DEVICE, SYSTEM AND METHOD FOR TREATMENT OF A MITRAL

AND/OR TRICUSPID HEART VALVE INSUFFICIENCY

Description

FIELD OF THE DISCLOSURE

The present disclosure relates generally to systems and methods for the treatment of a mitral or/and tricuspid valve insufficiency.

BACKGROUND

The mitral and the tricuspid valve are positioned at the inflow of the left and right ventricle respectively. They open during diastole to allow blood from the according atrium to fill the left and from right ventricle respectively. They close during systole to prevent blood from flowing back into the atrium. Leaky mitral or tricuspid valve reduce the pumping efficiency of the heart and can lead to heart failure and in some cases even to patient death. It is therefore generally recommended to treat leaky valves in order to improve or restore normal heart function.

Mitral regurgitation (MR) has for example two main causes. In degenerative MR, the chordae are elongated or ruptured. As a result, sections of the posterior or anterior leaflet or both can prolapse into the atrium. This may create a lack of coaptation between the posterior and anterior valve. In functional MR, the left ventricle enlarges or changes shape. This can cause the papillary muscles to misalign with respect to the annulus. The chordae which are anchored in the papillary muscle may pull on the leaflets during systole and prevent the leaflets from touching and coapting properly. The causes for tricuspid regurgitation are similar to that of MR.

Mitral repair techniques have been developed to treat degenerative MR. Typically, the segment of the leaflet that has elongated and ruptured chordae is resected and the adjacent segments of the leaflet are sewn together. To compensate for the loss of leaflet length, the annulus is typically slightly reduced and stabilized by sewing an annuloplasty ring or band onto the inflow rim of the valve. The Alfieri stich or edge-to-edge procedure is an alternative surgical technique in which the free margin of the diseased segment of the posterior leaflet is connected to the free margin of the opposing anterior leaflet or vis versa. The healthy chordae of the opposing leaflet then supports the free margin of the diseased leaflet. The Alfieri stich is effectively a chordae sharing procedure. Alternatively to mitral repair, the entire mitral valve may be replaced by a valve prosthesis. The leaflets are usually surgically removed and a mechanical or bioprosthetic valve prosthesis is sewn to the annulus. Mechanical valve

prostheses often require lifelong anticoagulation treatment to prevent blood clots from forming at the valve. Bioprotheses typically do not require chronic

anticoagulation treatment but may wear out with time, potentially necessitating a second valve replacement surgery. Therefore in general a mitral valve repair may be preferred over mitral valve replacement.

Minimally invasive surgical and trans-vascular techniques have been developed to repair mitral and/or tricuspid valves. Advancements in this field have been hampered by the complexity of the surgical techniques and the lack of visual access to the according valve. There is a need for alternative mitral and tricuspid valve repair techniques, including devices that may be delivered trans-apical and trans-vascular.

SUMMARY

In one aspect of the disclosure a mitral and/or tricuspid repair technique is provided that can be delivered surgically through the open arrested heart, or trans-apically or trans-vascularly to a beating heart. In another aspect a method is provided for the repair of leaking mitral or/and tricuspid heart valve. The system may prevent prolapse of leaflets into the atrium thereby to minimize or eliminate regurgitation of blood into the atrium during systole. Methods are provided to place the system into the heart in order to repair the leaking valve.

BRIEF DESCRIPTION OF TH E DRAWINGS

The Figures will describe various aspects without to being understood as restrictive. The skilled person will also appreciate that any of the features as described in the Figures or in any of the examples mentioned herein may be combined with any other or a number of features as described throughout the specification and claims herein. Fig. 1 at the left side (Fig . la) describes a sectional view of a heart (1) through a normal functioning mitral valve (2). In Fig . lb is depicted a degenerative mitral regurgitation (MR), caused by mitral valve prolapse into an atrium (4). Another degenerative MR is shown in Fig . lc, which is caused by flail leaflet. In degenerative M R, the chordae (3) may be elongated or ruptured. As a result sections of the posterior or anterior leaflet (5,6) or both may prolapse into the atrium (4). This may create a lack of coaptation between the posterior (6) and anterior (5) valve. In functional M R (see Fig . Id), the left ventricle may enlarge or change shape. This may cause the papillary muscles (7) to misalign with respect to the annulus. The chordae (3) which are anchored in the papillary muscle (7) may pull on the leaflets during systole and prevent the leaflets from touching and coapting properly.

Fig. 2 depicts the anatomy of a mitral valve and the treatment of mitral valve regurgitation according to some current techniques. The mitral valve (2) as shown is shaped like the letter D with the straight section located adjacent to the aortic valve. The mitral valve has two leaflets (5, 6).

The anterior leaflet (5) is hinged along the straight section of the D, the posterior leaflet (6) is hinged along the curved section of the D. The posterior leaflet (6) is further divided into three segments PI (6'), P2 (6") and P3 (6"') with PI (6') being most lateral and P3 (6"') being most medial . The opposing segments of the anterior leaflets (5) are referred to as Al (5'), A2 (5") and A3 (5'")- Chordae tendenae (3) connect the leaflets (5, 6) to the papillary muscles (7) in the left ventricle. The chordae (3) support the leaflets (5, 6) similar to the cords of a parachute supporting the parachute. Without the chordae (3), the leaflets (5, 6) would prolapse into the atrium during systole.

Fig. 2a illustrates a normal mitral valve with no insufficiency. Fig . 2b depicts a flail posterior leaflet (6) causing mitral valve insufficiency.

Mitral repair techniques have been developed to treat degenerative MR. Typically, in current repair techniques, the segment of the leaflet (5, 6) that has elongated and ruptured chordae (3) is resected . Fig. 2c shows a resection of flail segment. Then, as shown is Fig. 2d, the adjacent segments of the leaflet (6) are usually sewn together. To compensate for the loss of leaflet length, the annulus is typically slightly reduced and stabilized by sewing an annuloplasty ring (9) or band onto the inflow rim of the valve. Fig. 5 illustrates a system for treatment of a mitral or/and tricuspid valve insufficiency according to an embodiment of the present disclosure. As shown, a mesh (8) is disposed over an inflow area of the valve, which is shown for illustration purposes as a mitral valve (2). The person skilled in the art

understands that this exemplary embodiment also applies accordingly to tricuspid valves. In Fig. 3 the mesh (8) itself is shown in a top view (Fig . 3a) and a sectional view (Fig. 3b).

A schematic view of a mitral valve (2) according to Fig. 2a) is shown in Fig . 4. Fig. 6 shows a schematic view of a damaged mitral valve and a system for treatment according to an embodiment of the present disclosure. It is depicted a mitral valve (2) wherein for one leaflet (5, 6) the chordae (3) is ruptured . As a result sections of the leaflet (5,6) prolapse into the atrium (4). Fig. 7 shows how a system for treatment of a mitral valve insufficiency, which might also be used for tricuspid insufficiency, according to some embodiments of the present disclosure is provided. As shown, a mesh (8) is disposed at least over a portion of an inflow area of the valve. A frame (10) of the mesh (8) is at least partially located in an atrium (4) and at least partially engaged with the mesh (8). With this system, it can be achieved that during diastole blood passes through mesh openings and during systole at least one valve leaflet (5, 6) contacts the mesh (8) thereby preventing the leaflet (5, 6) from prolapsing into the atrium (4). Fig. 8 illustrates this in more detail . Fig. 9 illustrates a sectional view of a mesh (8) according to an embodiment of the disclosure. In this embodiment the frame (10) is provided in a manner, that it comprises two zones. The "inner zone" or core (13) of the frame exhibits a relatively higher rigidity that the "outer zone" (14) of the frame. In this embodiment the "inner zone" or more rigid part (13) of the frame (10) may ensure that the frame (10) keeps the correct form in the target. The "outer zone" or softer part (14) of the frame (10) may be made from a relatively softer material and may allow e.g. for needle penetration for placement of surgical sutures. Fig. 10 shows sutures (15) placed along the circumference of the frame to secure the mesh to the annulus of the mitral valve.

Fig. 11 is another variation of the system according to the present disclosure wherein anchoring means (11), here shown as hooks, are provided to secure the frame (10) and/or mesh (8) in a position in the heart, when introduced in a target.

Fig . 12 shows another variation of an embodiment of the present disclosure. Here the frame (10) may be expandable, e.g ., to secure position when introduced to a target. Fig . 13 shows the expandable frame (10) in a final position in the atrium (4). In this embodiment and some other embodiments, the frame can be introduced to a target and then when it is in the right position the frame may be expanded and therefore secured in its position. Another possibility to secure position of the mesh (8) in the target is illustrated in Figs. 14 and 15. A cage like formation is arranged at the mesh (8) as an anchoring means (11). Also this cage-like formation may secure the mesh (8) and frame (10) in the atrium (4).

Figs. 16 to 21 show other exemplary embodiments of securing the frame (10) and mesh (8) in a final position in the target. In Fig. 16 the mesh is provided with connection points (16) for anchoring means (11). These anchoring means (11) comprise at least a tether (12) that liaises the frame (10) and/or mesh (8) with a left ventricular wall (Fig . 17), the Apex and/or a papillary muscle (7); see Fig. 19. Further to that Fig. 17 and 18 show exemplary embodiments of the anchoring elements (17) of the anchoring means (11), provided according to this

embodiment and some other embodiments of the present disclosure to anchor the tether (12) in its final position. The embodiment shown in Fig . 17 may be used in transapical and transvascular (e.g., transfemoral) implantation methods whereas the embodiment shown in Fig . 18 is generally suitable for transapical implantation methods.

Various embodiments of the arrangement of the connection points (16) of anchoring means (11) are depicted in Figs. 20 and 21. For illustrative purposes only the mesh is omitted here and only the frame (10) is shown. In Fig. 20, exemplary points (16) at which the anchoring means pass through the mitral valve are provided. Passing the anchoring means through the mitral valves at the commissures between the leaflet segments may minimize interference between the anchor means and the closed mitral leaflets. According to the example shown in Fig. 21, two connection points (16) are provided, but in this example the connection points (16) are supported by the frame (10) and arranged so that in final position of the system in the target the connection points (16) are arranged on commissures (18) of the valve (2).

According to some embodiments of the present disclosure the frame (10) may be C-shaped with an opening (19) toward the anterior side (see e.g. Fig . 22). These openings can help to minimize interference of the implanted mesh (8) and frame (10) with the aortic valve. In some embodiments, the mesh (10) may not completely fill the space within the frame (10) but only cover selected areas within the frame.

Fig. 23 shows a mesh cut out of a sheet material and where mesh (8) and frame (10) are built of the same sheet material. Several exemplary embodiments of the frame (10) with a self-centering function are shown in Figs. 24 to 27. The embodiment of Fig. 24 shows means for self- centering (20) on two lateral sides of the frame (10) only, whereas Figs. 25 to 27 illustrate several self-centering means (20) arranged circumferentially at the frame (10). The embodiment illustrated in Fig. 27 further shows connection points (16) as already described in connection with Fig. 21, e.g ., the connection points (16) being arranged on commissures (18) of the valve (2). Figs. 28 to 30 show another embodiment of the disclosure. As shown, the frame (10) supports an anterior mesh (8a) and a posterior mesh (8b). Each mesh has connecting points (16) for anchoring means (11) to anchor the mesh (8a, 8b) in the left ventricle. Further, two struts (22) span across the frame (10), whereas each strut (22) provides a connecting point (16) for anchoring (11) means to anchor the frame (10) in the left ventricle. Figure 29 shows a side view of the embodiment in Figure 28 illustrating the anchoring means (11). The anchoring means (11) may comprise, for example, one or more tethers, cables, or strings, or any combination thereof. According to this example the anterior mesh (8a), the posterior mesh (8b), and the frame (10) may be anchored with their own respective anchoring means (11). This may allow for individual adjustment of the anchoring means by individual tightening . For example, by adjusting the tension on the anchoring means (11) for the anterior mesh (8a) the degree of prolapse of the anterior leaflet into the atrium can be controlled . Fig. 30 shows the

embodiment from Fig . 28 placed in the mitral valve with the anchoring means connected to the apex of the left ventricle.

Fig. 31 shows the damaged chordae and the prolapse of the P2 (6") leaflet into the atrium. A repair of the prolapsing P2 segment with a mesh according to an exemplary embodiment of the disclosure is illustrated in Fig. 32. As shown, a frame (10) contains a partial mesh (8) only. The arrangement and size of the partial mesh (8) may vary, and may be adapted according to the damage of the valve and/or to minimize the amount of foreign material in the body. According to this embodiment three connecting points (16) for anchoring means are provided, one connecting point (16) to anchor the mesh (8) and two connecting points (16) to anchor the frame (10). The next figures illustrate how systems according to the present disclosure may be delivered to a target in a correct position. Fig. 33 shows a mesh (8) and frame (10) in a top and sectional view and when rolled up in an introducer, such as, e.g., a catheter (23). To secure the mesh (8) may roll-out, unpacks and extends into the correct form after delivery. In some embodiments the mesh (8) and/or the frame (10) may comprise nitinol. Nitinol is a memory alloy(s). The mesh (8) may be provided as a lasercut. Other exemplary materials for the mesh (8) and/or frame (10) include ePTFE, surgical sutures, and/or glass fibres alone or in combination and with or without coatings.

Figs. 34 to 36 show examples of the mesh/frame in a catheter (23), and the anchoring means (11) generally aligned to secure correct placement in a target, wherein Fig . 34 shows the entire system still in the catheter (23), Fig. 35 shows the mesh (8) just exiting the catheter (23), and then opening as shown in Fig . 36 while the anchoring means (11) are still aligned in the catheter (23).

A delivery of the system in a transapical implantation is illustrated in Figs. 37 to 44. As shown, an introducer/catheter (23) may enter the heart in the atrium (4) of the according damaged valve (2). This may be done, e.g ., by using a point (24) which after reaching the desired area, is drawn back (Fig. 39). After that the rolled up mesh (8) may be pushed out of the introducer (23) (Fig. 40) and the mesh (8) opens (Fig . 41), and then positioned correctly (Figs. 42 and 43). The anchoring means (11) may be anchored by anchoring elements (17) to secure the mesh (8) in place, and the introducer (23) then may be retracted .

Another possibility to position the mesh (8) in an introducer may comprise rolling the mesh (8) and then folding it up, e.g. once. This is shown in Fig . 45. Two tethers are shown securing the mesh (8) and may be passed through separate lumens in the introducer (23). This arrangement may help to facilitate the positioning of the mesh (8).

A transvascular or transfemoral introduction of a system according to some embodiments of the present disclosure is shown in Figs. 46 to 51. For example, after the introducer (23) enters the heart via the ventricle the anchoring elements (17) may be anchored . In the example as depicted in Fig. 46 this may be done by helical fasteners. The introducer (23) then may be guided through the valve (2) to the atrium (4) (Fig. 47). As shown, the mesh (8) may be pushed out of the introducer (23) (Fig. 48) and positioned correctly (Fig. 49). At the end the anchoring elements (17) may be fixed to the connection points (16). This can for example be provided by a clip (25) or a suture lock, for example, so that the length of the anchoring means (11) can be adapted and the mesh (8) therefore secured in its correct position (Fig . 50). At the end the introducer (23) may be retracted (Fig. 51).

DETAILED DESCRIPTION OF EXEMPLARY EM BODIMENTS One or more objects of the present disclosure may be solved by the systems and methods disclosed herein.

In the following some terms of the disclosure will be defined and unless stated otherwise they will represent the meaning for the purpose of the description of the subject matter described herein.

"Mitral valve insufficiency" and/or "tricuspid valve insufficiency" as described in connection with the present disclosure generally refers to leaky mitral or tricuspid valves, respectively, which reduce the pumping efficiency of the heart and therefore may lead to heart failure, and potentially patient death. Accordingly, leaky valves may be treated in order to improve and/or restore normal heart function. While certain embodiments, examples, and descriptions herein relate to mitral valve insufficiency the skilled person will understand that the present disclosure applies equivalently also to tricuspid valve insufficiency and the according system and treatment.

The expression "mesh" according to the present disclosure includes any kind of materials and configurations of materials having structures with openings, e.g ., to prevent leaflets to prolapse but on the other hand to let pass blood into the valve during the diastole. The structure of the mesh may have any kind of suitable appearance, shape, or configuration. Also the mesh may only cover parts of the leaflets, e.g., depending on the nature of the malfunction and/or the design as may be advantageous. Moreover, the mesh in the sense of the present disclosure does not need to be a mesh in a classical sense; the skilled person will appreciate that any design of a means will be useful in the sense of the disclosure which allows for retaining the damaged leaflet(s) in or at the endogenous level when closed and/or for preventing prolapse into the atrium. Accordingly, in some embodiments it may suffice that the frame in the inside is connected by more or fewer elements, for example only a few connector means, such as, e.g., 3, or as many as 100 or more connector means. The connector means may have a diameter of 0.001 to 1.0 mm, such as 0.01 to 0.2 mm. Such connector means may be positioned to cross each other and/or may be parallel, e.g., designed to connect the frame in a parallel manner. The connector means may be positioned with a distance of between 0.1 and 20 mm. Further to that the mesh may comprise open cells, which may be woven, cut, and/or provided in any other manner. The open cells may have a diameter of diameter of between 0.1 and 20 mm, such as 1.0 and 10 mm, or 0.1 and 5 mm. Moreover, the device may comprise a single sheet with an integrated frame. In some embodiments, for example, the mesh may be made from a nitinol sheet wherein the cells are laser cut out, e.g., to provide for blood flow through the mesh upon deployment (cf. e.g. Fig. 23). In some embodiments, the mesh may provide a smooth surface, e.g., without sharp edges or ridges, for example to minimize abrasion of tissue etc. when placed in the target. The mesh may comprise a coating, e.g., to smoothen the surface, e.g ., a PTFE coating.

The expression "frame" as used in the present disclosure includes any kind of partial or entire circumferential surrounding of the mesh and/or connector means. In some embodiments, the frame may include just the circumference of the mesh but also may include a frame produced differently, e.g., showing different features and characteristics (like rigidity, etc). The frame according to

embodiments of the present disclosure may represent the means to position the device (e.g ., as represented by mesh and frame) on the valve and moreover it may represent a means for fixation of the device in its functional position for valve repair. The frame may also have the same thickness as the mesh or it may be bended and/or have a certain dimension, e.g., and thus may take a certain space in the atrium (cf. e.g. Fig 13) which may be usefu l for positioning and/or holding the device in the correct position. In some embodiments, the frame can thus contribute to a self-positioning or self-centering of the device. The frame may have a dimension of 5 to 20 mm into the atrium. In an exemplary

embodiment the mesh may be 0.1 to 1 mm in thickness and the frame may be 5 to 20 mm. In some embodiments, in addition to the frame as an outer boundary of the mesh, e.g., representing its limitation, the frame can be connected to and/or can be designed as a cage. For example, when positioned for repair the cage may contribute to a correct positioning and maintaining the correct position of the device for correct repair function (cf. e.g . Fig 14, 15). In some

embodiments, the frame may thus also be denoted a self-centering frame (cf. e.g. Fig. 24, 25). Further to that, "partially engaged" as used herein includes any kind of connection and includes also embodiments wherein two parts are built as one part, e.g ., and as used above with the term device.

As one example of material for use for the mesh according to an embodiment is mentioned "sheet material". This includes any kind of material(s) being in a sheet or sheet-like form, e.g., and suitable for the use as implant. This also includes memory materials, which after a possible minimal invasive introduction in the heart may have a predetermined form without any further adjustments. To receive a mesh out of a sheet material, a cutting process, including, but not limited to, laser-cutting may be suitable here.

In this disclosure the expression "anchoring means" is used and includes any kind of means which secure the mesh and/or frame in a position. For example, the frame itself may be provided in a manner to anchor, such as, e.g. by using a relatively rigid material to connect to the mesh and circumferentially a relatively soft or softer material which might be deformed when placed in the atrium and therefor anchors the frame/mesh. The same may be achieved by an expandable frame in some embodiments. Further to that the frame and/or mesh may comprise at least one element chosen from the group of sutures, clips, screws, and/or hooks, which may be anchored in the atrium. Further to that the mesh and/or frame may be connected by tethers with anchoring elements (like, e.g., sutures, clips, screws, and/or hooks) so that as another possibility the anchoring may be elongated from the position of the mesh and/or, for example, in the apex or left ventricle, respectively.

The above mentioned "tether" includes any kinds of connections between the frame/mesh (device) and the anchoring elements.

"Introducer" includes a means to be used depending on, e.g., the surgery to transport the mesh/frame/device to the desired target position. In case transapical or transvascular surgery is used, for example, the introducer may include a kind of catheter which is suitable to be used in minimal invasive surgery. In case surgery on open arrested heart is indicated, the introducer may include any kind of suitable means.

In some embodiments when minimal invasive surgery is applied, the introducer may be suitable to receive the mesh and/or frame/device. This can be, for example, accomplished by rolling up the mesh and/or frame/device in the introducer. The introducer may comprise a holding means, e.g., for maintaining the device in a rolled up and/or folded form exhibiting a relatively small diameter/volume during introduction through the vasculature or the apex in transapical application, a means for guiding the device through the vasculature to the target site, a handle for operating the guiding and release of the device to and at the target site. The handle may comprise connector means for operating the holding means, e.g., to be able to release the device at the target site. Any other terms used in the following will be understood by the skilled person in the art and in the usual sense and manner usually applied in the art.

In the following various embodiments will be described wherein the skilled reader will understand that any features described herein may represent one single feature of the device, system, or method, and any features as described herein may as well be combined in any way even if not explicitly so mentioned in the following.

In general the device as disclosed herein may provide for repair of a valve malfunction, such as a mitral valve malfunction. In general the device as disclosed herein may be designed in a manner to be applicable in a minimally invasive manner to the target site, which in general may include the

malfunctioning valve, e.g. a mitral valve. The device as disclosed in a minimalistic embodiment may exhibit one or more means to inhibit or prevent valve leaflet(s) from prolapse into an atrium, and thus may restores to a certain degree or substantially completely the natural valve function. The device in general may comprise a means for retaining the valve leaflets at a certain position, and/or a means for positioning and/or retaining itself at the target site to exert its function, e.g., its valve repair function. The means for retaining the leaflets may be denoted mesh and the means for positioning and/or retaining the device in place may be denoted frame. The combination may be also denoted device or system. In particular in one aspect the disclosure relates to a system for treatment of a mitral or/and tricuspid valve insufficiency, wherein the system may comprise a mesh disposed at least over a portion of an inflow area of the valve upon implantation. Further, the system may comprise at least a partial frame which is at least partially located in an atrium and at least partially engaged with the mesh. The system further may be provided so that during diastole blood passes through mesh openings and during systole at least one valve leaflet contacts the mesh, e.g., thereby preventing the leaflet from prolapsing into the atrium.

By providing as system as described above the mesh may inhibit or prevent the leaflet from prolapsing into the atrium. For example, the valve may function in a way as desired that leaflets are touching and therefore coapting properly.

Further, for example, the valve may close during systole and may prevent blood from flowing back into the atrium. According to some embodiments, pumping efficiency of the heart may be efficient or otherwise improved.

The mesh and the frame can be formed of different or the same material. The use of different materials for the mesh and the frame may be advantageous in some cases, e.g., to provide different properties. In case they are of the same material it may be advantageous if the mesh and frame are produced in one step and as one component. Such an embodiment may facilitate the production of the mesh and frame. In some embodiments, the mesh and frame may be cut of a sheet material, e.g., one sheet material. This may lead to lean and therefore cost effective production process.

In an exemplary embodiment of the disclosure further provided are anchoring means to secure the frame and/or mesh in a position. By providing the anchoring means the mesh and/or frame can be positioned in a desired position and secured in this position.

The frame and/or mesh can be secured to the heart and/or an annulus of the valve. Thereby the anchoring means for securing the mesh and/or frame may include an anchoring means which could be of any suitable form. For example, the anchoring means may comprise at least one element chosen from the group of sutures, clips, screws, and/or hooks, and combinations thereof.

According to an exemplary embodiment of the disclosure the anchoring means may comprise at least a tether that may liaise the frame and/or mesh with a left ventricular wall and/or a papillary muscle and there an anchoring means. It was found that in certain situations it may be of benefit if the tethers are arranged to pass through the closed valve along a line of coaptation of an anterior and posterior leaflet.

In yet another embodiment the frame may be provided as expandable. By this embodiment, anchoring of the frame and mesh can be achieved by expanding the frame when positioned correctly after introduction.

Thereby the mesh and/or frame may comprise any suitable materials and combinations of materials for an implant. In some embodiments, the mesh may comprise nitinol, nitrol, surgical sutures, Kevlar fibres, polymeric monofilaments, polymeric braids, wire, ePTFE and/or glass fibers. In case of use memory materials the mesh and/or frame may be partially or completely pleated and/or deformed for introduction into the heart. Also to have a mesh and/or frame which is suitable for production and packaging into an introducer or catheter for implanting, the use of a sheet material might be appropriate. The sheet material may be cut by laser-cutting, for example, and further it may be possible to provide the mesh and the frame by cutting the same material accordingly.

In some embodiments, the solidity of the mesh may be less than 0.05 or 5% respectively, such as less than 0.01 or 1% respectively. Solidity of the mesh may indicate the percentage of an area covered by material of the mesh if the mesh is projected on an area.

In yet another aspect of the present disclosure a method for treatment of a mitral or/and tricuspid valve insufficiency is provided. According to this method a mesh may be disposed at least over a portion of an inflow area of the valve. Further a frame may be disposed at least partially in an atrium and may be at least partially engaged with the mesh. The disposal of the mesh may be provided in such a manner that during diastole blood passes through mesh openings and during systole at least one valve leaflet contacts the mesh. Thereby the leaflet may be prevented from prolapsing into the atrium.

According to an embodiment of the present disclosure the mesh and the frame may be disposed by means of an introducer. The introducer thereby may lead the frame and mesh to a position transapically or transvasculary. The introducer hereby may include a kind of catheter which is suitable to be used in minimal invasive surgery. For example, the implant may be disposed to its position transapically or trans-vascularly to a beating heart. The introducer may comprise a handle comprising operating means for directing the leading and/or positioning of the mesh and/or frame or the device from outside an individual to a defined target site.

Some embodiments of the present disclosure may be used for surgery on open arrested heart.

In another aspect the present disclosure relates to a method of deployment of a device for mitral and/or tricuspid valve repair wherein the device may be mounted onto or into a holding means on a catheter (e.g., introducer means) in a relatively small diameter, the catheter may be introduced into the vasculature of an individual and the device may be directed towards the target site. At the target site the device may be released by way of the handle of the catheter, which handle may comprise, and may be connected to, operator means to operate the holding means to release the device to the target site, e.g. by unfolding and/or unrolling the device, and positioning the device to the target site, for example affixing anchoring means in or to the heart.

The introducer according to an embodiment may be used to lead and/or position the anchoring means. In such an embodiment the introducer may be suitable to dispose and/or position the mesh and/or frame in a correct position and further to secure the position by the anchoring means. In some embodiments, when supplied to the heart by an introducer the mesh and/or frame may be rolled up in the introducer. Rolling may not substantially influence the form and therefore positioning may be achieved after the mesh/frame are released or pushed out of the introducer.

List of reference numbers

1 heart

2 mitral valve

3 chordae

4 atrium

5 anterior leaflet

6 posterior leaflet

7 papillary muscle

8 mesh

8a anterior mesh

8b posterior mesh

9 annuloplasty ring

10 frame

11 anchoring means

12 tether

13 inner zone of frame

14 outer zone of frame

15 sutures

16 connection points

17 anchoring elements

18 commissure

19 opening in mesh

20 self-centering means

21 lumen

22 strut

23 catheter/introducer

24 point

25 clip