Transcatheter valve prosthesis

Abstract

The present invention relates to a replacement heart valve system and a method for implanting a replacement heart valve into a patient. The replacement heart valve system comprises a radially self-expandable tubular body and a valve, the valve comprising a plurality of leaflets connected to the tubular body. The tubular body comprises interconnected struts defining circumferential rows of cells, and has an outflow end and an inflow end, the inflow end flaring radially outwardly so that its outer diameter is greater than the outer diameter of the outflow end. The proximal cells of the first row formed at the inflow end comprise circumferentially adjacent cells, the circumferentially adjacent cells being separated from each other so as to be spaced apart from each other in the circumferential direction. The method for implanting the replacement heart valve comprises delivering the tubular body from a delivery catheter, expanding the tubular body so that the proximal cells are positioned against the native heart valve annulus.

Description

Background Art

[0001] Worldwide, approximately 300,000 people are affected by heart valve disease each year. These conditions translate into abnormal leaflet tissue, such as excessive tissue growth, tissue degeneration / rupture, or tissue hardening / calcification. They can also translate into abnormal tissue position during the heart's cardiac cycle, such as annular dilation or ventricular remodeling. This abnormal leaflet tissue and abnormal tissue position can lead to deterioration of valve function, including leakage / blood backflow (valvular insufficiency) or obstruction of forward blood flow (valvular stenosis).

[0002] Valve replacement surgery is a minimally invasive surgical procedure that repairs a patient's defective heart valve. Abnormal leaflet tissue or abnormal tissue position can be repaired, restoring the valve's operability. During valve replacement surgery, a prosthetic valve is delivered to the patient's native heart valve without removing it. Instead, the prosthetic valve replaces the function of the native valve. Summary of the Invention

[0003] The present invention discloses a replacement heart valve system and a method for implanting a replacement heart valve into a patient. The replacement heart valve system includes a radially self-expandable tubular body, the radially self-expandable tubular body including a distal outflow end, a proximal inflow end, and a plurality of interconnected struts; the proximal inflow end is radially flared outward so that the outer diameter of the inflow end is greater than the outer diameter of the outflow end; the plurality of interconnected struts define circumferential rows of units, including a first row disposed at the inflow end. The first row is formed by the most proximal units, which form the most proximal portion of the tubular body, are aligned in the circumferential direction, and include circumferentially adjacent units, wherein the circumferentially adjacent units are separated from each other so as to be spaced apart from each other in the circumferential direction. A valve including a plurality of valve leaflets is connected to the tubular body.

[0004] A method of implanting a replacement heart valve into a patient includes delivering a radially self-expandable tubular body from a delivery catheter and expanding the tubular body such that a proximal-most cell is positioned against an annulus of a native heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] In the accompanying drawings, like reference numerals generally refer to like parts throughout the different views. The drawings are not necessarily drawn to scale, emphasis generally being placed upon illustrating the principles of the invention. In the following description, various embodiments are described with reference to the following drawings, in which:

[0006] Figure 1 A transcatheter valve prosthesis according to disclosed embodiments is schematically illustrated.

[0007] Figure 2 A transcatheter valve prosthesis according to disclosed embodiments is schematically illustrated.

[0008] Figure 3 A transcatheter valve prosthesis according to an embodiment is schematically shown implanted in a patient.

[0009] Figure 4 A transcatheter valve prosthesis according to an embodiment is schematically shown implanted in a patient.

[0010] Figure 5 The inflow end of a transcatheter valve prosthesis according to an embodiment is schematically shown.

[0011] Figure 6A and Figure 6B An inflow end portion of a transcatheter valve prosthesis is shown, according to an embodiment. DETAILED DESCRIPTION

[0012] The following detailed description refers to the accompanying drawings, which illustrate specific details in which the disclosed embodiments may be implemented. Other embodiments may be utilized, and structural and logical changes may be made without departing from the scope of the present disclosure. The various embodiments are not necessarily mutually exclusive, as some aspects of an embodiment may be combined with one or more aspects of other embodiments to form additional embodiments.

[0013] The disclosed embodiments relate to a transcatheter valve prosthesis 1, which is used to functionally replace a patient's native heart valve in a connecting channel. The patient's native heart valve may be, for example, an atrioventricular valve, such as the mitral valve or the tricuspid valve. Transcatheter valve prosthesis 1 can be used as an artificial replacement valve for the patient's native valve.

[0014] The native atrioventricular heart valve to be replaced (e.g., mitral valve or tricuspid valve) has a generally circumferential wall structure that forms a connecting passage (or through-hole) between the atria 140 and ventricles 130 of the heart. The wall structure includes a circumferential valve annulus, valve leaflets 160 that open the connecting passage / through-hole and close the connecting passage / through-hole at a position close to the valve annulus, a generally circumferential chord structure (chordae tendineae) 170 connected between the valve leaflets 160 and the circumferential papillary muscles, and the generally circumferential papillary muscles.

[0015] like Figure 1 and Figure 2As shown, the transcatheter valve prosthesis 1 includes a radially self-expandable tubular body 5 having a proximal inflow end 10 and a distal outflow end 15 extending along the longitudinal axis (according to the direction of blood flow when the system is implanted in the patient's body). As used herein, "proximal" refers to the direction toward the inflow end 10, and "distal" refers to the direction toward the outflow end 15. In some embodiments, the tubular body 5 can be expanded with a balloon. The tubular body 5 may be formed by a mesh structure that is delivered to the patient's body through a delivery catheter. The mesh structure of the tubular body 5 may include a plurality of struts 8, which are formed by superalloys and / or shape memory alloys, including nickel, titanium and / or precious metals (e.g., gold). In some embodiments, the tubular body 5 is formed by nitinol. In other embodiments, the tubular body 5 is formed by a polymer including polyvinyl chloride, polystyrene, polypropylene and / or another polymer. For example, the tubular body 5 may be formed by one or more bioabsorbable polymers.

[0016] The tubular body 5 may be generally cylindrical. The inflow end 10 of the tubular body 5 may be radially flared outward so that its outer diameter is greater than the outer diameter of the outflow end 15. As discussed below, the tubular body 5 may also include a groove 7 extending in a circumferential direction and disposed between the inflow end 10 and the outflow end 15.

[0017] The inflow end portion 10 has a generally conical or flared shape along the central (longitudinal) axis of the tubular body, with its cross-sectional diameter increasing from the groove 7. The outflow end portion 15 may be generally cylindrical. Alternatively, both the inflow end portion 10 and the outflow end portion 15 may be conical along the axis of the tubular body, with their respective cross-sectional diameters increasing from the groove 7. In addition, the outflow end portion 15 of the tubular body 5 may include a frustoconical shape that slopes radially outward from the preformed groove 7 toward the outflow (distalmost) end.

[0018] The outer diameter of the inflow tip 10 may increase along the direction from the groove 7 to the most proximal side or the inflow tip 102. The inflow tip 10 may be designed to be large enough to provide an effective paravalvular leak seal. Figure 3 and Figure 4 As shown, the inflow end 10 is designed to abut against the surface of a native annulus when implanted in a patient. The inflow end 10 can be designed to abut against the surface of a native annulus within the left atrium 140 of the heart. The outflow end 15 of the tubular body 5 can include a truncated conical shape that is radially outwardly inclined. Optionally, the outflow end 15 of the tubular body 5 can taper inwardly.

[0019] The cross-section of the inflow end portion 10 and the outflow end portion 15 may be or include a non-circular shape, such as an elliptical or D-shaped cross-section. In addition, the curvature direction of the axial profile (seen along the axial section of the tubular body 5) between the groove 7 and the inflow end portion 10 and / or between the groove 7 and the outflow end portion 15 may be changeable (for example, the concave curvature of the groove 7 may be changed to a convex curvature at the transition between the groove 7 and the inflow end portion 10 or the outflow end portion 15).

[0020] The tubular body 5 comprises a plurality of interconnected struts 8 defining circumferential rows of cells. The circumferential rows of cells comprise a first row 101 disposed at the inflow end 10. The first row is formed by the most proximal or inflow end cells 101, which form the most proximal or inflow end portion of the tubular body. Figure 1 、 Figure 2 and Figure 5 As shown, the proximal cells 101 are aligned in the circumferential direction. For example, the vertices 102 of the proximal cells 101 are aligned with each other in the circumferential direction. The proximal cells 101 include circumferentially adjacent cells that are separated from each other. That is, the proximal cells 101 include circumferentially adjacent cells that are not in contact with each other or are not directly coupled or connected. Instead, some cells 101 are separated from each other in the circumferential direction by one or more spaces 107 ( Figure 1 、 Figure 2 and Figure 6B ) or space 108( Figure 5 and Figure 6A ).

[0021] For example, in Figure 1 and Figure 2 In the example, the first row comprises separate cells 101 from which the struts have been removed, thereby forming an irregular circumferential inflow edge, wherein some cells 101 are spaced apart from each other by a space 107. Figure 5 In the example, the first row also includes separated cells 101 separated from each other by a space 108. The space 107 is larger than the space 108 in the circumferential direction. For example, the circumferential size of the space 107 is substantially equal to the circumferential size of the cell 101. The separated cells 101 can be separated from each other by one or more spaces 107, such as Figure 1 and Figure 2 shown. Figure 5 The illustrated space 108 has a circumferential dimension that is substantially equal to the circumferential dimension of the strut.

[0022] The disclosed arrangement of the inflow end of the tubular body 5 provides a non-uniform stent stiffness to the tubular body 5. For example, the disclosed arrangement of the non-uniform stent stiffness of the tubular body 5 can achieve a better conformity to the patient's anatomy while maintaining the desired stent structural integrity and function. The strut interruptions and strut connections can be selectively formed to achieve a non-uniform stent stiffness, such as Figure 1 、 Figure 2 and Figure 5-6B For example, the inflow end portion 10 is designed to include a row of proximal-most cells 101 that are aligned in the circumferential direction and include circumferentially adjacent cells that are separated from each other so as not to contact each other or to be spaced apart from each other in the circumferential direction, thereby achieving non-uniform stent stiffness along the circumference and / or length of the tubular body 5.

[0023] Due to the required configuration, inward folding or stent invagination can be eliminated. Inward folding or stent invagination is when some of the inflow end units bend inward, resulting in the invagination of the stent towards the center. Stent invagination or inward folding may occur in various situations (including, for example, when a valve prosthesis is implanted in a native valve having a smaller geometry than the valve prosthesis). The inflow end 10 of the tubular body 5 is designed to have the most proximal units 101, which are separated from each other (for example, not in contact with each other or separated from each other by one or more spaces 107 or 108). Therefore, the inflow end 10 of the tubular body 5 can more easily distribute stress in a small native valve or a fastened native valve, thereby avoiding strut bending or inward folding. The more flexible inflow end of the tubular body 5 makes the prosthesis 1 more adaptable to the anatomical structures of different patients while still maintaining functionality and durability. In addition, the separated units 101 enable easier valve loading and a smaller delivery profile, and the functional evaluation of the prosthetic valve can be better evaluated without fully deploying the valve from the delivery system.

[0024] like Figure 1 As shown, the most proximal units 101 of the first row include multiple pairs of contact units that are directly coupled to each other. Multiple pairs of units 101 are separated from multiple pairs of units adjacent in the circumferential direction by a certain space 107. Multiple pairs of units 101 are equidistantly arranged around the circumference of the inflow end of the tubular body 5, as shown in FIG. Figure 1 As shown, or arranged at unequal distances from each other in the circumferential direction. The tubular body 5 is not limited to Figure 1 The configuration shown (or discussed below) Figure 2-6B Other configurations of the proximal cells 101 of the first row are possible, as long as at least some of the cells 101 are separated from one another such that they are circumferentially separated or spaced apart from one another (e.g., at least some of the cells 101 do not contact one another circumferentially in the absence of a force, such as a radially inward force).

[0025] For example, the proximal-most cells 101 of the first row may include a pair of contact cells 101 that are directly bonded to each other, while the other cells 101 of the first row are separated from each other such that they do not contact each other or are spaced apart by a certain space 107. The proximal-most cells 101 of the first row may include two pairs of contact cells 101 disposed on radially opposite sides of the tubular body 5. In another embodiment, the proximal-most cells 101 may include more than two pairs of contact cells 101 that are directly bonded to each other. The multiple pairs of contact cells 101 may be equidistant or unequally spaced from each other in the circumferential direction. The proximal-most cells 101 may include more than two pairs of contact cells 101 that are directly bonded to each other, as long as the group of contact cells 101 is separated from (e.g., not in contact with) at least one circumferentially adjacent cell. For example, the proximal-most cells 101 may include one or more groups of two, three, four, five, or more cells that are directly bonded to each other, as long as the group or groups of cells are separated from at least one circumferentially adjacent cell. The multiple groups of directly bonded cells 101 may include different numbers of cells 101. For example, a first row may include a first group of 2, 3, 4, 5, 6, or more cells 101 spaced apart from a second group of a different number of directly joined cells 101. The groups and / or individual cells are spaced apart from each other in the circumferential direction by one or more spaces 107. The cells 101 and / or groups of joined cells 101 may be equally or unequally spaced from circumferentially adjacent cells or groups of cells 101 around the circumference of the inflow end 10 of the tubular body 5. The apex 105 of the cells 103 of the second row is positioned between circumferentially adjacent pairs of contacting cells 101 or individual cells 101, so as to axially overlap with the spaces 107.

[0026] Alternatively, the first row may include cells 101 that are not in contact or directly coupled. For example, the first row may include only individual cells 101 that are separated (e.g., spaced) from one another such that the cells 101 do not contact any other proximal-most cells 101. Instead, each cell 101 is separated from a circumferentially adjacent cell 101 by a space 107. The individual cells 101 may be arranged equidistantly or unequally in the circumferential direction. Any suitable number of individual cells 101 may constitute the first row. For example, the first row may include only one proximal-most cell 101; or the first row may include two, three, four, five, six, seven, eight, nine, ten, or more proximal-most cells that are spaced 107 apart in the circumferential direction. The cells 101 may be arranged unequally in distance from one another. The cells 101 may be designed in any suitable shape and may be formed to have a vertex 102 as the proximal-most point of the tubular body 5.

[0027] exist Figure 1In the embodiment, cells 101 can be designed in any suitable shape and can be formed with apex 102 as the proximal-most point of tubular body 5. Apex 102 can be circumferentially aligned with one another. As discussed in more detail below, cells 103 in the second row of cells have proximal-most portions 105 that extend toward the inflow side and are circumferentially positioned between separated cells 101. For example, proximal-most portions 105 of cells 103 can overlap with spaces 107 in the axial direction. Proximal-most portions 105 of cells 103 can be formed as apex of proximal-most portions 102 of cells 101. Proximal-most apex 102 of cells 101 is positioned proximal to proximal-most portions 105 of cells 103 in the second row. Furthermore, proximal-most apex 102 of cells 101 and proximal-most portions 105 of cells 103 can collectively define the inflow end of tubular body 5. Cells 103, aligned axially with cells 101, can also include proximal-most portions 104. The struts forming the proximal-most portion 104 may also define the distal-most end of the unit 101 .

[0028] Alternatively, the first row may include the two most proximal cells 101a, 101b, such as Figure 2 shown. Figure 2 The cells 101a, 101b are arranged on radially opposite sides of the tubular body 5. Alternatively, the cells 101a, 101b may be arranged at different positions around the circumference of the inflow end 10 of the tubular body 5. In addition, the cells 101 at the nearest or inflow end of the first row may include more cells than Figure 2 The most proximal units 101a, 101b may be equidistant from each other around the circumference of the inflow end (see Figure 2 ) or unequal spacing. Figure 1 As discussed, the proximal-most cells 101 may include one or more pairs (having two) or one or more groups (having more than two) of contact cells that are directly coupled to each other, as long as the one or more pairs or one or more groups of contact cells are separated (e.g., not in contact) from at least one circumferentially adjacent cell of the first row. Alternatively, the first row may include non-contact cells 101. For example, the first row may include only independent cells 101 that are separated (e.g., spaced apart) from each other such that the cells 101 do not contact any other proximal-most cells 101. The independent cells 101 may be arranged equidistant or unequally spaced from each other in the circumferential direction. As discussed above with respect to Figure 1 As discussed, the first row may be composed of any suitable number of individual cells 101 .

[0029] exist Figure 2In the embodiment, the cells 101a, 101b disposed on radially opposite sides of the tubular body 5 can be designed into any suitable shape and can be formed to have vertices 102a, 102b as the proximal points of the tubular body 5. The vertices 102a, 102b can be circumferentially aligned with each other. The cells 101a, 101b neither contact each other nor are they directly connected to each other. Instead, the cells 101a, 101b are separated from each other by one or more spaces 107 in the circumferential direction. As discussed in more detail below, a plurality of arms 106 extending from the distal row of cells extend toward the inflow side, such that a portion of each arm 106 is circumferentially disposed between the cells 101a, 101b. For example, the arms 106 can define a space 107. The proximal vertices 102a, 102b are circumferentially disposed proximal to the proximal portion of the arm 106 between the proximal cells 101a, 101b.

[0030] like Figure 5 As shown, the nearest cells 101 may include multiple pairs of contact cells directly bonded to each other, separated by a space 108 from multiple pairs of circumferentially adjacent cells. Alternatively, each cell 101 in the first row may be separated by a space 108 from circumferentially adjacent cells. That is, the cells 101 in the first row, or the row at the end of the inflow, may not include cells directly bonded or connected to each other in the circumferential direction. Conversely, the cells 101 in the largest inflow row may only include independent cells 101 separated by a space 108.

[0031] Alternatively, individual cells 101 or groups of two, three, four, five, six, seven, eight, or more cells 101 (directly bonded to one another in the circumferential direction) may be separated from circumferentially adjacent cells by a space 108. For example, the proximal cells 101 may include one or more groups of two, three, four, five, or more cells directly bonded to one another, as long as the one or more groups are separated from at least one circumferentially adjacent cell. The separated cells 101 may be equidistant or unequally spaced from one another in the circumferential direction. For example, an individual cell 101 may be separated from a group of two or more cells directly bonded to one another by a space 108; or a first group of cells 101 may be separated from a second group of circumferentially adjacent cells 101 such that the first group has more cells than the second group. In other words, the inflow end 10 may include different numbers of directly bonded cells 101. In other words, the spaces 108 may be equidistant or unequally spaced from one another in the circumferential direction around the inflow end 10 of the tubular body 5.

[0032] Figure 5 The cells 101 of the second row of cells may be designed in any suitable shape and may be formed with a vertex 102 as the most proximal point of the tubular body 5. The vertices 102 may be circumferentially aligned with each other. As discussed in more detail below, the cells 103 of the second row of cells have a most proximal portion 104. The most proximal portion 104 may form a vertex, such as Figure 5 The most proximal portion 104 of the second row of cells 103 may also define the most distal portion of the first row of cells 101 .

[0033] As discussed above, space 108 is smaller than space 107. The circumferential dimension of space 108 is smaller than space 107. For example, the circumferential dimension of space 108 is substantially equal to the circumferential dimension of the struts forming the inflow end 10 of the tubular body 5. Figure 5 In the illustrated arrangement of the inflow end portion 10, the separate cells 101 can overlap one another circumferentially under radial compression, allowing the inflow end portion 10 to conform to the native anatomy without bending or infolding. For example, under radial compression of the native valve annulus, the separate cells 101 can be compressed to overlap one another circumferentially. The separate cells 101 can be radially compressed to overlap one another in a fan-shaped manner. This flexibility allows the tubular body 5 to better conform to the native valve anatomy, thereby preventing or reducing paravalvular leakage.

[0034] The inflow end 10 of the tubular body 5 may include a combination of spaces 107 and 108. For example, individual or multiple units 101 may be separated from circumferentially adjacent units by a combination of spaces 107 and 108. Figure 1 、 Figure 2 and Figure 5 Various other modifications and combinations of elements therebetween are possible, as long as the nearest-side unit 101 of the first row includes circumferentially adjacent units that are separated from each other in the circumferential direction by spaces 107 and / or 108 (e.g., not in contact or directly bonded to each other).

[0035] Due to the configuration of the proximal portion, the first row 101 comprises fewer cells than the remaining circumferential rows of the tubular body 5 (see Figure 1 and Figure 2 ).like Figure 1 、 Figure 2 and Figure 5 As shown, the proximal-most cells 101 each include a proximal-most apex 102 disposed proximal to the proximal-most portion 105 of the strut between the proximal-most cells 101 in the circumferential direction.

[0036] like Figure 1 、 Figure 2 and Figure 5 As shown, the tubular body 5 further comprises a second row of cells 103 axially adjacent to the first row of cells 101. The first row 101 may comprise fewer cells than the second row of cells 103, as shown in FIG. Figure 1 and Figure 2 or the first row of cells 101 and the second row of cells 103 may include the same number of cells, such as Figure 5The cells 103 of the second row may be larger than the most proximal cells 101 of the first row. The cells 103 of the second row may be larger than any other cell of the tubular body 5.

[0037] The proximal portions 105 of the second row of cells 103 may be disposed in a position between circumferentially adjacent cells 101 that do not touch, such as Figure 1 As shown. For example, the proximal portion 105 of the second row of cells 103 may be arranged to overlap with the space 107 in the axial direction. That is, the proximal portion 105 may be circumferentially aligned with the space 107. The proximal portion 105 of the second row of cells 103 may form a vertex between the separated cells 101. The second row of cells 103 does not include any space, such as space 107 or 108. That is, all cells 103 of the second row may be directly connected to circumferentially adjacent cells, such as Figure 1 and Figure 5 Alternatively, the second row of cells 103 includes a space 107 defined by the arm 106, as shown in FIG. Figure 2 shown.

[0038] The struts defining the distal portion (eg, outflow portion) 104 of each proximal-most cell 101 also define a portion of the axially adjacent cells 103 of the second row, as shown. Figure 1 、 Figure 2 and Figure 5 As shown. The struts defining the distal portion 104 of each proximal-most cell 101 also define the apex of the second row of axially adjacent cells 103. Apex 102, 104, 105 can be "V" shaped or "U" shaped, or any other suitable shape. Apex or peak 102, 104, 105 can be oriented to point in the proximal direction (e.g., the direction of inflow).

[0039] like Figure 2 As shown, the tubular body 5 may include a second row of cells 103a, 103b axially adjacent to the first row of cells 101a, 101b. The first row 101 includes fewer cells than the second row 103. The cells 103a, 103b of the second row may be larger than the most proximal cells 101a, 101b of the first row. The cells 103a, 103b of the second row may be larger than any other cell of the tubular body 5. Instead of a proximal portion 105 being disposed between the non-contacting cells 101a, 101b, a plurality of arms 106 are disposed circumferentially between the cells 101a, 101b. The arms 106 may extend from the apex or peak of the distal row of cells 151, as shown. Figure 2 shown.

[0040] Although Figure 2A plurality of arms 106 are shown disposed between the cells 101a, 101b, and the tubular body 5 may include any suitable number of arms 106 between the cells 101a, 101b, such as one or more arms 106. Alternatively, the tubular body 5 may include a proximal apex portion 105 between the non-contacting cells 101 of the first row (see FIG. Figure 1 ) and arm 106 (see Figure 2 ) combination. Figure 2 The arms 106 shown can be used in combination with multiple pairs (having two) or multiple groups (having more than two) of contact or bonding units 101, such as Figure 1 As shown. Similarly, Figure 1 The proximal portion 105 of the second row of cells 103 shown may be arranged at Figure 2 The separated units 101a, 101b are shown. Figure 1 、 Figure 2 and Figure 5 Various other modifications and combinations of elements therebetween are possible, as long as the nearest-side unit 101 of the first row includes circumferentially adjacent units that are separated from each other in the circumferential direction by spaces 107 and / or 108 (e.g., not in contact or directly bonded to each other).

[0041] like Figure 1 and Figure 2 As shown, the tubular body 5 may include a distal row of cells 151 disposed closer to the outflow end 15 than the most proximal cells 101 of the first row. The distal row of cells 151 is located distal to the groove 7 and is thus closer to the outflow end 15 than the groove 7. Figure 2 As shown, the tubular body 5 may include an arm 106 extending from the distal row of cells 151 such that a portion of the arm 106 is disposed between circumferentially adjacent cells 101a, 101b that are not in contact. The arm 106 extends from the apex of the distal row of cells 151. Although Figure 5 、 Figure 6A and Figure 6B Only the inflow ends 10 of the tubular body 5 are shown, but they have Figure 1-Figure 4 The same features of the tubular body 5 shown and discussed herein.

[0042] The tubular body 5 is not limited to Figure 1 、 Figure 2 and Figure 5 Other configurations of the nearest cells 101 of the first row are also possible, as long as at least some of the cells 10 are disconnected from each other such that they are separated from each other in the circumferential direction by one or more spaces 107 and / or 108 .

[0043] like Figure 6A and Figure 6BAs shown, the most proximal or first row of circumferentially separated cells 101 may include seals 109. Seals 109 may be attached to the sides of cells 101 adjacent to spaces 107 or 108 to extend in the circumferential direction toward circumferentially adjacent cells 101 (e.g., also adjacent to spaces 107 or 108). Separated cells 101 having sides forming spaces 107 or 108 may include seals 109. For example, Figure 6A and Figure 6B As shown, the separated units 101 having sides forming spaces 107 or 108 may have seals 109a and 109b, respectively. The seals 109a and 109b may extend circumferentially from the sides of the respective units 101 toward the other units 101 to overlap each other in the circumferential direction and seal the spaces 107, 108. Optionally, only one of the separated units 101 includes a seal 109. Each space 107 and / or 108 may be partially or completely covered by at least one seal 109, or only some spaces 107 and / or 108 may be covered by one or more seals 109, as shown. Figure 6A and Figure 6B shown.

[0044] Seal 109 may be formed from a strut or wire extension covered with fabric or any other suitable material. For example, any of the fabrics or materials discussed below may be used. Seal 109 may be of any suitable shape or size. For example, while Figure 6A and Figure 6B The seal 109 is shown as a rectangle, but the seal 109 can be a semicircle, square, triangle, diamond, star, pentagon, trapezoid, hexagon, polygon, parallelogram, heptagon, octagon, enneagon, or any other suitable shape. The seal 109 can extend through the space 107 or 108 to the circumferentially adjacent unit 101, or can extend partially through the space 107. The seal 109 can extend radially inwardly of the tubular body 5, such as Figure 6A and Figure 6B As shown, one seal 109 may extend radially outside the tubular body 5. Alternatively, one seal may extend radially outside and another seal may extend radially inside the tubular body 5. Seal 109 may help seal the prosthetic valve to the native valve annulus (e.g., to form a blood-tight seal therebetween) to prevent unwanted paravalvular leakage and / or regurgitation at the implantation site.

[0045] Adjacent seals 109a, 109b may extend toward each other in the circumferential direction to radially overlap each other, thereby facilitating sealing of the tubular body 5 to the native valve annulus. Adjacent seals 109a, 109b may radially overlap each other on the radially inner side of the tubular body 5, or may radially overlap each other on the radially outer side of the tubular body 5. Optionally, one of the seals 109a, 109b may extend radially inwardly and the other seal 109a, 109b may extend radially outwardly so that the seals radially overlap each other on the relatively radial upper side of the tubular body 5. Alternatively, adjacent seals 109a, 109b may not overlap each other. For example, adjacent seals 109a, 109b may extend toward each other in relative circumferential directions to avoid overlapping, so that the seals 109a, 109b only partially cover the spaces 107, 108. Alternatively, adjacent edges or sides of the seals 109a, 109b may touch but not overlap each other in the radial direction.

[0046] like Figure 1 and Figure 2 As shown, the tubular body 5 may further include a flexible strut 9. Such a flexible strut 9 may be S-shaped. The S-shaped strut 9 may overlap with the groove 7 or may be disposed on the inflow (e.g., proximal) side of the groove 7. The S-shaped strut 9 may form a portion of the arm portion 106 (see Figure 2 ), or the side of the second row of cells 103 (see Figure 1 ). The S-shaped struts 9 can each form a decorrelated portion that decouples movement between the inflow end 10 of the tubular body 5 and the outflow end 15 of the tubular body 5. Thus, the S-shaped struts 9 can be configured to generate stress and compression in response to movement of the inflow end 10 or the outflow end 15. Thus, movement at one end of the tubular body 5 is not translated or transmitted to the other end of the tubular body 5 due to the tension and / or compression of the S-shaped struts 9. The S-shaped struts 9 can be positioned completely proximal to the preformed groove 7 in the inflow direction.

[0047] The groove 7 of the tubular body 5 may be open to the radial outside of the tubular body 5. The prefabricated groove 7 may be an indentation defining a channel in the mesh structure of the tubular body 5. Figure 1 and Figure 2 As shown, the preformed groove 7 can extend around the entire circumference of the tubular body 5. In other embodiments, the preformed groove 7 extends for less than the entire outer circumference of the tubular body 5. The preformed groove 7 can be a continuous, uninterrupted groove, or can be an interrupted groove having, for example, two or more groove sections. In some embodiments, the preformed groove 7 can be located at an axial distance from the inflow end 10 and the outflow end 15 of the tubular body 5 along the longitudinal axis of the tubular body 5. Thus, the preformed groove 7 can be axially spaced from the proximal and distal ends of the tubular body 5.

[0048] The preformed groove 7 can be defined by protrusions (not shown) projecting outward from the tubular body 5. Thus, in some embodiments, the tubular body 5 can include a first set of protrusions positioned above the preformed groove 7 in the inflow direction, and a second set of protrusions positioned below the preformed groove 7 in the outflow direction. Thus, the first and second sets of protrusions can surround the top and bottom of the preformed groove 7. The first and second sets of protrusions can point toward each other. Furthermore, the first and second sets of protrusions can be configured to pierce tissue, such as, for example, spikes, triangular protrusions, barbs, and the like.

[0049] like Figure 3 and Figure 4 As shown, a tubular fabric 25 can be disposed on the outer surface of the tubular body 5. The fabric 25 can cover the entire outer surface of the tubular body 5, or only a portion of the outer surface of the tubular body 5. The fabric 25 can be disposed within the groove 7 such that the fabric 25 follows the contour of the groove 7. The fabric 25 can be loosely or tightly disposed to the tubular body 5. As discussed further below, the capture member 150 can be positioned around the tubular body 5. The fabric 25 can be disposed to the tubular body 5 in a relaxed state until the capture member 150 is positioned around the tubular body 5. Thus, the capture member 150 can move the fabric 25 into the preformed groove, placing the fabric 25 in a tensioned state.

[0050] The fabric 25 may be formed from a polymeric material, including, for example, a polyester fabric (e.g., or other PTFE graft materials). Additionally or alternatively, fabric 25 may be formed from pericardium and / or a metal mesh material (e.g., a metal mesh formed from nitinol). In some embodiments, fabric 25 may include one or more segments of material. For example, fabric 25 may include two, four, or six segments of material. The segments may be spaced apart to provide gaps between adjacent segments. Alternatively or additionally, some or all adjacent segments may overlap. Fabric 25 may include a single layer of material or multiple layers of material. In some embodiments, fabric 25 may include a coating or lining.

[0051] The fabric 25 can be attached to the tubular body 5 by any known fixing mechanism. For example, the fabric 25 and the tubular body 5 can be fixed by adhesive and / or sutures. The fabric 25 can be configured to assume an expanded configuration (expanded) and a contracted configuration (reduced) together with the tubular body 5. Thus, the fabric 25 can expand and contract based on the state of the tubular body 5.

[0052] The tubular body 5 can be connected to an artificial heart valve (not shown) so that the valve is arranged in the tubular body 5. The valve may include a plurality of valve leaflets. The valve can be used as an artificial replacement for the patient's own heart valve (e.g., mitral valve and / or tricuspid valve). For example, the valve can be arranged on the radial inner side of the tubular body 5 to be connected to the radial inner side of one or more struts 8. The valve can be connected to the radial inner side of the tubular body 5 at a position close to the groove 7, or to the outflow end 15 of the tubular body 5 so that the valve leaflets extend from the outflow end 15 of the tubular body 5 in the distal direction.

[0053] All embodiments of valvular prosthesis 1 may include positioning and / or orientation devices (not shown) that facilitate relative and / or absolute positioning of tubular body 5. These devices may include passive markers fixedly attached to tubular body 5. Passive markers may be made of a different material than tubular body 5 to improve contrast during medical imaging, for example, using magnetic resonance or X-ray-based imaging techniques. Passive markers may be made of, for example, highly radiopaque materials, thereby enabling precise determination of the relative and / or absolute position of components of valvular prosthesis 1 relative to the patient's body.

[0054] Figure 3 and Figure 4 A valve prosthesis 1 is shown implanted in a patient's native valve (eg, mitral valve). The valve prosthesis 1 can be deployed in the patient's body via a catheter. A method of delivering the valve prosthesis 1 can include delivering a tubular body 5 from a delivery catheter, with the valve disposed therein.

[0055] Next, if Figure 3 and Figure 4 As shown, the tubular body 5 and valve can be expanded so that the proximal-most cells 101, 101a, 101b are positioned against the annulus of the native valve. For example, the proximal-most cells 101, 101a, 101b can be disposed in an atrium 140 (e.g., the left atrium) to be positioned against the atrial surface of the annulus of the native valve. The tubular body 5 can be expanded so that the cells 103 of the second row are also positioned against the annulus of the native heart valve, e.g., the atrial 140 surface of the annulus of the native valve. Additionally or alternatively, the tubular body 5 can be expanded so that the arms 106 are also positioned against the annulus of the native heart valve, e.g., the atrial 140 surface of the annulus of the native valve.

[0056] Thus, for example, the valve prosthesis 1 can be delivered to a patient's defective mitral or tricuspid valve to restore operability. The valve prosthesis 1 can be delivered to the patient so that the preformed groove 7 is located on the ventricle 130 side of the native valve ring (e.g., at a certain distance from the native valve ring).

[0057] To place the valve prosthesis 1 within the patient's heart valve, the following approaches can be used: (1) retrograde arterial access through the aorta into the heart chamber, (2) through venous access and by puncturing the atrial septum (transseptal approach), (3) by puncturing the apex of the heart (transapical approach), (4) by puncturing the atrial wall from the outside of the heart, (5) arterial access (e.g., from the femoral artery to the groin), (6) directly through the vena cava to the right atrium (e.g., tricuspid valve replacement), or (7) any other method known to a skilled person.

[0058] To functionally replace the patient's heart valve, the valve prosthesis 1 can be fixed relative to the patient's connecting channel wall structure so that the exterior of the valve prosthesis 1 is sealed to prevent blood flow. To achieve this, tissue of the patient's connecting channel wall structure adjacent to the prefabricated groove 7 can be forced into or placed within the prefabricated groove 7.

[0059] The method may further include advancing a capture member 150 around the tubular body 5 and the preformed groove 7. Thus, the capture member 150 can capture portions of the native valve leaflets 160 and / or chordae tendineae 170 within the preformed groove 7. This helps secure the tubular body 5 within the patient. The capture member 150 may comprise a full or partial ring. Furthermore, the capture member 150 may be moved around the tubular body 5 after the tubular body 5 is fully expanded or when the tubular body 5 is only partially expanded. The capture member 150 may be loosely positioned within the preformed groove 7, such that an interference fit between the capture member 150 and the preformed groove 7 secures the tubular body 5 in place. Thus, the capture member 150 may be used to anchor the valve prosthesis 1 within the patient. In other embodiments, the capture member 150 may apply an inward radial force to the tubular body 5 to anchor the valve prosthesis 1 within the patient. Thus, in this embodiment, capture member 150 can apply frictional forces to native valve leaflets 160 and / or chordae tendineae 170 .

[0060] The capture member 150 can include a delivery structure within a delivery catheter and a deployment structure deployed from the delivery catheter. In embodiments, the capture member 150 can be biased to the deployment structure. For example, the capture member 150 can include a shape memory alloy, such as Nitinol or a Nitinol-based alloy.

[0061] In some embodiments, the elongated outer member 180 is advanced around the tubular body 5 and the preformed groove 7 (see Figure 4). After the tubular body 5 is fully expanded or when the tubular body 5 is only partially expanded, the elongated outer member 180 can surround the tubular body 5. The elongated outer member 180 can force the patient's native valve leaflets 160 and / or chordae tendineae 170 into the preformed groove 7. The capture member 150 can then be positioned on and along the elongated outer member 180 to advance the capture member 150 around the tubular body 5 and into the preformed groove 7. Then, after the capture member 150 is positioned around the tubular body 5, the elongated outer member 180 can be removed from the patient's body. After the elongated outer member 180 is removed from the patient's body, the capture member 150 can retain the patient's native valve leaflets 160 and / or chordae tendineae 170 in the preformed groove 7.

[0062] In some embodiments, the elongated outer member 180 can be a guidewire. The diameter of the elongated outer member 180 is smaller than the diameter of the capturing member 150.

[0063] The disclosed method of utilizing the valve prosthesis 1 can secure the tubular body 5 within the patient's connecting passage wall structure with minimal occlusion of the patient's native valve.

Claims

1. A heart valve replacement system, characterized in that: include: A radially self-expandable tubular body, the radially self-expandable tubular body comprising: Distal outflow end, a proximal inflow end portion that flares radially outwardly such that an outer diameter of the inflow end portion is greater than an outer diameter of the outflow end portion, and a plurality of interconnected struts defining circumferential rows of cells comprising: A first row is provided at the inflow end, the first row being formed by the most proximal cells, the most proximal cells: forming a proximal-most portion of said tubular body, aligned in the circumferential direction, and comprising circumferentially adjacent units separated from each other so as to be spaced apart from each other by a certain space in the circumferential direction, and cells in a second row adjacent to the cells in the first row, and a valve connected to the tubular body, the valve comprising a plurality of valve leaflets, wherein the size of the cells of the second row is larger than the nearest cells of the first row; and The proximal portions of the cells of the second row extend into the space between two circumferentially adjacent cells separated from each other in the first row, so that the proximal portions of the cells of the second row overlap with the cells of the first row in the circumferential direction.

2. The heart valve replacement system according to claim 1, wherein: The proximal-most cells each include a proximal-most apex disposed proximal to a proximal-most portion of the strut between the proximal-most cells in the circumferential direction.

3. The heart valve replacement system according to claim 1, wherein: The cells of the second row are adjacent to the cells of the first row in the axial direction, Proximal portions of the cells of the second row overlap with the space in the axial direction.

4. The heart valve replacement system according to claim 3, wherein: Circumferentially adjacent cells of the second row are bonded to each other such that the second row does not include any spaces between circumferentially adjacent cells thereof.

5. The heart valve replacement system according to claim 3, wherein: The struts defining the distal portion of each of the proximal-most cells also define a portion of the cells of the second row axially adjacent thereto.

6. The heart valve replacement system according to claim 3, wherein: Proximal portions of the cells of the second row form apexes between the circumferentially adjacent cells that are spaced apart from one another.

7. The heart valve replacement system according to claim 1, wherein: The struts defining the distal portion of each of the proximal-most cells also define the apex of the axially adjacent cells of the second row.

8. The heart valve replacement system according to claim 1, wherein: The tubular body also includes cells in a distal row and an arm portion, wherein the cells in the distal row are arranged closer to the outflow end than the most proximal cells in the first row, and the arm portion extends from the cells in the distal row so that a portion of the arm portion is arranged between the circumferentially adjacent cells spaced from each other.

9. The heart valve replacement system according to claim 8, wherein: The tubular body further includes a groove extending in a circumferential direction and provided between the inflow end and the outflow end. The cells of the distal row are located distally of the groove and thus closer to the outflow end than the groove.

10. The heart valve replacement system according to claim 8, wherein: The arms extend from the apexes of the cells of the distal row.

11. The heart valve replacement system according to claim 1, wherein: The most proximal unit of the first row further includes a pair of coupling units directly coupled to each other.

12. The heart valve replacement system according to claim 1, wherein: The most proximal units of the first row include a plurality of pairs of bonding units directly bonded to each other, the plurality of pairs of bonding units being equidistant from each other around the circumference of the inflow end portion of the tubular body.

13. The replacement heart valve system according to claim 1, wherein: The tubular body further includes a groove extending in a circumferential direction and provided between the inflow end and the outflow end.

14. The replacement heart valve system according to claim 13, wherein: An outer diameter of the inflow end portion increases in a direction from the groove to the proximal-most portion.

15. The replacement heart valve system according to claim 1, wherein: The first row comprises fewer cells than the remaining circumferential rows of the tubular body.

16. The replacement heart valve system according to claim 1, wherein: The circumferential dimension of the space is substantially equal to the circumferential dimension of the most proximal unit.

17. The replacement heart valve system according to claim 1, wherein: At least one of the circumferentially adjacent cells spaced apart from each other includes a seal, and the seal extends in a circumferential direction from a strut forming a side of one of the circumferentially adjacent cells and defining a side of the space.

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