Apparatus for controlled heart valve delivery

Abstract

The present application relates to devices for controlled heart valve delivery. A prosthetic implant delivery assembly can include a prosthetic implant and an elongate catheter. The prosthetic implant can include an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The catheter can include a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent can be releasably and pivotably coupled to at least one of the arms of the catheter such that the stent can pivot about the at least one of the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

Description

[0001] This application is a divisional application. The original application was filed on November 22, 2016, with application number 2016800774387 (the divisional application to which this application is filed has application number 202010529028X), and the invention is entitled "Device for Controlled Delivery of Heart Valve". Technical Field

[0002] This disclosure relates to implantable, expandable prosthetic devices, and to methods and delivery assemblies for such prosthetic devices. Background Technology

[0003] The human heart can be susceptible to a variety of valvular diseases. These diseases can lead to significant cardiac dysfunction and ultimately require repair of the natural valve or replacement with an artificial valve. Various known repair devices (e.g., stents) and artificial valves exist, along with numerous known methods for implanting these devices and valves in the human body. Due to the drawbacks associated with conventional open-heart surgery, percutaneous and minimally invasive surgical approaches are gaining significant attention. In one technique, prosthetic devices are configured for implantation via catheter insertion in a much less invasive procedure. For example, a crumplable transcatheter prosthetic heart valve can be crimped to a compressed state and percutaneously introduced in a compressed state on a catheter, and expanded to a functional size at the desired location by balloon inflator or by utilizing a self-expanding frame or stent.

[0004] One challenge in implanting a prosthetic valve via catheter insertion is the control and positioning of the distal end of the delivery device (i.e., the end of the device advanced into the patient's heart) and the prosthetic valve during the implantation procedure. Another challenge includes anatomical differences between patients, which can make some delivery devices or methods unsuitable for patients with specific anatomy.

[0005] Therefore, there is a continued need for improved transcatheter prosthetic devices and delivery equipment for implanting such devices. Summary of the Invention

[0006] This document discloses embodiments of an improved prosthetic implant delivery assembly, as well as related methods and apparatus for using such an assembly. In several embodiments, the assembly disclosed herein is configured for delivering a replacement heart valve into a patient's heart.

[0007] In one representative embodiment, the prosthetic implant delivery assembly may include a prosthetic implant comprising an expandable stent portion and an elongated catheter. The expandable stent portion has a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The elongated catheter has a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent is releasably and pivotally coupled to at least one arm of the catheter such that the stent can pivot about at least one arm so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

[0008] In some embodiments, the first end portion of the stent includes a plurality of apices circumferentially spaced apart from each other, each arm of the catheter includes an aperture at the distal end of the arm, and the apices extend through the corresponding aperture of the arm.

[0009] In some embodiments, the delivery assembly further includes a plurality of elongated locking elements corresponding to the arms of the catheter, wherein each tip of the stent includes a corresponding opening, and the locking elements are configured to extend through the openings of the stent tips such that the locking elements releasably couple the arms of the catheter to the stent when the stent tips are inserted through the holes in the arms. In some embodiments, at least one of the locking elements is axially movable relative to the other locking element. In some embodiments, the length of at least one of the locking elements differs from the length of the other locking element.

[0010] In some embodiments, at least one of the orifices in the arm has a different length than the other orifice in the arm. In some embodiments, the conduit further includes a plurality of sleeves, and the sleeves are configured to be axially slidable relative to the corresponding orifice of the arm, such that the sleeves can be used to change the effective size of the orifice of the arm, wherein the effective size of the orifice is the portion of the orifice not obstructed by the sleeve. In some embodiments, at least one arm of the conduit is axially movable relative to the other arm. In some embodiments, the length of at least one arm of the conduit is different from the length of the other arm.

[0011] In some implementations, the delivery assembly is configured to implant the prosthetic implant into the natural aortic valve via a retrograde approach.

[0012] In some embodiments, the longitudinal axis of the stent may be tilted up to 60 degrees relative to the longitudinal axis of the catheter. In some embodiments, the longitudinal axis of the stent may be tilted from 0 to 45 degrees relative to the longitudinal axis of the catheter.

[0013] In another representative embodiment, the prosthetic implant delivery assembly includes a prosthetic implant comprising an expandable stent portion having a plurality of apexes circumferentially spaced around a first end portion of the stent, wherein at least some of the apexes include orifices; and an elongated catheter comprising a plurality of radially expandable arms extending axially from a distal end of a shaft of the catheter, each arm having a radially inwardly extending hook portion wherein the hook portion of the arm releasably engages a corresponding orifice of the stent, and the arm of the catheter is configured such that when the arm is exposed from within a sheath, the arm can expand radially relative to the catheter, causing the hook portion to disengage from the orifice of the stent.

[0014] In some embodiments, the hook portion of the arm extends radially inward and angles proximally.

[0015] In some embodiments, the expandable stent is a self-expanding stent. In some embodiments, the expandable arm of the catheter is self-expanding.

[0016] In some embodiments, the delivery assembly further includes a shaft radially disposed within the catheter and an expansion element disposed on a distal portion of the shaft, wherein the expansion element is configured such that relative axial movement between the expansion element and the catheter arm in a first direction causes radial expansion of the arm, and relative axial movement between the expansion element and the catheter arm in a second direction allows radial compression of the arm. In some embodiments, the expansion element has a frusto-conical shape.

[0017] In some embodiments, the delivery assembly is configured such that relative rotational movement between the shaft and the dilation element results in relative axial movement between the dilation element and the catheter arm. In some embodiments, the delivery assembly is configured such that relative axial movement between the shaft and the arm results in relative axial movement between the dilation element and the catheter arm.

[0018] In some implementations, the multiple expandable arms include 2 to 15 arms.

[0019] The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0020] Figure 1 This is a perspective view of an embodiment of the prosthesis implant delivery assembly.

[0021] Figure 2 yes Figure 1 A perspective view of the delivery assembly, in which the prosthetic implant is in an inclined configuration.

[0022] Figure 3 yes Figure 1A perspective view of the delivery assembly of the prosthetic implant.

[0023] Figure 4 yes Figure 1 Side view of the locking conduit of the delivery assembly.

[0024] Figure 5A yes Figure 1 A perspective view of the delivery assembly, in which the prosthetic implant is in a compressed configuration.

[0025] Figures 5B-5C yes Figure 1 An enlarged perspective view of the delivery assembly, showing Figure 5A The area indicated in the middle is 5B.

[0026] Figure 6 yes Figure 1 A perspective view of an embodiment of the delivery assembly release catheter.

[0027] Figure 7 yes Figure 1 A perspective view of another embodiment of the delivery assembly release catheter.

[0028] Figure 8 yes Figure 1 A perspective view of another embodiment of the delivery assembly release catheter.

[0029] Figure 9 yes Figure 1 A perspective view of another embodiment of the delivery assembly release catheter.

[0030] Figure 10 yes Figure 1 A perspective view of another embodiment of the locking conduit for the delivery assembly.

[0031] Figure 11 yes Figure 1 A perspective view of another embodiment of the locking conduit for the delivery assembly.

[0032] Figure 12-16 This is a partial cross-section shown, illustrating the method for delivering a prosthetic implant into a patient's heart. Figure 1 A perspective view of the delivery assembly.

[0033] Figure 17 This is a perspective view of another embodiment of the prosthesis implant delivery assembly.

[0034] Figure 18 yes Figure 17 Detailed view of the prosthetic implant delivery assembly.

[0035] Figure 19-23 yes Figure 17Perspective views of various configurations of the prosthetic implant delivery assembly.

[0036] Figure 24-25 This is a perspective view of another embodiment of the prosthesis implant delivery assembly. Detailed Implementation

[0037] For this purpose of description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The methods, systems, and apparatuses described should not be construed as limiting in any way. Instead, this disclosure relates to all novel and non-obvious features and aspects (individually and in various combinations and sub-combinations) of the various disclosed embodiments. The methods, systems, and apparatuses of this disclosure are not limited to any particular aspect, feature, or combination thereof, nor do they require any one or more specific advantages to exist or any one or more specific problems to be solved.

[0038] Features, integers, characteristics, compounds, chemical parts, or groups described in connection with a particular aspect, embodiment, or example of the invention are to be understood as applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings) and / or all steps of any method or process so disclosed may be combined in any combination—except where at least some of such features and / or steps are mutually exclusive combinations. The invention is not limited to the details of any of the foregoing embodiments. The invention extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or to any novel step or any novel combination of steps in any disclosed method or process.

[0039] Although some operations in the methods of this disclosure are described in a specific sequential order for ease of illustration, it should be understood that this manner of description includes rearrangement unless a specific ordering is required by the particular language described below. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Furthermore, for the sake of brevity, the accompanying drawings may not show the various ways in which the methods, systems, and apparatus of this disclosure can be used in conjunction with other systems, methods, and apparatuses.

[0040] As used herein, the terms “a,” “an,” and “at least one” cover one or more of the referred elements. That is, if two specific elements exist, then one of those elements also exists, and therefore there is “an” element. The terms “a plurality of” and “multiple” mean two or more of the referred elements.

[0041] As used herein, the term “and / or” used between the last two elements in an element list means any one or more of the listed elements. For example, the phrase “A, B and / or C” means “A”, “B”, “C”, “A and B”, “A and C”, “B and C”, or “A, B and C”.

[0042] As used herein, the term “coupled” generally means physically coupled or connected, and does not exclude the presence of intermediate elements between the coupled elements unless otherwise specified.

[0043] This article describes examples of prosthetic implant delivery assemblies and their components that can improve physicians’ ability to control the distal end of the delivery assembly during implantation procedures and can be used for patients with a variety of anatomical structures.

[0044] For example, in some embodiments, the delivery assembly may allow the prosthetic valve to tilt relative to the delivery device, such that the prosthetic valve can be deployed coaxially with the heart's natural annulus—even if the delivery device is not coaxial with the heart's natural annulus. In some embodiments, for example, the delivery assembly may be used to recapture and / or reposition a prosthetic heart valve that has already been deployed with respect to the heart's natural annulus.

[0045] In some embodiments, the delivery assemblies (e.g., delivery assembly 100 and delivery assembly 200) are adapted to utilize a reverse route (see, e.g., Figure 12-16 Delivering and implanting a prosthetic heart valve in the natural aortic valve annulus or valve of the heart—although in other embodiments, it may be adapted to deliver and implant a prosthetic valve in other natural valve annulus of the heart (e.g., the annulus of the lung, mitral, and tricuspid valves) and / or via various other routes (e.g., antegrade, transseptal, transventricular, transatricular, etc.).

[0046] Delivery assemblies (e.g., delivery assembly 100 and delivery assembly 200) can also be adapted to deliver and implant prosthetic valves in other tubular organs or channels within the body. Furthermore, in addition to prosthetic valves, delivery assemblies can also be adapted to deliver and implant a variety of other prosthetic devices such as stents and / or other prosthetic prosthetic devices.

[0047] Figure 1 An example of a prosthetic implant delivery assembly 100 according to one embodiment is shown. The delivery assembly 100 may include two main components: a prosthetic heart valve 102 and a delivery device 104. The prosthetic valve 102 may be releasably and pivotally coupled to the delivery device 104, as further described below.

[0048] For reference Figure 3The prosthetic valve 102 may include an annular stent or frame 106 and a valve structure 108 coupled to the frame 106. The prosthetic valve 102 may have an inflow portion 110, a middle portion 112, and an outflow portion 114.

[0049] The frame 106 may include a plurality of interconnected struts 116 arranged in a grid pattern and forming a plurality of tips 118 at the inflow and outflow ends 110, 114 of the prosthetic valve 102. As shown, at least some of the tips 118 at the outflow end 114 of the prosthetic valve 102 may have corresponding holes or openings 120 formed therein (e.g., three, in the example embodiment). The openings 120 may, for example, be used to releasably and pivotally couple the prosthetic valve 102 to the delivery device 104, as further described below (see Figures 5A-5C ).

[0050] The tips 118 with openings 120 can be arranged in various ways relative to each other and relative to other tips 118 at the outflow end 114 of the prosthetic valve 102. For example, the tips 118 with openings 120 can be circumferentially distributed uniformly (e.g., symmetrically) around the outflow end 114 of the prosthetic valve 102 relative to other tips 118 at the outflow end 114 of the prosthetic valve 102. The tips 118 with openings 120 can be referred to as connecting arms or connecting posts, and can be longer than tips without openings 120.

[0051] Frame 106 can be made of any of the various suitable malleably expandable materials known in the art (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (“NiTi”), such as nitinol). When made of a malleably expandable material, frame 106 (and therefore prosthetic valve 102) can be crimped into a radially constricted configuration or state on the delivery catheter and then expanded in the patient to a functional state by an inflatable balloon or equivalent expansion mechanism. When made of a self-expanding material, frame 106 (and therefore prosthetic valve 102) can be crimped into a radially constricted configuration (see, e.g., Figure 3 And it is confined in a constricted configuration by being inserted into a sheath or equivalent mechanism of the delivery catheter. Once in vivo, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand radially to its functional state (e.g., Figure 15-16 ).

[0052] Further details regarding the wrinkleable transcatheter prosthetic heart valve (including the manner in which the valve structure 108 can be coupled to the frame 106 of the prosthetic valve 102) can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202.

[0053] See again Figure 1 The delivery device 104 may include a handle 122, an external catheter 124, a release catheter 126, and a locking catheter 128. The handle 122 may be positioned adjacent to the proximal portion 132 of the delivery device 104. The external catheter 124, the release catheter 126, and the locking catheter 128 extend coaxially along a longitudinal axis 134 from the proximal portion 132 of the delivery device 104 toward the opposite distal portion 136 of the delivery device 104. The release catheter 126 and the locking catheter 128 may be radially positioned within the lumen of the external catheter 124 and extend axially through the lumen of the external catheter 124. The locking catheter 128 may be radially positioned within the lumen 140 of the release catheter 126 (see [reference]). Figure 6 It extends axially through the lumen 140 of the release catheter 126.

[0054] Each of the external catheter 124, release catheter 126, and locking catheter 128 may be independently movable relative to each other. In some embodiments, the delivery device 104 may be configured such that relative axial movement between two or more of the catheters 124, 126, and 128 at the proximal end 132 of the delivery device 104 may cause a corresponding relative axial movement at or near the distal end 136 of the delivery device 104. For example, the delivery device 104 may be configured such that axial advancement of the proximal end of the release catheter 126 in a distal direction while maintaining the axial position of the external catheter 124 and the locking catheter 128 causes axial advancement of the distal end of the release catheter 126 relative to the external catheter 124 and the locking catheter 128 in a distal direction.

[0055] In an alternative embodiment, the delivery device 104 may be configured such that relative rotational movement between two or more of the catheters 124, 126, 128 at or near the proximal end of the delivery device 104 can cause a corresponding relative axial movement at or near the distal end 136 of the delivery device 104. For example, the delivery device 104 may be configured such that rotation of the proximal end of the release catheter 126 in a first direction while preventing rotational movement of the outer catheter 124 and the locking catheter 128 causes the distal end of the release catheter 126 to rotate relative to the outer catheter 124 and the locking catheter 128 in the first direction.

[0056] The external catheter 124 may include a sheath portion 144 disposed at the distal end 146 of the external catheter 124. The sheath 144 may be used to maintain the prosthetic valve 104 in a radially compressed state during delivery of the prosthetic valve 102 through the patient's body, as further described below.

[0057] For reference Figure 6The release conduit 126 may include a shaft portion (not shown) and a plurality of teeth or arms 150a, 150b, 150c (collectively referred to herein as "arms 150"). Arms 150 may extend axially from the distal end of the shaft and may be circumferentially spaced apart from each other. While the exemplary embodiment shows three arms (e.g., arms 150a, 150b, 150c), other embodiments may have fewer or more arms (e.g., two, four, five, or six arms). Each arm 150 of the release conduit 126 may have a corresponding hole or window 170 disposed near the distal end 171 of the arm 150.

[0058] For reference Figure 4 The locking conduit 128 may, for example, include a shaft 175 and locking elements or arms 172a, 172b, and 172c (collectively referred to herein as "arms 172") mounted at a location along a distal portion of the shaft 175. The arms 172 may be circumferentially spaced apart from each other. While the exemplary embodiment shows three arms (e.g., arms 172a, 172b, 172c) (one locking arm 172 for each release arm 150), other embodiments may, for example, have fewer or more arms (e.g., two, four, five, or six arms). Each arm 172 of the locking conduit 128 may have a curved or flared distal portion 177 that extends radially outward relative to the remaining arms 172, such as... Figure 4 As best shown in the diagram. The open distal portion 177 can facilitate improved interlocking between the tip 118 of the prosthetic valve 102 and the arm 172 of the locking catheter 128, as further described below.

[0059] The prosthetic valve 102 can be releasably and pivotally coupled to the release catheter 126—for example, by inserting the tip 118 of the prosthetic valve 102, having an opening 120, into a corresponding window 170 of the release catheter 126, as best shown in 5A-5C. The tip 118 of the prosthetic valve 102 can then be releasably secured within the window 170 of the release catheter 126—by radially inserting a corresponding locking element or arm 172 of the locking catheter 128 between the tip 118 of the prosthetic valve 102 and the arm 150 of the release catheter 126 (see [reference]). Figure 5A The arm 172 of the locking catheter 128 is axially advanced relative to the prosthetic valve 102 and the release catheter 126, such that the arm 172 of the locking catheter 128 extends through the opening 120 of the prosthetic valve 102, as... Figure 5B The best example shown is in the middle.

[0060] Coupled to the release catheter 126 in this manner, the prosthetic valve 102 is released from the release catheter 126 by retracting the arm 172 proximally relative to the release catheter 126, causing the arm 172 of the locking catheter to withdraw from the opening 120 of the prosthetic valve 102. This allows the tip 118 of the prosthetic valve 102 to slide out of the window 170 of the release catheter 126. Coupled to the release catheter 126 in this manner, the prosthetic valve 102 is also allowed to tilt or pivot relative to the release catheter 126, as the prosthetic valve 102 can pivot about the tip 118 of the prosthetic valve within the window 170 of the release catheter 126, as further described below.

[0061] In some embodiments, the arms 150 of the release catheter 126 may be independently axially movable relative to each other. For example, as Figure 6 As shown, each of arms 150a, 150b, and 150c can be independently axially movable relative to each other (e.g., in the direction indicated by arrow 174). In a specific embodiment, each arm 150 can extend axially into the handle 122 of the delivery device 104, and each arm can be actuated by a corresponding actuator (not shown) on or adjacent to the handle 122. In some embodiments, the proximal portions of the arms 150 can be supported on or coupled to a common axis that allows each arm to move axially independently.

[0062] This configuration of the release catheter 126 allows it to be used to deliver the prosthetic valve 102, and thus to pivot or tilt the delivery device 104 relative to the release catheter 126. For example, as Figure 1 As shown, when the arms 150 of the release catheter 150 are in the same axial position relative to each other, the longitudinal axis 176 of the prosthetic valve 102 can be aligned with the longitudinal axis 134 of the delivery device 104. The prosthetic valve 102 can be tilted—for example, by axially moving the arms 150 of the release catheter 126 relative to each other, such that the arms 150 are not all in the same axial position relative to each other, as... Figure 2 As shown in the diagram. This causes the longitudinal axis 176 of the prosthetic valve 102 to be oriented relative to the longitudinal axis 134 of the delivery device 104 toward the arm 150 that is retracted the furthest (e.g., Figure 2 The arm 150a) is tilted, causing axes 134 and 176 to be offset relative to each other by an angle θ.

[0063] In some embodiments, for example, the prosthetic valve 102 may be tilted relative to the delivery device 104 such that the angle θ is up to 60 degrees (e.g., 0 to 60 degrees). In other embodiments, for example, the prosthetic valve 102 may be tilted relative to the delivery device such that the angle θ is 0 to 45 degrees, 0 to 30 degrees, or 0 to 15 degrees.

[0064] In this way, the delivery device 104 allows the physician to actively manipulate the prosthetic valve, thereby positioning the prosthetic valve as desired at the implantation site. For example, Figure 15 A portion of the prosthetic valve 102 is shown, intended to be positioned within the natural valve annulus 160 (e.g., Figure 15 The left side of the prosthetic valve 102) and another portion of the prosthetic valve 102 that is unintentionally positioned within the natural valve annulus 160 (e.g., Figure 15 (Right side of prosthetic valve 102) (e.g., in) Figure 15 In the middle, too low in the annulus). In order to align the prosthetic valve 102 with the natural annulus 160, the physician may proximally retract (e.g., pull back) one or more of the arms 150 of the delivery device 104 (e.g., too low in the annulus). Figure 15 The rightmost arm (one or more) 150), while holding one or more of the arms 150 of the delivery device 104 (e.g., Figure 15 The positioning of the leftmost arm (one or more) 150 in the middle is such that the prosthetic valve is tilted relative to the inner duct 130 (e.g., moved upward to the right), as Figure 16 As shown in the image.

[0065] Furthermore, the delivery device 104 can allow the prosthetic valve to self-align relative to the natural valve annulus by allowing the prosthetic valve to tilt relative to the delivery device 104. For example, as Figure 1 As best illustrated, the frame 106 of the prosthetic valve 102 can be configured to have a radially tapering "waist" portion 182, which is positioned between the inlet end 110 and the middle portion 112 of the prosthetic valve 102. The waist portion 182 can have a relatively small radius relative to the inlet end 110 and the middle portion 112 of the prosthetic valve 102. Thus, when the prosthetic valve 102 expands radially to its functional state and begins to oppose the natural leaflets (e.g., leaflets 168, 184) and the natural annulus 160, the waist portion 182 of the prosthetic valve 102 tends to align itself with the natural annulus 160, as, for example… Figure 16 The best illustration is shown below. Therefore, if the delivery device 104 is coaxial with the natural annulus 160 during the deployment of the prosthetic valve 102, the prosthetic valve 102 can remain coaxial with the delivery device 104, and thus with the natural annulus 160; however, if the delivery device 104 is not coaxial with the natural annulus 160 during the deployment of the prosthetic valve 102, the prosthetic valve 102 can move proximally and / or tilt, such that the prosthetic valve 102 is relatively more coaxial with the natural annulus 160 (see, for example, Figure 16 ).

[0066] While in the example embodiment the outflow end (proximal) of the prosthetic valve is releasably coupled to the delivery device, in other embodiments the inflow end (distal) of the prosthetic valve may be releasably coupled to the delivery device. Furthermore, the orientation of the prosthetic valve may be reversed relative to the delivery device, such that the inflow end of the prosthetic valve is proximal and the outflow end is distal. This may, for example, allow the delivery assembly to be configured for various implantation sites (e.g., annular of the natural aorta, lung, mitral, and tricuspid valves) and / or for various delivery routes (e.g., antegrade, transseptal, transventricular, transatlantic).

[0067] In some embodiments, instead of axially movable release catheter arms, or in addition to axially movable release catheter arms, the release catheter 126' may have arms with different axial lengths relative to each other. For example, as Figure 7 As shown, arm 150b′ is axially longer than arm 150a′, and arm 150c′ is axially longer than arms 150a′ and 150b′. Arm 150 of the release catheter 126′ is configured in this manner such that the prosthetic valve 102 is oriented at an angle θ relative to the delivery device 104 toward the shortest arm 150 (e.g., ...). Figure 7 The arm 150a′ tilts or pivots—when the sheath 144 of the delivery device 104 is retracted relative to the prosthetic valve 102 and the prosthetic valve 102 expands to its functional configuration (see, for example, Figure 2 ).

[0068] In lieu of any of the foregoing examples, or in addition to any of the foregoing examples, in some embodiments, the release catheter 126″ may have release arms 150a, 150b, 150c, which have windows of different sizes relative to each other, such as Figure 8 As shown in the diagram. For example, the release catheter 126″ includes a window 170b, which is axially longer than windows 170a and 170c. This configuration of the windows in the release catheter 126″ allows the prosthetic valve 102 to be oriented at an angle θ relative to the delivery device 104 toward the longest window (e.g., ...). Figure 8 The window 170b in the middle tilts or shifts proximally—when the sheath 144 of the delivery device 104 is retracted relative to the prosthetic valve 102 and the prosthetic valve 102 expands to its expanded configuration (see, for example, Figure 2 ).

[0069] The release conduit 126″ may also have a plurality of circumferential openings or grooves 154 extending axially along the shaft portion 148 of the release conduit 126″. The grooves 154 may be configured to allow the release conduit 126″ to bend relatively more easily along the direction of the grooves 154. Therefore, the release conduit 126″ may be formed with grooves 154, which are formed in the first circumferential side portion 156 of the shaft 148; however, the second circumferential side portion 158 of the shaft 148 (… Figure 7 It can be formed without grooves. This configuration allows the release conduit 126″ to bend relatively more easily on the first side 156 toward the axis 148 than on the second side 158 toward the axis 148.

[0070] The release catheter 126″ can also be configured such that one of the arms of the release catheter 126″ can be axially aligned with the side of the shaft 148 having the groove 154. For example, as Figure 8 As shown, arm 150b is axially aligned with a first side 156 of shaft 148 having a groove 154. Aligning one of the arms 150 (e.g., arm 150b) with a relatively flexible side (e.g., the first side 156) of shaft 148 advantageously allows the physician to predetermine the orientation of arm 150 relative to the patient's natural anatomy when releasing catheter 126″ as delivery assembly 100 is advanced into the patient's body.

[0071] For example, when a prosthetic valve 104 is delivered to the natural aortic valve annulus 160 of the heart 162 via a retrograde approach using the delivery assembly 100 (e.g., as... Figure 15 As shown in the diagram, the release conduit 126″ can be self-oriented, allowing the slot 154 ( Figure 8 The release catheter 126″ is located near the inside curved portion 164 of the aortic arch 166 because it tends to bend toward the first side 156 due to the groove 154 in the shaft 148. Therefore, since the arm 150b is aligned with the first side 156 of the release catheter 126″, the arm 150b is expected to be guided toward the inside curved portion 164 of the aortic arch 166—near the natural left coronary leaflet or cusp 168 of the natural aortic valve.

[0072] In lieu of any of the foregoing examples, or in addition to any of the foregoing examples, in some embodiments, the release catheter 126″′ may have one or more sheaths, each sheath being slidably coupled to a corresponding arm 150 of the release catheter 126″′. For example, as Figure 9As shown, the release conduit 126″′ has three outer sleeves 180a, 180b, and 180c (collectively referred to herein as “outer sleeve 180”), which are slidably coupled to arms 150a, 150b, and 150c, respectively. Outer sleeve 180 can be axially slidable relative to arm 150 and independently of each other. Thus, outer sleeve 180 can be used to effectively change the length of the window—by axially sliding outer sleeve 180 relative to the corresponding window (e.g., in the direction indicated by arrow 174).

[0073] For example, sliding the sheath 180b of the release catheter 126″′ proximal to the window 170b of the release catheter 126″′ (while maintaining the positioning of the sheaths 180a and 180c relative to the corresponding windows 170a and 170c) effectively lengthens or extends the window 170b. Thus, the window 170b can be effectively longer than the windows 170a and 170c, which allows the prosthetic valve 102 to move and / or tilt (e.g., at an angle θ) relative to the delivery device 104 toward the window 170b of the release catheter 126″′—when the sheath 144 of the delivery device 104 is retracted relative to the prosthetic valve 102 and the prosthetic valve 102 expands to its functional configuration.

[0074] In lieu of any of the foregoing examples, or in addition to any of the foregoing examples, in some embodiments, the locking conduit 128' has locking arms that may be axially movable relative to each other. For example, as Figure 10 As shown, the locking conduit 128' may include locking arms 172, each of which can be independently moved axially (e.g., in the direction indicated by arrow 174). In a specific embodiment, each locking arm 172 may extend axially into the handle 122, and each arm may be actuated by a corresponding actuator (not shown) on or adjacent to the handle. In some embodiments, the proximal portion of the arm 172 may be supported on or coupled to a common axis. This common axis allows each arm to move independently.

[0075] This configuration of the locking catheter 128' allows the tip 118 of the prosthetic valve 102 to be simultaneously released from the delivery device 104—by simultaneously retracting the arm 172 of the locking catheter 128' proximally relative to the release catheter 126, or sequentially released—by retracting the arm 172 of the locking catheter 128' proximally relative to the release catheter 126 at relatively different speeds and / or at different times.

[0076] The successive release of the tips 118 of the prosthetic valve 102 from the delivery device 104 can, for example, allow the prosthetic valve 102 to tilt relative to the delivery device 104, thereby allowing the prosthetic valve 102 to self-align with the natural annulus 160, as described above. Furthermore, releasing one or more of the tips 118 of the prosthetic valve 102 can allow a physician to actively manipulate the positioning of the prosthetic valve 102 relative to the natural annulus 160—by axially moving the release catheter 126 and / or the arm 150 of the release catheter 126 that remains attached to the prosthetic valve 102. This axial movement can cause the prosthetic valve 102 to move and / or tilt (e.g., by an angle θ) relative to the delivery device 104, and therefore relative to the natural annulus 160.

[0077] In some embodiments, the locking conduit 128″ may have locking arms of different lengths. This may replace or be additional to any of the features described in the foregoing examples. For example, as Figure 11 As shown, the locking catheter 128″ may include an arm 172b longer than arm 172a, and an arm 172c longer than arms 172a and 172b. This configuration of the arms 172 of the locking catheter 128″ allows the tips 118 of the prosthetic valve 102 to be sequentially released from the delivery device 104. This can be accomplished by retracting the locking catheter 128″ proximally relative to the release catheter 126, such that the arms are retracted proximally from the openings 120 in the tips 118 of the prosthetic valve 102. As the locking catheter 128 is retracted proximally relative to the release catheter 126, the tip 118 of the prosthetic valve 102 corresponding to arm 172a (i.e., the shortest arm) is released from the delivery device 104, while the other arms 172b, 172c remain coupled to their corresponding tips 118 of the prosthetic valve 102.

[0078] refer to Figure 11 The locking catheter 128″ may include an arm 172 extending distal to the self-shaft 175′. In this embodiment, the delivery device 104 may include a separate shaft coaxially extending through the shaft 175′, on which the nasal cone 186 is mounted. The main shaft 175′ of the locking catheter 128″ may have a plurality of circumferential grooves 179 formed therein. The grooves 179 may serve as ports, for example, for adhesives applied to the delivery device 104 during assembly. The grooves 179 and / or additional grooves (not shown) may be configured to allow the locking catheter 128″ to bend more easily toward a first side toward the main shaft 175′ than toward a second side toward the shaft 175′ (where no grooves are formed) (e.g., similar to the groove 154 formed in the shaft 148 of the release catheter 126″).

[0079] The locking conduit 128″ can be configured such that when the locking conduit 128″ is inserted and axially advanced through the lumen 140 of the release conduit 126, the groove 179 is circumferentially aligned with the groove 154 of the release conduit 126″. Thus, the grooves 154 and 179 of the corresponding conduits 126 and 128 can work together to allow the delivery device 104 to bend more easily toward the side of the delivery device 104 on which the grooves 154 and 179 are provided.

[0080] It should be noted that the release conduit (e.g., release conduit 126″) and the locking conduit (e.g., locking conduit 128″) can be formed, for example, by laser cutting of the corresponding alloy tube. The alloy tube can be formed from a variety of suitable materials, including stainless steel, nitinol, and cobalt-chromium.

[0081] Releasing one or more of the tips 118 of the prosthetic valve while the other tips 118 remain attached allows the prosthetic valve 102 to self-align with the natural valve annulus (as described above), and / or allows the physician to manipulate the prosthetic valve 102—by axially moving the release catheter 126, which in turn causes the prosthetic valve 102 to move and / or tilt (e.g., at an angle θ) so that the prosthetic valve 102 is better aligned with the natural valve annulus 160.

[0082] In this manner, the delivery assembly 100 can be oriented, for example, within the natural aortic valve annulus 160, such that when the prosthetic valve 102 is dilated to its functional state, arm 172a of the locking catheter 128″ is positioned adjacent to the non-coronary tip (not shown), and arms 172b and 172c are positioned adjacent to the right coronary tip 184 and the left coronary tip 168, respectively (see [reference]). Figure 15 The prosthetic valve 102 can then be aligned with the natural aortic valve annulus 160—by retracting the locking catheter 128 proximally relative to the release catheter 126, such that the tip 118 of the prosthetic valve 102 corresponding to the arm 172a of the locking catheter 128 is released from the delivery device 104. The prosthetic valve 102 can then be positioned from a non-aligned and / or non-coaxial location (see, for example, Figure 15 Move to a more aligned and / or coaxial position (see, for example, Figure 16 — By self-aligning relative to the natural valve annulus 160 and / or by axially moving the release catheter 126 by the physician, the prosthetic valve 102 moves and / or tilts relative to the delivery device 104, thereby better aligning the prosthetic valve 102 with the natural valve annulus 160.

[0083] The configuration of the delivery assembly, which allows the prosthetic valve to move and / or tilt relative to the delivery device (e.g., as described above), can advantageously allow the prosthetic valve to be positioned coaxially or at least more coaxially within the heart's natural annulus, in cases where the delivery device cannot achieve the desired coaxiality relative to the natural annulus.

[0084] For example, Figure 12-16 An example of a prosthetic valve implantation procedure utilizing the delivery assembly 100 is shown. Figure 12 The image shows a delivery assembly 100 inserted into a patient's vascular system, and the distal end 136 of a delivery device 104, which is advanced to the natural aortic valve annulus 160 of the heart 162 via a retrograde route, and a prosthetic valve 102 (enclosed in a compression configuration within a sheath 144 of the delivery device 104). Figure 12 As shown, the delivery device 104 is approximately coaxial with the natural aortic valve annulus 160, but the distal end 136 of the delivery device 104 extends too deeply into the left ventricle 178 relative to the natural aortic valve annulus 160. Therefore, if the prosthetic valve 102 is deployed (deployed) from within the sheath 144 of the delivery device 104, the prosthetic valve 102 will be improperly positioned relative to the natural valve annulus 160 of the heart 162. Figure 13 As shown, with Figure 12 Compared to the positioning shown, the distal end 136 of the delivery device 104 is better positioned relative to the natural aortic valve annulus 160 and the left ventricle 178, but if the prosthetic valve 102 is deployed from within the sheath 144 of the delivery device 104, the distal end 136 of the delivery device 104, and therefore the prosthetic valve 102, will not be coaxial with the natural valve annulus.

[0085] For simultaneously achieving full coaxiality relative to the natural annulus ( Figure 12 ) and proper positioning ( Figure 13 The weakness of the delivery assembly may be caused by the relatively rigid distal portion of the delivery device, which prevents the distal portion of the delivery device from bending sufficiently to become coaxial with the natural valve annulus. Due to the concentration of material in this part of the delivery assembly, such as the compressed prosthetic valve and the relatively rigid delivery sheath, the distal portion can be relatively rigid compared to the rest of the delivery assembly.

[0086] This problem can also be affected by the size of the prosthetic valve in the delivery assembly. For example, a larger prosthetic valve can increase the relatively rigid portion of the delivery assembly. For instance, a prosthetic valve with a diameter of 29 mm can result in a relatively rigid segment of approximately 73 mm, a prosthetic valve with a diameter of 26 mm can result in a relatively rigid segment of approximately 67 mm, and a prosthetic valve with a diameter of 23 mm can result in a relatively rigid segment of approximately 62 mm (the relatively rigid segment is measured from the distal portion of the sheath towards the proximal end of the delivery device).

[0087] Furthermore, this problem can be compounded by the length of the patient's ascending aorta (e.g., the distance from the aortic arch to the natural aortic valve annulus). For example, a relatively short natural ascending aorta provides relatively less space for the delivery device to achieve coaxial alignment before the distal end of the delivery device is positioned too deep into the left ventricle (see, e.g., Figure 12).

[0088] For reference Figure 14 The prosthetic valve 102 can be deployed by retracting the external catheter 124 proximally relative to the release catheter 126, thereby exposing the prosthetic valve 102 from within the sheath 144. When the prosthetic valve 102 is fully exposed from the sheath 144, the prosthetic valve 102 can radially self-dilate to its functional state, such as... Figure 15 As shown in the figure. Alternatively, although not shown, if the frame 106 is formed of a malleable expandable material, the prosthetic valve 102 can be expanded to its functional state by expanding the balloon portion of the delivery device 104 on which the prosthetic valve 102 is folded.

[0089] If the prosthetic valve 102 is not coaxial with respect to the natural aortic valve annulus 160, for example... Figure 15 As shown, the prosthetic valve 102 can be moved and / or tilted relative to the delivery device 104 using the delivery device 104, which can improve the coaxiality and / or positioning of the prosthetic valve 102 relative to the natural aortic valve annulus 160, for example as... Figure 16 As shown in the figure. This can be accomplished by utilizing any of the above examples and / or techniques, including moving the arm 150 and / or sheath 180 of the release catheter 126, moving the arm 172 of the locking catheter 128, etc.

[0090] After the prosthetic valve 102 is desiredly positioned within the natural annulus 160, the prosthetic valve can be secured within the natural annulus and released from the delivery device 104. This can be accomplished by proximal retraction of the locking catheter such that all arms 172 of the locking catheter 128 retract from the openings 120 in the frame 106 of the prosthetic valve 102, thereby releasing the tip 118 of the frame 106 from the window 170 of the release catheter 126, and thus releasing the prosthetic valve 102 from the delivery device 104.

[0091] The release catheter 126 and locking catheter 128 can then be retracted proximally, such that the release and locking catheters 126, 128 are positioned within the outer catheter 124, and the nasal cone 186 of the inner catheter 130 is adjacent to the sheath 144 of the outer catheter 124. The delivery device 104 can then be removed from the patient's body by proximally retracting it.

[0092] In another embodiment, the delivery device 104 may include a rotatable torque shaft extending coaxially through the release catheter 126 and a sheath mounted on the distal end of the torque shaft. The sheath is operatively coupled to the torque shaft such that rotation of the torque shaft effectively retracts or advances the sheath relative to the implant. Further details of the delivery device are disclosed in U.S. Patent No. 9,155,619.

[0093] Figure 17An example of a prosthetic implant delivery assembly 200 according to another embodiment is shown. The delivery assembly 200 may include two main components: a prosthetic heart valve 202 and a delivery device 204. The prosthetic valve 202 may be releasably coupled to the delivery device 204, as further described below.

[0094] The prosthetic valve 202 may have an annular support or frame 206. Although the frame 202 of the prosthetic valve 202 is annular, for illustrative purposes and for clarity, only a portion of the annular portion of the frame 206 is shown. Similarly, although the prosthetic valve 202 may also have a valve structure radially disposed within and coupled to the frame 206 (e.g., in a manner similar to that of the prosthetic valve 102), for illustrative purposes and for clarity, the valve structure of the prosthetic valve 202 is not shown.

[0095] The frame 206 of the prosthetic valve 202 may have an inflow portion 208, a middle portion 210, and an outflow portion 212. The frame 206 may also have a plurality of interconnected struts 214 arranged in a grid pattern and forming a plurality of apexes 216, 218 at the corresponding ends 210, 214 of the frame 206.

[0096] At least some of the tips 218 at the outlet end 212 of frame 206 may have corresponding holes or openings 220 formed therein, such as Figure 23 The best illustration is shown below. For example, in the example embodiment, all tips 218 have openings 220 formed therein. In other embodiments, less than all tips 218 have openings 220 formed therein. For example, half, one-third, or one-quarter of the tips 218 may have openings 220 formed therein. In this embodiment, tips 218 with openings 220 may be evenly distributed circumferentially around the outlet end 212 of the frame 206 (e.g., symmetrically—in an alternating pattern).

[0097] The opening 220 in the tip 218 can include various shapes. For example, the opening 220 can be generally rectangular, circular, oval, etc. The opening 220 can be sized such that the opening 220 can be releasably coupled to the receiving and delivery device 204, as further explained below (see, for example, Figure 18 ).

[0098] Frame 206 can be made of any of a variety of suitable malleably expandable materials known in the art (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (“NiTi”), such as nitinol). When made of a malleably expandable material, frame 206 (and therefore prosthetic valve 202) can be folded into a radially constricted configuration or state on the delivery catheter and then expanded in the patient to a functional state by an inflatable balloon or equivalent expansion mechanism. When made of a self-expanding material, frame 206 (and therefore prosthetic valve 202) can be folded into a radially constricted configuration (see, e.g., Figure 19 And it is confined in a constricted configuration by being inserted into a sheath or equivalent mechanism of the delivery catheter. Once in vivo, the prosthetic valve can be advanced (expelled) from the delivery sheath, which allows the prosthetic valve to expand radially to its functional state (e.g., Figure 19-23 ).

[0099] Delivery device 204 may include a handle (not shown), an external catheter 222, and an implant delivery catheter 224. The handle may be positioned adjacent to the proximal portion of delivery device 204. The external catheter 222 and implant delivery catheter 224 extend coaxially from the proximal end of delivery device 104 toward the opposite distal portion 230 of delivery device 204. Implant delivery catheter 224 may be radially positioned within the lumen 232 of external catheter 222. Figure 18 It extends axially through the lumen 232 of the external conduit 222.

[0100] Although the implant delivery catheter 224 is radially positioned within the external catheter 222, for illustrative purposes, the external catheter 222 is shown transparently (except for...). Figure 19 (in the middle) to better illustrate the implant delivery catheter 224.

[0101] Each of the external catheter 222 and the implant delivery catheter 224 may be independently movable relative to each other. In some embodiments, the delivery device 204 may be configured such that relative axial movement between the external catheter and the implant delivery catheters 222, 224 at or near the proximal end of the delivery device 204 can result in a corresponding relative axial movement at or near the distal end 230 of the delivery device 204. For example, the delivery device 204 may be configured such that axial advancement of the proximal end of the implant delivery catheter 224 in a distal direction while maintaining axial positioning of the external catheter 222 results in axial advancement of the distal end of the implant delivery catheter 224 relative to the external catheter 222 in a distal direction.

[0102] In an alternative embodiment, the delivery device 204 may be configured such that relative rotational movement between the external catheter and the implant delivery catheters 222, 224 at or near the proximal end of the delivery device 204 can result in a corresponding relative rotational movement at or near the distal end 230 of the delivery device 204. For example, the delivery device 204 may be configured such that rotating the proximal end of the implant delivery catheter 224 in a first direction while preventing rotational movement of the external catheter 222 results in rotation of the distal end of the implant delivery catheter 224 relative to the external catheter 222 in the first direction.

[0103] The external catheter 222 may have a shaft portion 223, said shaft portion 223 having a distal portion including a sheath portion 236. The sheath 236 can be used to maintain the prosthetic valve 104 in a radially compressed state, such as... Figure 19 As best shown in the diagram. The sheath 236 of the external catheter 222 may include a distal portion 238 disposed at the distal end of the sheath 236.

[0104] For reference Figure 21 The implant delivery catheter 224 may include a shaft 240 and a plurality of teeth or arms 242. The arms 242 of the implant delivery catheter 224 may extend axially from the distal end 244 of the shaft 240 and may be circumferentially spaced apart from each other. While the exemplary embodiment shows eight arms, other embodiments may have fewer or more arms. For example, the implant delivery catheter 224 may have 2-20 arms, 5-16 arms, or 12-15 arms.

[0105] For reference Figure 23 The shaft 240 of the implant delivery catheter 224 may have a plurality of circumferentially extending grooves 246 formed on one or more sides of the shaft 240. Similar to the groove 154 of the release catheter 126″ of the delivery assembly 100, the grooves 246 may increase the flexibility of the implant delivery catheter 224 and may be configured such that the side of the implant delivery catheter facing the implant delivery catheter 224 is relatively easier to bend than the other side of the implant delivery catheter 224.

[0106] Each arm 242 of the implant delivery catheter 224 may have a curved or hooked portion 246 disposed at the distal end of the corresponding arm 242. The hook 246 may extend radially inward and may be used to releasably couple the prosthetic valve 202 to the delivery device 204. For example, now referenced... Figure 18 The hook 246 can be configured such that the hook 246 extends radially through the corresponding opening 220 of the tip 218 of the prosthetic valve 202, thereby releasably coupling the prosthetic valve 202 to the delivery device 204 via the implant delivery catheter 224, as further described below.

[0107] The arm 242 of the implant delivery catheter 224 can be configured from a radially compressed state (e.g., Figures 19-20 It can expand radially to a radially expanded state (e.g., Figure 23 , 25 This can be achieved, for example, by forming the arm 242 from any of a variety of suitable self-expanding materials (e.g., nickel-titanium alloys (“NiTi”), such as nitinol). The arm 242 can be formed, for example, by laser-cutting the nitinol tube and setting the shape of the arm 242 to a radially expanded state.

[0108] When constructed of a self-expanding material, the arm 242 of the implant delivery catheter 224 can be radially compressed by retracting the implant delivery catheter 224 relative to the outer catheter 222, or by advancing the outer catheter 222 relative to the implant delivery catheter 224, such that the arm 242 is disposed within the sheath 236 of the outer catheter 222. The arm 242 can be radially expanded by advancing the implant delivery catheter 224 relative to the outer catheter 222, or by retracting the outer catheter 222 relative to the implant delivery catheter 224, such that the arm 242 is exposed from the sheath 236 of the outer catheter 222.

[0109] like Figure 18 As best shown, arm 242 can be configured to have release point 254. At release point 254, arm 242 can be radially tapered or angled relative to the distal portion of the arm to allow arm 242 to expand radially outward such that hook 246 disengages from opening 220 of prosthetic valve 202 when release point 254 is exposed from sheath 236 of external catheter 222.

[0110] In some embodiments, each of the hooks 246 of the arm 242 may extend radially inward and may be at least slightly proximal angled. Thus, the hooks 246 may be configured such that when the arm 242 expands from a radially compressed state to a radially expanded state, the proximal angle of the hook 246 relative to the opening 220 of the frame 206 increases. In other words, the hooks 246 may be configured to engage the tip 218 of the frame 206 more closely when the arm 242 is in a radially compressed state (to facilitate interlocking between the arm 242 and the frame 206) than when the arm 242 is in a radially expanded state (to facilitate disengagement between the arm 242 and the frame 206).

[0111] In this manner, delivery device 204 can be used to percutaneously deliver and position a prosthetic valve 202 within the natural annulus of the heart. The prosthetic valve 202 can be releasably coupled to delivery device 204 by positioning the hook 246 of implant delivery catheter 224 into an opening 220 in the frame 206 of the prosthetic valve 202. The prosthetic valve 202 and the arm 242 of implant delivery catheter 224 can be radially compressed or folded and maintained in their respective compressed configurations by positioning the prosthetic valve 202 and the arm 242 of implant delivery catheter 224 within the sheath 236 of the external catheter. Delivery device 204, and thus the prosthetic valve 202, can then be inserted into the patient's body and advanced to the desired natural annulus of the patient's heart (e.g., the natural aortic valve annulus).

[0112] After the delivery device 204 and the prosthetic valve 202 are desiredly positioned within the natural annulus, the prosthetic valve 202 can be deployed by retracting the external catheter 222 proximally relative to the implant delivery catheter 224 (or advancing the implant delivery catheter 224 distally relative to the external catheter 222). When the prosthetic valve 202 is exposed from the sheath 236, the prosthetic valve 202 begins to expand radially, as... Figures 19-20 As shown. Further proximal retraction of the external catheter 222 allows the arm 242 of the implant delivery catheter 224 (and thus the outflow end 212 of the prosthetic valve 202) to dilate, as... Figure 21-22 As shown in the image.

[0113] The prosthetic valve 202 can be positioned and / or repositioned—for example, by moving the implant delivery catheter 224. The prosthetic valve 202 can also be partially and / or completely recompressed by retracting the implant delivery catheter 224 proximally relative to the external catheter 222 (or by advancing the external catheter 222 distally relative to the implant delivery catheter 224), thus allowing the prosthetic valve 202 to be repositioned and redeployed and / or retrieved from the patient's body.

[0114] After the prosthetic valve 202 is desiredly positioned and secured to the natural valve annulus, the sheath 236 can be retracted proximally relative to the implant delivery catheter 224, such that the release point 254 of the arm 242 ( Figure 18 The arm 242 is exposed from the sheath 236. This allows the arm 242 to expand radially outward sufficiently, causing the hook 246 to retract from the opening 220 of the prosthetic valve 202, thereby releasing the prosthetic valve 202 from the delivery device 204, as... Figure 23 As shown in the image.

[0115] For reference Figure 24-25In some embodiments, the delivery device 204 may have an inner catheter 326 having an expansion element 348. The inner catheter 326 may be radially positioned within the lumen 234 of the implant delivery catheter 224 (in this embodiment, an intermediate catheter). Figure 24 The lumen 234 extends axially through the implant delivery catheter 224 and can be independently movable relative to the external catheter and the implant delivery catheters 222, 224 (e.g., axially sliding / translating or rotating).

[0116] The dilation element 348 may be coupled to the distal end 350 of the inner catheter 326. The dilation element 348 may have a generally truncated conical shape. Thus, the dilation element 348 may be used to assist and / or cause radial dilation of the arm 242 of the implant delivery catheter 224. For example, when the arm 242 of the implant delivery catheter 224 is exposed from the sheath 236 of the outer catheter 222, the dilation element 348 may be retracted proximally relative to the implant delivery catheter 224, such that the dilation element 348 contacts the arm 242 and thus forces the arm 242 to dilate radially outward.

[0117] The dilation element 348 can provide several significant advantages. For example, the dilation element 348 can be used to release the prosthetic valve 202 from the delivery device 204 if the self-dilation force of the arm 242 of the implant delivery catheter 224 is insufficient to cause the arm 242 to dilate radially to a extent sufficient to remove the hook 246 from the opening 220 of the prosthetic valve 202. This can be particularly useful when, for example, the patient's natural anatomy interferes with the arm 242 and thus prevents the arm 242 from dilating sufficiently.

[0118] The expansion element 348 can also allow the arm 242 to be formed from a material with suitable plastic expansion (e.g., stainless steel, etc.), since the expansion element 348 can be used to expand the arm 242.

[0119] In some embodiments, the dilation element 348 may be fixedly coupled to the inner catheter 326. Thus, relative axial movement between the dilation element 348 and the arm 242 of the implant delivery catheter 224 can be caused by pushing the inner catheter 326 distally or pulling it proximally relative to the implant delivery catheter 224, which in turn causes the dilation element 348 to advance distally or retract proximally relative to the arm 242, respectively.

[0120] In other embodiments, the expansion element 348 may be slidably coupled to the inner catheter 326. For example, in some embodiments, rotation of the inner catheter 326 relative to the expansion element 348 in a first direction causes the expansion element 348 to slide or translate proximally along the inner catheter 326 and contact the arm 242 of the implant delivery catheter 224, while rotation of the inner catheter 326 relative to the expansion element 348 in a second opposite direction causes the expansion element 348 to slide or translate distally along the inner catheter 326 and away from the arm 242 of the implant delivery catheter 224. This can be accomplished, for example, by forming the inner catheter 326 with external threads 352, by forming the expansion element 348 with corresponding internal threads (not shown), and by preventing the expansion element 348 from rotating with the inner catheter 326—such as by slidably attaching or connecting the expansion element 348 to another component of the delivery device (e.g., the outer catheter 222, the shaft 240, and / or the arm 242) via a shaft or sleeve 354. In other embodiments, the outer surface of the expansion element 348 may, for example, be formed with a longitudinal groove (not shown) that receives the arm 242. This allows the arm 242 to slide axially relative to the groove, but the groove prevents the expansion element 348 from rotating when the inner shaft 326 rotates.

[0121] The techniques from any instance can be combined with the techniques described in any one or more other instances. Given that there are many possible implementations to which the principles of this disclosure are applicable, it should be recognized that the exemplary implementations are merely preferred examples and should not be used to limit the scope of this disclosure.

Claims

1. A prosthesis implant delivery assembly, comprising: A prosthetic implant comprising an expandable stent having a plurality of apexes circumferentially spaced around a first end portion of the stent, wherein at least some of the apexes include holes; and An elongated catheter comprising a plurality of radially expandable arms extending axially from the distal end of the catheter's axis, each arm having a radially inwardly extending hook portion, wherein the hook portion of the arm releasably engages a corresponding hole of the stent. and A shaft radially disposed within the catheter, wherein the shaft is movable relative to the catheter; and An expansion element is disposed radially inward on the distal portion of the shaft and relative to the arm of the conduit, wherein the expansion element is movable relative to the arm of the conduit and is configured to apply a radial force to the arm of the conduit to move the arm radially outward, such that the hook portion of the arm disengages from the hole of the support.

2. The delivery assembly of claim 1, wherein the hook portion of the arm extends radially inward and angles proximally.

3. The delivery assembly of claim 1, wherein the support is a self-expanding support.

4. The delivery assembly of claim 1, wherein the arm of the catheter is self-expanding.

5. The delivery assembly of claim 1, wherein the expansion element has a truncated conical shape.

6. The delivery assembly of claim 1, wherein the delivery assembly is configured such that relative rotational movement between the shaft and the expansion element results in relative axial movement between the expansion element and the arm of the conduit.

7. The delivery assembly of claim 6, wherein the expansion element includes one or more longitudinally extending slots, wherein the slots are configured to receive the arm of the conduit, allowing relative axial movement between the expansion element and the arm, and preventing relative rotational movement between the expansion element and the arm.

8. The delivery assembly of claim 1, wherein the delivery assembly is configured such that relative axial movement between the shaft and the arm results in relative axial movement between the expansion element and the arm of the conduit.

9. The delivery assembly of claim 1, wherein the dilation element is movable relative to the arm of the catheter between a first position and a second position, wherein in the first position the dilation element is positioned distally relative to the second position and radially inwardly spaced from the arm of the catheter, and wherein in the second position the dilation element contacts the arm of the catheter and forces the arm radially outward.

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