Cinch and release mechanism and method for a prosthetic heart valve

Abstract

A prosthetic device to engage a valve annulus is disclosed. A first body portion is configured to selectively translate within at least one passage defined by the prosthetic device. The prosthetic device defines a device perimeter surrounding the valve axis. The first body portion is configured to reduce a perimeter dimension of the device perimeter when an engagement device exerts a force on a second body portion. The outer support defines a device maximum height measured longitudinally from a base of the prosthetic device and the at least one passage has a passage height location measured longitudinally from the base of the prosthetic device. The passage height location is longitudinally spaced at least one of laterally adjacent to and longitudinally beneath the device maximum height from the base of the prosthetic device.

Description

CINCH AND RELEASE MECHANISM AND METHOD FOR A PROSTHETICHEART VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional Patent Application Serial No. 63 / 551,694, filed 9 February 2024, and from U.S. Provisional Patent Application Serial No. 63 / 754,038, filed 5 February 2025. The entire contents of both applications are incorporated herein by reference for all purposes.FIELD

[0002] The present technology is generally related to prosthetic valve delivery devices and, more particularly, to systems and methods for the placement of a prosthetic valve within an annulus of a native valve.BACKGROUND

[0003] Systems, devices, and techniques used to repair heart valves are one example of a category of medical devices to which this disclosure relates, although this disclosure also relates to the delivery of other medical devices. Native heart valves can be affected by several medical conditions. For example, mitral valves can be affected by mitral valve regurgitation, mitral valve prolapse and mitral valve stenosis. One method of treatment includes replacement of the heart valve by implanting a prosthetic heart valve in the heart in place of the native mitral valve. Another method of treatment includes repair, bypassing, or replacement of a previously implanted prosthetic heart valve. In some cases, one or more heart valve prostheses may be implanted percutaneously using delivery systems. In some cases, a heart valve prosthesis may be constrained in an initial delivery configuration to allow for the percutaneous delivery via a catheter, with the prosthetic heart valve assuming a relatively small cross-sectional dimension in an initial delivery configuration for delivery through the vasculature of a patient. In some cases, once delivered and placed in the target site, the heart valve prosthesis may be deployed, expanding to assume a larger cross-sectional dimension.

[0004] PCT Patent Application Publication No. WO 2023 / 144670, published 3 August 2023 by Erik Griswold et al., describes a device and method for providing andoperating a delivery catheter. PCT Patent Application Publication No. WO 2023 / 242719, published 21 December 2023 by David A. Grossman et al., describes a delivery system implant cinch and release mechanism. WO 2023 / 144670 and WO 2023 / 242719 are incorporated by reference herein in their entirety, for all purposes.SUMMARY

[0005] The techniques of this disclosure generally relate to the placement of a prosthetic valve within an annulus of a native valve.

[0006] In an aspect, the present disclosure provides a prosthetic device to engage an annulus of a heart valve of a heart, wherein the prosthetic device is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the prosthetic device engages the annulus. A cinch member includes a member body including a first body portion and a second body portion. The first body portion is configured to selectively translate within at least one passage defined by the prosthetic device. The prosthetic device defines a device perimeter surrounding the valve axis. The first body portion is configured to reduce a perimeter dimension of the device perimeter when a tensile force is exerted on the second body portion. The prosthetic device includes an outer support configured to engage the annulus. The outer support is configured to cause the valve axis to pass through the annulus when the outer support engages the annulus. The outer support defines a device maximum height measured longitudinally from a base of the prosthetic device and the at least one passage has a passage height location measured longitudinally from the base of the prosthetic device. The passage is located radially at or inward of an outer surface of the outer support.

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

[0008] Fig. 1A depicts a side view of a prosthetic heart valve in accordance with a first example aspect of the disclosure.

[0009] Fig. IB depicts a side view of an alternate aspect of the prosthetic heart valve of Fig. 1A.

[0010] Fig. 2A depicts an atrial end view of the prosthetic heart valve of Fig. 1 A in an expanded configuration.

[0011] Fig. 2B depicts an atrial end view of the prosthetic heart valve of Fig. A in a partially compressed configuration.

[0012] Fig. 3 depicts a side view of a delivery device according to an embodiment hereof, wherein the delivery device is configured for delivering a prosthetic heart valve, such as any of those of Figs. 1A-2B, within a capsule of the delivery device.

[0013] Fig. 4 depicts a side sectional view of the delivery device of Fig. 3, the delivery device being fluidly coupled to a hydraulic system and a deployment assist being disposed over a proximal end of the delivery device.

[0014] Fig. 5 is a cross-sectional view taken along line A- A of Fig. 3.

[0015] Fig. 6 is an exploded view of the delivery device of Fig. 3.

[0016] Fig. 7 is an enlarged view of a distal portion of an innermost shaft assembly of the delivery device of Fig. 3, wherein the innermost shaft assembly includes a flexible shaft, a piston mount, a piston, a tension cable, a distal shaft, a capsule, and a capsule cap.

[0017] Fig. 8 is a side view of a distal portion of the delivery device of Fig. 3, wherein the distal portion includes the capsule and the deployment piston, the capsule being shown in a first position relative to the deployment piston and a prosthetic heart valve, such as any of those of Figs. 1 A-2B, being loaded into the capsule.

[0018] Fig. 9 is an example of the prosthetic heart valve of any aspect of the disclosure, in an example use configuration.DETAILED DESCRIPTION

[0019] As used herein, the singular forms “a”, “an”, and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising”, as used herein, can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0020] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0021] As used herein, phrases such as “between X and Y” and “between about X and Y” can be interpreted to include X and Y.

[0022] It will be understood that when an element is referred to as being “on”, “attached” to, “connected” to, “coupled” with, “contacting”, “adjacent”, etc., another element, it can be directly on, attached to, connected to, coupled with, contacting, or adjacent the other element, or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on”, “directly attached” to, “directly connected” to, “directly coupled” with, “directly contacting”, or “directly adjacent” another element, there are no intervening elements present. It will also be appreciated by those of ordinary skill in the art that references to a structure or feature that is disposed “directly adjacent” another feature may have portions that overlap or underlie the adjacent feature, whereas a structure or feature that is disposed “adjacent” another feature might not have portions that overlap or underlie the adjacent feature.

[0023] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms can encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features.

[0024] As used herein, the phrase “at least one of X and Y” can be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element may, at a particular time, include X, Y, or a combination of X and Y, the selection of which could vary from time to time. In contrast, the phrase “at least one of X” can be interpreted to include one or more Xs.

[0025] It will be understood that, although the terms “first”, “second”, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing fromthe teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0026] Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position relative to a treating clinician. “Distal” or “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician.

[0027] The following detailed description is merely exemplary in nature and is not intended to be limiting. Although the description of examples is in the context of prosthetic heart valves, prosthetic devices according to the present disclosure may be other medical devices. Although delivery systems and techniques are described for delivering a heart valve prosthesis within a heart, the delivery systems and techniques described may be used for other medical devices delivered to other parts of the body.

[0028] The attached drawings are not shown at scale, and distances therein are not necessarily absolute or relative depictions of locations and interactions of the depicted structures. One of ordinary skill in the art will be able to interpret the drawings and specification of the present application for a particular use environment of the technology(ies) described and shown.

[0029] The “longitudinal” direction, as referenced herein, is substantially parallel to longitudinal arrow “Lo” in the Figures and is substantially vertical, in the orientation of Figs. 1A and 2A.

[0030] The “lateral” direction, as referenced herein, is substantially parallel to the “La” arrow in the Figures and is substantially perpendicular to the longitudinal direction.

[0031] The invention comprises, consists of, or consists essentially of the following features, in any combination.

[0032] Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” when used in the following description to refer to a delivery device or catheter are with respect to a position or direction relative to the treating clinician. Thus, “distal” and “distally” refer to positioned distant from, or in a direction away from the treating clinician, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the clinician.

[0033] The following detailed description merely provides example implementations and is not intended to limit the invention or the application and use of the invention. Although the description of the invention is in the context of the treatment and navigation of a tricuspid or mitral heart valve, this technology may be used where it is deemed useful in other anatomical sites that are not in the heart. For example, the present invention may be applied to other heart valves or venous valves as well. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description.

[0034] This disclosure describes a medical system including a prosthetic device, as is discussed above with reference to the Figures. The prosthetic device may be, for example, 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 engages tissue of the heart to position a valve assembly substantially within an annulus of the native heart valve. The prosthetic device includes a cinch member configured to aid in delivery, deployment, and / or recapture of the prosthetic device within the patient, such that a clinician may position, adjust, recapture, and / or deploy the prosthetic device during an implantation procedure before disengaging the prosthetic device from an engagement device (e.g., a portion of a delivery system).

[0035] In some examples, the cinch member is configured to enable disengagement from the engagement device (e.g., the delivery system) in a manner limiting and / or substantially eliminating forces imparted to the implanted prosthetic device. Limiting and / or substantially eliminating forces on the prosthetic device during disengagement may reduce a risk of dislodging and / or mispositioning the prosthetic device during the disengagement. In examples, and if necessary, the cinch member enables extraction of the prosthetic device from the patient. For example, the cinch member may be configured to reduce a size of an at least partially expanded prosthetic device to enable extraction from the patient.

[0036] In examples, the cinch member is configured to reduce a perimeter dimension (e.g., a diameter) of a device perimeter defined by the prosthetic device. The deviceperimeter may be defined by, for example, an outer support of the prosthetic device, such as an anchoring member and / or a brim substantially surrounding an axis of the prosthetic device. In some examples, the cinch member is configured to control and / or reduce the perimeter dimension (e.g., a diameter of a stent or frame of the prosthetic device) of the device perimeter such that an expanded size of the prosthetic device during placement and implantation can be controlled (e.g., by a clinician).

[0037] The perimeter dimension may be a length defined by the device perimeter of the prosthetic device. For example, when the prosthetic device defines a substantially circular (e.g., circular or nearly circular to the extent permitted by manufacturing tolerances) device perimeter, the perimeter dimension may be a diameter or other chord (e.g., a nondiametrical chord) between two or more points on the device perimeter. In examples, the perimeter dimension is a length of one or more line segments extending from a first point on the on the device perimeter to a second point on the device perimeter. The one or more line segments may be a single line segment or two or more joined line segments. A line segment may be a straight line segment, a curved line segment, a curvilinear line segment, or another type of line segment. The prosthetic device may define a perimeter having any shape, such as at least a portion of a substantially circular shape, elliptical shape, oval shape, polygonal shape, or other shape.

[0038] In some examples, the cinch member is configured such that a force imparted to the cinch member (e.g., a pulling force) by a clinician within a heart chamber causes a reduction in the perimeter dimension and a reduction in the size of the prosthetic device. The cinch member may be configured such that the cinch member allows the prosthetic device to expand and increase the size of the prosthetic device within the heart chamber. Hence, the cinch member is configured to allow a clinician to control a size defined by the prosthetic device during an implantation procedure. The cinch member is configured to limit forces imparted to the implanted prosthetic device by the engagement device as the engagement device is disengaged (e.g., by the clinician).

[0039] Prosthetic devices and systems according to the present disclosure may find application in, for example, delivery of many different medical devices including heart valve prosthesis (e.g., prosthetic mitral valve, tricuspid valve, aortic valve, or any native heart valve), self-expanding grafts and scaffolds, or occlusion devices as examples.

[0040] The prosthetic device is configured to reside with a heart of a patient to, for example, act in place of a native heart valve within the heart. The prosthetic device includes an outer structure configured to engage an annulus of a native heart valve to help secure the prosthetic device in an annulus of the native heart valve. For example, the outer structure may include an anchoring member configured to engage the annulus. The anchoring member may be configured such that a valve axis defined by the prosthetic device passes through the annulus when the anchoring member engages the annulus.

[0041] The prosthetic device may include a valve support mechanically supported by the outer support and surrounding the valve axis. The valve support may be configured to cause a valve assembly to position within or in the vicinity of the annulus when the outer structure grips the annular wall. The valve assembly may be configured to allow blood to flow along a flow path from an inflow region of the prosthetic device to an outflow region of the prosthetic device. In some examples, the valve axis passes through the valve assembly. In some examples, the prosthetic device (e.g., the outer support, valve support, or another portion of the prosthetic device) defines the device perimeter substantially conforming to a path over which the cinch member defines a closed loop. In examples, the device perimeter surrounds the valve axis. In some examples, the perimeter defined by the prosthetic device is substantially perpendicular to the valve axis (e.g., when the prosthetic device is in the expanded configuration).

[0042] In examples, the prosthetic device is configured to define a first perimeter dimension in the delivery configuration and a second perimeter dimension in the expanded configuration, wherein the second perimeter dimension is greater than or equal to the first perimeter dimension. In examples, the prosthetic device defines the first perimeter dimension when the prosthetic device is at least partially enclosed by a capsule housing of a delivery capsule. The cinch member is configured such that a clinician may increase and / or decrease the second perimeter dimension (e.g., using an engagement device engaged with the cinch member) as the prosthetic device radially expands from the delivery configuration.

[0043] In examples, the cinch member includes a first portion (“first body portion”) and a second portion (“second body portion”). The cinch member may be configured such that the first body portion resides within at least one passage (e.g., one or more passages) defined by the prosthetic device around the device perimeter. The outer support maydefine a device maximum height measured longitudinally from a base of the prosthetic device, and the at least one passage has a passage height location measured longitudinally from the base of the prosthetic device. .

[0044] The second body portion may be a portion of the cinch member residing substantially outside the one or more passages and / or otherwise accessible to a user. The first body portion may be configured to slidably translate within the one or more passages, such that when a user exerts a force on the second body portion in a direction away from the prosthetic device (e.g., pulls on the second body portion), the first portion translates within the one or more passages around the device perimeter to substantially cinch the prosthetic device, causing a reduction in the size of the defined perimeter. The cinching of the prosthetic device may reduce a radial displacement of the prosthetic device (e.g., reduce a displacement defined by the prosthetic device substantially perpendicular to the valve axis).

[0045] The one or more passages defined hy the prosthetic device may he configured to substantially contain some portion of the cinch member (e.g., the first body portion) while enabling the cinch member to cinch and relax about the device perimeter, depending on the force exerted on the cinch member (e.g., exerted on the second portion) by a user. The one or more passages may be defined by one or more portions of the prosthetic valve device, such as one or more portions of the outer support (e.g., the anchoring member), the valve support, and / or another portion of the prosthetic valve device. A selected passage may be a volume configured to allow at least a first portion of the cinch member to pass therethrough, such as by defining a channel or “sleeve” via a circumferentially extending pleat in the graft material, via an attached separate lumen-defining structure, or in any other desired manner. The prosthetic device may define a first opening (“first passage opening”) opening to the given passage and / or a second opening (“second passage opening”) opening to the given passage, such that the cinch member may pass through at least one of the first passage opening and (when present) the second passage opening when the member body slidably translates within the passage. In examples, the prosthetic device may define the one or more passages substantially around the device perimeter surrounded by the member body of the cinch member. The cinch member may be removed from the at least one passage when the prosthetic device is in the expanded configuration at a predetermined relationship with the annulus.

[0046] Figs. 1 A-2B illustrate a first example embodiment of a prosthetic heart valve 1000 for use in embodiments hereof. It is understood that any number of alternate heart valve prostheses can be used with the methods and devices described herein. The prosthetic heart valve 1000 is presented by way of example only, and other shapes and designs of prosthetic heart valves are also consistent with embodiments hereof. Although the prosthetic heart valve 1000 is configured for placement within a tricuspid heart valve or a mitral heart valve, embodiments of delivery devices and techniques described herein may be used in conjunction with any transcatheter valve prostheses. For example, embodiments described herein may be utilized with a transcatheter prosthetic heart valve configured for placement within a pulmonary, aortic, mitral, or tricuspid valve, or within a venous valve. There is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

[0047] The prosthetic heart valve 1000 is configured to be radially compressed into an at least partially reduced-diameter configuration for delivery within a vasculature and to return to an expanded, deployed configuration, which is shown in Fig. 1A. Stated another way, the prosthetic heart valve 1000 has a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. In accordance with embodiments hereof, when in the radially compressed or reduced- diameter configuration, the prosthetic heart valve 1000 has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery device that may be tracked to the deployment site of the native heart valve of a heart via any one of a transatrial, antegrade, or transapical approach. The prosthetic heart valve 1000 includes a stent or frame 1020 and a valve component 1010 including at least one leaflet 1070 disposed within and secured to the frame 1020. The valve component 1010 of the prosthetic heart valve 1000 is capable of regulating flow therethrough via valve leaflets 1070 that may form a replacement valve.

[0048] Any portion of the frame 1020 described herein as an element of the prosthetic heart valve 1000 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combinationof materials. A suitable biocompatible material would be selected to provide the prosthetic heart valve 1000 to be configured to be compressed into a reduced-diameter crimped configuration for transcatheter delivery to a native valve, whereby release from a delivery catheter returns the prosthesis to an expanded, deployed configuration. Alternatively, the prosthetic heart valve 1000 may be balloon-expandable as would be understood by one of ordinary skill in the art. The frame 1020 can be manufactured using a cut pattern which can be used to provide desired strut, connector, and barb structures to at least a portion of the frame 1020, and may be created via subtractive manufacturing (e.g., laser-cut from a cylindrical tube), additive manufacturing (e.g., 3D printing), any other desired manufacturing process, or any combination thereof.

[0049] In an aspect of the disclosure, the frame 1020 of the prosthetic heart valve 1000 includes a valve support 1020A at least partially surrounded by and attached to an anchoring member 1020B. The valve support 1020 A is configured to support the valve component 1010 therein. The valve support 1020 A is a tubular stent-like or frame structure that defines a central lumen from a first end of the valve support 1020 A to a second end of the valve support 1020A. When positioned in situ within a native mitral valve, the first end is an inflow or upstream end and the second end is an outflow or downstream end. At the second end, the valve support 1020 A is attached to the anchoring member 1020B via a plurality of connector components. For example, the plurality of connector components may be rivets, stitches, sutures, adhesive, soldering, welding, brazing, an integral formation between the valve support 1020A and the anchoring member 1020B, clips, staples, any other suitable connector component, or any combination thereof. In addition, at the second end, the valve support 1020 A also may include a plurality of attachment bars 1120 extending therefrom that function to releasably couple the prosthetic heart valve 1000 to a delivery device.

[0050] The anchoring member 1020B is a stent-like or frame structure that functions as an anchor for the prosthetic heart valve 1000 to secure its deployed position within a native annulus. The anchoring member 1020B is a substantially cylindrically-shaped structure that is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve. At the first end of the valve support 1020 A, the anchoring member 1020B is radially spaced a distance from the valve support 1020 A to mechanically isolate the inflow end of the valve support 1020A from the anchoringmember 1020B. The anchoring member 1020B includes one or more fixation elements 1050 that extend outward from an exterior side thereof to engage heart tissue. The fixation elements 1050 project radially outward and are inclined toward an upstream direction. The fixation elements 1050, for example, can be prongs, cleats, barbs, hooks, or other elements.

[0051] The anchoring member 1020B includes a plurality of crowns and a plurality of struts with each crown being formed between a pair of opposing struts. Each crown is a curved segment or bend extending between opposing struts. The anchoring member 1020B is tubular, with a plurality of side openings being defined by edges of the plurality of crowns and the plurality of struts. In an embodiment, the plurality of side openings may be substantially diamond- shaped. The anchoring member 1020B includes a plurality of nodes. A node is defined as a region where two crowns of the plurality of crowns within the anchoring member 1020B meet or connect. When attached to the valve support 1020A via the plurality of connecting components, the anchoring member 1020B forms an outer frame portion of the frame 1020 and the valve support 1020 A forms an inner frame portion of the frame 1020 with the anchoring member 1020B circumferentially surrounding the valve support 1020A disposed therein.

[0052] Each of the valve support 1020A and the anchoring member 1020B may include a skirt or lining of graft material 1030 secured thereto. More particularly, the graft material 1030 may be coupled to an inner surface of the valve support 1020A to line a portion thereof. Alternatively or additionally, the graft material 1030 may be coupled to an outer surface of the valve support 1020A to enclose a portion thereof as would be known to one of ordinary skill in the art of prosthetic valve construction. The graft material 1030, when present, may be coupled to an inner surface of the anchoring member 1020B to line a portion thereof. The outer engagement surface of the anchoring member 1020B could be absent from any sealing or graft material so that the outer engagement surface directly contacts the tissue of the native annulus, as shown in Figs. 1 A-2B, or could include a graft material outer surface for any desired reason(s), such as, but not limited to, promoting native tissue ingrowth. The graft material 1030 may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. Alternatively, the graft material 1030 may be a low-porosity woven fabric, such aspolyester, Dacron fabric, or PTFE, which creates a one-way fluid flow lumen when attached to the stent.

[0053] The valve component 1010 of the prosthetic heart valve 1000 is capable of regulating flow therethrough via valve leaflets 1070 that may form a replacement valve. Figs. 1 A-2B illustrate an example valve component having three leaflets, although a bicuspid leaflet configuration may alternatively be used in embodiments hereof. When deployed in situ, the valve component 1010 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the valve support 1020A. The valve component 1010 includes valve leaflets 1070, e.g., three valve leaflets 1070, that are disposed to coapt within an upstream portion of the valve support 1020A with leaflet commissures of the valve leaflets 1070 being secured within a downstream portion of the valve support 1020A, such that the valve leaflets 1070 open during diastole. Leaflets 1070 are attached along their bases to the valve support 1020A, for example, using sutures or a suitable biocompatible adhesive. Adjoining pairs of leaflets 1070 are attached to one another at their lateral ends to form leaflet commissures. The orientation of the leaflets 1070 within the valve support 1020A depends upon on which end of the prosthetic heart valve 1000 is the inflow end and which end of the prosthetic heart valve 1000 is the outflow end, thereby promoting one-way flow of blood through the prosthetic heart valve 1000.

[0054] The valve leaflets 1070 are attached to an inner lumen of the valve support 1020A (such as indirectly via a graft material 1030 lining the valve support 1020A) in order to form the valve component 1010. The valve leaflets 1070 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It may also be desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0055] The prosthetic valve device 1000 is configured to define a valve axis V and a device perimeter P substantially surrounding valve axis V. Prosthetic valve device 1000 is configured such that a radial expansion of the prosthetic valve device 1000 (e.g., from thedelivery configuration to the expanded configuration) increases a perimeter dimension defined by device perimeter P. In similar manner, the prosthetic valve device 1000 is configured such that a radial contraction of prosthetic valve device 1000 (e.g., from the expanded configuration to the delivery configuration) decreases a perimeter dimension defined by device perimeter P. Device perimeter P may be defined by any portion of prosthetic valve device 1000 measured radially relative to the valve axis V.

[0056] As was previously mentioned, prosthetic valve device 1000 includes cinch member 1032. Cinch member 1032 is configured to control and / or reduce the perimeter dimension defined by device perimeter P, such that an expanded size of prosthetic valve device 1000 during placement and implantation may be controlled (e.g., by a clinician). Cinch member 1032 may be, for example, a suture or some other material configured to define a strand, thread, cable, or wire. In some examples, cinch member 1032 may comprise a polymer fabric material. In some examples, cinch member 1032 may comprise an ultrahigh molecular weight polyethylene. In some examples, the cinch member 1032 may be manufactured from an echogenic material such that the cinch member 1032 may be visible by echocardiogram (echo) imaging and the device perimeter P can be more readily viewed during delivery and implantation of the prosthetic device 1000. In addition, a single member of echogenic material defining a closed loop can be inserted into the passage 1040 to provide improved imaging capabilities of the location of the passage 1040 which can correspond to a known feature (e.g., top T) of the anchoring member 1020b.

[0057] Cinch member 1032 includes a member body defining a first body portion 1034 (e.g., a “central” portion of an elongate cinch member 1032 defined as a cord or portion of a suture thread) and a second body portion 1036 (e.g., the “free ends” and adjacent areas between which the “central” portion of the elongate cinch member 1032 is interposed). The second body portion 1036 includes a first free end 1036a and a second free end 1036b. Thus, the cinch member 1032 is defined as a continuous suture extending between a first free end 1036a and a second free end 1036b with a central portion 1034 defined between the first free end 1036a and the second free end 1036b.

[0058] The first body portion 1034 is configured to selectively translate within at least one passage 1040 defined by the prosthetic valve device 1000. The passage 1040 can be formed as a folded portion of the skirt or graft material 1030 or as a separate pocket of graft material affixed (e.g., sewn or adhered) to the skirt or graft material 1030.

[0059] Accordingly, through cooperation between the cinch member 1032 and the passage(s) 1040, the prosthetic valve device can be pulled or cinched down in lateral size, in a drawstring-type action, between delivery (reduced- size) and expanded (enlarged- size) configurations. Use of the cinch member 1032 and the passage(s) 1040 to cinch the passage down in at least one location thereof is shown schematically in Fig. 9, in which a delivery system is shown as being coupled to the prosthetic valve device 1000 to assist with delivery thereof to a target annulus location, as will be discussed in detail below.

[0060] Cinch member 1032 is configured such that exerting a pulling force on second body portion 1036 in a direction away from prosthetic valve device 1000 pulls on second body portion 1036 such that first body portion 1034 translates to substantially cinch prosthetic valve device 1000, causing a reduction in the size of device perimeter P (e.g., a reduction in a radial displacement defined by perimeter P). A pulling force can be exerted on the second body portion 1036 of cinch member 1032 by pulling from a user (e.g., a physician) using a hand and fingers to grip the free ends 1036a, 1036b of the cinch member 1032 and imparting a tensile force on the cinch member 1032 to draw down the device perimeter P and reduce the device perimeter P.

[0061] In some aspects, the tensile force can be applied to the second body portion 1036 with a mechanical device (e.g., spool, wheel, reel) to enable pulling of the cinch member 1032. In further aspects, a locking device (e.g., a locking port through which the cinch member 1032 extends) can be used to hold a constant tensile force on the cinch member 1032. For example, a locking port having a lever selectively positionable between an open or unlocked orientation (which allows the cinch member 1032 to extend freely without stopping friction) to a closed or locked orientation (which creates sufficient friction on the cinch member 1032 to hold the cinch member 1032) can be provided. Upon releasing the pulling tensile force on the second body portion 1036, the device perimeter P will increase based on a shape-memory property of the frame structure 1020 to return to a predetermined shape. For example, applying and releasing a tensile force on the free ends 1036a, 1036b of the second body portion of cinch member 1032 can respectively reduce or increase the device perimeter P of the anchoring member 1020b.

[0062] In examples, prosthetic valve device 1000 may be resiliency biased to cause a radial expansion of prosthetic valve device 1000 (e.g., to engage an annulus of a heart valve such as the mitral valve or tricuspid valve). Cinch member 1032 may be configuredto overcome the resilient bias to control and / or reduce the perimeter dimension of perimeter P when exerting the force on second body portion 1036. Hence, cinch member 1032 may be configured such that a clinician may cause cinch member 1032 to constrain the radial expansion of prosthetic valve device 1000 during, for example, an implantation procedure. The clinician may release cinch member 1032 when prosthetic valve device 1000 is in position within the heart (e.g., within the annulus of the tricuspid valve), such that the tensile force on second body portion 1036 ceases. After implantation of the prosthetic valve 1000, the cinch member 1032 may be withdrawn from heart by pulling on one of the free ends 1036a, 1036b of the second body portion 1036 and extracting the cinch member from the passage 1040 and separating the cinch member 1032 from the prosthetic valve 1000. The cinch member 1032 can then be disposed of while the prosthetic valve 1000 remains implanted..

[0063] As depicted schematically in at least Fig. 1A, the outer support (e.g., anchoring member 1020B) may define a device maximum height DH which is measured longitudinally (i.e., parallel to direction L) from a lowermost point (e.g., base B) of the prosthetic valve device 1000 to and uppermost point (e.g., top T) of the prosthetic valve device 1000. The at least one passage 1040 has a passage height location PH which is also measured longitudinally from the base B of the prosthetic valve device 1000. The passage height location PH can be a linear position, such as an average, uppermost bound, or lowermost bound of the passage 1040 dimension through which the cinch member 1032 extends. The passage height location PH can also or instead be a “zone” or “range” of locations along the longitudinal valve axis V which the passage 1040 crosses and / or is present.

[0064] As shown in at least Fig. 1A, the passage height location PH is longitudinally spaced laterally adjacent to, and / or longitudinally above, the device maximum height DH as measured longitudinally from the base B of the prosthetic valve device 1000. Stated differently, the device maximum height DH corresponds to an “uppermost” (in the orientation of Fig. 1 A) extent of the stent or frame 1020 defining the distance anchoring member 1020B extends above (longitudinally “upward” from) the base B of the prosthetic valve device 1000. The at least one passage 1040-which may be, but is not necessarily, defined by a circumferentially extending pleat in, or a tube or other channel attached to, the graft material 1030— has a (linear or range / zone) passage height location PH which isat least partially either at or above the device maximum height DH as shown in Fig. 1 A, or at least partially below the device maximum height DH as shown in Fig. IB.. In other words, in the embodiment illustrated in Fig. IB, the passage 1040 is not wholly located further longitudinally upward from the base B of the prosthetic valve device than is the “uppermost” extent of the stent or frame 1020. On the other hand, in the embodiment illustrated in Fig. 1A, the passage 1040 is located further longitudinally upward from the base B. In both embodiments of Fig.1 A and IB, the passage 1040 and the corresponding cinch member 1032 extending through the passage 1040 are located, relative to the vertical axis V, substantially at the same radially location as anchoring member 1020b, corresponding to the device perimeter P. For example, in Fig. 1A, the passage 1040 can be formed by folding over and affixing (e.g., sewing or adhering) the graft material 1030 at the uppermost end T to form a pocket in which the cinch member 1032 extends. In Fig. IB, the passage 1040 can be formed by folding over and affixing (e.g., sewing or adhering) the graft material 1030 at an inner surface of the anchoring member 1020b below the uppermost end T to form a pocket in which the cinch member 1032 extends. The passage 1040 and corresponding cinch member 1032 are located radially inward of the fixation elements 1050.

[0065] Although a single passage 1040 is shown in each of Figs. 1 A and IB, in other aspects, two or more passages, with corresponding two or more cinch members extending therethrough, can be provided on a single prosthetic valve 1000 to provide a cinch member 1032 at multiple elevations of the anchoring member 1020b such that the radial expansion of the anchoring member 1020b can be controlled at multiple different longitudinal elevations.. It is also contemplated that one or more passages 1040 could be provided and longitudinally spaced from one another to allow a user to choose one or more of the passages 1040 for cinching the associated prosthetic valve device 1000 as desired. One of ordinary skill in the art can readily provide any suitable number of passages 1040, one or more of which may have an associated cinch member 1032, for a particular use environment of the prosthetic valve device 1000, following the teachings of the present disclosure.

[0066] A delivery device 320 which may be used for transcatheter delivery and deployment of an implant, such as the non-limiting example of the prosthetic heart valve 1000 of Figs. 1A-2B, is shown in Figs. 3-8. In general terms, the delivery device 320 isarranged and configured for percutaneously delivering an implant (e.g., prosthetic heart valve 1000) in a delivery configuration to a patient’s native defective heart valve or other portion of a patient’s anatomy via transcatheter delivery. Fig. 3 illustrates a side view of the delivery device 320, and Fig. 4 illustrates a system 319 that includes the delivery device 320 operably coupled to a hydraulic system 470 as well as a deployment assist 468. Fig. 5 is a cross-sectional view taken along line A- A of Fig. 3. Fig. 6 is an exploded view of the delivery device 320. The delivery device 320 includes an innermost shaft assembly 324, an inner steerable catheter 326 disposed over the innermost shaft assembly 324, and an outer steerable catheter 328 disposed over the inner steerable catheter 326. The innermost shaft assembly 324 incudes a capsule 322 for housing at least a portion of the prosthetic heart valve 1000 during delivery thereof. The inner steerable catheter 326 includes a handle 327 at a proximal portion thereof for manipulation in situ, and the outer steerable catheter 328 includes a handle 329 at a proximal portion thereof for manipulation in situ. During delivery, the prosthetic heart valve 1000 contained within the capsule 322 is steered by the inner steerable catheter 326 and the outer steerable catheter 328 into alignment within the native heart valve for which the prosthetic heart valve 1000 serves as a replacement. The inner steerable catheter 326 may be controlled or steered independently from the outer steerable catheter 328 and provides the delivery device 320 with omnidirectional steering capabilities to direct the capsule 322.

[0067] Components of the delivery device 320 will now be described in more detail. The innermost shaft assembly 324 includes a flexible shaft 324A, a piston mount 324B, a deployment piston 354, a tension cable 330, a distal shaft 324C, the capsule 322, and a capsule cap 353. At a proximal end thereof, as best shown in the exploded view of Fig. 6, the innermost shaft assembly 324 is fixedly secured to a manifold 325. Fig. 7 is an enlarged view of a distal portion of the innermost shaft assembly 324. The innermost shaft assembly 324 may be considered to include a first subassembly which includes the flexible shaft 324 A, the piston mount 324B and the deployment piston 354, and a second subassembly which includes the tension cable 330, the distal shaft 324C, the capsule 322, and the capsule cap 353. The first and second subassemblies are coupled together in that the distal shaft 324C of the second subassembly slides or telescopes within the piston mount 324B of the first subassembly. In addition, the first and second subassemblies are coupled together via the manifold 325.

[0068] With respect to the first subassembly, the flexible shaft 324A is a flexible elongated tubular body that may include, for example, a flexible metal tetris or spring disposed within a polymer jacket. A distal end of the flexible shaft 324A is attached and fixed relative to a proximal end of the piston mount 324B, which is a rigid, tubular body that distally extends from the flexible shaft 324A. The deployment piston 354 is attached and fixed relative to the piston mount 324B. More particularly, the deployment piston 354 is disposed over and mounted to a distal end of the piston mount 324B.

[0069] With respect to the second subassembly, the capsule 322 is a tubular component having a closed or distal end 355 A and an open or proximal end 355B. The capsule 322 may be rigid and made of metal. The capsule 322 is configured to house at least a portion of the prosthetic heart valve 1000 during delivery. The distal end 355A of the capsule 322 is closed via the capsule cap 353. The capsule cap 353 may be integrally formed with the capsule 322 or may be a separate component attached thereto to form the closed distal end 355A. The distal shaft 324C is further attached to the capsule cap 353. The distal shaft 324C may be integrally formed with the capsule cap 353, or in another embodiment, the distal end of the distal shaft 324C may be welded or otherwise attached to the capsule cap 353.

[0070] With additional reference to the cross-sectional view of Fig. 5, the tension cable 330 extends from the manifold 325 to the distal shaft 324C through the lumens of the flexible shaft 324A and the piston mount 324B. Reference number 331 is utilized in Fig. 5 to designate the lumen of the flexible shaft 324A. The lumens of the flexible shaft 324A and the piston mount 324B are in fluid communication with each other. A distal end of the tension cable 330 is secured or mounted within a proximal portion of the distal shaft 324C. In an embodiment, the tension cable 330 is configured to be selectively tensioned (proximally or distally) by hydraulic force to enable translation of the capsule 322 either proximally or distally with respect to the piston mount 324B and the deployment piston 354 attached thereto. Depending on which hydraulic system is engaged (deployment or recapture), the tension cable 330 will translate under tension through the innermost shaft assembly 324, with the capsule 322 moving in a distal direction during deployment or moving in a proximal direction during recapture, as will be described in more detail herein.

[0071] The distal shaft 324C is received within the lumen of the piston mount 324B and may move or slide relative thereto in an axial or longitudinal direction. Stated another way, the distal shaft 324C telescopes within the piston mount 324B. The capsule 322 is concentrically disposed over the distal shaft 324C, and an annular chamber 357 (shown in Fig. 7) is defined between an inner surface of the capsule 322, an outer surface of the distal shaft 324C, the deployment piston 354 and the capsule cap 353. The annular chamber 357 is a sealed cavity into which fluid can be introduced to increase fluid pressure therein and thereby move the capsule 322 away from the deployment piston 354, which remains stationary during fluid delivery as described below.

[0072] The inner steerable catheter 326 is disposed over the innermost shaft assembly 324 such that an annular lumen 332 (shown on Fig. 5) is defined between an outer surface of the innermost shaft assembly 324 and an inner surface of the inner steerable catheter 326 along an entire length of the inner steerable catheter 326. The innermost shaft assembly 324 is slidingly disposed within the inner steerable catheter 326 such that relative axial movement is permitted therebetween as will be described in more detail below. As used herein, “slidably” generally denotes back and forth movement in a longitudinal direction along or generally parallel to a central longitudinal axis LA of the delivery device 320. The inner steerable catheter 326 includes a flexible, steerable tubular component or shaft 334, the handle 327 fixedly secured to a proximal end 336 of the shaft 334, an inner distal flex component 340 extending distally from a distal end 338 of the shaft 334, and a first pullwire 342. The shaft 334 can assume various forms conventionally employed, and in some embodiments can be a braided catheter surrounded by a polymer outer layer or jacket. The inner distal flex component 340 is secured to and extends distally from the shaft 334 and can be configured to exhibit flexibility and / or hoop strength characteristics differing from that of the shaft 334. In an embodiment, the inner distal flex component 340 is a metal tube with a laser cut pattern that facilitates flexing or bending of the inner distal flex component 340. A cap 341 (shown in Fig. 3) is attached to a distal end of the inner distal flex component 340. The cap 341 is an annular component that permits the innermost shaft assembly 324 to slide therethrough. The handle 327 includes an actuator 327 A that is accessible to the user and may be manipulated to control flexing or bending of the inner distal flex component 340 of the shaft 334. More particularly, as will be explained in more detail herein, the first pullwire 342 is attached to and extends betweenthe handle 327 and the cap 341 attached to the inner distal flex component 340. The first pullwire 342 is selectively tensioned by the user to bend the inner distal flex component 340. The inner steerable catheter 326 is configured to transition between a non-flexed configuration when the first pullwire 342 is not tensioned and a flexed configuration in which the first pullwire 342 is tensioned.

[0073] The handle 327 includes the actuator 327A for tensioning the first pullwire 342. The handle 327 can have any shape or size appropriate for convenient handling by a user. The actuator 327A is coupled to the proximal end of the first pullwire 342 and is constructed to provide selective proximal retraction and distal advancement of the first pullwire 342. Stated another way, the actuator 327A is coupled to the proximal end of the first pullwire 342 and is constructed to selectively push or pull the first pullwire 342. The actuator 327A may assume any construction that is capable of providing the desired pullwire actuation functionality. In an embodiment, the actuator 327A is configured as a rotatable knob that is rotated in a first direction (i.e., clockwise) to proximally retract the first pullwire 342 and apply tension thereto, and is rotated in a second, opposing direction (i.e., counter-clockwise) to distally advance the first pullwire 342 and remove or release tension therefrom. In another embodiment, the actuator 327A may be configured as a button.

[0074] The outer steerable catheter 328 is slidably disposed over the inner steerable catheter 326 such that an annular lumen 343 (shown on Fig. 5) is defined between an outer surface of the inner steerable catheter 326 and an inner surface of the outer steerable catheter 328 along an entire length of the outer steerable catheter 328. The outer steerable catheter 328 includes a flexible, steerable tubular component or shaft 344, the handle 329 fixedly secured relative to a proximal end 346 of the shaft 344, an outer distal flex component 350 extending distally from a distal end 348 of the shaft 344, and a second pullwire 352. The shaft 344 can assume various forms conventionally employed, and in some embodiments can be a braided catheter surrounded by a polymer outer layer or jacket. The outer distal flex component 350 is secured to and extends distally from the shaft 344 and can be configured to exhibit flexibility and / or hoop strength characteristics differing from that of the shaft 344. In an embodiment, the outer distal flex component 350 is formed from a metal tube with a laser cut pattern that facilitates flexing or bending of the outer distal flex component 350. A cap 351 is attached to a distal end of the outerdistal flex component 350. The cap 351 is an annular component that permits the inner steerable catheter 326 to slide therethrough. The handle 329 includes an actuator 329A that is accessible to the user and may be manipulated to control steering of the outer distal flex component 350 of the shaft 344. More particularly, as will be explained in more detail herein, the second pullwire 352 is attached to and extends between the handle 329 and the cap 351 of the outer distal flex component 350. The second pullwire 352 is selectively tensioned by the user to bend the outer distal flex component 350. The outer steerable catheter 328 is configured to transition between a non- flexed configuration when the second pullwire 352 is not tensioned and a Hexed configuration in which the second pullwire 352 is tensioned.

[0075] The handle 329 includes the actuator 329A for tensioning the second pullwire 352. The handle 329 can have any shape or size appropriate for convenient handling by a user. The actuator 329A is coupled to the proximal end of the second pullwire 352 and is constructed to provide selective proximal retraction and distal advancement of the second pullwire 352. Stated another way, the actuator 329A is coupled to the proximal end of the second pullwire 352 and is constructed to selectively push or pull the second pullwire 352. The actuator 329A may assume any construction that is capable of providing the desired pullwire actuation functionality. In an embodiment, the actuator 329A is configured as a rotatable knob that is rotated in a first direction (i.e., clockwise) to proximally retract the second pullwire 352 and apply tension thereto, and is rotated in a second, opposing direction (i.e., counter-clockwise) to distally advance the second pullwire 352 and remove or release tension therefrom. In another embodiment, the actuator 329A may be configured as a button.

[0076] As stated above, the delivery device 320 is operatively coupled to the hydraulic system 470 (see Fig. 4). The hydraulic system 470 is utilized to axially or longitudinally move the capsule 322 relative to the prosthetic heart valve 1000. More particularly, the hydraulic system 470 includes a deployment pressure delivery device 472 and a recapture pressure delivery device 473. The deployment pressure delivery device 472 is configured to deliver hydraulic fluid to the annular chamber 357 of the delivery device 320 in order to drive the capsule 322 in a distal direction, thereby deploying the prosthetic heart valve 1000, as will be described in more detail herein. The deployment pressure delivery device 472 is configured to be fluidly coupled to a deployment valve 463 of the manifold 325.The recapture pressure delivery device 473 is configured to deliver hydraulic fluid to a recapture chamber 461 of the delivery device 320 in order to drive the capsule 322 in a proximal direction, thereby recapturing the prosthetic heart valve 1000, as will be described in more detail herein. The recapture pressure delivery device 473 is configured to be fluidly coupled to a recapture valve 464 of the manifold 325. In an embodiment, the deployment pressure delivery device 472 and the recapture pressure delivery device 473 are inversely related to each other. For example, when the delivery device 320 is in the delivery configuration, the deployment pressure delivery device 472 is full (as the annular chamber 357 is empty), while the recapture pressure delivery device 473 is empty (as the recapture chamber 461 is full). Conversely, when the delivery device 320 is in the deployed configuration, the deployment pressure delivery device 472 is empty (as the annular chamber 357 is full), while the recapture pressure delivery device 473 is full (as the recapture chamber 461 is empty). The fluid paths of the recapture chamber 461 and the annular chamber 357 are independent of one another. However, it is envisioned that in some embodiments, the recapture chamber 461 and the annular chamber 357 are fluidly connected to one another, allowing for the recapture chamber 461 and the annular chamber 357 to change volume inversely based on a single source of hydraulic fluid. In an embodiment, each of the pressure delivery devices 472, 473 may be a pump or a syringetype inflator. In another embodiment, the pressure delivery devices 472, 473 may be integrated into an inflation device that is configured to be coupled to a flow reverser that selects which hydraulic cylinder or chamber 461, 357 to pressurize, while venting the opposing or non-selected cylinder or chamber 461, 357.

[0077] The deployment piston 354 is an annular component that defines an opening or central bore 333 such that the deployment piston 354 is configured to be disposed over and attached to a distal end of the piston mount 324B. The deployment piston 354 includes a plurality of slots or recesses 358 configured to receive the attachment bars 1120 of the prosthetic heart valve 1000. The deployment piston 354 also includes an annular groove 360 on an outer surface thereof. A seal 356 (shown in Fig. 8) is disposed within the annular groove 360. The seal 356 is thus coupled to the deployment piston 354 and functions to provide a fluid seal between the deployment piston 354 and an inner surface of the capsule 322. The seal 356 may be, for example, an O-ring. When fluid is present inthe annular chamber 357, the seal 356 prevents fluid from leaking out between the outer surface of the deployment piston 354 and the inner surface of the capsule 322.

[0078] Referring now to Fig. 8, the prosthetic heart valve 1000 is loaded onto the deployment piston 354 and disposed within the capsule 322 for delivery thereof. It will be understood by one of ordinary skill in the art that other delivery configurations of the prosthetic heart valve 1000 are contemplated and the illustrated configuration is only exemplary. For example, the capsule 322 is not required to extend over the full length of the prosthetic heart valve 1000. In another embodiment (not shown), a portion of the prosthetic heart valve 1000 may extend proximally from the open or proximal end 355b of the capsule 322 and may be radially compressed for delivery within the vasculature via a cinch member 1032. In the delivery configuration depicted in Fig. 8, the capsule 322 is shown in a first position relative to the deployment piston 354 in which the deployment piston 354 abuts against or is disposed directly adjacent to the capsule cap 353. In this first position, the capsule 322 is positioned so as to compressively retain at least a portion of the prosthetic heart valve 1000. The prosthetic heart valve 1000 is coupled to the deployment piston 354 via the attachment bars 1120 being disposed within the plurality of slots 358. In the depicted embodiment, the capsule 322 has a length that is greater than or substantially equal to a length of the prosthetic heart valve 1000 such that the full length of the prosthetic heart valve 1000 is radially compressed by the capsule 322. However, in another embodiment (not shown), the capsule 322 may have a length that is shorter than a length of the prosthetic heart valve 1000 such that a proximal portion of the prosthetic heart valve 1000 extends proximally out of the proximal end 355b of the capsule 322. In Fig. 8, the distal shaft 324C is concealed from view since the piston mount 324B extends thereover. In this delivery configuration of Fig. 8, the clinician may then insert the distal end of the delivery device 320 into the patient and navigate the capsule 322 through the vasculature of the patient to the desired location within the patient’s heart.

[0079] Once in the proper position, the clinician may then use the deployment pressure delivery device 472 to begin to fill the annular chamber 357, moving capsule 322 axially relative to the deployment piston 354. More particularly, the capsule 322 is configured to be distally advanced relative to the deployment piston 354 in order to incrementally release and deploy the prosthetic heart valve 1000 from the capsule 322. Via the manifold 325, fluid is injected from the deployment pressure delivery device 472 into the innermostshaft assembly 324 in order to drive the capsule 322 distally. The prosthetic heart valve 1000 remains in a stationary longitudinal position relative to the native valve while the capsule 322 is driven distally, thereby increasing the precision of deployment.

[0080] More particularly, the manifold 325 is connected to the deployment pressure delivery device 472 of the hydraulic system 470 via the deployment valve 463. The deployment pressure delivery device 472 is fluidly connected to the annular chamber 357 within the capsule 322 via the lumens of the flexible shaft 324A and the piston mount 324B (which are in fluid communication with each other). Fluid enters the annular chamber 357 via the outlet of the piston mount 324B, around the distal shaft 324C through the annular space or lumen defined between the outer surface of the distal shaft 324C and the inner surface of the piston mount 324B. As the annular chamber 357 fills with fluid, the capsule 322 is distally advanced with respect to the deployment piston 354providing the capsule 322 at a second position relative to the deployment piston 354, in which the deployment piston 354 is disposed within the capsule 322 at approximately a midportion thereof. The annular chamber 357 between the deployment piston 354 and the capsule cap 353 is filled with fluid from the deployment pressure delivery device 472. The deployment piston 354, which is attached and fixed to the piston mount 324B and the flexible shaft 324A, remains stationary as the capsule 322 and distal shaft 324C move in an axial direction. The deployment piston 354 (and piston mount 324B and flexible shaft 324A) may be held in place by holding the manifold 325 stationary during fluid delivery.

[0081] The fluid continues to fill the annular chamber 357 until the capsule 322 reaches a third position relative to the deployment piston 354, in which the deployment piston 354 is partially disposed within the capsule 322 and is directly adjacent to the proximal end 355b of the capsule 322. The annular chamber 357 between the deployment piston 354 and the capsule cap 353 is filled with fluid from the deployment pressure delivery device 472. At this third position, the plurality of slots 358 of the deployment piston 354 are no longer covered by the capsule 322. With the plurality of slots 358 exposed, the attachment bars 1120 of the prosthetic heart valve 1000 are permitted to decouple from the deployment piston 354. Accordingly, via movement of the capsule 322, the prosthetic heart valve 1000 is unsheathed from the capsule 322. When the capsule 322 no longer covers or extends over the attachment bars 1120, the attachment bars 1120 are free or permitted to pop out of the slots 358 of the deployment piston 354 to decouple the prosthetic heart valve 1000from the deployment piston 354. Thus, once the prosthetic heart valve 1000 is no longer covered by the capsule 322, the prosthetic heart valve 1000 is permitted to radially selfexpand towards the expanded configuration of Figs. 1A and 2A.

[0082] As shown in Fig. 3, the cinch member 1032 described above with respect to Figs. 1A-2B extends from the prosthetic valve 1000 through the delivery system 324 and emerges from an aperture 301 in a proximal portion of the delivery system 324 such that the free ends 1036a, 1036b are accessible to a user during delivery and deployment (e.g., while a distal portion of the delivery system 324 is position inside a patient). It should be understood that the aperture 301 can be located on any component of the proximal portion of the delivery system including the manifold 325, or the handles 327, 329. In this manner, a user can selectively apply and release a tensile force on the cinch member 1032 to selectively control radial expansion and contraction of the anchoring member 1020b during delivery and deployment of the prosthetic valve 1000. In addition to controlling the radial expansion of the anchoring member 1020b, applying a tensile force on cinch member 1032 (e.g., by pulling on free ends 1036a, 1036b) can also permit additional control of the position of the prosthetic valve 1000 during delivery and deployment. For example, if a user determines that the prosthetic valve 1000 is position too low relative to the annulus of a patient, the user can pull on the free ends 1036a, 1036b and move (e.g., translate) the position of the prosthetic valve 1000 to raise the position of the valve 1000 relative to the patient annulus. The cinch member 1032 can therefore be used to adjust the position of the prosthetic valve 1000 thereby improving delivery accuracy and control. Upon placement of the prosthetic valve 1000, the user can then pull one of the free ends 1036a, 1036b to pull the cinch member out of the aperture 301 of the delivery system 324.

[0083] As shown in Fig. 5, the cinch member 1032 can extend through a lumen 370 provided along a longitudinal length of the delivery system. The lumen can be connected to aperture 301 such that the cinch member 1032 extends through the aperture 301 within the lumen 370 along the length of the delivery system 324 and through the passage 1040 of the prosthetic valve 1000. The lumen can be located (e.g., attached or affixed) to the innermost shaft assembly 324. In other aspects, the lumen 370 can be located on the inner steerable catheter 326 or the outer steerable catheter 328, or the lumen can be located within either of the annular lumens 332, 343. In additional aspects, the cinch member 1032 can extend through the delivery system alone (e.g., without a lumen).

[0084] In summary, a person having ordinary skill in the art will understand that, alone or in combination with any other aspect, the present disclosure provides an example aspect 1 of a prosthetic device to engage an annulus of a heart valve of a heart. The prosthetic device is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the prosthetic device engages the annulus. A cinch member includes a member body including a first body portion and a second body portion. The first body portion is configured to selectively translate within at least one passage defined by the prosthetic device. The prosthetic device defines a device perimeter surrounding the valve axis. The first body portion is configured to reduce a perimeter dimension of the device perimeter when a tensile force is exerted on the second body portion. The prosthetic device includes an outer support configured to engage the annulus. The outer support is configured to cause the valve axis to pass through the annulus when the outer support engages the annulus. The outer support defines a device maximum height measured longitudinally from a base of the prosthetic device. The at least one passage has a passage height location measured longitudinally from the base of the prosthetic device. The passage is located radially at or inward of an outer surface of the outer support.

[0085] An example aspect 2 includes the prosthetic device of aspect 1, wherein the prosthetic device includes a valve support 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.

[0086] An example aspect 3 includes the prosthetic device of aspect 1, wherein the valve support is mechanically supported by the outer support.

[0087] An example aspect 4 includes the prosthetic device of aspect 3, wherein the prosthetic device 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.

[0088] An example aspect 5 includes the prosthetic device of any of aspects 1-4, wherein the passage is located longitudinally at or above the device maximum height..

[0089] An example aspect 6 includes the prosthetic device of any of aspects 1-5, wherein the cinch member is configured to cause the first body portion to slidably translate within the at least one passage to selectively reduce the perimeter dimension when the tensile force is exerted on the second body portion.

[0090] An example aspect 7 includes the prosthetic device of any of aspects 1 -6, wherein the perimeter dimension is measured in a direction substantially perpendicular to the valve axis.

[0091] An example aspect 8 includes the prosthetic device of any of aspects 1-7, wherein the cinch member is configured to urge the outer support toward the valve axis when the tensile force is exerted on the second body portion.

[0092] An example aspect 9 includes the prosthetic device of aspect 8, wherein the prosthetic device is resiliently biased to resist the displacement of the outer support toward the valve axis.

[0093] An example aspect 10 includes the prosthetic device of aspect 9, wherein the first body portion is configured to overcome the resilient biasing when the tensile force is exerted on the second body portion.

[0094] An example aspect 11 includes the prosthetic device of any of aspects 1-10, wherein the prosthetic device is configured to establish a first perimeter dimension in a delivery configuration and a second perimeter dimension in an expanded configuration, wherein the second perimeter dimension is greater than the first perimeter dimension.

[0095] An example aspect 12 includes the prosthetic device of aspect 11, wherein the cinch member is removed from the at least one passage when the prosthetic device is in the expanded configuration at a predetermined relationship with the annulus.

[0096] An example aspect 13 includes a system of delivering the prosthetic device of any of aspects 1-12, further comprising a delivery system for delivering the prosthetic valve, wherein the delivery system comprises a lumen through which the cinch member extends and an aperture from which free ends of the cinch member exit.

[0097] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0098] While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means / options for placing the above-described apparatus, or components thereof,into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and / or any suitable material or combinations of materials. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status. The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified— a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.

[0099] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description andaccompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0100] Other aspects, objects, and advantages can be obtained from a study of the drawings, the disclosure, and the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A prosthetic device to engage an annulus of a heart valve of a heart, wherein the prosthetic device is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the prosthetic device engages the annulus; and a cinch member including a member body including a first body portion and a second body portion, wherein the first body portion is configured to selectively translate within at least one passage defined by the prosthetic device, wherein the prosthetic device defines a device perimeter surrounding the valve axis, and wherein the first body portion is configured to reduce a perimeter dimension of the device perimeter when a tensile force is exerted on the second body portion; wherein the prosthetic device includes an outer support configured to engage the annulus, and wherein the outer support is configured to cause the valve axis to pass through the annulus when the outer support engages the annulus; wherein the outer support defines a device maximum height measured longitudinally from a base of the prosthetic device and the at least one passage has a passage height location measured longitudinally from the base of the prosthetic device; and wherein the passage is located radially at or inward of an outer surface of the outer support.

2. The prosthetic device of claim 1 , wherein the prosthetic device includes a valve support 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.

3. The prosthetic device of claim 2, wherein the valve support is mechanically supported by the outer support.

4. The prosthetic device of claim 3, wherein the prosthetic device 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.

5. The prosthetic device of any of claims 1-4, wherein the passage is located longitudinally at or above the device maximum height..

6. The prosthetic device of any of claims 1-5, wherein the cinch member is configured to cause the first body portion to slidably translate within the at least one passage to selectively reduce the perimeter dimension when the tensile force is exerted on the second body portion.

7. The prosthetic device of any of claims 1-6, wherein the perimeter dimension is measured in a direction substantially perpendicular to the valve axis.

8. The prosthetic device of any of claims 1-7, wherein the cinch member is configured to urge the outer support toward the valve axis when the tensile force is exerted on the second body portion.

9. The prosthetic device of claim 8, wherein the prosthetic device is resiliently biased to resist the displacement of the outer support toward the valve axis.

10. The prosthetic device of claim 9, wherein the first body portion is configured to overcome the resilient biasing when the tensile force is exerted on the second body portion.

11. The prosthetic device of any of claims 1-10, wherein the prosthetic device is configured to establish a first perimeter dimension in a delivery configuration and a second perimeter dimension in an expanded configuration, wherein the second perimeter dimension is greater than the first perimeter dimension.

12. The prosthetic device of claim 11, wherein the cinch member is removed from the at least one passage when the prosthetic device is in the expanded configuration at a predetermined relationship with the annulus.

13. A system of delivering the prosthetic device of any of claims 1 -12, further comprising a delivery system for delivering the prosthetic valve, wherein the delivery system comprises a lumen through which the cinch member extends and an aperture from which free ends of the cinch member exit.

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