Implantable devices to repair heart valves

Abstract

An implantable device for repairing a heart valve having an annulus and two or more leaflets is provided. The implantable device includes a generally annular support member, the generally annular support member including a longitudinal axis, the generally annular support member being sized and configured to be attached to the annulus of the heart valve. The implantable device also includes a mid-member, the mid-member including a longitudinal axis, a distal portion, and a proximal portion, the distal portion of the mid-member being angled through the leaflets toward the ventricle such that the mid-member is obliquely attached to the generally annular support member, thereby inducing the leaflets to contact the mid-member.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 930,599 (filed on November 5, 2019) and U.S. Patent Application No. 63 / 109,322 (filed on November 3, 2020), the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates generally to surgical devices and methods for treating dysfunctional heart valves and, more particularly, to devices and related methods for providing valve support to passively assist in preventing or reducing heart valve regurgitation. Background Art

[0004] The use of an undersized, complete, and rigid annuloplasty ring to reduce the annulus size and allow the leaflets to coapt is accompanied by overcorrection of annular dilation, necessitating surgical correction of valvular regurgitation. Although total correction of valvular regurgitation has been demonstrated surgically, recurrence of valvular regurgitation is common after valve repair annuloplasty. Summary of the Invention

[0005] According to one embodiment, an implantable device for repairing a heart valve having an annulus and two or more leaflets is provided, the device comprising: a generally annular support member comprising a longitudinal axis, the generally annular support member being sized to be attached to the annulus of the heart valve; and a middle member comprising a longitudinal axis, a distal portion, and a proximal portion, the distal portion of the middle member being obliquely directed through the leaflets toward the ventricle so that the middle member is obliquely attached to the generally annular support member, thereby inducing the leaflets to contact toward the middle member. The proximal portion of the middle member is configured to be placed into the atrium. The device further comprises at least one connecting member configured to support the middle member via the generally annular support member. The middle member may have a croissant shape.

[0006] According to another embodiment, an implantable device for repairing a heart valve having an annulus and two or more leaflets is provided, the device comprising: a generally annular support member comprising a longitudinal axis, the generally annular support member being sized and configured to attach to the annulus of the heart valve; and a middle member comprising a longitudinal axis, a distal portion, and a proximal portion, the longitudinal axis of the generally annular support member being disposed at a predetermined angle relative to the longitudinal axis of the middle member such that the middle member is obliquely attached to the generally annular support member, thereby inducing the leaflets to contact the middle member. The distal portion of the middle member is configured to pass through the leaflets of the heart valve into the ventricle, while the proximal portion of the middle member is positioned in the atrium. The entire middle member is configured to be positioned between the leaflets. The entire middle member is configured to be positioned in the atrium. The entire middle member is configured to be positioned in the ventricle. The predetermined angle is approximately 0 degrees. The predetermined angle is approximately 90 degrees. The device further comprises at least one connecting member configured to support the middle member via the substantially annular support member.The middle member may have a croissant shape.

[0007] According to one aspect of the present invention, a method for treating blood regurgitation through a diseased tricuspid valve is provided. One step of the method includes providing a device comprising a generally annular support member and a mid-member securely attached thereto. Next, the generally annular support member is attached to the annulus of the diseased tricuspid valve such that the mid-member extends obliquely behind the anterior superior leaflet and in front of the posterior and septal leaflets.

[0008] According to another aspect of the present invention, a method for treating blood regurgitation through a diseased mitral valve is provided. One step of the method includes providing a device comprising a generally annular support member and a mid-member securely coupled thereto. Next, the generally annular support member is coupled to the annulus of the diseased mitral valve such that the mid-member extends obliquely between the anterior and posterior leaflets. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A Shown is a view of a diseased tricuspid valve with a regurgitant orifice (RO).

[0010] Figure 1B Shown is a view of a diseased mitral valve with a regurgitant orifice (RO).

[0011] Figure 1C A cross-sectional view of the regurgitant orifice (RO) and leaflets is shown.

[0012] Figure 2A A front view of the device for use with a tricuspid valve is shown.

[0013] Figure 2B Shown Figure 2A Side view of the device.

[0014] Figure 2C Shown is the implantation of a tricuspid valve Figure 2A Cross-sectional view of the device.

[0015] Figure 2D Shown Figure 2A Front view of an alternative configuration of a device for a tricuspid valve.

[0016] Figure 2E Shown Figure 2D Side view of the device.

[0017] Figure 2F Shown is the implantation of a tricuspid valve Figure 2D Cross-sectional view of the device.

[0018] Figure 3A A front view showing an alternative configuration of a device for a tricuspid valve is shown.

[0019] Figure 3B Shown Figure 3A Side view of the device.

[0020] Figure 3C Shown is the implantation of a tricuspid valve Figure 3A Cross-sectional view of the device.

[0021] Figure 3D Shown for tricuspid valve Figure 3A Front view of an alternative structure.

[0022] Figure 3E Shown Figure 3D Side view of the device.

[0023] Figure 3F Shown is the implantation of a tricuspid valve Figure 3D Cross-sectional view of the device.

[0024] Figure 4A A front view of an alternative structure for a tricuspid valve device is shown.

[0025] Figure 4B Shown Figure 4A Side view of the device in.

[0026] Figure 4C Shown is the implantation of a tricuspid valve Figure 4A Cross-sectional view of the device.

[0027] Figure 4D Shown for tricuspid valve Figure 4A A front view of an alternative configuration of the apparatus.

[0028] Figure 4E Shown Figure 4D Side view of the device in.

[0029] Figure 4F Shown is the implanted tricuspid valve Figure 4D Cross-sectional view of the device.

[0030] Figure 5A Shows when the tricuspid valve opens Figure 2A A perspective view of the device.

[0031] Figure 5B Shows when the tricuspid valve closes Figure 2A A perspective view of the device in FIG.

[0032] Figure 5C Shown is the implantation of a tricuspid valve Figure 5B Cross-sectional view of the device.

[0033] Figure 5D This is a 3D image showing the tricuspid valve opening. Figure 2D The device in.

[0034] Figure 5E Shows the tricuspid valve closing Figure 2D A perspective view of the device in FIG.

[0035] Figure 5F Shown Figure 5D Cross-sectional view of the device implanted in the tricuspid valve.

[0036] Figure 6A A front view of an alternative configuration of a tricuspid valve device is shown.

[0037] Figure 6B Shown Figure 6A Side view of the device in.

[0038] Figure 6C Shown Figure 6A Cross-sectional view of the device implanted in the tricuspid valve.

[0039] Figure 6D Shown for tricuspid valve Figure 6A A front view of an alternative configuration of the apparatus.

[0040] Figure 6E Shown Figure 6D Side view of the device in.

[0041] Figure 6F Shown is the implantation of a tricuspid valve Figure 6D Cross-sectional view of the device.

[0042] Figure 7A A front view of the mitral valve apparatus is shown.

[0043] Figure 7B Shown Figure 7A Side view of the device.

[0044] Figure 7C Shown is the implantation of the mitral valve Figure 7A Cross-sectional view of the device.

[0045] Figure 7D Shown for the mitral valve Figure 7A A front view of an alternative configuration of the apparatus.

[0046] Figure 7E Shown Figure 7D Side view of the device in.

[0047] Figure 7F Shown is the implantation of the mitral valve Figure 7D Cross-sectional view of the device.

[0048] Figure 8A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0049] Figure 8B Shown Figure 8A Side view of the device.

[0050] Figure 8C Shown is the implantation of the mitral valve Figure 8A Cross-sectional view of the device.

[0051] Figure 8D Shown for the mitral valve Figure 8A A front view of an alternative configuration of the apparatus.

[0052] Figure 8E Shown Figure 8D Side view of the device.

[0053] Figure 8F Shown is the implantation of the mitral valve Figure 8D Cross-sectional view of the device.

[0054] Figure 9A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0055] Figure 9B Shown Figure 9A Side view of the device.

[0056] Figure 9C Shown is the implantation of the mitral valve Figure 9A Cross-sectional view of the device.

[0057] Figure 9D Shown for the mitral valve Figure 9A Front view of an alternative configuration of the device.

[0058] Figure 9E Shown Figure 9D Side view of the device.

[0059] Figure 9F Shown is the implantation of the mitral valve Figure 9D Cross-sectional view of the device.

[0060] Figure 10A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0061] Figure 10B Shown Figure 10A A top view of the device.

[0062] Figure 10C Shown is the implantation of the mitral valve Figure 10A A top view of the device.

[0063] Figure 11A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0064] Figure 11B Shown Figure 11A Side view of the device.

[0065] Figure 11C Shown is the implantation of the mitral valve Figure 11A Cross-sectional view of the device.

[0066] Figure 12A A perspective view of the device implanted in the mitral valve is shown.

[0067] Figure 12B Another perspective view of the device implanted in the mitral valve is shown.

[0068] Figure 12C Shown Figure 12A A perspective view of the device.

[0069] Figure 12D Shown Figure 12A Side view of the device.

[0070] Figure 13A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0071] Figure 13B Shown Figure 13A Side view of the device.

[0072] Figure 13C Shown is the implantation of the mitral valve Figure 13A Cross-sectional view of the device.

[0073] Figure 14A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0074] Figure 14B Shown Figure 14A Side view of the device.

[0075] Figure 14C Shown is the implantation of the mitral valve Figure 14A Cross-sectional view of the device.

[0076] Figure 15A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0077] Figure 15B Shown Figure 15A Side view of the device.

[0078] Figure 15C Shown is the implantation of the mitral valve Figure 15A Cross-sectional view of the device.

[0079] Figure 16A A front view showing an alternative configuration of a device for a mitral valve is shown.

[0080] Figure 16B Shown Figure 16A Side view of the device.

[0081] Figure 16C Shown is the implantation of a tricuspid valve Figure 16A Cross-sectional view of the device.

[0082] Figure 17A A perspective view showing an alternative configuration of a device for a tricuspid valve is shown.

[0083] Figure 17B Shown Figure 17A Side view of the device.

[0084] Figure 17C Shown is the implantation of a tricuspid valve Figure 17A Cross-sectional view of the device.

[0085] Figure 18A A front view showing an alternative configuration of a device for a tricuspid valve is shown.

[0086] Figure 18B Shown Figure 18A Side view of the device.

[0087] Figure 18C Shown is the implantation of a tricuspid valve Figure 18A Cross-sectional view of the device.

[0088] Figure 19A A front view showing an alternative configuration of a device for a tricuspid valve is shown.

[0089] Figure 19B Shown Figure 19A Side view of the device.

[0090] Figure 19C Shown is the implantation of a tricuspid valve Figure 19A Cross-sectional view of the device.

[0091] Figure 20A A front view showing an alternative configuration of a device for a tricuspid valve is shown.

[0092] Figure 20B Shown Figure 20A Side view of the device.

[0093] Figure 20C Shown is the implantation of a tricuspid valve Figure 20A A top cross-sectional view of the device.

[0094] Figure 21A A front view of an alternative configuration of a tricuspid valve device is shown.

[0095] Figure 21B Shown Figure 21A Side view of the device.

[0096] Figure 21C Shown is the implantation of a tricuspid valve Figure 21A Cross-sectional view of the device.

[0097] Figure 22A A front view showing an alternative configuration of a device for a tricuspid valve is shown.

[0098] Figure 22B Shown Figure 22A Side view of the device.

[0099] Figure 22C Shown is the implantation of a tricuspid valve Figure 22A Cross-sectional view of the device.

[0100] Figure 23A A front view showing an alternative configuration of a device for a tricuspid valve is shown.

[0101] Figure 23B Shown Figure 23A Side view of the device.

[0102] Figure 23C Shown is the implantation of the mitral valve Figure 23A Cross-sectional view of the device. DETAILED DESCRIPTION

[0103] To aid understanding of the present invention, the accompanying drawings illustrate exemplary embodiments in which the present invention may be implemented. The drawings herein are not drawn to scale or true to scale. For example, the length and width of components may be adjusted to fit the page size.

[0104] This specification relates to devices and methods for treating dysfunctional heart valves, and more particularly to devices and related methods that help prevent or reduce heart valve regurgitation. As a representative embodiment, Figures 2A-2C A device 10 for treating blood flow reflux through a regurgitation orifice (RO) 3 is shown. Figure 1A-1B The tricuspid valve 1 and the mitral valve 2 are shown.

[0105] like Figure 1C As shown, a diseased valve leaflet 4 with a regurgitant vent 3 is shown in cross-section. The diseased valve leaflet 4 may include an X-axis and a Y-axis relative to the center of the regurgitant vent 3. Figure 1C As shown, the valve leaflets 4 may be located between the atrium and the ventricle, and their function is to prevent blood from flowing back from the ventricle to the atrium during contraction.

[0106] Reference Figure 2A-2C , a device 10 for a tricuspid valve may include a substantially annular support member 11, a middle member 12, and at least one connecting member 13, wherein the connecting member 13 is firmly connected between the annular support member 11 and the middle member 12. As described herein, the term "substantially annular" may be used to describe an annular support member 11 having a circular or semicircular structure. Therefore, the term "substantially annular" may refer to an annular support member 11 that is fully annular, fully circular, elliptical, partially annular, C-shaped (or reverse C-shaped), D-shaped (or reverse D-shaped), U-shaped (or reverse U-shaped), etc.

[0107] As used herein, the term "substantially" may refer to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, a "substantially" annular support member 11 means that support member 11 may be completely annular or nearly completely annular. In some cases, the exact degree of deviation from absolute annularity may depend on the specific context. However, generally speaking, the degree of approximation to annularity will generally result in the same outcome as achieving both absolute annularity and overall annularity.

[0108] like Figure 2A As shown, for example, the substantially annular support member 11 may be in the shape of an inverted C, sized and configured to be attached to the tricuspid annulus of the diseased tricuspid valve 1. Figure 2B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may be configured to have a rigid or semi-rigid structure.

[0109] Figure 2A1 shows a front view of the device 10. The device 10 may also include at least one middle member 12. The middle member 12 may be securely connected to the annular support member 11 at a first position by at least one connecting member 13. Figure 2A-2C As shown, for example, the middle member 12 can be connected to the annular support member 11 by at least two connecting members 13. The middle member 12 can include a longitudinal axis B1. The middle member 12 can have a proximal portion 14, a distal portion 15, and a middle portion.

[0110] Figure 2B A top view of the device 10 is shown. The size, shape and structure of the middle member 12 are configured as follows: Figure 2C As shown, when the device 10 is implanted at or near the tricuspid annulus of a diseased tricuspid valve 1, the middle member 12 is obliquely expanded to pass through the regurgitant orifice 3. Oblique expansion can be defined as the angle formed between the longitudinal axis A1 of the annular support member and the longitudinal axis B1 of the middle member 12. The angle of oblique expansion can vary depending on the patient.

[0111] like Figure 2C As shown, in a top view, the middle member 12 may have the following structure: Figure 2B The angle between A1 and B1 shown allows the middle member 12 to be dilated obliquely across the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle can be set so that the middle member 12 can induce the diseased leaflets 4 to contact the middle member 12. The angle of dilated dilation can be varied depending on the patient.

[0112] In one example embodiment, the angle can be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce or attract the diseased leaflet 4 toward contact with the middle member 12, the connecting member 13 can be selectively adjusted according to the leaflet structure. It should be noted that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0113] Figure 2C A top cross-sectional view of the device 10 attached to the tricuspid annulus of a diseased tricuspid valve 1 is shown, wherein the central portion of the middle member 12 may preferably be positioned where the X-axis and the Y-axis intersect within the regurgitant orifice 3 so as to induce the free edges of the leaflets 4 to abut against the middle member 12 during systole. Figure 2C As shown, the proximal portion 14 of the middle member 12 is preferably configured to be located in the atrium, while the distal portion 15 of the middle member 12 is preferably configured to be located in the ventricle. It should be understood that this configuration may vary depending on the diseased tricuspid valve structure.

[0114] Figure 5A yes Figure 2A Stereoscopic image. Figure 5BIt is shown that when the diseased tricuspid valve is closed, the diseased tricuspid valve leaflets 4 can be induced to adhere to the middle member 12. Figure 5A-5B As shown, for example, during systole, the distal portion 15 of the middle member 12 can be preferably configured to coapt behind the anterior superior leaflet 4, and the proximal portion 14 of the middle member 12 can be configured to coapt in front of the posterior leaflet and the septal leaflet. It should be noted that this coaptation may vary depending on the diseased tricuspid valve structure.

[0115] Reference Figure 2A-2C The middle member 12 may have a rigid, semi-rigid or flexible structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 may be bent or adjusted to various positions. The middle member 12 may have a 3D shape corresponding to the actual 3D shape of the patient's valve leaflet 4. The joint portion of the middle member 12 may be oval or elliptical. Figure 6A-6B As shown, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can be varied according to the diseased tricuspid valve structure to achieve optimal leaflet coaptation. For example, relative to Figure 2A-2C The middle member shown, such as Figure 2D-2F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0116] Figures 3A-3C Another embodiment for a tricuspid valve is shown. Figure 3A-3C The device 10 may include a substantially annular support member 11, a middle member 12, and at least one connecting member 13. The connecting member 13 may be firmly connected between the support member 11 and the middle member 12. For example, Figure 3A As shown, the substantially annular support member 11 may be in the shape of an inverted C and may be sized and configured to be attached to the tricuspid annulus of the diseased tricuspid valve 1. Figure 3B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid, semi-rigid or flexible structure.

[0117] Figure 3A 1 shows a front view of the device 10. The device 10 may also include at least one middle member 12, which may be securely connected to the annular support member 11 at a first position by at least one connecting member 13. For example, Figure 3A-3C As shown, the middle member 12 can be connected to the annular support member 11 by two connecting members 13. The middle member 12 includes a longitudinal axis B1. The middle member 12 has a proximal portion 14, a distal portion 15 and a central portion.

[0118] Figure 3B1 shows a top view of the device 10. The size, shape and structure of the middle member 12 can be configured as follows: Figure 3C As shown, when the device 10 is implanted in or near a diseased tricuspid valve 1, the middle member 12 can be expanded obliquely downward through the regurgitant orifice 3. Oblique expansion can be defined as the angle formed between the longitudinal axis A1 of the annular support member and the longitudinal axis B1 of the middle member 12. The angle of oblique expansion may vary from patient to patient.

[0119] like Figure 3C As shown, the top view of the middle member 12 has the following structure: Figure 3B At the angle shown between A1 and B1, the middle member 12 can be expanded obliquely downward through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle enables the middle member 12 to induce the diseased leaflets 4 to contact the middle member 12. The angle of oblique expansion may vary from patient to patient.

[0120] In one example of an embodiment, the angle between A1 and B1 can be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to contact the middle member 12, the connecting member 13 can be selectively adjusted according to the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0121] Figure 3C A top cross-sectional view of the device 10 is shown attached to the tricuspid annulus of a diseased tricuspid valve 1. The central portion of the middle member 12 is preferably positioned within the regurgitant orifice 3 at the intersection of the X-axis and the Y-axis to induce the free edges of the leaflets 4 to adhere or contact toward the middle member 12 during systole. Figure 3C As shown, the distal portion 15 of the mid-member 12 is preferably configured to be located within the ventricle, while the proximal portion 14 of the mid-member 12 is preferably configured to be located within the atrium. It should be understood that this configuration may vary depending on the diseased tricuspid valve structure.

[0122] Reference Figure 3A-3C , the middle member 12 may have a rigid, semi-rigid or flexible structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 may be bent or adjusted to various positions. The middle member 12 may have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 may be elliptical. Optionally, the middle member 12 may have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 may vary depending on the diseased tricuspid valve structure to achieve optimal leaflet engagement. For example, relative to Figure 3A-3C The middle member shown, such as Figure 3D-3F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0123] Figures 4A-4C Another embodiment for a tricuspid valve is shown. Figures 4A-4C The device 10 comprises a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the annular support member 11. Figure 4A As shown, the substantially annular support member 11 may be in the shape of an inverted C and may be sized and configured to engage the tricuspid annulus of the diseased tricuspid valve 1. Figure 4B As shown, the annular support member 11 includes a longitudinal axis A1 . The middle member 12 includes a longitudinal axis B1 . The middle member 12 has a proximal portion 14 and a distal portion 15 .

[0124] Figure 4B Shown Figure 4A A top view of the device 10 is shown. Figure 4C When the device 10 is implanted in or near the diseased tricuspid valve 1, the size, shape and structure of the middle member 12 are configured to expand obliquely upward through the regurgitant orifice 3. Figure 4C As shown, the structure of the middle member 12 is configured as follows: Figure 4B As shown, the angle between A1 and B1 allows the middle member 12 to expand obliquely upward across the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle allows the middle member 12 to coax the diseased leaflets 4 toward the middle member 12. Oblique expansion can be defined as the angle formed between the longitudinal axis A1 of the annular support member and the longitudinal axis B1 of the middle member 12. The angle of oblique expansion can vary depending on the patient.

[0125] In one example embodiment, the angle between A1 and B1 can be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0126] Figure 4C A top cross-sectional view of the device 10 is shown attached to the tricuspid annulus of a diseased tricuspid valve 1. The central portion of the middle member 12 is preferably positioned within the regurgitant orifice 3 at the intersection of the X-axis and the Y-axis to induce the free edges of the leaflets 4 to adhere or contact toward the middle member 12 during systole. Figure 4C As shown, the proximal portion 14 of the middle member 12 is preferably configured to be located within the atrium, while the distal portion 15 of the middle member 12 is preferably configured to be located within the ventricle. It should be understood that this configuration may vary depending on the diseased tricuspid valve structure.

[0127] Reference Figures 4A-4C, the middle member 12 may have a rigid, semi-rigid or flexible structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 may be bent or adjusted to various positions. The middle member 12 may have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 may be elliptical. Optionally, the middle member 12 may have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 may vary depending on the diseased tricuspid valve structure to achieve optimal leaflet engagement. For example, relative to Figures 4A-4C The middle member shown, such as Figure 4D-4F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0128] Figures 6A-6C Another embodiment for a tricuspid valve is shown. Figures 6A-6C The device 10 may include a substantially annular support member 11, a middle member 12, and at least one connecting member 13. The connecting member 13 may be firmly connected between the annular support member 11 and the middle member 12. Figure 6A As shown, the substantially annular support member 11 may be in the shape of an inverted C and may be sized and configured to be attached to the tricuspid annulus of the diseased tricuspid valve 1. Figure 6B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure.

[0129] Figure 6A A front view of the device 10 is shown. The device 10 may also include at least one mid-member 12 that can be securely connected to the annular support member 11 at a first location via a connecting member 13. The mid-member 12 includes a longitudinal axis B1. The mid-member 12 has a proximal portion 14 and a distal portion 15. Figure 6B Shown Figure 6A The size, shape and structure of the middle member 12 can be configured as follows: Figure 6C When the device 10 is implanted in or near the diseased tricuspid valve 1 , the middle member 12 can be expanded obliquely and horizontally through the regurgitant orifice 3 .

[0130] like Figure 6C As shown, Figure 6A The top view of the middle member 12 has the following structure: Figure 6BAt the angle between A1 and B1 shown, the middle member 12 can be obliquely expanded horizontally through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle enables the middle member 12 to induce the diseased leaflets 4 to contact toward the middle member 12. In one example of an embodiment, the angle between A1 and B1 can be approximately 90 degrees. In order to make the diseased leaflets 4 contact toward the middle member 12, the size of the middle member can be selectively adjusted based on the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined by A1 and B1.

[0131] Figure 6C A top cross-sectional view of the device 10 is shown attached to the tricuspid annulus of a diseased tricuspid valve 1. The central portion of the middle member 12 is preferably positioned within the regurgitant orifice 3 at the intersection of the X-axis and the Y-axis to induce the free edges of the leaflets 4 to adhere or contact toward the middle member 12 during systole. Figure 6C As shown, the proximal portion 14 of the mid-member 12 is preferably configured to be located in the atrium, and the distal portion 16 of the mid-member is preferably configured to be located in the ventricle. It should be understood that this configuration may vary depending on the diseased tricuspid valve structure.

[0132] Reference Figures 6A-6C , the middle member 12 may have a rigid, semi-rigid or flexible structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 may be bent or adjusted to various positions. The middle member 12 may have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 may be oval or elliptical. Optionally, the middle member 12 may have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 may vary depending on the diseased tricuspid valve structure to achieve optimal leaflet engagement. For example, relative to Figures 6A-6C The middle member shown, such as Figure 6D-6F The illustrated middle member 12 may have a more convex or protruding shape depending on the patient's condition. As another example, the shape of the middle member 12 may be similar to a croissant.

[0133] Figures 7A-7C An embodiment for a mitral valve is shown. Figures 7A-7C The device 10 comprises a substantially annular support member 11, a middle member 12 and at least one connecting member 13, the connecting member 13 being firmly connected between the annular support member 11 and the middle member 12. For example, Figure 7A As shown, the substantially annular support member 11 may be U-shaped and dimensioned to be attached to the mitral annulus of the diseased mitral valve 2, as shown. Figure 1B As shown. Figure 7BAs shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid, semi-rigid or flexible structure.

[0134] Figure 7A A front view of the device 10 is shown. The device 10 may also include at least one mid-member 12 that can be securely connected to the annular support member 11 at a first location via a connecting member 13. The mid-member 12 includes a longitudinal axis B1. The mid-member 12 has a proximal portion 14 and a distal portion 15. Figure 7B Shown Figure 7A The size, shape and structure of the middle member 12 can be configured as follows: Figure 7C As shown, when the device 10 is implanted in or near the diseased mitral valve 2, the middle member 12 can expand upward through the regurgitant orifice 3. Figure 7C As shown, the middle member 12 has the following structure: Figure 7B The angle between A1 and B1 shown allows the middle member 12 to expand upward through the regurgitant orifice 3 (ie, between the diseased leaflets 4). This angle allows the middle member 12 to induce the diseased leaflets 4 to contact the middle member 12.

[0135] In one example of an embodiment, the angle between A1 and B1 can be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to contact the middle member 12, the connecting member 13 can be selectively adjusted according to the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0136] Figure 7C A top cross-sectional view of the device 10 attached to the mitral valve annulus of a diseased mitral valve is shown. The central portion of the middle member 12 is preferably positioned within the regurgitant orifice 3 at the intersection of the X-axis and the Y-axis to induce the free edges of the leaflets 4 to adhere or contact toward the middle member 12 during systole. When the proximal portion of the middle member 12 is positioned in the atrium, the pressure between the proximal portion and the adjacent leaflets increases during systole. Simultaneously, the distal portion of the middle member 12 is positioned within the ventricle, and the pressure between the distal portion and the adjacent leaflets decreases during systole. The above interaction attracts and enhances the engagement between the diseased leaflets and the middle member 12 during systole.

[0137] For example, Figure 7CAs shown, the proximal portion of the middle member 12 is positioned within the atrium to induce the adjacent free edges of the diseased valve leaflets to adhere toward the middle member 12 during systole. Simultaneously, the distal portion of the middle member 12 is positioned within the ventricle to induce the adjacent free edges of the diseased valve leaflets to adhere toward the middle member 12 during systole. It should be understood that this arrangement may vary depending on the structure of the diseased mitral valve.

[0138] Reference Figures 7A-7C , the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The middle member 12 can have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 can be elliptical. Optionally, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can vary according to the diseased tricuspid valve structure to achieve optimal leaflet engagement. For example, relative to Figures 7A-7C The middle member shown, such as Figure 7D-7F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0139] Figures 8A-8C Another embodiment for a mitral valve is shown. Figures 8A-8C The device 10 may include a substantially annular support member 11, a middle member 12, and at least one connecting member 13. The connecting member 13 may be firmly connected between the annular support member 11 and the middle member 12. Figure 8A As shown, the substantially annular support member 11 may be U-shaped and may be sized and configured to be attached to the mitral annulus of the diseased mitral valve 2, as shown. Figure 1B As shown. Figure 8B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure.

[0140] Figure 8A 1 shows a front view of the device 10. The device 10 also includes at least one middle member 12, which is fixedly connected to the annular support member 11 at a first location by a connecting member 13. The middle member 12 includes a longitudinal axis B1. The middle member 12 has a proximal portion 14 and a distal portion 15.

[0141] Figure 8B Shown Figure 8A The size, shape and structure of the middle member 12 are as follows: Figure 8C As shown, when the device 10 is implanted in or near the diseased mitral valve 2, the middle member 12 expands downward through the regurgitant orifice 3. Figure 8CAs shown, the structure of the middle member 12 is configured as follows: Figure 8B The angle between A1 and B1 shown allows the middle member 12 to expand downwardly through the regurgitant orifice 3 (ie, between the diseased leaflets 4). This angle allows the middle member 12 to induce the diseased leaflets 4 to contact the middle member 12.

[0142] In one example embodiment, the angle between A1 and B1 can be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). To induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0143] Figure 8C A top cross-sectional view of the device 10 attached to the mitral valve annulus of a diseased mitral valve is shown. The central portion of the middle member 12 is preferably disposed at the location where the X-axis and the Y-axis intersect within the regurgitant orifice 3 to induce the free edges of the leaflets 4 to adhere (or contact) toward the middle member 12 during systole. When the proximal portion of the middle member 12 is disposed within the atrium, the pressure between the proximal portion and the adjacent leaflets increases during systole. Simultaneously, when the distal portion of the middle member 12 is disposed within the ventricle, the pressure between the distal portion and the adjacent leaflets decreases during systole. The above interaction attracts and enhances the engagement between the diseased leaflets and the middle member 12 during systole. It will be understood that this arrangement may vary depending on the structure of the diseased mitral valve.

[0144] Reference Figures 8A-8C , the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The middle member 12 can have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 can be elliptical. Optionally, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can vary according to the diseased mitral valve structure to achieve optimal leaflet engagement. For example, relative to Figures 8A-8C The middle member shown, such as Figure 8D-8F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0145] Figures 9A-9C Another embodiment for a mitral valve is shown. Figures 9A-9C The device 10 comprises a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the annular support member 11. For example, Figure 9AAs shown, the substantially annular support member 11 may be U-shaped and dimensioned to be attached to the mitral annulus of the diseased mitral valve 2, as shown. Figure 1B As shown. Figure 9B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid, semi-rigid or flexible structure.

[0146] like Figure 9B As shown, the midsection member 12 includes a longitudinal axis B1 . The midsection member 12 has a proximal portion 14 and a distal portion 15 . Figure 9B Shown Figure 9A The size, shape and structure of the middle member 12 are as follows: Figure 9C As shown, when the device 10 is implanted in or near the diseased mitral valve 2 , the middle member 12 expands upwardly through the regurgitant orifice 3 .

[0147] like Figure 9C As shown, the middle member 12 is configured as follows: Figure 9B At the angle between A1 and B1 shown, the middle member 12 expands upward through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle enables the middle member 12 to induce the diseased leaflets 4 to contact toward the middle member 12. In one example of an embodiment, the angle between A1 and B1 can be between about 10 degrees and about 60 degrees (e.g., about 45 degrees). In order to induce the diseased leaflets 4 to contact toward the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0148] Figure 9C A top cross-section of the device 10 is shown attached to the mitral annulus of a diseased mitral valve 1. The central portion of the middle member 12 is preferably positioned within the regurgitant orifice 3 at the intersection of the X-axis and the Y-axis to induce the free edges of the leaflets 4 to adhere or contact toward the middle member 12 during systole. When the proximal portion 14 of the middle member 12 is positioned within the atrium, the pressure between the proximal portion and the adjacent leaflets increases. Simultaneously, when the distal portion 15 of the middle member 12 is positioned within the ventricle, the pressure between the distal portion and the adjacent leaflets decreases during systole.

[0149] During systole, the above interaction attracts and enhances the coaptation between the diseased leaflets and the mid-member 12. It will be appreciated that this arrangement may vary depending on the diseased mitral valve structure.

[0150] Reference Figures 9A-9C, the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The middle member 12 can have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 can be elliptical. Optionally, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can vary according to the diseased mitral valve structure to achieve optimal leaflet engagement. For example, relative to Figures 9A-9C The middle member shown, such as Figure 9D-9F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0151] Figures 10A-10C Another embodiment for a mitral valve is shown. Figures 10A-10C The device 10 comprises a substantially annular support member 11 and a middle member 12, and a connecting member 13 is firmly connected to the support member 11 and the middle member 12. Figure 10A As shown, the substantially annular support member 11 may be U-shaped and sized to be attached to the mitral annulus of the diseased mitral valve 2, as shown. Figure 1B As shown. Figure 10B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure.

[0152] like Figure 10B As shown, the midsection member 12 includes a longitudinal axis B1 . The midsection member 12 has a proximal portion and a distal portion 15 . Figure 10B Shown Figure 10A The size, shape and structure of the middle member 12 are configured as follows: Figure 10C As shown, when the device 10 is implanted in or near the diseased mitral valve 2 , the middle member 12 expands horizontally toward the ventricle through the regurgitant orifice 3 .

[0153] like Figure 10C As shown, the middle member 12 is configured as follows: Figure 10B At the angle between A1 and B1 shown, the middle member 12 expands horizontally through the regurgitant orifice 3 (i.e., between the diseased leaflets 4). This angle enables the middle member 12 to induce the diseased leaflets 4 to contact toward the middle member 12. In one example of an embodiment, the angle between A1 and B1 can be about 80 degrees to about 100 degrees (e.g., about 90 degrees). In order to induce the diseased leaflets 4 to contact toward the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure. It should be understood that the adjustment mechanism can be operated to adjust the lateral position of the middle member 12 to adjust the angle defined between A1 and B1.

[0154] Reference Figures 10A-10C , the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The middle member 12 can have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 can be elliptical. Optionally, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can vary according to the diseased mitral valve structure to achieve optimal leaflet engagement. For example, relative to Figures 10A-10C The middle member shown, such as Figures 10D-10F The illustrated midsection member 12 may have a more convex or protruding shape depending on the patient's condition.

[0155] Figures 11A-11C Another embodiment for a mitral valve is shown. Figures 11A-11C The device 10 comprises a substantially annular support member 11 and a middle member 12, and a connecting member 13 is firmly connected to the support member 11 and the middle member 12. Figure 11A As shown, the substantially annular support member 11 may be U-shaped and sized to be attached to the mitral annulus of the diseased mitral valve 2, as shown. Figure 1B As shown. Figure 11B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure.

[0156] The midsection member 12 includes a longitudinal axis B1 . Figure 11B Shown Figure 11A A top view of the device 10 is shown. Figure 11C As shown, when the device 10 is implanted at or near a diseased mitral valve 2, the size, shape and structure of the middle member 12 are configured to be located within the atrium. Figure 11C As shown, the middle member 12 is configured to be located in the atrium. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0157] Reference Figures 11A-11C The middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0158] Figures 12A-12D Another embodiment for a mitral valve is shown. Figures 12A-12DThe device 10 comprises a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the support member 11 and the connecting member 13. Figure 12A As shown, the substantially annular support member 11 may be U-shaped and sized to be attached to the mitral annulus of the diseased mitral valve 2, as shown. Figure 1B shown.

[0159] like Figure 12C As shown, the middle member 12 is configured so that the middle member 12 is located in the atrium. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0160] Reference Figures 12A-12D The middle member 12 may have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 may be bent or adjusted to various positions. The joint portion of the middle member 12 may be elliptical. It should be understood that the stiffness and shape of the middle member 12 may be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0161] Figures 13A-13C Another embodiment for a mitral valve is shown. Figures 13A-13C The device 10 comprises a substantially annular support member 11, a middle member 12 and a connecting member 13, wherein the middle member 12 is firmly connected to the annular support member 11. For example, Figure 13A As shown, the substantially annular support member 11 may be U-shaped and may be sized to be connected to the mitral valve annulus of the diseased mitral valve 2, as shown in FIG. Figure 1B As shown. Figure 13B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure.

[0162] The midsection member 12 includes a longitudinal axis B1 . Figure 13B Shown Figure 13A A top view of the device 10 is shown. Figure 13C When the device 10 is implanted in or near a diseased mitral valve 2, the size, shape and structure of the middle member 12 are configured to be located within the leaflets 4. Figure 13C As shown, the middle member 12 is configured to be positioned within the leaflet 4. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0163] Reference Figures 13A-13C, the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The middle member 12 can have a 3D shape corresponding to the 3D shape of the leaflets 4. The engagement portion of the middle member 12 can be elliptical. Alternatively, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can vary depending on the structure of the diseased mitral valve to achieve optimal leaflet engagement.

[0164] Figures 14A-14C Another embodiment for a mitral valve is shown. Figures 14A-14C The device 10 comprises a substantially annular support member 11, a middle member 12 and a connecting member 13, wherein the middle member 12 is firmly connected to the annular support member 11. For example, Figure 14A As shown, the substantially annular support member 11 may be U-shaped and may be sized to be connected to the mitral valve annulus of the diseased mitral valve 2, as shown in FIG. Figure 1B As shown. Figure 14B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure.

[0165] The midsection member 12 includes a longitudinal axis B1 . Figure 14B Shown Figure 14A A top view of the device 10 is shown. Figure 14C When the device 10 is implanted in or near a diseased mitral valve 2, the size, shape, and structure of the middle member 12 are configured to be located within the diseased leaflet 4. Figure 14C As shown, the middle member 12 is configured to be positioned within the leaflet 4. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0166] Reference Figures 14A-14C , the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The engagement portion of the middle member 12 can be elliptical. Alternatively, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can vary depending on the structure of the diseased mitral valve to achieve optimal leaflet engagement.

[0167] Figures 15A-15C Another embodiment for a mitral valve is shown. Figures 15A-15C The device 10 comprises a substantially annular support member 11, a middle member 12 and a connecting member 13, wherein the middle member 12 is firmly connected to the annular support member 11. For example, Figure 15AAs shown, the substantially annular support member 11 may be U-shaped and may be sized to be connected to the mitral valve annulus of the diseased mitral valve 2, as shown in FIG. Figure 1B shown.

[0168] like Figure 15B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 15B Shown Figure 15A A top view of the device 10 is shown. Figure 15C As shown, when the device 10 is implanted in or near the diseased mitral valve 2, the size, shape and structure of the middle member 12 are configured to be positioned near the regurgitant orifice 3 toward the atrium. Figure 15C As shown, the middle member 12 is configured to be positioned toward the atrium and adjacent to the leaflets 4. In order to induce the diseased leaflets 4 to contact toward the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0169] Reference Figures 15A-15C The middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0170] Figures 16A-16C Another embodiment for a tricuspid valve is shown. Figures 16A-16C , the device 10 comprises a substantially annular support member 11, a middle member 12 and a connecting member 13, wherein the middle member 12 is firmly connected to the support member 11. For example, Figure 16A As shown, the substantially annular support member 11 may be in an inverted C-shape and configured to be sized to be attached to the tricuspid annulus of the diseased tricuspid valve 1, as shown in FIG. Figure 1A shown.

[0171] like Figure 16B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 16B Shown Figure 16A A top view of the device 10 is shown. Figure 16C As shown, when the device 10 is implanted in or near a diseased tricuspid valve 1, the size, shape and structure of the middle member 12 are configured to be placed toward the atrium onto or above the leaflets. Figure 16C As shown, the middle member 12 is configured so that the middle member 12 is located behind the annular support member and faces the atrium. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0172] Reference Figures 16A-16C , the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The engagement portion of the middle member 12 can be elliptical. Alternatively, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet engagement.

[0173] Figures 17A-17B yes Figure 16A A three-dimensional diagram of the device. Figure 17C As shown, the middle member 12 is configured as follows: the middle member 12 is located behind the annular support member and faces the atrium. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0174] Figures 18A-18C Another embodiment for a tricuspid valve is shown. Figures 18A-18C The device 10 comprises a substantially annular support member 11, a middle member 12 and a connecting member 13, wherein the middle member 12 is firmly connected to the annular support member 11. For example, Figure 18A As shown, the substantially annular support member 11 may be in an inverted C-shape and sized to be attachable to the tricuspid annulus of the diseased tricuspid valve 1, as shown in FIG. Figure 1A shown.

[0175] like Figure 18B As shown, the annular support member 11 includes a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 18B Shown Figure 18A The size, shape and structure of the middle member 12 are as follows: Figure 18C As shown, when the device 10 is implanted in or near the diseased tricuspid valve 1, the middle member 12 is located in the leaflet 4 (regurgitant orifice 3). Figure 18C As shown, the middle member 12 is configured so that the middle member 12 is located within the leaflet 4. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0176] Reference Figures 18A-18C, the middle member 12 can have a rigid or semi-rigid structure. For example, in the case where the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The engagement portion of the middle member 12 can be elliptical. Alternatively, the middle member 12 can have a convex shape relative to the axis B1. It should be understood that the stiffness and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet engagement.

[0177] Figures 19A-19C Another embodiment for a tricuspid valve is shown. Figures 19A-19C In the embodiment, the device 10 may include a substantially annular support member 11, a middle member 12 and a connecting member 13, the middle member 12 being firmly connected to the annular support member 11. For example, Figure 19A As shown, the substantially annular support member 11 may be in an inverted C-shape and sized to be attached to the tricuspid annulus of the diseased tricuspid valve 1, as shown. Figure 1A shown.

[0178] like Figure 19B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 19B Shown Figure 19A The size, shape and structure of the middle member 12 are as follows: Figure 19C As shown, when the device 10 is implanted in or near the diseased tricuspid valve 1, the middle member 12 is located near the regurgitant orifice toward the atrium. Figure 19C As shown, the middle member 12 is configured such that the middle member 12 is located near the leaflets 4 and faces the atrium. In order to induce the diseased leaflets 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0179] Reference Figures 19A-19C The middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0180] Figures 20A-20C Another embodiment for a tricuspid valve is shown. Figures 20A-20C , the device 10 may include a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the annular support member 11. For example, Figure 20A As shown, the substantially annular support member 11 may be inverted C-shaped and may be sized to be attached to the annular space of the diseased tricuspid valve 1, as shown. Figure 1Ashown.

[0181] like Figure 20B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 20B Shown Figure 20A The size, shape and structure of the middle member 12 are as follows: Figure 20C As shown, when the device 10 is implanted in or near the diseased tricuspid valve 1, the middle member 12 can be located within the leaflet 4. Figure 20C As shown, the middle member 12 is configured so that the middle member 12 can be positioned within the leaflet 4. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0182] Reference Figures 20A-20C The middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0183] Figures 21A-21C Another embodiment for a tricuspid valve is shown. Figures 21A-21C , the device 10 may include a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the annular support member 11. For example, Figure 21A As shown, the substantially annular support member 11 may be inverted C-shaped and sized to be attached to the annular space of the diseased tricuspid valve 1, as shown in FIG. Figure 1A shown.

[0184] like Figure 21B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 21B Shown Figure 21A The size, shape and structure of the middle member 12 are as follows: Figure 21C As shown, when the device 10 is implanted in or near the diseased tricuspid valve 1, the middle member 12 is located near the regurgitant orifice toward the atrium. Figure 21C As shown, the middle member 12 can be configured such that the middle member 12 is close to the leaflets 4 and faces the atrium. In order to induce the diseased leaflets 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0185] Reference Figures 21A-21CThe middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0186] Figures 22A-22C Another embodiment for a tricuspid valve is shown. Figures 22A-22C , the device 10 may include a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the annular support member 11. For example, Figure 22A As shown, the substantially annular support member 11 may be inverted C-shaped and may be sized to be attached to the annular space of the diseased tricuspid valve 1, as shown. Figure 1A shown.

[0187] like Figure 22B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 22B Shown Figure 22A The size, shape and structure of the middle member 12 are as follows: Figure 22C As shown, when the device 10 is implanted in or near the diseased tricuspid valve 1, the middle member 12 is located near the regurgitant orifice toward the atrium and in the same plane as the annular support member. Figure 22C As shown, the middle member 12 is configured so that the middle member 12 is close to the leaflets 4 and faces the atrium. In order to induce the diseased leaflets 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0188] Reference Figures 22A-22C The middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be bent or adjusted to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0189] Figures 23A-23C Another embodiment for a mitral valve is shown. Figures 23A-23C , the device 10 may include a substantially annular support member 11 and a middle member 12, the middle member 12 being firmly connected to the annular support member 11. For example, Figure 23A As shown, the substantially annular support member 11 may be U-shaped and sized to be attachable to the mitral valve annulus of the diseased mitral valve 2, as shown. Figure 1B shown.

[0190] like Figure 23B As shown, the annular support member 11 may include a longitudinal axis A1. The substantially annular support member 11 may have a rigid or semi-rigid structure. Figure 23B Shown Figure 23A The size, shape and structure of the middle member 12 are configured as follows: Figure 23C As shown, when the device 10 is implanted in or near the diseased mitral valve 1, the middle member 12 can be located within the leaflet 4. Figure 23C As shown, the middle member 12 can be configured so that the middle member 12 can be positioned on the leaflet 4. In order to induce the diseased leaflet 4 to contact the middle member 12, the size of the middle member 12 can be selectively adjusted according to the leaflet structure.

[0191] Reference Figures 23A-23C The middle member 12 can have a rigid or semi-rigid structure. For example, if the middle member 12 has a semi-rigid structure, the middle member 12 can be flexible or adjustable to various positions. The coaptation portion of the middle member 12 can be elliptical. It should be understood that the rigidity and shape of the middle member 12 can be varied according to the diseased mitral valve structure to achieve optimal leaflet coaptation.

[0192] The description and examples provided herein are only for illustrating the present invention and are not intended to limit the present invention. Each disclosed aspect and embodiment of the present invention can be considered individually or in conjunction with other aspects, embodiments and modifications of the present invention. In addition, unless otherwise specified, the steps of the inventive method are not limited to any particular order. Those skilled in the art will appreciate improvements to the disclosed embodiments that comprise the spirit and content of the present invention, and these improvements are also within the scope of the present invention.

Claims

1. An implantable device for repairing a heart valve, the heart valve having a valve ring and three leaflets, characterized in that: The device comprises: a generally annular support member comprising a longitudinal axis, the generally annular support member being sized and configured to be attachable to an annulus of the heart valve; and a mid-member comprising a longitudinal axis, a distal portion, and a proximal portion, the mid-member being obliquely attached to the substantially annular support member, the distal portion of the mid-member obliquely passing through the leaflets toward the ventricle and enticing the leaflets toward contact with the mid-member, The middle member is attached to the annular support member such that the middle member extends in a manner crossing the annular support member, as viewed in a direction along a plane in which the annular support member lies.

2. The device according to claim 1, characterized in that The proximal portion of the midsection member is configured to be placed into an atrium.

3. The device according to claim 1, characterized in that Also included is at least one connecting member configured to support the mid-section member via the substantially annular support member.

4. An implantable device for repairing a heart valve, the heart valve having a valve ring and three leaflets, characterized in that: The device comprises: a generally annular support member comprising a longitudinal axis, the generally annular support member being sized and configured to be attachable to an annulus of the heart valve; and a middle member comprising a longitudinal axis, a distal portion, and a proximal portion, the longitudinal axis of the substantially annular support member being disposed at a predetermined angle to the longitudinal axis of the middle member so that the middle member is obliquely attached to the substantially annular support member and the leaflets are induced to contact toward the middle member, The middle member is attached to the annular support member such that the middle member extends in a manner crossing the annular support member, as viewed in a direction along a plane in which the annular support member lies.

5. The device according to claim 4, characterized in that The distal portion of the midsection member is configured to pass through the leaflets of the heart valve into a ventricle, while the proximal portion of the midsection member is positioned in an atrium.

6. The device according to claim 4, characterized in that The entire mid-section member is configured to be placed between the leaflets.

7. The device according to claim 4, characterized in that The entire midsection member is configured to be placed in an atrium.

8. The device according to claim 4, characterized in that The entire midsection member is configured to be placed in a heart chamber.

9. The device according to claim 4, characterized in that The predetermined angle is 90 degrees.

10. The device according to claim 4, characterized in that Also included is at least one connecting member configured to support the mid-section member via the substantially annular support member.

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