Annuloplasty Device
An annuloplasty device is disclosed 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, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, a stent arranged around at least a portion of the first and/or second support ring, and wherein the stent comprises retention units. A related method of repairing a defective heart valve is also disclosed.
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 INVENTIONDiseased mitrel and tricuspid valves frequently need replacement or repair. The mitrel and tricuspid valve leaflets or supporting chordae may degenerate and weaken or the annulus may dilate leading to valve leak. Mitrel 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 INVENTIONAccordingly, 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, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, a stent arranged around at least a portion of the first and/or second support ring, and wherein the stent comprises retention units.
According to a second aspect a method of repairing a defective heart valve is provided. The method comprises positioning a first support ring of an annuloplasty device on a ventricular side of the heart valve, positioning a second support ring of the annuloplasty device on an atrial side of the heart valve, whereby the first and second support rings are arranged as a coil extending through a commissure of the heart valve, the first and/or second support ring comprising a stent arranged around at least a portion of the first and/or second support ring, the stent comprising retention units, and positioning the stent in abutment with valve tissue along said portion so that the retention units are engaged into tissue of the heart valve.
Further examples of the invention are defined in the dependent claims, wherein features for the first aspect may be implemented for the second aspect 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.
It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which
Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will 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 accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
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.
The annuloplasty device 100 further comprises a stent 105, 105a, 105b, 105c, arranged around at least a portion of the first and/or second support ring 101, 102.
As elucidated above, the retention units 104, 104′, may be formed from the material of the stent 105. The retention units 104, 104′, may thus be integrated with the stent 105. The detailed view of
It should be understood the support elements 108 may be cut to form varying patterns. Forming the retention units 104, 104′, as integrated structures of the framework of the stent 105 provides for robust and strong retention units 104, 104′, and a minimized risk of dislocations or deformations thereof over time. An overall robust and reliable fixation mechanism of the annuloplasty device 100 is thus provided. Manufacturing is also facilitated, as mentioned above, as the number of separate elements of the annuloplasty device 100 requiring assembly is minimized. The retention units 104, 104′, may be cut to form various shapes for optimizing the gripping force into the tissue. The retention units 104, 104′, may be formed by different cutting techniques such as by laser cutting techniques.
The retention units 104, 104′, may be heat-set to assume a defined bent shape as schematically illustrated in the example of
The retention units 104, 104′, may thus be resiliently moveable from a retracted state (p1) to the expanded state (p2). For example, a force may be applied to the retention unit 104 so that it bends and assumes a retracted position or state (p1), as exemplified in
Hence, the retention units 104, 104′, may be flexible to bend from the expanded state (p2) to the retracted state (p1). This allows also for the retention units 104, 104′, to flex to the retracted state (p1) if withdrawing the annuloplasty device 100 into a delivery catheter, in case the implantation is aborted or repositioning is needed. The annuloplasty device 100 may thus re-assume the compact cross-sectional profile.
In one example the retention units 104, 104′, may comprise a shape-memory material, where activation of the shape-memory material causes the retention units 104, 104′, to transfer from the retracted state (p1) to the expanded state (p2). For example, the shape-memory material may be temperature activated, so that the retention units 104, 104′, move towards the expanded state (p2) when subject to heating to the body temperature. This provides for an advantageous deployment of the retention units 104, 104′, in some applications.
The retention units 104, 104′, may be aligned essentially flush with an outer diameter (D) of the stent 105 in the retracted state (p1), as schematically illustrated in
The stent 105 may be radially contractible along a radial direction (R), perpendicular to a longitudinal direction (L) of the stent 105, so that the stent 105 exerts a force (F) on the first and/or second support ring 101, 102. The radial (R) and longitudinal direction (L) of the stent 105 is schematically indicated in
The stent 105 may comprise a shape-memory material in one example. Activation of the shape-memory material may cause the stent 105 to contract to a reduced diameter, along the radial direction R, to apply a force (F) on the first and/or second support ring 101, 102. For example, the shape-memory material may be temperature activated, so that the stent 105 strives towards a reduced inner diameter when subject to heating to the body temperature. This provides for increasing the force (F) exerted on the first and/or second support ring 101, 102, to attain a secure fixation of the stent 105 thereto.
The support elements 108 may have different shapes configured to predominantly allow movement of the overall framework of the stent 105 in the radial direction (R), with limited or no movement in the longitudinal direction (L).
As exemplified in
The annuloplasty device 100 may comprise a cover 106 arranged around at least a portion of the first and/or second support ring 101, 102. The cover 106 may be configured to promote endothelialization and the ingrowth of cells over the annuloplasty device 100. For example, the cover 106 may have a surface which is more porous than the surface of the first- and second support rings 101, 102, which promotes the growth of cells over the annuloplasty device 100. The cover 106 may comprise a weave of a textile or a polymer. The stent 105 may be arranged around at least a portion of the cover 106. The cover 106 may be arranged around the entire length of the first- and second support rings 101, 102.
The stent 105 may exert a force onto the cover 106 so that the cover 106 is pinched between the stent 105 and the first and/or second support ring 101, 102, as exemplified in the schematic illustration of
The first support ring 101 may comprise a first posterior bow 113 and a first anterior portion 114. The second support ring 101 may comprise a second posterior bow 113′ and a second anterior portion 114′. The first and second posterior bows 113, 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 portions 114, 114′, may each have a straighter extension or at least an extension which is less bent than the bow-shaped posterior sides 113, 113′. This is exemplified in
The first anterior portion 114 may comprises an anterior stent 105c. The anterior stent 105c comprises a plurality of retention units 104 extending towards the second support ring 102 in their expanded state (p2), as schematically illustrated in
The first posterior bow 113 may comprise a first posterior stent 105a. The first posterior stent 105a may comprise a first plurality of retention units 104 extending towards the second support ring 102 in their expanded state (p2), as schematically illustrated in
Each individual retention unit 104, 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 units 104, 104′, still provides for a strong fixation into the tissue. The scar healing will be quick since each individual retention unit 104, 104′, as relatively small dimensions. This provides for a non-traumatic and still secure fixation of the annuloplasty device 100. Hence, the retention units 104, 104′, may provide for tissue fixation at multiple points across the annuloplasty device 100 resulting 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 device 100 provides for ease of operation, and a less time consuming procedure than stitching.
Having a plurality of separate stents 105a, 105b, 105c, arranged along the posterior bows 113, 113′, and the first anterior portion 114 allows further for having the stents 105a, 105b, 105c, displaced from intermediate portions 109 extending therebetween. The intermediate portions 109 as indicated in
The retention units 104, 104′, may be evenly spaced along the stents 105, 105a, 105b, 105c, as exemplified in
The first support ring 101 may transition to the second support ring 102 over a transition section 120, as illustrated in
Further, having a step-down in the coil planes 101′, 102′, or an “S-shape”, or “Z-shape”, at the transition region 120 due to separation distance (d1) provides for a better coaptation of the first and second support rings 101, 102, at the commissure 302, 302′. I.e. the risk of having the moving valve leaflets pulling on any of the support rings 101, 102, at the commissure 302, 302′, is minimized because the first coil plane 101′ of the first support ring 101 on the atrial side transitions to the second coil plane 102′ of the second support ring 102 in a shorter distance at the transition region 120 due to the displacement (d1). This means that the first and second support rings 101, 102, may conform better to the two opposite sides of the valve close to the commissure 302, 302′. The annuloplasty device 100 may thus be secured at the valve in a safer manner, while the risk of dislocations is minimized. The position of the transition section 120 may be varied depending on which commissure 302, 302′, the first/second support rings 101, 102, extend through the valve leaflets. The transition section 120 may thus have an increased slope or pitch relative the central axis 103 compared to the remaining portions of the first and second support rings 101, 102.
The transition section 120 may bend at least partly along a radial direction (r) of the coiled configuration of the first and second support rings 101, 102, where the radial direction (r) is perpendicular to the central axis 103, so that the transition section 120 is concave towards the radial direction (r). Such concave bend, or “C-curve”, of the transition section 120 towards the radial direction (R) provides for further improving the coaptation of the first and second support rings 101, 102, to the valve anatomy close to the commissure 302, 302′. The risk of having a disadvantageous force transfer or friction between the moving valve leaflets and any of the support rings 101, 102, at the commissure 302, 302′, is minimized. The first and second support rings 101, 102, may extend along the annulus as far as possible while extending through the commissure 302, 302′, with minimized impact on the valve motion, as the concave bend of the transition section 120 allows for adapting to anatomies where the commissure 302, 302′, is located loser to the central axis 103 than the annulus. The annuloplasty device 100 may thus be secured at the valve in a further improved manner, while the risk of dislocations in the long term is minimized.
The first and second support rings 101, 102, may have respective free ends 116, 116′, as illustrated in
A method 200 of repairing a defective heart valve is disclosed. The method 200 is schematically illustrated in
A further method 200 is schematically illustrated in
The method 200 may further comprise engaging 2041 retention units 104 of the anterior stent 105c into valve tissue on the atrial side, and engaging 2042 retention units 104, 104′, of the first and second posterior stents 105a, 105b, into valve tissue on the respective atrial and ventricular side to anchor the annuloplasty device 100 at the heart valve. A secure fixation of the annuloplasty device at the opposite sides of the heart valve leaflets is thus provided, as described further above with respect to
The method 200 may comprise positioning the first and second support rings 101, 102, on the respective atrial and ventricular sides of the heart valve by ejecting 2021 the first and second support rings from a delivery catheter (not shown), where the retention units 104, 104′, move from a retracted state (p1) to an expanded state (p2) as the first and second support rings 101, 102, are ejected from the delivery catheter.
The retention units 104, 104′, may be aligned essentially flush with an outer diameter (D) of the stent 105, 105a, 105b, 105c, in the retracted state (p1) when the first and second support rings 101, 102, moves along a lumen if the delivery catheter.
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.
Claims
1. An annuloplasty device 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,
- 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 a stent is arranged around at least a portion of the first and/or second support ring, and
- wherein the stent comprises retention units.
2. The annuloplasty device according to claim 1, wherein the retention units are formed from the material of the stent, whereby the retention units are integrated with the stent.
3. The annuloplasty device according to claim 1, wherein the retention units comprise a shape-memory material, wherein activation of the shape-memory material causes the retention units to transfer from a retracted state (p1) to an expanded state (p2).
4. The annuloplasty device according to claim 1, wherein the retention units are resiliently moveable from a retracted state (p1) to an expanded state (p2).
5. The annuloplasty device according to claim 4, wherein the retention units are flexible to bend from the expanded state (p2) to the retracted state (p1).
6. The annuloplasty device according to claim 5, wherein the retention units are aligned essentially flush with an outer diameter (D) of the stent in the retracted state.
7. The annuloplasty device according to claim 1, wherein the stent comprises a plurality of support elements (108) forming a stent framework of closed cells (122), wherein a first support element (108a) of the plurality of support elements of a cell (122) is movable as a retention unit (104, 104′) along a radial direction (R), perpendicular to a longitudinal direction (L) of the stent.
8. The annuloplasty device according to claim 1, wherein the stent is radially contractible along a radial direction (R), perpendicular to a longitudinal direction (L) of the stent, so that the stent exerts a force (F) on the first and/or second support ring.
9. The annuloplasty device according to claim 8, wherein the stent comprises a shape-memory material, wherein activation of the shape-memory material causes the stent to contract to a reduced diameter, along a radial direction (R), to apply said force on the first and/or second support ring.
10. The annuloplasty device according to claim 1, wherein the stent comprises support elements configured to be contractible and expandable so that an outer diameter (D1, D2) of the stent is variable between an expanded diameter (D1) and a contracted diameter (D2) while a predefined length (L1) of the stent is essentially maintained.
11. The annuloplasty device according to claim 10, wherein the support elements comprise an elongated main frame extending essentially along the longitudinal direction (L) of the stent, and
- wherein the elongated main frame defines the predefined length (L1) of the stent, whereby the elongated main frame has an essentially fixed position in the longitudinal direction (L) when the outer diameter of the stent varies between the expanded diameter (D1) and the contracted diameter (D2).
12. The annuloplasty device according to claim 1, comprising a cover arranged around at least a portion of the first and/or second support ring, and
- wherein the stent is arranged around at least a portion of the cover.
13. The annuloplasty device according to claim 12, wherein the stent exerts a force onto the cover so that the cover is pinched between the stent and the first and/or second support ring.
14. The annuloplasty device according to claim 1, 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,
- the first anterior portion comprises an anterior stent, the anterior stent comprising a plurality of retention units, and
- the second anterior portion comprises a smooth surface free from retention units.
15. The annuloplasty device according to claim 14, wherein:
- the first posterior bow comprises a first posterior stent comprising a first plurality of retention units, and
- the second posterior bow comprises a second posterior stent comprising a second plurality of retention units extending in a direction towards the first plurality of retention units.
16. The annuloplasty device according to claim 1, wherein:
- 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,
- the first and second support rings extend in respective first and second coil planes being essentially perpendicular to the central axis, and
- the transition section bends at least partly along the central axis so that the first coil plane is separated a distance (d1) from the second coil plane along the central axis at the transition region.
17. A method of repairing a defective heart valve comprising;
- positioning a first support ring of an annuloplasty device on a ventricular side of the heart valve,
- positioning a second support ring of the annuloplasty device on an atrial side of the heart valve, whereby the first and second support rings are arranged as a coil extending through a commissure of the heart valve, the first and/or second support ring comprising a stent arranged around at least a portion of the first and/or second support ring, the stent comprising retention units, and
- positioning the stent in abutment with valve tissue along said portion so that the retention units are engaged into tissue of the heart valve.
18. The method according to claim 17, further comprising
- positioning an anterior stent on the atrial side along a first anterior portion of the first support ring,
- positioning a first posterior stent on the atrial side along a first posterior bow of the first support ring, and
- positioning a second posterior stent on the ventricular side along a second posterior bow of the second support ring.
19. The method according to claim 18, further comprising
- engaging retention units of the anterior stent into valve tissue on the atrial side, and
- engaging retention units of the first and second posterior stents into valve tissue on the respective atrial and ventricular side to anchor the annuloplasty device at the heart valve.
20. The method according to claim 17, further comprising
- positioning the first and second support rings on the respective atrial and ventricular sides of the heart valve by ejecting the first and second support rings from a delivery catheter, whereby the retention units move from a retracted state (p1) to an expanded state (p2) as the first and second support rings are ejected from the delivery catheter.
21. The method according to claim 20, wherein the retention units are aligned essentially flush with an outer diameter (D) of the stent in the retracted state when the first and second support rings moves along the delivery catheter.
Type: Application
Filed: Oct 31, 2021
Publication Date: Jan 18, 2024
Inventor: Olli Keränen (Bjärred)
Application Number: 18/036,800