An annuloplasty device is disclosed comprising first and second support rings having a coiled configuration, and respective first and second retention units, the first support ring transitions to the second support ring over a transition section, the transition section is adapted to be arranged at a commissure of the heart valve leaflets, a first posterior bow of the first support ring and a second posterior bow of the second support ring extend in respective first and second coil planes being essentially perpendicular to the central axis, the transition section bends at least partly along the central axis so that the first coil plane is separated a distance from the second coil plane along the central axis at the transition section.

FIELD OF THE INVENTION

This invention pertains in general to the field of cardiac valve repair. More particularly the invention relates to an annuloplasty device, such as an annuloplasty ring or helix, for positioning at the heart valve annulus and a method of repairing a defective heart valve.

BACKGROUND OF THE INVENTION

Diseased mitral and tricuspid valves frequently need replacement or repair. The mitral and tricuspid valve leaflets or supporting chordae may degenerate and weaken or the annulus may dilate leading to valve leak. Mitral and tricuspid valve replacement and repair are frequently performed with aid of an annuloplasty ring, used to reduce the diameter of the annulus, or modify the geometry of the annulus in any other way, or aid as a generally supporting structure during the valve replacement or repair procedure. The annuloplasty ring is typically implanted around the annulus of the heart valve.

A problem with prior art annuloplasty implants is to achieve correct positioning at the heart valve and fixate the implant in the correct position. Suturing devices for annuloplasty implants have disadvantages that makes it difficult to suture in the correct position, thereby resulting insufficient suturing strength, and also in a very time-consuming procedure, which increases the risks for the patient. Furthermore, suturing devices are often not sufficiently compact for catheter based procedures. The use of clips for positioning annuloplasty implants is also associated with challenges, in particular when implanting helix rings that are to be positioned on either side of a heart valve. Insufficient fixation of such implant lead to traumatic effects since the fixation structure must ensure the correct position of the device over time. A further problem in the prior art is thus also to achieve a reliable fixation at the annulus of the heart valve. An annuloplasty implant is intended to function for years and years, so it is critical with long term stability in this regard.

The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.

Hence, an improved annuloplasty implant or device would be advantageous and in particular allowing for avoiding more of the above mentioned problems and compromises, and in particular ensuring secure fixation of the annuloplasty device, during the implantation phase, and for long-term functioning, in addition to a less complex procedure, and increased patient safety. A related method would also be advantageous.

SUMMARY OF THE INVENTION

Accordingly, examples of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device according to the appended patent claims.

According to a first aspect an annuloplasty device is provided comprising first and second support rings having a coiled configuration in which the first and second support rings are arranged as a coil around a central axis, the central axis extending in an axial direction from the second support ring to the first support ring, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, wherein the first support ring is adapted to be arranged on an atrial side of said heart valve, and the second support ring is adapted to be arranged on a ventricular side of the heart valve, wherein the first support ring comprises a first posterior bow and a first anterior portion, the second support ring comprises a second posterior bow and a second anterior portion, the first and second posterior bows are adapted to conform to a posterior aspect of said heart valve, and the first and second anterior portions are adapted to conform to an anterior aspect of said heart valve, wherein the first support ring transitions to the second support ring over a transition section, wherein the transition section is adapted to be arranged at a commissure of the heart valve leaflets, wherein the first posterior bow of the first support ring and the second posterior bow of the second support ring extend in respective first and second coil planes being essentially perpendicular to the central axis, and wherein the transition section bends at least partly along the central axis so that the first coil plane is separated a distance from the second coil plane along the central axis at the transition section.

According to a second aspect an annuloplasty device is provided comprising first and second support rings having a coiled configuration in which the first and second support rings are arranged as a coil around a central axis, the central axis extending in an axial direction from the second support ring to the first support ring, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, wherein the first support ring is adapted to be arranged on an atrial side of said heart valve, and the second support ring is adapted to be arranged on a ventricular side of the heart valve, wherein the first support ring comprises a first posterior bow and a first anterior portion, the second support ring comprises a second posterior bow and a second anterior portion, the first and second posterior bows are adapted to conform to a posterior aspect of said heart valve, and the first and second anterior portions are adapted to conform to an anterior aspect of said heart valve, wherein a tilted section of the first anterior portion raise above the first posterior bow in the axial direction.

According to a third aspect an annuloplasty device is provided comprising first and second support rings having a coiled configuration in which the first and second support rings are arranged as a coil around a central axis, the central axis extending in an axial direction from the second support ring to the first support ring, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, wherein the first support ring is adapted to be arranged on an atrial side of said heart valve, and the second support ring is adapted to be arranged on a ventricular side of the heart valve, wherein the first support ring comprises a first posterior bow and a first anterior portion, the second support ring comprises a second posterior bow and a second anterior portion, the first and second posterior bows are adapted to conform to a posterior aspect of said heart valve, and the first and second anterior portions are adapted to conform to an anterior aspect of said heart valve, wherein the second anterior portion comprises an inverted section extending in parallel with the first and second coil planes, wherein the inverted section and the second posterior bow extend on opposite sides of the first posterior bow with respect to the direction of the central axis.

According to a fourth aspect a method of repairing a defective heart valve is provided, comprising positioning a second support ring of an annuloplasty device on a ventricular side of the heart valve, and positioning a first support ring of the annuloplasty device on an atrial side of the heart valve, the first and second support rings are arranged as a coil around a central axis on opposite sides of native heart valve leaflets of the heart valve. The first and second support rings are positioned so that the first support ring transitions to the second support ring over a transition section positioned at a commissure of the heart valve leaflets. The first and second support rings extend in respective first and second coil planes being essentially perpendicular to the central axis. The transition section bends at least partly along the central axis so that the first coil plane is separated a distance from the second coil plane along the central axis at the transition section.

Further examples of the invention are defined in the dependent claims, wherein features for the first aspect may be implemented for the second and subsequent aspects and vice versa.

Some examples of the disclosure provide for a facilitated positioning of an annuloplasty device at a heart valve.

Some examples of the disclosure provide for a facilitated fixation of an annuloplasty device at a heart valve.

Some examples of the disclosure provide for a less time-consuming fixation of an annuloplasty to a target site.

Some examples of the disclosure provide for securing long-term functioning and position of an annuloplasty device.

Some examples of the disclosure provide for a reduced risk of damaging the anatomy of the heart such as the annulus or the valve leaflets.

Some examples of the disclosure provide for a more secure implantation of an annuloplasty device in narrow anatomies.

Some examples of the disclosure provide for an annuloplasty device with improved accommodation to the anatomy of a heart valve.

Some examples of the disclosure provide for an annuloplasty device with an increased retention force at the heart valve.

DESCRIPTION OF EMBODIMENTS

The following description focuses on an embodiment of the present invention applicable to cardiac valve implants such as annuloplasty rings. However, it will be appreciated that the invention is not limited to this application but may be applied to many other annuloplasty implants and cardiac valve implants including for example replacement valves, and other medical implantable devices.

FIG.1schematically illustrates an example of an annuloplasty device100comprising a first support ring101and second support ring102which are adapted to be arranged as a coil, i.e. in a helix-shape, in a coiled configuration around a central axis103, as illustrated inFIG.1. The device100is arranged in the coiled configuration at least when in a relaxed state of the material from which the device100is formed, i.e. free from outside forces acting upon the device100. The coil-shaped device100has two free ends116,116′. The first and second support rings101,102, and the respective free ends116,116′, are configured to be arranged on opposite sides of native heart valve leaflets301of a heart valve, as illustrated in e.g. the side view ofFIG.11. As shown inFIG.11, the first support ring101may be arranged on an atrial side of the heart valve, and the second support ring102may be arranged on a ventricular side (the second support ring102is also shown with dashed lines in the top-down view ofFIG.12, where the valve leaflets have been omitted). The second support ring102is illustrated with a dashed line and is in these examples arranged on the ventricular side of the heart valve, whereas the first support ring101is arranged on the atrial side of the heart valve (shown with solid line). The first support ring101may thus extend along the annulus of the heart valve on the atrial side. The transition point between the first and second rings101,102, is in the example ofFIG.12at the commissure denoted302′.FIGS.1-8,10,11, show examples of an annuloplasty device100which may be arranged as illustrated inFIG.12.

The first and second support rings101,102, are connected to form a coil- or helix shaped ring, as an integral continuous ring. The coil extends through the valve opening at a commissure302′, thereof, as schematically illustrated inFIG.12. The first and second support rings101,102, may thus assume the coiled configuration also when in an implanted state. As explained further below, the device100may comprise a shape-memory material, so that the device100re-assumes the coiled configuration after having been delivered from a catheter (not shown) to the target site, after having been temporarily restrained in an elongated configuration of the catheter. The annuloplasty device100, i.e. annuloplasty implant100, may comprise a shape memory material, such as NiTiNol, or another suitable biocompatible alloy that can be heat-set in defined shapes, i.e. in a defined relaxed shape in absence of outside acting forces, as described further below, in a heat treatment procedure. The annuloplasty device100may pinch the tissue of the valve leaflets301, between the first and second support rings101,102, i.e. with forces acting parallel with the central axis103.

The annuloplasty device100may optionally comprise retention units104,104′, as schematically illustrated in the perspective view ofFIG.8and in the side view ofFIG.11.FIGS.8and11show examples where a plurality of retention units104,104′, are arranged on the first and second support rings101,102. The device100may be in an elongated stretched configuration while being restrained in a catheter. However, as mentioned above, the device100assumes the coiled shape when released from the catheter, whereupon the retention units104,104′, may engage the tissue on the atrial and ventricular sides of the heart valve, as exemplified inFIG.11. The retention units104,104′, are configured to engage the tissue of the valve and anchor the device100at the valve, and are described in more detail below.

The first support ring101transitions to the second support ring102over a transition section120, as illustrated in e.g.FIGS.1-4,5c,6-8,10a-b. The transition section120is adapted to be arranged at a commissure302,302′, of the heart valve leaflets, e.g. at a commissure302′ as illustrated inFIG.12. The first and second support rings101,102, extend in respective first and second coil planes101′,102′, being essentially perpendicular to the central axis103, as illustrated in e.g.FIG.2c. The transition section120may bend at least partly along the central axis103so that the first coil plane101′ is separated a distance (d1) from the second coil plane102′ along the central axis103(i.e. along a direction parallel to the central axis) at the transition section120. Having such transition section120where the coil planes101′,102′, are locally displaced a distance (d1), and at a position corresponding to the location of the commissure302,302′, provides for improved accommodation of the first and second support rings101,102, to the anatomy at the opposite sides of the valve, in particular as the heart beats. Having a step-down in the coil planes101′,102′, or an “S-shape”, or “Z-shape”, of the support rings101,102, at the transition section120due to separation distance (d1) provides for a better coaptation of the first and second support rings101,102, at the commissure302,302′. I.e. the risk of having the moving valve leaflets pulling on any of the support rings101,102, at the commissure302,302′, is minimized because the first coil plane101′ of the first support ring101on the atrial side transitions to the second coil plane102′ of the second support ring102over a reduced distance at the transition section120due to the displacement (d1) (i.e. corresponding to a local section120of increased pitch or rise of the coil formed by the adjacent support rings101,102). This means that the first and second support rings101,102, may conform better to the two opposite sides of the valve close to the commissure302,302′. The annuloplasty device100may thus be secured at the valve in a safer manner, while the risk of dislocations is minimized. The position of the transition section120may be varied depending on which commissure302,302′, the first/second support rings101,102, extend through the valve leaflets. The transition section120may thus have an increased slope or pitch relative the central axis103compared to the remaining portions of the first and second support rings101,102.

The length of the transition section120may in one example correspond to approximately an off-set distance117between free ends116,116′, as schematically illustrated inFIG.2a. In one example the transition section120may be arranged after the first support ring101forms essentially one complete loop, as exemplified inFIGS.1and2a.

The transition section120may bend at least partly along a radial direction (R), where the radial direction (R) is perpendicular to the central axis103, so that the transition section120is concave towards the radial direction (R).FIG.10aillustrates an example of such concave bend, or “C-curve”, of the transition section120towards the radial direction (R). This may provide for further improving the coaptation of the first and second support rings101,102, to the valve anatomy close to the commissure302,302′. The risk of having a disadvantageous force transfer or friction between the moving valve leaflets and any of the support rings101,102, at the commissure302,302′, can be minimized. The first and second support rings101,102, may extend along the annulus as far as possible while extending through the commissure302,302′, with minimized impact on the valve motion, as the concave bend of the transition section120allows for adapting to anatomies where the commissure302,302′, is located closer to the central axis103than the annulus. The annuloplasty device100may thus be secured at the valve in a further improved manner, while the risk of dislocations in the long term is minimized.

The first support ring101may comprise a first posterior bow113and a first anterior portion114. The second support ring102may comprise a second posterior bow113′ and a second anterior portion114′. The first and second posterior bows113,113′, may be adapted to conform to a posterior aspect of the heart valve, i.e. along the posterior leaflet, having a bow-shaped extension. The first and second anterior portions114,114′, may each have a straighter extension or at least an extension which is less bent than the bow-shaped posterior sides113,113′. This is exemplified in e.g.FIGS.1,2a,8. The first and second anterior portions114,114′, may thus be adapted to conform to an anterior aspect of the heart valve, i.e. along an anterior leaflet.

The first anterior portion114of the first support ring101may comprise a tilted section127, which is angled in the axial direction103′. The axial direction103′ is orthogonal to the first and second coil planes101′,102′, an is directed from the second support ring102to the first support ring101. The tilted section127is angled such that it raises above the first posterior bow113in the axial direction103′, as schematically illustrated inFIG.5c. A perspective view of the tilted section127is further schematically illustrated inFIG.1. Having a tilted section127of the first anterior portion114provides for an improved coaptation of the annuloplasty device100to the anterior portion of the heart valve on the atrial side with reduced risk of interference with the anterior leaflet of the mitral valve. As the first and second support rings101,102, are positioned on opposite sides of the valve leaflets, as schematically indicated inFIG.11, the valve tissue push the first and second support rings101,102, apart. The tilted section127may be movable about the transition section120, in the axial direction103′, so that the tilted section127is movable to extend essentially in parallel with the first and/or second coil planes101′,101′, of the first and second posterior bows113,113′.FIG.5dis a schematic illustration of such movement, where the first and second support rings101,102, are pushed apart, causing the tilted section127to assume a position where it is essentially in parallel with the first and second posterior bows113,113′. The dashed lines inFIG.5dcorrespond to the relaxed position of the annuloplasty device100shown inFIG.5c, where no external forces act upon the annuloplasty device100. The indicated arrows show the movement of the first support ring101and the tilted section127thereof about the transition section120. Having a tilted section127as described provides for accommodating the tissue between the first and second support rings101,102, with reduced interference with the anterior valve leaflet. As the annuloplasty device100is inserted into the implanted position the transition section120is inserted into place through the commissure302′ (FIG.12). The first anterior portion114in the atrium will transition to the second posterior bow113′ in the ventricle over the transition section120(see further perspective view ofFIG.1). Having a first anterior portion114raising above the first coil plane101′ of the first posterior bow113, by having a tilted section127as described above, allows for the second support ring102and the second posterior bow113′ to move downwards, i.e. opposite the axial direction103′, to accommodate leaflet tissue upon said insertion and pull the tilted section127to a position in parallel with the first and/or second coil plane101,102′, as illustrated inFIG.5d. The risk of having the first anterior portion114applying too high pressure onto the valve tissue on the atrial side, in particular close to the commissure302′, can thereby be reduced. The first anterior portion114may instead be arranged in a parallel position when implanted so that an even pressure is applied to the tissue along the length of the first anterior portion114. The risk of damage to the leaflet tissue is thus reduced.

The tilted section127may further assume a position essentially in parallel with an inverted section124of the second anterior portion114′ when the first and second support rings101,102, are separated to accommodate tissue, as further illustrated inFIG.5d. An even and effective retention force to the valve tissue may thus be provided between section127of the first anterior portion114and the inverted section124. A more secure and reliable implantation is thus provided. The inverted section124is described in more detail below.

FIG.7is a view of the annuloplasty device100according to an example where the first and second support rings101,102, have been unfolded or un-coiled to assume a stretched-out elongated configuration. The curvatures and relative positions of the first and second anterior portions114,114′, are illustrated in relation to the first and second posterior bows113,113′. The relative positions are shown in the axial direction103′ of the central axis103as well as in a direction perpendicular to the axial direction103′, i.e. horizontally inFIG.7. The extension of the first and second coil planes101′,102′, relative the axial direction103′, are also indicated for reference. As shown in the example ofFIG.7, the tilted section127is angled from the first posterior bow113, i.e. from the first coil plane101′, towards the axial direction103′. Moving from the left to the right inFIG.7, the tilted section127joins to the transition section120which curves in a direction against the axial direction103′ towards to the position of the second posterior bow113′. The second posterior bow113′ (or the second coil plane102′ thereof) and the tilted section127are thus arranged on opposite sides of the first posterior bow113(or the first coil plane101′ thereof). This further provides for the indicated separation distance d1between the first and second coil planes101′,102′.

The tilted section may raise to an apex128of maximum separation from the first posterior bow113along the axial direction103′, as schematically indicated in e.g. the side views ofFIGS.4c,5c, and7. The first anterior portion114transitions gradually with a smooth curved shape from the apex128to the transition section120. The tilted section127may extend in an essentially linear shape from the first posterior bow113to the apex128, as schematically illustrated in the examples ofFIGS.5cand7. The first anterior portion114may thus provide an incremental and linear increase in the separation from the first coil plane101′, towards the apex128. As the second support ring102is inserted into the ventricular side it pulls the tilted section127down towards the valve tissue via the transition section120, so that the tilted section127assumes a position essentially in parallel with the first and second posterior bows113,113′ (FIG.5d). Having a linear shape of the tilted section127allows for the first anterior portion114to apply an even retention force to the tissue along its length as the tilted section127assumes the essentially parallel position discussed in relation toFIG.5dabove. Thus, an improved and more secure fit to the surrounding anatomy is provided when the first anterior portion114is positioned at the anterior side of the valve in the atrium.

The advantageous features of the tilted section127as described above provides for an improved annuloplasty device100with a stronger retention into the tissue, also in absence of the aforementioned transition section120. The tilted section127thus also provides for a separate aspect of the invention.

In the examples illustrated in e.g.FIGS.1,2cand5c. The transition section120connects the apex128and the second support ring102. As illustrated, the transition section120may form a smooth curve from the apex128towards the second posterior bow113′ and the associated second coil plane102′. This provides for a reliable and non-traumatic coaptation to the anatomy at the commissure302′, through which the transitions section120is arranged.

As elucidated above, a separation (s1) between the apex128and the first posterior bow113in the axial direction103′ may be less than a separation (s2) between the apex128and the second posterior bow113′ in the axial direction103′. A tilted section127as described above may thus be provided while maintaining a separation distance d1between the first and second coil planes101′,102′.

The second anterior portion114′ may comprise an inverted section124extending in parallel with the first and second coil planes101′,102′. The inverted section124and the second posterior bow113′ extend on opposite sides of the first posterior bow113, of the first support ring101, with respect to the direction of the central axis103, as schematically illustrated in e.g. the side views ofFIGS.2c,5cand the perspective view ofFIG.1. The inverted section124is further illustrated in the view ofFIG.7, showing the first and second support rings101,102, in an un-coiled elongated configuration. Having a section of the second anterior portion114′ raised above the first support ring101, i.e. above the first posterior bow113, as illustrated inFIG.5c, provides for increasing the compression force along the first and second anterior portions114,114′, when the first and second support rings101,102, are arranged on opposite sides of the heart valve. When the annuloplasty device100is positioned at the heart valve, with the second support ring102arranged on the ventricular side, the inverted section124will be pushed down, i.e. against the axial direction103′ inFIG.5c, when forced into place at the heart valve. The second anterior portion114′ will thus be placed on the ventricular side of the heart valve. Having an inverted section124in the relaxed state of the annuloplasty device100means that the second anterior portion114′ will strive towards the relaxed shape, free from outside forces, as illustrated in e.g.FIG.5c. The inverted section124of the second anterior portion114′ will thus strive to a position above the first posterior bow113(as shown inFIG.5c), with respect to the central axis103. This will cause an increased pressure on the valve tissue along the inverted section124, and between the first and second anterior portions114,114′, when the annuloplasty device100is implanted. This provides for a more secure fixation of the annuloplasty device100at the heart valve. Having an inverted section124as described above provides for an effective anchoring of the second anterior portion114′ along the aorto-mitral curtain which is the junction between the base of anterior mitral leaflet and aortic root. The inverted section124may be effectively anchored behind the aorto-mitral curtain. The inverted section124provides for creating a retention force to the tissue which prevents rotation or slipping of the annuloplasty device100around central axis103, since the inverted section124forms an angle (v1) with the coil planes101′,102′ (seeFIG.2c). The inverted section124may thus exert a force onto the tissue which has a force vector component extending in parallel with the coil planes101′,102′. The aforementioned force may be applied along the extension of the inverted section124and/or any of the curved transition sections125,126thereof. This provides for a more secure, robust, and reliable anchoring of the annuloplasty device at the heart valve. This provides for an improved function and safety for the patient, both short term and long term. The implantation procedure may thus be accomplished in less time and with improved control. A secure positioning of the first and second support rings101,102, at the opposite sides of the heart valve is facilitated.

Turning again toFIG.5c, the inverted section124may raise above the first posterior bow113in the axial direction103′ along a width (w1) of the invented section124. The aforementioned width (w1) may be a fraction of a width (w2) of the first or second support rings101,102, in a direction essentially in parallel with the first or second anterior portions114,114′, as schematically illustrated in the example ofFIG.5c. The fraction may be in the range 30 - 80%. I.e. width w1may be 30 - 80% of width w2. This may provide for an advantageous compression of the tissue between the first and second anterior portions114,114′. The width w1may in some examples be in the range 50 -60 % of width w2, for a particularly advantageous and reliable positioning of the first and second anterior portions114,114′, on the opposite sides of the valve leaflets.

In one example the inverted section124may be arranged symmetrically with respect to the central axis103, e.g. essentially centrally with respect to the width w2of the support rings101,102, as exemplified inFIG.5c. The transition sections125,126, forming the curvature of the inverted section124along the axial direction103′ may also be essentially symmetrically shaped relative the central axis103, with respect to the respective degree of inclination and declination from the second coil plane102′, as illustrated in the example ofFIG.5c. This provides for an advantageous compression of the tissue between the first and second anterior portions114,114′. Turning to the top-down view ofFIG.2a, the curvature of the second anterior portion114′ in the coil planes101,102′, i.e. orthogonal to central axis103, may be essentially symmetrical with respect to a radial direction (R) extending vertically from the center axis103inFIG.2a. The free end116′ may be arranged radially outside the first anterior portion114. This provides for improved accommodation of the free end116′ into the subannular groove. The curvature of the first anterior portion114in the coil planes101,102′, may also be essentially symmetrical with respect to a radial direction (R) extending vertically from the center axis103inFIG.2a.

Turning again to the example ofFIG.7, a separation (s2) between the apex128and the second posterior bow113′ in the axial direction103′ may correspond essentially to a separation (s3) between the inverted section124and the second posterior bow113′ in the axial direction103′. Further, it is illustrated in the example side view ofFIG.2cthat the apex128and the inverted section124may be arranged at a similar height with respect to the second coil plane102′ and the axial direction103′. Such height of the apex128allows for advantageously accommodating the movement between the first and second support rings101,102, as tissue is pinched therebetween, while attaining an even distribution of the compression force between and along the first and second anterior portions114,114′, as described above in relation toFIG.5d.

The first and second support rings101,102, have respective first and second free ends116,116′, configured to be arranged on opposite sides of the native heart valve leaflets, as described above. In one example, the inverted section124transitions to the free end116′ of the second support ring102over an anterior transition section125, as schematically illustrated in the side view ofFIG.5cand the perspective view ofFIG.3. The anterior transition section125bends at least partly along the central axis103so that the free end116′ of the second support ring102is arranged on the same side of the first posterior bow113, of the first support ring101, as the second posterior bow113′, with respect to the direction of the central axis103. Having the free end116′ recessed from the inverted section124, against the axial direction103′, provides for a further improved accommodation to the anatomy of the heart valve. For example, the free end116′ may be positioned to sit in the subannular groove by having such anterior transition section125. The anterior transition section125may be arranged at the end of the first and second anterior portions114,114′, in a direction towards the free end116′, as further exemplified inFIGS.1and3. The second support ring102may comprise a free end116′ which is curved towards the free end116of the first support ring101, in the plane of the coil planes101′,102′, as further exemplified inFIG.2a. The second support ring102may thus be bent after the second anterior portion114′, i.e. adjacent the position of the commissure. In one example, the anterior transition section125is arranged towards the end of the second anterior portion114′, in a direction towards the free end116′, so that essentially the entire curved part of the second support ring102, after the second anterior portion114′, is arranged at the same side of the first support ring101as the second posterior bow113′ with respect to the direction of the central axis103(FIG.5c). This provides in some examples for an improved fit to the surrounding anatomy of the annuloplasty device100.

In one example the anterior transition section125may be curved such that the free end116′ is positioned with the same separation (d1) from first coil plane101′ as the second posterior bow113′. I.e. the free end116′ is arranged at the same position as the second posterior bow113′ with respect to the axial direction103′ (FIG.5candFIG.7). The anterior transition section125may comprise a smooth curvature forming a smooth transition from the inverted section124to an end section130of the second support ring102, as exemplified in e.g.FIG.7. The end section130may be aligned to extend in the second coil plane102′, and terminating with the free end116′.

The second anterior portion114′ may comprise a second anterior transition section126, where the second support ring102is bent in a direction along the central axis103to form the step-up curve of the inverted section124, as exemplified inFIGS.5cand7. The step-down curve of the inverted section124, towards the free end116′, may consequently be formed by the anterior transition section125described above. The advantageous features of the inverted section124, and anterior transition sections125,126, described in relation toFIGS.1,3,5c, provides for an improved annuloplasty device100with a stronger retention into the tissue, also in absence of the aforementioned transition section120and/or tilted section127. The inverted section124thus also provides for a separate aspect of the invention.

Turning toFIG.2c, the inverted section124may be angled from the second coil plane102′ towards the axial direction103′ with a first angle (v1). The transition section120may be angled from the second coil plane102′ towards the axial direction103′ with a second angle (v2). The second angle (v2) may be an acute angle, as schematically illustrated inFIG.2c. The second angle (v2) may be less than the first angle (v1), as further illustrated inFIG.2c. This provides for an advantageous coaptation of the annuloplasty device100to the anatomy around the commissure302′ as well as a reliable compression of the tissue between the first and second anterior portions114,114′. In one example, the inverted section124may extend in a direction essentially perpendicular to the second coil plane102′. I.e. the first angle v1may be an essentially right angle to the second coil plane102′. This provides for an effective anchoring of the annuloplasty device100along the anterior side of the valve.

At least part of the first anterior portion114and/or the second anterior portion114′ may be curved to form a respective concave section123,123′, being concave towards a radial direction (R), where the radial direction (R) is perpendicular to the central axis103, as schematically illustrated inFIG.10a. This provides for further improving the accommodation of the first and second support rings101,102, to the anatomy of the valve and its annulus. E.g. the concave sections123,123′, may provide for a better accommodation to the anatomy around the rounded aortic valve. A more secure attachment of the annuloplasty device100is achieved, and long-term reliability of the implantation.

The first anterior portion114may be displaced a distance (I1) from the second anterior portion114′ along a radial direction (R) so that at least part of the second anterior portion114′ extends with a greater radius (r) from the central axis103than the first anterior portion114, as schematically illustrated inFIG.2a. Thus, when the first support ring101is arranged on the atrial side and the second support ring102is arranged on the ventricular side, the second anterior portion114′ of the second support ring102will extend with a greater radius from the central axis103than the first anterior portion114of the first support ring101. Having a greater radius of the second support ring102on the ventricular side provides for an effective pinching of the valve tissue at the aorto-septal wall, and thus a more secure anchoring of the annuloplasty device100.

As schematically illustrated inFIG.2a, the first posterior bow113may be displaced a distance (I2) from the second posterior bow113′ along a radial direction (R). The radial direction (R) is perpendicular to the central axis103. The off-set between the first and second posterior bows113,113′, provides for an improved fixation of the annuloplasty device100on a downsized posterior annulus and thus a more effective anchoring of the annuloplasty device100. At least part of the first posterior bow113may thus extend with a greater radius (r) from the central axis103than the second posterior bow113′. Having the first support ring101extending with a greater radius in the radial direction along the posterior bow113on the atrial side compared to the posterior bow113′ of the second support ring102on the ventricular side provides for an improved coaptation to the anatomy around the valve on the ventricular side, and thus a more secure anchoring of the annuloplasty device100. Less interference with the native leaflets and chordae may be provided. Circumflexing of the chordae may also be facilitated. In one example the first posterior bow113may be displaced from the second posterior bow113′ with a distance (I2) being less than the thickness, i.e. diameter of the cross-section, of the first and/or second posterior bow113,113′, in the direction of the coil planes101′,102′. This provides for avoiding having a “scissor″-effect on the tissue pinched between the first and second posterior bows113,113′. The risk of tissue abrasion or cutting may thus be reduced. The distance I2may in one example correspond to half the diameter of the first and/or second posterior bow113,113′.

In another example however it should be understood that at least part of the second posterior bow113′ may extend with a greater radius (r) from the central axis103than the first posterior bow113.

The advantageous features of having displacement distances (I1, I2), as described in relation toFIG.2aprovides for an improved annuloplasty device100with an improved anchoring into the tissue. The displacement distances (I1, I2) thus also provide for a separate aspect of the invention.

In one example, the first and second support rings101,102, comprises a resilient shape-memory material and may be movable along the central axis103to pinch the valve leaflets from opposite sides.

In the examples ofFIGS.1-6,8,10-12, the length of the first and second support rings101,102, form essentially two complete loops. This provides in some examples for an improved anchoring of the annuloplasty device100to the heart valve. In some situations, an off-set distance117between free ends116,116′, as schematically illustrated inFIG.2amay be advantageous.

The second posterior bow113′ may comprise a central posterior arch113′a, and further a first commissure section113′band a second commissure section113′con either side of the central posterior arch113′a, as schematically illustrated inFIG.6. The first support ring101transitions to the first commissure section113′bover the transition section120, and the second commissure section113′cconnects to the second anterior portion114′. In one example, a separation distance between the first support ring101and the central posterior arch113′a, along the central axis103, is less than a separation distance between the first support ring101and any of the first and second commissure sections113′b,113′c. This provides for an improved compression between the first and second support rings101,102, along the central posterior arch113′a. The fixation of the annuloplasty device100may thus be facilitated. At the same time, the larger separation distance at the first and second commissure sections113′b,113′c, can provide for a more reliable fit to the tissue at the commissure anatomy of the heart valve, e.g. as described above with respect to having the separation distance (d1) at the transition section120.

In one example, a separation distance between the first commissure section113′band the first support ring101is larger than a separation distance between the second commissure section113′cand the first support ring101. Hence, as described above with respect to the transition section120, this provides for an improved fit to the anatomy where the first support ring101extends through the commissure and transitions to the second support ring102on the opposite side of the heart valve.

A proximal connector element121may be fixed to the free end116of the first support ring101. The example inFIG.1shows a connector element121comprising an aperture for interlocking with a delivery catheter (not shown). Different types of connector elements may be provided at the free end116. The distal end116′ of the second support ring102may be shaped with a blunt tip to reduce the risk of damaging the tissue, seeFIG.1.

The first and/or second support ring101,102, may comprise retention units104,104′, as schematically illustrated in e.g.FIGS.8and11. The first support ring101may comprises first retention units104and the second support ring102may comprise second retention units104′. The first and second retention units104,104′, may extend in opposite directions along the axial direction103′. The retention units104,104′, are directed towards the valve tissue between the first and second support rings101,102, from both of the opposite sides. The first and second retention units104,104′, may thus produce a retention force on opposite sides of the valve leaflets.

The annuloplasty device100may further comprise a stent105,105a,105b, arranged around at least a portion of the first and/or second support ring101,102.FIG.8shows an example where two stents105a,105b, are arranged around portions of the first and second support rings101,102.FIG.9is a further detailed view of a stent105configured to be arranged around at least a portion of the first and/or second support ring101,102. It should be understood that the annuloplasty device100may comprise a varying number of stents105depending on the particular implant site of the annuloplasty device100. Furthermore, the ratio of the total length of the first and/or second support ring101,102, covered by the stent105,105a,105b, may vary depending on the placement of the annuloplasty device100. Although reference is made to stent105in the present disclosure, it should be understood that any of the stents105a,105b, as exemplified inFIG.1may comprise the features as described for stent105in relation toFIG.9. The lattice or framework of the stent105may be formed by laser cutting of a tube-shaped material, such as NiTinol or other bio compatible metal alloy and then pushed over the first and/or second support rings101,102. The stent105thus has a hollow interior to accommodate the first and/or second support rings101,102.

The stent comprises retention units104,104′, as schematically illustrated inFIG.8and in the detailed view ofFIG.9. The retention units104,104′, are shaped to pierce into tissue at the heart valve. The retention units104,104′, are fixed in relation to the stent105, and the stent105is fixed in relation to the first and/or second support ring101,102, on which the stent105is arranged. Thus, having stents105a,105b, arranged around at least part of the first and/or second support rings101,102, provides for anchoring the annuloplasty device100to the valve tissue with the retention units104,104′. The first and/or second support rings101,102, are thus provided with a robust anchoring mechanism by utilizing a stent105,105a,105b, as an intermediate fixation structure for the retention units104,104′, thereby dispensing with the need to attach any retention structures directly to the first and/or second support rings101,102. The stent105thus provides for increasing the reliability of the anchoring mechanism of the annuloplasty device100as the number of separate structures needing to be joined together can be reduced, in particular in the example where the retention units104,104′, are integrated with the stent105as mentioned below. Long-term reliability of the annuloplasty device100may thus be improved. The manufacturing of the annuloplasty device100may thus also be facilitated, as the number of separate elements is minimized. Manufacturing tolerances may thus be easier to comply with and the overall complexity and associated costs may be reduced, providing for a more viable annuloplasty implant100. Having an annuloplasty device100with stents105,105a,105b, and associated retention units104,104′, also provides for a modular annuloplasty device100where a core structure of the first and second support rings101,102, may be provided with stents105,105a,105b, having retention units104,104′, in varying configurations and shapes depending on the particular application. The annuloplasty device100may thus be tailored to the particular patient and anatomical circumstances more easily and patient safety can be further improved.

As elucidated above, the retention units104,104′, may be formed from the material of the stent105. The retention units104,104′, may thus be integrated with the stent105. The detailed view ofFIG.9is a schematic example of how retention units104are formed as a part of the framework of the stent105. The retention unit104may thus be cut as an elongated structure with a free tip107within the structural framework of the stent105. In the example ofFIG.9, the retention unit104is surrounded by support elements108of the stent105. The support elements108may be arranged in a rhombic pattern or closed cells. The retention units104may have a retracted position where the retention units104are collapsed to a similar radius as the support elements108, e.g. by being arranged in the void of individual rhombs or cells at defined positions along the length of the stent105. As described further below, the retention units104may be collapsed when the annuloplasty device100is arranged in a delivery catheter (not shown), and subsequently expanded to the expanded state shown inFIGS.8-9, when removed from the delivery catheter.

In one example, some support elements of the plurality of support elements of a cell may be movable as a retention unit104,104′, along a radial direction (r), perpendicular to a longitudinal direction (L) of the stent105. The retention unit104illustrated inFIG.9may thus be part of the support elements108forming a closed cell.

In one example, the retention unit104, or support element, may be expanded like a bow-like structure in the radial direction (r) to the expanded state. The bow-like shape may thus be configured to apply a pressure into the valve tissue and increase the retention force of the stent105at the annulus.

It should be understood the support elements108may be cut to form varying patterns. Forming the retention units104,104′, as integrated structures of the framework of the stent105provides for robust and strong retention units104,104′, and a minimized risk of dislocations or deformations thereof over time. An overall robust and reliable fixation mechanism of the annuloplasty device100is thus provided. Manufacturing is also facilitated, as mentioned above, as the number of separate elements of the annuloplasty device100requiring assembly is minimized. The retention units104,104′, may be cut to form various shapes for optimizing the gripping force into the tissue. The retention units104,104′, may be formed by different cutting techniques such as by laser cutting techniques.

The retention units104,104′, may be heat-set to assume a defined bent shape as schematically illustrated in the example ofFIG.8, showing an expanded state of the retention units104. The expanded state may thus correspond to a relaxed state of the retention units104where the latter is not acted upon by external forces. The retention unit104may be bent and heat-treated during manufacturing so that the retention unit104assumes a defined shape in the expanded state. The retention unit104may thus have a bias towards the expanded state, by striving towards the relaxed expanded state.

The retention units104,104′, may thus be resiliently moveable from a retracted state to the expanded state. For example, a force may be applied to the retention unit104so that it bends and assumes a retracted position or state, e.g. if a delivery catheter (not shown) applies a compressive force onto the stent105and the related retention unit104. As the stent105is ejected from the delivery catheter, when the annuloplasty device100is deployed from the delivery catheter, the compressive force is removed and the resilience of the retention unit104cause it to move towards the expanded state. This provides for an effective deployment of the retention units104,104′, as the first and second support rings101,102, of the annuloplasty device100are ejected from the delivery catheter. The retention units104,104′, can thus expand and pierce into the valve tissue. The cross-section of the annuloplasty device100may be minimized as the retention units104,104′, may assume the retracted state when positioned inside the delivery catheter. A smaller cross-section provides for a facilitated navigation of the annuloplasty device100to a target site in the heart. The delivery catheter may also be subject to less abrasion and wear from the retention units104,104′, as these may assume the retracted state inside the delivery catheter, causing less friction between the tip107and the inside lumen of the delivery catheter. Reduced friction also facilitates moving the annuloplasty device100along the delivery catheter, requiring less force and improving the amount of control.

Hence, the retention units104,104′, may be flexible to bend from the expanded state to the retracted state. This allows also for the retention units104,104′, to flex to the retracted state if withdrawing the annuloplasty device100into a delivery catheter, in case the implantation is aborted or repositioning is needed. The annuloplasty device100may thus re-assume the compact cross-sectional profile.

In one example the retention units104,104′, may comprise a shape-memory material, where activation of the shape-memory material causes the retention units104,104′, to transfer from the retracted state to the expanded state. For example, the shape-memory material may be temperature activated, so that the retention units104,104′, move towards the expanded state when subject to heating to the body temperature. This provides for an advantageous deployment of the retention units104,104′, in some applications.

The retention units104,104′, may be aligned essentially flush with an outer diameter of the stent105in the retracted state. This provides for a compact cross-sectional profile of the annuloplasty device100as well as reduced risk of high pressure and abrasion of the retention units104,104′, against an inner lumen of a delivery catheter.

The stent105may be radially contractible along a radial direction (r), perpendicular to a longitudinal direction (L) of the stent105, so that the stent105exerts a force on the first and/or second support ring101,102. The radial (r) and longitudinal direction (L) of the stent105is schematically indicated inFIG.9. The stent105may thus assume a fixed position in relation to the first and/or second support ring101,102, as the force creates friction between the stent105and the first and/or second support ring101,102. The framework of the stent105may thus be cut to allow movement in the radial direction (r), i.e. allowing the support elements108of the framework to move in relation to eachother, so that the diameter of the stent105is variable. The stent105may be resiliently expandable in the radial direction (r) so that the stent105may be expanded to a radially stretched state. The stent105may then strive towards a contracted relaxed state with an inner diameter being less than the inner diameter in the radially stretched state. The inner diameter in the radially stretched state may be more or equal to an outer diameter of first and/or second support ring101,102. The stent105may thus be positioned over the first and/or second support ring101,102, when in the radially stretched state. The stent105will thus strive towards the contracted relaxed state with a reduced inner diameter, and accordingly exert the aforementioned force on the first and/or second support ring101,102. This provides for a facilitated fixation of the position of the stent105in relation to the first and/or second support ring101,102. The example inFIG.8shows a cover129between the stent105and the first and/or second support ring101,102, as described in more detail below.

The stent105may comprise a shape-memory material in one example. Activation of the shape-memory material may cause the stent105to contract to a reduced diameter, along the radial direction (r), to apply a force on the first and/or second support ring101,102. For example, the shape-memory material may be temperature activated, so that the stent105strives towards a reduced inner diameter when subject to heating to the body temperature. This provides for increasing the force exerted on the first and/or second support ring101,102, to attain a secure fixation of the stent105thereto.

The annuloplasty device100may comprise a cover129arranged around at least a portion of the first and/or second support ring101,102. The cover129may be configured to promote endothelialization and the ingrowth of cells over the annuloplasty device100. For example, the cover129may have a surface which is more porous than the surface of the first- and second support rings101,102, which promotes the growth of cells over the annuloplasty device100. The cover129may comprise a weave of a textile or a polymer. The stent105may be arranged around at least a portion of the cover106. The cover129may in some examples be arranged around the entire length of the first- and second support rings101,102.

The stent105may exert a force onto the cover106so that the cover129is pinched between the stent105and the first and/or second support ring101,102. Having a cover129pinched between the stent105and the first and/or second support ring101,102, provides for attaining a secure fixation of the position of the cover129and the stent105relative the first and/or second support ring101,102. The stent105may thus strive towards an inner diameter which is smaller than an outer diameter of the cover129when the latter is arranged around the first and/or second support ring101,102, so that a force is exerted radially inwards and pinches the cover129against the outer surface of the first and/or second support ring101,102. In case the stent105is formed from a temperature activated shape-memory material, the stent105may increase the force radially inwards as the stent105is heated to the body temperature, which further increases the strength of the fixation of the stent105relative the first and/or second support ring101,102.

The first posterior bow113may comprise a first posterior stent105acomprising a first plurality of retention units104, as exemplified inFIG.8. The second posterior bow113′ may comprise a second posterior stent105bcomprising a second plurality of retention units104′ extending in a direction towards the first plurality of retention units104′, as further exemplified inFIG.8. The first and second pluralities of retention units104,104′, may thus extend in opposite directions along the axial direction103′.

Having retention units104,104′, at both sides along the first and second posterior bows113,113′, provides for increasing the retention force and the strength by which the annuloplasty device100is fixated at the valve. The retention units104,104′, engage the tissue from both sides of the heart valve, creating a strong retention force in the radial direction, i.e. perpendicular to the axial direction103′. The first and second supports101,102, pinch the tissue from both sides of the valve, so that the retention units104,104′, a forced into the tissue. The retention units104,104′, provides for shaping the annulus as desired even with a reduced pinching force, since the retention units104,104′, provides for fixating the shape of the annulus in the radial direction because of the mentioned retention force. This provides for a more reliable implantation at the heart valve, both in the short term and in the long term.

Having a transition section120as described above allows for the retention units104,104′, of the stent105,105a,105b, to effectively pierce into the tissue as the first and second support rings101,102, accommodate to the anatomy.

Each individual retention unit104,104′, may engage or pierce into the tissue with a short distance, for a minimum amount of injury to the tissue. The sum of the retention force and friction created from all the retention units104,104′, still provides for a strong fixation into the tissue. The scar healing will be quick since each individual retention unit104,104′, as relatively small dimensions. This provides for a non-traumatic and still secure fixation of the annuloplasty device100. Hence, the retention units104,104′, may provide for tissue fixation at multiple points across the annuloplasty device100resulting in reduced forces per fixation point, and no need for bulky stitching device or knotting device. There is further no risk of coronary artery occlusion or coronary sinus perforation. Hence, the annuloplasty device100provides for ease of operation, and a less time consuming procedure than stitching.

In one example, a stent105may be further arranged along the first anterior portion114. This may provide for an advantageous anchoring of the annuloplasty device100in some applications. On one example, it is advantageous to have the second anterior portion114′ with a smooth surface free from retention units114.

In one example the length of the retention units104,104′, is in the range 0.5 -1.5 mm. In another example the length of the retention units104,104′, is in the range 0.8 -1.2 mm, such as 1.0 mm, which may provide for a particularly advantageous fixation into the tissue while being easy to deploy via a delivery catheter.

The retention units104,104′, may in other examples be integrated with the first and/or second support rings101,102. Having retention units104,104′, integrated with the first and/or second rings101,102, may provide for a robust fixation mechanism in some applications.

In some examples, the first and/or second support rings101,102, may have a cross-section which is non-circular, as schematically illustrated inFIGS.6and10a-b. Having a non-circular shape provides for increasing the compression force between the first and second rings101,102, in the coiled configuration while maintaining a compact cross-sectional profile of the first and second rings101,102. The dimensions of the sides of the cross-section may be varied in order to provide for an optimized bending resistance of the support rings101,102. The cross-section may be essentially rectangular.

The cross-section may vary along a longitudinal direction of the first and/or second support ring101,102. The longitudinal direction is the general direction in which the first and/or second support ring101,102, extend with an elongated shape. Varying the aforementioned dimensions of the sides (e.g. the sides of a rectangle) along the length of the first and second support rings101,102, i.e. along the longitudinal direction, allows for varying the flexibility of the rings101,102, along the longitudinal direction and be customized to different anatomical positions around the annulus of the heart valve. This provides for better accommodating movement of the tissue which may be greater at localized sections of the annulus, while other sections may have an increased rigidity for a stronger pinching effect between the first and second support rings101,102. A more secure and robust positioning of the device100may thus be provided and improved long-term functioning. A varying cross-section provides also for optimizing the flexibility with respect to the delivery and positioning phase of the annuloplasty device100. E.g. portions of the first and second support rings101,102, which are subject to the most bending movement when being inserted in a delivery catheter, such as commissure sections113′b,113′c, (see e.g.FIG.6) may have a cross-section which increases the flexibility, e.g. by having a reduced area and/or reduced width in the direction in which the support ring101,102, is bent. At the same time, the width of the cross-section of the first and/or second support ring101,102, may be increased in the direction of the central axis103to increase the rigidity and the compression force along the central axis.

Providing a cross-section of the first and second support rings101,102, which is non-circular, such as rectangular allows for a facilitated manufacturing of the annuloplasty device100. For example, the first and second support rings101,102, may be cut from a sheet in the form as indicated inFIG.7. The cut form may then be coiled-up so that the first and second support rings101,102, assume a coiled configuration as illustrated in the example ofFIG.6.

A method200of repairing a defective heart valve is disclosed. The method200is schematically illustrated inFIG.13a, in conjunction withFIGS.1-12. The order in which the steps are described should not be construed as limiting, and it is conceivable that the order of the steps may be varied depending on the particular procedure. The method200comprises positioning201a second support ring102of an annuloplasty device100on a ventricular side of the heart valve. The method200comprises positioning202a first support ring101of the annuloplasty device100on an atrial side of the heart valve. The first and second support rings101,102, are arranged as a coil around a central axis103on opposite sides of native heart valve leaflets of the heart valve. The first and second support rings101,102, are positioned so that the first support ring101transitions to the second support ring102over a transition section120positioned at a commissure302,302′, of the heart valve leaflets. The first and second support rings101,102, extend in respective first and second coil planes101′,102′, being essentially perpendicular to the central axis103. The transition section120bends at least partly along the central axis103so that the first coil plane101′ is separated a distance (d1) from the second coil plane102′ along the central axis103at the transition section120. The method200provides for the advantageous benefits as discussed above in relation to the annuloplasty device100andFIGS.1-12. The method200allows for a facilitated anchoring of the annuloplasty device100at the heart valve, due to the improved accommodation to the surrounding anatomy at the heart valve and increased compression force between the first and second support rings101,102.

FIG.13bis a further flowchart of a method200of repairing a defective heart valve. The method200may comprise positioning203a stent105,105a,105b, arranged around at least a portion of the first and/or second support ring, in abutment with valve tissue along said portion so that retention units104,104′, of the stent are engaged204into tissue of the heart valve. The method200provides for the advantageous benefits as discussed above in relation to the annuloplasty device100andFIGS.1-10. The method200allows for a facilitated anchoring of the annuloplasty device100at the heart valve, due to the robust and reliable fixation mechanism provided by stents105,105a,105b, and the retention units104,104′, fixed thereto.

The method200may comprise positioning 2031 a first posterior stent105aon the atrial side along a first posterior bow113of the first support ring101, and positioning 2032 a second posterior stent105bon the ventricular side along a second posterior bow113′ of the second support ring102. The method200may further comprise positioning an anterior stent (not shown) on the atrial side of the heart valve along a first anterior portion114of the first support ring101.

The present invention has been described above with reference to specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used.