Devices and assemblies for repairing heart valves

Abstract

This relates to valve repair using an approach that involves relatively aligning the original ventricular structures. [Solution] An assembly 1 for reshaping a patient's ventricle, comprising an implantable device for reshaping a ventricle with a tether, and a non-implantable tool that is removably connectable and has a proximal portion 2 and a distal portion 3 on the opposite side thereof, wherein the implantable device further comprises an active anchor 12 that is removably connected to the tool, the active anchor 12 having a contact portion adapted to contact the structure of the ventricle, the active anchor 12 having a device for adjusting the tension state of the tether, the distal portion 3 of the tool having an adjustment key, and the proximal portion 2 of the tool having an operating interface connectable to the adjustment key for adjusting the tension state of the tether.

Description

Technical Field

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

[0002] In particular, the present invention relates to valve repair by an approach that includes bringing native ventricular structures relatively together.

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

Background Art

[0004] The native atrioventricular heart valve may be damaged and unable to effectively close. A typical type of damage is associated with structural changes in the dilated ventricle, and the muscular-fibrous ring that forms the passage opening may also be dilated. These changes cause the valve leaflets to be unable to position themselves in the closed position, inevitably causing a very undesirable backflow from the ventricle to the atrium and significantly limiting the effectiveness of the heart pump.

[0005] Typically, for the repair of an atrioventricular valve, such as the mitral valve, a hoop ring is implanted to reinforce the annulus to return it to its original shape, thereby bringing the free edge of the valve leaflets closer to the closed valve.

[0006] Devices that can be implanted via a catheter have also been proposed in the form of clips for capturing and bringing the free edges of the valve leaflets closer together, resulting in the formation of a double-orifice valve according to the example of the Alfieri suture.

[0007] A further known approach involves implanting devices for bringing the walls of the heart cavities (atrium and ventricle) closer together or for bringing the papillary muscles that form the tendon fixation structures closer together inside the ventricle.

[0008] For example, U.S. Patent Publication No. 2017-0086975 describes a solution involving securing a tether between two atrial walls near the valve to be repaired. A similar solution is also described in U.S. Patent Publication No. 2005-222488. U.S. Patent Publication No. 2007-203391 describes a tether for bringing ventricular walls closer together. For example, U.S. Patent Publication No. 2019-380699 describes a transcatheter implantable device in the left ventricle having a pair of rigid plates fixed lateral to the papillary muscle, i.e., on the side facing the ventricular wall, and a thread-like structure such as suture filaments extending between them.

[0009] All of the above-mentioned types of solutions are inherently unsuitable for allowing precise adjustments, particularly to the extent necessary to bring the ventricular walls together after implantation, and may involve the replacement of implantable devices.

[0010] U.S. Patent Application Publication No. 2019-0365539 describes the implantation of an accordion element coupled to two opposing ventricular walls into the right ventricle, the device being pre-pressurized with a spring to affect the coupled walls and keep them together. While advantageous in some respects, this solution carries the risk of excessively stressing the ventricular wall in the initial moments after implantation due to the elastic action exerted by the spring, effectively compressing the ventricular cavity. Furthermore, the coupling of the device to the inner wall of the heart may fail very early under the elastic action of the spring.

[0011] Therefore, there is a perceived need to provide solutions for repairing atrioventricular valves that exhibit improved effectiveness in both the short and long term. [Overview of the project]

[0012] The objective of the present invention is to eliminate the aforementioned drawbacks of known technologies.

[0013] These and other objectives are achieved by the assembly described in claim 1.

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

[0015] Further features and advantages of the present invention will become apparent from the description provided below of preferred exemplary embodiments, which are given as non-limiting examples, with reference to the accompanying drawings. [Brief explanation of the drawing]

[0016] [Figure 1] A schematic diagram shows an implantable device, according to one embodiment, when implanted in a patient. [Figure 2] A schematic diagram shows an assembly including a tool and an implantable device when implanted in a patient, according to one embodiment. [Figure 3] An unequal angle projection view of an embedded device according to one embodiment is shown. [Figure 4] An isotropic projection view of an assembly including a tool and an embedded device according to one embodiment is shown. [Figure 5A] Several steps for implanting an implantable device, depending on the possible operating method, are illustrated graphically. [Figure 5B] Several steps for implanting an implantable device, depending on the possible operating method, are illustrated graphically. [Figure 6] The possible steps for implanting an implantable device, depending on the available operating methods, are illustrated graphically. [Figure 7A] The following diagrammatically illustrates several steps of implanting an implantable device, following the steps shown in Figures 5A and 5B or 6, depending on the possible operating method. [Figure 7B] The following diagrammatically illustrates several steps of implanting an implantable device, following the steps shown in Figures 5A and 5B or 6, depending on the possible operating method. [Figure 7C] The following diagrammatically illustrates several steps of implanting an implantable device, following the steps shown in Figures 5A and 5B or 6, depending on the possible operating method. [Figure 8]An isometric view of a separated portion of a fixing element of an embedded device according to an embodiment. [Figure 9A] Diagrammatically and partially shows an adjustment sequence achievable by the fixing element of FIG. 8. [Figure 9B] Diagrammatically and partially shows an adjustment sequence achievable by the fixing element of FIG. 8. [Figure 9C] Diagrammatically and partially shows an adjustment sequence achievable by the fixing element of FIG. 8. [Figure 9D] Diagrammatically and partially shows an adjustment sequence achievable by the fixing element of FIG. 8. [Figure 9E] Diagrammatically and partially shows an adjustment sequence achievable by the fixing element of FIG. 8. [Figure 9F] Diagrammatically and partially shows an adjustment sequence achievable by the fixing element of FIG. 8. [Figure 10A] Shows an axonometric projection view having a separated portion of a fixing element according to an embodiment. [Figure 10B] Shows an axonometric projection view of the fixing element of FIG. 10A during a possible adjustment sequence. [Figure 11] Shows an axonometric projection view having an assembled portion of the fixing element of FIG. 10A locked to a tether. [Figure 12A] Diagrammatically shows an adjustment sequence according to an embodiment. [Figure 12B] Diagrammatically shows an adjustment sequence according to an embodiment. [Figure 13A] Diagrammatically shows an adjustment sequence according to an embodiment. [Figure 13B] Diagrammatically shows an adjustment sequence according to an embodiment. [Figure 13C] Diagrammatically shows an adjustment sequence according to an embodiment. [Figure 13D] Diagrammatically shows an adjustment sequence according to an embodiment. [Figure 14] Shows an axonometric projection view of an assembly according to an embodiment. [Figure 15]An isometric projection view showing a separated portion of an assembly according to one embodiment is shown. [Figure 16] An unequal-angle projection view and a cross-sectional view of a portion of an assembly according to one embodiment are shown. [Figure 17] An unequal-angle projection view and a cross-sectional view of a portion of an assembly according to one embodiment are shown. [Figure 18] An unequal projection view of a portion of an assembly according to one embodiment is shown. [Figure 19] An unequal-angle projection view and a cross-sectional view of a portion of an assembly according to one embodiment are shown. [Figure 20A] Several configurations of the vertical height adjustment device are shown. [Figure 20B] Several configurations of the vertical height adjustment device are shown. [Figure 20C] Several configurations of the vertical height adjustment device are shown. [Figure 21A] The following shows some steps in the adjustment sequence. [Figure 21B] The following shows some steps in the adjustment sequence. [Figure 21C] The following shows some steps in the adjustment sequence. [Figure 21D] The following shows some steps in the adjustment sequence. [Figure 21E] The following shows some steps in the adjustment sequence. [Modes for carrying out the invention]

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

[0018] The active anchor 12 comprises a contact portion 13 adapted to abut against the structures of the ventricles 11, 21. Preferably, the term “ventricular structure” means the wall of the heart that defines the ventricles or is located inside the ventricles, such as the outer wall 4 of the patient’s heart 5 or the papillary muscle 6 of the heart 5 or the interventricular septum 7 that defines the ventricular cavity. For example, the structure of ventricle 11 is the outer wall 4 of the patient’s heart 5 that defines the ventricular cavity 11, such that the contact 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 embedded in the patient's heart 5, if the active anchor 12 forms a crossing gate in the outer wall 4 of the heart 5, and the contact portion 13 of the active anchor 12 is outside the right ventricle 11 and in contact with 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 understand that an implantable device 10 can also be implanted in the left ventricle 21 to reshape the left ventricle 21 for the treatment of the mitral valve.

[0021] In a preferred embodiment, the implantable device 10 includes a second additional anchor 22 on the opposite side of the active anchor 12 to the body of the tether 16. Preferably, the tether 16 is fixed to the second additional anchor 22. In one embodiment, the second anchor 22 also includes a second contact portion 23 adapted to contact a second structure of the ventricle 11 opposite to the first structure of the ventricle 11 to which the active anchor 12 abuts, thereby the active anchor 12 and the second anchor 22 have their respective contact portions 13, 23 on opposite sides to each other, thereby allowing the tether 16 to exert a tensile force between the two anchors 12, 22, resulting in the reshaping of the ventricles 11, 21. In one embodiment, the second anchor 22 includes a portion, such as a hook, for connecting to the second ventricular structure. For example, the abutment portion 23 of the second anchor 22 is intended to abut the wall of the interventricular septum 7 facing the left ventricle 21, such that the second anchor 22 is located in the left ventricle 21, the first anchor 12 is located on the wall 4 of the heart 5, and the tether 16 extends from the first anchor 12 to the 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 embedded device 10 is equipped with an adjustment device adapted to adjust the tension state of the tether 16. Adjustment of the tension state of the tether 16 is preferably achieved 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. By adjusting the tension state of the tether 16, it becomes possible to adjust the tensile force between the two anchors 12, 22. By adjusting the tension state of the tether 16, it becomes possible to adjust the relative position of the two anchors 12, 22.

[0023] The tether 16, having an elastic element, can provide an elastic influence intended to bring the two anchors 12 and 22 closer together, or to move the two anchors 12 and 22 further apart.

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

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

[0026] According to a typical embodiment, the assembly 1 for reshaping a patient's ventricle includes at least one implantable device 10 according to any of the embodiments described above.

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

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

[0029] Advantageously, the distal portion 3 of the tool 18 includes an adjustment key 48 adapted to cooperate with the 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 may have a distal head 35 having a polygonal shape adapted to engage with the proximal portion of the active anchor 12 in order to perform the adjustment of the tension state of the tether 16.

[0030] More advantageously, the proximal portion 2 of the tool 18 includes an operating interface 42 operably connectable to the adjustment key 48 for adjusting the tension state 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 while adjusting the tension state 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, so that the tool 18 does not need to penetrate the inside of the patient's heart 5 to adjust the tension state of the tether 16.

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

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

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

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

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

[0036] For example, as shown in Figure 7A, after the second anchor 22 has been delivered to its respective implantation site, the tether 16 can extend through the ventricle 11.

[0037] For example, as shown in Figures 7B and 7C, the active anchor 12 is then 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 of the Tether 16 can be adjusted in various ways.

[0039] According to a preferred embodiment, the adjustment device for the active anchor 12 of the embedded device 10 comprises two parts 28, 29 that are rotatably linked to each other. This makes it possible to adjust the tension state of the tether 16 by rotating the two parts 28, 29 of the active anchor 12 relative to each other.

[0040] In 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 a first part 28 of the adjustment device of the active anchor 12, and the shaft 49 of the tool 18 is integrally connectable to a second part 29 of the adjustment device of the active anchor 12. This makes it possible to adjust the tension of the tether by rotation applied to the adjustment key 48, preferably the operating interface 42.

[0041] By including such a tool 18, it becomes possible to adjust the tension state of the tether 16 by rotating the operating interface 42, both during and, if necessary, after implantation of the implantable device 10, while avoiding the need to access the inside of the patient's heart 5.

[0042] According to one embodiment, one of the two parts 28, 29 of the adjustment device of the active anchor 12, either part 28 or 29, can be integrally connected to the tether 16. This makes it possible, for example, to wind the tether 16 around a winding shaft 27 which may be contained inside the active anchor 12. For example, according to the embodiment shown in Figures 9A to 9F, the proximal portion 31 of the tether 16 has an extended portion, such as a knot 41, which acts as the end of a stroke for integrally connecting the tether 16 to the first part 28 of the adjustment device of the active anchor 12, so that the relative rotation of the two parts 28, 29 of the adjustment device winds the proximal portion of the tether 16 around the winding shaft 27. By including such a winding shaft 27, a winch system for adjusting the tension state of the tether can be obtained. The winding shaft 27 may be provided as a single piece or may be integral with the first part 28. The first portion 28 preferably includes a terminal portion 17 that can be integrally connected to a portion of the tether 16, for example, a through-hole with a gauge equivalent to the gauge of the tether 16. The second portion 29 may include a central channel 26 for receiving the tether 16. Preferably, the central channel 26 of the second portion 29 and the terminal portion 17 of the first portion 28 are offset from each other, i.e., they are not on the axis, in order to wind the tether 16 around the winding shaft 27.

[0043] For example, as shown in Figures 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 Figures 9C and 9D, by resisting the action of the spring 30, the two portions 28, 29 of the anchor element 12 are released so that they can rotate relative to each other, wrapping around the proximal portion 31 of the tether 16 and consequently pulling the tether 16. For example, as shown in Figures 9E and 9F, the action of the spring 30 connects the two portions 28, 29 of the anchor element 12 to each other in a predetermined reciprocal configuration. Preferably, the winch adjustment system includes one or more radial teeth 32 extending from the first portion 28 so as to be received in an annular groove 33 of the second portion 29 of the anchor element 12 when the action of the spring 30 is reversed. When the action of the spring 30 is not reversed, one or more radial teeth 32 abut against circumferential contact portions 34 that prevent portions 28 and 29 from rotating relative to each other.

[0044] For example, as shown in Figure 8, a preload spring 30 can be included between the two parts 28, 29 of the anchor element 12. Preferably, the spring 30 separates the two parts 28, 29 of the anchor element 12 from each other and connects them in a reciprocal configuration. By counteracting the action of the spring 30, the configuration can be unlocked, and one part 28 or 29 of the two parts 28, 29 can be rotated relative to the other part 29 or 28 to wind the tether 16 around the winding shaft 27. The winch adjustment system formed by the two parts 28, 29 of the anchor element 12 may include a ratchet mechanism adapted to allow relative rotation of the two parts 28, 29 in a single direction of rotation.

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

[0046] According to one embodiment, the two parts 28, 29 are rotatably related to each other by a screw connection. For example, as shown in Figures 10A, 10B, and 11, part 29 includes a passage channel 26 adapted to receive a tether 16 positioned on a male threaded element 37 through a gap, thereby allowing the tether to slide against part 29, while the other part 28 includes a tightening nut 36 that, when screwed onto the male threaded element 37, narrows the gauge of the passage channel 26, thereby frictionally stopping the sliding of part 29 against the male threaded element 37.

[0047] According to a preferred embodiment, the active anchor 12 of the implantable device 10 includes an anchor back 19 on the opposite side of the contact portion 13, and the distal portion 3 of the tool 18 is detachably connectable to the anchor back 19. When in operation, the anchor back 19 is adapted to remain outside the ventricle 11. This allows the active anchor 12 to form a kind of adjustment gate for the tension state of the tether 16 having the anchor back 19 positioned on the outer wall 4 of the heart 5, thereby allowing the access device 18 to reach and adjust the tension state of the tether 16 after implantation without requiring access to the heart 5.

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

[0049] In a preferred embodiment, the tool 18 is rotatable inside the longitudinally hollow shaft 49 and includes the operating key 48 adapted to engage with a first portion 28 of the active anchor, and the tool 18 includes one or more fingers 52 extending distally, like a crenellation, to engage with a second portion 29 of the active anchor 12, for example, in a snap-fit ​​manner, at the distal end of the shaft 49. Preferably, the set of operating key 48 and shaft 49 is movable forward and backward relative to the case 51. A forward control unit 53 may be included to move the case 51 forward and / or backward relative to the set of operating key 48 and shaft 49, which is positioned on the case 51 and defines a plurality of seats 54-a, 54-b, 54-c adapted to receive radial pins 55 that extend the shaft 51 to lock the set of operating key 48 and shaft 49 in relative positions relative to the case of the access device 18, for example, formed by longitudinal slots 54. The seat portions 54-a, 54-b, and 54-c are preferably aligned in the longitudinal direction of the tool 18. It may include a stroke endpoint pin 56 which is integral with the shaft 49 and forms a proximal contact portion for the case 51.

[0050] By including such pins 55 and such slots 54, it becomes possible to mechanically visualize the relative positions of the set of operating keys 48 and shafts 49 relative to the case 51.

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

[0052] According to one embodiment, the tool 18 includes a tether guide device 57 adapted to guide the proximal portion 31 of the tether 16. For example, the tether guide device 57 includes a perforated plate 58 positioned on the case 51, and the holes 59 of the perforated plate 58 of the tether guide device 57 receive the proximal portion of the tether 16. By including the tether guide device 57, it is possible to temporarily lock the proximal portion 31 of the tether 16, having a predetermined length, in order to obtain the knot 41 or the enlarged portion 41 on the proximal portion 31 of the tether 16. Furthermore, by including the tether guide device 57, it is possible to pre-assemble the active anchor 12 on the distal end 3 of the tool 18, in other words, by including the tether guide device 57, it is possible to avoid assembling the active anchor 12 on the tool 18 during operation and to provide an assembly 1 having the active anchor 12 of the embedded device 10 pre-assembled on the tool 18. For example, as shown in Figure 21-A, the proximal portion 31 of the tether 16 passes proximal to the active anchor 12, tool 18, and exits through the hole 59. As shown in Figure 21-B, by activating the command 47, the diameter of the hole 59 is reduced, and the proximal portion 31 of the tether 16 is frictionally locked into the hole 59. As shown in Figures 21-C and 21-D, a knot 41 or enlarged portion is formed on the proximal portion 31 of the tether 16, and the portion of the tether 16 proximal to the knot 41 is cut. As shown in Figure 21-E, the command 47 is stopped, and the cross section of the hole 59 passes through the tether 16 and the knot 41, thereby advancing the knot 41 distally so that it abuts against the terminal portion 17 of the active anchor 12. Including such a tether guide device 57 also makes it possible to keep the tether 16 close to the case 51.

[0053] According to one embodiment, the adjustment device for the active anchor 12 of the embedded device 10 comprises an expandable element 38, for example, an inflatable balloon. By expanding the expandable balloon 38, the end portion 17 to which the tether 16 is attached is separated from the contact portion 13 of the active anchor 12. The contact portion 13 of the active anchor 12 may be included in the expandable element 38. The expandable element 38 can be integrally connected to the end portion 17 in part. In this case, it is necessary to inflate the expandable element 38 in order to adjust the tension state of the tether 16, and the inflation of the expandable element 38 can be achieved by inflating it using a transcutaneous port 18' having a fluid communication duct with the expandable element 38, so that the fluid communication duct 48' functions as an adjustment key 48', and the transcutaneous port 18' is provided with an inflation tank 39, for example, a pouch that is deformable when pressed, having an operating interface 42'. By applying pressure to the deformable pouch acting as the operating interface 42', the expanding fluid moves from the expansion tank 39 to the expandable element 38, thereby allowing the tether 16 to be pulled by separating the tether end portion 17 from the contact portion 13 of the active anchor 12.

[0054] In a preferred embodiment, the active anchor 12 comprises two slidably coupled parts 28, 29, such that the tension state of a tether 16, which functions as an adjustment device, can be adjusted by the relative distance between the two parts. In a preferred embodiment, the two slidably coupled parts of the anchor element 12 can act as a locking device and interlock with each other. The sliding coupling between the two parts 28, 29 may be included in addition to, or instead of, a rotatable coupling between the two parts 28, 29.

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

[0056] Instead of adjusting the tension state of the tether 16 obtained by the active anchor 12, the adjustment of the tension state of the tether 16 can be performed by a transcatheter approach.

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

[0058] The above features, provided separately or together in certain embodiments, make it possible to obtain devices and assemblies that simultaneously satisfy the above requirements, which are contrasting with each other, and the above desired advantages, in particular, - To repair heart valves, it is possible to adjust the tension state of the tether of the implantable device for reshaping the ventricle, -Adjustments can be made using transthoracic tools. - The proximal end of the transthoracic tool allows for adjustment of tether tension by operating a control interface located outside the patient's body. - Transthoracic tools can also function as devices for delivering active anchors for implantable devices. - Allows adjustment of the tether tension after implantation without requiring direct access to the ventricle. - The active anchor forms an adjustment gate for the tether placed on the outer wall of the heart. - The active anchor acts as a device to adjust the tension state of the tether. -By bringing the ventricular structures, such as the ventricular wall, interventricular septum, papillary muscle, and combinations thereof, closer together, it becomes possible to repair the heart valves.

[0059] A person skilled in the art can make many modifications and adaptations to the above-described embodiments, or replace functionally equivalent elements with other elements, without departing from the scope of the appended claims, to satisfy incidental needs. [Explanation of symbols]

[0060] 1 Assembly 2. Proximal part of the tool Distal part of the 3rd stage 4. Outer wall of the heart 5. Heart 6 Papillary muscles 7 Ventricular septum 10 Embedded device 11 Right ventricle 12 Active anchor or first anchor 13 Contact part 15 Tricuspid valve 16 Tether 17 Termination section 18, 18' Tool 19 Anchorback 21 Left ventricle 22 The second anchor 23 Second contact portion 26 channels 27-wound shaft 28 The first part of the active anchor 29 The second part of the active anchor 30 springs 31. Proximal part of the tether 32 radial teeth 33 Ring groove 34 Circumferential contact part 35. Distal head of the adjustment key 36 nuts 37 Male thread element 38 Extensible Elements 39 Expansion Tank 41. Tether knot or extension 42, 42' Adjustment key operation interface 45, 45' Vascular catheter 46 Delivery Catheter 48, 48' adjustment key 49 Tool Shafts 51 Tool Cases 52-shaft distal finger 53 Forward Command 54 slots 54a~c Seat part 55 Radial pins 56 Stroke end point 57 Tethered guidance device 58 Perforated plate 59 holes 60 forceps or clips

Claims

1. An assembly (1) for reshaping a patient's ventricle, An implantable device (10) for reshaping a ventricle equipped with a tether (16), A non-implantable tool (18, 18') is detachably connected to the implantable device (10) and has a proximal portion (2) and a distal portion (3) opposite to 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) opposite the active anchor (12) relative to the tether (16), The active anchor (12) includes a contact portion (13) adapted to contact the structure of the ventricle, The active anchor (12) of the embedded device (10) is equipped with an adjustment device adapted to adjust the tension state of the tether (16), which is preferably achieved 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') is provided with adjustment keys (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') which is operably connected to the adjustment key (48, 48') to adjust the tension of the tether by acting on the operating interface of the proximal portion (2) of the tool (18, 18'). Assembly (1).

2. The tools (18, 18') also function as delivery tools for the active anchor (12) of the implantable device (10). The assembly (1) according to claim 1.

3. The aforementioned tools (18, 18') are transthoracic tools. The assembly (1) according to claim 1 or 2.

4. The proximal portion (31) of the tether (16) includes an enlarged portion, for example, a knot (41), to stop the adjustment of the tension of the tether (16). The assembly (1) according to any one of claims 1 to 3.

5. The adjustment device of the active anchor (12) of the embedded device (10) comprises two parts (28, 29) that are rotatably linked to each other. The 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'), thereby rotatably relating the adjustment key (48, 48') and the shaft (49) to each other. The adjustment keys (48, 48') can be integrally connected to the first part (28) of the adjustment device of the active anchor (12), The shaft (49) is integrally connectable to the second portion (29) of the adjustment device of the active anchor (12). The assembly (1) according to claim 5.

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

8. One of the two parts (28, 29) (28 or 29) is provided with a winding shaft for winding the tether (16), The assembly (1) according to claim 5, 6, or 7.

9. The two parts (28, 29) are rotatably connected to each other by a screw connection. The assembly (1) according to any one of claims 5 to 8.

10. The adjustment device of the active anchor (12) of the embedded device (10) comprises an expandable element (38), for example, an inflatable balloon. The assembly (1) according to any one of claims 1 to 4.

11. The active anchor (12) of the implantable device (10) is provided with an anchor back (19) on the opposite side of the contact 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 fitted to remain outside the ventricle. The assembly (1) according to any one of claims 1 to 10.

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

13. The tool (18, 18') includes a tether guide device (57) adapted to guide the proximal portion (31) of the tether (16) in order to enable the pre-assembly of the active anchor (12) of the embedded device (10) on the tool (18, 18'). The assembly (1) according to any one of claims 1 to 12.

14. The cardiac catheter (45, 45') for adjusting the tether (16) is further provided, and the cardiac catheter (45, 45') preferably has an elastic clip (60) at its distal end to deliver it into the ventricle in order to adjust the tension state of the tether (16). The assembly (1) according to any one of claims 1 to 13.

15. The implantable device (10) is provided with a vascular catheter for delivering at least a portion of it. The assembly (1) according to any one of claims 1 to 14.

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