Devices and Assemblies for Repairing Heart Valves

Abstract

The present invention relates to an implantable device (10) for reshaping a cardiac ventricle, the device comprising: an implantable device (10) for reshaping a cardiac ventricle, the implantable device (10) comprising a tether (16); and a non-implantable tool (18, 18') removably connectable to the implantable device (10) and having a proximal portion (2) and a distal portion (3) opposite the proximal portion (2), the implantable device (10) further comprising an active anchor (12) adapted to be removably connected to the distal portion (3) of the tool (18, 18'), the active anchor (12) comprising an abutment portion (13) adapted to abut against a structure of the cardiac ventricle, the active anchor (12) of the implantable device (10) being connected to the tether (16). an adjustment device adapted to adjust the tension of the tether; a distal portion of the tool having an adjustment key adapted to cooperate with the adjustment device of the active anchor; and a proximal portion of the tool having an operating interface operably connectable to the adjustment key for adjusting the tension of the tether by acting on the operating interface of the proximal portion of the tool.

Description

[Technical Field]

[0001] The present invention relates to the field of heart valve repair systems.

[0002] In particular, the present invention relates to valve repair through an approach that involves bringing the native ventricular structures together relative to one another.

[0003] The present invention relates to an assembly for repairing a heart valve. [Background technology]

[0004] The native atrioventricular heart valves may become damaged and no longer be able to close effectively. Typical types of damage are associated with structural changes in the ventricles, which are dilated, and the muscular-fibrous rings that form the passage openings may also be dilated. These changes cause the valve leaflets to be unable to position themselves in coaptation, inevitably resulting in highly undesirable backflow from the ventricles toward the atria, severely limiting the effectiveness of the heart's pump.

[0005] Typically, for repair of atrioventricular valves, such as the mitral valve, a hoop ring is implanted to reinforce the annulus so that it returns to its original shape, thereby approximating the free edges of the valve leaflets to the closed valve.

[0006] Transcatheter implantable devices have also been proposed in the form of clips to capture and approximate the free edges of the valve leaflets, resulting in the formation of a double-orifice valve following the example of the Alfieri suture.

[0007] Further known approaches include implantation of devices to bring the walls of the heart chambers (atria and ventricles) closer together or to bring the papillary muscles, which form tendon anchoring structures, closer together inside the ventricles.

[0008] For example, U.S. Patent Application Publication No. 2017-0086975 discloses a solution that involves fixing a tether between two atrial walls near the valve to be repaired. A similar solution is also disclosed in U.S. Patent Application Publication No. 2005-222488. U.S. Patent Application Publication No. 2007-203391 discloses a tether for approximating ventricular walls. For example, U.S. Patent Application Publication No. 2019-380699 discloses a device that can be implanted into the left ventricle via a catheter, having a pair of rigid plates fixed to the outer sides of the papillary muscles, i.e., the sides facing the ventricular walls, and a thread-like structure, such as a suture filament, extending between them.

[0009] All solutions of the above type are inherently unsuitable for allowing precise adjustment of the degree of bringing the ventricular walls together, especially after implantation, and may involve replacement of the implantable device.

[0010] U.S. Patent Application Publication No. 2019-0365539 involves the implantation into the right ventricle of an accordion element coupled to two opposing ventricular inner walls, with the device being preloaded with a spring to influence the coupled walls and force them together. While advantageous from some perspectives, this solution risks overstressing the ventricular walls in the first moments after implantation due to the elastic action exerted by the spring, effectively compressing the ventricular cavity. Furthermore, the device's coupling to the inner wall of the heart may fail very prematurely under the elastic action of the spring.

[0011] Therefore, a need is felt to provide a solution for repairing atrioventricular valves that has improved efficacy in both the short and long term. Summary of the Invention

[0012] The object of the present invention is to obviate the aforementioned drawbacks of the known art.

[0013] These and other objects are achieved by the assembly according to claim 1.

[0014] Some advantageous embodiments are the subject matter of the dependent claims.

[0015] Further features and advantages of the present invention will become apparent from the description given below of preferred exemplary embodiments thereof, given as non-limiting examples, with reference to the attached drawings, in which: [Brief explanation of the drawings]

[0016] [Figure 1] 1 illustrates a schematic representation of an implantable device when implanted in a patient, according to one embodiment. [Figure 2] 1A and 1B illustrate diagrammatically an assembly including a tool and an implantable device when implanted in a patient, according to one embodiment. [Figure 3] 1 shows an axonometric view of an implantable device, according to one embodiment. [Figure 4] 1 illustrates an axonometric view of an assembly including a tool and an implantable device, according to one embodiment. [Figure 5A] 1A-1C are diagrams illustrating several steps in the implantation of an implantable device, along with possible methods of operation. [Figure 5B] 1A-1C are diagrams illustrating several steps in the implantation of an implantable device, along with possible methods of operation. [Figure 6] 1A-1C are diagrams illustrating possible steps for implanting an implantable device, along with possible methods of operation. [Figure 7A] 5A and 5B or 6, according to a possible method of operation. [Figure 7B] 5A and 5B or 6, according to a possible method of operation. [Figure 7C] 5A and 5B or 6, according to a possible method of operation. [Figure 8]FIG. 1 is an isometric view with portions separated of a fixation element of an implantable device, according to one embodiment. [Figure 9A] 9A and 9B show diagrammatically and partially the adjustment sequence achievable by the fixing element of FIG. 8; [Figure 9B] 9A and 9B show diagrammatically and partially the adjustment sequence achievable by the fixing element of FIG. 8; [Figure 9C] 9A and 9B show diagrammatically and partially the adjustment sequence achievable by the fixing element of FIG. 8; [Figure 9D] 9A and 9B show diagrammatically and partially the adjustment sequence achievable by the fixing element of FIG. 8; [Figure 9E] 9A and 9B show diagrammatically and partially the adjustment sequence achievable by the fixing element of FIG. 8; [Figure 9F] 9A and 9B show diagrammatically and partially the adjustment sequence achievable by the fixing element of FIG. 8; [Figure 10A] 1 illustrates an axonometric view with separated portions of a fixation element according to one embodiment. [Figure 10B] 10B shows axonometric views of the fixing element of FIG. 10A during possible adjustment sequences. [Figure 11] 10B shows an axonometric view with the assembled parts of the fixation element of FIG. 10A engaged with a tether. [Figure 12A] 10 illustrates a schematic representation of a regulation sequence according to one embodiment. [Figure 12B] 10 illustrates a schematic representation of a regulation sequence according to one embodiment. [Figure 13A] 10 illustrates a schematic representation of a regulation sequence according to one embodiment. [Figure 13B] 10 illustrates a schematic representation of a regulation sequence according to one embodiment. [Figure 13C] 10 illustrates a schematic representation of a regulation sequence according to one embodiment. [Figure 13D] 10 illustrates a schematic representation of a regulation sequence according to one embodiment. [Figure 14] FIG. 1 illustrates an axonometric view of an assembly according to one embodiment. [Figure 15]FIG. 1 illustrates an axonometric view with parts separated of a portion of an assembly according to one embodiment. [Figure 16] 1A and 1B show an axonometric view and a cross-sectional view of a portion of an assembly according to one embodiment. [Figure 17] 1A and 1B show an axonometric view and a cross-sectional view of a portion of an assembly according to one embodiment. [Figure 18] 1 illustrates an axonometric view of a portion of an assembly according to one embodiment. [Figure 19] 1A and 1B show an axonometric view and a cross-sectional view of a portion of an assembly according to one embodiment. [Figure 20A] 1 shows several configurations of adjustment devices in vertical height. [Figure 20B] 1 shows several configurations of adjustment devices in vertical height. [Figure 20C] 1 shows several configurations of adjustment devices in vertical height. [Figure 21A] 2 shows some steps of the adjustment sequence. [Figure 21B] 2 shows some steps of the adjustment sequence. [Figure 21C] 2 shows some steps of the adjustment sequence. [Figure 21D] 2 shows some steps of the adjustment sequence. [Figure 21E] 2 shows some steps of the adjustment sequence. DETAILED DESCRIPTION OF THE INVENTION

[0017] According to a general embodiment, an implantable device 10 is included for reshaping a patient's ventricle 11, 21. The implantable device 10 comprises at least one tether 16 and an active or first anchor 12. Preferably, the implantable device 10 is designed to reshape the right ventricle 11 of the patient's heart 5 for treatment of a tricuspid valve 15.

[0018] The active anchor 12 comprises an abutment portion 13 adapted to abut against a structure of the ventricle 11, 21. Preferably, the term "ventricular structure" refers to a wall of the heart that defines or is located inside the ventricle, such as the outer wall 4 of the patient's heart 5 that defines the ventricular cavity, or the papillary muscles 6 of the heart 5, or the ventricular septum 7. For example, the structure of the ventricle 11 is the outer wall 4 of the patient's heart 5 that defines the ventricular cavity 11, such that the abutment portion 13 of the active anchor 12 of the implantable device 10 is adapted to abut against the outer wall 4 of the heart 5.

[0019] According to one embodiment, with the implantable device 10 implanted in the patient's heart 5, the active anchor 12 forms a crossing gate in the outer wall 4 of the heart 5, and when the abutment portion 13 of the active anchor 12 is outside the right ventricle 11 and abuts against the outer wall 4 of the heart 5, the tether 16 crosses the right ventricle 11 and connects to a second structure of the right ventricle 11, such as the wall of the interventricular septum 7 or the wall of the papillary muscle 6 of the right ventricle 11.

[0020] Those skilled in the art will appreciate that the implantable device 10 may also be implanted in the left ventricle 21 to reshape the left ventricle 21 for the treatment of the mitral valve.

[0021] According to a preferred embodiment, implantable device 10 comprises a second, additional anchor 22 on the opposite side of the body of tether 16 from active anchor 12. Preferably, tether 16 is secured to said second, additional anchor 22. According to one embodiment, second anchor 22 also comprises a second abutment portion 23 adapted to abut a second structure of ventricle 11 opposite the first structure of ventricle 11 against which active anchor 12 abuts, such that active anchor 12 and second anchor 22 have respective abutment portions 13, 23 opposite each other, such that tether 16 can exert a traction effect between the two anchors 12, 22, resulting in reshaping of ventricles 11, 21. According to one embodiment, second anchor 22 comprises a portion, such as a hook, for coupling to a second ventricular structure. For example, the abutment portion 23 of the second anchor 22 is intended to abut against the wall of the interventricular septum 7 facing the left ventricle 21, so that the second anchor 22 is in the left ventricle 21, the first anchor 12 is on the wall 4 of the heart 5, and the tether 16 extends from said first anchor 12 to said second anchor 22. According to one embodiment, the second anchor 22 is different from the first anchor 12. The second further anchor 22 is preferably a passive anchor and preferably does not include a device for adjusting the tension state of the tether 16.

[0022] Advantageously, the active anchor 12 of the implantable device 10 comprises an adjustment device adapted to adjust the tension state of the tether 16. The adjustment of the tension state of the tether 16 is preferably obtained by changing the effective length of the tether 16, i.e., the working length of the tether 16 between the two anchors 12, 22. Adjusting the tension state of the tether 16 can result in a change in the effective length of the tether. Adjusting the tension state of the tether 16 makes it possible to adjust the traction force between the two anchors 12, 22. Adjusting the tension state of the tether 16 makes it possible to adjust the relative position of the two anchors 12, 22.

[0023] The tether 16 may be provided with an elastic element to provide an elastic influence aimed at bringing the two anchors 12, 22 closer together or moving the two anchors 12, 22 away from each other.

[0024] The tether 16 may include at least a portion made from a shape memory material.

[0025] At least one of the two anchors 12, 22, 12 or 22, may include at least a portion made of a shape memory material.

[0026] According to a general embodiment, an assembly 1 for reshaping a patient's ventricle is included that includes at least one implantable device 10 according to any of the previously described embodiments.

[0027] Assembly 1 further comprises a tool 18 that is not implantable and is removably connectable to implantable device 10. Tool 18 comprises a proximal portion 2 and a distal portion 3 opposite proximal portion 2. A longitudinal axis is defined between proximal portion 2 and distal portion 3 of tool 18.

[0028] The active anchor 12 of the implantable device 10 is adapted to removably connect to the distal portion 3 of the tool 18 .

[0029] Advantageously, the distal portion 3 of the tool 18 comprises an adjustment key 48 adapted to cooperate with an adjustment device of the active anchor 12. By operating the adjustment key 48, the tension state of the tether 16 can be adjusted by operating the adjustment device. The adjustment key 48 can have a distal head 35 with a polygonal shape adapted to engage with a proximal portion of the active anchor 12 to effect the adjustment of the tension state of the tether 16.

[0030] Further advantageously, the proximal portion 2 of the tool 18 comprises an operating interface 42 operatively connectable to said adjustment key 48 for adjusting the tension of the tether by acting on the operating interface of the proximal portion 2 of the tool 18. Preferably, the operating interface 42 is intended to remain outside the patient's body during adjustment of the tension of the tether 16, while the distal portion 3 of the tool 18 is connected to the active anchor 12 inside the patient's body. The active anchor 12 can be positioned on the outer wall 4 of the heart 5, avoiding the need for the tool 18 to penetrate inside the patient's heart 5 to adjust the tension of the tether 16.

[0031] According to a preferred embodiment, tool 18 also functions as a delivery tool for at least active anchor 12 of implantable device 10. In other words, tool 18 has the dual function of delivering active anchor 12 to the implantation site and enabling adjustment of the tension state of tether 16 of implantable device 10 by actuating an adjustment device of active anchor 12 from outside heart 5. For example, as shown in FIG. 7-B , active anchor 12 can be delivered onto outer wall 4 of heart 5 by tool 18 attached to distal end 3 of tool 18.

[0032] According to one embodiment, tool 18 also functions as a delivery tool for tether 16 .

[0033] The inclusion of such a tool 18 makes it possible to adjust the tension state of the tether 16 both during implantation of the implantable device 10 and, if necessary, during post-implantation steps, while avoiding the need to access the inside of the patient's heart 5.

[0034] According to one embodiment, assembly 1 further comprises a delivery catheter 46 for delivering at least a portion of implantable device 10. As shown, for example, in Figures 5A and 5B, delivery catheter 46 is intended to deliver second, additional anchor 22 to a respective implantation site, for example, the wall of interatrial septum 7 facing right ventricle 21 and across interventricular septum 7.

[0035] According to one embodiment, the assembly 1 further comprises a vascular catheter 45 for delivering at least a portion of the implantable device 10. For example, as shown in Figure 6, the vascular catheter 45 is intended to deliver a second, additional anchor 22 to a respective implantation site, e.g., the wall of the interatrial septum 7 facing the right ventricle 21 across the patient's vasculature.

[0036] For example, as shown in FIG. 7A, after second anchors 22 are delivered to their respective implantation sites, tether 16 can extend through ventricle 11.

[0037] For example, as shown in FIGS. 7B and 7C, the active anchor 12 can then be delivered by the tool 18 and the tension state of the tether 16 can be adjusted before removing the active anchor 12 from the tool 18.

[0038] The tension in the tether 16 can be adjusted in a variety of ways.

[0039] According to a preferred embodiment, the adjustment device of the active anchor 12 of the implantable device 10 comprises two parts 28, 29 that are rotatably associated with each other, thereby allowing the tension state of the tether 16 to be adjusted by rotating the two parts 28, 29 of the active anchor 12 relative to each other.

[0040] According to a preferred embodiment, the tool 18 further comprises a shaft 49 attached to the adjustment key 48 such that the adjustment key 48 and the shaft 49 are rotatably associated with each other. Preferably, the adjustment key 48 of the tool 18 is integrally connectable to the first portion 28 of the adjustment device of the active anchor 12, and the shaft 49 of the tool 18 is integrally connectable to the second portion 29 of the adjustment device of the active anchor 12. This allows the tension in the tether to be adjusted by rotation of the adjustment key 48, preferably the operating interface 42.

[0041] The inclusion of such a tool 18 makes it possible to adjust the tension state of the tether 16 by rotating the operating interface 42 both during implantation of the implantable device 10 and, if necessary, during post-implantation steps, while avoiding the need to access the interior of the patient's heart 5.

[0042] According to one embodiment, one of the two portions 28, 29 of the adjustment device of the active anchor 12 can be integrally connected to the tether 16. This allows, for example, the tether 16 to be wound around a winding shaft 27 that can be included inside the active anchor 12. For example, according to the embodiment shown in FIGS. 9A-9F , the proximal portion 31 of the tether 16 has an enlarged portion, e.g., a knot 41, that serves as the end point of the stroke for integrally connecting the tether 16 to the first portion 28 of the adjustment device of the active anchor 12, such that relative rotation of the two portions 28, 29 of the adjustment device causes the proximal portion of the tether 16 to wind around the winding shaft 27. The inclusion of such a winding shaft 27 provides a winch system for adjusting the tension state of the tether. The winding shaft 27 may be provided as a single piece or may be integral with the first portion 28. First portion 28 preferably includes a termination region 17 integrally connectable to a portion of tether 16, such as a through-hole of a gauge comparable to that of tether 16. Second portion 29 can include a central channel 26 that receives tether 16. Preferably, central channel 26 of second portion 29 and termination region 17 of first portion 28 are offset from one another, i.e., not aligned, to allow for winding of tether 16 around winding shaft 27.

[0043] 9A and 9B, the tether 16 is secured to the terminal portion 17 of the anchor element 12 by forming a knot 41 in the proximal portion 31 of the tether 16. For example, as shown in FIGS. 9C and 9D, by opposing the action of the spring 30, the two portions 28, 29 of the anchor element 12 are released to allow them to rotate relative to one another, wrapping around the proximal portion 31 of the tether 16 and thereby tensioning the tether 16. For example, as shown in FIGS. 9E and 9F, the action of the spring 30 couples the two portions 28, 29 of the anchor element 12 to one another in a predetermined mutual configuration. Preferably, the winch adjustment system includes one or more radial teeth 32 extending from the first portion 28 to be received in an annular groove 33 in the second portion 29 of the anchor element 12 when the action of the spring 30 is opposed. When the action of the spring 30 is not opposed, the one or more radial teeth 32 abut against a circumferential abutment portion 34 which prevents the portions 28, 29 from rotating relative to one another.

[0044] For example, as shown in FIG. 8 , a preload spring 30 can be included between the two portions 28, 29 of the anchor element 12. Preferably, the spring 30 separates the two portions 28, 29 of the anchor element 12 from one another and connects them in a mutual configuration. By opposing the action of the spring 30, the configuration can be unlocked and one portion 28 or 29 of the two portions 28, 29 can be rotated relative to the other portion 28 or 29 to wind the tether 16 onto the winding shaft 27. The winch adjustment system formed by the two portions 28, 29 of the anchor element 12 can include a ratchet mechanism adapted to allow relative rotation of the two portions 28, 29 in a single rotational direction.

[0045] The operating interface 42 may include a ratchet mechanism adapted to allow rotation of the operating key 48 relative to the shaft 49 in a single rotational direction.

[0046] According to one embodiment, the two portions 28, 29 are rotatably associated with one another by a threaded connection. For example, as shown in Figures 10A, 10B, and 11, portion 29 includes a passage channel 26 adapted to receive tether 16 disposed on externally threaded element 37 via a clearance, thereby allowing the tether to slide relative to portion 29, and the other portion 28 includes a locking nut 36 that, when threaded onto externally threaded element 37, narrows the gauge of passage channel 26 and frictionally stops the sliding of tether 16 relative to externally threaded element 37 of portion 29.

[0047] According to a preferred embodiment, the active anchor 12 of the implantable device 10 comprises an anchor back 19 opposite the abutment portion 13, and the distal portion 3 of the tool 18 is removably connectable to the anchor back 19. When in an activated state, the anchor back 19 is adapted to remain outside the ventricle 11. The active anchor 12 thereby forms a kind of adjustment gate for the tension state of the tether 16 with the anchor back 19 located on the outer wall 4 of the heart 5, which can be reached by the access device 18 even after implantation of the implantable device 10, allowing the tension state of the tether 16 to be adjusted after implantation without requiring access into the heart 5.

[0048] According to a preferred embodiment, tool 18 further comprises an outer case 51 slidably associated with said shaft 49 such that distal portion 3 of tool 18 can protrude various distances distally from outer case 51. When in an operative state, outer case 51 of access device 18 is positioned so that its distal end is near outer wall 4 of heart 5, shaft 49 and adjustment key 48 can be advanced distally to engage active anchor 12 and adjust the tension state of tether 16.

[0049] According to a preferred embodiment, the tool 18 includes the operating key 48 rotatable within the longitudinally hollow shaft 49 and adapted to engage the first portion 28 of the active anchor, and the tool 18 includes one or more fingers 52 at the distal end of the shaft 49 extending distally, like a crenellation, for engaging the second portion 29 of the active anchor 12, e.g., in a snap-fit ​​manner. Preferably, the set of operating keys 48 and shafts 49 is movable back and forth relative to the case 51. An advancement control 53 can be included for moving the case 51 forward and / or backward relative to the set of operating keys 48 and shafts 49, e.g., formed by longitudinal slots 54 disposed on the case 51, which defines a plurality of seats 54-a, 54-b, 54-c adapted to receive radial pins 55 extending through the shafts 51 to lock the set of operating keys 48 and shafts 49 in position relative to the case of the access device 18. The seats 54-a, 54-b, 54-c are preferably aligned longitudinally of the tool 18. Integral to the shaft 49 may be an end-of-stroke pin 56 that forms a proximal abutment for the case 51.

[0050] The inclusion of such pins 55 and such slots 54 allows for mechanical visualization of the relative positions of the set of operating keys 48 and shafts 49 relative to the case 51 .

[0051] For example, as shown in FIGS. 20B and 20C, by advancing the operating key 48 and shaft 49 distally relative to the case 51, the pin 55 moves from the seat 54-b to the seat 54-c.

[0052] According to one embodiment, tool 18 includes a tether guide 57 adapted to guide proximal portion 31 of tether 16. For example, tether guide 57 includes a perforated plate 58 disposed on case 51, and holes 59 in perforated plate 58 of tether guide 57 receive the proximal portion of tether 16. By including the tether guide 57, it is possible to temporarily lock proximal portion 31 of tether 16 having a predetermined length in order to obtain the knot 41 or the enlarged portion 41 on proximal portion 31 of tether 16. Furthermore, by including the tether guide 57, it is possible to pre-assemble active anchor 12 to distal end 3 of tool 18. In other words, by including the tether guide 57, it is possible to provide assembly 1 having active anchor 12 of implantable device 10 pre-assembled on tool 18, avoiding assembling active anchor 12 on tool 18 during operation. For example, as shown in FIG. 21A, the proximal portion 31 of the tether 16 passes proximally through the active anchor 12, the tool 18, and exits through a hole 59. As shown in FIG. 21B, by activating the command 47, the diameter of the hole 59 decreases, frictionally locking the proximal portion 31 of the tether 16 into the hole 59. As shown in FIGS. 21C and 21D, a knot 41 or enlarged portion is made in the proximal portion 31 of the tether 16, and the portion of the tether 16 proximal to the knot 41 is severed. As shown in FIG. 21E, the command 47 is deactivated, and the cross section of the hole 59 allows the tether 16 and the knot 41 to pass through, thereby advancing the knot 41 distally until it abuts the terminal portion 17 of the active anchor 12. Including such a tether guide 57 also allows the tether 16 to remain close to the case 51.

[0053] According to one embodiment, the adjustment device for the active anchor 12 of the implantable device 10 includes an expandable element 38, such as an inflatable balloon. By expanding the expandable balloon 38, the terminal end portion 17, to which the tether 16 is fixed, moves away from the abutment portion 13 of the active anchor 12. The abutment portion 13 of the active anchor 12 can be included in the expandable element 38, which can be integrally connected to the terminal end portion 17 at a portion thereof. In this case, to adjust the tension state of the tether 16, the expandable element 38 needs to be expanded. This can be achieved by expanding the expandable element 38 using a percutaneous port 18' having a fluid communication duct with the expandable element 38. The fluid communication duct 48' thus functions as an adjustment key 48'. The percutaneous port 18' is provided with an expansion tank 39, such as a pouch that can be deformed when pressed, having an operating interface 42'. By applying pressure to the deformable pouch, which acts as the operating interface 42', inflation fluid is transferred from the expansion tank 39 to the expandable element 38, thereby tensioning the tether 16 by moving the tether terminal portion 17 away from the abutment portion 13 of the active anchor 12.

[0054] According to a preferred embodiment, the active anchor 12 comprises two slidably coupled portions 28, 29 that function as an adjustment device, allowing the tension state of the tether 16 to be adjusted by the relative distance between the two portions. According to a preferred embodiment, the two slidably coupled portions of the anchor element 12 can interlock with each other, acting as a locking device. A sliding coupling between the two portions 28, 29 can be included in addition to or instead of a rotatable coupling between the two portions 28, 29.

[0055] According to one embodiment, as shown in Figures 13A-13D, adjustment of the tension state of tether 16 can be performed by a cardiac catheter 45' having vascular access to deliver a forceps 60, such as an elastic clip 60, into the ventricle 11 to adjust the tension state of tether 16. This allows adjustment of the tension state of tether 16 to be performed by acting on active anchor 12 with tool 18 or by transcatheter movement performed with cardiac catheter 45'. Preferably, cardiac catheter 45' includes elastic clip 60 at its distal end, preferably removably connected to cardiac catheter 45, which is delivered into ventricle 11 to adjust the tension state of tether 16.

[0056] An alternative to adjusting the tension state of the tether 16 achieved by the active anchor 12 may include adjusting the tension state of the tether 16 achieved by a transcatheter approach.

[0057] According to a typical embodiment, an assembly 1 for reconstructing a patient's ventricle includes an implantable device 10 for reconstructing a ventricle including a tether 16, and a cardiac catheter 45' for adjusting the tension of the tether 16. The cardiac catheter 45' is preferably a vascular access catheter adapted to reach a ventricle 11, 21, e.g., the right ventricle 11, of the patient's heart 5 at its distal portion. The cardiac catheter 45' preferably includes a forceps 60 or clip 60 at its distal end for adjusting the tension of the tether 16 of the implantable device 10, as shown, for example, in FIGS. 13A-13D . The implantable device 10 preferably includes two opposing anchors at both ends of the tether 16. For example, the implantable device 10 is adapted to reconstruct a ventricle and repair a heart valve, e.g., tricuspid valve 15.

[0058] The above features, provided separately or together with one another in specific embodiments, make it possible to obtain devices and assemblies that simultaneously satisfy the above-mentioned contrasting requirements and the above-mentioned desired advantages, in particular: -allows for adjusting the tension state of the tether of an implantable device for reshaping a ventricle to repair a heart valve; -Adjustments can be made using transthoracic tools, at the proximal end of the transthoracic tool, allowing the tension of the tether to be adjusted by operating an operating interface located outside the patient's body; The transthoracic tool can also serve as a device for delivering an active anchor for the implantable device; - allows for adjustment of the tension state of the tether after implantation without requiring direct access to the ventricle; the active anchor forms an adjustable gate for the tether placed in the outer wall of the heart; -The active anchor acts as a device for adjusting the tension state of the tether, - Allows heart valves to be repaired by approximating ventricular structures such as the ventricular wall, interventricular septum, papillary muscles, or a combination of the above, i.e. by bringing them closer together.

[0059] Those skilled in the art can make many modifications and adaptations to the above-described embodiments or can substitute functionally equivalent elements with other elements to meet their fortuitous needs without departing from the scope of the appended claims. [Explanation of symbols]

[0060] 1 Assembly 2 Proximal part of the tool 3. Distal part of the tool 4. Outer wall of the heart 5. Heart 6 Papillary muscles 7 Ventricular septum 10 Implantable Devices 11 Right ventricle 12 Active anchor or first anchor 13 Contact part 15 Tricuspid valve 16 Tether 17 Termination section 18, 18' Tools 19 Anchor Back 21 Left ventricle 22 Second Anchor 23 Second abutment part 26 channels 27 Winding shaft 28 First part of the active anchor 29 Second part of the active anchor 30 spring 31 Proximal portion of tether 32 radial teeth 33 Annular groove 34 Circumferential contact part 35 Distal head of adjustment key 36 Nut 37 Male thread element 38 Extensible Elements 39 Expansion Tank 41 Tether knot or enlarged section 42, 42' adjustment key operation interface 45, 45' Vascular Catheter 46 Delivery Catheter 48, 48' adjustment key 49 Tool shaft 51 Tool Case 52 Distal finger of shaft 53 Advance Command 54 slots 54a~c Seat part 55 Radial pin 56 End of stroke 57 Tether guide device 58 Perforated plate 59 holes 60 forceps or clips

Claims

1. An assembly (1) for reshaping a patient's ventricle, comprising: an implantable device (10) for reshaping a cardiac ventricle comprising a tether (16); a non-implantable tool (18, 18') removably connectable to the implantable device (10) and having a proximal portion (2) and a distal portion (3) opposite the proximal portion (2); Equipped with The implantable device (10) further comprises an active anchor (12) adapted to be removably connected to the distal portion (3) of the tool (18, 18'), and a second anchor (22) on the opposite side of the tether (16) from the active anchor (12); The active anchor (12) comprises an abutment portion (13) adapted to abut against a structure of the ventricle; the active anchor (12) of the implantable device (10) comprises an adjustment device adapted to adjust the tension state of the tether (16), the adjustment of the tension state of the tether (16) being obtained by changing the effective length of the tether (16), i.e., the working length of the tether (16) between the two anchors (12, 22); the distal portion (3) of the tool (18, 18') comprises an adjustment key (48, 48') adapted to cooperate with the adjustment device of the active anchor (12); the proximal portion (2) of the tool (18, 18') comprises an operating interface (42, 42') operably connectable to the adjustment key (48, 48') for adjusting the tension state of the tether by acting on the operating interface of the proximal portion (2) of the tool (18, 18'); Assembly (1).

2. The tool (18, 18') also functions as a delivery tool for the active anchor (12) of the implantable device (10). Assembly (1) according to claim 1.

3. the tool (18, 18') is a transthoracic tool; Assembly (1) according to claim 1 or 2.

4. The proximal portion (31) of the tether (16) comprises an enlarged portion to stop the adjustment of the tension state of the tether (16). Assembly (1) according to any one of claims 1 to 3.

5. The adjustment device of the active anchor (12) of the implantable device (10) comprises two parts (28, 29) rotatably associated with each other. Assembly (1) according to any one of claims 1 to 4.

6. The tool (18, 18') further comprises a shaft (49) attached to the adjustment key (48, 48'), whereby the adjustment key (48, 48') and the shaft (49) are rotatably associated with each other; the adjustment key (48, 48') is integrally connectable to the first part (28) of the adjustment device of the active anchor (12); The shaft (49) is integrally connectable to the second part (29) of the adjustment device of the active anchor (12). Assembly (1) according to claim 5.

7. One of the two parts (28, 29) of the adjusting device (28 or 29) is integrally connectable to the tether (16). Assembly (1) according to claim 5 or 6.

8. One of the two sections (28, 29) (28 or 29) comprises a winding shaft for winding the tether (16). Assembly (1) according to claim 5, 6 or 7.

9. The two parts (28, 29) are rotatably associated with each other by a threaded connection. Assembly (1) according to any one of claims 5 to 8.

10. The adjustment device of the active anchor of the implantable device comprises an expandable element. Assembly (1) according to any one of claims 1 to 4.

11. the active anchor (12) of the implantable device (10) comprises an anchor back (19) opposite the abutment portion (13), and the distal portion (3) of the tool (18, 18') is removably connectable to the anchor back (19), and / or the anchor back (19) is adapted to remain outside the ventricle; Assembly (1) according to any one of claims 1 to 10.

12. The tool (18, 18') comprises an outer case (51) slidably associated with a shaft (49) such that the distal portion (3) of the tool (18, 18') can protrude distally from the outer case (51) at various distances. Assembly (1) according to any one of claims 1 to 11.

13. the tool (18, 18') comprises a tether guide (57) adapted to guide a proximal portion (31) of the tether (16) to enable pre-assembly of the active anchor (12) of the implantable device (10) on the tool (18, 18'); Assembly (1) according to any one of claims 1 to 12.

14. and a cardiac catheter (45, 45') for adjusting the tether (16), the cardiac catheter (45, 45') having an elastic clip (60) at its distal end for delivering the elastic clip into the cardiac chamber to adjust the tension state of the tether (16). Assembly (1) according to any one of claims 1 to 13.

15. a vascular catheter for delivering at least a portion of the implantable device (10); Assembly (1) according to any one of claims 1 to 14.

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