Prosthetic valve with coaxial frame

Abstract

The present invention provides an artificial valve having a coaxial frame and a device for use with the artificial valve, the device comprising a connector (510, 610), the connector comprising a flexible sheet (512, 612) folded to define: (i) a sheet (508, 608) having: a first side facing in a first direction; and a second side opposite the first side; (ii) a leaflet receptacle (514, 614) disposed on the first side of the sheet and projecting away from the sheet in the first direction; and (iii) a plurality of flaps (504, 604), each flap folded about a respective fold axis such that at least a portion of each flap is disposed on the second side of the sheet. Other embodiments are also described.

Description

[0001] This application is a divisional application of application number 201780061210.3 (PCT application number PCT / IL2016 / 050873), application date August 8, 2017, and invention name “Artificial valve with coaxial frame”. Technical Field

[0002] Some applications of the present invention generally relate to valve replacement. More specifically, some applications of the present invention relate to prosthetic valves for heart valve replacement. Background Art

[0003] Ischemic heart disease causes regurgitation of a heart valve through a combination of ischemic dysfunction of the papillary muscles, followed by displacement of the papillary muscles and dilation of the valve annulus, causing regurgitation of a heart valve.

[0004] When the valve closes, expansion of the annulus prevents the valve leaflets from fully coapting. Backflow of blood from the ventricles into the atria results in an increased total pulse volume and decreased cardiac output, and ultimately weakens the ventricles, secondary to volume overload and pressure overload in the atria. Summary of the Invention

[0005] For certain applications, an implant is provided having a tubular portion, an upstream support portion, and one or more flanges. The implant is assembled from two coaxial frames. An inner frame defines the tubular portion and the upstream support portion, and an outer frame defines the flanges. The implant can be delivered percutaneously to a native heart valve in a compressed state and can be deployed at the native valve. The implant is secured to the native heart valve by clamping the tissue of the native valve between the upstream support portion and the flanges.

[0006] For some applications, the outer frame is radially thicker than the inner frame. For some applications, the outer frame is undersized relative to the inner frame so that it defines the inner frame even in a relaxed, expanded state of the implant, and does so even in the relaxed, expanded state residual. Pressure exists in one or both of the frames. For some applications, an annular space is defined by the tubular portion, the upstream support portion, and the plurality of flanges. For some such applications, the implant is configured such that the size of the annular space is proportional to the size of the tubular portion.

[0007] Thus, according to one aspect of the present invention, there is provided a device for use with an artificial valve, the device comprising a connector comprising a flexible sheet folded so as to define:

[0008] A plate having: a first side facing a first direction; and a second side opposite to the first side;

[0009] a leaflet container disposed on the first side of the sheet and projecting away from the sheet in the first direction; and

[0010] A plurality of flaps are provided, each flap being folded about a respective fold axis such that at least a portion of each flap is disposed on the second side of the sheet.

[0011] In one application, the sheet has an edge between the first side and the second side, and each flap is foldable over the edge so that each flap is disposed on the second side of the sheet.

[0012] In one application, the plurality of flaps are arranged within a tube such that each flap has two adjacent flaps around the tube, and the folding axis of each flap is oriented 60 to 120 degrees relative to the folding axis of each of the adjacent flaps of each flap.

[0013] In one application, the flexible sheet is a single unitary flexible sheet, and the unitary flexible sheet is folded to define the plate, the leaflet container, and the plurality of flaps.

[0014] In one application, the plurality of flaps includes exactly four flaps.

[0015] In an application,

[0016] The leaflet container comprises:

[0017] a first leaflet engagement tab extending from the first side of the sheet and defining a first row of a plurality of first tab suture holes and a second row of a plurality of first tab suture holes, and

[0018] a second leaflet engaging tab extending from the first side of the sheet and defining a first row of a plurality of second tab suture holes and a second row of a plurality of second tab suture holes;

[0019] The container is configured to clamp leaflets of one or more prosthetic valves between the plurality of leaflet coaptation tabs such that on opposing sides of the clamped leaflets:

[0020] The plurality of first tab sewing holes in the first row and the plurality of second tab sewing holes in the first row are aligned with each other; and

[0021] The plurality of first tab sewing holes in the second row and the plurality of second tab sewing holes in the second row are aligned with each other.

[0022] In one application, the first row of first tab stitching holes and the second row of first tab stitching holes are staggered 10 to 45 degrees relative to each other, and the first row of second tab stitching holes and the second row of second tab stitching holes are staggered 10 to 45 degrees relative to each other.

[0023] In one application, the plurality of first tab sewing holes in the first row and the plurality of first tab sewing holes in the second row are staggered 10 to 30 degrees relative to each other, and the plurality of second tab sewing holes in the first row and the plurality of second tab sewing holes in the second row are staggered 10 to 30 degrees relative to each other.

[0024] In one application, the plurality of first tab stitching holes in the first row and the plurality of first tab stitching holes in the second row are staggered 15 to 25 degrees relative to each other, and the plurality of second tab stitching holes in the first row and the plurality of second tab stitching holes in the second row are staggered 15 to 25 degrees relative to each other.

[0025] In one application, the flexible sheet is folded so that each of the first leaflet engagement tab and the second leaflet engagement tab comprises: (i) an outer layer; and (ii) an inner layer positioned to be sandwiched between the outer layer and one or more leaflets, and:

[0026] The first and second rows of a plurality of first tab suture holes are defined in the inner layer of the first leaflet engagement tab; and

[0027] The first and second rows of a plurality of second tab suture holes are defined in the inner layer of the second leaflet engagement tab.

[0028] In an application,

[0029] The first leaflet engagement tab further defines a third row of a plurality of first tab suture holes, the third row of a plurality of first tab suture holes being defined in the outer layer of the first leaflet engagement tab and aligned with the first row of a plurality of first tab suture holes; and

[0030] The second leaflet engagement tab further defines a third row of a plurality of second tab suture holes, the third row of a plurality of second tab suture holes being defined in the outer layer of the second leaflet engagement tab and aligned with the first row of a plurality of second tab suture holes.

[0031] In one application, the apparatus further comprises:

[0032] a tubular frame defining a lumen therethrough; and

[0033] a first artificial valve leaflet and a second artificial valve leaflet, wherein the first and second artificial valve leaflets are disposed in the inner cavity,

[0034] The device defines an interface where the first and second leaflets meet each other and are connected to the frame via the connector.

[0035] In one application, the plurality of leaflets are arranged and connected to the frame to define an upstream end and a downstream end of the lumen, so that a fluid flows unidirectionally through the lumen.

[0036] In an application,

[0037] The leaflet container comprises:

[0038] a first leaflet engagement tab extending from the first side of the sheet; and

[0039] a second leaflet engagement tab extending from the first side of the sheet; and

[0040] The first and second leaflets are clamped together between and sutured to the first and second leaflet coaptation tabs such that on opposing sides of the clamped leaflets:

[0041] The plurality of first tab sewing holes in the first row and the plurality of second tab sewing holes in the first row are aligned with each other; and

[0042] The plurality of first tab sewing holes in the second row and the plurality of second tab sewing holes in the second row are aligned with each other.

[0043] In one application, the first lobe has a first lobe downstream edge, and the second lobe has a second lobe downstream edge, and each of the first lobe engagement tab and the second lobe engagement tab extends beyond the first lobe downstream edge and the second lobe downstream edge in a downstream direction.

[0044] In an application,

[0045] The first lobe has a first lobe downstream edge, and the second lobe has a second lobe downstream edge;

[0046] The first and second leaflets are configured as follows:

[0047] inhibiting fluid flow in an upstream direction by causing the first and second leaflets to move toward each other in response to fluid flow in the upstream direction such that a downstream edge of the first leaflet and a downstream edge of the second leaflet move away from the frame; and

[0048] Prompting fluid flow in a downstream direction by causing the first and second leaflets to move away from each other in response to fluid flow in the downstream direction, such that a downstream edge of the first leaflet and a downstream edge of the second leaflet move toward the frame;

[0049] The first leaflet engagement protrusion defines a first cushion, the first cushion inhibiting a portion of an engagement surface of the first leaflet from moving toward the frame; and

[0050] The second leaflet engagement protrusion defines a second cushion, which inhibits movement of an engagement surface portion of the second leaflet toward the frame.

[0051] In one application, the first cushion and the second cushion are disposed further downstream than a downstream edge of the first leaflet and a downstream edge of the second leaflet.

[0052] In one application, the first and second cushions are each defined by a plurality of folds in the flexible sheet.

[0053] In an application,

[0054] The leaflet container comprises:

[0055] a first leaflet engaging tab extending from the first side of the plate and defining a first row of a plurality of first tab suture holes and a second row of a plurality of first tab suture holes;

[0056] and

[0057] a second leaflet engaging tab extending from the first side of the plate and defining a first row of a plurality of second tab suture holes and a second row of a plurality of second tab suture holes;

[0058] as well as

[0059] The first and second leaflets are clamped between and sewn to the first and second leaflet coaptation tabs such that on opposing sides of the clamped leaflets:

[0060] The plurality of first tab sewing holes in the first row and the plurality of second tab sewing holes in the first row are aligned with each other; and

[0061] The plurality of first tab sewing holes in the second row and the plurality of second tab sewing holes in the second row are aligned with each other.

[0062] In one application, the first and second rows of first tab stitching holes are diverged relative to each other so that progressively, the downstream portions of the first and second rows of first tab stitching holes are progressively further diverged relative to each other; and the first and second rows of second tab stitching holes are diverged relative to each other so that progressively, the downstream portions of the first and second rows of second tab stitching holes are progressively further diverged relative to each other.

[0063] In one application, the plurality of first tab stitching holes in the first and second rows are staggered 10 to 45 degrees relative to each other; and the plurality of second tab stitching holes in the first and second rows are staggered 10 to 45 degrees relative to each other.

[0064] In an application,

[0065] The connector is a first connector;

[0066] The joint surface is a first joint surface;

[0067] The device further comprises a second connector, a third connector and a third leaflet; and

[0068] The device definition is:

[0069] a second joint surface where the second and third lobes meet each other and are connected to the frame via the second connector; and

[0070] A third joint surface where the third and first leaflets meet each other and are connected to the frame via the third connector.

[0071] In one application, the fold axis of each flap is oriented 70 to 110 degrees relative to the fold axis of each of the plurality of adjacent flaps of each flap.

[0072] In one application, the fold axis of each flap is oriented 80 to 100 degrees relative to the fold axis of each of the plurality of adjacent flaps of each flap.

[0073] In one application, the connector has a folded state, in which the sheet is folded to define the plate, the leaflet container, and the plurality of flaps; and the sheet further has an unfolded state, in which the sheet defines a plane, and further defined in the plane:

[0074] The plate is located in a middle area of ​​the sheet;

[0075] The plurality of flaps are arranged on the periphery of the plate; and

[0076] a first convex portion and a second convex portion, each of the plurality of convex portions being disposed on the periphery of the plate,

[0077] In the folded state, each of the plurality of tab portions defines a corresponding leaflet engagement tab, and the leaflet receptacle includes the leaflet engagement tab of each of the plurality of tab portions.

[0078] In one application, in the folded state, a first flap portion of each of the plurality of flaps is disposed on the first side of the sheet; and each of the plurality of flaps is folded around the sheet so that a second flap portion of each of the plurality of flaps is disposed on the second side of the sheet.

[0079] In one application, the sheet material further defines: a first bridge element, the first tab portion is connected to the plate material via the first bridge element; and a second bridge element, the second tab portion is connected to the plate material via the second bridge element.

[0080] In one application, in the folded state, the first and second bridging elements extend from multiple corresponding edges of the sheet and over the first side of the sheet toward each other; and each of the first and second tab portions protrudes from the corresponding bridging element in the first direction away from the first side of the sheet.

[0081] In one embodiment, the plurality of flaps are connected to the sheet independently of the plurality of bridging elements.

[0082] In one application, the plurality of flaps are connected to the sheet material via the plurality of bridging elements.

[0083] In an application, in the expanded state:

[0084] The sheet material, the first and second bridging elements, and the first and second tab portions are arranged in a row to define a transverse axis in the plane, the transverse axis passing through the sheet material, the first and second bridging elements, and the first and second tab portions; and

[0085] For each of the plurality of bridge elements, a first flap of the plurality of flaps and a second flap of the plurality of flaps are connected to the bridge element, and the transverse axis passes between the first and second flaps.

[0086] In one application, in the folded state, the plurality of bridging elements are disposed on the first side of the sheet; and each flap extends from one of the plurality of bridging elements and surrounds the sheet such that a flap portion of each flap is disposed on the second side of the sheet.

[0087] In one application, in the expanded state, the first tab portion and the second tab portion flank the sheet material by being disposed on opposite sides of the sheet material in the plane.

[0088] In one application, in the expanded state, the first and second tab portions, the first and second bridging elements and the sheet material are arranged in a row to define a transverse axis in the plane; and the folding axis of each of the plurality of flaps is 30 to 60 degrees relative to the transverse axis.

[0089] According to one application of the present invention, there is provided a device for use with an artificial valve, the device comprising a connector, the connector comprising:

[0090] A plate having: a first side facing a first direction; and a second side facing an opposite second direction; and

[0091] a leaflet engagement tab protruding from the first side in the first direction; and

[0092] a plurality of flaps, each flap extending from the sheet and configured to fold along a corresponding folding axis toward the second direction, the plurality of flaps being arranged in a tube such that each flap has two adjacent flaps surrounding the tube,

[0093] and:

[0094] The fold axis of each flap is oriented 60 to 120 degrees relative to the fold axis of each of the plurality of adjacent flaps of each flap.

[0095] In one application, the sheet of material substantially defines a plane, and each flap is configured to fold out of the plane along a respective fold axis of each flap.

[0096] In one application, each flap is configured to fold over a corresponding portion of the second side of the sheet.

[0097] In one application, the connector is comprised of a single unitary sheet of material that is folded to define the panels, the leaflet engagement tabs, and the plurality of flaps.

[0098] In one application, the plurality of flaps includes exactly four flaps.

[0099] In one application, the fold axis of each flap is oriented 70 to 110 degrees relative to the fold axes of the plurality of adjacent flaps of each flap.

[0100] In one application, the fold axis of each flap is oriented 80 to 100 degrees relative to the fold axes of the plurality of adjacent flaps of each flap.

[0101] In one application, the fold axis of each flap is oriented at approximately 90 degrees relative to the fold axes of the plurality of adjacent flaps of each flap.

[0102] According to an application of the present invention, a method is provided, comprising:

[0103] A flexible sheet is folded to define a connector, the connector having:

[0104] A plate having: a first side facing a first direction; and a second side opposite to the first side;

[0105] a leaflet container disposed on the first side of the sheet and protruding away from the sheet in the first direction; and

[0106] a plurality of flaps, each flap folded about a respective fold axis such that at least a portion of each flap is disposed on the second side of the sheet;

[0107] attaching the one or more leaflets to the connector by suturing the one or more leaflets to the leaflet receptacle; and

[0108] The connector is attached to a frame assembly by folding each of the plurality of flaps around a corresponding component of the frame assembly and securing them by sewing.

[0109] According to one application of the present invention, there is provided a device for use at a heart valve of a subject, the device comprising:

[0110] A frame assembly is capable of being advanced intracavitarily into the heart, the frame assembly comprising:

[0111] an inner stent frame defining a tubular portion; and

[0112] an outer stent frame defining a ring body connected to the inner stent frame and surrounding the tubular portion; and

[0113] a plurality of prosthetic valve leaflets connected to the frame assembly and disposed within the tubular portion,

[0114] The inner support frame is cut from a first nitinol tube and has a first tube wall thickness; and the outer support frame is cut from a second nitinol tube and has a second tube wall thickness, which is greater than the first tube wall thickness.

[0115] In one application, the first tube wall thickness is 0.45 to 0.65 mm, and the second tube wall thickness is 0.6 to 0.8 mm.

[0116] In one application, the second tube wall thickness is at least 20% greater than the first tube wall thickness.

[0117] In one application, the second tube wall thickness is at least 30% greater than the first tube wall thickness.

[0118] In an application,

[0119] The inner frame further defines: an annular upstream support portion extending from the tubular portion and sized to rest against an upstream surface of a heart valve; and

[0120] The outer frame further defines a plurality of flanges extending from the tubular portion and sized to rest against a downstream surface of a heart valve.

[0121] According to one aspect of the present invention, there is provided a device for use with a subject's heart, the device comprising:

[0122] An inner support frame, wherein:

[0123] defining a tubular portion and a plurality of inner frame connecting elements; and

[0124] having a relaxed, expanded state, wherein the tubular portion defines a relaxed, expanded diameter of the inner stent framework in the relaxed, expanded state; and

[0125] An outer support frame, the outer support frame:

[0126] A ring body and a plurality of outer frame connecting elements are defined; and

[0127] having a relaxed deployment state, wherein the ring body defines a relaxed deployment diameter of the outer stent frame in the relaxed deployment state, the relaxed deployment diameter of the outer stent frame being smaller than the relaxed deployment diameter of the inner stent frame,

[0128] and:

[0129] The inner stent frame and the outer stent frame together define at least a portion of a frame assembly in which the outer frame connecting element is secured to the inner frame connecting element and the annulus surrounds the tubular portion, and

[0130] The framework components:

[0131] Also included: a plurality of artificial valve leaflets fixed to and disposed within the tubular portion;

[0132] having a compressed state in which the frame assembly is advanceable intracavitarily into the heart; and

[0133] The tubular portion is expandable to an expanded state in which the tubular portion defines an expanded diameter defined by the inner stent frame, the expanded diameter defined by the inner stent frame being smaller than the expanded diameter of the inner stent frame in a relaxed state.

[0134] In one application, the outer frame is connected to the inner frame such that:

[0135] In the compressed state of the frame assembly, the outer frame is in circumferential contact with the tubular portion; and

[0136] Circumferential contact is maintained between the outer frame and the tubular portion throughout the deployment of the frame assembly to its deployed state.

[0137] In one application, the plurality of outer frame connecting elements are welded to the plurality of inner frame connecting elements.

[0138] In an application,

[0139] The device defines a plurality of articulation surfaces at which the plurality of leaflets are secured to the frame assembly; and

[0140] The outer frame is secured to the inner frame by (i) securing the outer frame connecting elements to the inner frame connecting elements, and (ii) sewing the outer frame to the inner frame at the joint surfaces.

[0141] In an application,

[0142] The device is defined to have a plurality of engagement surfaces; and

[0143] At each of the plurality of engagement surfaces, the device comprises a plurality of sutures, and

[0144] The plurality of joint surface portions of the two artificial valve leaflets are fixed to the inner stent frame and the outer stent frame by the plurality of sutures.

[0145] In one application, at each joint surface, the device includes: a fabric connector, to which the multiple joint surface portions of the two leaflets are fixed, and the multiple sutures fix the multiple joint surface portions of the two leaflets to the inner stent frame and the outer stent frame by being attached to the fabric connector.

[0146] In one application, the fabric connector is formed to define: (i) a sheet having a first side and a second side; (ii) one or more leaflet engagement tabs, to which the multiple engagement surface portions of the two leaflets are sutured, the multiple tabs protruding from the first side of the sheet; and (iii) multiple folds wrapped around multiple elements of the inner support frame and multiple elements of the outer support frame and secured by suturing.

[0147] According to one application of the present invention, there is provided a device for use in a heart of a subject, the device comprising:

[0148] A framework component definition has:

[0149] a tubular portion defining a longitudinal lumen extending therethrough;

[0150] an upstream support portion connected to the tubular portion; and

[0151] a plurality of flanges connected to the tubular portion; and

[0152] a plurality of artificial valve leaflets connected to the tubular portion and disposed within the lumen,

[0153] and:

[0154] The framework components:

[0155] having a compressed state for transluminal delivery to the heart; and

[0156] There is an extended state, in which:

[0157] the upstream support portion extending radially outward from the tubular portion;

[0158] the plurality of flanges extending radially outward from the tubular portion and toward the upstream support portion;

[0159] The tubular portion has a transverse cross-sectional area; and

[0160] The frame assembly defines an annular space between the plurality of flanges, the upstream support portion, and the tubular portion. The annular space surrounds the tubular portion and has a cross-sectional area that is 5 to 10% of the transverse cross-sectional area of ​​the tubular portion.

[0161] In an application,

[0162] The frame assembly is a first frame assembly, the plurality of leaflets are a plurality of first leaflets, and the device comprises a first implant comprising the first frame assembly and the plurality of first leaflets, and

[0163] The device further comprises a second implant comprising:

[0164] A second framework component is defined as follows:

[0165] a second tubular portion defining a second longitudinal lumen extending therethrough;

[0166] a second upstream support portion connected to the second tubular portion; and

[0167] a plurality of second flanges connected to the second tubular portion; and

[0168] a plurality of second artificial valve leaflets connected to the second tubular portion and disposed within the second lumen,

[0169] and:

[0170] The second frame assembly:

[0171] having a compressed state for transluminal delivery to the heart; and

[0172] There is an extended state, in which:

[0173] The second upstream support portion extends radially outward from the second tubular portion; and

[0174] the plurality of flanges of the second plurality of flanges extending radially outward from the second tubular portion and toward the second upstream support portion,

[0175] The second tubular portion has a transverse cross-sectional area that is at least 30% greater than a transverse cross-sectional area of ​​the first tubular portion of the first implant; and

[0176] The second frame assembly defines a second annular space between the plurality of flanges of the plurality of second flanges, the second upstream support portion and the second tubular portion, the second annular space surrounding the second tubular portion and having a cross-sectional area that is 5 to 10% of the transverse cross-sectional area of ​​the second tubular portion.

[0177] In one application, the frame assembly is sized such that the cross-sectional area of ​​the annular space is 5 to 8% of the transverse cross-sectional area of ​​the tubular portion.

[0178] In one application, the frame assembly is sized such that the cross-sectional area of ​​the annular space is 6 to 7% of the transverse cross-sectional area of ​​the tubular portion.

[0179] In one application, the frame assembly is sized such that the cross-sectional area of ​​the annular space is 6.5 to 7.5% of the transverse cross-sectional area of ​​the tubular portion.

[0180] In one application, the upstream support portion includes a plurality of arms that project radially outwardly from the tubular portion in the deployed state of the frame assembly.

[0181] In an application,

[0182] The tubular portion has an upstream end and a downstream end;

[0183] The plurality of prosthetic leaflets are configured to provide unidirectional blood flow through the lumen from the upstream end to the downstream end; and

[0184] each arm of the plurality of arms is attached to the tubular portion at a location downstream from the upstream end;

[0185] The progressive lateral portion of each arm is defined by:

[0186] a rising portion extending in an upstream direction beyond the upstream end of the tubular portion;

[0187] an arched portion curved in a downstream direction to form an arch; and

[0188] A lateral portion is curved in an upstream direction.

[0189] In one application, the frame assembly defines the annular space between the flanges, the tubular portion, and the arcuate portions of the arms of the upstream support portion.

[0190] In one application, each flange extends radially outward from the tubular portion toward a tip of the flange, and the arcuate portions of the arms curve in a downstream direction beyond the tips of the flanges.

[0191] According to one application of the present invention, there is further provided a device for use at a heart valve of a subject, the device comprising:

[0192] A first implant and a second implant, each implant being advanceable intracavitarily into the heart and comprising:

[0193] A framework component, including:

[0194] an inner stent frame defining a tubular portion, wherein the tubular portion defines an inner lumen;

[0195] and

[0196] an outer stent frame defining a ring body connected to the inner stent frame and surrounding the tubular portion; and

[0197] a plurality of prosthetic valve leaflets connected to the frame assembly and disposed within the tubular portion; and

[0198] A delivery tool includes a delivery capsule having a capsule diameter, and:

[0199] The first implant comprises:

[0200] an expanded state, wherein the lumen has a lumen diameter in the expanded state; and

[0201] a compressed state in which the first implant has a compressed diameter and is sized to be received within the delivery capsule; and

[0202] The second implant has:

[0203] an expanded state, wherein the lumen has a lumen diameter at least 15% greater than the lumen diameter of the first implant; and

[0204] A compressed state in which the second implant has a compressed diameter no greater than 2% of the compressed diameter of the first implant and is sized to be received within the delivery capsule.

[0205] According to one application of the present invention, there is provided a device for use with a native valve disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0206] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis, the tubular portion defining a plurality of valve frame connection elements circumferentially disposed about the longitudinal axis;

[0207] a plurality of artificial valve leaflets connected to the frame, disposed within the inner cavity, and configured to provide a unidirectional flow of blood from an upstream end of the inner cavity to a downstream end of the inner cavity;

[0208] One outer frame:

[0209] comprising a ring body defined by a pattern of alternating peaks and valleys, the peaks being longitudinally closer to the upstream end than the downstream end and the valleys being longitudinally closer to the downstream end than the upstream end, and the pattern of the ring body having an amplitude longitudinally positioned between the peaks and valleys;

[0210] comprising a plurality of legs, each leg being connected to a corresponding valley of the ring body; and

[0211] configured to define a plurality of outer frame connection elements, (i) each of the outer frame connection elements being connected to a corresponding peak of the annulus, and (ii) each of the outer frame connection elements being secured to a corresponding valve frame connection element,

[0212] The tubular portion has (i) a compressed state and (ii) an expanded state, wherein in the compressed state, the tubular portion has a compressed diameter, and in the expanded state, the tubular portion has an expanded diameter that is greater than the compressed diameter; and

[0213] The outer frame connection element is fixed to the valve frame connection element so that the tubular portion is compressed from the expanded state to the compressed state, and the valve frame connection element pulls the outer frame connection element radially inward, thereby (i) reducing the circumferential distance between each outer frame connection element and its adjacent outer frame connection element, and (ii) increasing the amplitude of the pattern of the ring body.

[0214] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0215] In one application, the expanded state of the tubular portion is a defined expanded state, and the plurality of outer frame connecting elements are secured to the plurality of valve frame connecting elements such that, in a relaxed expanded state of the device, the outer frame defines the tubular portion in the defined expanded state.

[0216] In one application, the device further comprises an upstream support portion, the upstream support portion comprising a plurality of arms connected to the tubular portion, and:

[0217] The upstream support portion has (i) a restrained arm state, and (ii) a released arm state, wherein the plurality of arms extend radially outward from the tubular portion,

[0218] Each leg has a tissue engaging flange having (i) a restrained flange state, and (ii) a released flange state, wherein the flange extends radially outward from the tubular portion and toward the upstream support portion, and

[0219] In a relaxed, deployed state of the device, (i) the tubular portion is in its deployed state, (ii) the upstream support portion is in its released arm state, and (iii) the plurality of flanges are in the released flange state:

[0220] The tubular portion has a transverse cross-sectional area, and

[0221] The frame assembly defines an annular space between the plurality of flanges, the upstream support portion, and the tubular portion. The annular space surrounds the tubular portion and has a cross-sectional area that is 5 to 10% of a transverse cross-sectional area of ​​the tubular portion.

[0222] In one application, the ring surrounds the tubular portion.

[0223] In one application, the valve frame connection element is disposed circumferentially about the longitudinal axis between the upstream end and the downstream end, but not at the upstream end or the downstream end.

[0224] In one application, the upstream support portion comprises one or more circumferentially disposed fabric pockets, each of the one or more pockets having an opening facing in a downstream direction.

[0225] In one application, the outer frame is connected to the valve frame simply by securing the outer frame connection elements to corresponding valve frame connection elements.

[0226] In one application, the device further comprises an upstream support portion comprising a plurality of arms extending radially from the tubular portion.

[0227] The upstream support portion has (i) an arm-restrained state and (ii) an arm-released state, wherein the arms extend radially outward from the tubular portion;

[0228] Each leg has a tissue engaging flange having (i) a flange-restricted state and (ii) a flange-released state, wherein the flange extends radially outward from the tubular portion; and

[0229] The device has an intermediate state in which (i) the tubular portion is in its compressed state, (ii) the upstream support portion is in its arm-released state, and (iii) the foot is in its flange-released state.

[0230] In one application, the device comprises an implant comprising the valve frame, the leaflets, and the outer frame; and

[0231] The apparatus further comprises a tool, wherein:

[0232] comprising a delivery capsule sized to (i) receive and retain the implant in the compressed state of the implant, wherein (a) the tubular portion is in its compressed state, (b) the upstream support portion is in its arm-defining state, and (c) the legs are in their flange-defining state, and (ii) be percutaneously advanced into the heart of the subject while the implant is received and in its compressed state; and

[0233] Operable from outside the body:

[0234] transitioning the implant from its compressed state to the intermediate state while maintaining the tubular portion in its compressed state; and

[0235] The tubular portion is then deployed to its expanded state.

[0236] In one application, the tool can be operated from outside the body to transition the implant from its compressed state to the intermediate state by (i) releasing the leg to its flange-released state while maintaining the tubular portion in its compressed state, and (ii) subsequently releasing the upstream support portion to its arm-released state while maintaining the tubular portion in its compressed state.

[0237] In one application, the tool can be operated from outside the body to transition the implant from its compressed state to the intermediate state by (i) releasing the upstream support portion to its arm-released state while maintaining the tubular portion in its compressed state, and (ii) subsequently releasing the leg to its flange-released state while maintaining the tubular portion in its compressed state.

[0238] In one application, the outer frame connection element is secured to the valve frame connection element such that when the device is in its intermediate state, expansion of the tubular portion from its compressed state to its expanded state causes the flange to move longitudinally away from the valve frame connection element.

[0239] In one application, the outer frame connecting element is secured to the valve frame connecting element such that when the device is in its intermediate state, expansion of the tubular portion from its compressed state to its expanded state reduces the amplitude of the pattern of the ring body and transfers the flange between the arms.

[0240] In one application, the upstream support portion further comprises a cover which covers the arm in the released state of the arm to form a ring, and wherein when the device is in its intermediate state, expansion of the tubular portion from its compressed state to its expanded state causes the flange to press against the cover.

[0241] In one application, in the compressed state of the tubular portion, the downstream end of each leg is longitudinally closer to the downstream end than the valve frame connecting element, and the flange of each leg is configured to be longitudinally closer to the upstream end than the valve frame connecting element.

[0242] In one application, in the expanded state of the tubular portion, the downstream end of each leg is longitudinally closer to the downstream end than the valve frame connecting element, and the flange of each leg is configured to be longitudinally closer to the upstream end than the valve frame connecting element.

[0243] According to one application of the present invention, there is further provided a device for use with a native valve of a subject's heart, the device comprising an implant, the implant comprising:

[0244] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis, the tubular portion having an upstream end, a downstream end, a longitudinal length between the upstream and downstream ends, and a diameter transverse to the longitudinal axis;

[0245] a valve member connected to the tubular portion, disposed within the inner cavity, and configured to provide a one-way blood flow from the upstream end to the downstream end through the inner cavity;

[0246] an upstream support portion connected to the tubular portion; and

[0247] an outer frame connected to the tubular portion and comprising a tissue engaging flange,

[0248] and:

[0249] The implant has a first state and a second state;

[0250] In the first and second states, (i) the upstream support portion extends radially outward from the tubular portion, and (ii) the tissue-engaging flange extends radially outward from the tubular portion; and

[0251] The tubular portion, the upstream support portion and the outer frame are configured to transform the implant from the first state to the second state:

[0252] increasing the diameter of the tubular portion by a diameter increase;

[0253] reducing the length of the tubular portion by a length reduction; and

[0254] The flange is moved toward or beyond the upstream support portion a longitudinal distance greater than the length reduction.

[0255] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0256] In one application, the tubular portion, the upstream support portion, and the outer frame are arranged such that the longitudinal distance is greater than the length reduction by more than 20%.

[0257] In one application, the tubular portion, the upstream support portion, and the outer frame are arranged such that the longitudinal distance is greater than the length reduction by more than 30%.

[0258] In one application, the tubular portion, the upstream support portion, and the outer frame are arranged such that the longitudinal distance is greater than the length reduction by more than 40%.

[0259] According to one application of the present invention, there is further provided a device for use with a native valve, the native valve being disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0260] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis;

[0261] a plurality of artificial valve leaflets connected to the frame, disposed within the inner cavity, and configured to provide a unidirectional flow of blood from an upstream end of the inner cavity to a downstream end of the inner cavity;

[0262] An outer frame, comprising:

[0263] A ring, defined by a pattern of alternating peaks and valleys:

[0264] The peak is longitudinally closer to the upstream end than the valley;

[0265] The peaks are secured to corresponding locations of the tubular portion at corresponding connection points disposed circumferentially about the longitudinal axis; and

[0266] The pattern of the ring has an amplitude with a longitudinal position between the peaks and the valleys; and

[0267] a plurality of legs, each leg being connected to a corresponding valley of the ring body,

[0268] and:

[0269] The tubular portion has (i) a compressed state and (ii) an expanded state, wherein in the compressed state, the tubular portion has a compressed diameter, and in the expanded state, the tubular portion has an expanded diameter that is greater than the compressed diameter; and

[0270] The peaks are secured to the corresponding locations of the tubular portion so that the tubular portion is compressed from the expanded state to the compressed state, and so that the corresponding locations of the tubular portion pull the peaks radially inwardly through radially inward tension of the connection points, thereby (i) reducing the circumferential distance between each of the connection points and its adjacent connection points, and (ii) increasing the amplitude of the pattern of the ring body.

[0271] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0272] In one application, the expanded state of the tubular portion is a defined expanded state, and the peaks of the tubular portion at various positions are fixed, so that: when the device is in a relaxed expanded state, the outer frame defines the tubular portion in the defined expanded state.

[0273] In one application, the outer frame is connected to the corresponding connection points of the valve frame simply by securing the peaks to the corresponding locations of the tubular portion.

[0274] According to one application of the present invention, there is further provided a device for use with a native valve, the native valve being disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0275] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis, the valve frame defining a plurality of valve frame connection elements circumferentially disposed about the longitudinal axis;

[0276] a plurality of artificial valve leaflets connected to the frame, disposed within the inner cavity, and configured to provide a unidirectional flow of blood from an upstream end of the inner cavity to a downstream end of the inner cavity;

[0277] One outer frame:

[0278] comprising a ring body defined by a pattern of alternating peaks and valleys, the peaks being longitudinally closer to the upstream end than the downstream end and the valleys being longitudinally closer to the downstream end than the upstream end, and the pattern of the ring body having an amplitude longitudinally positioned between the peaks and valleys;

[0279] comprising a plurality of legs, each leg being connected to a corresponding valley of the ring body; and

[0280] configured to define a plurality of outer frame connection elements, (i) each of the outer frame connection elements being connected to a corresponding peak of the annulus, and (ii) each of the outer frame connection elements being secured to a corresponding valve frame connection element,

[0281] and:

[0282] The tubular portion has (i) a compressed state and (ii) an expanded state, wherein in the compressed state, the tubular portion has a compressed diameter, and in the expanded state, the tubular portion has an expanded diameter that is greater than the compressed diameter; and

[0283] The outer frame connecting elements are fixed to the valve frame connecting elements respectively so that the tubular portion is compressed from the expanded state to the compressed state, and so that (i) the outer frame connecting elements are pulled radially inward by pulling the valve frame connecting elements radially inward onto the outer frame connecting elements, (ii) the circumferential distance between the outer frame connecting elements and their adjacent outer frame connecting elements is reduced, and (iii) the amplitude of the pattern of the ring body is increased without increasing the radial gap between the valve frame and the ring body by more than 1.5 mm.

[0284] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0285] In one application, the outer frame is connected to the valve frame simply by securing the outer frame connection elements to corresponding valve frame connection elements.

[0286] According to one application of the present invention, there is further provided a device for use with a native valve, the native valve being disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0287] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis;

[0288] a plurality of artificial valve leaflets connected to the frame, disposed within the inner cavity, and configured to provide a unidirectional flow of blood from an upstream end of the inner cavity to a downstream end of the inner cavity;

[0289] An outer frame, comprising:

[0290] A ring, defined by a pattern of alternating peaks and valleys:

[0291] The peak is longitudinally closer to the upstream end than the valley;

[0292] The peaks are secured to corresponding locations of the tubular portion at corresponding connection points disposed circumferentially about the longitudinal axis; and

[0293] The pattern of the ring has an amplitude with a longitudinal position between the peaks and the valleys; and

[0294] a plurality of legs, each leg connected to a corresponding valley of the ring body;

[0295] and:

[0296] The tubular portion has (i) a compressed state and (ii) an expanded state, wherein in the compressed state, the tubular portion has a compressed diameter, and in the expanded state, the tubular portion has an expanded diameter that is greater than the compressed diameter; and

[0297] The peaks are secured to the corresponding locations of the tubular portion so that the tubular portion is compressed from the expanded state to the compressed state, and so that (i) the peaks are pulled radially inward by pulling the corresponding locations of the tubular portion radially inward onto the peaks, (ii) the circumferential distance between each of the connection points and its adjacent connection points is reduced, and (iii) the amplitude of the pattern of the ring body is increased without increasing the radial gap between the valve frame and the ring body by more than 1.5 mm.

[0298] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0299] In one application, the outer frame is connected to the corresponding connection points of the valve frame simply by securing the peaks to the corresponding locations of the tubular portion.

[0300] According to one application of the present invention, there is further provided a device for use with a native valve, the native valve being disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0301] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis, the tubular portion having an upstream end and a downstream end and defining a plurality of valve frame connection elements disposed circumferentially about the longitudinal axis, the valve frame connection elements being located between the upstream end and the downstream end but not at either the upstream end or the downstream end;

[0302] a plurality of artificial valve leaflets disposed within the inner cavity and configured to provide unidirectional blood flow through the inner cavity;

[0303] One outer frame:

[0304] comprising a ring body defined by a pattern of alternating peaks and valleys, the peaks being longitudinally closer to the upstream end than the downstream end and the valleys being longitudinally closer to the downstream end than the upstream end;

[0305] comprising a plurality of legs, each leg being connected to a corresponding valley of the ring body; and

[0306] configured to define a plurality of outer frame connection elements, (i) each of the outer frame connection elements being connected to a respective peak of the annulus, and (ii) each of the outer frame connection elements being secured to a respective connection point of a respective valve frame connection element,

[0307] and:

[0308] The tubular portion has (i) a compressed state and (ii) an expanded state, wherein in the compressed state, the tubular portion has a compressed diameter, and in the expanded state, the tubular portion has an expanded diameter that is greater than the compressed diameter; and

[0309] Expanding the tubular portion from the compressed state to the expanded state causes (i) the circumferential distance between each of the outer frame connecting elements and its adjacent outer frame connecting element to increase, and (ii) the plurality of legs to move in a longitudinal upstream direction relative to the tubular portion.

[0310] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0311] In one application, the outer frame is connected to the valve frame simply by securing the outer frame connection elements to corresponding valve frame connection elements.

[0312] According to one application of the present invention, there is further provided a device for use with a native valve, the native valve being disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0313] a valve frame comprising a tubular portion surrounding a longitudinal axis of the valve frame to define a lumen along the axis, the tubular portion having an upstream end and a downstream end;

[0314] a plurality of artificial valve leaflets disposed within the inner cavity and configured to provide unidirectional blood flow through the inner cavity;

[0315] An outer frame, comprising:

[0316] A ring, defined by a pattern of alternating peaks and valleys:

[0317] The peak is longitudinally closer to the upstream end than the valley;

[0318] The peaks are secured to respective locations of the tubular portion at respective connection points disposed circumferentially about the longitudinal axis, between the upstream end and the downstream end, but not at the upstream end and not at the downstream end; and

[0319] a plurality of legs, each leg connected to a corresponding valley of the ring body;

[0320] and:

[0321] The tubular portion has (i) a compressed state and (ii) an expanded state, wherein in the compressed state, the tubular portion has a compressed diameter, and in the expanded state, the tubular portion has an expanded diameter that is larger than the compressed diameter; and expanding the tubular portion from the compressed state to the expanded state causes (i) the circumferential distance between each of the connection points and its adjacent connection point to increase, and (ii) the plurality of legs to move in a longitudinal upstream direction relative to the tubular portion.

[0322] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the outer frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0323] In one application, the outer frame is connected to the corresponding connection points of the valve frame simply by securing the peaks to the corresponding locations of the tubular portion.

[0324] According to one application of the present invention, there is further provided a device for use with a native valve of a subject's heart, the device comprising:

[0325] A frame assembly having an upstream end and a downstream end and a central longitudinal axis between the upstream end and the downstream end, the frame assembly comprising:

[0326] A valve frame comprising:

[0327] a tubular portion having an upstream end and a downstream end and configured to define a lumen between the upstream end and the downstream end; and

[0328] an upstream support portion extending from the upstream end of the tubular portion; and

[0329] at least one leg connected to a connection point of the valve frame and having a tissue engaging flange; and

[0330] a valve member disposed within the lumen and configured to facilitate unidirectional fluid flow through the lumen from the upstream end of the tubular portion to the downstream end of the tubular portion,

[0331] The framework components:

[0332] having a compressed state for percutaneous delivery to the heart, wherein the tubular portion has a compressed diameter;

[0333] being biased to assume an expanded condition wherein the tubular portion has an expanded diameter greater than the compressed diameter; and

[0334] configured such that increasing the diameter of the tubular portion toward the expanded diameter causes longitudinal movement:

[0335] The upstream support portion is towards the connection point; and

[0336] The tissue engaging flange is distal to the connection point.

[0337] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the at least one leg is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0338] In one application, the device comprises an implant comprising the frame component and the valve component; and

[0339] The apparatus further comprises a tool, wherein:

[0340] comprising a delivery capsule sized to (i) receive and retain the implant in the compressed state, and (ii) be percutaneously advanced into the heart of the subject while the implant is received and in its compressed state; and

[0341] operable from outside the body to increase the diameter of the tubular portion from the compressed diameter to the expanded diameter, such that the diameter increases, thereby causing longitudinal movement:

[0342] The upstream support portion is towards the connection point; and

[0343] The tissue engaging flange is distal to the connection point.

[0344] In one application, the frame assembly is configured such that expanding the frame assembly to the expanded state increases the diameter of the tubular portion, thereby causing longitudinal movement of the upstream end of the tubular portion toward the connection point.

[0345] In one application, the connection point is located closer to the downstream end of the frame assembly than to the tissue engaging flange or the upstream support portion.

[0346] In one application, in the expanded state of the frame assembly, the legs extend away from the central longitudinal axis.

[0347] In one application, the deployed state of the frame assembly is a fully deployed state of the frame assembly;

[0348] The legs are deployable to the deployed state of the legs independently of increasing the diameter of the tubular portion; and

[0349] In the deployed state of the legs, the legs extend away from the central longitudinal axis.

[0350] In one application, in the expanded state of the frame assembly, the legs extend away from the central longitudinal axis; and

[0351] In the compressed state of the frame assembly, the legs are generally parallel to the central longitudinal axis.

[0352] In one application, the frame assembly is configured such that longitudinal movement of the tissue engaging flange away from the connection point is a translational movement of the tissue engaging flange that does not involve rotation of the tissue engaging flange.

[0353] In one application, the frame assembly is configured such that expanding the frame assembly to the expanded state increases the diameter of the tubular portion, thereby causing the tissue-engaging flange to move longitudinally 1 to 20 millimeters away from the connection point.

[0354] In one application, the frame assembly is configured such that expanding the frame assembly to the expanded state increases the diameter of the tubular portion, thereby causing the upstream support portion to move longitudinally toward the connection point by 1 to 20 millimeters.

[0355] In one application, the frame assembly is configured such that expanding the frame assembly to the expanded state increases the diameter of the tubular portion, thereby reducing the distance between the upstream support portion and the tissue engaging flange by 5 to 30 mm.

[0356] In one application, the frame assembly is configured such that expanding the frame assembly to the expanded state increases the diameter of the tubular portion, thereby moving the tissue-engaging flange longitudinally through the upstream support portion.

[0357] In one application, the tubular portion is defined by a plurality of cells of the valve frame; and

[0358] Increasing the diameter of the tubular portion by expanding the frame assembly to the expanded state:

[0359] comprising (i) increasing the width of each cell perpendicular to the longitudinal axis of the frame assembly, and (ii) decreasing the height of each cell parallel to the longitudinal axis of the frame assembly; and

[0360] The upstream support portion is moved longitudinally toward the connection point by reducing the height of each cell to reduce the height of the tubular portion parallel to the longitudinal axis of the frame assembly.

[0361] In one application, the legs are located outside the tubular portion.

[0362] In one application, the at least one leg comprises a plurality of legs;

[0363] The connection point includes a plurality of connection points; and

[0364] The frame assembly includes a leg frame surrounding the tubular portion, the leg frame including the plurality of legs and connected to the plurality of connection points of the valve frame such that the plurality of legs are circumferentially distributed around the tubular portion.

[0365] In one application, the plurality of connection points are disposed circumferentially around the frame assembly in a transverse plane orthogonal to the longitudinal axis of the frame assembly.

[0366] In one application, the plurality of legs are connected to the valve frame via a plurality of struts, each strut:

[0367] having a first end connected to one of the plurality of legs, and a second end connected to one of the plurality of connection points;

[0368] in the compressed state of the frame assembly, disposed at a first angle wherein the first end is closer to the downstream end of the frame assembly than the second end; and

[0369] The frame assembly is deflectable relative to one of the plurality of connection points such that the diameter of the tubular portion is increased by expanding the frame assembly to the expanded state, thereby causing the strut to deflect to a second angle wherein the first end is further from the downstream end of the frame assembly than in the compressed state of the frame assembly.

[0370] In one application, the leg frame is configured such that each leg of the plurality of legs is connected to two legs of the plurality of legs, and two legs of the plurality of legs are connected to each connection point of the plurality of connection points.

[0371] In one application, the legs are connected to the valve frame via struts, the struts:

[0372] having a first end connected to the leg, and a second end connected to the connection point;

[0373] in the compressed state of the frame assembly, disposed at a first angle wherein the first end is closer to the downstream end of the frame assembly than the second end; and

[0374] Deflectable relative to the connection point such that the diameter of the tubular portion is increased by expanding the frame assembly to the expanded state, thereby causing the strut to deflect to a second angle wherein the first end is further from the downstream end of the frame assembly than in the compressed state of the frame assembly.

[0375] In one application, the at least one leg includes at least a first leg and a second leg.

[0376] In one application, the first leg and the second leg are both connected to the connection point of the valve frame.

[0377] In one application, the first leg is connected to the connection point via a corresponding first strut, and the second leg is connected to the connection point via a corresponding second strut.

[0378] In one application, in the expanded state of the frame assembly, the first and second legs, the first and second struts, and the connection points are configured such that:

[0379] The connection point is disposed circumferentially relative to the tubular portion between the first strut and the second strut;

[0380] The first strut is disposed circumferentially relative to the tubular portion between the connection point and the first leg; and

[0381] The second strut is disposed circumferentially relative to the tubular portion between the connection point and the second leg.

[0382] In one application, the connection point includes at least a first connection point and a second connection point.

[0383] In one application, the legs are connected to the first and second connection points of the valve frame.

[0384] In one application, the legs are connected to the first connection point via respective first struts and to the second connection point via respective second struts.

[0385] In one application, in the expanded state of the frame assembly, the first and second legs, the first and second struts, and the connection points are configured such that:

[0386] The support leg is disposed circumferentially relative to the tubular portion and between the first support and the second support;

[0387] The first strut is disposed circumferentially relative to the tubular portion between the leg and the first connection point; and

[0388] The second strut is disposed circumferentially relative to the tubular portion between the foot and the second connection point.

[0389] In one application, in the deployed state of the frame assembly, the upstream support portion extends radially outward from the tubular portion.

[0390] In one application, the deployed state of the frame assembly is a fully deployed state of the frame assembly;

[0391] independently increasing the diameter of the tubular portion such that the upstream support portion can be deployed to the deployed state of the upstream support portion; and

[0392] In the deployed state of the upstream support portion, the upstream support portion extends radially outward from the tubular portion.

[0393] In one application, in the compressed state of the frame assembly, the upstream support portion is generally tubular, co-linear with the tubular portion, and disposed about the central longitudinal axis.

[0394] In one application, in the expanded state of the frame assembly, the inner region of the upstream support portion extends radially outward from the tubular portion at a first angle relative to the tubular portion, and the outer region of the upstream support portion extends further radially outward from the inner region of the upstream support portion at a second angle relative to the tubular portion, wherein the second angle is less than the first angle.

[0395] According to one application of the present invention, there is further provided a device for use with a native valve of a subject's heart, the device comprising:

[0396] A frame assembly having an upstream end and a downstream end and a central longitudinal axis between the upstream end and the downstream end, the frame assembly comprising:

[0397] A valve frame comprising:

[0398] a tubular portion having an upstream end and a downstream end and configured to define a lumen between the upstream end and the downstream end; and

[0399] an upstream support portion extending from the upstream end of the tubular portion; and at least one leg connected to a connection point of the valve frame and having a tissue engaging flange; and

[0400] a valve member disposed within the lumen and configured to facilitate unidirectional fluid flow through the lumen from the upstream end of the tubular portion to the downstream end of the tubular portion,

[0401] The framework components:

[0402] having a compressed state for percutaneous delivery to the heart, wherein the tubular portion has a compressed diameter;

[0403] being biased to assume an expanded condition wherein the tubular portion has an expanded diameter greater than the compressed diameter; and

[0404] configured such that the diameter of the tubular portion is reduced toward the compressed diameter, thereby causing longitudinal movement:

[0405] the upstream support portion being distal to the connection point; and

[0406] The tissue engaging flange is oriented toward the connection point.

[0407] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the at least one leg is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0408] According to one application of the present invention, there is further provided a device for use with a native valve of a subject's heart, the device comprising:

[0409] A frame assembly having an upstream end and a downstream end and a central longitudinal axis between the upstream end and the downstream end, the frame assembly comprising:

[0410] A valve frame comprising:

[0411] a tubular portion having an upstream end and a downstream end and configured to define a lumen between the upstream end and the downstream end; and

[0412] an upstream support portion extending from the upstream end of the tubular portion; and at least one leg connected to a connection point of the valve frame and having a tissue engaging flange; and

[0413] a valve member disposed within the lumen and configured to facilitate unidirectional fluid flow through the lumen from the upstream end of the tubular portion to the downstream end of the tubular portion,

[0414] The framework components:

[0415] having a compressed state for transcutaneous delivery to the heart;

[0416] expandable in vivo to an expanded state, wherein the tubular portion has a larger diameter in the expanded state than in the compressed state; and

[0417] The apparatus is configured to increase the diameter of the tubular portion by expanding the frame assembly to the expanded state, thereby causing longitudinal movement of the tissue-engaging flange away from the connection point.

[0418] In one application, the valve frame is cut from a first nitinol tube and has a first wall thickness, and the at least one leg is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0419] According to one application of the present invention, there is further provided a device for use with a native valve of a subject's heart, the device comprising:

[0420] A frame assembly having an upstream end and a downstream end and a central longitudinal axis between the upstream end and the downstream end, the frame assembly comprising:

[0421] an inner frame comprising: an inner frame tubular portion surrounding the central longitudinal axis, the inner frame having an upstream end and a downstream end and defining a passageway between the upstream end and the downstream end, the inner frame defining a plurality of inner frame connectors disposed circumferentially in a longitudinal direction of the inner frame;

[0422] an outer frame comprising: an outer frame tubular portion coaxially surrounding at least a portion of the inner frame tubular portion, the outer frame defining a plurality of outer frame connectors disposed circumferentially in a longitudinal direction of the outer frame; and

[0423] a plurality of connectors, each connector connected to a corresponding inner frame and to a corresponding outer frame connector;

[0424] a liner disposed over at least a portion of the inner frame tubular portion; and

[0425] a plurality of artificial valve leaflets connected to the inner frame tubular portion and disposed within the channel,

[0426] and:

[0427] The frame assembly is: (i) compressible by a radial compressive force into a compressed state, wherein the inner frame is in its compressed state and the outer frame is in its compressed state, and (ii) configured to automatically expand into an expanded state, wherein the inner frame is in its expanded state and the outer frame is in its expanded state, upon removal of the radial compressive force;

[0428] In the expanded state of the frame assembly, the prosthetic valve leaflet is configured to facilitate unidirectional fluid flow through the passageway in a downstream direction; and

[0429] Connection of the inner frame connectors to corresponding outer frame connectors causes the frame assembly to expand from the compressed state to the expanded state, thereby causing the inner frame tubular portion to slide longitudinally in a downstream direction relative to the outer frame tubular portion.

[0430] In one application, the inner frame is cut from a first Nitinol tube and has a first wall thickness, and the outer frame is cut from a second Nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0431] According to one application of the present invention, there is further provided a device for use with a native valve, the native valve being disposed between an atrium and a ventricle of a subject's heart, the device comprising:

[0432] a tubular portion having an upstream portion including an upstream end and a downstream portion including a downstream end, and configured to define a lumen in the upstream portion and the downstream portion;

[0433] a plurality of artificial valve leaflets disposed within the lumen and configured to provide unidirectional blood flow from the upstream portion to the downstream portion;

[0434] 1. Annular upstream support part:

[0435] having an inner portion extending radially outward from the upstream portion; and

[0436] One or more fabric bladders are included that are circumferentially disposed about the interior, each of the one or more bladders having an opening facing in a downstream direction.

[0437] In one application, the upstream support portion includes (i) a plurality of arms extending radially outward from the tubular portion, and (ii) a cover disposed over the plurality of arms;

[0438] Each arm has (i) a radially inner portion at the inner portion of the upstream support portion, and (ii) a radially outer portion at the outer portion of the upstream support portion;

[0439] In the interior of the upstream support portion, the cover fits tightly between the radially inner portions of the arms; and

[0440] On the exterior of the upstream support portion, the pocket is formed by the cover fitting loosely between the radially outer sides of the arms.

[0441] In one application, the upstream support portion includes (i) a plurality of arms extending radially outward from the tubular portion, and (ii) a cover disposed over the plurality of arms;

[0442] Each arm has (i) a radially inner portion at the inner portion of the upstream support portion, and (ii) a radially outer portion at the outer portion of the upstream support portion, the radially outer portion being more flexible than the radially inner portion.

[0443] In one application, the upstream support portion includes (i) a plurality of arms extending radially outward from the tubular portion, and (ii) a cover disposed over the plurality of arms;

[0444] Each arm has (i) a radially inner portion at the inner portion of the upstream support portion, and (ii) a radially outer portion at the outer portion of the upstream support portion;

[0445] At the outer portion of the upstream support portion, the pocket is formed by bending each arm into a hook shape.

[0446] In one application, each pocket is shaped and arranged to undulate in response to paravalvular flow of blood in an upstream direction.

[0447] In one application, the device is configured to be delivered intraluminally to the heart and implanted into the native valve upon deployment of the device.

[0448] The upstream support portion is positioned in the atrium, and the tubular portion extends from the upstream support portion to the ventricle, and wherein each pocket is shaped and arranged such that circumferential flow of blood in an upstream direction presses the pocket against tissue of the atrium.

[0449] According to an application of the present invention, there is further provided a device comprising:

[0450] multiple prosthetic valve leaflets; and

[0451] A framework component, including:

[0452] a tubular portion defined by a repeating pattern of cells, the tubular portion extending circumferentially about the longitudinal axis to define a longitudinal lumen, the prosthetic valve leaflets being connected to the inner frame and disposed within the lumen;

[0453] an outer frame comprising a plurality of legs circumferentially distributed around the tubular portion, each leg having a tissue engaging flange;

[0454] an upstream support portion comprising a plurality of arms extending radially outward from the tubular portion; and

[0455] a plurality of appendages, each appendage having a first end and a second end, the first end defining a connecting element through which the tubular portion is connected to the outer frame,

[0456] The frame assembly defines a plurality of hubs distributed circumferentially around the longitudinal axis in a plane perpendicular to the longitudinal axis, each hub being defined by the convergence and connection of (i) two adjacent cells of the tubular portion, (ii) one of the plurality of arms, and (iii) one of the plurality of appendages.

[0457] In one application, the tubular portion is cut from a first Nitinol tube and has a first wall thickness, and the outer frame is cut from a second Nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness.

[0458] In one application, each hub has six radiating spokes, two of the six spokes are part of a first cell of two adjacent cells, two of the six spokes are part of a second cell of two adjacent cells, one of the six spokes is the arm, and one of the six spokes is the second end of the appendage.

[0459] In one application, the appendage is coplanar with the tubular portion.

[0460] In one application, the appendage is coplanar with the outer frame.

[0461] The present invention will be more fully understood from the following detailed description of its application taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0462] Figure 1A to Figure 1B and Figures 2A to 2E is a schematic diagram of an implant for use with a native valve of a subject's heart according to some applications of the present invention;

[0463] Figures 3A to 3C A schematic diagram showing the structural transition of a frame assembly between its compressed and expanded states according to some applications of the present invention;

[0464] Figures 4A to 4F is a schematic diagram of an implant according to some applications of the present invention being implanted in a native valve;

[0465] Figure 5 is a schematic diagram of the steps of implanting an implant according to some applications of the present invention;

[0466] Figure 6 is a schematic diagram of an implant according to some applications of the present invention;

[0467] 7A to 7B and Figures 8A to 8B is a schematic diagram of a frame assembly of various implants according to some applications of the present invention; and

[0468] Figures 9A to 9C is a schematic diagram of an implant including a framework assembly according to some applications of the present invention.

[0469] Figure 10 is a schematic diagram of a framework assembly of an implant according to some applications of the present invention.

[0470] Figures 11A to 11C is a schematic diagram of the interface between a connector and an artificial valve according to some applications of the present invention.

[0471] FIG. 12A to FIG. 12B and 13A to 13Fis a schematic diagram of a connector for connecting prosthetic valve leaflets to a frame of a prosthetic valve implant according to some applications of the present invention. DETAILED DESCRIPTION

[0472] Reference Figure 1A to Figure 1B and Figures 2A to 2E , which is a schematic diagram of an implant 20 for use with a native valve of a subject's heart according to some applications of the present invention. Implant 20 includes a frame assembly 22 having an upstream end 24, a downstream end 26, and a central longitudinal axis ax1 between the upstream end 24 and the downstream end 26. Frame assembly 22 includes a valve frame 30 including a tubular portion 32. Tubular portion 32 has an upstream end 34 and a downstream end 36 and is shaped to define a lumen 38 from the upstream end to the downstream end of the tubular portion. The tubular portion 32 surrounds axis ax1, thereby defining the lumen 38 along the axis. Valve frame 30 also includes an upstream support portion 40 extending from the upstream end 34 of the tubular portion 32. Frame assembly 22 also includes at least one leg 50 connected to valve frame 30 at (e.g., by) a connection point 52 and having a tissue engaging flange 54.

[0473] Typically, as described below, the foot 50 is part of an outer frame (or "foot frame") 60, with the frames 30 and 60 defining respective connecting elements 31 and 61 that are secured to one another at a connection point. Typically, the frames 30 and 60 are connected to one another only at the connection point 52 (e.g., only by securing the connecting elements 31 and 61 relative to one another).

[0474] The implant 20 also includes a valve member 58 (e.g., one or more artificial valve leaflets) disposed within the lumen 38 and configured to facilitate unidirectional fluid flow from the upstream end 34 of the lumen to the downstream end 36 (e.g., thereby defining the directions of the upstream and downstream ends of the tubular portion 32). Figure 1A Implant 20 is shown in a fully expanded state, with frame assembly 22 in the fully expanded state. Figure 1B An exploded view of the frame assembly 22 is shown in its fully deployed condition. Figures 2A to 2E Various states of the implant 20 are shown, and implantation and anatomy of the implant will be discussed in more detail below. Figure 2A Implant 20 is shown in a compressed state (frame assembly 22 is in a compressed state) for percutaneous delivery to a subject's heart. Typically, in the compressed state, legs 50 (including flanges 54 thereof) are in a flange-defined state, wherein the flanges are generally parallel to axis ax1. Furthermore, typically, in the compressed state, upstream support portion 40 is generally tubular, colinear with (e.g., extending colinearly from) tubular portion 32 and disposed about axis ax1.

[0475] Figure 2BImplant 20 is shown in a condition in which the tissue-engaging flange 54 of each leg 50 extends radially from axis ax1 (eg, radially away from tubular portion 32). Figure 2C The implant 20 is shown in a state in which the upstream support portion 40 extends radially away from the axis ax1 (and thus radially away from the tubular portion 32). Figure 2D The implant 20 is shown in a state where both the flange 54 and the portion 40 extend away from the axis ax1. Figure 1A to Figure 1B ), the upstream support portion 40 and the flange 54 both extend radially away from the axis ax1. Figure 2E As shown, framework assembly 22 is biased (for example, shaped) to present its fully expanded state.The variation of implant 20 between various states is usually controlled by conveyor, for example, by limiting the implant in the compressed state in the delivery tube and / or on the control rod, and selectively releasing a part of implant to allow them to expand.For some applications, as shown in the figure, in its expanded state, tubular portion 32 is slightly convex (for example, slightly barrel-shaped) in the middle thereof.For this application, the value of diameter d2 is the average diameter along the tubular portion. Similarly, the value of the cross-sectional area of ​​the tubular portion is the average cross-sectional area along the tubular portion. This also applies to other implants as herein described, with necessary changes.

[0476] In the compressed state of the frame assembly 22, the tubular portion 32 has a diameter d1, and in the expanded state, the tubular portion has a diameter d2 that is larger than the diameter d1. For some applications, the diameter d1 is 4 to 15 mm (e.g., 5 to 11 mm) and the diameter d2 is 20 to 50 mm (e.g., 23 to 33 mm).

[0477] The frame assembly 22 is configured such that an increase in the diameter of the tubular portion 32 (e.g., from d1 to d2) results in longitudinal movement of the flange 54 away from the connection point 52. Similarly, a decrease in the diameter of the tubular portion 32 (e.g., from d2 to d1) results in longitudinal movement of the flange 54 toward the connection point 52. It should be noted that the term "longitudinal movement" (including the specification and claims) refers to movement parallel to the central longitudinal axis ax1. Therefore, longitudinal movement of the flange 54 away from the connection point 52 means increasing the distance between the flange 54 and the connection point 52 measured parallel to the longitudinal axis ax1. About Figure 3A An example of such a configuration is described in more detail.

[0478] Similarly, reference to an element being "upstream of" (or "above") or "downstream of" (or "below") another element refers to their relative positions along the central longitudinal axis of the implant ("upstream" and "downstream" being defined by the direction of blood flow facilitated by the implant).

[0479] Thus, expansion of the tubular portion 32 from its compressed state to its expanded state (i) increases the circumferential distance between each connection point 52 and its adjacent connection point (e.g., between each outer frame connection element 61 and its adjacent outer frame connection element) (e.g., from d8 to d9), and (ii) moves the support foot 50 in a longitudinal upstream direction relative to the tubular portion.

[0480] Generally, the frame assembly 22 is configured such that the diameter of the tubular portion 32 increases and causes longitudinal movement of the upstream support portion 40 toward the connection point 52, e.g., as described with respect to FIG. Figure 3B and Figure 3C Generally, the frame assembly 22 is configured such that increasing the diameter of the tubular portion 32 causes longitudinal movement of the upstream end 34 of the tubular portion 32 toward the connection point 52. Similarly, decreasing the diameter of the tubular portion 32 causes longitudinal movement of the upstream end 34 away from the connection point 52.

[0481] For some applications, upstream support portion 40 includes a plurality of arms 46, each arm 46 extending radially outward from tubular portion 32 (e.g., from upstream end 34 of the tubular portion). Arms 46 are generally flexible. For some such applications, arms 46 are connected to tubular portion 32 such that each arm can deflect independently of adjacent arms during implantation (e.g., due to anatomical configuration).

[0482] For some applications, upstream support portion 40 includes a plurality of barbs 48 extending from a downstream surface of the upstream support portion. For example, each arm 46 may include one or more barbs 48. Barbs 48 press into the tissue upstream of the native valve (e.g., into the annulus), thereby inhibiting downstream movement of implant 20 (in addition to inhibiting downstream movement provided by the geometry of upstream support portion 40).

[0483] One or more surfaces of the frame assembly 22 are covered by a cover 23, which typically comprises a flexible sheet, such as fabric, such as polyester. Typically, the cover 23 covers at least a portion of the tubular portion 32, typically lining the inner surface of the tubular portion, thereby defining an inner cavity 38.

[0484] More typically, the upstream support portion 40 is covered by a cover 23, for example extending between the arms 46 to form a ring. This is assumed to reduce the likelihood of valve leakage. For such applications, an additional cover 23 may be provided between the arms 46 of the upstream support portion 40 to facilitate their independent movement. Although Figure 1A A covering 23 is shown covering the upstream side of the upstream support portion 40, and the covering typically additionally (or alternatively) covers the downstream side of the upstream support portion. For example, the covering 23 may extend beyond the tips of the arms 46 and extend outside the arms, or a separate covering may be provided on the downstream side of the upstream support portion.

[0485] Alternatively, each arm 46 may be individually covered in a sleeve of the covering 23, thereby facilitating independent movement of the arms.

[0486] For some applications, at least a portion of foot 50 (eg, a flange thereof) is covered by covering 23 .

[0487] Typically, the frame assembly 22 includes a plurality of legs 50 (e.g., two or more legs, such as 2 to 16 legs, such as 4 to 12 legs, such as 6 to 12 legs) arranged circumferentially around the valve frame 30 (e.g., around the outside of the tubular portion 32). Typically, the frame assembly 22 includes a plurality of connection points 52 at which the legs are connected to the valve frame 30.

[0488] As described in more detail below (e.g., with reference to FIG. 1 ), each leg 50 is typically connected to a connection point 52 by a strut 70. For some applications, each leg 50 is connected to a plurality (e.g., two) of connection points 52 by a corresponding plurality (e.g., two) of struts 70. For some such applications, in the deployed configuration of the frame assembly, the frame assembly 22 is configured such that the leg 50 is disposed circumferentially relative to the tubular portion 32 between the two struts, and each of the two struts is disposed circumferentially relative to the tubular portion between the leg and the corresponding connection point 52.

[0489] For some applications, a plurality (e.g., two) of legs are connected to each connection point 52 by a corresponding plurality (e.g., two) of struts 70. For some such applications, in the deployed state of the frame assembly, the frame assembly 22 is positioned so that the connection point 52 is circumferentially disposed relative to the tubular portion 32 between the two struts 70, and each of the two struts is circumferentially disposed relative to the tubular portion between the connection point and the corresponding leg 50.

[0490] For some applications, the frame assembly 22 includes an outer frame (e.g., a leg frame) 60 that surrounds the tubular portion 32, includes (or defines) a plurality of legs 50 and a plurality of struts 70, and is connected to the valve frame 30 at a plurality of connection points 52 such that the plurality of legs are distributed circumferentially around the tubular portion. For such applications, the outer frame 60 includes an annulus 66 defined by a pattern of alternating peaks 64 and valleys 62 and generally surrounds the tubular portion 32. For example, the annulus can include struts 70 extending between the peaks and valleys. The peaks 64 are longitudinally closer to the upstream end 34 of the tubular portion 32 than to the downstream end 36, and the valleys 62 are longitudinally closer to the downstream end than to the upstream end. (It should be noted that throughout this patent application, including the specification and claims, the term "longitudinal" refers to relative to the longitudinal axis ax1. For example, "longitudinally closer" means closer along the axis ax1 (whether located on or outside the axis ax1), and "longitudinal movement" refers to a change in position along the axis ax1 (which may move further toward or away from the axis ax1).) Thus, the peak 64 is closer to the upstream end 34 than the trough 62, and the trough 62 is closer to the downstream end 36 than the peak 64. For applications where the frame 60 includes the ring body 66, each leg 50 is connected to the ring body (or defined by the frame 60) at a corresponding trough 62.

[0491] In the illustrated embodiment, the peaks and valleys are defined by a ring body 66 having a generally sawtooth shape. However, the scope of the present invention includes ring bodies 66 having other shapes defining the peaks and valleys, such as a serpentine or sinusoidal shape.

[0492] For applications where the frame assembly 22 has a plurality of connection points 52, the connection points (and therefore the connection elements 31 and 61) are arranged circumferentially around the frame assembly (e.g., around the axis ax1), typically in a transverse plane that is orthogonal to the axis ax1. Figure 2B AA portion in . Optionally, the connection point 52 can be positioned at different longitudinal heights of the frame assembly 22, for example so that different flanges 54 are positioned and / or moved differently from each other. Typically, the connection point 52 (and therefore the connecting elements 31 and 61) is longitudinally disposed between the upstream end 24 and the downstream end 26 of the frame assembly 22, but not at either end of these ends. More typically, the connection point 52 is longitudinally disposed between the upstream end 34 and the downstream end 36 of the tubular portion 32, but not at either end of these ends. For example, the connection point can be 3 mm (e.g., 4 to 10 mm) larger than both the upper end 34 and the downstream end 36. It is assumed that this advantageously positions the connection point at a portion of the tubular portion 32 that is stronger than the upper end 34 and the downstream end 36.

[0493] It should be noted that the leg 50 is generally deployable to its deployed state (eg, flange-released state) such that the flange 54 extends away from the axis ax1 regardless of an increase in the diameter of the tubular portion 32 (eg, as shown in FIG. 1 ). Figure 2B and 2D Similarly, the upstream support portion 40 is generally deployable to its deployed state (e.g., arm released state) such that it (e.g., the arms 46) extends away from the axis ax1 regardless of an increase in the diameter of the tubular portion 32 (e.g., as shown). Figure 2C and 2D shown). Figure 2D The state shown in FIG can be considered an intermediate state. Thus, the implant 20 is generally configured such that the legs 50 (e.g., flanges 54 thereof) and the upstream support portion 40 are expandable such that they both extend away from the axis ax1 while maintaining a distance d5 therebetween. The distance is increased by expanding the tubular portion 32 (e.g., Figure 2E As shown) can then be reduced to distance d4.

[0494] For some applications, when the tubular portion 32 is maintained in its compressed state, the flange 54 may extend from the axis ax1 by at least 40% (e.g., 40 to 80%, such as 40 to 70%). The flange 54 extends from the axis ax1 after the tubular portion is deployed. For example, for applications in which the implant 20 includes flanges on opposite sides of the implant, when the tubular portion 32 is in its compressed state, the span d15 of the flanges may be at least 40% (e.g., 40 to 80%, such as 40 to 70%) of the span d16 of the flanges after deployment of the tubular portion. For some applications, the span d15 is greater than 15 mm and / or less than 50 mm (e.g., 20 to 30 mm). For some applications, the span d16 is greater than 30 mm and / or less than 60 mm (e.g., 40 to 50 mm). It should be noted that the flange 54 is effectively fully deployed relative to the legs 50 and / or relative to other portions of the tubular portion 32 before and after deployment of the tubular portion.

[0495] Similarly, for some applications, when the tubular portion 32 is maintained in its compressed state, the upstream support portion 40 (e.g., arm 46) may extend more than 30% (e.g., 30 to 70%) of the distance away from the axis ax1. After the tubular portion is deployed, the upstream support portion 40 extends from the axis ax1. That is, for some applications, when the tubular portion 32 is in its compressed state, the span d17 of the upstream support portion may be at least 30% (e.g., 30 to 70%) of the span d18 of the upstream support portion after deployment of the tubular portion. For some applications, span d17 is greater than 16 mm (e.g., greater than 20 mm) and / or less than 50 mm (e.g., 30 to 40 mm). For some applications, span d18 is greater than 40 mm and / or less than 65 mm (e.g., 45 to 56 mm, such as 45 to 50 mm). It is noted that the upstream support portion 40 is effectively fully deployed relative to the tubular portion 32 both before and after deployment of the tubular portion.

[0496] Note that when the tubular portion 32 is deployed, the flange 54 moves generally radially outward from the span d15 to the span d16 (e.g., without deflection). Generally, the upstream support portion 40 behaves similarly (e.g., the arm 46 transitions radially outward from the span d17 to the span d18, e.g., without deflection). That is, in the Figure 2E In the illustrated state, each flange 54 and / or each arm 46 is oriented relative to the tubular portion 32 and / or the axis ax1 in the same manner as in the embodiment shown. Figure 2D Similarly, for some applications, the orientation of each flange 54 relative to the upstream support portion 40 (eg, relative to one or more arms 46 thereof) is the same before and after expansion of the tubular portion 32 .

[0497] For some applications, increasing the diameter of the tubular portion 32 from d1 to d2 may result in a longitudinal movement of the flange 54 away from the connection point 52 of greater than 1 mm and / or less than 20 mm (e.g., 1 to 20 mm, such as 1 to 10 mm or 5 to 20 mm). For some applications, increasing the diameter of the tubular portion 32 from d1 to d2 may result in a longitudinal movement of the upstream support portion 40 toward the connection point 52 of greater than 1 mm and / or less than 20 mm (e.g., 1 to 20 mm, such as 1 to 10 mm or 5 to 20 mm). For some applications, the distance d3 is 7 to 30 mm. For some applications, the distance d4 is 0 to 15 mm (e.g., 2 to 15 mm). For some applications, increasing the diameter of the tubular portion 32 from d1 to d2 may reduce the distance between the upstream support portion and the flange 54 by greater than 5 mm and / or less than 30 mm, such as 5 to 30 mm (e.g., 10 to 30 mm, such as 10 to 20 mm or 20 to 30 mm). For some applications, the difference between d3 and d4 is approximately equal to the difference between d1 and d2. For some applications, the difference between d3 and d4 is greater than 1.2 and / or less than 3 times (e.g., 1.5 to 2.5 times, such as about 2 times) the difference between d1 and d2.

[0498] For some applications, flanges 54 are curved such that the tip of each flange is disposed at a shallower angle relative to inner region 42 of upstream support portion 40 than the portion of leg 50 closer to downstream end 26 of frame assembly 22. For some such applications, the tip of each flange may be substantially parallel to inner region 42. For some such applications, when tubular portion 32 is in its deployed state, a tip portion 55 of each flange 54 extending at least 2 millimeters along the flange from the tip of the flange is disposed within 2 millimeters of upstream support portion 40. Thus, for some applications, while tubular portion 32 is in its deployed state, at least 5 percent (e.g., 5 to 8 percent, or at least 8 percent) of span 18 of upstream support portion 40 is disposed within 2 millimeters of flange 54.

[0499] For some applications, in the absence of any obstruction between the flange 54 and the upstream support portion 40 (e.g., tissue of the valve or cover 23), increasing the diameter of the tubular portion 32 from d1 to d2 causes the flange and the upstream support portion to move relative to each other (e.g., the flange can move between the arms 46 of the upstream support portion) so that the flange is closer to the upstream end of the implant 20 than the upstream support portion, for example, as shown below, with appropriate adjustments to the frame assemblies 122 and 222. (For applications in which the upstream support portion 40 is covered by the cover 23, the flange 54 typically does not pass through the cover. For example, in the absence of any obstruction, the flange 54 can pass between the arms 46 and press directly against the cover 23.) It is assumed that for some applications, the configuration applies greater force to the clamped valve tissue, thereby further assisting in anchoring the implant. That is, for some applications, the distance d3 is less than the sum of the distance d5 and the distance d14 (see Figure 3C For some applications, increasing the diameter of tubular portion 32 from d1 to d2 advantageously enables flange 54 and upstream support portion 40 to move relative to each other (e.g., toward each other and then toward each other) by more than 3 mm and / or less than 25 mm (e.g., more than 5 mm and / or less than 15 mm, such as 5 to 10 mm, such as about 7 mm).

[0500] For some applications, in the deployed state of frame assembly 22, upstream support portion 40 has an inner region (e.g., an inner ring) 42 extending radially outward at a first angle relative to axis ax1 (and generally relative to tubular portion 32), and an outer region (e.g., an outer ring) 44 extending from the inner region further radially outward from the tubular portion at a second angle relative to the tubular portion. The second angle is less than the first angle. For example, for some applications, inner region 42 extends radially outward at an angle α_1 of 60 to 120 degrees (e.g., 70 to 110 degrees) relative to axis ax1, and outer region 44 extends radially outward at an angle α_2 of 5 to 70 degrees (e.g., 10 to 60 degrees) relative to axis ax1.

[0501] It should be noted that the angles α_1 and α_2 are measured between the respective zone support portion 40 and a portion of the axis ax1 extending in an upstream direction from the level of the frame assembly 22 where the respective zone begins to extend radially outward.

[0502] For some applications where implant 20 is configured to be placed in a subject's atrioventricular valve (e.g., a mitral valve or a tricuspid valve), region 42 is configured to abut the upstream surface of the annulus of the atrioventricular valve, and region 44 is configured to abut the wall of the valve atrium upstream.

[0503] For some applications, outer region 44 is more flexible than inner region 42. For example, as shown, each arm 46 can have a different structure in region 44 than in region 42. It is assumed that the relative stiffness of region 42 provides resistance to ventricular migration of implant 20, while the relative flexibility of region 44 facilitates the conformation of upstream support portion 40 to the atrial anatomy.

[0504] For some applications, two or more arms 46 are connected by a connector (not shown) that reduces the flexibility and / or independence of the connected arms relative to each other. For some applications, arms 46 are connected in specific sectors of the upstream support portion 40, thereby making these sectors more rigid than sectors without connected arms. For example, a relatively rigid sector can be provided configured to rest against the posterior portion of the mitral annulus, and a relatively flexible sector can be provided configured to rest against the anterior side of the mitral annulus to reduce the force exerted by the upstream support portion 40 on the aortic sinuses.

[0505] For some applications, as shown, connection point 52 is positioned closer to downstream end 26 of frame assembly 22 than flange 54 or upstream support portion 40 .

[0506] As about Figures 4A to 4F Described in more detail, movement of the flange 54 away from the connection point 52 (and typical movement of the upstream support portion 40 toward the connection point) helps to clamp tissue of the native valve (e.g., leaflets and / or annular tissue) between the flange and the upstream support portion, thereby securing the implant 20 to the native valve.

[0507] Typically, in the compressed state of the tubular portion 32, the downstream end of each leg 50 is longitudinally closer to the downstream end 36 than the valve frame connection element 31, and the flange 54 of each leg is longitudinally closer to the upstream end 34 than the valve frame connection element. Typically, the same is true for the expanded state of the tubular portion 32.

[0508] According to some applications of the present invention, Figures 3A to 3C The frame assembly 22 is shown transitioning in configuration between its compressed and expanded states. Figures 3A to 3C Each shows a portion of a framework component whose structural transition represents the structural transition occurring in other portions of the framework component. Figure 3A The legs 50 and struts 70 (eg, a portion of the outer frame 60 ) are shown, and the structural transitions occurring around the outer frame 60 are shown. Figure 3B A portion of the valve frame 30 is shown, and illustrates the structural transitions that occur around the valve frame. Figure 3C The valve frame 30 is shown in its entirety. Figures 3A to 3CIn each of the figures, state (A) shows the structure of the frame assembly 22 (especially the tubular portion 32) in its compressed state, and state (B) shows the structure of the frame assembly (especially the tubular portion 32) in its expanded state.

[0509] Figure 3A 6. The transition of the frame assembly 22 (particularly the tubular portion 32) between its compressed and expanded states is shown, with the legs 50 connected to the connection points 52 (e.g., the structural transition of the outer frame 60). Each leg 50 is connected to the valve frame 30 via at least one strut 70, which connects the leg to the connection point 52. Typically, each leg 50 is connected to the valve frame 30 via a plurality of struts 70. A first end 72 of each strut 70 is connected to the leg 50, and a second end 74 of each strut is connected to the connection point 52. As described above, for applications in which the frame 60 includes an annulus 66, each leg 50 is connected to the annulus at a corresponding valley 62. The annulus 66 can include struts 70 extending between a peak and a valley, with each first end 72 located at (or near) a valley 62, and each second end 74 located at (or near) a peak 64.

[0510] In the compressed state of frame assembly 22 (particularly tubular portion 32), each strut 70 is positioned at a first angle, with first end 72 closer to the downstream end of the frame assembly than second end 74. Deployment of frame assembly 22 (particularly tubular portion 32) toward its deployed state causes strut 70 to deflect to a second angle. This deflection causes first end 72 to move away from the downstream end of frame assembly 22. That is, in the deployed state of frame assembly 22, first end 72 is further away from the downstream end of the frame assembly than when the frame assembly is in its compressed state. This movement is shown as distance d5 between the position of end 72 in state (A) and the position in state (B). This movement results in the aforementioned movement of flange 54 away from connection point 52. As shown, flange 54 moves approximately the same distance d5 in response to deployment of frame assembly 22.

[0511] For applications where the outer frame 60 includes the annulus 66, the pattern of alternating peaks and valleys can be described as having an amplitude between the peaks and valleys in the longitudinal direction, i.e., measured parallel to the central longitudinal axis ax1 of the frame assembly 22, and the transition between the compressed and expanded states can be described as follows: In the compressed state of the frame assembly 22 (particularly the tubular portion 32), the pattern of the annulus 66 has an amplitude d20. In the expanded state of the frame assembly 22 (particularly the tubular portion 32), the pattern of the annulus 66 has an amplitude d21 that is lower than the amplitude d20. Because (i) at the peaks 64, the annulus 66 is connected to the valve frame 30 at the connection point 52, and (ii) at the valleys 62, the annulus 66 is connected to the leg 50, this reduction in the amplitude of the pattern of the annulus 66 causes the leg 50 (e.g., its flange 54) to move further longitudinally from the downstream end of the frame assembly. The magnitude of this longitudinal movement (e.g., the difference between the amplitudes d20 and d21) is equal to d5.

[0512] Typically, distance d5 is the same as the distance that flange 54 moves away from connection point 52 during deployment of the frame assembly. That is, the distance between flange 54 and the portion of leg 50 connected to strut 70 generally remains fixed during deployment of the frame assembly. For some applications, the longitudinal movement of flange 54 away from connection point 52 is a translational movement (e.g., a movement that does not involve rotation or deflection of the flange).

[0513] For some applications, when assembly 22 is in its compressed state, a distance d6 measured parallel to axis ax1 of frame assembly 22 between connection point 52 and first end 72 of strut 70 is 3 to 15 mm. For some applications, when assembly 22 is in its expanded state, a distance d7 measured parallel to axis ax1 between connection point 52 and first end 72 of strut 70 is 1 to 5 mm (e.g., 1 to 4 mm).

[0514] For some applications, the amplitude d20 is 2 to 10 mm (e.g., 4 to 7 mm). For some applications, the amplitude d21 is 4 to 9 mm (e.g., 5 to 7 mm).

[0515] For some applications, as shown, in the deployed state, first ends 72 of struts 70 are positioned closer to the downstream end of frame assembly 22 than connection point 52. For some applications, in the deployed state, first ends 72 of struts 70 are positioned further from the downstream end of frame assembly 22 than connection point 52.

[0516] For applications where the frame assembly 22 includes multiple legs 50 and multiple connection points 52 (e.g., for applications where the frame assembly includes an outer frame 60), spreading the frame assembly increases the circumferential distance between adjacent connection points 52 and increases the circumferential distance between adjacent legs 50. Figure 3AThe circumferential distance between adjacent connection points 52 increases from the circumferential distance d8 in the compressed state to the circumferential distance d9 in the expanded state. For some applications, the distance d8 is 1 to 6 mm. For some applications, the distance d9 is 3 to 15 mm.

[0517] For some applications, in addition to being connected via ring 66 (e.g., struts 70 thereof), legs 50 are also connected to each other by connectors 78. Connectors 78 allow for the described movement of legs 50 during deployment of frame assembly 22, but generally stabilize legs 50 relative to each other when the frame assembly is in its deployed state. For example, connectors 78 may bend and / or deflect during deployment of the frame assembly.

[0518] Figures 3B to 3C 2 and 3. The structural transitions in the valve frame 30 are shown during the transition of the frame assembly 22 between its compressed and expanded states. The tubular portion 32 of the valve frame 30 is defined by a plurality of cells 80, which are defined by a repeating diagram of the valve frame. As the frame assembly 22 expands from its compressed state to its expanded state, the cells 80 (i) widen from a width d10 to a width d11 (measured orthogonally to the axis ax1 of the frame assembly), and (ii) shorten from a height d12 to a height d13 (measured parallel to the axis ax1 of the frame assembly). This shortening reduces the overall height of the tubular portion 32 (i.e., the longitudinal length between the upstream end 34 and the downstream end 36) from a height d22 to a height d23, thereby causing the aforementioned longitudinal movement of the upstream support portion 40 toward the connection point 52 by a distance d14 (e.g., Figure 3C For some applications, as shown, connection points 52 are located at the widest portion of each cell.

[0519] Due to the configuration described herein, the distance that the flange 54 moves relative to (e.g., toward and / or toward and beyond) the upstream support portion 40 (e.g., the arms 46 thereof) is substantially greater than (e.g., more than 20%, such as more than 30%, such as more than 40%) the reduced overall height of the tubular portion 32. That is, the implant 20 includes:

[0520] a valve frame 30 comprising a tubular portion 32 extending about a longitudinal axis ax1 of the valve frame to define a lumen 38 along the axis, the tubular portion having an upstream end 34, a downstream end 36, a longitudinal length therebetween, and a diameter transverse to the longitudinal axis (e.g., d1 or d2);

[0521] a valve member 58 connected to the tubular portion 32, disposed within the lumen, and configured to provide unidirectional blood flow from the upstream end to the downstream end through the lumen;

[0522] an upstream support portion 40 connected to the tubular portion; and

[0523] An outer frame 60 connected to the tubular portion and including a tissue engaging flange 54,

[0524] The implant has a first state (e.g. Figure 2D and Figure 4D shown) and a second state (e.g. Figure 2E and Figure 4E shown);

[0525] In the first and second states, (i) the upstream support portion extends radially outward from the tubular portion, and (ii) the tissue-engaging flange extends radially outward from the tubular portion; and

[0526] The tubular portion, the upstream support portion and the outer frame are configured to transform the implant from the first state to the second state:

[0527] increasing the diameter of the tubular portion by an increase in diameter (e.g., the difference between d1 and d2);

[0528] reducing the length of the tubular portion by a length reduction (e.g., the difference between d22 and d23); and

[0529] The flange is moved relative to (eg, toward or toward and outwardly of) the upstream support portion by a longitudinal distance (eg, the difference between d3 and d4) that is greater than the length reduction.

[0530] As shown, the valve frame 30 is connected to the outer frame 60 by a connection between (i) a valve frame connecting element 31 defined by the valve frame 30 and (ii) an outer frame connecting element 61 defined by the outer frame 60 (e.g., an outer frame connecting element is connected to the end 74 of each strut). Typically, elements 31 and 61 are fixed relative to each other. Thus, each connection point 52 is roughly defined as a point at which the valve frame connecting element and the corresponding outer frame connecting element 61 are connected (e.g., fixed relative to each other). For some applications, as shown, elements 31 and 61 are eyelets that are configured to be connected together by a connector, such as a pin or needle (e.g., a suture). The fixation of elements 31 and 61 relative to each other can be achieved by welding, soldering, hemming, stitching (e.g., suturing), gluing, or any other suitable technique.

[0531] Typically, as shown, the valve frame connecting element 31 is defined by a tubular portion 32 and is disposed circumferentially about a central longitudinal axis ax1. The outer frame connecting element 61 is connected to respective peaks 64 of the annulus 66 (or defined by the frame 60, such as by the annulus 66). Figures 2A to 2E As shown, the valve frame 30 (e.g., its tubular portion 32) and the outer frame 60 (e.g., its annulus 66) are closely coaxially disposed in both the expanded and compressed states of the frame assembly 22. Between the compressed and expanded states and during transitions therebetween, the radial clearance d19 between the valve frame 30 (e.g., its tubular portion 32) and the outer frame 60 (e.g., its annulus 66) is substantially less than 2 mm (e.g., less than 1 mm) due to the frame's cellular structure, ignoring spacing. This facilitates the aforementioned behavior through the connection between the frames 30 and 60 and the ability of the frame 60 to respond to changes in the diameter of the tubular portion 32 (e.g., not simply due to delivery techniques and / or tools). For some applications, the annulus 66 is more than 50% (e.g., more than 60%) disposed within 2 mm of the tubular portion 32 in both the compressed and expanded states and during transitions therebetween. For some applications, the outer frame 60, excluding the flange 54, is more than 50% (e.g., more than 60%) disposed within 2 mm of the tubular portion 32 in both the compressed and expanded states and during transitions therebetween.

[0532] During (e.g., as a result of) the deployment of the frame assembly (particularly the tubular portion 32 thereof), the aforementioned structural changes of the frame assembly 22 (e.g., to its outer frame 60) occur. This is a natural way to describe these changes, as will be discussed below with respect to Figures 4A to 6 As shown, this is a natural way to describe these changes because the assembly 22 is in its compressed state during percutaneous delivery to the implant site and is subsequently deployed. However, by describing the structural changes that occur during compression of the frame assembly (particularly the tubular portion 32 thereof) (e.g., from Figure 2E The expanded state to Figure 2D The properties of the implant 20 (including if the tubular portion 32 is compressed by applying a compressive force to the tubular portion, rather than by the tubular portion pulling the frame 60 radially inwardly) can be further understood by describing the transitions between the intermediate states of the implant 20. Such description may also be relevant because the implant 20 is typically compressed (i.e., "crimped") prior to its percutaneous delivery, and therefore these changes may occur during the procedure of the implant 20.

[0533] For some applications, peak 64 is secured to a corresponding portion of tubular portion 32 such that the tubular portion is compressed from its expanded state to its compressed state such that, through radially inward tension on connection point 52, the corresponding portion of the tubular portion pulls the peak radially inward to: (i) reduce the circumferential distance between the connection point and its adjacent connection point (e.g., from d9 to d8), and (ii) increase the amplitude of the pattern of ring body 66 (e.g., from d21 to d20).

[0534] For some applications, the outer frame connection element 61 is secured to the valve frame connection element 31 such that the tubular portion 32 is compressed from its expanded state to its compressed state, such that the valve frame connection element pulls the outer frame connection element radially inward to: (i) reduce the circumferential distance between each outer frame connection element and its adjacent outer frame connection element (e.g., from d9 to d8), and (ii) increase the amplitude of the pattern of the ring body 66 (e.g., from d21 to d20).

[0535] For some applications, the peaks 64 are secured to corresponding portions of the tubular portion 32 such that the tubular portion is compressed from its expanded state to its compressed state (i) by pulling the corresponding portions of the tubular portion toward the peaks to pull the peaks radially inward, (ii) reducing the circumferential distance between each connection point 52 and its adjacent connection point (e.g., from d9 to d8), and (iii) increasing the amplitude of the pattern of the annulus 66 (e.g., from d21 to d20) without increasing the radial gap d19 between the valve frame 30 (e.g., the tubular portion 32 thereof) and the annulus by more than 1.5 mm.

[0536] For some applications, the outer frame connection element 61 is fixed relative to the valve frame connection element 31 so that the tubular portion is compressed from its expanded state to its compressed state (i) by pulling the valve frame connection element 31 radially inward onto the outer frame connection element 61 to pull the outer frame connection element 61 radially inward, (ii) reducing the circumferential distance between each outer frame connection element and its adjacent outer frame connection element (e.g., from d9 to d8), and (iii) increasing the amplitude of the pattern of the ring body 66 (e.g., from d21 to d20) without increasing the radial gap d19 between the valve frame 30 (e.g., its tubular portion 32) and the ring body by more than 1.5 mm.

[0537] According to some applications of the present invention, reference Figures 4A to 4F , which shows a schematic diagram of implanting an implant 20 into a native valve 10 of a subject's heart 4. The valve 10 is the subject's mitral valve, which is disposed between the subject's left atrium 6 and left ventricle 8. However, the implant 20 can be appropriately adapted to be implanted into other heart valves of the subject. Similarly, even if Figures 4A to 4FWhile implant 20 is shown delivered laterally through sheath 88, the implant may be delivered by any other suitable route, such as percutaneously or transapically.

[0538] The implant 20 is delivered in its compressed state to the native valve 10 ( Figure 4A Typically, the implant 20 is delivered within a delivery capsule 90 of a tool 89, which holds the implant in its compressed state. A transseptal approach, such as a transfemoral approach, is shown. Typically, the implant 20 is positioned so that at least the flange 54 is positioned downstream of the native valve (i.e., within the ventricle 8). At this stage, the frame assembly 22 of the implant 20 is positioned as shown in FIG. Figure 2A shown.

[0539] The flange 54 is then allowed to protrude radially outward, as described above, for example by releasing it from the capsule 90 ( Figure 4B ). For example, as shown, capsule 90 may include a distal capsule portion 92 and a proximal capsule portion 94, and the distal capsule portion may be moved distally relative to implant 20 to expose flange 54. At this stage, the frame assembly 22 of implant 20 is as shown. Figure 2B shown.

[0540] Subsequently, implant 20 is moved upstream so that upstream support portion 40, in its compressed state, is disposed upstream of leaflets 12 (i.e., within ventricle 6). For some applications, the upstream movement of implant 20 causes flange 54 to engage leaflets 12. However, due to the relatively large distance d3 provided by implant 20 (as described above), for some applications, it is not necessary to move the implant upstream, with flange 54 tightly engaging leaflets 12 and / or pulling the upstream leaflets of the valve annulus. Upstream support portion 40 is then allowed to expand so that it projects radially outward, as described above, for example by releasing it from capsule 90 ( Figure 4D ). For example, as shown, the proximal capsule portion 94 can be moved proximally relative to the implant 20 to expose the upstream support portion 40. At this stage, the frame assembly 22 of the implant 20 is Figure 2D , wherein: (i) a distance d3 exists between the upstream support portion 40 and the flange 54, (ii) the flange has a span d15, (iii) the upstream support portion has a span d17, and (iv) the tubular portion 32 has a diameter d1.

[0541] Typically, deployment of frame assembly 22 is inhibited by distal capsule portion 92 (eg, by inhibiting deployment of tubular portion 32 ) and / or by another portion of delivery tool 89 (eg, a portion of the delivery tool disposed within lumen 38 ).

[0542] Subsequently, the implant 20 is allowed to expand toward its expanded state such that the tubular portion 32 widens to a diameter d2 and the distance between the upstream support portion 40 and the flange 54 decreases to a distance d4 ( Figure 4E These retaining tissues of the valve 10 (typically comprising the annulus and / or leaflets 12) are positioned between the upstream support portion 40 and the flange 54, thereby securing the implant 20 to the valve. Figure 4F Delivery capsule 90 is shown having been removed from the subject's body, leaving implant 20 in place at valve 10 .

[0543] As described above, the implant 20 is configured such that when the tubular portion 32 is deployed, the flange 54 and the upstream support portion 40 move toward each other a relatively large distance. This allows the distance d3 to be relatively large, while the distance d4 is small enough to provide effective anchoring. As described above, the implant 20 is configured such that the flange 54 and the upstream support portion 40 can extend radially outward a relatively large distance while the tubular portion 32 remains compressed. It is assumed that in certain applications, these configurations (independently and / or together) promote effective anchoring of the implant 20 by causing a relatively large proportion of valve tissue (e.g., leaflets 12) to be placed between the flange and the upstream support portion, and before the tubular portion 32 is deployed and the valve tissue is clamped.

[0544] It is also assumed that the relatively large radial outward extension of the flange 54 and upstream support portion 40 further facilitates the anchoring / clamping step by reducing the radial outward push of the valve tissue (e.g., leaflets 12) prior to expansion of the tubular portion 32, thereby increasing the amount of valve tissue clamped.

[0545] It is further hypothesized that this configuration of implant 20 facilitates identification of the correct positioning of the implant (ie, with support portion 40 upstream of leaflets 12 and flange 54 downstream of the leaflets) prior to deploying tubular portion 32 and clamping valve tissue.

[0546] like Figure 1A As shown, for some applications, in the expanded state of the frame assembly 22, the implant 20 defines an annular space 49 (e.g., a space wider than the distance d4) between the flange 54 and the upstream support portion 40. For example, the space 49 can have a generally triangular cross-section. It is assumed that for some such applications, in addition to clamping tissue of the native valve between the upstream support portion 40 and the flange 54 (e.g., the tip of the flange), the space 49 advantageously promotes tissue growth therein (e.g., between the leaflet tissue and the cover 23), which further secures the implant 20 within the native valve over time.

[0547] According to some applications of the present invention, reference is now made to Figure 5 , which is a schematic diagram of the steps of implanting the implant 20. Figures 4A to 4FThe implantation technique is shown with the flange 54 deployed before the upstream support portion 40, which for some applications is deployed before the flange. Figure 5 Shows a step in such an application.

[0548] Reference again Figures 2A to 5 . As described above, the implant 20 can be implanted by causing the flange 54 to protrude radially before causing the upstream support portion 40 to protrude radially, or can be implanted by causing the upstream support portion to protrude before causing the flange to protrude. For some applications, the implant 20 is therefore configured to be deliverable in a downstream direction (e.g., transseptally, as shown, or transapically) or in an upstream direction (e.g., transapically or via the aortic valve). Thus, for some applications, the surgeon can decide which delivery route is preferred for a given application (e.g., for a given subject, and / or based on available equipment and / or expertise), and the implant 20 is responsively prepared for the selected delivery route (e.g., by loading the implant into a suitable delivery tool).

[0549] It should be noted that for some applications, downstream delivery of implant 20 may be performed by first deploying flange 54 (e.g., Figures 4A to 4F as shown) or by first deploying the upstream support portion 40 (e.g. Figure 5 Similarly, for some applications, upstream delivery of implant 20 may be performed first by upstream support portion 40, or first by deploying flange 54.

[0550] According to some applications of the present invention, reference is now made to Figure 6 , which is displayed in Figure 4D Schematic diagram of implant 20 in the state and position shown. For some applications, when implant 20 is in Figure 4D In the state and position shown, the leaflets 12 of the valve 10 are able to move at least partially in response to the beating of the heart. Frame (A) shows the leaflets 12 during ventricular systole and frame (B) shows the leaflets during ventricular diastole. For some such applications, blood is thus able to flow from the atrium 6 to the ventricle 8 between the leaflets 12 and the implant 20. It is assumed that this facilitates a more relaxed implantation procedure, for example, facilitating maintenance of the implant 20 in this state for a period of greater than 8 minutes. During this period, imaging techniques can be used to verify the position of the implant 20 and / or to position the leaflets 12 between the upstream support portion 40 and the flange 54.

[0551] According to some applications of the present invention, reference 7A to 7B and Figures 8A to 8B, which shows schematic diagrams of frame assemblies 122 and 222 of various implants. Unless otherwise noted, frame assemblies 122 and 222 are substantially identical to frame assembly 22, mutatis mutandis. Components of frame assemblies 122 and 222 share the same designations as corresponding components of frame assembly 22. Additionally, unless otherwise noted, frame assemblies 122 and 222 are similar to implant 20, mutatis mutandis.

[0552] Frame assembly 122 includes (i) a valve frame 130 including a tubular portion 132 and an upstream support portion 140 generally including a plurality of arms 146, and (ii) an outer frame (e.g., a leg frame) 160 that surrounds the valve frame and includes a plurality of legs 150, each leg 150 including a tissue-engaging flange 154. Typically, outer frame 160 includes an annulus 166 to which legs 150 are connected. Annulus 166 is defined by a pattern of alternating peaks and valleys, with the peaks being secured to frame 130 at corresponding connection points 152, such as described above for frame assembly 22, mutatis mutandis.

[0553] Frame assembly 222 includes (i) a valve frame 230 including a tubular portion 232 and an upstream support portion 240 generally including a plurality of arms 246, and (ii) an outer frame (e.g., a leg frame) 260 that surrounds the valve frame and includes a plurality of legs 250, each leg 250 including a tissue-engaging flange 254. Typically, outer frame 260 includes an annulus 266 to which legs 250 are connected. Annulus 266 is defined by a pattern of alternating peaks and valleys, with the peaks being secured to frame 230 at corresponding connection points 252, such as described above for frame assembly 22, mutatis mutandis.

[0554] Although the arm 46 of frame assembly 22 is shown as extending from the upstream end 34 of tubular portion 32, the arms 146 and 246 of frame assemblies 122 and 222 can extend from the downstream position respectively (this distinction can also be used for frame assembly 22, plus necessary modifications). Tubular portion 32, 132 and 232 are each defined by the repetitive pattern of cells extending around the central longitudinal axis. Typically, as shown in the figure, tubular portion 32, 132 and 232 are each defined by two stacked subdivision rows of cells. In the expanded state of each tubular portion, these cells are roughly narrower than the middle between these ends at their upstream and downstream ends. For example, as shown in the figure, the cell shape may be roughly diamond or star-shaped. In frame assembly 22, each arm 46 is attached to the position 35 at the upstream end of the cell located in the upstream row and extends therefrom. In contrast, in frame assemblies 122 and 222, each arm 146 or 246 is attached to and extends from a location 135 (assembly 122) or 235 (assembly 222) located at the connection between two adjacent cells in the upstream row (or described as being at the upstream end of the cells in the downstream row).

[0555] The inventors hypothesize that, while maintaining the lumen length of the tubular portion, the lower position of the arms advantageously reduces the distance that the tubular portion (i.e., its downstream end) extends into the subject's ventricle, thereby reducing the likelihood of obstructing blood flow out of the ventricle through the left ventricular outflow tract. It is further hypothesized that this position of the arms reduces radial compression of the tubular portion by cardiac motion because the tubular portion at positions 135 and 235 (which are supported by two adjacent cells) is stronger than at position 35 (which is supported by only one cell).

[0556] As shown, in the expanded state of the frame assemblies 22, 122, and 222, the legs (50, 150, and 250, respectively) are circumferentially interlaced with the upstream support portion (46, 146, and 246), respectively. This allows the legs to move in an upstream direction between the arms during expansion of the tubular portion (32, 132, and 232), helping to exert a greater clamping force on the tissue of the native valve. The lower position of the arms of assemblies 122 and 222 involves circumferentially shifting the position of the arms by half a cell width. To maintain the circumferential interlacing of the arms and legs, the rings 166 and 266 (and thus the legs 150 and 250) are circumferentially displaced accordingly. As a result, the peak of the ring 66 is generally aligned with the connection between adjacent cells in the downstream row of cells of the tubular portion 32 (and is fixed in these positions), and the peak of the rings 166 and 266 is roughly aligned with the middle between these positions (i.e., at the space between the cell structure of the tubular portion). Appendages 168 (assembly 122) or 268 (assembly 222) help secure the peak to the relative tubular structure.

[0557] For assembly 122, appendages 168 are defined by the valve frame 130 (e.g., by the tubular portion 132 thereof) and are secured by extending (in the downstream direction) to the peak of the annulus 166. For example, each appendage 168 can be defined by a valve frame connecting element 131 secured to a corresponding outer frame connecting element 161 defined by the outer frame 260. Typically, the appendages 168 extend from location 135. Typically, the appendages 168 are integral with the tubular portion 132 and / or are coplanar with the tubular portion (e.g., a portion of its tubular shape).

[0558] For assembly 222, appendages 268 are defined by outer frame 260 and extend (e.g., in an upstream direction) from the peak of annulus 266. Typically, appendages 268 extend to the location 235 to which they are secured. For example, each appendage 268 can define an outer frame connection element 261 secured to a corresponding valve frame connection element 231 defined by valve frame 230 (e.g., by tubular portion 232 thereof). Typically, appendages 268 are integral with outer frame 260 and / or coplanar with adjacent portions of outer frame 260 (e.g., annulus 266).

[0559] Thus, frame assembly 122 defines a hub at location 135, and frame assembly 222 defines a hub at location 235. Thus, for some applications, the apparatus includes:

[0560] multiple prosthetic valve leaflets; and

[0561] A framework component, including:

[0562] a tubular portion 132 or 232 defined by a repeating pattern of cells, the tubular portion extending circumferentially about the longitudinal axis to define a longitudinal lumen, the prosthetic valve leaflets being connected to the inner frame and disposed within the lumen;

[0563] an outer frame 160 or 260 comprising a plurality of legs 150 or 250 circumferentially distributed around the tubular portion, each leg having a tissue engaging flange 154 or 254;

[0564] an upstream support portion 140 or 240 comprising a plurality of arms 146 or 246 extending radially outward from the tubular portion; and

[0565] a plurality of appendages 168 or 268, each appendage having a first end and a second end, the first end defining a connecting element 161 or 261 through which the tubular portion is connected to the outer frame,

[0566] The frame assembly defines a plurality of hubs distributed circumferentially around the longitudinal axis in a plane perpendicular to the longitudinal axis, each hub 135 or 235 being defined by the convergence and connection of (i) two adjacent cells of the tubular portion, (ii) one of the plurality of arms, and (iii) one of the plurality of appendages.

[0567] According to some applications of the present invention, reference Figures 9A to 9C , which shows a schematic diagram of an implant 320 including a frame assembly 322. Unless otherwise noted, the frame assembly 322 is identical to the frame assembly 122, and the implant 300 is identical to the implant to which the frame assembly 122 belongs, mutatis mutandis. Figure 9A is a side view of implant 320, and Figure 9B is an isometric bottom view of the implant.

[0568] Frame assembly 122 includes (i) a valve frame 330 including a tubular portion 332 and an upstream support portion 340 generally including a plurality of arms 346, and (ii) an outer frame (e.g., a leg frame) 360 surrounding the valve frame and including a plurality of legs 350, each leg 350 including a tissue-engaging flange 354. Typically, outer frame 360 ​​includes an annulus 366 connected to legs 350, annulus 366 being defined by a pattern of alternating peaks and valleys, the peaks being secured to frame 330 at corresponding connection points 352, e.g., as described above with respect to frame assembly 22 and / or frame assembly 122, mutatis mutandis.

[0569] The frame assembly 322 includes an annular upstream support portion 340 having an interior portion 342 extending radially outward from an upstream portion (e.g., an upstream end) of the tubular portion 332. The upstream support portion 340 further includes one or more fabric pockets 344 disposed circumferentially around the interior portion 342, each of the one or more pockets having an opening facing in a downstream direction (i.e., generally toward the downstream end of the implant 320). In the figures, the upstream support portion 340 includes a single annular pocket 344 extending circumferentially around the interior portion 342.

[0570] Typically, a cover 323 (e.g., similar to cover 23 described above, mutatis mutandis) is disposed on arms 346 to form pockets 344. Typically, arms 346 are shaped to form pockets 344 from the cover 323. For example, as shown, arms 346 can be bent to form a hook shape.

[0571] For some applications, portion 340 has multiple individual pouches 344, e.g., separated at arms 346. For some such applications, cover 323 fits loosely (e.g., pouch-like) between radially outward portions of arms 346, e.g., compared to inner portion 342, where the cover fits more tightly between radially inward portions of the arms.

[0572] Figure 9C The implant 320 is shown implanted in the native valve 10. The sac 344 is generally shaped and arranged to undulate in response to the paravalvular flow 302 of blood in the upstream direction. If the ventricular contraction caused by blood filling the sac 344 and squeezing it (e.g., the radially outer portion of the cover 323 and / or the arms 346), the blood in the ventricle 8 between the implant 320 and the native valve 10 is forced to flow against the tissue of the atrium 6, thereby responsively increasing the seal. The inventors hypothesize that the shape and orientation of the sac 344 (e.g., the hooks of the arms 346) facilitates radial outward squeezing in response to the sac receiving blood flowing upstream.

[0573] The balloon 344 may be used with any combination of the implants described herein, mutatis mutandis.

[0574] Now refer to Figure 10 , Figure 10 1 is a schematic diagram of a frame assembly 422 of an implant according to some applications of the present invention. Unless otherwise noted, frame assembly 422 is generally identical to frame assembly 122, mutatis mutandis. Elements of frame assembly 422 share the names of corresponding elements of frame assembly 122. Additionally, unless otherwise noted, the implant to which frame assembly 422 belongs is similar to other implants described herein (e.g., implant 20), mutatis mutandis. Figure 10 Frame assembly 422 is shown in an expanded state (eg, in the absence of external deforming forces, such as those provided by a delivery tool during implantation, or those provided by cardiac tissue after implantation).

[0575] Frame assembly 422 comprises (i) a valve frame (e.g., an inner frame) 430 comprising a tubular portion 432 and an upstream support portion 440, which typically comprises a plurality of radial arms 446, and (ii) an outer frame (e.g., a leg frame) 460 surrounding the valve frame and comprising a plurality of legs 450, each leg 450 comprising a tissue-engaging flange 454. Typically, outer frame 460 comprises an annulus 466 to which legs 450 are attached. Annulus 466 is defined by a pattern of alternating peaks and valleys, with the peaks being secured to frame 430 at corresponding connection points 452, e.g., as described above for frame assemblies 22 and 122, mutatis mutandis. Tubular portion 432 has a diameter d26 (corresponding to diameter d2 of implant 20) and a transverse cross-sectional area that is a function of diameter d26.

[0576] Similar to other frame assemblies described herein, in the deployed state of the frame assembly 422, the legs 450 are circumferentially staggered with the arms 446 of the upstream support portion 440. This allows the legs (e.g., the flanges 454 of the legs) to move in an upstream direction between the arms during deployment of the implant (although the presence of cardiac tissue generally reduces the amount of movement of the flanges 454 between the arms 446). Figure 10 The frame assembly 422 is shown in a deployed configuration, wherein the upstream support portion 440 (e.g., arms 446) and flanges 454 extend radially outward from the tubular portion 432 and intersect at an intersection 470. Opposite intersections 470 define an intersection diameter d27. Generally, the flanges 454 extend radially outward from the tubular portion and toward the upstream support portion 440 (i.e., outward and in an upstream direction). An annular space 449 is defined between the flanges 454, the upstream support portion 440, and the tubular portion 432, surrounding the tubular portion.

[0577] As described above with respect to other implants, the implant to which the frame assembly 422 belongs is secured to the native valve by clamping cardiac tissue (e.g., the plurality of leaflets 12 and / or the valve annulus) between the upstream support portion 440 and the plurality of flanges 54 (e.g., within the space 449). Typically, the plurality of leaflets 12 are trapped in the space 449. The size of the space 449 is large enough to accommodate the plurality of leaflets 12 because the inventors have observed that if the space 449 is too small, the implant tends to become secured to tissue suboptimally near the middle of the native valve orifice (e.g., closer to the plurality of free edges of the plurality of leaflets) and positioned in a suboptimal downstream position (i.e., into the ventricle 8). Additionally, the size of the space 449 is small enough to snugly accommodate the plurality of leaflets 12 because the inventors have observed that if the space 449 is small enough, the plurality of leaflets fill the space (typically folding or gathering within the space) and a clamping force is applied to the leaflet tissue throughout the space 449. Conversely, if the space 449 is too large, the clamping force applied to the multiple leaflets may only be at or near the intersection 470, reducing the effectiveness of the anchoring and / or increasing the likelihood of damaging tissue at or near the intersection.

[0578] The inventors hypothesize that an optimally sized space 449 (i.e., a size large enough to accommodate multiple leaflets 12, but small enough to fit tightly) is achieved when the space has a transverse area 451 that is 5 to 10% (e.g., 5 to 8%, such as 6 to 7% or 6.5 to 7.5%) of the transverse cross-sectional area of ​​the tubular portion 432. It is further hypothesized that this relative size is optimal in multiple implants having tubular portions of multiple different diameters. For example:

[0579] For an implant having a diameter d26 of 25 mm, an optimally sized cross-sectional area 451 may be 25 to 40 (eg, about 35) square millimeters.

[0580] For an implant having a diameter d26 of 27 mm, an optimally sized cross-sectional area 451 may be 30 to 45 (eg, approximately 40) square millimeters.

[0581] For an implant having a diameter d26 of 29 mm, an optimally sized cross-sectional area 451 may be 35 to 50 (eg, about 45) square millimeters.

[0582] The inventors hypothesize that the optimal relative size range for area 451 applies to implants having the tubular portion narrower or wider than the embodiments described above (eg, 23 mm or 31 mm diameter).

[0583] For some applications, implants d26 of different diameters are provided, and each implant has a cross-sectional area 451 that is 5 to 10% (e.g., 5 to 8%, such as 6 to 7% or 6.5 to 7.5%) of the transverse cross-sectional area of ​​the tubular portion 432 of the implant. For example, the transverse cross-sectional area of ​​the tubular portion 432 of one of the plurality of implants may be at least 15% (e.g., at least 30%) greater than that of another implant.

[0584] Tubular portion 432 has an upstream end 434 and a downstream end 436. Similar to frame assembly 122, a plurality of arms 446 are attached to and extend from a location 435 downstream of upstream end 434, for example, at a connection between two adjacent cells in an upstream row of cells of tubular portion 432 (or alternatively, described as being at the upstream extremities of the cells in a downstream row of cells).

[0585] The gradually lateral portions of each arm 446 define: (i) an upstream portion 446a that extends in an upstream direction past the upstream end 434 of the tubular portion 432 (e.g., a distance d28), (ii) an arched portion 446b that curves in a downstream direction to form an arch (portion 446b may alternatively be described as convex in the upstream direction), and (iii) a lateral portion 446c that curves in the upstream direction. For some applications, in the absence of tissue, the arched portion 446b curves in the downstream direction until (and typically past) the tip 455 of the flange 454 (i.e., at the arched portion, each arm 446 extends below (i.e., further downstream than) the adjacent tip 455). For some applications, and as shown, the intersection 470 is typically near where the arm 446 begins to curve upstream.

[0586] Height d29 is the height along the central longitudinal axis of the implant between (i) the top of arched portion 446b and (ii) intersection 470. For some applications, height d29 is 0.5 to 3.5 mm (e.g., 1.8 to 2.6 mm).

[0587] Height d30 is the height along the central longitudinal axis of the implant between (i) the top of arched portion 446b and (ii) location 435. For some applications, height d30 is 4 to 7.5 mm (e.g., 5.2 to 6.5 mm).

[0588] Thus, it should be noted that, for some applications, arm 446 (i) extends radially outward and above the tips of (a) upstream end 434 and (b) flange 454, and then (ii) extends further radially outward and below the tips of (a) upstream end 434 and / or (b) flange 454 (i.e., toward the flanges). This configuration of arm 46 increases the size of annular space 449 (compared to similar arms in which d28 and / or d29 are smaller), e.g., by providing an optimal transverse cross-sectional area 451, as described above. (In contrast, for example, in frame assemblies 122 and 222, the arms do not have arcuate portions extending above (i) the corresponding tubular portions of the upstream ends, or (ii) the tips of the corresponding flanges. While lateral portions of these arms do extend upward, such lateral portions extend radially outward of the flanges and, therefore, do not increase the cross-sectional area of ​​the annular space defined by these frame assemblies.)

[0589] For some applications, end 446d (ie, the lateral end) of arm 446 is disposed in a more upstream direction than arcuate portion 446b.

[0590] For some applications, the outer stent frame (e.g., leg frame) 460 has a radial thickness d24 (i.e., thickness measured along an axis extending radially outward from the central longitudinal axis of the implant) that is greater than the radial thickness d25 of the inner stent frame (e.g., valve frame) 430. That is, the outer stent frame is radially thicker than the inner stent frame. This is typically achieved by cutting (e.g., laser cutting) the inner stent frame from a Nitinol tube having a first wall thickness (e.g., equal to d25) and the outer stent frame from another Nitinol tube having a second, greater wall thickness (e.g., equal to d24). However, other manufacturing methods, including 3D printing, may be used.

[0591] For some applications, thickness d24 is at least 10% (e.g., at least 20%, such as at least 30%) greater than thickness d25 and / or no greater than 80% (e.g., no greater than 50%). For some applications, thickness d24 is 0.6 to 0.8 mm (e.g., 0.7 to 0.75 mm, such as 0.71 to 0.73 mm, such as 0.72 mm), and thickness d25 is 0.45 to 0.65 mm (e.g., 0.5 to 0.55 mm, such as 0.52 to 0.54 mm, such as 0.53 mm).

[0592] Making the outer stent frame (eg, leg frame) radially thicker than the inner stent frame (eg, valve frame) can be applied to the other frame components described herein, mutatis mutandis.

[0593] Therefore, according to some applications of the present invention, there is provided an apparatus comprising:

[0594] (1) A frame assembly, percutaneously advanceable to the heart, comprising:

[0595] (i) an inner stent frame defining a tubular portion; and

[0596] (ii) an outer stent frame defining a ring connected to the inner stent frame and surrounding the tubular portion; and

[0597] (2) a plurality of artificial valve leaflets connected to the frame assembly and disposed within the tubular portion;

[0598] The inner stent frame is cut from a first nitinol tube and has a first wall thickness, and the outer stent frame is cut from a second nitinol tube and has a second wall thickness, which is greater than the first wall thickness.

[0599] The inventors have hypothesized that a frame assembly would be provided in which the outer frame has a greater radial thickness to advantageously provide (i) radial expansion strength (and resistance to radially inward deformation) to the portion of the frame assembly in which the plurality of artificial leaflets are disposed, and (ii) rigidity (and fatigue resistance) to the legs 450.

[0600] For some applications, when the frames 430 and 460 are separate and independent (e.g., during manufacturing, before the frames are secured to each other), and the frames are in their respective relaxed, expanded states (e.g., without external deforming forces, such as when placed on a table), the relaxed, expanded diameter of an inner stent frame defined by the tubular portion 432 (measured as an outer diameter of the tubular portion) is greater than the relaxed, expanded diameter of an outer stent frame defined by the annulus 466 (measured as an inner diameter of the annulus). For some applications, the relaxed, expanded diameter of the inner stent frame is 0.5 to 1.5 mm (e.g., 0.5 to 1 mm, such as 0.8 mm) greater than the relaxed, expanded diameter of the outer stent frame.

[0601] Therefore, in the frame assembly 422 (such as Figure 10 ), the frame 460 (e.g., the ring 466) constrains the tubular portion 432 to a stent frame-defined expanded diameter that is smaller than the inner stent frame's relaxed expanded diameter. Figure 10 ), residual stresses typically exist in the frame 430 (e.g., the tubular portion 432 thereof) and / or the frame 460 (e.g., the ring 466 thereof). Additionally, when the frame assembly is in its compressed state, and during its expansion to its deployed state, circumferential contact (and reciprocating deployment and compression forces) is maintained between the frame 460 and the tubular portion 432.

[0602] The inventors hypothesize that this optional residual stress configuration advantageously increases the strength of the frame components (e.g., the strength of the tubular portion), and particularly its resistance to deformation, for example, in response to forces applied directly to the frame assembly through tissue of the native valve, and / or indirectly applied to the frame assembly during ventricular systole when ventricular blood is forced against the prosthetic valve leaflets, which pulls on the frame assembly.

[0603] It should be noted that the plurality of frames 430 and 460 are secured to one another independently of any additional connections that may be provided by the residual stress configuration. For example, and as described above, the frames are secured to one another at connection points 452, such as by welding, soldering, hemming, hemming, stitching (e.g., suturing), gluing, or any other suitable technique. As described below with reference to Figures 11A to 11C As mentioned, for some applications, the frames are also fixed to each other at the interface of the implant. That is, the residual stress configuration provides strength and rigidity to the frame assembly (and is used to ensure that the circumferential contact between the frames is maintained), rather than being used to connect the frames to each other.

[0604] refer to Figures 11A to 11C , which is a schematic diagram of a connector 510 and a mating surface 500 of a prosthetic valve according to some applications of the present invention. Connector 510 typically comprises a flexible sheet 512 that is folded to define the various elements of the connector. Further typically, sheet 512 is a single, unitary sheet (e.g., cut from a single piece of stock). Figure 11A Two perspective views of the connector 510 (eg, its sheet 512) are shown in its folded state. Figure 11B Its expanded state is shown. Figure 11C Connector 510 is shown secured to frame assembly 422 at interface 500. Interface 500 is described with respect to an implant to which frame assembly 422 belongs, but it may be used in combination with other prosthetic valves described herein, and / or with other prosthetic valves, mutatis mutandis.

[0605] The implant to which the frame assembly 422 belongs is defined by a plurality of joints 500 where the two artificial valve leaflets of the implant (e.g., a plurality of leaflets 58 or the like) meet and are secured to the frame assembly. At each joint, the implant includes a plurality of sutures (e.g., a plurality of sutures) 502 by which the plurality of joint portions of the two artificial valve leaflets are secured to the frame assembly. For some applications, a plurality of sutures secure the plurality of artificial valve leaflets to the inner stent frame (frame 430, e.g., its tubular portion 432) and to the outer stent frame (frame 460). That is, the plurality of leaflets are not connected to the outer stent frame merely by being secured to the inner stent frame, which in turn is connected to the outer stent frame. Instead, the plurality of leaflets are secured to both frames by a plurality of sutures 502. Because (as described above) (i) the radial thickness of frame 460 is thicker than the radial thickness of frame 430, and (ii) the relative diameters of the multiple frames cause residual stress and maintain circumferential contact between the multiple frames 430 and 460, the fixation of the multiple leaflets to the two frames advantageously provides the implant with enhanced resistance so that the multiple artificial leaflets pull the engagement surface 500 radially inward when ventricular pressure increases during ventricular contraction.

[0606] For some applications, and as shown, sutures 502 secure the leaflets to the two frames by securing a connector 510 (typically comprised primarily or solely of a fabric) to the two frames. The connector 510 is shaped to define a plurality of flaps 504 and a leaflet receptacle 514 containing one or more (e.g., two) leaflet engagement tabs 506, such as a first leaflet engagement tab 506a and a second leaflet engagement tab 506b. For some applications, the connector 510 is shaped to define a sheet (e.g., a flat sheet) 508 with the tabs 506 protruding from one side of the sheet, and each flap 504 is folded over a corresponding portion of the other side of the sheet. The coaptation surfaces of the leaflets are sutured to the leaflet engagement tabs 506 (e.g., to the corresponding leaflet engagement tabs). The leaflets 504 are sutured to the frames 430 and 460, i.e., secured to the frames by the sutures 502. Typically, flaps 504 are folded or wrapped around elements of frames 430 and 460. They are secured in this arrangement by sutures 502, thereby providing added strength to the securing of the leaflets to the frames (and to each other).

[0607] Typically, connector 510 includes four flaps 504. For some applications, and as shown, multiple flaps 504 are arranged in a pipeline so that each flap has two adjacent flaps around the pipeline, and the fold axis ax2 of each flap is oriented 60 to 120 degrees (e.g., 70 to 110 degrees, such as 80 to 100 degrees) relative to the fold axis of each of its adjacent flaps. For applications in which the frame to which connector 510 is connected has a honeycomb structure with generally diamond-shaped cells, such an arrangement facilitates connecting the connector to the frame.

[0608] For some applications, as shown, and as shown, the connector 510 has four flaps arranged in a generally diamond shape, wherein two upstream flaps 504a taper to each other in a downstream direction, and two downstream flaps 504b taper to each other in a downstream direction. Each upstream flap 504a is typically folded over or wrapped around one element of the frame 430 and one element of the frame 460. Figure 11C As shown, at the interface 500, elements of the frame 430 are aligned with elements of the frame 460, and a plurality of flaps 504a are arranged to align with these elements of both frames. The flaps 504 are folded over or wrapped around these elements of the frame and secured to these elements by stitches 502. At the location of the plurality of downstream flaps 504b, the elements of the frame 430 are not aligned with the elements of the frame 460 and may even be perpendicular to them. The plurality of downstream flaps 504b are arranged to align with the elements of the frame 430 and fold over or wrap around them, but generally not fold over or wrap around them. The plurality of elements of the frame 430 and the plurality of flaps 504b are sewn to the plurality of elements of the frame 460; these stitches are indicated by reference numeral 502b, while the stitches securing the flaps to or around the frame elements are indicated by reference numeral 502a. For some applications, sheet 508 is also stitched to elements of frame 430 and / or frame 460; these stitches are indicated by reference numeral 502c.

[0609] It should be noted that frames 430 and 460 are thereby secured to one another at interface 500 (ie, except at connection point 452).

[0610] Alternatively, the connector 510 and / or the plurality of sutures may secure the plurality of leaflets only to the inner frame 430 , such that the plurality of leaflets are connected to the outer frame 460 only through the inner frame 430 .

[0611] Thus, according to some applications of the present invention, a connector (e.g., connector 510) is provided comprising a flexible sheet (e.g., sheet 512) folded to define: (i) a plate (e.g., plate 508) having a first side (e.g., side 508a) and a second side (e.g., side 508b) opposite the first side; (ii) a leaflet container (e.g., container 514) disposed on the first side of the plate and protruding away from the plate in the first direction; and (iii) a plurality of flaps (e.g., plurality of flaps 504), each folded about a respective folding axis (e.g., axis ax2) such that at least a portion of each flap is disposed on the second side of the plate.

[0612] The container 514 is configured to clamp one or more artificial leaflets between the leaflet engagement tabs 506a and 506b. Typically, suture holes 516 are defined in the leaflet engagement tabs 506 to guide the introduction of sutures that clamp the multiple leaflets between the multiple tabs. For some applications, the multiple holes 516 are arranged in multiple rows. For example, as shown, each leaflet engagement tab 506 can define a first row 518a of the multiple suture holes and a second row 518b of the multiple suture holes, with one tab of the multiple rows aligned with another tab of the multiple rows. For some such applications, the rows 518a and 518b are diverged relative to each other by an angle α_3, typically such that the multiple downstream portions of the multiple rows gradually diverge further relative to each other. For example, the angle α_3 can be 10 to 45 degrees (e.g., 10 to 30 degrees, e.g., 15 to 25 degrees, e.g., approximately 20 degrees).

[0613] For some applications, sheet 512 is folded such that each leaflet engagement tab 506 comprises an outer layer 520o and an inner layer 520i, the inner layer positioned sandwiched between the outer layer and one or more leaflets.

[0614] At connector 510( Figure 11B ), the sheet 512 defines a plane (i.e., the plane of the page). In the unfolded state, the sheet 512 defines in the plane (i.e., the plane of the page). In the unfolded state, the sheet 512 defines (i) a panel 508 at a central region of the sheet 512, (ii) a plurality of flaps 504 disposed at a periphery of the panel, and (iii) first and second tab portions 526, also disposed at a periphery of the panel. Each tab portion 526 includes an outer layer 520o and an inner layer 520i and, in the folded state, defines a corresponding leaflet engagement tab 506.

[0615] Typically, the sheet 512 further defines a plurality of bridge elements 522, each bridge element 522 connecting a corresponding tab portion 526 to the sheet 508. The plurality of flaps 504 are connected to the sheet 508 independently of the plurality of bridge elements.

[0616] In the expanded state, the plurality of tab portions 526 flank the sheet 508 by being disposed on opposing sides of the sheet in the plane. In the expanded state, the sheet 508, the plurality of tab portions 526, and the plurality of bridging elements 522 are arranged in a row to define a transverse axis ax3 in the plane that passes through the sheet, the plurality of tab portions, and the plurality of bridging elements. The axis ax3 typically passes between the plurality of upstream flaps 504a and the plurality of downstream flaps 504b. Typically, the fold axis ax2 of each flap 504 is disposed at an angle α_4 of 30 to 60 degrees relative to the transverse axis ax3.

[0617] In the folded state, a plurality of bridging elements 522 extend from corresponding edges of the sheet 508 and extend toward each other across the first side 508a of the sheet, and each of the leaflet engagement tabs 506 protrudes from its corresponding bridging element in a direction away from the first side of the sheet.

[0618] refer to FIG. 12A to FIG. 12B and 13A to 13F , a schematic diagram illustrating a connector 610 for connecting multiple artificial valve leaflets (e.g., multiple leaflets 58) to a frame of a prosthetic valve implant frame is shown. According to some applications of the present invention, connector 610 can be used with any implant described herein, or with a different prosthetic valve, mutatis mutandis.

[0619] The connector 610 typically comprises a flexible sheet 612 that is folded to define the elements of the connector. Further typically, the sheet 612 is a single, unitary sheet (eg, cut from a single piece of stock). Figure 12A Two perspective views of the connector 610 (eg, its sheet 612) are shown in a folded state. Figure 12B The connector 610 is shown in its unfolded state. Figure 12B and 13A to 13F In the embodiment, opposite sides of the sheet have different shades, e.g. Figure 12B A corner of the sheet 612 is shown curled up to show its reverse side.

[0620] The connector 610 (e.g., in its folded state) is shaped to define a plurality of flaps 604, and a leaflet receptacle 614 containing one or more (e.g., two) leaflet engagement tabs 606, such as a first leaflet engagement tab 606a and a second leaflet engagement tab 606b. The connector 610 is generally shaped to define a sheet (e.g., a flat sheet) 608. In the folded state, the tabs 606 protrude from a first side 608a of the sheet, and each flap 604 is folded over a second side 608b of the sheet (e.g., a respective portion of the sheet). The engagement surface portions of the plurality of flaps 58 are sewn to the leaflet engagement tabs 606. The flaps 604 are folded over or wrapped around elements of the frame of the prosthetic valve implant, for example, as Figure 13F Typically, the flap 604 is secured in this arrangement by a plurality of stitches (not shown).

[0621] Typically, the connector 610 includes four flaps 604, typically two upstream flaps 604a and two downstream flaps 604b. For some applications, and as shown, multiple flaps 604 are arranged in a pipeline so that each flap has two adjacent flaps surrounding the pipeline, and the fold axis ax4 of each flap is oriented at 60 to 120 degrees (e.g., 70 to 110 degrees, such as 80 to 100 degrees) relative to the fold axis of each of the adjacent flaps of each flap. For applications in which the frame is connected to the connector 610, such an arrangement facilitates attaching the connector to the frame, for example, as a cell structure having generally diamond-shaped cells. Figure 13F shown.

[0622] Thus, according to some applications of the present invention, a connector (e.g., connector 610) is provided comprising a flexible sheet (e.g., sheet 612) that is folded to define: (i) a plate (e.g., plate 608) having a first side (e.g., side 608a) and a second side (e.g., side 608b) opposite the first side; (ii) a leaflet container (e.g., container 614) disposed on the first side of the plate and protruding from and away from the plate in a first direction; and (iii) a plurality of flaps (e.g., plurality of flaps 604), each folded about a corresponding folding axis (e.g., axis ax4) such that at least a portion of each flap is disposed on the second side of the plate.

[0623] Container 614 is configured to clamp one or more prosthetic leaflets between leaflet engagement tabs 606a and 606b. Typically, a plurality of suture holes 616 are defined in leaflet engagement tabs 606 to guide the introduction of a plurality of sutures that clamp the leaflets between the tabs. For some applications, the plurality of holes 616 are arranged in a plurality of rows. For example, as shown, each leaflet engagement tab 606 can define a first row 618a of suture holes and a second row 618b of suture holes, with the plurality of rows of suture holes of one tab aligned with the corresponding plurality of rows of the other tab. For some such applications, rows 618a and 618b diverge relative to each other at an angle α_5, typically such that the plurality of downstream portions of the plurality of rows diverge further relative to each other. For example, angle α_5 can be 10 to 45 degrees (e.g., 10 to 30 degrees, e.g., 15 to 25 degrees, e.g., approximately 20 degrees). Downstream is defined as the direction in which unidirectional fluid flow is facilitated by the plurality of prosthetic leaflets, which itself depends in part on the orientation in which the plurality of leaflets are attached to the connector 610 .

[0624] Typically, sheet 612 is folded so that each leaflet engagement tab 606 comprises an outer layer 620o and an inner layer 620i, positioned so as to be sandwiched between the outer layer and one or more leaflets. For some applications, and as described further below, rows 618a and 618b are defined by inner layer 620i, and a third row 618c of suture holes is defined by outer layer 620, with sheet 612 folded so that row 618c is aligned with row 618a. For such applications, only row 618c is visible in the folded state. In the expanded state, an angle α_7 between rows 618a and 618c is typically 40 to 120 degrees (e.g., 40 to 90 degrees, e.g., 40 to 70 degrees, e.g., 40 to 60 degrees, e.g., 50 to 60 degrees).

[0625] At connector 610( Figure 12B ), the sheet 612 defines a plane (i.e., the plane of the page). In the unfolded state, the sheet 612 defines in the plane: (i) a panel 608 at a central region of the sheet 612, (ii) a plurality of flaps 604 disposed about the periphery of the panel, and (iii) first and second tab portions 626, also disposed about the periphery of the panel. Each tab portion 626 comprises an outer layer 620o and an inner layer 620i and, in the folded state, defines a corresponding leaflet engagement tab 606.

[0626] The sheet 612 further defines a plurality of bridging elements 622 that connect each tab portion 626 to the sheet 608. The plurality of flaps 504 are connected to the sheet 508 via the plurality of bridging elements.

[0627] Typically, in the folded state, a portion of each flap 604 is disposed on the first side 608a and a portion of each flap is disposed on the second side 608b of the sheet 608. For example, a plurality of bridging elements 622 are generally disposed on the first side 608a, and each flap 604 extends from one of the plurality of bridging elements and surrounds the sheet 608 such that a portion of the flap is disposed on side 608a and a portion of the flap is disposed on side 608b.

[0628] In the expanded state, the plurality of tab portions 626 flank the sheet 608 by being disposed on opposing sides of the sheet in the plane. In the expanded state, the sheet 608, the plurality of tab portions 626, and the plurality of bridging elements 622 are arranged in a row to define a transverse axis ax5 in the plane, which passes through the sheet, the plurality of tab portions, and the plurality of bridging elements. The axis ax5 typically passes between the plurality of upstream flaps 604a and the plurality of downstream flaps 604b. Typically, the fold axis ax4 of each flap 604 is disposed at an angle α_6 of 30 to 70 degrees with respect to the transverse axis ax5.

[0629] The sheet 612 is further generally defined by a fold 640, located, in the expanded state, on the side of each tab portion 626. The fold 640 is further described below.

[0630] In the folded state, a plurality of bridging elements 622 extend from a plurality of corresponding edges of the sheet 608 and extend toward each other at a first side 608a of the sheet, and each of the leaflet engagement tabs 606 protrudes from its corresponding bridging element in a direction away from the first side of the sheet facing the first side of the sheet.

[0631] 13A to 13F 6. The step of folding the sheet 612 from the unfolded state to the folded state is shown in accordance with some applications of the present invention to define the connector 610. The folds are formed in the downstream region of the plurality of tab portions 626, for example, the downstream edge of each layer 610o and each layer 610i is folded to form a corresponding fold 628 ( Figure 13A ). This will provide a cushion 630 for each leaflet coaptation tab, as described below. The fold 628 can be secured by suturing.

[0632] The sheet 612 is folded in half along its longitudinal axis ax6 so that the plurality of protruding portions 626 are brought together ( Figure 13B). The joint surface portions of two leaflets 58 (e.g., a first leaflet 58a and a second leaflet 58b) are introduced so that they are clamped together between the plurality of sections 626. As shown, the plurality of leaflets are generally positioned so that they are disposed between the holes 616 of one section 626 and the holes 616 of another section 626. The holes 616 of the rows 618b of the two sections 626 are sutured together, as shown by reference numeral 632. Thus, the suture passes through the leaflets 58a and 58b, thereby securing them to the connector 610.

[0633] Subsequently, the plurality of tab portions 626 are folded back to define an inner layer 620i and an outer layer 620o ( Figure 13C ) and align row 618c with row 618a. The apertures 616 of rows 618a and 618b are now hidden by the outer layer 620o. Then, one tab portion 626, the rows 618c and 618a of the plurality of leaflets 58a and 58b, and the rows 618a and 618c of the other tab portion are sewn together, as indicated by reference numeral 634. This strengthens the connection of the leaflets to the connector 610. Thus, the tab portion 626 is formed in the leaflet engagement tab 606.

[0634] exist Figure 13C Following the steps shown, step 13B shows the folding of the sheet 612 in half, mutatis mutandis, away from each other and folding the plurality of bridging elements 622 over the sheet 608 ( Figure 13D Typically, the region of each leaflet 58 disposed outside of row 618 c is disposed between the bridging element 622 and the sheet 608 .

[0635] generally, Figure 13C The step shown brings the fold 640 into contact with the bridging element 622 . Figure 13D The steps shown generally cause each bridge element 622 to move with the bridge element 622 it contacts and to fold relative to the outer layer 620i of the leaflet engagement tab 606. For some applications, sutures are passed through the folds 640, bridge elements 622, leaflets 58, and sheet 608. This suturing can be a separate step or can be performed when securing the flaps 604 to the frame of the prosthetic valve, for example, as described below.

[0636] Figure 13E Shown Figure 13D63. Each leaflet 58 has a downstream edge 638. It should be noted that the leaflet engagement tabs 606 generally extend beyond the downstream edge 638 in a downstream direction. It should be further noted that the cushions 630 are generally positioned so that at least a portion of each cushion is disposed further downstream than the downstream edge 638. The tabs 606 and / or cushions 630 are thereby configured to prevent movement of the engagement surface portion of each leaflet 58 toward the frame of the prosthetic valve (particularly movement of the downstream edge 638). The inventors hypothesize that this reduces the likelihood of the leaflets 58 being damaged over time due to contact with the frame.

[0637] Then, the connector 610 is fixed to the frame of the artificial valve ( Figure 13F ). A plurality of flaps 604 are folded over a component of the artificial valve frame (shown in dotted lines) and secured by sutures. For some applications, some of these sutures may pass through several components, such as the flaps 604, the sheet 608, the leaflets 58, the bridging element 622, and / or the hem 640.

[0638] although 13A to 13F A particular order is shown, and although some steps must be performed before other steps, it should be understood that some steps can be performed in a different order than the steps shown. For example, fold 628 can be folded at a later stage than those shown.

[0639] Typically, three connectors 610 are used to connect the three leaflets 58 to the frame of the prosthetic valve at three interfaces to form a tri-leaflet check valve.

[0640] Reference again Figures 1A to 13F One of the advantages provided by assembling an artificial valve from two (e.g., coaxial) frames is the ability to divide the required frame elements between the two frames in a manner that is not possible with a single frame. Alternatively, if a separate frame is used, the size (e.g., diameter or length) of the implant in its compressed state will be increased. In addition, for certain applications, the use of two frames allows implants of different sizes to be compressed ("crimped") to the same or similar diameter and, for some such applications, delivered using the same delivery tool (e.g., delivery tool 89). For example, for an implant comprising frame assembly 422, a larger sized implant can have a lumen diameter that is at least 15% larger than the lumen diameter of a smaller sized implant (in their respective expanded states), but in its compressed state, the diameter of the larger sized implant can be no more than 2% larger than the diameter of the smaller sized implant.

[0641] For some applications, a delivery tool is provided for implants of different sizes, for example, and a plurality of implants are provided separately. For some such applications, a kit is provided comprising a delivery tool and a plurality of implants of different sizes.

[0642] Reference again Figures 1A to 13F It should be noted that, unless otherwise specifically stated, the term "radially outward" (e.g., as used to describe upstream support portion 40 and flange 54) means that the portion of the component gradually expands outward from a center point (e.g., longitudinal axis ax1 or tubular portion 32), but does not necessarily mean that it is arranged at 90 degrees relative to longitudinal axis ax1. For example, flange 54 may extend radially outward 90 degrees relative to longitudinal axis ax1, but may alternatively extend radially outward at a shallower angle relative to the longitudinal axis.

[0643] Those skilled in the art will appreciate that the present invention is not limited to what has been specifically shown and described hereinabove. On the contrary, the scope of the present invention encompasses combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications of these features not within the prior art which would occur to those skilled in the art upon reading the foregoing description.

Claims

1. A device for use with an artificial valve, characterized in that: The device comprises a connector comprising a flexible sheet folded to define: A plate having: a first side facing a first direction; and a second side opposite to the first side; a leaflet receptacle disposed on the first side of the sheet and projecting away from the sheet in the first direction, the leaflet receptacle comprising a first leaflet engagement tab extending from the first side of the sheet and a second leaflet engagement tab extending from the first side of the sheet, the leaflet receptacle being configured to clamp one or more leaflets of a prosthetic valve between the leaflet engagement tabs such that on a plurality of opposite sides of the clamped leaflets; and a plurality of flaps, each flap folded about a respective fold axis such that at least a portion of each flap is disposed on the second side of the sheet; The flexible sheet is a single, integral flexible sheet, and the integral flexible sheet is folded to define the plate, the leaflet container, and the plurality of flaps; The sheet material further defines a plurality of bridging elements which, in a folded state, extend from respective edges of the sheet material and extend towards each other across the first side of the sheet material, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet material in a direction away from the first side of the sheet material.

2. The device according to claim 1, wherein: The sheet of material has an edge between the first side and the second side, and each flap can be folded over the edge so that each flap is disposed on the second side of the sheet of material.

3. The device according to claim 1, wherein: The plurality of flaps comprises exactly four flaps.

4. The device according to any one of claims 1 to 3, characterized in that: The first leaflet engagement tab defines a first row of a plurality of first tab suture holes and a second row of a plurality of first tab suture holes; The second leaflet engagement tab defines a first row of a plurality of second tab suture holes and a second row of a plurality of second tab suture holes; The plurality of first tab sewing holes in the first row and the plurality of second tab sewing holes in the first row are aligned with each other; and The plurality of first tab sewing holes in the second row and the plurality of second tab sewing holes in the second row are aligned with each other.

5. The device according to claim 4, characterized in that The first row of first tab stitching holes and the second row of first tab stitching holes are staggered 10 to 45 degrees relative to each other, and the first row of second tab stitching holes and the second row of second tab stitching holes are staggered 10 to 45 degrees relative to each other.

6. The device according to claim 5, characterized in that: The first row of first tab stitching holes and the second row of first tab stitching holes are staggered 10 to 30 degrees relative to each other, and the first row of second tab stitching holes and the second row of second tab stitching holes are staggered 10 to 30 degrees relative to each other.

7. The device according to claim 6, characterized in that: The first row of first tab stitching holes and the second row of first tab stitching holes are staggered 15 to 25 degrees relative to each other, and the first row of second tab stitching holes and the second row of second tab stitching holes are staggered 15 to 25 degrees relative to each other.

8. The device according to claim 4, characterized in that: The flexible sheet is folded such that each of the first leaflet engagement tab and the second leaflet engagement tab comprises: (i) an outer layer; and (ii) an inner layer positioned sandwiched between the outer layer and one or more leaflets, and wherein: The first and second rows of a plurality of first tab suture holes are defined in the inner layer of the first leaflet engagement tab; and The first and second rows of a plurality of second tab suture holes are defined in the inner layer of the second leaflet engagement tab.

9. The device according to claim 8, characterized in that: The first leaflet engagement tab further defines a third row of a plurality of first tab suture holes, the third row of a plurality of first tab suture holes being defined in the outer layer of the first leaflet engagement tab and aligned with the first row of a plurality of first tab suture holes; and The second leaflet engagement tab further defines a third row of a plurality of second tab suture holes, the third row of a plurality of second tab suture holes being defined in the outer layer of the second leaflet engagement tab and aligned with the first row of a plurality of second tab suture holes.

10. The device according to any one of claims 1 to 3, characterized in that: The device further comprises: a tubular frame defining an inner cavity passing through the tubular frame; and a first artificial valve leaflet and a second artificial valve leaflet, wherein the first and second artificial valve leaflets are disposed in the inner cavity, The device defines a joint surface where the first and second artificial valve leaflets meet each other and are connected to the frame via the connector.

11. The device according to claim 10, characterized in that: The leaflets are arranged and connected to the frame to define an upstream end and a downstream end of the lumen so as to allow a fluid to flow through the lumen in one direction.

12. The device according to claim 11, characterized in that: The first leaflet engagement tab defines a first row of a plurality of first tab suture holes and a second row of a plurality of first tab suture holes; The second leaflet coaptation tab defines a first row of a plurality of second leaflet suture holes and a second row of a plurality of second leaflet suture holes; the first and second prosthetic leaflets are clamped together between the first and second leaflet coaptation tabs and sutured to the first and second leaflet coaptation tabs such that on opposite sides of the clamped leaflets: The plurality of first tab sewing holes in the first row and the plurality of second tab sewing holes in the first row are aligned with each other; and The plurality of first tab sewing holes in the second row and the plurality of second tab sewing holes in the second row are aligned with each other.

13. The device according to claim 12, wherein: The first artificial leaflet has a first leaflet downstream edge, and the second artificial leaflet has a second leaflet downstream edge, and each of the first leaflet coaptation protrusion and the second leaflet coaptation protrusion extends beyond the first leaflet downstream edge and the second leaflet downstream edge in a downstream direction.

14. The device according to claim 12, wherein: The first artificial valve leaflet has a first leaflet downstream edge, and the second artificial valve leaflet has a second leaflet downstream edge; The first and second artificial valve leaflets are configured as follows: inhibiting fluid flow in an upstream direction by causing the first and second prosthetic leaflets to move toward each other in response to fluid flow in the upstream direction, such that a downstream edge of the first leaflet and a downstream edge of the second leaflet move away from the frame; and promoting fluid flow in a downstream direction by causing the first and second prosthetic leaflets to move away from each other in response to fluid flow in the downstream direction, such that a downstream edge of the first leaflet and a downstream edge of the second leaflet move toward the frame; The first leaflet engagement protrusion defines a first cushion, the first cushion inhibiting a portion of an engagement surface of the first artificial leaflet from moving toward the frame; as well as The second leaflet engagement protrusion defines a second cushion that inhibits movement of an engagement surface portion of the second artificial leaflet toward the frame.

15. The device according to claim 14, characterized in that: The first cushion and the second cushion are disposed downstream of a downstream edge of the first leaflet and a downstream edge of the second leaflet.

16. The device according to claim 14, wherein: The first and second cushioning pads are each defined by a plurality of folds in a flexible sheet.

17. The device according to claim 12, wherein: The first and second rows of multiple first tab sewing holes diverge relative to each other so that the multiple downstream portions of the first and second rows of multiple first tab sewing holes diverge further relative to each other; and the first and second rows of multiple second tab sewing holes diverge relative to each other so that the multiple downstream portions of the first and second rows of multiple second tab sewing holes diverge further relative to each other.

18. The device according to claim 17, wherein: The plurality of first tab stitching holes in the first and second rows are staggered 10 to 45 degrees relative to each other; and the plurality of second tab stitching holes in the first and second rows are staggered 10 to 45 degrees relative to each other.

19. The device according to claim 10, wherein: The connector is a first connector; The joint surface is a first joint surface; The device further comprises a second connector, a third connector and a third artificial valve leaflet; and The device definition is: a second interface where the second and third artificial valve leaflets meet each other and are connected to the frame via the second connector; and A third interface where the third and first artificial valve leaflets meet each other and are connected to the frame via the third connector.

20. The device according to any one of claims 1 to 3, characterized in that: The connector has a folded state, in which the sheet is folded to define the plate, the leaflet container, and the plurality of flaps; and the sheet also has an unfolded state, in which the sheet defines a plane, and further defined in the plane: The plate is located in a middle area of ​​the sheet; The plurality of flaps are arranged on the periphery of the plate; and a first tab portion and a second tab portion, each of the tab portions being disposed on the periphery of the plate, wherein in the folded state, each of the tab portions defines a corresponding leaflet engagement tab, and the leaflet receptacle includes the leaflet engagement tab of each of the tab portions.

21. The device according to claim 20, characterized in that: In the folded state, a first flap portion of each of the plurality of flaps is disposed on the first side of the sheet; and each of the plurality of flaps is folded around the sheet material such that a second flap portion of each of the plurality of flaps is disposed on the second side of the sheet material.

22. The device according to claim 20, wherein: The plurality of bridge elements include a first bridge element through which the first tab portion is connected to the sheet material; and a second bridge element through which the second tab portion is connected to the sheet material.

23. The device according to claim 22, characterized in that: In the folded state, the first and second bridging elements extend from respective edges of the sheet and over the first side of the sheet toward each other; and each of the first and second tab portions protrudes from the respective bridging element in the first direction away from the first side of the sheet.

24. The device according to claim 22, wherein: The plurality of flaps are connected to the sheet material independently of the plurality of bridging elements.

25. The device according to claim 22, wherein: The plurality of flaps are connected to the sheet material by the plurality of bridging elements.

26. The device according to claim 25, characterized in that: In the described expanded state: The sheet material, the first and second bridging elements, and the first and second tab portions are arranged in a row to define a transverse axis in the plane, the transverse axis passing through the sheet material, the first and second bridging elements, and the first and second tab portions; and For each of the plurality of bridge elements, a first flap of the plurality of flaps and a second flap of the plurality of flaps are connected to the bridge element, and the transverse axis passes between the first and second flaps.

27. The device according to claim 25, characterized in that: In the folded state, the plurality of bridging elements are disposed on the first side of the sheet; and each flap extends from one of the plurality of bridging elements and surrounds the sheet material such that a flap portion of each flap is disposed on the second side of the sheet material.

28. The device according to claim 22, wherein: In the expanded state, the first tab portion and the second tab portion flank the sheet material by being disposed on opposing sides of the sheet material in the plane.

29. The device according to claim 28, characterized in that: In the expanded state, the first and second tab portions, the first and second bridging elements, and the sheet material are arranged in a row to define a transverse axis in the plane; The folding axis of each of the plurality of flaps is 30 to 60 degrees relative to the transverse axis.

30. A device for use with an artificial valve, characterized in that: The device includes a connector, the connector including: A plate having: a first side facing a first direction; and a second side facing an opposite second direction; and a first leaflet engagement tab protruding from the first side in the first direction, and a second leaflet engagement tab protruding from the first side in the first direction, for clamping one or more leaflets of the artificial valve between the leaflet engagement tabs; and a plurality of flaps, each flap extending from the sheet and configured to fold along a corresponding folding axis toward the second direction, the plurality of flaps being arranged in a tube such that each flap has two adjacent flaps surrounding the tube, in: the fold axis of each flap being oriented 60 to 120 degrees relative to the fold axis of each of the two adjacent flaps of each flap; The connector is comprised of a single unitary flexible sheet of material folded to define the panel, the leaflet engagement tab, and the plurality of flaps; The flexible sheet is further defined by a plurality of bridging elements extending from respective edges of the sheet and extending toward each other across the first side of the sheet in a folded state, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet in a direction away from the first side of the sheet.

31. The device according to claim 30, characterized in that: The sheet material generally defines a plane, wherein each flap is configured to fold out of the plane along a fold axis corresponding to each flap.

32. The device according to claim 30, wherein: Each flap is configured to be folded over a corresponding portion of the second side of the sheet.

33. The device according to claim 30, wherein: The plurality of flaps comprises exactly four flaps.

34. The device according to claim 30, wherein: The fold axis of each flap is oriented at 70 to 110 degrees relative to the fold axes of the two adjacent flaps of each flap.

35. The device according to claim 34, characterized in that: The fold axis of each flap is oriented 80 to 100 degrees relative to the fold axes of the two adjacent flaps of each flap.

36. The device according to claim 35, characterized in that: The fold axis of each flap is oriented at approximately 90 degrees relative to the fold axes of the two adjacent flaps of each flap.

37. A method comprising: The method comprises: A single unitary flexible sheet is folded to define a connector having: A plate having: a first side facing a first direction; and a second side opposite to the first side; a leaflet receptacle comprising a first leaflet engagement tab and a second leaflet engagement tab disposed on the first side of the sheet material and projecting away from the sheet material in the first direction; and a plurality of flaps, each flap folded about a respective fold axis such that at least a portion of each flap is disposed on the second side of the sheet; attaching the one or more prosthetic leaflets to the connector by suturing the one or more prosthetic leaflets between the first leaflet coaptation tab and the second leaflet coaptation tab of the leaflet receptacle; and attaching the connector to a frame assembly by folding each flap of the plurality of flaps around a corresponding component of the frame assembly; and secure them by suturing; The sheet material further defines a plurality of bridging elements which, in a folded state, extend from respective edges of the sheet material and extend towards each other across the first side of the sheet material, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet material in a direction away from the first side of the sheet material.

38. A device for use at a heart valve of a subject, characterized in that: The device comprises: a frame assembly that can be advanced into the heart through the cavity, the frame assembly comprising: an inner stent frame defining a tubular portion; and an outer stent frame defining a ring body connected to the inner stent frame and surrounding the tubular portion; as well as a plurality of artificial valve leaflets connected to the frame assembly via connectors and disposed within the tubular portion, wherein the inner stent frame is cut from a first nitinol tube and has a first wall thickness; and the outer stent frame is cut from a second nitinol tube and has a second wall thickness, the second wall thickness being greater than the first wall thickness; The connector comprises a single unitary flexible sheet, and the unitary flexible sheet is folded to define a plate, a leaflet container, and a plurality of flaps; The plate has a first side facing a first direction; and a second side opposite to the first side; The leaflet container includes a first leaflet engagement tab extending from the first side of the plate, and a second leaflet engagement tab extending from the first side of the plate, wherein a plurality of artificial valve leaflets are clamped between the leaflet engagement tabs; Each flap of the plurality of flaps is folded about a corresponding folding axis such that at least a portion of each flap is disposed on the second side of the sheet; The sheet material further defines a plurality of bridging elements which, in a folded state, extend from respective edges of the sheet material and extend towards each other across the first side of the sheet material, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet material in a direction away from the first side of the sheet material.

39. The device according to claim 38, characterized in that: The first tube wall thickness is 0.45 to 0.65 mm, and the second tube wall thickness is 0.6 to 0.8 mm.

40. The device according to claim 38, wherein: The second tube wall thickness is at least 20% greater than the first tube wall thickness.

41. The device according to claim 38, wherein: The second tube wall thickness is at least 30% greater than the first tube wall thickness.

42. The device according to any one of claims 38 to 41, characterized in that: The inner frame further defines: an annular upstream support portion extending from the tubular portion and sized to be positioned against an upstream surface of the heart valve; and The outer frame further defines a plurality of flanges extending from the tubular portion and sized to rest against a downstream surface of the heart valve.

43. A device for use with a subject's heart, characterized in that The device comprises: an inner support frame, wherein: defining a tubular portion and a plurality of inner frame connecting elements; and having a relaxed, expanded state, wherein the tubular portion defines a relaxed, expanded diameter of the inner stent frame in the relaxed, expanded state; as well as An outer support frame, the outer support frame: A ring body and a plurality of outer frame connecting elements are defined; and having a relaxed deployment state, wherein the ring body defines a relaxed deployment diameter of the outer stent frame in the relaxed deployment state, the relaxed deployment diameter of the outer stent frame being smaller than the relaxed deployment diameter of the inner stent frame, in: The inner stent frame and the outer stent frame together define at least a portion of a frame assembly in which the outer frame connecting element is secured to the inner frame connecting element and the annulus surrounds the tubular portion, and The framework components: Also included: a plurality of artificial valve leaflets fixed to the tubular portion via a connector and disposed within the tubular portion; having a compressed state in which the frame assembly is advanceable intracavitarily into the heart; and expandable to an expanded state, wherein the tubular portion defines an expanded diameter defined by the inner stent frame in the expanded state, the expanded diameter defined by the inner stent frame being smaller than a relaxed expanded diameter of the inner stent frame; The connector comprises a single unitary flexible sheet, and the unitary flexible sheet is folded to define a plate, a leaflet container, and a plurality of flaps; The plate has a first side facing a first direction; and a second side opposite to the first side; The leaflet container includes a first leaflet engagement tab extending from the first side of the plate, and a second leaflet engagement tab extending from the first side of the plate, wherein a plurality of artificial leaflets are clamped between the leaflet engagement tabs; Each flap of the plurality of flaps is folded about a corresponding folding axis such that at least a portion of each flap is disposed on the second side of the sheet; The sheet material further defines a plurality of bridging elements which, in a folded state, extend from respective edges of the sheet material and extend towards each other across the first side of the sheet material, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet material in a direction away from the first side of the sheet material.

44. The device according to claim 43, wherein: The outer stent frame is connected to the inner stent frame such that: In the compressed state of the frame assembly, the outer stent frame is in circumferential contact with the tubular portion; and Circumferential contact is maintained between the outer stent frame and the tubular portion throughout deployment of the frame assembly to its deployed state.

45. The device according to claim 43, wherein: The plurality of outer frame connection elements are welded to the plurality of inner frame connection elements.

46. ​​The device according to claim 43, wherein: The device defines a plurality of articulation surfaces where the leaflets are secured to the frame assembly; and The outer stent frame is secured to the inner stent frame by (i) securing the outer frame connecting elements to the inner frame connecting elements, and (ii) suturing the outer stent frame to the inner stent frame at the joints.

47. A device for use in a heart of a subject, characterized in that The device comprises: A framework component definition has: a tubular portion defining a longitudinal lumen extending therethrough; an upstream support portion connected to the tubular portion; and a plurality of flanges connected to the tubular portion; as well as A plurality of artificial valve leaflets are connected to the tubular portion via a connector and disposed within the lumen, wherein: The framework components: having a compressed state for transluminal delivery to the heart; and There is an extended state, in which: the upstream support portion extending radially outward from the tubular portion; the plurality of flanges extending radially outward from the tubular portion and toward the upstream support portion; The tubular portion has a transverse cross-sectional area; and The frame assembly defines an annular space between the plurality of flanges, the upstream support portion, and the tubular portion, the annular space surrounding the tubular portion and having a cross-sectional area that is 5 to 10% of the transverse cross-sectional area of ​​the tubular portion; The connector comprises a single unitary flexible sheet, and the unitary flexible sheet is folded to define a plate, a leaflet container, and a plurality of flaps; The plate has a first side facing a first direction; and a second side opposite to the first side; The leaflet container includes a first leaflet engagement tab extending from the first side of the plate, and a second leaflet engagement tab extending from the first side of the plate, wherein a plurality of artificial valve leaflets are clamped between the leaflet engagement tabs; Each flap of the plurality of flaps is folded about a corresponding folding axis such that at least a portion of each flap is disposed on the second side of the sheet; The sheet material further defines a plurality of bridging elements which, in a folded state, extend from respective edges of the sheet material and extend towards each other across the first side of the sheet material, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet material in a direction away from the first side of the sheet material.

48. The device according to claim 47, characterized in that: The frame component is a first frame component and defines a first tubular portion, the plurality of leaflets are a plurality of first leaflets, and the device comprises a first implant comprising the first frame component and the plurality of first leaflets, and The device further comprises a second implant comprising: A second framework component is defined as follows: a second tubular portion defining a second longitudinal lumen extending therethrough; a second upstream support portion connected to the second tubular portion; and a plurality of second flanges connected to the second tubular portion; as well as a plurality of second artificial valve leaflets connected to the second tubular portion and disposed within the second longitudinal lumen, in: The second frame assembly: having a compressed state for transluminal delivery to the heart; and There is an extended state, in which: The second upstream support portion extends radially outward from the second tubular portion; and The plurality of second flanges extend radially outward from the second tubular portion and toward the second upstream support portion, The second tubular portion has a transverse cross-sectional area that is at least 30% greater than a transverse cross-sectional area of ​​the first tubular portion of the first implant; and The second frame assembly defines a second annular space between the plurality of second flanges, the second upstream support portion, and the second tubular portion. The second annular space surrounds the second tubular portion and has a cross-sectional area that is 5 to 10% of the transverse cross-sectional area of ​​the second tubular portion.

49. The device according to claim 47, wherein: The frame assembly is sized such that the cross-sectional area of ​​the annular space is 5 to 8% of the transverse cross-sectional area of ​​the tubular portion.

50. The device according to claim 49, wherein: The frame assembly is sized such that the cross-sectional area of ​​the annular space is 6 to 7% of the transverse cross-sectional area of ​​the tubular portion.

51. The device of claim 49, wherein: The frame assembly is sized such that the cross-sectional area of ​​the annular space is 6.5 to 7.5% of the transverse cross-sectional area of ​​the tubular portion.

52. The device of claim 47, wherein: The upstream support portion includes a plurality of arms that project radially outwardly from the tubular portion in the deployed state of the frame assembly.

53. The device according to claim 52, characterized in that: The tubular portion has an upstream end and a downstream end; the plurality of prosthetic valve leaflets being configured to provide unidirectional blood flow through the lumen from the upstream end to the downstream end; and each arm of the plurality of arms is attached to the tubular portion at a location downstream from the upstream end; The progressive lateral portion of each arm is defined by: a rising portion extending in an upstream direction beyond the upstream end of the tubular portion; an arched portion curved in a downstream direction to form an arch; and A lateral portion is curved in an upstream direction.

54. The device according to claim 53, wherein: The frame assembly defines the annular space between the plurality of flanges, the tubular portion, and the plurality of arcuate portions of the plurality of arms of the upstream support portion.

55. The device according to claim 53, wherein: Each flange extends radially outward from the tubular portion and toward a tip of the flange, and the arcuate portions of the arms curve beyond the tips of the flanges in a downstream direction.

56. A device for use at a heart valve of a subject, characterized in that The device comprises: a first implant and a second implant, each implant being advanceable intracavitarily into the heart and comprising: A framework component, including: an inner stent framework defining a tubular portion, the tubular portion defining an inner lumen; and an outer stent frame defining a ring body connected to the inner stent frame and surrounding the tubular portion; and a plurality of prosthetic valve leaflets connected to the frame assembly via connectors and disposed within the tubular portion; as well as A delivery tool includes a delivery capsule having a capsule diameter, wherein: The first implant has: an expanded state, wherein the lumen has a lumen diameter in the expanded state; and a compressed state in which the first implant has a compressed diameter and is sized to be received within the delivery capsule; and The second implant has: an expanded state, wherein the lumen has a lumen diameter that is at least 15% greater than the lumen diameter of the first implant; and a compressed state in which the second implant has a compressed diameter no greater than 2% of the compressed diameter of the first implant and is sized to be received within the delivery capsule; The connector comprises a single unitary flexible sheet, and the unitary flexible sheet is folded to define a plate, a leaflet container, and a plurality of flaps; The plate has a first side facing a first direction; and a second side opposite to the first side; The leaflet container includes a first leaflet engagement tab extending from the first side of the plate, and a second leaflet engagement tab extending from the first side of the plate, wherein a plurality of artificial valve leaflets are clamped between the leaflet engagement tabs; Each flap of the plurality of flaps is folded about a corresponding folding axis such that at least a portion of each flap is disposed on the second side of the sheet; The sheet material further defines a plurality of bridging elements which, in a folded state, extend from respective edges of the sheet material and extend towards each other across the first side of the sheet material, each of the leaflet engagement tabs protruding from its respective bridging element from the first side of the sheet material in a direction away from the first side of the sheet material.

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