Prosthetic heart valve

Abstract

In some examples, a prosthetic device is configured to expand radially outward to position a valve assembly to control blood flow through an annulus of a heart valve. The prosthetic device supports an echogenic member around a perimeter defined by the prosthetic device. In examples, the prosthetic device includes an anchoring member configured to expand to engage the annulus of the heart valve. In examples, the anchoring member defines the perimeter. The prosthetic device may support the echogenic member.

Description

PROSTHETIC HEART VALVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 516,224, filed July 28, 2023, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure relates generally to prosthetic heart valve devices and associated systems and techniques.BACKGROUND

[0003] Human hearts can suffer from various diseases or conditions related to heart valves. One method of treatment includes replacement of the heart valve by implanting a prosthetic heart valve device into the heart in place of a native heart valve (e.g., a mitral valve or tricuspid valve). Another method of treatment includes repair, bypassing, or replacement of a previously implanted prosthetic heart valve device. In some cases, one or more prosthetic heart valve devices may be implanted percutaneously using valve delivery devices. In some cases, a prosthetic heart valve device may be sheathed within a capsule to allow for the percutaneous delivery via a catheter, with the prosthetic heart valve device assuming a relatively small cross-sectional dimension in the fully sheathed configuration. Once delivered and placed in the target site, the prosthetic heart valve device may be unsheathed to expand to assume a larger cross-sectional dimension. During and / or following implantation, alignment of the prosthetic heart valve device within the patient may be evaluated using imaging techniques such as ultrasound.SUMMARY

[0004] In some examples, the disclosure is directed to a prosthetic device such as a prosthetic heart valve device configured to operate as a heart valve within a heart of a patient. The prosthetic device is configured to expand radially outward to position a valve assembly that is configured to control blood flow through an annulus of the heart valve. The prosthetic device supports echogenic member around a perimeter defined by the prosthetic device to aid in imaging the prosthetic device within the patient, such that aclinician may assess a position and / or orientation of the prosthetic device. In some examples, the echogenic member may include a plurality of echogenic markers. In some examples, the echogenic member may include an echogenic brim which surrounds at least a portion of the perimeter. In any case, whether the echogenic member is configured as a brim or a plurality of echogenic markers, the echogenic member is configured to alter the echogenic properties (e.g., the image of the device on an ultrasound image) to enhance deployment and positioning accuracy of the prosthetic device. The prosthetic device is configured to support the echogenic member in a manner enhancing the visual clarity of a resulting image. In some examples, the image may be relatively more readable than an image of a prosthetic device that does not include echogenic member, because the echogenic member may have a distinctive shape or shapes that are visible on the resulting image.

[0005] In examples, a prosthetic device comprises: an anchoring member configured to engage an annulus of a heart valve of a heart, wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus; a valve support mechanically supported by the anchoring member and surrounding the valve axis, wherein the valve support is configured to define a flow path from an inflow region of the valve support to an outflow region of the valve support; a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path; and echogenic member mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis, wherein the echogenic member is configured to alter the echogenic properties of the prosthetic device to enhance deployment and positioning accuracy of the prosthetic device.

[0006] In examples, a method comprises: expanding a prosthetic device within a heart of patient. The prosthetic device includes an anchoring member configured to engage an annulus of a heart valve of the heart, wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus. The prosthetic device also includes a valve support mechanically supported by the anchoring member and surrounding the valve axis, wherein the valve support is configured to define a flow path from an inflow region of thevalve support to an outflow region of the valve support. The prosthetic device further includes a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path. The prosthetic device further includes echogenic member mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis. The method further includes capturing an image of the prosthetic device within the heart using an imaging system, wherein the image is based at least partially on echogenic properties of the echogenic member.

[0007] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0008] FIG. 1A is a conceptual diagram illustrating an example delivery system including a prosthetic device in a delivery configuration.

[0009] FIG. IB is a conceptual diagram of the delivery system of FIG. 1A with the prosthetic device in an expanded configuration.

[0010] FIG. 2A is a conceptual diagram of an example prosthetic device supporting a plurality of echogenic markers.

[0011] FIG. 2B is a conceptual diagram illustrating the prosthetic device of FIG. 2A from a cross-sectional sideview.

[0012] FIG. 2C is a conceptual diagram illustrating the example device of FIG. 2A from a top view.

[0013] FIG. 3 is a conceptual diagram illustrating a cross-section of an example prosthetic device supporting a plurality of echogenic markers as rivets, the cross-section being taken through an axis L of the prosthetic device.

[0014] FIG. 4 is a conceptual diagram illustrating a cross-section of an example prosthetic device supporting an example echogenic member.

[0015] FIG. 5 is a conceptual diagram illustrating a cross-section of an example prosthetic device supporting an echogenic member as a rolled fabric surrounding a device perimeter.

[0016] FIG. 6A-6B are conceptual diagrams illustrating an example prosthetic device which includes an echogenic brim from a perspective view and a cross-sectional view, respectively.

[0017] FIG. 7 is a conceptual side-view illustrating a portion of an example prosthetic device which includes a shaped echogenic brim.

[0018] FIG. 8 is a conceptual side-view illustrating a portion of an example prosthetic device which includes a shaped echogenic brim and a brim wire.

[0019] FIG. 9 is a conceptual side-view illustrating an example shaped echogenic brim.

[0020] FIG. 10 is a conceptual side-view illustrating an example prosthetic device that includes an echogenic brim which comprises a foam.

[0021] FIG. 11 is a flowchart illustrating an example technique for using a prosthetic device.

[0022] FIG. 12 is schematic front view of an echogenic member including a rivet.

[0023] FIG. 13 is a schematic side view of the echogenic member of FIG. 12.

[0024] FIG. 14 is a schematic side view of an echogenic member including a shaped rivet.

[0025] FIG. 15 is a schematic perspective view of an example prosthetic device supporting another example echogenic member.

[0026] FIG. 16 is a perspective view of an example prosthetic device supporting an echogenic member as a rolled fabric.

[0027] FIG. 17 is a perspective view of an example prosthetic device supporting a component echogenic member.

[0028] FIG. 18 is a perspective view of a brim defining one or more voids.

[0029] FIG. 19 is a schematic view of a prosthetic device including a plurality of brim wires.

[0030] FIG. 20 is a schematic view of a prosthetic device including a scalloped brim.DETAILED DESCRIPTION

[0031] This disclosure describes a prosthetic device such as a prosthetic heart valve device configured to operate as a heart valve within a heart. The prosthetic device is configured to establish a relatively compact delivery configuration for delivery to a heart of a patient. The prosthetic device is configured such that a clinician may cause the prosthetic device to expand from the delivery configuration to an expanded configuration when the prosthetic device is positioned in proximity to a native heart valve, such that the prosthetic device may engage tissue of the heart to position a valve assembly substantially within an annulus of the native heart valve. The prosthetic device supports one or more echogenic members. In examples, an echogenic member includes a plurality of echogenic markers and / or one or more echogenic components supported by the prosthetic device (e.g., supported by a brim or another portion of the prosthetic device). The echogenic member is configured to aid in imaging the prosthetic device within the patient using an imaging system, such that a clinician may assess a position and / or orientation of the prosthetic device during, for example, an implantation procedure, a post-operative check, a check-up of the patient, or at other times.

[0032] The prosthetic device is configured to support the echogenic member in way that enhances the visual clarity of a resulting image. Thus, the echogenic member is configured to enhance deployment and positioning accuracy of the prosthetic device. In examples, the echogenic member may be hyperechogenic and / or hypoechogenic relative to the remainder of the device and / or the surrounding tissue, such that the echogenic member is visible by contrast on, for example, an ultrasound image. Hyperechogenic structures, materials, or tissue, as defined herein, are those materials, tissue, or structures that reflect more acoustic waves than surrounding structures, materials, or tissue, such that they appear white or bright on an ultrasound image. Conversely, hypoechogenic structures, tissue, or materials are those that reflect fewer acoustic waves, such that they appear gray or dimly on an ultrasound image. The prosthetic device may support the echogenic member such that the echogenic member(s) extend in an upstream and / or downstream direction of the prosthetic device. In examples, radial and / or lateral extension of the echogenic member may assist in displacing the echogenic member from tissues within the heart, enhancing the visual clarity of the image markers relative to tissue interfaces. In examples, the prosthetic device may include an echogenic member that is configured toimprove deployment and positioning accuracy relative to other prosthetic devices by reducing acoustic shadowing from the aorta, acoustic shadowing from other cardiac devices, difficulty with getting leaflets in plane, or other associated difficulties with positioning and deployment of prosthetic devices in the heart. Acoustic shadowing, as defined herein, is a phenomenon in which tissue located further away from an ultrasound probe is obstructed by the prosthetic device or intervening medical equipment, thus occluding the tissue from the clinician when an image is captured. In some examples, prosthetic devices which include an echogenic member described herein may reduce or eliminate acoustic shadowing, allowing the clinician to better position and deploy the prosthetic device. In some examples, prosthetic devices which include an echogenic member described herein may allow for a smaller echogenic member to yield the same or improved visibility, allowing for a smaller delivery capsule.

[0033] During the implantation of the prosthetic device within a heart, the clinician may position a delivery capsule (using a delivery system) in the vicinity of an annulus of the native heart valve in preparation for unsheathing the prosthetic device. The prosthetic device may be configured such that, when the capsule unsheathes the prosthetic device to allow for expansion, the prosthetic device grips the annular wall of the native heart valve to substantially secure the prosthetic device within the heart. For example, the prosthetic device may include an anchoring member which includes a fixation structure including one or more fixation elements (e.g., barbs, hooks, cleats, tines, and the like) configured to engage with the annular wall when the prosthetic device expands. Consequently, during and following the transition of the prosthetic device to the expanded configuration, alignment of the prosthetic device with the annular wall is typically evaluated using an imaging system, in order to allow a clinician to evaluate the relative positions of the prosthetic device and the native heart valve of the patient.

[0034] The prosthetic device includes an echogenic member configured to aid in identifying the prosthetic device within the patient using an imaging system, such as an ultrasound system. The echogenic member may be configured to enhance the image of the prosthetic device captured by the imaging system, such that an approximate location of the prosthetic device within the heart of the patient may be assessed by the clinician. In examples, the echogenic member may be located at one or more fixed locations on the prosthetic device, such that an approximate orientation of the prosthetic device within theheart may be assessed using the imaging system. Hence, the echogenic member may enhance the ability of a clinician to assess the position and / or orientation of the prosthetic device within the heart of the patient during and / or following the transition of the prosthetic device to the expanded configuration (i.e., during deployment and implantation of the prosthetic device.

[0035] In some examples, the echogenic member may be configured to reflect and or otherwise interact with energy transmitted by the imaging system. The imaging system may be configured to transmit energy (e.g., acoustic energy as sound waves) and produce an image based on the return of at least some portion of the transmitted energy to the image device. In examples, the echogenic member is configured to interact with the transmitted energy to enhance a resulting image of the echogenic member produced by the imaging system. For example, the echogenic member may be configured to interact with the transmitted energy such that the imaging system provides a contrast and / or other distinction (e.g., visual distinction) between the imaged echogenic member and one or more structures of the heart. The contrast and / or other distinction may assist the clinician in assessing a position and / or orientation of the prosthetic device during a procedure in which the prosthetic device is deployed.

[0036] In some examples, the imaging system may be an ultrasound device configured to utilize an ultrasound technique to produce an image of the prosthetic device within the heart of the patient. In an ultrasound technique, acoustic wave energy generated by an ultrasound probe (which is sometimes located in the esophagus of a patient) reflect off of the prosthetic device back to the ultrasound probe. Reflected wave energy captured by the probe may be sensed and used to generate an image displaying the position of the prosthetic device within the patient. In examples, the prosthetic device includes an echogenic member which defines one or more echogenic surfaces configured to reflect acoustic waves back to an ultrasound probe, such that echogenic visibility of the prosthetic device is improved. In an example echocardiograph device for use with prosthetic devices described herein, a transducer with a piezo-electric crystal array may produce high- frequency sound waves. The sound waves may be projected toward the subject (e.g., toward the heart from the esophagus) at set pulse intervals. As the sound wave interacts with matter, the sound wave may be reflected back to a transducer as a function of the acoustic impedance of the matter. The returning sound wave may be detected by the piezo-electric current as a function of its amplitude. A representation of the detected electrical current at a particular point in time may be output as an image. The image may be output in substantially real-time to assist a clinician in positioning and deploying the prosthetic device from a delivery configuration to an expanded configuration within the annulus.

[0037] In examples, when a structure, material, tissue, and / or other component is described as echogenic, this means the structure, material, tissue, and / or other component reflects some portion of an acoustic wave when the structure, material, tissue, or other component is impinged by the acoustic wave. In examples, the acoustic wave is an ultrasound wave. In examples, the ultrasound wave has a frequency of from about 2 megahertz (MHz) to about 18 MHz. In some examples, when a first structure, first material, first tissue, and / or other first component has a first echogenicity greater than a second echogenicity of a second structure, second material, second tissue, and / or other second component, this means the first structure, first material, first tissue, and / or other first component has a first acoustic impedance greater than a second acoustic impedance of the second structure, second material, second tissue, and / or other second component. In examples, the first structure, first material, first tissue, and / or other first component has the first acoustic impedance to an acoustic wave at a specific frequency and / or specific incidence angle and the second structure, second material, second tissue, and / or other second component has the second acoustic impedance to the acoustic wave at the specific frequency and / or specific incidence angle.

[0038] The prosthetic device may be configured to spatially position the echogenic member such that the spatial positioning indicates an orientation of the prosthetic device within the heart. For example, the prosthetic device may be configured to allow blood flow generally along a valve axis from an inflow region of the prosthetic device to an outflow region of the prosthetic device when the prosthetic device is in the expanded configuration. The prosthetic device may be configured such that the relative position of the echogenic member is defined relative to the valve axis (e.g., in a perimeter around the valve axis) and / or a portion of the prosthetic device when the prosthetic device is in the expanded configuration. Hence, the spatial positioning of the echogenic member may assist a clinician in assessing the orientation of the valve axis and / or the perimeter relative to other structures of the heart (e.g., structures of the annulus) when the clinician views an image of the prosthetic device within the heart. In like manner, the relative position of theechogenic member may be defined relative to other portions of the prosthetic device (e.g., a fixation structure, a valve assembly, and / or other portions), such that the spatial positioning of the echogenic markers may assist a clinician in assessing the orientation of other portions of the prosthetic device relative to other structures of the heart.

[0039] The echogenic member may take several different forms or combinations of forms, each of which is configured to alter echogenic properties of the prosthetic device relative to a prosthetic device which does not include an echogenic member. In some examples, the echogenic member may be a plurality of discreet echogenic members, which may be called echogenic markers. In some examples, the prosthetic device may include a brim having limited echogenic visibility relative to an echogenic member. In some examples, the prosthetic device may substantially lack a brim. The plurality of echogenic markers, each of which may define a closed boundary having a shape, may be attached to and extend upstream of a perimeter of an anchoring member of the prosthetic device, or may extend from another part of the prosthetic device. The plurality of echogenic markers may be displaced from each other around a portion of the perimeter of the prosthetic device. The displacement of the echogenic members may alleviate occlusions of tissue that might otherwise occur, such that a clinician may view tissues that might otherwise be substantially shielded from an ultrasound probe by some portion of the prosthetic device.

[0040] In some examples, a portion of the prosthetic device may be configured to serve as the echogenic member. For example, an upstream portion of the anchoring member may be coated in a hyperechogenic material, such that the portion is relatively more visible on an ultrasound image and a clinician may position and / or deployment the prosthetic device based at least partially on the position and / or orientation of the coated portion. In addition to or as an alternative to a coated portion, the portion may be a textured portion of the prosthetic device. The textured portion may increase echogenic visibility of the portion by increasing a number of incidence angles that acoustic energy directed at the textured portion is reflected. Such examples may also omit a brim, and thus may eliminate acoustic shadowing caused by a brim.

[0041] In some examples, the echogenic member may include an echogenic brim. The echogenic brim may be attached to and extend upstream of the anchoring member, and may be configured to extend radially outward away from the valve axis when theanchoring member engages the annulus. In some examples, the echogenic brim may define a first end at a perimeter defined by the prosthetic device and a second end displaced from the first end in an upstream direction. The echogenic brim may define a first brim perimeter including the first end and a second brim perimeter including the second end. The second brim perimeter may be configured to displace radially outward from the first brim perimeter when the prosthetic device is in the expanded state. In some examples, the echogenic brim may include one or more modifications to shape, size, or materials to alter echogenic properties of the brim. For example, the echogenic brim may define a plurality of void areas configured to allow waves of acoustic energy to pass through the echogenic brim, which may reduce acoustic shadowing due to the brim and / or present a more recognizable shape to a clinician on an image of the echogenic brim. In some examples, the plurality of void areas may be disposed proximate to the second end of the brim. For examples, the brim may define a sinusoidal or scalloped shape at the second end. The shape may be recognizable on the resulting image, allowing for relatively simple recognition of the position and orientation of the echogenic brim and thus, the prosthetic device.

[0042] In some examples, the echogenic brim may include one or more unconventional materials (i.e., materials not conventionally deployed in prosthetic devices). For example, the echogenic brim may include an animal-derived tissue (e.g., bovine pericardium tissue). The animal-derived tissue may thicken the echogenic brim to provide more bulk density to enhance an echogenicity of the brim and / or an echogenic visibility of the brim on the resulting image. Animal-derived tissue such as bovine pericardium tissue may have good compressibility, such that an echogenic brim comprising such a material may have improved echogenic visibility in the expanded configuration, without a corresponding increase in the size of the prosthetic device in the delivery configuration, because the animal-derived tissue may be packed into a delivery capsule in a compressed state. In some examples, other compressible materials may be included in the echogenic brim for similar reasons. In some examples, the brim may include a compressible foam, such as a high-density foam, an intermediate density foam, or a low-density foam. A high-density foam may be characterized by relatively smaller void sizes, while a low-density foam may be characterized by relatively larger void sizes. In some examples, a high-density foam may be relatively more echogenic due to increasedmaterial density, while a low-density foam may be more compressible for delivery to the heart. In some examples, a low-density foam may be characterized as having a density less than 20 kilograms per cubic meter, while a high-density foam may be characterized as having a density greater than 20 kilograms per cubic meter.

[0043] In some examples, the echogenic member may be spatially positioned around a perimeter or a portion of a perimeter defined by the prosthetic device in the expanded configuration. The prosthetic device may, for example, define the perimeter around the valve axis. In examples, the prosthetic device defines the perimeter around a flow path from the inflow region of the prosthetic device (e.g., a region fluidically coupled to an atrium of a heart) to an outflow region of the prosthetic device (e.g., a region fluidically coupled to a ventricle of the heart). In some examples, the perimeter defined by the prosthetic device is substantially perpendicular to the valve axis defined by the prosthetic device when the prosthetic device is in the expanded state. The spatial positioning of the echogenic markers around the defined perimeter may assist a clinician in assessing the orientation of the prosthetic device relative to other structures of the heart when the clinician views an image of the prosthetic device within the heart.

[0044] In some examples, the prosthetic device includes an anchoring member. The anchoring member may include a fixation structure configured to grip an annular wall of a native heart valve when the prosthetic device is in an expanded configuration to help secure the prosthetic device in an annulus of the native heart valve. The prosthetic device may be configured to cause a valve assembly to position within or in the vicinity of the annulus when the fixation structure grips the annular wall. The valve assembly may be configured to allow blood to flow along a flow path from the inflow region of the prosthetic device to the outflow region of the prosthetic device. In some examples, the valve axis passes through the valve assembly. The prosthetic device (e.g., an anchoring member, a valve support, or another portion of the prosthetic device) may define the perimeter substantially surrounding the flow path, such that the spatial positioning of the echogenic member around the defined perimeter may assist a clinician in assessing the orientation of the flow path when the clinician views an image of the prosthetic device within the heart.

[0045] In examples, as mentioned above, the echogenic member is a series of individual echogenic markers arranged around the defined perimeter. An individualechogenic marker may be a discrete image marker configured to interact with the transmitted energy of an imaging system. The individual echogenic markers can be separated from an adjacent echogenic marker. For example, the individual image marker may substantially reside on the defined perimeter and be separated from a nearest neighboring image marker by an arc-length of the defined perimeter. As an example, an individual image marker may be separated by an arc-length defined by a subtending angle of about 30 degrees, 45 degrees, 90 degrees, or some other subtending angle. Stated similarly, each individual echogenic marker in the plurality of image markers may define a closed boundary defining one or more spatial parameters of the individual image marker, such as a length, a surface area, a volume, and / or another spatial parameter. Individual echogenic markers may be arranged around the perimeter defined by the prosthetic device such that each closed boundary of an echogenic marker is displaced from every other closed boundary of the other echogenic markers.

[0046] The echogenic member, whether as an echogenic brim, a plurality of echogenic markers, a portion of the prosthetic device itself, or a combination of these, may be configured to enhance the imaged visibility of the prosthetic device while accommodating the space considerations present when operating in a human heart. For example, in some examples, the prosthetic device may be configured such that the defined perimeter is substantially surrounded by the annular wall of a native heart valve when the fixation structure grips the annular wall. The prosthetic device may mechanically support the echogenic member such that the echogenic member extends substantially from the defined perimeter in an upstream direction of the prosthetic device toward an upstream portion of the prosthetic device (e.g., extend in a direction opposite the blood flow through the valve assembly). In examples, an echogenic member may include a first end mechanically coupled to the perimeter of the prosthetic device (e.g., defined by an anchoring member, a valve support, or another portion) and a second end substantially opposite the first end. The prosthetic device may mechanically support the echogenic member such that the second end extends in the upstream direction of the prosthetic device, such that a radial extension of the echogenic member beyond the defined perimeter is limited. Further, this may allow the echogenic member to position and / or extend in a direction away from tissue interfaces (e.g., the annular wall), enhancing the visual clarity of the image markers relative to the tissue interfaces and providing for clarity and / or enhanced assessment of aprosthetic device deployment.

[0047] In some examples, the echogenic member may be configured to extend radially. The echogenic member may be configured to extend inwards toward the valve axis when supported by the prosthetic device, extend outward away from the valve axis, or both. For example, an echogenic marker or echogenic brim may have an angled, curved, or curvilinear portion. This may provide beneficial imaging angles to an imaging system when the prosthetic device is positioned within and / or in the vicinity of an annulus of a native heart valve. This may also assist is displacing at least some portion of the echogenic member from tissues within the heart, enhancing the visual clarity of the image markers relative to the tissue interfaces and providing for clarity and / or enhanced assessment of a prosthetic device deployment.

[0048] Any of the echogenic member configurations described herein may be used in combination with each other. That is, the plurality of echogenic markers, coatings or textures applied to one or more portions of the prosthetic device, an echogenic brim, or any of the various features from each example prosthetic device may be included in any prosthetic device described herein except where mutually exclusive.

[0049] The echogenic member described herein may enable a reduction in a length of the prosthetic device in the delivery configuration. The reduction in the length of the prosthetic device in the delivery configuration may enable a reduction in the required length of a capsule configured to carry the prosthetic device to a treatment site. A reduced length of the capsule may ease navigation and / or maneuvering of the capsule through a patient’s vasculature. For example, when the prosthetic device is configured to replace a native tricuspid valve, a shorter capsule length may ease the navigation and / or maneuvering of the capsule through shorter and more difficult anatomical structures such as chordae, papillary muscles, and structures of the right ventricle. The shorter capsule length may broaden the population of patients eligible to receive transcatheter tricuspid valve replacement, since the anatomical dimensions and / or shape of the right ventricle in some patients may be too short or shaped in a way that might limit navigation of the capsule to the annulus of the native heart valve the prosthetic device is configured to replace.

[0050] In examples, the disclosure provides a prosthetic device configured to enhance the visibility (e.g., echogenic visibility) of the prosthetic device to an imaging systemwhen the prosthetic device is within the heart of a patient. In some examples, the imaging system is an ultrasound probe configured to produce an image using acoustic energy. The prosthetic device may include echogenic member configured to reflect acoustic waves at incident angles substantially defined by a location of the ultrasound probe during a valve replacement procedure (e.g., when the ultrasound probe is located within or in the vicinity of the esophagus of a patient).

[0051] FIG. 1A illustrates a portion of an example delivery system 10 for delivering an example prosthetic device 12 (“device 12”) to a target site within a heart 14. Delivery system 10 includes a delivery catheter 16 supporting a capsule 18, with delivery catheter16 extending from a lumen defined by a guide catheter 20. FIG. 1A illustrates device 12 in a delivery configuration within capsule 18, where capsule 18 constrains device 12 against radial expansion. FIG. IB illustrates delivery system 10 with device 12 an expanded configuration, where capsule 18 has been withdrawn such that capsule 18 provides substantially no constraint on the radial expansion of device 12.

[0052] For the purpose of illustration, FIG. 1A and FIG. IB illustrate delivery system 10 positioning the device 12 in a native mitral valve MV of heart 14 using a trans-apical delivery approach. In some examples, device 12 may be configured to be placed in a native tricuspid valve using a transcatheter percutaneous delivery system. Other approaches may be utilized, such as a trans-septal delivery approach.

[0053] Referring to FIG. 1A, guide catheter 20 is positioned in a trans-apical opening17 to provide access to the left ventricle LV. Delivery catheter 16 extends through guide catheter 20 such that a distal portion 22 of a catheter body 23 projects beyond a distal end 26 of guide catheter 20. Capsule 18 may then be positioned between a posterior leaflet PL and an anterior leaflet AL of mitral valve MV. Using a control unit (not pictured), catheter body 23 may be moved in the distal direction (as indicated by arrow D), the proximal direction (as indicated by arrow P), and / or rotated along a longitudinal axis of catheter body 23 to position capsule 18 at a desired location and orientation within the opening of mitral valve MV (or another native heart valve within heart 14).

[0054] At the target location, capsule 18 (e.g., capsule housing 28) may be at least partially retracted (e.g., in the proximal direction P) to deploy device 12 from capsule 18. Delivery system 10 may be configured such that withdrawal of capsule housing 28 displaces at least some portion of capsule housing 28 from device 12, such that device 12may be deconstrained and expand into the expanded configuration of FIG. IB. In some examples, device 12 may define a delivery radius defined as the displacement between a valve axis (L, FIG. 2A) and a perimeter defined by device 12 while device 12 is in capsule housing 28 in FIG. 1A. In some examples, device 12 may define an expanded radius defined as the displacement between valve axis (L, FIG. 2A) and the perimeter defined by device 12 while device 12 is in the expanded configuration of FIG. IB. In some examples, the expanded radius may be greater than the delivery radius.

[0055] In some examples, capsule 18 may include an end cap 30 at the distal end of a capsule housing 28 of capsule 18. In some examples, capsule 18 may be open-ended at the distal end of capsule housing 28. In some examples, capsule 18 may be configured to circumferentially surround at least part of device 12. In the illustrated example of FIG. IB, device 12 may be deployed from capsule 18 by drawing capsule housing 28 proximally (e.g., further into the left ventricle LV) and, optionally, moving end cap 30 distally (e.g., further into the left atrium LA). As device 12 exits capsule housing 28, device 12 may expand radially to secure the device 12 in an annulus of a native heart valve (e.g., the annulus of mitral valve MV).

[0056] As will be discussed further, device 12 includes echogenic member 24. In the illustrated example of FIG. IB, echogenic member 24 includes a plurality of echogenic markers 32, such as echogenic marker 34, echogenic marker 35, and echogenic marker 36 (“echogenic markers 34, 35, 36”). In other examples described below, the echogenic member 24 includes an echogenic brim, and in still other examples echogenic member 24 may include a portion of device 12. Echogenic markers 34, 35, 36 may be configured to provide imaging feedback (e.g., echogenic feedback) to assist in positioning device 12 at a target location within heart 14 before, during, and / or after deployment of device 12. Echogenic member 24 is capable of reflecting an acoustic wave, such that echogenic member 24 may be captured by an ultrasound imaging system, as will be further described below. Although discussed below mainly with reference to echogenic marker 34, descriptions below may additionally describe echogenic marker 35, echogenic marker 36, of any other echogenic markers in the plurality of echogenic markers.

[0057] Echogenic marker 34 is configured to reflect and or otherwise interact with energy transmitted by an imaging system (not shown) configured to transmit energy (e.g., acoustic energy as sound waves) to produce an image. In examples, echogenic marker 34is configured to interact with the transmitted energy to enhance a visual distinction from one or more structures of the heart 14 in the resulting image. The visual distinction enabled by echogenic marker 34 may assist a clinician in assessing a position and / or orientation of device 12 during and / or following a deployment of device 12 within heart 14. In the illustrated example of FIG. IB, the plurality of echogenic markers 32 and / or echogenic markers 34, 35, 36 may not be drawn to scale.

[0058] In examples, device 12 is configured to mechanically support echogenic marker 34 in a manner that helps to limit or even prevent the extension of echogenic marker 34 into a chamber of heart 14 (e.g., the left atrium LA) when device 12 is in the expanded configuration and implanted to extend through an annulus of a native heart valve. Limiting the extension of echogenic marker 34 reduce a length of device 12 when in the delivery configuration, and may enable a reduction in the length of capsule 18. A reduced length of capsule 18 may ease navigation and / or maneuvering of the capsule. In some examples, where capsule 18 and / or distal portion 22 of catheter body 23 define a relatively stiff section of delivery catheter 16, the reduced length of capsule 18 may allow a length of the relatively stiff section to be reduced by up to 5 millimeters (mm), 8mm, 10 mm, or more. This may increase the maneuverability of delivery catheter 16 within heart 14, opening certain medical procedures to a wider patient population. For example, percutaneous transcatheter replacement of a tricuspid valve may involve turning capsule 18 over an angle of about ninety degrees for placement. A reduced length of capsule 18 and the relatively stiff section of delivery catheter 16 may be of benefit to patients who might otherwise be candidates for a medical procedure (e.g., transcatheter tricuspid valve replacement), but have an anatomy that will not accommodate a catheter system with a relatively long stiff section.

[0059] The examples provided are described herein with reference to devices, systems, and methods for positioning and deploying a prosthetic heart valve to a native mitral valve or tricuspid valve. However, other applications and other embodiments in addition to those described herein are within the scope of the present technology. For example, at least some embodiments of the present technology may be useful for delivering and deploying prosthetics to other native valves such as the aortic valve or pulmonary valve.

[0060] FIG. 2A illustrates a perspective view of portions of device 12 of FIGS. 1A and IB illustrated in an expanded configuration. FIG. 2B is a cross-sectional view of device 12in an expanded configuration, with the cross-section taken through valve axis L. FIG. 2C is atop plan view of device 12 in an expanded configuration supporting a plurality of echogenic markers 32 including echogenic markers 34, 35, 36. Device 12 includes a valve support 38, anchoring member 40 attached to the valve support 38, and a prosthetic valve assembly 42 (“valve assembly 42”) within the valve support 38. Anchoring member 40 may be coupled to (e.g., attached) to valve support 38. Valve assembly 42 may be coupled to valve support 38 (illustrated, for example, in FIG 3A and / or FIG 3B). In examples, valve support 38 mechanically supports valve assembly 42. In some examples, device 12 defines a valve axis L intersecting valve assembly 42. In some examples, valve support 38 and / or anchoring member 40 surround some portion of valve axis L.

[0061] In examples, device 12 (e.g., anchoring member 40 and / or brim 534 (FIG. 6A)) is configured to expand radially outward from a delivery configuration (e.g., when housed within capsule 18 (FIG. 1A)) to the expanded configuration depicted in FIG. IB and FIGS. 2A-2C. Device 12 may be configured to expand radially outward to substantially grip an annulus of a native heart valve when, for example, device 12 transitions from the delivery configuration to the expanded configuration. Device 12 (e.g., anchoring member 40) may be configured to expand radially to accommodate (e.g., substantially conform to) a perimeter of the annulus of the native heart valve when device 12 is in the expanded configuration. In examples, anchoring member 40 is configured to expand radially outward from valve support 38 to establish a gap G between anchoring member 40 and valve support 38. Gap G may define a radial displacement relative to valve axis L. In some examples, the radial displacement is substantially perpendicular to valve axis L. In some examples, anchoring member 40 is configured to define an anchoring delivery radius relative to valve axis L when device 12 is in the delivery configuration and an anchoring expanded radius relative to valve axis L when device 12 is in the expanded configuration, and the anchoring delivery radius is less than the anchoring expanded radius.

[0062] In examples, valve support 38 is a substantially rigid member configured to retain its shape (e.g., define a substantially constant radius around valve axis L) when anchoring member 40 expands radially outward. In some examples, valve support 38 may be configured to expand radially outward when anchoring member 40 expands radially outward. In some examples, valve assembly 42 may be configured to expand radially when valve support 38 and / or anchoring member 40 expands radially.

[0063] Referring to FIG. 2B, valve support 38 includes an inflow region 44 and an outflow region 46. In examples, device 12 defines a downstream direction (e.g., the direction of the arrows BF) extending from the inflow region 44 toward the outflow region 46 and an upstream direction (e.g., substantially opposite the direction of arrows BF) extending from outflow region 46 toward inflow region 44. The downstream direction and / or upstream direction may be substantially parallel to valve axis L. In examples, inflow region 44 defines an inlet 48 of valve support 38 (“valve support inlet 48”). Outflow region 46 may define an outlet 50 of valve support 38 (“valve support outlet 50”). In examples, device 12 is configured to define a flow path for blood flow (BF) from valve support inlet 48 to valve support outlet 50.

[0064] Valve assembly 42 is configured to be supported within the valve support 38 to allow blood to flow through device 12 in the downstream direction (e.g., from valve support inlet 48 to valve support outlet 50). In examples, valve assembly 42 is configured to allow blood flow through device 12 in the downstream direction, but limit and / or substantially prevent blood flow through device 12 in the upstream direction. In examples, device 12 is configured such that valve assembly 42 controls substantially all blood flow through device 12 when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve.

[0065] For example, device 12 may include a first sealing member 52 configured define the flow path through valve support 38. First sealing member 52 may be configured to substantially direct blood flow from valve support inlet 48 to valve support outlet 50. In examples, first sealing member 52 is configured to limit and / or substantially prevent a flow of blood through valve support 38 in a radial direction away from valve axis L. Device 12 may include a second sealing member 54 configured to limit and / or substantially prevent a flow of blood through anchoring member 40. Device 12 may be configured such that, when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve, first sealing member 52 and second sealing member 54 cause substantially all blood flow (e.g., all or nearly all to the extent permitted by the material from which sealing members 52, 54 are formed) passing through device 12 to flow through valve assembly 42. In examples, when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve, first sealing member 52, second sealing member 54, and valve assembly 42 allow blood flow throughdevice 12 in the downstream direction (e.g., from inflow region 44 to outflow region 46), while limiting and / or substantially preventing blood flow through device 12 in the upstream direction e.g., from outflow region 46 to inflow region 44). Device 12 may be configured such that, when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve, inflow region 44 is fluidically coupled to a first chamber (e.g., an atrium) of heart 14 (FIG. 1), and outflow region 46 is fluidically coupled to a second chamber (e.g., a ventricle) of heart 14.

[0066] Device 12 includes a fixation structure 56 configured to engage with tissue to help secure device 12 in a heart of a patient. In some examples, fixation structure 56 may be a portion of anchoring member 40. For example, fixation structure 56 can be configured to grip an annular wall of a native heart valve when device 12 is positioned within an annulus of the native heart valve and device 12 is in the expanded configuration. Fixation structure 56 may be configured to secure device 12 within the annulus of the native heart valve, such that valve assembly 42 may allow blood to flow from inflow region 44 through outflow region 46. Device 12 may be configured to cause valve assembly 42 to substantially position within or in the vicinity of the annulus when fixation structure 56 grips the annular wall, such that valve assembly 42 allows blood to flow along a flow path substantially parallel to valve axis L (e.g., from inflow region 44 to outflow region 46). In examples, fixation structure 56 includes a plurality of fixation elements 58 (e.g., barbs, hooks, cleats, tines, or other elements) configured to engage tissue of heart 14. In examples, the plurality of fixation elements 58 are configured to engage an annular wall of a native heart valve when device 12 is positioned within an annulus of the native heart valve and device 12 is in the expanded configuration.

[0067] Device 12 includes echogenic member 24, which includes plurality of echogenic markers 32. Echogenic marker 34 is configured to aid in identifying device 12 within heart 14 via medical imaging. For example, echogenic marker 34 may be configured to enhance an image of device 12 captured by an imaging system 60 (FIG. 2B), such that an approximate location of device 12 within heart 14 may be assessed by a clinician. In examples, the echogenic member 24 (e.g., echogenic markers 34, 35, 36) may be located at one or more fixed locations on device 12, such that an approximate orientation of device 12 within heart 14 may be assessed using imaging system 60. In examples, as will be discussed, echogenic marker 34 is configured to reflect and orotherwise interact with energy transmitted (e.g., the energy E (FIG. 2B)) by imaging system 60 to enhance a visual distinction from one or more structures of the heart 14 in a resulting image produced by imaging system 60. The visual distinction enabled by echogenic marker 34 may assist a clinician in assessing a position and / or orientation of device 12 during and / or following a deployment of device 12 within heart 14.

[0068] In examples described herein, device 12 is configured to mechanically support echogenic marker 34 such that echogenic marker 34 is displaced from (e.g., substantially does not contact) tissue when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve. In some examples, echogenic marker 34 may be hyperechogenic, meaning that a relatively large amount of energy E transmitted by device 60 is reflected back to imaging system 60 by echogenic marker 34 than is reflected by other portions of device 12 or other sensed materials. However, some heart tissue, such as calcified tissue, may be similarly hyperechogenic as echogenic marker 34. Displacing echogenic marker 34 may increase a visibility (e.g., an echogenic visibility) of echogenic marker 34 in a resulting image of device 12 and portions of heart 14 produced by imaging system 60. For example, because an ultrasound image may display tissue in the same color (e.g., white) as echogenic markers 34, 35, 36, echogenic marker 34 configured to displace from tissue (e.g., not contact tissue) when device 12 is positioned or being positioned within heart 14 may help echogenic marker 34 stand out from other structures of heart 14 (e.g., contrast with blood and / or tissues, which may be dark or black in color) on the resulting image (e.g., an ultrasound image). In examples, echogenic marker 34 has an echogenicity greater than an echogenicity of another portion of device 12. For example, echogenic marker 34 may have an echogenicity greater than an echogenicity of anchoring member 40, an echogenicity of valve support 38, an echogenicity of fixation structure 56 and / or fixation elements 58, an echogenicity of first sealing member 52 and / or second sealing member 54, and / or an echogenicity of valve assembly 42.

[0069] In some examples, device 12 is be configured to mechanically support echogenic marker 34 such that at least some portion of echogenic marker 34 is displaced from other portions of device 12 (e.g., anchoring member 40, valve support 38, fixation elements 58, and others) when device 12 is in the expanded configuration. This may assist the visibility (e.g., echogenic visibility) of echogenic marker 34 when the other parts (e.g., anchoring member 40, valve support 38, fixation elements 58) have limited visibility in aresulting image generally, or when the other parts have limited visibility when positioned near (e.g., adjacent to) a tissue wall. In some examples, echogenic 34 may be disposed proximate inflow region 44.

[0070] In examples, device 12 is configured to limit a radial extension (e.g., relative to valve axis L) of echogenic marker 34 at least when device 12 is in the expanded configuration. For example, device 12 may be configured to mechanically support echogenic marker 34 such that a radial extension of echogenic marker 34 beyond anchoring member 40 is substantially limited or even prevented. In some examples, device 12 is configured to mechanically support echogenic marker 34 such that echogenic marker 34 do not extend radially beyond anchoring member 40 (e.g., beyond a perimeter defined by anchoring member 40) when device 12 is positioned within the annulus of a native heart valve. This may assist in displacing echogenic marker 34 from tissue of heart 14 when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve.

[0071] In some examples, echogenic marker 34 extends from anchoring member 40 and / or valve support 38. In some examples, echogenic marker 34 is configured to extend from device 12 (e.g., from anchoring member 40 and / or valve support 38) in the upstream direction of device 12 (e.g., a direction substantially opposite the arrows BF) at least when device 12 is in the expanded configuration. In addition to or instead of the upstream direction, in some examples, echogenic marker 34 or another echogenic marker 35, 36 is configured to extend from device 12 (e.g., from anchoring member 40 and / or valve support 38) in a downstream direction of device 12 (e.g., a direction substantially opposite the arrows BF) at least when device 12 is in the expanded configuration. Device 12 may mechanically support echogenic marker 34 on any portion of device 12. For example, device 12 may mechanically support echogenic marker 34 such that echogenic marker 34 is laterally positioned (e.g., positioned relative to a point on axis L) substantially upstream (relative to the arrows BF) of inflow region 44, laterally positioned substantially downstream of outflow region 46, and / or laterally positioned substantially between inflow region 44 and outflow region 46.

[0072] In examples, device 12 mechanically supports the plurality of echogenic markers 24 (e.g., echogenic markers 34, 35, 36) such that echogenic markers 34, 35, 36 are spatially positioned around a perimeter defined by device 12. For example, device 12may mechanically support echogenic markers 34, 35, 36 such that echogenic markers 34, 35, 36 are spatially positioned around a perimeter Pl defined by anchoring member 40. Device 12 may mechanically support echogenic markers 34, 35, 36 such that echogenic markers 34, 35, 36 are spatially positioned around a perimeter P2 defined by valve support 38. In some examples, device 12 may mechanically support echogenic markers 34, 35, 36 such that echogenic markers 34, 35, 36 are spatially positioned around a brim perimeter defined by a valve brim (e.g., brim perimeter PB1, brim perimeter PB2, and or another brim perimeter defined by valve brim 534 (FIG. 6A)). In examples, device 12 is configured such that the defined perimeter (e.g., perimeter Pl and / or perimeter P2) is substantially surrounded by the annular wall of a native heart valve when fixation structure 56 grips the annular wall. In examples, device 12 defines the perimeter around the flow path provided by first sealing member 52, second sealing member 54, and valve assembly 42. In examples, device 12 defines the perimeter around valve axis L. The spatial positioning of echogenic markers 34, 35, 36 around a defined perimeter (e.g., perimeter Pl and / or perimeter P2) may assist a clinician in assessing the orientation of device 12 relative to other structures of the heart when the clinician views an image of device 12 (e.g., an image generated by imaging system 60) within heart 14. In some examples, perimeter Pl and / or perimeter P2 may be a planar perimeter. In some examples, perimeter Pl and / or perimeter P2 may be a non-planar perimeter.

[0073] Device 12 may define the perimeter around any portion of device 12. In examples, the perimeter is a closed boundary extending around some portion of device 12 (e.g., anchoring member 40 and / or valve support 38). In some examples, the perimeter is an outer perimeter (along an outer surface of device 12). In some examples, the defined perimeter is a substantially planar perimeter, such that the perimeter substantially lies within a geometric plane (e.g., lies in the geometric plane or nearly fully lies in the geometric plane to the extent permitted by manufacturing tolerances). In some examples, the defined perimeter is a nonplanar perimeter, such that portions of the defined perimeter may lie in different geometric planes. In some examples, the defined perimeter is substantially perpendicular to valve axis L.

[0074] In some examples, device 12 is configured to mechanically support echogenic markers 34, 35, 36 in a manner enabling a reduction in a length of device 12 in the delivery configuration and / or the expanded configuration. For example, device 12 mayenable a reduction in length compared to a prosthetic device configured to extend a brim supported by and / or substantially encircling anchoring member 40, valve support 38, or another portion of device 12. In examples, device 12 mechanically supports one or more of echogenic markers 34, 35, 36 such that echogenic markers 34, 35, 36 extend from a defined perimeter (e.g., perimeter Pl and / or perimeter P2) in an upstream direction of device 12 (e.g., extend in a direction substantially opposite the arrows BF). In some examples, one or more of echogenic markers 34, 35, 36 (e.g., echogenic marker 36) includes a first end 62 mechanically coupled to a portion of device 12 (e.g., anchoring member 40, valve support 38, or another portion) and a second end 64 substantially opposite the first end. Device 12 may mechanically support the echogenic marker such that second end 64 extends away from first end 62 in the upstream direction of device 12 to, for example, limit a radial extension of the echogenic marker. In some examples, device 12 mechanically supports one or more of echogenic markers 34, 35, 36 such that an echogenic marker extends from a defined perimeter (e.g., perimeter Pl and / or perimeter P2) in a downstream direction of device 12 (e.g., extends in a direction substantially the same as the arrows BF). Device 12 may mechanically support the echogenic marker such that second end 64 extends away from first end 62 in a downstream direction of device 12.

[0075] In examples, echogenic marker 34 is configured to present angles to imaging system 60 to enhance a resulting image. The displayed angles may enhance an image generated by an ultrasound probe as sound waves leave the ultrasound probe, reflect from echogenic marker 34, and return to the ultrasound probe to generate an image. For example, imaging system 60 may be a transesophageal probe (e.g., positioned in the esophagus of a patient) such as an ultrasound probe. In examples, echogenic marker 34 may be shaped to increase the imaging feedback (e.g., increase an echogenic signal returned by echogenic marker 34 when image from a particular angle. In some examples, as illustrated, echogenic marker 34 may define a shape configured to reflect energy E back to imaging system E throughout a range of incidence angles of energy E. One such shape is the illustrated hemisphere. In some examples, each echogenic marker 34, 35, 36 may be substantially similar to each other echogenic marker 34, 35, 36 (e.g., similar shape and size). Alternatively in some examples, at least two echogenic markers 34, 35 may define a different shape and or a different size. The size and or shape may be selectively tailored based on the expected position of the respective echogenic marker 34 relative to imagingsystem 60. For examples, echogenic marker 34 may define a surface at a substantially perpendicular angle to energy beam E, such that energy E may be reflected back to imaging system 60.

[0076] In examples, anchoring member 40 includes a plurality of anchoring member struts 66, such as anchoring member strut 68 and anchoring member strut 70. In examples, anchoring member struts 68, 70 are configured to urge device 12 (e.g., anchoring member 40) from the delivery configuration to the expanded configuration when an element constraining the radial expansion of device 12 (e.g., capsule 18 (FIGS 1A-1B)) is at least partially displaced from device 12. Anchoring member struts 68, 70 may be resiliently biased to expand radially outward from valve axis L. In examples, anchoring member struts 68, 70 are configured to urge device 12 from the delivery configuration to the expanded configuration to cause device 12 to substantially fit into the annulus of a native heart valve. In examples, anchoring member struts 68, 70 are elongated members configured to substantially define a shape of anchoring member 40 in the expanded configuration and / or delivery configuration. In some examples, anchoring member struts 68, 70 may be joined to define one or more cells such as cell 72. For example, anchoring members 68, 70 may be joined to define one or more acute angles and / or obtuse angles defining cell 72. In examples, cell 72 is a substantially diamond-shaped cell. Anchoring member struts 68, 70 may be configured such that a size of cell 72 is variable, such that an expansion of cell 72 allows anchoring member struts 68, 70 to expand radially outward as device 12 transitions from the delivery configuration to the expanded configuration. In examples, anchoring member struts 68, 70 mechanically support other portions of device 12, such as fixation structure 56, second sealing member 54, and / or other portions of device 12. In examples, device 12 is configured such that the plurality of anchoring member struts 66 substantially surround valve axis L, valve support 38, valve assembly 42, and / or valve axis L.

[0077] Valve support 38 may include a plurality of valve support struts 74, such as valve support strut 76 and valve support strut 78. Valve support struts 76, 78 may be substantially elongated members configured to substantially define a shape of valve support 38 (e.g., in the expanded configuration and / or delivery configuration). In some examples, valve support struts 76, 78 may be joined to define one or more cells such as cell 80. For example, valve support struts 76, 78 may be joined to define one or moreacute angles and / or obtuse angles defining cell 80. In examples, cell 80 is a substantially diamond-shaped cell. Valve support struts 76, 78 may be configured to mechanically support other portions of device 12, such as valve assembly 42, second sealing member 54, and / or other portions of device 12.

[0078] In examples, device 12 is configured such that valve support 38 and / or anchoring member 40 surround valve axis L at when device 12 is in the expanded configuration. In examples, valve support 38 includes a substantially tubular member (e.g., tubular, or nearly tubular to the extent permitted by manufacturing tolerances). Valve support 38 (e.g., valve support struts 76, 78) may define one or more upstream crowns 82 at a first end 84 of valve support 38 (“first valve support end 84”). Valve support 38 (e.g., valve support struts 76, 78) may define one or more downstream crowns 86 defining a second end 88 of valve support 38 (“second valve support end 88”) opposite first valve support end 84. Anchoring member 40 (e.g., anchoring member struts 68, 70) may define one or more upper crowns 90 defining a first end 92 of anchoring member 40 (“first anchoring end 92”). Anchoring member 40 (e.g., anchoring member struts 68, 70) may include one or more lower crowns 94 defining a second end 96 of anchoring member 40 (“second anchoring end 96”) opposite first anchoring end 92. Anchoring member 40 may include and / or mechanically support fixation structure 56. Fixation structure 56 may include a first portion 102 (“first fixation portion 102”) and a second portion 104 (“second fixation portion 104’). Fixation structure 56 may be configured such that first fixation portion 102 is substantially between first anchoring end 92 and second fixation portion 104. Fixation structure 56 may be configured such that second fixation portion 104 is substantially between second anchoring end 96 and first fixation portion 102. In examples, fixation structure 56 (e.g., first fixation portion 102 and / or second fixation portion 104) defines a substantially annular shape surrounding valve axis L. In examples, fixation structure 56 defines a substantially annular shape surrounding valve support 38 and / or valve assembly 42.

[0079] In examples, the perimeter Pl is a perimeter defined by one or more portions of device 12. For example, perimeter Pl may be defined by one or more first anchoring ends such as first anchoring end 92, one or more upper crowns such as upper crown 90, and / or one or more anchor support struts such as anchoring member struts 68, 70. Device 12 may define perimeter Pl by mechanically supporting the one or more first anchoring ends, theone or more upper crowns, and / or the one or more anchor support struts such that the one or more first anchoring ends, the one or more upper crowns, and / or the one or more anchor support struts position on the perimeter P 1. In some examples, the perimeter P 1 may be a substantially contiguous component of device 12 (e.g., a component at least partially surrounding valve axis L). In some examples, perimeter Pl may be defined by one or more second anchoring ends such as second anchoring end 96 and / or one or more lower crowns such as lower crown 94.

[0080] In examples, the perimeter P2 is a perimeter defined by one or more portions of device 12. For example, perimeter P2 may be defined by one or more first valve support ends such as first valve support end 84, one or more upstream crowns such as upstream crown 90, and / or one or more valve support struts such as valve supports struts 76, 78. Device 12 may define perimeter P2 by mechanically supporting the one or more first valve support ends and / or the one or more upstream crowns such that the one or more first valve support ends and / or the one or more upstream crowns position on the perimeter P2. In some examples, the perimeter P2 may be a substantially contiguous component of device 12 (e.g., a component at least partially surrounding valve axis L). Device 12 may define the perimeter Pl by mechanically supporting one or more other portions of device 12 such that the other portions of device 12 position on the perimeter Pl, such as other portions of valve support 38. Device 12 may define the perimeter P2 by mechanically supporting one or more other portions of device 12 such that the other portions of device 12 position on the perimeter P2, such as other portions of anchoring member 40 and / or fixation structure 56. In some examples, perimeter Pl may be defined by one or more second anchoring ends such as second anchoring end 96 and / or one or more lower crowns such as lower crown 94. In some examples, perimeter P2 may be defined by one or more second valve support ends such as second valve support end 88 and / or one or more downstream crowns such as downstream crown 86.

[0081] In examples, echogenic marker 34 extends from upper crowns 90 of anchoring member 40. Additionally, or alternatively, in some examples, echogenic marker 34 may extend from upstream crown 90 of valve support 38. In some examples, echogenic marker 34 may extend from other portions of device 12, such as from downstream crown 86, lower crown 94, a suitable location on valve support 38 between first valve support end 84 and second valve support end 88, a suitable location on anchoring member 40 betweenfirst anchoring end 92 and second anchoring end 96, or some other portion of device 12. For examples, where device 12 does not include crowns, echogenic marker 34 may extend from an upstream edge and / or a downstream edge of device 12. As discussed previously, device 12 may be configured to expand radially from a delivery configuration to an expanded configuration when deployed at a target site within heart 14 (FIG. 1A-1B). Other states, representing stages of partial deployment, may exist between the delivery configuration and the expanded configuration, such as a partially expanded state wherein capsule 18 (FIG. 1A-1B) is positioned to allow an initial radial expansion of device 12 while continuing to constrain device 12 from further expansion.

[0082] In examples, anchoring member 40 includes a base 106 attached to outflow region 46 of valve support 38. In some examples, second anchoring end 96, second valve support end 88, downstream crowns 86, and / or lower crowns 94 are joined with and / or define base 106. In examples, the plurality of anchoring member struts (e.g., anchoring member struts 68, 70) define a plurality of arms 108 projecting radially outward (relative to valve axis L) from base 106. Fixation structure 56 may extend from arms 108. In examples, fixation structure 56 is configured such that, when device 12 is in the expanded configuration (as shown, for example, in FIGS. 2, 3A, 3B), fixation structure 56 and / or anchoring member 40 is spaced radially outward apart from valve support 38 by the gap G. When prosthetic heart valve is in a delivery configuration (FIG. 1A), gap G may be reduced or substantially eliminated. In examples, fixation structure 56 includes a ring (e.g., a cylindrical or conical ring). Fixation structure 56 may define an engagement surface 110 configured to press outwardly against the native annulus. In examples, engagement surface 110 mechanically supports a plurality of fixation elements 58 projecting radially outward from engagement surface 110. In examples, one or more of fixation elements 58 may be inclined toward an upstream direction (e.g., inclined in a direction from outflow region 46 to inflow region 44). The fixation elements 58, for example, can be barbs, hooks, cleats, tines, or other elements configured to engage tissue when device 12 is in the expanded configuration within heart 14.

[0083] In examples, device 12 is configured such that first valve support end 84 is displaced by a displacement C from first anchoring end 92 when device 12 is in the expanded configuration. The displacement C may be substantially parallel to the valve axis L. In examples, first valve support end 84 is displaced from first anchoring end 92 ina direction from outflow region 46 toward inflow region 44. In some examples, first valve support end 84 is displaced from first anchoring end 92 in a direction from inflow region 44 toward outflow region 46. The displacement C may be any displacement. In some examples, as indicated in FIG 2B, the displacement C may be substantially zero (subject to manufacturing and / or other tolerances), such that first valve support end 84 is substantially even with first anchoring end 92 when device 12 is in the expanded configuration.

[0084] In examples, anchoring member 40 includes a smooth bend 112 (FIG. 2B) defining a transition between arms 108 and fixation structure 56. In examples, second fixation portion 104 extends from arms 108 substantially at smooth bend 112. Arms 108 and fixation structure 56 can be formed integrally from a continuous strut or support element such that smooth bend 112 is a bent portion of the continuous strut. In other embodiments, smooth bend 112 may be a separate component with respect to either the arms 108 or the fixation structure 56. For example, smooth bend 112 may be attached to arms 108 and / or fixation structure 56 using a weld, adhesive or other technique. In examples, smooth bend 112 is configured to ease a recapture of device 12 by capsule 18 (FIG. 1A-1B) or other container after the device 12 has been at least partially deployed.

[0085] First sealing member 52 is configured to limit (e.g., substantially reduce) blood flow in a radial direction (e.g., substantially perpendicular to valve axis L) through valve support 38. Second sealing member 54 is configured to limit blood flow in a radial direction (e.g., substantially perpendicular to valve axis L) through anchoring member 40. In examples, first sealing member 52 and / or second sealing member 54 may be made from a flexible material, such as Dacron® or another type of polymeric material. In some examples, second sealing member may be a cotton fabric, which may be filled with one or more other materials as will be further described below. First sealing member 52 may substantially cover (e.g., be in contact with) an interior surface of valve support 38 facing valve axis L and / or an exterior surface of valve support 38 facing away from valve axis L. Second sealing member 54 may substantially cover (e.g., be in contact with) an interior surface of anchoring member 40 facing valve axis L and / or an exterior surface of anchoring member 40 facing away from valve axis L. In some examples, first sealing member 52 is attached to valve assembly 42. In examples, second sealing member 54 is attached to anchoring member 40 such that fixation elements 58 are uncovered by second sealing member 54, such that, for example, fixation elements 58 may engage tissue whendevice 12 is in the expanded configuration.

[0086] Device 12 may be configured to replace any native heart valve. In examples, device 12 may be configured to replace a previously implanted prosthetic heart valve. In examples, valve assembly 42 includes one or more leaflets configured to control a flow of blood through device 12, such as leaflet 43. Valve assembly 42 may comprise any suitable number of leaflets (e.g., three leaflets for a prosthetic tricuspid valve). Leaflet 43 and or other portions of valve assembly 42 may be movable from a closed position in which blood flow from the inflow region to the outflow region is blocked and an open position in which blood flow in a direction from the inflow region to the outflow region is allowed.

[0087] Echogenic marker 34 may be configured such that at least some portion of echogenic marker 34 extends inward toward valve axis L when device 12 mechanically supports echogenic marker 34. In some examples, the portion of echogenic marker 34 is configured such that a radial extension of echogenic marker 34 beyond anchoring member 40 is substantially limited at least when device 12 is in the expanded configuration. In some examples, the portion of echogenic marker 34 is configured such that echogenic marker 34 does not extend radially beyond anchoring member 40 at least when device 12 is in the expanded configuration. This may assist in displacing echogenic marker 34 from tissue of heart 14 when device 12 is in the expanded configuration and positioned within an annulus of a native heart valve.

[0088] As illustrated in FIG. 2C, in examples, each individual echogenic marker in the plurality of echogenic markers 32 (regardless of a location of the individual echogenic marker on device 12) may define a closed boundary defining one or more spatial parameters of the individual image marker. The spatial parameter may be, for example, a length, a surface area, a volume, and / or another spatial parameter. For example, echogenic marker 34 may define a closed boundary Bl defining one or more the spatial parameters of echogenic marker 34, Echogenic marker 35 may define a closed boundary B2 defining one or more spatial parameters of echogenic marker 35. Individual echogenic markers (e.g., echogenic markers 34, 35, 36) may be mechanically supported by device 12 such that each closed boundary of an image marker is displaced from every other closed boundary of an image marker. The plurality of echogenic markers 32 spatially arranged on device 12 (e.g., on perimeter Pl and / or perimeter P2) may enhance the ability of a clinician to assess the position and / or orientation of device 12 within heart 14 using animage generated by imaging system 60.

[0089] Device 12 may be configured to mechanically support echogenic markers 34, 35, 36 on a defined perimeter (e.g., perimeter Pl and / or perimeter P2) such that echogenic markers 34, 35, 36 are separated from an adjacent echogenic marker positioned on the perimeter by any suitable subtending angle (e.g., a subtending angle having a vertex on longitudinal axis L). In examples, an individual echogenic marker of echogenic member 24 may extend from one or more of or each upper crown, lower crown, upstream crown, and / or downstream crown of device 12. In some examples, a first echogenic marker may extend from a first crown on a perimeter and a second echogenic marker may extend from a second crown on the perimeter, and one or more additional crowns on the perimeter which do not support an echogenic marker may be between the first crown and the second crown. In other words, any two adjacent markers (e.g., echogenic marker 34 and echogenic marker 35) may be spaced apart from each other by one or more crowns that do not mechanically support an echogenic marker. In some examples, anchoring member 40 and / or valve support 38 may not include crowns, and echogenic member 24 may be attached to an upstream edge or a downstream edge of either or both anchoring member 40 or valve support 38.

[0090] In some examples, device 12 is configured to mechanically support echogenic markers 34, 35, 36 of echogenic member 24 such that echogenic markers 34, 35, 36 are spaced apart at substantially equal intervals about a defined perimeter of device 12 (e.g., symmetrically, such that each imaging member on a perimeter defines a substantially equal subtending angle with an adjacent imaging member on the perimeter). In some examples, device 12 is configured to mechanically support echogenic markers 34, 35, 36 such that a first spacing between an echogenic marker on the perimeter and a first adjacent echogenic marker on the perimeter is different from a second spacing between the echogenic marker and a second adjacent echogenic marker on the perimeter (e.g., when the echogenic marker is between the first adjacent echogenic marker and the second adjacent echogenic marker). Hence, echogenic markers 34, 35, 36 may be spaced apart at any suitable interval.

[0091] In some examples, reducing the interval by which adjacent echogenic markers are spaced apart, and / or including more echogenic markers about a defined perimeter of device 12, may reduce a need to rotate device 12 about valve axis L in order to achievesufficient visibility (e.g., echogenic visibility) of device 12. In examples, echogenic markers 34, 35, 36 may be spaced apart from an adjacent echogenic marker to define a subtending angle between approximately 10 and 90 radial degrees. In some examples, echogenic markers 34, 35, 36 are spaced apart from an adjacent echogenic marker to define a subtending angle of about 15 degrees, about 30 degrees, about 45 degrees, or some other subtending angle.

[0092] FIG. 3 is a conceptual side view of device 12. Device 12 of FIG. 3 may be generally described similarly to device 12 of FIGS. 1A-2C, differing as described below. Similar reference characters indicate similar elements. Device 12 includes echogenic member 224, which is an example of echogenic member 24. In the example of FIG. 3, echogenic member 224 of FIG. 3 includes one or more rivets, such as rivet 234 and / or rivet 235. Rivet 234, 235 may include a substantially elongate member extending through a member of device 12, such as through an upstream crown of upstream crowns 82, an upper crown of upper crowns 90, a lower crown of lower crowns 94, anchoring member strut 68, and / or valve support strut 74. In examples, rivet 234, 235 provides one or more out-of-plane surfaces with the member of device 12 when rivet 234, 235 extends through the member of device 12. The out-of-plane surfaces may enhance an echogenic visibility of rivet 234, 235 and / or a region of device 12 which includes rivet 234, 235. In examples, the member of device 12 defines an access extending through the member, and rivet 234, 235 extends through the access.

[0093] Rivets 234 and 235 may be formed as rivets through upstream crowns 90 of anchoring member 40. Rivets 234 and 235 of echogenic member 224 may be a different material than anchoring member 40. For instance, rivets 234 and 235 may include titanium or another hyperechogenic material when compared to the materials forming anchoring member 40. Stated similarly, rivets 234 and / or 235 may include one or more materials having an echogenicity greater than an echogenicity of one or more materials comprising anchoring member 40, valve support 38, valve assembly 42, fixation structure 56, a valve brim (e.g., brim 534 (FIG. 6A)), and / or another portion of device 12. Accordingly, echogenic member 224 may provide for enhanced echogenic visibility of device 12, even without the added size and bulk of a brim. As such, acoustic shadowing may be minimized in some examples.

[0094] In some examples, rivets 234 and 235 may provide out-of-plane surfaces(illustrated as dark hemispheres in FIG. 3), which may enhance visibility by reflecting energy 3 (FIG. 2B) at a number of angles. For example, anchoring member 40 may define a thickness Tl, and rivet 234 may extend radially beyond thickness T1 toward valve axis L or away from valve axis L. Thickness Tl may be a cross-sectional dimension (e.g., a cross-sectional dimension substantially perpendicular to valve axis L). Although illustrated as hemispheres, in some examples echogenic markers 234 and 235 may include one or more flat surfaces extending radially beyond thickness Tl of anchoring member 40 that are disposed at a selected angle relative to the position of imaging system 60 (FIG. 2B). For example, rivet 234 and / or rivet 235 may include a rectilinear shape such as a square, an octagon, an irregular or curvilinear shape, or combinations thereof.

[0095] For example, FIG. 12 illustrates a front view of a member 236 including a body 237 (“member body 237”) defining a first surface 238 (“first member surface 238”) and a second surface 239 (“second member surface 239”). FIG. 13 illustrates a side view of member 236. In examples, first member surface 238 is opposite second member surface 239, such that member body 237 is between and separating first member surface 238 and second member surface 239. Member body 237 defines an access 240 which extends through member body 237. In examples, access 240 extends through member body 237 from first member surface 238 to second member surface 239.

[0096] Rivet 234 may be configured to extend through access 240. For example, rivet 234 may include a body 247 (“rivet body 247’) extending through access 240. In examples, when rivet 234 extends through access 240, rivet body 247 substantially defines a protrusion extending from first member surface 238 and / or second member surface 239. For example, a first portion 243 of rivet body 247 may define a surface 241 (“first rivet surface 241”) configured to extend out of access 240 and in a direction away from first member surface 238 when rivet 234 extends through access 240. A second portion 244 of rivet body 247 may define a surface 242 (“second rivet surface 242”) configured to extend out of access 240 and in a direction away from second member surface 239 when rivet 234 extends through access 240.

[0097] Rivet 234 may be configured such that movement of rivet body 247 relative to member body 237 is substantially limited and / or constrained when rivet body 247 extends through access 240. In some examples, first portion 243 may define a first rivet head configured to limit and / or substantially prevent first portion 243 from entering access 240,such that, for example, movement of first portion 243 toward first member surface 238 is substantially limited. For example, first portion 243 may define a cross-sectional dimension which limits and / or substantially prevents first portion 243 from entering access 240. In some examples, second portion 244 may define a second rivet head configured to limit and / or substantially prevent second portion 244 from entering access 240, such that, for example, movement of second portion 244 toward second member surface 239 is substantially limited. In some examples, rivet body 247 may be attached to an inner surface of member body 237 defining a boundary of access 240 by, for example, welding, soldering, an adhesive, a fastener, or some other method. In some examples, rivet body 247 is configured to establish an interference fit with the inner surface defining the boundary of access 240 to substantially limit and / or constrain movement of rivet body 247 relative to member body 237. In examples, rivet 234 is a substantially separate component attached to member 236. In some examples, rivet 234 and member 236 are substantially unitary members, such that rivet 234 defines one portion of a unitary body and member 236 defines a second portion of the unitary body.

[0098] Rivet 234 may be configured to define one or more out-of-plane surfaces relative to member 236 to enhance an echogenic visibility of rivet 234 and / or member 236. For example, first member surface 238 may define a plane PL-A and first rivet surface 241 may define a plane PL-B. For example, plane PL-A may be defined by a vector defined by (e.g., substantially lying within some portion of) first member surface 238. Plane PL-B may be defined by a vector defined by (e.g., substantially lying within some portion of) first rivet surface 241. Plane PL-B may be nonparallel to plane PL-A, such that an intersection of plane PL-B and plane PL-A define a dihedral angle. In some examples, the dihedral angle is about 90 degrees. In some examples, the dihedral angle is less than 90 degrees, in some examples less than 80 degrees, in some examples less than 60 degrees, and in some examples less than 30 degrees.

[0099] Rivet 234 may define a cross-sectional area defining any shape. The crosssection area may be, for example, substantially parallel to first member surface 238 and / or substantially perpendicular to first rivet surface 241. In examples, the cross-sectional area defines a curved, curvilinear, or polygonal boundary. For example, the cross-sectional area may define a substantially circular or oval-shaped boundary. In some examples, rivet 234 is configured to provide a plurality of surfaces which are out-of-plane with first membersurface 238. For example, FIG. 13 illustrates a side view of member 236 with a rivet 245 extending through access 240 and defining a polygonal boundary (e.g., a hexagon). Rivet 245 defines first rivet surface 241 out-of-plane with member 236 and a second rivet surface 246 out-of-plane with member 236. Rivet 245 is an example of rivet 234.

[0100] Although illustrated as rivets 234 and 235 through upstream crowns 90 in FIG. 3, echogenic member 224 (e.g., rivets 234, 235) may include rivets disposed elsewhere on device 12. For example, echogenic member 224 may be disposed, in addition to or alternatively, through one or more of downstream crowns 86 or elbows where anchoring member struts (68, 70, FIG. 2A) interface or elbows where valve support struts (76, 78, FIG. 2A) interface. In examples where device 12 does not include crowns, echogenic member 224 may include rivets through a body or other portion of device 12, such as through one or more anchoring member struts (e.g., anchoring member strut 68), one or more of valve support struts (e.g., valve support strut 74), and / or other portions of device 12.

[0101] FIG. 4 is a conceptual side view of device 12. Device 12 of FIG. 4 may be generally described similarly to device 12 of FIGS. 1A-3, differing as described below. Similar reference characters indicate similar elements. In the example of FIG. 4, device 12 includes a portion 334 defining echogenic member 324. Echogenic member 324 is an example of echogenic member 24. Portion 334 (e.g., echogenic member 324) may be a portion of anchoring member 40 and / or valve support 38 that has different echogenic properties than the remainder of anchoring member 40, valve support 38, and / or another portion of device 12. For example, as illustrated, portion 334 may be a portion of anchoring member 40 proximate inflow region 44. Portion 334 may cover upper crowns 90 and / or upstream crowns 82. In examples, portion 334 and extends at least part way towards base 106 (e.g., extends in the downstream direction of device 12). In some examples, portion 334 may include first fixation portion 102 as described above. In some examples, portion 334 may be defined near inflow region 44 of device 12 and include first anchoring end 92 and / or first valve support end 84.

[0102] In examples, portion 334 is a coated and / or covered portion of device 12. In examples, echogenic member 324 includes a material coating and / or covering the portion of device 12. For example, echogenic member 324 may coat and / or cover the portion of device 12 such that at least a portion of echogenic member 324 is between the portion ofdevice 12 and the flow path for blood flow (BF) defined by device 12. In examples, the portion of echogenic member 324 fluidically isolates the portion of device 12 and the flow path for blood flow (BF) defined by device 12.

[0103] In examples, portion 334 extends around at least some portion of a perimeter defined by device 12 (e.g., perimeter Pl, perimeter P2, brim perimeter PB1, and / or brim perimeter PB2). Echogenic member 324 may coat and / or cover substantially all or some portion of portion 334 when portion 334 extends around the at least some portion of the perimeter. For example, FIG. 15 illustrates device 12 with anchoring member 40 (e.g., upper crown 90, an upper crown 91, and an upper crown 93) defining perimeter Pl. Upper crown 90 may include end 93, upper crown 91 may include end 95, and upper crown 93 may include end 97. First anchoring end 92 may include one or more of end 93, end 95, and / or end 97. Portion 334 includes upper crown 90, upper crown 91, and upper crown 93, and extends at least partially around perimeter Pl .

[0104] Portion 334 further includes echogenic member 324. In the example of FIG. 15, echogenic member includes one or more of member portion 99 coating and / or covering upper crown 90, member portion 101 coating and / or covering upper crown 91, and / or member portion 103 coating / and / or covering upper crown 93. In examples, member 99 coats and / or covers a portion of upper crown 90 substantially between end 93 and first fixation portion 102 of fixation structure 56. In some examples, member 99 extends substantially from end 93 and extends in the downstream direction defined by device 12.

[0105] Member portion 101 may be configured with respect to upper crown 91 and / or member portion 103 may be configured with respect to upper crown 93 in substantially the same manner as member portion 99 is configured with respect to upper crown 90. In examples, first member portion (e.g., one of member portion 99, member portion 101, and member portion 103) is discrete from (e.g., substantially separated from) a second member portion (e.g., another of member portion 99, member portion 101, and member portion 103). For example, the first member portion may extend over a first section of perimeter Pl and the second member portion may extend over a second portion of perimeter Pl separate from the first section. In some examples, the first member portion is substantially connected and / or attached to the second member portion, such that the first section of perimeter Pl and the second section of perimeter Pl define a continuous portion of perimeter Pl.

[0106] Although depicted as a coating and / or covering on upper crown 91, upper crown 93, and upper crown 95 in FIG. 15, echogenic member 324 may include one or more member portions such as member portions 99, 101, 103 on any portion of device 12, such as one or more lower crowns (e.g., lower crown 94), one or more upstream crowns (e.g., upstream crown 82), one or more downstream crowns (e.g., downstream crown 86), one or more anchoring member struts (e.g., anchoring member strut 68), one or more of valve support struts (e.g., valve support strut 74), and / or other portions of device 12. In examples, echogenic member 324 is configured such that member portions 99, 101, 103 are limited and / or substantially constrained from movement relative to device 12. In examples, member portions 99, 101, 103 are substantially attached to device 12 by an interface boundary between member portions 99, 101, 103 and device 12, or by welding, soldering, an adhesive, a fastener, or some other method.

[0107] Portion 334 may be configured to alter echogenic properties of anchoring member 40 relative to uncoated and / or uncovered portions of anchoring member 40. For examples, portion 334 may be hyperechogenic, such that visibility of portion 334 on an image (e.g., by imaging system 60 of FIG. 2B) may be improved. In some examples, portion 334 may be coated and / or covered with an echogenic coating such as Sono-Coat™ material, available from Encapson Company. Coated and / or covered in this way, portion 334 may appear as relatively brighter on an ultrasound image than another portion of device 12, allowing a clinician to view and adjust the position and / or orientation of portion 334 during a medical procedure.

[0108] In examples, portion 334 (e.g., echogenic member 324) includes an echogenic filler material. For example, portion 334 may include titanium, bioglass or another echogenic filler material configured to make portion 334 more visible on an ultrasound image. In some examples, the echogenic filler material comprises a plurality of beads or other discrete particles.

[0109] In some examples, in addition to or alternative to inclusion of an echogenic coating and / or covering, portion 334 may be a textured portion of anchoring member 40. Portion 334 may be textured to increase echogenic visibility of portion 334. In some examples, portion 334 defines a substantially smooth surface finish configured to provide a substantially specular reflection when imaged by imaging system 60 (FIG. 2B). The smooth surface finish may be a surface finish configured to reflect incident energy (e.g.,an echogenic sound wave) in substantially a single direction from the surface. The smooth surface finish may enhance the return of transmitted energy (e.g., acoustic energy) to imaging system 60. The surface may be smoothed by polishing, grinding, other abrasive methods, and / or other surface smoothing techniques. As such, in examples, portion 334 may have a specular reflectance greater than a specular reflectance of another portion of device 12, such as one or more portions or substantially all of anchoring member 40, one or more portions or substantially all of valve support 38, one or more portions or substantially all of valve assembly 42 and / or surrounding tissues of the heart. In examples, portion 334 (e.g., echogenic member 324) includes a surface having a first surface roughness and the portion of device 12 includes a surface having a second surface roughness greater than the first surface roughness. In some examples, the first surface roughness is less than 80% of the second surface roughness, in some examples less than 50% of the second surface roughness, and in some examples less than 20% of the second surface roughness.

[0110] In other examples, in addition to or instead of a smooth surface finish, portion 334 defines a substantially rough surface finish configured to provide a substantially diffuse reflection when imaged by imaging system 60. A diffuse reflection will reflect an incident acoustic wave at many angles. As such, portion 334 may include a surface finish configured to reflect incident energy (e.g., a sound wave) at many angles from the surface. Portion 334 may be configured to provide a more diffuse reflection than (e.g., have a specular reflectance less than) another portion of device 12, such as one or more portions or substantially all of anchoring member 40, one or more portions or substantially all of valve support 38, one or more portions or substantially all of valve assembly 42 and / or surrounding tissues of the heart. The rough surface may enhance the return of transmitted energy (e.g., acoustic energy) to imaging system 60 over a variety of imaging angles between the surface and imaging system 60. The surface may be roughened by bead blasting, sandblasting, media blasting, and / or other surface roughening techniques. In examples, portion 334 (e.g., echogenic member 324) includes a surface having a third surface roughness and the portion of device 12 includes a surface having a fourth surface roughness less than the third surface roughness. In some examples, the fourth surface roughness is less than 80% of the third surface roughness, in some examples less than 50% of the third surface roughness, and in some examples less than 20% of the third surfaceroughness.[oni] In some examples, portion 334 may include a combination of both smooth surface finishes and rough surface finishes tailored to improve echogenic properties of device 12.

[0112] In examples, anchoring member 40 (e.g., anchoring member struts 68, 70) and / or valve support 38 (e.g., valve support struts 76, 78) comprises a metal and / or other material defining a first cross-sectional dimension (e.g., a first cross-sectional dimension substantially perpendicular to valve axis L). Echogenic member 324, whether present as portion 334, member 24 or 224, or as an echogenic brim (described below) may comprise a metal, a polymeric material, a fabric, and / or other material defining a second cross- sectional dimension (e.g., a second cross-sectional dimension substantially perpendicular to valve axis L). The second cross-sectional dimension may be less than, equal to, or higher than the first cross-sectional dimension. In some examples, echogenic member 324 (e.g., portion 334 of FIG. 4) may be substantially thinner than at least some portion of anchoring member 40 and / or at least some portion of valve support 38. In some examples, echogenic member 324 (e.g., portion 334 of FIG. 4) may be substantially thicker than at least some portion of anchoring member 40 and / or at least some portion of valve support 38. Portion 334 may be made thinner than the portions of anchoring member 40 and / or valve support 38 by grinding, swaging, other thinning or stretching processes, or attaching portion 334 to anchoring member 40 or valve support 38 as a substantially separate component. Portion 334 may be made thicker that the portions of anchoring member 40 and / or valve support 38 by coating portion 334, or by another process.

[0113] FIG. 5 is a conceptual side view of device 12. Device 12 of FIG. 5 may be generally described similarly to device 12 of FIGS. 1A-4, differing as described below, where similar reference characters indicate similar elements. In the example of FIG. 4, echogenic member 424 includes a ring 434 formed around all or part of perimeter Pl of anchoring member 40. Echogenic member 424 is an example of echogenic member 24, 324. Ring 434 may be defined around perimeter Pl as a rolled fabric in some examples. For example, where device 12 includes second sealing member 54 configured to limit and / or substantially prevent a flow of blood through anchoring member 40, an extra length of second sealing member 54 extending upstream of first end 92 of anchoring member 40 may be rolled to form ring 434. In some examples, ring 434 may be crimped with theframe during manufacturing. Crimping may be a term for packing device 12 into the deployment configuration of FIG. 1A. In some instances, the fabric of second sealing member 54 may include an echogenic filler, or an echogenic filler may be added to and included with ring 434. For example, ring 434 may include titanium, bioglass or another echogenic filler material configured to make continuous ring 434 more visible on an ultrasound image. In some examples, echogenic filler material may be included as a plurality of beads (e.g., a string of beads). In examples which include beads as echogenic filler material, forming continuous ring from a rolled fabric may enable use of larger beads for increased echogenic visibility as the tube can be pulled distal during crimping.

[0114] In examples, ring 434 extends around some portion of or substantially all of a perimeter defined by device 12 (e.g., perimeter Pl and / or perimeter P2). As an example, FIG. 16 illustrates a perspective view of device 12 including ring 434. Ring 434 extends around perimeter Pl defined by upper crowns 90. In examples, ring 434 comprises some portion of second sealing member 54. In some examples, ring 434 may extend at least partially around perimeter P2 defined by upstream crowns 82 and / or another perimeter defined by device 12. In examples, ring 434 may comprise some portion of first sealing member 52. In examples, ring 434 is configured to cover some portion of device 12 such that at least a portion of ring 434 is between the portion of device 12 and the flow path for blood flow (BF) defined by device 12. The portion of device 12 may be, for example, one or more of upper crowns 90, one or more of upstream crowns 82, one or more of lower crowns 94, one or more of downstream crowns 86, and / or another portion of device 12. In examples, at least a portion of ring 434 fluidically isolates the portion of device 12 and the flow path for blood flow (BF) defined by device 12.

[0115] Ring 434 may reduce acoustic shadowing relative to other prosthetic devices. As such, ring 434 may allow echogenic visibility of device 12 while also allowing visibility of native structures of the heart, because the ring 434 may be a relatively small band. Although illustrated as rolled fabric extending radially away from valve axis L from anchoring member 40, ring 434 need not be rolled fabric. In some examples ring 434 may be a band which includes echogenic material. In some examples, ring 434 may surround a downstream end of anchoring member 40 near base 106, another portion of anchoring member 40, or a portion of valve support 38.

[0116] For example, FIG. 17 illustrates a perspective view of device 12 including aring 435 supported by anchoring member 40. Ring 435 is an example of ring 434. Ring 435 includes a body 437 (“ring body 437”) extending at least partially around a perimeter defined by device 12. Although depicted in FIG. 17 as extending around perimeter Pl, ring 435 may extend at least partially around any perimeter (e.g., perimeter P2, brim perimeter PB1, brim perimeter PB2) defined by device 12. In examples, ring body 437 is supported by at least one of anchoring member 40 or valve support 38 (FIG. 5). Device 12 may support ring body 437 such that movement of ring 435 relative to anchoring member 40 and / or valve support 38 is substantially limited when device 12 is in the expanded configuration. In examples, ring body 437 may be a substantially separate component from another portion of ring 12 (e.g., anchoring member 40 and / or valve support 38) and coupled to the other portion of device 12. Ring body 437 may be coupled to (e.g., fastened to) the other portion by, for example, welding, soldering, an adhesive, a fastener, or some other method. In some examples, ring body 437 is configured as a unitary component with another portion of device 12, such as anchoring member 40 and / or valve support 38.

[0117] For example, ring body 437 may be supported by upper crowns 90 and / or upstream crowns 82 (FIG. 5). Ring body 437 may be supported by lower crowns 94 and / or downstream crowns 86 (FIG. 5). In examples, ring body 437 is supported by one or more anchoring member struts such as anchoring member strut 68, one or more valve support struts such as valve support strut 74, brim structure 661 (FIG. 7), and / or another portion of device 12.

[0118] FIG. 6A illustrates a perspective view of portions of device 12 in an expanded configuration. FIG. 6B is a cross-sectional view taken along valve axis L defined by device 12. Device 12 of FIGS. 6A and 6B may be generally described similarly as device 12 of FIGS. 1A-5, differing as described below. Similar reference characters indicate similar elements. Device 12 of FIGS. 6A and 6B includes a brim 534. In examples, brim 534 is an echogenic member. Brim 534 may be an example of echogenic member 24.

[0119] Brim 534 is configured to reflect and or otherwise interact with energy transmitted by an imaging system (not shown) configured to transmit energy (e.g., acoustic energy as sound waves) to produce an image. In examples, brim 534, like the other echogenic member described above, is configured to interact with the transmitted energy to enhance a visual distinction from one or more structures of the heart 14 in the resulting image. The visual distinction enabled by brim 534 may assist a clinician inassessing a position and / or orientation of device 12 during and / or following a deployment of device 12 within heart 14. In the illustrated example of FIGS. 6A and 6B, brim 534 may not be drawn to scale.

[0120] In examples, device 12 is configured to mechanically support brim 534. For example, as illustrated, brim 534 may attached to anchoring member 40 of device 12. In some examples, brim 534 may be attached to valve support 38, and / or attached to another portion of device 12. Brim 534 may be configured to extend radially outward away from valve axis L when device 12 is in the expanded configuration (e.g., when anchoring member 40 engages the annulus). The dimensions and angle of brim 534 relative to valve axis L may be tailored similarly as described above with respect to echogenic markers to enhance positioning and deployment accuracy of device 12.

[0121] In some examples, as mentioned, device perimeter Pl which surrounds anchoring member 40 may define the perimeter to which brim 534 is attached. As such, brim 534 may define brim perimeter PB1 at a brim first end 555. Brim 534 may define brim perimeter PB2 at a brim second end 557 defined by brim 534 opposite brim first end 555. In some examples, brim 534 may be configured such that brim PB2 is displaced radially outward of PB1 (e.g., radially outward relative to valve axis L) when device 12 is in the expanded state, as illustrated. Configured in this way, brim 534 may assist in seating device 12 within an annulus of the heart. Additionally, the illustrated configuration, which positions brim 534 at an acute angle relative valve axis L, may displace at least a portion of brim 534 from surrounding tissue.

[0122] In examples, brim 534, brim perimeter PB1, and / or brim perimeter PB2 at least partially surround valve axis L when device 12 is in the expanded configuration. In some examples, brim 534, brim perimeter PB1, and / or brim perimeter PB2 define a closed boundary (e.g., a substantially circular or oval shaped boundary) surrounding valve axis L when device 12 is in the expanded configuration. Some portion of brim 534 (e.g., brim first end 555 and / or a portion defining brim perimeter PB1) may be coupled to device 12. In examples, brim 534 is coupled to a portion of anchoring member 40 (e.g., upper crowns 90). Further, although depicted in FIG. 6A as defining a substantially planar perimeter relative to valve axis L (e.g., a substantially circular perimeter), in some examples, as discussed below, brim perimeter PB2 may be configured to define wavy perimeter, a scalloped perimeter, or some other shaped perimeter at least partially surrounding valveaxis L when device 12 is in the expanded configuration. In examples, when device 12 is in the expanded configuration, brim perimeter PB2 is displaced from anchoring member 40 and / or brim perimeter PBlin the upstream direction defined by device 12.

[0123] FIG. 7 illustrates a portion of device 12 which includes echogenic member 24 as brim 634. FIG. 18 illustrates a schematic perspective view of device 12 including brim 634. Device 12 may generally be described similarly to device 12 of FIGS. 1A-6B above, where similar reference numerals indicate similar elements. Likewise, brim 634 may be generally may generally be described similarly to brim 534 of FIGS. 6A and 6B, differing as described below. In examples, brim 634 is an echogenic member. Brim 634 may be an example of brim 534 and / or echogenic member 24. In some examples, as illustrated, brim 634 may define a shape configured to improve echogenic visibility.

[0124] For example, brim 634 may define a plurality of void areas 665. Void areas 665 may be areas between the points of greatest distance of brim first end 655 and second brim end 657 that are not covered by brim material. For example, brim 634 may be shaped such that brim perimeter PB2 defines a substantially wavy and / or scalloped shape at least partially surrounding valve axis L. Brim 634 may be configured such that the substantially wavy and / or scalloped shape of brim perimeter PB2 defines a series of wave crests and wave troughs (e.g., relative to brim perimeter PB1) as brim perimeter PB2 at least partially surrounds valve axis L. Brim 634 may be configured to define void area 665 as a space (e.g., a substantially empty space) between a first crest defined by brim perimeter PB2, an adjacent second crest defined by brim perimeter PB2, and a trough defined by brim perimeter PB2 and separating the first crest and the second crest. In this way, void areas 665 may substantially limit and / or reduce occlusion of acoustic energy by brim 634, thus substantially limiting and / or reducing acoustic shadowing of brim 634. In some examples, void areas 665 may be disposed proximate second brim end 657. Additionally, or alternatively, void areas 665 may be slots or apertures through brim 634 (e.g., through a brim material 663) configured to limit acoustic shadowing, allowing for ultrasound waves to more effectively pass through brim 634 to enhance a visibility of native tissue when device 12 is located within a heart. In some examples, brim 634 may define a sinusoidal shape at second brim end 657.

[0125] In examples, brim 634 defines a radius R extending from brim perimeter PB 1 to brim perimeter PB2. The radius R may extend over, for example, a shortest distancebetween brim perimeter PB1 and brim perimeter PB2. In examples, the radius R is substantially coplanar with valve axis L. In some examples, for example as depicted in FIG. 6A, a displacement defined by radius R may be substantially constant as brim 634 at least partially or substantially completely surrounds valve axis L. In some examples, for example as depicted in FIG. 7, the displacement defined by radius R may vary as brim 634 at least partially or substantially completely surrounds valve axis L. For example, when brim 634 defines a series of wave crests and wave troughs, radius R may define a first displacement at one or more crests of brim 634 and a define a second displacement less than the first displacement at one or more troughs of brim perimeter PB2.

[0126] In examples, brim 634 comprises a brim fabric 663 substantially extending from brim perimeter PB1 to brim perimeter PB2. Brim material 663 may be, for example, a fabric or type of other material). Brim material 663 may be configured such that an upstream boundary 664 of brim material 663 (e.g., an upstream edge of brim material 663) at least partially defines the substantially wavy and / or scalloped shape of brim perimeter PB2. Upstream boundary 664 may define the series of wave crests and wave troughs (e.g., relative to brim perimeter PB1) as brim perimeter PB2 at least partially surrounds valve axis L. In examples, brim material 663 is configured such that upstream boundary 664 defines void area 665 between a first crest defined by upstream boundary 664, an adjacent second crest defined by upstream boundary 664, and a trough defined by upstream boundary 664 and separating the first crest of upstream boundary 664 and the second crest of upstream boundary 664. In examples, brim material 663 (e.g., upstream boundary 664) defines the radius R.

[0127] In examples, brim material 663 defines a downstream boundary 667. Brim material 663 may be configured to extend from downstream boundary 667 to upstream boundary 664. In examples, downstream boundary 667 is coupled to (e.g., fastened to) second sealing member 54 (e.g., coupled by sewing, an adhesive, or some other method). In some examples, brim material 663 comprises an upstream portion of second sealing member 54. For example, at least a portion of brim material 663 and at least a portion of second sealing member 54 may form a substantially unitary component, such that a material defining second sealing member 54 and brim material 663 extends as a continuous member from the portion of second sealing member 54 to the portion of brim material 663 (e.g., extends over downstream boundary 667). In examples, upstreamboundary 664 defines at least some portion of brim perimeter PB1. Brim 634 may be configured such that upstream boundary 663 is displaced radially outward of downstream boundary 667 (e.g., radially outward relative to valve axis L) when device 12 is in the expanded state. In examples, when device 12 is in the expanded configuration, upstream boundary 664 is displaced from anchoring member 40 and / or downstream boundary 667 in the upstream direction defined by device 12.

[0128] In examples, brim 634 includes a brim structure 661. Brim structure 661 may include a metal or other rigid material. In examples, brim structure 661 is configured to mechanically support brim material 663. For example, brim structure 661 may be configured to mechanically support brim material 663 as brim material 663 extends from brim perimeter PB1 to brim perimeter PB2. In examples, brim structure 661 configured to enable and / or cause upstream boundary 664 to position radially outward (e.g., relative to valve axis L) of downstream boundary 667 when device 12 transition from the delivery configuration to the expanded configuration when an element constraining the radial expansion of device 12 (e.g., capsule 18 (FIGS 1A-1B)) is at least partially displaced from device 12. In examples, brim structure 661 is configured to rotate and / or otherwise alter its orientation relative to relative to valve axis L when device 12 transitions from the delivery configuration to the expanded configuration. In some examples, brim structure 661 is resiliently biased to expand radially outward from valve axis L when device 12 transitions from the delivery configuration to the expanded configuration. Brim structure 661 may be coupled to and / or supported by another portion of device 12, such as anchoring member 40 and / or valve support 38.

[0129] In examples, brim structure 661 includes one or more brim struts such as brim strut 669 and brim strut 673. Brim struts 669, 673 may be substantially elongate members configured to substantially define a shape of brim 634 in the expanded configuration and / or delivery configuration. In examples, brim strut 669 is coupled to brim strut 673, such that brim strut 669 and brim strut 673 define a substantially continuous portion of brim structure 661. In some examples, brim strut 669 and brim strut 673 are joined to define a unitary portion of brim structure 661. In some examples, brim strut 669, brim strut 673, and one or more other brim struts such as brim strut 675 define a substantially continuous portion (e.g., a unitary portion) of brim structure 661 extending at least partially around valve axis L. In some examples, brim structure 661 (e.g., brim strut 669,brim strut 673, brim strut 675, and other brim struts of brim structure 661) is a unitary member extending at least partially or substantially completely around valve axis L. Brim struts 669, 673, 675 may be configured to expand radially outward (e.g., relative to valve axis L) as device 12 transitions from the delivery configuration to the expanded configuration.

[0130] Brim structure 661 may support brim material 663 in any manner relative to brim struts 669, 673. In some examples, brim structure 661 is configured such that brim material 663 is substantially atop (e.g., displaced in the upstream direction defined by device 12) brim struts 669, 673 when device 12 is in the expanded configuration. In some examples, brim structure 661 is configured such that brim material 663 is substantially beneath (e.g., displaced in the downstream direction defined by device 12) brim struts 669, 673 when device 12 is in the expanded configuration. In some examples, brim structure 661 is configured such that brim struts 669, 673 are substantially sandwiched (e.g., enveloped) by brim material 663, such that a first layer of brim material 663 is atop brim struts 669, 673 and a second layer of brim material 663 is beneath brim struts 669, 673 when device 12 is in the expanded configuration.

[0131] Brim material 663 may include any suitable fabric including a polymeric or natural fiber. In some examples, brim material 663 may include a knitted fabric with properties in circumferential direction which may be more compliant and may allow for better crimping, and thus less fabric bulk when device 12 is in the delivery configuration. In examples, brim material 663 may be the same material as sealing member 52 or sealing member 54, or may be a different material. In some examples, brim material 663 may be omitted, and brim 634 may consist of brim structure 661, which may provide both echogenic visibility and reduce acoustic shadowing. In some examples, as discussed further below, brim material 663 may include a material configured to provide bulk for echogenic visibility and / or compressibility such that brim 634 may be crimped for a small footprint during deployment. For example, brim material 663 may include an animal- derived tissue, such as bovine pericardium tissue. Brim material 663 may include a foam, such as at least one of a low-density foam, an intermediate density foam, or a high-density foam. The foam may be selected based at least partially on both the echogenic requirements and compressible packing requirements of the application.

[0132] In examples, brim 634 may support one or more brim wires configured to enhance an echogenic visibility of brim 634. For example, as illustrated by FIG. 8, brim 634 may include one or more brim wires such as brim wire 671 supported by brim 634. In examples, brim 634 supports brim wire 671 over an area between and / or including brim perimeter PB1 and brim perimeter PB2.

[0133] In some examples, brim wire 671 may define a wave-like shape, such as a substantially sinusoidal shape or another shape. The wave-like shape may define a series of peaks and valleys. The wave-like shape may aid in recognition of brim wire 671 on an image (e.g., an ultrasound image) due to the recognizable shape, while also being better suited to crimping than a solid brim. In examples, brim wire 671 defines a radius R1 extending over brim 634 from brim wire 671 to brim perimeter PB1. The radius R1 may extend over, for example, a shortest distance between brim wire 671 and brim perimeter PB1. In examples, the radius R1 is substantially coplanar with valve axis L. In some examples, for example as depicted in FIG. 8, the displacement defined by radius R1 may vary as brim wire 671 at least partially or substantially completely surrounds valve axis L. For example, when brim wire 671 defines a series of peaks and valleys, radius R1 may define a first displacement at one or more peaks of brim wire 671 and a define a second displacement less than the first displacement at one or more valleys of brim wire 671. In some examples, a displacement defined by radius R1 may be substantially constant as brim wire 671 at least partially or substantially completely surrounds valve axis L. In examples, brim wire 671 defines a substantially sinusoidal shape.

[0134] Brim 634 may support brim wire 671 and brim material 663 in any manner relative to each other. In some examples, brim 634 is configured such that brim wire 671 is substantially atop (e.g., displaced in the upstream direction defined by device 12) brim material 663 when device 12 is in the expanded configuration. In some examples, brim 634 is configured such that brim wire 671 is substantially beneath (e.g., displaced in the downstream direction defined by device 12) brim material 663 when device 12 is in the expanded configuration. In some examples, brim wire 671 is substantially sandwiched (e.g., enveloped) by brim material 663, such that a first layer of brim material 663 is atop brim wire 671 and a second layer of brim material 663 is beneath brim wire 671 when device 12 is in the expanded configuration.

[0135] In examples, brim 634 may support a plurality of wires over the area between and / or including brim perimeter PB1 and brim perimeter PB2. For example, FIG. 19 illustrates a portion of device 12 with brim 634 supporting a plurality of brim wires 677 (“brim wires 677”) including brim wire 671 and a brim wire 679. Brim wire 679 may define a second series of peaks and valleys which are substantially offset from the peaks and valleys defined by brim wire 671. The offset may aid in recognition of brim wire 671 and brim wire 679 on an image (e.g., an ultrasound image). In examples, brim wire 679 defines a substantially sinusoidal shape. In examples, brim 634 is configured such that the sinusoidal shape defined by brim wire 679 is out-of-phase with a sinusoidal shape defined by brim wire 671. For example, brim wire 671 may define a first substantially sinusoidal shape having a first periodicity and brim wire 679 may define a second substantially sinusoidal shape having a second periodicity different from the first periodicity. Brim wire 671 may define the first substantially sinusoidal shape having a first amplitude and brim wire 679 may define the second substantially sinusoidal shape having a second amplitude different from the first amplitude. Brim wires 677 may include any number of brim wires in addition to and configured similarly to brim wire 671 and / or brim wire 679.

[0136] Brim wire 679 may define the second series of peaks and valleys in a manner similar to brim wire 671. For example, brim wire 679 may define a radius R2 extending over brim 634 from brim wire 679 to brim perimeter PB 1. The radius R2 may extend over a shortest distance between brim wire 679 and brim perimeter PB1, and / or may be substantially coplanar with valve axis L. When brim wire 679 defines the second series of peaks and valleys, radius R2 may define a first displacement at one or more peaks of the second series and a define a second displacement less than the first displacement at one or more valleys of the second series. In some examples, a displacement defined by radius R2 may be substantially constant as brim wire 679 at least partially or substantially completely surrounds valve axis L. Brim wire 671 and / or brim wire 679 may include metal or another hyperechogenic material.

[0137] In examples, a thickness (e.g., the gauge) of brim wire 671 and / or brim wire 679 may be tailored or tuned for echo visualization. In some examples, the thicknesses of brim wire 671 and brim wire 679 may differ to enhance echo visualization. For example, brim wire 671 may define a first thickness (e.g., a first gauge) and brim wire 679 may define a second thickness (e.g., a second gauge) different from the first thickness. Otherbrim wires which may be included in wires 677 may define thicknesses substantially similar to or different from the first thickness and / or the second thickness.

[0138] In some examples, as depicted in FIG. 9, a brim 734 may define a series of scallops 776 at a second brim end 757, such that brim 734 may define a scalloped shape. Each of scallops 776 may, in some examples, correspond to a peak of an underlying brim wire. For example, FIG. 20 depicts brim 734 including brim wire 671 defining the first series of peaks and valleys and brim wire 679 defining the second series of peaks and valleys. Brim 734 may be configured such that brim material 663 extends from brim perimeter PB2 to a one or more of peaks in the first series and one or more peaks in the second series. In examples, brim material 663 extends from brim perimeter PB2 to substantially all of the peaks in the first series and the peaks in the second series. Brim 734 is an example of brim 634, 624 and echogenic member 24.

[0139] FIG. 10 is a conceptual side-view illustrating an example device 12. Device 12 of FIG. 10 includes echogenic member 824 which includes brim 834. As such, device 12 may generally be described similarly to device 12 of FIG. 6A-6B. However, in the illustrated example of FIG. 10, brim 834 may include a material configured to both provide bulk for echogenic visibility and be compressible such that brim 834 may be crimped for a small footprint during deployment. In some examples, brim 834 may be thickened to provide more bulk density under echo when device 12 is in the expanded configuration, enhancing visibility of brim 834. For example, brim 834 may define thickness T2 while another portion of device 12, such as anchoring member 40 may define a thickness Tl. In some examples, thickness T1 may be a first cross-sectional dimension (e.g., a first cross-sectional dimension substantially perpendicular to valve axis L) of anchoring member 40, while thickness T2 may be a second cross-sectional dimension (e.g., a second cross-sectional dimension substantially perpendicular to valve axis L). In some examples, thickness T2 may be greater than thickness Tl to provide the increased echogenic visibility. In some examples, brim 834 may include an animal-derived tissue, such as bovine pericardium tissue. In some examples, brim 834 may include a foam, such as at least one of a low-density foam, an intermediate density foam, or a high-density foam. The foam may be selected based at least partially on both the echogenic requirements and compressible packing requirements of the application.

[0140] An example technique for positioning a prosthetic device within a heart of a patient is illustrated in FIG. 11. Although the technique is described mainly with reference to device 12 of FIGS. 1-10, the technique may be applied to other prosthetic devices in other examples, and the described devices may be used to perform other techniques.

[0141] The technique includes expanding a device 12 within a heart of a patient (902). Device 12 may be in proximity to an annulus of a heart valve of heart 14. In examples, device 12 expands from a delivery configuration defining a first displacement from a valve axis L defined by device 12 to an expanded configuration defining a second displacement from the valve axis L, wherein the second displacement is greater than the first displacement. In examples, device 12 is positioned with a capsule 18 in the delivery configuration, and capsule 18 is displaced from device 12 to expand to the expanded configuration. In examples, capsule 18 is displaced by a delivery catheter 16 coupled to capsule 18. In some examples, capsule 18 and device 12 are delivered to the heart using a guide catheter 20 defining a lumen configured to allow capsule 18 and device 12 to pass therethrough.

[0142] Device 12 may include an anchoring member 40 configured to engage the annulus of the heart valve when device 12 expands from the delivery configuration to the expanded configuration. Anchoring member 40 may expand when device 12 expands from the delivery configuration to the expanded configuration. In examples, anchoring member 40 causes the valve axis L to pass through the annulus when anchoring member 40 engages the annulus. In examples, anchoring member 40 includes a fixation structure 56 including one or more fixation elements 58. Anchoring member 40 may engage the annulus by causing fixation structure 56 to engage the annulus.

[0143] Anchoring member 40 may position a valve support 38 substantially within the annulus when anchoring member 40 engages the annulus. Valve support 38 may define a flow path for a blood flow through device 12 from an inflow region 44 of valve support 38 to an outflow region 46 of valve support 38. Valve support 38 may mechanically support a valve assembly 42 configured to allow the blood flow through the flow path. In examples, device 12 defines a downstream direction from inflow region 44 to outflow region 46. Device 12 may define an upstream direction from outflow region 46 to inflow region 44. Valve assembly 42 may allow blood to flow through device 12 in at least the downstream direction. In examples, valve assembly 42 may substantially prevent blood from flowingthrough device 12 in the upstream direction.

[0144] Device 12 may support an echogenic member (e.g., echogenic member 24 (FIGS. 1A-2C), echogenic member 224 (FIG. 3), echogenic member 324 (FIG. 4), echogenic member 424 (FIG. 5), echogenic member 524 (FIGS. 6A-6B), echogenic member 624 (FIGS. 7-8), echogenic member 724 (FIG. 9), and / or echogenic member 824 (FIG. 10)around a perimeter defined by device 12 (e.g., when device 12 is in the expanded configuration). The defined perimeter may surround valve axis L. In examples, the defined perimeter surrounds the flow path defined by valve support 38. The perimeter may be defined by any portion of device 12. In examples, anchoring member 40 defines at least some portion of the perimeter (e.g., perimeter Pl). In examples, valve support 38 defines at least some portion of the perimeter (e.g., perimeter P2).

[0145] The technique includes imaging device 12 within heart 14 using an imaging system 60 (904). In some examples, device 12 may support echogenic member 24 such that echogenic member 24 alters the echogenic properties of device 12 to enhance deployment and positioning accuracy of device 12. In some examples, echogenic member 24 may interact with energy E from imaging system 60 when imaging system 60 transmits energy to capture an image of device 12 within heart 14. Device 12 may support echogenic member 24 such that echogenic marker 34 reflects one or more acoustic waves to imaging system 60 when imaging system 60 is positioned in the esophagus of a patient, such that the echogenic member 24 is visible on the image. In examples, imaging system 60 is an ultrasound probe which transmits acoustic energy to capture the image. In some examples, the visibility of echogenic member 24 may be known relative to other portions of device 12, such that deployment and positioning accuracy of device 12 may be improved during a medical procedure.

[0146] In some examples, as illustrated in FIGS. 1A-5, echogenic members according to the present disclosure may not include a brim extending from the device perimeter (Pl, P2). For example, with concurrent reference to FIGS. 1A-2C and 11, supporting echogenic member 24 around device perimeter Pl of device 12 may include supporting first echogenic marker 34 and second echogenic marker 35. In some examples, echogenic marker 34 may define closed boundary Bl and echogenic marker 35 may define closed boundary B2 such that closed boundaries B 1 and B2 are displaced from each other. Closed boundaries B 1 and / or B2 may be selectively shaped to provide echogenic visibility.The shapes defined by closed boundaries Bl and B2 may be the same in some examples, or may be different than each other. Furthermore, echogenic markers 34 and 35 may include the same or different materials. The materials may be the same as the materials included in other portions of device 12, such as anchoring member 40 and / / or valve support 38, or may be different than these materials.

[0147] With concurrent reference to FIGS. 4 and 11, in some examples the technique of FIG. 10 may include defining, with anchoring member 40, valve support 38, or another portion of device 12, a portion 334 of echogenic member 324. In some examples, portion 334 may be defined proximate inflow region 44, although it is considered that portion 334 may be defined elsewhere on device 12. In some examples, the defining portion 334 may include coating portion 334. In some examples, the coating may be an echogenic coating. In some examples, defining portion 334 may include texturing portion 334 of anchoring member 40 or valve support 38 to define at least a portion 334. In some examples, textured portion 334 may increase the echogenic visibility of portion 334 by increasing a number of incidence angles that acoustic energy directed from imaging system 60 to portion 334 is reflected.

[0148] With concurrent reference to FIGS. 5 and 11, in some examples supporting echogenic member 424 may include forming ring 434 around perimeter Pl to define echogenic member 424. Forming ring 434 may include, in some examples, rolling a fabric to form to ring 434. In some examples, the fabric may be a portion of sealing member 52 or sealing member 54. In some examples, the fabric may include titanium or bioglass, or another echogenic material.

[0149] With concurrent reference to FIGS. 6A, 6B, and 11, in some examples supporting echogenic member 524 may include supporting brim 534 extending from device 12. Brim 534 may be attached to and upstream of anchoring member 40 in examples where the device perimeter is perimeter Pl. In some examples, brim 534 may extend radially outward away from valve axis L when anchoring member 40 engages the annulus. In some examples, brim 534 defines first end 555 at perimeter Pl and second end 557 displaced from first end 555 in an upstream direction. In some examples, brim perimeter PB2 at second end 557 may be radially outward of brim perimeter PB1 at first end 555.

[0150] Referring to FIGS. 7 and 11, in some examples, the technique may include defining, with brim 634, void areas 665. In some examples, void areas 665 may allow waves of acoustic energy to pass through brim 634. In some examples, void areas 665 may be disposed proximate second end 657 of brim 634. In some examples, the technique of FIG. 11 may include defining, with second end 657, a sinusoidal, scalloped shape (FIG. 9) or another shape.

[0151] Referring to FIGS. 8 and 11, In some examples, the technique of FIG. 11 may further include supporting, with brim 634, one or more brim wires 671. Referring to FIGS.10 and 11, in some examples, brim 834 may include an animal-derived tissue. In some examples, brim 834 comprises a foam. The foam may be configured to enhance echogenic visibility of device 12 when device 12 is in the expanded configuration (FIG. IB) and compressible pack into delivery capsule 18 when the prosthetic device is in the delivery configuration FIG. 1A. In some examples, anchoring member 40 may define anchoring member thickness T1 and brim 834 may define echogenic brim thickness T2. Thickness T2 may be greater than thickness T1 when device 12 is in the expanded configuration.

[0152] As used here, when a first portion of a system (e.g., delivery system 10) is substantially parallel to a second portion of or an axis defined by the system, this may mean the first portion is parallel or nearly parallel to the second portion or the axis to the extent permitted by manufacturing tolerances. In some examples, when the first portion is substantially parallel to the second portion or the axis, this may mean a first vector defined by the first component of the system defines an angle of less than 10 degrees, in some examples less than 5 degrees, and in some examples less than 1 degree, with a second vector defined by the second component or the axis. When a first portion of the system is substantially perpendicular to a second portion of or an axis defined by the system, this may mean the first portion is perpendicular or nearly perpendicular to the second portion or the axis to the extent permitted by manufacturing tolerances. In some examples, when the first portion is substantially perpendicular to the second portion or the axis, this may mean that the first vector defined by the first component of the system defines an angle of at least 80 degrees, in some examples at least 85 degrees, and in some examples at least 89 degrees, with the second vector defined by the second component.

[0153] As used here, when a first portion of a system (e.g., delivery system 10) supports a second portion of the system, this means that when the second portion causes afirst force to be exerted on the first portion, the first portion causes a second force to be exerted on the second portion in response to the first force. The first force and / or second force may be a contact force and / or an action-at-a-distance force. For example, first force and / or second force may be mechanical force, a magnetic force, a gravitational force, or some other type of force. The first portion of the system may be a portion of the system or a portion of a component of the system. The second portion of the system may be another portion of the system or another portion of the same component or a different component. In some examples, when the first portion of the system supports the second portion of the system, this may mean the second portion is mechanically supported by and / or mechanically connected to the first portion.

[0154] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

[0155] Example 1. A prosthetic device, comprising: an anchoring member configured to engage an annulus of a heart valve of a heart, wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus; a valve support mechanically supported by the anchoring member and surrounding the valve axis, wherein the valve support is configured to define a flow path from an inflow region of the valve support to an outflow region of the valve support; a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path; an echogenic member mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis, and wherein the echogenic member is configured to alter echogenic properties of the prosthetic device to enhance deployment and positioning accuracy of the prosthetic device.

[0156] Example 2. The prosthetic device of Example 1, wherein the prosthetic device is configured to expand radially outwards from a delivery configuration to an expanded configuration, wherein the prosthetic device is configured to define a delivery radius defining a first displacement from the valve axis in the delivery configuration, wherein the prosthetic device is configured to define an expanded radius defining a second displacement from the valve axis in the expanded configuration, and wherein the seconddisplacement is greater than the first displacement.

[0157] Example 3. The prosthetic device of Example 2, wherein the anchoring member is configured to define the delivery radius and configured to define the expanded radius.

[0158] Example 4. The prosthetic device of any of Examples 1-3, wherein the echogenic member extends from the defined perimeter in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region.

[0159] Example 5. The prosthetic device of any of Examples 1-4, wherein the echogenic member extends from the defined perimeter in a downstream direction of the prosthetic device, wherein the downstream direction is a direction from the inflow region toward the outflow region.

[0160] Example 6. The prosthetic device of any of Examples 1-5, wherein at least a portion of the echogenic member extends from the defined perimeter in a direction toward the valve axis.

[0161] Example 7. The prosthetic device of any of Examples 1-6, wherein the anchoring member defines at least some portion of the perimeter.

[0162] Example 8. The prosthetic device of any of Examples 1-7, wherein the valve support defines at least some portion of the perimeter.

[0163] Example 9. The prosthetic device of any of Examples 1-8, wherein the anchoring member includes one or more anchoring member struts configured to urge the anchoring member radially outward from the valve axis.

[0164] Example 10. The prosthetic device of any of Examples 1-9, wherein the anchoring member includes a fixation structure including one or more fixation elements, wherein the fixation elements are configured to engage the annulus of the heart valve when the prosthetic device is implanted in the annulus.

[0165] Example 11. The prosthetic device of Example 10, wherein perimeter is displaced from the one or more fixation elements in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region.

[0166] Example 12. The prosthetic device of any of Example 1-11, wherein the perimeter defines a closed boundary extending around some portion of the prosthetic device.

[0167] Example 13. The prosthetic device of any of Examples 1-12, wherein the perimeter defines a closed boundary extending around the flow path.

[0168] Example 14. The prosthetic device of any of Examples 1-13, wherein the perimeter defines a closed boundary extending around the valve axis.

[0169] Example 15. The prosthetic device of any of Examples 1-14, wherein the perimeter is a planar perimeter.

[0170] Example 16. The prosthetic device of Example 15, wherein the planar perimeter is substantially perpendicular to the valve axis.

[0171] Example 17. The prosthetic device of any of Examples 1-16, wherein the perimeter is a nonplanar perimeter.

[0172] Example 18. The prosthetic device of any of Examples 1-17, wherein the flow path is substantially parallel to the valve axis.

[0173] Example 19. The prosthetic device of any of Examples 1-18, wherein the valve assembly is movable from a closed position in which blood flow in a direction from the outflow region to the inflow region is blocked and an open position in which blood flow in a direction from the inflow region to the outflow region is allowed.

[0174] Example 20. The prosthetic device of any of Examples 1-19, wherein the valve assembly includes one or more leaflets extending from the valve support in a direction toward the valve axis.

[0175] Example 21. The prosthetic device of any of Examples 1-20, wherein the anchoring member comprises a plurality of anchoring member struts defining a plurality of upper crowns, wherein the plurality of upper crowns define at least a portion of the perimeter.

[0176] Example 22. The prosthetic device of any of Examples 1-21, wherein the valve support comprises a plurality of valve support struts defining a plurality of upstream crowns, wherein the plurality of upstream crowns define at least a portion of the perimeter.

[0177] Example 23. The prosthetic device of any of Examples 1-22, wherein the echogenic member extends from the anchoring member.

[0178] Example 24. The prosthetic device of any of Examples 1-23, wherein the prosthetic device does not include a brim extending from the prosthetic device.

[0179] Example 25. The prosthetic device of any of Examples 1-24, wherein the echogenic member includes a first echogenic member and a second echogenic member,wherein each of the first echogenic member and the second echogenic member defines a closed boundary, wherein the closed boundary of the first echogenic member is displaced from the closed boundary of the second echogenic member, and wherein the closed boundary of the first echogenic member and the closed boundary of the second echogenic member are shaped to provide echogenic visibility.

[0180] Example 26. The prosthetic device of Example 25, wherein the first echogenic member and the second echogenic member are separated by an arc-length of the perimeter when the prosthetic device mechanically supports the first echogenic member and the second echogenic member.

[0181] Example 27. The prosthetic device of any of Examples 25-26, wherein the first echogenic member and the second echogenic member define closed boundaries of different shapes.

[0182] Example 28. The prosthetic device of any of Examples 1-27, wherein the echogenic member comprises a different material than the anchoring member, valve support, and valve assembly.

[0183] Example 29. The prosthetic device of any of Examples 1-28, wherein the echogenic member forms a ring around the perimeter.

[0184] Example 30. The prosthetic device of Example 29, wherein the ring comprises a rolled fabric.

[0185] Example 31. The prosthetic device of Example 30, wherein the rolled fabric comprises titanium or bioglass.

[0186] Example 32. The prosthetic device of any of Example 1-31, wherein a portion of the anchoring member or the valve support defines at least a portion of the echogenic member.

[0187] Example 33. The prosthetic device of Example 32, wherein the portion of the anchoring member or valve support defining at least a portion of the echogenic member is proximate the inflow region.

[0188] Example 34. The prosthetic device of Example 32 or 33, wherein the echogenic member is a coated portion of the anchoring member, wherein the coated portion comprises an echogenic coating configured to increase echogenic visibility of the coated portion on an ultrasound image.

[0189] Example 35. The prosthetic device of any of Example 32-34, wherein the echogenic member is a textured portion of the anchoring member, wherein the textured portion increases echogenic visibility of the portion by increasing a number of incidence angles that acoustic energy directed at the textured portion is reflected.

[0190] Example 36. The prosthetic device of any of Example 1-35, wherein the echogenic member includes an echogenic brim, wherein the echogenic brim is attached to and upstream of the anchoring member, and wherein the echogenic brim extends radially outward away from the valve axis when the anchoring member engages the annulus.

[0191] Example 37. The prosthetic device of Example 36, wherein the echogenic brim defines a first end at the perimeter and a second end displaced from the first end in an upstream direction, wherein a brim perimeter of the echogenic brim at the second end is radially outward of a brim perimeter at the first end of the echogenic brim.

[0192] Example 38. The prosthetic device of Example 36 or 37, wherein the echogenic brim defines a plurality of void areas, wherein the void areas configured to allow waves of acoustic energy to pass through the echogenic brim, wherein the plurality of void areas are configured to reduce acoustic shadowing.

[0193] Example 39. The prosthetic device of Example 38, wherein the plurality of void areas are disposed proximate the second end of the echogenic brim.

[0194] Example 40. The prosthetic device of any of Examples 36-39, wherein the echogenic brim defines a sinusoidal or scalloped shape at the second end of the echogenic brim.

[0195] Example 41. The prosthetic device of any of Examples 36-40, wherein the echogenic brim further comprises one or more brim wires.

[0196] Example 42. The prosthetic device of any of Examples 36-41, wherein the echogenic brim comprises an animal-derived tissue.

[0197] Example 43. The prosthetic device of any of Examples 36-42, wherein the echogenic brim comprises a foam, wherein the foam is configured to enhance echogenic visibility of the prosthetic device when the prosthetic device is in the expanded configuration and compressibly pack into a delivery capsule when the prosthetic device is in the delivery configuration.

[0198] Example 44. The prosthetic device of any of Examples 36-40, wherein the anchoring member defines at least some portion of the perimeter, wherein the anchoringmember defines an anchoring member thickness, and wherein a thickness of the echogenic brim is greater than the anchoring member thickness.

[0199] Example 45. A system comprising: the prosthetic device of any of Examples 1-44; and an ultrasound probe configured to transmit acoustic wave energy to the heart.

[0200] Example 46. A system comprising: the prosthetic device of any of Examples 1- 44, wherein the prosthetic device is configured to radially expand relative to the valve axis from a delivery configuration to an expanded configuration; and a capsule configured to radially constrain the prosthetic device in the delivery configuration.

[0201] Example 47. The system of Example 46, further comprising a delivery catheter mechanically supporting the capsule, wherein delivery catheter is configured to displace the capsule from the prosthetic device to deconstrain the prosthetic device.

[0202] Example 48. The system of Example 46 or Example 47, further comprising a guide catheter defining a lumen, wherein the lumen is configured to allow the capsule to pass therethrough.

[0203] Example 49. A method, comprising: expanding a prosthetic device within a heart of patient, the prosthetic device comprising: an anchoring member configured to engage an annulus of a heart valve of the heart, wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus, a valve support mechanically supported by the anchoring member and surrounding the valve axis, wherein the valve support is configured to define a flow path from an inflow region of the valve support to an outflow region of the valve support, a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path, and an echogenic member mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis; and capturing an image of the prosthetic device within the heart using an imaging system, wherein the image is based at least partially on echogenic properties of the echogenic member.

[0204] Example 50. The method of Example 49, wherein the prosthetic device is configured to establish a delivery configuration and an expanded configuration, and further comprising expanding the prosthetic device from the delivery configuration to the expanded configuration, wherein the prosthetic device is configured to define a deliveryradius defining a first displacement from the valve axis in the delivery configuration, wherein the prosthetic device is configured to define an expanded radius defining a second displacement from the valve axis in the expanded configuration, and wherein the second displacement is greater than the first displacement.

[0205] Example 51. The method of Example 50, wherein the anchoring member defines the delivery radius and defines the expanded radius.

[0206] Example 52. The method of any of Examples 49-51, further comprising extending, by the prosthetic device, the echogenic member from the defined perimeter in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region.

[0207] Example 53. The method of any of Examples 49-52, further comprising extending, by the prosthetic device, the echogenic member from the defined perimeter in a downstream direction of the prosthetic device, wherein the downstream direction is a direction from the inflow region toward the outflow region.

[0208] Example 54. The method of any of Examples 49-53, further comprising extending, by the prosthetic device, a portion of the echogenic member from the defined perimeter in a direction toward the valve axis.

[0209] Example 55. The method of any of Examples 49-54, wherein the anchoring member defines at least some portion of the perimeter.

[0210] Example 56. The method of any of Examples 49-55, wherein the valve support defines at least some portion of the perimeter.

[0211] Example 57. The method of any of Examples 49-56, wherein the anchoring member includes a fixation structure including one or more fixation elements, and wherein the fixation structure engages the annulus of a heart valve.

[0212] Example 58. The method of any of Examples 49-57, further comprising: transmitting, using an ultrasound probe, acoustic wave energy to a heart when the prosthetic device is positioned within the heart.

[0213] Example 59. The method of any of Examples 49-58, wherein the prosthetic device is configured to radially expand relative to the valve axis from a delivery configuration to an expanded configuration, and further comprising radially constraining, by a capsule, the prosthetic device in the delivery configuration.

[0214] Example 60. The method of Example 59, further comprising displacing, by a delivery catheter mechanically supporting the capsule, the capsule from the prosthetic device to deconstrain the prosthetic device.

[0215] Example 61. The method of Example 59 or Example 60, further comprising transporting, by a guide catheter, the capsule to the heart, wherein guide catheter defines a lumen is configured to allow the capsule to pass therethrough.

[0216] Example 62. The method of any of Examples 49-61, wherein expanding the prosthetic device does not include supporting a brim extending from the device perimeter.

[0217] Example 63. The method of any of Examples 49-62, further comprising supporting, with the prosthetic device, a first echogenic member and a second echogenic member, wherein each of the first echogenic member and the second echogenic member defines a closed boundary, wherein the closed boundary of the first echogenic member is displaced from the closed boundary of the second echogenic member, and wherein the closed boundary of the first echogenic member and the closed boundary of the second echogenic member are shaped to provide echogenic visibility.

[0218] Example 64. The method of Example 63, wherein the first echogenic member and the second echogenic member are separated by an arc -length of the perimeter when the prosthetic device mechanically supports the first echogenic member and the second echogenic member.

[0219] Example 65. The method of Example 63 or Example 64, wherein the first echogenic member and the second echogenic member define closed boundaries of different shapes.

[0220] Example 66. The method of any of Examples 49-65, further comprising supporting an echogenic member comprising a different material than the anchoring member, valve support, and valve assembly.

[0221] Example 67. The method of any of Examples 49-66, further comprising forming a continuous ring around the perimeter to define the echogenic member.

[0222] Example 68. The method of Example 67, further comprising rolling a fabric to form to continuous ring.

[0223] Example 69. The method of Example 68, wherein the rolled fabric comprises titanium or bioglass.

[0224] Example 70. The method of any of Examples 49-69, further comprising defining, with the anchoring member or valve support, at least a portion of the echogenic member.

[0225] Example 71. The method of Example 70, wherein the portion of the anchoring member or valve support defining at least a portion of the echogenic member is proximate the inflow region.

[0226] Example 72. The method of Example 70 or 71, further comprising coating a portion of the anchoring member or valve support to define at least a portion of the echogenic member, wherein the coating is an echogenic coating configured to increase echogenic visibility of the coated portion on an ultrasound image.

[0227] Example 73. The method of any of Example 70-72, further comprising texturing a portion of the anchoring member or valve support to define at least a portion of the echogenic member, wherein the textured portion increases echogenic visibility of the portion by increasing a number of incidence angles that acoustic energy directed at the textured portion is reflected.

[0228] Example 74. The method of any of Examples 49-73, further comprising supporting an echogenic brim extending from the prosthetic device, wherein the echogenic brim is attached to and upstream of the anchoring member, and wherein the echogenic brim extends radially outward away from the valve axis when the anchoring member engages the annulus.

[0229] Example 75. The method of Example 74, wherein the echogenic brim defines a first end at the perimeter and a second end displaced from the first end in an upstream direction, wherein a brim perimeter of the echogenic brim at the second end is radially outward of a brim perimeter at the first end of the echogenic brim.

[0230] Example 76. The method of Example 74 or Example 75, further comprising defining, with the echogenic brim, a plurality of void areas, wherein the void areas configured to allow waves of acoustic energy to pass through the echogenic brim, wherein the plurality of void areas are configured to reduce acoustic shadowing.

[0231] Example 77. The method of Example 76, wherein the plurality of void areas are disposed proximate the second end of the echogenic brim.

[0232] Example 78. The method of any of Examples 74-77, further comprising defining, with the second end of the echogenic brim, a sinusoidal or scalloped shape.

[0233] Example 79. The method of any of Examples 74-78, further comprising supporting, with the echogenic brim, w one or more brim wires.

[0234] Example 80. The method of any of Examples 74-79, wherein the echogenic brim comprises an animal-derived tissue.

[0235] Example 81. The method of any of Example 74-79, wherein the echogenic brim comprises a foam, wherein the foam is configured to enhance echogenic visibility of the prosthetic device when the prosthetic device is in the expanded configuration and compressibly pack into a delivery capsule when the prosthetic device is in the delivery configuration.

[0236] Example 82. The method of any of Examples 74-80, wherein the anchoring member defines at least some portion of the perimeter, wherein the anchoring member defines an anchoring member thickness, and wherein a thickness of the echogenic brim is greater than the anchoring member thickness.

Claims

WHAT IS CLAIMED IS:

1. A prosthetic device, comprising: an anchoring member configured to engage an annulus of a heart valve of a heart, wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus; a valve support mechanically supported by the anchoring member and surrounding the valve axis, wherein the valve support is configured to define a flow path from an inflow region of the valve support to an outflow region of the valve support; a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path; an echogenic member mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis, and wherein the echogenic member is configured to alter echogenic properties of the prosthetic device to enhance deployment and positioning accuracy of the prosthetic device.

2. The prosthetic device of claim 1, wherein the prosthetic device is configured to expand radially outwards from a delivery configuration to an expanded configuration, wherein the prosthetic device is configured to define a delivery radius defining a first displacement from the valve axis in the delivery configuration, wherein the prosthetic device is configured to define an expanded radius defining a second displacement from the valve axis in the expanded configuration, and wherein the second displacement is greater than the first displacement.

3. The prosthetic device of claim 2, wherein the anchoring member is configured to define the delivery radius and configured to define the expanded radius.

4. The prosthetic device of any of claims 1-3, wherein the echogenic member extends from the defined perimeter in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region.

5. The prosthetic device of any of claims 1-4, wherein the echogenic member extends from the defined perimeter in a downstream direction of the prosthetic device, wherein the downstream direction is a direction from the inflow region toward the outflow region.

6. The prosthetic device of any of claims 1-5, wherein at least a portion of the echogenic member extends from the defined perimeter in a direction toward the valve axis.

7. The prosthetic device of any of claims 1-6, wherein the anchoring member defines at least some portion of the perimeter.

8. The prosthetic device of any of claims 1-7, wherein the valve support defines at least some portion of the perimeter.

9. The prosthetic device of any of claims 1-8, wherein the anchoring member includes one or more anchoring member struts configured to urge the anchoring member radially outward from the valve axis.

10. The prosthetic device of any of claims 1-9, wherein the anchoring member includes a fixation structure including one or more fixation elements, wherein the fixation elements are configured to engage the annulus of the heart valve when the prosthetic device is implanted in the annulus.

11. The prosthetic device of claim 10, wherein perimeter is displaced from the one or more fixation elements in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region.

12. The prosthetic device of any of claims 1-11, wherein the perimeter defines a closed boundary extending around some portion of the prosthetic device.

13. The prosthetic device of any of claims 1-12, wherein the perimeter defines a closed boundary extending around the flow path.

14. The prosthetic device of any of claims 1-13, wherein the perimeter defines a closed boundary extending around the valve axis.

15. A method, comprising: expanding a prosthetic device within a heart of patient, the prosthetic device comprising: an anchoring member configured to engage an annulus of a heart valve of the heart, wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus, a valve support mechanically supported by the anchoring member and surrounding the valve axis, wherein the valve support is configured to define a flow path from an inflow region of the valve support to an outflow region of the valve support, a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path, and an echogenic member mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis; and capturing an image of the prosthetic device within the heart using an imaging system, wherein the image is based at least partially on echogenic properties of the echogenic member.

Images