Heart valve implants

Abstract

The present invention relates to an implant (10) for a heart valve comprising two leaflets, the implant comprising: a clamp (11), the clamp comprising a main body (13) and a clamping jaw element (14) rotatably hinged to the main body (13) so as to pivot between an open position and a closed position, in which the main body (13) and the clamping jaw element (14) are capable of clamping a first leaflet of the heart valve leaflets, thereby attaching the implant (10) to the first leaflet; a movement device (41, 42) comprising a pusher element (41), the movement device being constructed to move the clamping jaw element (14) from an open or closed position to another position relative to the main body (13) when the pusher element (41) is pushed by a rod (101); and a pocket (12) for closing an opening retained between the leaflets of a heart valve (VM) during heart contraction in order to limit blood backflow.

Description

Technical Field

[0001] The present invention relates to a cardiac implant for treating valve leakage. It is particularly suitable for treating mitral regurgitation in patients, but its use can be extended to heart valves other than the mitral valve. More specifically, the present invention relates to an implant that can be percutaneously implanted and placed on one of the leaflets of the heart valve to be treated. Background Art

[0002] Figure 1 The heart of a patient is shown. It comprises a left ventricle LV separated from a left atrium LA by a mitral valve MV. When the left ventricle LV contracts (systole), the left atrium LA is filled with oxygenated blood from the pulmonary veins PV, and the mitral valve MV then closes. The left ventricle LV then relaxes (diastole). The mitral valve MV opens, and blood flows from the left atrium LA to the left ventricle LV. This ventricle then contracts, opening the aortic valve AV and closing the mitral valve MV, in order to eject the oxygenated blood into the aorta A to the rest of the body.

[0003] like Figure 2a and Figure 2b As shown, the mitral valve MV is composed of the mitral valve annulus MA, the posterior leaflet PL and the anterior leaflet AL defining the opening between the left atrium LA and the left ventricle LV. The posterior leaflet PL and the anterior leaflet AL extend from the posterior and anterior portions of the mitral valve annulus MA, respectively. The mitral valve subvalvular structure MSVA is formed by chordae tendineae connecting the posterior leaflet PL and the anterior leaflet AL to the wall of the left ventricle LV via papillary muscles.

[0004] Figure 2a and Figure 2b A top view of a healthy mitral valve MV during diastole and during systole is shown, respectively. During diastole, the anterior leaflet AL and the posterior leaflet PL of the mitral valve MV are separated from each other, allowing blood to flow from the left atrium LA to the left ventricle LV. During systole, the anterior leaflet AL and the posterior leaflet PL of the mitral valve MV come into contact with each other so as to close the passage between the left ventricle LV and the left atrium LA, thereby ensuring coaptation and preventing any backflow of blood from the left ventricle LV to the left atrium LA.

[0005] Figure 3a and Figure 3b A top view of the mitral valve MV of a patient with mitral regurgitation is shown during diastole (relaxing movement of the heart) and systole (systolic movement of the heart), respectively. Figure 3b In Figure 1, it can be seen that a portion of the posterior leaflet PL fails to contact the anterior leaflet AL during systole. The mitral valve MV does not close properly, which causes regurgitation (backflow) of blood from the left ventricle LV to the left atrium LA. As a result, the blood flow delivered by the heart to the rest of the body is reduced.

[0006] This regurgitation is called mitral regurgitation and is usually accompanied by dilation of the left ventricle LV. This dilation leads to an increase in the diameter of the mitral annulus MA, which causes a greater deviation between the posterior leaflet PL and the anterior leaflet AL during systole and thus further increases mitral regurgitation (thus forming a vicious cycle).

[0007] In addition to cardiac medical therapy, standard treatment for this pathology includes surgical valve repair or replacement. When this pathology is secondary to cardiomyopathy (secondary or functional mitral regurgitation), surgery carries non-negligible risks due to the associated cardiomyopathy, other associated health problems or the patient's advanced age.

[0008] Therefore, several percutaneous solutions for the treatment of mitral regurgitation have been proposed to limit the invasiveness of the procedure.

[0009] Document US 2003 / 0130571 describes a system for mitral valve repair, with which the free edges of the anterior and posterior leaflets are stapled together in their central portion to ensure complete closure of the mitral valve during systole. During diastole, the opening formed between the anterior and posterior leaflets stapled in the middle has the form of a bow tie.

[0010] In order to repair the mitral valve in this way, the system proposed in the document includes a guide, a hollow rod provided with a clamp and a catheter with an inflatable bag extending at its end, and a suture nail. First, the guide is inserted into the left ventricle until the left atrium with the help of a valve preformed at the apex of the left ventricular wall. Then, the rod slides along the guide until the clamp is positioned in the left atrium. Then the guide is removed, and the clamp is opened in the left atrium so that the free edges of the front leaflet and the rear leaflet are positioned facing the apex of the left ventricle and are kept in this position, which is called the clamping position. Then, the catheter slides along the inside of the rod until the bag is positioned in the left atrium, and the bag expands in the left atrium. Then, the clamp slides into the left ventricle, while the bag keeps the free edges of the front leaflet and the rear leaflet in the clamping position, and the clamp clamps the free edges. Finally, the suture nail is conveyed along the inside of the rod toward the free edges of the front leaflet and the rear leaflet clamped by the clamp until they are attached together at their central parts.

[0011] Such mitral valve repair, particularly placement of the implant, requires a surgical procedure including a thoracotomy, which increases the risk of the procedure.

[0012] Another solution is proposed in document WO 2008 / 141322. This document describes an implant for mitral valve repair that can be implanted transapically. The implant comprises a rod, at the first end of which extends an anchoring portion for insertion into the myocardial apex, and at the second end of which unfolds a sac for contacting the anterior and posterior leaflets of the mitral valve during cardiac contraction, thereby preventing any backflow of blood between the left ventricle and the left atrium. The device increases the engagement surface between the valve leaflets. To this end, the sac slides freely in the rod. During cardiac contraction, the pressure difference between the left ventricle LV and the left atrium LA causes the sac to move upward to the left atrium LA. The sac is then positioned between the two valve leaflets and reduces valve regurgitation during cardiac contraction. The sac can be inflated, which allows it to be implanted percutaneously in a folded state. Once the implant is correctly positioned in the patient's heart, the sac is unfolded.

[0013] However, in its current state, this solution can only be performed transthoracically and not percutaneously.

[0014] Document US 2014 / 0236198 further proposes another alternative solution to the solution described in document US 2003 / 0130571, in which the free edges of the anterior leaflet and the posterior leaflet of the mitral valve are also stapled together at their central parts, so that during diastole, the opening formed between the anterior leaflet and the posterior leaflet has the shape of a bow tie. However, in this document, the mitral valve can be repaired percutaneously. To this end, the proposed device includes a rod, and the suture staple is removably fastened to the end of the rod. The suture staple has a pair of distal arms and a pair of proximal arms, and each pair of arms is arranged radially opposite to each other. When the device is inserted into the patient's vascular system, each pair of arms of the suture staple is folded and extends along the rod. Once the suture staple is delivered to the mitral valve, the arm is unfolded so that the first group of proximal arms and distal arms clamp the anterior leaflet, and the second group of proximal arms and distal arms clamp the posterior leaflet, thereby fastening the anterior leaflet and the posterior leaflet together at their central parts. Then, the rod and the suture staple can be separated, and the rod can be removed.

[0015] Compared to the solution proposed in document US 2003 / 0130571, this solution has the advantage of allowing percutaneous implementation, thus limiting the risks of the operation.

[0016] However, for the solution proposed in document US 2003 / 0130571, calcification of the anterior and posterior leaflets limits the effectiveness of such stapling of the mitral valve leaflets.

[0017] Document US 9,510,948 also proposes an implant comprising a clamp capable of clamping a heart valve leaflet. In order to bring the implant close to the heart valve, a delivery device separate from the implant is used (in US 9,510,948). Fig.12 A is shown in Figure 1. The delivery device includes a rod and a second clamp (separate from the clamp of the implant itself) mounted on the rod. The implant is clamped by the jaws of the second clamp. Once the implant is close, the implant is released from the second clamp. However, the implant has the disadvantage that it is difficult to position by a remote control rod. In particular, it is difficult to perform the release of the implant from the clamp of the delivery device.

[0018] Document WO2007 / 078772 also proposes a device that helps treat blood regurgitation through a heart valve. The proposed implant has an occluding element, in particular a sac, which is constructed to be placed in the mitral valve so that at least a portion of the occluding element is close to the heart valve. A suspension wire allows the occluding element to be positioned in the heart valve. The suspension wire includes an attachment portion to attach the suspension wire to the heart wall around the heart chamber containing the heart valve. The sac is then located between the two leaflets. However, attaching the suspension wire by means of an attachment element is not simple to manipulate, as is the case with the occluding element; the sac is not easy to position at the exact location where blood regurgitation is found. Therefore, the efficacy of the device is limited.

[0019] Document US 14,577,852 is also known. This document teaches an implant for use in the treatment of mitral regurgitation, in particular for the mitral valve. More precisely, this document describes a mitral clip for bringing the two leaflets of the mitral valve together when the implant is attached to the first leaflet of the valve. However, the proximity of the two leaflets is sometimes not sufficient to prevent any blood regurgitation.

[0020] Therefore, there is a need to provide a mitral valve implant that can achieve effective repair of the mitral valve and can be implanted more easily with minimal risk to the patient. Summary of the invention

[0021] More precisely, according to a first aspect, the invention solves this problem by proposing an implant for a heart valve comprising two leaflets, in particular a mitral valve, comprising:

[0022] a clamp comprising a body and a jaw rotatably hinged to the body to pivot between an open position and a closed position, in which the body and the jaw are capable of clamping a first leaflet of the heart valve leaflets to attach the implant to the first leaflet,

[0023] - a movement device comprising a pusher element configured to move the jaws relative to the body from an open position to a closed position, or vice versa, when the pusher element is pushed by the rod,

[0024] - a pocket attached to the clamp and configured to at least partially close a portion of an opening remaining between the heart valve leaflets during systole when the implant is attached to the first leaflet, thereby limiting blood backflow through the portion of the opening remaining during systole.

[0025] The implant according to the first aspect of the invention may further comprise the following optional features, which are used alone or in combination when technically possible.

[0026] Preferably, the implant is configured to be inserted into the main catheter 100 for percutaneous or transapical implantation.

[0027] Preferably, the bladder is expandable.

[0028] Preferably, the bladder has a generally elongate shape extending along a transverse axis parallel to the first axis of rotation.

[0029] Preferably, the bladder has a first face arranged facing the clamp, said first face being convex along the transverse axis between each end of the bladder.

[0030] Preferably, the implant includes a support tab attached to the pouch, the support tab comprising a shape memory material that assumes a first shape state within a first temperature range and a second shape state within a second temperature range, wherein in the first shape state the support tab is folded backward and in the second shape state the support tab is unfolded.

[0031] Preferably, the clamp comprises locking means configured to lock the clamp in the closed position, and the movement means is configured to act on the locking means so that the jaws are locked in the closed position when the movement means moves the jaws relative to the body to the closed position.

[0032] Preferably, the locking means comprises a toggle.

[0033] Preferably, the jaw is rotatably articulated relative to the body about a first rotation axis, and wherein the clamp comprises a connecting rod rotatably articulated with the jaw about a second rotation axis, the second rotation axis being parallel to the first rotation axis, wherein the clamp comprises at least one rocker element, which is rotatably articulated with the connecting rod about a third rotation axis on the one hand and rotatably articulated with the body of the clamp about a fourth rotation axis on the other hand, the third rotation axis and the fourth rotation axis being parallel to each other and to the first rotation axis and the second rotation axis, and wherein the rocker element and the connecting rod together form a toggle, wherein the toggle is constructed to move between an unlocked configuration and a locked configuration, in which the third rotation axis is located on a first side of a plane formed by the second rotation axis and the fourth rotation axis and the clamp is in an open position, and in which the third rotation axis is located on a second side of the plane and the clamp is in a closed position.

[0034] Preferably, the clamp comprises locking means configured to lock the toggle in a locked configuration.

[0035] Preferably, the locking device comprises:

[0036] - a stop of the connecting rod, the stop being configured to come into contact with the rocker element when the toggle is in the locked configuration, or

[0037] - a protrusion of the jaw configured to come into contact with the connecting rod when the toggle is in the locked configuration.

[0038] Preferably, the body extends along a longitudinal axis, the jaw is rotatably articulated relative to the body about a first rotation axis perpendicular to the longitudinal axis, and the pusher element is configured to move translationally relative to the body of the clamp along the longitudinal axis.

[0039] Preferably, the movement device further comprises a lever element which is rotatably articulated relative to the connecting rod about a third rotation axis on the one hand and rotatably articulated relative to the pusher element about a fifth rotation axis parallel to the first rotation axis.

[0040] Preferably, the body and the jaws each include a clamping portion, which is arranged facing each other and is constructed to clamp a first leaflet of a heart valve, such as the posterior leaflet of a mitral valve, when the clamp is in a closed position, and wherein the pusher element is further constructed to move translationally along the longitudinal axis by sliding against a surface of the body opposite to the clamping portion of the jaws.

[0041] Preferably, the body extends along a longitudinal axis, and wherein the pusher element is provided with an opening extending along the longitudinal axis and configured to cooperate with the distal end of the rod.

[0042] Preferably, the body comprises a guide element configured to guide translation of the distal end of the rod along the longitudinal axis.

[0043] Preferably, the guide element extends from a face of the body opposite the gripping portion of the jaws and includes an opening coaxial with and facing the opening of the pusher element, the opening of the guide element being configured to slidably receive the distal end of the rod.

[0044] Preferably, the body and the jaws each include a clamping portion, which are arranged facing each other and are constructed to clamp a first leaflet of a heart valve, such as a posterior leaflet of a mitral valve, when the clamp is in a closed position, and wherein the clamping portion of the body or the jaws includes a plurality of spikes that are constructed to be implanted in the first leaflet when the jaws clamp the first leaflet.

[0045] Preferably, at least one opening facing the spikes of the body is arranged in the jaws or in the clamping portion of the body.

[0046] According to a second aspect of the present invention, a component is also proposed, which includes an implant for a heart valve according to the first aspect of the present invention and a rod, the distal end of which is constructed to cooperate with a pusher element of the implant to open and close the clamp.

[0047] Preferably, the assembly further comprises a main catheter configured to accommodate the implant and the stem. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Other features, objects and advantages of the present invention will appear from the following description, which is illustrative only and not restrictive and should be read with reference to the accompanying drawings, in which:

[0049] Figure 1 (already described) is a schematic diagram of a sagittal section of a patient's heart showing the positioning of the mitral valve and the other three heart valves;

[0050] Figure 2a and Figure 2b (already described) are top views of a healthy mitral valve of a patient during diastole and during systole, respectively;

[0051] Figure 3a and Figure 3b (already described) is a top view of the mitral valve of a patient with mitral regurgitation during diastole and during systole, respectively;

[0052] Figure 4 is a perspective view of an implant for a mitral valve in a patient suffering from mitral regurgitation according to one embodiment of the present invention;

[0053] Figure 5a yes Figure 4 a perspective view of one example of a pocket of the implant shown;

[0054] Figure 5b to Figure 5e It is shown that it can be Figure 4 perspective views of other examples of pockets showing a portion of an implant;

[0055] Figure 6 yes Figure 4 a perspective exploded view of the implant shown;

[0056] Figure 7 The steps of expanding the bladder are schematically shown;

[0057] Figure 8 yes Figure 4 a perspective view of one example of an implant with a clamp shown in an open position;

[0058] Fig. 9 yes Figure 8 a side view of one example of the clamp shown in an intermediate position;

[0059] Fig.10a yes Figure 8 and Fig. 9 a side view of the clamp shown in a closed position;

[0060] Fig.10b yes Fig.10a a longitudinal cross-sectional perspective view of the fixture shown;

[0061] Fig.11 is with Figures 8 to 10a and Fig.10b Side view of an example of a different clamp shown in a closed position;

[0062] Fig.12 According to an embodiment of the present invention, Figure 4 A flow chart of a method for transseptal positioning of an implant is shown;

[0063] Fig.13 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during a first step of the method;

[0064] Fig.14 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during a second step of the illustrated method;

[0065] Fig.15 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during a fourth step of the illustrated method;

[0066] Fig.16 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during a sixth step of the illustrated method;

[0067] Fig.17 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during a seventh step of the illustrated method;

[0068] Fig.18 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during an eighth step of the illustrated method;

[0069] Fig.19 is Fig.12 a schematic diagram of a sagittal cross-section of the left side of a patient's heart during a ninth step of the illustrated method;

[0070] Fig. 20 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during a tenth step of the illustrated method;

[0071] Fig.21 is Fig.12 a schematic diagram of a sagittal section of the left side of a patient's heart during an eleventh step of the illustrated method;

[0072] Fig. 22 is Fig.12 a schematic diagram of a sagittal cross-section of the left side of a patient's heart during systole during a twelfth step of the illustrated method;

[0073] Fig.23 is Fig.12 a schematic diagram of a sagittal cross-section of the left side of a patient's heart during a fourteenth step of the illustrated method;

[0074] Fig.24 is Fig.12 a schematic diagram of a sagittal cross-section of the left side of a patient's heart during systole during a fifteenth step of the illustrated method;

[0075] Fig.25 is Fig.12 A schematic illustration of a sagittal cross-section of the left side of a patient's heart during systole during a sixteenth step of the illustrated method. DETAILED DESCRIPTION

[0076] As mentioned earlier, Figure 3a and Figure 3b The mitral valve MV of a patient with mitral regurgitation is shown during diastole and during systole, respectively. During diastole, the anterior leaflet AL and the posterior leaflet PL of the mitral valve MV together define an opening O that allows blood to flow from the left atrium LA to the left ventricle LV. The mitral valve MV then opens. During systole, the anterior leaflet AL and the posterior leaflet PL of the mitral valve MV only partially contact each other, so that a portion O1 of the opening O remains. Therefore, the mitral valve MV is only partially closed, causing a reverse flow of blood from the left ventricle LV to the left atrium LA.

[0077] Figure 4 An implant 10 for a mitral valve MV in a patient suffering from mitral regurgitation is schematically shown according to a possible embodiment of the invention.

[0078] The implant 10 includes a clamp 11 and a bag 12 attached to the clamp 11 .

[0079] The clamp 11 includes a body 13 extending along the longitudinal axis X and a jaw 14 rotatably hinged relative to the body 13 about a first rotation axis 15 perpendicular to the longitudinal axis X. The jaw 14 of the clamp 11 is configured to pivot relative to the body 13 about the first rotation axis 15 between an open position and a closed position, in which the body 13 and the jaw 14 of the clamp 11 are capable of clamping one of the leaflets (e.g., the posterior leaflet PL) of the mitral valve MV, thereby attaching the implant 10 to the leaflet.

[0080] The pocket 12 is constructed to at least partially close the opening portion O1 retained between the posterior leaflet PL and the anterior leaflet AL of the mitral valve MV during heart contraction after the implant 10 has been attached to the leaflets, thereby limiting blood backflow occurring through the opening portion O1 of the mitral valve MV during heart contraction.

[0081] The implant is more likely to be attached to the posterior leaflet PL because the stability of the implant is likely to be better than attachment to the anterior leaflet AL.

[0082] The implant 10 is configured to be insertable into a main catheter 100 for percutaneous or transthoracic implantation. When the implant 10 is implanted percutaneously, the main catheter is inserted into the femoral vein, for example, at the inguinal fold, and delivered transseptally (through the atrial septum: the membrane that separates the left atrium LA from the right atrium RA) to the left ventricle LV, and then to the mitral valve MV. When the implant 10 is implanted transthoracically, the main catheter 100 is inserted at the apex of the left ventricle LV.

[0083] The clamp 11 is configured to cooperate with the distal end of an actuator rod 101, by means of which the clamp 11 is opened and closed. The rod 101 is, for example, partially mounted inside a delivery catheter 102, with the distal end of the rod 101 being arranged outside the delivery catheter 102. In the first configuration, the rod 101 is integral with the delivery catheter 102, while in the second configuration, the rod 101 is free to slide along the delivery catheter 102. Thus, in the first configuration, the rod 101 does not slide inside the delivery catheter 102. Thus, the rod 101 and the delivery catheter 102 move integrally. In contrast, in the second configuration, the rod 101 can perform a back-and-forth movement by sliding inside the delivery catheter 102.

[0084] Preferably, the bag 12 is expandable. In this way, when the implant 10 is moved along the main catheter 100 to the mitral valve MV, the bag 12 is in a contracted state. The diameter of the main catheter 100 can therefore be small, and the movement of the implant 10 along the main catheter 100 is simplified. Conversely, once the implant 10 is attached to the posterior leaflet PL of the mitral valve MV, the bag 12 can be expanded. In use, the bag remains in an expanded state.

[0085] The bladder 12 is expanded, for example, by means of the rod 101. To this end, the bladder 12 includes, for example, an opening that communicates with the interior space of the bladder 12. The opening is configured to be fluidically connected to the inner cavity provided in the rod 101. Therefore, a filling material can be injected through the inner cavity of the rod 101 and the opening of the bladder 12 to fill the interior space of the bladder 12 and expand it.

[0086] First, prior to injecting the filling material, saline may be injected into the interior space of the balloon 12. With this prior step, the operator can determine the volume of filling material required to inflate the balloon 12 to sufficiently close the opening O1 in the mitral valve MV and thereby significantly reduce or eliminate blood backflow.

[0087] Thus, after draining saline from balloon 12, the operator may fill balloon 12 with a determined volume of fill material.

[0088] In a second step, a filling material is injected into the interior space of the balloon 12. The filling material is preferably a biocompatible material having a density less than or approximately equal to the density of blood (1056 to 1066 kg / m 3 ). The filling material is, for example, a material based on a self-hardening resin. Since the filling material is self-hardening, it eliminates any risk of shrinkage or pressure loss inside the bladder 12 after filling.

[0089] Alternatively, the filling material may be a material with a honeycomb structure, such as foam or sponge. Other possible filling materials are: hyaluronic acid based hydrogel, poly(ethylene glycol) dimethacrylate (PEGDM) or poly(ethylene glycol) urethane-dimethacrylate (PEGUDM).

[0090] Figure 7 The expansion step of the balloon is schematically shown. The filling material M is injected into the inner cavity of the balloon 12 via an injection conduit extending from the inside of the delivery catheter 102 and the body 13 of the attachment balloon 12 of the clamp 11. The balloon 12 is preferably formed of an airtight, biocompatible and wear-resistant elastic material membrane. The membrane material is preferably selected from polyamide (especially nylon), for example. ), polyethylene terephthalate ("PET") or silicone.

[0091] The use of an inflatable balloon allows the size of the balloon to be adjusted to the degree of mitral valve leak and the morphology of the patient. The operator can actually adjust the volume of the balloon until the mitral valve leak disappears. The inflation of the balloon can be monitored in real time by transesophageal echocardiography (TEE).

[0092] A first example of a pouch 12 is Figure 5a Shown in.

[0093] The bag 12 has a generally elongated shape extending along a transverse axis Y parallel to the first rotation axis 15. Therefore, when the implant 10 is attached to the posterior leaflet PL, the bag 12 extends along the anterior leaflet AL and the posterior leaflet PL of the mitral valve MV and optimally conforms to the shape of the opening portion O1 retained between the anterior leaflet AL and the posterior leaflet PL during systole, thereby closing the retained opening portion O1.

[0094] More specifically, the pouch 12 has an overall arched (or crescent-shaped) shape. The pouch 12 has a first face 16 positioned facing the clamp 11 and a second face 25 opposite the first face 16. For example, the first face 16 is convex between each end 17 and 18 of the pouch 12 along the transverse axis Y. The first face 16 of the pouch 12 is able to conform to the curvature of the posterior leaflet. In fact, the "natural" coaptation line between the anterior and posterior leaflets of the mitral valve has a concave shape towards the left ventricular outflow tract (aortic canal). Therefore, the convex shape of the pouch 12 takes into account the morphology of the valve.

[0095] A groove 19 may further be provided in the first face 16 of the pouch 12 along the longitudinal axis X to accommodate the clamp 11 and in particular the body 13. Preferably, the groove 19 extends from one side of the pouch 12 to the other side.

[0096] The second face 25 of the pouch 12 may have an excess thickness 26 disposed generally midway between the lateral ends 17 and 18 of the pouch 12. Thus, the pouch 12 optimally conforms to the shape of the opening portion O1 retained between the anterior leaflet AL and the posterior leaflet PL during systole. In this manner, closing of the opening portion O1 is more effective.

[0097] Other examples of sacs are Figure 5b to Figure 5e Shown in.

[0098] like Figure 4 As shown, the implant 10 further has a support tab 20, by means of which the bag 12 is attached to the clamp 11. According to a possible embodiment, the bag 12 can be attached to the support tab 20, for example by suturing, welding, gluing or dipping, and the support tab 20 is then attached to the clamp 11.

[0099] exist Figure 4 , the support tab 20 extends along the transverse axis Y. The support tab 20 has a first face 21 attached to the first face 16 of the bladder 12 and a second face 22 opposite the first face 21 .

[0100] The support tab 20 is formed of a shape memory material having a mesh shape, for example. The shape memory material is a material having the ability to remember an initial shape and return to the initial shape after deformation. Therefore, the shape memory material has, for example, a first shape in a first temperature range below a critical temperature Tc, and a second shape in a second temperature range above the critical temperature Tc. Therefore, a temperature change near the critical temperature Tc can change the shape of the material. The shape memory material is selected to have a critical temperature between 20°C and 37°C.

[0101] In the first shape state, the support tab 20 is, for example, folded back on itself. In this first shape state, the bladder 12 is contracted. Therefore, the support tab 20 can limit the volume of the implant 10 when the implant is delivered to the patient's heart within the main catheter 100. The support tab 20 is found to be in the first shape state when the temperature of the support tab is within a first temperature range below the critical temperature Tc of the material. The support tab 20 is found to be in the first shape state when the support tab 20 is at a temperature below the critical temperature, in particular when the support tab is immersed in an ambient medium (such as ambient air) with a temperature of about 20°C.

[0102] In the second shape state, the support tab 20 is unfolded. In the unfolded state, the first face 21 of the support tab 20 is concave between each of its ends 23 and 24 along the transverse axis Y. Thus, the support tab 20 gives the first face 16 of the pouch 12 its convex shape. In this second shape state, the pouch 12 can expand to close the opening portion O1 of the mitral valve MV that remains open during systole. The support tab 20 is found to be in the second shape state when the temperature of the support tab 20 is above a critical temperature, in particular when the support tab is immersed in an ambient medium (such as blood) having a temperature of about 37°C.

[0103] When the support tab 20 comes into contact with blood, the temperature of the support tab 20 automatically changes. When the temperature of the medium in which the support tab 20 is immersed changes, the support tab 20 changes shape and changes from the first shape state (folded) to the second shape state (unfolded).

[0104] Preferably, the support tab 20 is made of Nitinol. Nitinol is a nickel-titanium alloy. Once in contact with blood at 37°C, the support tab 20 changes from a folded state to an unfolded state. It is particularly advantageous to make the support tab 20 from Nitinol. In fact, Nitinol is biocompatible and blood-compatible. In addition, it has very good corrosion resistance and is super elastic.

[0105] Figure 5b to Figure 5e Schematically shows that it can be used as Figure 4 Other examples of pockets that are part of an implant are shown.

[0106] Figure 7 and Figure 10a-10b The clamp 11 is shown in an open position and a closed position, respectively. Figure 8 The clamp 11 is shown in an intermediate position between the open position and the closed position.

[0107] The clamp 11 has a rotation drive 27 which is configured to rotate the clamping jaw 14 relative to the body 13 about the first rotation axis 15 between an open position and a closed position.

[0108] The rotation drive device 27 comprises, for example, a connecting rod which is rotatably articulated with the clamping jaw 14 around a second rotation axis 28. The second rotation axis 28 is parallel to the first rotation axis 15 and does not coincide with the first rotation axis. Therefore, the movement of the connecting rod 27 causes the clamping jaw 14 to pivot relative to the body 13 around the first rotation axis 15 between an open position and a closed position.

[0109] The clip 11 may further comprise locking means 27, 29 configured to lock the clip 11 in a closed position. Locking the clip 11 in a closed position reduces the risk of untimely opening of the clip 11 once the implant 10 is attached to the posterior leaflet PL of the mitral valve MV.

[0110] Fig.10a and Fig.10b The clamp 11 is shown in a closed and locked position.

[0111] The clamp 11 comprises, for example, at least one rocker element 29 which is rotatably articulated with the connecting rod 27 on the one hand about a third rotation axis 30 and rotatably articulated with the body 13 of the clamp 11 on the other hand about a fourth rotation axis 31. The third rotation axis 30 and the fourth rotation axis 31 are parallel to each other and do not coincide with each other and do not coincide with the first rotation axis 15 and the second rotation axis 28.

[0112] The rocker element 29 and the connecting rod 27 together form a toggle. The toggle is configured to move between an unlocked configuration, in which the third rotation axis 30 is located on a first side of a plane P formed by the second rotation axis 28 and the fourth rotation axis 31, and the clamp 11 is then in an open position, and a locked configuration, in which the third rotation axis 30 is located on a second side of said plane P, and the clamp 11 is then in a closed position.

[0113] The clamp 11 comprises, for example, two rocker elements 29 located on either side of the body 13 and the connecting rod 27 .

[0114] The body 13 and the jaws 14 comprise respective gripping portions 32, 33. The gripping portions 32, 33 of the body 13 and the jaws 14 are arranged facing each other and are configured to grip the posterior leaflet PL of the mitral valve MV when the clamp 11 is in the closed position.

[0115] The clamping portion 32 of the body 13 accommodates the bladder 12. To this end, the clamping portion 32 of the body 13 is, for example, inserted into a groove 19 provided in the first face of the bladder 12 for this purpose.

[0116] The clamping portion 32 of the body 13 may further have a plurality of spikes 34 configured to be implanted into the posterior leaflet PL of the mitral valve MV when the clip 11 clamps the posterior leaflet PL of the mitral valve. Thus, the spikes 34 improve the clamping of the clip 11 on the posterior leaflet PL of the mitral valve MV.

[0117] The spike 34 extends, for example, substantially perpendicularly from one face of said clamping portion 32 of the body 13 facing the jaw 14. To this end, a plate provided with the spike 34 is attached to the face of the clamping portion 32 of the body 13 facing the jaw 14.

[0118] Preferably, one or more through openings 35 are provided in the clamping portion 33 of the jaw 14, facing the spikes 34 of the body 13. The openings 35 are configured to receive the spikes 34 of the body 13 when the clamp 11 is in the closed position. Thus, it is ensured that the closing of the clamp 11 is not hindered by the spikes 34 of the body 13. The openings 35 may be replaced by one or more recesses.

[0119] Alternatively, the spike 34 is supported by the clamping portion 33 of the jaw 14 , for example by means of a plate, and, where appropriate, the opening 35 is provided in the clamping portion 32 of the body 13 .

[0120] The body 13 and the jaw 14 each have an actuator portion 36, 37 which respectively accommodates the first and fourth rotation axes 15 and 31, and the first and second rotation axes 15 and 28. The actuator portions 36 and 37 of the body 13 and the jaw 14 are arranged facing each other.

[0121] The first rotation axis 15 is located in an actuator portion 36 of the body 13 , for example between the clamping portion 32 and the fourth rotation axis 31 of the body 13 .

[0122] The first rotation axis 15 is located, for example, in an actuator part 37 of the clamping jaw 14 between the clamping part 33 and the second rotation axis 28 of the clamping jaw 14 .

[0123] The second rotation axis 28 is, for example, positioned on the side opposite to the gripping portion 33 of the jaw 14 , whereas the fourth rotation axis 31 is positioned on the side opposite to the gripping portion 32 of the body 13 .

[0124] For this purpose, a through opening 38 is provided, for example, in the actuator portion 36 of the body 13 to accommodate the actuator portion 37 of the jaw 14 and to allow the second rotation axis 28 to be located on the side opposite to the clamping portion 33 of the jaw 14. Thus, the body 13 and the jaw 14 intersect at the first rotation axis 15.

[0125] The clamp 11 may further include locking devices 39, 40 configured to lock the toggles 27, 29 in the closed position. Locking the clamp 11 in the closed and locked position further reduces the risk of the clamp 11 opening inadvertently once the implant 10 is attached to the posterior leaflet PL of the mitral valve MV.

[0126] To this end, the connecting rod 27 comprises, for example, a stop 39 which is configured to come into contact with the rocker element 29 in the locked configuration of the toggle. The stop 39 is formed, for example, by an axis parallel to the second 18 and third 20 axes of rotation. Figures 7 to 9 An example of a clamp 11 having a stop 39 is shown.

[0127] As a variation, the jaw 14 includes a protrusion 40 extending from the actuator portion 37 of the jaw 14 and configured to contact the link 27 in the locked configuration of the toggle. Fig.11 Shown in.

[0128] The clamp 11 may further comprise movement means 41 , 42 configured to move the link 27 and thereby cause the jaw 14 to pivot relative to the body 13 about the first rotation axis 15 between the open position and the closed position.

[0129] The movement means 41, 42 comprise, for example, a pusher element 41, which is configured to be movable in translation along the longitudinal axis X relative to the body 13 of the clamp 11, and a lever element 42, which is articulated in rotation about the third rotation axis 30 relative to the connecting rod 27 on the one hand, and in rotation about the fifth rotation axis 43 relative to the pusher element 41. The fifth rotation axis 43 is parallel to the first, second, third and fourth rotation axes 15, 28, 30 and 31 and does not coincide with them.

[0130] Thus, when the pusher element 41 moves in translation relative to the body 13 along the longitudinal axis X, it causes the third rotation axis 30 to move by means of the lever element 42. When the pusher element 41 moves in the first direction D1, the jaws 14 pivot about the first rotation axis 15 to the clamping position CP, and the third rotation axis 30 is driven to the locked position. When the pusher element 41 moves in the second direction D2 opposite to the first direction D1, the jaws 14 pivot about the first rotation axis 15 to the separation position, and the third rotation axis 30 is driven to the locked position.

[0131] Preferably, the pusher element 41 is configured to move in translation along the longitudinal axis X by sliding against a face 44 of the body 13 opposite the gripping portion 33 of the jaws 14 . The movement of the pusher element 41 is therefore guided by the body 13 .

[0132] The pusher element 41 is for example provided with an opening 45 extending along the longitudinal axis X. The opening 45 is configured to cooperate with the distal end of the rod 101. Thus, the operator manipulates the proximal end of the rod 101 to move the pusher element 41 and thus activate the opening and closing of the clamp 11 and, where appropriate, the locking of the clamp. Fig.10b An example of an opening 45 of a pusher element 41 is shown.

[0133] The body 13 may further include a guide element 46 configured to guide translation of the distal end of the rod 101 along the longitudinal axis X.

[0134] The guide element 46 extends, for example, from a face 44 of the body 13 opposite the gripping portion 33 of the jaws 24 and comprises a through opening 47 extending along the longitudinal axis X, which is configured to slidably accommodate the distal end of the rod 101. The opening 47 of the guide element 46 and the opening 45 of the pusher element 40 are coaxial and arranged facing each other. Thus, the opening 47 guides the translational movement of the distal end of the rod 101 along the longitudinal axis X, which translational movement can then drive the pusher element 41 in translation along said longitudinal axis X and thus open and close the clamp 11. Fig.10b An example of an opening 47 of a guide element 46 is shown.

[0135] The clamp 11 is covered with, for example, Coating. This material contributes to the endothelialization of the implant (the colonization of the tissue by endothelial cells), which improves its retention at the implantation site and reduces the risk of thrombosis (blockage of the blood vessel). In other words, the clamp 11 is made of titanium, for example, and is covered with a thin layer of As a variant, the clamp 11 is made of a chromium-cobalt alloy.

[0136] Fig.12 is a diagram showing, by way of example, the different steps of a method P for transseptal positioning of an implant 10 .

[0137] In a first step Q1, the guide 103 is inserted into the femoral vein, reaches the right atrium RA, and then a transseptal catheterization (through the atrial septum) is performed, reaching the left atrium LA and the mitral annulus MA. Fig.13 Shown in.

[0138] In the second step Q2, the dilator 104 is threaded onto the guide 103, which is then inserted into the left atrium LA. The dilator 104 is thus guided to the left atrium LA by the guide 103. The dilator 104 dilates the tissue of the atrial septum to allow the main catheter 100 to be inserted. The second step Q2 is Fig.14 Shown in.

[0139] In a third step Q3, the catheter guide 103 is removed.

[0140] In a fourth step Q4, the main catheter 100 is then inserted over the guide, through the atrial septum and into the left ventricle LA. To this end, the main catheter 100 is passed, for example, around the dilator 104. The fourth step Q4 is Fig.15 Shown in.

[0141] In a fifth step Q5 , the dilator 104 is removed.

[0142] In a sixth step Q6, the distal end 105 of the main catheter 100 is oriented so as to extend substantially coaxially with the mitral valve annulus MA. Thus, the distal end 105 of the main catheter 100 includes a portion that can be oriented. Fig.16 Shown in.

[0143] In a seventh step Q7, a rod 101, whose distal end is engaged with the implant 10, and, where appropriate, a delivery catheter 102, are introduced into the main catheter 100. The rod 101 and the delivery catheter 102 are then in a first configuration, in which the rod 101 and the delivery catheter 102 move as one. The clamp 11 is in a closed position. The balloon 12 is in a contracted state, and, where appropriate, the support tab 20 is in a first shape state. In the seventh step Q7, Fig.17 Shown in.

[0144] In an eighth step Q8, the distal end of the rod 101 and, where appropriate, the distal end of the delivery catheter 102 exit the main catheter 100 and pass through the mitral valve MV until the distal end of the delivery catheter 102 is positioned in the left ventricle LV. The pocket 12 of the implant 10 is then oriented toward the anterior leaflet AL of the mitral valve MV, while the jaws 14 of the clamp 11 are oriented toward the posterior leaflet PL of the mitral valve MV. The clamp 11 remains in the closed position. The pocket 12 is in a contracted state and, where appropriate, in contact with blood, the support tab 20 changes from the first shape state (folded) to the second shape state (expanded). In the eighth step Q8, Fig.18 Shown in.

[0145] In a ninth step Q9, the clamp 11 is opened. To this end, the rod 101 pulls, for example, the pusher element 41 towards the end of the body 13 carrying the bladder 12. The rod 101 and the rod guide 102 are then in the second configuration, in which the rod 101 slides freely inside the rod guide 102. Fig.19 Shown in.

[0146] In a tenth step Q10, the rod 101 and, where appropriate, the delivery catheter 102 are moved toward the mitral valve MV so that the posterior leaflet PL of the mitral valve MV is positioned between the body 13 and the jaws 14 of the still open clamp 11. The rod 101 and the delivery catheter 102 are then in a first configuration in which the rod 101 and the delivery catheter 102 move as one. Fig. 20 Shown in.

[0147] In an eleventh step Q11, the clamp 11 is closed and, where appropriate, locked. The implant 10 is thus attached to the posterior leaflet PL of the mitral valve MV. To this end, the rod 101 pushes the pusher element 41 downstream, for example in the direction of the apex of the body 13 of the implant 10 (opposite to the pocket 12). The rod 101 and the delivery catheter 102 are then in a second configuration, in which the rod 101 slides freely inside the delivery catheter 102. In the eleventh step Q11, Fig.21 Shown in.

[0148] In the twelfth step Q12, the pouch 12 is inflated with saline solution, and the volume of the saline solution filling the pouch 12 is determined. Fig. 22 Shown in.

[0149] In a thirteenth step Q13, the effect of inflating the balloon 12 to the determined filling volume is checked by injecting physiological saline into the cavity of the balloon 12. To this end, the operator observes with the aid of transesophageal echocardiography (TEE) whether the blood backflow is sufficiently reduced. If the determined filling volume is considered satisfactory, the determined filling volume is confirmed. Otherwise, the filling volume is adjusted and then checked again.

[0150] In the optional fourteenth step Q14, the saline solution is removed from the pouch 12. Fig.23 Shown in.

[0151] In a fifteenth step Q15, the bladder 12 is inflated with a filling material. The volume of the filling material injected into the bladder 12 corresponds, for example, to the filling volume determined in the twelfth step Q12. Fig.24 Shown in.

[0152] In a sixteenth step Q16, the implant 10 is released. To this end, for example, the rod 101 is disconnected from the pusher element 41. Preferably, the sixteenth step Q16 is performed once the resin has hardened. The sixteenth step Q16 is Fig.25 Shown in.

[0153] In a seventeenth step Q17, the shaft 101, the delivery catheter 102, and, if appropriate, the main catheter 100 are removed from the patient's body.

[0154] All of these steps can be performed under cardiac fluoroscopic control and transesophageal echocardiographic (TEE) monitoring.

[0155] The method for percutaneously positioning implant 10 is particularly advantageous because it reduces risk to the patient compared to open heart surgery.

[0156] The implant and the method as described above are not only intended for positioning on the mitral valve. The proposed implant can also be positioned on heart valves other than the mitral valve, in particular another atrioventricular valve, namely the tricuspid valve.

Claims

1. An implant (10) for a heart valve comprising two leaflets, the implant (10) comprising: a clamp (11) comprising a body (13) and a jaw (14) rotatably hinged to the body (13) so as to pivot between an open position and a closed position, in which the body (13) and the jaw (14) are capable of clamping a first leaflet of the heart valve leaflets, thereby attaching the implant (10) to the first leaflet, - movement means (41, 42) comprising a pusher element (41) configured to move the jaw (14) relative to the body (13) from an open position to a closed position, or vice versa, when the pusher element (41) is pushed by a rod (101), It is characterized in that the implant includes a bag (12) attached to the clamp (11), and the bag is constructed to at least partially close the opening portion (O1) retained between the heart valve leaflets during heart contraction when the implant (10) is attached to the first leaflet, thereby limiting the backflow of blood through the opening portion (O1) retained during heart contraction.

2. The implant (10) according to claim 1, which is configured to be inserted into a main catheter (100) for percutaneous or transapical implantation.

3. The implant (10) according to claim 1, wherein: The bladder (12) is expandable.

4. The implant (10) according to claim 1, wherein: The pouch (12) has an elongated shape extending along a transverse axis (Y) parallel to the first axis of rotation (15).

5. The implant (10) according to claim 4, wherein: The bladder (12) has a first face (16) arranged facing the clamp (11), the first face (16) being convex along the transverse axis (Y) between the ends (17, 18) of the bladder (12).

6. The implant (10) according to claim 1 comprises a support tab (20) attached to the sac (12), the support tab (20) comprising a shape memory material, the shape memory material presenting a first shape state within a first temperature range and a second shape state within a second temperature range, in the first shape state, the support tab (20) is folded backward, and in the second shape state, the support tab (20) is unfolded.

7. The implant (10) according to claim 1, wherein: The clamp (11) comprises a locking device (27, 29) which is configured to lock the clamp (11) in a closed position, and wherein the movement device (41, 42) is configured to act on the locking device so that when the movement device moves the clamping jaw (14) relative to the body (13) to the closed position, the clamping jaw is locked in the closed position.

8. The implant (10) according to claim 7, wherein: The locking device (27, 29) comprises a toggle.

9. The implant (10) according to claim 8, wherein: The clamp (14) is rotatably articulated about a first rotation axis relative to the body (13), and wherein the clamp (11) includes a connecting rod (27) rotatably articulated with the clamp (14) about a second rotation axis (28), the second rotation axis (28) being parallel to the first rotation axis (15), wherein the clamp (11) includes at least one rocker element (29), which is rotatably articulated with the connecting rod (27) about a third rotation axis (30) on the one hand and rotatably articulated with the body (13) of the clamp (11) about a fourth rotation axis (31) on the other hand, the third and fourth rotation axes being arranged so as to rotate relative to each other. The rotation axes (30, 31) are parallel to each other and to the first and second rotation axes (15, 28), and wherein the rocker element (29) and the connecting rod (27) together form the toggle, wherein the toggle is constructed to move between an unlocked configuration and a locked configuration, in which the third rotation axis (30) is located on a first side of a plane (P) formed by the second and fourth rotation axes (28, 31), and the clamp (11) is in an open position, and in the locked configuration, the third rotation axis (30) is located on a second side of the plane (P), and the clamp (11) is in a closed position.

10. The implant (10) according to claim 9, wherein: The clamp (11) comprises a second locking device (39, 40) configured to lock the toggle in a closed position.

11. The implant (10) according to claim 10, wherein: The second locking device (39, 40) comprises: - a stop (39) of the connecting rod (27), the stop being configured to come into contact with the rocker element (29) when the toggle is in the locked configuration, or - a protrusion (40) of the jaw (14) configured to come into contact with the connecting rod (27) when the toggle is in the locked configuration.

12. The implant (10) according to claim 9, wherein: The body extends along a longitudinal axis (X), the jaws (14) are rotatably articulated relative to the body (13) around a first rotation axis perpendicular to the longitudinal axis (X), and the pusher element (41) is constructed to move translationally along the longitudinal axis (X) relative to the body (13) of the clamp (11).

13. The implant (10) according to claim 12, wherein: The movement device further comprises a lever element (42), which is rotatably articulated relative to the connecting rod (27) on the one hand about the third rotation axis (30) and is rotatably articulated relative to the pusher element (41) on the other hand about a fifth rotation axis (43) parallel to the first rotation axis (15).

14. The implant (10) according to claim 12, wherein: The body (13) and the jaw (14) include corresponding clamping portions (32, 33), which are arranged facing each other and are constructed to clamp the first leaflet of the heart valve when the clamp (11) is in a closed position, and wherein the pusher element (41) is further constructed to move translationally along the longitudinal axis (X) by sliding against a surface (44) of the body (13) opposite to the clamping portion (33) of the jaw (14).

15. The implant (10) according to claim 1, wherein: The body extends along a longitudinal axis (X), and wherein the pusher element (41) is provided with an opening (45) extending along the longitudinal axis (X), and wherein the opening is configured to cooperate with the distal end of the rod (101).

16. The implant (10) according to claim 15, wherein: The body (13) comprises a guide element (46) configured to guide the translation of the distal end of the rod (101) along the longitudinal axis (X).

17. The implant (10) according to claim 16, wherein: The guide element (46) extends from that face (44) of the body (13) opposite the clamping portion (33) of the jaw (14) and comprises an opening (47) facing the opening (45) of the pusher element (41) and coaxial therewith, the opening (47) of the guide element (46) being configured to slidably accommodate the distal end of the rod (101).

18. Implant (10) according to any one of the preceding claims, wherein The body (13) and the jaws (14) include corresponding clamping portions (32, 33), which are arranged facing each other and are constructed to clamp the first leaflet of the heart valve when the clamp (11) is in a closed position, and wherein the clamping portion (32, 33) of the body (13) or the jaws (14) includes a plurality of spikes (34) that are constructed to be implanted in the first leaflet when the jaws (14) clamp the first leaflet.

19. The implant (10) according to claim 18, wherein: At least one opening (35) facing a spike (34) of the body (13) is arranged in the clamping portion (32, 33) of the clamping jaw (14) or of the body (13).

20. An assembly comprising: - implant (10) according to any one of the preceding claims, - a rod (101), the distal end of which is configured to cooperate with a pusher element of said implant (10) in order to open and close said clamp (11).

21. The assembly of claim 20, further comprising a main catheter (100) configured to accommodate the implant (10) and the rod (101).

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