Mechanically expandable prosthetic device

Abstract

The invention relates to a mechanically expandable prosthetic device. A prosthetic device, such as a prosthetic heart valve, may include a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. In some examples, the prosthetic device may include a locking mechanism configured to maintain the prosthetic device in a radially expanded state. In some examples, the locking mechanism may be integrated into the frame of the prosthetic device.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 2021107737292, entitled “Mechanically Expandable Prosthetic Device”, filed on July 8, 2021.

[0002] Cross-reference to related applications This application claims the benefits of U.S. Provisional Application No. 63 / 211,892, filed June 17, 2021; U.S. Provisional Application No. 63 / 138,599, filed January 18, 2021; U.S. Provisional Application No. 63 / 073,622, filed September 2, 2020; and U.S. Provisional Application No. 63 / 049,812, filed July 9, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to implantable, mechanically expandable prosthetic devices (such as prosthetic heart valves), and methods, components, and apparatus for delivering, expanding, implanting, and deploying such prosthetic devices. Background Technology

[0004] The human heart can suffer from various valvular diseases. These diseases can lead to serious heart dysfunction, ultimately requiring repair of the native valve or replacement with a prosthetic valve. Many known repair devices (such as stents) and prosthetic valves exist, along with numerous known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices into locations within the body that are not easily accessible through surgery or where access is desired without surgery. In a particular example, a prosthetic heart valve can be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic heart valve reaches its implantation site in the heart. The prosthetic heart valve then expands to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery device, allowing the prosthetic heart valve to self-expand to its functional size.

[0005] Prosthetic heart valves that rely on mechanical actuators for expansion can be termed "mechanically expandable" prosthetic heart valves. Mechanically expandable prosthetic heart valves can offer one or more advantages over self-expanding and balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to a wide range of fully functional working diameters. Some mechanically expandable prosthetic heart valves can also be compressed after initial expansion (e.g., for repositioning and / or retrieval).

[0006] Despite recent advances in percutaneous valve technology, there is still a need for improved transcatheter heart valves and delivery devices for such valves. Summary of the Invention

[0007] This disclosure relates to implantable, mechanically expandable prosthetic devices (such as prosthetic heart valves), and methods, components, and apparatus for delivering, expanding, implanting, and deploying such prosthetic devices.

[0008] In one representative embodiment, a prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts, a plurality of links, and a plurality of compliant joints. The plurality of posts extend axially from an inlet end of the frame to an outlet end. The plurality of links extend circumferentially between adjacent posts. Each of the plurality of compliant joints pivotally couples one of the plurality of links to one of the plurality of posts. As the frame moves from the radially compressed state to the radially expanded state, the plurality of compliant joints deflect circumferentially.

[0009] In another representative embodiment, a prosthetic device includes a frame that can radially expand and compress between a radially compressed state and a radially expanded state. The frame includes a plurality of posts and a plurality of links. Each post includes an axially extending first member and two axially extending second members, wherein the first member is configured to move axially relative to the second members within a channel of the second members to radially expand and / or radially compress the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints.

[0010] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a radially expandable and compressible frame and at least one expansion locking device. The at least one expansion locking device is movable between an extended position and a retracted position and includes a distal member and a proximal member. The proximal member includes a locking element configured to prevent the distal member and the proximal member from moving away from each other. The distal member and the proximal member are coupled to the frame at axially spaced locations on the frame. The distal member is coupled to the frame at a portion of the frame more distal to the proximal member. The delivery device includes at least one actuating component configured to be removably coupled to the expansion locking device and to move the distal member and the proximal member toward each other to radially expand the prosthetic device. When the expansion locking device is in the extended position, the actuating component extends distally through the locking element. When the expansion locking device is in the retracted position, the distal member extends proximally through the locking element. The locking element is configured to continuously frictionally engage the actuating component when the actuating component extends distally through the locking element, and is configured to continuously frictionally engage the distal component when the distal component extends proximally through the locking element, so as to continuously lock the extended locking device at any position between the extended position and the retracted position.

[0011] In another representative embodiment, a prosthetic device includes a radially compressible and expandable frame comprising a plurality of posts. The plurality of posts extend axially from a proximal end of the frame to an opposite distal end of the frame, wherein each post in a subset of the plurality of posts includes a proximal member and a distal member, the proximal member and the distal member being axially movable relative to each other to radially expand and / or radially compress the frame. The proximal member includes a channel receiving the distal member, and the distal member is configured to slide axially relative to the proximal member within the channel to radially expand and / or compress the prosthetic device. The proximal member further includes an axially extending aperture extending distally from the proximal end of the frame to the channel, wherein the axially extending aperture is configured to receive an actuating member of a delivery device. The distal member is configured to be removably coupled to the actuating member of the delivery device.

[0012] In another representative embodiment, a prosthetic device includes a radially compressible and expandable frame comprising a plurality of posts, a plurality of links, a plurality of first compliant joints, and a plurality of interconnects. The plurality of posts extend axially from a proximal end of the frame to opposite distal ends. The plurality of links extend circumferentially between adjacent posts. Each of the plurality of first compliant joints pivotally couples one of the links to one of the posts, wherein the plurality of first compliant joints includes a plurality of first flexible neck portions. The plurality of interconnects are circumferentially positioned between the plurality of posts and include a plurality of second compliant joints, wherein each of the plurality of interconnects pivotally couples four of the links, and wherein the plurality of second compliant joints includes a plurality of second flexible neck portions. When the frame expands radially from a radially compressed state to a partially expanded state within the initial expansion range of the frame, one or more of the first compliant joints and / or one or more of the second compliant joints elastically deform, and then when the frame expands radially from the partially expanded state to a fully expanded state within a subsequent expansion range, one or more of the first compliant joints and / or one or more of the second compliant joints plastically deform.

[0013] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a radially compressible and expandable frame comprising a plurality of posts, a plurality of links, a plurality of first compliant joints, and a plurality of interconnects. The plurality of posts extend axially from a proximal end of the frame to an opposite distal end of the frame. Each post in a subset of the plurality of posts includes a proximal member and a distal member. The proximal member includes a channel, and the distal member is configured to slide axially within the channel relative to the proximal member to radially expand and / or compress the prosthetic device. The proximal member further includes an axially extending aperture extending distally from the proximal end of the frame to the channel. The plurality of links extend circumferentially between adjacent posts. Each of the plurality of first compliant joints pivotally couples one of the links to one of the posts. The plurality of interconnects are circumferentially positioned between the plurality of posts and include a plurality of second compliant joints, each of the plurality of interconnects pivotally coupling four of the links. The delivery device includes at least one actuating member configured to extend through the axial extension hole of the proximal member and removably coupled to the distal member.

[0014] In yet another representative embodiment, a method includes radially expanding and / or compressing the prosthetic device by axially moving an actuating member of the delivery device through an axially extending hole in a column of a frame of the prosthetic device, wherein the hole extends axially from the proximal end of the frame to a channel of a proximal member of the column, a distal member of the column being configured to move axially within the channel, and wherein the actuating member is releasably coupled to the distal member.

[0015] In another representative embodiment, a prosthetic device includes a radially compressible and expandable frame comprising a plurality of posts, a plurality of links, a plurality of first compliant joints, and a plurality of interconnects, the plurality of interconnects including a plurality of second compliant joints. The plurality of posts extend axially from a first end of the frame to opposite second ends of the frame, each post in a subset of the plurality of posts including a first member and a second member, the first and second members being axially movable relative to each other to radially expand and / or radially compress the frame. The plurality of links extend circumferentially between adjacent posts. Each of the plurality of first compliant joints pivotally couples one of the links to one of the posts. The plurality of interconnects are circumferentially positioned between the plurality of posts and include the plurality of second compliant joints, wherein each of the plurality of interconnects is pivotally coupled to four of the links. At least one of the plurality of posts includes a locking mechanism configured to prevent radial compression of the prosthesis when the prosthesis diameter is greater than a threshold prosthesis diameter, and / or one or more of the first compliant joints and / or one or more of the interconnects are configured to help prevent radial compression of the prosthesis when the prosthesis diameter is greater than or equal to the threshold prosthesis diameter.

[0016] In another representative embodiment, a prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts, a plurality of links, and a plurality of compliant joints. The plurality of posts extend axially from an inlet end to an outlet end of the frame. The plurality of links extend circumferentially between adjacent posts. Each of the plurality of compliant joints pivotally couples one of the links to one of the posts. The compliant joints deflect circumferentially as the frame moves from the radially compressed state to the radially expanded state.

[0017] In another representative embodiment, a prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts and a plurality of links. Each of the plurality of posts includes an axially extending first member and two axially extending second members. The first member includes a plurality of teeth, and each of the second members includes locking teeth configured to engage the plurality of teeth to allow movement in a first direction to allow radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints, and each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves between the radially compressed and radially expanded states.

[0018] In another representative embodiment, a prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of rigid links, each link including a first end portion coupled to a first adjacent link via a first compliant joint and a second end portion coupled to a second adjacent link via a second compliant joint. Each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state.

[0019] In another representative embodiment, a prosthetic device includes a frame movable between a radially compressed state and a radially expanded state. The frame includes a first subframe and a second subframe radially disposed within the first subframe. Each subframe includes a set of rigid links, each link including a first end portion coupled to a first adjacent link via a first compliant joint and a second end portion coupled to a second adjacent link via a second compliant joint. Each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state. The first and second subframes are coupled together via a plurality of fasteners.

[0020] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured to extend and lock, and include an inner member and one or more outer members. The inner member includes a linear rack with a plurality of teeth. The one or more outer members are configured to engage the rack to allow movement in a first direction to allow radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints, and each compliant joint is configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state. The delivery device includes a handle, a first actuating member, and a second actuating member. The first actuating member extends from the handle and is coupled to an outlet end of the frame, and is configured to apply a distally directed force to the inner member. The second actuating member extends from the handle and is coupled to the inlet end of the frame. The second actuating member is configured to apply a proximal force to the one or more outer members. When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, the prosthetic device can radially expand from the radially compressed state to the radially expanded state. When the prosthetic device is in the radially expanded state, the one or more outer members engage the rack to prevent compression of the frame.

[0021] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a frame movable between a radially compressed state and a radially expanded state. The frame includes a first subframe and a second subframe, the second subframe being radially disposed within the first subframe and coupled to the first subframe via a plurality of fasteners. Each subframe includes a set of links coupled to adjacent links via one or more compliant joints, and each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state. The prosthetic device also includes one or more expansion locking mechanisms, each expansion locking mechanism including a first member, a second member, and a locking member. The first member is coupled to the frame at a first position. The second member is coupled to the frame at a second position spaced apart from the first position and extends at least partially into the first member. The locking member is coupled to the first member and configured to engage the second member to allow movement in a first direction to allow radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The delivery device includes a handle, a first actuating member, and a second actuating member. The first actuating member extends from the handle and is coupled to the first member. The first actuating member is configured to apply a distal force to the first member. The second actuating member extends from the handle and is coupled to the second member. The second actuating member is configured to apply a proximal force to the second member. When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, the prosthetic device can radially expand from the radially compressed state to the radially expanded state. When the prosthetic device is in the radially expanded state, the locking member engages the second member to prevent compression of the frame.

[0022] In another representative embodiment, a method includes inserting a distal end of a delivery device into a patient's vascular system, the delivery device being releasably coupled to a prosthetic device comprising a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state, the frame including a plurality of posts and a plurality of links. Each post includes an inner member and two outer members, the inner member including a plurality of teeth, and each outer member including a pawl configured to engage the plurality of teeth to allow movement in a first direction to allow radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links are configured to couple adjacent posts to each other via one or more compliant joints. The method further includes advancing the prosthetic device to a selected implantation site, and radially expanding the prosthetic device by distally moving at least one of the inner member and proximally moving at least one of the outer members, such that the compliant joints are circumferentially deflected, and that the pawls engage the plurality of teeth to lock the prosthetic device in the radially expanded state.

[0023] In another representative embodiment, a prosthetic device includes a radially expandable and compressible frame comprising a plurality of posts and a plurality of links. The plurality of posts include an axially extending first member and an axially extending second member. One or more posts are configured to extend a locking mechanism. The axially extending second member includes a first side portion and a second side portion. The first side portion includes locking teeth configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints.

[0024] In another representative embodiment, a prosthetic device includes a radially expandable and compressible frame comprising a plurality of posts and a plurality of links. One or more of the plurality of posts are configured as an expansion locking mechanism and include an axially extending first member, an axially extending second member, and a cap. The axially extending second member includes a first side portion and a second side portion defining a channel therebetween, with at least a portion of the first member extending into the channel. The cap is disposed above an outlet portion of the second member. The cap includes a biasing member configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints.

[0025] In another representative embodiment, a prosthetic device includes a radially expandable and compressible frame comprising a plurality of posts and a plurality of links. One or more of the plurality of posts are configured to expand and lock, and include an axially extending first member, an axially extending second member, and an annular cap. The axially extending second member includes a first side portion and a second side portion defining a channel therebetween, with at least a portion of the first member extending into the channel. The annular cap is disposed above an outlet portion of the second member. The cap includes an inner lumen extending along the length of the cap, the inner lumen tapering from a first diameter at the inlet end of the cap to a second smaller diameter at the outlet end of the cap. The plurality of links couple adjacent posts to each other via one or more compliant joints. The cap is configured to abut against the first member, forcing the first and second side portions to prevent movement of the first member relative to the second member, thereby preventing radial compression of the frame.

[0026] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured as an expansion locking mechanism and include an axially extending first member and an axially extending second member, the axially extending second member including a first side portion and a second side portion. The first side portion includes locking teeth configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints. The delivery device includes a handle, a first actuating member, and a second actuating member. The first actuating member extends from the handle and is coupled to an outlet end of the frame. The first actuating member is configured to apply a distal force to the first member. The second actuating member extends from the handle and is coupled to an inlet end of the frame. The second actuating member is configured to apply a proximal force to the second member. When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, the prosthetic device can radially expand from the radially compressed state to the radially expanded state. When the prosthetic device is in the radially expanded state, the locking teeth engage the first member to prevent compression of the frame.

[0027] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured as an expansion locking mechanism and include an axially extending first member, an axially extending second member, and a cap. The axially extending second member includes a first side portion and a second side portion defining a channel therebetween, with at least a portion of the first member extending into the channel. The cap is disposed above an outlet portion of the second member. The cap includes a biasing member configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links couple adjacent posts to each other via one or more compliant joints. The delivery device includes a handle, a first actuating member, and a second actuating member. The first actuating member extends from the handle and is coupled to the outlet portion of the frame. The first actuating member is configured to apply a distally directed force to the first member. The second actuating member extends from the handle and is coupled to the inlet end of the frame. The second actuating member is configured to apply a proximal force to the second member. When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, the prosthetic device can radially expand from the radially compressed state to the radially expanded state. When the prosthetic device is in the radially expanded state, the biasing member engages the first member to prevent compression of the frame.

[0028] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured as an expansion locking mechanism and include an axially extending first member, an axially extending second member, and an annular cap. The axially extending second member includes a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel. The annular cap is disposed above an outlet portion of the second member. The cap includes an inner lumen extending along the length of the cap, the inner lumen tapering from a first diameter at the inlet end of the cap to a second smaller diameter at the outlet end of the cap. The plurality of links couple adjacent posts to each other via one or more compliant joints. The delivery device includes a handle, a first actuating member, and a second actuating member. The first actuating member extends from the handle and is coupled to the outlet end of the frame. The first actuating member is configured to apply a distally directed force to the first member. The second actuating member extends from the handle and is coupled to the inlet end of the frame. The second actuating member is configured to apply a proximal force to the second member. When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, the prosthetic device can radially expand from the radially compressed state to the radially expanded state. When the prosthetic device is in the radially expanded state, the first and second side portions engage the first member to prevent compression of the frame.

[0029] In another representative embodiment, a method includes inserting a distal end of a delivery device into a patient's vascular system, the delivery device being releasably coupled to a prosthetic device comprising a radially expandable and compressible frame. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured to extend a locking mechanism and include an axially extending first member and an axially extending second member, the axially extending second member including a first side portion and a second side portion. The first side portion includes locking teeth configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links are configured to couple adjacent posts to each other via one or more compliant joints. The method further includes advancing the prosthetic device to a selected implantation site and distally moving at least one of the first member and proximally moving the second member to radially expand the prosthetic device, such that the compliant joints are circumferentially deflected, and that the locking teeth engage the first member to lock the prosthetic device in a radially expanded state.

[0030] In another representative embodiment, a method includes inserting a distal end of a delivery device into a patient's vascular system, the delivery device being releasably coupled to a prosthetic device including a radially expandable and compressible frame. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured to extend a locking mechanism and include an axially extending first member, an axially extending second member, and a cap. The axially extending second member includes a first side portion and a second side portion defining a channel therebetween. At least a portion of the first member extends into the channel, and the cap is disposed above an outflow portion of the second member. The cap includes a biasing member configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame. The plurality of links are configured to couple adjacent posts to each other via one or more compliant joints. The method further includes advancing the prosthetic device to a selected implantation site, and moving at least one of the first member distally and the second member proximally to radially expand the prosthetic device, such that the compliant connector is circumferentially deflected, and that the biasing member engages the first member to lock the prosthetic device in a radially expanded state.

[0031] In another representative embodiment, a method includes inserting a distal end of a delivery device into a patient's vascular system, the delivery device being releasably coupled to a prosthetic device including a radially expandable and compressible frame. The frame includes a plurality of posts and a plurality of links. One or more of the plurality of posts are configured to extend a locking mechanism and include an axially extending first member, an axially extending second member, and an annular cap. The axially extending second member includes a first side portion and a second side portion defining a channel therebetween. At least a portion of the first member extends into the channel, and the annular cap is disposed above an outflow portion of the second member. The cap includes an inner lumen extending along its length, the inner lumen tapering from a first diameter at the inflow end of the cap to a second, smaller diameter at the outflow end of the cap. The plurality of links are configured to couple adjacent posts to each other via one or more compliant joints. The method further includes advancing the prosthetic device to a selected implantation site, and moving at least one of the first member distally and the second member proximally to radially expand the prosthetic device, such that the compliant connector is circumferentially deflected, and such that the first and second side portions engage the first member to lock the prosthetic device in a radially expanded state.

[0032] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a radially expandable and compressible frame and at least one expansion locking device movable between an extended position and a retracted position. The expansion locking device includes a distal member and a proximal member, the proximal member including a locking element configured to prevent the distal member and the proximal member from moving away from each other. The distal member and the proximal member are coupled to the frame at axially spaced locations on the frame. The distal member is coupled to the frame at a portion of the frame more distal than the proximal member. The delivery device includes at least one actuation component configured to be removably coupled to the expansion locking device and to move the distal member and the proximal member toward each other to radially expand the prosthetic device. When the expansion locking device is in the extended position, the actuation component extends distally through the locking element, and when the expansion locking device is in the retracted position, the distal member extends proximally through the locking element. The locking element is configured to continuously frictionally engage the actuating component when the actuating component extends distally through the locking element, and is configured to continuously frictionally engage the distal component when the distal component extends proximally through the locking element, so as to continuously lock the extended locking device at any position between the extended position and the retracted position.

[0033] In another representative embodiment, a prosthetic device includes a radially expandable and compressible frame and at least one expansion locking mechanism coupled to the frame. The expansion locking mechanism includes a distal member and a proximal member, the distal member being configured to be removably coupled to an actuation assembly of a delivery device for the prosthetic device, the proximal member including a locking element configured to frictionally engage the actuation assembly and the distal member. The locking element is configured to allow movement of the actuation assembly and the distal member relative to the proximal member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame. The proximal member is coupled to a portion of the frame more proximal to the distal member.

[0034] In another representative embodiment, a component includes a prosthetic device and a delivery device. The prosthetic device includes a frame and at least one expansion locking mechanism, the frame being radially expandable and compressible between a radially compressed position and a radially expanded position, the at least one expansion locking mechanism including a distal member and a proximal member. The proximal member is coupled to the frame at a portion of the frame more proximal to the distal member and includes a locking element configured to allow movement of the distal member relative to the proximal member in a proximal direction to cause radial expansion of the frame, and configured to prevent movement in the distal direction to prevent radial compression of the frame. The delivery device includes a handle, a first actuating member, and a second actuating member. The first actuating member is configured to apply a distally directed force to the proximal member. The first actuating member extends distally from the handle to the proximal member. The second actuating member is configured to apply a proximally directed force to the distal member. The second actuating member extends distally from the handle and is removably coupled to the distal member. When the prosthetic device is in the radially compressed position, the locking element frictionally engages the second actuating member, and when the prosthetic device is in the radially extended position, the locking element frictionally engages the distal member to continuously lock the prosthetic device at any position between the radially compressed position and the radially extended position.

[0035] In another representative embodiment, a method includes inserting a distal end of a delivery device into a patient's vascular system, the delivery device being releasably coupled to a prosthetic device including a radially expandable and compressible frame and an expansion locking mechanism comprising a distal member and a proximal member. The method further includes advancing the prosthetic device to a selected implantation site and radially expanding the prosthetic device by applying a distally directed force to the proximal member of the expansion locking mechanism via a first actuating member of the delivery device, the first actuating member being releasably coupled to the proximal member, and applying a proximally directed force to the distal member of the expansion locking mechanism via a second actuating member extending to the proximal member. The method further includes continuously locking the prosthetic device throughout the radial expansion process via spring teeth included in the proximal member to prevent movement of the prosthetic device toward a more radially compressed position, the spring teeth frictionally engaging the second actuating member and the distal member.

[0036] In another representative embodiment, a prosthetic device includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes a plurality of links and a plurality of compliant joints. The plurality of links are connected via the plurality of compliant joints. Each of the plurality of compliant joints is pivotally coupled to two of the links. As the frame moves from the radially compressed state to the radially expanded state, the plurality of compliant joints deflect circumferentially.

[0037] The foregoing and other objects, features and advantages of this disclosure will become more apparent from the following detailed description taken with reference to the accompanying drawings. Attached Figure Description

[0038] Figure 1 This is a perspective view of a prosthetic heart valve according to one embodiment.

[0039] Figure 2 This is a side view of a delivery device for a prosthetic heart valve according to one embodiment.

[0040] Figure 3 This is a perspective view of the frame of a prosthetic heart valve according to one embodiment, wherein the frame is shown in a partially radially extended state.

[0041] Figure 4 yes Figure 3 A perspective view of the frame, in which the frame is shown as being in a radially compressed state.

[0042] Figure 5 yes Figure 3 A perspective view of a portion of the frame.

[0043] Figure 6 yes Figure 3 A perspective view of the frame, in which the frame is shown as being in a radially extended state.

[0044] Figure 7A According to one embodiment Figure 3 A side view of a portion of the frame, showing the extended locking mechanism.

[0045] Figure 7B It is coupled to the delivery device according to one embodiment. Figure 3 A side view of part of the frame.

[0046] Figure 8A yes Figure 3 A side view of part of the frame.

[0047] Figure 8B It is coupled to the valve structure according to one embodiment. Figure 3 A cross-sectional view of the connecting part of the frame.

[0048] Figure 9A This is a perspective view of the frame of a prosthetic heart valve according to another embodiment.

[0049] Figure 9B It includes fasteners. Figure 9A A sectional view of a portion of the frame.

[0050] Figures 10A-10B Various views of a leaf-shaped hinge compliant joint according to one embodiment are illustrated.

[0051] Figure 11A-11E Various views of a beam-type hinge compliant joint according to one embodiment are illustrated.

[0052] Figure 12A-12B Various views of a leaf spring type hinge compliant joint according to one embodiment are illustrated.

[0053] Figure 13 This is a perspective view of the frame of a prosthetic heart valve according to one embodiment, wherein the frame is shown in a radially expanded state.

[0054] Figure 14 According to one embodiment Figure 13 A side view of a portion of the frame, showing the extended locking mechanism.

[0055] Figure 15 This is a side view of an extended locking mechanism according to another embodiment.

[0056] Figure 16 This is a side view of an extended locking mechanism according to yet another embodiment.

[0057] Figure 17 It is coupled to the frame. Figure 16 A side view of a portion of the extended locking mechanism.

[0058] Figure 18A This is a schematic diagram of an extended locking mechanism according to another embodiment, shown in an axially extended position.

[0059] Figure 18B This indicates the position of axial compression. Figure 18A A schematic diagram of the extended locking mechanism.

[0060] Figure 19A This is a perspective view of a portion of a prosthetic heart valve frame shown in a radially compressed position according to one embodiment, the prosthetic heart valve frame including... Figures 18A-18B Extended locking mechanism.

[0061] Figure 19B It is shown in the radially extended position. Figure 19A A perspective view of the prosthetic heart valve frame.

[0062] Figure 20 According to one embodiment, it can be included in Figures 18A-19B A cross-sectional view of the locking element in the extended locking mechanism.

[0063] Figure 21 This is a schematic representation of an extended locking mechanism according to another embodiment, shown in an axially extended position.

[0064] Figure 22 This is a side view of a portion of a prosthetic heart valve frame according to another embodiment.

[0065] Figure 23 It is related to delivery devices (such as) Figure 2 Separation of the actuating components of the delivery device Figure 22 A perspective view of the prosthetic heart valve frame.

[0066] Figure 24 It can be received. Figure 23 An enlarged view of the proximal portion of the prosthetic heart valve frame, which is the actuating component.

[0067] Figure 25 It is coupled to Figure 23-24 Actuating components Figure 22-24 A perspective view of the prosthetic heart valve frame.

[0068] Figure 26 This is a perspective view of the connector of a prosthetic heart valve frame according to one embodiment.

[0069] Figure 27A yes Figure 26 A side view of the connector, in which the prosthetic heart valve frame is radially expanded and axially shortened.

[0070] Figure 27B yes Figure 26-27A A side view of the connector, in which the prosthetic heart valve frame is in a state of radial compression and axial elongation. Detailed Implementation

[0071] General considerations For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, which may be individual and in various combinations and sub-combinations of each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, nor is the existence of any one or more particular advantages or problems necessarily required to be solved by the embodiments of this disclosure.

[0072] Although the operations of some of the disclosed methods are described in a specific, sequential order for ease of expression, it should be understood that this descriptive approach includes rearrangement unless a specific statement requires a particular order. For example, the sequentially described operations may be rearranged or performed concurrently in some cases. Furthermore, for simplicity, the accompanying drawings may not show various methods by which the disclosed methods can be used in combination with other methods. In addition, the description sometimes uses terms such as "provides" or "implements" to describe the disclosed methods. These terms are high-level extractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily discerned by those skilled in the art.

[0073] All features described in this paper are independent of each other and, except in structurally impossible cases, can be combined with any other feature described in this paper. For example, such as Figure 2 The delivery device 100 shown can be used in combination with the prosthetic valves 10, 200, 300, 800, 1200 and / or 1300 described herein. In another embodiment, the extended locking mechanism 332 shown in FIG9 can be used with... Figure 3 -8 shows the prosthetic valve 200 and / or Figure 1 The illustrated prosthetic valve 10 is used in combination. In other embodiments, the extended locking mechanisms 206, 810, 900, 1000, 1100, and / or 1400 can be used with any of the disclosed prosthetic valves 10, 200, 300, 800, 1200, and / or 1300. Additionally, Figure 10A-12BThe disclosed hinges 500, 600, 700 and / or connectors 750 shown in 26-27B can be used with any one or more of the disclosed prosthetic valves 10, 200, 300, 800, 1200 and / or 1300.

[0074] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms, unless the context clearly specifies otherwise. Furthermore, the term “comprising” means “including.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked, and in the absence of specific contrary language, does not exclude the presence of intermediate elements between coupled or associated items.

[0075] As used herein, the term "proximal" refers to a location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending along the proximal and distal directions.

[0076] Overview of the disclosed technology The prosthetic valve disclosed herein can be advanced through a patient's vascular system using a delivery device. The prosthetic valve may include one or more expansion locking mechanisms that can be actuated using the delivery device to radially expand the valve and lock it in one or more radially expanded states. As an example, the prosthetic valve may be coiled in a radially compressed state on or held by the delivery device during delivery, and then radially expanded (and axially shortened) to the radially expanded state once the prosthetic valve reaches the implantation site. It should be understood that the valve disclosed herein can be used with a variety of implant delivery devices, examples of which will be discussed in more detail later.

[0077] Figure 1 It shows that it can be delivered by devices such as Figure 2 An exemplary prosthetic valve is delivered to the native heart valve and implanted at the site of the native heart valve using the exemplary delivery device shown. Figure 3-27B Various embodiments of a prosthetic valve frame according to this disclosure and an associated expansion locking mechanism are shown, the expansion locking mechanism being included in the prosthetic valve (such as...) Figure 1In the exemplary prosthetic valve shown, to prevent the prosthetic valve from collapsing back to a more radially compressed position during and / or after radial expansion of the valve (such as during and / or after implantation of the prosthetic valve at the native heart valve). In some embodiments, the expansion locking mechanism of this disclosure can be configured to continuously expand and lock the prosthetic valve at any valve diameter, thereby allowing physicians to expand the prosthetic valve more smoothly as needed without concern about valve collapse (i.e., retracting back to a more radially compressed position).

[0078] Exemplary embodiments of the disclosed technology Figure 1 An exemplary prosthetic valve 10 according to one embodiment is shown. The prosthetic valve 10 may include an annular support or frame 12 having an inflow end 14 and an outflow end 16. The prosthetic valve 10 may also include a valve structure 18 coupled to and supported within the frame 12. The valve structure 18 is configured to regulate the flow of blood from the inflow end 14 through the prosthetic valve 10 to the outflow end 16.

[0079] The valve structure 18 may include, for example, a leaflet assembly comprising one or more leaflets 20 made of a flexible material. The leaflets 20 may be made wholly or partially of biological materials, biocompatible synthetic materials, or other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 20 may be anchored to each other at adjacent sides to form commissures, each commissure being anchored to a corresponding actuator 50 or frame 12.

[0080] In the depicted embodiment, the valve structure 18 includes three leaflets 20, which can be arranged to collapse in a tricuspid valve configuration. Each leaflet 20 may have an inflow edge portion 22. Figure 1 As shown, the inflow edge portion 22 of the leaflet 20 can define a wavy, curved fan shape that follows or tracks multiple interconnected support segments of the frame 12 in the circumferential direction when the frame 12 is in a radially extended state. The inflow edge of the leaflet can be referred to as a "fan line".

[0081] In some embodiments, the inflow edge portion 22 of the leaflet 20 can be sutured generally along a fan-shaped line to an adjacent strut of the frame. In other embodiments, the inflow edge portion 22 of the leaflet 20 can be sutured to an inner skirt, which in turn is sutured to an adjacent strut of the frame. By forming leaflets 20 with this fan-shaped geometry, stress on the leaflets 20 is reduced, which in turn improves the durability of the prosthetic valve 10. Furthermore, due to the fan-shaped shape, folds and corrugations at the ventral side of each leaflet 20 (the central region of each leaflet) can be eliminated or at least minimized, which can cause early calcification in those areas. The fan-shaped geometry also reduces the amount of tissue material used to form the valve structure 18, thereby allowing for a smaller, more uniform curl profile at the inflow end 14 of the prosthetic valve 10.

[0082] Further details regarding transcatheter prosthetic heart valves (including the manner in which valve structures can be fitted to prosthetic valve frames) can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394 and 8,252,202, U.S. Patent Application No. 15 / 978,459 (published as U.S. Publication No. 2018 / 0325665) and U.S. Provisional Application No. 62 / 854,702, filed May 30, 2019, the entire contents of which are incorporated herein by reference.

[0083] The prosthetic valve 10 can be radially compressed and expanded between a radially compressed state (also referred to herein as a "radial compression position" and / or "radial compression configuration") and a radially expanded state (also referred to herein as a "radial expansion position" and / or "radial expansion configuration"). The frame 12 may include a plurality of interconnected mesh struts 24 arranged in a mesh pattern and forming a plurality of vertices 34 at the outflow end 16 of the prosthetic valve 10. The struts 24 may also form similar vertices 32 at the inflow end 14 of the prosthetic valve 10.

[0084] The struts 24 may be pivotally coupled to each other along the length of each strut at one or more pivot joints or pivot connections 28. For example, in one embodiment, each of the struts 24 may be formed with holes 30 at opposite ends of the strut and the holes being spaced apart along the length of the strut. Corresponding hinges may be formed at locations where the struts 24 overlap each other via fasteners 38, such as rivets or pins extending through the holes 30. The hinges may allow the struts 24 to pivot relative to each other when the frame 12 expands or contracts radially, such as during the assembly, preparation, or implantation of the prosthetic valve 10.

[0085] The frame struts and components used to form the pivot joint of frame 12 (or any frame described below) can be made of any of a variety of suitable materials, such as stainless steel, cobalt-chromium alloys, or nickel-titanium alloys (“NiTi”) (e.g., nitinol). In some embodiments, frame 12 can be constructed by forming separate components (e.g., frame struts and fasteners) and then mechanically assembling and connecting the separate components together. Further details regarding the construction of the frame and prosthetic valve are described in U.S. Patent Publications 2018 / 0153689 and 2018 / 0344456 and U.S. Patent Applications 16 / 105,353 and 62 / 748,284, all of which are incorporated herein by reference.

[0086] In the illustrated embodiment, the prosthetic valve 10 can be mechanically expanded from a radially contracted state to a radially expanded state. For example, the prosthetic valve 10 can be radially expanded by applying a force in the axial direction toward the inlet end 14 of the frame 12 against the outlet end 16 while holding the outlet end 14 in a fixed position. Alternatively, the prosthetic valve 10 can be expanded by applying an axial force against the inlet end 14 while holding the outlet end 16 in a fixed position, or by applying opposite axial forces to the inlet end 14 and the outlet end 16, respectively.

[0087] like Figure 1 As shown, the prosthetic valve 10 may include one or more actuators 50, which are mounted to and equally spaced around the inner surface of the frame 12. Each of the actuators 50 may be configured to form a releasable connection with one or more corresponding actuators of the delivery device.

[0088] In the illustrated embodiment, both expansion and compression forces can be applied to the frame via actuator 50. (See again...) Figure 1 Each of the actuators 50 may include a screw or threaded rod 52, a first anchor in the form of a cylinder or sleeve 54, and a second anchor in the form of a threaded nut 56. The threaded rod 52 extends through the sleeve 54 and the nut 56. The sleeve 54 may be secured to the frame 12, for example, by a fastener 38 that forms a hinge at the joint between the two supports. Each actuator 50 is configured to increase the distance between the attachment points of the respective sleeve 54 and the nut 56, which causes the frame 12 to elongate axially and compress radially, and each actuator 50 is configured to decrease the distance between the attachment points of the respective sleeve 54 and the nut 56, which causes the frame 12 to shorten axially and expand radially.

[0089] For example, each threaded rod 52 may have an external thread that engages with the internal thread of the nut 56, such that rotation of the rod causes a corresponding axial movement of the nut 56 toward or away from the sleeve 54 (depending on the direction of rotation of the threaded rod 52). Depending on the direction of rotation of the threaded rod 52, this causes the hinges of the support sleeve 54 and the nut 56 to move toward each other to radially expand the frame, or causes the hinges of the support sleeve 54 and the nut 56 to move away from each other to radially compress the frame.

[0090] In other embodiments, actuator 50 may be a reciprocating actuator configured to apply an axial force to the frame to produce radial expansion and compression of the frame. For example, the threaded rod 52 of each actuator may be axially fixed relative to the nut 56 and may slide relative to the sleeve 54. Thus, moving the threaded rod 52 distally relative to the sleeve 54 and / or moving the sleeve 54 proximally relative to the threaded rod 52 radially compresses the frame. Conversely, moving the threaded rod 52 proximally relative to the sleeve 54 and / or moving the sleeve 54 distally relative to the threaded rod 52 causes radial expansion of the frame.

[0091] When using a reciprocating actuator, the prosthetic valve may also include one or more locking mechanisms to hold the frame in an extended state. The locking mechanisms may be separate components mounted on the frame separately from the actuator, or they may be sub-components of the actuator itself.

[0092] Each threaded rod 52 may include an attachment member 58 along the proximal portion of the threaded rod 52, the attachment member 58 being configured to form a releasable connection with a corresponding actuator of the delivery device. One or more actuators of the delivery device may apply force to the rod to radially compress or expand the prosthetic valve 10. The attachment member 58 in the illustrated configuration includes a notch 60 and a protrusion 62 that can engage a corresponding protrusion of the actuator of the delivery device.

[0093] In the illustrated embodiment, the prosthetic valve 10 includes three such actuators 50, although more or fewer actuators may be used in other embodiments. The leaflet 20 may have a connecting attachment member 64 wound around a sleeve 54 of the actuator 50. Further details of the actuators, locking mechanisms, and delivery devices for actuating the actuators can be found in U.S. Patent Nos. 10,806,573 and 10,603,165, U.S. Patent Publications 2018 / 0153689 and 2018 / 0325665, and PCT applications PCT / US20 / 57691 and PCT / US21 / 22467, filed November 28, 2020, and March 16, 2021, respectively, each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed applications may be incorporated into any prosthetic valve disclosed herein. Additionally, any delivery device disclosed in a previously filed application may be used to deliver and implant any of the prosthetic valves disclosed herein.

[0094] The prosthetic valve 10 may include a skirt assembly comprising one or more skirts or sealing members. In some embodiments, the prosthetic valve 10 may include an inner skirt (not shown) mounted on the inner surface of a frame. The inner skirt may serve as a sealing member to prevent or reduce paravalvular leakage, anchor the leaflet to the frame, and / or protect the leaflet from damage due to contact with the frame during curling and during the prosthetic valve's working cycle. Figure 1 As shown, the prosthetic valve 10 may further include an outer skirt 70 mounted on the outer surface of the frame 12. The outer skirt 70 serves as a sealing member for the prosthetic valve by sealing against the native valve annulus and helping to reduce paravalvular leakage through the prosthetic valve. The inner and outer skirts may be formed of any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including fabrics (e.g., polyethylene terephthalate fabrics) or native tissue (e.g., pericardial tissue). Further details regarding the use of the skirt or sealing member in prosthetic valves can be found, for example, in PCT application No. PCT / US20 / 24559, filed March 25, 2020, the entire contents of which are incorporated herein by reference.

[0095] Figure 2 A delivery device 100, according to one embodiment, is illustrated for delivering a prosthetic valve (prosthetic heart valve) 102 (such as the illustrated prosthetic heart valve 10) described above. The prosthetic valve 102 can be releasably coupled to the delivery device 100, such as a removable coupling between a distal member of the extended locking mechanism of the prosthetic valve 102 and a second actuating member of the actuation assembly of the delivery device 100, as will be referred to below at least Figure 18A-20Described in more detail. The prosthetic valve 102 may include a distal end 103 and a proximal end 105, wherein the proximal end 105 is positioned closer to the handle 104 of the delivery device 100 than the distal end 103, and wherein the distal end 103 is positioned further away from the handle 104 than the proximal end 105. It should be understood that the delivery device 100 and other delivery devices disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0096] In the illustrated embodiment, the delivery device 100 generally includes a handle 104, a first elongated shaft 106 extending distally from the handle 104 (in the illustrated embodiment, this includes an outer shaft), at least one actuator assembly 108 extending distally through the first elongated shaft 106 (i.e., the outer shaft), a second elongated shaft 118 extending distally from the handle through the first elongated shaft 106 (i.e., the outer shaft) (in the illustrated embodiment, this includes an inner shaft), and a nasal cone 120 connected to the distal end of the second shaft 118. The second shaft 118 and the nasal cone 120 may define a guidewire lumen configured to receive a guidewire, such that the delivery device 100 can advance the guidewire across the patient's vascular system. At least one actuator assembly 108 may be configured to radially expand and / or radially ulcerate the prosthetic valve 102 when actuated, and may be removably coupled to the prosthetic valve 102, as will be described in more detail below.

[0097] Although the illustrated embodiment shows two actuator assemblies 108 for illustrative purposes, it should be understood that one actuator 108 may be provided for each actuator on the prosthetic valve. For example, three actuator assemblies 108 may be provided for a prosthetic valve having three actuators. In other embodiments, more or fewer actuator assemblies may be present.

[0098] In some embodiments, the distal portion of the first elongated shaft 106 may be sized to accommodate the prosthetic valve in its radially compressed delivery state during delivery through the patient's vascular system. In this way, the distal portion acts as a delivery sheath or sac for the prosthetic valve during delivery.

[0099] Each actuator assembly 108 may include a support tube (or sleeve) 122 and an actuating member 124. The support tube 122 may engage and / or abut a proximal end 105 of the prosthetic valve 102, while the actuating member 124 may be releasably coupled to a corresponding actuating member of the prosthetic valve. In some embodiments, the actuator assembly 108 may also include a locking tool. When actuated, the actuator assembly 108 may transmit thrust and / or pull forces to portions of the prosthetic valve to cause radial expansion and collapse of the prosthetic valve. Specifically, the support tube 122 may provide a distal thrust to the proximal end 105 of the prosthetic valve 102, while the actuating member 124 may provide a proximal pull force to an axially movable member of the prosthetic valve 102, which in turn may transmit the proximal pull force to the distal end 103 of the prosthetic valve 102. In this way, the counteracting forces provided by the sleeve and the actuating member pull the proximal end 105 and distal end 103 of the prosthetic valve 102 toward each other, thereby causing the prosthetic valve 102 to expand radially. The actuator assembly 108 may be at least partially radially disposed within one or more lumens of the first elongated shaft 106 and extend axially through one or more lumens of the first elongated shaft 106. For example, the actuator assembly 108 may extend through the central lumen of the first elongated shaft 106 or through a separate corresponding lumen formed in the first elongated shaft 106.

[0100] The handle 104 of the delivery device 100 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling the different components of the delivery device 100 to expand and / or deploy the prosthetic valve 102. For example, in the illustrated embodiment, the handle 104 includes a first knob 110, a second knob 112, and a third knob 114.

[0101] The first knob 110 may be a rotatable knob configured to produce axial movement of the first elongated shaft 106 relative to the prosthetic valve 102 in a distal and / or proximal direction, so as to deploy the prosthetic valve from the delivery sheath 116 once the prosthetic valve has been advanced to or near the desired implantation location on the patient's body. For example, rotation of the first knob 110 in a first direction (e.g., clockwise) may retract the delivery sheath 116 proximally relative to the prosthetic valve 102, and rotation of the first knob 110 in a second direction (e.g., counterclockwise) may advance the delivery sheath 116 distally. In other embodiments, the first knob 110 may be actuated by axially sliding or moving the first knob 110 (such as pulling and / or pushing the knob). In other embodiments, actuation of the first knob 110 (rotation or sliding movement of the first knob 110) can produce axial movement of the actuator assembly 108 (and thus the prosthetic valve 102) relative to the delivery sheath 116 to advance the prosthetic valve distally from the delivery sheath 116.

[0102] The second knob 112 may be a rotatable knob configured to produce radial expansion and / or contraction of the prosthetic valve 102. For example, rotation of the second knob 112 may cause axial movement of the actuating member 124 and the support tube 122 relative to each other. Rotation of the second knob 112 in a first direction (e.g., clockwise) may radially expand the prosthetic valve 102, and rotation of the second knob 112 in a second direction (e.g., counterclockwise) may radially collapse the prosthetic valve 102. In other embodiments, the second knob 112 may be actuated by axially sliding or moving the second knob 112 (such as pulling and / or pushing the knob).

[0103] The third knob 114 may be a rotatable knob configured to hold the prosthetic valve 102 in its extended configuration. For example, the third knob 114 may be operatively connected to the proximal portion of the locking tool of each actuator assembly 108. Rotation of the third knob in a first direction (e.g., clockwise) may cause each locking tool to rotate to advance the locking nut to its distal position, thereby preventing radial compression of the frame of the prosthetic valve, as described above. Rotation of the third knob 114 in the opposite direction (e.g., counterclockwise) may cause each locking tool to rotate in the opposite direction to disengage each locking tool from the prosthetic valve 102. In other embodiments, the third knob 114 may be actuated by axially sliding or moving the third knob 114 (such as pulling and / or pushing the knob). As further described below, in some embodiments, the frame of the prosthetic valve may include a locking element or member that engages the actuator of the frame to hold the prosthetic valve in its radially extended state, in which case a locking tool is not required.

[0104] Although not shown, the handle 104 may include a fourth rotatable knob operably connected to the proximal portion of each actuating member. The fourth knob may be configured to rotate each actuating member 124 when the knob is rotated, thereby unscrewing each actuating member from the proximal portion of the corresponding actuator of the prosthetic valve frame. As described above, once the locking tool and actuating members are separated from the prosthetic valve 102, they can be removed from the patient.

[0105] Figure 3-7 illustrates an exemplary embodiment of a prosthetic valve 200 comprising an integral, fastener-free frame 202. The prosthetic valve may include valve structures comprising multiple leaflets (such as valve structure 18 including leaflets 20) as previously described, as well as inner and / or outer skirts, but these components are omitted for illustrative purposes. In the illustrated embodiment, the frame 202 includes one or more posts 204 configured as an integral extension locking mechanism 206, which can be used to radially extend the frame 202 and lock the frame 202 in a radially extended state, as described in more detail below. In other embodiments, the frame 202 may include one or more separately formed extension locking mechanisms. Figure 3 The diagram illustrates frame 202 in a partially extended configuration. Figure 4 The diagram illustrates frame 202 under radial compression, and Figure 6 The diagram illustrates frame 202 in its fully extended configuration.

[0106] Reference Figure 3 The frame 202 may include an inflow end portion 208 (which, in the illustrated embodiment, is the distal end of the frame in the delivery configuration) and an outflow end portion 210 (which, in the illustrated embodiment, is the proximal end portion of the frame in the delivery configuration). The frame 202 may be a mechanically expandable frame comprising a plurality of posts 204 coupled together by a plurality of rigid members or links 212 (which may also be referred to as “posts”). For example, in the illustrated embodiment, the frame 202 includes three posts 204, and each pair of adjacent posts 204 is coupled together by four links 212 defining two generally triangular units 214. In the illustrated embodiment, the links 212 are arranged in an X-shape. However, in other embodiments, the frame 202 may include more or fewer posts 204 and / or links 212, and the posts 204 and / or links 212 may be arranged in any of a variety of shapes.

[0107] Each link 212 may be coupled to one or more adjacent links 212 and / or coupled to an adjacent post 204 via a compliant hinge or joint 216 integrally formed with the frame 202. Each link 212 may have a first end portion 218 and a second end portion 220. The first end portion 218 may be coupled to the post 204 via a first compliant joint 216a, and the second end portion 220 may be coupled to an adjacent link 212 via a second compliant joint 216b. For example, an exemplary first link 212a may have a first end portion 218a coupled to a first post 204a via a first compliant joint 216a, and a second end portion 220a coupled to an adjacent second link 212b via a second compliant joint 216b. The second compliant joint 216b may be coupled to an additional compliant joint 216c connecting links 212c and 212d. The compliant joint 216 can be configured to allow the link 212 to move relative to each other and / or the column 204 via the elastomeric deformation of the compliant joint 216.

[0108] like Figure 5 As best seen in the illustrated embodiment, each compliant connector 216 may include a flexible neck portion 222 that at least partially defines a C-shaped cutout 224 including the gap G. In alternative embodiments, the cutout 224 may have other shapes, such as V-shaped, elliptical, square, etc., open at one end to define the gap G. As shown in the illustrated embodiment, compliant connectors 216 coupled to the same link 212 may be oriented in opposite directions (e.g., the gap G may face different directions). For example, see reference... Figure 3 The first link 212a may have a first compliant connector 216a oriented in a first direction (e.g., toward the inflow end 208 of the prosthetic valve 200) and a second compliant connector 216b oriented in a second direction (e.g., toward the outflow end 210 of the prosthetic valve 200). In other embodiments, compliant connectors 216 coupled to the same link 212 may be oriented in the same direction.

[0109] When frame 202 is constructed from compression ( Figure 4 Move to partial extended construction ( Figure 3 ) or fully extended construction ( Figure 3When the flexible neck portion 222 is circumferentially deformable or deflected, the gap G can widen. Specifically, the flexible neck portion 222 can be more flexible than the links 212 and the column 204, and therefore the flexible neck portion 222 is more prone to bending and / or deformation in response to applied forces or moments. As an example, the flexible neck portion 222 is more flexible due to its width W1 being narrower than the width W2 of each link 212. This configuration allows the frame 202 to move between a radially compressed state and a radially expanded state without using fasteners to couple adjacent links 212 to each other. Furthermore, the compliant joint 216 can be aligned with or flush with the links 212 (e.g., the compliant joint does not protrude beyond the radially inner and / or radially outer surfaces of the links 212), thereby reducing the overall curl profile of the prosthetic valve 200.

[0110] However, in other embodiments, other forms of compliant joints or flexural linkages may be used. In some embodiments, such as the illustrated embodiment, each compliant joint 216 may include the same type of hinge. However, in other embodiments, the frame may include one or more different hinge types. Examples of different flexural or hinge types may include a leaf-shaped hinge 500 ( Figures 10A-10B ) and compliant connector 752 ( Figure 26-27B ), beam hinge 600 ( Figure 11A-11E ), leaf spring type hinge 700 ( Figure 12A-12B), circular flexures, elliptical flexures, rounded corner flexures, cross flexures (also known as cross leaf hinges), prism cross hinges, notched hinges, multi-trapezoidal hinges (also known as butterfly hinges), chamfered V-shaped flexures, cyclone flexures, circular bending beam flexures, spherical flexures and / or selective compliant hinges. Further details of compliant hinges that can be used with the disclosed frame embodiments can be found, for example, in Linß et al.’s International Publication No. WO2009 / 034551 (2019), “Modeling and Design of Flexure Hinge-Based Compliant Mechanisms, Kinematics – Analysis and Applications” (pp. 1–24) and / or Rad, F.’s (2014), “Design and Characterization of Curved and Spherical Flexure Hinges for Planar and Spatial Compliant Mechanisms (Research Doctorate)” ((2014), University of Bologna), each of which is incorporated herein by reference in its entirety.

[0111] although Figure 10A-12B Some of the connectors and hinges shown in 26-27B are described as being included in the prosthetic valve 200, but it should be understood that these connectors and / or hinges may be included in any of the other prosthetic valves 10, 300, 800, 1200 and / or 1300 disclosed herein.

[0112] The geometry of the compliant joint and / or hinge and / or the materials constituting the compliant joint and / or hinge can be selected to provide desired properties and / or characteristics (e.g., elasticity, plasticity, strength, etc.). For example, some or all of the compliant joints and / or hinges can be formed such that they are fully elastic, partially elastic (also known as “partially plastic”), and / or fully plastic. While both material and geometry can contribute to the elasticity and / or plasticity of the compliant joint and / or hinge, the geometry can have a greater influence than the material on the elasticity and / or plasticity of the compliant joint and / or hinge, as referenced below. Figure 11A-11E describe.

[0113] The fully resilient connector and / or hinge remain flexible and resilient under all operating conditions (i.e., all valve diameters from fully compressed to fully expanded), and thus allow the frame 202 to expand radially and / or compress when subjected to loads such as radial compressive loads that can be applied to the frame 202 by surrounding tissue when implanted at the native valve. Therefore, when the frame 202 includes a fully resilient connector and / or hinge, the frame 202 may include a locking mechanism to prevent the frame 202 from collapsing toward the radially compressed position. When the connector and / or hinge are constructed to be fully resilient, the frame 202 may be made of a hyperelastic or shape memory material (e.g., nitinol).

[0114] During valve expansion, the partially elastic compliant connectors and / or hinges behave elastically up to a threshold (i.e., their yield point / strength or elastic limit), but beyond that threshold (yield point), they lose elasticity and behave plastically (deform plastically). Within the elastic range of the frame, compared to the plastic range, the prosthetic valve can be more easily recompressed with less force during implantation. The geometry of the connectors can be selected to reach the elastic limit of the frame material at a predetermined diameter of the frame during valve expansion, depending on the desired degree of recompressibility. For example, if it is desired to be able to recompress the valve even at a considerably large valve diameter (e.g., allowing the surgeon to recompress and / or reposition the prosthetic valve even when it is almost fully radially expanded), the geometry of the connectors can be selected such that the frame 202 remains elastic over a wide range of valve diameters and only deforms plastically (i.e., becomes irreversibly plastic) when the frame 202 is at or near full radial expansion. For example, the connector may be constructed of a material with a high yield point, and / or the shape and / or size of the connector may be modified such that the load is distributed more evenly along the connector (so that stress in the connector is not concentrated in a particular area of ​​the connector), and the connector may elastically deform within at least the initial expansion range of the prosthetic valve. For example, as explained below, by making the corners of the connector curved and / or less sharp, stress along the corners can be reduced, because curved corners can distribute the applied load more evenly than sharp (orthogonal) corners. Once within the plastic deformation range in the frame, the connector and / or hinge become more rigid and can help hold the prosthetic valve in its final radially expanded state within the body. In this way, when the connector and / or hinge become plastically deformed, they contribute a locking function to the prosthetic valve. In some embodiments, the frame may have partially elastic compliant connectors and / or hinges without additional locking components to help hold the prosthetic valve in its final expanded state, and alternatively, it may rely on the plasticity of the connector and / or hinge exhibiting plastic properties to hold the prosthetic valve in its expanded state. In other embodiments, in addition to the locking components, the frame may also have partially resilient compliant joints and / or hinges, such that the prosthetic valve can be held in its final expanded state by the plasticity of the combination of the locking components and the joints and / or hinges.

[0115] However, it should be understood that the geometry of the hinge (and therefore the range of its elasticity and plasticity) can be selected based on the valve diameter under which recompression is not required and / or locking is desired. A geometry that reaches the elastic limit of the material at a larger valve diameter provides a wider range of valve diameters under which the valve can be reversibly compressed and / or expanded within its elastic range, but provides a narrower range of diameters under which the valve can be locked, and vice versa. Partially elastic / partially plastic compliant joints and / or hinges may include fully plastic portions and other fully elastic portions. Frame 202 may include the same type of hinge at all compliant joints 216, or frame 202 may include a mixture of different types of hinges at compliant joints 216 depending on the specific characteristics desired. When the joints and / or hinges are constructed to be partially elastic, the frame 202 may be made of a plastically deformable material (such as stainless steel or cobalt-chromium alloys (e.g., nickel-cobalt-chromium alloys, such as MP35N)), and the joints are configured to deform elastically within an initial extension range and then plastically within a subsequent extension range.

[0116] In other embodiments, the frame may be fully plastic, meaning that the compliant joints and / or hinges are plastically deformable throughout the entire range of valve expansion. When the joints and / or hinges are configured to be fully plastic, the frame 202 may be made of a malleable material, such as stainless steel or a cobalt-chromium alloy (e.g., a nickel-cobalt-chromium alloy, such as MP35N).

[0117] Figures 10A-10B An exemplary leaf-shaped hinge 500 is illustrated. The leaf-shaped hinge 500 may include a flexible neck portion 502, which at least partially defines a bell-shaped cutout 504 including a gap G. Figure 10B As the frame 202 moves between the compressed configuration and the extended configuration, the flexible neck portion 502 can deform or deflect circumferentially, allowing the gap G to widen.

[0118] Figure 11A-11E An exemplary beam-type hinge 600 coupling link 212 and column 204 is illustrated. Specifically, Figure 11A and 11C This is a perspective view of a beam hinge 600. Figure 11B and 11D This is a side view of the beam hinge 600, and Figure 11EThis is a cross-sectional view of the flexible neck portion 602 of the beam hinge 600, taken along a cutting plane orthogonal to the longitudinal axis of the flexible neck portion (the axis extending along the length of the flexible neck portion 602). The beam hinge 600 may include a flexible neck portion 602 extending between the link 212 and the post 204. The flexible neck portion 602 may have a length L, a width W, and a thickness T. Additionally, in some examples, the flexible neck portion 602 and the post 204 may form a curved corner 604 where they meet.

[0119] The radius R of these curved corners can also affect the durability and elasticity and / or plasticity of the hinge 600. Bending the corners rather than making them orthogonal can reduce stress on the ends (post ends) of the adjacent posts 204 of the flexible neck portion 602, thereby improving the durability of the hinge 600. Increasing the radius R of the curved corner 604 (i.e., making the corner less sharp) can also make the corner 604 more flexible and / or elastic. That is, the corner 604 will remain elastic over a larger range of valve diameters and will not begin to become plastic until the valve expands to a larger diameter. In some examples, the radius R of the corner (the radius of the circle produced if the corner is extended to produce a complete circle) can be at least half the thickness of the flexible neck portion 602.

[0120] The flexible neck portion 602 may define a clearance G between the link 212 and the post 204 (or, alternatively, between two adjacent links 212). Figure 11B When frame 202 moves from a radially compressed state to a radially expanded state, the flexible neck portion 602 can deform or deflect, causing the gap G to widen. Specifically, as... Figure 11C-11DAs shown, the torque caused by the axial compressive load can cause the link 212 to pivot relative to the column 204 about a rotational axis determined by the deflection of the flexible neck portion 602. Therefore, during the radial expansion and / or compression of the frame 202, the link 212 can pivot relative to the longitudinal axis of the frame 202, while the column 204 remains aligned with the longitudinal axis of the frame 202. Thus, when the frame expands radially, the end of the flexible neck portion 602 adjacent to the link 212 (the link end) deflects toward the nearest end of the frame (including the flexible neck portion 602 at the inlet end portion of the frame deflecting toward the inlet end of the frame, and the flexible neck portion 602 at the outlet end portion of the frame deflecting toward the outlet end of the frame), while the end of the flexible neck portion 602 adjacent to the column 204 (the column end) can remain stationary because the column 204 remains axially aligned during radial expansion. As described above, the elasticity and / or plasticity of hinge 600 can depend more on the geometry (length, width, and thickness) of the flexible neck portion 602 than on the materials used to construct it. As an approximation, it can be assumed that the flexible neck portion 602 behaves similarly to a constrained beam under the applied moment. Therefore, the deflection of the end of the flexible neck portion 602 adjacent to the link 212 (link end) can be approximated using the formula for the deflection of the unsupported end of a constrained beam, as follows: In the above formula, M is the torque, L is the length of the flexible neck portion 602, W is the width of the flexible neck portion 602, T is the thickness of the flexible neck portion 602, and E is the elastic modulus. The bending stress of the flexible neck portion 602 can be approximated similarly using the bending stress equation for a constrained beam, given by: In the above formula, M is the torque and Z is the section modulus.

[0121] Therefore, the geometry of the flexible neck portion 602 can be selected to provide the desired elasticity and / or plasticity. As an example, the thickness of the flexible neck portion 602 may be substantially smaller than its width and length and / or substantially smaller than the thickness and / or width of the column 204 and the link 212. In some examples, the flexible neck portion 602 may be made of a cobalt-chromium alloy, nitinol, and / or other elastic and / or plastically deformable materials.

[0122] Figure 12A-12B An exemplary leaf spring type hinge 700 is illustrated. The leaf spring type hinge 700 may include a flexible neck portion 702, which is configured to include a spring 704 comprising a plurality of wavy or sinusoidal segments. The spring type hinge 700 may define a gap G between the link 212 and the post 204 (or alternatively, between two adjacent links 212). Figure 12B As the frame 202 moves between the compression configuration and the expansion configuration, the flexible neck portion 702 can deform or deflect, allowing the gap G to widen.

[0123] Although the hinges 500, 600, and 700 described above are shown as connecting one link 212 and one post 204, hinges can also be used to connect two or more links 212 to each other. For example, as Figure 3 As shown, both the second compliant connector 216b and the additional compliant connector 216c connect to two links 212. Specifically, the second compliant connector 216b can connect the first link 212a and the second link 212b, and the additional compliant connector 216c can connect links 212c and 212d. Furthermore, the second compliant connector 216b and the additional compliant connector 216c can be connected to each other via a stem, body, or post, thereby forming a four-way connector / connection between links 212a-d.

[0124] Figure 26-27B An example of such a four-way connector is shown. Specifically, Figure 26 A perspective view of the four-way connector (or interconnect) 750 is shown, while Figure 27A -B shows a side view of connector 750, including the valve of connector 750 in a radially extended position ( Figure 27A ) and radial compression state ( Figure 27B ).

[0125] Connector 750 (also referred to as an interconnect) may include two or more compliant connectors 752, 754 joined together by a stem or hub 756. Compliant connectors 752 may face opposite directions along an axis parallel to the central longitudinal axis of the frame (e.g., one may face the inflow end of the valve, and the other may face the outflow end). Compliant connectors 754 may face opposite directions along an axis perpendicular to the longitudinal axis of the frame. Throughout the entire extension of the frame, compliant connectors 752 are expected to define acute angles between adjacent links 760, and compliant connectors 754 are expected to define obtuse angles between adjacent links 760. However, in other embodiments, the angle defined by compliant connector 752 may be obtuse, and the angle defined by compliant connector 754 may be acute, or the angle defined by compliant connector 752 may be the same as the angle defined by compliant connector 754. When the frame expands radially, the angle defined by the compliant joint 752 can increase, while the angle defined by the compliant joint 754 can decrease, and vice versa when the frame is compressed radially.

[0126] Each of the compliant joints 752, 754 can be similar to the other C-shaped compliant joints 216, and for example, can be similar to the leaf-shaped hinge 500. Specifically, like the leaf-shaped hinge 500, each of the compliant joints 752, 754 may include a flexible neck portion 758, which may be thinner than the link 760, and the flexible neck portion 758 may define a bell-shaped cutout 762 and a clearance G ( Figure 27A -B). Each of the flexible neck portions 758 may have a width W (in the radial direction), a length L, and a thickness T (measured in the direction perpendicular to the length L).

[0127] like Figure 27A As shown in -B, when the valve is in a radially compressed state ( Figure 27B ) towards radial expansion state ( Figure 27A As the valve moves, links 760a and 760b deflect away from each other, and links 760c and 760d deflect away from each other, causing the gap G to widen. Specifically, the flexible neck portion 758 is more flexible / elastic than the links 760 and / or the hub 756 (e.g., because they are thinner than the links 760 and / or the hub 756), and therefore bends and / or deforms as the valve moves between a radially compressed state and a radially expanded state, thereby widening or narrowing the gap G between the links 760. Specifically, when the valve moves from a radially compressed state ( Figure 27B Move to radial expansion state ( Figure 27A When ), links 760a and 760b deflect away from each other, and the gap G between them widens. Similarly, links 760c and 760d deflect away from each other, and the gap G between them widens.

[0128] Similar to other connectors, connector 750 can be configured to be fully plastic, partially plastic, and / or fully elastic. In some examples, it may be particularly desirable for connector 750 to be at least partially plastic, so that it can help lock the valve in a radially expanded state (with or without additional locking components). In some examples, the flexible neck portion 758 may be wider (in the radial direction) than its thickness. In some such examples, the width W of the flexible neck portion 758 may be approximately 1.2 times the thickness T of the flexible neck portion 758. However, other and / or additional geometries may be chosen such that the flexible neck portion 758 is elastic for a wide range of valve diameters and only becomes plastically deformable at the desired valve diameter (e.g., when the valve is near and / or in a fully radially expanded state). In some examples, by reducing the thickness of the flexible neck portion 758 and increasing the length and / or width of the flexible neck portion 758, the yield point of the flexible neck portion 758 can be increased (so that connector 750 remains elastic over a wider range of valve diameters).

[0129] exist Figure 26-27B In the example shown, the flexible neck portion 758 is thinner than the link 760, but just the same width. However, in other examples, the flexible neck portion 758 may have other geometries, such as being thinner than the link 760 (not the same thickness) and narrower than the link 760 (not the same width).

[0130] Joint 750 can be made of a material similar to other compliant joints, such as a cobalt-chromium alloy, stainless steel, or other suitable malleable materials. If constructed to be fully elastic, joint 750 can be made of nitinol or a similar hyperelastic material.

[0131] This construction advantageously eliminates separately formed fasteners (which may be difficult to manufacture and / or install in such a small size) and allows for a single degree of freedom (pivotable movement between links 212), thereby preventing or mitigating radial displacement of links 212 and thus deformation of frame 202. The elimination of separately formed fasteners advantageously reduces friction and wear on frame 202, thereby increasing the long-term reliability and accuracy of the prosthetic valve 200.

[0132] In some embodiments, frame 202 may be formed from a single piece of material. For example, frame 202 may be formed using simpler processing and machining procedures, such as laser cutting, waterjet cutting, etc. In some specific embodiments, frame 202 may be cut from a material tube (e.g., laser cutting), which may be made of any suitable biocompatible metal, such as stainless steel, nickel-cobalt-chromium alloy (e.g., MP35N), or nickel-titanium alloy (e.g., Nitinol). In other embodiments, the material tube may be made of any suitable biocompatible polymer material. Furthermore, the absence of fasteners significantly reduces the number of parts and simplifies assembly complexity, thereby reducing material and time costs.

[0133] refer to Figure 3 As previously mentioned, in some embodiments, each post 204 may be configured to extend the locking mechanism 206. In the illustrated embodiment, the frame 202 includes three posts 204, each post 204 being configured to extend the locking mechanism 206. In other embodiments, the frame 202 may include more or fewer posts, and a selected number of posts may be configured to extend the locking mechanism.

[0134] like Figures 7A-7BAs best viewed, each extended locking mechanism 206 may include a rack mechanism or rack assembly comprising an inner member 226 and one or more outer members 228. The outer member 228 may define a channel 229, within which the inner member 226 is configured to move axially (e.g., slide) relative to the outer member 228. The inner member 226 and / or the outer member 228 may extend from and be integrally formed with the respective end of the frame 202. For example, in the illustrated embodiment, the inner member 226 extends from the outflow end 210 of the frame 202 toward the inflow end 208, and one or more outer members 228 extend from the inflow end 208 of the frame toward the outflow end 210. In other embodiments, the inner member 226 may extend from the inflow end 208 of the frame 202, and one or more outer members 228 may extend from the outflow end 210 of the frame. In some other embodiments, the inner member 226 and / or the outer member 228 may be formed separately from the frame 202 and coupled to the frame 202 using, for example, welding, adhesives and / or mechanical fasteners (such as screws or pins).

[0135] The internal component 226 may include one or more linear racks 230, each linear rack 230 including a plurality of teeth 232. The internal component 226 may include an elongated member including a first circumferential edge and a second circumferential edge. Figure 7A One or more linear racks 230 may be disposed on one or more circumferential edges 234 of the inner member 226. In the illustrated embodiment, the inner member 226 includes two linear racks 230, one linear rack 230 disposed on each circumferential edge 234 of the inner member 226. However, in other embodiments, the inner member 226 may include only a single linear rack 230. In the illustrated embodiment, the linear rack 230 extends only partially along the length of the inner member 226; however, in other embodiments, the linear rack 230 may extend along the entire length of the inner member 226.

[0136] One or more of the outer members 228 may include a pawl 236 configured to engage the teeth 232 of the linear rack(s) 230. The pawl 236 and teeth 232 are configured such that when the pawl 236 engages with the linear rack 230, the inner member 226 and one or more outer members 228 may move relative to each other in a first axial direction, but are prevented from moving relative to each other in the opposite second axial direction. For example, in the illustrated embodiment, when the pawl 236 engages with the linear rack 230, the inner member 226 may move axially in a distal direction (e.g., downward in the orientation shown in FIG. 7), but not axially in a proximal direction (e.g., upward in the orientation shown in FIG. 7). This ensures that when the pawl 236 engages with the linear rack 230, the frame 202 can expand radially but cannot compress radially. In other words, the inlet end 208 and outlet end 210 of the frame 202 may move axially toward each other, but cannot move axially away from each other.

[0137] Once the prosthetic valve 200 has been implanted at the selected implantation site in the patient, the patient's native anatomy (e.g., the native aortic valve annulus) can exert radial forces against the prosthetic valve 200 that would tend to compress the frame 202. However, the engagement between the pawl 236 and the linear rack 230 prevents these forces from compressing the frame 202, thereby ensuring that the frame remains locked in the desired radially extended state (also referred to herein as the "radial extended position").

[0138] In the illustrated embodiment, each extended locking mechanism 206 includes two outer members 228 configured such that they define a space between them through which at least a portion of the inner member 226 can extend. That is, the two outer members 228 can be circumferentially disposed on either side of the inner member 226, such as... Figure 7A As shown. In the illustrated embodiment, each outer member 228 includes a pawl 236 configured to engage a corresponding linear rack 230 of the inner member 226. In other embodiments where the inner member 226 includes a single linear rack 230, only one of the outer members 228 may include a corresponding pawl 236. In other such embodiments, the extended locking mechanism 206 may include only a single outer member 228, which may be positioned adjacent to the linear rack 230 such that the pawl 236 can engage the linear rack.

[0139] Each pawl 236 may include an elongated body terminating in a locking tooth 238, which may engage a tooth 232 of the linear rack 230. As shown, the locking tooth 238 may have a shape complementary to the shape of the tooth 232, such that when the locking tooth 238 engages with one of the teeth of the linear rack 230, the tooth 232 allows the inner member 226 to be positioned relative to the pawl 236 in one direction (e.g., downward in the illustrated embodiment, as by means of...). Figure 4 The sliding movement of the inner member 226 (as indicated by arrow 240 in the figure) is prevented, and the sliding movement of the inner member 226 in the opposite direction (e.g., upward in the illustrated embodiment) is also prevented.

[0140] Each outer member 228 may be biased toward the inner member 226 such that the locking teeth 238 of each pawl 236 are resiliently held in an engaged position with one of the teeth 232 of the inner member 226 (which may be referred to as the "engaged position" of the pawl). In the illustrated embodiment, the body 242 of each outer member 228 is configured as a leaf spring. The biased configuration of the body 242 ensures that, under normal operation, the locking teeth 238 remain engaged with their corresponding linear rack 230.

[0141] In some embodiments (such as the illustrated embodiment), the inner member 226 may include a toothless portion 244 adjacent to the linear rack 230. The toothless portion 244 may be positioned closer to the inlet end than the linear rack 230 and may be a recessed, flat portion of the inner member, as shown. The toothless portion 244 is configured to allow bidirectional axial movement of the inner member 226 relative to the outer member 228 (in both distal and proximal directions). This allows the frame 202 to expand and / or compress before engagement of the pawl(s) 236 with the plurality of teeth 232. The length L1 of the toothless portion 244 may be selected. Figure 7A This provides the prosthetic valve 200 with a range of reversibility that allows it to expand and compress freely without locking.

[0142] The inner member 226 may be in the distal direction relative to the outer member 228 (e.g., in Figure 3 The orientation shown is towards the inlet end 208 of the frame and the proximal direction (e.g., in the direction shown). Figure 3The inner member 226 and outer member 228 are axially moved toward the outlet end 210 of the frame (as shown in the diagram). Therefore, since the inner member 226 and outer member 228 are fixed to the frame 202 at axially spaced positions (inlet end 208 and outlet end 210, respectively), axially moving the inner member 226 and outer member 228 relative to each other in a telescoping manner can cause radial expansion or compression of the frame 202. For example, moving the inner member 226 distally toward the inlet end 208 of the frame while holding the outer member 228 in a fixed position and / or moving the outer member 228 proximally toward the outlet end 210 of the frame can cause the frame 202 to shorten axially and expand radially. Conversely, moving the inner member 226 proximally toward the outlet end of the frame and / or moving the outer member 228 distally causes the frame 202 to lengthen axially and compress radially.

[0143] Each extended locking mechanism 206 can be advantageously configured to be aligned with or flush with the frame 202 (e.g., the extended locking mechanism 206 does not protrude beyond the radial inner and / or radial outer surfaces of the frame 202), thereby reducing the overall curl profile of the prosthetic valve.

[0144] refer to Figure 8A In some embodiments, each post 204 may further include a junction opening (or slot) 246. The junction opening 246 may extend radially through the thickness of the post 204 and may be configured to receive a portion of the valve structure to couple the valve structure to the frame 202. In the illustrated embodiment, the junction opening 246 has a rectangular shape and is completely surrounded by the post 204 (e.g., the junction opening 246 does not extend to the inflow and / or outflow edges of the post 204). However, in other embodiments, the junction opening 246 may have any of a variety of shapes (e.g., square, elliptical, square-elliptical, triangular, L-shaped, T-shaped, C-shaped, etc.). In some embodiments, the junction opening 246 may extend to the edge of the post 204 (e.g., the outflow edge) such that a portion of the valve structure can slide axially (rather than radially) into the junction opening 246.

[0145] In some embodiments, a valve structure including a plurality of leaflets 256 may be coupled to the frame 202 in the exemplary configuration described below. Figure 8BThe illustration shows a cross-sectional view of a portion of the post 204 of the frame 202. Lug portions 258 of adjacent leaflets 256 may extend through the joining opening 246 and may fold along the radially outer surface 260 of the frame 202. A flexible connector 262 (e.g., comprising fabric) may extend along the radially inner surface 264 of the frame 202, through the joining opening 246, around the outer edge 266 of each lug 258, and across the radially outer surface of the lug 258, such that the flexible connector forms multiple layers (e.g., a first layer 262a, a second layer 262b, and a third layer 262c in the illustrated embodiment). The various components may be coupled together using one or more stitches 268. For example, in the illustrated embodiment, each stitch 268 extends through the first and second layers 262a and 262b of the flexible connector, through the leaflet lugs 258, and through the third layer 262c. Further details regarding the construction of the joints and additional joints that can be used with frame 202 can be found at least in U.S. Patent Nos. 9,393,110 and U.S. Publications 2018 / 0325665 and 2019 / 0105153, which are incorporated herein by reference in their entirety. The inlet or tip edge of leaflet 256 may be connected via stitches to the inner and / or outer skirt (such as...) Figure 1 (as shown) and / or connected to the adjacent link 212.

[0146] The prosthetic valve 200, including a fastenerless frame 202 and an integrated extended locking mechanism 206, can be extended in the following exemplary manner. Typically, the prosthetic valve 200 is placed in a radially compressed state and releasably coupled to a delivery device (such as delivery device 100). Figure 2 The distal portion of the prosthetic valve 200 is advanced through the patient's vascular system to the selected implantation site. For example, when replacing the native aortic valve, the distal portion of the prosthetic valve 200 and the delivery device can be advanced through the aorta to position the prosthetic valve 200 within the native aortic valve annulus. If held within the delivery sheath, the delivery sheath can be retracted, or the prosthetic valve can be advanced distally from the sheath. The prosthetic valve 200 can then be expanded to its desired functional size and locked in place using the expansion locking mechanism 206. The prosthetic valve 200 can also be delivered and implanted within other native valves of the heart (mitral, tricuspid, and pulmonary valves) using any known delivery method.

[0147] Each extended locking mechanism 206 can be releasably coupled to a corresponding actuation component 400 of the delivery device, similar to the actuation component 108 of the delivery device 100. Now refer to Figure 7BIn a particular example, the actuation assembly 400 may include a first actuation member (or support tube) 402 (similar to support tube 122) and a second actuation member 404 (similar to actuation member 124), such as in the form of a rod, tension member, suture, or pull cable. The distal portion of the first actuation member 402 may engage or abut the outflow portion 209 of the inner member 226, and the second actuation member 404 may be releasably coupled to the inflow portion 211 of the outer member 228. For example, the distal portion of the second actuation member 404 may have a threaded section that is screwed into a corresponding threaded hole in the outer member 228. The second actuation member 404 may extend through the first actuation member 402. The proximal portions of the first actuation member 402 and the second actuation member 404 may be operatively connected to the handle of the delivery device. The delivery device in this embodiment may include the same features described above for delivery device 100.

[0148] The delivery device can be used to apply a distal force (as indicated by arrow 240) to the outflow portion 209 of the expansion locking mechanism 206 via a first actuating member 402 and a proximal force (as indicated by arrow 248) to the inflow portion 211 of the expansion locking mechanism via a second actuating member 404, so that the inner member 226 and the outer member 228 move axially relative to each other in a telescopic manner, thereby causing the frame to expand radially.

[0149] Now for reference Figure 4 When frame 202 is in a radially compressed state, inner member 226 can move relative to outer member 228 in a proximal and / or distal direction. As inner member 226 moves, locking teeth 238 can slide along the distal portion 250 and / or the toothless portion 244 of inner member 226 until locking teeth 238 engage linear rack 230, as... Figure 3 As shown. The engagement of the pawl 236 with the multiple teeth 232 allows for continued radial expansion of the frame, but prevents radial compression of the frame.

[0150] By moving the inner member 226 distally and / or the outer member 228 proximally, the frame 202 can continue to expand until a selected prosthetic valve diameter is reached. The selected diameter may correspond to a selected position of the locking teeth 238 of the pawl 236, in which the locking teeth 238 of the pawl 236 engage any of the plurality of teeth 232 of the linear rack 230. For example, in the illustrated embodiment, as... Figure 6 As shown, the selected diameter (e.g., the fully extended diameter) corresponds to the position of the locking tooth 238 engaging the fourth tooth of each linear rack 230. In other embodiments, the selected diameter (e.g., the partially extended diameter) may correspond to the position of the locking tooth 238 engaging any of the other teeth.

[0151] Reference Figure 5 In some embodiments (such as the illustrated embodiment), the inner member 226 may include one or more stop surfaces 252 provided on the inner member 226. The stop surfaces 252 may be located proximal to the linear rack 230 and may be positioned to engage the outflow edge 254 of each pawl 236 to prevent further distal movement of the inner member 226 relative to the outer member 228, thereby preventing overexpansion of the prosthetic valve 200. Once the selected diameter of the prosthetic valve 200 is reached, the delivery device can disengage from the prosthetic valve 200 and remove it from the patient's body.

[0152] Once the prosthetic valve 200 has been implanted in the patient using the selected implantation method, the patient's native anatomy (e.g., the native aortic valve annulus) can resist the prosthetic valve to apply radial forces that would tend to compress the frame 202. However, the radial forces applied by the native anatomy are orthogonal to the degrees of freedom of the plurality of compliant connectors 216, which advantageously allows the compliant connectors 216 to distribute the forces across the entire frame 202, thereby preventing radial forces from compressing the frame 202 and ensuring that the frame remains locked in the desired radially expanded shape. After the expansion of the prosthetic valve 200, the second actuating member 404 can be released from the prosthetic valve, such as by unscrewing the second actuating member 404 from its corresponding threaded section of the outer member 228 of the frame.

[0153] As described above, in some embodiments, frame 202 may have a compliant joint 216 that can plastically deform throughout its extended range or only after the frame has partially extended. In some embodiments, as described above, the plastically deformable joint 216 can hold the frame in a radially extended state without locking features on the frame. For example, in such embodiments, inner member 226 and outer member 228 may be formed without any teeth forming a ratchet mechanism therebetween. In this way, each pair of inner member 226 and outer member 228 forms an extension mechanism for extending the frame but does not provide a locking force for holding the frame in the extended state.

[0154] Figure 9 illustrates an exemplary embodiment of a prosthetic valve 300 having a frame 302. The prosthetic valve 300 may further include valve structures (such as valve structure 18) as previously described, as well as inner and / or outer skirts, but these components are omitted for illustrative purposes.

[0155] Frame 302 can be configured as two or more sub-frames 304 coupled together. Each sub-frame 304 may include a plurality of links 310 coupled together via a compliant connector 312. Such a configuration can be advantageous where a higher density of links 310 is required. For example, in cases where including a smaller open unit region around the periphery of the prosthetic valve is advantageous for the prosthetic valve, for example, to offset against the arterial wall or capture the native leaflet during the expansion of the prosthetic valve.

[0156] In the illustrated embodiment, frame 302 includes a first subframe 304a and a second subframe 304b. Frame 302 may include an inflow portion 306 (in the illustrated embodiment, this is the distal end of the frame in the delivery configuration) and an outflow portion 308 (in the illustrated embodiment, this is the proximal end of the frame in the delivery configuration). The first subframe 304a and the second subframe 304b may be coupled together such that one frame is positioned radially outside the other frame. For example, in the illustrated embodiment, the first subframe 304a is positioned radially outside the second subframe 304b. In other embodiments, the second subframe 304b may be positioned radially outside the first subframe 304a. In still other embodiments, the first subframe 304a and the second subframe 304b may be coupled together in a woven or mesh manner such that a portion of the second subframe 304b is positioned radially outside the first subframe 304a, and vice versa.

[0157] Each subframe 304 may be similar to the frame 202 described above, but subframe 304 does not include columns or an integral extended locking mechanism. As previously mentioned, each subframe 304 may include a plurality of links 310 coupled together via compliant joints 312. In the illustrated embodiment, each subframe 304 includes a plurality of rhomboid units, each rhomboid unit 314 defined by four links 310. Each unit 314 may have an inflow vertex 316, an outflow vertex 318, and two side vertices 320. Each unit 314 may be coupled to one or more adjacent units 314 at the side vertices 320. In other embodiments, each subframe 304 may include links 310 arranged in any of a variety of shapes.

[0158] Each link 310 can be coupled to one or more adjacent links 310 via a compliant hinge or compliant joint 312 integrally formed with the frame 302. Each link 310 can have a first end portion 322 and a second end portion 324. The first end portion 322 of each link 310 can be coupled to an adjacent link 310 via the compliant joint 312 at the inflow or outflow vertex 316, 318 of each unit 314, and the second end portion 324 of each link 310 can be coupled to an adjacent link 310 via the compliant joint 312 at a side vertex 320. Two compliant joints 312 can be coupled together at each side vertex 320. The compliant joint 312 can be configured to allow movement of the links 310 relative to each other via the elastomeric deformation of the compliant joint 312. In the illustrated embodiment, each compliant joint 312 may include a flexible neck portion 326, which at least partially defines a C-shaped cutout 328 including the gap G. However, in other embodiments, each other form of compliant joint or flexural link may be used, for example, Figure 10A-12B Any of the hinge types shown. As shown, compliant joints 312 coupled to the same link 310 can be oriented in opposite directions. In other embodiments, compliant joints 312 coupled to the same link 310 can be oriented in the same direction.

[0159] As frame 302 moves from a compression configuration to a fully extended configuration, the flexible neck portion 326 can deform or deflect, and the gap G can widen. The flexible neck portion 326 can have a width narrower than the width of each link 310. This configuration allows frame 302 to move between radially compressed and radially extended states without using fasteners to couple adjacent links 310 to each other. Additionally, the compliant joint 312 can be aligned with or flush with the links 310 (compared to fasteners protruding from the surface of the struts), thereby reducing the overall curl profile of the prosthetic valve 300.

[0160] In some embodiments, each subframe 304 may be formed from a single piece of material. For example, each subframe 304 may be formed using simpler processing and machining procedures, such as laser cutting, waterjet cutting, etc. In some specific embodiments, all subframes 304 may be cut from a tube of material (e.g., laser cutting), as previously described with respect to frame 202. Furthermore, the absence of fasteners in each subframe significantly reduces the number of parts and simplifies assembly complexity, thereby reducing material and time costs.

[0161] The first subframe 304a and the second subframe 304b can be coupled to each other using, for example, multiple fasteners (such as rivets or pins). Each subframe 304 may include multiple openings 330 extending through a link 310 in the subframe 304 at the joint where the first subframe 304a and the second subframe 304b overlap. Figure 9B As shown, the corresponding fastener 350 can extend through a pair of openings 330 of a pair of overlapping links 310 to form a hinge joint between the links. Further details regarding the hinge joint are disclosed in U.S. Publications 2018 / 0153689 and 2018 / 0344456, which are incorporated herein by reference. This configuration can be advantageous if the frame 302 requires a higher density of links 310, resulting in a smaller open unit area around the valve periphery, for example, to facilitate biasing of the native leaflet against the native arterial wall during expansion of the prosthetic valve.

[0162] In some embodiments (such as the illustrated embodiment), instead of or in addition to an integrally formed expansion locking mechanism (such as the expansion locking mechanism 206 described above), frame 302 may include one or more separately formed expansion locking members 332. Although the illustrated embodiment shows three expansion locking mechanisms 332 spaced apart from each other around the circumference of the frame, it should be noted that the prosthetic valve may include any number of expansion locking mechanisms 332. For example, in some embodiments, the prosthetic valve may include a single expansion locking mechanism, or two expansion locking mechanisms, or four expansion locking mechanisms, etc. The expansion locking mechanisms 332 may be positioned anywhere around the circumference of frame 302. For example, in some embodiments (such as the illustrated embodiment), the expansion locking mechanisms 332 are equally spaced apart from each other around the circumference of frame 302. In other embodiments, having two or more expansion locking mechanisms located close to each other may be advantageous.

[0163] Each extended locking mechanism 332 may include an outer member or sleeve 334 having a bore and an inner member 336 extending at least partially into the sleeve 334. The distal portion of the inner member 336 may be coupled to the frame 302 at a first position via a fastener attached to and extending radially from the distal portion of the inner member 336. The fastener may be, for example, a rivet or a pin. As shown, in some embodiments, the fastener may extend through a corresponding opening 330 at the junction of two overlapping links 310 of the first subframe 304a and the second subframe 304b and may serve as a pivot pin about which the links 310 may pivot relative to each other and the inner member 336. The sleeve 334 may be coupled to the frame 302 at a second position axially spaced from the first position. For example, in the illustrated embodiment, the inner member 336 is secured to the frame 302 near the distal end or inlet end 306 of the frame, and the sleeve 334 is secured to the frame 302 closer to the proximal end or outlet end 308 of the frame, such as via a fastener 338 (e.g., a rivet or pin). The fastener 338 is attached to the sleeve 334 and extends radially from the sleeve 334 via the junction of two overlapping links 310 of the first subframe 304a and the second subframe 304b, and can serve as a pivot pin about which the links 310 can pivot relative to each other and the sleeve 334.

[0164] The extended locking mechanism 332 may further include a locking member configured to lock the sleeve 334 and the inner member 336 such that it prevents the sleeve 334 and the inner member 336 from moving relative to each other in one or more directions. Further details of the extended locking mechanism can be found, for example, in PCT application No. PCT / US2020 / 057691, filed October 28, 2020, the entire contents of which are incorporated herein by reference.

[0165] The inner member 336 can move axially relative to the sleeve 334 in both the proximal and distal directions. Therefore, since the inner member 336 and the sleeve 334 are fixed to the frame 302 at axially spaced positions, axially moving the inner member 336 and the sleeve 334 relative to each other in a telescopic manner can cause radial expansion or compression of the frame 302. For example, moving the inner member 336 proximally toward the outflow end 308 of the frame while holding the sleeve 334 in a fixed position and / or moving the sleeve 334 distally toward the inflow end 306 of the frame can cause the frame 302 to shorten axially and expand radially. Conversely, moving the inner member 336 distally toward the inflow end of the frame and / or moving the sleeve 334 proximally causes the frame 302 to lengthen axially and compress radially.

[0166] As described above, in some embodiments, frame 202 may have a compliant joint 312 that plastically deforms throughout the entire extension range or only plastically deforms after the frame has partially extended. In some embodiments, as described above, the plastically deformable joint can help hold the frame in a radially extended state and / or can hold the frame completely in a radially extended state without any other locking features on the frame. In some such embodiments, the extension locking mechanism 332 may be omitted, and therefore may be used only for radially extended frames (without providing any locking function).

[0167] Figure 13 An exemplary embodiment of a prosthetic valve 800 having a frame 802 is illustrated. The prosthetic valve 800 may further include valve structures (such as valve structure 18) and inner and / or outer skirts as previously described, but these components are omitted for illustrative purposes. The prosthetic valve 800 may be similar to the prosthetic valve 200 described above, including a plurality of posts 804 coupled together via a compliant joint 808 by a plurality of rigid members or links 806, except that, instead of the expansion locking mechanism 206, the prosthetic valve 800 includes an integral expansion locking mechanism 810. The expansion locking mechanism 810 may be used to radially expand the frame 802 and lock the frame in a radially expanded state. The frame 802 in this embodiment may include substantially the same features as those described above for frame 202.

[0168] The extended locking mechanism 810 can be integrally formed with the frame 802, allowing the frame 802 to be formed from a single piece of material (e.g., a tube). For example, the frame 802 including the extended locking mechanism 810 can be formed using simpler processing and machining procedures, such as laser cutting, waterjet cutting, etc. In some specific embodiments, the frame 802 can be cut from a cobalt-chromium alloy (e.g., MP35N) tube. Furthermore, since the extended locking mechanism is not formed separately, the number of parts is significantly reduced and the complexity of assembly is simplified, thereby reducing material and time costs.

[0169] In the illustrated embodiment, frame 802 includes three posts 804, each post 804 configured to extend the locking mechanism 810. In other embodiments, frame 802 may include more or fewer posts 804, a selected number of posts 804 that may be configured to extend the locking mechanism 810. Each extending locking mechanism 810 may include an inner member 812 and an outer member 814. Each inner member 812 and / or outer member 814 may extend from a corresponding end of frame 802 and be integrally formed with the corresponding end of frame 802. For example, in the illustrated embodiment, inner member 812 extends from an outlet end 816 of frame 802 toward an inlet end 818, and outer member 814 extends from the inlet end 818 of frame toward an outlet end 816. In other embodiments, inner member 812 may extend from the inlet end 818 of frame 802, and outer member 814 may extend from the outlet end 816 of frame.

[0170] Reference Figure 14 The inner member 812 may include a body 820 and an elongated member or rod 822. The outer member 814 may include a first side portion 824 and a second side portion 826, which define an opening or channel 828 therebetween, into which at least a portion of the rod 822 may extend. The second side portion 826 may be configured to terminate in a biasing member 830 (e.g., a leaf spring) in a V-shaped locking tooth 832. The biasing member 830 may be biased toward the rod 822 such that a first leg 834 of the V-shaped locking tooth 832 frictionally engages the rod 822. The biasing configuration ensures that the V-shaped locking tooth 832 remains engaged with the rod 822 during normal operation.

[0171] The V-shaped locking tooth 832 can be configured to frictionally engage the surface of the rod 822 such that when the V-shaped locking tooth 832 and the rod 822 are engaged, the inner member 812 and the outer member 814 can move relative to each other in a first axial direction, but are prevented from moving relative to each other in the opposite second axial direction. For example, in the illustrated embodiment, when the V-shaped locking tooth 832 engages with the rod 822, the inner member 812 can move in the distal direction (e.g., in the...) Figure 14 The orientation shown is upward and downward, but it is prevented from moving axially in the proximal direction (e.g., in the direction shown). Figure 14 (As shown, the orientation is upward) axial movement. This ensures that when the V-shaped locking tooth 832 engages with the rod 822, the frame 802 can expand radially but cannot compress radially. In other words, the inlet end 818 and the outlet end 816 of the frame 802 can move axially toward each other, but cannot move axially away from each other.

[0172] Unlike the ratchet mechanism described above, the outer surface of lever 822 can be formed without locking features, such as teeth, that contact the V-shaped locking teeth 832. In the illustrated embodiment, lever 822 has a rectangular cross-sectional profile in a plane perpendicular to the length of the lever and a flat side surface 823 that contacts the V-shaped locking teeth 832. In other embodiments, lever 822 may have a cylindrical outer surface and a circular cross-sectional profile in a plane perpendicular to the length of the lever.

[0173] like Figure 14 As shown, in the illustrated embodiment, the V-shaped locking tooth 832 can be oriented in the distal direction (e.g., where the point of the V faces the outflow end of the frame). This orientation allows the leg 834 to deflect toward the side portion 826 as the rod 822 moves distally between the first side portion 824 and the second side portion 826 of the outer member 814. However, due to the offset of the leg 834 against the rod 822 and its distal orientation, the leg 834 can prevent the rod 822 from traveling proximally relative to the first side portion 824 and the second side portion 826 of the outer member 814. In other embodiments (e.g., where the inner member 812 extends from the inflow end 818 of the frame 802), the V-shaped locking tooth 832 can be oriented proximally to allow proximal movement of the rod 822 but prevent distal movement. An advantage of the locking mechanism 810 of this embodiment is that the V-shaped locking tooth 832 allows for continuous expansion and continuous locking of the frame at any diameter when the inner member engages with the locking tooth. In other words, unlike a ratchet mechanism that is limited to locking the valve frame at discrete steps corresponding to the locking positions of the pawl relative to the teeth of the ratchet mechanism, the locking teeth can hold the frame at any expansion diameter during expansion. In this way, the locking mechanism 810 can provide a continuous range of expansion and locking.

[0174] Once the prosthetic valve 800 has been implanted at the selected site within the patient's body, the patient's native anatomy (e.g., the native aortic valve annulus) can exert radial forces against the prosthetic valve 800 that tend to compress the frame 802. However, the engagement between the V-shaped locking teeth 832 of the bias member 830 and the rod 822 prevents such forces from compressing the frame 802, thereby ensuring that the frame remains locked in the desired radially extended state.

[0175] In the illustrated embodiment, only the second side portion 826 of the outer member 814 includes a biasing member 830 and a V-shaped locking tooth 832; however, in other embodiments, both the first side portion 824 and the second side portion 826 may include corresponding biasing members and locking teeth.

[0176] The inner member 812 may be in the distal direction relative to the outer member 814 (e.g., in Figure 14The inner member 812 is axially moved toward the inlet end 818 of the frame (as shown in the diagram). Therefore, since the inner member 812 and the outer member 814 are fixed to the frame 802 at axially spaced positions (inlet end 818 and outlet end 816, respectively), axially moving the inner member 812 and the outer member 814 relative to each other in a telescoping manner can cause radial expansion or compression of the frame 802. For example, moving the inner member 812 distally toward the inlet end 818 of the frame while holding the outer member 814 in a fixed position and / or moving the outer member 814 proximally toward the outlet end 816 of the frame can cause the frame 802 to shorten axially and expand radially.

[0177] In some embodiments, when frame 802 is in a compression configuration, the distal end of inner member 812 may be spaced apart from outer member 814 by a selected distance, thereby allowing movement of inner member 812 relative to outer member 814 in both distal and proximal directions. This allows frame 802 to expand and / or compress prior to engagement of inner member 812 with outer member 814, at which point frame 802 may expand further but can no longer be compressed. The length of the space between inner member 812 and outer member 814 may be selected to provide a reversible range in which prosthetic valve 800 can freely expand and compress without locking.

[0178] like Figure 13-14 As shown, in the illustrated embodiment, each post 804 further includes a junction opening 836. The junction opening 836 may extend radially through the thickness of the post 804 and may be configured to receive a portion of the valve structure to couple the valve structure to the frame 802. In the illustrated embodiment, the junction opening 836 has a rectangular shape and is completely surrounded by the post 804 (e.g., the opening 836 does not extend to the inflow and / or outflow edges of the post 804). However, in other embodiments, the junction opening 836 may have any of a variety of shapes (e.g., square, elliptical, square-elliptical, triangular, L-shaped, T-shaped, C-shaped, etc.). In some embodiments, the opening 836 may extend to the edge of the post 804 (e.g., the outflow edge) such that a portion of the valve structure can slide axially (rather than radially) into the junction opening 836. In some embodiments, the valve structure comprising multiple leaflets may be... Figure 8B The structure shown and previously described with respect to the prosthetic valve 200 is coupled to the frame.

[0179] In the illustrated embodiment, the joint opening 836 is disposed within the inner member 812 of the column 804. However, in other embodiments (e.g., in which the inner member extends from the inlet end 818 of the frame and the outer member 814 extends from the outlet end 816), the joint opening 836 may be configured as part of the outer member 814.

[0180] The prosthetic valve 800 can be coupled to a delivery device (e.g., delivery device 100) via an expansion locking mechanism 810, similar to... Figure 7B As shown and described above with respect to the extended locking mechanism 206. That is, the prosthetic valve 800 can be coupled to the delivery device via a first actuating member (or support tube) 402 (or support tube 122) configured to engage or abut the outflow portion 838 of the inner member 812 and a second actuating member 404 (or actuating member 124) (such as in the form of a rod, tension member, or cable) configured to be releasably coupled to the outer member 814, as previously described. The proximal portions of the first and second actuating members 402, 404 can be operatively connected to the handle of the delivery device. The delivery device in this embodiment may include the same features as those described above with respect to the delivery device 100.

[0181] The delivery device can be used to apply a distal force to the outflow portion 838 of the expansion locking mechanism 810 via a first actuating member 402 and a proximal force to the inflow portion 840 of the expansion locking mechanism via a second actuating member 404, so that the inner member 812 and the outer member 814 move axially relative to each other in a telescopic manner, thereby causing the frame to expand radially.

[0182] The prosthetic valve 800 can be deployed at the selected implantation site using the same method described above for the prosthetic valve 200. The frame 802 can be expanded by distally moving the inner member 812 and / or proximally moving the outer member 814 until the selected prosthetic valve diameter is achieved.

[0183] In some embodiments (such as the illustrated embodiment), the inner member 812 may include one or more inclined or angled surfaces 842 extending from the rod 822 to the body 820. As the prosthetic valve 800 expands and the inner member 812 moves distally relative to the outer member 814, the V-shaped locking teeth 832 may slide along the angled surfaces 842 until the outflow portion of the outer member 814 contacts the surfaces 842, preventing further advance of the inner member 812 and thus preventing over-expansion of the prosthetic valve 800. The first side portion 824 and the second side portion 826 of the outer member 814 may be sufficiently rigid to prevent deflection away from each other. Once the selected diameter of the prosthetic valve 800 is reached, the delivery device can disengage from the prosthetic valve 800 and remove it from the patient's body.

[0184] refer to Figure 15 In some embodiments, instead of or in addition to the extended locking mechanism 810, the prosthetic valve 800 may include an extended locking mechanism 900. The extended locking mechanism 900 may be similar to the extended locking mechanism 810, except that each extended locking mechanism 900 includes a biasing member 902 formed separately from the frame 802.

[0185] The extended locking mechanism 900 may include an inner member 904 and an outer member 906. The inner member 904 may be similar to the inner member 812 and may include a body 908 and an elongated rod 910. In some embodiments, the body 908 may include a coupling opening 912 similar to the coupling opening 836 described previously. The outer member 906 may include a first side portion 914 and a second side portion 916 defining an opening or channel 918 therebetween, into which at least a portion of the elongated rod 910 may extend.

[0186] The extended locking mechanism 900 may further include a locking member or cap 920. Cap 920 may be a separately formed component coupled to the outflow portion 922 of the outer member 906 and may define an opening 924 through which an elongated rod 910 extends into the channel 918. This configuration can advantageously prevent or mitigate the risk of disconnection between the outer member 906 and the inner member 904.

[0187] like Figure 15 As shown, the cap 920 may include a biasing member 902 coupled to an inner surface 926 of the cap 920. The biasing member 902 may be biased toward the elongated rod 910 such that, under normal operation, the biasing member 902 remains engaged with the elongated rod 910. An end portion of the biasing member 902 may be configured to frictionally engage a surface of the elongated rod such that, when the biasing member 902 and the elongated rod 910 are engaged, the inner member 904 and the outer member 906 may move relative to each other in a first axial direction, but are prevented from moving relative to each other in the opposite second axial direction. For example, in the illustrated embodiment, when the biasing member 902 is engaged with the elongated rod 910, the inner member 904 may move in a distal direction (e.g., in…) Figure 15 The orientation shown is upward and downward, but it is prevented from moving axially in the proximal direction (e.g., in the direction shown). Figure 15 The orientation shown is upward (axial movement). This ensures that when the biasing member 902 engages with the elongated rod 910, the frame 802 can expand radially but cannot compress radially. In other words, the inlet end 818 and the outlet end 816 of the frame 802 can move axially toward each other, but cannot move axially away from each other.

[0188] In some embodiments (such as the illustrated embodiment), the inner member 904 may include one or more inclined or angled surfaces 928 extending from the elongated rod 910 to the body 908. As the prosthetic valve 800 expands and the inner member 904 moves distally relative to the outer member 906, the cap 920 may slide along the angled surface 928 until the width of the inner member 904 is too great to be advanced through the opening 924, thereby preventing further advancement of the inner member 904 and preventing over-expansion of the prosthetic valve 800.

[0189] The prosthetic heart valve, including the expansion locking mechanism 900, can be coupled to a delivery device and expanded in the same manner as the prosthetic valve 800, including the expansion locking mechanism 810. The frame 802 can be expanded by distally moving the inner member 904 and / or proximally moving the outer member 906 until the selected prosthetic valve diameter is reached.

[0190] refer to Figure 16 In another embodiment, instead of or in addition to the extended locking mechanisms 810 and / or 900, the prosthetic valve (e.g., prosthetic valve 800) may include the extended locking mechanism 1000.

[0191] The extended locking mechanism 1000 may include an inner member 1002 and an outer member 1004. The inner member 1002 may be similar to the inner member 812 and may include a body (not shown) and an elongated rod 1006. In some embodiments, the inner member 1002 may include a connecting opening similar to the connecting opening 836.

[0192] The outer member 1004 may include a first side portion 1008 and a second side portion 1010, the first and second side portions 1008 and 1010 defining an opening or channel 1012 therebetween, at least a portion of the elongated rod 1006 extending into the opening or channel 1012. The first side portion 1008 and the second side portion 1010 may be flexible, such that they may bend elastically toward or away from each other.

[0193] The extended locking mechanism 1000 may further include a locking member or cap 1014 that can be disposed above the outflow portion 1016 of the outer member 1004. The cap 1014 may be an annular member having an outer surface 1018 and an inner surface 1020 defining a lumen 1021. Figure 16 As shown, the inner surface 1020 of the cap 1014 can be angled, such that the inner diameter D1 of the cap 1014 at the inlet end 1022 is greater than the inner diameter D2 of the cap 1014 at the outlet end 1024. In other words, the lumen 1021 of the cap 1014 gradually tapers from the inlet end 1022 to the outlet end 1024.

[0194] During the assembly of the prosthetic valve, including the extension locking mechanism 1000, the elongated rod 1006 can be configured such that it extends through the lumen 1021 of the cap 1014 and into the channel 1012 between the first side portion 1008 and the second side portion 1010. The cap 1014 can be advanced over the outflow end portion 1016 of the first side portion 1008 and the second side portion 1010 such that the inclined inner surface 1020 forces the first side portion 1008 and the second side portion 1010 toward the elongated rod 1006, such that the first side portion 1008 and the second side portion 1010 engage the surface of the rod 1006.

[0195] In use (e.g., when the frame 802 is expanded and / or compressed), the inner member 1002 can move relative to the outer member 1004 within the channel 1012. When the cap is positioned on the outer member 1004, the angled inner surface 1020 of the cap 1014 prevents the inner member 1002 from moving relative to the outer member 1004.

[0196] In some embodiments, during the expansion of frame 802, cap 1014 may be spaced apart from outer member 1004, and inner member 1002 may be in a distal direction relative to outer member 1004 (e.g., in...). Figure 16 The orientation shown is upward and downward) and the proximal direction (e.g., in the direction shown) Figure 16 (As shown, the orientation is upward) and moves upward. Once the frame 802 reaches the selected diameter, the cap 1014 can slide distally above the end outer member 1004, such that the first side portion 1008 and the second side portion 1010 engage the rod 1006, and prevent the frame 802 from further radially expanding and / or compressing. The cap 1014 can be actuated (e.g., slid distally) using an actuating member of, for example, a delivery device.

[0197] refer to Figure 17 In other embodiments, the cap 1014 may be coupled to a unit of the frame 802 or to a joint between adjacent units, such that the cap 1014 may move distally and / or proximally as the frame 802 expands and / or contracts. During the expansion of the frame 802, the cap 1014 may move relative to the outer member 1004, such that the clamping force of the cap 1014 on the first side portion 1008 and the second side portion 1010 gradually increases due to the gradually tapering lumen 1021 until a selected diameter is reached, at which point the movement of the inner member 1002 and the outer member 1004 relative to each other is restricted.

[0198] In some embodiments, the cap 1014 may be formed as a component separate from the frame 802, which includes, for example, an inner member 1002 and an outer member 1004 of an extended locking mechanism 1000. In other embodiments, the cap 1014 may be separate from other components of the frame (such as...). Figure 17The units of the frame shown are integrally formed. For example, a cap 1014 may be integrally formed with one or more links 806 of the frame 802, such that when the frame 802 expands radially and / or compresses, movement of the links 806 causes a corresponding movement of the cap 1014. In the illustrated embodiment, the cap 1014 may be connected to adjacent ends of two links of the first unit and adjacent units of two links of the second unit in the same row as the first unit, such that the cap 1014 defines a joint between the first unit and the second unit or is located at the joint between the first unit and the second unit.

[0199] Advantageously, the extended locking mechanisms 810, 900, and 1000 described above can be formed using simpler processing and machining procedures, such as laser cutting, waterjet cutting, etc. In some specific embodiments, the frame 802 (including the extended locking mechanisms 810, 900, 1000, and / or selected components thereof) can be cut (e.g., laser cutting) from a metal tube made of, for example, a cobalt-chromium alloy (e.g., MP35N), stainless steel, or nitinol. Since there is no separately formed extended locking mechanism, the number of parts is significantly reduced and the complexity of assembly is simplified, thereby reducing material and time costs.

[0200] Furthermore, the described expansion locking mechanisms 810, 900, and 1000 can advantageously be wholly or partially aligned with or flush with the frame 802 (e.g., the expansion locking mechanisms do not protrude beyond the radially inner and / or radially outer surfaces of the frame, or only partially protrude from them), thereby reducing the overall curl profile of the prosthetic valve. Moreover, the expansion locking mechanisms 810, 900, and 1000 allow for continuous expansion of the prosthetic valve without the stepped expansion produced by the ratchet mechanism.

[0201] Figure 18A-21 The illustration shows an extended locking mechanism 1100 (which may also be referred to herein as "extended locking device 1100" and / or "valve deployment device") according to yet another embodiment. Specifically, Figure 18A , 19A Figure 21 illustrates the extended locking mechanism 1100 in its axially extended position, wherein Figure 19A This illustrates how the expansion locking mechanism 1100 can hold the prosthetic valve 1200 (which may also be referred to herein as "prosthetic heart valve 1200") in a radially compressed (and axially extended) position when the expansion locking mechanism is included within the prosthetic valve 1200 and adjusted to the axially extended position. Figure 18B and 19B The diagram illustrates the extended locking mechanism 1100 in its axially compressed or retracted position, wherein... Figure 19BThis illustrates how the expansion locking mechanism 1100 can hold the prosthetic valve 1200 in a radially expanded (and axially shortened) position when the expansion locking mechanism is included within the prosthetic valve 1200 and adjusted to the axially compressed position.

[0202] The extended locking mechanism 1100 is similar to extended locking mechanisms 810, 900, and 1000 because it is self-locking (i.e., it allows the prosthetic valve 1200 to lock). Figures 19A-19B In the radially compressed (and axially elongated) position ( Figure 19A ) and radial compression (and axial shortening) position ( Figure 19B (Continuous expansion and locking between ) . However, the expansion locking mechanism 1100 is configured slightly differently from the expansion locking mechanisms 810, 900 and 1000. For example, unlike in Figure 13-14 The V-shaped locking teeth 832 shown are included in the distal member (outer member 814) of the extension locking mechanism 810. The locking element of the extension locking mechanism 1100 can be included in the proximal member of the extension locking mechanism 1100. Furthermore, unlike the distal member (outer member 814) of the extension locking mechanism 810 (which is configured as the outer member of the extension locking mechanism 810), the distal member of the extension locking mechanism 1100 can be configured as an inner member (i.e., the distal member extends into and through the proximal member). Therefore, in operation, the distal member of the extension locking mechanism 1100 can be pulled toward and through the proximal member of the extension locking mechanism 1100, and the locking element in the proximal member of the extension locking mechanism 1100 continuously holds the distal member in place and prevents the distal member from retracting to a more distal position (e.g., sliding backward). As described above, the prosthetic valve 1200 can be rolled up onto the distal end of the delivery device in a radially compressed position and delivered to the implantation site (e.g., a native heart valve) in this low-profile configuration. Once at the implantation site, the prosthetic valve 1200 can be extended to a radially extended position, which can be the operational / functional configuration of the prosthetic valve 1200.

[0203] The expansion locking mechanism 1100 includes a distal member 1102 and a proximal member 1104 that are axially movable relative to each other. Specifically, the distal member 1102 is configured to move proximally toward, into, and / or through the proximal member 1104 to radially expand the prosthetic valve 1200. Similar to expansion locking mechanisms 810, 900, and 1000, a physician can pull the distal member 1102 toward the proximal member 1104 and / or pull the distal member 1102 through the proximal member 1104 via an actuation assembly 1106. The actuation assembly 1106, together with the expansion locking mechanism 1100, may include an expansion locking assembly 1107 (which may also be referred to herein as "valve deployment assembly 1107"). The actuation assembly 1106 may include a first actuation member 1108 (which may also be referred to herein as "sleeve 1108", "support tube 1108" and / or "outer sheath 1108") and a second actuation member 1110 (which may also be referred to herein as "tension member") slidably received within the first actuation member 1108. In a particular embodiment, the second actuation member 1110 may include a cable. In other embodiments, the second actuation member 1110 may include a rod or a line.

[0204] A first actuating member 1108 and a second actuating member 1110 may be included in a delivery device (e.g., delivery device 100) and may be coupled to a handle of the delivery device (e.g., handle 104) and / or extend distally from the handle of the delivery device (e.g., handle 104). The first actuating member 1108 may be configured to carry a distally directed force applied to the handle. For example, the first actuating member 1108 may be fixedly attached to the handle such that the first actuating member 1108 does not move relative to the handle. Therefore, the first actuating member 1108 may move synchronously with the handle, and any distally directed force applied to the handle may be transmitted to the distal end of the first actuating member 1108. The second actuating member 1110 is configured to move relative to the first actuating member 1108. Specifically, when a proximally directed force is applied, the second actuating member 1110 may move proximally relative to the first actuating member 1108. For example, a physician can apply a proximal force to the second actuating member 1110 by directly pulling the second actuating member 1110 (in an example where the second actuating member 1110 extends proximally and / or through the handle) or by adjusting a control mechanism (e.g., a second knob 112) included on the handle of the delivery device.

[0205] The second actuating member 1110 is detachably connected to the distal member 1102 of the expansion locking mechanism 1100 to pull the distal member 1102 toward the proximal member 1104 and / or pull the distal member 1102 through the proximal member 1104 when a proximal-directed force is applied (and thereby radially expand the prosthetic valve 1200), while the first actuating member 1108 is adjacent to the proximal portion of the proximal member 1104 and / or the proximal portion of the prosthetic valve 1200 to facilitate valve expansion and / or retain the prosthetic valve 1200 in place when the prosthetic valve 1200 is expanded with a distal-directed force. Specifically, when a proximal-directed force (e.g., a pulling force) is applied to the second actuating member 1110, a physician may provide a counteracting distal-directed force (e.g., a pushing force) to the first actuating member 1108 to facilitate valve expansion and retain the prosthetic valve 1200 in place relative to the surrounding tissues. As an example only, a physician can apply a distal force by grasping, holding, and / or pushing the handle (e.g., handle 104) of a delivery device (e.g., delivery device 100). Simultaneously, the physician can adjust (e.g., rotate, pull, slide, etc.) a control mechanism included in the handle (e.g., second knob 112), or directly pull the second actuating member 1110, to apply a proximal force to the second actuating member 1110. In this way, the physician can axially shorten and radially expand the prosthetic valve 1200 while maintaining its relative position within the surrounding tissue.

[0206] The distal member 1102 of the extended locking mechanism 1100 is coupled to the prosthetic valve frame 1202 of the prosthetic valve 1200 at a position on the frame 1202 that is more distal than the proximal member 1104 (i.e., closer to the distal end 1204 of the frame 1202 and further away from the proximal end 1206 of the frame 1202 than the proximal member 1104). Figures 19A-19B For example, such as Figures 19A-19B As shown in the embodiment illustrated in the figure, the distal member 1102 may be coupled to the distal vertex 1208 of the frame 1202 located at and / or near the distal end 1204 of the frame 1202. As another example, the distal member 1102 may be coupled to the distal joint 1210 of the frame 1202. Correspondingly, the proximal member 1104 may be coupled to the proximal vertex 1212 or the proximal joint 1214 of the frame 1202. In this way, at least when the frame 1202 is in a radially compressed (e.g., curled) position (such as... Figure 19A When in the radially compressed position shown, the distal member 1102 and the proximal member 1104 can be axially spaced apart from each other. In this way, the distal member 1102 and the proximal member 1104 can be pulled toward each other (as described above) to axially shorten and radially expand the frame 1202.

[0207] In some embodiments, the distal member 1102 and / or the proximal member 1104 may be coupled to the frame 1202 via fasteners (e.g., screws, pins), adhesives, sutures, thermal bonding (e.g., welding) or other suitable coupling means. In other embodiments, the distal member 1102 and / or the proximal member 1104 may be integrally formed with and / or monolithically integrated with the frame 1202. In some embodiments (such as...) Figures 19A-19B In the embodiment shown, the distal member 1102 and the proximal member 1104 may be coupled to the interior of the frame 1202 within the lumen 1218 of the frame 1202, formed together with the interior of the frame 1202, and / or otherwise included in the interior of the frame 1202 (i.e., on the inner side 1216).

[0208] In some such embodiments, the distal member 1102 and / or the proximal member 1104 may be configured to receive and / or retain leaflets of the valve structure of the frame 1202. As one such example, the proximal member 1104 and / or the distal member 1102 may include a commissural opening (e.g., commissural opening 836) for receiving leaflets, and commissural clamping members or connectors (e.g., flexible connector 262) may be used to couple, retain, and / or otherwise secure the leaflets to the frame 1202 to prevent them from being pulled out of the commissural opening. Thus, in such embodiments, the expansion locking mechanism 1100 may also be configured to retain the commissural of adjacent leaflets in addition to expanding and locking the prosthetic valve 1200. For example, the expansion locking mechanism 1100 may be included as part of a commissural clamping structure (e.g., a commissural post) of the prosthetic valve 1200. In some such examples, the prosthetic valve 1200 may include a plurality of fusion clamping structures (e.g., three fusion posts), and the extended locking mechanism 1100 may be incorporated into and / or included in at least one of the fusion clamping structures.

[0209] However, in other such embodiments, the extended locking mechanism 1100 may be separate from the joint clamping structure (e.g., the joint post) configured to hold the joint of the leaflet. In such examples, the extended locking mechanism 1100 does not need to be aligned with one or more of the joint clamping structures along a common longitudinal axis. That is, in some such embodiments, the extended locking mechanism 1100 may be circumferentially spaced from the joint clamping structure.

[0210] In other embodiments, the extended locking mechanism 1100 may be coupled to the outer side of the frame 1202 opposite to the inner side 1216, formed together with the outer side of the frame 1202 opposite to the inner side 1216, and / or otherwise included on the outer side of the frame 1202 opposite to the inner side 1216 (i.e., on the outer side 1220), such as between the frame 1202 and the outer skirt (e.g., outer skirt 70) of the prosthetic valve 1200. In further embodiments, the extended locking mechanism 1100 may span the frame 1202 (between the inner and outer sides of the frame 1202) such that it is included on both sides of the frame 1202.

[0211] The distal member 1102 may include an end portion 1112 and an elongated member or rod 1114. In some embodiments, the elongated member may include a wire or cable. The end portion 1112 (e.g., at the distal apex 1208 or distal junction 1210) is coupled to and / or integrally formed with the frame 1202, and the rod 1114 extends axially toward the proximal member 1104 of the extended locking mechanism 1100 and / or the proximal end 1206 of the frame 1202. In some such examples, the end portion 1112 may include an attachment member 1116 configured to be coupled to the frame 1202. For example, the attachment member 1116 may extend through an opening in the frame 1202 to help secure the distal member 1102 to the frame 1202. In some such examples, mating mechanical fasteners (e.g., nuts) may be coupled to the ends of attachment member 1116 on opposite sides of frame 1202 to prevent attachment member 1116 from being pulled out of an opening in frame 1202. Alternatively, attachment member 1116 may be welded to frame 1202.

[0212] The proximal member 1104 may include a body 1118 having an opening 1120 (which may also be referred to herein as a "channel" and / or "passage") extending through the body 1118 and configured to receive a rod 1114 and / or a second actuating member 1110 of the distal member 1102 and actuating assembly 1106. That is, the rod 1114 and / or the second actuating member 1110 may be configured to extend through the opening 1120 of the proximal member 1104. Specifically, and as described above, the rod 1114 and / or the second actuating member 1110 may be configured to move proximally (e.g., pull) toward the handle of the delivery device through the opening 1120 of the proximal member 1104. The proximal member 1104 also includes a locking element 1122, in Figure 18A-20In the embodiment illustrated in the figure, locking element 1122 includes a spring tooth 1124 (which may have a Wago® wire connector configuration) extending into opening 1120. Locking element 1122 is configured to allow only unidirectional movement of lever 1114 and / or distal member 1102 in the proximal direction (first axial direction) through proximal member 1104 to ensure that the prosthetic valve 1200 does not collapse posteriorly toward a more radially compressed position. That is, locking element 1122 is configured to provide continuous compressive and / or locking forces to lever 1114 and / or second actuating member 1110 to prevent distal (second axial) movement of distal member 1102 toward an extended position, thereby holding frame 1202 in the proper position at any valve diameter, as referenced above. Figure 14 Described.

[0213] Specifically, such as Figure 20 As best viewed, spring tooth 1124 can be oriented toward the extended position (e.g.) Figure 20 As shown, a bias is applied, wherein a spring tooth 1124 extends into the opening 1120 of the proximal member 1104 and frictionally engages, compresses, physically contacts, and / or otherwise applies a holding force (e.g., pressure) to the rod 1114 and / or the second actuating member 1110 to prevent relative movement between the proximal member 1104 and the distal member 1102 (and thus prevent radial compression of the prosthetic valve 1200). For example, and as referenced above. Figure 14 As explained, the spring tooth 1124 may include a biasing member 1126 (e.g., a leaf spring). Figure 20The spring tooth 1126 is configured to apply a constant biasing force to the rod 1114 and / or the second actuating member 1110 to allow only unidirectional movement of the rod 1114 and / or the second actuating member 1110 relative to the proximal member 1104 in the first axial direction. In this way, the biasing member 1126 can ensure that the spring tooth 1124 remains engaged with the rod 1114 and / or the second actuating member 1110 to provide a continuous locking force, while still allowing the rod 1114 and / or the second actuating member 1110 to move relative to the proximal member 1104 in the first axial direction, such that the prosthetic valve 1200 can expand radially. More simply, the spring tooth 1124 allows the prosthetic valve 1200 to expand radially, but does not allow the prosthetic valve 1200 to compress radially (i.e., it prevents the prosthetic valve 1200 from collapsing back to a more radially compressed position). Due to its shape and / or geometry, the spring tooth 1124 may allow only movement of the rod 1114 and / or the second actuating member 1110 in the proximal direction (first axial direction) toward the handle of the delivery device (rather than the second axial direction). That is, even though the spring tooth 1124 applies a retaining force on the rod 1114 and / or the second actuating member 1110 and prevents movement of the rod 1114 and / or the second actuating member 1110 in the distal direction (second axial direction) toward the extended position, it still allows the rod 1114 and / or the second actuating member 1110 to move in the first axial direction (so that the prosthetic valve 1200 can expand) due to its shape and / or geometry. For example, the spring tooth 1124 may be bent and / or angled relative to the central longitudinal axis AA of the opening 1120 ( Figure 20 As such an example, the spring tooth 1124 can be bent and / or angled in a first axial direction toward the handle of the delivery device. In some embodiments (such as...) Figure 20 As shown), the spring tooth 1124 may have a concave curvature relative to the first axial direction, meaning that the concave surface of the spring tooth faces the first axial direction. In other embodiments (such as...), the spring tooth 1124 may have a concave curvature relative to the first axial direction. Figure 21As shown), the spring tooth 1124 may have a convex curvature relative to the first axial direction, meaning that the convex surface of the spring tooth 1124 faces the first axial direction. Because the spring tooth 1124 extends from the fixed end 1129 to the free end 1127 (which engages the rod 1114) in the first axial direction, the spring tooth 1124 can prevent the second actuating member 1110 and / or the rod 1114 from moving in the second axial direction (distal direction) away from the handle of the delivery device. However, when the physician applies a proximal force to the second actuating member 1110 in the first axial direction (proximal direction) to achieve movement of the extended locking mechanism 1100 toward the axially compressed position, the rod 1114 can slide against the free end 1127 of the spring tooth 1124 in the first axial direction (thus allowing the prosthetic valve 1200 to move toward the radially extended position). In some embodiments, the free end 1127 may have a sharp edge that can increase the frictional resistance between the free end 1127 and the rod 1114 when a distal force is applied to the rod 1114 and the second actuating member 1110.

[0214] In some embodiments, as described above, the spring tooth 1124 is configured to provide a constant holding force to the rod 1114 and / or the second actuating member 1110. However, in other embodiments, the spring tooth 1124 may be configured to vary the holding force applied to the rod 1114 and / or the second actuating member 1110 while still maintaining contact with the rod 1114 and / or the second actuating member 1110. As an example only, the biasing member 1126 and / or the spring tooth 1124 may be configured to move away from the opening 1120 (in the...) when a physician pulls the second actuating member 1110 (while still maintaining contact with the rod 1114 and / or the second actuating member 1110). Figure 20 The valve can deform, deflect, and / or bend downwards to reduce the holding force applied to the lever 1114 and / or the second actuating member 1110, thereby making it easier for the physician to expand the prosthetic valve 1200 (i.e., requiring less force to pull (e.g., slide) the lever 1114 and / or the second actuating member 1110 through the opening 1120 in the proximal member 1104, past the spring tooth 1124). However, in such an example, when the physician pauses valve expansion (e.g., stops pulling the second actuating member 1110), the spring tooth 1124 can automatically and / or passively return to the extended position to increase the holding force, thereby ensuring that the distal member 1102 cannot be extended in the second axial direction (in the rearward direction toward the extended position). Figure 20 (From the center to the left) distally. Therefore, by allowing only the lever 1114 and / or the second actuating member 1110 to move relative to the proximal member 1104 in the first axial direction, the spring tooth 1124 can continuously lock the prosthetic valve 1200 in the appropriate position at any valve diameter during the expansion process.

[0215] As described above, when the extended locking mechanism 1100 is in the axially extended position ( Figure 18A The prosthetic valve 1200 is in a radially compressed position. Figure 19A In the illustrated embodiment, when in the axially extended position, the second actuating member 1110 of the actuating assembly 1106 can extend distally through the proximal member 1104, passing over the locking element 1122. However, when the physician pulls the second actuating member 1110 proximally toward the handle of the delivery device, the second actuating member 1110 retracts from the proximal member 1104, and the lever 1114 moves toward and through the proximal member 1104 (in...). Figure 19A Downward). Rod 1114 is long enough that in the axial compression position ( Figure 18B The prosthetic valve 1200 is in a radially expanded position ( Figure 19B The rod 1114 extends proximally through the proximal member 1104, at least past the locking element 1122, such that the locking element 1122 frictionally engages the rod 1114 to hold the prosthetic valve 1200 in a radially extended position. In some examples, the rod 1114 may be sized such that it does not extend proximally through the proximal end 1206 of the prosthetic valve 1200 by more than a threshold amount, such as more than a quarter of the axial length of the radially extended prosthetic valve 1200. In an alternative embodiment, the rod 1114 may be sized such that it extends proximally through the proximal member 1104 when the prosthetic valve 1200 is in a radially compressed and extended state, such that the locking element 1122 can remain engaged with the rod 1114 at each diameter of the prosthetic valve 1200 between the fully radially compressed and fully radially extended states, and the second actuating member 1110 is always positioned proximal to the proximal member 1104.

[0216] The rod 1114 and the second actuating member 1110 are sized, shaped, and / or otherwise configured to engage and be held by the locking element 1122, such that the rod 1114 and the second actuating member 1110 cannot be (oriented towards) Figure 18A The extended position shown can be moved in the second axial direction. For example, the rod 1114 and the second actuating member 1110 can be thick enough to frictionally engage with the locking element 1122 of the proximal member 1104. In some embodiments (such as...) Figures 18A-19B In the embodiment shown, the rod 1114 and the second actuating member 1110 may have the same or similar cross-sectional area, thickness and / or shape, such that they are configured to require the same or similar amount of force to move in a first axial direction toward the handle of the delivery device.

[0217] However, in other embodiments, the second actuating member 1110 and the lever 1114 may have different cross-sectional areas, thicknesses, and / or shapes, and may require different amounts of force to move (e.g., pull) proximally toward the handle of the delivery device. As an example only, the second actuating member 1110 may be thinner than the lever 1114. In such an example, pulling the second actuating member 1110 through the proximal member 1104 may be easier than pulling the lever 1114. Thus, the second actuating member 1110 may become more difficult to pull when the thicker lever 1114 reaches the locking element 1122 (i.e., the physician may have to apply greater force to continue expanding the prosthetic valve 1200), thereby providing the physician with an indication that the prosthetic valve is approaching its radially expanded position. In this way, the expansion locking mechanism 1100 can provide the physician with tactile feedback indicating the expansion process (i.e., the current valve diameter, how the valve is expanding, how much further expansion is needed before reaching the radially expanded position, etc.).

[0218] In some embodiments, the lever 1114 and / or the second actuating member 1110 may have a uniform and / or consistent thickness, cross-sectional area, and / or shape. In other embodiments, the lever 1114 and / or the second actuating member 1110 may have a non-uniform and / or variable thickness, cross-sectional area, and / or shape, which can provide the physician with a finer indication of the valve's current diameter (i.e., how the valve expands) and thus more precise control over the expansion process. For example, the lever 1114 may be tapered, such that when the lever 1114 first enters the proximal member 1104, the lever 1114 is initially easier to pull through the locking element 1122, but due to its increased thickness, the lever 1114 may become increasingly difficult to pull through the locking element. This can help ensure a smoother end to the expansion process and can prevent excessive traction that could cause the prosthetic valve 1200 to over-expand and / or vibrate and / or displace relative to the tissue. As an example, the rod 1114 may be thick enough and / or may include a stop member (e.g., a flange) to prevent the valve from radially expanding beyond a predetermined point. In this way, the physician can have more precise control over the final stage of the expansion process and can avoid over-expanding the valve.

[0219] The proximal member 1104 may also include an attachment member configured (e.g., at the proximal joint 1214 or proximal apex 1212) to couple to the frame 1202. For example, the attachment member may extend through an opening in the frame 1202 to help secure the distal member 1102 to the frame 1202. In some such examples, mating mechanical fasteners (e.g., nuts) may be coupled to the ends of the attachment member on opposite sides of the frame 1202 to prevent the attachment member from being pulled out of the opening in the frame 1202.

[0220] As described above, the rod 1114 and the second actuating member 1110 are detachably coupled to each other such that the second actuating member 1110 is configured to pull the rod 1114 along with it through the proximal member 1104 during the expansion of the prosthetic valve 1200. Specifically, due to its removable coupling to the distal member 1102 of the expansion locking mechanism 1100, when the second actuating member 1110 moves proximally (e.g., slides) relative to (e.g., via) the first actuating member 1108 toward the handle of the delivery device, the second actuating member 1110 pulls the distal member 1102 along with it, thereby axially shortening and radially expanding the prosthetic valve 1200.

[0221] Once the prosthetic valve 1200 expands, the second actuating member 1110 is configured to disengage from and / or detach from the rod 1114, allowing the actuating assembly 1106 and the delivery device to be removed from the patient. In some embodiments, the rod 1114 and the second actuating member 1110 are coupled to each other at the proximal end 1128 of the rod 1114 and the distal end 1130 of the actuating member 1110. In some embodiments, the rod 1114 may include a first removable coupling member 1132, and the second actuating member 1110 may include a second removable coupling member 1134 configured to be removably coupled to the first removable coupling member 1132 of the rod 1114. The removable coupling member may include mechanical, magnetic, and / or other suitable removable coupling means. For example, in Figure 18A-20 In the embodiment illustrated, the removable coupling member may include a threaded engagement. Specifically, the first removable coupling member 1132 of the rod 1114 may include a male thread, and the second removable coupling member 1134 of the second actuating member 1110 may include a mating female thread configured to threadedly connect to the thread of the first removable coupling member 1132. However, in other embodiments, the removable coupling member may include alternative types of mechanical coupling arrangements, such as hook-and-loop fasteners, snap-fit ​​coupling arrangements, latches, etc.

[0222] In this way, the physician can expand the prosthetic valve 1200 as needed without the risk of valve collapse. Specifically, because the locking element 1122 prevents the lever 1114 and / or the second actuating member 1110 (whichever is positioned within the opening 1120 of the proximal member 1104 where the locking element 1122 is located) from moving distal to the extended position, the prosthetic valve 1200 cannot be radially compressed once it has been radially expanded. Furthermore, because the locking element 1122 is self-locking (i.e., it continuously holds the lever 1114 and / or the second actuating member 1110 in place), the physician can expand the prosthetic valve 1200 in any desired manner. For example, if needed, the physician can expand the prosthetic valve continuously and smoothly. As another example, if needed, the physician can expand the prosthetic valve in a series of pulsatile motions. As yet another example, the physician can partially expand the prosthetic valve, pause expansion to assess the operating conditions, and then resume expansion.

[0223] During operation, the physician can advance the prosthetic valve 1200 to the implantation site via a delivery device. For example, the physician can advance the delivery device through the patient's vascular system by grasping the handle of the delivery device and applying a distal force (e.g., a thrust). Once at the implantation site, the physician can deploy the prosthetic valve 1200 from a delivery sheath (e.g., a delivery sheath 116) by, for example, adjusting a first control mechanism (e.g., a first knob 110) included on the handle. When the prosthetic valve 1200 is in the desired position at the implantation site, the physician can apply a distal force to the proximal member 1104 via a first actuating member 1108 and / or can apply a proximal force to the distal member 1102 via a second actuating member 1110 to cause the prosthetic valve 1200 to expand radially. As an example, the physician can directly pull the second actuating member 1110 to apply a proximal force to the distal member 1102. In other examples, the physician may adjust a second control mechanism (e.g., a second knob 112) included on the handle of the delivery device to apply a proximal force to the second actuating member 1110. During radial expansion of the prosthetic valve 1200, the locking element 1122 continuously locks the expansion locking mechanism 1100 to prevent the prosthetic valve from retracting toward a more radially compressed position. When the prosthetic valve has expanded to the desired position, the physician can remove the second actuating member 1110 from the distal member 1102, for example, by unscrewing it from the distal member 1102, and the delivery device can then be removed from the patient.

[0224] exist Figure 19A and 19B For simplicity and clarity, only roughly half of the valve frame 1202 is shown in the diagram. However, it should be understood that the valve frame 1202 is essentially cylindrical and surrounds the lumen 1218, like... Figure 1 , 3 The frames shown in 5-6, 9A, and 13. Additionally, like in... Figure 3 , 5 In sections -6, 9A, and 13, the valve structure of the prosthetic valve 1200 is omitted for simplicity and clarity; however, it should be understood that the prosthetic valve 1200 may include... Figure 1 The same and / or similar valve structures shown (valve structure 18).

[0225] In addition, although in Figures 19A-19B Only one extended locking mechanism 1100 is shown, but it should be understood that in other examples, the prosthetic valve 1200 may include more than one extended locking mechanism 1100. For example, the prosthetic valve 1200 may include two, three, and / or four or more extended locking mechanisms 1100. When more than one extended locking mechanism 1100 is included within the prosthetic valve 1200, the extended locking mechanisms 1100 may be circumferentially spaced uniformly or non-uniformly around the frame 1202. Similarly, the delivery device may have an equal number of actuation components 1106 as the number of extended locking mechanisms 1100. The delivery device may be configured to actuate each of the actuation components 1106 individually and / or simultaneously.

[0226] Additionally, it should be understood that the distal end 1204 of the prosthetic valve 1200 is positioned further away from the handle of the delivery device than the proximal end 1206 of the prosthetic valve 1200. That is, the distal end 1204 is configured to be positioned deeper within the patient's vascular system. In some examples, the distal end 1204 of the prosthetic valve 1200 may be the inflow end of the prosthetic valve 1200, and the proximal end 1206 of the prosthetic valve 1200 may be the outflow end of the prosthetic valve 1200, such as when the prosthetic valve 1200 is configured to replace the native aortic valve and the prosthetic valve 1200 is delivered to the native aortic valve via a retrograde femoral artery delivery method (e.g., via the femoral artery and aorta). However, in other embodiments, the distal end 1204 may be the outflow end of the prosthetic valve 1200, and the proximal end 1206 may be the inflow end of the prosthetic valve 1200, such as when the prosthetic valve 1200 is delivered to the native aortic valve via a transapical delivery method, or when the prosthetic valve is configured to replace the native mitral valve and is delivered to the native mitral valve via a transseptal delivery method in which the delivery device and the prosthetic valve are advanced into the right atrium, through the interatrial septum, and into the left atrium, wherein the right atrium may be accessed via the femoral vein and inferior vena cava or via the superior vena cava.

[0227] Figure 22-25An exemplary embodiment of a prosthetic valve 1300 having a frame 1302 is illustrated. The prosthetic valve may include a valve structure comprising multiple leaflets (such as valve structure 18 including leaflets 20) as previously described, as well as inner and / or outer skirts, but these components are omitted for illustrative purposes. The prosthetic valve 1300 may be similar to the prosthetic valve 200, except that the prosthetic valve 1300 may include a slightly different structure than the prosthetic valve 200 and can be extended in a different manner by a delivery device. Regarding structural differences, the prosthetic valve 1300 may include additional units not shown with respect to the prosthetic valve 200. Specifically, unlike the prosthetic valve 200, which may include both a syndesmotic window and an expansion locking mechanism at or within the same post and / or unit, the prosthetic valve 1300 may include separate units and / or posts for the syndesmotic window and the expansion locking mechanism. Regarding the difference in how prosthetic valves 200 and 1300 expand and / or actuate, unlike prosthetic valve 200 which can be radially expanded by applying a distal force (e.g., thrust) to the inner member of the expansion locking mechanism, prosthetic valve 1300 can be radially expanded by applying a proximal force (e.g., pull) to the inner member of the expansion locking mechanism of prosthetic valve 1300.

[0228] For convenience, components of the prosthetic valve 1300 that are identical or similar to components of the prosthetic valve 200 are similarly numbered. For example, the frame 1302, post 1304, expansion locking mechanism 1306, link 1312, compliant connector 1316, and C-shaped incision 1324 of the prosthetic valve 1300 can respectively correspond to the frame 202, post 204, expansion locking mechanism 206, link 212, compliant connector 216, and C-shaped incision 224 of the prosthetic valve 200. For simplicity, in this document... Figures 22 to 25 In the description, these similarly numbered parts may not be reintroduced or discussed again in any other way.

[0229] exist Figure 22-25 In the illustrated embodiment, frame 1302 includes a first set of units 1303 (also referred to herein as “actuating units 1303”) and a second set of units 1305 (also referred to herein as “connecting units”). The first set of units 1303 includes an extended locking mechanism 1306, and the second set of units 1305 may include a connecting window 1346. Each of units 1303 and 1305 is formed and / or defined by four links or struts 212 directly coupled to a given post 1304.

[0230] Frame 1302 further includes a proximal end 1307 and a distal end 1309, wherein the proximal end 1307 is configured to be positioned closer to the handle of the delivery device than the distal end 1309. In some examples, the proximal end 1307 may be the outflow end of the prosthetic valve 1300, such as when the prosthetic valve 1300 is configured to replace the native aortic valve and the prosthetic valve 1300 is delivered to the native aortic valve via a retrograde transfemoral delivery method (e.g., via the femoral artery and aorta). However, in other embodiments, the distal end 1309 may be the outflow end of the prosthetic valve 1300, and the proximal end 1307 may be the inflow end of the prosthetic valve 1300, such as when the prosthetic valve 1300 is delivered to the native aortic valve via a transapical delivery method, or when the prosthetic valve is configured to replace the native mitral valve and is delivered to the native mitral valve via a transseptal delivery method in which the delivery device and the prosthetic valve are advanced into the right atrium, through the interatrial septum, and into the left atrium, wherein the right atrium may be accessed via the femoral vein and inferior vena cava or via the superior vena cava.

[0231] Like the frame 202 of the prosthetic valve 200, frame 1302 may include compliant connectors 1316 at or near the proximal end 1307 and distal end 1309, which connect (e.g., pivotally coupled) each of the links 1312 to one of the posts 1304. Additionally, toward the axially intermediate portion of the prosthetic valve 1300, frame 1302 may include a four-way connector or interconnect 1314 (e.g., connector 750) that includes a hub 1315 connecting (e.g., pivotally coupled) four links 1312 between units 1303 and 1305. Thus, one of units 1303, 1305 is included between adjacent interconnects 1314. Each of the compliant joints 1316 and / or interconnects 1314 may include a thin, flexible neck portion 1322 that allows the linkage to pivot relative to the post 1304 and / or hub 1315 when the prosthetic valve 1300 expands radially and / or compresses. As described above, the compliant joints 1316 and / or interconnects 1314 may include one or more of the different types of joints and / or hinges described above (e.g., leaf hinge 500, beam hinge 600, leaf spring hinge 700, etc.). Moreover, as described above, one or more of the compliant joints 1316 and / or one or more of the interconnects 1314 may, for example, be fully or partially plastic to help lock the frame 1302 in a radially expanded state.

[0232] Alternatively or additionally, one or more of the extended locking mechanisms 1306 may help lock the frame 1302 in a radially extended state. For example, as Figure 22As shown, one or more of the inner member 1326 (which may also be referred to as the “distal member” and / or “actuator”) and outer member 1328 (which may also be referred to as the “proximal member”) in the extended locking mechanism 1306 may optionally include locking teeth 1332 and 1338, respectively. Locking teeth 1332 and 1338 can engage with each other to prevent distal movement of the inner member 1326 relative to the outer member 1328, thereby holding the prosthetic valve 1300 in a radially extended state and preventing radial compression of the valve. The outer members 1328 can temporarily deflect away from each other (circumferentially) to allow the locking teeth 1332 of the inner member 1326 to slide past the locking teeth 1338 of the outer member 1328, and when the locking teeth 1332 of the inner member 1326 pass over the teeth of the outer member 1328, the outer member 1328 can return to its original state (e.g., ...). Figure 22 As shown), this ensures that the locking teeth 1332 of the inner member 1326 cannot slide backward (distally) past the locking teeth 1338, thereby locking the frame 1302 in a radially expanded state. However, in other examples, the inner member 1326 and the outer member 1328 may include other types of locking mechanisms. In yet another example, the locking mechanisms for the inner member 1326 and the outer member 1328 may be omitted entirely. In such examples, the inner member 1326 and the outer member 1328 can move freely relative to each other without locking, and thus allow the prosthetic valve 1300 to expand and / or compress without restriction within a range of valve diameters.

[0233] Alternatively or alternatively, the post 1304 of the second set of units 1305 may include internal support units 1340, one or more of which may help lock the frame 1302 in a radially extended state. For example, one or more of the support units 1340 may be fully or partially plastic, like the compliant connectors 1316 and / or interconnects 1314, such that they are elastic for narrower valve diameters but plastic for wider valve diameters to help lock the prosthetic valve 1300 in one or more radially extended states. However, in other examples, one or more of the support units 1340 may be fully elastic and may not provide any locking function. Alternatively or alternatively, one or more of the compliant connectors 1316 and / or interconnects 1314 may be fully elastic. The support units 1340 may be bent and / or otherwise deformed at corner C via compliant connectors 1342, 1344. The gap at joint 1342 can widen as frame 1302 expands radially, while the gap at joint 1344 can narrow as frame 1302 expands radially.

[0234] In this way, one or more of the conformal connector 1316, interconnect 1314, support unit 1340 and / or extended locking mechanism 1306 can help lock the frame 1302 in a radially extended state.

[0235] Similar to prosthetic valve 200, the distal and proximal components can move axially (e.g., slide) relative to each other to radially expand and / or compress prosthetic valve 1300. Figure 22-25 In the example shown, the distal member is configured as an inner member, and the proximal member is configured as two outer members 1328, wherein the distal member can slide axially within the two outer members 1328. However, it should be understood that this configuration can be reversed, such that the distal member is configured as an outer member, wherein the proximal member can slide axially within the distal member. In other examples, the proximal and distal members may include any number of overlapping forks and / or arms that can move axially relative to each other. The distal member may include a base portion 1331, which may be wider than the remainder of the distal member. The distal member may also include a bulbous or widened end portion 1329, which is configured to be coupled to a delivery device (such as...). Figure 2 The actuating member 1350 (similar to the actuating member 124) of the delivery device 100. Specifically, as Figure 23-24 As shown, frame 1302 may include an axially extending channel (or hole) 1352 configured to receive an actuating member 1350 of a delivery device, and the end portion 1329 of the distal member may include an axially extending hole (or channel) 1354 configured to receive and / or couple to the distal portion 1351 of the actuating member 1350. As an example, the distal portion 1351 may be threaded and screwed into and / or screwed out of the hole 1354 to couple and / or decouple the actuating member 1350 from the distal member of frame 1302. However, other releasable mechanical connections may be used, such as snap-fit ​​and / or friction-fit arrangements, latches, hooks, pins, etc. Thus, the actuating member 1350 is configured to extend through the channel 1352 in the proximal end of frame 1302 and into the hole 1354 in the distal member. The hole 1354 can extend axially from the proximal end 1307 of the frame 1302 through the column 1304 to the channel 1358 formed between the outer members 1328 in the column 1304.

[0236] In operation, the actuating member 1350 can move axially through channel 1352, while a sleeve or support tube (e.g., support tube 122 or 1108) or other structure (not shown) of the delivery device can engage and / or abut the proximal end of the prosthetic valve 1300, and simultaneously provide balancing forces to help expand and / or compress the prosthetic valve 1300 while holding the prosthetic valve 1300 in proper position relative to surrounding tissues. For example, the actuating member 1350 can move proximally (e.g., pull) through channel 1352 in frame 1302, for example, by physician-actuated control mechanisms of the delivery device (e.g., pulling a cord attached to the actuating member 1350, turning one or more knobs that may be included on the handle of the delivery device, etc.), while the sleeve can provide a distally directed force to the proximal end 1307 of the prosthetic valve 1300 to radially expand the prosthetic valve 1300. Because the actuating member 1350 is releasably coupled to the distal member, when the actuating member 1350 is coupled to the distal member, the distal member moves axially together with the actuating member 1350. In this way, the distal member can move axially toward the proximal end 1307 of the prosthetic valve 1300 to cause radial expansion of the prosthetic valve 1300, and can move axially toward the distal end 1309 of the prosthetic valve 1300 to cause radial compression of the prosthetic valve 1300. When the valve is fully radially expanded, the actuating member 1350 can be dissociated from the distal member (e.g., by unscrewing them from the distal member), and the delivery device can then be removed from the patient.

[0237] The distal and proximal members can move axially relative to each other in both directions. However, in examples where the distal and proximal members include locking mechanisms (e.g., locking teeth 1332, 1338), once the frame 1302 extends radially to the point where the locking teeth 1332, 1338 engage with each other, the frame 1302 cannot be recompressed and can only extend further radially. The number and position of the locking teeth 1332, 1338 can be adjusted according to the valve diameter at which locking is desired. For example, the locking teeth 1332 of the distal member can be positioned closer to the widened end portion 1329 of the distal member, and / or the locking teeth 1338 of the proximal member can be positioned closer to the distal end of the pawl 1336 to provide locking over a wider range of valve diameters, and vice versa. In examples where the distal and proximal members do not include teeth or other locking mechanisms, they can move freely axially relative to each other in the proximal and distal axial directions.

[0238] In other words, the widened portion 1329 can prevent the distal member from moving distally relative to the proximal member past a certain point. Specifically, the widened portion 1329 may only be able to move within the channel 1358 of the proximal member and may be too wide to pass through the narrower channel 1360 of the proximal member, including the locking teeth 1338. Alternatively or additionally, the base portion 1331 of the distal member can prevent the distal member from moving proximally relative to the proximal member past a certain point. Specifically, the base portion 1331 may be too wide to pass through the narrower channel 1360 of the proximal member, and therefore, when the prosthetic valve 1300 contacts and / or engages the proximal member, the base portion 1331 can prevent further radial expansion of the prosthetic valve 1300. In this way, even when the distal and proximal members do not include any locking mechanism, the widened end portion 1329 and / or the base portion 1331 of the distal member can constrain the prosthetic valve 1300 to a range of valve diameters.

[0239] The support unit 1340 can be positioned closer to the distal end 1309 of the prosthetic valve 1300 than the merging window 1346, for example, in the axially intermediate portion of the column 1304. Thus, in some examples, the support unit 1340 can be substantially axially aligned with the interconnect 1314.

[0240] exist Figure 23 and 25 In the example shown, the first group of units 1303 may include three units 1303, and the second group of units 1305 may include three units 1305, wherein the units are positioned circumferentially around the frame 1302 in an alternating order such that two units 1303 are positioned adjacently on either side of each of the units 1305, and vice versa. Therefore, the frame 1302 includes three extended locking mechanisms 1306, three support units 1340, three connecting windows 1346, and three channels 1352. However, it should be understood that the frame 1302 may include more or fewer than three of each of these components, and / or the units 1303 and 1305 may be arranged in different orders. Furthermore, not all units 1305 must include both the connecting window 1346 and the internal support unit 1340. In some examples, unit 1305 may include one or the other. Additionally, in some examples, frame 1302 may include additional units, wherein column 1304 does not include any of the extended locking mechanism 1306, connecting window 1346, and support unit 1340. Furthermore, although in Figure 23 and 25 Three actuating elements 1350 are shown, but other numbers of actuating elements 1350 can be used to radially expand and / or compress the prosthetic valve 1300.

[0241] In this way, the prosthetic valve 1300 can expand radially across a range of valve diameters until the locking mechanism engages (e.g., locking teeth 1332, 1338 engage with each other and / or one or more of the compliant connector 1316, interconnect 1314, and / or support unit 1340 become malleably deformable). Once the prosthetic valve 1300 has expanded radially to the threshold valve diameter (the valve diameter where the locking mechanism engages), the prosthetic valve 1300 can no longer be radially recompressed and can be irreversibly held in at least a partially radially expanded state. However, in other examples, particularly where locking teeth are not present and only malleably deformable connectors are used to help lock the valve in the radially expanded state, the prosthetic valve 1300 can still be recompressed if sufficient compressive force is applied. In yet another example, the prosthetic valve 1300 may include an unlocking mechanism configured to disengage from a locking mechanism (e.g., locking teeth) to allow the prosthetic valve 1300 to be radially recompressed even after the prosthetic valve 1300 has radially expanded beyond a threshold valve diameter.

[0242] As described above, the threshold valve diameter at which the prosthetic valve 1300 becomes self-locking can be selected, for example, by adjusting the position of the locking teeth 1332, 1338 and / or the elasticity and / or plasticity of the compliant connector 1316, the interconnect 1314, and / or the support unit 1340. In some examples, this threshold valve diameter at which the valve is locked can be when the prosthetic valve 1300 is in a radially compressed state (e.g., Figure 4 The diameter of the prosthetic valve 1300 may be at least 1.2 times, at least 1.5 times, at least 2 times, at least 2.5 times, at least 3 times, up to 50 times, up to 25 times, up to 10 times, and / or up to 5 times. In some examples, where the prosthetic valve 1300 includes multiple locking mechanisms (e.g., where the prosthetic valve 1300 includes locking teeth 1332, 1338, and where one or more of the compliant connector 1316, interconnect 1314, and / or support unit 1340 are malleably deformable), the various locking mechanisms may engage at the same or different valve diameters.

[0243] Other examples of the disclosed technology In view of the embodiments described above for the disclosed subject matter, this application discloses further examples listed below. It should be noted that examples obtained by using one feature of an example alone or by combining more than one feature of an example in combination with one or more features of other examples are also further examples falling within the scope of the disclosure of this application.

[0244] Example 1. A prosthetic device comprising: A radially compressible and expandable frame, the radially compressible and expandable frame comprising: A plurality of posts extend axially from the proximal end of the frame to opposite distal ends of the frame, wherein each post in a subset of the plurality of posts includes a proximal member and a distal member, the proximal member and the distal member being axially movable relative to each other to radially expand and / or radially compress the frame, wherein the proximal member includes: A channel receiving the distal member, the distal member being configured to slide axially relative to the proximal member within the channel to radially expand and / or compress the prosthetic device; and An axially extending aperture extending distally from the proximal end of the frame to the channel, wherein the axially extending aperture is configured to receive an actuating member of a delivery device; and The distal component is configured to be removably coupled to the actuating component of the delivery device.

[0245] Example 2. A prosthetic device according to any of the examples in this document (particularly Example 1), wherein the distal member includes an axially extending aperture configured to receive an actuating member of the delivery device.

[0246] Example 3. A prosthetic device according to any of the examples in this document (especially Example 1 or Example 2), wherein the distal member is configured to be removably coupled to the actuating member via a threaded connection.

[0247] Example 4. A prosthetic device according to any of the examples in this document (in particular any one of Examples 1-3), wherein the proximal and distal members include a locking mechanism configured to prevent radial compression of the prosthetic device when the diameter of the prosthetic device is greater than a threshold diameter of the prosthetic device.

[0248] Example 5. A prosthetic device according to any of the examples in this document (particularly Example 4), wherein the locking mechanism includes interlocking teeth on the proximal member and the distal member.

[0249] Example 6. A prosthetic device according to any of the examples herein (in particular any one of Examples 1-5), wherein the subset of the plurality of pillars is a first subset of pillars, and wherein the plurality of pillars further includes a second subset of pillars, wherein the second subset of pillars differs from the first subset of pillars in that the pillars of the second subset of pillars contain structures different from those of the pillars in the first subset of pillars.

[0250] Example 7. A prosthetic device according to any example in this document (particularly Example 6), wherein each of one or more pillars in the second subset of pillars includes a connecting window extending radially through each pillar.

[0251] Example 8. A prosthetic device according to any example in this document (particularly Example 6 or Example 7), wherein each of one or more columns of the second subset of columns includes an internal support unit configured to deform with radial compression and / or radial expansion of the prosthetic device.

[0252] Example 9. A prosthetic device according to any example in this document (particularly Example 8), wherein at least one internal support unit is configured to undergo plastic deformation when the diameter of the prosthetic device is equal to or greater than a threshold prosthetic device diameter / the threshold prosthetic device diameter, in order to help prevent radial compression of the prosthetic device when the diameter of the prosthetic device is greater than the threshold prosthetic device diameter.

[0253] Example 10. A prosthetic device according to any of the examples herein (particularly any one of Examples 7-9), wherein the at least one internal support unit includes a compliant joint configured to deflect when the prosthetic device expands radially and / or compresses radially.

[0254] Example 11. A prosthetic device according to any of the examples in this document (in particular any one of Examples 1-10), wherein the proximal end is the outflow end of the frame and the distal end is the inflow end of the frame.

[0255] Example 12. The prosthetic device according to any of the examples in this document (in particular any one of Examples 1-11) further includes a plurality of links that extend circumferentially between adjacent posts.

[0256] Example 13. The prosthetic device according to any of the examples herein (particularly Example 12) further includes a plurality of first compliant joints, each of the plurality of first compliant joints pivotally coupling one of the links to one of the posts.

[0257] Example 14. The prosthetic device according to any example in this document (particularly Example 13) further includes a plurality of interconnects circumferentially positioned between the plurality of posts and includes a plurality of second compliant joints, wherein each of the plurality of interconnects is pivotally coupled to four of the links.

[0258] Example 15. A prosthetic device according to any example herein (particularly Example 14), wherein one or more of the first compliant connectors, one or more of the interconnects and / or at least one of the plurality of pillars are configured to be plastically deformable to help prevent radial compression of the prosthetic device when the prosthetic device diameter is greater than or equal to a threshold prosthetic device diameter / the threshold prosthetic device diameter, and to allow radial compression of the prosthetic device when the prosthetic device diameter is less than the threshold prosthetic device diameter.

[0259] Example 16. A prosthetic device according to any example herein (particularly Example 15), wherein one or more of the first compliant joints, one or more of the interconnects and / or one or more of at least one of the plurality of pillars reach their yield strength at the threshold prosthetic device diameter.

[0260] Example 17. A prosthetic device comprising: A radially compressible and expandable frame, the radially compressible and expandable frame comprising: A plurality of columns extending axially from the proximal end of the frame to the opposite distal end of the frame; Multiple links, the multiple links extending circumferentially between adjacent columns among the multiple columns; A plurality of first compliant joints, each of the plurality of first compliant joints pivotally coupling one of the connecting rods to one of the posts, wherein the plurality of first compliant joints includes a plurality of first flexible neck portions; and A plurality of interconnects are circumferentially positioned between a plurality of posts and include a plurality of second compliant joints, wherein each of the plurality of interconnects is pivotally coupled to four of the links, and wherein the plurality of second compliant joints include a plurality of second flexible neck portions; When the frame expands radially from a radially compressed state to a partially expanded state within the initial expansion range of the frame, one or more of the first compliant joints and / or one or more of the second compliant joints elastically deform, and then when the frame expands radially from the partially expanded state to a fully expanded state within a subsequent expansion range, one or more of the first compliant joints and / or one or more of the second compliant joints plastically deform.

[0261] Example 18. A prosthetic device according to any example in this document (particularly Example 17), wherein the first flexible neck portion and / or the second flexible neck portion is thinner than the link and / or the post.

[0262] Example 19. A prosthetic device according to any of the examples in this document (in particular Example 17 or Example 18), wherein the first flexible neck portion and / or the second flexible neck portion is as wide as the link and / or the post in the radial direction.

[0263] Example 20. A prosthetic device according to any of the examples herein (in particular any one of Examples 17-19), wherein the first flexible neck portion and / or the second flexible neck portion is wider than its thickness.

[0264] Example 21. A prosthetic device according to any of the examples in this document (in particular any one of Examples 17-20), wherein the width of the first flexible neck portion and / or the second flexible neck portion is 1.2 times its thickness.

[0265] Example 22. A prosthetic device according to any of the examples herein (in particular any of Examples 17-21), wherein one or more of the first compliant joints and / or one or more of the second compliant joints are fully elastic, such that they remain elastic across all prosthetic device diameters.

[0266] Example 23. A prosthetic device according to any of the examples herein (in particular any of Examples 17-22), wherein one or more of the first compliant joints and / or one or more of the second compliant joints are partially plastic.

[0267] Example 24. A prosthetic device according to any of the examples in this document (in particular any of Examples 17-23), wherein the plurality of interconnects are substantially X-shaped.

[0268] Example 25. A component comprising: A prosthetic device comprising a radially compressible and expandable frame, the frame comprising: A plurality of posts extend axially from the proximal end of the frame to the opposite distal end of the frame, wherein each post in a subset of the plurality of posts includes a proximal member and a distal member, wherein the proximal member includes a channel, the distal member is configured to slide axially relative to the proximal member within the channel to radially expand and / or compress the prosthetic device, and wherein the proximal member further includes an axially extending aperture extending distally from the proximal end of the frame to the channel; Multiple links, the multiple links extending circumferentially between adjacent columns among the multiple columns; A plurality of first compliant joints, each of the plurality of first compliant joints pivotally coupling one of the connecting rods to one of the posts; and A plurality of interconnecting elements, circumferentially positioned between the plurality of posts, and including a plurality of second compliant joints, wherein each of the plurality of interconnecting elements is pivotally coupled to four of the connecting rods; and A delivery device comprising at least one actuating member configured to extend through the axially extending hole of the proximal member and removably coupled to the distal member.

[0269] Example 26. The component according to any example in this document (especially Example 25), wherein the actuating member and the distal member of the delivery device are configured to be removably coupled to each other via a threaded connection.

[0270] Example 27. A component according to any of the examples herein (particularly Example 25 or Example 26), wherein the actuating member is configured to move proximally to cause the distal member to slide within the channel of the proximal member toward the proximal end of the frame, thereby radially extending the prosthetic device.

[0271] Example 28. A component according to any of the examples in this document (in particular any one of Examples 25-27), wherein the subset of the plurality of pillars is a first subset of the pillars, and wherein the plurality of pillars further includes a second subset of the pillars, wherein the second subset of the pillars differs from the first subset of the pillars in that the pillars of the second subset of the pillars contain a different structure than the pillars in the first subset of the pillars.

[0272] Example 29. The component according to any example in this document (especially Example 28), wherein each of one or more columns in the second subset of columns includes a joint window extending radially through each column.

[0273] Example 30. A component according to any of the examples in this document (in particular Example 28 or Example 29), wherein each of one or more columns of the second subset of columns includes an internal support unit configured to deform with radial compression and / or radial expansion of the prosthetic device.

[0274] Example 31. A component according to any of the examples herein (particularly Example 30), wherein at least one internal support unit is fully plastic and is configured to undergo plastic deformation at the threshold prosthesis device diameter to help prevent radial compression of the prosthesis device when the prosthesis device diameter is larger than the threshold prosthesis device diameter.

[0275] Example 32. The component according to any example herein (particularly any one of Examples 25-31), wherein each of the first compliant joints is configured to undergo plastic deformation when the prosthesis device diameter is equal to or greater than the threshold prosthesis device diameter / the threshold prosthesis device diameter, to help prevent radial compression of the prosthesis device when the prosthesis device diameter is greater than the threshold prosthesis device diameter.

[0276] Example 33. The component according to any of the examples herein (particularly any one of Examples 25-32), wherein each of the compliant joints of one or more of the interconnects is configured to undergo plastic deformation when the prosthesis device diameter is equal to or greater than the threshold prosthesis device diameter / the threshold prosthesis device diameter, to help prevent radial compression of the prosthesis device when the prosthesis device diameter is greater than the threshold prosthesis device diameter.

[0277] Example 34. The component according to any of the examples in this document (in particular any one of Examples 25-33), wherein each column in the subset of the plurality of columns includes a locking mechanism configured to prevent radial compression of the prosthesis when the diameter of the prosthesis is greater than a threshold prosthesis diameter / the threshold prosthesis diameter.

[0278] Example 35. The component according to any example in this document (particularly Example 34), wherein the locking mechanism includes interlocking teeth on the proximal member and the distal member.

[0279] Example 36. A method comprising: The prosthetic device is radially expanded and / or compressed by axially moving an actuating member of the delivery device through an axially extending hole in the column of the frame of the prosthetic device, wherein the hole extends axially from the proximal end of the frame to a channel of the proximal member of the column, the distal member of the column being configured to move axially within the channel, and wherein the actuating member is releasably coupled to the distal member.

[0280] Example 37. The method according to any example herein (especially Example 36) further includes, after the prosthetic device has been radially extended to a radially extended state, separating the actuating member from the distal member and withdrawing the actuating member from the axially extending hole.

[0281] Example 38. The method according to any example in this document (especially Example 37), wherein separating the actuating member from the distal member comprises unscrewing the actuating member from the distal member.

[0282] Example 39. The method according to any of the examples herein (particularly any one of Examples 36-38), wherein the radial expansion and / or compression of the prosthesis device comprises applying a proximal force to the actuating member to radially expand the prosthesis device and / or applying a distal force to the actuating member to radially compress the prosthesis device.

[0283] Example 40. The method according to any example in this document (especially Example 39), wherein the application of one or more forces directed towards the proximal and / or distal side includes adjusting a control mechanism included on a handle of the delivery device.

[0284] Example 41. The method according to any of the examples herein (in particular any of Examples 36-40) further includes locking the prosthetic device in a radially extended state.

[0285] Example 42. The method according to any example in this document (especially Example 41), wherein the prosthetic device is locked in the radially extended state, and the distal member is moved proximally within the channel of the proximal member until the interlocking teeth of the proximal and distal members engage with each other.

[0286] Example 43. A prosthetic device comprising: A radially compressible and expandable frame, the radially compressible and expandable frame comprising: A plurality of columns extending axially from a first end of the frame to an opposite second end of the frame, wherein each column in a subset of the plurality of columns includes a first member and a second member, the first member and the second member being axially movable relative to each other to radially expand and / or radially compress the frame; Multiple links, which extend circumferentially between adjacent posts; A plurality of first compliant joints, each of the plurality of first compliant joints pivotally coupling one of the connecting rods to one of the posts; and A plurality of interconnecting elements, circumferentially positioned between the plurality of posts, and including a plurality of second compliant joints, wherein each of the plurality of interconnecting elements is pivotally coupled to four of the connecting rods; and At least one of the plurality of pillars includes a locking mechanism configured to prevent radial compression of the prosthesis when the prosthesis diameter is greater than a threshold prosthesis diameter, and / or one or more of the first compliant joints and / or one or more of the interconnects are configured to help prevent radial compression of the prosthesis when the prosthesis diameter is greater than or equal to the threshold prosthesis diameter.

[0287] Example 44. A prosthetic device according to any example in this document (particularly Example 43), wherein the subset of the plurality of pillars is a first subset of pillars, and wherein the plurality of pillars further includes a second subset of pillars, wherein the second subset of pillars differs from the first subset of pillars in that the pillars of the second subset of pillars contain structures different from those of the pillars in the first subset of pillars.

[0288] Example 45. A prosthetic device according to any example in this document (particularly Example 44), wherein each of one or more pillars in the second subset of pillars includes a joint window extending radially through each pillar.

[0289] Example 46. A prosthetic device according to any of the examples in this document (in particular Example 44 or Example 45), wherein each of one or more columns of the second subset of columns includes an internal support unit configured to deform with radial compression and / or radial expansion of the prosthetic device.

[0290] Example 47. A prosthetic device according to any of the examples herein (particularly Example 46), wherein at least one internal support unit is fully plastic and is configured to undergo plastic deformation when the diameter of the prosthetic device is equal to or greater than the threshold prosthetic device diameter, in order to help prevent radial compression of the prosthetic device when the diameter of the prosthetic device is greater than the threshold prosthetic device diameter.

[0291] Example 48. A prosthetic device according to any of the examples herein (particularly any one of Examples 43-47), wherein each of the one or more of the first compliant joints is configured to undergo plastic deformation when the diameter of the prosthetic device is equal to or greater than the threshold prosthetic device diameter, in order to help prevent radial compression of the prosthetic device when the diameter of the prosthetic device is greater than the threshold prosthetic device diameter.

[0292] Example 49. A prosthetic device according to any of the examples herein (particularly any one of Examples 43-48), wherein each of the compliant joints of the one or more of the interconnects is configured to undergo plastic deformation when the diameter of the prosthetic device is equal to or greater than the threshold prosthetic device diameter, in order to help prevent radial compression of the prosthetic device when the diameter of the prosthetic device is greater than the threshold prosthetic device diameter.

[0293] Example 50. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-49), wherein the locking mechanism includes interlocking teeth included on the first member and the second member.

[0294] Example 51. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-50), wherein one or more of the first compliant joint and / or the second compliant joint are fully elastic and do not plastically deform at any prosthetic device diameter.

[0295] Example 52. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-51), wherein one or more of the first compliant joint and / or the second compliant joint is partially elastic and / or partially plastic.

[0296] Example 53. A prosthetic device according to any of the examples herein (particularly any one of Examples 43-52), wherein each of the interconnects includes a hub and four flexible neck portions, wherein each of the four flexible neck portions connects one of the links to the hub and is configured to bend to allow the link coupled thereto to pivot relative to the hub, thereby allowing the prosthetic device to expand radially and / or compress.

[0297] Example 54. A prosthetic device according to any of the examples in this document (especially Example 53), wherein the flexible neck portion is thinner in the radial direction than its width in the circumferential direction.

[0298] Example 55. A prosthetic device according to any of the examples in this document (particularly Example 54), wherein the width of the flexible neck portion is at least 1.2 times its thickness.

[0299] Example 56. A prosthetic device according to any of the examples in this document (in particular any one of Examples 53-55), wherein the flexible neck portion is thinner and / or narrower than the link and / or the post.

[0300] Example 57. A prosthetic device according to any of the examples herein (particularly any one of Examples 43-56), wherein each of the plurality of first compliant joints includes a flexible neck portion configured to bend to allow the connecting rod to which it is coupled to to bend relative to the post to which it is coupled, thereby allowing the prosthetic device to expand radially and / or compress.

[0301] Example 58. A prosthetic device according to any example in this document (particularly Example 57), wherein the flexible neck portion of each of the plurality of first compliant joints is narrower and / or thinner than the link and / or the post.

[0302] Example 59. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-58), wherein one or more of the plurality of first compliant joints comprises a leaf-shaped joint.

[0303] Example 60. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-59), wherein one or more of the plurality of first compliant joints comprises a beam-type joint.

[0304] Example 61. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-60), wherein one or more of the plurality of first compliant joints comprises a leaf spring type joint.

[0305] Example 62. A prosthetic device according to any of the examples herein (in particular any of Examples 43-61), wherein the first member includes a channel configured to receive the second member, and wherein the second member is configured to slide axially within the channel of the first member.

[0306] Example 63. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-62), wherein the first member extends axially from the first end of the frame toward the second end of the frame, and wherein the second member extends axially from the second end of the frame toward the first end of the frame.

[0307] Example 64. A prosthetic device according to any example herein (particularly any one of Examples 43-63), comprising each of the subset of the plurality of pillars including a first member and a second member, including an axially extending hole configured to receive an actuating member of a delivery device, wherein the hole extends between the first end of the frame and a channel / channel of the first member of the pillar.

[0308] Example 65. A prosthetic device according to any of the examples herein (particularly any one of Examples 43-64), wherein the second member includes an axially extending hole configured to receive a delivery device / actuator of the delivery device, wherein the hole extends from one end of the second member toward the second end of the frame.

[0309] Example 66. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-65), wherein the first end is the proximal end of the frame and the second end is the distal end of the frame, wherein the proximal end is configured to be positioned closer to the handle of the delivery device than the distal end.

[0310] Example 67. A prosthetic device according to any of the examples herein (in particular any one of Examples 43-66), wherein a first end of the frame is an outlet end of the prosthetic device, and wherein a second end of the frame is an inlet end of the prosthetic device.

[0311] Example 68. A prosthetic device comprising: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: Multiple columns, which extend axially from the inlet end to the outlet end of the frame; A plurality of links, the plurality of links extending circumferentially between adjacent posts of the plurality of posts; and Multiple compliant joints, each of which pivotally couples one of the multiple links to one of the multiple posts; and When the frame moves from the radially compressed state to the radially expanded state, the compliant joint deflects circumferentially.

[0312] Example 69. A prosthetic device according to any of the examples in this document (especially Example 68), wherein each compliant connector includes a flexible neck portion defining a C-shaped incision including a gap.

[0313] Example 70. A prosthetic device according to any of the examples in this document (especially Example 69), wherein the gap widens as the frame moves from the radially compressed state to the radially expanded state.

[0314] Example 71. A prosthetic device according to any of the examples in this document (in particular any of Examples 68-70), wherein the frame comprises three columns.

[0315] Example 72. A prosthetic device according to any of the examples in this document (in particular any of Examples 68-71), wherein each link has a first width and the flexible neck portion has a second width that is narrower than the first width.

[0316] Example 73. A prosthetic device according to any of the examples in this document (in particular any of Examples 68-72), wherein each pair of adjacent posts is coupled together by four links.

[0317] Example 74. A prosthetic device according to any of the examples in this document (especially Example 73), wherein the linkage is arranged in an X-shape.

[0318] Example 75. A prosthetic device according to any of the examples herein (in particular any one of Examples 68-74), wherein each link includes a first end portion and a second end portion, and wherein each link is coupled to a post at the first end via a first compliant joint and at the second portion via a second compliant joint to an adjacent link.

[0319] Example 76. A prosthetic device according to any of the examples herein (particularly Example 75), wherein the first and second compliant joints are oriented in opposite directions.

[0320] Example 77. A prosthetic device according to any of the examples herein (particularly Example 76), wherein the first compliant connector is oriented toward the inlet end of the frame and the second compliant connector is oriented toward the outlet end of the frame.

[0321] Example 78. A prosthetic device according to any of the examples in this document (in particular any of Examples 68-77), wherein the compliant joints are flush with the connecting rods such that they do not protrude through the radial inner or outer surfaces of the connecting rods.

[0322] Example 79. A prosthetic device according to any of the examples in this document (in particular any one of Examples 68-78), wherein the links and posts define a row of circumferentially extending triangular units.

[0323] Example 80. A prosthetic device according to any of the examples in this document (in particular any one of Examples 68-79), wherein the frame is formed of a monolithic material.

[0324] Example 81. A prosthetic device according to any of the examples in this document (in particular any one of Examples 68-80), wherein each post includes a connecting window extending through the thickness of the post.

[0325] Example 82. A prosthetic device according to any of the examples in this document (especially Example 81), wherein the connecting window has a rectangular shape.

[0326] Example 83. The prosthetic device according to any of the examples herein (particularly Example 81 or Example 82) further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0327] Example 84. A prosthetic device according to any of the examples in this document (in particular any of Examples 68-83), wherein one or more pillars are configured as an extended locking mechanism including an inner member and one or more outer members.

[0328] Example 85. A prosthetic device according to any example herein (particularly Example 84), wherein the inner member extends from the outflow portion of the frame toward the inflow portion of the frame, and wherein one or more outer members extend from the inflow portion of the frame toward the outflow portion.

[0329] Example 86. A prosthetic device according to any of the examples herein (particularly Example 84 or Example 85), wherein the inner member comprises a linear rack having a plurality of teeth arranged along the length of the inner member, and wherein at least one outer member comprises a pawl configured to engage the rack to allow the inner member to move relative to the outer member in a first direction and to prevent the inner member from moving relative to the outer member in a second direction opposite to the first direction.

[0330] Example 87. A prosthetic device according to any of the examples herein (particularly Example 86), wherein the at least one pawl is biased toward the plurality of teeth.

[0331] Example 88. A prosthetic device according to any of the examples herein (in particular any one of Examples 84-87), wherein the internal member includes a first linear rack disposed on a first circumferential edge and a second linear rack disposed on a second circumferential edge.

[0332] Example 89. A prosthetic device according to any example herein (particularly Example 88), wherein each post includes a first outer member and a second outer member, the first outer member including a first pawl configured to engage the first linear rack, and the second outer member including a second pawl configured to engage the second linear rack.

[0333] Example 90. A prosthetic device according to any example in this document (particularly Example 89), wherein the first and second outer members are circumferentially disposed on either side of the inner member.

[0334] Example 91. A prosthetic device according to any of the examples herein (in particular any of Examples 87-90), wherein the inner member includes a toothless portion, and the pawls of the one or more outer members can slide along the toothless portion without engaging.

[0335] Example 92. A prosthetic device according to any of the examples herein (particularly any one of Examples 84-91), wherein the inner member includes one or more stop surfaces positioned to selectively abut end portions of the one or more outer members to prevent distal movement of the inner member past a predetermined point.

[0336] Example 93. A prosthetic device comprising: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: A plurality of posts, each post including an axially extending first member and two axially extending second members, the first member including a plurality of teeth, and each of the second members including locking teeth, the locking teeth being configured to engage the plurality of teeth to allow movement in a first direction to allow radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, which couple adjacent columns to each other via one or more compliant joints, each compliant joint including a flexible neck portion configured to circumferentially deflect as the frame moves between the radially compressed state and the radially expanded state.

[0337] Example 94. A prosthetic device according to any of the examples in this document (especially Example 93), wherein the frame is formed from a monolithic material piece.

[0338] Example 95. A prosthetic device according to any of the examples in this document (in particular Example 93 or Example 94), wherein each link has a first width and the flexible neck portion has a second width that is narrower than the first width.

[0339] Example 96. A prosthetic device according to any of the examples in this document (in particular any one of Examples 93-95), wherein each pair of adjacent posts is coupled together by four links.

[0340] Example 97. A prosthetic device according to any of the examples (particularly 96) herein, wherein the linkage is arranged in an X-shape.

[0341] Example 98. A prosthetic device according to any of the examples herein (in particular any one of Examples 93-97), wherein each link includes a first end portion and a second end portion, and wherein each link is coupled to a post at the first end via a first compliant joint and at the second portion via a second compliant joint to an adjacent link.

[0342] Example 99. A prosthetic device according to any of the examples herein (particularly Example 98), wherein the first and second compliant joints are oriented in opposite directions.

[0343] Example 100. A prosthetic device according to any of the examples herein (particularly Example 99), wherein the first compliant connector is oriented toward the inlet end of the frame and the second compliant connector is oriented toward the outlet end of the frame.

[0344] Example 101. A prosthetic device according to any of the examples in this document (in particular any of Examples 93-100), wherein the compliant joints are flush with the connecting rods such that they do not protrude through the radially inner or radially outer surfaces of the connecting rods.

[0345] Example 102. A prosthetic device according to any of the examples in this document (in particular any of Examples 93-101), wherein the links and posts define a row of circumferentially extending triangular units.

[0346] Example 103. A prosthetic device according to any of the examples in this document (in particular any one of Examples 93-102), wherein each post includes a connecting window extending through the thickness of the post.

[0347] Example 104. A prosthetic device according to any of the examples in this document (particularly Example 103), wherein the connecting window has a rectangular shape.

[0348] Example 105. The prosthetic device according to any of the examples herein (particularly Example 103 or Example 104) further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0349] Example 106. A prosthetic device comprising: A frame that can expand and compress radially between a radially compressed state and a radially expanded state, the frame including a plurality of rigid links, each link including a first end portion coupled to a first adjacent link via a first compliant joint and a second end portion coupled to a second adjacent link via a second compliant joint, each compliant joint including a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state.

[0350] Example 107. A prosthetic device according to any example herein (particularly Example 106), wherein the frame is a first subframe, and wherein the prosthetic device further includes a second subframe radially disposed within and coupled to the first subframe.

[0351] Example 108. A prosthetic device according to any example herein (particularly Example 107), wherein the second subframe includes a plurality of rigid links, each link including a first end portion coupled to a first adjacent link via a first compliant joint and a second end portion coupled to a second adjacent link via a second compliant joint, each compliant joint including a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state.

[0352] Example 109. A prosthetic device according to any of the examples in this document (in particular Example 107 or Example 108), wherein the first and second subframes are coupled together via fasteners extending through holes in the link.

[0353] Example 110. The prosthetic device according to any of the examples herein (particularly any one of Examples 106-109) further includes one or more extended locking mechanisms, each extended locking mechanism comprising: A first component is coupled to the frame at a first location. A second member, coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and A locking member coupled to the first member, the locking member being configured to engage the second member to allow movement in a first direction to allow radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame.

[0354] Example 111. A prosthetic device comprising: A frame, movable between a radially compressed state and a radially expanded state, the frame comprising: A first subframe and a second subframe, the second subframe being radially disposed within the first subframe, each subframe including a set of rigid links, each link including a first end portion coupled to a first adjacent link via a first compliant joint and a second end portion coupled to a second adjacent link via a second compliant joint; Each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state; and The first subframe and the second subframe are coupled together by a plurality of fasteners.

[0355] Example 112. The prosthetic device according to any example herein (particularly Example 111) further includes one or more extended locking mechanisms, each extended locking mechanism including A first component is coupled to the frame at a first location. A second member, coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and A locking member coupled to the first member, the locking member being configured to engage the second member to allow movement in a first direction to allow radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame.

[0356] Example 113. A component comprising: The prosthetic device includes: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: A plurality of posts, one or more posts being configured as an extended locking mechanism, the extended locking mechanism comprising an inner member and one or more outer members, the inner member comprising a linear rack having a plurality of teeth, the one or more outer members being configured to engage the rack to allow movement in a first direction to allow radial expansion of the frame and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links are configured to couple adjacent columns to each other via one or more compliant joints, each compliant joint being configured to deflect circumferentially as the frame moves from the radially compressed state to the radially expanded state; Delivery device, the delivery device comprising: handle; A first actuating member extends from the handle and is coupled to the outlet end of the frame, the first actuating member being configured to apply a distal force to the inner member; A second actuating member extends from the handle and is coupled to the inlet end of the frame, the second actuating member being configured to apply a proximal force to the one or more outer members; When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, respectively, the prosthetic device can radially expand from the radially compressed state to the radially expanded state; and When the prosthetic device is in the radially extended state, the one or more external components engage the rack to prevent compression of the frame.

[0357] Example 114. The component according to any example in this document (especially Example 113), wherein each compliant connector includes a flexible neck portion defining a C-shaped cut including a gap.

[0358] Example 115. A component according to any example in this document (particularly Example 114), wherein the gap widens as the prosthetic device moves from the radially compressed state to the radially expanded state.

[0359] Example 116. The component according to any of the examples in this document (in particular any one of Examples 113-115), wherein each column includes a connecting window extending through the thickness of the column.

[0360] Example 117. The component according to any example in this document (especially Example 116), wherein the connecting window has a rectangular shape.

[0361] Example 118. The component according to any of the examples herein (particularly Example 116 or Example 117) further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0362] Example 119. A component comprising: The prosthetic device includes: A frame, movable between a radially compressed state and a radially expanded state, the frame comprising: A first subframe and a second subframe, the second subframe being radially disposed within the first subframe and coupled to the first subframe via a plurality of fasteners, each subframe including a set of links coupled to adjacent links via one or more compliant joints, each compliant joint including a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially expanded state. One or more extended locking mechanisms, each including a first member, a second member, and a locking member, the first member being coupled to the frame at a first position, the second member being coupled to the frame at a second position spaced apart from the first position, the second member extending at least partially into the first member, the locking member being coupled to the first member, the locking member being configured to engage the second member to allow movement in a first direction to allow radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Delivery device, the delivery device comprising: handle; A first actuating member, extending from the handle and coupled to the first member, is configured to apply a distally directed force to the first member; and A second actuating member extends from the handle and is coupled to the second member, the second actuating member being configured to apply a proximal force to the second member; When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, respectively, the prosthetic device can radially expand from the radially compressed state to the radially expanded state; and When the prosthetic device is in the radially expanded state, the locking member engages the second member to prevent compression of the frame.

[0363] Example 120. A method comprising: The distal end of a delivery device is inserted into a patient's vascular system. The delivery device is releasably coupled to a prosthetic device, which includes a frame that is radially expandable and compressible between a radially compressed state and a radially expanded state. The frame includes: A plurality of posts, each post including an inner member and two outer members, the inner members including a plurality of teeth, and each outer member including a pawl, the pawl being configured to engage the plurality of teeth to allow movement in a first direction to allow radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, the multiple links being configured to couple adjacent posts to each other via one or more compliant joints; Advance the prosthetic device to the selected implantation site; and At least one of the inner member is moved distally and the outer member is moved proximally to radially expand the prosthetic device, such that the compliant joint is circumferentially deflected, and the pawl engages the plurality of teeth to lock the prosthetic device in the radially expanded state.

[0364] Example 121. A prosthetic device comprising: A radially expandable and compressible frame, the frame comprising: Multiple posts, one or more posts are configured as an extended locking mechanism, the extended locking mechanism comprising: The first member extending axially; and An axially extending second member, the axially extending second member including a first side portion and a second side portion, the first side portion including locking teeth configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints.

[0365] Example 122. A prosthetic device according to any of the examples in this document (especially Example 121), wherein the frame is formed from a monolithic material.

[0366] Example 123. A prosthetic device according to any of the examples herein (particularly Example 121 or Example 122), wherein the first side portion includes a biasing member configured to bias the locking tooth against the first member.

[0367] Example 124. A prosthetic device according to any of the examples herein (in particular any one of Examples 121-123), wherein the first member includes a main portion, an elongated rod, and first and second angled surfaces that taper from the main portion to the elongated rod, the angled surfaces being configured to prevent distal movement of the first member relative to the second member past a predetermined point.

[0368] Example 125. A prosthetic device according to any example in this document (particularly Example 124), wherein the first and second side portions define a channel therebetween, and at least a portion of the elongated rod extends into the channel.

[0369] Example 126. A prosthetic device according to any of the examples in this document (in particular any one of Examples 121-125), wherein the posts are flush with the connecting rods such that they do not protrude through the radially inner or radially outer surfaces of the connecting rods.

[0370] Example 127. A prosthetic device according to any of the examples in this document (in particular any one of Examples 121-126), wherein each post includes a connecting window extending through the thickness of the post.

[0371] Example 128. The prosthetic device according to any example herein (particularly Example 127) further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0372] Example 129. A prosthetic device according to any of the examples herein (in particular any one of Examples 121-128), wherein the first member extends from the outflow portion of the frame toward the inflow portion of the frame, and wherein the second member extends from the inflow portion of the frame toward the outflow portion.

[0373] Example 130. A prosthetic device according to any of the examples herein (in particular any one of Examples 121-129), wherein the first and second side portions are circumferentially disposed on either side of the first member.

[0374] Example 131. A prosthetic device according to any of the examples herein (in particular any one of Examples 121-130), wherein each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from a radially compressed state to a radially expanded state.

[0375] Example 132. A prosthetic device according to any of the examples in this document (in particular any one of Examples 121-131), wherein the frame comprises three columns.

[0376] Example 133. A prosthetic device comprising: A radially expandable and compressible frame, the frame comprising: Multiple posts, one or more posts are configured as an extended locking mechanism, the extended locking mechanism comprising: The first component extending axially; An axially extending second member, the axially extending second member including a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel; and A cap, disposed above the outlet portion of the second member, the cap including a biasing member configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints.

[0377] Example 134. A prosthetic device according to any of the examples in this document (especially Example 133), wherein the frame, except for the cap, is formed of a single piece of metal.

[0378] Example 135. A prosthetic device according to any of the examples herein (particularly Example 133 or Example 134), wherein the first member includes a main portion, an elongated rod, and first and second angled surfaces that taper from the main portion to the elongated rod, the angled surfaces being configured to prevent distal movement of the first member relative to the second member past a predetermined point.

[0379] Example 136. A prosthetic device according to any of the examples in this document (in particular any one of Examples 133-135), wherein each post includes a connecting window extending through the thickness of the post.

[0380] Example 137. The prosthetic device according to any example herein (particularly Example 136) further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0381] Example 138. A prosthetic device according to any of the examples herein (in particular any one of Examples 133-137), wherein the first member extends from the outflow portion of the frame toward the inflow portion of the frame, and wherein the second member extends from the inflow portion of the frame toward the outflow portion.

[0382] Example 139. A prosthetic device according to any of the examples herein (in particular any one of Examples 133-138), wherein the first and second side portions are circumferentially disposed on either side of the first member.

[0383] Example 140. A prosthetic device according to any of the examples in this document (in particular any one of Examples 133-139), wherein each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from a radially compressed state to a radially expanded state.

[0384] Example 141. A prosthetic device according to any of the examples in this document (in particular any of Examples 133-140), wherein the frame comprises three columns.

[0385] Example 142. A prosthetic device comprising: A radially expandable and compressible frame, the frame comprising: Multiple posts, one or more posts are configured as an extended locking mechanism, the extended locking mechanism comprising: The first component extending axially; An axially extending second member, the axially extending second member including a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel; and An annular cap, disposed above the outlet portion of the second member, the cap including an inner cavity extending along the length of the cap, the inner cavity gradually tapering from a first diameter at the inlet end of the cap to a second smaller diameter at the outlet end of the cap; and Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints; The cap is configured to abut against the first member, forcing the first and second side portions to prevent movement of the first member relative to the second member, thereby preventing radial compression of the frame.

[0386] Example 143. A prosthetic device according to any of the examples in this document (especially Example 142), wherein the frame, except for the cap, is formed of a single piece of metal.

[0387] Example 144. A prosthetic device according to any of the examples in this document (in particular Example 142 or Example 143), wherein the cap is coupled to one or more links such that radial expansion of the frame causes distal movement of the cap.

[0388] Example 145. A prosthetic device according to any of the examples herein (in particular any one of Examples 142-144), wherein the first member includes a main portion, an elongated rod, and first and second angled surfaces that taper from the main portion to the elongated rod, the angled surfaces being configured to prevent distal movement of the first member relative to the second member past a predetermined point.

[0389] Example 146. A prosthetic device according to any of the examples in this document (in particular any one of Examples 142-145), wherein each post includes a connecting window extending through the thickness of the post.

[0390] Example 147. The prosthetic device according to any example herein (particularly Example 146) further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0391] Example 148. A prosthetic device according to any of the examples herein (in particular any one of Examples 142-147), wherein the first member extends from the outflow portion of the frame toward the inflow portion of the frame, and wherein the second member extends from the inflow portion of the frame toward the outflow portion.

[0392] Example 149. A prosthetic device according to any of the examples herein (in particular any one of Examples 142-148), wherein the first and second side portions are circumferentially disposed on either side of the first member.

[0393] Example 150. A prosthetic device according to any of the examples herein (in particular any one of Examples 142-149), wherein each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from a radially compressed state to a radially expanded state.

[0394] Example 151. A prosthetic device according to any of the examples in this document (in particular any one of Examples 142-150), wherein the frame comprises three columns.

[0395] Example 152. A component comprising: The prosthetic device includes: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: A plurality of posts, one or more posts, are configured as an expansion locking mechanism, the expansion locking mechanism comprising an axially extending first member and an axially extending second member, the axially extending second member including a first side portion and a second side portion, the first side portion including locking teeth configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints; and Delivery device, the delivery device comprising: handle; A first actuating member, extending from the handle and coupled to the outlet end of the frame, is configured to apply a distal force to the first member; and A second actuating member extends from the handle and is coupled to the inlet end of the frame, the second actuating member being configured to apply a proximal force to the second member; When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, respectively, the prosthetic device can radially expand from the radially compressed state to the radially expanded state; and When the prosthetic device is in the radially extended state, the locking teeth engage the first member to prevent compression of the frame.

[0396] Example 153. The component according to any of the examples in this document (especially Example 152), wherein the frame is formed of a monolithic material part.

[0397] Example 154. The component according to any of the examples in this document (in particular Example 152 or Example 153), wherein the first side portion includes a biasing member configured to bias the locking tooth against the first member.

[0398] Example 155. An assembly according to any of the examples herein (particularly any one of Examples 152-154), wherein the first member comprises a main portion, an elongated rod, and first and second angled surfaces that taper from the main portion to the elongated rod, the angled surfaces being configured to prevent the first member from moving distally relative to the second member past a predetermined point.

[0399] Example 156. The component according to any example in this document (especially Example 155), wherein the first and second side portions define a channel therebetween, and at least a portion of the elongated rod extends into the channel.

[0400] Example 157. An assembly according to any of the examples in this document (in particular any one of Examples 152-156), wherein the posts are flush with the link such that they do not protrude through the radial inner or radial outer surface of the link.

[0401] Example 158. The component according to any of the examples in this document (in particular any one of Examples 152-157), wherein each column includes a connecting window extending through the thickness of the column.

[0402] Example 159. The component according to any example in this document (particularly Example 158), wherein the prosthetic device further includes a valve structure comprising a plurality of leaflets, each leaflet including one or more auricles, wherein the auricles of adjacent leaflets are disposed within the commissural window to couple the valve structure to the frame.

[0403] Example 160. A component according to any of the examples herein (in particular any one of Examples 152-159), wherein the first member extends from the outflow portion of the frame toward the inflow portion of the frame, and wherein the second member extends from the inflow portion of the frame toward the outflow portion.

[0404] Example 161. The component according to any of the examples in this document (in particular any one of Examples 152-160), wherein the first and second side portions are circumferentially disposed on either side of the first member.

[0405] Example 162. An assembly according to any of the examples in this document (in particular any one of Examples 152-161), wherein each compliant joint includes a flexible neck portion configured to circumferentially deflect as the frame moves from the radially compressed state to the radially extended state.

[0406] Example 163. A component according to any of the examples in this document (in particular any one of Examples 152-162), wherein the frame comprises three columns.

[0407] Example 164. A component comprising: The prosthetic device includes: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: A plurality of columns, one or more columns, are configured as an extended locking mechanism, the extended locking mechanism including an axially extending first member, an axially extending second member, and a cap, the axially extending second member including a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel, the cap being disposed above an outlet portion of the second member, the cap including a biasing member configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints; and Delivery device, the delivery device comprising: handle; A first actuating member, extending from the handle and coupled to the outlet end of the frame, is configured to apply a distal force to the first member; and A second actuating member extends from the handle and is coupled to the inlet end of the frame, the second actuating member being configured to apply a proximal force to the second member; When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, respectively, the prosthetic device can radially expand from the radially compressed state to the radially expanded state; and When the prosthetic device is in the radially extended state, the biasing member engages the first member to prevent compression of the frame.

[0408] Example 165. A component comprising: The prosthetic device includes: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: A plurality of columns, one or more columns, are configured as an extended locking mechanism, the extended locking mechanism including an axially extending first member, an axially extending second member, and an annular cap, the axially extending second member including a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel, the annular cap being disposed above an outlet portion of the second member, the cap including an inner lumen extending along the length of the cap, the inner lumen gradually tapering from a first diameter at the inlet end of the cap to a second smaller diameter at the outlet end of the cap, and... Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints; and Delivery device, the delivery device comprising: handle; A first actuating member, extending from the handle and coupled to the outlet end of the frame, is configured to apply a distal force to the first member; and A second actuating member extends from the handle and is coupled to the inlet end of the frame, the second actuating member being configured to apply a proximal force to the second member; When at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, respectively, the prosthetic device can radially expand from the radially compressed state to the radially expanded state; and When the prosthetic device is in the radially extended state, the first and second side portions engage the first member to prevent compression of the frame.

[0409] Example 166. A method comprising: The distal end of a delivery device is inserted into the patient's vascular system, the delivery device being releasably coupled to a prosthetic device comprising a radially expandable and compressible frame, the frame comprising: A plurality of posts, one or more posts, are configured as an expansion locking mechanism, the expansion locking mechanism comprising an axially extending first member and an axially extending second member, the axially extending second member including a first side portion and a second side portion, the first side portion including locking teeth configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, the multiple links being configured to couple adjacent posts to each other via one or more compliant joints; Advance the prosthetic device to the selected implantation site; and At least one of the first member is moved distally and the second member is moved proximally to radially expand the prosthetic device, such that the compliant joint is circumferentially deflected, and the locking teeth engage the first member to lock the prosthetic device in the radially expanded state.

[0410] Example 167. The method according to any example in this document (especially Example 166), wherein the first side portion includes a biasing member configured to bias the locking tooth against the first member.

[0411] Example 168. A method comprising: The distal end of a delivery device is inserted into the patient's vascular system, the delivery device being releasably coupled to a prosthetic device comprising a radially expandable and compressible frame, the frame comprising: A plurality of columns, one or more columns, are configured as an extended locking mechanism, the extended locking mechanism including an axially extending first member, an axially extending second member, and a cap, the axially extending second member including a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel, the cap being disposed above an outlet portion of the second member, the cap including a biasing member configured to frictionally engage a surface of the first member to allow movement of the first member relative to the second member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame; and Multiple links, the multiple links being configured to couple adjacent posts to each other via one or more compliant joints; Advance the prosthetic device to the selected implantation site; and At least one of the first member is moved distally and the second member is moved proximally to radially expand the prosthetic device, such that the compliant joint is circumferentially deflected, and the biasing member engages the first member to lock the prosthetic device in the radially expanded state.

[0412] Example 169. A method comprising: The distal end of a delivery device is inserted into the patient's vascular system, the delivery device being releasably coupled to a prosthetic device comprising a radially expandable and compressible frame, the frame comprising: A plurality of columns, one or more columns, are configured as an extended locking mechanism, the extended locking mechanism including an axially extending first member, an axially extending second member, and an annular cap, the axially extending second member including a first side portion and a second side portion defining a channel therebetween, at least a portion of the first member extending into the channel, the annular cap being disposed above an outlet portion of the second member, the cap including an inner lumen extending along the length of the cap, the inner lumen gradually tapering from a first diameter at the inlet end of the cap to a second smaller diameter at the outlet end of the cap; and Multiple links, the multiple links being configured to couple adjacent posts to each other via one or more compliant joints; Advance the prosthetic device to the selected implantation site; and At least one of the first member is moved distally and the second member is moved proximally to radially expand the prosthetic device, such that the compliant joint is circumferentially deflected, and such that the first and second side portions engage the first member to lock the prosthetic device in a radially expanded state.

[0413] Example 170. The method according to any example herein (particularly Example 169) further includes advancing the cap above the outflow portion of the second member to abut against the first member and force the first and second side portions.

[0414] Example 171. A component comprising: The prosthetic device includes: A frame that can expand and compress radially; At least one extended locking device, movable between an extended position and a retracted position, the extended locking device comprising: Distal components; and A proximal member, the proximal member including a locking element configured to prevent the distal member and the proximal member from moving away from each other; The distal member and the proximal member are coupled to the frame at axially spaced locations on the frame, wherein the distal member is coupled to the frame at a portion of the frame more distal to the proximal member; and A delivery device comprising at least one actuation component configured to be removably coupled to the extended locking device and to move the distal member and the proximal member toward each other to radially extend the prosthesis device; When the extended locking device is in the extended position, the actuating component extends distally through the locking element, and when the extended locking device is in the retracted position, the distal component extends proximally through the locking element, wherein the locking element is configured to continuously frictionally engage the actuating component when the actuating component extends distally through the locking element, and is configured to continuously frictionally engage the distal component when the distal component extends proximally through the locking element, so as to continuously lock the extended locking device at any position between the extended position and the retracted position.

[0415] Example 172. The component according to any example in this document (especially Example 171), wherein the locking element includes a spring tooth having a free end that bends in a proximal direction toward the handle of the delivery device.

[0416] Example 173. A component according to any example herein (particularly Example 172), wherein when the actuation component extends distally through the locking element, the spring tooth applies a constant retaining force on the actuation component, and when the distal component extends proximally through the locking element, the spring tooth applies a constant retaining force on the distal component.

[0417] Example 174. The component according to any of the examples in this document (in particular any one of Examples 171-173), wherein the proximal member includes a body having an opening configured to receive the distal member of the extended locking device.

[0418] Example 175. A component according to any example in this document (particularly Example 174), wherein the body is configured to be coupled to the proximal apex or proximal junction of the frame of the prosthetic device.

[0419] Example 176. A component according to any of the examples herein (particularly any one of Examples 171-175), wherein the actuation component includes a first actuation member and a second actuation member, the first actuation member being configured to extend to a proximal member or proximal end of the prosthetic device, and the second actuation member being removably coupled to the distal member.

[0420] Example 177. The component according to any example in this document (particularly Example 176), wherein the body of the proximal member / the opening of the body / the opening is configured to receive the second actuating member of the actuating component.

[0421] Example 178. The component according to any example in this document (in particular Example 176 or Example 177), wherein the distal member of the extended locking device includes a first removable coupling member at the proximal end of the distal member, and wherein the second actuating member includes a second removable coupling member at the distal end of the second actuating member, and wherein the first and second removable coupling members are configured to be removably coupled to each other to removably couple the distal member and the second actuating member.

[0422] Example 179. The component according to any example in this document (especially Example 178), wherein the first and second removable coupling members include mating threads.

[0423] Example 180. A component according to any of the examples herein (in particular any one of Examples 176-179), wherein the first actuating member includes a sleeve surrounding the second actuating member, and wherein the second actuating member includes a cable extending through the sleeve.

[0424] Example 181. The component according to any example herein (particularly Example 180), wherein the first actuating member is configured to apply a distal force to the proximal member, and wherein the second actuating member is configured to apply a proximal force to the distal member, wherein the proximal force is opposite to the distal force.

[0425] Example 182. The component according to any of the examples in this document (in particular any one of Examples 170-181), wherein the distal member includes a rod configured to extend axially toward the proximal member.

[0426] Example 183. The component according to any example in this document (especially Example 182), wherein the body of the proximal member / the opening of the body / the opening is configured to receive the rod of the distal member.

[0427] Example 184. The component according to any of the examples in this document (in particular Example 182 or Example 183), wherein the distal member and the second actuating member / second actuating member of the actuating assembly have substantially the same thickness.

[0428] Example 185. A component according to any of the examples in this document (in particular any one of Examples 170-184), wherein the distal member includes a body configured to be coupled to the frame of the prosthetic device / the distal apex or distal junction of the frame.

[0429] Example 186. The component according to any example in this document (especially Example 185), wherein the rod of the distal member extends axially from the body.

[0430] Example 187. A component according to any of the examples herein (in particular any one of Examples 170-186), wherein the prosthetic device is in a radially compressed position when the extended locking mechanism is in the extended position, and wherein the prosthetic device is in a radially extended position when the extended locking mechanism is in the retracted position.

[0431] Example 188. The component according to any example herein (particularly Example 187), wherein the second actuating member of the actuating component extends through the body of the proximal member in the extended position through the opening in the body, and wherein the rod of the distal member extends through the opening in the body of the proximal member in the retracted position.

[0432] Example 189. An assembly according to any of the examples herein (particularly Example 187 or Example 188), wherein when the second actuating member is positioned in the body of the proximal member / the opening of the body / the opening, the spring teeth of the proximal member / the spring teeth frictionally engage the second actuating member of the actuating assembly / the second actuating member, and when the rod is positioned in the opening, the spring teeth of the proximal member / the spring teeth frictionally engage the rod of the distal member / the rod, to hold the extended locking device at any position between the extended position and the retracted position.

[0433] Example 190. The assembly according to any example in this document (especially Example 189), wherein the spring tooth allows the rod and the second actuating member to move through the opening in a first axial direction relative to the proximal member, but prevents the rod and the second actuating member from moving in the opposite second axial direction.

[0434] Example 191. The component according to any example in this document (especially Example 190), wherein the spring tooth is angled or bent relative to the central longitudinal axis of the opening, such that the spring tooth has a concave curvature relative to the first axial direction.

[0435] Example 192. A prosthetic device comprising: A radially expandable and compressible frame; and At least one extended locking mechanism, coupled to the frame, the extended locking mechanism comprising: The distal member, configured to be removably coupled to an actuation component of a delivery device for the prosthesis; and A proximal member, the proximal member including a locking element configured to frictionally engage the actuation assembly and the distal member, wherein the locking element is configured to allow the actuation assembly and the distal member to move relative to the proximal member in a first direction to cause radial expansion of the frame, and to prevent movement in a second direction to prevent radial compression of the frame, wherein the proximal member is coupled to a portion of the frame that is more proximal than the distal member.

[0436] Example 193. A prosthetic device according to any of the examples herein (particularly Example 192), wherein the actuation component is configured to selectively adjust to move the proximal member and the distal member toward each other to radially expand the frame.

[0437] Example 194. A prosthetic device according to any of the examples herein (particularly Example 192 or Example 193), wherein the locking element is configured to continuously lock the distal member to prevent movement of the distal member in the second direction.

[0438] Example 195. A prosthetic device according to any of the examples herein (particularly any one of Examples 192-194), wherein the locking element includes a spring tooth biased toward an extended position in which the spring tooth frictionally engages the distal member to prevent movement of the distal member in the second direction.

[0439] Example 196. A prosthetic device according to any example herein (particularly Example 195), wherein the spring tooth is angled or bent relative to the central longitudinal axis of the channel of the proximal member, such that the distal end of the spring tooth is bent or angled in the first direction.

[0440] Example 197. A prosthetic device according to any of the examples herein (in particular any one of Examples 192-196), wherein the distal member includes a rod extending axially toward the proximal member, and wherein the proximal member has a channel / channel configured to receive the actuation assembly and the rod of the distal member.

[0441] Example 198. A prosthetic device according to any example herein (particularly Example 197), wherein the frame is radially expandable and compressible between a radially compressed position and a radially expanded position, wherein the rod extends proximally through the channel in the radially expanded position such that the locking element frictionally engages the rod rather than the actuating assembly, and wherein the actuating assembly extends distally through the channel in the radially compressed position such that the locking element frictionally engages the actuating assembly rather than the rod.

[0442] Example 199. A prosthetic device according to any of the examples herein (particularly Example 198), wherein when the frame is in the radially compressed position, the rod extends proximally toward the proximal member, but does not extend into the proximal member.

[0443] Example 200. A prosthetic device according to any of the examples in this document (in particular any one of Examples 197-199), wherein the rod has a uniform thickness.

[0444] Example 201. A prosthetic device according to any of the examples in this document (in particular any one of Examples 197-199), wherein the rod has a non-uniform thickness.

[0445] Example 202. A prosthetic device according to any of the examples in this document (particularly Example 201), wherein the rod is tapered such that it becomes thinner towards the proximal end of the rod.

[0446] Example 203. A prosthetic device according to any of the examples in this document (in particular any of Examples 182-202), wherein the distal member is coupled to the distal joint or distal vertex of the frame.

[0447] Example 204. A prosthetic device according to any of the examples in this document (in particular any one of Examples 182-203), wherein the proximal member is coupled to the proximal junction or proximal apex of the frame.

[0448] Example 205. The prosthetic device according to any of the examples herein (in particular any of Examples 182-204) further includes a valve structure comprising one or more leaflets configured to regulate the flow of blood through the prosthetic device.

[0449] Example 206. A component comprising: The prosthetic device includes: A frame that can radially expand and compress between a radially compressed position and a radially expanded position; and At least one extended locking mechanism, said at least one extended locking mechanism comprising: Distal components; and A proximal member, coupled to the frame at a portion of the frame more proximal to the distal member, the proximal member including a locking element configured to allow movement of the distal member relative to the proximal member in a proximal direction to cause radial expansion of the frame, and configured to prevent movement in the distal direction to prevent radial compression of the frame; and Delivery device, the delivery device comprising: handle; A first actuating member is configured to apply a distal force to the proximal member, wherein the first actuating member extends distally from the handle to the proximal member; A second actuating member is configured to apply a proximal force to the distal member, wherein the second actuating member extends distally from the handle and is removably coupled to the distal member; When the prosthetic device is in the radially compressed position, the locking element frictionally engages the second actuating member, and when the prosthetic device is in the radially extended position, the locking element frictionally engages the distal member to continuously lock the prosthetic device at any position between the radially compressed position and the radially extended position.

[0450] Example 207. The component according to any example herein (particularly Example 206), wherein when at least one of the distal force and the proximal force is applied to the prosthetic device via the first and second actuating members, the prosthetic device can be radially extended from the radially compressed position to the radially extended position.

[0451] Example 208. The component according to any of the examples herein (in particular Example 206 or Example 207), wherein when the prosthetic device is in the radially compressed position, the second actuating member extends distally through the locking element, and wherein when the prosthetic device is in the radially extended position, the distal member extends proximally through the locking element.

[0452] Example 209. An assembly according to any example herein (particularly any one of Examples 206-208), wherein the locking element includes a biasing member configured to bias the locking element against the second actuating member when the second actuating member extends over the locking element, and configured to bias the locking element against the distal member when the distal member extends over the locking element, to allow only movement of the distal member and the second actuating member relative to the proximal member in a proximal direction, and to continuously prevent movement of the distal member and the second actuating member relative to the proximal member in the opposite distal direction.

[0453] Example 210. An assembly according to any of the examples herein (particularly any one of Examples 206-209), wherein the proximal member includes a channel configured to receive the distal member and the second actuating member, and wherein the locking element extends into the channel to frictionally engage the distal member when the distal member is positioned within the channel, and frictionally engage the second actuating member when the second actuating member is positioned within the channel.

[0454] Example 211. The component according to any example herein (particularly Example 210), wherein the locking element is configured to deflect away from the central longitudinal axis of the channel when one or more of the distal force and the proximal force are applied, to allow the distal member and the second actuating member to move proximal to the proximal member.

[0455] Example 212. An assembly according to any of the examples in this document (in particular any of Examples 206-211), wherein the distal member comprises a body and a rod, the body being coupled to the distal apex or distal joint of the frame, the rod extending axially from the body toward the proximal member.

[0456] Example 213. The component according to any of the examples in this document (in particular any of Example 212), wherein the rod is configured to extend through the channel / channel of the proximal member.

[0457] Example 214. The component according to any of the examples in this document (in particular any one of Examples 206-213), wherein the locking element includes a spring tooth that is angled or bent relative to the channel of the proximal member / the central longitudinal axis of the channel, such that the distal end of the spring tooth is bent or angled in the proximal direction.

[0458] Example 215. The assembly according to any of the examples in this document (in particular any of Examples 206-214), wherein the proximal end of the distal member is removably coupled to the distal end of the second actuating member via a threaded engagement.

[0459] Example 216. A method comprising: The distal end of the delivery device is inserted into the patient's vascular system. The delivery device is releasably coupled to a prosthetic device, which includes a radially expandable and compressible frame and an expansion locking mechanism comprising a distal member and a proximal member. Advance the prosthesis device to the selected implantation site; The prosthetic device is radially expanded in the following manner: A distal force is applied to the proximal member of the extended locking mechanism via a first actuating member of the delivery device, the first actuating member being removably coupled to the proximal member; and A proximal force is applied to the distal member of the extended locking mechanism via a second actuating member that extends to the proximal member; and Throughout the radial expansion process, the prosthesis is continuously locked via spring teeth included in the proximal member to prevent the prosthesis from moving toward a more radially compressed position; the spring teeth frictionally engage the second actuating member and the distal member.

[0460] Example 217. The method according to any example herein (particularly Example 216) further includes separating the delivery device from the prosthetic device by separating the second actuating member from the distal member of the extended locking mechanism.

[0461] Example 218. The method according to any example in this document (especially Example 217), wherein separating the second actuating member from the distal member includes unscrewing the second actuating member from the distal member.

[0462] Example 219. The method according to any of the examples in this document (in particular any of Examples 216-218), wherein applying the proximal force includes pulling the second actuating member.

[0463] Example 220. The method according to any of the examples in this document (in particular any of Examples 216-218), wherein applying the proximal force includes adjusting a control mechanism included on the handle of the delivery device.

[0464] Example 221. The method according to any of the examples in this document (in particular any of Examples 216-220), wherein the application of the distal force comprises pushing the handle of the delivery device / the handle.

[0465] Example 222. The method according to any of the examples in this document (in particular any of Examples 216-221), wherein the radial expansion of the prosthetic device comprises radially expanding the prosthetic device in a series of pulsations.

[0466] Example 223. The method according to any of the examples in this document (in particular any of Examples 216-222), wherein the radial expansion of the prosthesis device comprises radially expanding the prosthesis device from a radially compressed position to a radially expanded position.

[0467] Example 224. The method according to any example in this document (especially Example 223) further includes holding the prosthetic device in the radially extended position via the spring teeth.

[0468] Example 225. The method according to any example herein (particularly any one of Examples 216-224), wherein the spring tooth extends into a channel included in the proximal member of the extended locking mechanism, and wherein the radial extension of the prosthetic device comprises moving the second actuating member proximally over the spring tooth through the channel until the second actuating member leaves the spring tooth, and then moving the distal member proximally over the spring tooth through the channel.

[0469] Example 226. The method according to any example herein (particularly Example 225) further includes frictionally engaging the spring tooth with the second actuating member, and then, once the second actuating member disengages from the spring tooth, frictionally engaging the spring tooth with the distal member to continuously lock the prosthetic device.

[0470] Example 227. A prosthetic device comprising: A frame, which can radially expand and compress between a radially compressed state and a fully radially expanded state, the frame comprising: Multiple columns, which extend axially from the inlet end to the outlet end of the frame; A plurality of links, the plurality of links extending circumferentially between adjacent posts of the plurality of posts; and Multiple compliant joints, each of which pivotally couples one of the multiple links to one of the multiple posts; and When the frame moves from the radially compressed state to the fully radially expanded state, the plurality of compliant joints deflect circumferentially.

[0471] Example 228. A prosthetic device according to any example herein (particularly Example 227), wherein each of the plurality of compliant joints includes a flexible neck portion defining a gap between one of the plurality of posts and one of the plurality of links.

[0472] Example 229. A prosthetic device according to any of the examples in this document (especially Example 228), wherein the gap widens as the frame moves from the radially compressed state to the fully radially expanded state.

[0473] Example 230. A prosthetic device according to any of the examples in this document (in particular Example 228 or Example 229), wherein the flexible neck portion of each compliant joint is thinner and / or narrower than the plurality of links and the plurality of posts.

[0474] Example 231. A prosthetic device according to any example herein (in particular any one of Examples 227-230), wherein one or more of the plurality of compliant joints elastically deform as the frame radially expands from the radially compressed state to the partially expanded state within the initial expansion range of the frame, and then one or more of the plurality of compliant joints plastically deform as the frame radially expands from the partially expanded state to the fully expanded state within a subsequent expansion range.

[0475] Example 232. A prosthetic device according to any of the examples herein (in particular any of Examples 227-231), wherein one or more of the plurality of compliant joints comprises a leaf-shaped joint.

[0476] Example 233. A prosthetic device according to any of the examples in this document (in particular any one of Examples 227-232), wherein one or more of the plurality of compliant joints include a beam-type joint.

[0477] Example 234. A prosthetic device according to any of the examples in this document (in particular any one of Examples 227-233), wherein one or more of the plurality of compliant joints include leaf spring type joints.

[0478] Example 235. The prosthetic device according to any of the examples herein (in particular any of Examples 227-234) further includes a plurality of interconnects circumferentially positioned between each pair of adjacent posts of the plurality of posts, wherein each of the plurality of interconnects is pivotally coupled to four of the links.

[0479] Example 236. A prosthetic device according to any example herein (particularly Example 235), wherein one or more of the interconnects elastically deform as the frame expands radially from the radially compressed state to a partially expanded state within the initial expansion range of the frame, and then plastically deforms as the frame expands radially from the partially expanded state to a fully expanded state within a subsequent expansion range.

[0480] Example 237. A prosthetic device according to any of the examples herein (in particular any one of Examples 227-236), wherein each of the plurality of pillars includes a connecting window extending through the thickness of the pillar.

[0481] Example 238. A prosthetic device according to any of the examples herein (in particular any one of Examples 227-237), wherein one or more of the plurality of pillars are configured to extend the locking mechanism and include an inner member and one or more outer members.

[0482] Example 239. A prosthetic device according to any example herein (particularly Example 238), wherein the inner member includes a linear rack having a plurality of teeth arranged along the length of the inner member, and wherein at least one of the one or more outer members includes a pawl configured to engage the rack to allow the inner member to move relative to the outer member in a first direction and to prevent the inner member from moving relative to the outer member in a second direction opposite to the first direction.

[0483] Example 240. A prosthetic device comprising: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: A plurality of columns, each column comprising an axially extending first member and two axially extending second members, wherein the first member is configured to move axially relative to the second member within a channel of the second member to radially expand and / or radially compress the frame; and Multiple links, wherein adjacent posts are coupled to each other via one or more compliant joints.

[0484] Example 241. A prosthetic device according to any of the examples in this document (especially Example 240), wherein the frame is formed from a monolithic material.

[0485] Example 242. A prosthetic device according to any of the examples in this document (in particular Example 240 or Exam...

Claims

1. A prosthetic device comprising: A frame, which can radially expand and compress between a radially compressed state and a radially expanded state, the frame comprising: Multiple columns, which extend axially from the inlet end to the outlet end of the frame; A plurality of links, the plurality of links extending circumferentially between adjacent posts of the plurality of posts; and Multiple compliant joints, each of which pivotally couples one of the multiple links to one of the multiple posts; and When the frame moves from the radially compressed state to the radially expanded state, the plurality of compliant joints deflect circumferentially.

2. The prosthetic device of claim 1, wherein each of the plurality of compliant joints includes a flexible neck portion defining a gap between one of the plurality of posts and one of the plurality of links.

3. The prosthetic device of claim 2, wherein the gap widens as the frame moves from the radially compressed state to the radially expanded state.

4. The prosthetic device according to claim 2 or claim 3, wherein the flexible neck portion of each compliant connector is thinner and / or narrower than the plurality of links and the plurality of posts.

5. The prosthetic device according to any one of claims 1-4, wherein one or more of the plurality of compliant joints elastically deform as the frame expands radially from the radially compressed state to a partially radially expanded state within the initial expansion range of the frame, and then one or more of the plurality of compliant joints plastically deform as the frame expands radially from the partially expanded state to a fully radially expanded state within a subsequent expansion range.

6. The prosthetic device according to any one of claims 1-5, wherein one or more of the plurality of compliant joints comprises a leaf-shaped joint.

7. The prosthetic device according to any one of claims 1-6, wherein one or more of the plurality of compliant joints comprises a beam-type joint.

8. The prosthetic device according to any one of claims 1-7, wherein one or more of the plurality of compliant joints comprises a leaf spring type joint.

9. The prosthetic device according to any one of claims 1-8, further comprising a plurality of interconnects circumferentially positioned between each pair of adjacent posts of the plurality of posts, wherein each of the plurality of interconnects is pivotally coupled to four of the links.

10. The prosthetic device of claim 9, wherein one or more of the interconnects elastically deform as the frame expands radially from the radially compressed state to a partially expanded state within the initial expansion range of the frame, and then plastically deforms as the frame expands radially from the partially expanded state to a fully radially expanded state within a subsequent expansion range.

Images