bypasses, represented during the systole of the left ventricle,
FIG. 9 is a view similar to FIG. 8 showing the diastole of the left ventricle,
FIG. 10 is a view similar to FIG. 9 showing another example of implantation of a prosthesis according to the invention in the form of a bioprosthesis comprising a concave portion associated with a semi-tubular intra-aortic bypass bypass,
FIG. 11 is a bottom view of the example of FIG. 10 along the arrow F11 of FIG. 10,
FIG. 12 is a view similar to FIG. 10 illustrating another example with two semi-tubular intra-aortic coronary bypasses with an alternative embodiment of the semi-tubular bypasses,
FIG. 13 is a bottom view of the example of FIG. 12 along the arrow F13 of FIG. 12,
FIG. 14 is a cross-sectional view of the aorta above the implanted prosthesis, along the line XIV-XIV of FIG. 8,
FIG. 15 is a cross-sectional view of the aorta above the implanted prosthesis, along the line XV-XV of FIG. 12.

 A mechanical aortic valve prosthesis comprises a peripheral annular support 2 for fixing it in an aortic cavity 3 of a patient, and a device 4 forming a valve generally in the form of one (or more) movable tilting disc (s) ( s) 5 acting as a valve in an annular seat 6 of valve.

 Figures 1 to 4 show examples of mechanical prostheses according to the invention.

 In a bioprosthesis (FIG. 5), the valve forming device 4 is formed from a valve of natural origin, for example from a pig valve comprising three flexible sigmoid valves 7 sewn onto an artificial peripheral annular support 2.

 In a manner known per se, the peripheral annular support 2 of an aortic valve prosthesis comprises a rigid annular metallic core 8 or of synthetic material, and a hemocompatible textile sheath 9 (for example made of DACRON (registered trademark)) surrounding this core 8 and / or sutured to the friend 8 so as to allow the peripheral suturing of the prosthesis to the aortic wall 10.

once the prosthesis implanted and sutured to the aortic wall 10, the support 2 and its core 8 are kept fixed.

 The rigid core 8 of the support 2 surrounds the annular seat 6 of the valve. The latter has a concave cross section (FIG. 6) with a concavity oriented outward radially to receive and maintain the friend 8 with the sheath 9 wedged between the friend 8 and the seat 6.

 In the embodiment of Figure 1, a rigid segment 11 of the annular friend 8 has a particular shape to define a rigid through hole 12 with an axis parallel to the axial direction of the prosthesis. This segment 11 is radially undeformable and forms a radially outward protuberance in which is formed a circular or oval through lumen defining the rigid orifice deformable orifice 12. The textile sheath 9 is pierced opposite the lumen and is passed around the peripheral edges 13 of the lumen, so that a bridging tube 14 can be sutured to the orifice 12 thus formed. To obtain the covering of the edges 13 of the lumen by the textile sheath, several methods can be used. For example, one can pass a textile sheath all around the friend 8 as in the prior art, then pierce right through the sheath 9 axially opposite the light to a diameter slightly smaller than that of the light, then fold the textile margins thus obtained inside the edges 13 and glue them and / or sew them together and / or at the edges 13. The segment 11 preferably has a convex outer contour adapting to the curvature of the aortic wall 10.

 Figures 6 and 7 illustrate an example of implantation of a prosthesis according to the invention according to the embodiment of Figure 1 following the valvulectomy. It should be noted that in these figures, the cut is made along a broken line (Figure 1) to illustrate each coronary ostium 16a, 16b in section.

The orifice 12 is connected to the left coronary ostium 16a by means of a bypass tube 14 extending in the ascending aorta 3. In fact, the proximal part of the left coronary is not accessible from the outside because it is masked by the trunk of the pulmonary artery.

The upper end 17 of the tube 14 is sutured tightly at the edges 13 of the orifice 12 opposite. The lower end 18 of the tube 14 is cut obliquely to facilitate its suturing around the left coronary ostium 16a and avoid forming an excessive bend. Furthermore, the annular support 2 is sutured over its entire periphery to the aortic wall 10 above the coronary ostia.

 During systole (Figure 6), the prosthesis opens to normally allow blood to flow into the aorta through the device 4 forming valve. During the diastole (FIG. 7), the device 4 forming the valve closes like the natural valve and the irrigation of the left coronary is ensured by the orifice 12 and the tubular bypass 14 intra-aortic coronary artery.

 The fitting of such a prosthesis is carried out as follows. After performing the valvulectomy, the lower end 18 of the tube 14 (artificial or homograft) is sutured around the left coronary ostium 16a. The tube 14 is cut to the appropriate length and its upper end 17 is placed and sutured in the through hole 12 of the prosthesis. The periphery of the support 2 is then sutured to the aortic wall 10 above the conar ostia. Then there is a traditional external bypass of the right coronary, which is more accessible from the outside, thanks to a tube 27 sutured at one end to an orifice 28 formed above the prosthesis through the aortic wall, and by the other end to an orifice 29 formed in the coronary artery.

The right coronary artery is closed by ligation between the right coronary ostium 16b and the bypass orifice 29. Then the surgical procedure is completed in the traditional way.

 FIG. 2 represents another embodiment in which the prosthesis is provided with two orifices 12a, 12b, one of which 12a allows bypass for the left coronary ostium 16a and the other 12b allows bypass for the right coronary ostium 16b. This embodiment also differs from the previous one in that each orifice 12a, 12b is formed not through a segment of the core 8 but through a reinforcement piece 15a, 15b, rigid, radially undeformable, attached and inserted in the textile sheath 9 outside the core 8 of the support 2. This frame 15a, 15b is in the general shape of a crescent to adapt to the contour of the core 8 and itself present a convex contour s' adapting to the curvature of the aortic wall 10.

 The two orifices 12a, 12b are spaced at the periphery angularly about 1200 from each other like the coronary ostia. In other words, radial straight lines passing through the center of the annular seat 6 and through these two orifices 12a, 12b form between them an angle of approximately 1200. In this way, each orifice 12a, 12b can be placed and centered above each coronary ostium.

 Again, each orifice 12a, 12b has its edges 13a, 13b covered with hemocompatible textile so as to allow the connection of a tubular bypass connecting the coronary ostium corresponding to this orifice 12a, 12b.

 Figures 8 and 9 illustrate an example of implantation of a prosthesis according to 1 invention according to the embodiment of Figure 2. Following the valvulectomy, each orifice 12a, 12b is connected to a coronary ostium 16a, 16b by the intermediate a bypass tube 14a, 14b extending in the ascending aorta 3.

The upper end 17a, 17b of each tube 14a, 14b is sutured in a sealed manner at the edges 13a, 13b of the orifice 12a, 12b opposite. The lower end 18a, 18b of each tube 14a, 14b is cut obliquely and sutured around the coronary ostium 16a, 16b. Furthermore, the annular support 2 is sutured over its entire periphery to the aortic wall 10 above the coronary ostia.

 During systole (Figure 8), the prosthesis opens to allow blood to flow normally through the aorta. During the diastole (FIG. 9), the device 4 forming the valve closes like the natural valve and the irrigation of the two coronaries is ensured by the tubular bypasses 14a, 14b intra-aortic coronaries.

 The fitting of such a prosthesis is carried out as follows. After carrying out the valvulectomy, each lower end 18a, 18b of each tube 14a, 14b of artificial bypass or homograft is sutured around the ostium co

 The embodiment of FIG. 3 differs from that of FIG. 1 in that the segment defines the orifice passing through only partially, that is to say on only part of its contour, the other part being defined by the aortic wall 10 opposite after implantation. The core 8 of the support 2 has a segment 19 indented in the form of a concave arch with a concavity oriented towards the outside. This segment 19 thus constitutes a portion of the support 2 which is concave with a concavity oriented radially outward to define a through orifice 20 with the part of the aortic wall 10 (shown diagrammatically partially in dashed dashed lines in FIG. 3) opposite after implantation. The textile sheath 9 surrounds the entire core 8, including the segment 19, so that the prosthesis can be sutured to the aortic wall 10 over its entire periphery, except for the segment 19 which is connected to the upper end of a so-called hemi-tubular bypass 21, as shown in FIGS. 10 and 11. The hoop-shaped segment 19 is rigid, non-deformable and can be formed by a radial protuberance (as shown), relative to the current radial thickness of the core 8, or hollow, if this current thickness is greater (variant not shown).

 It should be noted that the segment 19 in the form of an arch is more oblong (longer and less curved) than the lumen of segment 11 of the embodiment of FIG. 1. The orifice 20 defined by the segment 19 in the form of the arch is therefore more oblong and flattened than the orifice 12 defined by the lumen of the segment 11. Nevertheless, the area of each through orifice 12, 20 is adapted to correspond to that of the coronary ostium to which the orifice is connected so as to allow the circulation of a blood flow equivalent to physiological blood flow. Preferably, the area of each orifice 12, 20 is slightly greater than that of a normal coronary ostium, and is for example from 40 mm2 to 65 mm2, in particular of the order of 50 mm2 for adults (corresponding to an equivalent circular section of 7 mm to 9 mm, in particular of the order of 8 mm in diameter) or of 20 mm2 to 40 mm2, in particular of the order of 28 mm2 for the child (corresponding to an equivalent circular section of 5 mm to 7 mm, in particular of the order of 6 mm in diameter).

 The hemi-tubular bypass 21 is formed of an artificial patch or of autograft biological tissue taken from the patient (for example from the pericardium) in the form of a band, chosen and adapted to be sutured and to achieve a blood-tight partitioning and a bypass inside the aortic cavity 3. This band-shaped patch 21 is sutured by its lower end 23 to the aortic wall 10 under the left coronary ostium 16a (FIGS. 10 and 11) or at the base of the natural sigmoid valve when it can be preserved during valvulectomy (as in the example in FIGS. 12 and 13), along its longitudinal edges 24 (between its two ends 22 and 23) at the aortic wall 10, and by its upper end 22 to the concave portion 19 formed by the hoop-shaped segment covered with textile. The prosthesis is then sutured at its periphery to the aortic wall 10 above the coronary ostia. An internal bypass 21 is thus produced between this patch and the opposite aortic wall 10, from the orifice 20 to the left coronary ostium 16a.

 It should be noted that such an internal hemitubular bypass 21 is sometimes rigid (case of a synthetic patch in DACRON, registered mark, or GORETEX, registered mark), or on the contrary sufficiently flexible (in particular when it is formed of a autograft tissue, such as a portion of pericardium) to be pressed against the aortic wall 10 during systole. The entire aortic section is thus available for blood flow, as in the physiological circulation. In addition, no blood residue stagnates inside the bypass.

 Thus, such a hemi-tubular bypass carried out against and along the aortic wall 10 has many advantages: it does not disturb the main blood flow repressed from the left ventricle during systole; it prevents blood accumulations and turbulence; it allows a supply of the coronary ostium in conditions similar to the natural organ, in particular in the case where the lower end of the patch is sutured to the preserved base of the patient's natural sigmoid valve, (Figures 12 and 13) blood circulating in the Valsalva sinus to supply the coronary artery.

In addition, this semi-tubular bypass can be performed in very little space, especially in children, with relative ease.

 In the example of FIGS. 10 and 11, a traditional external bypass of the right coronary is also carried out, as described and represented in the example of FIGS. 1, 6 and 7.

 FIG. 4 shows another embodiment in which the prosthesis defines two through holes 20a, 20b, one of which 20a allows bypass for the left coronary ostium 16a and the other 20b allows bypass for the right coronary ostium 16b.

The orifice 20a is delimited, as in the embodiment of FIG. 3, by a rigid concave portion 19a with a concavity oriented outward radially. It is the same for the orifice 20b delimited by a rigid concave portion 19b of the prosthesis. This embodiment also differs from that of FIG. 3 by the fact that each concave portion 19a, 19b is not formed on a segment of the core 8 of the support 2 but on a frame piece 25a, 25b, in hoop shape, rigid, radially undeformable, attached and inserted into the textile sheath 9 outside the core 8 of the support 2.

 The frame 25a, 25b also has on either side of the concave portion 19a, 19b, a convex contour matching the curvature of the aortic wall 10 and, on the side of the core 8, a concave contour inwardly adapting to the curvature of the core 8.

 The two concave portions 19a, 19b and the two orifices 20a, 20b are angularly spaced at approximately 1200 as in the case of FIG. 2. Each orifice 20a, 20b is intended to be connected, by a semi-tubular bridging formed by a patch sutured against the aortic wall 10 and the concave portion 19a, 19b, to a coronary ostium 16a, 16b, similarly to the embodiment of FIG. 2.

 FIGS. 12, 13 and 15 illustrate an example of implantation of a bioprosthesis according to the invention comprising two concave portions 19a, 19b forming two orifices 20a, 20b like the prosthesis shown in FIG. 4.

Two intra-aortic coronary bypasses 21a, 21b are provided to connect the orifices 20a, 20b to the coronary ostia 16a, 16b and ensure the irrigation of the two coronaries. In this variant, each bypass 21a, 21b is produced by a patch similar to that 21 of the example in FIGS. 10 and 11, but whose lower end 23a, 23b is sutured not under the coronary ostium, but at the base 26a, 26b of a natural sigmoid which could be preserved. In this way, the functionality of the Valsalva sinus is preserved (Figure 12). The longitudinal edges 24a, 24b of each patch 21a, 21b are sutured to the aortic wall 10, and go towards each other upwards taking into account the fact that the base 26a, 26b of the sigmoid is more as wide as the orifice 20a, 20b formed through the prosthesis between the support 2 and the aortic wall 10.

 FIG. 5 illustrates another embodiment of prosthesis combining the previous ones, and comprising a through hole 12a similar to that of FIGS. 1 or 2 for tubular bypass of the left coronary ostium 16a and a through hole 20b similar to that of the figures 3 or 4 for the hemi-tubular bypass of the right coronary ostium 16b. In addition, there is shown in Figures 5, 10 to 13 and 15, the example of a bioprosthesis according to the invention.

 It should be noted that a prosthesis according to the invention generally has an external peripheral contour which is not perfectly circular and therefore induces a deformation of the aortic wall 10. Nevertheless, this phenomenon is in practice possible taking into account the flexibility of the wall of the ascending aorta (unlike the much more rigid aortic ring). In addition, if necessary, it is possible to enlarge the aorta radially locally, by placing a patch for enlarging the aorta, made of synthetic material or autograft (taken from the pericardium) opposite the part in projection of the prosthesis (segment 11 or 19 or frame 15a, 15b, 25a, 25b).

 Furthermore, it is possible, thanks to the invention, to implant a large valve prosthesis in children thanks to the fact that the diameter of the ascending aorta is larger than that of the aortic ring. It is even possible to implant an adult-sized valve prosthesis by widening the aorta radially using an enlargement patch before fitting the prosthesis, as indicated above. This allows growth to be taken into account in advance and avoids further operation.

 The various embodiments described above can be combined and be the subject of many other variants. For example, the core 8 can have two segments such as the segment 1 1 of FIG. 1 or that 19 of FIG. 3, in place of the reinforcements of FIGS. 2 and 4; the embodiment of FIG. 5 can be modified by using reinforcements such as 15a, 15b, 25a, 25b of the location of segments of the core 8; the prosthesis may have a left orifice 20a for hemitubular bridging of the left coronary ostium 16a and a right orifice 12b for tubular bridging of the right coronary ostium 16b, produced by a segment of the core 8 and / or by an attached reinforcement .

 All the embodiments and all the variants apply equally to a mechanical prosthesis or to a bioprosthesis and to all types of devices 4 forming a valve (disc (s), ball, sigmoid, etc.).

 A prosthesis according to the invention can be offered for sale in the form of a surgical kit comprising a prosthesis according to the invention and means for carrying out each intra-aortic coronary bypass between each orifice passing through the prosthesis and the coronary ostium corresponding. These means comprise for each through orifice such as 12, 12a, 12b, a tube 14, 14a, 14b of artificial bypass, allograft or xenograft, and for each through orifice such as 20, 20a, 20b, a patch 21, 21a, 21b artificial, allograft or xenograft.

The tube (s) or patch (s) can be rigidly fixed in advance to the prosthesis by suturing, and / or welding and / or by any other suitable fixing means so as to spare each through hole and to subsequently facilitate and shorten the fitting of the prosthesis. The whole is packaged in sterile form and, for the allograft or xenograft elements, in tanning solution baths. The kit also includes in a traditional way the instrument for handling and placing the prosthesis (calibrators, insertion handle, test probe, etc.).

Claims (16)

 1 / - Aortic valve prosthesis comprising a peripheral annular support (2) for fixing in the aortic cavity and a device (4) forming a valve, carried by the support, adapted to close during the diastole of the left ventricle and to open when systole of the left ventricle, characterized in that it comprises means (11, 15a, 15b, 19, 25a, 25b) defining at least one through orifice (12, 12a, 12b, 20, 20a, 20b) suitable for establish a blood circulation through the prosthesis when the valve device (4) is closed, and to be connected to one end of an intra-aortic bypass (14, 14a, 14b, 21, 21a, 21b) extending to the interior of the aortic cavity between at least one coronary ostium (16a, 16b) and the orifice (12, 12a, 12b, 20, 20a, 20b), so that a blood circulation can be preserved, during the diastole, in this intra-aortic bypass (14, 14a, 14b, 21, 21a, 21b) between the aortic cavity above of the prosthesis and the coronary ostium (16a, 16b) while the prosthesis is implanted above the coronary ostia (16a, 16b).  2 / - Prosthesis according to claim 1, characterized in that it comprises means (11, 15a, 19, 25a) defining a through orifice (12, 12a, 20, 20a) adapted to be connected to an intra-aortic bypass (14, 14a, 21, 21a) connecting the left coronary ostium (16a) to the orifice (12,12a, 20,20a).  3 / - Prosthesis according to one of claims 1 and 2, characterized in that it comprises means (15a, 15b, 25a, 25b) defining two orifices (12a, 12b, 20a, 20b) through adapted to be connected respectively to a bypass (14a, 14b, 21a, 21b) connecting each coronary ostium (16a, 16b) to each orifice.  4 / - Prosthesis according to one of claims 1 to 3, characterized in that said means (11, 15a, 15b, 19, 25a, 25b) are adapted to define at least one orifice (12, 12a, 12b, 20, 20a, 20b) placed at least in the vicinity of the periphery of the prosthesis.  5 / - prosthesis according to claims 3 and 4, characterized in that said means are adapted to define two orifices (12a, 12b, 20a, 20b) angularly spaced about 1200 from one another, so as to be able be focused above the coronary ostia (16a, 1 lob).  6 / - Prosthesis according to one of claims 1 to 5, characterized in that it comprises at least one orifice (12, 12a, 12b, 20, 20a, 20b) through formed through a peripheral piece (2) fixed the prosthesis.  7 / - Prosthesis according to one of claims 1 to 5, characterized in that it comprises at least one through orifice (12, 12a, 12b, 20, 20a, 20b) formed through the annular support (2) peripheral the prosthesis.  8 / - Prosthesis according to one of claims 1 to 7, characterized in that the annular support (2) peripheral of the prosthesis comprises at least one portion (19, 19a, 19b) concave with concavity oriented outward to define a through hole (20, 20a, 20b) with a portion of aortic wall (10) facing after implantation.  9 / - Prosthesis according to one of claims 1 to 8, characterized in that said means comprise at least one segment (11, 19) of a core (8) of the peripheral annular support (2), this segment (11, 19) being adapted to delimit entirely or in part a through orifice (12, 20).  10 / - Prosthesis according to claim 9, characterized in that at least one segment (11) of the core (8) forms a radial protrusion outward in which is formed a through lumen defining a rigid non-deformable orifice (12 ).  11 / - Prosthesis according to one of claims 9 and 10, characterized in that at least one segment (19) of the core (8) is in the form of a concave ring with concavity oriented towards the outside.  12 / - Prosthesis according to one of claims 1 to 11, characterized in that it comprises a sheath (9) of hemocompatible textile adapted to allow suturing of a tubular intra-aortic bypass (14a, 14b) or hemi-tubular ( 21, 21a, 21b) to the prosthesis.  13 / - Prosthesis according to one of claims 1 to 12, characterized in that said means comprise at least one rigid reinforcement piece (15a, 15b, 25a, 25b) extending outside of a core ( 8) peripheral of the peripheral annular support (2) in a sheath (9) of hemocompatible suture textile surrounding the peripheral core (8) and the reinforcement piece (15a, 15b, 25a, 25b) while providing an orifice (12a , 12b, 20a, 20b).  14 / - Surgical kit for fitting an aortic valve prosthesis, characterized in that it comprises a prosthesis according to one of claims 1 to 13 and means (14, 14a, 14b, 21, 21a, 21b) for perform at least one intra-aortic coronary bypass between each through orifice (12, 12a, 12b, 20, 20a, 20b) of the prosthesis and at least one coronary ostium (16a, 16b).  15 / Kit Kit according to claim 14, characterized in that it comprises, for each through orifice (2, 12a, 12b, 20, 20a, 20b) of the prosthesis, at least one tube (14, 14a, 14b) and / or at least one bridging patch (21, 21a, 21b) adapted to this orifice (12, 12a, 12b, 20, 20a, 20b).  16 / - Kit according to claim 15, characterized in that a bypass tube or patch is previously rigidly associated with the prosthesis.