IT202100027770A1 - DEVICE FOR MITRAL ANULOPLASTY - Google Patents

Description

DEVICE FOR MITRAL ANULOPLASTY

DESCRIPTION

Technical field of the invention

The present invention refers to a device for annuloplasty of a mitral valve and to a kit that includes it.

Background

As ? known, mitral insufficiency and stenosis are cardiac pathologies that affect the mitral valve and which occur when there are alterations in the normal systo-diastolic movement of the mitral annulus. In particular, mitral stenosis refers to a narrowing of the mitral orifice which hinders the passage of blood from the left atrium to the left ventricle. On the contrary, in conditions of mitral insufficiency, the valve does not close completely during the contraction and emptying of the left ventricle: this? causes part of the blood pumped by the left ventricle to flow back into the left atrium instead of? go into the aorta, causing fatigue and breathing disorders.

The treatment of these pathologies generally requires targeted surgical interventions that prevent irreversible damage to the heart. Where in cases of particular damage? Is it necessary to resort to a mitral valve replacement in other cases? repair procedures can be adopted.

Mitral valve repair involves the restoration, by the cardiac surgeon, of the normal geometry-anatomy of the valve ring, the leaflets and the sub-valvular apparatus of the mitral valve. This repair can be carried out by annuloplasty, an operation which generally involves the implantation of a reinforcing prosthetic ring in correspondence with the deformed valve annulus, in order to restore the natural support of the mitral leaflets and guarantee the normal function of the heart.

Annuloplasty represents a fundamental component in the repair of the mitral valve, for three main reasons stated by Carpentier: the ability of 1) re-establish the size and shape of the native annulus without altering the motility? of the mitral leaflets, 2) prevent a new dilation of the annulus, and 3) guarantee functional support to the annulus itself.

Over the years, numerous types of mitral rings have been developed and introduced into clinical use. Was the first annuloplasty ring designed by Carpentier designed for the purpose of reshaping the mitral annulus into the shape it takes in the systolic phase? i.e. the phase of greatest stress on the entire mitral valve apparatus - allowing greater coaptation of the valve leaflets. To this end, the first, original, Carpentier ?Classic? it appeared as a flat and rigid ring.

After Carpentier's rigid ring, various models of mitral rings were developed with the aim of ?fixing? the shape and area of the damaged annulus. The main drawback linked to the use of these rings is? represented by a reduced capacity? to adapt to the actual annular conformation during the phases of the cardiac cycle.

The numerous studies and in-depth studies conducted in recent years relating to the functioning and anatomy of the mitral valve and its apparatus have in fact made it possible to highlight the following aspects: 1) the annular dysfunction mainly affects the posterior portion of the mitral valve; 2) the morphology of the annulus, as emerged from 3D studies, is not flat but? has a "saddle" shape; finally, 3) the annulus is not characterized by a static structure rather? dynamics during the various phases of the cardiac cycle.

In this context, the need therefore appears urgent to have more annuloplasty devices? effective, which can combine, in particular, excellent flexibility and capacity? to adapt to the real morphology of the mitral annulus during the various phases of the cardiac cycle, to a better capacity to restore its functionality? physiological.

Summary of the invention

The technical problem underlying the present invention? therefore, that of providing a device for annuloplasty of a mitral valve, which allows the above-mentioned needs to be met with reference to the known art.

This problem is solved by a device according to claim 1.

Preferred characteristics of the present invention are the subject of the dependent claims.

The invention provides a device which, in one of its preferred meanings, comprises in particular a main body of substantially annular shape, which main body in turn comprises:

- a hollow deformable portion intended to be anchored to an anterior portion of the mitral valve annulus; And

- a portion of support that interconnects the ends? of the hollow deformable portion, which support portion is? intended to be anchored to a posterior portion of the mitral valve annulus;

wherein the hollow deformable portion carries adjustment means configured to allow the introduction or withdrawal of a filling agent into/from the hollow deformable portion, such that, in use, a selective introduction or withdrawal of the agent filling, said hollow deformable portion allows to restore optimal coaptation of the mitral valve leaflets.

An aim of the present invention? therefore, that of providing a device for mitral annuloplasty which is capable of overcoming the drawbacks of the prostheses conventionally used in the sector, and which is in particular capable of containing the degenerative processes of dilation and/or narrowing of the mitral annulus without altering the dynamics of the annulus during normal systolic-diastolic movement.

The device object of the invention is, in its various embodiments described here, intended to be anchored in correspondence with the annulus of a mitral valve that requires repair, in such a way as to guarantee, through the selective introduction or withdrawal of an agent of filling inside/from the hollow deformable portion of the device, a restoration of the physiological shape of the annulus. Preferably, the main body of the device of the invention has a "saddle" shape. substantially coinciding with the anatomy of the annulus of the mitral valve, so to be able to surround him continuously.

What will it be like? better illustrated below, when the device of the invention is anchored at the mitral annulus of the valve to be repaired, is It is possible to carry out a selective introduction or withdrawal of a filling agent, for example a fluid in the form of air or physiological solution, inside/from the hollow deformable portion of the main body: this operation can? be carried out for example by connecting a graduated syringe to the regulation means mentioned above; the introduction or withdrawal of the filling agent advantageously determines a swelling or narrowing of the aforementioned hollow deformable portion, which translates, respectively, into an approaching or distancing of the commissures of the mitral valve, until reaching, for example, a minimal reduction in the antero-posterior distance characteristic of the annulus.

The inter-commeasure distance, i.e. between the antero-lateral (A-L) and postero-medial (P-M) commissure of the mitral annulus, can therefore be modified by the cardiac surgeon by operating on the implanted device of the invention, until optimal coaptation of the two mitral valve leaflets is obtained/restored.

According to preferred aspects, the device developed by the authors of the present invention allows intra-operative evaluation, using two markers placed on the surface of the device in correspondence with the extremities. 2a and 2b of the hollow deformable portion of the main body of the device, the distance between the A-L and P-M commissure of the mitral valve. In other words, the device of the invention can? be advantageously adapted in real time, intra-operatively, to the dimensions of the patient's native annulus.

Therefore, the device of the invention allows, in its various embodiments, to guarantee all the standard requirements of a modern valvuloplasty operation, i.e. to ensure and maintain over time an annular shape similar to the physiological "saddle" shape. (rigidity?) and at the same time promote normal dynamism? of the mitral annulus (flexibility), thanks to the capacity to follow the physiological changes of the valve during the systolic (narrowing) and diastolic (dilatation) phases of the cardiac cycle.

By virtue? of its capacity? to restore physiological functionality? of the mitral annulus, the device object of the invention can therefore be used to avoid the onset of a phenomenon known as anterior systolic movement (SAM), generally resulting from an anomalous coaptation of the two mitral leaflets.

In particular, the device object of the present invention provides, in its embodiments, a more effective alternative to solutions conventionally used in the sector, being able to:

- optimize the physiological shape of the mitral annulus;

- guarantee, through flexibility? of the components that constitute it, the physiological annular movements;

- can be used in all types of acquired mitral valve disease;

- be easy to install;

- ?tailor-made clothing? and in real time the native annulus favoring a reduction of the intercommeasureal distance and, in part, of the anteroposterior, septo-lateral and/or septo-medial distance;

- eliminate the risk of not being able to have an annuloplasty device of the right size for the patient.

In particular, the device of the invention can be used in repair operations of all types of acquired mitral valve insufficiency due to dilation and deformation of the mitral annulus, also associated with mitral leaflet disease. In the latter case, reshaping annuloplasty is preferably associated with standard techniques, described in the literature, for repairing the components of the mitral valve apparatus (e.g. resection, folding, translocation of the papillaries, positioning of neo-chords, etc.).

Other benefits, features and modes? of use of the present invention will be evident from the following detailed description of some embodiments, presented for illustrative and non-limiting purposes.

Brief description of the figures

Will he come? referred to the figures in the attached drawings, in which:

? Figure 1 refers to a device according to a first embodiment of the invention and schematically shows a perspective view of the aforementioned device, partially in section;

? Figures 2 A, B and C schematically show an anteroposterior, lateral and posteroanterior view of the device of Figure 1, respectively. In the figures introduced above, the dimensions are to be understood as purely illustrative and not necessarily with components shown in proportion.

Detailed description of preferred embodiments

Below, different embodiments and variations of the invention and its parts will be described, based on different aspects of it that can be used separately or in combination.

Similar components are denoted in the different Figures with the same numerical reference.

In the detailed description that follows, further embodiments and variants compared to embodiments and variants already treated in the description itself will be illustrated limited to the differences with what is already exposed.

Furthermore, as mentioned, the different embodiments and variants described below are likely to be used in combination.

The terms used in the present description and in the claims have the meaning commonly used in the art, unless otherwise indicated.

Referring initially to Figure 1, a device according to a preferred embodiment of the invention is overall denoted by 100.

The device 100 ? configured to be used in an annuloplasty operation of a mitral valve, where the term ?annuloplasty? means a repair operation of a mitral valve which involves the restoration of the normal geometry-anatomy of the valve ring (or annulus), the valve leaflets and the sub-valvular apparatus of the mitral valve.

In the context of the present invention, the term mitral (or mitral) valve means, with reference to the human body, a?unit? functional complex positioned between the left atrium and ventricle of the heart, which includes various components, including the sub-valvular structures and the portions of the left ventricle, which, being in relationship with the mitral valve itself, form a single structure both from an anatomical-functional and pathophysiological point of view, known as the mitral valve apparatus.

The mitral valve apparatus is? composed of the following elements:

? Valvular ring or annulus;

? Valve leaflets (anterior and posterior);

? Cordae tendineae;

? Papillary muscles; And

? Left ventricle.

The chordae tendineae, papillary muscles and left ventricle constitute the subvalvular apparatus.

The term ?mitral annulus?, used in the context of the present application, refers to the flexible structure made up of fibrous and muscular tissue, which unites the left atrium and ventricle, and onto which the valve leaflets (or mitral leaflets) are directly inserted. The conformation of the mitral annulus varies in relation to the cardiac cycle, moving towards the apex of the left ventricle in systole and towards the left atrium in diastole. Seen in three dimensions, the mitral annulus has a "saddle" shape, or more? precisely a hyperbolic paraboloid, with the pi? tall, right? the most point? distant from the apex of the left ventricle, located in the median part of the anterior portion of the annulus. The most important point the bottom of the annulus is located antero-laterally and postero-medially, with reference to the human body, near the two commissures. In the context of this question, the term ?commissure? refers in particular to the two points, in the posteromedial (P-M) and anterolateral (A-L) position, with reference to the human body, where the mitral leaflets join each other and the mitral annulus.

As mentioned above, there are two valve leaflets that make up the mitral valve, distinguished by their spatial arrangement, with reference to the human body, into anterior and posterior leaflets. With their movement they are responsible for closing and opening the valve during the different phases of the cardiac cycle. Both, as mentioned, are inserted directly onto the mitral annulus, and meet at the level of the two commissures P-M and A-L.

The flaps of the mitral valve are therefore not completely separated from each other but consist of a continuous veil of tissue whose free edge shows numerous incisions, two of these the A-L and P-M commissures, which allow the division into anterior and posterior flaps.

The anterior leaflet (also called aortic, septal, major or anteromedial) has a triangular shape and covers approximately 1/3 of the valve orifice, and is divided into three portions that are not anatomically defined: A1-A2-A3.

The posterior leaflet (also called ventricular, parietal, minor or posterolateral)? divided by two notches into an intermediate sector (P2), relatively large, and two smaller sectors? small, anterolateral commissural and posteromedial commissural (P1 and P3).

How already? mentioned, the device 100 according to the invention is intended to be implanted in subjects suffering from valvular diseases causing stenosis or mitral insufficiency and allows, when in use, to restore optimal coaptation of the anterior and posterior leaflets of the mitral valve.

In the context of this question, with the expression ?optimal coaptation? means an optimal adhesion of the free margins of the anterior and posterior leaflets of a mitral valve, i.e. an adhesion such as to guarantee the normal functioning of the mitral valve apparatus in regulating the passage of blood between the atrium and the left ventricle of the heart. An incomplete or inadequate coaptation of the flaps can be due, for example, to alterations of the leaflets (fibrosis, prolapse, laceration), to the dilation of the valve ring (or annulus) which separates the two leaflets, or to both phenomena.

As ? known to an expert in the field, the movement of the anterior and posterior mitral leaflets is given by a combination between the independent movements of the two leaflets and the movement of the valve ring.

The existence of optimal coaptation between the anterior and posterior leaflets of a mitral valve can be determined through the measurement of various physical parameters. Among these are:

- the depth? of coaptation (also known as ?coaptation depth?), i.e. the distance between the valve plane and the coaptation point of the anterior and posterior leaflets of the valve in end-systole (>11 mm);

- the coaptation length (also known as ?coaptation length?), i.e. the distance between the coaptation point of the anterior and posterior leaflets of the valve and their free margin (< 2 mm).

With the expression "restore optimal coaptation of the anterior and posterior leaflets of the mitral valve?" reference is therefore made, in the context of this question, to the capacity? of the device to determine the transition from a pathological or altered state to a state of normal functionality? of the mitral valve apparatus in regulating the passage of blood between the atrium and the left ventricle of the heart.

For this purpose, the device 100 comprises a main body 1 of substantially annular shape, which main body 1 comprises:

- a hollow deformable portion 2 intended to be anchored to an anterior portion of the mitral valve annulus; And

- a support portion 3 that interconnects the ends? 2a, 2b of the hollow deformable portion 2, which support portion is? intended to be anchored to a posterior portion of the mitral valve annulus.

As previously mentioned, the terms ?anterior? and ?posterior?, are used in the context of the present description and in the claims with reference to the human body.

According to one aspect of the invention, the hollow deformable portion 2 and the support portion 3 of the device of the invention are suitable for being fixed by suture along an anterior and posterior portion of the mitral annulus respectively. The type of anchor or suture is not ? essential for the purposes of the invention, as long as? this is distributed along the entire extension of the hollow deformable portions 2 and of the support portion 3 of the main body 1.

According to the present invention, when the device 100? anchored to the annulus of a mitral valve to be repaired, the main body 1 of the device appears to surround the annulus preferably with continuity. In particular, when in use, the ends? 2a, 2b of the hollow deformable portion 2 of the device are positioned in correspondence with the commissures A-L and P-M of the mitral annulus.

How will it come? explained more? in detail below, once the device 100 according to the invention is anchored to the annulus of a mitral valve to be repaired, it allows the dimensions of the mitral annulus to be adjusted until optimal coaptation of the mitral leaflets is achieved: this adjustment is carried out through the swelling or shrinking of the hollow deformable portion 2 of the main body 1 of the device. In particular, with the expression ?regulate the size of the mitral annulus? it is intended, in the context of the present invention, to increase or reduce, with reference to the human body, the distance between the commissures A-L and P-M and/or the antero-posterior distance of the mitral annulus.

For this purpose, the hollow deformable portion 2 of the main body 1 of the device according to the invention carries adjustment means 4 configured to allow the introduction or withdrawal of a filling agent, inside/from the hollow deformable portion itself.

There? does it? that, when in use, upon selective introduction or withdrawal of the filling agent inside/from the hollow deformable portion 2 of the device 100, it is possible to restore optimal coaptation of the anterior and posterior leaflets of the mitral valve. In other words, the selective introduction or withdrawal of the filling agent inside/from the hollow deformable portion 2 of the device of the invention determines, when this is anchored to the anterior portion of the annulus of a mitral valve to be repaired, a swelling or narrowing of the same, which translates into the consequent approaching or distancing of the commissures A-L and P-M (i.e. a reduction or increase in the intercommeasureal distance) and/or in the increase or reduction of the antero-posterior distance of the annulus.

In the context of the present invention, with the expression ?filling agent? means any biocompatible material capable of being introduced into/taken from the hollow deformable portion 2 of the device of the invention. A filling agent suitable for use according to the present invention? in particular a fluid, for example a gas, a liquid such as an aqueous solution, a semi-liquid or a plastic solid. Preferably, called filling agent ? selected from the following: a physiological solution, an inert gel, air or a biocompatible polymer.

According to the invention, the cardiac surgeon can control the introduction or withdrawal of the filling agent inside/from the hollow deformable portion 2 of the main body 1 of the device 100 intraoperatively, through the adjustment means 4, until optimal coaptation of the mitral leaflets is achieved. Adjusting the size of the device 100, when in use, is ? therefore bidirectional: ? It is possible to obtain both a swelling and a shrinkage of the hollow deformable portion 2 of the main body of the device 100 through the introduction or withdrawal of the filling agent into/from the same, and it is possible completely reversible until such input or withdrawal is interrupted.

The expression "substantially annular in shape", used in the context of the present application with reference to the main body 1 of the device 100, includes any shape that circumscribes at least most of the perimeter of a mitral annulus.

Preferably, the main body 1 of the device according to the invention has a "saddle" shape in space, which is substantially coinciding with the anatomy of the annulus of the mitral valve, so to be able to surround him continuously. This main body 1 ? flexible enough to conform, in use, to the movements of the mitral annulus.

According to one aspect of the invention, the hollow deformable portion 2 of the device according to the invention comprises a first hollow deformable element 21 and a second hollow deformable element 22, which elements are operationally connected to the adjustment means 4 interposed between them.

According to one aspect of the invention, the conformation of the hollow deformable elements 21, 22 is substantially tubular, as in the preferred embodiment shown in Figure 1. In particular, the first hollow deformable element 21 and the second hollow deformable element 22 have a conformation such as to define two internal chambers suitable for receiving a filling agent at the entrance according to a any of the previously described forms, preferably a fluid.

Adjustment means suitable for use in a device according to the invention include any element that is capable of receiving a filling agent as defined in the present description at the input and conveying it inside the hollow deformable portion 2 of the device 100.

According to one aspect of the invention, the adjustment means 4 are placed in a median position with respect to the length of the hollow deformable portion 2.

According to an aspect of the invention, the adjustment means 4 are positioned between said first hollow deformable element 21 and said second hollow deformable element 22, and operationally connected to them so as to allow the introduction or withdrawal of the filling agent to the internally or by themselves.

In one embodiment of the invention, the regulating means 4 have a substantially cylindrical shape and/or include a valve configured to allow selective introduction or withdrawal of a filling agent, preferably a fluid, inside the/from the portion deformable hollow 2 of the main body 1 of the device 100.

A valve suitable for use in the device of the invention preferably includes at least one passage channel bearing an inlet opening in communication with the outside and one or more outlet openings in communication with the hollow deformable portion 2 of the main body 1.

Preferably, the valve passage channel is made of a material suitable to receive a fluid in any of the forms selected from: liquid, semi-liquid, gaseous, plastic solid.

The operations of introducing or withdrawing a filling agent into/from the hollow deformable portion 2 of the device according to any of the embodiments described here can be carried out, preferably, by using a standard graduated syringe.

According to one aspect of the invention, the hollow deformable portion 2 is made of a flexible and biocompatible material with the human or animal organism, preferably a material with properties elastic, for example a material comprising silicone, polyethylene, or polyurethane.

According to one aspect of the invention, the area of the device 100 according to any of the embodiments described herein may vary between 24 mm<2 >to 38 mm<2>. According to the invention, the area of a device 100 according to any of the embodiments described herein is ? the area defined by the perimeter of the main body 1 of the device.

According to one aspect of the invention, the support portion 3 of the main body 1 of the device of the invention can be made up of a solid or hollow arcuate body (for example a tube), preferably made of rigid or flexible material, provided? biocompatible with the human or animal organism. The material used to make the support portion 3 can? be, therefore, identical or different with respect to the material constituting the hollow deformable portion 2. In one embodiment of the device 100, the support portion 3? made of a flexible material, preferably silicone. According to one aspect of the invention, the support portion 3 is not quarry.

The support portion 3, as mentioned, interconnects the ends? 2a, 2b of the hollow deformable portion 2 of the device of the invention. There? does it? what are the ends? 2a and 2b of the hollow deformable portion 2 of the main body 1 of the device are sealed.

In a preferred embodiment of the invention, the device 100 further comprises one or more covering layers 6, 7 suitable for partially or completely covering the main body 1. Materials suitable for being used for the creation of said one or more? coating layers are materials biocompatible with the human or animal organism. Non-limiting examples of materials that can be used to create said one or more? 6,7 coating layers include polyester, silicone, polyurethane, or any fabric suitable for implantation in the human or animal body. A preferred embodiment according to the invention refers to a device 100 according to any of the previously described variants, comprising a first coating layer 6 suitable for partially or totally covering the main body 1 and a second coating layer 7 suitable for covering partially or totally said first covering layer.

Preferably, the first layer 6? made of silicone while the second layer 7 more? external? made of polyester.

According to one aspect of the invention, the coating layer 7 is more external can? be made of any material known in the sector which is suitable to allow the anchoring, by means of suture, of the hollow deformable portion 2 and of the support portion 3 of the main body 1 of the device 100 of the invention, corresponding, respectively, to the portion anterior and posterior portion of the mitral valve annulus to be repaired.

By way of example only, said covering layer 7 pi? external can? be made of any biocompatible mesh fabric, preferably polyester, which is suitable for being fixed by suture in correspondence with the annulus of the mitral valve to be repaired.

As mentioned, the device 100 according to any of the embodiments of the invention can be anchored in correspondence with the mitral annulus of a subject who needs a mitral valve repair operation through annuloplasty, for example a subject suffering from valvular diseases causing stenosis or mitral insufficiency.

The positioning and anchoring operations of the device 100 according to the invention can be carried out using any of the techniques known to an expert in the field of cardiac surgery.

By way of example only, the device according to the invention can be implanted through a thoracic incision (e.g. through open heart surgery) or percutaneously under echocardiographic monitoring, according to any of the techniques known to an expert in the field. For example, under transesophageal ultrasound control, the device according to the invention can be placed at the mitral valve. When the operator believes that the positioning of the device is correct, ? It is possible to proceed with the introduction or withdrawal of the filling agent inside/from the hollow deformable portion 2 of the main body 1 of the device, as previously illustrated, in such a way as to modify the dimensions of the annulus until optimizing the coaptation of the mitral leaflets and restore normal functionality? of the mitral valve.

According to one aspect of the invention, the introduction or withdrawal of the filling agent into/from the hollow deformable portion 2 of the main body 1 of a device according to any of the embodiments described herein, can be carried out intra-operatively following the anchoring of the device of the invention in correspondence with the annulus of a mitral valve to be repaired. The operations of introducing or withdrawing the filling agent can be carried out in such a way as to modify the dimensions of the device along an antero-posterior direction (for example the antero-posterior distance A) and a lateral-lateral direction (for example the lateral distance L ), and consequently the area of the same, until reaching the optimal dimensions characteristic of the native annulus of the mitral valve subject to the repair operation, i.e. dimensions such as to restore normal functionality? of the mitral valve apparatus in regulating the passage of blood between the atrium and the left ventricle of the heart.

Achieving the optimal size of the mitral valve annulus to be repaired can help. be determined according to any of the techniques known to one skilled in the art, for example by echocardiography and/or intra-operative measurements of annular dimensions. Such measurements may include, for example, the measurement of the anteroposterior diameter of the mitral annulus, the measurement of the commissural distance, the determination of the base and height, and therefore the area, of the anterior leaflet of the mitral valve in question, as well as the determination of the depth? and/or the coaptation length, as previously mentioned.

In particular, according to one aspect of the invention, the introduction or withdrawal of the filling agent into/from the hollow deformable portion 2 of the main body 1 of a device according to any of the embodiments described here, can be carried out, when the device ? anchored at the annulus to be repaired, until the distance between the ends? 2a and 2b of the hollow deformable portion 2 of the device does not reach a value corresponding to an optimal commissural distance. As previously mentioned, the optimal commissural distance can? be determined intra-operatively and represents the distance between the commissures of the mitral valve annulus which corresponds to optimal coaptation of the mitral leaflets.

Preferably, the main body 1 of the device according to any of the embodiments described herein, bears, preferably on the external surface, one or more location markers configured to drive ? intraoperatively - the positioning of the device in correspondence with the annulus of the mitral valve of the subject undergoing annuloplasty and/or to monitor the variation in the dimensions of the device during the operations of introducing or withdrawing the filling agent inside it.

In a preferred embodiment, the main body 1 carries two position markers which are placed, respectively, on the surface, at the ends 2a, 2b of the hollow deformable portion 2 of the main body 1 of the device according to the invention.

A preferred variant of the invention refers, in particular, to a device 100 according to any of the embodiments described here, comprising at least one external covering layer 7 which bears two position markers on the surface, which markers are placed in correspondence of the extremities? 2a, 2b of the hollow deformable portion 2 of the main body 1.

The position markers are preferably made of a material suitable for monitoring, when the device is in use, of the distance between the ends? 2a, 2b of the hollow deformable portion 2, by visual inspection, or alternatively by echocardiography.

According to a preferred aspect of the invention, the position markers are made of a colored material.

According to one aspect of the invention, the selective introduction or withdrawal of the filling agent inside or from the hollow deformable portion 2 of the main body 1 of the device is carried out intra-operatively, in particular following the anchoring of the device at of the mitral annulus to be repaired in a person who needs it.

As previously mentioned, the device object of the present invention is? therefore, in its various forms of embodiment, intended to be implanted in the body of any subject who needs mitral valve repair, for example a man or an animal.

The object of the present invention is also a kit for annuloplasty of a mitral valve, comprising a device 100 according to any of the previously described embodiments and means for introducing or withdrawing a filling agent, preferably a fluid according to any of the previously described forms , inside/from the device.

Examples of means for injecting or withdrawing a filling agent according to the present invention include, but are not limited to, a graduated syringe.

The kit object of the invention can? further include also any device known in the sector which is configured to manage the positioning of the device of the invention at the annulus of the mitral valve to be repaired by annuloplasty.

This invention? has been described so far with reference to preferred embodiments. ? it is to be understood that other embodiments may exist that relate to the same inventive core, as defined by the scope of protection of the claims reported below.

Claims (13)

1. Device (100) for annuloplasty of a mitral valve, comprising a main body (1) of substantially annular shape, which main body (1) comprises: - a hollow deformable portion (2) intended to be anchored to an anterior portion of the mitral valve annulus; And - a support portion (3) that interconnects the ends? (2a, 2b) of said hollow deformable portion (2), which support portion is? intended to be anchored to a posterior portion of the mitral valve annulus; wherein said hollow deformable portion (2) carries adjustment means (4) configured to allow the introduction or withdrawal of a filling agent inside/from the hollow deformable portion (2), in such a way that, in use, upon selective introduction or withdrawal of the filling agent, said hollow deformable portion (2) allows for the restoration of optimal coaptation of the anterior and posterior leaflets of the mitral valve. 2. Device (100) according to claim 1, wherein said hollow deformable portion (2) comprises a first hollow deformable element (21) and a second hollow deformable element (22), of substantially tubular shape, which elements are operationally connected to said adjustment means (4) interposed between them. 3. Device (100) according to claims 1 or 2, wherein said regulating means (4) comprise a valve configured to allow selective introduction or withdrawal of the filling agent into/from said hollow deformable portion (2 ). 4. Device (100) according to claim 3, wherein said valve comprises at least one passage channel which carries an inlet opening in communication with the outside and one or more outlet openings in communication with said hollow deformable portion (2). 5. Device (100) according to claim 4, wherein said at least one passage channel is? made of a material suitable to receive a filling agent in any of the forms selected from: liquid, semi-liquid, gaseous, plastic solid, preferably a fluid selected from air or physiological solution. 6. Device (100) according to any one of claims 1 to 5, wherein said main body (1) has a "saddle" shape. substantially coinciding with the anatomy of the annulus of the mitral valve, so to be able to surround him continuously. 7. Device (100) according to any one of claims 1 to 6, wherein said hollow deformable portion (2) is? made of a flexible biocompatible material, preferably a material of your choice between silicone, polyester or polyurethane. Device (100) according to any one of claims 1 to 7, further comprising one or more? covering layers (6, 7) designed to partially or completely cover said main body (1). 9. Device (100) according to claim 8, wherein said one or more? coating layers are made of biocompatible material, preferably a material selected from polyester or silicone. 10. Device (100) according to any one of claims 1 to 9, comprising a first coating layer (6) suitable for covering said main body (1) and a second coating layer (7) suitable for covering said first layer of coating, in which said first layer is preferably made of silicone and called second layer? preferably made of a material suitable for being sutured, preferably polyester. Device (100) according to any one of claims 8 to 10, further comprising, on the surface, one or more? position markers, preferably comprising two position markers placed, respectively, in correspondence with said ends? (2a, 2b) of the hollow deformable portion (2). 12. Device (100) according to claim 11, wherein said one or more? Position markers are made of a material suitable for monitoring, when the device is ? in use, of the distance between said ends? (2a, 2b) of the hollow deformable portion (2), by visual inspection. 13. Kit for annuloplasty of a mitral valve, comprising a device (100) according to any one of the previous claims and means for introducing or withdrawing a filling agent into/from the device.