Prosthetic implant for leaflet displacement

Abstract

Embodiments disclosed herein may be directed to devices, systems, and methods for addressing leaflets within a patient's body, including displacement of such leaflets. The leaflets may be native heart valves or prosthetic heart valves that have been pre-implanted within the patient's body. The leaflets may be displaced to reduce the likelihood that the leaflets will obstruct access to structures within the patient's body, which may include cardiac structures such as coronary artery ostia. Thus, a reduced likelihood of disease resulting from obstruction of the cardiac structures may occur.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 040,235, filed June 17, 2020, the specification of which is incorporated herein in its entirety by this specific reference. [Background technology]

[0002] A variety of diseases may affect an individual's body. Such diseases may be of an individual's heart and may include diseases of an individual's heart valves, including the aortic valve, mitral valve, tricuspid valve, and pulmonary valve. For example, stenosis is a common and serious valve disease that can affect the function of the heart valves and the overall health of an individual.

[0003] Implants may be provided that can replace or repair portions of a patient's heart. Prosthetic implants, such as prosthetic valves, may be provided to replace portions of a patient's heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may also be provided.

[0004] The implant may be deployed in a desired portion of a patient's body in a minimally invasive, percutaneous manner, such deployment may be performed transcatheterically, where a catheter may be deployed through the individual's vascular system.

[0005] For example, during deployment of such an implant into a native heart valve, the native heart valve leaflets may remain within the patient. The native leaflets may be pushed aside by deployment of the prosthetic valve, and the prosthetic leaflets may perform the functions previously performed by the native leaflets. The native leaflets that remain within the body may be positioned in undesirable locations because they may obstruct access to cardiac structures. Such structures may include, for example, one or more coronary artery ostia. Obstructing access to such structures may result in other health conditions that may be undesirable. Accordingly, improvements may be desired in addressing the location of native structures within a patient, including the native leaflets. Summary of the Invention [Means for solving the problem]

[0006] Embodiments disclosed herein may be directed to devices, systems, and methods for addressing leaflets within a patient's body, including the displacement of such leaflets. The leaflets may be native heart valves or prosthetic heart valves that have been previously implanted within the patient's body. The leaflets may be displaced to reduce the likelihood that the leaflets will obstruct access to structures within the patient's body, which may include, for example, cardiac structures such as coronary artery ostia. Thus, a reduced likelihood of disease resulting from obstruction of cardiac structures may occur. Furthermore, access to cardiac structures following implantation may be easier with leaflets that do not obstruct access to such structures.

[0007] Embodiments disclosed herein may include a prosthetic valve. The prosthetic valve may include a valve body having a proximal end, a distal end, an outer surface, and an inner surface facing a flow channel. A plurality of valve leaflets may be positioned within the flow channel and may extend inward from the inner surface of the valve body. One or more protrusions may be configured to extend outward from the outer surface of the valve body and may be configured to distally bias one or more valve leaflets positioned outside the flow channel of the valve body.

[0008] Embodiments disclosed herein may include a method. The method may include expanding a prosthetic valve in a patient's body, the prosthetic valve including a valve body having a proximal end, a distal end, an outer surface, and an inner surface facing a flow channel, and a plurality of valve leaflets positioned within the flow channel and extending inward from the inner surface of the valve body. The method may include distally displacing one or more valve leaflets positioned outside the flow channel of the valve body with one or more protrusions extending outward from the outer surface of the valve body.

[0009] Embodiments disclosed herein may include a crimping device for a prosthetic valve. The crimping device may include a compression body having an inner surface surrounding a channel configured to receive the prosthetic valve, the inner surface configured to be contracted to apply a compressive force to the prosthetic valve within the channel to crimp the prosthetic valve, the inner surface having recesses molded therein to accommodate protrusions on the prosthetic valve. The crimping device may include an actuator for contracting the inner surface.

[0010] Embodiments disclosed herein may include a method for crimping a prosthetic valve. The method may include positioning the prosthetic valve within a channel of a crimping device having an inner surface surrounding the channel. The method may include positioning protrusions of the prosthetic valve within recesses molded into the inner surface to accommodate the protrusions of the prosthetic valve. The method may include compressing the inner surface against the prosthetic valve to crimp the prosthetic valve.

[0011] These and other features, aspects and advantages are described below with reference to the drawings, which are intended to illustrate, but not limit, the disclosure, in which like reference numerals designate corresponding features consistently throughout like embodiments. [Brief explanation of the drawings]

[0012] [Figure 1]1 is a perspective view of a prosthetic valve according to one embodiment of the present disclosure; [Figure 2] FIG. 2 is a top schematic view of the prosthetic valve shown in FIG. 1. [Figure 3] FIG. 2 is a cross-sectional schematic view of the prosthetic valve shown in FIG. 1. [Figure 4] 2 is a cross-sectional schematic view of the prosthetic valve shown in FIG. 1 in an unexpanded configuration and within the aortic annulus of a patient's body. [Figure 5] 2 is a cross-sectional schematic view of the prosthetic valve shown in FIG. 1 in an expanded configuration and within the aortic annulus of a patient's body. [Figure 6] 1 is a cross-sectional schematic view of a prosthetic valve according to one embodiment of the present disclosure. [Figure 7] FIG. 1 is a plan view of a frame of a prosthetic valve in a flattened configuration, according to one embodiment of the present disclosure. [Figure 8] FIG. 1 is a plan view of a frame of a prosthetic valve in a flattened configuration, according to one embodiment of the present disclosure. [Figure 9] 9 is a cross-sectional schematic view of a prosthetic valve including the frame shown in FIG. 8 according to one embodiment of the present disclosure. [Figure 10] 1 is a perspective view of a prosthetic valve according to one embodiment of the present disclosure; [Figure 11] FIG. 1 is a plan view of a frame of a prosthetic valve in a flattened configuration, according to one embodiment of the present disclosure. [Figure 12] FIG. 1 is a plan view of a frame of a prosthetic valve in a flattened configuration, according to one embodiment of the present disclosure. [Figure 13] 13 is a cross-sectional schematic view of a prosthetic valve including the frame shown in FIG. 12 according to one embodiment of the present disclosure. [Figure 14] FIG. 1 is a plan view of a frame of a prosthetic valve in a flattened configuration, according to one embodiment of the present disclosure. [Figure 15] FIG. 15 is a close-up view of a portion of the frame shown in FIG. 14. [Figure 16] 15 is a cross-sectional schematic view of a prosthetic valve including the frame shown in FIG. 14 according to one embodiment of the present disclosure. [Figure 17]17 is a cross-sectional schematic view of the prosthetic valve shown in FIG. 16 with the protrusions extending radially outward. [Figure 18] 1 is a side schematic view of a prosthetic valve according to one embodiment of the present disclosure. [Figure 19] 19 is a schematic side view of the prosthetic valve shown in FIG. 18 with the prosthetic valve expanded and the prongs extending radially outward. [Figure 20] 20 is a cross-sectional schematic view of the prosthetic valve shown in FIG. 19 with the protrusions extending radially outward. [Figure 21] 1 is a cross-sectional schematic view of a prosthetic valve according to one embodiment of the present disclosure with protrusions extending radially outward; [Figure 22] 1 is a cross-sectional schematic view of a prosthetic valve according to one embodiment of the present disclosure. [Figure 23] 1 is a perspective view of a prosthetic valve according to one embodiment of the present disclosure; [Figure 24] FIG. 1 is a perspective view of a crimping device according to one embodiment of the present disclosure. [Figure 25] 25 is a cross-sectional schematic view of a channel of the crimping device shown in FIG. 24. [Figure 26] 26 is a cross-sectional schematic view of the channel of the crimping device shown in FIG. 25 with the prosthetic valve and elongate shaft of the delivery system positioned within the channel. [Figure 27] 26 is a cross-sectional schematic view of the channel of the crimping device shown in FIG. 25 with a prosthetic valve crimped within the channel. [Figure 28] FIG. 1 is a side view of a delivery device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] The following description and examples illustrate in detail some exemplary embodiments of the present disclosure. Those skilled in the art will recognize that there are many variations and modifications of the present disclosure that are encompassed by its scope. Therefore, the description of a particular exemplary embodiment should not be considered to limit the scope of the present disclosure.

[0014] 1 illustrates a perspective view of an implant in the form of a prosthetic valve 10. The prosthetic valve 10 may include a valve body 12 that may have a proximal end 14, a distal end 16, and a length 18 (as marked in FIG. 3) between the proximal end 14 and the distal end 16. The proximal end 14 may comprise the outflow end of the prosthetic valve 10, and the distal end 16 may comprise the inflow end of the prosthetic valve 10.

[0015] Valve body 12 may include a plurality of struts 22 that may be connected together at connection points 24, and may include a frame 20 that may have spaces 26 between struts 22. Spaces 26 may comprise openings in frame 20 that may allow fluid to pass therethrough or that may allow other components to pass therethrough. The configuration of the frame may vary in other embodiments.

[0016] The frame 20 may be configured to allow the valve body 12 to be collapsible and expandable in a crimped state, in which the frame 20 moves to a folded (or undeployed or non-expanded) state, and in an expanded state, in which the frame 20 moves to an expanded (or deployed) state. The struts 22 may be configured to move closer together, in which case the frame 20 moves to the folded state. The width of the openings between the struts 22 may decrease, and the length of the openings increases, as the frame 20 moves to the folded (or undeployed or non-expanded) state. The struts 22 of the frame 20 may be configured to move circumferentially away from each other to move to the expanded state. The width of the openings between the struts 22 may increase, and the length of the openings decreases, as the frame 20 moves to the expanded (or deployed) state.

[0017] Valve body 12 may further include one or more covers 27 that may cover a portion of frame 20. Cover 27 may extend circumferentially around frame 20 and may be positioned to form all or a portion of outer surface 30 of valve body 12. Cover 27 may enhance fixation of deployed prosthetic valve 10 to a desired location within a patient's body.

[0018] The valve body 12 may enclose a flow channel 28 (as marked in FIGS. 2 and 3 ) that may allow fluid flow (e.g., blood or another fluid) through the valve body 12. The valve body 12 may include an outer surface 30 that may face outward from the valve body 12 and an inner surface 32 (as marked in FIGS. 2 and 3 ) that faces the flow channel 28. The outer surface 30 may provide an anchoring surface that may be utilized to securely anchor the prosthetic valve 10 within a desired portion of a patient's body (e.g., a heart valve annulus, if desired). The outer surface 30 may exert a radially outward force to securely anchor the prosthetic valve 10 within the annulus.

[0019] A plurality of valve leaflets 34 may be positioned within the flow channel 28 and may extend inward from the inner surface 32 of the valve body 12. The valve leaflets 34 may include outer end portions 35 (as marked in FIGS. 1 and 2) that connect to the frame 20 of the valve body 12 and inner portions 37 that are drawn toward each other when the valve leaflets 34 are closed. The outer end portions 35 may connect to the frame 20 at the leaflet's 34 seam points or may pass through openings in the frame 20 to connect to the frame 20. Each leaflet 34 may include a proximal end 39 (as marked in FIG. 3) that may form the edge of the leaflet 34 in the outflow direction. The proximal end 39 may be opposite the distal end 41 (as marked in FIG. 3) of each leaflet. The prosthetic valve 10 may include three leaflets 34 as shown in FIGS. 1 and 2, or may include a greater or lesser number of leaflets 34, as desired.

[0020] The valve leaflets 34 may move between an open state (fluid flows through the flow channels 28) and a closed state (fluid flow is prevented through the flow channels 28), which may mimic the movement of native heart valve leaflets. The valve leaflets 34 may have their proximal ends 39 move toward each other in a radially inward manner to contact each other and close the valve, and then move away from each other in a radially outward manner to open the valve. The valve leaflets 34 may open in a proximal direction. FIG. 2, for example, illustrates the valve leaflets 34 in an open state, where the valve leaflets 34 are positioned away from each other in a radially outward manner.

[0021] The plurality of valve leaflets 34 may be configured to open to allow flow in a proximal direction of the prosthetic valve 10, i.e., in the outflow direction, and may be configured to close to prevent flow in a distal direction of the prosthetic valve 10, i.e., in the inflow direction.

[0022] Referring to FIG. 1 , the prosthetic valve 10 may include one or more protrusions 36 configured to extend outward from the outer surface 30 of the valve body 12. The one or more protrusions 36 may be configured to distally deflect one or more valve leaflets positioned outside the flow channel 28 of the valve body 12. The one or more protrusions 36 may each have a first end 38 (as marked in FIG. 3 ) coupled to the frame 20 of the valve body 12 and may extend outward to a second end 40 of the protrusion 36. The second end 40 of the protrusion 36 may comprise a tip of the protrusion 36, which may be atraumatic. Each protrusion 36 may be angled distally, as shown in FIGS. 1 and 3 , with the second end 40 positioned distally from the first end 38. Each protrusion 36 may be straight, as shown, or may have another shape as desired. In embodiments, each protrusion 36 may comprise a forked protrusion.

[0023] Each protrusion 36 may be axially positioned on the valve body 12 at a location that may allow the protrusion 36 to contact a native (or host) leaflet upon expansion of the valve body 12. Each protrusion 36 may be positioned in a variety of locations, including at the proximal portion of the valve body 12 (as shown in FIG. 1 ). The protrusion 36 may be positioned between the proximal end 14 and the distal end 16 of the valve body 12, although other locations may be utilized as desired. In embodiments, the protrusion 36 may be axially positioned distal to the proximal end 39 of the prosthetic leaflet 34 (when such leaflet 34 is in the open state and / or when such leaflet 34 is in the closed state). Such positioning may allow the protrusion 36 to displace the native (or host) leaflet when the native or host leaflet has its proximal end at the same axial location as the proximal end 39 of the prosthetic leaflet 34. Thus, the protrusions 36 may be positioned axially closer to the inflow, or distal, end 16 of the valve body 12 than to the proximal end of the native or host leaflet. In other embodiments, other locations for the protrusions 36 may be utilized.

[0024] Each protrusion 36 may be spaced from one another circumferentially around the outer surface 30 of the valve body 12. Figure 2, for example, illustrates a top schematic view of the prosthetic valve 10, showing the protrusions 36 extending radially outward from the outer surface 30 and spaced from one another circumferentially around the outer surface 30 of the valve body 12. The spacing may be uniform, as shown in Figure 2, or other variable spacing may be utilized in embodiments, as desired.

[0025] In embodiments, the number of protrusions 36 may be eight, as shown in FIG. 2, or a greater or lesser number may be provided as desired. For example, in one embodiment, three protrusions 36 may be utilized, one protrusion for each native or host leaflet. In one embodiment, only one protrusion may be utilized. In one embodiment, two may be utilized, or a greater number (e.g., four or more) may be utilized. A greater number of protrusions 36 may increase the likelihood that the protrusions 36 will displace a native or host leaflet. The number of protrusions 36 may be selected to match the number of leaflets to be displaced, or different numbers of protrusions 36 may be provided.

[0026] FIG. 2 illustrates the valve leaflets 34 in an open configuration, allowing fluid flow through the flow channel 28 .

[0027] Valve body 12 may have a cylindrical shape, as shown in Figures 1 and 2, or may have another shape (e.g., a tapered or "V" shape, or a bulb shape, or any other desired shape). The cylindrical shape may, in embodiments, include a uniform outer diameter for the outer surface 30 of valve body 12 and a uniform inner diameter for the inner surface 32. Other configurations of the cylindrical shape may be utilized as desired.

[0028] FIG. 3 illustrates a cross-sectional schematic view of the prosthetic valve 10. The valve body 12 extends along and circumscribes an axis 42 of the valve body 12. The valve body 12 has a width 44 transverse to the axis 42 of the valve body 12. The valve body 12 may have a length 18 that varies as the width 44 of the valve body 12 changes. For example, referring back to FIG. 1, each space 26 between the struts 22 of the frame 20 may have a particular width and a particular length. The valve body 12 may be foldable and expandable, and in the folded state, the struts 22 may be pulled together such that the width of each space 26 is smaller than that shown in FIG. 1 and the length of each space 26 is larger than that shown in FIG. 1. When the valve is expanded radially outward from the axis 42 (as marked by arrows 46 in FIG. 3), the length of each space 26 may decrease and the width of each space 26 may increase. A corresponding change in the size of each space and movement of the struts 22 may allow the entire frame 20 to shrink in length and expand in width.

[0029] Thus, during expansion of the valve body 12, the width 44 of the valve body 12 may increase, which correspondingly reduces the length 18 of the valve body 12. The expansion may be controlled such that the proximal end 14 or the distal end 16 of the valve body 12 may be held in place so that the reduction in length 18 occurs in a particular direction. For example, if the distal end 16 is held in place and the valve body 12 is expanded, the proximal end 14 may then move toward the distal end 16. If the proximal end 14 is held in place, the distal end 16 may then move toward the proximal end 14. Thus, the axial movement of one or more protrusions 36 may be controlled by holding either the distal end 16 or the proximal end 14 of the valve body 12 in place during expansion. The protrusions 36 may be configured to move axially with the frame 20 in the direction of the reduction in the length of the frame 20.

[0030] The prosthetic valve 10 may be deployed at a desired treatment site within a patient. The treatment site may be an implantation site for the prosthetic valve 10 to be implanted within the patient. The treatment site may be a valve within the patient's body, which may be a native valve or may comprise a previously deployed prosthetic valve within the patient. The treatment site may include leaflets, which may be native leaflets (of a native valve) or host leaflets (of a previously deployed or host valve). The leaflets may suffer from a variety of diseases that may require replacement of the leaflets with leaflets of the prosthetic valve 10. For example, calcification of the leaflets or other valve conditions (e.g., stenosis or other conditions) may require surgery to replace the leaflets with leaflets of the prosthetic valve 10. The leaflets may remain within the patient when the prosthetic valve 10 is deployed. The prosthetic valve 10 may be deployed between the native and host leaflets such that the native or host leaflets are pushed radially outward upon expansion of the prosthetic valve. Such a configuration may result whether the prosthetic valve 10 is deployed within a native valve or a previously deployed host valve.

[0031] Pushing the native or host leaflets radially outward can cause a variety of ailments. For example, FIG. 4 illustrates a schematic diagram of a native aortic valve 48, which includes native valve leaflets 50 extending proximally, i.e., in the outflow direction, from an aortic valve annulus 52. The leaflets 50 are positioned between the flow channel of the native aortic valve 48 and the surface of the aorta (ascending aorta). Notably, the coronary ostia 54 may be positioned on the surface of the aorta. If a prosthetic valve is expanded within the native aortic valve 48, the expanded prosthetic valve may push the native leaflets 50 radially outward, causing the native leaflets 50 to completely or partially cover one or more of the coronary ostia 54, which can lead to cardiac disease. Similar problems can arise if a prosthetic valve is expanded within the aortic valve annulus 52 within a previously deployed prosthetic valve or a host prosthetic valve.

[0032] The protrusions 36 may be utilized to distally deflect one or more of the native leaflets 50 positioned outside the flow channel 28 of the valve body 12. The protrusions 36 extending outward from the outer surface 30 of the valve body 12 may contact the native leaflets 50 and deflect them distally to reduce the likelihood of the leaflets 50 completely or partially covering a coronary ostium 54 or other cardiac structures. Such an effect may occur with respect to the leaflets of a previously expanded prosthetic or host prosthetic valve within the aortic annulus 52 when the prosthetic valve 10 (functioning as a guest valve) is implanted within such a prosthetic valve.

[0033] FIG. 4 illustrates the prosthetic valve 10 in a collapsed (or undeployed or unexpanded) state, where the valve 10 may be configured to expand to expand the width 44 of the valve body 12 and reduce the length 18 (as marked in FIG. 3 ). The prosthetic valve 10 may be positioned on an elongate shaft of a delivery device (not shown in FIG. 4 ), which may be configured to deliver the valve 10 to the aortic valve annulus 52. An exemplary delivery device 154 is shown in FIG. 28 . The valve 10 may be passed by the elongate shaft transvascularly and over the aortic arch to reach the aortic valve annulus 52. In other embodiments, other approaches (e.g., a transapical approach or another approach) may be utilized. In embodiments in which other native valves are treated, other approaches may be utilized to reach the native valve.

[0034] Referring to FIG. 4 , as the prosthetic valve 10 approaches the native aortic valve 48, the protrusions 36 may be positioned proximal to the proximal ends of the leaflets 50 (on the outflow side of the leaflets). The protrusions 36 may contact the proximal ends of the leaflets 50. The prosthetic valve 10 may then be expanded, increasing the width 44 of the valve body 12 and decreasing the length 18 (as marked in FIG. 3 ). One end, such as the distal end 16, of the prosthetic valve 10 may be held in an axial position (as marked by line 56) relative to the aortic annulus 52 or other portion of the native valve or other implantation site during expansion of the valve 10. The distal end 16 may be held in place by actuation of a delivery device that may be utilized to deploy the prosthetic valve 10. The distal end 16, held in place, may allow the proximal end 14 to move toward the distal end 16, thereby moving one or more protrusions 36 distally.

[0035] FIG. 5 illustrates the prosthetic valve 10 in an expanded (or deployed) state. The prosthetic valve 10 is expanded within a patient. The length 18 of the valve body 12 is reduced, and the width 44 (as marked in FIG. 3 ) of the valve body 12 is expanded. The distal end 16 of the valve body 12 is held in place, allowing the proximal end 14 to move toward the distal end 16 while the valve body 12 is radially expanded, causing one or more protrusions 36 to move distally with the movement of the frame 20. The one or more protrusions 36 contact and distally displace the native valve leaflets 50, which may bend or otherwise compress the native valve leaflets 50. Thus, the valve body 12 may be radially expanded such that the protrusions 36 displace one or more leaflets. The proximal ends of the native valve leaflets 50 are displaced distally of the coronary ostia 54. The leaflets 50 are held distal to the coronary ostia 54 by one or more protrusions 36, which reduces the likelihood that the native valve leaflets 50 will completely or partially cover the coronary ostia 54 or other cardiac structures in the patient's body. The native valve leaflets 50 may be biased distal to the proximal ends 39 (as marked in FIG. 1 ) of the valve leaflets 34. Upon implantation, the valve leaflets 34 function as prosthetic substitutes for the native valve leaflets 50.

[0036] The native valve leaflets 50 may be held by one or more protrusions 36 in a space 58 that is distal to the one or more protrusions 36 and outside the outer surface 30 of the valve body 12. The space 58 may be distal to the coronary ostia 54. The space 58 is bounded by the outer surface 30 of the valve body 12 and an outer surface (here, the surface of the aorta) that surrounds the outer surface 30. The outer surface may be an inner surface of the patient's vasculature, such as the surface of the aorta, and / or may include, among other surfaces, a previously deployed prosthetic valve that surrounds the space 58. The space 58 may be an annular space extending around the outer surface 30 of the valve body 12. Furthermore, the angle of the protrusions 36 may function to hold the native valve leaflets 50 against the outer surface 30 of the valve body 12, preventing the leaflets 50 from moving radially outward from the outer surface 30. Thus, the leaflets 50 may be held against the outer surface 30 of the valve body 12 to further reduce the likelihood that the leaflets 50 will completely or partially cover the coronary ostia 54 .

[0037] The force of the outer surface 30 of the valve body 12 against the annulus 52 may securely anchor the prosthetic valve 10 within the annulus 52 .

[0038] The configuration and operation of the prosthetic valve 10 may advantageously function to reduce the likelihood of occlusion of the structure by the native or host leaflets, and expansion of the valve 10 may be used to move the protrusions 36 in a desired direction to displace the native or host leaflets.

[0039] The configuration and operation of the prosthetic valve 10 may further enable access to structures with the valve 10 in place. For example, in embodiments in which the valve 10 is deployed in an aortic valve, a space may exist between the outer surface 30 of the valve body 12 and the coronary ostia 54. The space may be proximal to one or more of the prongs 36 as well as proximal to the native leaflets 50. The coronary ostia 54 may be accessed through the space. A catheter may be passed through the space to access the coronary ostia 54.

[0040] In embodiments, the native valve leaflets 50 may be biased at least somewhat distal to one or more openings in the frame 20. Referring to FIG. 1 , the frame 20 may include spaces 26 that form openings, and the protrusions 36 may bias the leaflets 50 at least somewhat distal to such openings. The openings may be proximal to the proximal ends of the prosthetic valve leaflets 34. Fluid flow may thus be permitted through the openings to reach the coronary ostia 54. Furthermore, a catheter may be passed through one of the openings from inside the valve body 12 to outside the valve body 12 to reach the coronary ostia 54.

[0041] In embodiments, prosthetic valve 10 may have a variety of shapes, including balloon-expandable or mechanically expandable valve types as desired. Self-expandable valves may also be utilized. The delivery system utilized to deploy valve 10 may be configured to hold distal end 16 in place and expand valve 10 according to the desired expansion method (balloon-expandable, mechanically expandable, self-expandable, among others).

[0042] Variations in the construction and use of the prosthetic valve 10 may be provided.

[0043] FIG. 6 illustrates an embodiment of a prosthetic valve 60 configured similarly to valve 10, but including multiple protrusions 36 axially spaced from one another. The protrusions 36 may be positioned at one or more axially spaced levels relative to one another on the valve body 62. The protrusions 36 at each level may be circumferentially spaced from one another, such that the protrusions 36 form a row of protrusions extending around the outer surface of the valve body 62. The axially spaced configuration of the protrusions 36 may increase the likelihood that the protrusions 36 will contact and displace a leaflet during expansion of the valve 60. For example, if a protrusion 36 at a lower (or distal) level fails to engage a leaflet, then a protrusion 36 at a higher (or proximal) level can engage the leaflet. Furthermore, axially spaced protrusions 36 may allow both levels of protrusions to contact and displace the leaflet, thereby engaging the leaflet. The configuration of the protrusions 36 shown in FIG. 6 may be modified as desired.

[0044] FIG. 7 illustrates the frame 64 of the valve body in a flattened configuration. The frame 64 may be formed in the flattened configuration and then moved to a desired shape, such as a cylinder (as shown in FIG. 1) or another shape as desired for use. The frame 64 may be cut from a flat plate of material in the flattened configuration, such that the frame 64 comprises a flattened body. For example, the frame 64 may be laser cut or otherwise formed from a flat plate of material to form the struts 66, attachment points 68, and spaces 70 between the struts 66 that form openings. The cut material may then be rolled to form a cylinder or other shape as desired. Certain spaces may include openings 67 for receiving the outer end portions 35 of the valve leaflets 34 and may serve as seam points for the leaflets 34. The struts 66, attachment points 68, and spaces 70 may comprise a cellular pattern that repeats circumferentially around the frame 64.

[0045] 8 illustrates a frame 72 formed to include one or more protrusions 74 integral with the frame 72. Thus, when the pattern of the frame 72 is cut, the cut pattern may produce the protrusions 74. The protrusions 74 may each comprise a flattened body formed from the same flattened body as the frame 72 and formed during the cutting process, such as laser cutting or another form of cutting. The protrusions 74 may be formed to be initially positioned within an opening 75 of the frame 72, such as a proximal or upper opening of the frame configured similarly to the proximal or upper opening shown in FIG.

[0046] Protrusions 74 may each be formed to include a neck portion 76 and a head portion 78. Neck portion 76 may connect head portion 78 to frame 72, for example, at a connection point 80 on frame 72. Connection point 80 may be positioned distal to opening 75. Neck portion 76 may be formed to initially extend proximally from connection point 80. Neck portion 76 may be configured to be flexible to allow neck portion 76 to be bent radially outward from frame 72 as desired.

[0047] The head portion 78 may be formed and sized to be larger than the neck portion 76 and may be formed to be initially positioned within the opening 75. The head portion 78 may be a flattened body and may comprise one end of the protrusion 74. The head portion 78 may surround the opening 82, such that the head portion 78 comprises a ring of material extending around the opening 82. The opening 82 may reduce the amount of material comprising the head portion 78. The head portion 78 may have a rounded shape, such as a circular or oval shape, or another shape as desired. In embodiments, the head portion 78 may have a diamond shape, or a combination of shapes, or another shape as desired. The protrusions 74 may be formed in a circumferentially repeating pattern around the frame 72. The neck portion 76 may comprise one end of the protrusion 74 connected to the valve body, and the head portion 78 may comprise an atraumatic tip of the protrusion 74.

[0048] Each protrusion 74 may be configured to be bent radially outward from frame 72 such that protrusion 74 extends outward from the outer surface of the valve body, including the frame. Thus, after formation of frame 72 and protrusions 74, frame 72 may be formed into a desired shape, such as a cylinder, and protrusions 74 may be bent with head portion 78 extending distally and neck portion 76 forming a curved or "u" shape that bends protrusion 74. Head portion 78 may extend distally of opening 75.

[0049] 9 illustrates a cross-sectional schematic view of a prosthetic valve 84 including protrusions 74 extending outward from an outer surface 86 of a valve body 88, with the head portion 78 angled distally relative to the neck portion 76. The protrusions 74 are angled distally. The head portion 78 may extend parallel to the outer surface 86 of the valve body 88 and, in embodiments, may be oriented distally, with the neck portion 76 extending radially outward. The neck portion 76 may extend radially outward perpendicularly from the outer surface 86. The protrusions 74 may be spaced apart circumferentially around the outer surface 86 of the valve body 88.

[0050] A space 79 may be positioned between the outer surface 86 of the valve body 88 and the head portion 78, which may retain the native leaflets therein. The space 79 may be bounded proximally by the neck portion 76 and radially outwardly by the head portion 78. The native leaflets may be biased accordingly by the protrusions 74 and retained within the space 79, thereby extending radially outward from the outer surface 86. FIG. 10 illustrates a perspective view of a prosthetic valve 90 including, for example, the protrusions 74.

[0051] The protrusions 74 may be configured to operate similarly to the one or more protrusions 36 discussed with respect to FIGS. 1-5. The one or more protrusions 74 may each be configured to extend outward from the outer surface of the valve body. The one or more protrusions 74 may be configured to distally deflect one or more valve leaflets positioned outside the flow channel of the valve body. The head portion 78 may function as a large, atraumatic tip of the protrusions 74, which may reduce the likelihood of damaging the leaflets. The protrusions 74 may be configured to move in accordance with the direction of valve expansion, as discussed with respect to FIGS. 1-5.

[0052] The axial location of the protrusions 74 may be further distal to the openings 92 in the frame (marked in FIG. 10 ) to allow fluid flow through the openings 92 and to the coronary ostia or other cardiac structures as desired. Access to the coronary ostia may be achieved through the openings via a catheter or other device as desired.

[0053] The shape of the head portion 78 may vary in embodiments. Figure 11, for example, illustrates an embodiment in which the head portion 94 has a diamond shape. The diamond shape may improve the crimping profile of a prosthetic valve utilizing the frame 96 and may improve the ability of the frame 96 to be crimped. The neck portion may be curved to orient the head portion in a manner similar to the protrusion embodiment shown in Figures 8-10.

[0054] The location of the protrusions may vary in embodiments. FIG. 12, for example, illustrates that protrusions 97 may be coupled to the proximal end 98 (or outflow end) of the frame 100. The protrusions 97 may then be bent distally from the proximal end 98 of the frame 100. FIG. 13, for example, illustrates a cross-sectional schematic view of one such embodiment, in which the protrusions 97 have a first end coupled to the proximal end 98 of the frame 100. The head portion 94 of the protrusions 97 comprises the tip of the protrusions 97 and extends distally from the proximal end 98 or outflow end of the frame 100. The neck portion may be bent to orient the head portion in a manner similar to the protrusion embodiment shown in FIGS. 8-10. Such a configuration may improve engagement with the leaflets and improve the crimp profile of the prosthetic valve.

[0055] In embodiments, the protrusions may be stationary relative to the valve body or frame to which they are coupled. In embodiments, the protrusions may be configured to move or rotate distally. FIG. 14, for example, illustrates the configuration of a frame 99 having the cut pattern of frame 72 shown in FIG. 8. Frame 99 includes protrusions 101 having a head portion 103 configured similarly to head portion 78 shown in FIG. 8. Neck portion 105, however, may include a hinge about which head portion 103 may rotate distally.

[0056] One or more tether cords 102 may be coupled to the protrusions 101 and may be coupled to the frame 99. Each tether cord 102 may couple the valve body to a respective one of the one or more protrusions 101 and may be configured to apply a force to a respective one of the one or more protrusions 101 to rotate the respective one of the one or more protrusions 101 in a distal direction. The frame 99 may be an expandable frame, and the one or more tether cords 102 may be coupled to the expandable frame such that expansion of the frame causes the one or more tether cords 102 to apply a force to a respective one of the one or more protrusions 101.

[0057] FIG. 15 illustrates a close-up view of a portion of the frame 99, showing the configuration of the tether cords 102. Each tether cord 102 may include a first end 104, or proximal end, coupled to a respective one of the lugs 101. The first end 104 may be coupled to a head portion 103 of the lug 101. The coupling may occur toward the tip of the head portion 103, or elsewhere as desired (e.g., further distally on the head portion 103, or the coupling may occur on the neck portion 105 as desired). The first end 104 may form a loop around the body of the respective lug 101. Each tether cord 102 may include a second end 106 coupled to a portion of the frame 99. The portion of the frame 99 may include frame struts 109, which are separated by openings in the frame 99. For example, the coupling may occur at a connection point 107 on the struts 109 of the frame 99. The bond may occur at a connection point circumferentially offset from the location of each projection 101. Each end 106 may comprise a loop or other configuration.

[0058] The loop configuration may allow the body of another adjacent tether cord 102 to pass through the looped end 106. The body of the tether cord 102 may then span the space between the attachment points 107. The body of the tether cord 102 may extend circumferentially to the left from the looped end 106, as shown in FIG. 15, and then pass through the looped end of an adjacent tether cord. The body of the tether cord 102 may then be biased upward in the proximal direction to couple to the head portion 103. Thus, when the frame 99 expands radially outward, the width of the space 111 between the attachment points 107 increases. The looped end 106 is thus pulled circumferentially, which pulls the body of the tether cord 102 circumferentially. The deflection of the tether cord 102 through the adjacent loop pulls the portion of the tether cord 102 coupled to the head portion 103 in the distal direction. The protrusions 101 may be pulled distally accordingly and rotate distally about the neck portion 105. The tethering cords 102 may expand radially outwardly accordingly, causing the protrusions 101. The configuration of the tethering cord(s) 102 may vary in embodiments, for example, a single loop may extend around the entire outer surface of the frame such that expansion of the valve body causes the loop to expand and pull the protrusions 101 distally.

[0059] FIG. 16 illustrates a cross-sectional schematic view of the embodiment shown in FIGS. 14 and 15, for example. FIG. 16 illustrates a prosthetic valve 108 having protrusions 101 configured to rotate distally. The prosthetic valve 108 is shown in a folded (or undeployed or unexpanded) state. The protrusions 101 may be positioned within openings 113 in the frame 99, as marked in FIG. 14, and may extend proximally. In such a configuration, the outer diameter of the prosthetic valve 108 is not enlarged by the presence of the protrusions 101 when in the folded configuration. Thus, the valve 108 may have a relatively low outer profile or diameter with the protrusions 101 extending proximally, which may be the same diameter or outer profile as without the protrusions 101. Such a feature may improve the ability of the valve 108 to be delivered to a treatment site while maintaining a relatively low outer diameter. The protrusions 101 may have an outer diameter that is less than or does not exceed the outer diameter of the outer surface of the valve body. As discussed, when the prosthetic valve 108 is expanded, the tether cord 102 may pull and rotate the protrusions 101 distally.

[0060] FIG. 17 illustrates a protrusion 101 that is rotated distally by a pulling force applied, for example, by a tethering cord 102. The tethering cord 102 is used to apply a force to the protrusion 101, causing it to rotate distally. The head portion 103 rotates distally and is oriented distally parallel to the outer surface of the valve body. The head portion 103 rotates about a neck portion 105, which may include a hinge. The protrusion 101 may be oriented, for example, as shown in FIG. 9 and may operate in a manner similar to the protrusion shown in FIG. 9. The pulling force is generated by radial expansion of the prosthetic valve 108. In such a configuration, the proximal or distal end of the valve body may not need to be held in a particular position during expansion, as distal movement of the protrusion 101 due to rotation about the neck portion 105 may distally displace the leaflets. Such mechanisms may be used alone to deflect the leaflets distally, or may be utilized in combination with valve expansion to cause distal movement of the protrusions as disclosed herein.

[0061] The one or more protrusions 101 may each be configured to extend outward from an outer surface of the valve body and may be configured to distally displace one or more valve leaflets positioned outside the flow channel of the valve body.

[0062] Other configurations of prongs and mechanisms for rotating or deploying the prongs may be utilized.

[0063] FIG. 18 illustrates one embodiment of a prosthetic valve 110 in which the protrusions include one or more flaps 112 each configured to rotate distally. The flaps 112 may be coupled to the valve body 120 and may be positioned at a proximal end 115 of the prosthetic valve 110. The flaps 112 may be coupled to the proximal end 115 of the valve body at hinges 117 (as marked in FIG. 19 ). Opposite ends of the flaps 112 may comprise atraumatic tips of the flaps 112. The flaps 112 may each be circumferentially spaced from one another around the outer surface of the valve body 120. Three flaps 112, or a greater or lesser number of flaps 112, may be utilized as desired.

[0064] The flaps 112 may each be configured as a body having a particular width and a particular length, forming a broad surface area for contacting and engaging with the leaflets. The flaps 112 may be configured to form an arcuate shape when rotated distally, as shown in FIG. 19. Other shapes for the flaps 112 may be utilized as desired. Other positions for the flaps 112 may be utilized as well. Any of the protrusion embodiments disclosed herein may include a flap.

[0065] FIG. 18 illustrates the prosthetic valve 110 in a folded (or undeployed or unexpanded) state. The flap 112 in such a configuration may extend proximally and may extend parallel to the outer surface of the valve body 120. The flap 112 may protrude proximally from the proximal end 115 of the valve body 120, but not radially outward. In such a configuration, the outer diameter of the prosthetic valve 110 may not be enlarged by the presence of the flap 112 when in the folded configuration. Thus, the valve 110 may have a relatively low outer profile or diameter with the flap 112 extending proximally, which may be the same diameter or diameter as if the flap 112 were not present. Such a feature may improve the ability of the valve 110 to be delivered to a treatment site while maintaining a relatively low outer diameter. The flap 112 may have an outer diameter that is less than or does not exceed the outer diameter of the outer surface of the valve body 120.

[0066] Each flap 112 may be coupled to a tether cord 114, which may operate similarly to the tether cord 102 discussed with respect to Figures 14-17. Each tether cord 114 may couple the valve body 120 to a respective one of one or more protrusions in the form of the flap 112 and may be configured to apply a force to a respective one of the one or more flaps 112 to rotate the flap 112 distally. The valve body 120 may include an expandable frame, and the one or more tether cords 114 may be coupled to the expandable frame such that expansion of the frame causes the one or more tether cords 114 to apply a force to the flaps 112. Each tether cord 114 may have a first end 116 coupled to a respective flap 112 and an opposite second end 118 coupled to a portion of the valve body 120, which may include a frame 122. A portion of a frame 122 is shown in FIG. 18, including struts 121 separated by openings 123 and connected at junctures 125 .

[0067] Each tether cord 114 may be coupled to the frame 122 such that radial expansion of the frame 122 causes the tether cord 114 to apply a force to the respective flap 112, rotating the respective flap in a distal direction. The tether cord 114 is used to apply a force to the flap 112, rotating the flap in a distal direction. The second end 118 of each tether cord may be coupled, for example, to a connection point 125 of the strut 121 of the frame 122, such that as the width of the space between the connection points (e.g., the opening 123) expands, the tether cord 114 may pull the respective flap 112 in a distal direction. The tether cord 114 may have a "Y" shape, as shown in FIG. 18 , with two distal bodies 127 extending outward from connection points 129 of the tether cord 114. A proximal body 131 may extend upward from the connection point 129.

[0068] FIG. 19 illustrates the frame 122 being expanded, thereby rotating the flaps 112 distally. The flaps 112 may bend over the proximal edge of the prosthetic valve. The tethering cords 114 may move from a "Y" shape, as shown in FIG. 18, to a "T" shape, as shown in FIG. 19. Pulling on the tethering cords 114 may rotate the flaps 112 about their respective hinges 117. The flaps 112 may accordingly extend radially outward from the outer surface of the valve 110 and may be configured to distally deflect one or more valve leaflets positioned outside the flow channel of the valve body. The flaps 112 are angled distally. A protrusion in the form of the flaps 112 may deflect one or more valve leaflets in a manner similar to that disclosed herein. However, rotation of the flap 112 may allow the proximal or distal ends of the valve body to not be fixed in a particular position during expansion, as distal movement of the flap 112 may distally displace the leaflets. Such a mechanism may be used alone to distally displace the leaflets, or may be utilized in combination with valve expansion that causes distal movement of the prongs as disclosed herein.

[0069] The wide surface area of ​​the flap 112 may increase the likelihood that the flap 112 will engage the leaflet and deflect the leaflet distally.

[0070] FIG. 20 illustrates a cross-sectional schematic view of prosthetic valve 110 in an expanded configuration.

[0071] The tether cord 114 may be coupled to the valve body 120 at various locations and may likewise be coupled to each one of the flaps 112 at various locations. For example, as shown in FIG. 21 , the tether cord 114 may be coupled to one of the flaps 112 proximal to the hinge 117 (or distal to the tip of the flap) in certain embodiments. This contrasts with the embodiment shown in FIG. 20 , where the tether cord 114 may be coupled to the flap 112 proximal to the tip of the flap 112 and distal to the hinge 117. In the configuration shown in FIG. 21 , the tether cord 114 is coupled further from the tip of the flap 112 than shown in FIG. 20 , so more surface area of ​​the flap 112 may be available to engage and bias the leaflets. A space 133 may be provided between the flap 112 and the outer surface of the valve body to retain the leaflets therein.

[0072] The protrusion may be in a variety of forms as disclosed herein and in certain embodiments may comprise a single protrusion. For example, in embodiments where the protrusion comprises a flap, the single flap may extend from the valve body and be configured to displace the leaflets as desired.

[0073] 22 illustrates a side cross-sectional schematic view of an embodiment in which a skirt 124 couples to and covers one or more protrusions 74. The skirt 124 may be made of a material having openings that allow fluid to pass therethrough, but are appropriately sized to allow the skirt 124 to capture material such as emboli. The skirt 124 may be made of a fabric, or in embodiments, may be made of a polymer or other material. The skirt 124 may function as a filter to filter fluid (such as blood) passing through the skirt 124.

[0074] The skirt 124 may extend circumferentially around the entire outer surface of the valve body 88, or over a portion thereof. The skirt 124 may extend radially outward from the outer surface 86 of the prosthetic valve 84 and may cover one or more protrusions 74 extending from the outer surface 86. The protrusions 74 may be configured similar to the protrusions 74 shown in FIG. 9, or in certain embodiments may be configured to rotate, or may have another configuration.

[0075] The skirt 124 may form a space 126 between the skirt 124 and the outer surface of the valve body 88. The space 126 may be annular in shape around the outer surface of the valve body. The space 126 may be configured to trap material that may pass through the patient's vasculature. Such material may include embolism or other material that may be dislodged during the implantation process. The skirt 124 may trap such material to reduce the likelihood of illnesses associated with the propagation of such material, such as stroke. Such material may be trapped during deployment of the prosthetic valve, or before or after such deployment. The skirt 124 may trap material, for example, produced by leaflet deflection due to the protrusions 74 covered by the skirt 124. Such material (e.g., calcified material) may be released from the leaflets during leaflet deflection.

[0076] The projections 74, covered by the skirt 124, may continue to function to distally deflect the valve leaflets. Figure 23, for example, illustrates a perspective view of such a skirt 124 covering the projections 74 (as shown in Figure 22) and extending radially outward from the outer surface of the valve body of the prosthetic valve 128.

[0077] In embodiments in which the prosthetic valve includes protrusions as disclosed herein, a crimping device may be utilized to crimp the prosthetic valve and accommodate the protrusions, which may extend outward from the valve body. Figure 24, for example, illustrates such a crimping device 130. The crimping device 130 may include a base 132, a compression body 134, and an actuator 136 configured to operate the crimping device by contracting the inner surface of the crimping device.

[0078] The base 132 may be configured to be positioned on a particular surface and may support the compression body 134 and the actuator 136. The actuator 136 may include a handle that is configured to be rotated or may have another configuration as desired. For example, in embodiments, the actuator 136 may include a pump, motor, or other mechanism for actuating the crimping device. In embodiments in which the actuator 136 is a handle, the handle may be rotated to move the compression body 134 to have a reduced inner diameter.

[0079] The compression body 134 may have an inner surface 138 surrounding a channel 140 configured to receive a prosthetic valve. The valve may be threaded through an opening 141 to enter the channel 140. The inner surface 138 may be configured to contract to apply a compressive force to the prosthetic valve within the channel 140 to crimp the prosthetic valve. The compression body 134 may be configured in a variety of ways, including multiple plates forming a restrictor structure, where rotation of the plates reduces the inner diameters 142, 146 of the channel 140 (as marked in FIG. 25 ). The inner surface 138 accordingly contracts upon rotation of the plates. An actuator in the form of a handle may be rotated to move the plates and reduce the inner diameter. In other embodiments, other configurations of the compression body may be utilized, including levers and bladders, among others.

[0080] FIG. 25 illustrates a cross-sectional schematic view of a channel 140 configured to receive a prosthetic valve. The channel 140 may be defined by and surrounded by an inner surface 138 configured to contract. The inner surface 138 may have an inner diameter 142. The inner surface 138 may have a recess 144 molded therein that may accommodate a protrusion of the prosthetic valve. The recess 144 may have an inner diameter 146 that is larger than the inner diameter 142 of the inner surface 138 outside the recess 144. The inner diameter 146 of the recess 144 and the inner diameter 142 of the inner surface 138 outside the recess 144 may each be uniform. The recess 144 may have a cylindrical shape, and the channel 140 outside the recess 144 may likewise have a cylindrical shape. The recess 144 may comprise a groove formed in the inner surface 138.

[0081] FIG. 26 illustrates a prosthetic valve 148 in an uncrimped or expanded state, including protrusions 150 that may be configured similarly to the protrusions disclosed herein. The prosthetic valve 148 may be positioned within the channel 140 and may be positioned on an elongated shaft 152 of a delivery device onto which the prosthetic valve 148 is to be crimped. FIG. 28, for example, illustrates a delivery device 154 onto which the prosthetic valve 148 may be crimped and that may be utilized to deliver any of the prosthetic valves disclosed herein to a desired implantation site. The configuration of the delivery device 154 may vary in other embodiments. The delivery device 154 may include an elongated shaft 152, which may include an implant holding region 156 onto which the valve 148 is crimped. An exterior sheath of the elongated shaft 152 may cover the crimped, compressed, or unclamped valve 148 within the implant holding region 156 to hold the valve 148 relative to the shaft 152. The implant holding region 156 may be positioned at the distal end 158 of the elongate shaft 152. A nosecone 160 may be further positioned at the distal end 158 of the elongate shaft 152. The elongate shaft 152 may include a proximal end 162 that may be coupled to a handle 164 utilized to grasp the delivery device 154 or may be coupled to another form of housing.

[0082] Referring back to FIG. 26 , the protrusions 150 may be positioned within the recesses 144. The inner surface 138 may be compressed against the prosthetic valve 148 with a radial compressive force to crimp the prosthetic valve 148. FIG. 27 , for example, illustrates a compressive force applied to the prosthetic valve 148. The prosthetic valve 148 is crimped with the protrusions 150 continuing to extend radially outward from the outer surface of the valve body. The recesses 144 may prevent the protrusions 150 from being compressed to the same diameter as the rest of the valve 148. The portion of the inner surface 138 within the recesses 144 may contact the protrusions 150 during crimping, or may be separated from the protrusions 150 during crimping, as shown in FIG. 27 . The valve 148 may be crimped onto the elongate shaft 152, for example, at an implant holding region 156 shown in FIG. 28 . The valve 148 may be coupled to a delivery device in a predetermined position to be deployed at a desired treatment site.

[0083] In certain embodiments, cushioning may be added to the prosthetic valve 148. The cushioning may include Qualcrimp® or another form of cushioning as desired. Such cushioning may absorb shock to the valve and prongs 150 during crimping, thereby avoiding damage to the prongs during crimping.

[0084] Although the embodiments as disclosed herein may be discussed with respect to prosthetic valves, the systems, devices, and methods disclosed herein are not limited to prosthetic valves. Other forms of implants and prosthetic implants may utilize the systems, devices, and methods disclosed herein, including stents and other forms of medical implants.

[0085] The systems, devices, and methods disclosed herein are not limited to treating the aortic valve, but may be extended to treating the mitral, pulmonary, and tricuspid valves, as well as other parts of a patient's body. The systems, devices, and methods disclosed herein may be utilized as docking support members that can be folded over and placed against native anatomical structures, such as the native mitral valve or elsewhere. Other uses may also be provided. Embodiments of the protrusions may be utilized to displace leaflets, or in embodiments may be configured to displace other anatomical structures as desired.

[0086] The implant may be a cylindrical implant, or in other embodiments, may have other shapes, such as a "V" shape, or other shapes as desired. The implant may be configured to extend radially outward from an axis about which the implant is circumscribed, such as the longitudinal axis of the implant. The implant may be balloon-expandable or mechanically expandable, or in embodiments, may be self-expanding. The delivery device utilized may be configured to produce the desired form of expansion, for example. In the case of a balloon-expandable valve, for example, the delivery device may include an expansion balloon and a lumen for inflating and expanding the balloon positioned within the valve. In the case of a mechanically expandable valve, the delivery device may include a mechanical deployment mechanism for expanding the valve. In the case of a self-expanding valve, the delivery device may include a retractable sheath or the like to reveal the valve and allow the valve to expand. Other forms of deployment and delivery devices may be utilized as desired.

[0087] The systems, devices, and methods disclosed herein may be used in a variety of procedures, including transcatheter aortic valve implantation (TAVI). The delivery devices and systems disclosed herein may be utilized with hepatic artery access, including femoral access, to a patient's heart. The approach to the delivery site may be in a variety of ways. For example, the approach to the native aortic valve may be via the aortic arch. In embodiments, a ventricular approach may be utilized, approaching the native aortic valve from the inflow side of the native aortic valve. The prosthetic valve may be implanted from such an orientation, with the prongs displaced distally from the native leaflets.

[0088] In embodiments, the systems, devices, and methods disclosed herein may be used for mitral valve replacement, tricuspid valve replacement, and pulmonary valve replacement, as well as repair. The delivery device may be used in transcatheter percutaneous procedures, including hepatic artery procedures, which may be transfemoral or transjugular. Transapical procedures, among others, may also be used. The systems, devices, and methods disclosed herein may be used to deploy a guest prosthetic valve within a host prosthetic valve to treat dysfunction of the host prosthetic valve. Such embodiments may include a valve-in-valve (ViV) procedure.

[0089] A tether cord as disclosed herein may comprise a flexible body such as a suture, cord, cable or wire, or may comprise other forms of tether cord if desired.

[0090] Features of the embodiments may be modified, substituted, eliminated, or combined across embodiments as desired.

[0091] Additionally, the methods herein are not limited to the methods specifically described, but may include methods utilizing the systems and devices disclosed herein. Method steps may be modified, eliminated, or added to the systems, devices, and methods disclosed herein.

[0092] The features of the embodiments disclosed herein may be implemented independently of the other components disclosed herein. The various devices of the system may be implemented independently.

[0093] In closing, it should be understood that aspects of the present specification have been emphasized with reference to specific embodiments, and those skilled in the art will readily appreciate that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. It should therefore be understood that the disclosed subject matter is in no way limited to the particular methodology, protocols, and / or reactants described herein. Accordingly, various modifications or variations of the disclosed subject matter, or alternative configurations thereof, can be made in accordance with the teachings herein without departing from the spirit of the specification. Finally, the terminology used herein is for the purpose of describing particular embodiments and is not intended to limit the scope of the systems, apparatus, and methods as disclosed herein, which are defined only by the claims. Therefore, the systems, apparatus, and methods are not limited to that precisely as shown and described.

[0094] Particular embodiments of the systems, apparatus, and methods have been described herein, including the best modes known to the inventors for carrying them out. Of course, variations on these described embodiments will become apparent to those skilled in the art upon reading the foregoing description. The inventors expect that skilled artisans will adopt such variations as appropriate, and the inventors intend for the systems, apparatus, and methods to be practiced otherwise than as specifically described herein. Accordingly, the systems, apparatus, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Furthermore, any combination of the above-described embodiments in all possible variations thereof is encompassed by the systems, apparatus, and methods unless otherwise indicated herein or clearly contradicted by context.

[0095] Groupings of alternative embodiments, elements, or system steps, apparatus, and methods are not to be construed as limiting. The members of each group may be referenced and claimed individually or in any combination with the members of other groups disclosed herein. It is considered that one or more members of a group may be included in a particular group, or deleted from such a group, for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to include the group as modified to so implement the written description of all Markush groups used in the appended claims.

[0096] Unless otherwise indicated, all numbers expressing features, products, qualities, parameters, characteristics, terms, etc. used in the specification and claims should be understood to be modified in all instances by the term "approximately." As used herein, the term "approximately" encompasses approximations that are capable of performing the desired operation or process discussed herein, although the feature, product, quality, parameter, characteristic, or term, etc. so modified may vary.

[0097] The terms "a," "an," "the," and similar referents used in the context of describing systems, apparatus, and methods (particularly in the context of the claims below) should be construed to cover both the singular and the plural unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended merely to better elucidate the systems, apparatus, and methods and does not pose a limitation on the scope of the systems, apparatus, and methods otherwise claimed. No language in this specification should be construed as indicating any non-claimed element essential to the practice of the systems, apparatus, and methods.

[0098] All patents, patent publications, and other publications referenced or identified herein are individually and specifically incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that may be used in connection with the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or presentation of the contents of these documents are based on the information available to the applicant and do not constitute any admission as to the accuracy of the dates or contents of these documents. [Explanation of symbols]

[0099] 10 Prosthetic valve 12 Valve body 14 proximal end 16 distal end 18 Length 20 frames 22 Posts 24 connection points 26 Space 27 Cover 28 flow channels 30 Outer surface of valve body 32 Inner 34 Valve leaflet 35 Outer end section 36 Protrusion 37 Inner part 38 First end 39 Proximal end 40 second end 41 distal end 42 axes 44 width 46 Arrow 48 Aortic valve 50 Native valve leaflets, leaflets 52 Aortic valve annulus 54 Coronary ostium 56 lines 58 Space 60 Prosthetic valve 62 Valve body 64 frames 66 Pillar 68 connection points 70 space 72 frames 74 Protrusion 75 Aperture 76 Neck part 78 Head part 79 Space 80 connection points 82 Aperture 84 Prosthetic valve 86 Exterior 88 Valve body 90 Prosthetic valve 92 Aperture 96 frames 97 Protrusion 98 Proximal end 99 frames 100 frames 101 Protrusion 102 Mooring cord 103 Head part 104 first end 105 Neck part 106 Second end 107 connection points 108 Prosthetic valve 109 Post 111 Space 112 Flap 113 Aperture 114 Mooring cord 115 proximal end 116 first end 117 Hinge 118 Second End 120 Valve body 121 Post 122 frames 123 Aperture 124 Skirt 125 connection points 126 Space 127 Distal body 128 Prosthetic Valve 129 connection points 130 Crimping Device 131 Proximal body 132 base 133 Space 134 Compression body 136 Actuator 138 Inside 140 channels 141 Aperture 142, 146 inner diameter 144 recess 148 Prosthetic Valve 150 protrusions 152 Long and thin shaft 154 Delivery device 156 Implant Retention Area 158 Distal end of shaft 160 Nosecone 162 Proximal end of shaft 164 Handle

Claims

1. a valve body (12) having a proximal end (14), a distal end (16), an outer surface (30), and an inner surface (32) facing the flow channel, the valve body (12) being radially collapsible and expandable; a plurality of valve leaflets (34) positioned within the flow channel and extending inwardly from the inner surface of the valve body; one or more protrusions (36, 74) configured to extend outward from the outer surface of the valve body and configured to distally bias one or more native valve leaflets (50) positioned outside the flow channel of the valve body, The one or more protrusions are each configured to extend proximally when the valve body is in a collapsed state and to rotate distally when the valve body is expanded.

2. 2. The prosthetic valve of claim 1, wherein the one or more protrusions are configured to retain the one or more patient-native valve leaflets in a space (58) distal to the one or more protrusions and outside the outer surface of the valve body.

3. 3. The prosthetic valve of claim 1 or claim 2, wherein the plurality of valve leaflets are configured to open proximally.

4. 4. The prosthetic valve of claim 1, wherein the proximal end of the valve body is an outflow end of the valve body and the distal end is an inflow end of the valve body.

5. A prosthetic valve as described in any one of claims 1 to 4, including a plurality of said protrusions spaced circumferentially from one another around the outer surface of said valve body.

6. A prosthetic valve as described in any one of claims 1 to 5, comprising a plurality of said protrusions axially spaced apart from one another.

7. 7. The prosthetic valve of claim 1, wherein the one or more protrusions each include a first end (38) coupled to the valve body and a second end (40) configured to contact the patient's native valve leaflets upon expansion of the valve body.

8. 8. The prosthetic valve of claim 7, wherein the second end includes a portion (78) having one or more of a rounded or diamond shape surrounding an opening (82).

9. 9. The prosthetic valve of claim 1, wherein the one or more protrusions comprise one or more bifurcated protrusions.

10. 10. The prosthetic valve of claim 1, further comprising one or more tethering cords (102) configured to couple the valve body to a respective one of the one or more protrusions and to apply a force to the respective one of the one or more protrusions to rotate the respective one of the one or more protrusions in the distal direction.

11. A prosthetic valve as described in claim 10, wherein the valve body includes an expandable frame (20, 122), and the one or more tethering cords are coupled to the expandable frame such that expansion of the expandable frame causes the one or more tethering cords to apply the force to each one of the one or more protrusions.

12. 12. The prosthetic valve of claim 11, wherein the expandable frame has struts (22) separated by openings (67), and each of the one or more tether cords has a first end (106) coupled to the strut and a second end (104) coupled to the respective one of the one or more protrusions.

13. 12. The prosthetic valve according to any one of claims 1 to 11, wherein the one or more protrusions comprise one or more flaps (112).

14. each of the one or more protrusions includes a first end (38) and a second end (40); the first end is coupled to the proximal end of the valve body; or 14. The prosthetic valve of claim 1, wherein the first end is coupled to the valve body between the proximal end of the valve body and the distal end of the valve body, and the second end comprises a tip.

15. 15. The prosthetic valve of any one of claims 1 to 14, further comprising a skirt (124) coupled to the one or more protrusions and extending circumferentially around the outer surface of the valve body.

Images