Prosthetic valve and delivery tool therefor

Abstract

A device for a native valve of a heart of a subject, comprising: a tubular frame (30) defining a longitudinal axis to define a lumen; a valve member (62) disposed within the lumen and coupled to the tubular frame; an outer frame (40) and a pin (50). The outer frame is made of shape memory alloy. The tubular frame and the pins are composed of a non-shape memory alloy material. The outer frame includes a flange (42) defining an aperture (44) and is disposed radially outward from the tubular frame. The pin defines a stem (52) and a head (54) and couples the outer frame to the tubular frame. The head is disposed radially outward against the outer frame from the eyelet, the rod extends from the head through the eyelet to the tubular frame, and the rod is welded to the tubular frame.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a divisional application of application number CN201880076340.9 (PCT application number is PCT / IL2018 / 051350), application date December 12, 2018, and invention name “Artificial valve and delivery tool therefor”.

[0003] Technical field of the invention

[0004] Some applications of the present invention generally relate to the percutaneous delivery of medical implants. More specifically, some applications of the present invention relate to artificial heart valves and their implantation techniques. Background Art

[0005] Dilatation of the heart valve annulus, such as that caused by ischemic heart disease, prevents the valve leaflets from fully coapting when the valve closes. The reverse flow of blood from the ventricles to the atria results in an increase in total stroke volume and a decrease in cardiac output, which in turn eventually weakens the ventricles due to volume and pressure overload in the atria. Summary of the invention

[0006] An implant having a self-expanding portion and a non-self-expanding portion is provided. The implant includes a non-self-expanding tubular frame that is balloon expandable. The implant also includes an outer frame that includes a self-expanding flange and a self-expanding upstream support portion. The self-expanding properties of the flange and the upstream support portion are provided by an outer frame composed of a shape memory alloy. The tubular frame is composed of different materials.

[0007] The outer frame is coupled to the tubular frame by pins, which are made of the same material as the tubular frame. One end of each pin is fixed to the outer frame by the head of the pin. The other end of each pin is fixed to the tubular frame by welding.

[0008] The delivery tool includes a capsule having two capsule parts, one capsule part constraining the flange and the other capsule part constraining the upstream support part. The delivery tool also includes an airbag arranged in the tubular frame. At the implantation site, the flange and the upstream support part are released from the capsule and automatically deflected radially outward. Subsequently, the airbag is expanded to radially expand the tubular frame.

[0009] The delivery tool also includes a protrusion that is rigid enough to axially push the tubular frame so as to press the flange toward tissue at the implantation site, but flexible enough not to inhibit inflation of the balloon.

[0010] Therefore, according to an application of the present invention, there is provided a device for a natural valve of a heart of a subject, the device comprising:

[0011] A delivery tool, including:

[0012] A rod having a rod axis;

[0013] a capsule disposed at the distal end of the tool and comprising an upstream capsule portion and a downstream capsule portion, the capsule being openable by separating the upstream capsule portion and the downstream capsule portion; and

[0014] an air bag coupled to the rod and disposed in the capsule; and

[0015] An artificial valve, comprising:

[0016] a tubular frame compressed around the airbag and disposed within the capsule;

[0017] one or more shape memory flanges captured in the downstream bladder portion; and

[0018] a shape memory upstream support portion, constrained within the upstream capsule portion,

[0019] as well as:

[0020] the plurality of flanges being configured to automatically deflect radially outward when exposed from the downstream capsule portion;

[0021] The upstream support portion is configured to automatically deflect radially outward when exposed from the upstream capsule portion;

[0022] The tubular frame is configured to maintain compression around the balloon when the tubular frame is exposed from the capsule; and

[0023] When the tubular frame is exposed from the capsule, inflation of the balloon causes the tubular frame to plastically expand radially.

[0024] In one application, the artificial valve further includes one or more artificial valve leaflets disposed in the inner cavity and coupled to the tubular frame.

[0025] In one application, the tubular frame is disposed within the downstream capsule portion of the capsule.

[0026] In one application, the tubular frame is composed of a material other than a shape memory alloy.

[0027] In one application, the material is steel.

[0028] In one application, the material is cobalt chromium.

[0029] In one application, the plurality of flanges are comprised of a shape memory alloy.

[0030] In one application, the plurality of flanges are comprised of nickel titanium.

[0031] In one application, the airbag is fixed on the rod.

[0032] In one application, both the upstream capsule portion and the downstream capsule portion move axially relative to the rod.

[0033] In an application:

[0034] a first capsule portion selected from the group consisting of the upstream capsule portion and the downstream capsule portion, the first capsule portion being attached to a tube and axially movable relative to the rod by sliding the tube on the rod; and

[0035] A second capsule portion selected from the group is attached to a rod and is axially movable relative to the rod by sliding the rod through the rod.

[0036] In one application, the upstream capsule portion is retractable from above the upstream support portion by moving away from the airbag, and the downstream capsule portion is retractable from above the plurality of flanges by moving away from the airbag.

[0037] In one application, the delivery tool also includes one or more slender protrusions disposed in the downstream capsule portion, each of the plurality of protrusions having (i) a tip portion, and (ii) a base portion disposed deeper into the downstream capsule portion than the tip portion, the plurality of protrusions being disposed circumferentially around the rod axis so that the plurality of tip portions are disposed circumferentially around a downstream airbag portion of the airbag, and the tip portion of each protrusion is closer to the tubular frame than its corresponding base portion.

[0038] In one application, each of the plurality of protrusions is sufficiently rigid so that when pushed toward the tubular frame, it can apply an axial thrust of at least 0.5N to the tubular frame.

[0039] In one application, each of the plurality of protrusions is sufficiently rigid such that when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 3N to the tubular frame.

[0040] In one application, when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 3N and no more than 100N to the tubular frame.

[0041] In one application, when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 3N and no greater than 30N to the tubular frame.

[0042] In one application, when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 6N and no more than 30N to the tubular frame.

[0043] In one application, when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 40N and no more than 100N to the tubular frame.

[0044] In one application, when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 40N and no greater than 80N to the tubular frame.

[0045] In one application, when pushed toward the tubular frame, the one or more protrusions can collectively apply an axial thrust of at least 60N and no more than 100N to the tubular frame.

[0046] In one application, the tubular frame is disposed within the downstream capsule portion of the capsule, and wherein the downstream capsule portion is retractable from the tubular frame and at least the plurality of tip portions, exposing the tubular frame and at least the plurality of tip portions from the downstream capsule portion.

[0047] In one application, when the tubular frame and the plurality of tip portions are exposed from the downstream capsule portion, inflation of the airbag (i) causes the tubular frame to radially expand and (ii) causes each of the plurality of protrusions to deflect radially outward within a corresponding radial plane, wherein the rod axis and the protrusions are located in the corresponding radial plane.

[0048] In one application, when the tubular frame and the plurality of tip portions are exposed from the downstream capsule portion, inflation of the airbag uniformly fills the inner cavity of the tubular frame.

[0049] In one application, a widest portion of the airbag is disposed within the inner cavity.

[0050] In one application, each protrusion has a radial stiffness in a radial plane thereof and a transverse stiffness in a corresponding transverse plane, the transverse stiffness being greater than the radial stiffness.

[0051] In an application:

[0052] The airbag comprises an upstream airbag portion, a downstream airbag portion and a main airbag portion therebetween;

[0053] The tubular frame is compressed around the main body airbag portion; and

[0054] When the tubular frame and the multiple tip portions are exposed from the downstream capsule portion, inflation of the airbag (i) causes the tubular frame to radially expand by pressing the main airbag portion radially outward against the tubular frame, and (ii) causes the multiple protrusions to deflect radially outward by pressing the downstream airbag portion radially outward against the multiple protrusions.

[0055] In one application, the downstream airbag portion of the airbag extends away from the tubular frame and is tapered.

[0056] In one application, the upstream airbag portion of the airbag extends away from the tubular frame and is tapered.

[0057] In one application, a tip portion of each of the plurality of protrusions abuts the tubular frame, and the device is configured such that the tip portion of each of the plurality of protrusions remains in contact with the tubular frame when the airbag is inflated.

[0058] In one application, a downstream end of the tubular frame defines a frame circumference, the plurality of tip portions define a protrusion circumference, and when the tubular frame and the plurality of tip portions are exposed from the downstream capsule portion, inflation of the airbag increases the protrusion circumference at the same rate as the airbag increases the frame circumference.

[0059] In one application, the tip portion of each of the plurality of protrusions abuts the tubular frame.

[0060] In one application, the plurality of protrusions are not attached to the tubular frame.

[0061] According to the application of the present invention, there is further provided a device for delivering an artificial heart valve to a natural heart valve ring, the device comprising:

[0062] a rod having a longitudinal rod axis;

[0063] an inflatable airbag disposed at a distal end of the rod; and

[0064] one or more protrusions extending distally from the rod such that the plurality of protrusions are disposed around a proximal portion of the balloon,

[0065] as well as:

[0066] Inflation of the airbag causes radial expansion of the airbag, and the radial expansion of the airbag applies a radial force to each of the plurality of protrusions; and

[0067] Each of the plurality of protrusions has sufficient radial flexibility such that the radial force deflects the plurality of protrusions radially outward.

[0068] In one application, for each of the plurality of protrusions:

[0069] The protrusions are defined as:

[0070] a corresponding radial plane, the rod axis and the protrusion being located on the corresponding radial plane, and the protrusion being deflected in the corresponding radial plane in response to the radial force; and

[0071] a corresponding transverse plane, transverse to the corresponding radial plane, and the protrusion is located on the corresponding transverse plane;

[0072] The protrusion has a radial stiffness in its radial plane; and

[0073] The protrusion has a lateral stiffness in its lateral plane which is greater than the radial stiffness.

[0074] In one application, the device further comprises a tubular frame at the distal end of the rod, the tubular frame defining a longitudinal lumen, wherein the balloon is disposed within the lumen.

[0075] In one application, each of the plurality of protrusions is sufficiently rigid to apply an axial thrust of at least 0.5N to the tubular frame.

[0076] In one application, each of the plurality of protrusions is sufficiently rigid so that the one or more protrusions can collectively apply an axial thrust of at least 3N to the tubular frame.

[0077] In one application, the device further comprises one or more artificial valve leaflets disposed within the lumen and coupled to the tubular frame.

[0078] In one application, the airbag:

[0079] having a longitudinal balloon axis, co-linear with the longitudinal rod axis, the balloon axis extending through the inner cavity;

[0080] having (i) a deflated state; and (ii) an inflated state, wherein the airbag has a widest portion; and

[0081] Positioned relative to the tubular frame so that the widest portion is within the lumen.

[0082] In one application, the airbag uniformly fills the inner cavity in its inflated state.

[0083] In one application, in the inflated state of the balloon, the proximal portion of the balloon tapers toward a proximal end away from the tubular frame.

[0084] In one application, the balloon has a tapered distal portion in its inflated state, the tapered distal portion gradually becoming thinner from the tubular frame toward the distal end.

[0085] In one application, the widest portion of the airbag is disposed longitudinally between the proximal portion and the distal portion.

[0086] In one application, each of the plurality of protrusions has a tip portion that abuts a proximal surface of the tubular frame.

[0087] In one application, the tip portion of each of the plurality of protrusions is not attached to the tubular frame.

[0088] In one application, inflation of the bladder simultaneously increases (i) a radial distance between the tip portion of one of the plurality of protrusions and the tip portion of an opposite one of the plurality of protrusions, and (ii) a circumference of the tubular frame.

[0089] According to the application of the present invention, there is also provided a device for a heart of a subject, the device comprising:

[0090] a tubular frame surrounding a longitudinal axis to define an inner cavity along the longitudinal axis;

[0091] a valve member disposed within the lumen and coupled to the tubular frame;

[0092] 1. External frame:

[0093] disposed radially outwardly from said tubular frame;

[0094] including a flange; and

[0095] defines an eyelet; and

[0096] One pin:

[0097] define a member and a head; and

[0098] coupling the outer frame to the tubular frame,

[0099] in:

[0100] The outer frame is made of shape memory alloy;

[0101] The tubular frame and the pin are made of a material other than a shape memory alloy;

[0102] The head abuts against the outer frame radially outward from the eye;

[0103] The rod extends from the head through the eyelet to the tubular frame; and

[0104] The rods are welded to the tubular frame.

[0105] In one application, the outer frame further includes an upstream support portion shaped to extend radially outward from the tubular frame.

[0106] In one application, the flange is shaped to extend radially outwardly from the tubular frame.

[0107] In one application, the outer frame further includes an upstream support portion shaped to extend radially outward from the tubular frame, and the flange is shaped to extend radially outward from the tubular frame toward the upstream support portion.

[0108] In an application:

[0109] The flange: has a root and a tip; and extends away from the tubular frame from the root to the tip;

[0110] The eyelet is defined at the root of the flange; and

[0111] The head abuts against the root of the flange radially outward from the flange.

[0112] In one application, the eyelet is an outer eyelet, and wherein the tubular frame defines an inner eyelet through which the rod extends.

[0113] In one application, the shape memory alloy is nickel titanium.

[0114] In one application, the material is not a shape memory material.

[0115] In one application, the material is steel.

[0116] In one application, the material is cobalt chromium.

[0117] In one application, the flange is one of a plurality of flanges, and the outer frame: comprises the plurality of flanges; and the tubular frame.

[0118] In one application, the eyelet is one of a plurality of eyelets, and the outer frame defines the plurality of eyelets.

[0119] In one application, the plurality of flanges is equal in number to the plurality of holes.

[0120] In one application, the eyelet is one of a plurality of eyelets, and the root of each of the plurality of flanges defines a corresponding eyelet of the plurality of eyelets.

[0121] According to an application of the present invention, a method for constructing an artificial heart valve is further provided, the method comprising:

[0122] Cutting an outer frame from a tube of shape memory alloy, the outer frame including a flange and defining an eyelet;

[0123] cutting a tubular frame about a longitudinal axis from a tube of a material other than a shape memory alloy to define an interior cavity along the longitudinal axis;

[0124] positioning the outer frame on the tubular frame radially outward from the tubular frame;

[0125] Passing a rod of a pin through the eyelet such that (i) the rod of the eyelet extends into the tubular frame and (ii) a head of the pin is disposed radially outward from the eyelet against the outer frame;

[0126] welding the rods to the tubular frame;

[0127] applying a lining to at least part of the inner cavity; and

[0128] A plurality of artificial valve leaflets are fixed within the inner cavity.

[0129] In one application, the method further includes shaping the flange to extend radially outward.

[0130] In an application:

[0131] Cutting the outer frame includes: cutting the outer frame so that the flange has a root and a tip, and the eyelet is defined at the root; and

[0132] Passing the rod of the pin through the eyelet so that the head of the pin abuts against the outer frame radially outward from the eyelet comprises: passing the rod of the pin through the eyelet so that the head of the pin abuts against the root of the flange radially outward from the eyelet.

[0133] In an application:

[0134] The eyelet is an outer eyelet, and wherein cutting the tubular frame comprises: cutting the tubular frame such that the tubular frame defines an inner eyelet; and

[0135] The step of passing the rod comprises: passing the rod through the outer eyelet and the inner eyelet; and

[0136] Welding the rod to the tubular frame includes welding the rod to the tubular frame at the inner eyelet.

[0137] In one application, the shape memory alloy is nickel titanium, and cutting the outer frame from the tube of the shape memory alloy includes: cutting the outer frame from the tube of nickel titanium.

[0138] In one application, the material is not a shape memory material, and wherein cutting the tubular frame includes cutting the tubular frame from the material that is not a shape memory material.

[0139] In one application, the material is steel, and wherein cutting the tubular frame from a tube of the material comprises cutting the tubular frame from a tube of steel.

[0140] In one application, the material is cobalt chromium, and wherein cutting the tubular frame from a tube of the material includes cutting the tubular frame from a tube of cobalt chromium.

[0141] In one application, cutting the outer frame includes cutting the outer frame, wherein the outer frame further includes an upstream support portion.

[0142] In one application, the method further includes configuring the upstream support portion to extend radially outward.

[0143] In an application:

[0144] The flange is one of the plurality of flanges;

[0145] Cutting the outer frame includes: cutting the outer frame so that the outer frame defines the plurality of flanges; and

[0146] Positioning the outer frame includes positioning the outer frame such that the outer frame surrounds the tubular frame.

[0147] In one application, the hole is one of a plurality of holes, and cutting the outer frame includes cutting the outer frame such that the outer frame defines the plurality of holes.

[0148] In one application, cutting the outer frame includes cutting the outer frame so that the outer frame has an equal number of flanges and holes.

[0149] According to the application of the present invention, there is further provided a method for a natural valve of a heart of a subject, the method comprising:

[0150] advancing toward the heart an implant comprising a tubular frame disposed on a distal portion of a tool, the distal portion of the tool comprising:

[0151] a distal end of a rod;

[0152] an inflatable airbag having a main body portion disposed within the tubular frame;

[0153] one or more projections extending distally from the rod and on at least a proximal portion of the balloon toward the tubular frame, the proximal portion of the balloon being proximal to the main balloon portion of the balloon;

[0154] Pushing the plurality of protrusions distally toward the tubular frame to apply a distal pushing force to the tubular frame; and

[0155] While maintaining contact between the plurality of protrusions and the tubular frame, the airbag is inflated, thereby:

[0156] The radial expansion of the main body balloon portion causes the tubular frame to radially expand; and

[0157] Radial expansion of the proximal portion deflects the plurality of protrusions radially outward.

[0158] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 3N to the tubular frame.

[0159] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 3N and no greater than 100N.

[0160] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 3N and no greater than 30N.

[0161] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 6N and no greater than 30N.

[0162] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 40N and no greater than 100N.

[0163] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 40N and no greater than 80N.

[0164] In one application, pushing the plurality of protrusions distally toward the tubular frame includes pushing the plurality of protrusions distally toward the tubular frame such that the plurality of protrusions collectively apply a distal pushing force of at least 60N and no greater than 100N.

[0165] In an application:

[0166] The implant includes one or more self-expanding flanges;

[0167] The tool distal portion of the tool includes a capsule;

[0168] Advancing the implant includes: advancing the tubular frame while at least the flange is disposed within and constrained by the capsule;

[0169] The method further includes: prior to distally pushing the plurality of protrusions, self-expanding the plurality of flanges by exposing the plurality of flanges from the capsule; and

[0170] The step of pushing the plurality of protrusions distally against the tubular frame includes pushing the implant distally such that the plurality of flanges press against tissue of the native valve.

[0171] In one application, advancing the implant includes advancing the implant while positioning the plurality of protrusions within the capsule, and wherein exposing the plurality of flanges from the capsule includes retracting the capsule proximally relative to the implant such that the plurality of flanges and the plurality of protrusions are exposed from the capsule.

[0172] According to the application of the present invention, there is further provided a method for a natural valve of a heart of a subject, the method comprising:

[0173] Advancing towards the heart:

[0174] A distal portion of a delivery tool, the delivery tool comprising:

[0175] a rod extending to the distal end portion of the delivery tool;

[0176] a capsule disposed at the distal portion of the delivery tool and comprising an upstream capsule portion and a downstream capsule portion; and

[0177] a bladder coupled to the rod and at least partially disposed within the capsule;

[0178] and

[0179] an implant disposed within the capsule and comprising a tubular frame and one or more shape memory flanges, the tubular frame being compressed around the balloon and the plurality of flanges being restrained within the downstream capsule portion;

[0180] exposing the plurality of flanges from the downstream capsule portion so that the flanges automatically deflect radially outward;

[0181] Thereafter, the plurality of flanges are pressed against a downstream surface of the native valve by moving the implant in an upstream direction; and

[0182] The tubular frame is plastically expanded radially by inflating the bladder when the plurality of flanges are in contact with the downstream surface.

[0183] In one application, plastically expanding the tubular frame includes radially plastically expanding the tubular frame by inflating the bladder while continuing to press the plurality of flanges toward the downstream surface.

[0184] In one application, exposing the plurality of flanges from the downstream capsule portion includes moving the downstream capsule portion away from the upstream capsule portion.

[0185] In one application, advancing the implant includes advancing the implant while disposing the tubular frame within the downstream capsule portion, and the method further includes exposing the tubular frame from the downstream capsule portion.

[0186] In one application, exposing the tubular frame from the downstream capsule portion includes exposing the tubular frame from the downstream capsule portion before the step of pressing the plurality of flanges.

[0187] In one application, exposing the tubular frame from the downstream capsule portion includes: completely exposing the tubular frame from the downstream capsule portion without causing expansion of the tubular frame.

[0188] In one application, the implant further includes a shape memory upstream support portion confined within the upstream capsule portion, and the method further includes exposing the upstream support portion from the upstream capsule portion prior to expanding the tubular frame so that the upstream support portion automatically deflects radially outward.

[0189] In one application, moving the implant in the upstream direction includes: moving the implant so that the upstream support portion confined within the upstream capsule portion is located upstream of the natural valve, and wherein exposing the upstream support portion includes: exposing the upstream support portion so that the upstream support portion automatically deflects radially outward and contacts an upstream surface of the natural valve.

[0190] In an application:

[0191] The implant is compressed around a main balloon portion of the balloon;

[0192] The tool further includes one or more protrusions, any one of the plurality of protrusions having a base portion and a tip portion;

[0193] The plurality of protrusions extend from the rod toward the tubular frame on at least a downstream airbag portion of the airbag such that the tip portion of each of the plurality of protrusions is closer to the tubular frame than its corresponding base portion; and

[0194] Pressing the plurality of flanges against the downstream surface by moving the implant in the upstream direction includes pushing the implant in the upstream direction by urging the plurality of tip portions toward the tubular frame.

[0195] In one application, expanding the tubular frame includes inflating the airbag so that (i) the main airbag portion radially expands the tubular frame by pressing radially outward against the tubular frame, and (ii) the downstream airbag portion deflects the multiple protrusions radially outward by pressing radially outward against the multiple protrusions.

[0196] In one application, advancing the distal portion of the delivery tool includes: advancing the distal portion of the delivery tool while positioning the plurality of protrusions within the downstream capsule portion, and wherein the method further includes: exposing at least the plurality of tip portions of the plurality of protrusions from the downstream capsule portion before radially expanding the tubular frame.

[0197] In one application, exposing at least the tip portions of the projections from the downstream capsule portion includes exposing at least the tip portions of the projections from the downstream capsule portion before pressing the flanges against the downstream surface of the native valve.

[0198] According to the application of the present invention, there is further provided a method for a natural valve of a heart of a subject, the method comprising:

[0199] Advancing towards the heart:

[0200] A distal portion of a delivery tool, the delivery tool comprising:

[0201] a rod extending to the distal end portion of the delivery tool;

[0202] a capsule disposed at the distal end portion of the delivery tool; and a balloon coupled to the rod; and

[0203] an implant disposed within the capsule and comprising: a tubular frame; and an array of a plurality of shape memory flanges arranged around the exterior of the tubular frame, the tubular frame being compressed around the balloon, and the plurality of flanges being confined within the downstream capsule portion;

[0204] Then, exposing the plurality of flanges from the capsule so that the plurality of flanges automatically deflect radially outward from the tubular frame and the array defines an inter-flange distance; then, partially inflating the balloon to a partially inflated state:

[0205] (i) partially radially expanding the tubular frame, and (ii) partially increasing the distance between the flanges;

[0206] While the balloon remains in the partially inflated state, pressing the plurality of flanges against a downstream surface of the native valve by moving the implant in an upstream direction; and

[0207] Subsequently, the tubular frame is further radially expanded by further inflating the balloon to a further inflated state.

[0208] In one application, inflating the airbag to a further inflated state further includes: increasing the distance between the flanges.

[0209] In an application:

[0210] Exposing the plurality of flanges comprises: exposing the plurality of flanges while the plurality of flanges are located upstream of the native valve; and

[0211] The method further includes moving the exposed plurality of flanges downstream of the native valve prior to pressing the plurality of flanges toward a downstream surface of the native valve.

[0212] In one application, partially inflating the balloon includes partially inflating the balloon while the plurality of flanges are upstream of the native valve.

[0213] In one application, inflating the airbag to the further inflated state includes inflating the airbag to the further expanded state while continuing to press the plurality of flanges toward the downstream surface.

[0214] In one application, exposing the plurality of flanges from the capsule includes moving a downstream capsule portion of the capsule away from an upstream capsule portion of the capsule.

[0215] In one application, advancing the implant includes advancing the implant while disposing the tubular frame within the downstream capsule portion, and the method further includes exposing the tubular frame from the downstream capsule portion.

[0216] In one application, exposing the tubular frame from the downstream capsule portion includes exposing the tubular frame from the downstream capsule portion before pressing the plurality of flanges toward the downstream surface of the native valve.

[0217] In one application, exposing the tubular frame from the downstream capsule portion includes: completely exposing the tubular frame from the downstream capsule portion without causing expansion of the tubular frame.

[0218] In one application, the implant also includes a shape memory upstream support portion constrained within the capsule, and the method further includes: after pressing the multiple flanges toward a downstream surface of the natural valve, exposing the upstream support portion from the capsule so that the upstream support portion automatically deflects radially outward.

[0219] In one application, exposing the upstream support portion includes: exposing the upstream support portion so that the upstream support portion contacts an upstream surface of the native valve.

[0220] In an application:

[0221] The implant disposed in the capsule is advanced, and the tubular frame is compressed around the airbag, comprising: advancing the implant disposed in the capsule, and the tubular frame is compressed around a body airbag portion of the airbag;

[0222] The distal portion of the delivery tool includes one or more protrusions, each of the plurality of protrusions having a base portion and a tip portion;

[0223] Advancing the distal portion of the delivery tool comprises:

[0224] Advancing the distal portion of the delivery tool while the one or more protrusions extend from the rod toward the tubular frame over at least a downstream balloon portion of the balloon such that the tip portion of each of the plurality of protrusions is closer to the tubular frame than its corresponding base portion; and

[0225] Pressing the plurality of flanges against the downstream surface by moving the implant in the upstream direction includes pushing the implant in the upstream direction by urging the plurality of tip portions toward the tubular frame.

[0226] In one application, inflating the airbag includes: inflating the airbag so that (i) the main airbag portion radially expands the tubular frame by pressing radially outward against the tubular frame, and (ii) the downstream airbag portion deflects the multiple protrusions radially outward by pressing radially outward against the multiple protrusions.

[0227] In one application, advancing the distal portion of the delivery tool includes: advancing the distal portion of the delivery tool while positioning the plurality of protrusions within the capsule, and wherein the method further includes: exposing at least the plurality of tip portions of the plurality of protrusions from the capsule before partially radially expanding the tubular frame.

[0228] According to the application of the present invention, there is also provided a device for delivering an artificial heart valve to a natural heart valve ring, the device comprising:

[0229] a rod having a longitudinal rod axis;

[0230] a capsule disposed at a distal end of the rod;

[0231] an air bag coupled to the rod and disposed in the capsule;

[0232] one or more protrusions extending distally from the rod such that the plurality of protrusions are arranged around a proximal portion of the balloon; and

[0233] an artificial valve, comprising a tubular frame compressed around the balloon and disposed within the capsule,

[0234] in:

[0235] The tubular frame is configured to maintain compression around the balloon when the tubular frame is exposed from the capsule such that:

[0236] Inflation of the airbag to a partially inflated state partially radially expands the tubular frame; and

[0237] The airbag is inflated to a further inflated state to further expand the tubular frame radially;

[0238] Inflation of the airbag applies a radial force to each of the plurality of protrusions; and

[0239] Each of the plurality of protrusions is:

[0240] having sufficient radial flexibility so that the radial force deflects the plurality of protrusions radially outward;

[0241] Having sufficient rigidity to propel the tubular frame axially while:

[0242] The airbag is in the partially inflated state within the tubular frame; and

[0243] The plurality of protrusions are deflected radially outwardly by the airbag in the partially inflated state.

[0244] The present invention can be more fully understood through the following detailed description of the application program in conjunction with the accompanying drawings, in which:

[0245] Brief description of the accompanying drawings

[0246] Figures 1A to 1I is a schematic diagram of an implant according to some applications of the present invention;

[0247] Figures 2A to 2D is a schematic diagram of a tool according to some applications of the present invention;

[0248] Figures 3A to 3H A schematic diagram showing a tool for delivering an implant to a native valve of a subject's heart according to some applications of the present invention;

[0249] Figures 4A to 4B , Figures 5A to 5B and Figures 6A to 6B is a schematic diagram of an implant delivery tool according to some applications of the present invention; and

[0250] Figures 7A to 7H and Figures 8A to 8C is a schematic diagram of an additional embodiment of an implant delivery tool according to some applications of the present invention. DETAILED DESCRIPTION

[0251] refer to Figures 1A to 1I , which is a schematic diagram of an implant 20 according to some applications of the present invention.

[0252] The implant 20 includes a tubular frame 30 that surrounds a longitudinal axis ax1 to define a lumen 32 along the axis ax1. The implant 20 also typically includes at least one valve component (eg, an artificial valve leaflet 62) ( Fig. 1I ), placed in the inner cavity 32 and coupled to the frame 30. Therefore, the implant 20 generally includes or serves as an artificial valve 22.

[0253] The implant 20 also includes an outer frame 40 and one or more pins 50. The outer frame 40 is radially disposed outward from the tubular frame 30, includes one or more flanges 42, and defines one or more eyelets, such as external eyelets 44. Typically, the frame 40 includes a plurality of flanges (e.g., 3 to 18 flanges, such as 6 to 12 flanges, such as 8 to 12 flanges). Typically, the frame 40 defines a plurality of eyelets 44 (e.g., 3 to 18 eyelets, such as 6 to 12 eyelets, such as 8 to 12 eyelets). For some applications, the number of eyelets 44 is equal to the number of flanges. More typically, the number of pins 50 is equal to the number of eyelets 44. In the illustrated embodiment, there are 12 eyelets, 12 flanges, and 12 pins.

[0254] Typically, as shown, the frame 40 surrounds the tubular frame 30. For example, the frame 40 may include at least one ring 46 that surrounds the tubular frame 30 and to which the flange 42 is coupled. The ring 46 typically defines alternating peaks and valleys, such as a sawtooth or wavy shape.

[0255] Typically, the tubular frame 30 also defines one or more eyelets, such as inner eyelet 34. Typically, the frame 30 defines a plurality of eyelets 34 (e.g., 3 to 18 eyelets, such as 6 to 12 eyelets, such as 8 to 12 eyelets). Typically, the number of eyelets 34 is equal to the number of eyelets 44.

[0256] The outer frame 40 is composed of a shape memory alloy such as nickel titanium (e.g., Nitinol), while the tubular frame 30 and the pin 50 are composed of a material that is not a shape memory alloy. That is, the frame 30 and the pin 50 are both composed of the same material, and this material is not a shape memory alloy constituting the frame 40. Generally, the material constituting the frame 30 and the pin 50 is not any shape memory material. For example, the frame 30 and the pin 50 can be composed of steel (e.g., stainless steel, such as 316LVM) or a cobalt-chromium alloy (e.g., MP35N or L605). It is to be noted that in this patent application (including the specification and claims), the term "composed of x" means that x is the main substance constituting the element, so x imparts its properties to the element composed of x.

[0257] The pins 50 couple the outer frame 40 to the tubular frame 30. Each pin 50 defines a rod 52 and a head 54. The rod 52 passes radially inward through the eyelets 44 to the tubular frame 30 so that the head 54 is disposed radially outward from the eyelets 44 against the outer frame 40. The rods 52 are welded to the tubular frame 30. Typically, the rods 52 also pass radially inward through the corresponding eyelets 34 and are welded to the tubular frame 30 at the eyelets 34. Because the pins 50 and the frame 30 are both made of the same material, they can be welded together. In contrast, the frame 40 is made of a different material than the pins 50, and the coupling therebetween is provided by the head 54 being larger than the eyelets 44.

[0258] Typically, each flange 42 has a root 41 and a tip 43, and extends away from the tubular frame from the root to the tip. Each outer eyelet 44 is typically at (e.g., defined by) the root 41 of the corresponding flange 42. For example, such that the head 54 of the corresponding pin 50 is disposed radially outward from the eyelet against the root of the flange.

[0259] Thus, according to some applications of the present invention, there is provided a device for use with a heart of a subject, the device comprising:

[0260] a tubular frame surrounding a longitudinal axis to define an inner cavity along the longitudinal axis;

[0261] a valve member disposed within the lumen and coupled to the tubular frame;

[0262] 1. External frame:

[0263] disposed radially outwardly from said tubular frame;

[0264] including a flange; and

[0265] defines an eyelet; and

[0266] One pin:

[0267] defining a member and a head; and

[0268] coupling the outer frame to the tubular frame,

[0269] in:

[0270] The outer frame is made of shape memory alloy;

[0271] The tubular frame and the pin are made of a material other than a shape memory alloy;

[0272] The head abuts against the outer frame radially outward from the eye;

[0273] The rod extends from the head through the eyelet to the tubular frame; and

[0274] The rods are welded to the tubular frame.

[0275] Typically, frame 40 is cut from a tube of shape memory alloy. Typically, frame 30 is cut (e.g., laser cut) from a tube of another material. To facilitate use of implant 20 as a prosthetic heart valve, lumen 32 is typically lined with a liner 60 (e.g., comprising fabric), and a plurality of prosthetic leaflets 62 (e.g., comprising bovine pericardium) are secured within the lumen, e.g., by suturing the leaflets to liner 36 and / or frame 30. For clarity, the implant 20 is not shown in FIG. Figures 1A to 1H The liner 60, the flaps 62 and other fabric elements are omitted.

[0276] Therefore, according to some applications of the present invention, there is further provided a method for constructing an implant 20 (e.g., an artificial heart valve), the method comprising:

[0277] Cutting an outer frame from a tube of shape memory alloy, the outer frame including a flange and defining an eyelet;

[0278] cutting a tubular frame about a longitudinal axis from a tube of a material other than a shape memory alloy to define an interior cavity along the longitudinal axis;

[0279] positioning the outer frame on the tubular frame radially outward from the tubular frame;

[0280] Passing a rod of a pin through the eyelet such that (i) the rod of the eyelet extends into the tubular frame and (ii) a head of the pin is disposed radially outward from the eyelet against the outer frame;

[0281] welding the rods to the tubular frame;

[0282] applying a lining to at least part of the inner cavity; and

[0283] A plurality of artificial valve leaflets are fixed within the inner cavity.

[0284] Typically, as shown, the implant 20 also includes an upstream support portion 48, for example, including a plurality of radial arms 49 optionally covered in an annular sheet. More typically, the outer frame 40 defines the upstream support portion 48, and therefore, the upstream support portion is also composed of a shape memory alloy. The flange 42 extends radially outward from the tubular frame 30 and extends toward the upstream support portion 48. As discussed in more detail below, the flange 42 is configured to engage the downstream surface of the natural heart valve, and the upstream support portion is configured (e.g., shaped and / or dimensioned) to be placed against the upstream surface of the natural heart valve.

[0285] The shape and memory arrangement of the frame 40 are designed so that when unconstrained, the upstream support portion 48 and the flanges 42 extend radially outward from the tubular frame 30. Generally, when unconstrained, the flanges 42 are arranged around the exterior of the tubular frame 30 in an array 56 that defines an inter-flange distance D58. Figure 1G The inter-flange distance D58 is shown as the distance between opposing flanges 42, but in some embodiments, the inter-flange distance may refer to an alternative measurement (e.g., the distance between adjacent flanges 42). Figures 3A to 3H ), the implant 20 is delivered while being radially compressed (i.e., "crimped"), wherein the upstream support portion 48 and the flange 42 are constrained within the capsule. Because the frame 40 is made of a shape memory alloy, the flange 42 automatically deflects radially outward when the upstream support portion 48 is exposed from the capsule. In contrast, although the tubular frame 30 is also radially compressed during delivery, it maintains its radially compressed state when exposed from the capsule, and is subsequently plastically expanded, for example, using an air bag. Typically, in the absence of the frame 30, the frame 40 (e.g., the ring 46) will automatically expand radially when exposed from the capsule. However, since the frame 40 is coupled to the frame 30 (e.g., by a pin 50), the frame 30 prevents the frame 40 (e.g., its ring 46) from expanding radially until the frame 30 expands plastically. That is, although the frame 40 is elastic, the frame 30 is typically rigid enough to prevent the frame 40 from automatically expanding radially after being exposed from the capsule. Similarly, the elasticity of frame 40 is generally insufficient to pull frame 30 into its radially expanded state (ie, the state in which implant 20 functions as a prosthetic valve).

[0286] refer to Figures 2A to 2D , which is a schematic diagram of a tool 100 according to some applications of the present invention. For some applications, the tool 100 is used to implant an implant 20 at a native valve (e.g., as shown in FIG. Figure 3A-3H described above).

[0287] The tool 100 includes a rod 106, a capsule 110 and a balloon 120, which is typically a non-compliant balloon. The rod 106 has a central longitudinal rod axis ax2, which is typically identical or colinear with the central longitudinal axis of the tool 100. The capsule 110 is disposed at the distal end portion 104 of the tool (e.g., at the distal end of the rod 106), and the capsule 110 includes an upstream capsule portion 112 and a downstream capsule portion 114, and the capsule 110 can be opened by separating the upstream capsule portion and the downstream capsule portion. The balloon 120 is coupled to the rod 106 and is disposed in the capsule 110 (e.g., its downstream capsule portion 114). As shown, the tool 100 typically includes a controller and / or handle 108 at the proximal portion 102 of the tool.

[0288] Figure 2A The tool 100 is shown in a closed state, with the capsule portions 112 and 114 proximate to each other (eg, in contact with each other). Figure 2B The tool 100 is shown in an open state after the capsule 110 has been opened by retracting the capsule portion 114 away from the capsule portion 112 . Figure 2C Shows Figure 2B longitudinal cross section. Figure 2D Shown with Figure 2C Same longitudinal cross section, but with airbag 120 inflated. For clarity, Figures 2A to 2D The implant 20 is not shown.

[0289] As described above, the outer frame 40 of the implant 20 is made of a shape memory alloy. The flange 42 is shaped to protrude radially outward. The upstream support portion 48 (e.g., its arm 49) is also shaped to protrude radially outward. Figures 3A to 3H Described in more detail, during delivery, the flange 42 and the upstream support portion 48 are disposed within the capsule 110 and are constrained radially inward by the capsule 110. For example, the flange 42 may be constrained by the downstream capsule portion 114 (e.g., constrained within the downstream capsule portion), and the upstream support portion 48 may be constrained by the upstream capsule portion 112 (e.g., constrained within the upstream capsule portion). In order to deliver the implant 20, the tubular frame 30 is compressed around the balloon 120, which will eventually be used to radially expand the tubular frame. Typically, during delivery, the tubular frame 30 is disposed within the downstream capsule portion 114. Therefore, in preparation for implantation of the implant 20, the operator typically compresses (e.g., "crimps") the tubular frame 30 around the balloon 120, radially compresses the flange 42 and encapsulates it at least partially within the downstream capsule portion 114, and radially compresses the upstream support portion 48 (e.g., its arms 49) and encapsulates it at least partially within the upstream capsule portion 112.

[0290] In the delivery state of the device, the balloon 120 is generally disposed within the capsule 110, the flange 42 is generally confined within the downstream capsule portion 114, and the upstream support portion 48 is generally confined within the upstream capsule portion 112. For some applications, the term "within" means "completely within", i.e., no portion of the balloon, flange, or upstream support portion is disposed outside the capsule or capsule portion. For some applications, the term "within" means "at least partially therein", i.e., a portion of the balloon, flange, or upstream support portion may be disposed outside the capsule or capsule portion.

[0291] Therefore, according to some applications of the present invention, a device is provided, comprising:

[0292] A delivery tool, including:

[0293] A rod having a rod axis;

[0294] a capsule disposed at the distal end of the tool and comprising an upstream capsule portion and a downstream capsule portion, the capsule being openable by separating the upstream capsule portion and the downstream capsule portion; and

[0295] an air bag coupled to the rod and disposed in the capsule; and

[0296] An artificial valve, comprising:

[0297] a tubular frame compressed around the airbag and disposed within the capsule;

[0298] one or more shape memory flanges captured in the downstream bladder portion; and

[0299] a shape memory upstream support portion, constrained within the upstream capsule portion,

[0300] as well as:

[0301] the plurality of flanges being configured to automatically deflect radially outward when exposed from the downstream capsule portion;

[0302] The upstream support portion is configured to automatically deflect radially outward when exposed from the upstream capsule portion;

[0303] The tubular frame is configured to maintain compression around the balloon when the tubular frame is exposed from the capsule; and

[0304] When the tubular frame is exposed from the capsule, inflation of the balloon causes the tubular frame to plastically expand radially.

[0305] The balloon 120 has an upstream (e.g., distal) balloon portion 122, a downstream (e.g., proximal) balloon portion 126, and a main (e.g., middle) balloon portion 124 therebetween. The main balloon portion 124 generally comprises the widest portion of the balloon 120. Generally, the main balloon portion 124 is disposed within the lumen 32 of the tubular frame 30. That is, for delivery, the tubular frame 30 is generally compressed around the main balloon portion 25. As shown in FIG. Figure 2D As shown, when inflated, the main balloon portion 124 is generally cylindrical, and the balloon portions 122 and 126 generally taper from the main balloon portion and tubular frame 30. For example, the balloon portions 126 and 126 may be conical or hemispherical.

[0306] Typically, the balloon 120 is secured to the rod 106, for example, by attaching at least one end of the balloon to the rod. For example, and as shown, the balloon portion 124 can be attached to the rod 106. The tool 100 defines an inflation passage 119 from the proximal portion 102 to the distal portion 104. For some applications, and as shown, the tool 100 includes a conduit 118 through which the rod 106 extends and defines the passage 119 therebetween. For such applications, the balloon portion 126 of the balloon 120 is typically attached to the conduit 118, placing the balloon 120 in fluid communication with the passage 119 so that the balloon can be inflated through the passage.

[0307] Typically, the conduit 118 is fixed relative to the rod 106. However, the upstream capsule portion 112 and the downstream capsule portion 114 are typically both axially movable relative to the rod 106, such as by attaching one capsule portion to a rod 116 that can slide through the rod, and a portion of the other capsule portion is attached to a tube (not shown) that can slide on the rod. For example, and as shown, the capsule portion 112 can be attached to the rod 116, and the capsule portion 114 can be attached to the tube. The upstream capsule portion 112 can be retracted from above the upstream support portion 48 by moving away from the airbag 120 (i.e., in the upstream direction), and the downstream capsule portion 114 can be retracted from above the flange 42 by moving away from the airbag (i.e., in the downstream direction).

[0308] Typically, tool 100 includes one or more (usually multiple) elongated protrusions 130. Protrusions 130 are configured to apply axial thrust to implant 20 (e.g., its tubular frame 30) to maintain the position of the implant during deployment. For example, and as described in reference Figures 3A to 3HDescribed in more detail, after the flange 42 is exposed and expanded, the flange can be pushed and held against the downstream surface of the native valve (e.g., its leaflets), typically until the balloon 120 is at least partially expanded. Typically, each protrusion 130 has sufficient stiffness (e.g., axial stiffness) so that when pushed toward the tubular frame 30, it is capable of applying an axial thrust of at least 0.5N, such as at least 5N, such as at least 10N. 10N-for example, without protrusion bending. For example, each protrusion 130 can be capable of applying a thrust of 0.5 to 50N, such as 0.5 to 20N (e.g., 0.5 to 15N) or 5 to 50N (e.g., 5 to 20N, such as 5N to 15N, such as 5-10N or 10-15N). Typically, the protrusions 130 are collectively capable of applying an axial thrust of at least 3N (e.g., at least 6N, such as at least 20N, such as at least 40N, such as at least 60N) to the tubular frame 30. – For example, no protrusion bending. For example, the protrusions 130 may collectively be capable of applying a thrust of 3 to 100 N (e.g., 3 to 30 N (e.g., 6 to 30 N) or 40 to 100 N (e.g., 40 to 80 N or 60 to 100 N)). For clarity, these axial thrust values ​​are measured at one or more protrusions aligned parallel to the axis ax1.

[0309] During delivery (i.e., in the delivery state of the tool 100 and the implant 20), the protrusions 130 are typically disposed within the downstream capsule portion 114. Each protrusion 130 has a tip portion (e.g., a free end) 132 and a base 134. The base 134 is disposed deeper in the downstream capsule portion than the tip portion 132. The protrusions 130 are circumferentially disposed about the rod axis ax2 such that the tip portions 132 are circumferentially disposed about the balloon portion 126 of the balloon 120, with the tip portion of each protrusion being closer to the tubular frame 30 than its corresponding base 134. Typically, in the delivery state, the tip portions 132 abut the tubular frame 30 (e.g., its proximal end and / or downstream surface). However, the protrusions 130 (e.g., their tip portions 132) are typically not attached to the tubular frame 30. Therefore, after the tubular frame 30 is expanded and the balloon 120 is deflated (e.g., as described with reference to Figures 3A to 3H As described above, the protrusions 130 can be withdrawn without actively disengaging them from the tubular frame.

[0310] Despite the presence of the tapered balloon portion 126, the tool 100 is generally configured to facilitate continued application of axial thrust to the tubular frame 30 via the protrusions 130 while expanding the tubular frame. Figures 4A to 4B , Figures 5A to 5B and Figures 6A to 6BThis feature and its advantages are discussed in more detail. Once the tubular frame 30 and tip portion 132 are exposed from the downstream capsule portion 114, inflation of the bladder 120 both (i) radially expands the tubular frame (e.g., by the main body bladder portion 124 pressing radially outwardly on the tubular frame) and (ii) deflects each protrusion 130 radially outwardly (e.g., by the bladder portion 124 pressing radially outwardly on the protrusion).

[0311] The device can be configured so that the protrusion 130 deflects simultaneously and / or at the same rate as the tubular frame expands, thereby allowing the contact between the protrusion and the tubular frame to be maintained. For example, the tubular frame 30 can define a frame perimeter, the tip portion can jointly define a protrusion perimeter, and when the tubular frame and the tip portion are exposed from the downstream capsule portion, the inflation of the balloon 120 can increase the protrusion perimeter at the same rate as the increase in the frame perimeter.

[0312] Thus, each protrusion 130 has sufficient flexibility (e.g., radial flexibility) to enable it to be deflected by the radial force F1 applied by the radial expansion of the balloon portion 126. However, as described above, each protrusion 130 is also typically capable of applying an axial thrust F2 of at least 0.5 N to the tubular frame 30 (e.g., to overcome the axial resistance F3 of the frame 30 against the protrusion in the opposite direction of the force F2). The forces F1, F2, and F3 are Figure 4B Instructions.

[0313] For some applications of the present invention, the configuration is facilitated by each protrusion 130 being non-isometrically flexible. For example, each protrusion 130 may have a radial stiffness in its radial plane 136 and a transverse stiffness in its transverse plane 138, the transverse stiffness being greater than the radial stiffness (e.g., greater than twice the radial stiffness). For clarity, the radial plane 136 is the plane in which the protrusion and the axis ax2 lie, and in which the protrusion deflects, and the transverse plane 138 is generally transverse to the radial plane. The transverse plane 138 may also be tangent to the protrusion perimeter defined by the tip portion of the protrusion 130.

[0314] For some applications of the invention, the magnitude of outward radial force F1 is greater than the magnitude of axial resistance force F3. The inventors hypothesize that for at least some such applications of the invention, F1 being greater than F3 helps deflect protrusion 130 while axially pushing tubular frame 30.

[0315] For some applications, and as shown, the tip portion 132 is shaped to define a surface having a larger cross-sectional area than a portion of the protrusion 130 closer to the base 134. These surfaces are Figures 2C to 2D By Figure 3BThe element marked "130" in the lower cross section of Figure 3B The difference in cross-sectional area can be understood by comparing the elements marked "130, 132" in the upper cross-section of FIG. The inventors assume that these faces facilitate the application of axial thrust to the tubular frame 30 due to their larger cross-sectional area.

[0316] Reference now Figures 3A to 3H is a schematic diagram showing a tool 100 being used to deliver an implant 20 to a native valve 10 of a subject's heart 4, according to some applications of the present invention. Figures 3A to 3H A percutaneous transapical approach is shown, and it should be noted that the scope of the present invention includes other percutaneous approaches, such as transatrial or transluminal (e.g., transfemoral), mutatis mutandis. It should be noted that the scope of the present invention includes modifications to tool 100 to facilitate these approaches. Although Figures 3A to 3H While the valve 10 is shown as a mitral valve, it should be noted that the scope of the present invention also applies mutatis mutandis to include mutatis mutandis where the native valve is a tricuspid valve, an aortic valve, or a pulmonary valve.

[0317] When the tool 100 and implant 20 are in a delivery state (eg, with the capsule 110 closed and the implant 20 compressed therein), the tool 100 is advanced transapically into the left ventricle 8 ( Figure 3A ). For some applications, and as shown, tool 100 is positioned (e.g., facilitated by fluoroscopy) such that capsule portion 112 is disposed between native leaflets 12 of valve 10. Capsule portion 114 is then retracted from capsule portion 112 in a downstream direction, exposing (i) at least flange 42 of implant 20, and (ii) at least tip portion 132 of protrusion 130 ( Figure 3B ). The flange 42 automatically deflects radially outward when exposed. Figure 3C As shown in the inset of , the flanges 42 are arranged around the outside of the tubular frame 30 in an array 56, the array defining a flange-to-flange distance D58. Typically, this step also exposes the tubular frame 30 from the capsule portion 114. As described above, the tubular frame 30 typically does not expand after being exposed from the capsule portion 114.

[0318] Figure 3BTwo cross sections are included. The upper cross section is at the contact level between the protrusion 130 and the implant 20, and therefore shows the tip portion 132 of the protrusion, which is arranged circumferentially around the uninflated balloon 120, and the rod 106 extends through the tip portion. The lower cross section is closer to the downstream / proximal end, closer to the base 134 of the protrusion 130. For one protrusion 130, the lower cross section also shows a radial plane 136 and a transverse plane 138. As described above, the radial plane 136 is a plane on which the protrusion 130 and the axis ax1 are located and in which the protrusion deflects, and the transverse plane 138 is generally transverse to the radial plane.

[0319] Subsequently, by moving the implant 20 in the upstream direction, the flange 42 is pressed against the downstream surface of the native valve 10 ( Figure 3C ). This is performed by applying the above-mentioned axial thrust by means of the protrusion 130. Typically, the flange 42 is pressed against the leaflets 12 of the native valve.

[0320] like Figure 3C As shown, for applications where the artificial valve 22 includes an upstream support portion 48, such movement of the implant 20 includes positioning the upstream support portion constrained by the capsule portion 112 upstream of the native valve 10 (i.e., into the left atrium 6). For such applications, the protrusion 130 generally promotes the retention of the upstream support portion 48 within the capsule portion 112 by preventing the implant 20 from moving axially away from the capsule portion.

[0321] Subsequently, the upstream support portion 48 is exposed from the capsule portion 112 and automatically deflects radially outward, for example, to contact the upstream surface of the native valve 10 ( Figure 3D ).

[0322] When the flange 42 remains in contact with the downstream surface of the native valve, and typically when the upstream support portion 48 remains in contact with the upstream surface of the native valve, the tubular frame 30 is radially plastically expanded ( Figure 3E-Figure 3F ). For some applications, this is done while continuing to use protrusions 130 to press flange 42 against the downstream surface. As described above, when tubular frame 30 expands when balloon 120 is inflated, protrusions 130 are configured to deflect radially outward and thereby (i) not inhibit radial expansion of the balloon, and (ii) facilitate optional continued application of axial thrust during balloon inflation.

[0323] After the implant 20 has been implanted and expanded, the balloon 120 is deflated and the tool 100 is removed from the body, typically after closing the capsule 110. Figures 3G to 3H ).

[0324] Reference now Figures 4A to 4B, 5A-5B and 6A-6B are schematic diagrams of implant delivery tools 100, 200 and 300 according to some applications of the present invention. Figures 4A to 4B , 5A-5B and 6A-6B, a universal expandable implant 180 is shown implanted using a corresponding tool. For some applications, implant 180 can represent tubular framework 30 of implant 20.

[0325] Figures 4A to 4B Tool 100 is shown in use with an implant 180 , such as described above with respect to implant 20 . Figures 4A to 4B The states of the tool 100 in the embodiment generally correspond to Figures 2C to 2D The status of the tool 100, except Figures 4A to 4B The implant 180 is shown. That is, (i) Figure 4A The implant 180 is shown disposed about the main balloon portion 124 of the balloon 120, the downstream capsule portion 114 has been withdrawn, and the balloon 120 has not yet been inflated, and (ii) Figure 4B The airbag 120 is shown inflated. Figures 5A to 5B 6A-6B show the same state of tools 200 and 300 (eg, the same deployment step).

[0326] Tool 200 is the same as tool 100 except that it includes protrusions 230 instead of protrusions 130. Protrusions 230 are the same as protrusions 130 except that they are more rigid. Protrusions 330 are the same as protrusions 130 except that they are shorter and therefore do not extend over the balloon portion 126 to the implant 180. As described above, tool 100 is generally configured to facilitate continued application of axial thrust to the tubular frame 30 by protrusions 130 while the tubular frame is being expanded despite the presence of the tapered balloon portion 126. The advantages imparted by protrusions 130 can be illustrated by comparing the results of using tool 200 and / or tool 300 with the results of using tool 100 as follows.

[0327] As described above, the main balloon portion 124 is generally cylindrical, and the balloon portions 122 and 126 generally taper from the main balloon portion. Such a shaped balloon can advantageously withstand greater inflation pressures than a similar balloon that is completely cylindrical (i.e., has flat ends). However, in order to allow the implant 180 to expand uniformly, the implant is arranged around the main balloon portion 124, which is cylindrical when inflated.

[0328] Prior to inflation of the balloon 120, there is no difference between using tool 100 and using tool 200. When the balloon 120 of tool 100 is inflated, the protrusions 130 are pushed radially outward by the balloon, allowing the downstream balloon portion 126 (on which the protrusions are placed) to assume its conical shape and the main balloon portion 124 to assume its cylindrical shape, thereby uniformly expanding the implant 180. When inflated, the balloon 120 generally uniformly fills the lumen of the implant 180.

[0329] In contrast, when the balloon 120 of the tool 200 is inflated, the protrusions 130 are not pushed radially outward by the balloon, but rather restrict the expansion of the balloon portion 126 (on which the protrusions are arranged). As a result, the downstream region 124a of the main balloon portion 124 is inhibited from fully expanding and joining the rest of the main balloon portion to become cylindrical. As a result, the portion of the implant 180 arranged around the region 124a does not expand to the same extent as the rest of the implant. That is, the implant 180 does not expand uniformly.

[0330] The protrusions 330 of the tool 300 do not extend to the implant 180 on the balloon portion 126 and therefore do not restrict the expansion of the balloon portion 126. However, because they do not reach the implant 180, they cannot function to apply axial force to the implant so as to properly position the implant during implantation. In addition, in some cases, the implant 180 may slide relative to the balloon 120 and become positioned on the tapered balloon portion 126 or 122, which may result in uneven expansion of the implant as described above.

[0331] Thus, the specific mass of protrusion 130 is both (i) rigid enough to apply axial force to the implant and (ii) flexible enough radially to be pushed radially outward by balloon 120, giving tool 100 the ability to (i) control the position of the implant and (ii) uniformly expand the implant.

[0332] refer to Figures 7A to 7H and 8A to 8C, which are schematic diagrams of additional embodiments of an implant delivery tool 100 according to some applications of the present invention, wherein the implant delivery tool 100 is used to deliver an implant 20 to a native valve 10 of a heart 4 of a subject. In such an embodiment, the balloon 120 is configured to be expandable to at least (i) a partially inflated state and (ii) a further inflated state. For example, the proximal portion 102 of the tool 100 (e.g., the controller / handle 108) can be configured to inflate the balloon 120 to different partially inflated states, and can be further configured to inflate the balloon 120 to a further inflated state. The inventors hypothesize that regulating the inflation of the balloon 120 so that the balloon can be maintained in a partially inflated state can facilitate some applications of the tool 100, as described below. Since such an embodiment is similar to the above referenced Figures 3A to 3HThe following description will focus on the differences between them and the above references. Figures 3A to 3H Aspects of the embodiments are described.

[0333] although Figures 7A to 7H 8A to 8C illustrate a transapical approach to the native mitral valve, but these embodiments of the invention may be modified as necessary to accommodate alternative approaches mutatis mutandis to the mitral valve or other native heart valves. Fig. 7A The tool is shown being advanced while the implant 20 is placed within the capsule 110, and the implant is subsequently exposed from the capsule 110. In general, and as Figure 7B As shown, the flange 42 automatically deflects radially outward when exposed from the capsule 110, while the tubular frame 30 generally does not expand when partially or fully exposed from the capsule. Further typically, and as shown, the capsule 110 includes an upstream capsule portion 112 and a downstream capsule portion 114, and the flange 42 is exposed from the capsule by moving the downstream capsule portion away from the upstream capsule portion. Further typically, before the flange 42 is pressed against the downstream surface of the native valve 10, the flange 42 (i) is exposed from the downstream capsule portion and (ii) is arranged in an array 56 around the outside of the tubular frame 30.

[0334] For certain applications, it may be desirable to at least partially expand the tubular frame and / or array 56 of flanges 42 before the flanges contact the downstream surface of the native valve 10 . Figure 7C The balloon 120 is shown inflated to a partially inflated state before the flange 42 contacts the surface of the native valve 10. Inflation of the balloon 120 to the partially inflated state causes, among other things, (i) partial radial expansion of the tubular frame 30, and / or (ii) a partial increase in the inter-flange distance D58 defined by the array 56. Fig.7D The flange 42 is shown pressed against the downstream surface of the native valve 10 by moving the implant 20 in the upstream direction while the inter-flange distance D58 remains partially increased. Typically, and as shown, this is achieved by moving the implant in the upstream direction while the balloon 120 remains partially inflated. In this way, the partial inflation of the balloon 120 can enable the flange to reach further laterally while contacting the downstream surface of the native valve 10. The inventors hypothesize that increasing the inter-flange distance D58 defined by the array 56 before the flange 42 is pressed against the downstream surface can facilitate capture of tissue (e.g., the native leaflets 12) of the native valve 10, for example, increasing the amount of tissue ultimately captured between the flange 42 and the upstream support portion 48.

[0335] Subsequently, while the flange 42 remains in contact with the downstream surface (e.g., continues to press against the downstream surface), while the inter-flange distance D58 remains partially increased, and generally while the bladder 120 remains partially inflated ( Fig. 7E ), the upstream support portion 48 is exposed from the capsule 110. This can be similar to Figure 3D The steps shown, however, the inter-flange distance D58 is partially increased and the airbag 120 is typically partially inflated.

[0336] Subsequently, the airbag 120 is further inflated to a further inflated state, thereby causing the tubular frame 30 to further expand radially ( Figure 7F ). For some applications, this also further increases the inter-flange distance D58 by expanding the array 56. That is, further inflation of the airbag 120 may enable the flanges to reach further laterally than when the airbag 120 is in a partially inflated state.

[0337] Figure 7G and 7H The subsequent deflation of the balloon 120 and the withdrawal of the tool 100 is shown, for example, similar to that applied to Figures 3G to 3H .

[0338] For certain applications, it may be desirable to expose flange 42 from capsule 110 and / or at least partially expand array 56 while the flange is positioned upstream of native valve 10 (e.g., within atrium 6), and subsequently move the flange downstream of the native valve (e.g., within ventricle 8) while the flange remains in this state. Figures 8A to 8C Involving such applications.

[0339] Fig. 8A Shown is the exposure of a flange disposed upstream of a native valve 10 according to some applications of the present invention. Heretofore, tool 100 is typically positioned within the heart such that the flange is disposed within capsule 110 upstream of the native valve.

[0340] For some applications, and if Figure 8B As shown, the balloon 120 is then inflated to a partially inflated state while the flange 42 remains disposed upstream of the native valve 10 .

[0341] The tool 100 is then moved downstream (approximately, for a transapical approach) until the leaflets are visualized (eg, using fluoroscopy and / or ultrasound) to engage the upstream ( Figure 8C). The inventors hypothesize that this reduces the distance the flange is positioned downstream when deployed. That is, the position of the implant 20 where the leaflets are engaged upstream of the flange represents the minimum depth into the ventricle that the flange needs to reach in order to subsequently cause the leaflets to open. Thus, this reduces the distance the deployed flange must move in an upstream direction when the leaflets are subsequently engaged. The inventors hypothesize that this reduces the likelihood of inadvertent or premature entry into tissue such as chordae tendineae, which might occur if the deployed flange was deeper in the ventricle and therefore moved a greater distance upstream through the ventricle in the deployed state. Similar techniques are also described mutatis mutandis by Hammer et al. in US 2018 / 0014932 and Hariton et al. in WO 2016 / 125160, which are incorporated herein by reference.

[0342] For some applications where the flange 42 is exposed upstream of the native valve, the balloon 120 is partially inflated only after the exposed flange is moved downstream of the native valve (embodiment not shown).

[0343] Therefore, according to some applications of the present invention, a method is provided, comprising:

[0344] Advancing towards the heart:

[0345] A distal portion of a delivery tool, the delivery tool comprising:

[0346] a rod extending to the distal end portion of the delivery tool;

[0347] a capsule disposed at the distal end portion of the delivery tool; and a balloon coupled to the rod; and

[0348] an implant disposed within the capsule and comprising: a tubular frame; and an array of a plurality of shape memory flanges arranged around the exterior of the tubular frame, the tubular frame being compressed around the balloon, and the plurality of flanges being confined within the downstream capsule portion;

[0349] Then, exposing the plurality of flanges from the capsule so that the plurality of flanges automatically deflect radially outward from the tubular frame and the array defines an inter-flange distance; then, partially inflating the balloon to a partially inflated state:

[0350] (i) partially radially expanding the tubular frame, and (ii) partially increasing the distance between the flanges;

[0351] While the balloon remains in the partially inflated state, pressing the plurality of flanges against a downstream surface of the native valve by moving the implant in an upstream direction; and

[0352] Subsequently, the tubular frame is further radially expanded by further inflating the balloon to a further inflated state.

[0353] According to some applications of the present invention (for example, as reference Figures 8A to 8C There is further provided a method, wherein:

[0354] Exposing the flange includes: exposing the flange when the flange is upstream of the native valve; and

[0355] The method further includes, prior to pressing the flange against a downstream surface of the native valve, moving the exposed flange downstream of the native valve.

[0356] Those skilled in the art will recognize that the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that do not exist in the prior art that will occur to those skilled in the art when reading the above description.

Claims

1. A device for use on a subject's heart, characterized in that: The device comprises: a tubular frame surrounding a longitudinal axis to define an inner cavity along the longitudinal axis; a valve member disposed within the lumen and coupled to the tubular frame; 1. External frame: disposed radially outwardly from said tubular frame; and A pin; The outer frame is coupled to the tubular frame via the pins; in: The outer frame is made of shape memory alloy; The tubular frame and the pin are made of a material other than a shape memory alloy.

2. The device according to claim 1, characterized in that: The outer frame further includes a flange shaped to extend radially outward from the tubular frame.

3. The device according to claim 2, characterized in that: The outer frame further includes an upstream support portion shaped to extend radially outwardly from the tubular frame.

4. The device according to claim 3, characterized in that: The flange is shaped to extend radially outwardly from the tubular frame and toward the upstream support portion.

5. A device according to any one of claims 2 to 4, characterized in that: The pin defines a shaft and a head to couple the outer frame to the tubular frame.

6. The device according to claim 5, characterized in that: The outer frame further includes an eyelet.

7. The device according to claim 6, characterized in that: The eyelet is an external eyelet, And wherein the tubular frame defines an inner aperture, and the rod extends through the inner aperture.

8. The device according to claim 6, characterized in that: The flange has a root and a tip; and extends away from the tubular frame from the root to the tip; The eyelet is at the root of the flange; and The head abuts against the root of the flange radially outward from the flange.

9. The device according to claim 7, characterized in that: The head abuts against the outer frame radially outward from the hole; the rod extends from the head through the hole to the tubular frame; And the rods are welded to the tubular frame.

10. The device according to claim 1, characterized in that: The shape memory alloy is nickel titanium.

11. The device according to claim 1, characterized in that: The material is not a shape memory material.

12. The device according to claim 1, characterized in that: The material is steel or cobalt chrome.

13. The device according to any one of claims 6 to 12, characterized in that: The flange is one of a plurality of flanges, and the outer frame: includes the plurality of flanges; and surrounds the tubular frame.

14. The device according to claim 13, characterized in that: The eyelet is one of a plurality of eyelets, and the outer frame defines the plurality of eyelets.

15. The device according to claim 14, characterized in that: The plurality of flanges is equal in number to the plurality of holes.

16. The device according to claim 14, characterized in that: The eyelet is one of a plurality of eyelets, and a root of each of the plurality of flanges defines a corresponding eyelet of the plurality of eyelets.

17. A method for constructing an artificial heart valve, characterized in that: The method comprises: Cutting an outer frame from a tube of shape memory alloy, the outer frame including a flange and defining an eyelet; cutting a tubular frame about a longitudinal axis from a tube of a material other than a shape memory alloy to define an interior cavity along the longitudinal axis; positioning the outer frame on the tubular frame radially outward from the tubular frame; Passing a rod of a pin through the eyelet such that (i) the rod of the eyelet extends into the tubular frame and (ii) a head of the pin is disposed radially outward from the eyelet against the outer frame; welding the rods to the tubular frame; applying a lining to at least part of the inner cavity; and A plurality of artificial valve leaflets are fixed within the inner cavity.

18. The method according to claim 17, characterized in that: Further including: The flange is shaped so as to extend radially outward.

19. The method of claim 17, wherein: Cutting the outer frame includes: cutting the outer frame so that the flange has a root and a tip, and the eyelet is defined at the root; and Passing the rod of the pin through the eyelet so that the head of the pin abuts against the outer frame radially outward from the eyelet comprises: passing the rod of the pin through the eyelet so that the head of the pin abuts against the root of the flange radially outward from the eyelet.

20. The method of claim 17, wherein: The eyelet is an outer eyelet, and wherein cutting the tubular frame comprises: cutting the tubular frame such that the tubular frame defines an inner eyelet; and The step of passing the rod comprises: passing the rod through the outer eyelet and the inner eyelet; and Welding the rod to the tubular frame includes welding the rod to the tubular frame at the inner eyelet.

21. The method of claim 17, wherein: The shape memory alloy is nickel titanium, wherein cutting the outer frame from the tube of the shape memory alloy comprises: cutting the outer frame from the tube of nickel titanium.

22. The method of claim 17, wherein: The material is not a shape memory material, and wherein cutting the tubular frame comprises cutting the tubular frame from the material that is not a shape memory material.

23. The method of claim 17, wherein: The material is steel, and wherein cutting the tubular frame from a tube of the material comprises cutting the tubular frame from a tube of steel.

24. The method of claim 17, wherein: The material is cobalt chromium, and wherein cutting the tubular frame from a tube of the material comprises cutting the tubular frame from a tube of cobalt chromium.

25. The method according to any one of claims 17 to 24, characterized in that: Cutting the outer frame includes: cutting the outer frame, wherein the outer frame further includes an upstream support portion.

26. The method of claim 25, wherein: Further comprising configuring the upstream support portion to extend radially outward.

27. The method according to any one of claims 17 to 24, characterized in that: The flange is one of a plurality of flanges; Cutting the outer frame includes: cutting the outer frame so that the outer frame defines the plurality of flanges; and Positioning the outer frame includes positioning the outer frame such that the outer frame surrounds the tubular frame.

28. The method of claim 27, wherein: The eyelet is one of a plurality of eyelets, and cutting the outer frame includes cutting the outer frame such that the outer frame defines the plurality of eyelets.

29. The method of claim 28, wherein: Cutting the outer frame includes cutting the outer frame so that the outer frame has an equal number of flanges and holes.

30. A device for delivering an artificial heart valve to a native heart valve annulus, characterized in that: The device comprises: a transfer tool, comprising: A rod having a rod axis; a capsule disposed at the distal end of the delivery tool and comprising an upstream capsule portion and a downstream capsule portion, the capsule being openable by separating the upstream capsule portion and the downstream capsule portion; and an airbag coupled to the rod and disposed in the capsule, the airbag having an upstream airbag portion, a downstream airbag portion and a main airbag portion therebetween; An inflation passage extends from the proximal portion to the distal portion. A conduit through which the rod extends and to which the downstream balloon portion of the balloon is typically attached places the balloon in fluid communication with the passageway so that the balloon can be inflated through the passageway.

31. The device according to claim 30, characterized in that: The airbag is fixed on the rod.

32. The device according to claim 30, characterized in that: The upstream capsule portion and the downstream capsule portion both move axially relative to the rod.

33. The device according to claim 30, characterized in that: The delivery tool further comprises: One or more protrusions extend distally from the rod such that a plurality of protrusions are disposed around a proximal portion of the balloon.

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