Device for enabling trans-catheter implantation

Abstract

Device comprising a body having a central part from which an anterior part and a posterior part extend, wherein said posterior part comprises at least 2 elements and an end which is distal with respect to said central part, said anterior part comprising at least 1 longitudinal element having a proximal end connected to said central part and an end which is distal with respect to said central part, and wherein each of the distal ends of said at least 1 or 2 longitudinal elements is in a raised position with respect to said central part.

Description

[0001] DEVICE FOR ENABLING TRANS-CATHETER IMPLANTATION

[0002] The present invention relates to a medical device arranged to allow trans-catheter implantation to treat mitral regurgitation.

[0003] Typically, known devices can be in the form of a ring that is placed by open heart surgery, which has many disadvantages, particularly in terms of mortality risks.

[0004] Thus, other solutions have moved towards trans-catheter implantation, which requires the medical device to be transported in a confined space, such as a catheter, and then deployed during the implantation procedure. For example, such a device may be in the form of an atrioventricular valve repair ring, and a barrier is assembled on this ring to allow blood flow after the device has been placed. Trans-catheter clips are also available.

[0005] Typically, known devices come in the form of a kit or devices that may include several elements that need to be assembled in order to be functional. These known devices still present difficulties in positioning and implantation, they are often indicated for a very specific patient population and therefore do not allow the treatment of a large number of patients or a wide range of mitral pathologies.

[0006] WO 2020 / 154797 describes a device for treating mitral regurgitation that has a ring and chordae. WO 2020 167 672 relates to a system for enabling implantation of a medical device within a heart valve percutaneously.

[0007] For these reasons, there is a real need to provide a medical device for treating mitral regurgitation that is simple in terms of its proposed structure and effective in its functionality to effectively treat mitral regurgitation. The handling and placement of the device should also be improved.

[0008] To solve this problem, the present invention provides a device arranged to allow trans-catheter implantation and to treat mitral regurgitation, comprising a body (1) having a central part (2) from which extends an anterior part (3) and a posterior part (4), said device having a folded position arranged to be held in a medical device in the form of a flexible tube, preferably a catheter, and a deployed position arranged to treat mitral regurgitation, and, in that, in the deployed position:

[0009] - said posterior part (4) being arranged to be placed above the posterior mitral leaflet and arranged to be fixed on the posterior side of the mitral valve and comprising at least 2, preferably at least 3, longitudinal elements (5) each of which has a proximal end (5a) connected to said central part (2) and a distal end (5b) relative to said central part (2) so that said at least 2 longitudinal elements (5) each extend opposite said central part (2),

[0010] - said anterior part (3) being arranged to be placed above the anterior mitral leaflet and arranged to be fixed on the anterior side of the mitral valve and comprising at least 1 longitudinal element (6) (preferably at least 2 longitudinal elements) which has a proximal end (6a) connected to said central part (2) and a distal end (6b) relative to said central part (2) so that said at least 1 longitudinal element (6) extends opposite said central part (2) and also said at least 2 longitudinal elements (5), and in that

[0011] - the distal end (6b) of said at least 1 longitudinal element (6) and / or each of said distal ends (5b) of said at least 2 longitudinal elements (5) being in a raised position relative to said central portion (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0012] Thus, the device according to the invention has a first folded position in which it can be held, for example in a catheter in a secure manner (see figure 15). As soon as the device is in the deployed position, it has a relatively simple and efficient structure in terms of functionality.

[0013] Preferably, said at least 2 longitudinal elements (5), preferably said at least 3 longitudinal elements (5), more preferably said at least 4 longitudinal elements (5), more preferably still said at least 5 longitudinal elements, advantageously said at least 6 longitudinal elements, of the rear part (4) are separated from each other in such a way as to form distinct elements.

[0014] Advantageously, when the longitudinal elements (6) of the front part (3) are at least 2, preferably at least 3, more preferably at least 4, these are separated from each other in such a way as to form distinct elements.

[0015] The rear part (4) has a number of longitudinal elements (5) between 2 and 20, preferably between 2 and 18, more preferably between 2 and 16, even more preferably between 2 and 12. These are advantageously separated from each other in such a way as to form distinct elements.

[0016] The front part (3) has a number of longitudinal elements (6) between 1 and 18, preferably between 1 and 15, more preferably between 1 and 12. These are advantageously separated from each other in such a way as to form distinct elements.

[0017] Advantageously, the rear part (4) has (at least) 6 longitudinal elements (5) and the front part (3) has (at least) 2 longitudinal elements (6). These are advantageously separated from each other in such a way as to form separate elements.

[0018] These embodiments concerning the number of longitudinal elements (5, 6) of the front (3) and rear (4) parts can be applied to all the other preferred embodiments listed below.

[0019] This makes it possible to provide a device that has a certain magnitude in space, which makes it easier to handle.

[0020] In a particularly preferred manner, said at least 1 longitudinal element (6) of the front part (3) and said at least 2 longitudinal elements (5) of the rear part (4) each have a hollow shape (7) arranged to allow blood passage, in the deployed position. This means that blood passage can take place through each of the aforementioned longitudinal elements.

[0021] Even more preferably, said at least 1 longitudinal element (6) has a hollow internal part (13b) and a solid external part (13a), the hollow internal part (13b) defining a surface greater than the surface defined by the solid external part (13a). The external part (13a) being in the form of a segment extending around the circumference of said longitudinal element.

[0022] Advantageously, said at least 2 longitudinal elements (5) each have a hollow internal part (12b) and a solid external part (12a), the hollow internal part (12b) defining a surface greater than the surface defined by the solid external part (12a). The external part (12a) preferably being in the form of a segment extending around the circumference of said longitudinal element.

[0023] Advantageously, the posterior part (4) comprises a number of longitudinal elements (5) greater than the number of longitudinal elements (6) present in the anterior part (3). This ensures clinical effectiveness which is superior to that of known devices. This embodiment makes it possible to better cover the posterior zone of the valve which may have more or less numerous and more or less marked indentations, during placement which makes it possible to better manage possible prolapses of the posterior leaflet of the valve.

[0024] In a particularly advantageous mode, in the deployed position, said distal ends (6b) of said at least 1 longitudinal element (6) of the front part (3) being in a raised position by a height of between 0.5 and 15 mm, preferably between 0.5 and 10 mm, more preferably between 3 and 10 mm, relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0025] Thus, when the device is used to treat mitral regurgitation, the pressure applied to the anterior side of the mitral valve is such that the device can be held in position effectively over time. Preferably, in the deployed position, said distal ends (5b) of said at least 2 longitudinal elements (5) of the posterior part (4) being in a raised position by a height of between 0.5 and 15 mm, preferably between 0.5 and 10 mm, more preferably between 3 and 10 mm, relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body.

[0026] Thus, when the device is used to treat mitral regurgitation, the pressure applied to the posterior side of the mitral valve is such that the device can be held in position effectively over time.

[0027] Advantageously, when the device according to the invention is in the deployed position on the mitral valve, all the ends (5b, 6b) of the respective longitudinal elements (5, 6) rest (in part) on the mitral ring, while remaining free with respect to each other. This means that there are no connection means which connect said free ends of the longitudinal elements together when the device is in the deployed position on the mitral valve.

[0028] Advantageously, said at least 1 longitudinal element (6) of the front part (3) and said at least 2 longitudinal elements (5) of the rear part (4) have a curved shape.

[0029] Advantageously, said central portion (2) is provided with an opening (11) arranged to receive a placement means for bringing the device above the mitral leaflets. This allows easy positioning, validation of the size of the implant before its anchoring and immediate clinical functionality. In this way, it is for example possible to insert a guide, such as a wire, arranged to orient the device in space, preferably at the level of the native mitral annulus.

[0030] Even more advantageously, said body (2) is molded in a single piece, preferably after laser or water cutting, in the form of a sheet of a material, advantageously with shape memory or superelastic, intended for medical use.

[0031] The shape can then be cut from a sheet of metal (e.g. nitinol) using a laser or water jet and then placed in a high-temperature thermoforming mold for rapid cooling.

[0032] The body is advantageously made of a biocompatible material selected from the group comprising alloys, nitinol, titanium, stainless steel, polymer material and mixtures thereof.

[0033] According to a particularly preferred embodiment, the thickness of the body (1) is between 0.01 and 1 mm, preferably between 0.1 and 0.5 mm, more preferably between 0.2 and 0.4 mm, even more preferably between 0.2 and 0.3 mm, advantageously between 0.2 and 0.35 mm. The thickness ensures the solidity of the implant while being able to follow and withstand movements and forces when it is placed. The thinness makes it possible to minimize the presence of foreign bodies while ensuring the effectiveness of the device. In addition, it has such flexibility that it can also be folded in a catheter without losing effectiveness when it is in the deployed position.

[0034] In an advantageous embodiment, said at least 1 longitudinal element (6) of the front part (3) and said at least 2 longitudinal elements (5) of the rear part (4) have the shape of lobes, petals or branches.

[0035] Preferably, said longitudinal elements (5) of the rear part (4) of said device, in the deployed position, extend so that the distal ends (5b) form an arc of a circle.

[0036] Advantageously, the distal end (6b) of said at least 1 longitudinal element (6) of the front part (3) and each distal end (5b) of said at least 2 longitudinal elements (5) of the rear part (4) being provided with a fixing means or a receiving means (8, 9) arranged to receive a hooking means (10).

[0037] Preferably, the device according to the invention also comprises at least one attachment means (10) for fixing it to a native mitral ring.

[0038] According to a preferred embodiment, the fixing means(s) or the attachment means(s) (10) of said at least 1 longitudinal element (6) of the anterior part (3) being arranged to be placed above the anterior mitral leaflet or ring and fixed on the anterior side of the mitral valve.

[0039] According to an even more preferred embodiment, the fixing means(s) or the attachment means(s) (10) of the at least 2 longitudinal elements (5) of the posterior part (4) being arranged to be placed above the leaflet or the posterior mitral ring and fixed on the posterior side of the mitral valve.

[0040] Advantageously, the fixing means or attachment means (8, 9) of their respective longitudinal elements (5, 6) being independent of each other, preferably not being connected to each other by any means. According to an even more advantageous embodiment, said attachment means (10), arranged to be connected to said receiving means (8), has a distal attachment end (10a) arranged to be fixed to the native mitral ring and a proximal end (10b), possibly provided with a connection means (10b) arranged to maintain said attachment means (10) in said receiving means (8).

[0041] Preferably, said attachment means (10) has a first position arranged to allow its introduction into said reception means (8) and a second position arranged to maintain it in said reception means (8), when it is fixed on the native mitral ring in a fixed and stable manner over time.

[0042] According to a particular embodiment of the device according to the invention, in the folded position, it is arranged to be held in a medical device in the form of a flexible tube, preferably a catheter, which has an external diameter of between 3 and 15 mm, preferably between 4 and 12 mm, more preferably between 6 and 10 mm, even more preferably between 6 and 8 mm.

[0043] The present invention also relates to a kit which comprises a device according to the invention and a medical device in the form of a flexible tube, preferably a catheter, having an external diameter of between 3 and 15 mm, preferably between 4 and 12 mm, more preferably between 6 and 10 mm, even more preferably between 6 and 8 mm, in which the device according to the invention is held in the folded position in said medical device.

[0044] Other embodiments of the kit will be detailed below.

[0045] The present invention also relates to a method of trans-catheter implantation using the device according to the invention for treating mitral regurgitation, comprising the following steps:

[0046] - Providing the device which comprises a body having a central part (2) from which extends an anterior part (3) and a posterior part (4), said body (1) being in a folded position in which said body is held in a first medical device in the form of a flexible tube, preferably a catheter,

[0047] - Delivery of the device in the folded position into the left atrium of the heart by vascular route, preferably by venous, transfemoral or trans-septal route,

[0048] - Deployment of the device so that it adopts a deployed position and orientation thereof above the mitral valve with: o said posterior part (4) of said body being placed above the posterior mitral leaflet and fixed on the posterior side of the mitral valve, said posterior part comprising at least 2 longitudinal elements (5) each of which has a proximal end (5a) connected to said central part (2) and a distal end (5b) relative to said central part (2) so that said at least 2 longitudinal elements (5) each extend opposite said central part (2), and with: o said anterior part (3) which is placed above the anterior mitral leaflet and arranged to be fixed on the anterior side of the mitral valve,said front part comprising at least 1 longitudinal element (6) which has a proximal end (6a) connected to said central part (2) and a distal end (6b) relative to said central part (2) so that said at least 1 longitudinal element (6) extends opposite said central part (2) and also said at least 2 longitudinal elements (5), and,

[0049] - Stable and fixed placement of the device above the mitral leaflets and removal of said medical device in the form of a flexible tube, preferably a catheter.

[0050] Advantageously, the step of placing the device is carried out using a second medical device, in the form of a flexible tube, such as a delivery catheter, acting as a placement device.

[0051] In the removal step, the first and second medical devices are removed from the body. Preferably, the second (delivery) medical device is removed before the first medical device.

[0052] Preferably, said at least 2 longitudinal elements (5), preferably said at least 3 longitudinal elements (5), more preferably said at least 4 longitudinal elements (5), more preferably still said at least 5 longitudinal elements, advantageously said at least 6 longitudinal elements, of the rear part (4) are separated from each other in such a way as to form distinct elements.

[0053] Advantageously, when the longitudinal elements (6) of the front part (3) are at least 2, preferably at least 3, more preferably at least 4, these are separated from each other in such a way as to form distinct elements.

[0054] The rear part (4) has a number of longitudinal elements (5) between 2 and 20, preferably between 2 and 18, more preferably between 2 and 16, even more preferably between 2 and 12. These are advantageously separated from each other in such a way as to form separate elements. The front part (3) has a number of longitudinal elements (6) between 1 and 18, preferably between 1 and 15, more preferably between 1 and 12. These are advantageously separated from each other in such a way as to form separate elements.

[0055] Advantageously, the rear part (4) has (at least) 6 longitudinal elements (5) and the front part (3) has (at least) 2 longitudinal elements (6). These are advantageously separated from each other in such a way as to form separate elements.

[0056] These embodiments concerning the number of longitudinal elements (5, 6) of the front (3) and rear (4) parts can be applied to all the other preferred embodiments listed below.

[0057] This makes it possible to provide a device that has a certain magnitude in space, which makes it easier to handle.

[0058] In a particularly preferred manner, said at least 1 longitudinal element (6) of the front part (3) and said at least 2 longitudinal elements (5) of the rear part (4) each have a hollow shape (7) arranged to allow blood passage, in the deployed position. This means that blood passage can take place through each of the aforementioned longitudinal elements.

[0059] Even more preferably, said at least 1 longitudinal element (6) has a hollow internal part (13b) and a solid external part (13a), the hollow internal part (13b) defining a surface greater than the surface defined by the solid external part (13a). The external part (13a) being in the form of a segment extending over the circumference of said longitudinal element. Advantageously, said at least 2 longitudinal elements (5) each have a hollow internal part (12b) and a solid external part (12a), the hollow internal part (12b) defining a surface greater than the surface defined by the solid external part (12a). The external part (12a) preferably being in the form of a segment extending over the circumference of said longitudinal element.

[0060] Advantageously, the posterior part (4) comprises a number of longitudinal elements (5) greater than the number of longitudinal elements (6) present in the anterior part (3). This ensures clinical effectiveness which is superior to that of known devices. This embodiment makes it possible to cover the entire posterior zone of the valve which may have more or less numerous and more or less marked indentations, during placement which makes it possible to better manage all types of prolapse of the posterior leaflet of the valve.

[0061] In a particularly advantageous mode, in the deployed position, said distal ends (6b) of said at least 2 longitudinal elements (6) of the front part (3) being in a raised position with a height of between 0.5 and 15 mm, preferably between 0.5 and 10 mm, more preferably between 3 and 10 mm relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0062] Thus, when the device is used to treat mitral regurgitation, the pressure applied to the anterior side of the mitral valve is such that the device can be held in position effectively over time.

[0063] Preferably, in the deployed position, said distal ends (5b) of said at least 2 longitudinal elements (5) of the rear part (4) being in a raised position with a height of between 0.5 and 15 mm, preferably between 0.5 and 10 mm, more preferably between 3 and 10 mm, relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body.

[0064] Thus, when the device is used to treat mitral regurgitation, the pressure applied to the posterior side of the mitral valve is such that the device can be held in position effectively over time.

[0065] Advantageously, when the device according to the invention is in the deployed position on the mitral valve, all the ends (5b, 6b) of the respective longitudinal elements (5, 6) rest (in part) on the mitral ring, while remaining free with respect to each other. This means that there are no connection means which connect said free ends of the longitudinal elements together when the device is in the deployed position on the mitral valve.

[0066] Advantageously, said at least 1 longitudinal element (6) of the front part (3) and said at least 2 longitudinal elements (5) of the rear part (4) have a curved shape.

[0067] Advantageously, said central portion (2) is provided with an opening (11) arranged to receive a placement means for bringing the device above the mitral leaflets. This allows easy positioning and better clinical functionality.

[0068] In this way, it is possible, for example, to insert a guide, such as a wire, arranged to orient the device in space, preferably at the level of the native mitral annulus.

[0069] Even more advantageously, said body (2) is molded in a single piece, preferably after laser or water cutting, in the form of a sheet of a material, advantageously with shape memory or superelastic, intended for medical use. The shape can thus be cut from a sheet of metal (for example nitinol) using a laser and then placed in a high-temperature thermoforming mold to then undergo very rapid cooling.

[0070] The body is advantageously made of a biocompatible material selected from the group comprising alloys, nitinol, titanium, stainless steel, polymer material and mixtures thereof.

[0071] According to a particularly preferred embodiment, the thickness of the body (1) is between 0.01 and 1 mm, preferably between 0.1 and 0.5 mm, more preferably between 0.2 and 0.4 mm, even more preferably between 0.2 and 0.3, advantageously between 0.2 and 0.35 mm.

[0072] In an advantageous embodiment, said at least 1 longitudinal element (6) of the front part (3) and said at least 2 longitudinal elements (5) of the rear part (4) have the shape of lobes, petals or branches.

[0073] Preferably, said longitudinal elements (5) of the rear part (4) of said device, in the deployed position, extend so that the distal ends (5b) form an arc of a circle.

[0074] Advantageously, the distal end (6b) of said at least 1 longitudinal element (6) of the front part (3) and each distal end (5b) of said at least 2 longitudinal elements (5) of the rear part (4) being provided with a fixing means or a receiving means (8, 9) arranged to receive a hooking means (10).

[0075] Preferably, the device according to the invention also comprises at least one attachment means (10) for fixing it to a native mitral annulus. Thus, the method can advantageously comprise a step of positioning each attachment means or attachment means according to attachment points which are located on the native mitral fibrous annulus.

[0076] During the step of placing the device (which may be in the form of a grid) according to the invention, it is held in position and the behavior of the mitral valve and the mitral leaflets are observed by imaging means known to the person skilled in the art. Thus, and if necessary, the device is repositioned until its functionality is confirmed. This is advantageously carried out before fixing the device.

[0077] Then, once the desired position is adopted, each means of fixation or attachment is fixed on the mitral fibrous ring so that it can function appropriately to treat mitral regurgitation.

[0078] According to a particularly advantageous embodiment, the device is thus first held in the folded position in the first medical device in the form of a flexible tube (a first catheter). Then, it adopts the deployed position in which it can be placed on the mitral fibrous annulus. Optionally, if necessary, it is also possible after having placed and fixed the device or even before placement to return to the folded position in order to easily remove the device from the body. The sequence of these folded, deployed and folded positions ensures flexibility of use during placement or even after placement in order to have control over the device, which limits the risks associated with such an implantation procedure.

[0079] According to a preferred embodiment, the fixing means(s) or the attachment means(s) (10) of said at least 1 longitudinal element (6) of the anterior part (3) being arranged to be placed above the anterior mitral leaflet and fixed on the anterior side of the mitral valve.

[0080] According to an even more preferred embodiment, the fixing means(s) or the attachment means(s) (10) of the at least 2 longitudinal elements (5) of the posterior part (4) being arranged to be placed above the posterior mitral leaflet and fixed on the posterior side of the mitral valve.

[0081] According to an even more advantageous embodiment, said attachment means (10), arranged to be connected to said reception means (8), has a distal attachment end (10a) arranged to be fixed to the native mitral ring and a proximal end (10b), possibly provided with a connection means (10b) arranged to maintain said attachment means (10) in said reception means (8).

[0082] Preferably, said attachment means (10) has a first position arranged to allow its introduction into said reception means (8) and a second position arranged to maintain it in said reception means (8), when it is fixed on the native mitral ring in a fixed and stable manner over time.

[0083] According to a particular embodiment of the device according to the invention, in the folded position, it is arranged to be held in a medical device in the form of a flexible tube, preferably a catheter, which has an external diameter of between 3 and 15 mm, preferably between 4 and 12 mm, more preferably between 6 and 10 mm, even more preferably between 6 and 8 mm.

[0084] Other embodiments of the method according to the invention will be detailed below.

[0085] According to a preferred embodiment of the device according to the invention, the latter is in the deployed position and has the following characteristics: - said posterior part (4) being arranged to be placed above the posterior mitral leaflet and arranged to be fixed on the posterior side of the mitral valve and comprising at least 3 longitudinal elements (5) each of which has a proximal end (5a) connected to said central part (2) and a distal end (5b) relative to said central part (2) so that said at least 3 longitudinal elements (5) each extend opposite said central part (2),

[0086] - said anterior part (3) being arranged to be placed above the anterior mitral leaflet and arranged to be fixed on the anterior side of the mitral valve and comprising at least 2 longitudinal elements (6) each of which has a proximal end (6a) connected to said central part (2) and a distal end (6b) relative to said central part (2) so that said at least 2 longitudinal elements (6) each extend opposite said central part (2) and also said at least 3 longitudinal elements (5), and in that

[0087] - each of the distal ends (6b) of said at least 2 longitudinal elements (6) and / or each of said distal ends (5b) of said at least 3 longitudinal elements (5) being in a raised position relative to said central portion (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0088] The device according to the invention can thus preferably adopt the following successive positions: folded position, deployed position, return to folded position. Other characteristics, details and advantages of the invention will emerge from the description given below, without limitation and with reference to the drawings and examples.

[0089] Figure 1 is a top view of an embodiment of the device according to the present invention.

[0090] Figure 2 is a side view of a preferred embodiment of the device according to the present invention.

[0091] Figure 3 is a top view of the device according to the invention when it is placed at the level of the native mitral annulus.

[0092] Figure 4 is an illustration of a means of attaching the device according to the invention.

[0093] Figure 5 is an illustration of an advantageous embodiment of the device according to the invention.

[0094] Figure 6 represents a means of attachment of the device according to the invention and Figure 7 illustrates this means of attachment on the device of the invention.

[0095] Figures 8 and 9 show a preferred means of attachment.

[0096] Figure 10 illustrates the attachment means of Figure 9 when it is present on the device according to the invention.

[0097] Figures 11-A, 11-B, 11-C and 11-D) illustrate an additional embodiment of the device according to the invention.

[0098] Figures 12 and 13 represent two examples of embodiments of the device according to the invention in two distinct deployed positions.

[0099] Figure 1 illustrates a means of attaching the device according to the invention. Figure 15 is a photograph of the device in the folded position in a catheter.

[0100] In the figures, identical or similar elements bear the same references.

[0101] Other features and advantages of the present invention will be drawn from the following non-limiting description, and with reference to the drawings and examples.

[0102] In the context of the present invention, the device provided may for example be placed and fixed on a ring which may have a D shape. This ring may have a first diameter corresponding to a first position and a second diameter corresponding to a second position. Thus, when the ring moves from the first position to the second position, the device according to the invention follows this movement while remaining fixed on said ring in a secure and stable manner. The first diameter being less than the second diameter of the aforementioned ring. The ring can thus move from the first position to the second position and vice versa. The device according to the invention is advantageous in that it makes it possible to follow these changes of position while remaining attached to the ring.

[0103] Having the central part (2) in a lower position relative to the distal ends as indicated above makes it possible to provide a device which has a certain flexibility. Indeed, when the device according to the invention is placed and fixed on a ring (which can be D-shaped), the fixing of the distal ends (5b, 6b) on the periphery of the ring makes it possible to fix the device stably (over time) on said element. Also, if a fluid passes through the ring on which the device according to the invention is fixed, the structure of each longitudinal element (5, 6) allows the fluid to pass, while guaranteeing fixing over time, which is particularly advantageous. The ring indicated above can advantageously be a native mitral ring.

[0104] For the purposes of the present invention, the term 'native' refers to the organs of the heart. Thus, the 'native' mitral annulus refers to the annulus present in the left atrioventricular valve of the heart.

[0105] Thus, the at least 2 longitudinal elements (5) of the rear part (4) and / or the at least 1 longitudinal element (6) of the front part (3) have a structure (hollow, see claims and figures) such that they allow the passage of a fluid, when the device is fixed to a ring.

[0106] The central part (2) has a first position corresponding to that described for the device in the deployed position. Thus, when a fluid passes through the grid (device according to the invention), the central part (2) is arranged to adopt a second position corresponding to an inverted position (when the fluid passes through the grid with a certain force) in that the central part is raised relative to the distal ends (5b, 6b). It can thus slide along a vertical axis (perpendicular to the longitudinal axis A1) in such a way as to reverse the configuration of the device according to the invention. The distal ends (5b, 6b) are then in a low position relative to the central part (2) which is then raised.

[0107] Other configurations are also shown in Figures 12 and 13 where a different direction of curvature can be seen depending on the figure.

[0108] This flexibility is particularly preferred.

[0109] Preferably, the at least 1 longitudinal element (6) of the front part (3) extends over a distance which is greater than that of the at least 2 longitudinal elements (5) of the rear part (4).

[0110] Figure 1 illustrates a top view of an embodiment of the device according to the invention.

[0111] The device has a body (1) which comprises a central part (2) from which extends an anterior part (3) and a posterior part (4). The central part (2) is provided with an opening (11) which is arranged to allow the passage of blood and also to allow easy manipulation of the device, for example by the passage of a guide (a wire) which can be attached to the device in order to move it in space (left atrial of the heart).

[0112] Although the device has a collapsed position when housed in a medical device in the form of a flexible tube, such as a catheter, the illustrated embodiment relates to the expanded position which is arranged to treat mitral regurgitation.

[0113] In the deployed position, said posterior part (4), arranged to be placed above the posterior mitral leaflet and arranged to be fixed on the posterior side of the mitral valve, comprises 6 longitudinal elements (5). Each longitudinal element (5) has a proximal end (5a) which is connected to said central part (2) and a distal end (5b), relative to said central part (2), which is provided with a receiving means (9) arranged to receive a hooking means (not shown). Thus, the 6 longitudinal elements (5) each extend opposite said central part (2).

[0114] In this deployed position, said anterior part (3), arranged to be placed above the anterior mitral leaflet and arranged to be fixed on the anterior side of the mitral valve, comprises 2 longitudinal elements (6). Each longitudinal element (6) has a proximal end (6a) which is connected to said central part (2) and a distal end (6b), relative to said central part (2), which is provided with a receiving means (8) arranged to receive a hooking means (not illustrated). Thus, the 2 longitudinal elements (6) each extend opposite said central part (2) and also the 6 longitudinal elements (5).

[0115] As illustrated in Figure 1, all longitudinal elements (5, 6) are distinct from each other in that they form separate elements and each have a hollow shape (7) which is arranged to allow blood passage. Thus, each longitudinal element (5, 6) comprises a hollow inner portion (12b, 13b) which defines a surface area greater than the surface area defined by the solid outer portion (12a, 13a). The outer portion (12a, 13a) is in the form of a segment extending around the circumference of a longitudinal element (5, 6). Thus, the longitudinal elements (5, 6) are in the form of hollow lobes.

[0116] The receiving means is not essential. Thus, the distal end of each longitudinal element (5, 6) may comprise a fixing means which is then arranged to fix the device on the native mitral annulus.

[0117] Although not visible in the figure, each of the distal ends (6b) of the 2 longitudinal elements (6) and each of said distal ends (5b) of the 6 longitudinal elements (5) are in a raised position relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0118] Figure 2 illustrates the device described in Figure 1 above. However, the illustration is a side view which makes it possible to visualize how the device is arranged in space. In this case, the distal ends (5b, 6b) of the longitudinal elements (5, 6) are in a raised position relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0119] The distal ends (5b, 6b) of the longitudinal elements (5, 6) being in a raised position by a height of between 3 and 10 mm, relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

[0120] Also, the longitudinal elements (5, 6) have a curved shape, as shown in Figure 2.

[0121] Figure 3 illustrates a top view when the device according to the invention is placed and fixed on the mitral fibrous ring in the presence of the medical device, in this case a catheter.

[0122] Figure 4 is a view of a hooking means (10) which has a V-shaped distal hooking end (10a) which is arranged to be fixed to the native mitral annulus, and a proximal end which is provided with a connection means (10b) which can engage in one of the receiving means of the device according to the invention. Thus, the connection means (10b) can be oriented in order to pass into a receiving means of the device, as illustrated in Figure 5.

[0123] Figure 5 represents a view in which the device according to the invention comprises 3 attachment means (10), shown in Figure 4.

[0124] It should be noted that, preferably, the connection means (10b) and the distal attachment end (10a) extend in the same plane as that which crosses the part of the attachment means (10) which is located between the 2 ends. In addition, a protrusion extending opposite the plane which crosses the connection means (10b) and the distal attachment end (10a) makes it possible to ensure effective fixing.

[0125] Figure 6 illustrates a hooking means (10) according to another variant of the invention. The hooking means (10) comprises a loop and 2 sharp ends which point towards said loop.

[0126] Figure 7 is an embodiment in which 3 attachment means (10) are held in their respective receiving means of the device according to the invention.

[0127] Figure 8 illustrates an additional variant of a hooking means (10) which has a distal hooking end (10a) and a proximal end provided with a connection means (10b).

[0128] It should be noted that, preferably, the connection means (10b) and the distal attachment end (10a) extend in the same plane as that which crosses the part of the attachment means (10) which is located between the 2 ends. Figure 8 illustrates the attachment means in a first position in which it can be introduced into the receiving means of the device according to the invention. Also, in this first position, the distal end of the attachment means extends opposite the connection means (10b).

[0129] Figure 9 illustrates the hooking means (10) of the variant shown in Figure 8, in a second position, called the hooking position. In this second position, the distal hooking end extends towards the connection means. The distal hooking ends are sharp.

[0130] Thus, the hooking means of Figure 8 is inserted into the receiving means (8) and then adopts the second position, as illustrated in Figure 9. Figure 10 illustrates the device according to the invention when the hooking means (10) is connected to the receiving means (8).

[0131] Figure 1 1 -A includes all the elements described for Figure 1. Figure 1 1 -B is another view of this device and Figure 1 1 -C is a side view of the device according to the invention. All the elements described above are found in this Figure 1 1 with the exception of the attachment means. Figure 1 1 -D has a bowl shape.

[0132] Figures 12 and 13 illustrate two possible positions of the device according to the invention with particular curvatures depending on clinical needs.

[0133] Figure 14 illustrates an additional embodiment of a fastening means which is in the form of a screw whose proximal end (10b) is shown in a top view. This fastening means can be used to secure the device to a ring, preferably a native mitral ring as explained in the context of the present invention.

[0134] Figure 15 is a photograph of an embodiment of the device according to the invention when it is in the folded position in a catheter.

[0135] In this embodiment, the central portion (2) is diametrically opposite the distal ends (5b, 6b) of the respective longitudinal elements (5, 6).

[0136] In the figures, identical or similar elements bear the same references.

[0137] Within the scope of the present invention, any singular article such as, for example, "a", "an", "the", "the", "of", "of the" may be replaced by an article which designates a plural such as, for example, "at least 2", "at least 3", "several" etc. The word "include", "contains" or any equivalent term or derivatives may be replaced by "consisting of" in order to define a list or possibilities of exclusive selection so as not to include other elements not mentioned in the expression used. Within the meaning of the present invention, any range of values ​​listed above includes the limit values ​​indicated. Thus, when it is indicated "between 1 and 10" for example, the values ​​1 and 10 are also included.

[0138] It is understood that the present invention is in no way limited to the embodiments described above and that many modifications may be made thereto without departing from the scope of the appended claims.

Claims

CLAIMS 1. Device arranged to allow trans-catheter implantation, comprising a body (1) having a central part (2) from which extends an anterior part (3) and a posterior part (4), said device having a folded position arranged to be held in a medical device in the form of a flexible tube, preferably a catheter, and a deployed position arranged to treat mitral regurgitation, and, in that, in the deployed position: - said posterior part (4) being arranged to be placed above the posterior mitral leaflet and arranged to be fixed on the posterior side of the mitral valve and comprising at least 2 longitudinal elements (5) each of which has a proximal end (5a) connected to said central part (2) and a distal end (5b) relative to said central part (2) so that said at least 2 longitudinal elements (5) each extend opposite said central part (2), - said anterior part (3) being arranged to be placed above the anterior mitral leaflet and arranged to be fixed on the anterior side of the mitral valve and comprising at least 1 longitudinal element (6) which has a proximal end (6a) connected to said central part (2) and a distal end (6b) relative to said central part (2) so that said at least 1 longitudinal element (6) extends opposite said central part (2) and also said at least 2 longitudinal elements (5), and in that - the distal end (6b) of said at least 1 longitudinal element (6) and / or each of said distal ends (5b) of said at least 2 longitudinal elements (5) being in a raised position relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

2. Device according to claim 1, wherein said at least 2 longitudinal elements (5) are separated from each other in such a way as to form separate elements.

3. Device according to claim 1 or 2, wherein said at least 1 longitudinal element (6) and said at least 2 longitudinal elements (5) each have a hollow shape (7) arranged to allow blood passage, in the deployed position.

4. Device according to any one of the preceding claims, in which the rear part (4) comprises a number of longitudinal elements (5) greater than the number of longitudinal elements (6) present in the front part (3).

5. Device according to any one of the preceding claims, wherein, in the deployed position, the distal end (6b) of said at least 1 longitudinal element (6) being in a raised position by a height of between 0.5 and 15 mm, preferably between 0.5 and 10 mm, more preferably between 3 and 10 mm, relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body (1).

6. Device according to any one of the preceding claims, wherein, in the deployed position, said distal ends (5b) of said at least 2 longitudinal elements (5) being in a raised position by a height of between 0.5 and 15 mm, preferably between 0.5 and 10 mm, more preferably between 3 and 10 mm, relative to said central part (2) which is located in a longitudinal axis (Al) relative to the length (L) of said body.

7. A device according to any preceding claim, wherein, wherein, when the device is in the deployed position on the mitral valve, all ends (5b, 6b) of the elements respective longitudinal (5, 6) rest on the mitral valve, while remaining free from each other.

8. Device according to any one of the preceding claims, wherein said at least 1 longitudinal element (6) and said at least 2 longitudinal elements (5) have a curved shape.

9. A device according to any preceding claim, wherein said central portion (2) is provided with an opening (11) arranged to receive a placement means for bringing the device above the mitral leaflets and for allowing blood circulation.

10. Device according to any one of the preceding claims, wherein said body (2) is molded in one piece, preferably after laser or water cutting, in the form of a sheet of a material, advantageously with shape memory or superelastic, intended for medical use. 1 1. Device according to any one of the preceding claims, in which the thickness of said body (1) is between 0.01 and 1 mm, preferably between 0.1 and 0.5 mm, more preferably between 0.2 and 0.4 mm, more preferably still between 0.2 and 0.3 mm, advantageously between 0.2 and 0.35 mm.

12. Device according to any one of the preceding claims, wherein said at least 1 longitudinal element (6) and said at least 2 longitudinal elements (5) have a shape of lobes, petals or branches.

13. Device according to any one of the preceding claims, wherein each distal end (6b) of said at least 1 longitudinal element (6) and of said at least 2 longitudinal elements (5) being provided with a fixing means or a receiving means (8, 9) arranged to receive a hooking means (10).

14. Device according to claim 13, wherein said attachment means (10) arranged to be connected to said receiving means has a distal attachment end arranged to be fixed to the native mitral ring and a proximal end possibly provided with a connection means (10b) arranged to maintain said attachment means (10) in said receiving means (8).

15. Device according to any one of the preceding claims, wherein, in the folded position, said device is arranged to be held in a medical device in the form of a flexible tube, preferably a catheter, which has an external diameter of between 3 and 15 mm, preferably between 4 and 12 mm, more preferably between 6 and 10 mm, even more preferably between 6 and 8 mm.

16. A kit which comprises a device according to any one of the preceding claims and a medical device in the form of a flexible tube, preferably a catheter, having an outer diameter of between 3 and 15 mm, preferably between 4 and 12 mm, more preferably between 6 and 10 mm, even more preferably between 6 and 8 mm, in which the device is held in a folded position in said medical device.

17. Method for trans-catheter implantation of the medical device according to any one of the preceding claims, comprising the following steps: - Providing the device which comprises a body having a central part (2) from which extends an anterior part (3) and a posterior part (4), said body (1) being in a folded position in which said body is held in a medical device in the form of a flexible tube, preferably a catheter, - Delivery of the device in the folded position into the left atrium of the heart by venous, trans-femoral or trans-septal route, - Deployment of the device so that it adopts a deployed position and orientation thereof above the mitral valve with o said posterior part (4) of said body being placed above the posterior mitral leaflet and fixed on the posterior side of the mitral valve (or native mitral fibrous ring), said posterior part comprising at least 2 longitudinal elements (5) each of which has a proximal end (5a) connected to said central part (2) and a distal end (5b) relative to said central part (2) so that said at least 2 longitudinal elements (5) each extend opposite said central part (2), and with o said anterior part (3) which is placed above the anterior mitral leaflet and arranged to be fixed on the anterior side of the mitral valve (or ditto),said front part comprising at least 1 longitudinal element (6) which has a proximal end (6a) connected to said central part (2) and a distal end (6b) relative to said central part (2) so that said at least 1 longitudinal element (6) extends opposite said central part (2) and also said at least 2 longitudinal elements (5), and, - Stable placement of the device above the mitral leaflets and removal of said medical device in the form of a flexible tube, preferably a catheter.

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