Annuloplasty device

Abstract

The present application discloses an annuloplasty device comprising a first arcuate support, a second arcuate support, the first arcuate support comprising a first posterior curvature, the second arcuate support comprising a second posterior curvature, the first posterior curvature and the second posterior curvature bending about a central axis, the first rear bow and the second rear bow have respective first free ends and second free ends, the first rear bow and the second rear bow extend from the respective free ends and are connected together at an apex, and the first plane and the second plane are substantially perpendicular to the central axis. Whereby the first posterior curvature transitions to the second posterior curvature via an apex, where the apex is configured to be disposed at the first commissure of the heart valve. A related method is also disclosed.

Description

Technical Field

[0001] This invention generally relates to the field of heart valve replacement and repair. More specifically, this invention relates to an annulusoplasty device for positioning at the annulus of a heart valve. Background Technology

[0002] Diseased mitral and tricuspid valves often require replacement or repair. The leaflets or supporting tendons of the mitral and tricuspid valves may degenerate and weaken, or the annulus may dilate, leading to valvular regurgitation. Mitral and tricuspid valve replacement and repair are typically performed using annuloplasty rings, which are used to reduce the diameter of the annulus, or otherwise alter its geometry, or serve as a general support structure during valve replacement or repair surgery.

[0003] The problem with existing annuloplasty implants is that they fail to achieve reliable fixation at the annulus while adapting to the movement of the beating heart. That is, while implants can provide reliable fixation in specific situations, a trade-off is usually required to achieve optimal adaptation to cardiac motion. This means that the implant may, to some extent, impede those natural movements and / or may interact adversely with the surrounding anatomy at the implantation site over longer periods. Annuloplasty implants are designed to function year after year, so long-term stability in this regard is crucial. Another problem with existing devices stems from the aforementioned tendency to interfere with anatomy, leading to reduced tolerance for changes in these anatomy structures that adapt to the heart valve. Therefore, in addition to the aforementioned problems, existing implants have limited adaptability to changing anatomy. This, in turn, necessitates more meticulous customization of implants and / or procedures for specific cases, increasing complexity and overall surgical time. This poses a higher risk to patients and is therefore another problem with existing devices.

[0004] The aforementioned problems could have serious consequences for patients and the healthcare system. Patients face increased risks.

[0005] Therefore, improved valve annuloplasty devices are advantageous, and in particular, they can avoid more of the aforementioned problems and trade-offs, and especially improve the adaptation to valve anatomy to achieve reliable fixation during implantation while achieving long-term effects. Summary of the Invention

[0006] Therefore, by providing means according to the appended patent claims, examples of the present invention preferably seek to mitigate, alleviate, or eliminate one or more defects, disadvantages, or problems in the prior art, such as those described above, whether alone or in any combination.

[0007] According to a first aspect, a valve annuloplasty device is provided, comprising a first arcuate support and a second arcuate support, wherein the first arcuate support and the second arcuate support are configured to be disposed on opposite sides of the natural leaflets of a heart valve, wherein the first arcuate support includes a first posterior bow, the first posterior bow being configured to be disposed on the atrial side of the heart valve and adhering to its posterior region, wherein the second arcuate support includes a second posterior bow, the second posterior bow being configured to be disposed on the ventricular side of the heart valve and adhering to its posterior region, wherein the first posterior bow and the second posterior bow are curved about a central axis and extend in corresponding first and second planes substantially perpendicular to the central axis, wherein the first posterior bow and the second posterior bow have corresponding first and second free ends, the first posterior bow and the second posterior bow extending from their respective free ends and connecting together at an apex, thereby transitioning the first posterior bow to the second posterior bow via the apex, wherein the apex is configured to be disposed at a first commissure of the heart valve.

[0008] According to a second aspect, an annulusoplasty system is provided, comprising an annulusoplasty device according to a first aspect and a delivery device, wherein the delivery device is configured to connect with a first arcuate support and a second arcuate support and force the first arcuate support and the second arcuate support to separate such that the spacing distance (d) between them temporarily increases along a central axis, thereby presenting an expanded state of the annulusoplasty device, and wherein the delivery device is configured to disconnect from the first arcuate support and the second arcuate support such that the spacing distance (d) decreases and the annulusoplasty device transitions from an expanded state to a contracted state.

[0009] According to a third aspect, a method for repairing a defective heart valve is provided, comprising: positioning a first posterior bow of an annulus repair device on the atrial side of the heart valve to conform to its posterior region; and positioning a second posterior bow of the annulus repair device on the ventricular side of the heart valve to conform to its posterior region, wherein the first and second posterior bows are curved about a central axis and extend in corresponding first and second planes substantially perpendicular to the central axis, wherein the first and second posterior bows have corresponding first and second free ends, the first and second posterior bows extend from their respective free ends and join together at an apex, thereby transitioning the first posterior bow to the second posterior bow via the apex, the method comprising positioning the apex at a first juncture of the heart valve.

[0010] Other examples of the invention are defined in the dependent claims, wherein the features of the second and subsequent aspects of this disclosure are modified as necessary with reference to the features of the first aspect.

[0011] Some examples of this disclosure implement annulusoplasty devices that are easy to attach to heart valves.

[0012] Some examples disclosed herein enable more reliable fixation of annuloplasty devices to heart valves.

[0013] Some examples of this disclosure enable the annulusoplasty device to be fixed to the heart valve in a more time-efficient manner.

[0014] Some examples of implementations in this disclosure ensure the long-term function and position of the annulusoplasty device.

[0015] Some examples of this disclosure implement less complex fixation steps for annulusoplasty devices.

[0016] Some examples disclosed herein achieve the risk of damaging cardiac anatomy (such as valve annulus or valve leaflets).

[0017] Some examples of this disclosure demonstrate the adaptability of annulusoplasty devices to improve the anatomical structure of changes in heart valves.

[0018] It should be emphasized that, when used in this specification, the term "comprising" is intended to indicate the presence of the said feature, integral, step, or component, but does not exclude the presence or addition of one or more other features, integrals, steps, components, or combinations thereof. Attached Figure Description

[0019] Referring to the accompanying drawings, these and other aspects, features, and advantages of the present invention will become apparent and clear from the following description of embodiments of the invention, wherein: Figure 1a This is a top view schematic diagram based on an example annulusoplasty device; Figure 1b This is a side view schematic diagram based on an example annulusoplasty device; Figure 2a -b is a schematic diagram of an annulusoplasty device located on opposite sides of a heart valve, based on an example. Figure 3a -c is a schematic diagram of a first side view (a), a top view (b), and a second side view (c) of an example annulusoplasty device; Figure 4 This is a perspective view of an example annulusoplasty device; Figure 5 This is a side view schematic diagram based on an example annulusoplasty device; Figure 6a -b is a schematic side view of a valve annuloplasty apparatus according to an example of this disclosure; Figure 7a -b is a schematic side view of a valve annuloplasty apparatus according to an example of this disclosure; Figure 8This is a side view schematic diagram based on an example annulusoplasty device; Figure 9a -b is a schematic side view of a valve annuloplasty apparatus according to an example of this disclosure; Figure 10a -c is a schematic side view of a valve annuloplasty apparatus according to an example of this disclosure; Figure 11a This is a side view schematic diagram based on an example annulusoplasty device; Figure 11b This is a top view schematic diagram based on an example annulusoplasty device; Figure 12a -b is a schematic side view of a valve annuloplasty apparatus according to an example of this disclosure; Figure 13 This is a side view schematic diagram based on an example annulusoplasty device; Figure 14a -b is a perspective view showing details of an annulusoplasty apparatus according to an example of this disclosure; Figure 15a It is a flowchart illustrating a method for repairing a defective heart valve, based on an example. Figure 15b This is a flowchart illustrating a method for repairing a defective heart valve, based on an example. Detailed Implementation

[0020] Specific examples of the invention will now be described with reference to the accompanying drawings. However, the invention can be embodied in many different ways and should not be construed as limited to the examples set forth herein; rather, these examples are provided to make this disclosure thorough and complete, and to fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the drawings is not intended to limit the invention. In the drawings, the same numerals denote the same elements.

[0021] The following description focuses on embodiments of the invention, which are suitable for heart valve implants, such as annuloplasty rings. However, it should be understood that the invention is not limited to this application, but can be applied to many other annuloplasty implants and heart valve implants, including, for example, replacement valves and other implantable medical devices.

[0022] Figure 1a -b schematically illustrates an example of annulusoplasty apparatus 100 in top and side views, including a first arcuate support 101 and a second arcuate support 102. The first arcuate support 101 and the second arcuate support 102 are configured to be arranged on opposite sides of the natural heart valve leaflets 301 of the heart valve. Figure 2a-b illustrates an example where a first arcuate support 101 is disposed on a first side of the heart valve, and a second arcuate support 102 is disposed on a second side of the heart valve opposite to the first side. The aforementioned first side may be the atrial side of the heart valve (…). Figure 2a The second side mentioned above can be the ventricular side of the heart valve. Figure 2b The heart valve can be a mitral valve. Therefore, the first arcuate support 101 includes a first posterior bow 103, configured to be disposed on the atrial side of the heart valve. The first posterior bow 103 has an arcuate extension and is configured to conform to the posterior region (P) of the heart valve, i.e., along the posterior leaflet. The second arcuate support 102 includes a second posterior bow 104, configured to be disposed on the ventricular side of the heart valve and conform to the posterior region (P) of the heart valve, the second posterior bow having an arcuate extension. Typically, the posterior side (P) of the heart valve can be considered as the arcuate portion of the valve, extending from the anterior side (A) (i.e., the anterior leaflet), with a curvature less than the posterior arcuate portion, see, for example... Figure 2a .

[0023] The first rear bend 103 and the second rear bend 104 bend about the central axis 105 and extend in corresponding first plane 101' and second plane 102' that are substantially perpendicular to the central axis 105. Figure 1a The top view shows an example of a first rear bow 103 and a second rear bow 104 that bends around a central axis 105. Figure 1b The side view shows the corresponding planes 101', 102', in which the first rear bow 103 and the second rear bow 104 extend. Figure 3b and 3c Another example is shown of a first rear bow 103 and a second rear bow 104 that are bent (i.e., in a bent configuration) about a central axis 105. The first rear bow 103 and the second rear bow 104 are arranged in a bent configuration at least when the material forming the device 100 is in a relaxed state (i.e., no external force is acting on the device 100).

[0024] The first rear bow 103 and the second rear bow 104 have corresponding first free ends 106 and second free ends 107, such as, for example Figure 1a -b is shown schematically. The first free end 106 and the second free end 107 are configured to be arranged on corresponding opposite sides of the heart valve leaflet 301, such as, for example Figure 2a As shown in -b. The first rear bow 103 and the second rear bow 104 extend from their respective free ends 106 and 107 and connect at the vertex 108, thereby transitioning the first rear bow 103 to the second rear bow 104 via the vertex 108, as shown in -b. Figure 1a-b, 3a, and 3c are schematically shown. Vertex 108 is configured to be located at the first commissure 302 of the heart valve, as shown... Figure 2a As shown. Although Figure 2a An example is shown in which vertex 108 is arranged through the junction indicated by reference numeral 302, but it should be understood that in some examples the valvular angioplasty device 100 may be flipped so that vertex 108 is arranged through the opposite junction indicated by reference numeral 303.

[0025] Therefore, when positioned and implanted at the heart valve, the apex 108 of the annulusoplasty device 100 can extend through the first junction 302, such that a first posterior bend 103 extends through the first junction 302 to a second posterior bend 104. The first posterior bend 103 and the second posterior bend 104 can be curved to conform to the corresponding curved extensions of the heart valve annulus along the posterior side of the heart valve. Thus, in the implanted state, the first posterior bend 103 and the second posterior bend 104 can also present a curved configuration. The annulusoplasty device 100 may include a shape memory material such that after delivery from a catheter (not shown) to the target site at the heart valve (temporarily confined to an elongated configuration within such a catheter), the annulusoplasty device 100 re-presents a curved configuration. The annulusoplasty device 100 may include a shape memory material, such as nitinol, or other suitable biocompatible alloy, which can be heat-formed into a defined shape (i.e., a defined relaxed shape) without external force during a heat treatment process. Alternatively, the device 100 may maintain a curved configuration upon delivery to the target site, in which case it may be implanted at the target site, for example, through an intercostal incision or through open-chest surgery. The relevant advantages described in this disclosure and with respect to the various examples are applicable to these variations of the device 100.

[0026] During implantation, the annulusoplasty device 100 can be held or fixed at the heart valve by clamping the tissue of the valve leaflet 301 between the first posterior bend 103 and the second posterior bend 104, i.e., by applying a force parallel to the central axis 105. Therefore, the interval (d) between the first posterior bend 103 and the second posterior bend 104 can be selected (see example...). Figure 3c This allows for tissue clamping during implantation. Alternatively or in combination, the annulusoplasty device 100 can be secured to the heart valve via sutures (not shown) and / or retention units 115, 115', as referenced below. Figure 7a -b and 8 further explain.

[0027] Figure 4This is a perspective view of an example of annular plasty device 100. A first posterior bow 103 and a second posterior bow 104 are connected by a vertex 108 and extend from the vertex toward the free ends 106, 107 with corresponding curved configurations. (Refer to the above example...) Figure 2a As described in section -b, the first posterior bow 103 and the second posterior bow 104 are connected at apex 108, with the apex configured to be positioned at the commissure 302 of the heart valve. This achieves secure fixation along the posterior region (P) of the heart valve at the valve annulus, while minimizing interference with the anterior (A) anatomical structures, as no structures may be implanted on the atrial and ventricular sides of the anterior (A). The anterior (A) of the mitral valve faces the aorta and the associated aortic valve. In some cases, it has been observed that mitral valve dilation can be advantageously reversed by reshaping the valve annulus along the posterior (P), since dilation towards the anterior (A) and aortic outflow tract may be less pronounced in comparison. The annuloplasty device 100 is particularly advantageous in such cases because the annulus can be reshaped into a modified shape along the first posterior curve 103 and the second posterior curve 104, and the modified tissue shape can be secured by any of the aforementioned mechanisms, such as by clamping the valve tissue between the first posterior curve 103 and the second posterior curve 104 and / or by retaining units 115, 115' and / or sutures. This annuloplasty can be performed while avoiding any implanted structures along the anterior side (A), which promotes the natural movement of the heart valve and reduces the risks that may be associated with securing units (e.g., sutures) along the anterior side (A). Therefore, by avoiding any repetitive interference along the anterior side (A), the risk of long-term tissue damage can be reduced as the leaflets move with the beating heart. Reducing the length of the annuloplasty device 100 that needs to be secured also enables a more time-efficient implantation procedure, as the number of sutures can be reduced, for example.

[0028] As described above, connecting the first posterior bend 103 and the second posterior bend 104 at apex 108, with the apex positioned at the commissure 302 of the heart valve, further optimizes compliance with variations in valve anatomy by minimizing interference with the anatomical structure. For example, it can accommodate greater variations in valve geometry and dynamics without interfering with the annuloplasty device 100. This also allows for an increased range of valve sizes compliant with a specific size of the annuloplasty device 100. Consequently, the annuloplasty device 100 achieves better adaptability and increased tolerance to variations during the actual implantation procedure.

[0029] Therefore, regarding the benefits of facilitating implantation and improving long-term outcomes, the annulusoplasty device 100 enables an effective annulusoplasty procedure while still achieving stable and secure fixation of the valve annulus in a modified shape, wherein the valve leaflets can mate as intended.

[0030] The annulusoplasty device 100 may be generally C-shaped in the first plane 101' or the second plane 102', such as, for example Figure 1a and 3b As shown in the top view, the first arcuate support 101 or its first rear bow 103 may extend in a generally C-shape between the first free end 106 and the apex 108. The second arcuate support 102 or its second rear bow 104 may extend in a generally C-shape between the second free end 107 and the apex 108. The aforementioned generally C-shape of the first arcuate support 101 and the second arcuate support 102 can be shaped to follow the curvature of the valve annulus along the posterior side of the heart valve. This provides an effective adaptation of the valve annulus shape to the anatomy of the heart valve for reliable fixation.

[0031] Vertex 108 may extend in a curved shape between the first rear bow 103 and the second rear bow 104, such as, for example Figure 4 Perspective view or Figure 5 The side view is schematically shown. Therefore, the apex 108 provides a smooth transition between the first rear bend 103 and the second rear bend 104, reducing the risk of tissue damage at the junction 302 as the apex 108 is positioned across the junction 302. This results in improved long-term performance and reliability.

[0032] The first arc-shaped support 101 may include an extension 109 from the vertex 108 to the third free end 110, such as Figure 1a The example is schematically illustrated. Extension 109 can provide additional support for tissue, for example, on the atrial side of a heart valve. Even with the extension 109 for support, apex 108 can extend in a curved shape between a first rear bend 103 and a second rear bend 104, as described above. First arcuate support 101 can extend in a generally C-shape between a first free end 106 and an opposing third free end 110, as shown in the example. Figure 1a As shown.

[0033] The first rear curve 103 may overlap with the second rear curve 104 in either the first plane 101' or the second plane 102'. In one example, the first rear curve 103 may extend from the central axis 105 with substantially the same radius (R) as the second rear curve 104, such as... Figure 3b As shown in the example. This achieves an adaptation favorable to the anatomical structure in some applications. The valve tissue can be effectively clamped between the first posterior arch 103 and the second posterior arch 104. In another example, the radius (R) to the central axis 105 can be different between the first posterior arch 103 and the second posterior arch 104, but overlap still exists. Figure 1aAn example is shown where the aforementioned radii (R) differ, for example, by slight variation, but in the top view, i.e., in the extension of planes 101', 102', there is still overlap between the first posterior bow 103 and the second posterior bow 104. In one example, the radius (R) of the second posterior bow 104 configured to be arranged in the ventricle may be larger than the radius (R) of the first posterior bow 103, but they still overlap. This achieves an adaptation favorable to the anatomical structures on the ventricular and atrial sides, while enabling tissue to be clamped between the first posterior bow 103 and the second posterior bow 104.

[0034] The first free end 106 and / or the second free end 107 may include at least partially spherical shapes 111, 111' for non-invasive tissue apposition, such as, for example Figure 4 As illustrated schematically, when the annulusoplasty device 100 is positioned at the heart valve, these blunt free ends 106, 107 reduce the risk of damage to surrounding tissues.

[0035] The first free end 106 may extend from the first plane 101' at an angle (a1), such as Figure 5 The side view is schematically shown. Therefore, in the direction toward the central axis 105, the first free end 106 can be tilted upwards away from the second support 102. When the first support 101 is placed in the atrium, the tilted first free end 106 facilitates easy engagement of the delivery device (not shown) with the first free end 106 in certain situations, thereby enabling easy manipulation and deployment of the annulusoplasty device 100. The upward tilt of the first free end 106 can further minimize the risk of tissue exposure at the annulus to the tip of the first free end 106. Tissue can instead be exposed to the smoother curvature of the first support 101.

[0036] Alternatively or additionally, the second free end 107 may extend from the second plane 102' at an angle (a2). Figure 5 An example is shown where the second free end 107 is inclined downwards away from the first support 102 in a direction opposite to the central axis 105. Figure 5 The central axis 105 extends vertically upward from the second support 102 to the first support 101. The downward inclination of the second free end 107 facilitates its insertion into the junction 302. Therefore, when the second support 102 of the annulusoplasty device 100 is to be inserted through the valve, the second free end 107 can more easily engage with the junction 302. Angles (a1, a2) can be in the range of 5-15 degrees with the corresponding planes 101', 102' to achieve the above advantages. Angles (a1, a2) of approximately 10 degrees with the corresponding planes 101', 102' allow for particularly advantageous positioning of the annulusoplasty device 100 while avoiding interference with surrounding tissues.

[0037] The annular plasty device 100 may include a cover 112 disposed on at least a portion of the first arcuate support 101, such as Figure 6a As shown schematically. Alternatively or additionally, the annulusoplasty device 100 may include a cover 112' disposed on at least a portion of the second arcuate support 102, such as Figure 6b As illustrated schematically, the annulusoplasty implant 100 may include a shape memory material (i.e., the material forming the first arcuate support 101 and / or the second arcuate support 102) as an inner core and outer covers 112, 112' arranged radially outside the inner core material to cover at least a portion of the inner core. Therefore, the outer covers 112, 112' may be elastic to conform to the inner core during movement of the shape memory material (e.g., from an elongated delivery configuration within a delivery catheter to a curved configuration in the implanted state).

[0038] Covers 112, 112' may include materials with surface properties to promote endothelialization and inward cell growth on the annulusoplasty device 100. For example, covers 112, 112' may have a more porous surface than the surfaces of the first arcuate support 101 and / or the second arcuate support 102, which promotes cell growth on the annulusoplasty device 100. Covers 112, 112' may include a mesh structure or any structure containing irregular, wavy, porous, or other non-flat surfaces to promote endothelialization. Covers 112, 112' may include a woven fabric or polymer.

[0039] Covers 112, 112' can be configured to be passed through by fastening units such as sutures and clips for securing the annulusoplasty device 100 to the tissue. Covers 112, 112' can be arranged around the entire length of the first arcuate support 101 and the second arcuate support 102.

[0040] The cover 112 can be attached to at least one fixing point 113, 113', at least one fixing point 113, 113' is arranged at the first arc-shaped support 101. Figure 1a , 4 Figures 5 and 6 show examples of fixing points 113, 113' for the cover 112 (the cover 112 is omitted from the figures for clarity). Alternatively or additionally, the cover 112' may be attached to at least one fixing point 114, 114', at least one fixing point 114, 114' being arranged at the second arcuate support 102, as shown in Figure 5. Figure 4 and Figure 5 As further shown, fixing points 113, 113', 114, 114' may include grooves, protrusions or through holes in the corresponding first arcuate support 101 and / or second arcuate support 102.

[0041] The annulusoplasty device 100 may include a holding unit 115 arranged along the first arcuate support 101, such as... Figure 7a -b and 8 are schematically illustrated. Alternatively or additionally, the annular flap repair device 100 may include a retaining unit 115' arranged along the second arcuate support 102, as shown in Figures 1-b and 8. Figure 7a and 8 As further shown in the diagram, retaining units 115 and 115' securely hold the annulusoplasty device 100 at the annulus of the heart valve. Retaining units 115 and 115' can extend along the central axis 105 in opposite directions from corresponding first arcuate supports 101 and second arcuate supports 102 to engage tissue from opposite sides of the heart valve, thereby generating a strong retaining force. Retaining units 115, 115' can deflect within a delivery catheter (not shown) and are exposed or unfolded to engage tissue once the annulusoplasty device 100 is extended from the delivery catheter.

[0042] The annulusoplasty device 100 may include supports 116, 116', which are arranged around at least a portion of the first arcuate support 101 and / or the second arcuate support 102, such as Figure 7a -b is schematically shown. The supports 116, 116' may include corresponding retaining units 115, 115'. The retaining units 115, 115' are fixed relative to the supports 116, 116', and the supports 116, 116' are fixed relative to the first arcuate support 101 and / or the second arcuate support 102, with the supports 116, 116' arranged on the arcuate supports 101, 102. Therefore, by arranging the supports 116, 116' around at least a portion of the first arcuate support 101 and / or the second arcuate support 102, the annulusoplasty device 100 is anchored to the valve tissue via the retaining units 115, 115'. Thus, by utilizing the supports 116, 116' as intermediate fixing structures for the retaining units 115, 115', the first arcuate support 101 and / or the second arcuate support 102 are provided with a robust anchoring mechanism. This achieves effective anchoring of the annulusoplasty device 100 at the heart valve, thanks to the robust and reliable fixation mechanism provided by the stents 116, 116' and the retaining units 115, 115' to which they are fixed.

[0043] It should be understood that, depending on the specific implantation site, the annulusoplasty device 100 may include a varying number of stents 116, 116'. The mesh or frame of the stents 116, 116' can be formed by laser-cutting tubular material (e.g., nitinol or other biocompatible metal alloys) and then pushed onto the first arcuate support 101 and / or the second arcuate support 102. Thus, the stents 116, 116' have a hollow interior to accommodate the first arcuate support 101 and / or the second arcuate support 102. Retention units 115, 115' can be formed from the material of the stents 116, 116', thereby integrating the retention units 115, 115' with the stents 116, 116'.

[0044] The supports 116 and 116' can be radially retractable in the radial direction (r), such that the supports 116 and 116' apply force to the first arcuate support 101 and / or the second arcuate support 102, with the radial direction perpendicular to the longitudinal direction (L) of the supports 116 and 116'. The radial direction (R) and longitudinal direction (L) of the supports 116 and 116' are in... Figure 7b The diagram illustrates this. Therefore, supports 116, 116' can be in a fixed position relative to the first arcuate support 101 and / or the second arcuate support 102 because the aforementioned forces generate friction between supports 116, 116' and the first arcuate support 101 and / or the second arcuate support 102. Therefore, the frame of supports 116, 116' can be cut to allow movement in the radial direction (r), i.e., allowing the support elements of the frame to move relative to each other, such that the diameter of supports 116, 116' is variable.

[0045] The supports 116 and 116' are elastically expandable in the radial direction (r), allowing them to expand into a radially stretched state. Then, the supports 116 and 116' can tend towards a relaxed, contracted state with an inner diameter smaller than that in the radially stretched state. The inner diameter in the radially stretched state can be greater than or equal to the outer diameter of the first arcuate support 101 and / or the second arcuate support 102. Therefore, when in the radially stretched state, the supports 116 and 116' can be positioned on the first arcuate support 101 and / or the second arcuate support 102. Consequently, the supports 116 and 116' will tend towards a relaxed, contracted state with a reduced inner diameter, and the aforementioned force will be applied accordingly to the first arcuate support 101 and / or the second arcuate support 102. This facilitates easy fixation of the positions of the supports 116 and 116' relative to the first arcuate support 101 and / or the second arcuate support 102.

[0046] The supports 116 and 116' can apply force to the covers 112 and 112', causing the covers 112 and 112' to be clamped between the supports 116 and 116' and the first arc-shaped support 101 and / or the second arc-shaped support 102, such as... Figure 7b As shown in the schematic diagram, the covers 112 and 112' are clamped between the brackets 116 and 116' and the first arc-shaped support 101 and / or the second arc-shaped support 102, thus achieving a firm fixation of the positions of the covers 112 and 112' and the brackets 116 and 116' relative to the first arc-shaped support 101 and / or the second arc-shaped support 102. Therefore, when the covers 112 and 112' are arranged around the first arc-shaped support 101 and / or the second arc-shaped support 102, the brackets 116 and 116' tend to have an inner diameter smaller than the outer diameter of the covers 112 and 112', so that a radially inward force is applied and the covers 112 and 112' are clamped against the outer surface of the first arc-shaped support 101 and / or the second arc-shaped support 102. If the supports 116 and 116' are formed of a temperature-activated shape memory material, then when the supports 116 and 116' are heated to body temperature, the supports 116 and 116' can increase the aforementioned radially inward force, which further enhances the strength of the supports 116 and 116' fixed relative to the first arcuate support 101 and / or the second arcuate support 102.

[0047] Figure 8 The diagram illustrates an example where retaining units 115, 115' are directly fixed to the first arcuate support 101 and / or the second arcuate support 102, for example, by welding or bonding materials. Retaining units 115, 115' can also be provided by machining and shaping the materials forming the first arcuate support 101 and / or the second arcuate support 102.

[0048] As described above, the annulusoplasty device 100 may include a shape memory material having an elongated delivery configuration for travel in a catheter (not shown) and a predetermined arcuate shape for positioning at the annulus of the heart valve, i.e., when ejected from the delivery catheter. Furthermore, the shape memory material may be configured to activate such that the spacing (d) between the first arcuate support 101 and the second arcuate support 102 decreases, thereby clamping valve tissue when positioned on opposite sides of the heart valve. Figure 9a -b illustrates an example where, when the shape memory material of the first arcuate support 101 and / or the second arcuate support 102 is activated, the spacing distance (d) decreases as the first arcuate support 101 and the second arcuate support 102 move closer to each other. That is, the first arcuate support 101 and the second arcuate support 102 move closer to each other. Figure 9a The position shown changes to Figure 9bThe position shown transitions from an expanded state to a contracted state. In one example, the first arc-shaped support 101 and the second arc-shaped support 102 can present an angle (v) in the expanded state, as shown... Figure 9a As illustrated, this angle subsequently decreases during the contraction phase, as... Figure 9b As shown. It is also conceivable that the first arcuate support 101 and the second arcuate support 102 remain substantially parallel in the expanded state, for example, by extending the length of the vertex 108 in the direction of the central axis 105, rather than increasing the angle (v). In this case, the length of the vertex 108 in the direction of the central axis 105 can be reduced in the contracted state. In another example, the expanded state can be achieved by a combination of increasing the angle (v) and increasing the length of the vertex 108.

[0049] The shape memory material can be configured to activate in response to setting the temperature of at least one of the first arcuate support 101 and the second arcuate support 102 to an activation temperature. It is conceivable that, when disposed in a delivery catheter (not shown), the annulusoplasty device 100 can be maintained at a defined temperature, for example, below the activation temperature. Subsequently, when the annulusoplasty device 100 is ejected from the delivery catheter and exposed to warm tissue, the activation temperature can be reached, causing the first arcuate support 101 and the second arcuate support 102 to press against each other. The activation temperature can be close to body temperature, for example, slightly below body temperature, so that the annulusoplasty device 100 requires a longer time to reach the activation temperature when exposed to heat from the body. Therefore, the annulusoplasty device 100 can be positioned on opposite sides of the heart valve in a curved or arcuate configuration before the spacing distance (d) is further reduced to clamp the valve tissue. This allows the annulusoplasty device 100 to be easily positioned on opposite sides of the heart valve in an expanded state before the annulusoplasty device 100 is in a contracted state to clamp the valve tissue. In another example, the delivery catheter can be used as a thermal barrier to further delay the heating of the annulusoplasty device 100, and / or a cooling medium can be circulated in the catheter to maintain the temperature of the annulusoplasty device 100 below the activation temperature.

[0050] Figure 10a -c illustrates a valve annuloplasty system 400, including the valve annuloplasty device 100 and delivery device 401 as described above. The delivery device 401 is configured to connect with a first arcuate support 101 and a second arcuate support 102, and to force the first arcuate support 101 and the second arcuate support 102 apart, such that the distance (d) between them is temporarily increased along the central axis 105. Figure 10a This is a schematic diagram showing the engagement of the delivery device 401 with the first arc-shaped support 101 and the second arc-shaped support 102, and then as follows... Figure 10bThe schematic diagram forces the first arcuate support 101 and the second arcuate support 102 further apart. Therefore, the annulusoplasty device 100 is in an expanded state to facilitate positioning on opposite sides of the heart valve. The delivery device 401 is configured to disconnect from the first arcuate support 101 and the second arcuate support 102, such that the spacing distance (d) decreases and the annulusoplasty device 100 transitions from an expanded state to a contracted state, as... Figure 10c As shown. Therefore, when the annulusoplasty device 100 is positioned correctly at the heart valve, the delivery device 401 is removed, and in the contracted state, the valve tissue clamps the first arcuate support 101 and the second arcuate support 102.

[0051] The delivery device 401 can push, pull, bend, or otherwise move the first arcuate support 101 and the second arcuate support 102 to present an expanded state. Figure 10a -c illustrates an example in which the delivery device 401 pushes the first arcuate support 101 and the second arcuate support 102 apart. Figure 11a The delivery device 401 is shown near the apex 108 with the first arcuate support 101 and the second arcuate support 102. Figure 11b Another example of engagement is to bend and separate the first arcuate support 101 and the second arcuate support 102, for example, such that... Figure 10b The angle (v) shown increases, and / or causes the interval distance (d) to increase.

[0052] The first arcuate support 101 and / or the second arcuate support 102 may comprise a shape memory material, such as nitinol, or other suitable biocompatible alloy, which can be heat-set in a defined shape during a heat treatment process. In one example, the first arcuate support 101 and / or the second arcuate support 102 may comprise a polymer material having shape memory properties. The shape memory material may comprise a material having more than one phase, such that the shape of the arcuate supports 101 and 102 can be actively changed as described above. The shape memory material can be contemplated as any material capable of changing shape on demand in response to external interactions, such as by providing an energy source such as thermal and / or electromagnetic energy, which can be transferred to the annulusoplasty device 100 to change its shape. It is also contemplated that the shape of the annulusoplasty device 100 can be influenced by directly mechanically manipulating the curvature of the first arcuate support 101 and / or the second arcuate support 102, for example by transmitting force or torque to the annulusoplasty device 100 via a delivery device. Through the various shape-affecting steps described above, the annulusoplasty device 100 can present an elongated delivery configuration for travel in a catheter; present an initial shape when positioned in a curved configuration along the valve annulus; and can also present an activated shape, such as a contracted state, in which the septal distance (d) is reduced as described above to enhance fixation strength at the valve annulus of the heart valve.

[0053] The annuloplasty device 100 may include a protective sleeve 117 that extends along at least a portion of a first arcuate support 101. Alternatively or additionally, the protective sleeve 117 may extend along at least a portion of a second arcuate support 102. When the annuloplasty device 100 is positioned at a heart valve, the protective sleeve 117 is configured to be removed from the annuloplasty device 100. Figure 12a This is a schematic diagram showing the protective sleeve 117 arranged around the first arc-shaped support 101. Figure 12b This is a schematic diagram showing the protective sleeve 117 arranged around the first arcuate support 101 and the second arcuate support 102. The protective sleeve 117 facilitates the correct placement of the annulusoplasty device 100 at the heart valve because, when the protective sleeve 117 is positioned on the first arcuate support 101 and / or the second arcuate support 102, it prevents the retaining unit 115 of the first arcuate support 101 and / or the second arcuate support 102 from engaging with the tissue. Therefore, once the annulusoplasty device 100 is positioned on opposite sides of the heart valve leaflets, the protective sleeve 117 can be removed to expose the retaining unit 115, which can then be inserted into the tissue and fix the position of the annulusoplasty device 100. The protective sleeve 117 can be gradually removed, allowing the retaining unit 115 to be gradually exposed and inserted into the tissue. The retaining unit 115 can be flexible and can be in a bent or tilted position when surrounded by the protective sleeve 117, such as... Figure 12a or Figure 13As shown. When the protective sleeve 117 is removed, the retaining unit 115 can unfold outward. In one example, the direction in which the retaining unit 115 extends into the tissue when released from the protective sleeve 117 may be influenced by the direction in which the protective sleeve 117 is pulled away from the annulusoplasty device 100. That is, if the retaining units 115 are flexible, they can be deflected in the direction in which the protective sleeve 117 is pulled away, thereby penetrating the tissue at an angle of such deflection, as per the description of... Figure 14a -b provides further explanation.

[0054] The protective sleeve 117 can be removed from the annulusoplasty device 100 by pulling out the first arcuate support 101 and / or the second arcuate support 102 in a direction 118a extending along the first arcuate support 101 and / or the second arcuate support 102. This is in Figure 13 As shown in, where Figure 13 Pull the protective sleeve 117 upwards in the direction indicated by the middle arrow 118a. This allows the retaining unit 115 to be gradually exposed, as... Figure 13 As shown in the example. At this point, the retaining unit 115 can transition from a compressed or tilted position to an extended position; if the retaining unit 115 is flexible, the extended position can correspond to the heat-set relaxation shape of the retaining unit 115. The protective sleeve 117 can be made of a flexible material to facilitate the pull-out of the annulusoplasty device 100.

[0055] The protective sleeve 117 may include a slit or perforated portion 119, which extends along the longitudinal direction 121 of the protective sleeve 117, such as... Figure 14a As illustrated schematically. In this configuration, the protective sleeve 117 can be configured to be removed from the annulusoplasty device 100 along the slit or perforation portion 119, as shown. Figure 14b As shown. The protective sleeve 117 can be torn open along the perforated portion 119, thereby allowing access through, for example... Figure 14bThe protective sleeve 117 is removed by pulling in the direction indicated by the middle arrow 118b. If a slit 119, i.e., a pre-made incision already provided along the longitudinal direction 121, is present, the protective sleeve 117 can be bent or otherwise manipulated to remove it from the annulusoplasty device 100. In this case, as long as no force is applied to the protective sleeve 117 (e.g., along a direction 118b not parallel to the longitudinal direction 121) to peel the protective sleeve 117 from the annulusoplasty device 100, the protective sleeve 117 can have rigidity and structural integrity to remain in position around the first arcuate support 101 and / or the second arcuate support 102. Thus, the slit or perforation portion 119 allows the protective sleeve 117 to be removed in multiple possible directions, which can facilitate the removal of the protective sleeve 117, thereby exposing the retaining unit 115. For example, the protective sleeve 117 can be pulled in a direction toward the center of the heart valve, so that once the protective sleeve 117 is removed, this can cause the retaining unit 115 to deflect in a direction toward the center of the heart valve, as described above. In this configuration, the exposed retaining unit 115 can be secured to the annular tissue in an advantageous orientation to further enhance the retention force of the annuloplasty device 100 at the heart valve. It is also envisioned that the protective sheath 117 may include additional slits or perforations to facilitate removal of the protective sheath 117 from the annuloplasty device 100.

[0056] A method 200 for repairing defective heart valves is provided. Referring to Figures 1-14, Figure 15aMethod 200 is illustrated schematically. The order of the steps is not to be construed as limiting, but rather envisioned as being adaptable to specific surgical procedures. Method 200 includes positioning 201 of a first posterior bow 103 of the annulusoplasty device 100 on the atrial side of the heart valve to conform to its posterior region. Method 200 includes positioning 202 of a second posterior bow 104 of the annulusoplasty device 100 on the ventricular side of the heart valve to conform to its posterior region. The first posterior bow 103 and the second posterior bow 104 are curved about a central axis 105 and extend in corresponding first planes 101' and second planes 102' substantially perpendicular to the central axis 105. The first posterior bow 103 and the second posterior bow 104 have corresponding first free ends 106 and second free ends 107. The first posterior bow 103 and the second posterior bow 104 extend from their respective free ends 106 and 107 and join together at a vertex 108. The first posterior bow 103 transitions to the second posterior bow 104 via an apex 108. Method 200 includes positioning the apex 108 203 at the first commissure 302 of the heart valve. Method 200 achieves the advantageous benefits described above with respect to the annulusoplasty device 100 and Figures 1-14. Method 200 achieves secure fixation and implantation of the annulusoplasty device 100 at the annulus along the posterior (P) side of the heart valve while minimizing interference with the anterior (A) anatomical structures. This provides adaptation to improved surrounding anatomy at the heart valve, ultimately resulting in improved fixation of the annulusoplasty implant 100 and increased patient safety.

[0057] Figure 15b This is another flowchart of method 200 for repairing defective heart valves. The first free end 106 and the second free end 107 can be positioned 204 near the second junction 303 opposite to the first junction 302 of the heart valve, as shown below. Figure 2a -b is shown schematically.

[0058] The present invention has been described above with reference to specific embodiments. However, other embodiments besides those described above are equally feasible within the scope of the present invention. Different features and steps of the present invention may be combined in combinations other than those described above. The scope of the present invention is limited only by the appended patent claims. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and constructions described herein are exemplary, and actual parameters, dimensions, materials, and / or constructions depend on the specific application for which the teachings of the present invention are used.

Claims

1. A valve annuloplasty device (100), comprising: First arc-shaped support (101), The second arc-shaped support (102), The first and second arc-shaped supports are configured to be arranged on opposite sides of the natural leaflets (301) of the heart valve. The first arc-shaped support includes a first posterior bow (103), which is configured to be positioned on the atrial side of the heart valve and to conform to its posterior region. The second arc-shaped support includes a second posterior bow (104), which is configured to be positioned on the ventricular side of the heart valve and to conform to its posterior region. The first and second rear bends curve about the central axis (105) and extend in corresponding first plane (101') and second plane (102') substantially perpendicular to the central axis. The first and second rear bows have corresponding first free ends (106) and second free ends (107), and the first and second rear bows extend from their respective free ends and connect at the apex (108), thereby transitioning the first rear bow to the second rear bow via the apex. The vertex is configured to be located at the first commissure of the heart valve.

2. The annulusoplasty device according to claim 1, wherein the annulusoplasty device is generally C-shaped in a first plane or a second plane.

3. The annulusoplasty apparatus of claim 2, wherein the first arcuate support extends in a generally C-shape between the first free end and the vertex, and the second arcuate support extends in a generally C-shape between the second free end and the vertex.

4. The valve annuloplasty apparatus according to any one of claims 1 to 3, wherein the apex extends in a curved shape between the first posterior bow and the second posterior bow.

5. The valve annuloplasty apparatus according to any one of claims 1 to 3, wherein the first arcuate support includes an extension (109) from the apex to the third free end (110).

6. The annulusoplasty apparatus of claim 5, wherein the first arcuate support extends in a generally C-shape between the first free end and the opposite third free end.

7. The valve annuloplasty apparatus according to any one of claims 1 to 6, wherein the first posterior bowing overlaps with the second posterior bowing in a first plane or a second plane.

8. The valve annuloplasty device according to any one of claims 1 to 7, wherein the first free end and / or the second free end comprises at least a partially spherical shape (111, 111') for non-invasive tissue apposition.

9. The valve annuloplasty apparatus according to any one of claims 1 to 8, wherein the first free end extends from the first plane at an angle (a1), and / or wherein the second free end extends from the second plane at an angle (a2).

10. The valve annuloplasty apparatus according to any one of claims 1 to 9, comprising a cover (112, 112') disposed on the first arcuate support and / or the second arcuate support.

11. The valve annuloplasty apparatus of claim 12, wherein the cover is attached to at least one fixed point (113, 113') arranged at the first arcuate support, and / or wherein the cover is attached to at least one fixed point (114, 114') arranged at the second arcuate support.

12. The valve annuloplasty apparatus according to any one of claims 1 to 11, comprising retaining units (115, 115') arranged along a first arcuate support and / or a second arcuate support.

13. The annulusoplasty apparatus of claim 12, comprising a support (116, 116') arranged around at least a portion of a first arcuate support and / or a second arcuate support, wherein the support includes a retaining unit.

14. The annulusoplasty device according to any one of claims 1 to 13, wherein the annulusoplasty device comprises a shape memory material and has an elongated delivery configuration for travel in a catheter, and a predetermined arcuate shape of the shape memory material for positioning at the annulus of the heart valve.

15. The valve annuloplasty apparatus according to any one of claims 1 to 14, wherein the first arcuate support and the second arcuate support are separated along the central axis by a distance (d), and The first arc-shaped support and / or the second arc-shaped support include shape memory material, wherein activation of the shape memory material causes a reduction in the interval distance, resulting in the annulusoplasty device being in a contracted state.

16. The annuloplasty device according to any one of claims 1 to 15, comprising a protective sleeve (117) extending along at least a portion of a first arcuate support and / or along at least a portion of a second arcuate support, wherein when disposed at a heart valve, the protective sleeve is configured to be removed from the annuloplasty device.

17. The annulusoplasty device of claim 16, wherein the protective sheath includes a slit or perforation portion (119) extending along the longitudinal direction (121) of the protective sheath, thereby configuring the protective sheath to be removed from the annulusoplasty device along the slit or perforation portion.

18. A valve annuloplasty system (400) comprising a valve annuloplasty device and a delivery device (401) according to any one of claims 1 to 17, wherein the delivery device is configured to connect with a first arcuate support and a second arcuate support, and forces the first arcuate support and the second arcuate support apart such that the spacing (d) between them temporarily increases along the central axis, thereby causing the valve annuloplasty device to be in an expanded state, and The delivery device is configured to be disconnected from the first and second arcuate supports, thereby reducing the interval distance (d) and causing the annulusoplasty device to change from an expanded state to a contracted state.

19. A method for repairing a defective heart valve (200), comprising: Position (201) the first posterior bow (103) of the annulus repair device (100) on the atrial side of the heart valve to fit its posterior region; Position (202) the second posterior bow (104) of the annulus repair device (100) on the ventricular side of the heart valve to fit its posterior region; The first and second rear bows bend about the central axis (105) and extend in a first plane (101') and a second plane (102') that are substantially perpendicular to the central axis; The first and second rear bows have corresponding first free ends (106) and second free ends (107), the first and second rear bows extend from their respective free ends and connect at a vertex (108), thereby transitioning the first rear bow to the second rear bow via the vertex. The method includes: The vertex is positioned (203) at the first commissure of the heart valve.

20. The method of claim 19, wherein the first free end and the second free end are arranged (204) near the second commissure opposite the first commissure of the heart valve.

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