Annuloplasty device

Abstract

The present application discloses an annuloplasty device comprising a detachable and elastic elongated displacement unit for insertion into a coronary sinus (CS) adjacent to a mitral valve, a proximal reversibly deployable portion reversibly deployable to a deployed state for positioning against a tissue wall at an entrance of the CS, a distal anchoring portion movable relative to the proximal deployable portion in a longitudinal direction of the displacement unit to an activated state in which a shape of the annulus is modified to a modified shape, a stent arranged around the displacement unit and movable relative to the displacement unit in the longitudinal direction for insertion into the CS, and wherein the stent is releasably connected to the delivery device and radially arranged between the displacement unit and the proximal deployable portion in a radial direction.

Description

Technical Field

[0001] This invention generally belongs to the field of annulusoplasty devices for treating defective mitral valves. More specifically, this invention relates to annulusoplasty devices and methods for treating defective mitral valves via the coronary sinus. Background Technology

[0002] Diseased mitral and tricuspid valves often require replacement or repair. The leaflets or supporting chordae tendineae of the mitral and tricuspid valves may degenerate and weaken, or the valve annulus may expand, leading to valve leakage. Mitral and tricuspid valve replacement and repair are frequently performed with the aid of annuloplasty rings, used to reduce the diameter of the valve annulus, or to modify the geometry of the valve annulus in any other way, or as an adjunct to general support structures during valve replacement or repair surgery.

[0003] Previously, implants have been introduced into the coronary sinus (CS) to influence the shape of the valvular annulus, thereby affecting valvular function. WO02 / 062270 discloses such an implant aimed at replacing the annulusoplasty annulus. Implantation of annulusoplasty devices in the CS is a process that requires addressing several challenges, such as correcting the annulus in a manner that maintains normal valvular function and ensuring the device's correct position in the CS over time. The potential traumatic effects on the CS itself, as well as the complexity of the implant and the procedure, must be considered. Existing devices generally exhibit suboptimal performance in several of the aforementioned aspects of annulusoplasty via the CS. One issue is ensuring the correction of vital portions of the annulus while providing non-invasive engagement with the anatomy. The problem with existing devices is their complexity and difficulty in operation, which may require frequent adjustments and repositioning to ensure correct function over time. This can have dire consequences for patients and the healthcare system. Patient risks are increased.

[0004] The aim is to improve the control of reduction surgery, i.e., valve ring correction, while ensuring secure anchoring of the implant and minimizing the risk of CS damage.

[0005] Therefore, an improved annuloplasty device for performing the reduction and reshaping of the mitral annulus is advantageous, and in particular allows for ensuring long-term function, less complex surgery, less anatomical trauma, and increased patient safety. Furthermore, the method of reducing and reshaping the mitral valve annulus using such an annuloplasty device is also advantageous. Summary of the Invention

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

[0007] According to a first aspect, an annuloplasty device for treating a defective mitral valve with an annulus is provided, comprising a removable and resilient elongated displacement unit for temporary insertion into a coronary sinus (CS) adjacent to the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state from which the displacement unit is temporarily and reversibly transferable, and a proximal reversibly deployable portion reversibly foldable to an unfolded state for positioning against a tissue wall at the entrance of the CS, wherein the displacement unit includes a distal anchoring portion movable relative to the proximal deployable portion in the longitudinal direction of the displacement unit relative to the activated state, wherein in the activated state, when inserted into the CS, the shape of the annulus is modified to a modified shape, a stent arranged around the displacement unit and movable relative to the displacement unit in the longitudinal direction for insertion into the CS, and wherein the stent is releasably connected to a delivery device and radially arranged in a radial direction (R) between the displacement unit and the proximal deployable portion, the radial direction (R) being perpendicular to the longitudinal direction.

[0008] According to a second aspect, a method for treating a defective mitral valve with a valve annulus is provided, the method comprising: inserting a resilient and detachable elongated displacement unit in a delivery state into a coronary sinus (CS) adjacent to the valve; positioning a proximal reversibly deployable portion against a tissue wall at the entrance of the CS; anchoring a distal anchoring portion in the CS; activating the displacement unit in an activated state, whereby the distal anchoring portion moves in the longitudinal direction of the displacement unit to shorten the distance (L) between the distal anchoring portion and the proximal deployable portion, thereby correcting the shape of the valve annulus to a corrected shape; advancing a stent through the proximal deployable portion and over the displacement unit into the CS; anchoring the stent in the CS to maintain the corrected shape of the valve annulus; and, after temporary activation in the activated state, withdrawing the displacement unit through the stent to remove the displacement unit.

[0009] Further examples of the invention are defined in the dependent claims, wherein the features of the second and subsequent aspects are equivalent to the features of the first aspect.

[0010] Some examples of the present invention provide long-term functionality of the repaired mitral valve.

[0011] Some examples of the present invention provide less complex mitral valve reduction surgery.

[0012] Some examples of the present invention provide improved control of mitral valve reduction surgery.

[0013] Some examples of the present invention provide a reduced risk of damage to anatomical structures (such as the CS).

[0014] Some examples of the present invention provide safe reduction while minimizing the risk of damaging anatomical structures (such as CS).

[0015] Some examples of the present invention provide improved reduction of the mitral valve annulus while ensuring a non-invasive procedure.

[0016] Some examples of the present invention provide for reducing the risk of long-term negative effects of CS implants.

[0017] It should be emphasized that, when used in this specification, the term "comprising" means the presence of the described feature, integral, step, or component, but does not exclude the presence or addition of one or more other features, integrals, steps, or components or combinations thereof. Attached Figure Description

[0018] Referring to the accompanying drawings, these and other aspects, features, and advantages of the embodiments of the present invention will become apparent and elucidated from the following description of the embodiments of the present invention, wherein:

[0019] Figure 1 This is a schematic cross-sectional view of an example annulusoplasty device;

[0020] Figure 2a This is a schematic diagram based on an example annulusoplasty device;

[0021] Figure 2b Based on an example Figure 2a A schematic diagram of the valve annuloplasty device, showing an expanded proximal portion;

[0022] Figure 3a -b is a schematic diagram of an example annulusoplasty device, with different lengths between the proximal expandable portion and the distal anchoring portion;

[0023] Figure 4a This is a schematic diagram of an example annulusoplasty device, in which a catheter is advanced on an elongated displacement unit;

[0024] Figure 4b Based on an example Figure 4a A schematic diagram of a valve annuloplasty device, in which a stent is advanced on an elongated displacement unit;

[0025] Figure 4c Based on an example Figure 4b A schematic diagram of a valve annuloplasty device, in which the stent is exposed on an elongated displacement unit;

[0026] Figure 4d Based on an example Figure 4c A schematic diagram of a valve annuloplasty device, in which an elongated displacement unit is retracted through a support;

[0027] Figure 4e Based on an example Figure 4d A schematic diagram of the cross-section of the valve annuloplasty device passing through the radial direction;

[0028] Figure 5a -b is a schematic diagram of an annulus valvuloplasty device based on an example located in the coronary sinus (CS), wherein an elongated displacement unit is anchored with a proximal deployable portion and a distal anchor.

[0029] Figure 5c -d is a schematic diagram of an annulusoplasty device according to an example, in which the catheter is advanced through the proximal deployable portion and advanced on the elongated displacement unit;

[0030] Figure 5e -f is a schematic diagram of an example annulusoplasty device, in which a stent is advanced. Figure 5c -d in the duct;

[0031] Figure 5g -h is a schematic diagram of an example annulusoplasty device, in which... Figure 5e The -f bracket is at least partially deployed in CS;

[0032] Figure 5i This is a schematic diagram of an example annulusoplasty device, in which... Figure 5e The -f bracket is fully deployed in CS;

[0033] Figure 5j This is a schematic diagram of an example annulusoplasty device, in which... Figure 5i The slender displacement unit is withdrawn through the support;

[0034] Figure 5k -l is a schematic diagram of an example valve annulusoplasty device, in which... Figure 5e The -f scaffold fully expands and is implanted in the CS;

[0035] Figure 6a This is a schematic diagram of the mitral valve and the adjacent coronary sinus;

[0036] Figure 6b This is a schematic diagram of an example annulusoplasty device, in which... Figure 5e The -f stent is fully deployed and implanted in the CS to correct the valve annulus;

[0037] Figure 7 This is a schematic cross-sectional view of an example annulusoplasty device;

[0038] Figure 8a This is a flowchart illustrating an example method for treating a defective mitral valve; and

[0039] Figure 8b This is a flowchart illustrating an example method for treating a defective mitral valve. Detailed Implementation

[0040] Specific embodiments of the invention will now be described with reference to the accompanying drawings. However, the invention can be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided to make the disclosure complete and thorough, 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 illustrated in the drawings is not intended to limit the invention. In the drawings, similar numerals refer to similar elements.

[0041] Figure 1 An annuloplasty device 100 for treating a defective mitral valve with an annulus is illustrated schematically. The annuloplasty device 100 includes a removable and resilient elongated displacement unit 101 for temporary insertion into the coronary sinus (CS) adjacent to the mitral valve. The displacement unit 101 has a delivery state for delivery into the CS and an activated state from which the displacement unit 101 is temporarily and reversibly transferable. The annuloplasty device 100 includes a proximal reversibly deployable portion 102. The proximal deployable portion 102 is reversibly foldable into an deployed state for positioning against the tissue wall at the entrance of the CS. Figure 2a -b indicates the proximal deployable portion 102 from Figure 2a The contraction state moves to Figure 2b An example of the expanded state. Figure 5a The illustration schematically shows how the proximal deployable portion 102 is positioned outside the CS to push against the wall at the entrance of the CS. The displacement unit 101 includes a distal anchoring portion 103 that is movable relative to the proximal deployable portion 102 in the longitudinal direction 104 of the displacement unit 101 in the aforementioned activated state. Figure 5b This illustration shows how the distal anchoring portion 103 is anchored in the CS. The distal anchoring portion 103 can be anchored in the great cardiac vein. Figure 3a -b illustrates an example where the distal anchoring portion 103 is movable, causing the distance between the proximal deployable portion 102 and the distal anchoring portion 103 to vary. The distance from... Figure 3a The length L represented in the middle is reduced to Figure 3b The shortened length L' is represented in the diagram. In the active state, when placed in the CS, the annulusoplasty device 100 corrects the annulus to a modified shape where the annulus is reduced and the leaflets can co-apt. Therefore, as... Figure 5a -b As exemplarily shown, when the annulusoplasty device 100 is placed in the CS and the distal anchoring portion 103 is anchored, the distal anchoring portion can be retracted toward the proximal deployable portion 102, which exerts a reaction force on the tissue wall at the entrance of the CS. This allows for the reshaping of the mitral valve annulus.

[0042] Back to Figure 1The annular valvularization device 100 includes a support 105 arranged around the displacement unit 101 and movable relative to the displacement unit 101 in the longitudinal direction 104 for insertion into the CS. Figure 4b The illustration shows how the support 105 is advanced toward the distal anchoring portion 103 on the displacement unit 101. Figure 5e The -f option specifies the position of the stent 105 on the displacement unit 101 when the annulusoplasty device 100 is placed in the CS. When the displacement unit 101 has corrected the annulus, the stent 105 can be deployed for anchoring in the CS, as shown below. Figure 5g The -i option is explained and further elaborated below. For example... Figure 4d and 5j As schematically shown, the stent 105 is releasably connected to the delivery device 106 and can be released in the CS to maintain the orthotic form of the valve annulus after the displacement unit 101 is withdrawn, as... Figure 5j -l and 6b are explained. Figure 6a This is a schematic diagram of the heart, showing a top view of the CS relative to the mitral valve (MV). The CS is adjacent to the MV and follows the arc around the valve annulus (A) of the MV. Figure 4d As exemplarily shown, the support 105 may have a releasable connection 114 to the delivery device 106. It is conceivable that the delivery device 106 may be configured to push or pull the support 105 relative to the displacement unit 101 along the longitudinal direction 104. Figure 1 As shown, the stent 105 is radially arranged between the displacement unit 101 and the proximal deployable portion 102 in the radial direction (R). The radial direction (R) is perpendicular to the longitudinal direction 104. The arrangement of the stent 105 between the displacement unit 101 and the proximal deployable portion 102 allows the stent 105 to be advanced into the CS on the displacement unit 101, while the proximal deployable portion 102 deploys outside the CS and the displacement unit 101 is activated. Therefore, before the stent 105 is positioned and finally anchored in the CS, the annulus orthopedic shape can be carefully controlled and optimized by changing the length (L) using the displacement unit 101. For example, by observing flow characteristics and leaflet movement, once the leaflets close properly and no backflow occurs, the stent 105 can be gradually deployed. Figure 5g -i), for example by withdrawing the conduit 109 disposed on the stent 105, as further described below. After the stent 105 is fully deployed, the connection to the stent 105 can be maintained by the delivery device 106. Figure 5i The force applied to the annulus by the displacement unit 101 can then be gradually released, for example, by reducing the tension between the proximal deployable portion 102 and the distal anchoring portion 103. Flow characteristics and leaflet motion can be continuously observed to ensure no backflow occurs. The displacement unit 101 can be completely retracted via the support 105. Figure 5j If no backflow occurs, the stent 105 can be released. Figure 5k-l). Alternatively, stent 105 can be captured, for example by advancing catheter 109 on stent 105, and the valve annulus can be further adjusted by displacement unit 101, and / or another stent 105 of different size can be introduced through proximal deployable portion 102 and onto displacement unit 101 to repeat the process.

[0043] It is conceivable that, before or after the orthopedic valve annulus of displacement unit 101, stent 105 can be advanced through the proximal deployable portion 102 and onto displacement unit 101 into the CS ( Figure 5e -f). In any case, after orthodontic treatment, the stent 105 is deployed and secured in the CS.

[0044] Therefore, the annulusoplasty device 100 provides a convenient annulusoplasty procedure via the CS. The annulus reshaping can be carefully controlled and optimized by the displacement unit 101, and the stent 105 can be anchored in the CS to maintain the corrected shape once normal valve function can be confirmed. Since the position of the stent 105 relative to the displacement unit 101 and the CS can be varied and optimized, and since the displacement unit 101 already provides valve reduction in its activated state, surgical safety is improved. Due to the aforementioned cooperation between the displacement unit 101 and the stent 105, the introduction of complex elements into the implanted device, i.e., the stent, to provide valve reduction can be omitted. Therefore, the stent 105 can be more stable and less complex, thus more reliably maintaining the desired valve function over time. Prior art implants, on the contrary, may require repeated adjustments to provide annulus reduction due to the complex interactions between several moving parts. The annulusoplasty device 100 also provides a reduced risk of damage to the CS, as reduction can be provided by the displacement unit 101 with its undamaged shape, rather than the stent 105 which may have a retaining unit 110, as further described below. Therefore, the risk of tissue tearing in the CS by such retaining units can be reduced.

[0045] As described, when the displacement unit 101 transitions from the delivery state to the activated state, the distance (L) between the proximal deployable portion 102 and the distal anchoring portion 103 in the longitudinal direction 104 can be reduced to a shortened distance (L'). The proximal deployable portion 102 and the distal anchoring portion 103 can be connected to different sheaths or conductors, which can be independently movable in the longitudinal direction 104 to provide a changed distance (L), such as... Figure 3a -b is shown.

[0046] The proximal deployable portion 102 can be connected to the sheath 107 and can be configured to deploy in a radial direction (R) perpendicular to the longitudinal direction 104 by pushing the proximal portion 108 of the sheath 107 toward the distal anchoring portion 103, as shown. Figure 2bAs shown (see the arrow next to the sheath 107). This provides convenient development of the deployable portion 102 into a deployable configuration.

[0047] When the displacement unit 101 is positioned to provide the desired reduction interval (L') of the valve between the proximal deployable portion 102 and the distal anchoring portion 103, the stent 105 can be moved to a position on the displacement unit 101 for positioning and anchoring into the CS. Figure 4a -b and Figure 5c -f Schematic illustration: The annulusoplasty device 100 may include a catheter 109 to surround a stent 105 and position the stent 105 relative to the displacement unit 101 in the longitudinal direction 104. Figure 4a An example is shown in which the catheter 109 is first advanced on the displacement unit 101 before the stent 105 is pushed forward within the catheter 109 by the delivery device 106. However, it is conceivable that the stent 105 can be advanced on the displacement unit 101 simultaneously with the catheter 109. The stent 105 can be ejected from the catheter 109 and retracted into the catheter via the aforementioned delivery device 106. Figure 4c This is a schematic diagram showing that the catheter 109 has been withdrawn to expose the stent 105 to the displacement unit 101. Figure 4d This is a schematic diagram of the displacement unit 101 being retracted through the support 105. The proximal deployable portion 102 retracts, and the support 105 can be released from the delivery device 106.

[0048] Therefore, the catheter 109 can be movable within the sheath 107 in the longitudinal direction 104. Thus, the support 105 can be positioned at the desired location on the displacement unit 101, while the proximal deployable portion 102 connected to the sheath 107 deploys and anchors against the inlet of the CS.

[0049] Therefore, in the activated state described above, the catheter 109 is movable in the longitudinal direction 104 on the displacement unit 101 and inside the sheath 107. This provides effective and reliable positioning and deployment of the stent 105 in the CS, while the amount of annular shrinkage is effectively controlled by the displacement unit 101.

[0050] In the activated state, the support 105 can be reversibly deployed in the radial direction (R). Therefore, once deployed, for example, as Figure 5gThe stent 105, in its (partially) deployed state, can retract and be retracted again when needed for repositioning or replacement. For retraction, the stent 105 can be pulled into the catheter 109 by retracting the delivery device 106 relative to the catheter 109, thereby forcing the stent 105 into the confinement of the catheter 109. The stent 105 can be self-deployable, striving to expand towards its deployed diameter once released from the catheter 109. In this case, the stent 105 can be formed of a shape memory material that has been heat-set to a deployed diameter configuration, where the diameter is larger than the diameter of the CS. Before ejection from the CS, the stent 105 can be compressed and inserted into the catheter 105, where it will strive to expand towards its heat-set shape, thereby pressing against the tissue wall within the CS. It is also conceivable that the stent 105 can be actively deployed to expand its diameter by, for example, a balloon catheter pushed within the stent 105.

[0051] like Figure 4c As illustrated in -d, 5g-l, and 6b, the support 105 may include a retaining unit 110 to anchor the support 105 in the CS. Thus, once the displacement unit 101 is shortened from length (L) to shortened length (L') ( Figure 3a -b) While shrinking the tissue around the CS to correct the valve annulus, the shape of the modified tissue can be held by a scaffold 105 anchored in the tissue. The holding unit 110 provides effective and reliable anchoring of the scaffold 105 in the tissue. The scaffold 105 can extend along most of the length of the CS in an uninterrupted length close to the tissue wall of the CS. This provides reliable retention of the corrected valve annulus over time, especially when the holding unit 110 extends substantially along the entire length of the scaffold 105. Figure 5k As schematically shown, the stent 105 may have a length substantially corresponding to the CS length. A retaining unit 110 may be provided along the length of the stent 105. This further provides particularly reliable retention of the orthopedic valve annulus over time.

[0052] The retaining unit 110 can be arranged on the surface portion 111 of the support 105, and when the support 105 is in the CS, the retaining unit is adapted to be arranged toward the valve annulus, such as... Figure 6b The top view combined with an example shows the cross-section of bracket 105. Figure 4e As illustrated. Therefore, as Figure 4e As shown, the retaining unit 110 can be arranged on the surface of the stent at a defined circular sector (v). The arrangement of the retaining unit 110 in the direction toward the valve annulus provides effective retention of the corresponding portion of tissue along the CS and reliable retention of the modified valve annulus shape. In one example, the stent 105 may include at least one radiopaque marker (not shown). This provides convenient orientation of the stent 105 relative to the valve annulus.

[0053] It is conceivable that, in one example, multiple retaining units 110 could be arranged around the periphery of the support 105. Therefore, the retaining units 110 can be arranged along the periphery of the support 105 at multiple circular sectors (v). This can be advantageous in applications where increased retaining force is desired.

[0054] The retaining unit 110 can be molded into the tissue for insertion into the CS, thereby providing a retaining force into the tissue. The retaining unit 110 can be formed from the material of the scaffold 105. Therefore, the retaining unit 110 can be integrated with the scaffold 105. Thus, the retaining unit 110 can be cut into a corresponding elongated structure with a puncture tip within the structural framework of the scaffold 105. Forming the retaining unit 110 as an integrated structure within the framework of the scaffold 105 provides a robust retaining unit 110 and minimizes the risk of misalignment or deformation over time. Therefore, an overall robust and reliable fixation mechanism is provided. The retaining unit 110 can be formed using various cutting techniques, such as laser cutting.

[0055] The retaining unit 110 can be elastically moved from a retracted state to an deployed state. Therefore, the retaining unit 110 can be elastic, bending from the deployed state to the retracted state when positioned within the catheter 109, and deploying from the retracted state to the deployed state when released from the catheter 109. This provides convenient delivery of the stent 105 through the catheter 109, while enabling the retaining unit 110 to deploy and anchor in the tissue once deployed from the boundaries of the catheter 109. Thus, as Figure 4d As shown in -e, the retaining unit 110 can be heat-set to present a defined unfolded shape. Therefore, the unfolded shape can correspond to the relaxed state of the retaining unit 110 when it is not subjected to external force. Therefore, when released from the conduit 109, the retaining unit 110 can tend to unfold into the shape by exerting effort toward the relaxed unfolded state.

[0056] In the retracted state, the retaining unit 110 can be aligned substantially flush with the outer diameter of the stent. This further facilitates the delivery of the stent 105 through the catheter 109, as friction between the retaining unit 110 and the lumen of the catheter 109 is reduced. Additionally, it provides a compact cross-section and minimizes the risk of wear and damage to the catheter 109.

[0057] In one example, the holding unit 110 may include a shape memory material, wherein activation of the shape memory material causes the holding unit 110 to transition from a retracted state to an extended state. For example, the shape memory material may be temperature-activated, such that when heated to body temperature, the holding unit 110 moves toward the extended state. In some applications, this provides an advantageous deployment of the holding unit 110.

[0058] The distal anchoring portion 103 may include an inflatable unit, such as a balloon, which is deployable in the radial direction (R). This provides effective and non-invasive fixation of the distal end of the displacement unit 101, combined with effective anchoring of the proximal portion 102 against the wall of the CS, allowing the contractile forces of the proximal portion 102 and the distal portion 103 to be effectively transferred toward each other. This allows for effective correction of the radius of curvature of the CS to facilitate correction of the shape of the valve annulus. The annulusoplasty device 100 may include an inflation chamber (not shown) connected to the inflatable unit and configured to deliver an inflation medium to the inflatable unit.

[0059] The length of the inflatable unit 103 can be adapted to different anatomical structures. The length of the inflatable unit 103 can be selected so that it does not obstruct blood vessels connected to the CS, for example, if the inflatable unit 103 is further anchored in the CS, such as towards the great cardiac vein / left coronary vein. The length of the inflatable unit 103 can also be adjusted so that it can be effectively anchored behind bends or "angles" in the CS as it transitions into the great cardiac vein / left coronary vein. The length of the inflatable unit 103 can be short enough to facilitate this anchoring and avoid slipping out of such bends or "angles" in the CS.

[0060] The proximal deployable portion 102 may include a deployable bow or rib 112. The sheath 107 may be pushed relative to the distal portion 114, which is distally connected to the bow or rib 112. Therefore, the compressive force between the distal portion 114 and the proximal portion 108 may push the bow 112 radially outward. However, it is conceivable that the bow 112 may include a shape-memory material that tends to present a deployed configuration in its relaxed state, and the bow may be confined within a pulled-back outer sheath (not shown) such that the bow 112 springs into the deployed configuration.

[0061] The deployable bow 112 provides further reduction in the risk of damaging tissue at the CS entrance because it offers a soft, approximate fit against the tissue without sharp edges or kinks. The bow 112 can extend in the longitudinal direction 104, which facilitates symmetrical engagement against the tissue wall, uniformly distributing force around the CS entrance, thus allowing for stable anchoring. The longitudinal extension of the bow 112 also provides favorable deployment by applying force to it in the longitudinal direction 104. Multiple bows 112 can be arranged circumferentially to apply force symmetrically and uniformly around the tissue wall.

[0062] The proximal deployable portion 102 may include elongated ribs 112 formed in the sheath through elongated cuts 113 in the sheath 107, extending in the longitudinal direction 104, such as Figure 2aThis is for illustrative purposes only. Rib 112 can be foldable to unfold in the radial direction (R). This provides a simple and robust structure. Therefore, rib or bow 112 can be formed of the same material as sheath 107. The material can be a soft, elastic material that is non-invasive to tissues. Figure 2a In the shown contraction configuration, ribs 112, i.e., the ribs 112 that are about to unfold, extend in the longitudinal direction 104 and provide a compact radial profile. Ribs or bows 112 can be positioned at equal intervals around the circumference of the sheath 107. As described above, this can provide a uniform distribution of anchoring force.

[0063] The maximum deployable diameter (D) of the proximal deployable portion 102 can be at least three times the diameter of the CS. In some examples, the ratio of the maximum deployable diameter (D) of the proximal deployable portion 102 to the diameter of the CS is in the range of 3-5. In some examples, the above ratio can be in the range of 3.5-4.5, which provides particularly advantageous anchoring of the proximal deployable portion 102 while maintaining a compact and easy-to-use annulusoplasty device 100.

[0064] like Figure 7 Schematic illustration: The annulusoplasty device 100 may include a wire 115 arranged to extend within a cavity 116 of the displacement unit 101 and exit the cavity 116 at a distal opening 117 of the displacement unit 101. The wire 115 may be inserted into the CS, and the displacement unit 101 may subsequently be advanced along the wire 115 for positioning within the CS. This provides convenient positioning of the displacement unit 101.

[0065] Figure 8a Method 400 for treating a defective mitral valve is described. The order of steps in method 400 should not be construed as limiting, and it is conceivable that the order of steps in method 400 may vary. Method 400 includes inserting a resilient and removable elongated displacement unit 101 in a delivered state into the coronary sinus CS adjacent to the valve; positioning the proximal reversibly deployable portion 102 against the tissue wall at the entrance of the CS. Figure 5a ); Anchor the distal anchoring portion 103 to 403 within CS ( Figure 5b ); Activating displacement unit 101 404 puts it in an active state, thereby moving the distal anchoring portion 103 in the longitudinal direction 104 of displacement unit 101 to reduce the distance (L) between the distal anchoring portion 103 and the proximal deployable portion 102, so that the shape of the annulus is corrected to a corrected shape. Method 400 further includes advancing the support 105 through the proximal deployable portion 102 and on the displacement unit 101 into the CS ( Figure 5e -f); Anchor the stent 105 to 406 in the CS to maintain the corrected shape of the valve annulus ( Figure 5g-i); withdraw 407 displacement unit 101 via bracket 105 to temporarily activate 408 displacement unit 101 after it has been temporarily activated in the active state. Figure 5j -l, 6b). Therefore, method 400 provides the above-mentioned annulusoplasty device 100 and Figure 1-7 The aforementioned advantages. Method 400 provides an improved annulusoplasty device procedure, increasing the degree of control over the reduction surgery while ensuring secure anchorage of the stent 105 and minimizing the risk of damage to the CS. When the proximal deployable portion 102 is deployed outside the CS and the displacement unit 101 is activated, advancing the stent 105 into the CS on the displacement unit 101 provides secure positioning and fixation of the stent 105 after the valve has been corrected by the displacement unit 101. Therefore, a particularly robust and reliable annulusoplasty procedure is provided.

[0066] Figure 6b Another flowchart illustrates method 400 for treating defective mitral valves. The order of steps in method 400 should not be interpreted as restrictive, and it is conceivable that the order in which the steps of method 400 are performed can vary.

[0067] The distal anchoring portion 103 may include an inflatable unit, also indicated by reference numeral 103. The distal anchoring portion 103 may include inflating the inflatable unit 103 in the coronary sinus and / or great cardiac vein and / or anterior interventricular branch or vein and / or posterior vein and / or posterior ventricular vein 4031.

[0068] The proximal deployable portion 102 can be connected to the sheath 107. Positioning the proximal deployable portion 102 may include pushing the proximal portion 108 of the sheath 107 toward the distal anchoring portion 103 4021 so that the proximal deployable portion 102 deploys in the radial direction (R).

[0069] The anchoring stent 105 may include retracting 4061 the conduit 109 surrounding the stent 105 and deploying 4062 the stent 105 in a radial direction (R) perpendicular to the longitudinal direction 104, such as... Figure 5g -h is an illustrative example.

[0070] The conduit 109 is movable in the longitudinal direction 104 through the proximal expandable portion 102 and is movable on the displacement unit 101, providing the aforementioned advantageous effects.

[0071] The anchoring bracket 105 may include anchoring the retaining unit 110 of the bracket 105 4063 in the CS to maintain the corrected shape of the valve annulus when the displacement unit 101 is retracted, such as Figure 5g -l is used to illustrate.

[0072] The anchoring retaining unit 110 may include anchoring the retaining unit 110 4064 in the tissue wall of the CS in the direction of the valve annulus.

[0073] Method 400 may include advancing catheter 109 on stent 105 4065 to disengage stent 105 from CS for repositioning or removing stent 105 from CS.

[0074] Anchoring support 105 may include a delivery device 106 4066 for releasing support 105 from a delivery device 106 movably disposed within conduit 109. Figure 5k ).

[0075] The present invention has been described above with reference to specific embodiments. However, other embodiments besides those described above may also be within the scope of the present invention. Different features and steps of the present invention may be combined in ways different from those described. The scope of the present invention is limited only by the appended claims.

[0076] More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described in this application are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on the specific application or the application using the teachings of this invention.

Claims

1. An annuloplasty device (100) for treating a defective mitral valve with a valve annulus, comprising: A removable and resilient elongated displacement unit (101) for temporary insertion into the coronary sinus (CS) adjacent to the valve, wherein the displacement unit has a delivery state for delivery into the CS and an activation state from which the displacement unit can temporarily and reversibly transition temporarily and reversibly. A reversibly foldable, unfoldable portion (102) of the proximal reversibly unfoldable part of the tissue wall at the entrance of the CS is used to position the tissue wall. The displacement unit includes a distal anchoring portion (103) movable relative to the proximal deployable portion in the longitudinal direction (104) of the displacement unit in the activated state. When inserted into the CS, the shape of the valve annulus is corrected to a modified shape in the activated state. A bracket (105) arranged around the displacement element and movable relative to the displacement element in the longitudinal direction for insertion into the CS, and The support and delivery device (106) are releasably connected and arranged radially in the radial direction (R) between the displacement unit and the proximal deployable portion, the radial direction (R) being perpendicular to the longitudinal direction. The proximal deployable portion is connected to the sheath (107) and configured to unfold in the radial direction (R) by pushing the proximal portion (108) of the sheath toward the distal anchoring portion. The annulusoplasty device includes: A catheter (109) surrounds and positions the stent relative to the displacement unit in the longitudinal direction, wherein the stent can be ejected from and retracted into the catheter by a delivery device. In the activated state, the catheter is movable in the longitudinal direction on the displacement unit and inside the sheath.

2. The valve annuloplasty device according to claim 1, wherein the stent is reversibly deployable in the radial direction (R) in the activated state.

3. The annulusoplasty device according to claim 1 or 2, wherein the stent includes a retaining unit (110) to anchor the stent in the CS.

4. The valve annulusop apparatus according to claim 3, wherein the retaining unit is arranged on the defined surface portion (111) of the stent, and the retaining unit is adapted to be arranged toward the valve annulus when the stent is in the CS.

5. The valve annuloplasty apparatus of claim 3, wherein a plurality of retaining units are arranged around the periphery of the support.

6. The annulusoplasty apparatus of claim 3, wherein the retaining unit is elastically movable from a retracted state to an extended state, thereby the retaining unit being elastic to: When placed inside a catheter, it bends from the deployed state to the retracted state, and When released from the catheter, it unfolds from the retracted state to the unfolded state.

7. The annulusoplasty device according to claim 6, wherein the unit remains substantially flush with the outer diameter of the stent in the retracted state.

8. The valve annuloplasty apparatus of claim 1, wherein when the displacement unit transitions from the delivery state to the activation state, the longitudinal distance (L) between the proximal deployable portion and the distal anchoring portion is reduced to a shortened distance (L').

9. The annulusoplasty device according to claim 1, wherein the proximal deployable portion includes an elongated rib (112) formed in the sheath (107) through an elongated cut (113) in the sheath, extending in the longitudinal direction, the rib being foldable to deploy in the radial direction (R).

10. The valve annuloplasty apparatus of claim 1, wherein the distal anchoring portion includes an inflatable unit that is deployable in the radial direction (R).

11. The valve annuloplasty apparatus of claim 1, comprising a wire (115) arranged to extend within the cavity (116) of the displacement unit and exit the cavity at a distal opening (117) of the displacement unit.

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