阅读说明：本技术 心脏瓣膜植入件 (Heart valve implant ) 是由 安妮-维尔日妮·萨尔萨克 阿德里安·拉佩罗萨兹 埃里克·贝尔格恩德 让-保罗·库埃蒂尔 于 2019-09-13 设计创作，主要内容包括：本发明涉及一种用于包括两个小叶的心脏瓣膜的植入件(10),该植入件包括：夹具(11),该夹具包括主体(13)和与主体(13)可旋转地铰接以在打开位置与闭合位置之间枢转的夹爪元件(14),在闭合位置,主体(13)和夹爪元件(14)能够夹紧心脏瓣膜小叶中的第一小叶,从而将植入件(10)附接到第一小叶；包括推动器元件(41)的运动装置(41、42),所述运动装置被构造为当推动器元件(41)被杆(101)推动时,使夹爪元件(14)相对于主体(13)从打开或闭合位置移动到另一位置；用于关闭在心脏收缩期间保留在心脏瓣膜(VM)小叶之间的开口以便限制血液回流的囊袋(12)。(The invention relates to an implant (10) for a heart valve comprising two leaflets, comprising: a clamp (11) comprising a main body (13) and a jaw member (14) rotatably hinged with the main body (13) to pivot between an open position and a closed position, in the closed position the main body (13) and the jaw member (14) being capable of clamping a first leaflet of the heart valve leaflets to thereby attach the implant (10) to the first leaflet; movement means (41, 42) comprising a pusher element (41) configured to move the jaw element (14) from the open or closed position to another position with respect to the body (13) when the pusher element (41) is pushed by the rod (101); a capsular bag (12) for closing an opening remaining between leaflets of a heart Valve (VM) during systole so as to limit backflow of blood.)

1. An implant (10) for a heart valve, in particular a Mitral Valve (MV), comprising two leaflets, the implant (10) comprising:

-a clamp (11) comprising a body (13) and a clamping jaw (14) rotatably hinged with the body (13) to pivot between an open position and a closed position in which the body (13) and the clamping jaw (14) are capable of clamping a first leaflet of heart valve leaflets to attach the implant (10) thereto,

-movement means (41, 42) comprising a pusher element (41) configured to move the jaws (14) from an open position to a closed position, or vice versa, with respect to the body (13) when the pusher element (41) is pushed by a rod (101),

characterized in that the implant comprises a capsular bag (12) attached to the clip (11) and configured to at least partially close an opening portion (O1) remaining between the leaflets of the heart valve (MV) during systole when the implant (10) is attached to the first leaflet, thereby limiting backflow of blood through the opening portion (O1) remaining during systole.

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

3. The implant (10) according to claim 1 or 2, wherein the capsular bag (12) is expandable.

4. Implant (10) according to any one of claims 1 to 3, wherein the capsular bag (12) has a substantially elongated shape extending along a transversal axis (Y) parallel to the first rotational axis (15).

5. Implant (10) according to claim 4, wherein the capsular bag (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 capsular bag (12).

6. The implant (10) according to any one of claims 1 to 5, comprising a support tab (20) attached to the capsular bag (12), the support tab (20) comprising a shape memory material that assumes a first shape state in a first temperature range in which the support tab (20) is folded back and a second shape state in a second temperature range in which the support tab (20) is unfolded.

7. Implant (10) according to any one of the preceding claims, wherein the clamp (11) comprises locking means (27, 29) configured to lock the clamp (11) in the closed position, and wherein the movement means (41, 42) are configured to act on the locking means such that the jaws (14) are locked in the closed position when they are moved to the closed position with respect to the body (13).

8. The implant (10) according to any one of the preceding claims, wherein the locking means (27, 29) comprises a toggle.

9. Implant (10) according to the preceding claim, wherein the clamping jaw (14) is rotatably articulated relative to the body (13) about a first axis of rotation, and wherein the clamp (11) comprises a connecting rod (27) rotatably articulated with the clamping jaw (14) about a second axis of rotation (28), the second axis of rotation (28) being parallel to the first axis of rotation (15), wherein the clamp (11) comprises at least one rocker element (29) rotatably articulated with the connecting rod (27) about a third axis of rotation (30) on the one hand, and with the body (13) of the clamp (11) about a fourth axis of rotation (31) on the other hand, the third and fourth axes of rotation (30, 31) being parallel to each other and to the first and second axis of rotation (15, 28), and wherein, the rocker element (29) and the link (27) together form the toggle, wherein the toggle is configured to move between an unlocked configuration, in which the third rotational axis (30) is located on a first side of a plane (P) formed by the second and fourth rotational axes (28, 31) and the clamp (11) is in an open position, and a locked configuration, in which the third rotational 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 8 or 9, wherein the clamp (11) comprises a locking device (39, 40) configured to lock the toggle (27, 29) in a closed position.

11. The implant (10) according to claim 10, wherein the locking means (39, 40) comprises:

-a stop (39) of the link (27) configured to come into contact with the rocker element (29) when the toggle (27, 29) is in the locking configuration, or

-a protrusion (40) of the jaw (14) configured to come into contact with the link (27) when the toggle (27, 29) is in the locking configuration.

12. Implant (10) according to any one of the preceding claims, wherein the body extends along a longitudinal axis (X), the jaws (14) are rotatably articulated with respect to the body (13) about a first rotation axis perpendicular to the longitudinal axis (X), and the pusher element (41) is configured for translational movement along the longitudinal axis (X) with respect to the body (13) of the clamp (11).

13. Implant (10) according to the preceding claim, wherein the movement means further comprise a lever element (42) rotatably articulated, on the one hand, with respect to the link (27) about the third rotation axis (30) and, on the other hand, with respect to the pusher element (41) about a fifth rotation axis (43) parallel to the first rotation axes (15, 28, 30, 31).

14. Implant (10) according to claim 12, wherein the body (13) and the clamping jaws (14) comprise respective clamping portions (32, 33) arranged facing each other and configured to clamp a first leaflet of a heart valve, for example the Posterior Leaflet (PL) of a Mitral Valve (MV), when the clamp (11) is in the closed position, and wherein the pusher element (41) is further configured to move translationally along the longitudinal axis (X) by sliding against one face (44) of the body (13) opposite the clamping portion (33) of the clamping jaws (14).

15. Implant (10) according to any one of the preceding claims, 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 configured to cooperate with a distal end of the rod (101).

16. The implant (10) according to claim 15, wherein the body (13) comprises a guiding element (46) configured to guide a 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 grip portion (33) of the jaw (14) and comprises an opening (47) facing and coaxial with the opening (45) of the pusher element (41), the opening (47) of the guide element (46) being configured to slidably receive the distal end of the rod (101).

18. Implant (10) according to any one of the preceding claims, wherein the body (13) and the clamping jaw (14) comprise respective clamping portions (32, 33) arranged facing each other and configured to clamp a first leaflet of a heart valve, for example the Posterior Leaflet (PL) of a Mitral Valve (MV), when the clamp (11) is in the closed position, and wherein the clamping portions (32, 33) of the body (13) or the clamping jaw (14) comprise a plurality of spikes (34) configured to be implanted in the first leaflet when the clamping jaw (11) clamps the first leaflet.

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

20. An assembly, comprising:

-an implant (10) for a heart valve according to any of the preceding claims,

-a rod (101) whose distal end is configured to cooperate with a pusher element of the implant (10) in order to open and close the clamp (11).

21. The assembly according to the preceding claim, further comprising a main catheter (100) configured to house the implant (10) and the stem (101).

Technical Field

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 onto one of the leaflets of a heart valve to be treated.

Background

Fig. 1 shows a heart of a patient. It comprises a left ventricle LV separated from the left atrium LA by a mitral valve MV. When the left ventricle LV contracts (systole), the left atrium LA fills 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. The ventricle then contracts, opening the aortic valve AV and closing the mitral valve MV, so as to eject oxygenated blood into the aorta a to the rest of the body.

As shown in fig. 2a and 2b, the mitral valve MV consists of a mitral annulus MA, a posterior leaflet PL and an anterior leaflet AL defining an 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 annulus MA, respectively. The mitral 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 by means of papillary muscles.

Fig. 2a and 2b show a top view of a healthy mitral valve MV during diastole and systole, respectively. During diastole, the anterior and posterior leaflets AL, PL of the mitral valve MV separate from each other, allowing blood to flow from the left atrium LA to the left ventricle LV. During systole, the anterior and posterior leaflets AL, PL of the mitral valve MV contact each other to close the passage between the left ventricle LV and the left atrium LA, thereby ensuring engagement and preventing any backflow of blood from the left ventricle LV to the left atrium LA.

Fig. 3a and 3b show top views of the mitral valve MV of a patient suffering from mitral regurgitation during diastole (diastolic movement of the heart) and systole (systolic movement of the heart), respectively. In fig. 3b, it can be seen that a portion of the posterior leaflet PL cannot come into contact with the anterior leaflet AL during systole. The mitral valve MV does not close normally, which causes regurgitation (regurgitation) of blood from the left ventricle LV to the left atrium LA. Thus, the flow of blood delivered by the heart to the rest of the body is reduced.

This regurgitation is called mitral regurgitation and is usually accompanied by left ventricular LV dilation. This dilation results in 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 (thereby forming a vicious circle).

In addition to cardiac medical treatment, standard treatments for this pathology include surgical valve repair or replacement. When this pathology is secondary to cardiomyopathy (secondary or functional mitral regurgitation), there is a non-negligible risk of surgery due to the associated cardiomyopathy, other associated health problems or the patient's advanced age.

Therefore, several percutaneous solutions to treat mitral regurgitation have been proposed to limit the invasiveness of the procedure.

Document US 2003/0130571 describes a system for mitral valve repair, by means of which the free edges of the anterior and posterior leaflets are stapled together in their central part to ensure the mitral valve closes completely during systole. During diastole, the opening formed between the anterior and posterior leaflets stapled in the middle has the form of a bow-tie.

In order to repair the mitral valve in this way, the system proposed in this document comprises a guide, a hollow rod provided with a clamp and a conduit with an inflatable balloon extending at its end, and staples. First, the guide is inserted into the left ventricle up to the left atrium by means of a valve pre-formed at the apex of the left ventricle wall. The rod is then slid along the guide until the clip is positioned in the left atrium. The guide is then removed and the clamp is opened in the left atrium to position the free edges of the anterior and posterior leaflets facing the apex of the left ventricle and to hold them in this position, referred to as the clamped position. The catheter is then slid along the interior of the shaft until the bladder is positioned in the left atrium, where it expands. The clip is then slid into the left ventricle while the capsular bag holds the free edges of the anterior and posterior leaflets in a clamped position, and the clip grips the free edges. Finally, the staples are delivered along the inside of the rod towards the free edges of the anterior and posterior leaflets clamped by the clamp until they are attached together at their central portions.

Such mitral valve repair, and in particular implant placement, requires surgical procedures including thoracotomy, which increases the risk of the procedure.

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 a first end of which an anchoring portion extends for insertion into the apex of the myocardium, and at a second end of which a capsular bag is deployed for contact with the anterior and posterior leaflets of the mitral valve during systole, thereby preventing any backflow of blood between the left ventricle and the left atrium. The device increases the coaptation surface between the valve leaflets. For this purpose, the capsular bag is free to slide in the stem. During systole, the pressure difference between the left ventricle LV and the left atrium LA causes the capsular bag to move up to the left atrium LA. The capsular bag is then positioned between the two valve leaflets and reduces valve regurgitation upon systole. The pouch may be inflated, which allows it to be implanted percutaneously in a folded state. Once the implant is properly positioned in the patient's heart, the capsular bag is deployed.

However, in the present state of the art, this solution can only be implemented transthoracically, not percutaneously.

Document US 2014/0236198 further proposes another alternative to the solution described in document US 2003/0130571, in which the free edges of the anterior and posterior leaflets of the mitral valve are also stapled together at their central portion, so that during diastole the opening formed between said anterior and posterior leaflets has the shape of a bow-tie. However, in this document, the mitral valve can be repaired percutaneously. To this end, the proposed device comprises a rod, at the end of which staples are removably fastened. The staple has a pair of distal arms and a pair of proximal arms, each pair of arms being arranged diametrically opposite. When the device is inserted into the vascular system of a patient, each pair of arms of the staple folds and extends along the rod. Once the staples are delivered to the mitral valve, the arms are deployed such that the first set of proximal and distal arms pinch the anterior leaflet and the second set of proximal and distal arms pinch the posterior leaflet, securing the anterior and posterior leaflets together at their central portions. The rod and staples may then be separated and the rod removed.

This solution has the advantage of allowing percutaneous implementation, compared to the solution proposed in document US 2003/0130571, thus limiting the risks of surgery.

However, for the solution proposed in document US 2003/0130571, calcification of the anterior and posterior leaflets limits the efficacy of this stapling of the mitral valve leaflets.

Document US 9,510,948 also proposes an implant comprising a clamp capable of clamping a heart valve leaflet. To bring the implant close to the heart valve, a delivery device separate from the implant is used (shown in figure 12A of US 9,510,948). 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 gripped by the jaws of the second clamp. Once the implant is approximated, the implant is released from the second clamp. However, this implant has the disadvantage of being difficult to position by means of a remote joystick. In particular, releasing the implant from the clamp of the delivery device is difficult to perform.

Document WO2007/078772 also proposes a device to assist in the treatment of regurgitation of blood through the heart valve. The proposed implant has an occlusion element, in particular a pocket, which is configured to be placed in the mitral valve such that at least a portion of the occlusion element is close to the heart valve. The suspension wires allow positioning of the occluding element in the heart valve. The suspension wire comprises an attachment portion to attach the suspension wire to a heart wall surrounding a heart chamber containing the heart valve. The capsular bag is then located between the two leaflets. However, attaching the suspension wires by means of attachment elements is not simple to handle, as is the occlusion element; the pouch is not easily positioned in the exact location where reflux of blood is found. Thus, the efficacy of the device is limited.

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 specifically, this document describes a mitral valve clip for bringing together two leaflets of a mitral valve when an implant is attached to a first leaflet of the valve. However, the proximity of the two leaflets is sometimes insufficient to prevent any blood regurgitation.

Accordingly, there is a need to provide a mitral valve implant that can achieve effective repair of the mitral valve, and that can be more easily implanted with minimal risk to the patient.

Disclosure of Invention

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

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

movement means comprising a pusher element configured to move the jaws from the open position to the closed position, or vice versa, with respect to the body when the pusher element is pushed by the rod,

a capsular bag attached to the clip and configured to at least partially close the portion of the opening remaining between the leaflets of the heart valve during systole when the implant is attached to the first leaflet, thereby limiting backflow of blood through the portion of the opening remaining during systole.

The implant according to the first aspect of the present invention may further comprise optional features which may be used individually or in combination when technically possible.

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

Preferably, the balloon is inflatable.

Preferably, the bladder has a generally elongated shape extending along a transverse axis parallel to the first rotational axis.

Preferably, the capsular bag has a first face arranged facing the clip, the first face being convex along the transverse axis between each end of the capsular bag.

Preferably, the implant comprises a support tab attached to the capsular bag, the support tab comprising a shape memory material that assumes a first shape state in a first temperature range in which the support tab is folded back and a second shape state in a second temperature range in which the support tab is unfolded.

Preferably, the clamp comprises a locking arrangement configured to lock the clamp in the closed position, and the movement arrangement is configured to act on the locking arrangement such that when the movement arrangement moves the jaws to the closed position relative to the body, the jaws are locked in the closed position.

Preferably, the locking means comprises a toggle.

Preferably, the clamping jaws are rotatably articulated relative to the body about a first axis of rotation, and wherein the clamp comprises a link rotatably articulated with the clamping jaws about a second axis of rotation, which is parallel to the first axis of rotation, wherein the clamp comprises at least one rocker element rotatably articulated with the link about a third axis of rotation on the one hand and with the body of the clamp about a fourth axis of rotation on the other hand, which are parallel to each other and to the first and second axis of rotation, and wherein the rocker element and the link together form a toggle joint, wherein the toggle joint is configured to move between an unlocked configuration, in which the third axis of rotation is located on a first side of a plane formed by the second and fourth axis of rotation, and the clamp is in an open position, in the locked configuration, the third axis of rotation is located on a second side of the plane and the clamp is in the closed position.

Preferably, the clamp includes a locking arrangement configured to lock the toggle in the locked configuration.

Preferably, the locking means comprises:

a stop of the connecting rod configured to come into contact with the rocker element when the toggle is in the locking configuration, or

-a protrusion of the jaw configured to contact the link when the toggle is in the locked configuration.

Preferably, the body extends along a longitudinal axis, the jaws are rotatably articulated with respect to the body about a first rotation axis perpendicular to the longitudinal axis, and the pusher element is configured for translational movement along the longitudinal axis with respect to the body of the clamp.

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

Preferably, the body and the clamping jaws each comprise a clamping portion arranged facing each other and configured to clamp a first leaflet of a heart valve, for example the posterior leaflet of a mitral valve, when the clamp is in the closed position, and wherein the pusher element is further configured to move translationally along the longitudinal axis by sliding against a face of the body opposite the clamping portions of the clamping jaws.

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.

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

Preferably, the guide element extends from the 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.

Preferably, the body and the clamping jaws each comprise a clamping portion arranged facing each other and configured to clamp a first leaflet of a heart valve, for example the posterior leaflet of a mitral valve, when the clamp is in the closed position, and wherein the clamping portions of the body or the clamping jaws comprise a plurality of spikes configured to be implanted in the first leaflet when the clamping jaws clamp the first leaflet.

Preferably, at least one opening of the spike facing the body is arranged in the clamping part of the jaw or the body.

According to a second aspect of the invention, there is also proposed an assembly comprising an implant for a heart valve according to the first aspect of the invention and a rod, the distal end of which is configured to cooperate with a pusher element of the implant in order to open and close the clamp.

Preferably, the assembly further includes a main catheter configured to receive the implant and the rod.

Drawings

Other features, objects and advantages of the invention will appear from the following description, which is given by way of illustration and not of limitation, and which should be read with reference to the accompanying drawings, in which:

FIG. 1 (already described) is a schematic sagittal cross-sectional view of a patient's heart showing the positioning of the mitral valve and the other three heart valves;

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

figures 3a and 3b (already described) are top views of the mitral valve of a patient suffering from mitral regurgitation during diastole and systole, respectively;

FIG. 4 is a perspective view of an implant for a mitral valve of a patient having mitral regurgitation in accordance with one embodiment of the present invention;

FIG. 5a is a perspective view of one example of a capsular bag of the implant of FIG. 4;

fig. 5 b-5 e are perspective views showing other examples of capsular bags that may be part of the implant of fig. 4;

FIG. 6 is a perspective exploded view of the implant of FIG. 4;

fig. 7 schematically illustrates the step of inflating the bladder;

FIG. 8 is a perspective view of one example of a clamp of the implant of FIG. 4 in an open position;

FIG. 9 is a side view of one example of the clamp of FIG. 8 in an intermediate position;

FIG. 10a is a side view of the clamp of FIGS. 8 and 9 in a closed position;

FIG. 10b is a perspective view in longitudinal section of the clamp shown in FIG. 10 a;

FIG. 11 is a side view of an example of a clamp in a closed position that differs from the clamp shown in FIGS. 8-10 a and 10 b;

FIG. 12 is a flow chart of a method for transseptal positioning of the implant of FIG. 4 according to one embodiment of the present disclosure;

FIG. 13 is a schematic sagittal cross-sectional view of the left side of the patient's heart during the first step of the method of FIG. 12;

FIG. 14 is a schematic sagittal cross-sectional view of the left side of the patient's heart during the second step of the method of FIG. 12;

FIG. 15 is a schematic sagittal cross-sectional view of the left side of the patient's heart during a fourth step of the method shown in FIG. 12;

FIG. 16 is a schematic sagittal cross-sectional view of the left side of the patient's heart during a sixth step of the method shown in FIG. 12;

FIG. 17 is a schematic sagittal cross-sectional view of the left side of the patient's heart during a seventh step of the method shown in FIG. 12;

FIG. 18 is a schematic sagittal cross-sectional view of the left side of the patient's heart during an eighth step of the method shown in FIG. 12;

FIG. 19 is a schematic sagittal cross-sectional view of the left side of the patient's heart during a ninth step of the method shown in FIG. 12;

FIG. 20 is a schematic sagittal cross-sectional view of the left side of the patient's heart during a tenth step of the method shown in FIG. 12;

FIG. 21 is a schematic sagittal cross-sectional view of the left side of the patient's heart during an eleventh step of the method of FIG. 12;

FIG. 22 is a schematic sagittal cross-sectional view of the left side of the patient's heart during systole during the twelfth step of the method shown in FIG. 12;

FIG. 23 is a schematic sagittal cross-sectional view of the left side of the patient's heart during a fourteenth step of the method shown in FIG. 12;

FIG. 24 is a schematic sagittal cross-sectional view of the left side of the patient's heart during systole during the fifteenth step of the method of FIG. 12;

FIG. 25 is a schematic sagittal cross-sectional view of the left side of the patient's heart during systole during the sixteenth step of the method of FIG. 12.

Detailed Description

As mentioned before, fig. 3a and 3b show the mitral valve MV of a patient suffering from mitral regurgitation during diastole and 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 and posterior leaflets AL, PL of the mitral valve MV only partially contact each other, such that a portion O1 of the opening O remains. Thus, the mitral valve MV is only partially closed, causing a backflow of blood from the left ventricle LV to the left atrium LA.

Fig. 4 schematically shows an implant 10 for a mitral valve MV of a patient suffering from mitral regurgitation according to one possible embodiment of the present invention.

The implant 10 comprises a clip 11 and a capsular bag 12 attached to the clip 11.

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

The capsular bag 12 is configured to at least partially close the opening portion O1 remaining between the posterior leaflet PL and the anterior leaflet AL of the mitral valve MV during systole after the implant 10 has been attached to the leaflets, thereby limiting blood backflow that occurs through the opening portion O1 of the mitral valve MV during systole.

The implant is more likely to attach to the posterior leaflet PL because the implant may be more stable than to the anterior leaflet AL.

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 groin fold, and is delivered transseptally (through the interatrial: the membrane separating 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.

The clamp 11 is configured to engage with the distal end of the actuator rod 101, by which the clamp 11 is opened and closed. The shaft 101 is for example partly mounted inside a delivery catheter 102, the distal end of the shaft 101 being arranged outside said 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. Conversely, in a second configuration, the rod 101 may perform a back and forth motion by sliding inside the delivery catheter 102.

Preferably, the bladder 12 is inflatable. In this manner, the capsular bag 12 is in a deflated state when the implant 10 is moved along the main catheter 100 to the mitral valve MV. The diameter of the main catheter 100 can thus be small and the movement of the implant 10 along said main catheter 100 is simplified. Conversely, once the implant 10 is attached to the posterior leaflet PL of the mitral valve MV, the capsular bag 12 may expand. In use, the capsular bag remains in an inflated state.

The bladder 12 is inflated, for example, by means of the stem 101. To this end, the sachet 12 comprises an opening, for example communicating with the interior space of said sachet 12. The opening is configured to fluidly communicate with a lumen disposed in the shaft 101. Thus, a filling material may be injected through the lumen of the stem 101 and the opening of the balloon 12 to fill and expand the interior space of the balloon 12.

First, before injecting the filling material, physiological saline may be injected into the inner space of the capsular bag 12. With this prior step, the operator can determine the volume of filler material required to inflate the balloon 12 to substantially close the opening portion O1 in the mitral valve MV and thus significantly reduce or eliminate blood regurgitation.

Thus, after draining saline from the bladder 12, the operator may fill the bladder 12 with a determined volume of filling material.

In a second step, a filling material is injected into the interior space of the capsular bag 12. The filler material is preferably a biocompatible material having a density of less than or aboutEqual to the density of blood (1056 to 1066 kg/m)³). The filler 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 capsular bag 12 after filling.

Alternatively, the filler material may be a material having a honeycomb structure, such as foam or sponge. Other possible filler materials are: hyaluronic acid-based hydrogels, poly (ethylene glycol) dimethacrylate (PEGDM) or poly (ethylene glycol) urethane-dimethacrylate (PEGUDM).

Fig. 7 schematically shows the expansion step of the capsular bag. The filling material M is injected into the interior cavity of the capsular bag 12 via an injection tube extending from the interior of the delivery catheter 102 and the body 13 of the clip 11 to which the capsular bag 12 is attached. The capsular bag 12 is preferably formed of an airtight, biocompatible, and abrasion resistant film of elastomeric material. The membrane material is for example preferably selected from polyamides (especially nylon)) Polyethylene terephthalate ("PET"), or silicone.

The use of an inflatable balloon allows the balloon to be sized to accommodate mitral valve leakage and patient morphology. The operator may actually adjust the volume of the capsular bag until the mitral valve leak disappears. The expansion of the capsular bag can be monitored in real time by transesophageal echocardiography (TEE).

A first example of a sachet 12 is shown in fig. 5 a.

The sachet 12 has a generally elongate shape extending along a transverse axis Y parallel to the first rotational axis 15. Thus, when implant 10 is attached to posterior leaflet PL, capsular bag 12 extends along anterior leaflet AL and posterior leaflet PL of mitral valve MV and optimally conforms to the shape of opening portion O1 remaining between anterior leaflet AL and posterior leaflet PL during systole, thereby closing remaining opening portion O1.

More specifically, the capsular bag 12 has a generally dome (or crescent) shape. The pocket 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 along the transverse axis Y between each end 17 and 18 of the pocket 12. The first face 16 of the capsular bag 12 is able to conform to the curvature of the posterior leaflet. In fact, the "natural" junction line between the anterior and posterior leaflets of the mitral valve has a concave shape towards the left ventricular outflow tract (aortic duct). Thus, the convex shape of the capsular bag 12 takes into account the morphology of the valve.

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

The second face 25 of the pocket 12 may have an excess thickness 26 disposed generally at an intermediate distance between the lateral ends 17 and 18 of the pocket 12. Thus, the capsular bag 12 optimally conforms to the shape of the opening portion O1 remaining between the anterior leaflet AL and the posterior leaflet PL during systole. In this way, the closing of the opening portion O1 is more effective.

Other examples of pouches are shown in fig. 5 b-5 e.

As shown in fig. 4, the implant 10 further has support tabs 20 by which the capsular bag 12 is attached to the clip 11. According to one possible embodiment, the pouch 12 may be attached to the support tab 20, for example by sewing, welding, gluing or dipping, and the support tab 20 is in turn attached to the clip 11.

In fig. 4, the support tab 20 extends along a transverse axis Y. Support tab 20 has a first face 21 attached to first face 16 of pocket 12 and a second face 22 opposite first face 21.

The support tab 20 is formed of a shape memory material, for example, having a mesh shape. Shape memory materials are materials that have the ability to remember an original shape and return to the original shape after deformation. Thus, the shape memory material has, for example, a first shape in a first temperature range below the 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 may change the shape of the material. The shape memory material is selected to have a critical temperature between 20 ℃ and 37 ℃.

In the first shape state, the support tab 20 is folded back on itself, for example. In this first shape state, the capsular bag 12 is deflated. Thus, the support tabs 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 a critical temperature, particularly when the support tab is immersed in an ambient medium, such as ambient air, having a temperature of about 20 ℃.

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 along the transverse axis Y between each of its ends 23 and 24. Thus, support tabs 20 give first face 16 of pocket 12 its convex shape. In this second shape state, the capsular bag 12 may be inflated to close the open 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, particularly when the support tab is immersed in an ambient medium, such as blood, having a temperature of about 37 ℃.

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

Preferably, the support tabs 20 are made of nitinol. Nitinol is a nickel titanium alloy. Upon contact with blood at 37 ℃, the support tab 20 changes from the folded state to the unfolded state. It is particularly advantageous to make the support tab 20 from nitinol. In fact, nitinol is biocompatible and hemocompatible. Furthermore, it has very good corrosion resistance and is superelastic.

Fig. 5 b-5 e schematically illustrate other examples of capsular bags that may be part of the implant of fig. 4.

Figures 7 and 10a-10b show the clamp 11 in an open position and a closed position, respectively. Fig. 8 shows the clamp 11 in an intermediate position between the open and closed position.

The gripper 11 has a rotary drive 27 configured to rotate the gripping jaws 14 relative to the body 13 about the first axis of rotation 15 between the open position and the closed position.

The rotary drive 27 comprises, for example, a connecting rod which is rotatably articulated about a second axis of rotation 28 with the clamping jaw 14. The second rotation axis 28 is parallel to the first rotation axis 15 and does not coincide with the first rotation axis. Thus, movement of the link 27 pivots the jaw 14 relative to the body 13 about the first axis of rotation 15 between the open and closed positions.

The clamp 11 may further include locking devices 27, 29 configured to lock the clamp 11 in the closed position. Locking the clamp 11 in the closed position reduces the risk of untimely opening of the clamp 11 once the implant 10 is attached to the posterior leaflet PL of the mitral valve MV.

Fig. 10a and 10b show the clamp 11 in the closed and locked position.

The clamp 11 comprises, for example, at least one rocker element 29 which is rotationally articulated, on the one hand, with the connecting rod 27 about a third axis of rotation 30 and, on the other hand, with the body 13 of the clamp 11 about a fourth axis of rotation 31. The third rotation axis 30 and the fourth rotation axis 31 are parallel and non-coincident with each other and with the first rotation axis 15 and the second rotation axis 28.

The rocker member 29 and the link 27 together form a toggle joint. 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, the clamp 11 then being in the open position, and a locked configuration, in which the third rotation axis 30 is located on a second side of said plane P, the clamp 11 then being in the closed position.

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

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

The grip portion 32 of the body 13 receives the sachet 12. For this purpose, the holding portion 32 of the body 13 is inserted, for example, into a groove 19 provided for this purpose in the first face of the pocket 12.

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 clamp 11 clamps the posterior leaflet PL of the mitral valve. Thus, the spikes 34 improve the grip of the clip 11 on the posterior leaflet PL of the mitral valve MV.

The spikes 34 extend, for example, substantially perpendicularly from a face of said gripping portion 32 of the body 13 facing the jaws 14. To this end, a plate provided with spikes 34 is attached to the face of the clamping portion 32 of the body 13 facing the jaws 14.

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 opening 35 is configured to receive the spike 34 of the body 13 when the clamp 11 is in the closed position. Thus, it is ensured that the closure of the clamp 11 is not hindered by the spikes 34 of the body 13. The opening 35 may be replaced by one or more recesses.

Alternatively, the spikes 34 are supported by the clamping portions 33 of the jaws 14, for example by means of a plate, and, where appropriate, the openings 35 are provided in the clamping portions 32 of the body 13.

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

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

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

The second rotation axis 28 is positioned, for example, on the side opposite to the clamping portion 33 of the jaw 14, while the fourth rotation axis 31 is positioned on the side opposite to the clamping portion 32 of the body 13.

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

The clamp 11 may further include locking means 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 untimely opening of the clamp 11 once the implant 10 is attached to the posterior leaflet PL of the mitral valve MV.

To this end, the link 27 comprises, for example, a stop 39 configured to come into contact with the rocker element 29 in the locking configuration of the toggle. The stopper 39 is formed of, for example, an axis parallel to the second rotation axis 18 and the third rotation axis 20. Fig. 7 to 9 show an example of the jig 11 having the stopper 39.

As a variant, the jaw 14 comprises a projection 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. The clamp 11 with the protrusion 40 is shown in fig. 11.

The clamp 11 may further comprise movement means 41, 42 configured to move the link 27 and thus cause the jaws 14 to pivot relative to the body 13 about the first rotation axis 15 between the open and closed positions.

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

Thus, when the pusher element 41 moves in translation along the longitudinal axis X with respect to the body 13, it causes, by means of the lever element 42, the movement of the third rotation shaft 30. When the pusher element 41 is moved in the first direction D1, the jaw 14 is pivoted about the first rotation axis 15 to the clamping position CP and the third rotation axis 30 is driven to the locking position. When the pusher element 41 is moved in the second direction D2 opposite to the first direction D1, the jaw 14 is pivoted about the first rotation axis 15 to the disengaged position, and the third rotation axis 30 is driven to the locked position.

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 jaw 14. Thus, the movement of the pusher element 41 is guided by the body 13.

The pusher element 41 is for example provided with an opening 45 extending along the longitudinal axis X. The opening 45 is configured to mate with the distal end of the stem 101. Thus, the operator manipulates the proximal end of the rod 101 to move the pusher element 41 and thus initiate the opening and closing of the clamp 11 and, where appropriate, the locking of the clamp. Fig. 10b shows an example of an opening 45 of the pusher element 41.

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

The guide element 46 extends, for example, from a face 44 of the body 13 opposite the grip portion 33 of the jaw 24 and comprises a through opening 47 extending along the longitudinal axis X, configured to slidably receive the distal end of the stem 101. The opening 47 of the guiding 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 can then drive the pusher element 41 in translation along said longitudinal axis X and thus open and close the clamp 11. Fig. 10b shows an example of an opening 47 of the guide element 46.

The clamp 11 is covered with, for exampleAnd (4) coating. This material facilitates endothelialization of the implant (colonization of the tissue by endothelial cells), which improves its retention at the implantation site and reduces thrombosis (vascular occlusion)Plug). In other words, the clamp 11 is made of titanium, for example, and is covered with a thin layerAs a variant, the clamp 11 is made of chromium cobalt alloy.

Fig. 12 is a diagram illustrating, by way of example, various steps of a method P for transseptal positioning of the implant 10.

In a first step Q1, the guide 103 is inserted into the femoral vein to the right atrium RA, and transseptal catheterization (through the interatrial septum) is then performed to the left atrium LA and the mitral annulus MA. The first step Q1 is shown in fig. 13.

In a second step Q2, dilator 104 is threaded over guide 103, which is then inserted into left atrium LA. The dilator 104 is thus guided by the guide 103 to the left atrium LA. The dilator 104 dilates the tissue of the atrial septum to allow insertion of the main catheter 100. The second step Q2 is shown in fig. 14.

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

In a fourth step Q4, the main catheter 100 is then inserted over the guide, through the interatrial septum, and to the left ventricle LA. To this end, the main catheter 100 is passed, for example, around a dilator 104. The fourth step Q4 is shown in fig. 15.

In a fifth step Q5, dilator 104 is removed.

In a sixth step Q6, the distal end 105 of the main catheter 100 is oriented so as to extend in a substantially coaxial manner with the mitral annulus MA. Thus, the distal end 105 of the main catheter 100 includes a portion that can be oriented. The sixth step Q6 is shown in fig. 16.

In a seventh step Q7, the shaft 101, the distal end of which is mated with the implant 10, and where appropriate the delivery catheter 102, are introduced into the main catheter 100. The shaft 101 and delivery catheter 102 are then in a first configuration, in which the shaft 101 and delivery catheter 102 move integrally. The clamp 11 is in the closed position. The pouch 12 is in a contracted state and, where appropriate, the support tabs 20 are in a first shape state. The seventh step Q7 is shown in fig. 17.

In an eighth step Q8, the distal end of the shaft 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 capsular bag 12 of the implant 10 is then oriented towards the anterior leaflet AL of the mitral valve MV, while the jaws 14 of the clip 11 are oriented towards the posterior leaflet PL of the mitral valve MV. The clamp 11 is still in the closed position. The pouch 12 is in a contracted state and, where appropriate, in contact with blood, the support tabs 20 change from a first shape state (folded) to a second shape state (unfolded). An eighth step Q8 is shown in fig. 18.

In a ninth step Q9, the clamp 11 is opened. To do this, the lever 101 pulls the pusher element 41 towards the end of the body 13 carrying the sachet 12, for example. The rod 101 and the rod guide 102 are then in a second configuration, in which the rod 101 is free to slide inside the rod guide 102. The ninth step Q9 is shown in fig. 19.

In a tenth step Q10, the stem 101 and, where appropriate, the delivery catheter 102 are moved towards 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 clamp 11, which is still open. The shaft 101 and delivery catheter 102 are then in a first configuration, in which the shaft 101 and delivery catheter 102 move integrally. The tenth step Q10 is shown in fig. 20.

In an eleventh step Q11, the clamp 11 is closed and, where appropriate, locked. Thus, the implant 10 is attached to the posterior leaflet PL of the mitral valve MV. To do so, 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 the capsular bag 12). The rod 101 and delivery catheter 102 are then in a second configuration, in which the rod 101 is free to slide within the delivery catheter 102. An eleventh step Q11 is shown in fig. 21.

In a twelfth step Q12, the balloon 12 is inflated with saline and the volume of saline filling the balloon 12 is determined. A twelfth step Q12 is shown in fig. 22.

In a thirteenth step Q13, the effect of inflating the capsular bag 12 to the determined filling volume is checked by injecting saline into the cavity of the capsular bag 12. To do this, the operator observes whether the blood reflux is sufficiently reduced by means of transesophageal echocardiography (TEE). If the determined fill volume is deemed satisfactory, the determined fill volume is confirmed. Otherwise, the fill volume is adjusted and then checked again.

In an optional fourteenth step Q14, saline is removed from the capsular bag 12. A fourteenth step Q14 is shown in fig. 23.

In a fifteenth step Q15, bladder 12 is inflated with a filling material. The volume of filling material injected into the capsular bag 12 corresponds for example to the filling volume determined in the twelfth step Q12. The fifteenth step Q15 is shown in fig. 24.

In a sixteenth step Q16, the implant 10 is released. For this purpose, for example, the rod 101 is disconnected from the pusher element 41. Preferably, once the resin is hardened, a sixteenth step Q16 is performed. A sixteenth step Q16 is shown in fig. 25.

In a seventeenth step Q17, the shaft 101, the delivery catheter 102, and, where appropriate, the main catheter 100 are removed from the patient.

All of these steps may be performed under control by cardiac fluoroscopy and monitoring by transesophageal echocardiography (TEE).

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

The implants and methods as described above are not only used for positioning on the mitral valve. The proposed implant may also be positioned on heart valves other than the mitral valve, in particular the other atrioventricular valve, i.e. the tricuspid valve.