A MEDICAL DEVICE FOR IMPROVING FUNCTION OF A HEART VALVE

Abstract

A medical device for improving function of a heart valve comprises at least a first partly pliant leaflet having a distal section and a proximal section. The distal section is configured to be oriented towards said inner section of said valve tissue in use. The first leaflet comprises at least two curving segments, such as bending lines extending from the proximal section towards said distal section thereby dividing said first leaflet to at least three portions. The distance between the line ends in the distal section area is shorter than the distance between the line ends in the proximal section area, thereby allowing at least a distal part of the portion locating between said curving segments, such as bending lines and being oriented towards said inner section of said valve tissue to bend to a first direction along the curving segments, such as bending lines when in use.

Claims

1. A medical device for improving function of a heart valve, the heart valve comprising valve tissue, including an annulus at an outer section of said valve tissue and a plurality of leaflets (24) at an inner section of said valve tissue, wherein the medical device comprises: at least a first partly pliant leaflet having a distal section and a proximal section, wherein said distal section is configured to be oriented towards said inner section of said valve tissue, and said first leaflet comprising at least two curving segments extending from the proximal section towards said distal section thereby dividing said first leaflet to at least three portions so that the distance between the line ends of the curving segments in the distal section area is shorter than the distance between the line ends in the proximal section area and thereby allowing at least a distal part of the portion locating between said curving segments and being oriented towards said inner section of said valve tissue to bend to a first direction.

2. A medical device of claim 1, wherein the medical device further comprises: at least a second partly pliant leaflet positioned essentially opposite said first partly flexible leaflet, said second partly flexible leaflet having a distal section and a proximal section, wherein said distal section is configured to be oriented towards said inner section of said valve tissue and said first partly flexible leaflet patch.

3. A medical device of claim 2, wherein said second leaflet comprises at least two curving segments extending from the proximal section towards said distal section thereby dividing said second leaflet to at least three portions so that the distance between the line ends in the distal section area is shorter than the distance between the line ends in the proximal section area and thereby allowing at least a distal part of the portion locating between said curving segments and being oriented towards said inner section of said valve tissue to bend to a first direction along the bending lines.

4. A medical device of claim 2, wherein at least the distal section of the second partly pliant leaflet and at least the distal section of the first partly pliant leaflet are configured to overlap each other to form a coaptation surface area.

5. A medical device of claim 4, wherein the coaptation surface area is configured to be formed in a position where a first length of the first leaflet and second length of the second leaflet overlap, wherein the first length is longer than said second length and advantageously about two times said second length.

6. A medical device of claim 2, wherein at least a distal part of said first and second partly flexible leaflets is configured to bend to a first direction.

7. A medical device of claim 1, wherein the medical device comprises a tissue anchoring unit having first or anterior and second or posterior sections and configured to abut a first side of the heart valve, wherein the first partly flexible leaflet is fastened to the first section of the tissue anchoring unit.

8. A medical device of claim 7, wherein the second partly flexible leaflet is fastened to the second section of the tissue anchoring unit.

9. A medical device of claim 7, wherein the tissue anchoring unit comprises a first loop-shaped support structure having said first and second sections, where said first and second sections are arranged to locate essentially at the opposite sides of the loop-shaped support structure when the tissue anchoring unit is in the loop formation.

10. A medical device of claim 7, wherein the tissue anchoring unit has a delivery state and an activated state, wherein in said delivery state the tissue anchoring unit has an elongated form so that said first and second sections locate essentially successively in a longitudinal direction of said elongated form, wherein in the activated state the tissue anchoring unit has said loop-shaped formation and wherein the tissue anchoring unit is transferable from said delivery state to said activated state.

11. A medical device of claim 7, wherein the tissue anchoring unit comprises additionally a second loop-shaped support structure configured to abut a second, opposite, side of the valve to thereby trap a portion of the valve tissue between the second and the first support structures.

12. A medical device of claim 7, wherein the tissue anchoring unit comprises a first loop-shaped support structure having essentially a D-shape form having essentially an elongated portion and a curved portion, wherein the first section of the tissue anchoring unit locates essentially at said elongated portion and whereupon the first partly flexible leaflet is fastened to said first section of the tissue anchoring unit advantageously via the proximal section of the first partly flexible leaflet.

13. A medical device of claim 12, wherein the end of at least one of said two curving segments, in the proximal section of the first partly flexible leaflet origins or extends essentially from the portion of the tissue anchoring unit where the elongated portion and curved portion join together.

14. A medical device of claim 7, wherein the tissue anchoring unit comprises a first loop-shaped support structure having essentially a D-shape form having essentially an elongated portion and a curved portion, wherein the second section of the tissue anchoring unit locates essentially at said curved portion and whereupon the second partly flexible leaflet is fastened to said second section of the tissue anchoring unit via the proximal section of the second partly flexible leaflet.

15. A medical device of claim 1, wherein the first or second partly flexible leaflet comprises leather, tissue, pericardium tissue or artificial tissue, fabric, polyester or coretex, or porosity material or fabric supporting endothelial surface growth or mesh like surface thereby enabling the leaflet to grow into a natural leaflet in use where the flexible leaflet is in juxtaposition against the natural leaflet.

16. A medical device of claim 1, wherein said curving segments are configured to allowing at least a distal part of the portion locating between said curving segments and being oriented towards said inner section of said valve tissue to bend only to said first direction along the bending lines and preventing to bend to the opposite direction.

17. A medical device of claim 1, wherein at least a part of the proximal portion of the flexible leaflet is configured to be in juxtaposition to at least one leaflet in use.

18. A medical device of claim 1, wherein said curving segments are implemented by bending lines.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Next the invention will be described in greater detail with reference to exemplary embodiments in accordance with the accompanying drawings, in which:

[0032] FIGS. 1A-1B illustrate schematically a portion of a heart and mitral valve,

[0033] FIG. 2 illustrates an exemplary tissue anchoring unit for securing the flexible leaflet to the adjacent tissue and/or annulus according to an advantageous embodiment of the invention,

[0034] FIG. 3 illustrates an example of a first flexible leaflet according to an advantageous embodiment of the invention,

[0035] FIGS. 4A-4B illustrate examples of a second flexible leaflet according to advantageous embodiments of the invention,

[0036] FIG. 5 illustrates an exemplary medical device having the first and second flexible leaflets in a delivery state according to an advantageous embodiment of the invention, and

[0037] FIGS. 6A-6C illustrate exemplary medical devices having the first and second flexible leaflets secured to the annulus by the tissue anchoring unit according to advantageous embodiments of the invention.

DETAILED DESCRIPTION

[0038] FIGS. 1A-1B illustrating schematically a portion of a heart and mitral valve are already discloses in the connection with the background portion of the invention.

[0039] FIG. 2 illustrates an exemplary tissue anchoring unit 130 for securing the flexible leaflets 101, 111 (not shown in FIG. 2) to the adjacent tissue and/or annulus 20 according configured to abut a first side of the heart valve and configured to abut a first side of the heart valve. The tissue anchoring unit 130 comprises a first loop-shaped support structure 133. The first loop-shaped support structure 133 comprises first and second sections 131, 132, and the first and second sections 131, 132 are arranged to locate (in use so in an activated state) essentially at the opposite sides of the loop-shaped support structure 133 when the tissue anchoring unit 130 takes the loop formation in an activated state.

[0040] The first loop-shaped support structure 133 is advantageously anatomical D-shape or anatomical kidney shape having essentially an elongated portion 137 and a curved portion 138. The elongated portion 137 is configured to be faced to the anterior side of the mitral valve 18 and the curved portion 138 to the posterior side of the mitral valve 18, when in use. The first section 131 of the tissue anchoring unit 130 is located essentially at the elongated portion 137 to which the first partly flexible leaflet 101 is fastened via the proximal section 103 of the first partly flexible leaflet 101 (as shown in FIGS. 3 and 5). In addition, according to an exemplary and optional embodiment, the second partly flexible leaflet 111 is fastened to the second section 132 (so to the curved portion 138) of the tissue anchoring unit 130 advantageously via the proximal section 112 of the second partly flexible leaflet patch 111 (as shown in FIGS. 4 and 5A-5B).

[0041] Advantageously the tissue anchoring unit 130 comprises additionally also a second loop-shaped support structure 136 forming with the first loop-shaped support structure a continuous helix structure, when being in activated state 135 (as is depicted in FIG. 2). The second loop-shaped support structure is configured to abut a second, opposite, side of the valve to thereby trap a portion of the valve tissue 20 between the second and the first support structures 133, 136.

[0042] The tissue anchoring unit 130 has also a delivery state 134 (depicted in FIG. 5), where the tissue anchoring unit 130 has an elongated form so that said first and second sections 131, 132 locate essentially successively in a longitudinal direction 136 of the elongated form. In said delivery state the medical device can be transferred advantageously through a catheter having diameter 5-7 mm, for example.

[0043] The tissue anchoring unit advantageously comprises a shape memory material having a first shape, such as the elongated form of the delivery state in a first temperature, and the second shape, such as the loop-shaped form in a second temperature. The second temperature corresponds advantageously essentially the body temperature, whereupon the tissue anchoring unit takes the second shape, so the loop-shaped form, when introduced for example with the blood flow in the atrium.

[0044] As is illustrated the first and/or second leaflets can be arranged to the first loop-shaped support structure 133. However, even if not depicted in Figures, the first and/or second leaflets can also be arranged to the corresponding portions of the second loop-shaped support structure 136, which can offer advantages such that the distal portions of the first and second leaflets will be pressed against each other more tightly and thereby prevent the backflow more effectively during the left ventricle contract. However, sometimes the chordae might be problematic if the leaflets are arranged to the second loop-shaped support structure 136, which in turn is not problem when the leaflets are arranged to the first loop-shaped support structure 133.

[0045] FIG. 3 illustrates an example of a medical device 100 having a first flexible leaflet 101 and FIGS. 4A and 4B second flexible leaflets 111 according to advantageous embodiments of the invention. The first (anterior, dominant) leaflet 101 has a distal section 102 and a proximal section 103, where the distal section 102 is configured to be oriented towards the inner section of the valve tissue when in use. The first leaflet 101 comprises at least two bending lines 104, 105 (as an example of the curving segments) extending from the proximal section 103 towards the distal section 102, thereby dividing the first leaflet to at least three portions 106, 107, 108. The bending lines 104, 105 can be provided for example by creasing or bending or folding the leaflet, or by some other way known by the skilled person. The bending lines are advantageously provided so that the area 107 between the bending lines, most advantageously the distal portion 107a of the area 107 between the bending lines, can open or bend only into a first direction 121 from its normal state (when no external force is applied) so in the direction of the flow when in use, but essentially not to the opposite direction thereby preventing any backflow from the left ventricle back to the atrium.

[0046] The distance 109 between the line ends in the distal section 102 is advantageously shorter than the distance 110 between the bending line ends in the proximal section 103 area of the leaflet. The first partly flexible leaflet 101 is fastened to the first section 131 of the tissue anchoring unit 130 advantageously via the proximal section 103 of the first partly flexible leaflet 101.

[0047] The end of at least one of the two bending lines 104, 105 in the proximal section 103 of the first partly flexible leaflet 101 origins or extends advantageously and essentially from the portion 139 of the tissue anchoring unit 130 where the elongated portion 137 and curved portion 138 join together. This allows very advantageous and proper bending to at least for the distal part of the portion 107a of the first leaflet 101.

[0048] The exemplary second flexible leaflet 111 comprises advantageously also at least two bending lines 114, 115 extending from the proximal section 113 towards the distal section 112 thereby dividing the second leaflet 111 to at least three portions 116, 117, 118. Most advantageously the bending lines 114, 115 are provided to the second leaflet so that a distance 119 between the bending line ends in the distal section 112 area of the second leaflet is shorter than the distance 120 between the bending line ends in the proximal section 112 area of the second leaflet.

[0049] The second leaflet 111 is advantageously fastened to the second section 132 of the tissue anchoring unit 130, advantageously via the proximal section 112 of the second leaflet 111. Advantageously the second leaflet 111 is positioned essentially opposite side of the first partly flexible leaflet 101 in the tissue anchoring unit 130 of the device 100.

[0050] In a particularly advantageous embodiment, such as that seen in FIG. 4B, the second leaflet 111 is provided or shaped so that when the second leaflet 111 is positioned essentially opposite to the first leaflet 101 in the tissue anchoring unit 130 of the device 100 and when the tissue anchoring unit 130 takes the loop formation in an activated state, the first and/or second leaflets 101, 111 have positions and/or shapes configured in such manner that the anatomical form of one or both native heart valve leaflets may be simulated or reproduced more effectively.

[0051] FIG. 5 illustrates an exemplary medical device 100 having the first and second flexible leaflets 101, 111 in a delivery state 134 according to an advantageous embodiment of the invention. In said delivery state 134 the tissue anchoring unit 130 has an elongated form so that said first and second sections 131, 132 locate essentially successively in a longitudinal direction 136 of the elongated form. As described elsewhere in this document, the tissue anchoring unit 130 advantageously comprises a shape memory material having a first shape, such as the elongated form of the delivery state 134 (illustrated in FIG. 5) in a first temperature. When the tissue anchoring unit 130 is exposed to the second temperature, for example when introduced with the blood flow in the atrium, it will take the second shape, such as the loop-shaped form depicted in FIGS. 2 and 6A, 6B (in use).

[0052] In said loop-shaped form of the tissue anchoring unit 130, so in use, the first and second sections 131, 132 are configured to turn or twist from the delivery state so to the said first and second sections 131, 132 will be located essentially at the opposite sides of the loop-shaped support structure 133. In said loop-shaped form the tissue anchoring unit 130 can be secured to the annulus 20, as is depicted in FIGS. 6A and 6B.

[0053] FIGS. 6A-6C illustrate an exemplary medical device 100 having the first and second flexible leaflets 101, 111 secured to the annulus 20 by the tissue anchoring unit 130 according to advantageous embodiments of the invention.

[0054] The first leaflet 101 is typically bigger (the extension or length is greater) than the second leaflet 111 so that the first leaflet 101 has the first extension, whereas the second leaflet 111 has the second extension. Therefore the first leaflet 101 is used advantageously as a dominant leaflet and it is configured to be arranged in the anterior side 141. The second leaflet 111 is a non-dominant leaflet it is configured to be arranged in the posterior side 142.

[0055] The first and second leaflets 101, 111 are arranged advantageously so that at least the distal section 112 of the second partly pliant leaflet 111 and at least the distal section 102 of the first partly pliant leaflet 101 overlap each other to form a coaptation surface area 122. The first and second leaflets 101, 111 may be configured for example to overlap so that a first length of the first leaflet 101 is faced and a second length of the second leaflet 111 are faced towards the left atrium before overlapping each other at the coaptation surface area. The first length is advantageously about two times greater than said second length. In addition, the first and/or second leaflets 101, 111 advantageously extend also beyond the coaptation surface area 122 towards the left ventricle 14. This effectively ensures the coaptation surface area 122 to be sufficient. In most cases this corresponds about 7-9 mm coaptation.

[0056] As can be seen in FIGS. 6A-6C the distal section 112 of the second leaflet 111 is advantageously configured to locate on the top of the first leaflet 101 in the direction of the flow 140 so to allowing at least the distal part of the portion 107a of the first leaflet to bend to the first direction 121. This is advantageous because the first leaflet 101 is the dominant and must be clear for opening in the direction of the flow 121.

[0057] In the exemplary FIGS. 6A-6C the tissue anchoring unit 130 comprises both the first loop-shaped support structure 133 and the second loop-shaped support structure 136 forming with the first loop-shaped support structure as a continuous helix structure so to abut a second, opposite, side of the valve and thereby to trap a portion of the valve tissue 20 between the second and the first support structures 133, 136. However, even if the both first and second loop-shaped support structure are shown in FIGS. 6A-6C, it should be noted that the tissue anchoring unit 130 having only the first loop-shaped support structure 133 can also be applied.

[0058] In addition it is to be noted that the first and second loop-shaped support structures 136 may be made of same structure or material so that the tissue anchoring unit 130 having both first and second loop-shaped support structures is as a continuous unit or helix structure. Alternative the first and second loop-shaped support structures may be two separate portions, which are physically connected to each other and thereby form said helix structure.

[0059] The elongated portion 137 and thus also the first section 131 (and the first leaflet 101 fastened to said first section 131) of the tissue anchoring unit 130 is configured to be faced to the anterior side 141 of the mitral valve 18. The curved portion 138 and thus also the second section 132 (and the second leaflet 111 fastened to said second section 132) of the tissue anchoring unit 130 is configured to be faced to the posterior side 142 of the mitral valve 18. In use, so when the tissue anchoring unit 130 has the loop-shaped form, the first leaflet 101 locates essentially opposite to the second leaflet 111.

[0060] FIGS. 6A and 6C show alternative embodiments of a medical device 100 with first loop-shaped support structure 133 and second loop-shaped support structure 136 abutting opposite sides of the valve. In FIG. 6A, the shape of the helix structure is configured so that the first loop-shaped structure 133 resides inward towards the center of an area defined by the loop-shaped structures 133, 136 and away from the annulus as compared to the second loop-shaped structure 136. In FIG. 6C the situation is opposite, i.e. the first loop-shaped structure 133 resides outwards from the center of an area defined by the loop-shaped structures 133, 136 and more towards the annulus as compared to the second loop-shaped structure 136. These embodiments may be achieved by loop-shaped structures with differing radii situated at either side of the valve. Of course, loop-shaped supports 133, 136 could also lie at corresponding positions with respect to the valve and reside on the same axis in a first direction 121. In the embodiment of FIG. 6C, the second loop-shaped support 136 may help support native leaflet tissue of a native heart valve.

[0061] The invention has been explained above with reference to the aforementioned embodiments, and several advantages of the invention have been demonstrated. It is clear that the invention is not only restricted to these embodiments, but comprises all possible embodiments within the spirit and scope of the inventive thought and the following patent claims.

[0062] The features recited in dependent claims are mutually freely combinable unless otherwise explicitly stated. For example, it is to be noted that the bending lines in the second leaflet is an optional feature and that the second leaflet can be provided also to the medical device of the invention without any bending lines. This is possible because the first leaflet having the bending lines, is a dominant leaflet. In addition it is to be noted that even if only two bending lines are described in the embodiments, also more than two bending lines can be provided.

[0063] In addition it is to be noted that the bending lines illustrated and depicted in Figures and description above are examples of the curving segments, but naturally the curving segments can be implemented also in other ways described elsewhere in this document.