Protruding artificial heart valve delivery device and system

Abstract

A device for treating a diseased native valve in a patient is provided, the device comprising: a frame structure; valve segments radially arranged within the frame structure, the valve segments including a plurality of leaflets; and a plurality of commissure attachment mechanisms coupling the leaflets to the frame structure, each commissure attachment mechanism extending radially inward from the outflow end of the frame structure to form a gap between an inner diameter of the outflow end and an outflow edge of the valve segment. Other embodiments and methods of use are also provided.

Description

Technical Field

[0004] ,

[0003] ,

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 121,812, filed Dec. 4, 2020, entitled "MINIMAL FRAME PROSTHETIC CARDIAC VALVE DELIVERY DEVICES, SYSTEMS, AND METHODS"; U.S. Provisional Application No. 63 / 173,281, filed Apr. 9, 2021, entitled "FLARED PROSTHETIC CARDIAC VALVE DELIVERY DEVICES AND SYSTEMS"; and U.S. Provisional Application No. 63 / 274,821, filed Nov. 2, 2021, entitled "FLARED PROSTHETIC CARDIAC VALVE DELIVERY DEVICES AND SYSTEMS", which are hereby incorporated by reference in their entirety as if fully set forth herein.

Background Art

[0002]

[0002] Blood flow between cardiac chambers is regulated by native valves, namely the mitral valve, aortic valve, pulmonary valve, and tricuspid valve. These valves are each passive one - way valves that open and close in response to pressure differences. Patients with valvular heart disease have abnormalities in the anatomical structure and / or function of at least one valve. For example, a valve can become dysfunctional, also called regurgitation, when the valve does not close completely, thereby allowing blood to flow backward. Valve stenosis can cause the valve to fail to open properly. Other diseases can also lead to valve dysfunction.

[0003]

[0003] For example, the mitral valve is located between the left atrium and the left ventricle and, when functioning properly, allows blood to flow from the left atrium to the left ventricle while preventing backward flow or regurgitation. However, the native valve leaflets of an affected mitral valve do not deviate completely, and the patient will experience regurgitation.

[0004]

[0004] Drug therapy can be used to treat affected native valves, but the damaged valve often needs to be repaired or replaced at some point in the patient's lifetime. Existing prosthetic valves, as well as surgical repair and / or replacement procedures, carry high risks, have a limited lifespan, and / or are highly invasive. While some less invasive transcatheter options are available, most are not ideal. For example, a major limitation of existing transcatheter mitral valve devices is that their diameter is too large to be delivered transseptally, requiring transapical access instead. Furthermore, existing mitral valve replacement devices are not optimized in terms of strength-to-weight ratio and often occupy excessive space within the valve chamber, thereby causing obstruction and / or thrombosis of outflow from the ventricle to the aorta. [Overview of the project] [Problems that the invention aims to solve]

[0005]

[0005] Therefore, there is a need for new valve devices that overcome some or all of these defects. [Means for solving the problem]

[0006]

[0006] A device is provided for treating a patient's affected valve, the device comprising a frame structure, valve segments arranged radially within the frame structure, each including a plurality of leaflets, and a plurality of commissure attachment mechanisms for connecting the leaflets to the frame structure, each commissure attachment mechanism extending radially inward from the outflow end of the frame structure to form a gap between the inner diameter of the outflow end of the frame structure and the outflow edge of the valve segment.

[0007]

[0007] In some embodiments, the inlet edge of the valve segment is not supported by the frame structure. In other embodiments, the inlet edge is spaced radially inward from the inlet end of the frame structure. In some embodiments, the inlet end of the frame structure protrudes radially outward.

[0008]

[0008] In one embodiment, the outflow end of the frame structure protrudes radially outward, and the tip of the outflow end is substantially oriented axially.

[0009]

[0009] In some embodiments, the coupling attachment mechanism each comprises a paddle, the paddle having a slot through which the tab of the coupling of the leaflet passes.

[0010]

[0010] In one example, the paddle further comprises several through holes for sewing a tab to the paddle.

[0011]

[0011] In another embodiment, each connecting mechanism includes a post that is attached to the outflow end of the frame structure and curves radially inward.

[0012]

[0012] In some cases, the post is curved at approximately 180 degrees.

[0013]

[0013] In some embodiments, the post is attached to a support at the outflow end, and the thickness of the post is greater than the thickness of the support.

[0014]

[0014] In one embodiment, when the leaflet is fully opened, the gap is 1.5 mm to 4 mm.

[0015]

[0015] In some cases, the leaflet is not supported except by the coupling attachment mechanism.

[0016]

[0016] In some embodiments, the device further comprises a helical anchor configured to be positioned around a frame structure.

[0017]

[0017] In some embodiments, the frame structure comprises a plurality of support columns, each having a constricted portion adjacent to a helical anchor.

[0018]

[0018] A device is also provided for treating a patient's affected self-valve, which comprises a frame structure including a central annular portion, an inlet portion, and an outlet portion, the outlet portion projecting radially outward from the central annular portion; valve segments arranged radially within the frame structure, each including a plurality of leaflets; and a plurality of commissure attachment mechanisms for connecting the leaflets to the outlet portion of the frame structure, each commissure attachment mechanism extending radially inward, such that the inner circumference formed by the commissure attachment mechanisms is substantially equal to the inner circumference of the central annular portion.

[0019]

[0019] In some embodiments, the inlet edge of the valve segment is not supported by the frame structure. In other embodiments, the inlet edge is spaced radially inward from the inlet portion of the frame structure. In some examples, the inlet portion of the frame structure protrudes radially outward.

[0020]

[0020] In some embodiments, the tip of the outflow portion is substantially oriented axially. In one embodiment, each of the coupling attachment mechanisms comprises a paddle, the paddle having a slot through which the tab of the coupling portion of the leaflet passes.

[0021]

[0021] In another embodiment, the paddle further comprises a plurality of through holes for sewing tabs to the paddle.

[0022]

[0022] In some examples, each connecting mechanism is attached to the outflow portion of the frame structure and includes a post that curves radially inward.

[0023]

[0023] In one embodiment, the post is curved at approximately 180 degrees. In another example, the post is attached to a support column in the outflow section, and the thickness of the post is greater than the thickness of the support column.

[0024]

[0024] In one embodiment, the gap between the outlet edge of the valve segment and the inner circumference (e.g., diameter) of the outlet portion of the frame structure is 1.5 mm to 4 mm when the leaflet is fully open.

[0025]

[0025] In some examples, the leaflets are not supported except in the commissure attachment mechanism.

[0026]

[0026] In one embodiment, the device further comprises a helical anchor configured to be disposed around the frame structure at a central annular portion.

[0027]

[0027] In some examples, the frame structure comprises a plurality of struts, and the struts have a constricted portion within the central annular portion.

[0028]

[0028] A device for treating a diseased native valve of a patient is provided, the device comprising a frame structure including an annular central portion, a projecting inflow portion, and a projecting outflow portion, a valve segment radially disposed within the frame structure and including a plurality of leaflets, and an inner skirt portion attached to the frame structure, the inner skirt portion including a plurality of convex segments configured to at least partially conform to the inflow edge of the leaflets.

[0029]

[0029] In some embodiments, the convex segments have a radius of curvature greater than the inflow edge of the leaflets.

[0030]

[0030] In one example, the outflow edge of the inner skirt portion includes a zigzag pattern configured to match the pattern of the cells of the frame structure. In other examples, the outflow edge of the inner skirt portion is attached to the frame in proximity to the annular central portion. In another embodiment, the outflow edge of the inner skirt portion does not extend to the outflow end of the frame structure.

[0031]

[0031] In some examples, the inflow edge of the leaflets is not supported by the frame structure. In another embodiment, the inflow edge of the leaflets is disposed radially inwardly spaced from the inflow end of the frame structure.

[0032]

[0032] In some embodiments, the device further comprises a helical anchor configured to be positioned around a frame structure.

[0033]

[0033] A device is provided for treating a patient's affected valve, the device comprising a frame structure including an annular central portion, an overhanging inlet portion, and an overhanging outlet portion; valve segments arranged radially within the frame structure, each including a plurality of leaflets; and an outer skirt portion attached to the frame structure, the outer skirt portion including an integral structure covering the overhanging inlet portion and the overhanging outlet portion.

[0034]

[0034] In some examples, the outer skirt portion includes a tubular knitted fabric. In another embodiment, the outer skirt portion includes a coating thereon.

[0035]

[0035] In some embodiments, the device further comprises a helical anchor configured to be positioned around a frame structure.

[0036]

[0036] In one embodiment, the outer skirt portion is wrapped around the outflow edge of the frame structure.

[0037]

[0037] In another embodiment, an additional skirt portion is stacked on the outer skirt portion. In some examples, the additional skirt portion is positioned along the overhanging outflow portion. In one embodiment, the additional skirt portion is positioned along the central annular portion of the frame structure.

[0038]

[0038] A device is provided for treating a patient's affected valve, the device comprising a frame structure including an overhanging inlet portion including first and second rows of cells, an annular central portion including a third row of cells, and an overhanging outlet portion including a fourth row of cells, and valve segments radially arranged within the frame structure, each including a plurality of leaflets.

[0039]

[0039] In some embodiments, the inlet portion extends radially outward further than the outlet portion.

[0040]

[0040] In other embodiments, the inlet portion is curved so as to face radially inward.

[0041]

[0041] In one embodiment, the device further comprises a plurality of non-shortened elements extending from the inlet portion.

[0042]

[0042] In some cases, the tip of the outflow portion is substantially oriented axially.

[0043]

[0043] In one embodiment, the cells of the third column include a plurality of constricted supports that extend in the axial direction.

[0044]

[0044] In other embodiments, the tip of the overhanging outflow portion is substantially oriented axially.

[0045]

[0045] In some examples, the cells are substantially diamond-shaped.

[0046]

[0046] In another embodiment, the device includes a helical anchor configured to be positioned around the frame structure in a central annular portion.

[0047]

[0047] In another example, the device includes a plurality of coupling attachment mechanisms that connect the leaflet to a frame structure, each coupling attachment mechanism extending radially inward from the outlet end of the frame structure so as to form a gap between the inner diameter of the outlet end of the frame structure and the outlet edge of the valve segment.

[0048]

[0048] A method is provided for treating a patient's affected self-valve, the method comprising: providing a device comprising a frame structure; valve segments arranged radially within the frame structure, each segment comprising a plurality of leaflets; and a plurality of commissure attachment mechanisms for connecting the leaflets to the frame structure; advancing the device into the patient's affected self-valve; deploying the device within the affected self-valve and securing the device to the affected self-valve; and enabling the outflow edges of the plurality of leaflets to open to a radius greater than the radius formed by the plurality of commissure attachment mechanisms.

[0049]

[0049] In some embodiments, the outflow edges of the multiple leaflets can be opened to a radius smaller than the inner circumference of the frame structure.

[0050]

[0050] In other embodiments, the openings of the leaflets are configured to maintain a cylindrical flow path.

[0051]

[0051] A method is provided for treating a patient's affected valve, the method comprising: providing a device comprising a frame structure; valve segments arranged radially within the frame structure, each segment comprising a plurality of leaflets; and a plurality of commissure attachment mechanisms for connecting the leaflets to the frame structure, each extending radially inward such that the inner circumference formed by the commissure attachment mechanisms is smaller than the inner circumference formed by the frame structure; advancing the device into the patient's affected valve; positioning the device within the affected valve and securing the device to the affected valve; and enabling the outflow edges of the plurality of leaflets to open to a radius larger than the radius formed by the plurality of commissure attachment mechanisms.

[0052]

[0052] In some embodiments, the outflow edges of the multiple leaflets can be opened to a radius smaller than the inner circumference of the frame structure.

[0053]

[0053] In other embodiments, the openings of the leaflets are configured to maintain a cylindrical flow path.

[0054]

[0054] Novel features of the present disclosure are described in detail in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by referring to the following detailed description, which describes exemplary embodiments in which the principles of the present disclosure are utilized, and to the appended drawings. [Brief explanation of the drawing]

[0055] [Figure 1A]

[0055] Figure 1A shows an implantable flap prosthesis according to an embodiment. [Figure 1B] Figure 1B shows an implantable flap prosthesis according to an embodiment. [Figure 2]

[0056] This diagram shows the frame structure of a partially hourglass-shaped valve prosthesis. [Figure 3]

[0057] This diagram shows a non-expandable (or folded or crimped) valve prosthesis. [Figure 4]

[0058] This figure shows typical examples of anchors used for valve prosthetics. [Figure 5]

[0059] This is a diagram showing an example of a frame structure having one or more leaflets. [Figure 6]

[0060] This figure shows a frame with valve segments attached to one or more support columns of the frame structure. [Figure 7] This figure shows a frame with valve segments attached to one or more support columns of the frame structure. [Figure 8A]

[0061] Figure 8A shows another flap prosthesis in which substantially the entire inflow margin extends proximal beyond the proximal arch of the frame structure. [Figure 8B] Figure 8B shows another flap prosthesis in which substantially the entire inflow margin extends proximal beyond the proximal arch of the frame structure. [Figure 9]

[0062] This figure shows another embodiment of the frame structure. [Figure 10A]

[0063] Figure 10A shows a valve prosthesis in which the inflow edge of the valve segment is not fully supported. [Figure 10B] Figure 10B shows a valve prosthesis in which the inflow edge of the valve segment is not fully supported. [Figure 11A]

[0064] Figure 11A shows another valve prosthesis in which the inflow edge of the valve segment is not fully supported. [Figure 11B] Figure 11B shows another valve prosthesis in which the inflow edge of the valve segment is not fully supported. [Figure 11C] Figure 11C shows another valve prosthesis in which the inflow edge of the valve segment is not fully supported. [Figure 12A]

[0065] Figure 12A shows the frame structure, including an enlarged view of the coupling attachment mechanism. [Figure 12B] Figure 12B shows the frame structure, including an enlarged view of the coupling attachment mechanism. [Figure 12C] Figure 12C shows the frame structure, including an enlarged view of the coupling attachment mechanism. [Figure 12D] Figure 12D shows the frame structure, including an enlarged view of the coupling attachment mechanism. [Figure 12E] Figure 12E shows the frame structure, including an enlarged view of the coupling attachment mechanism. [Figure 12F] Figure 12F shows the frame structure, including an enlarged view of the coupling attachment mechanism. [Figure 13A]

[0066] Figure 13A shows an example of a leaflet attached to a frame structure. [Figure 13B] Figure 13B shows an example of a leaflet attached to a frame structure. [Figure 13C]Figure 13C shows an example of a leaflet attached to a frame structure. [Figure 13D] Figure 13D shows an example of a leaflet attached to a frame structure. [Figure 13E] Figure 13E shows an example of a leaflet attached to a frame structure. [Figure 14A]

[0067] Figure 14A shows how the leaflet closes. [Figure 14B] Figure 14B shows how the leaflet closes. [Figure 14C] Figure 14C shows how the leaflet closes. [Figure 15A]

[0068] Figure 15A shows how the leaflet opens. [Figure 15B] Figure 15B shows how the leaflet opens. [Figure 15C] Figure 15C shows how the leaflet opens. [Figure 16A]

[0069] Figure 16A shows various diagrams, including dimensions of the frame structure with leaflet. [Figure 16B] Figure 16B shows various diagrams, including dimensions of the frame structure with leaflet. [Figure 16C] Figure 16C shows various diagrams, including dimensions of the frame structure with leaflets. [Figure 16D] Figure 16D shows various diagrams, including dimensions of the frame structure with leaflets. [Figure 17A]

[0070] Figure 17A shows an example of a frame structure. [Figure 17B] Figure 17B shows an example of a frame structure. [Figure 17C] Figure 17C shows an example of a frame structure. [Figure 17D] Figure 17D shows an example of a frame structure. [Figure 18A]

[0071] Figure 18A shows another example of a frame structure. [Figure 18B] Figure 18B shows another example of a frame structure. [Figure 18C] Figure 18C shows another example of a frame structure. [Figure 18D] Figure 18D shows another example of a frame structure. [Figure 19A]

[0072] Figure 19A shows an example of a frame structure. [Figure 19B] Figure 19B shows an example of a frame structure. [Figure 19C] Figure 19C shows an example of a frame structure. [Figure 19D] Figure 19D shows an example of a frame structure. [Figure 20A]

[0073] Figure 20A shows yet another example of a frame structure. [Figure 20B] Figure 20B shows yet another example of a frame structure. [Figure 20C] Figure 20C shows yet another example of a frame structure. [Figure 20D] Figure 20D shows yet another example of a frame structure. [Figure 21]

[0074] This table shows exemplary dimensions for various frame structures. [Figure 22A]

[0075] Figure 22A shows an example of a frame structure. [Figure 22B] Figure 22B shows an example of a frame structure. [Figure 23A]

[0076] Figure 23A shows another example of a frame structure. [Figure 23B] Figure 23B shows another example of a frame structure. [Figure 23C] Figure 23C shows another example of a frame structure. [Figure 23D] Figure 23D shows another example of a frame structure. [Figure 24A]

[0077] Figure 24A shows an example of a frame structure. [Figure 24B] Figure 24B shows an example of a frame structure. [Figure 24C] Figure 24C shows an example of a frame structure. [Figure 24D] Figure 24D shows an example of a frame structure. [Figure 25A]

[0078] Figure 25A shows another example of a frame structure. [Figure 25B] Figure 25B shows another example of a frame structure. [Figure 26A]

[0079] Figure 26A shows the inner skirt portion attached to the frame. [Figure 26B] Figure 26B shows the inner skirt portion attached to the frame. [Figure 26C] Figure 26C shows the inner skirt portion attached to the frame. [Figure 27A]

[0080] Figure 27A shows the attachment or sewing points of the skirt portion to the frame. [Figure 27B] Figure 27B shows the attachment or sewing points of the skirt portion to the frame. [Figure 27C] Figure 27C shows the attachment or sewing points of the skirt portion to the frame. [Figure 27D] Figure 27D shows the attachment or sewing points of the skirt portion to the frame. [Figure 27E] Figure 27E shows the attachment or sewing points of the skirt portion to the frame. [Figure 27F] Figure 27F shows the attachment or sewing points of the skirt portion to the frame. [Figure 28]

[0081] This diagram shows a frame equipped with an integrated skirt section. [Figure 29]This diagram shows a frame equipped with an integrated skirt section. [Figure 30A]

[0082] Figure 30A shows a frame equipped with an inner skirt portion or an outer skirt portion. [Figure 30B] Figure 30B shows a frame equipped with an inner skirt portion or an outer skirt portion. [Modes for carrying out the invention]

[0056]

[0083] This specification describes systems, devices, and methods for treating or replacing affected heart valves, such as the mitral valve.

[0057]

[0084] Generally, replacement prostheses that may include a valve frame and helical anchors around it are described herein.

[0058]

[0085] Figures 1A-1B show a valve prosthesis (in other words, a valve prosthesis) 10 having a valve frame 12a and a plurality of leaflets 16 therein. The valve frame 12a may include an internal commissure attachment mechanism 1111 for attaching the commissures (in other words, joints) 1112 of the leaflets 16 to the frame structure 12. The valve frame 12a can be deployed from a folded (delivery) configuration to an expanded configuration during a method of replacing or repairing a self-propelled valve such as a mitral valve. As shown in Figures 1A-1B, the valve frame 12a may include a plurality of rows (e.g., 3-7 rows) of substantially rhomboid cells 122. The valve frame 12a can be foreshortened during delivery (i.e., as the valve frame 12 transitions from a folded configuration to an expanded configuration) due to the cell structure. In some embodiments, the valve frame 12a may be configured to self-expand from a folded configuration to an expanded configuration (e.g., it may be made of nitinol). The valve frame 12a can provide the valve prosthesis 10 with circumferential and / or longitudinal strength.

[0059]

[0086] The valve prosthesis 10 can be deployed in an expanded configuration according to the methods described herein. For example, the valve prosthesis 10 can be deployed in an expanded configuration in a method of replacing or restoring an autologous structure. In an expanded configuration, the valve prosthesis 10 can be placed and / or fixed in a target area of ​​the subject (e.g., an organ or tissue of an animal such as a dog, cat, horse, or human). For example, the valve prosthesis 10 can be placed in an expanded configuration within the opening of a heart valve such as a mitral valve or a tricuspid valve (e.g., to function as a temporary or permanent replacement for an existing mitral valve or tricuspid valve in the heart).

[0060]

[0087] One or more portions of the valve frame 12a may be shaped or configured to help fix the valve frame 12 in a certain position (for example, within the opening of the native heart valve). For example, the valve frame 12a may include an atrial projection 102 and a ventricular projection 103 configured to help fix the frame in an anatomical structure. The atrial and ventricular projections 102, 103 may extend radially laterally from the central circumferential portion 101. The atrial projection 102 may extend into the atrium of the heart from the central circumferential portion 101, for example, when the valve prosthesis is deployed in the native mitral valve. The ventricular projection 103 may then extend into the ventricle of the heart from the central circumferential portion 101 when the valve prosthesis is deployed in the native mitral valve. The atrial and ventricular protrusions 102, 103 may be configured to be positioned on either side of an outer flat helical anchor (e.g., wrapped around a cord) to secure the valve frame 12 to an anatomical structure. Alternatively or additionally, the atrial and ventricular protrusions 102, 103 may be configured to engage with tissue to prevent the valve prosthesis from sliding down through the valve opening.

[0061]

[0088] Referring to Figure 2, the frame structure 12a of the valve prosthesis 10 can have a partial hourglass shape such that the protruding ventricular portion 103 initially protrudes radially outward but then curves substantially axially (i.e., ventricularly). This semi-hourglass or cup shape of the ventricular portion 103 may be advantageous in providing space for ligatures around it.

[0062]

[0089] As shown in Figure 2, the spacing between the atrial portion 102 and the ventricular portion 103 (i.e., along the smaller diameter central annular portion 101) allows the anchor 15 to stay between them, enabling good fixation of the prosthesis in place on the prostate valve. Furthermore, as shown in Figure 2, the annular central portion 101 may include axially extending struts 123 that are thinner than the struts forming the rest of the rhomboid cell 122. The axially extending, constricted (in other words, narrowed) struts 123 can form a flexible region within the annular central portion 101, which helps the anchor 15 to abut (in other words, seat) in that portion of the frame structure 12a.

[0063]

[0090] Furthermore, as shown in Figures 1A-1B and Figure 2, the atrial protrusion 102 can extend radially laterally beyond the ventricular protrusion 103. Increasing the size of the atrial protrusion can help prevent perivalvular leakage (PVL).

[0064]

[0091] Figure 3 shows a valve prosthesis in a non-expanded (or folded or crimped) configuration. In some cases, the valve prosthesis 10 can be delivered to a target area (e.g., a region of the heart including the prostate valve) in a non-expanded configuration. In some cases, the valve prosthesis 10 in a non-expanded configuration can be delivered via minimally invasive means (e.g., delivery devices described herein).

[0065]

[0092] In some embodiments, the longitudinal length 127 of the folded valve frame 12a can be minimized, which may be advantageous for the delivery of the valve frame 12a. For example, by minimizing the total longitudinal length of the folded valve frame 12a, it is possible to improve operability within the delivery device while maintaining the structural strength of the device. In some embodiments, by minimizing the total longitudinal length of the folded valve frame 12a, it is possible to insert the valve frame 12a through access paths that would be difficult for longer devices to pass through (e.g., access paths including meandering passages or passages with sharp curves). In some embodiments, the valve frame 12a in a non-extended configuration may have a longitudinal length of 1mm to 50mm, 1mm to 45mm, 1mm to 40mm, 1mm to 35mm, 1mm to 30mm, 1mm to 25mm, 1mm to 20mm, 1mm to 10mm, 10mm to 45mm, 20mm to 45mm, 20mm to 30mm, 25mm to 35mm, or 27.5mm to 32.5mm. In some embodiments, the valve frame 12a in an extended configuration may have a longitudinal length of 1mm to 45mm, 10mm to 45mm, 15mm to 45mm, 15mm to 35mm, 16mm to 34mm, 17mm to 33mm, 18mm to 32mm, 19mm to 31mm, 20mm to 30mm, 25mm to 35mm, or 27.5mm to 32.5mm. In some embodiments, the valve frame 12a can be shortened as it expands, such that its length in the expanded configuration is shorter than its length in the folded configuration.

[0066]

[0093] In some embodiments, the valve frame 12a and / or the entire prosthesis may have specific functions designed to increase rigidity, improve control of valve deployment, promote uniform radial expansion of the central circumferential portion, ensure fixation within the ring, and / or reduce PVL.

[0067]

[0094] Furthermore, the diameter 128 of the folded valve prosthesis 10 can be minimized, which may also be advantageous for the delivery of the valve prosthesis 10. For example, a folded valve prosthesis 10 with a smaller diameter 128 can fit inside a delivery device with a smaller diameter, enabling less invasive delivery and improving maneuverability within the body of the patient. Reducing the diameter 128 of the folded valve prosthesis 10 (for example, for use in the treatment or replacement of the mitral, tricuspid, aortic, or pulmonary valve) can further facilitate the delivery of the valve prosthesis 10 to the target area of ​​the patient, enabling faster recovery of the patient who has received the valve prosthesis 10 and / or improved clinical outcomes of the patient who has received the valve prosthesis 10 (e.g., improved patient survival, improved ejection fraction, improved cardiac output, reduced valve regurgitation, and / or reduced edema). In some cases, reducing the diameter 128 of the folded valve prosthesis 10 may enable transseptal access and delivery in addition to transapical access. In some cases, the diameter 128 of the folded valve prosthesis 10 or a part thereof (e.g., frame structure 12) is 0.01mm~20mm, 0.01mm~15mm, 0.01mm~10mm, 0.01mm~9mm, 0.01mm~8mm, 0.01mm~7mm, 0.01mm~6mm, 0.01mm~5mm, 0.01mm~4mm, 0.01mm~3mm, 0.01mm The possible dimensions are m~2mm, 0.01mm~1mm, 1mm~15mm, 2mm~14mm, 3mm~13mm, 4mm~12mm, 5mm~10mm, 6mm~10mm, 7mm~10mm, 8mm~10mm, 9mm~10mm, 10mm~15mm, 20mm or less, 15mm or less, 10mm or less, 9mm or less, 8mm or less, 7mm or less, 6mm or less, or 5mm or less.

[0068]

[0095] In some cases, the valve prosthesis 10 or a part thereof may be sized or shaped to be positioned in a specific location or target area. For example, the frame structure 12 may be sized to be positioned within a valve such as a mitral valve (for example, by designing the dimensions of the frame structure to fit a valve such as a mitral valve when in an expanded configuration).

[0069]

[0096] Figure 4 shows a typical example of an anchor 15 configured to position or fix a valve prosthesis within a specific location, such as a native valve. In some embodiments, the anchor 15 may include a flat shape that extends around the valve prosthesis 10 in, for example, a non-expanding configuration and / or an expandable configuration. The anchor 15 may have a free end 22. In some cases, the free end 22 of the anchor 15 may be useful during the deployment of the anchor 15 within a native heart valve (for example, by capturing a cord or other structure as the prosthesis 10, anchor 15, and / or delivery device rotate around the longitudinal axis of the valve prosthesis 10). The anchor 15 may be directly coupled to a frame structure 12a, for example, at its first end (e.g., proximal end) or second end (e.g., distal end). Alternatively, the anchor 15 may be physically released from the frame structure 12 while providing an anchor to the frame 12 as the frame expands within the native valve opening (thereby sandwiching tissue between the frame 12 and the anchor 15). In some embodiments, the frame structure 12a can be at least partially held in place within the self-valve through interaction with the anchor 15. For example, the expanded diameter of the frame structure 12a can be greater than or equal to the inner diameter of the helical anchor 15 so that the frame structure 12a expands into the anchor 15 and engages with the anchor 15 (along with the self-valve leaflet, cord, or other tissue between them).

[0070]

[0097] In some embodiments, the valve prosthesis 10 described herein may include one or more protruding portions to engage with an anchor 15 and / or to help prevent the valve prosthesis 10 from sliding through the valve opening. For example, as shown in Figure 5, the frame structure 12a of the valve prosthesis 10I may include an atrial protruding portion 157 extending radially outward from a central annular portion 158. The atrial protruding portion 157 may extend into the atrium of the heart from the central annular portion 158 when the valve prosthesis 10A is deployed in the patient's own mitral valve, for example. Alternatively, or in combination, the atrial protruding portion 157 may contact the tissue of the heart's atrial region, such as the mitral valve ring, when the valve prosthesis 10A is deployed in the patient's own mitral valve.

[0071]

[0098] Referring to Figures 5-6, the valve prosthesis 10 described herein may include one or more valve segments 14 positioned therein to replace the original valve leaflets. For example, the valve segment 14 may include a plurality of leaflets 16 forming, for example, a biocompatible unidirectional valve. Unidirectional flow can deflect and open the leaflets 16, while opposing flow can close the leaflets 16.

[0072]

[0099] Any of the valve segments 14 described herein may be formed from multilayer materials for preferred function. Referring to Figure 6, for example, a valve prosthesis 10C may include a valve segment 14 having a seal 177 (also called an outer leaflet, outer layer, or skirt portion) radially arranged between a leaflet 16 (also called an inner leaflet or inner layer) and a frame structure 12. The seal 177 may be a single piece wound around the leaflet 16, or it may be a separate piece shaped to fit the leaflet 16. In some cases, the seal 177 and / or the leaflet 16 may be formed from or coated from a material that provides advantages to the valve segment 14. For example, a layer or surface of the valve segment 14 may be formed from or coated with a biocompatible material. In some cases, a layer or surface of the valve segment 14 may be formed from or coated with an antithrombotic material. In some cases, the valve segment 14 (or a part thereof, such as the leaflet 16 of the valve segment) may contain a synthetic material. In some cases, the valve segment 14 (or a portion thereof, such as a leaflet) contains biological tissue. In many cases, the valve segment 14 (or a portion thereof, such as a leaflet) contains pericardial tissue. In some embodiments, the valve segment 14 (or a portion thereof, such as a leaflet 16 of the valve segment 14) contains decellularized biological tissue. For example, the valve segment 14 (or a portion thereof, such as a leaflet 16 of the valve segment) may contain decellularized pericardium.

[0073]

[0100] The valve segment 14 can be attached to the frame structure 12, and the frame structure 12 can then be attached to the anchor 15. The frame structure 12 can be connected to the anchor 15 before or after the frame structure 12 is deployed adjacent to the valve itself. The frame structure 12 can be attached to the valve segment 12, for example, by attaching the frame structure 12 to the seal 177, and the seal 177 can then be attached to the leaflet 16.

[0074]

[0101] In some embodiments, two or more portions of the valve segment 15 (e.g., two or more leaflets 16, and / or seals 177) may include a single material (e.g., a single biological or artificial tissue formed into the shape of a functional valve). In some cases, two or more portions of the valve segment (e.g., two or more of the first and second leaflets 16, and / or seals 177) may be joined together. In some embodiments, two or more portions of the valve segment (e.g., two or more of the first and second leaflets 16, and / or seals 177) may be joined together by suturing the two or more portions together (e.g., at the suture joint 166 shown in Figure 6). In some cases, one, two, three, four, five, or more than five leaflets 16 may be joined to a single seal 177.

[0075]

[0102] In many cases, the leaflet joint 166 is positioned at the inlet end of the valve prosthesis 10 during deployment (i.e., closest to the source of flow through the device caused, for example, by a contracting chamber). In some cases, joining two or more portions of the valve segment 14 at the inlet end of the valve prosthesis 10 (or a portion thereof) allows the valve segment 14 to fold or be folded (e.g., radially away from the longitudinal axis of the valve prosthesis device 10) during contraction of the chamber upstream of the deployed device (i.e., during diastole). Furthermore, in some cases, joining two or more portions of the valve segment 14 at the inlet end of the valve prosthesis 10 allows the valve segment 14 to expand (e.g., radially toward the longitudinal axis of the valve prosthesis device 10) during refilling of the chamber upstream of the deployed device (i.e., during systole). This expansion of the valve segment 14 could cause it to bulge or become parachute-like (for example, between the seal 177 and the leaflet 16), potentially blocking the flow of blood through the valve segment 14.

[0076]

[0103] As shown in Figure 6, the valve segment 14 can be attached to one or more struts 113 of the frame structure 12. In some embodiments, a portion of the valve segment 14 (e.g., a leaflet 16 or seal 177) can be sutured to the central annular portion 158 of the frame structure 12, rather than to the inlet or outlet portion of the frame structure 12 (for example, it may not be attached to the distal arch 116 and proximal arch 115, as shown in Figure 6).

[0077]

[0104] In some embodiments, a portion of the valve segment 14 (e.g., a leaflet 16 or seal 177) can be sutured to one or more outflow portions of the frame structure 12, rather than to the inflow portion of the frame structure 12 (e.g., sutured to one or more distal arches 116 but not to one or more proximal arches 115, as shown in Figure 8A).

[0078]

[0105] In some embodiments, a portion of the valve segment 14 may be sutured or otherwise attached using an outflow attachment mechanism (e.g., an inwardly extending commissure attachment mechanism, as further illustrated and described herein) rather than the inflow portion of the frame. In some embodiments, a portion of the valve segment 14 (e.g., a leaflet 16 or seal 177) may be sutured to one or more outflow portions and inflow portions of the frame structure 12 (e.g., also sutured to one or more distal arches 116 and one or more proximal arches 115, as shown in the valve prosthesis 10E in Figure 9). In some embodiments, the inflow end of the valve segment 14 may not be substantially supported by the frame 12, but the outflow end of the valve segment 14 may be fully supported by and within the valve segment 14 (as shown in Figure 6). The valve segment 14 (or a portion thereof, such as a seal 177) may be continuously coupled to the frame 12 along the inner circumference of the frame 12 (e.g., at the distal or outflow end of the valve prosthesis device 10).

[0079]

[0106] In some cases, the amount of valve segment 14 (e.g., valve leaflet 16) attached to the frame structure 12 can be minimized, which advantageously enhances ease of delivery and shortens the required frame length, thereby reducing the likelihood of thrombosis and the possibility of obstructing ventricular outflow to the aorta. Minimizing the frame structure 12 can also improve the manufacturing speed and cost of the valve prosthesis device 10.

[0080]

[0107] In some embodiments, a leaflet 16 attached to a first part of the frame structure 12 (e.g., one or more struts 113) at the distal end of the frame structure 12 can be detached from the proximal end of the frame structure 12 (e.g., a strut or part thereof at the proximal end of the frame structure 12). In some cases, a valve prosthesis device 10 in which the valve segment 14 is attached to the proximal end of the frame structure 12 and not at the proximal end of the frame structure 12 (and / or the proximal end of the valve segment 14) may require fewer metal and / or struts than a valve prosthesis 10 in which the valve segment 14 is attached to both the proximal and distal ends of the frame structure 12 of the valve prosthesis device 10. In some cases, minimizing the amount of metal used in the construction of the valve prosthesis 10 (e.g., by reducing the number and / or length of struts of the valve prosthesis device 10) can reduce the risk of thrombus formation and improve the ease with which the device can be deployed to the target location.

[0081]

[0108] Furthermore, the valve segment 14 may be configured so as not to be substantially supported at its inflow edge 95. For example, as shown in Figure 6, the entire inflow edge 95 of the valve segment may be unsupported except for a minimal valve support 124 located at the lowest point (nadir) 96 of each leaflet 16. The valve support 124 may have a pointed proximal tip and may extend, for example, from two adjacent struts 113 of the frame structure 12. The minimal valve support 124 may help prevent the valve segment 14 (e.g., seal) from folding radially inward in the outflow direction (i.e., towards the ventricle) when implanted in the heart. Figure 7 shows a valve prosthesis 10D similar to the valve prosthesis 10C of Figure 4, except that the valve support 124 of Figure 5 includes an aperture 97 for suturing the leaflet 16 to the valve support 124.

[0082]

[0109] Figures 10A-10B show a valve prosthesis 10F in which the inflow edge 95 of the valve segment 14 is not fully supported (i.e., there is no valve support therefor).

[0083]

[0110] Figures 11A–11C show another valve prosthesis 10G in which the inlet edge 95 of the valve segment 14 is not fully supported (i.e., there is no valve support therefor). In fact, as shown in Figures 11A–11C, the prosthesis 10G may include an inlet portion 167, a central annular portion 158, and an outlet portion 168. The valve segment 14 may be supported circumferentially by a frame structure 12 within the central annular portion 158. However, the valve segment 14 may not be supported by the frame structure 12 in the inlet portion 167, and / or may not be disconnected from the frame structure 12. Furthermore, the frame structure 12 may project radially outward within the inlet portion 167. The projecting portion 157 of the frame structure 12 may include a plurality of separate flanges (i.e., formed from the projecting proximal arch 115) which may function, for example, to assist in engagement with an external anchor. Furthermore, the overhang portion 157 allows the valve segment 14 to be radially separated from the frame structure 12 by a distance 134 within the inlet portion 167 (see Figure 11C). In some embodiments, the distance 134 can be 1 to 10 mm, e.g., 2 to 8 mm, e.g., 3 to 5 mm. Finally, the frame structure 12 can also overhang radially outward within the outlet portion 168. The overhang portion 160 of the frame structure 12 can also function to facilitate engagement with an external anchor 15. For example, the external anchor 15 can be positioned between the overhang portions 157 and 160 during transplantation.

[0084]

[0111] Figures 8A and 8B show another valve prosthesis 10H similar to the valve prosthesis 10G in Figures 11A-11C, except that substantially the entire inlet edge 95 extends proximal beyond the proximal arch 115 of the frame structure 12. When the leaflet is closed (as shown in Figure 8B), the fluid pressure can act to fill the space formed by the leaflet 16 and seal 177, thereby preventing the valve segment 14 from moving inward or folding.

[0085]

[0112] Referring to Figures 12A–12D, and in particular Figure 12D (showing an enlarged view of the mounting mechanism 1111), each internal commissure mounting mechanism 1111 may include a distal post (in other words, a column) 1113, which extends continuously from the distal end of the distal arch (e.g., crown, or apex) 116 (i.e., the most distal part of the cell 122) of the frame structure 12a and curves radially inward, for example, by about 180 degrees. The commissure mounting mechanism 1111 can be formed integrally with the valve frame 12, which offers several advantages, including simplification of the manufacturing process, increased mechanical strength, reduced wear, and elimination of the need for a separate mounting mechanism. As shown in Figures 12E–12F, the distal post 1113 may have a distance d from the distal end of the distal arch 116 to the position where the distal post curves radially inward. In some embodiments, this distance d may be about 2.5 mm ± 0.25 mm in length. In other embodiments, this distance d can be in the range of 2 to 4 mm. Each connecting attachment mechanism 1111 may further include a round paddle 1114 (e.g., continuous with a post 1113) which includes a slot 1115 configured to allow a portion of the leaflet 16 (e.g., a tab 1661 shown in Figure 13C) to pass through. The slot 1115 may be surrounded by a plurality of suture holes 1117 configured to allow the leaflet 16 to be sewn onto the attachment mechanism 1111.

[0086]

[0113] As shown in Figures 13A–13C, each leaflet 16 may include an inlet edge 95 and tabs 1661 at each commissar extending radially and parallel to the outlet (e.g., free) edge 1133. To attach the leaflet 16 to the mounting mechanism 1111, the tabs 1661 may be sewn to the paddle 1114 with sutures 1663 that pass through slots 1115, fold around the outside of the paddle 1114, and pass through suture holes 1117. Referring to Figures 13B–C, the first tab 1661a of the leaflet 16 may pass through a slot in the first mounting mechanism, and the second tab 1661b may pass through a slot in the second mounting mechanism. Each mounting mechanism is configured to accept a single tab from two adjacent leaflets (e.g., tab 1661a from the first leaflet and tab 1661b from the second leaflet). Looking at Figure 13B, it should be understood that two adjacent leaflets are attached to the tab (not two tabs from the same leaflet). In some embodiments, an additional layer of fabric 1662 can be placed between the tab 1661 and the paddle 1114 to provide cushioning and / or prevent the leaflet 16 from rubbing against the paddle 1114. This additional piece of fabric can optionally be wrapped around the paddle 1114 and secured on the opposite side with sutures, as shown. Figure 13D shows the overlap of the additional layer of fabric 1662 on the back of the attachment mechanism 1111, sewn to the attachment mechanism 1111 with sutures 1663. Figure 13E shows the location where the leaflet 16 is attached to the attachment mechanism 1111 and the additional layer of fabric 1662, viewed from the outflow edge.

[0087]

[0114] In some embodiments, the crossover attachment mechanism 1111 may have a width or thickness greater than the width or thickness of the cell support or distal arch 116 or other cell 122 of the frame structure 12a. In some embodiments, this increased width or thickness of the crossover attachment mechanism 1111 may help ensure that the attachment mechanism 1111 maintains substantially rigidity and / or does not bend even when the leaflet 16 is being opened and closed. In other embodiments, the increased width or thickness of the attachment mechanism 1111 may be configured to allow slight bending, thereby distributing the strain between the crossover attachment mechanism 1111 and the frame 12a.

[0088]

[0115] As shown in Figures 14A-14C (leaflet closed) and 15A-15C (leaflet open), the internal coupling attachment mechanism 1111 can hold the outflow edge 1133 of the leaflet 16 away from the inner circumference (e.g., diameter) of the frame structure 12a during both opening and closing of the leaflet 16. Referring to Figures 16A-16C, for example, the internal coupling attachment mechanism 1111 can hold the outflow edge 1133 of the leaflet 16 at a distance d from the inner diameter ID of the frame 12a, for example, 1.5 mm to 4 mm, for example, 2 to 3 mm, for example, about 2.5 mm. Since the outflow edge 1133 of the leaflet 16 is held away from the inner diameter of the frame 12a during both opening and closing of the leaflet 16, deformation of the leaflet 16 is minimized even if the frame structure 12a is deformed (e.g., during transplantation). Furthermore, the gap between the leaflet 16 and the inner diameter of the frame structure 12a has the advantage that while the leaflet 16 is open, more blood can flow through that area, which can help prevent blood stagnation between the frame 12a and the leaflet 12a. Finally, the gap between the leaflet 16 and the inner diameter of the frame structure 12a can help maintain the durability of the leaflet 16 (i.e., prevent frictional wear of the leaflet 16 over time). In some embodiments, the leaflet is configured to open to a radius that is larger than the radius of the commissar mounting mechanism but smaller than the diameter or perimeter radius of the frame structure.

[0089]

[0116] As a result of the internal commissure attachment mechanism 1111, the attached edge of the leaflet 16 can extend substantially straight (i.e., without curving radially outward) from the central annular portion 101. The free (e.g., outflow) edge of the leaflet (e.g., between the commissure attachment mechanisms 1111) can open to a radius larger than the inner diameter without contacting the frame 12a. That is, as shown in Figures 16A-16D, the inner diameter id and / or circumference formed by the commissure attachment mechanism 1111 can be approximately equal to the inner diameter id and / or circumference of the frame 12a in the central annular portion 101. Thus, the leaflet 16 can form a substantially cylindrical channel for blood to pass through. Figure 16D shows the contour 161 of the leaflet material when open. Specifically, the offset can increase the expansion of the leaflet (into the "gap") without contacting the frame. This increases the blood flow space without deforming the attachment of the leaflet (from its cylindrical profile (in other words, contour)).

[0090]

[0117] In some embodiments described herein, the inlet edge 95 of the leaflet may not be fully supported except for the connecting portion of the leaflet 16, for example, the internal connecting portion mounting mechanism 1111 and / or the minimum valve support 124.

[0091]

[0118] Figures 17A–17D show further details of frame 12a. Frame 12a may include multiple rows (e.g., three rows) of cells 122, such that a first row of cells is in the atrial projection 102, a second row is in the central annular portion 101, and a third row of cells is in the ventricular projection 103. The cells 122 may be substantially rhomboid in shape and therefore can be shortened during deployment (e.g., expansion). Furthermore, the rows of cells 122 in the central annular portion 101 may include constricted struts 123 that extend axially within them and are not shortened. In addition, the atrial projection 102 of frame 12a may include multiple eyelets 222 (e.g., elliptical eyelets) extending from some or all of the vertices of the atrial cells 122 (e.g., from every other vertex as shown in Figures 17A–17D). The eyelet 222 can be configured to remain (or protrude) above the rest of the atrial protrusion 102 when implanted, which can advantageously allow for gripping and / or manipulation (e.g., by hook or suture) of the valve frame 12 during deployment. The eyelet 222 can be connected to the arch (or apex) of the cell 122 via a linear extension 132. The linear extension 132 can remain non-shortened during deployment, which can advantageously contribute to the traceability and coverage of the atrial protrusion 102 during delivery of the frame 12a. The non-shortened extension 132 can, even more advantageously, increase the apposition on the atrial side, allowing for a reduction in the length of the shortened element (e.g., the rhomboid cell 122), and thus increasing the radial stiffness of the valve frame 12a. In some embodiments, the length of the non-shortened extension 132 can be selected to match the size of the atrial margin of the frame with a given anatomical structure of the implantation site. The structure of the base valve remains the same even when the length of these extensions is adjusted. This makes it possible to provide frames with multiple different atrial rim sizes while the rest of the frame has consistent dimensions. The frame 12a may further include a number (e.g., three) of frame tabs 144 that extend from the eyelets 222 and are configured to engage with the valve delivery system for deployment.In one embodiment, each of the frame tabs 144 can be spaced 120° apart. As shown in Figure 17A, the frame 12a may have an overall height of 24 mm and a landing height of 4 mm (e.g., the “landing zone,” the height at which the anchor is configured to rest). As shown in Figure 17D, the frame 12a may have a ventricular diameter of 35 mm.

[0092]

[0119] Another exemplary frame 12e is shown in Figures 18A-18D. Frame 12e is similar to frame 12a, except that frame 12e includes four rows of cells 122. The rows of cells 122 can be configured to have an additional row of cells within the atrial protrusion 102 (i.e., one row of cells in the ventricular protrusion 103, one row of cells in the central annular portion 101, and two rows of cells in the atrial protrusion 102). Furthermore, the cells 122 in the atrial protrusion 102 can protrude further radially outward within frame 12e than frame 12a, allowing for better engagement with the atrial wall adjacent to the ring. Additionally, the linear extension 132 can be curved so that the eyelet 222 is oriented substantially axially (i.e., towards the atrium). The additional rows of cells 122 on the atrial side can favorably increase the rigidity of the atrial protrusion 102, thereby helping to fix the atrial protrusion 102 within the atrium (and / or pull the anchor towards the ring when deploying the frame 12e). The frame 12e may have a total height of 27 mm and a landing height of 4 mm. As shown in Figure 18D, the frame 12e may have a ventricular diameter of 35 mm.

[0093]

[0120] Another exemplary frame 12f is shown in Figures 19A–19D. Frame 12f is similar to frame 12e except that the additional row of cells 122 at the atrial end does not protrude much radially laterally (i.e., the apex can point more axially than radially laterally). Reducing the amount of protrusion allows for an increase in the height of the landing zone, which in turn allows for a better positioning of the anchor 15 relative to the central annular portion 101. Frame 12f can have a total height of 28 mm and a landing height of 7 mm. As shown in Figure 19D, frame 12f can have a ventricular diameter of 35 mm.

[0094]

[0121] Another exemplary frame 12g is shown in Figures 20A-20D. Frame 12g is similar to frame 12e, except that the most atrial cell 122 is elongated to extend to the axial position of the eyelet 222 (the linear extension 132 is omitted). This increase in the length of the most atrial cell 122 causes the apex to be more axially oriented, thereby reducing the trauma to the apex. Similar to frame 12e, frame 12g can have a total height of 27 mm and a landing height of 4 mm. As shown in Figure 20D, frame 12g can have a ventricular diameter of 35 mm.

[0095]

[0122] A table showing exemplary dimensions for frames 12a, 12e, 12f, and 12g is shown in Figure 21. Referring to the table in Figure 21, the inner diameter of all frames can be 28 mm and the outer ventricular diameter can be 35 mm. However, the outer atrial diameter is adjusted between frames, ranging from 47 mm for frame 12a to 49 mm for frame 12g. The extended height can also differ between frames, ranging from 24 mm for frame 12a, 27 mm for frames 12e and 12g, and 28 mm for frame 12f. The landing height of the frame can be approximately 4 mm for frames 12a, 12e, and 12g, and approximately 7 mm for frame 12f. The ventricular height can be approximately 14 mm for frames 12a, 12e, and 12g, and approximately 18 mm for frame 12f. Frame 12a may have a coverage height of less than 33 mm, while frames 12e, 12f, and 12g may have a coverage height of less than 38 mm.

[0096]

[0123] Another exemplary frame 12h is shown in Figures 22A-22B. Frame 12h is similar to frame 12g, except that the atrial projection 102 extends further outward to a larger radius. Furthermore, the most distal cell 122 is more elongated. Finally, the landing height is slightly larger, which can be about 4-5 mm.

[0097]

[0124] Referring to Figures 23A–23B, any of the frames 12 described herein (e.g., frames 12a–12h) can be modified so that the atrial projection 102 curves (e.g., C-shaped) such that the distal tip faces radially inward. Doing so can help reduce trauma to the atrium when implanting the valve prosthesis. In some embodiments, at least a portion of the distal tip may be inward with a radius of curvature of less than 10 mm. In other embodiments, the radius of curvature of the distal tip can be 3–10 mm. In some embodiments, as shown in Figures 23C–23D, the inward curvature of the atrial projection 102 can be formed by increasing the length of the atrial non-shortening elements (e.g., the linear extension 132, the eyelet 222, or the frame tab 144) while maintaining the shortening cell 122 to the same dimensions, and curving those non-shortening elements upward and / or inward.

[0098]

[0125] Figures 24A–24D show another frame embodiment with a total height of 26 mm, ventricular height of 14 mm, ventricular OD of 35 mm, and landing height of 4 mm. This embodiment includes a longer atrial column that lacks inward curvature and extended paddle arms compared to some of the embodiments described above.

[0099]

[0126] Figures 25A–25B show another embodiment of frame 12h, including a pattern of cells 122 that terminate in the horizontal portion 255 of the frame near the atrial portion 102. This allows for easy modification of the atrial margin size according to the specific needs of a particular patient. For example, frame 12h in Figures 25A–25B may have an atrial OD of 53 mm. In another embodiment, to increase the atrial diameter of the frame, the length of the cells on the atrial side of the frame, such as cells that terminate in or within the horizontal portion 255, can be made longer than other cells.

[0100]

[0127] Any of the valve frames 12 described herein (e.g., frames 12a to 12h) may include one or more skirts or seals thereon. For example, the valve frame 12 may include an inner skirt and one or more outer skirts. The skirts may be made of, for example, PET.

[0101]

[0128] Referring to Figures 26A-26C, the inner skirt portion 177 can be attached to the inner circumference of the frame 12. The inlet edge 195 of the inner skirt portion 177 may include three convex segments 166 configured to at least partially conform (in other words, match) the inlet edge 95 of the leaflet 16. In some embodiments, as shown in Figures 26B-26C, the radius of curvature of the convex segments 166 of the inlet edge 195 of the inner skirt portion 177 may be greater than the radius of curvature of the inlet edge 95 of the leaflet 16. Furthermore, the inner skirt portion 177 (e.g., the inlet edge 195) can be attached to the inlet edge 95 of the leaflet 16. This allows the inner skirt portion 177 to connect (e.g., indirectly) the inlet edge 95 of the leaflet 16 to the frame 12. The outlet edge 196 of the inner skirt portion 177 may be cut in a pattern (e.g., a zigzag or repeating triangular pattern) configured to match the cell pattern of the frame 12. The outflow edge 196 can be attached to the frame 12 within and / or distal to the central circumferential portion 101 and close to the outflow region 103. Therefore, the inner skirt portion 177 does not need to extend completely to the ventricular end of the frame 12.

[0102]

[0129] Referring to Figures 27A-27F, in some embodiments, the ventricular overhang portion 103 may further include an outer skirt portion 225 over it. The ventricular outer skirt portion 225 can advantageously prevent the cord from interacting (e.g., getting caught) with the cells and / or tips of the ventricular overhang portion 103 and / or may help reduce the trauma of the ventricular overhang portion 103. The outer skirt portion 225 may be wrapped around the ventricular end of the frame 12, for example, to cover the exposed apex of the cell 122.

[0103]

[0130] Figures 27A–27F also show exemplary frame mounting positions for the medial skirt portion 177, the atrial lateral skirt portion 224, and the ventricular lateral skirt portion 225. As best shown in Figures 27B, 27C, and 27D, the medial skirt portion 177 can be sewn to the frame 12 close to the tip of the atrial protrusion (indicated by arrow c pointing to the seam). As best shown in Figures 27B–27C, the atrial lateral skirt portion 224 can be mounted to the frame 12 such that the skirt tab 229 folds over (and is sewn to) the eyelet 222 (indicated by arrow a pointing to the seam). Furthermore, the atrial lateral skirt portion 224 can be sewn along the perimeter of the frame 12 near the tip of the protrusion (indicated by arrow b pointing to the seam). As best shown in Figures 27D–27E, the ventricular lateral skirt portion 225 can be mounted such that the edge of the skirt portion 225 folds over the tip of the ventricular protrusion. Furthermore, the ventricular lateral skirt portion 225 can be sewn to the frame 12 along the most distal (ventricular) support of the frame 12 (indicated by arrow d pointing to the seam). In some embodiments, the lateral skirt portions 224, 225 may overlap each other near the central annular circumferential portion 101. In other embodiments, the lateral skirt portions 224, 225 may have an axial space between them, for example, such that the central portion (e.g., the central annular portion 101) does not have an lateral skirt portion on it.

[0104]

[0131] Referring to Figure 27F, the frame may include an inner skirt portion 177 and an outer skirt portion 224. The outer skirt portion 224 may be sewn to the frame at attachment point 199a. The inner skirt portion 177 may be sewn to the frame at attachment point 199b. Furthermore, both the outer and inner skirt portions may be sewn to the frame at attachment point 199c. In addition, as described above, the crossover attachment mechanism may include attachment points 199d for sewing the fabric strip, fabric, and frame.

[0105]

[0132] Referring to Figure 28, in some embodiments, the atrial and ventricular lateral skirt portions 224, 225 may be part of a single, integrated skirt portion 230. A single, integrated skirt portion 230 can be advantageous in preventing bunching and / or folding that may occur in two separate skirt portions. In some embodiments, the single, integrated skirt portion 230 may be manufactured from a flat sheet of knitted material that is laser-cut and sewn together (e.g., along seams 231). In this embodiment, the cylindrical single, integrated skirt portion 230 can then be dipped-coated and shaped on a mandrel. In other embodiments, the single, integrated skirt portion 230 may be manufactured from a tubular knitted fabric. In this embodiment, the tubular knitted fabric can be slid on a mandrel, dipped-coated, and then laser-cut into a pattern while still positioned on the mandrel. This embodiment can advantageously form a seamless single, integrated skirt portion 230.

[0106]

[0133] Referring to Figure 29, in some embodiments, the frame may include an integrated skirt portion 230 (for example, as described with respect to Figure 28) with an additional layer along a portion of the frame 12. For example, a single integrated skirt portion 230 may be laminated with an additional ventricular skirt portion 991 positioned along and / or folded over the most distal support of the frame 12. The additional ventricular skirt portion may be advantageous in reducing trauma to the own valve (e.g., ligament). The single integrated skirt portion 230 may additionally or alternatively be laminated with an additional skirt portion 992 in the central annular portion 101, which may help prevent damage to the own leaflet.

[0107]

[0134] The skirt portion described herein can be made from a polymer such as polyethylene terephthalate (PET). Furthermore, the skirt portion described herein can be woven and / or knitted (for example, in 15 to 25 denier, such as about 20 denier). For example, Figure 30A shows a frame 12 having a woven lateral atrial skirt portion 224 and a knitted lateral ventricular skirt portion 225. In contrast, Figure 30B shows a frame 12 having a knitted integrated skirt portion 230.

[0108]

[0135] Any of the skirt portions described herein may include a coating, such as a Chronoflex AR coating, to reduce the pore size of the skirt portion and increase resistance to fluid flow through the skirt portion. For example, in some embodiments, only the lateral atrial skirt portion 224 may have a coating on it. In other embodiments, both the lateral skirt portion 224 and the atrial skirt portion 225 (either individually or as a whole) may have a coating on them.

[0109]

[0136] As described herein, a valve prosthesis may include a frame structure having a leaflet (e.g., having a tapered waist and atrial and ventricular protrusions). In some embodiments, the leaflet may be formed from a multilayer material for preferred function. The leaflet may be directly attached to the frame structure, or it may be attached to an intermediate valve structure that is then connected to the frame structure. The leaflet may be connected to the frame structure before or after the frame structure is deployed adjacent to the own valve. The leaflet may include a biocompatible unidirectional valve. Unidirectional flow can deflect and open the leaflet, and opposite-direction flow can close the leaflet. The frame structure may be configured as a stent. The frame structure may comprise a rhomboid patterned scaffold formed from, for example, a shape memory material (e.g., nitinol, NiTi). Those skilled in the art will understand that many other structures, materials, and configurations can be employed for the frame structure. For example, the frame structure may be formed from a polymer having sufficient elasticity. The frame structure may be formed from a combination of metal and polymer, such as a polymer-coated metal (e.g., a shape memory material). The frame structure can include various patterns other than rhombuses. In some embodiments, the frame structure is a closed frame that forces blood flow through the leaflet within. One or more skirt portions and / or seals can help push blood through the leaflet.Exemplary frame structures and valve prostheses are described in PCT application number PCT / US2019 / 047542, titled "PROSTHETIC CARDIAC VALVE DEVICE, SYSTEMS, AND METHODS," filed on August 21, 2019, currently published as PCT publication number WO2020 / 041495; international patent application number PCT / US2020 / 027744, titled "MINIMAL FRAME PROSTHETIC CARDIAC VALVE DELIVERY DEVICES, SYSTEMS, AND METHODS," filed on April 10, 2020, currently published as PCT publication number WO2020 / 210685; and "MINIMAL FRAME PROSTHETIC CARDIAC VALVE DELIVERY DEVICES, SYSTEMS, AND METHODS," filed on June 16, 2021. This is described in international patent application PCT / US2021 / 037661, titled “METHODS”, which is incorporated herein by reference in its entirety.

[0110]

[0137] Furthermore, in some embodiments, the valve prostheses described herein include one or more anchors. An anchor may include a flat helical shape having a plurality of windings or loops spiraling radially outward from a central point. The loops of the flat helical anchor may be arranged substantially in the same plane. The anchor may be formed from a shape memory material (e.g., NiTi). The anchor may be configured to extend around the ligaments of a valve (e.g., a mitral valve) and around the valve prosthesis to hold the valve prosthesis in place. A flat helical anchor is described in U.S. Patent Application No. 16 / 723,537, titled “PROSTHETIC CARDIAC VALVE DEVICES, SYSTEMS, AND METHODS,” filed December 20, 2019, currently published under U.S. Publication No. US-2020-0261220-A1, which is incorporated herein by reference in its entirety.

[0111]

[0138] Valve prosthetics and / or anchors described herein can be delivered via a delivery system. Exemplary delivery systems are described in International Application No. PCT / US2020 / 023671, entitled “PROSTHETIC CARDIAC VALVE DEVICES, SYSTEMS, AND METHODS,” filed on 19 March 2020, currently published as PCT Publication No. WO2020 / 191216, and in International Application No. PCT / US2021 / 040623, entitled “VALVE DELIVERY SYSTEM,” filed on 7 July 2021, which are incorporated herein by reference in their entirety.

[0112]

[0139] It should be understood that any feature described herein in relation to one embodiment may be replaced with or combined with any feature described in relation to another embodiment. For example, any frame structure, frame structure feature (e.g., connecting mechanism), or skirt portion described in relation to one embodiment may be replaced with and / or combined with any of the other frame structures described herein.

[0113]

[0140] Where a feature or element is referred to herein as being "on top of" another feature or element, it may be immediately above the other feature or element, or there may be intervening features and / or elements. In contrast, where a feature or element is referred to as being "directly on top of" another feature or element, there are no intervening features or elements. Where a feature or element is referred to as being "connected," "attached," or "linked" to another feature or element, it will also be understood that it may be directly connected, attached, or linked to the other feature or element, or there may be intervening features or elements. In contrast, where a feature or element is referred to as being "directly connected," "directly attached," or "directly linked" to another feature or element, there are no intervening features or elements. Features and elements described or illustrated in relation to one embodiment may be applicable to other embodiments. It will also be understood by those skilled in the art that a reference to a structure or feature positioned "adjacent" to another feature may have portions that overlap with or lie beneath the adjacent feature.

[0114]

[0141] The terminology used herein is intended solely to describe specific embodiments and is not intended to limit the invention. For example, the singular forms “a,” “an,” and “the” as used herein are intended to include the plural form unless otherwise explicitly indicated in the context. It will be further understood that the terms “contains” and / or “contains,” as used herein, specify the presence of the described features, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. As used herein, the terms “and / or” include any and all combinations of one or more of the relevant list items and may be abbreviated as “ / ”.

[0115]

[0142] Spatially relative terms such as “down,” “below,” “underside,” “up,” and “upperside” may be used herein to facilitate explanation and describe the relationship between one element or feature and another, as shown in the figures. It should be understood that spatially relative terms are intended to encompass various orientations of a device in use or operation, in addition to the orientations shown in the figures. For example, if the device in the figure is inverted, an element described as “below” or “below” another element or feature will be oriented “above” that other element or feature. Thus, the exemplary term “down” can encompass both up and down orientations. The device may be oriented in a different direction (rotated 90 degrees or otherwise), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as “upward,” “downward,” “vertical,” and “horizontal” are used herein for illustrative purposes only, unless otherwise indicated.

[0116]

[0143] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but unless otherwise indicated in the context, these features / elements should not be limited by these terms. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0117]

[0144] Throughout this specification and the following claims, unless specifically required by context, the word “includes,” and variations such as “includes” and “contains,” mean that various components can be used together in a method and article (e.g., a composition and apparatus including a device and a method). For example, the term “contains” is understood to mean that it includes any element or step described, but not that it excludes any other element or step.

[0118]

[0145] Where used herein and in the claims, including where used in examples, all numbers may be read as if preceded by the terms “about” or “approximately,” even if the terms “about” or “approximately” are not explicitly indicated. The terms “about” or “approximately” may be used when describing size and / or location to indicate that the described value and / or location is within a reasonable expected range of the value and / or location. For example, a number may have values ​​such as + / -0.1% of the stated value (or range of value), + / -1% of the stated value (or range of value), + / -2% of the stated value (or range of value), + / -5% of the stated value (or range of value), + / -10% of the stated value (or range of value), etc. Any number given herein should also be understood to include about or approximately that value unless the context indicates otherwise. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical range enumerated herein is intended to include all subranges contained therein. As will be well understood by those skilled in the art, when a value is disclosed, it is understood that values ​​less than or equal to that value, values ​​greater than or equal to that value, and possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (for example, if X is a number) are also disclosed. Throughout this application, data is provided in numerous different forms, and it is understood that these data also represent ranges of endpoints and starting points, and any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that not only the range between 10 and 15 is disclosed, but also values ​​greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are disclosed. It is also understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0119]

[0146] Preferred embodiments of the present invention have been shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided merely as examples. Now, those skilled in the art will recall numerous variations, modifications, and substitutions without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed when carrying out the present invention. The following claims define the scope of the present invention, and the methods and structures within these claims, as well as their equivalents, are intended to be covered thereby. The present invention includes the following embodiments. 1. A device for treating a patient's affected native valve, Frame structure and, Valve segments arranged radially within the frame structure, comprising a plurality of leaflets, A device comprising a plurality of coupling attachment mechanisms for connecting the leaflet to the frame structure, wherein each coupling attachment mechanism extends radially inward from the outlet end of the frame structure, forming a gap between the inner circumference of the outlet end and the outlet edge of the valve segment. 2. The device according to 1, wherein the inlet edge of the valve segment is not supported by the frame structure. 3. The device according to 2, wherein the inlet edge is positioned radially inward from the inlet end of the frame structure. 4. The device according to 1, wherein the inlet end of the frame structure protrudes radially outward. 5. The device according to 1, wherein the outflow end of the frame structure protrudes radially outward, and the tip of the outflow end is substantially oriented axially. 6. The device according to 1, wherein each of the coupling attachment mechanisms includes a paddle, the paddle having a slot therein through which the tab of the coupling of the leaflet passes. 7. The device according to 6, wherein the paddle further includes a plurality of through holes for sewing the tab to the paddle. 8. The device according to 1, wherein each of the connecting portion mounting mechanisms includes a post that is attached to the outflow end of the frame structure and curves radially inward. 9. The device described in 8., wherein the post is curved at approximately 180 degrees. 10. The device according to 8, wherein the post is attached to the support column of the outflow end, and the thickness of the post is greater than the thickness of the support column. 11. The device according to 1, wherein the gap is 1.5 mm to 4 mm when the leaflet is fully opened. 12. The device according to 1, wherein the leaflet is not supported except by the coupling attachment mechanism. 13. The device according to 1, further comprising a helical anchor configured to be positioned around the frame structure. 14. The device according to 13, wherein the frame structure includes a plurality of support columns, the support columns configured to form a flexible region within the central portion of the frame structure. 15. The device according to 1, wherein each connecting part mounting mechanism is integrally formed with the frame structure. 16. A device for treating a patient's affected native valve, A frame structure comprising a central annular portion, an inlet portion, and an outlet portion, wherein the outlet portion extends radially outward from the central annular portion, Valve segments arranged radially within the frame structure, comprising a plurality of leaflets, A device comprising a plurality of connecting attachment mechanisms for connecting the leaflet to the outflow portion of the frame structure, wherein each connecting attachment mechanism extends radially inward such that the inner circumference formed by the connecting attachment mechanism is substantially equal to the inner circumference of the central annular portion. 17. The device according to 16, wherein the inlet edge of the valve segment is not supported by the frame structure. 18. The device according to 17, wherein the inlet edge is positioned radially inward from the inlet portion of the frame structure. 19. The device according to 16, wherein the inlet portion of the frame structure protrudes radially outward. 20. The device according to 16, wherein the tip of the outflow portion is substantially oriented in the axial direction. 21. The device according to 16, wherein each of the coupling attachment mechanisms includes a paddle, the paddle having a slot therein through which the tab of the coupling of the leaflet passes. 22. The device according to 21, wherein the paddle further includes a plurality of through holes for sewing the tab to the paddle. 23. The device according to 16, wherein each of the connecting portion mounting mechanisms includes a post that is attached to the outflow portion of the frame structure and curves radially inward. 24. The device described in 23., wherein the post is curved at approximately 180 degrees. 25. The device according to 23, wherein the post is attached to the support column of the outflow portion, and the thickness of the post is greater than the thickness of the support column. 26. The device according to 16, wherein when the leaflet is fully open, the gap between the outlet edge of the valve segment and the inner diameter of the outlet portion of the frame structure is 1.5 mm to 4 mm. 27. The device according to 16, wherein the leaflet is not supported except by the coupling attachment mechanism. 28. The device according to 16, further comprising a helical anchor configured to be positioned around the frame structure in the central annular portion. 29. The device according to 28, wherein the frame structure includes a plurality of support columns, and each support column has a constricted portion within the central annular portion. 30. A device for treating a patient's affected native valve, A frame structure including a ring-shaped central section, an overhanging inlet section, and an overhanging outlet section, Valve segments arranged radially within the frame structure, comprising a plurality of leaflets, A device comprising: an inner skirt portion attached to the frame structure, the inner skirt portion including a plurality of convex segments configured to at least partially conform to the inlet edge of the leaflet. 31. The device according to 30, wherein the convex segment has a larger radius of curvature than the inlet edge of the leaflet. 32. The device according to 30, wherein the outflow edge of the inner skirt portion includes a zigzag pattern configured to match the cell pattern of the frame structure. 33. The device according to 30, wherein the outflow edge of the inner skirt portion is attached to the frame in close proximity to the annular central portion. 34. The device according to 30, wherein the outflow edge of the inner skirt portion does not extend to the outflow end of the frame structure. 35. The device according to 30, wherein the inlet edge of the leaflet is not supported by the frame structure. 36. The device according to 30, wherein the inlet edge of the leaflet is spaced radially inward from the inlet end of the frame structure. 37. The device according to 30, further comprising a helical anchor configured to be positioned around the frame structure. 38. A device for treating a patient's affected native valve, A frame structure including a ring-shaped central section, an overhanging inlet section, and an overhanging outlet section, Valve segments arranged radially within the frame structure, comprising a plurality of leaflets, A device comprising an outer skirt portion attached to the frame structure, the outer skirt portion including an integral structure that covers the protruding inlet portion and the protruding outlet portion. 39. The device according to 38, wherein the outer skirt portion includes a tubular knitted fabric. 40. The device according to 38, wherein the outer skirt portion includes a coating thereon. 41. The device according to 38, further comprising a helical anchor configured to be positioned around the frame structure. 42. The device according to 38, wherein the outer skirt portion is wrapped around the outflow edge of the frame structure. 43. The device according to 38, further comprising an additional skirt portion laminated on the outer skirt portion. 44. The device according to 43, wherein the additional skirt portion is arranged along the protruding outflow portion. 45. The device according to 38, wherein the additional skirt portion is arranged along the central annular portion of the frame structure. 46. ​​A device for treating a patient's affected native valve, The frame structure comprises valve segments arranged radially within the frame structure, The aforementioned frame structure is The overhanging inflow portion includes the cells of the first and second columns, The ring-shaped central portion containing the cells of the third column, The protruding outflow portion includes the cells in the fourth column, The valve segment is a device that includes multiple leaflets. 47. The device according to 46, wherein the inlet portion extends radially outward further than the outlet portion. 48. The device according to 46, wherein the inlet portion is curved so as to face radially inward. 49. The device according to 46, further comprising a plurality of non-shortened elements extending from the inflow portion. 50. The device according to 46, wherein the tip of the outflow portion is substantially oriented in the axial direction. 51. The device according to 46, wherein the cells of the third column include a plurality of axially extending constricted supports. 52. The device according to 46, wherein the tip of the protruding outflow portion is substantially oriented axially. 53. The device according to 46, wherein the cell is substantially rhomboid. 54. The device according to 46, further comprising a helical anchor configured to be positioned around the frame structure in the central annular portion. 55. The device according to 46, further comprising a plurality of coupling attachment mechanisms for connecting the leaflet to the frame structure, each coupling attachment mechanism extending radially inward from the outlet end of the frame structure to form a gap between the inner diameter of the outlet end and the outlet edge of the valve segment.

Claims

1. A device for treating a patient's affected natural valve, A frame structure comprising a central annular portion, an inlet portion, and an outlet portion, wherein the outlet portion extends radially outward from the central annular portion, Valve segments arranged radially within the frame structure, comprising a plurality of leaflets, wherein the inlet edge of each valve segment is not supported by the frame structure, and the valve segments are... A device comprising a plurality of commissure attachment mechanisms for connecting the leaflet to the frame structure, each commissure attachment mechanism extending radially inward from the outflow end of the frame structure, curving approximately 180 degrees, to form a gap between the inner circumference of the outflow end and the outflow edge of the valve segment, thereby forming a cylindrical flow path for blood having an inner diameter equal to the inner diameter of the central annular portion to pass through.

2. The device according to claim 1, wherein the inlet edge is positioned radially inward from the inlet end of the frame structure.

3. The device according to claim 1, wherein the inlet end of the frame structure protrudes radially outward.

4. The device according to claim 1, wherein the outflow end of the frame structure protrudes radially outward, and the tip of the outflow end is substantially oriented in the axial direction.

5. The device according to claim 1, wherein each of the connection mounting mechanisms includes a paddle, the paddle having a slot through which the tab of the connection of the leaflet passes.

6. The device according to claim 5, wherein the paddle further includes a plurality of through holes for sewing the tab to the paddle.

7. The device according to claim 1, wherein each of the aforementioned connecting part mounting mechanisms includes a post that is attached to the outflow end of the frame structure and curves radially inward.

8. The device according to claim 7, wherein the post is curved by approximately 180 degrees.

9. The device according to claim 7, wherein the post is attached to the support column of the outflow end, and the thickness of the post is greater than the thickness of the support column.

10. The device according to claim 1, wherein the gap is 1.5 mm to 4 mm when the leaflet is fully opened.

11. The device according to claim 1, wherein the leaflet is not supported except by the connection attachment mechanism.

12. The device according to claim 1, further comprising a spiral anchor configured to be positioned around the frame structure.

13. The device according to claim 12, wherein the frame structure includes a plurality of support columns, and the support columns are configured to form a flexible region within the central portion of the frame structure.

14. The device according to claim 1, wherein each connecting part mounting mechanism is integrally formed with the frame structure.

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