ITUB20159281A1 - DEVICE FOR THE PERCUTANEOUS TREATMENT OF THE FUNCTIONAL TRICUSPIDAL INSUFFICIENCY - Google Patents

Description

DEVICE FOR PERCUTANEOUS TREATMENT

OF FUNCTIONAL TRICUSPIDAL INSUFFICIENCY

The present invention relates to a device for the percutaneous treatment of functional tricuspid insufficiency.

The tricuspid valve (also called the tricuspid valve) is the valve that joins the right atrium to the right ventricle. The tricuspid valve has an atrial margin or tricuspid ring, which corresponds to the outline of the orifice, and very thin free margins, which float in the ventricular cavity and are represented by three cusps that make up the valve itself.

The opening and closing of the tricuspid valve is linked to intracardiac pressure variations, as there is no nervous or muscular control over its activity. In other words, the cusps are pushed by the blood flow itself. The function of the valve is to pass blood from the atrium to the ventricle in diastole, allowing the right ventricle to be filled. During the subsequent systole, with the ventricular contraction, the intracavitary pressure increases and the tricuspid flaps are pushed towards the atrium, collaborating with each other and closing the orifice by functioning as a valve.

The main task of the tricuspid valve is to prevent the backflow of blood to the atrium during the systolic phase or "ventricular contraction" ensuring valve sealing and ensuring the regular flow of blood to the pulmonary artery.

The tricuspid valve can be prone to functional tricuspid insufficiency. Functional tricuspid insufficiency can be caused by repercussions on the right heart of a pathology of the left heart or, more rarely, by a pathology of the right heart such as primary or ischemic cardiomyopathy with direct involvement of the right ventricle. Functional tricuspid insufficiency secondary to left heart disease occurs when primary or ischemic cardiomyopathy or valvular heart disease causes an increase in pressure in the left atrium and pulmonary veins and a consequent increase in pulmonary arterial pressure. Pulmonary arterial hypertension causes pressure overload of the right ventricle. Due to pressure overload, the right ventricle dilates and, in agreement with the right ventricle, the tricuspid ring dilates. The dilation of the tricuspid ring causes a lack of coaptation of the valve flaps with consequent valve insufficiency. Examples of investigational devices and procedures to try to resolve functional tricuspid insufficiency are described in the following publications:

TARAMASSO, VANERMEN, MAISANO, GUIDOTTI, LA CANNA, ALFIERI - The Growing Clinical Importance of Secondary Tricuspid Regurgitation - Journal of American College of Cardiology - Vol. 59, No. 8, 2012 ISSN 0735-1097;

NAVIA et al. - Surgical management of secondary tricuspid valve regurgitation: Annulus, commissure, or leaflet procedure? - The Journal of Thoracic and Cardiovascular Surgery - Volume 139, Number 6, June 2010;

MAS, PALOMARES, ANTUNES - Secondary tricuspid valve regurgitation: a forgotten entity - Heart 2015; 101: 1840-1848;

ROGERS, BOLLING - The Tricuspid Valve Current Perspective and Evolving Management of Tricuspid Regurgitation - Contemporary Reviews in Cardiovascular Medicine.

In a first known example, a traction is performed on a point of the tricuspid ring, bringing it towards the inferior vena cava to deform the valve and limit the reflux; the traction cable is anchored to a large stent, expanded in the inferior vena cava.

In a second known example, a cerclage band is applied to the annular edge of the valve to limit its expansion.

In a third example, a suture is applied at the base of the anterior cusp and one at the base of the posterior one.

It is therefore evident that the proposed systems are of complex application, of dubious efficacy and risk altering the functional behavior of the valve. In particular, many of the systems adopted so far represent an attempt to adapt known devices and procedures for the mitral valve to the treatment of tricuspid valve insufficiency, but are not easily applicable and with potential risks of malfunction given the anatomical functional differences of the two valves. The object of the present invention is to make available a device for the percutaneous treatment of functional tricuspid insufficiency which overcomes the aforementioned drawbacks of the known art.

In particular, the purpose of the present invention is to provide a device for the percutaneous treatment of functional tricuspid insufficiency that is feasible, effective, and possibly adjustable to adapt to different operating conditions of the valve itself.

Said objects are fully achieved by the device for the percutaneous treatment of functional tricuspid insufficiency object of the present invention, which is characterized by the contents of the claims reported below.

In particular, according to a first aspect, these objects are achieved by a device for the percutaneous treatment of functional tricuspid insufficiency comprising at least two anchoring elements. Each anchoring element is configured to be fixed, for example, to the tricuspid ring tissue.

At least one tie rod is provided configured to be arranged between two or more anchoring elements so as to exert on them a pulling force suitable for bringing them closer to each other.

A self-locking clamping device is suitable for being associated with two end portions of the tie rod. This clamping device is configured to allow the two end portions of the tie rod to slide together in a direction of approach of the two anchoring elements and to prevent the two end portions from sliding together in a direction of separation of the two anchoring elements.

In this way the invasiveness of the device and of the application procedure is reduced to a minimum, obtaining a particularly effective device in which the tie rod is suitable for working in traction to bring the anchoring elements closer and can be adjusted over time thanks to the presence of the device. self-locking clamping device.

According to a further aspect, these purposes are achieved by a system for the percutaneous treatment of functional tricuspid insufficiency comprising a device for the percutaneous treatment of functional tricuspid insufficiency in which the anchoring elements are configured to be fixed to the tissue of a tricuspid valve by passing from the opening configuration to a closing configuration. The system includes an implant catheter designed for insertion of the aforementioned device into the tricuspid ring and a guide catheter to bring the implant catheter close to the tricuspid valve. The guide catheter is a long, large-caliber introducer suitable for insertion in the groin into the femoral vein and for being advanced along the inferior vena cava to the right atrium, in front of the tricuspid valve, to guide the implantation catheter into the operative position.

The guide catheter, in addition to the passage function of the implant catheter, can be equipped with a mechanism that allows the tip to be bent up to 90 degrees and beyond, to orient the implant catheter towards the edges of the tricuspid ring.

The implant catheter is configured in the distal part to allow the housing of an anchoring element and maneuver by pulling and pushing the transition from the opening configuration to the closing configuration of the anchoring element.

A traction and thrust catheter runs inside the implantation catheter which exerts the traction and thrust function of the anchoring element, for example by means of a preassembled wire inside the traction-thrust catheter, passing inside the portion of return of the anchoring element to retrace the entire traction-thrust catheter from the external portion of which the two ends of the wire then emerge.

The simultaneous traction of both ends of the wire makes the anchoring element integral with the traction-thrust catheter so that the anchoring element can enter and exit for the transition from the opening configuration to the closing configuration.

In one or more of the aspects indicated, one or more of the following characteristics are possible.

Preferably at least three anchoring elements are provided, even more preferably at least one anchoring element for each cusp of the valve in order to uniformly distribute the loads and improve the efficiency of the valve closure.

Preferably, the anchoring elements comprise a return portion of the tie rod so that the tie rod can be inserted and not directly fixed on the anchoring elements.

Preferably the tie rod is configured to be arranged according to a closed line passing through the return portions so that the reduction of the ring is uniform with respect to the three cusps, with convergence lines directed towards the center of the valve to obtain a remodeling.

Preferably, the return portion includes a loop or an eyelet suitable for receiving the tie rod, making both the anchoring element itself and the coupling with the tie rod particularly simple.

Preferably, the self-locking clamping device is fixed to an end portion of the tie rod, preferably a first end portion, thus requiring no further actions by the operator. Preferably, the self-locking clamping device comprises a sliding channel suitable for receiving an end portion of the tie rod, in particular a second end portion of the tie rod not fixed to the self-locking clamping device.

Preferably, the sliding channel comprises monodirectional clamping means configured to allow the sliding of at least one end portion of the tie rod according to a direction of approach of the anchoring elements and to prevent sliding thereof according to a direction of removal of the anchoring elements.

Preferably, the self-locking clamping device is configured to be completely crossed by an end portion of the tie rod, defining an adjustment portion of the tie rod itself and allowing the adjustment also in subsequent times according to any changes in the anatomical / functional conditions of the valve. Preferably an anchoring element comprises a folded wire for example made of elastic material.

Preferably, the folded wire forms a return portion in the form of a loop or eyelet.

Preferably, the folded wire forms an anchoring portion for example comprising pointed ends which are movable between a closed position, in which they are approached, and an open position in which they are spaced apart.

Preferably, the anchoring element is configured to assume a closing configuration, in which two pointed ends are placed side by side, and an opening configuration, in which the pointed ends are spaced apart.

Preferably, the folded wire is configured to assume a stable closing configuration and an unstable opening configuration. For example, in the stable closing configuration, two pointed ends of the wire are close together and in the unstable opening configuration the two pointed ends are spaced apart.

Preferably, the folded wire has the shape of an eight with a central crossing which divides the return portion in the form of an eyelet and the anchoring portion. Alternatively, the folded wire has an eight shape with central loops which divide the return portion in the form of a loop and the anchoring portion.

Preferably, the folded wire is configured to assume an unstable closing configuration and a stable opening configuration. For example, in the unstable closing configuration, two pointed ends are joined together, and in the stable opening configuration the two pointed ends are spaced apart.

Preferably, the anchoring element comprises a cerclage ring configured to make the closed position stable. For example, the cerclage ring is configured to be placed around the folded wire.

Preferably, an anchoring element comprises a fixing portion (or rear portion) configured for fixing the tie rod for the mutual tensioning of the anchor points and an anchoring portion (or front portion) configured to be fixed to the tricuspid ring tissue.

The anchoring portion may comprise one or more semicircular or circular pointed metal wires or arms, configured to penetrate the tissue of the tricuspid ring with insertion methods similar to those of a needle applying a surgical suture.

The fixing portion of the tie rod can comprise a metal element in continuity with the anchoring portion, having a variable shape, for example circular, for the passage and support of the tie rod that connects the anchoring elements.

Preferably, the anchoring elements are made in the form of tweezers with a fixing portion also having the function of opening and / or closing the anchoring portion. The anchoring portion may comprise semicircular shaped ferrules, with pointed anterior ends which are pushed against the tricuspid ring with the tips spread apart. The pointed front end penetrates the fabric while the anchoring portion is brought closer by surrounding a portion of the fabric that represents the attachment point at the end of the insertion.

Preferably, the anchoring portion can comprise two opposite arms or three arms, two of which are parallel and one opposite, facing and interposed between the other two.

Alternatively, anchoring elements can be provided in the form of anchoring hooks comprising for example a single hook or two opposing hooks.

Preferably, the traction and thrust catheter includes a slot suitable for housing the anchoring element to facilitate its positioning and fixing.

Preferably, reciprocal sliding means of the anchoring element are provided inside the slot. Even more preferably, the slot is configured to cause the transition at least from the opening configuration to the closing configuration of the anchoring element following its sliding with respect to the traction and thrust catheter.

In accordance with further embodiments, the device and the system in accordance with the present description can be used for the treatment of insufficiency of valves, for example cardiac, also different from the tricuspid valve.

In accordance with a further aspect, the purposes specified above are achieved by a method for the percutaneous treatment of functional tricuspid insufficiency comprising the steps of fixing at least two anchoring elements in correspondence with a tissue portion of a tricuspid valve, arranging a tie rod between two anchoring elements by exerting on them a pulling force suitable for bringing them closer together, blocking the tie rod in the desired approaching position of the anchoring elements.

Preferably, the locking takes place by making two end portions of the tie rod slide reciprocally in a direction of approach of the two anchoring elements and preventing reciprocal sliding of the two end portions in a direction of separation of the two anchoring elements.

Preferably it is provided to fix the anchoring elements at or near the atrial margin of the tricuspid valve. Preferably it is provided to fix the anchoring elements along a perimeter close to or coinciding with the atrial margin.

It is preferably provided to fix an anchoring element for each cusp, for example by arranging it in an area substantially equidistant from the vertices at the base of the valve itself along the perimeter. Preferably it is provided to fix at least three anchoring elements. It is preferably provided to insert the tie rod in a return portion of the anchoring element before fixing it to the valve fabric and to configure the tie rod according to a closed line passing through return portions of the anchoring elements fixed to the valve.

Preferably the tie rod is locked leaving an adjustment portion of the tie rod itself suitable for being grasped for further adjustment of the mutual position of the anchoring elements.

Preferably it is provided to insert the anchoring elements vascularly, for example using a guide catheter, an implant catheter and a traction and thrust catheter sliding inside the implant catheter and configured to receive an anchoring element and to cause its transition at least from an opening configuration to a closing configuration.

Preferably it is provided to associate a tie rod portion to each anchoring element before inserting them by means of a catheter and connecting said portions to form a single tie rod and pull the end portions thereof after fixing the anchoring elements. Alternatively, a portion of the same tie rod is associated with each anchoring element before inserting them by means of a catheter and pulling the end portions after having fixed the anchoring elements.

Alternatively, the above method can be applied to the treatment of the failure of any preferably heart valve.

This and other characteristics will be more evident from the following description of a preferred embodiment, illustrated purely by way of non-limiting example in the accompanying drawing tables, in which:

Figure 1 schematically illustrates a tricuspid valve and a device for the percutaneous treatment of functional tricuspid insufficiency in the preparation stage;

figure 2 illustrates the tricuspid valve of figure 1 with the device for the percutaneous treatment of functional tricuspid insufficiency in operative condition;

Figures 3a-3b schematically illustrate a possible embodiment of a detail of a device for the percutaneous treatment of functional tricuspid insufficiency in two different conditions;

Figures 4a-4b schematically illustrate a possible embodiment of a detail of a device for the percutaneous treatment of functional tricuspid insufficiency in two different conditions;

- Figures 5a-5b schematically illustrate a possible embodiment of a detail of a system for the percutaneous treatment of functional tricuspid insufficiency in two different conditions;

- Figure 6 schematically illustrates a possible embodiment of a detail of a system for the percutaneous treatment of functional tricuspid insufficiency;

- Figures 7, 8a-8c illustrate some phases of a method for the percutaneous treatment of functional tricuspid insufficiency.

With reference to Figures 1 and 2, 1 has overall indicated a device for the percutaneous treatment of functional tricuspid insufficiency, referred to as device 1 in the continuation of this description.

100 indicates a tricuspid valve, seen from the atrial side. 101 indicates the atrial margin of the valve which corresponds to the outline of the orifice of the tricuspid valve, also known as the tricuspid ring. 102 indicates a free margin defined by the three cusps 103 of which the tricuspid valve is composed. The three cusps 103 have a substantially triangular shape with vertices at the base 104 integrated in the tricuspid ring 101 and apexes 105 approached in the closed configuration of the valve or spaced apart in the open position of the valve. The device 1 comprises at least two anchoring elements 2 configured to be fixed to the tissue of the tricuspid valve. For example, the anchoring elements are configured to be fixed by passing from an opening configuration to a closing configuration of the anchoring element itself.

In the example shown, three anchoring elements 2 are provided, one for each cusp 103.

Figures 3a-3b and 4a-4b illustrate two possible different embodiments of the anchoring element 2. Both of the illustrated embodiments provide for the use of a folded wire 21 made of elastic material, for example harmonic steel or titanium or nitinol.

The shape given to the folded wire is such as to provide a return portion 22 and an anchoring portion 23.

In the embodiment of Figure 3a-3b, the transmission portion 22 is in the form of an eyelet. This eyelet is for example made by means of an eight-shape of the folded wire which crosses in a central intersection 24 which divides the transmission portion 22 in the form of an eyelet and the anchoring portion 23.

In the embodiment of figures 4a-4b, the return portion 22 is in the form of a loop. This loop is for example made by means of an eight-shape of the folded wire having central shapes 25 which divide the return portion 22 in the form of a loop and the anchoring portion 23. The anchoring portion 23 comprises pointed ends 26 of the folded wire 21 suitable pinching the tissue of the tricuspid valve by penetrating it.

The shape of the folded wire 21 is such as to allow the movement of the pointed ends 26 between a closed position (fig.3a or fig.4b) in which they are approached and an opening position (fig.3b or fig.4a) in which are spaced apart. The closing position of the pointed ends 26 corresponds to the closing configuration of the anchoring element and the opening position of the pointed ends 26 corresponds to the opening configuration of the anchoring element.

In accordance with a possible embodiment, an example of which is illustrated in Figure 3a-3b, the folded wire 21 is configured to assume a stable closing configuration and an unstable opening configuration. For example, the return portion 22 includes two angled arms 27 normally spread apart in the closing configuration and mutually approachable following a compression action (arrows "A") to distance the pointed ends 26 and bring them to the open position. Maintaining the compression action maintains the open configuration of the anchoring element 2. When the compression action is released, the pointed ends 26 return elastically to the closed position, returning the anchoring element 2 to the closed configuration.

In accordance with a possible embodiment, an example of which is illustrated in Figure 4a-4b, the folded wire 21 is configured to assume an unstable closing configuration and a stable opening configuration. For example, the return portion 22 includes two angled arms 27 normally spread apart in the opening configuration and can be mutually approached following a compression action (arrows "A") to bring the pointed ends 26 closer together and bring them to the closed position. Maintaining the compression action maintains the closed configuration of the anchoring element 2. When the compression action is released, the pointed ends 26 return elastically to the open position, returning the anchoring element 2 to the opening configuration.

To make the closed position stable, the anchoring element can comprise a cerclage ring 28 configured to be arranged around the folded wire. For example, the cerclage ring 28 is movable along the folded wire, starting from the return portion 22, until it abuts in correspondence with the central shapes 25, helping to divide the return portion 22 and the anchoring portion 23.

The device 1 also comprises at least one tie rod 3 configured to be arranged between two anchoring elements so as to exert on them a pulling force suitable for bringing them closer together.

The tie rod 3 can be made of wear-resistant material, for example nitinol.

According to a possible embodiment, an example of which is illustrated in Figures 1 and 2, the anchoring elements 2 comprise respective transmission portions suitable for receiving the tie rod 3 and the tie rod 3 is configured to be arranged according to a closed line passing through the transmission portions 22 of the anchoring elements 2.

According to a possible embodiment, an example of which is illustrated in Figures 1 and 2, the device 1 comprises a single tie rod which extends between a first end portion 31 and a second end portion 32 terminating at respective free ends 33 and 34. The device 1 further comprises a self-locking clamping device 4 suitable for being associated with the two end portions 31-32 of the tie rod 3.

The self-locking clamping device 4 can be made of biocompatible plastic or metal material.

The self-locking clamping device 4 is configured to allow the mutual sliding of the two end portions 31-32 in an approach direction (arrow "B" in figure 2) of the two anchoring elements 2 and to prevent the reciprocal sliding of the two portions end 31-32 according to a direction of separation of the two anchoring elements 2 (opposite direction to the arrow “B” of figure 2).

For example, the self-locking clamping device 4 can be fixed to the first end portion 31 of the tie rod 3 (preferably to the free end 33).

For example, the self-locking clamping device 4 comprises a sliding channel 41 suitable for receiving the second end portion 32 of the tie rod 3.

The sliding channel 41 comprises monodirectional clamping means configured to allow the sliding of the second end portion 32 in the direction of approach "B" of the anchoring elements 2 and to prevent the sliding of the second end portion 32 in a moving away direction of the anchoring elements 2, opposite the direction of approach "B". Said monodirectional clamping means can comprise a segment with saw teeth or the like or other systems for example defining a differentiated friction according to the approach / departure direction.

The self-locking clamping device 4 is configured to be completely crossed by the second end portion 32 of the tie rod 3 defining an adjustment portion 35 of the tie rod itself.

When the device 1 is in position, the anchoring elements 2 are preferably fixed to the tissue of the tricuspid valve 100 along a perimeter 5 close to or coinciding with the atrial margin 101. An anchoring element 2 is preferably provided for each cusp 103, for example arranged in an area substantially equidistant from the vertices to the base 104 along the perimeter 5.

For the positioning of the device 1, in particular comprising at least two anchoring elements 2 configured to be fixed to the tissue of the tricuspid valve by passing from the opening configuration to a closing configuration, it is possible to use a system for the percutaneous treatment of tricuspid insufficiency. functional comprising, in addition to the device 1 itself, an implant catheter 6 suitable for the insertion of the aforementioned device into the tricuspid ring and a guide catheter 6a to bring the implant catheter 6 close to the tricuspid valve.

The guide catheter 6a can be of a known type comprising an elongated hollow body extending between a proximal end, not shown, and a distal end 61. The proximal end which remains outside the patient comprises the operating members which can be operated by the operator while the distal end 61 is intended to reach the tricuspid valve to position the device 1.

A traction and thrust catheter 62 is sliding inside the implant catheter and configured to receive an anchoring element 2 and to cause it to pass at least from the opening configuration to the closing configuration. Preferably, the traction and thrust catheter 62 has a cylindrical conformation, even more preferably cup-shaped.

By using an anchoring element 2 made by means of a folded wire 21, it is possible to use a traction and thrust catheter 62 comprising a slot 63 suitable for housing the anchoring element itself, as for example illustrated in figure 5a, 5b or 6. Preferably the slot 63 is made in a base 64. Preferably the return portion 22 of the anchoring element 2 is inserted in the slot 63 (arrow "C" in figure 5a) so that the anchoring portion 23 protrudes outside the traction and thrust catheter 62.

Reference 65 (figure 6) indicates mutual sliding means of the anchoring element inside the slot 63 which is preferably configured to cause the passage at least from the opening configuration to the closing configuration of the anchoring element following the aforementioned sliding reciprocal.

The reciprocal sliding means 65 can comprise at least one rod 66 integral with the traction and thrust catheter 62 and extending along the guide catheter 6a. The rod 66 is suitable for pushing or pulling the traction and thrust catheter 62 to slide it along the implantation catheter 6.

The reciprocal sliding means 65 can also comprise a traction element 67 inserted in the return portion 22 to make the anchoring element 2 slide with respect to the traction and thrust catheter 62.

The traction element 67 can coincide, once the positioning is complete, with the tie rod 3. Alternatively, as illustrated with a broken line in figure 6, the tie rod 3 can be distinguished from the traction element 67 and inserted in the transmission portion 22 together with it.

With reference to figures 7, 8a-8c, some phases of a method for the percutaneous treatment of functional tricuspid insufficiency are illustrated. In accordance with this method, it is envisaged to insert the anchoring elements by vascular route, for example using the implant catheter 6 and the traction and thrust catheter 62. The anchoring elements are implanted on the atrial side of the tricuspid valve, in correspondence with the 'insertion of the cusps on the tricuspid ring.

Subsequently, it is envisaged to fix at least two anchoring elements in correspondence with a tissue portion of a tricuspid valve and to exert on them a traction force suitable to approach them reciprocally by means of the tie rod 3. The tie rod is locked in the approach position of the elements of desired anchoring, preferably configuring it according to a closed line passing through the return portions of the anchoring elements fixed to the valve.

Preferably the tie rod is locked leaving an adjustment portion 35 of the tie rod itself suitable to be gripped for further adjustment of the mutual position of the anchoring elements.

The anchoring elements are fixed at or near the atrial margin of the tricuspid valve, for example along the perimeter 5 near or coinciding with the atrial margin.

It can be envisaged to fix one or more anchoring elements for each cusp, for example by arranging it in an area substantially equidistant from the vertices at the base 104 of the valve itself along the perimeter 5.

As illustrated for example, it is envisaged to fix at least three anchoring elements.

The tie rod 3 is inserted in the return portion 22 of the anchoring element 2 before fixing it to the valve fabric. It can be the same tie rod or three different portions which are then connected to each other.

According to a possible alternative embodiment, not shown, anchoring elements can be provided in the form of anchoring hooks comprising for example a single hook or two opposing hooks.

Claims (14)

CLAIMS 1. Device (1) for the percutaneous treatment of functional tricuspid insufficiency comprising: at least two anchoring elements (2), each anchoring element (2) being configured to be preferably fixed to the tissue of the tricuspid ring, at least one tie rod (3) configured to be arranged between two anchoring elements (2) so as to exert on them a pulling force suitable for bringing them closer to each other, a self-locking clamping device (4) suitable to be associated with two end portions (31, 32) of said tie rod (3) and configured to allow the reciprocal sliding of said two end portions (31, 32) in a direction of approaching the two anchoring elements (2) and to prevent the reciprocal sliding of said two end portions (31, 32) in a direction of distancing of the two anchoring elements (2). 2. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 1, comprising at least three anchoring elements (2). 3. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 1 or 2, in which said anchoring elements (2) comprise a return portion (22) of said tie rod (3) and in which said tie rod (3) it is configured to be arranged according to a closed line passing through said transmission portions (22). 4. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 3, in which said return portion (22) comprises a loop or an eyelet suitable for receiving said tie rod (3). 5. Device for the percutaneous treatment of functional tricuspid insufficiency according to one or more of the preceding claims, wherein said self-locking clamping device (4) is fixed to a first end portion (31) of said tie rod (3) and comprises a sliding channel (41) suitable for receiving a second end portion (32) of said tie rod (3), said sliding channel (41) comprising monodirectional clamping means configured to allow the sliding of said second end portion (32) according to a direction of approach of the anchoring elements (2) and to prevent the sliding of said second end portion (32) according to a direction of removal of the anchoring elements (2). 6. Device for the percutaneous treatment of functional tricuspid insufficiency according to one or more of the preceding claims, in which the self-locking clamping device (4) is configured to be completely crossed by an end portion (32) of the tie rod (3) defining an adjustment portion (35) of the tie rod itself. 7. Device for the percutaneous treatment of functional tricuspid insufficiency according to one or more of the preceding claims, in which an anchoring element (2) comprises a folded wire (21) made of elastic material, in which said folded wire forms a portion of return (22) in the form of a loop or eyelet and an anchoring portion (23) comprising pointed ends (26) of said folded wire movable between a closing position, in which said pointed ends are approached, and an opening position in which said pointed ends are spaced apart. 8. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 7, in which said folded wire (21) is configured to assume a stable closure configuration, in which said pointed ends (26) are approached, and an unstable configuration opening in which said pointed ends (26) are spaced apart. 9. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 7 or 8, in which said folded wire (21) has an eight shape with a central crossing (24) which divides the return portion (22) in the form of an eyelet and the anchoring portion (23). 10. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 7, in which said folded wire (21) is configured to assume an unstable closure configuration, in which said pointed ends (26) are approached, and a stable configuration opening in which said pointed ends (26) are spaced apart. 11. Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 7 or 10, in which said folded wire (21) has an eight shape with central shapes (25) which divide the return portion (22) in the form of a loop and the anchoring portion (23). Device for the percutaneous treatment of functional tricuspid insufficiency according to claim 10 or 11, wherein said anchoring element (2) comprises a cerclage ring (28) configured to be arranged around said folded wire to stabilize the position closing. 13. System for the percutaneous treatment of functional tricuspid insufficiency comprising: a device (1) for the percutaneous treatment of functional tricuspid insufficiency according to one or more of the preceding claims and comprising at least two anchoring elements (2) configured to be fixed to the tissue of a tricuspid valve, for example by passing from the opening configuration to a closing configuration, an implant catheter (6) suitable for the insertion of the aforementioned device into the tricuspid ring, a guide catheter (6a) to bring the implant catheter (6) close to the tricuspid valve, a traction and thrust catheter (62) sliding inside said implant catheter (6) and configured to receive an anchoring element (2) and to cause it to pass at least from the opening configuration to the closing configuration. System for the percutaneous treatment of functional tricuspid insufficiency according to claim 13, comprising a device (1) for the percutaneous treatment of functional tricuspid insufficiency according to one or more of claims 7 to 12, wherein said traction catheter and thrust (62) comprises a slot (63) suitable for housing said anchoring element (2), reciprocal sliding means (65) of said anchoring element (2) inside said slot (63), said slot being configured to cause the passage at least from the opening configuration to the closing configuration of said anchoring element following said sliding reciprocal.