Transcatheter delivery system

Abstract

The present invention relates to a transcatheter delivery system including a sheath, a delivery catheter, and an implantable device (e.g., a prosthetic valve, a stent, a stent graft, an occluder, or a vascular filter) held in a collapsed configuration by the delivery catheter. The delivery catheter includes a plurality of fiber guides separated by one or more reduced profile sections each having a transverse outer profile that is smaller than a transverse outer profile of the fiber guides.

Description

[0001] This application is a divisional application of Chinese patent application number 201880084461.8 entitled "Catheter Deployment System and Associated Method" (the invention patent application number 201880084461.8 is an application that entered the Chinese national phase of international patent application PCT / US2018 / 050768).

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Application No. 16 / 129,657, filed September 12, 2018, which claims the benefits of U.S. Provisional Application No. 62 / 579,756, filed October 31, 2017, U.S. Provisional Application No. 62 / 579,762, filed October 31, 2017, and U.S. Provisional Application No. 62 / 682,692, filed June 8, 2018, all of which are incorporated herein by reference in their entirety for all purposes. Background Technology

[0004] Depending on the device design and the delivery system used, various methods can be used to deliver implantable devices, such as prosthetic valves, to the treatment site. As an example, U.S. Patent No. 9,629,718, published April 25, 2017, to Gloss et al., relates to a system comprising a prosthetic valve having a self-expanding frame and a retainer configured to hold the frame of the prosthetic valve in a contractile configuration and control the expansion of the frame. According to Gloss et al., the retainer has a ring capable of controllably contracting and expanding, wherein the ring is disposed around at least a portion of the self-expanding frame such that contraction or expansion of the first ring controls the contraction or expansion of the frame.

[0005] In this field, progress relative to existing and anticipated transcatheter delivery systems remains to be achieved. Summary of the Invention

[0006] Various examples relate to transcatheter delivery systems that include a cannula, a delivery catheter, and an implantable device (e.g., a prosthetic valve, stent, stent graft, occluder, or vascular filter) held in a collapsed configuration by the delivery catheter. The delivery catheter includes multiple fiber guides separated by one or more reduced profile segments, each reduced profile segment having a smaller lateral external profile than the lateral external profile of the fiber guides.

[0007] According to one example (“Example 1”), a transcatheter delivery system includes a delivery catheter for use with an implantable device. The delivery catheter includes a body portion, a support portion extending from the body portion, a proximal restraint, and a distal restraint. The support portion has a longitudinal axis and includes a proximal guide having a restraint channel and a transverse outer profile, and a distal guide having a restraint channel and optionally a post member channel, the distal guide defining the transverse outer profile. The delivery catheter also has a first reduced profile segment located between the proximal and distal guides, the first reduced profile segment having a transverse outer profile smaller than the transverse outer profiles of the proximal and distal guides. The proximal restraint extends longitudinally from the body portion through the restraint channel of the proximal guide and extends radially from the restraint channel of the proximal guide. The proximal restraint is secured with a releasable looping configuration to define a proximal restraint ring. The distal restraint extends longitudinally from the body portion through the restraint channel of the distal guide and extends radially from the restraint channel of the distal guide. The distal constraint is secured with a releasable ring structure to define the distal constraint ring.

[0008] According to another example (“Example 2”) that is further than Example 1, the constraint channel of the proximal guide is located at an angular position relative to the longitudinal axis of the support portion, and the constraint channel of the distal guide is located at an angular position relative to the longitudinal axis of the support portion, the angular position of the constraint channel of the distal guide being different from that of the constraint channel of the proximal guide.

[0009] According to another example (“Example 3”) that goes further than Example 1 or 2, the lateral outer profile of the first reduced profile segment is at least 10% smaller than the lateral outer profile of the proximal guide and the lateral outer profile of the distal guide.

[0010] According to another example (“Example 4”) that goes further than any of Examples 1 to 3, the lateral outer profile of the first reduced profile segment is at least 20% smaller than the lateral outer profile of the proximal guide and the lateral outer profile of the distal guide.

[0011] According to another example (“Example 5”) that goes further than any of Examples 1 to 4, the lateral outer profile of the first reduced profile segment is at least 50% smaller than the lateral outer profile of the proximal guide and the lateral outer profile of the distal guide.

[0012] According to another example (“Example 6”) that goes further than any of Examples 1 to 5, the support portion further includes an intermediate guide having a lateral outer profile and a constraint channel, the intermediate guide being longitudinally spaced from and located between the proximal and distal guides, the constraint channel of the intermediate guide being at an angular position relative to the longitudinal axis of the support portion. The support portion also includes a second reduced profile segment extending between the distal guide and the intermediate guide, the second reduced profile segment having a lateral outer profile smaller than that of the distal guide and the intermediate guide, wherein the first reduced profile segment is located between the proximal guide and the intermediate guide. Furthermore, the transcatheter delivery system also includes an intermediate constraint extending longitudinally from the body portion through the constraint channel of the intermediate guide and radially from the constraint channel of the intermediate guide, the intermediate constraint being secured in a releasable loop configuration to define an intermediate constraint ring.

[0013] According to another example (“Example 7”) that goes further than any of Examples 1 to 6, the lateral outer profile of the second reduced profile segment is at least 50% smaller than the lateral outer profile of the distal guide and the lateral outer profile of the intermediate guide.

[0014] According to another example (“Example 8”) that goes further than any of Examples 1 to 7, the angular position of the constraint channel of the proximal guide is offset angularly by 10 to 350 degrees from the angular position of the constraint channel of the distal guide.

[0015] According to another example (“Example 9”) that goes further than any of Examples 6 to 8, the angular position of the constraint channel of the intermediate guide is offset by 10 to 350 degrees from the angular position of the constraint channel of the distal guide.

[0016] According to another example (“Example 10”) that goes further than any of Examples 6 to 9, the intermediate guide defines a lateral outer profile that is at least 50% smaller than the lateral outer profiles of the proximal guide and the distal guide.

[0017] According to another example further than any of Examples 1 to 10 (“Example 11”), the transcatheter delivery system further includes a pile member that releasably secures at least one of a proximal restraint in a releasable ring configuration and a distal restraint in a releasable ring configuration, such that the pile member is operable to release at least one of the proximal restraint ring and the distal restraint ring.

[0018] According to another example (“Example 12”) that goes further than any of Examples 1 to 11, the transcatheter delivery system further includes an end portion having a distal front section and a proximal support section, the proximal support section having a reduced lateral outer profile defining a recess configured to receive and support the end of a prosthetic valve in a compressed delivery state; and / or the proximal guide is a support guide having a stepped distal end defining a support surface for receiving the end of a prosthetic valve in a compressed delivery state.

[0019] According to another example further than any of Examples 1 to 12 (“Example 13”), the transcatheter delivery system also includes a prosthetic valve held in a compact delivery configuration by a proximal restraint ring and a distal restraint ring, the prosthetic valve including an expandable frame portion and a leaflet configuration supported by the frame portion to define a leaflet region of the prosthetic valve, and further wherein the leaflet region is positioned on a support portion between the proximal guide and the distal guide.

[0020] According to another example (“Example 14”) that goes further than Example 13, the leaflet region does not extend beyond the proximal and distal guides.

[0021] According to another example (“Example 15”) that goes further than Example 13 or Example 14, the distal guide tapers proximally on its lateral outer profile to receive the distal end of the leaflet region.

[0022] According to another example (“Example 16”) that goes further than any of Examples 13 to 15, the frame portion of the prosthetic valve has a distal end and a proximal end, and includes multiple rows of frame members defining an undulating pattern of alternating distally facing vertices and proximally facing vertices. The multiple rows of frame members include a distal row at the distal end of the frame portion and a proximal row at the proximal end of the frame portion. Furthermore, a distal restraint ring surrounds the distal row at a proximal position of the distally facing vertices of the distal row, and a proximal restraint ring surrounds the proximal row at a distal position of the distally facing vertices of the proximal row.

[0023] According to another example (“Example 17”) that goes further than any of Examples 13 to 16, the frame portion of the prosthetic valve has a distal end and a proximal end, and includes multiple rows of closed cells defined by a plurality of frame members, each of the multiple rows of closed cells having a distal end, a proximal end, and an intermediate portion between the proximal and distal ends, the multiple rows of closed cells including a distal row of closed cells at the distal end of the frame portion and a proximal row of closed cells at the proximal end of the frame portion, and further wherein a distal restraint ring surrounds the distal row of closed cells at the intermediate portion of the distal row of closed cells, and a proximal restraint ring surrounds the proximal row of closed cells at the intermediate portion of the proximal row of closed cells.

[0024] According to another example (“Example 18”) that goes further than any of Examples 13 to 17, the frame portion of the prosthetic valve has a distal end and a proximal end, and further wherein a distal restraint ring restrains the distal end of the frame portion in a tapered configuration such that the frame portion defines a reduced lateral external profile at the distal end of the frame portion, and a proximal restraint ring restrains the proximal end of the frame portion in a tapered configuration such that the proximal end of the frame portion defines a reduced lateral external profile at the proximal end of the frame portion.

[0025] According to another example (“Example 19”) that goes further than any of Examples 1 to 18, the proximal guide has a second constraint channel and the distal constraint extends through the second constraint channel of the proximal guide.

[0026] According to another example (“Example 20”) that goes further than any of Examples 1 to 19, the proximal guide has an angled portion.

[0027] According to another example (“Example 21”), a method of delivering an implantable medical device to a desired treatment site in a patient using any one of Examples 1 to 20 includes: positioning the implantable medical device at a desired location in the patient using the transcatheter delivery system, the implantable medical device being mounted on a support portion of the transcatheter delivery system and held in a collapsed delivery configuration by a proximal restraint ring and a distal restraint ring of the transcatheter delivery system; releasing the proximal restraint ring by reducing tension on the proximal restraint member, causing the proximal portion of the implantable medical device to self-expand; and releasing the distal restraint ring by reducing tension on the distal restraint member, causing the distal portion of the implantable medical device to self-expand.

[0028] According to another example (“Example 22”) that goes further than Example 21, the proximal constraint ring and the distal constraint ring are released simultaneously.

[0029] According to another example (“Example 23”) that goes further than Example 21, the proximal constraint ring and the distal constraint ring are released sequentially.

[0030] According to another example (“Example 24”), a method of assembling a transcatheter delivery system includes: placing a prosthetic valve on a support portion of a delivery catheter as described in any one of Examples 1 to 20, such that the central longitudinal axis of the prosthetic valve is laterally offset from the central longitudinal axis of the support portion, and the leaflet region of the prosthetic valve is located between the proximal guide and the distal guide of the support portion; compressing the prosthetic valve into a radially compressed delivery configuration such that the leaflet region is received when the proximal and distal restraints are fixed around the prosthetic valve and secured to the delivery catheter using a post member; and constraining the prosthetic valve into a radially compressed delivery configuration having a proximal restraint ring defined by the proximal restraint and a distal restraint ring defined by the distal restraint.

[0031] According to one example (“Example 25”), a transcatheter delivery system includes a delivery catheter. The delivery catheter includes: a body portion; a support portion extending from the body portion; a support portion configured to support an implantable device; a post member; at least one constraint configured to be tensioned to the post member to hold the implantable device in a compact delivery configuration, relaxed from the post member to allow the implantable device to transition to an expanded deployment configuration, and released from the post member to release the implantable device from the delivery catheter; and an actuation portion configured to tension the at least one constraint, relax the at least one constraint, and release the at least one constraint from the post member. The actuating component includes: a housing assembly coupled to the main body; a shelf assembly housed within the housing assembly and including a slide rail fixed to the post member and slidably receiving a sliding member fixed to the at least one constraint member; a drive assembly slidably received on the slide rail and engaged with the sliding member to cause longitudinal translation of the sliding member within the slide rail; and an actuating component including a rotatable deployment knob and configured to cause longitudinal translation of the drive assembly along the slide rail.

[0032] According to another example (“Example 26”) that goes further than Example 25, the actuation part also includes a release component configured to longitudinally translate the slide rail to longitudinally translate the pile member.

[0033] According to another example (“Example 27”) that goes further than Example 25 or 26, the at least one constraint includes a catch that can be releasably fixed to the pile member.

[0034] According to another example (“Example 28”) that goes further than any of Examples 25 to 27, the drive assembly includes a clutch.

[0035] According to another example (“Example 29”) that goes further than Example 28, the clutch is a ratchet clutch.

[0036] According to another example (“Example 30”) that goes further than any of Examples 25 to 29, the main body, shelf assembly and drive assembly are releasably secured to the housing assembly by one or more clamps such that the shelf assembly and drive assembly are configured to be released from the drive assembly and the housing and slide longitudinally out from the distal end of the housing assembly.

[0037] According to another example (“Example 31”) relative to any one of Examples 25 to 30, the transcatheter delivery system includes an implantable device held on a support portion by at least one restraint member in a compact delivery configuration.

[0038] According to another example (“Example 32”) that goes further than Example 31, the implantable device is a prosthetic valve.

[0039] According to another example (“Example 33”) that goes further than any of Examples 25 to 32, the delivery conduit includes at least two restraints, each constrained to be tensioned to a post member to hold an implantable device in a compact delivery configuration, to be de-tensioned from the post member to allow the implantable device to transition to an expanded deployment configuration, and to be released from the post member to release the implantable device from the delivery conduit.

[0040] According to another example (“Example 34”) that goes further than any of Examples 25 to 33, the actuation assembly also includes a nut portion and a gear portion that defines a clutch arrangement such that rotation of the gear portion causes rotation of the nut portion until a torsional limit is reached, at which point the gear portion is allowed to slide against the nut portion.

[0041] According to another example (“Example 35”) that goes further than Example 34, the nut portion is screwed onto the drive assembly.

[0042] According to another example (“Example 36”) that goes further than either Example 34 or 35, the gear portion includes a plurality of teeth that mesh with a plurality of teeth of the deployment knob.

[0043] According to another example (“Example 37”) that goes further than either Example 1 or 25, the delivery conduit further includes a post member and an actuation portion configured to: tension at least one of the distal and proximal restraints, relax at least one of the distal and proximal restraints, and release at least one of the distal and proximal restraints from the post member. The actuation portion includes: a housing assembly coupled to the body portion; a shelf assembly housed within the housing assembly, the shelf assembly including a slide rail fixed to the post member and slidably receiving a slider fixed to at least one of the distal and proximal restraints; a drive assembly slidably received on the slide rail and engaged with the slider to cause longitudinal translation of the slider within the slide rail; and an actuation assembly including a rotatable deployment knob and configured to cause longitudinal translation of the drive assembly along the slide rail.

[0044] According to another example (“Example 38”), the features of any one of Examples 25 to 36 are further included in the features of Example 37.

[0045] According to another example (“Example 39”) that goes further than any of the foregoing examples, the implantable device includes a frame portion having a plurality of circumferentially oriented eyelets configured to receive one or more constraints.

[0046] According to another example (“Example 40”) that goes further than any of the foregoing examples, the transcatheter delivery system includes one or more restraints that are formed together with an eye ring knot to define a capture element.

[0047] According to another example (“Example 41”) that goes further than any of Examples 2 to 6, the distal guide includes a filament that extends around the support portion to form a first retaining ring that connects the distal guide to the support portion and a first guide ring that defines a constraint channel for the distal guide.

[0048] According to another example (“Example 42”) that goes further than any of Examples 2 to 6 and 41, the proximal guide includes a filament that extends around the support portion to form a first retaining ring that connects the proximal guide to the support portion and a first guide ring that defines a constraint channel for the proximal guide.

[0049] According to another example (“Example 43”) that is further than Example 42, the filament of the proximal guide extends around the support portion to form a second retaining ring, which connects the proximal guide to the support portion, and further wherein a first guide ring of the proximal guide is located between the first retaining ring and the second retaining ring of the proximal guide.

[0050] According to another example (“Example 44”) that goes further than either Example 42 or 43, the filament of the proximal guide is formed as a second guide ring that defines a channel and is positioned adjacent to the first guide ring of the proximal guide.

[0051] According to another example (“Example 45”) that goes further than Example 44, the constraint channel of the first guide ring of the proximal guide is angularly offset from the channel of the second guide ring of the proximal guide.

[0052] According to another example (“Example 46”) that goes further than any of Examples 2 to 6 and 41, the proximal guide includes a fiber guide tube defining a constraint channel for the proximal guide and includes a receiving portion and an exiting portion. The receiving portion extends along the outer surface of the support portion at a first lateral angular position relative to the top of the support portion and at a first longitudinal angle relative to the longitudinal axis of the support portion, and the exiting portion extends along the outer surface of the support portion at a second lateral angular position relative to the top of the support portion, different from the first lateral angular position, and at a second longitudinal angle relative to the longitudinal axis of the support portion, different from the first longitudinal angle.

[0053] According to another example (“Example 47”) that goes further than Example 46, the first longitudinal angle is from -15 degrees to 15 degrees.

[0054] According to another example (“Example 48”) that goes further than Example 46 or 47, the second longitudinal angle is from 75 degrees to 105 degrees.

[0055] According to another example (“Example 49”) that goes further than any of Examples 46 to 48, the first lateral angle position is 165 to 195 degrees.

[0056] According to another example (“Example 50”) that goes further than any of Examples 46 to 49, the second lateral angle position is 120 to 150 degrees.

[0057] According to another example (“Example 51”) that goes further than any of Examples 46 to 50, the fiber guide tube also defines a transition portion between the receiving portion and the exit portion, which extends longitudinally and circumferentially to bend along the surface of the supporting portion.

[0058] According to another example (“Example 52”) that goes further than any of Examples 46 to 51, the exit portion defines the outwardly flared outlet of the fiber guide tube.

[0059] According to another example (“Example 53”) that goes further than any of Examples 46 to 52, the receiving portion defines the inlet of the outwardly flared fiber guide tube.

[0060] According to another example (“Example 54”) that goes further than any of Examples 46 to 53, the proximal guide also includes a pile guide tube that extends along the outer surface of the support portion at a third lateral angle relative to the top of the support portion and at a third longitudinal angle relative to the longitudinal axis of the support portion.

[0061] According to another example (“Example 55”) that goes further than Example 54, the third lateral angle position is from -15 degrees to 15 degrees, and the third longitudinal angle is from -15 degrees to 15 degrees.

[0062] According to another example (“Example 56”) that goes further than any of Examples 2 to 6 and 41 to 55, the distal guide includes a fiber guide tube defining a constraint channel for the distal guide and includes a receiving portion and a disengaging portion. The receiving portion of the distal guide extends along the outer surface of the support portion at a first lateral angular position relative to the top of the support portion and at a first longitudinal angle relative to the longitudinal axis of the support portion. The disengaging portion of the distal guide extends along the outer surface of the support portion at a second lateral angular position relative to the top of the support portion, different from the first lateral angular position, and at a second longitudinal angle relative to the longitudinal axis of the support portion, different from the first longitudinal angle.

[0063] According to another example further than any of the foregoing examples (“Example 57”), the transcatheter delivery system includes a delivery catheter and an implantable device such as a prosthetic valve, wherein the implantable device includes at least one row of: a plurality of restraint guides included in the cover of the implantable device, a plurality of restraint retainers attached to the frame members of the implantable device, or a plurality of holes in the cover of the implantable device for receiving the restraints of the transcatheter delivery system to secure the implantable device in a compact delivery state.

[0064] According to another example (“Example 58”), a transcatheter delivery system for a prosthetic valve includes a support portion configured to support a first frame and a second frame positioned in series such that the first and second frames are longitudinally offset from each other. The delivery system also includes a plurality of post members, including a first post member and a second post member. The delivery system further includes a first restraint member disposed around the first frame and operable to retain the first frame in the delivery configuration, wherein the first restraint member is releasably engaged with the first post member. The delivery system also includes a second restraint member disposed around the second frame and operable to retain the second frame in the delivery configuration, wherein the second restraint member is releasably engaged with the second post member, and wherein the first and second post members are operable to independently release the first and second restraint members.

[0065] According to another example (“Example 59”) that goes further than Example 58, the delivery system also includes a plurality of guides, including a first guide and a second guide, wherein a first constraint extends through the first guide and a second constraint extends through the second guide.

[0066] According to another example (“Example 60”) that goes further than Example 59, the first pile member extends through the first guide.

[0067] According to another example (Example “61”) that goes further than either of Examples 58 and 59, the outer frame is supported at least partially by a first guide, and wherein the inner frame is supported at least partially by a second guide.

[0068] According to another example (“Example 62”) that goes further than any of the foregoing examples, the first frame and the second frame are longitudinally offset from each other such that the proximal end of the inner frame is located far to the distal end of the outer frame.

[0069] According to another example (“Example 63”), a method of delivering a prosthetic valve includes providing a prosthetic valve comprising an outer frame and an inner frame nestable within the outer frame. The method also includes providing a transcatheter delivery system including a first constraint and a second constraint, and a first post member fixed to the first constraint and a second post member fixed to the second constraint, wherein the prosthetic valve is loaded onto the delivery system such that the inner frame and the outer frame are longitudinally offset relative to each other. The method further includes releasing the first constraint from the first post member such that the outer frame expands from a delivery configuration to a deployment configuration, and, after the outer frame has expanded, advancing the delivery system relative to the outer frame such that the inner frame advances relative to the outer frame. The method further includes nesting the inner frame within the outer frame and then releasing the first constraint from a first locking element such that the inner frame expands from the delivery configuration to the deployment configuration.

[0070] According to another example (“Example 64”) that goes further than any of the foregoing examples, the inner frame and the outer frame are longitudinally offset from each other such that the proximal end of the inner frame is located far to the distal end of the outer frame.

[0071] According to another example (“Example 65”) that goes further than any of Examples 63 to 64, the first constraint is released from the first pile member by withdrawing the first pile member proximally.

[0072] According to another example further than any of the foregoing examples (“Example 66”), the transcatheter delivery system includes a shaft extending through a body portion and a support portion of the system, the shaft including an enhanced flexible portion proximal to the support portion, the enhanced flexible portion including a distal segment having a cutting pattern characterized by a first pitch and a proximal segment having a cutting pattern characterized by a second pitch greater than the first pitch.

[0073] According to another example (“Example 67”) that goes further than Example 66, the distal segment includes a distal transition portion having a cutting pattern characterized by a third spacing greater than the first spacing.

[0074] The foregoing examples are merely, and should not be construed as limiting or otherwise narrowing the scope of any inventive concept provided in this disclosure. Attached Figure Description

[0075] The accompanying drawings are included to provide a further understanding of this disclosure, and the drawings are incorporated in and form a part of this specification, illustrating embodiments and, together with the specification, explaining the principles of this disclosure.

[0076] Figure 1 A transcatheter delivery system according to some embodiments is shown.

[0077] Figure 2This is a side view of the delivery catheter of a transcatheter delivery system according to some embodiments.

[0078] Figure 3 According to some embodiments Figure 2 The sectional view is obtained by cutting along line 3-3 and rotating it 90 degrees counterclockwise.

[0079] Figure 4 It is an isometric or perspective view of the support portion of a delivery conduit according to some embodiments.

[0080] Figure 5A This is a top view of the support portion of a delivery catheter according to some embodiments.

[0081] Figure 5B According to some embodiments, from Figure 5A The top view is a complete cross-sectional view of the delivery catheter taken along the longitudinal axis Xs.

[0082] Figure 6A This is a top view of the support portion of a delivery catheter according to some embodiments.

[0083] Figure 6B According to some embodiments, from Figure 6A The top view is a complete cross-sectional view of the delivery catheter taken along the longitudinal axis Xs.

[0084] Figure 6C According to some embodiments Figure 5A The sectional end view taken from line 6C-6C in the diagram.

[0085] Figure 7A and 7B Optional features for the body portion and support portion of a delivery catheter, according to some embodiments, are shown.

[0086] Figure 8 A cylindrical prosthetic valve is shown according to some embodiments, which is received on the support portion of a delivery catheter.

[0087] Figure 9 This is a separate view showing a proximal restraint member assembled with a proximal guide and a pile member according to some embodiments.

[0088] Figure 10 This is a separate view showing a distal restraint assembled with a distal guide and a pile member according to some embodiments.

[0089] Figure 11 This is a separate view showing an intermediate constraint member assembled with intermediate guides and pile members according to some embodiments.

[0090] Figure 12A prosthetic valve is shown, according to some embodiments, being received on a delivery catheter, wherein the prosthetic valve is in a deployed or expanded state.

[0091] Figures 13A to 13D Additional designs for the frame portion of a prosthetic valve, according to various embodiments, are shown.

[0092] Figure 14A A prosthetic valve in a compact delivery state is shown according to some embodiments.

[0093] Figure 14B A prosthetic valve that is partially retracted into a cannula according to some embodiments is shown.

[0094] Figures 15 to 18B An additional transcatheter delivery system configuration according to some embodiments is shown, which includes an additional guiding configuration.

[0095] Figure 19 and 20 A partial side view of an additional embodiment of a transcatheter delivery system according to some embodiments is shown.

[0096] Figure 21A A side view of a transcatheter delivery system according to some embodiments is shown.

[0097] Figure 21B The following are shown according to some embodiments. Figure 21A The sectional view taken from line BB in the middle.

[0098] Figure 21C The following are shown according to some embodiments. Figure 21A The sectional view is taken from line CC.

[0099] Figure 21D The following are shown according to some embodiments. Figure 21A The sectional view taken from line DD in the diagram.

[0100] Figure 21E The following are shown according to some embodiments. Figure 21A The sectional view taken from the line EE in the diagram.

[0101] Figure 21F The following are shown according to some embodiments. Figure 21A The sectional view is taken from the line FF in the middle.

[0102] Figure 21G A complete cross-sectional view of a transcatheter delivery system, taken along the longitudinal axis of the system according to some embodiments, is shown.

[0103] Figure 21H An example of a delivery operation according to some embodiments is shown.

[0104] Figures 22A-22D Additional examples of designs for proximal, distal, and intermediate guides according to some embodiments are shown.

[0105] Figures 23A-23F Additional examples of designs for proximal, distal, and intermediate guides according to some embodiments are shown.

[0106] Figures 24A-24C Figures 25 and 26 illustrate various examples of options for forming one or more of a plurality of constraints, according to some embodiments.

[0107] Figures 26-31 show examples of features that can be used to secure a constraint to a frame portion of an implantable device according to some embodiments.

[0108] Figure 32 This is an isometric view of the actuating portion of a delivery conduit in an assembled state according to some embodiments.

[0109] Figure 33 It is in a decomposed state according to some embodiments. Figure 32 Axonometric view of the actuating part.

[0110] Figure 34 This is an isometric view of an actuation component according to some embodiments. Figure 35 yes Figure 34 A magnified view of the circled part.

[0111] Figure 36 This is an isometric view of a drive assembly for an actuation portion according to some embodiments.

[0112] Figure 37 This is an isometric view of the nut and gear portions of the actuation assembly of a delivery conduit according to some embodiments.

[0113] Figure 38A and 38B This is a longitudinal sectional view of a portion of a delivery catheter according to some embodiments.

[0114] Figure 38C According to some embodiments Figure 38A and Figure 38B A partial longitudinal sectional view of a portion of the delivery catheter, with additional components removed to show the interaction between the drive assembly and the slider of the delivery catheter.

[0115] Figure 39 This is an isometric view of the release assembly of a delivery catheter according to some embodiments.

[0116] Figure 40This is an enlarged view of the distal connector of a catheter subassembly according to some embodiments, which is fixed to the connector interface of the main body portion of the delivery catheter, which is juxtaposed with the distal end of the slide rail.

[0117] Figures 41-44 This is a longitudinal sectional view of the actuating portion of the delivery catheter at various operational stages according to some embodiments.

[0118] Figure 45 This is a side view of another transcatheter delivery system according to some embodiments.

[0119] Figure 46 This is a side view of another transcatheter delivery system according to some embodiments.

[0120] Figure 47 This is a side view of another transcatheter delivery system according to some embodiments.

[0121] Figure 48 The enhanced flexibility of the axis of the delivery catheter is shown according to some embodiments. Detailed Implementation

[0122] Various aspects of this disclosure relate to transcatheter delivery systems, including other additional or alternative features and advantages, that facilitate a reduced delivery profile, selective deployment at desired locations, and / or provide reduced crimping / clamping forces on the valve leaflet structure. Various examples relate to prosthetic valves for cardiac valve replacement (e.g., prostheses for treating aortic or mitral valve failure or other defects) or other applications associated with natural valves or other valve orifices, and related systems, methods, and devices. In some related treatments, prosthetic valves are used to treat valvular stenosis (e.g., aortic stenosis) and / or valvular insufficiency (e.g., aortic valve insufficiency). Although features of transcatheter delivery systems for prosthetic valves are generally shown and described in this disclosure, similar features and operating principles can be used with other types of implantable devices, primarily including, for example, stents, stent grafts, occluders, and vascular filters.

[0123] Unless otherwise stated, when the terms “distal” and “proximal” are used in this disclosure with respect to the features of the delivery catheter, these terms are generally used with reference to the distal side in a direction away from the user of the delivery catheter (e.g., away from the handle portion) and the proximal side in a direction toward the user (e.g., toward the handle portion).

[0124] Unless otherwise stated, when the terms “distal” and “proximal” are used in this disclosure in relation to the characteristics of a prosthetic valve or other implantable device, the term “distal” is generally used to refer to the inflow end or the direction opposite to the mainstream through the device, while “proximal” is generally used to refer to the outflow end or the direction through the mainstream through the device.

[0125] Figure 1 A transcatheter delivery system 10 is shown, comprising a cannula 12, a delivery catheter 14, and a prosthetic valve 16 held in a collapsed configuration by the delivery catheter 14. As shown, the prosthetic valve 16 is positioned on the delivery catheter 14 in a position extending distally from the cannula 12. Alternatively, in other words, the prosthetic valve 16 is in an extended position. As previously mentioned, the prosthetic valve 16 can be replaced by various self-expanding implantable devices, such as stents, stent grafts, occluders, or vascular filters.

[0126] As shown in the figure, the sheath 12 may optionally be a guide sleeve including, for example, a hemostatic valve 18, though any of a variety of additional or alternative features may be contemplated.

[0127] Figure 2 This is a side view of a delivery conduit 14 according to some embodiments. As shown, the delivery conduit 14 includes an actuating portion 20, a main body portion 22, a support portion 24, an end portion 26, a plurality of restraints 28, and a pile member 30.

[0128] In some embodiments, the actuation portion 20 may optionally include a plurality of spindles 32, each rotatable, including a first spindle 34, a second spindle 36, and a third spindle 38. One or more of the first spindle 34, the second spindle 36, and the third spindle 38 may optionally be rotatably connected to each other and / or independently rotatable as desired. For reference, the term “connection” should be understood broadly, depending on the context, to refer to direct or indirect attachment and to include both fixed attachment and translational attachment. Various forms of clutches, gears, or other devices for controlling the relative rotational speed, timing, or other interactions between the spindles 32 are contemplated. Each of the first spindle 34, the second spindle 36, and the third spindle 38 may optionally be configured to tighten or tension, release or relax, constraints received in the body portion 22 of the delivery conduit 14, as described below. Similarly, as described below, additional designs for the actuation portion 20 are contemplated.

[0129] The main body 22 defines a central longitudinal axis Xb and has a proximal segment 40, a distal segment 42, an intermediate segment 44 between the proximal and distal segments 40 and 42, and a connector interface 46. The main body 22 has an appropriate length to allow a user (not shown) to manipulate the delivery catheter 14 from the location where the prosthetic valve 16 is implanted outside the patient. Typically, the main body 22 has sufficient flexibility, length, and column strength to be suitable for traversing the vascular system or other body lumens and conduits within the patient (not shown).

[0130] Figure 3 According to some embodiments Figure 2The sectional view is obtained by cutting along line 3-3 and rotating it 90 degrees counterclockwise. (See figure.) Figure 3 As shown, the main body portion 22 has a plurality of cavities 50 extending within it, which can also be described as pathways or channels. The plurality of cavities 50 allow the length of the main body portion 22 to extend through the proximal segment 40, the distal segment 42, and the intermediate segment 44. Figure 2 In some embodiments, the plurality of cavities 50 include a pile member cavity 52, a first constraint cavity 54, a second constraint cavity 56, a third constraint cavity 58, and a central cavity 60; however, any number of cavities is contemplated (e.g., one, six, twelve, etc.). The pile member cavity 52, the first constraint cavity 54, the second constraint cavity 56, and the third constraint cavity 58 are each optionally located at a desired angular position around the central longitudinal axis Xb of the body portion 22.

[0131] As shown in the figure, the pile member cavity 52 is located at a position corresponding to 12 o'clock or 0 degrees, the first constraint cavity 54 is located at a position corresponding to 8 o'clock or 120 degrees, the second constraint cavity 56 is located at a position corresponding to 4 o'clock or 60 degrees, and the third constraint cavity 58 is located at a position corresponding to 6 o'clock or 90 degrees. In some embodiments, the pile member cavity 52 is positioned on one half of the cross-section of the main body portion 22 (e.g., the upper half as shown in the figure), and the first constraint cavity 54, the second constraint cavity 56, and the third constraint cavity 58 are positioned on opposite halves of the cross-section of the main body portion 22 (e.g., the lower half as shown in the figure). This positioning can help balance the overall design, including reducing unwanted bending and / or enhancing preferred bending / bending flexibility in the desired direction, although various features and considerations can be adopted. Although some examples of angular positions are provided, any number of positions can be adopted as desired. As shown in the figure, the central cavity 60 can be positioned coaxially with the longitudinal axis Xb of the main body portion 22, but similarly, any number of positions can be adopted as desired.

[0132] like Figure 2 As shown, the proximal portion 40 is coupled to and supports the actuation portion 20, such that the first spindle 34, the second spindle 36, and the third spindle 38 are rotatable (e.g., transverse to the longitudinal axis Xb of the body portion 22). Although not shown, one or more of the first spindle 34, the second spindle 36, and the third spindle 38 may optionally include a handle or other features to assist their operation (e.g., rotation).

[0133] The distal segment 42 is coupled to the support portion 24 and optionally includes one or more features to facilitate the entry, exit, and / or passage of the distal segment 42 through the sleeve 12. For example, as Figure 2As shown, the distal segment 42 includes a flare 70, also referred to as a flange or taper, to provide an increased diameter profile to the distal segment 42 adjacent to the support portion 24. This increased diameter profile, also referred to as an outer lateral profile, has a relatively smooth transition to reduce entanglement or mechanical friction between the cannula 12 and the distal segment 42 as the distal segment 42 slides over, extends from, and / or retracts into the cannula 12 and through the vascular system or other catheters (not shown) within the patient's body.

[0134] For reference, the lateral outer profile at the cross-sectional location of the component can be calculated by calculating the cross-sectional area defined by the outer surface at that location. For clarity, the cross-sectional area of ​​the lateral outer profile in the calculation will include the area of ​​any passages, channels, cavities, holes, etc. Alternatively, the lateral outer profile can be calculated using the maximum diameter dimension defined by the component at that location.

[0135] As previously described, the intermediate section 44 has sufficient flexibility, length and column strength to be suitable for traversing the vascular system or other body cavities or other catheters within the patient's (not shown) body.

[0136] The connector interface 46 is optionally used to secure the body portion 22 to the actuating portion 20 and / or other components, and may include Luer connectors, seals, and / or other features as desired. Generally, a plurality of restraint members 28 and post members 30 optionally pass through the connector interface 46 so that they can be coupled to the actuating portion 20.

[0137] Figure 4 This is an axonometric or perspective view of the delivery catheter 14 according to some embodiments, which shows the support portion 24 in more detail. The support portion 24 is generally configured to be received in the prosthetic valve 16 ( Figure 1 The prosthetic valve 16 is supported by delivery into the patient's body (not shown) and deployment at the desired treatment location. As shown, the support portion 24 extends from the distal segment 42 of the body portion 22 and has a central longitudinal axis Xs. According to some embodiments, the support portion 24 includes an axis 80, a proximal guide 82, a distal guide 84, and an intermediate guide 86. Although three guides 82, 84, and 86 are shown, any number of guides (e.g., one, two, four, nine, etc.) is conceivable.

[0138] Figure 5A This shows a top view of the delivery conduit 14 of the support portion 24, while Figure 5B From Figure 5A The top view is a cross-sectional view of the delivery conduit 14 taken along the longitudinal axis Xs. Figure 6A This is a top view showing the delivery conduit 14 of the support portion 24. Figure 6B From Figure 6A The top view is a cross-sectional view of the delivery conduit 14 taken along the longitudinal axis Xs. Figure 6C It is used for attaching references along Figure 5A The cross-sectional end view is taken along line 6C-6C. Shaft 80 can be flexible, relatively rigid, or a combination thereof. For example, shaft 80 may optionally be relatively more rigid in the support portion 24 (e.g., a continuous thallium tube) and relatively more flexible along the remainder of the delivery conduit 14 (e.g., having cuts, recesses, or other features to enhance flexibility). Shaft 80 is elongated and, as... Figure 6B The illustration optionally includes a central lumen 89 (e.g., for receiving a guidewire). As shown... Figure 4 and Figure 5A As shown, the central longitudinal axis of shaft 80 (not separately labeled) is coaxial with the central longitudinal axis Xb of the main body portion 22 and / or the central longitudinal axis Xs of the support portion 24. However, in other examples, shaft 80 may be located at a lateral offset from the central longitudinal axes Xb and / or Xs (e.g., parallel but offset from them).

[0139] In various embodiments, shaft 80 is formed as a hollow tube (e.g., a hypo tube), for example using a nickel-titanium alloy, stainless steel, or other metal or polymeric material. In various examples, shaft 80 is configured to receive a guidewire (not shown) for guiding the delivery catheter 14 to a desired treatment location. However, shaft 80 may also be formed as a solid member without any lumen, if desired. Shaft 80 may optionally be coupled to distal portion 26 (e.g., inserted and press-fitted or coupled to distal portion 26), extending a length of support portion 24, and may also form part of body portion 22 (e.g., extending through central lumen 60 and protruding from proximal end 206 of body portion 22). In other words, body portion 22 may also include shaft 80. Shaft 80 may optionally be a single integral member, although separate connecting parts are conceivable.

[0140] like Figure 4 , 5A As shown in 5B, 6A, and 6B, the proximal guide 82 is generally cylindrical, having a cylindrical lateral outer profile that also corresponds to a lateral outer profile with a circular cross-section. Because the lateral outer profile is cylindrical, the proximal guide 82 typically defines a maximum lateral outer profile along its entire length. However, in other examples, the proximal guide 82 defines a maximum lateral outer profile at one or more cross-sections along its length and a minimum lateral outer profile at one or more cross-sections along its length. For example, although a cylindrical profile is envisioned, any of various tapers, steps, chamfers, and other features are also conceivable.

[0141] According to some examples, the proximal guide 82 defines a central longitudinal axis (not separately marked) that is coaxial with the central longitudinal axis Xs of the support portion 24, and, according to the transmission principle, is coaxial with the central longitudinal axis of the shaft 80.

[0142] like Figure 5B As shown, in some embodiments, the proximal guide 82 includes a central cavity 88 through which the shaft 80 is received to couple the proximal guide 82 to the shaft 80. Figure 4 As shown, the proximal guide 82 also includes a plurality of channels 90, also referred to as pathways or cavities. As shown, these plurality of channels 90 include a pile member channel 92, a first constraint channel 94, and a second constraint channel 96, though more or fewer may be envisioned (e.g., one, four, ten, etc.). The pile member channel 92, the first constraint channel 94, and the second constraint channel 96 are each optionally located at a desired angular position around the central longitudinal axis Xs of the support portion 24.

[0143] As shown in the figure, the pile column member channel 92 is located at an angle corresponding to 12 o'clock or 0 degrees, the first constraint channel 94 is located at an angle corresponding to 11 o'clock or -15 degrees, and the second constraint channel 96 is located at an angle corresponding to 1 o'clock or 15 degrees. Although some examples of angle positions are provided, any number of angle positions can be used as desired.

[0144] As in Figure 4 , 5A Referring to 5B, 6A, and 6B, the distal guide 84 is substantially similar to the proximal guide 82. In some examples, the distal guide 84 is also generally cylindrical, having a cylindrical lateral outer profile, which also corresponds to a lateral outer profile with a circular cross-section. Because the lateral outer profile is cylindrical, the distal guide 84 typically defines a maximum lateral outer profile along its entire length. However, in other examples, the distal guide 84 defines a maximum lateral outer profile at one or more cross-sections along its length and a minimum lateral outer profile at one or more cross-sections along the length of the proximal guide 82. For example, although a cylindrical profile with a circular cross-section is contemplated, any of various tapers, steps, chamfers, and other features are also contemplated.

[0145] According to some examples, the distal guide 84 also defines a central longitudinal axis (not separately marked), which is coaxial with the central longitudinal axis Xs of the support portion 24, and according to the transmission principle, it is coaxial with the central longitudinal axis of the shaft 80 (and the proximal guide 82).

[0146] In some embodiments, the distal guide 84 includes a central cavity 100 through which the shaft 80 is received to couple the distal guide 84 to the shaft 80. For example... Figure 4 As shown, the distal guide 84 also includes a plurality of channels 102, also referred to as passages or cavities. As shown, the plurality of channels 102 include a pile member channel 104, a first constraint channel 106, and a second constraint channel 108, although more or fewer channels (e.g., one, four, ten, etc.) are conceivable. The pile member channel 104, the first constraint channel 106, and the second constraint channel 108 are each optionally located at a desired angular position around the central longitudinal axis Xs of the support portion 24.

[0147] As shown in the figure, the pile component channel 104 is located at an angle corresponding to 12 o'clock or 0 degrees, the first constraint channel 106 is located at an angle corresponding to 11 o'clock or -15 degrees, and the second constraint channel 108 is located at an angle corresponding to 1 o'clock or 15 degrees. Although some examples of angle positions are provided, any number of angle positions can be used as desired.

[0148] In some embodiments, each of the plurality of channels 90 of the proximal guide 82 is aligned with each of the plurality of channels 102 of the distal guide 84. In other words, the pile member channel 104 is angularly aligned with the pile member channel 92, the first constraint channel 106 with the first constraint channel 94, etc. In other embodiments, one or more of the plurality of channels 90 and the plurality of channels 102 are angularly misaligned or misaligned with each other. Furthermore, it should be readily understood that the proximal guide 82 need not have the same number of channels as the distal guide 84.

[0149] In some embodiments, the angular position of the first constraint channel 94 of the proximal guide 82 is angularly offset from the angular position of the second constraint channel 108 of the distal guide 84 by 10 to 350 degrees, although any different offset (e.g., 15 to 45 degrees) is conceivable. In some examples, the angular position of the first constraint channel 116 of the intermediate guide 86 is angularly offset from the angular position of the second constraint channel 108 of the distal guide 84 by 10 to 350 degrees, although any different offset (e.g., 15 to 45 degrees) is conceivable.

[0150] like Figure 4 , 5A As shown in 5B, 6A and 6B, the intermediate guide 86 has a reduced lateral outer profile, or a smaller lateral cross section than the proximal guide 82 and the distal guide 84 (e.g., calculated by comparing the cross-sectional areas of the shapes of the respective lateral outer profiles).

[0151] For example, both the proximal guide 82 and the distal guide 84 define a lateral outer profile with a circular cross-section, and thus define a cross-sectional area that can be calculated using a simple formula: pi multiplied by the square of the diameter of the proximal guide 82 and / or the distal guide 84. For clarity, the cross-sectional area of ​​the lateral outer profile will include the area of ​​any passageways, channels, cavities, holes, etc., in the calculation. Furthermore, for more complex lateral outer profiles, such as the lateral outer profile of the intermediate guide 86, other mathematical methods can be used to calculate the cross-sectional area of ​​the lateral outer profile based on well-known principles. Alternatively, the lateral outer profile can be calculated using the maximum diameter dimension (in this case, the outer diameter) of the proximal guide 82 and / or the distal guide 84.

[0152] In some examples, the cross-sectional area of ​​the lateral outer contour of the intermediate guide 86 is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80%, or any percentage between the foregoing percentages, smaller than the cross-sectional area of ​​the proximal guide 82 (e.g., the largest and / or smallest lateral outer contour) and / or the cross-sectional area of ​​the distal guide 84 (e.g., the largest and / or smallest lateral outer contour). As described later, minimizing the cross-sectional area of ​​the intermediate guide 86, for example, can help reduce the clamping force on the prosthetic valve 16 and / or reduce the overall delivery profile of the prosthetic valve 16 as received on the delivery catheter 14.

[0153] The intermediate guide 86 has a more irregular shape, with a generally rounded and truncated pie-shaped lateral outer profile. In different terms, the intermediate guide 86 has a lateral outer profile that is generally trapezoidal, with convex or outward-facing curves at the top and bottom and at the four rounded corners.

[0154] As shown in the figure, the cross-section of the intermediate guide 86 is constant along its length. Therefore, the lateral outer profile of the intermediate guide 86 is substantially uniform along its length. And thus, the intermediate guide 86 generally defines a maximum lateral outer profile along its entire length. However, in other examples, the intermediate guide 86 defines a maximum lateral outer profile at one or more cross-sectional locations along its length. For example, various tapers, steps, chamfers, and other features can also be envisioned.

[0155] like Figure 4 and 6CAs shown, the intermediate guide 86 also defines a longitudinal axis Xi, which longitudinally passes through the center of mass or center of inertia of the maximum lateral outer profile of the intermediate guide 86. According to some examples, the longitudinal axis Xi is parallel to the central longitudinal axis (corresponding to the central longitudinal axis Xs) of the proximal guide 82 and the distal guide 84 and is laterally offset from the central longitudinal axis.

[0156] like Figure 5B and 6B As shown, in some embodiments, the intermediate guide 86 includes a central cavity 110 through which the shaft 80 is received to connect the intermediate guide 86 to the shaft 80. Figure 4 As shown, the intermediate guide 86 also includes a plurality of channels 112, also referred to as passages or cavities. As shown, these channels 112 include a pile member channel 114 and a first constraint channel 116, although more or fewer channels (e.g., one, three, ten, etc.) are conceivable. The pile member channel 114 and the first constraint channel 116 are each located at a desired angular position around the central longitudinal axis Xs of the support portion 24.

[0157] As shown in the figure, the pile member channel 114 is located at an angle corresponding to 12 o'clock or 0 degrees, and the first constraint channel 116 is located at an angle corresponding to 11 o'clock or -15 degrees. Although some examples of angle positions are provided, any number of angle positions can be used as desired.

[0158] like Figure 6C As shown, in some examples, the intermediate guide 86 has a first side 120, a second side 122, a top 124, and a bottom 126. As illustrated, the bottom 126 is positioned closer to the central lumen 110 than the top 124, such that the central lumen 110 is offset between the top 124 and the bottom 126. This offset helps provide a packing or receiving space for receiving a selected portion of the prosthetic valve 16, which may benefit from additional space (e.g., the leaflet region 262, further described) as part of compressing the prosthetic valve 16 onto the support portion 24.

[0159] In some embodiments, each of the proximal guide 82, distal guide 84, and intermediate guide 86 is coupled (e.g., by welding, crimping, press-fitting, adhesive, or other techniques) to the shaft 80. In some examples, the shaft 80 holds and supports each of the proximal guide 82, distal guide 84, and intermediate guide 86 in a longitudinally spaced relationship and longitudinally spaced from the body portion 22 and the end portion 26. Figure 5A and 5BAs shown, in this manner, the support portion 24 defines a plurality of reduced profile segments 150, including a proximal reduced profile segment 152 extending between the proximal guide 82 and the distal segment 42 of the main body portion 22, a first reduced profile segment 154 extending between the proximal guide 82 and the intermediate guide 86, a second reduced profile segment 156 extending between the intermediate guide 86 and the distal guide 84, and a distal reduced profile segment 158 ​​extending between the distal guide 84 and the end portion 26. As shown, both the first reduced profile segment 154 and the second reduced profile segment 156 are located in the middle or between the proximal guide 82 and the distal guide 84.

[0160] As shown, each reduced profile segment 150 is defined by the lateral outer profile of the shaft 80, which has the same maximum and minimum lateral outer profiles along the entire length of the support portion 24, and its cross-section is circular, defining a cross-sectional area determined by pi multiplied by the square of the diameter of the shaft 80, although the shaft 80 may also take various shapes. The reduced profile segment 150 can help provide various advantages, including increased flexibility of the support portion 24, additional space for receiving the prosthetic valve 16 during compression onto the delivery catheter 14, or other advantages. For example, in some embodiments, each reduced profile segment 150 has increased bending flexibility relative to adjacent segments of the support portion 24, such as the bending flexibility of the support portion 24 at the proximal guide 82, distal guide 84, and / or intermediate guide 86, although this feature may not be present in other examples.

[0161] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​the proximal guide 82 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the reduced diameter section on the proximal side is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of the proximal guide 82 (or any percentage range between any of the above percentages).

[0162] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​the distal guide 84 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter segment is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of the distal guide 84 (or any percentage range between any of the above percentages).

[0163] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​intermediate guide 86 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter segment is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of intermediate guide 86 (or any percentage range between any of the above percentages).

[0164] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​the distal segment 42 of body portion 22 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced-diameter segment is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of the distal segment 42 of body portion 22 (or any percentage range between any of the above percentages).

[0165] like Figure 6A and 6B As shown, the distal portion 26 has a post member channel 160 and a central lumen 162, and includes a proximal support section 164 and a distal anterior section 166. The proximal support section 164 has a reduced lateral outer profile relative to the distal anterior section 166 to define a recess for receiving a portion of the prosthetic valve 16. Generally, the proximal support section 164 is optionally configured to receive the end of the prosthetic valve 16, wherein the adjacent increased profile of the distal anterior section 166 helps to protect the prosthetic valve 16. Figure 1 The end of the sleeve 12 is free from tangling or otherwise obstructing passage. Figure 1 ) and delivery into the patient's body (not shown).

[0166] The proximal support segment 164 defines a lateral outer profile with a circular cross-section, and thus defines a cross-sectional area that can be calculated using a simple formula: multiplying the number pi by the square of the diameter of the proximal support segment 164. Although a circular cross-section is shown and described, any shape for the lateral outer profile of the proximal support segment 164 can be contemplated. For clarity, the cross-sectional area of ​​the lateral outer profile will include the area of ​​any channels, cavities, holes, etc., in the calculation (i.e., it will be considered as a solid cross-section that determines the cross-sectional area of ​​the lateral outer profile). As previously mentioned, the lateral outer profile can be calculated by using the maximum diameter dimension.

[0167] As shown in the figure, the cross-section of the proximal support section 164 is constant along its length. Therefore, the lateral outer profile of the proximal support section 164 is substantially uniform along its length. Consequently, the proximal support section 164 defines a maximum lateral outer profile approximately along its entire length. However, in other examples, the proximal support section 164 defines a maximum lateral outer profile at one or more cross-sectional locations along its length. For example, various taper, steps, chamfers, and other features can be envisioned, which would result in different lateral outer profiles.

[0168] According to some examples, the proximal support section 164 also defines a central longitudinal axis (not separately labeled), which is coaxial with the central longitudinal axis Xs of the support portion 24. For example... Figure 5B and 6B As shown, shaft 80 is received in central cavity 162 for coupling the proximal support section 164 to shaft 80, and thus to support portion 24. As in Figure 4 , 5A As is most clearly seen in 6B, the pile member channel 160 is located at a desired angular position around the central longitudinal axis of the end portion 26.

[0169] As shown in the figure, the pile member channel 160 is located at an angular position corresponding to 12 o'clock or 0 degrees. Although examples of angular positions are provided, any number of angular positions can be used as desired. According to some examples, the angular position of the pile member channel 160 may optionally correspond to the angular position of the pile member cavity 52 of the main body 22, the pile member channel 92 of the proximal guide 82, and the pile member channel 104 of the distal guide 84.

[0170] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​the proximal support section 164 of end portion 26 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter section is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of the proximal support section 164 of end portion 26 (or any percentage range between any of the above percentages).

[0171] Various additional and / or alternative scenarios for the delivery catheter 14 can be envisioned. For example, Figure 7A and 7BSome optional features that may be used for the body portion 22 and the support portion 24 are shown. As shown, the body portion 22 has a step 176 in the distal section 42 for proximal support of the prosthetic valve 16. Furthermore, the delivery catheter 14 optionally includes a cover 178 (e.g., a thin layer of material, such as a heat-shrinkable capillary of ePTFE or PET) on the support portion 24, which extends over the proximal guide 82, the distal guide 84, and the intermediate guide 86. As shown, the cover 178 may also optionally extend over the proximal support section 164 and the step 176 of the distal portion 26. The cover 178 includes holes or other openings (not shown), and a plurality of restraints 28 (…). Figure 2 It is possible to pass through it. Furthermore, such as... Figure 7A and 7B As shown, both the proximal guide 82 and the intermediate guide 86 taper proximally, improving the ability to withdraw the delivery catheter 14 via the deployed prosthetic valve 16 and / or through the cannula 12.

[0172] like Figure 2 As shown, the plurality of constraint members 28 includes a proximal constraint member 180, a distal constraint member 182, and an intermediate constraint member 184. In some embodiments, each of the plurality of constraint members 28 is formed as a fiber, strand, wire, combination thereof, etc., and may be woven, wound, extruded, or otherwise formed from a metallic or polymeric material. Generally, each of the plurality of constraint members 28 can be described as an elongated and flexible filament. For reference, the term "filament" includes both monofilament and multifilament constructions. In some examples, each of the constraint members 28 may be formed from braided strands of a material such as UHMWPE or ePTFE. Although three constraint members are shown, any number of constraint members 28 (e.g., one, two, four, nine, etc.) is contemplated. In some embodiments, the proximal constraint member 180 includes a catch member 190 in the form of, for example, a terminal, a closed loop, or an eyelet. The catch member 190 may optionally be formed using a braiding method (e.g., by twisting the braid into itself or by a continuous braiding method that forks a single strand into two separate strands and then re-braids them into a single strand to form an eyelet). The distal constraint 182 similarly includes a catcher 192, as does the intermediate constraint 184, which also includes a catcher 194. Figures 24A-24C 24 provides various examples for forming one or more of the plurality of constraint elements 28.

[0173] Figure 2 , 3Figures 6B and 6B show the pile member 30 from various angles; this pile member can also be described as a wire. In some embodiments, the pile member 30 is formed as a wire, strand, fiber, etc., and can be woven, wound, extruded, or otherwise formed from a metal or polymer material. In some examples, the pile member 30 is a wire formed from stainless steel, nickel-titanium alloy, or other materials. Figure 6B As shown, the pile member 30 extends from the proximal end 30a into the proximal section 40 of the main body 22, enters the inner cavity 52 of the pile member, passes through the main body 22, and extends from the inner cavity 52 out of the distal section 42 of the main body 22. Figure 3 ), through the pile member channel 92 of the proximal guide 82 ( Figure 6B ), through the pile member channel 104 of the distal guide 84 ( Figure 6B ), through the pile member channel 114 of the intermediate guide 86 ( Figure 6B ), and enter the pile component channel 160 of the end part 26 ( Figure 6B The pile member 30 is slidably received in the pile member cavity 52 and corresponding channels, such that the pile member 30 can be retracted from the proximal guide 82, the distal guide 84 and the intermediate guide 86, as described below.

[0174] Figure 8 A prosthetic valve 16, in a generally cylindrical shape for ease of observation, is shown. This prosthetic valve 16 is received on a support portion 24 of a delivery catheter 14, with a proximal restraint 180, a distal restraint 182, and an intermediate restraint 184 looping around the prosthetic valve 16, each restraint in a releasable loop configuration. Assembly of the delivery catheter 14 includes assembling the prosthetic valve 16 onto the delivery catheter 14, and assembling the proximal restraint 180, distal restraint 182, and intermediate restraint 184 into corresponding proximal guides 82, distal guides 84, and intermediate guides 86, and circumferentially surrounding the prosthetic valve 16. As shown, the prosthetic valve 16 is received on the delivery catheter 14, with the delivery catheter 14 received within the prosthetic valve 16 in a laterally offset position.

[0175] Figure 9 This is a separate view showing the proximal restraint 180 assembled with the proximal guide 82 and the post member 30. According to some embodiments, the prosthetic valve 16 and other parts are removed to help understand how the proximal restraint 180 is secured in a loop configuration to define a proximal restraint ring 195. In some embodiments, the proximal restraint 180 is formed by a first spindle 34 (… Figure 2 ) Acceptance, allowing the proximal constraint to be wound onto the first spindle 34 and enter the main body portion 22 ( Figure 3 The first constraint cavity 54 is then located within the first constraint cavity 54. Then, the proximal constraint 180 exits from the first constraint cavity 54. Figure 3 It exits, enters one of the plurality of channels 90 of the proximal guide 82 (e.g., the first constraint channel 94 as shown), extends through one of the plurality of channels 90 (e.g., the first constraint channel 94 as shown), and extends distally from one of the plurality of channels 90 (e.g., the first constraint channel 94 as shown), and then extends radially away from the central longitudinal axis Xs of the support portion 24.

[0176] Then, the proximal constraint 180 loops around the support portion 24, crosses itself, and is secured to the pile member 30, which is received through the capture member 190. For example, using the first main shaft 34 of the actuating portion 20 ( Figure 2 Tensing the proximal restraint 180 towards the proximal side causes the proximal restraint ring 195 to contract, reducing the diameter of the proximal restraint ring 195, and thus causing collapse or restraint force within the proximal restraint ring 195. Subsequently, releasing the tension allows the proximal restraint ring 195 to expand.

[0177] Similarly, Figure 10 This is a separate view showing the distal restraint 182 assembled with the distal guide 84 and the post member 30 according to some embodiments (again, the prosthetic valve 16 and other parts have been removed to aid understanding). In some embodiments, the distal restraint 182 is supported by a second spindle 36 ( Figure 2 ) Acceptance, allowing the distal constraint to be wound onto the second spindle 36 and enter the main body 22 ( Figure 3 The second constraint cavity 56 of the second constraint cavity 56. Then, the distal constraint member 182 exits from the second constraint cavity 56. Figure 3 It exits, enters one of the plurality of channels 90 of the proximal guide 82 (e.g., the second constraint channel 96 as shown), extends through one of the plurality of channels 90 (e.g., the second constraint channel 96 as shown), and extends distally from one of the plurality of channels 90 (e.g., the second constraint channel 94 as shown).

[0178] Then, on the way from the intermediate guide 86 to the distal guide 84, the distal constraint 182 extends across the intermediate guide 86 on one side (e.g., the first side 120 as shown).

[0179] Then, the distal constraint 182 enters the multiple channels 102 of the distal guide 84 ( Figure 4One of the multiple channels 102 (e.g., the second constraint channel 108 shown), and emerges distally from one of the multiple channels 102 (e.g., the second constraint channel 108). Then, the distal constraint 182 extends radially away from the central longitudinal axis Xs of the support portion 24, loops around the support portion 24, crosses itself, and is fixed to the pile member 30, wherein the pile member 30 is received through the capture member 192 of the distal constraint 182 to define the distal constraint ring 196. For example, using the second spindle 36 of the actuation portion 20 ( Figure 2 Tensing the distal restraint 182 proximally causes the distal restraint ring 196 to contract, resulting in collapse or restraint force within the distal restraint ring 196, reducing the diameter of the distal restraint ring 196. Releasing the tension then allows the distal restraint ring 196 to expand.

[0180] Figure 11 This is a similar separate view showing the intermediate restraint 184 assembled with the intermediate guide 86 and the post member 30 according to some embodiments (again, the prosthetic valve 16 is removed to aid understanding). In some embodiments, the intermediate restraint 184 is supported by a third spindle 38 ( Figure 2 The intermediate constraint member is received, allowing it to be wound onto the third spindle 38 and enter the third constraint cavity 58 of the main body 22. Figure 3 Then, the intermediate constraint 184 exits from the third constraint cavity 58, enters one of the plurality of channels 90 of the proximal guide 82 (e.g., the second constraint channel 96 as shown), extends through one of the plurality of channels 90 (e.g., the second constraint channel 96 as shown), and extends distally from one of the plurality of channels 90 (e.g., the second constraint channel 94 as shown).

[0181] Then, the intermediate constraint 184 extends into one of the plurality of channels 112 (e.g., the first constraint channel 116 shown in the figure) and emerges distally from one of the plurality of channels 112 (e.g., the first constraint channel 116 shown in the figure). The intermediate constraint 184 then extends radially away from the central longitudinal axis Xs of the support portion 24, then loops around the support portion 24, intersecting on itself, and is secured to the pile member 30, wherein the pile member 30 is received by the capture member 194 of the intermediate constraint 184 to define the intermediate constraint ring 197. For example, using the third spindle 38 of the actuation portion 20 ( Figure 2 Tensing the intermediate constraint member 184 proximally causes the intermediate constraint ring 197 to contract, thus causing collapse or constraint force within the intermediate constraint ring 197 and reducing its diameter. Subsequently, releasing the tension allows the distal constraint ring 196 to expand.

[0182] Figure 12A prosthetic valve 16, according to some embodiments, is shown received on a delivery catheter 14, wherein the prosthetic valve is in a deployed or expanded state. In some examples, the prosthetic valve 16 is a prosthetic heart valve, such as a prosthetic valve for aortic or mitral valve replacement / repair. As shown, according to some embodiments, the prosthetic valve 16 has a central longitudinal axis Xv, a proximal portion 200, also referred to as the end, a distal portion 202, also referred to as the end, and a middle portion 204, also referred to as the middle, and extends between a proximal end 206 and a distal end 208. The prosthetic valve 16 includes a self-expanding frame portion 210 (e.g., formed of a shape memory alloy such as nitinol) and a cover 212, and leaflet structures 214 (hidden but shown in dashed lines) operatively attached to the frame portion 210 (e.g., directly attached or indirectly attached to the frame portion 210 via the cover 212).

[0183] As shown, frame portion 210 has a distal end 220 and a proximal end 222, and includes multiple rows of frame members 224 defining a wavy alternating pattern of distally facing vertices 226 and proximally facing vertices 228. In some embodiments, the multiple rows of frame members 224 include a distal row 230 at the distal end 220 of frame portion 210 and a proximal row 232 at the proximal end 222 of frame portion 210. Frame portion 210 also includes multiple rows of closed cells 240 defined by a plurality of frame members 224, each of the multiple rows of closed cells 240 having a distal end 242, a proximal end 244, and a middle portion 246 between the proximal end 244 and the distal end 242. In some examples, the multiple rows of closed cells 240 include a distal row of closed cells 250 at the distal end 220 of frame portion 210 and a proximal row of closed cells 252 at the proximal end 222 of frame portion 210. Figures 13A to 13D Additional designs for the frame portion 210 of the prosthetic valve 16, according to various embodiments, are shown. As shown, each design includes a plurality of fusion attachment regions 224P (e.g., fusion columns) configured to support the fusion region of the leaflet structure.

[0184] In some embodiments, the leaflet configuration 214 includes a plurality of leaflets 260 (hidden, but marked with dashed lines) that fit together to form a unidirectional valve. The location or position of the leaflet configuration 214 along the length of the prosthetic valve 16 is referred to as leaflet region 262 or leaflet portion. Various leaflet materials and configurations are conceivable, including the examples described below.

[0185] In some embodiments, the cover 212 has one or more rows of holes 270 for receiving one or more of the proximal restraint 180, the distal restraint 182, and the intermediate restraint 184. For example, the rows of holes 270 may optionally include distal row holes 272 (e.g., defined in the cover 212 along the middle portion 246 of the distal row 250 of the closed cell), proximal row holes 274 (e.g., defined in the cover 212 along the middle portion 246 of the proximal row 252 of the closed cell), and intermediate row holes 276 (defined in the cover 212 along the middle portion 246 of another row of the multiple rows of closed cavity cells 240).

[0186] Figure 12 The positions of the proximal restraint 180, distal restraint 182, and intermediate restraint 184 relative to the prosthetic valve 16 are shown according to some embodiments. As illustrated, the distal restraint 182 and therefore the distal restraint ring 196 (…) Figure 10 At position 246 in the middle of the far row 250 of the closed cell, the constraint ring 195 surrounds the far row 250 of the closed cell. Figure 9 The near-side constraint 182 surrounds the near-side row 252 of the closed cell at the middle portion 246. As shown, the far-side constraint 182 surrounds the far-side row 250 of the closed cell at the position near the far-facing vertex 226, and the near-side constraint loop 195 surrounds the near-side row 252 of the closed cell at the position far from the near-facing vertex 228. In some examples, the middle constraint loop 197 ( Figure 11 The prosthetic valve 16 is surrounded at a position between the proximal restraint ring 195 and the distal restraint ring 196, and this position also corresponds to the leaflet region 262.

[0187] like Figure 12 As shown, in some examples, the distal constraint loop 196 ( Figure 10 The distal restraint 182 is woven through the distal hole 272, causing the distal restraint 182 to extend outward on the frame member 224. In some embodiments, the proximal restraint 180 and the intermediate restraint 184 are similarly woven through the proximal row holes 274 and the intermediate row holes 276, respectively, causing the proximal restraint ring 195 ( Figure 9 ) and intermediate constraint ring 197 ( Figure 11 The ) extends on frame member 224. In other examples, proximal constraint 180, distal constraint 182 and / or intermediate constraint 184 are woven through frame portion 210 using alternative weaving patterns (e.g., top and bottom patterns relative to frame portion 210 passing through closed cell row 240).

[0188] In some embodiments, the proximal restraint 180 exits the proximal guide 82, emerges from the prosthetic valve 16, surrounds the prosthetic valve 16, and defines an intersection point 300 (for visualization purposes, in...). Figure 9 In the generalized view (without the prosthetic valve 16), the proximal restraint 180 is arranged in a tightened configuration, passing over itself and then returning through the prosthetic valve 16 to reach the post member 30. Similarly, in some embodiments, the distal restraint 182 exits the distal guide 84, emerges from the prosthetic valve 16, surrounds the prosthetic valve 16, and defines an intersection point 302 (for visualization purposes, in...). Figure 10 The central portion generally shows the absence of the prosthetic valve 16), with the distal restraint 182 extending across itself in a tightened arrangement before returning through the prosthetic valve 16 and reaching the post member 30. Similarly, in some embodiments, the intermediate restraint 184 exits the intermediate guide 86, emerges from the prosthetic valve 16, surrounds the prosthetic valve 16, and defines an intersection point 304 (for visualization purposes, in...). Figure 11 The central portion generally shows the absence of a prosthetic valve 16, with the intermediate restraint 184 arranged in a tightened manner across itself before returning through the prosthetic valve 16 and reaching the post member 30.

[0189] Figures 13A-13D Additional positions of the proximal constraint ring 195, distal constraint ring 196, and intermediate constraint ring 197 according to other embodiments of frame portion 210 are shown. As shown, the proximal constraint ring 195, distal constraint ring 196, and intermediate constraint ring 197 do not necessarily extend on the middle portion 246 of each row of multiple rows of closed cells 240. For example, the distal constraint ring 196 may simply wrap around the distal row of closed cells 250 at a position proximal to the distal vertex 226. Additionally or alternatively, the distal constraint ring 195 wraps around the proximal row of closed cells 252 at a position distal to the proximal vertex 228.

[0190] like Figure 8 As shown, the central longitudinal axis Xv of the prosthetic valve 16 may optionally be laterally offset from the central longitudinal axis Xs of the support portion 24. In some examples, the prosthetic valve 16 is received on the support portion 24, wherein the support portion 24 is positioned adjacent to the commissure post (not shown) of the prosthetic valve 16 and / or at the intersection of the two leaflets (not shown) of the prosthetic valve 16. Figure 8 and Figure 12 As shown, the prosthetic valve 16 is received on the support portion 24, wherein the proximal portion 200 is above the proximal guide 82, the distal portion 202 is above the distal guide 84, and the intermediate portion 204 is above the intermediate guide 86. In some embodiments, the leaflet region 262 ( Figure 12The leaflet region 262 is positioned on the support portion 24 between the proximal guide 82 and the distal guide 84. For example, in some embodiments, the leaflet region 262 does not extend longitudinally beyond the proximal guide 82 and the distal guide 84. As previously mentioned, the first reduced profile segment 154 and the second reduced profile segment 156 are located midway between the proximal guide 82 and the distal guide 84, and provide leaflet construction 214 before and during the compression of the prosthetic valve 16 onto the support portion 24. Figure 12 This provides additional space. Furthermore, the relatively reduced profile of the intermediate guide 86 helps to provide space for the leaflet structure 214.

[0191] Figure 14A A prosthetic valve 16 in a compact delivery state is shown, wherein each of the proximal restraint ring 195, the distal restraint ring 196, and the intermediate restraint ring 197 restrains the prosthetic valve 16 in the delivery state. As shown, the proximal restraint ring 195 is positioned along the proximal portion 200 of the prosthetic valve 16 on the frame portion 210. Figure 12 The following location on the proximal portion 200 results in a tapered, compressed lateral outer profile or tapered structure, which facilitates the retraction and / or extension into and / or exit from the cannula 12, as shown in reference. Figure 14B As understood. Therefore, according to some embodiments, the proximal end 206 of the prosthetic valve 16 defines a reduced lateral outer profile compared to the adjacent portion of the prosthetic valve 16.

[0192] Similarly, the distal restraint ring 196 is positioned on the frame portion 210 along the distal portion 202 of the prosthetic valve 16 at a location that causes the proximal portion 200 to exhibit a tapered, compressed lateral outer profile or tapered construction, which facilitates the retraction and / or extension of the prosthetic valve 16 from and / or into the cannula 12, as... Figure 14B As shown. By placing the proximal constraint ring 195 and the distal constraint ring 196 at the previously described positions, the proximal constraint ring 195 makes the closed cell proximal row 252 ( Figure 12 The hinges are further inward or angled, and the far side of the closed cells is arranged at 250 degrees. Figure 12 The prosthetic valve 16 is hinged or angled inwards. Therefore, according to some embodiments, the distal end 208 of the prosthetic valve 16 defines a reduced lateral outer profile compared to adjacent portions of the prosthetic valve 16. Figure 12 ).

[0193] Figures 15 to 18BVarious features of another support portion 524 that can be used with the delivery catheter 14 of the transcatheter delivery system 10 are shown, wherein support portion 524 employs the additional or alternative guide configurations described for support portion 24. As previously stated, any number of restraints (e.g., one, two, four, nine, etc.) can be implemented as desired. The various features and components of support portion 524 can be used interchangeably with any component of support portion 24 previously described (and vice versa).

[0194] Figure 15 This is an axonometric or perspective view of a portion of the delivery catheter 14 according to some embodiments, which shows the support portion 524 in more detail. Similar to support portion 24, support portion 524 is generally configured to be received within the prosthetic valve 16 ( Figure 1 The prosthetic valve 16 is supported by delivery into the patient's body (not shown) and deployment at the desired treatment location. As shown, the support portion 524 extends from the distal segment 42 of the main body portion 22 and has a central longitudinal axis Xs. According to some embodiments, the support portion 524 includes a portion of a shaft 80, a support guide 562, a proximal guide 582, a distal guide 584, and an intermediate guide 586.

[0195] In some embodiments, each of the support guide 562, proximal guide 582, distal guide 584, and intermediate guide 586 is coupled to shaft 80 (e.g., by welding, crimping, press fitting, adhesive, or other techniques) to hold and support the respective guides in a longitudinally spaced relationship and longitudinally spaced from the body portion 22 and the end portion 26.

[0196] Figure 16 This is an isometric view of the distal orientation of the support guide 562. Figure 17 This is an isometric view of the proximal orientation of the support guide 562. (See image below.) Figure 16 and Figure 17 As shown, the support guide 562 includes a central cavity 564 configured to receive a shaft 80 for coupling the support guide 562 to the shaft 80. As also shown, the support guide 562 includes a plurality of channels 566, also referred to as passages or cavities. These channels 566 include a pile member channel 568, a first constraint channel 570, a second constraint channel 572, and a third constraint channel 574, although more or fewer channels (e.g., one, four, ten, etc.) are conceivable. Each of the channels 566 is optionally located at a desired angular position around the central longitudinal axis Xs of the support portion 524.

[0197] like Figure 16 and 17As shown, the support guide 562 has a circular, hemispherical, or dome-shaped proximal end 576 and a stepped distal end 578, which is also described as a recess 578 that defines a support surface 580 (e.g., similar to...). Figure 7B The stepped portion 176 shown is used to receive the end of the prosthetic valve 16. Generally, the support surface 580 of the distal end 578 is optionally configured to receive the end of the prosthetic valve 16, and the adjacent increased profile of the distal end 578 helps to protect the end of the prosthetic valve 16.

[0198] In some embodiments, the plurality of channels 566 are typically positioned on the radial side opposite the first constraint lumen 54, the second constraint lumen 56, and the third constraint lumen 58 of the body portion 22 (e.g., positioned on the lower half of the body 22, as shown). This positioning can help balance the overall design, including reducing unwanted bends and / or enhancing preferred bends / bending flexibility in the desired direction. For example, various constraint members 28 can optionally be tensioned on the side of the delivery catheter 14 opposite to the direction in which the prosthetic valve 16 is to expand during deployment. Although some examples of angular positions are provided, any number of positions can be used as desired.

[0199] Figure 18A This is an isometric view of the proximal guide 582 according to some embodiments. For example... Figure 18A As shown, the proximal guide 582 has a substantially the same construction as the intermediate guide 86 of the support portion 24. Subsequently, the distal guide 584 and the intermediate guide 586 are shown as each having a substantially the same construction as the distal guide 84 of the support portion 24 (or the proximal guide 82 of the support portion 24).

[0200] In some embodiments, the proximal guide 582 includes a central cavity 588 through which the shaft 80 is received to couple the proximal guide 582 to the shaft 80. As shown, the proximal guide 582 also includes a plurality of channels 590, also referred to as pathways or cavities. As shown, the plurality of channels 590 includes a pile member channel 592 and a first constraint channel 594, although more or fewer channels (e.g., one, four, ten, etc.) are conceivable. The pile member channel 592 and the first constraint channel 594 are each optionally located at a desired angular position around the central longitudinal axis Xs of the support portion 524.

[0201] Some features of the proximal guide 582 may differ from the design of the intermediate guide 86. For example, as Figure 15 and 18AAs shown, the proximal guide 582 may optionally include a recessed or cut-back region 582A, such that, relative to the design of the intermediate guide 86, additional material is removed, which helps to further reduce the outer profile of the proximal guide 582 compared to the profile described with reference to the intermediate guide 86. Additionally or alternatively, as Figure 18B As shown, the proximal guide 582 optionally defines an open shaft receiving portion 582B (instead of...). Figure 18A The enclosed inner cavity shown is used to receive shaft 80. Figure 15 Compared to the intermediate guide 86, this feature, namely the open shaft receiver 582B, also allows for material reduction. Where the open shaft receiver 582B is present, instead of receiving the shaft 80 in a closed cavity such as a central cavity 588 (e.g., as...),... Figure 15 and 18A As shown), the proximal guide 582 receives the shaft 80 in the open shaft receiving portion 582B, and can be welded along the edge and / or end to secure the proximal guide 582 to the shaft 80.

[0202] like Figure 15 As shown, the design of the distal guide 584 is substantially similar to, or identical to, the intermediate guide 586, and both of these designs are similar to the proximal guide 82 and distal guide 84 of the support portion 524. As shown, both the distal guide 584 and the intermediate guide 586 are generally cylindrical, with a cylindrical lateral outer profile, which also corresponds to a lateral outer profile with a circular cross-section.

[0203] In some embodiments, the distal guide 584 also includes a plurality of channels 602, also referred to as passages or cavities. As shown, the plurality of channels 602 includes a pile member channel 604, a first constraint channel 606, and a second constraint channel 608, although more or fewer channels (e.g., one, four, ten, etc.) are conceivable. The pile member channel 604, the first constraint channel 606, and the second constraint channel 608 are each optionally located at a desired angular position about the central longitudinal axis Xs of the support portion 524.

[0204] In some embodiments, the pile member channel 604 is angularly aligned with the pile member channel 592. In some embodiments, one or more of the plurality of channels 590 and the plurality of channels 602 are angularly misaligned or misaligned with each other. Furthermore, it should be readily understood that the proximal guide 582 may have the same number or a different number (as shown) of channels as the distal guide 584.

[0205] As shown, the proximal guide 582 has a reduced lateral outer profile, or a smaller lateral cross-section than the distal guide 584 and the intermediate guide 586 (e.g., calculated by comparing the cross-sectional areas of the shapes of the respective lateral outer profiles). In some examples, the cross-sectional area of ​​the lateral outer profile of the proximal guide 582 is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80%, or any percentage between these percentages, smaller than the cross-sectional area of ​​the distal guide 584 (e.g., the largest and / or smallest lateral outer profile) and / or the cross-sectional area of ​​the intermediate guide 586 (e.g., the largest and / or smallest lateral outer profile). For example, minimizing the cross-sectional area can help reduce the clamping force on the leaflet region of the prosthetic valve 16 and / or reduce the overall delivery profile of the prosthetic valve 16 as received on the delivery catheter 14.

[0206] like Figure 15 As shown, the intermediate guide 586 includes a central cavity 610 through which the shaft 80 is received to connect the intermediate guide 586 to the shaft 80. The intermediate guide 586 also includes a plurality of channels 612, also referred to as passages or cavities. As shown, the plurality of channels 612 includes a pile member channel 614, a first constraint channel 616, and a second constraint channel 618, although more or fewer channels (e.g., one, three, ten, etc.) are conceivable. The pile member channel 614, the first constraint channel 616, and the second constraint channel 618 are each located at a desired angular position around the central longitudinal axis Xs of the support portion 524.

[0207] In some embodiments, pile member channels 604 and 614 are angularly aligned, first constraint channels 606 and 616 are angularly aligned, and second constraint channels 608 and 618 are angularly aligned. In other embodiments, one or more of the plurality of channels 602 and 612 are angularly misaligned or misaligned with each other. Furthermore, it should be readily understood that in other examples, the intermediate guide 586 may have a different number of channels than the distal guide 584.

[0208] In some embodiments, the pile component channel 568, pile component channels 592, 604, 614, and the pile component channel 160 of the end portion 26 are... Figure 6B Each of the constraint channels 570 and 594 is angularly aligned. In some embodiments, the first constraint channel 572 and the first constraint channel 616 are angularly aligned. In some embodiments, the third constraint channel 574 and the second constraint channels 608 and 618 are angularly aligned.

[0209] like Figure 15 As shown, the support portion 524 defines a plurality of reduced profile segments 650, including a proximal reduced profile segment 652 extending between the proximal guide 582 and the support guide 562, a first reduced profile segment 654 extending between the proximal guide 582 and the intermediate guide 586, a second reduced profile segment 656 extending between the intermediate guide 586 and the distal guide 584, and a distal reduced profile segment 658 extending between the distal guide 584 and the end portion 26. Furthermore, a proximal reduced profile segment 660 is defined between the support guide 562 and the distal portion 42 of the main body portion 22. As shown, both the first reduced profile segment 654 and the second reduced profile segment 656 are located in the middle or between the proximal guide 582 and the distal guide 584.

[0210] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​support guide 562 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter section is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of support guide 562 (or any percentage range between any of the above percentages).

[0211] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​the proximal guide 582 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter segment is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of the proximal guide 582 (or any percentage range between any of the above percentages).

[0212] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​the distal guide 584 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter segment is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of the distal guide 584 (or any percentage range between any of the above percentages).

[0213] In some examples, the cross-sectional area of ​​the lateral outer profile of shaft 80 (e.g., the maximum and / or minimum lateral outer profile) is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the cross-sectional area of ​​intermediate guide 586 (e.g., the maximum and / or minimum lateral outer profile), such that the lateral outer profile of the proximal reduced diameter segment is at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 80% smaller than the lateral outer profile of intermediate guide 586 (or any percentage range between any of the above percentages).

[0214] In some embodiments, the post member 30 is received in each of the post member channels 160, 568, 592, 604, 614 to secure the respective restraint 28 in a ring for restraining the prosthetic valve 16. Although in Figure 15 Constraint 28 is not shown, but the following constraint features related to the assembly and operation of support portion 524 can be referred to. Figures 8 to 11 .

[0215] Contrary to the configuration having support portion 24, in some embodiments implementing support portion 524, the proximal restraint 180 passes through the second restraint cavity 56. Figure 3 The proximal restraint 180 then enters and passes through one of the channels 566 of the support guide 562 (e.g., the first restraint channel 570). The proximal restraint 180 then enters and passes through one of the multiple channels 590 of the proximal guide 582 (e.g., the first restraint channel 594), exits distally from one of the multiple channels 590 (e.g., the first restraint channel 594), and then loops radially away from the central longitudinal axis Xs of the support portion 524 around the support portion 524, intersecting on itself and securing to the pile member 30, which is received through the capture member 190.

[0216] Similar to the support portion 24, for example, the first spindle 34 of the actuation portion 20 ( Figure 2 Tensing the proximal restraint 180 towards the proximal side causes the proximal restraint ring 195 to contract, thereby reducing the diameter of the proximal restraint ring 195 and thus causing collapse or restraint force within the proximal restraint ring 195. Releasing the tension then allows the proximal restraint ring 195 to expand.

[0217] In contrast to the configuration with support portion 24, in some embodiments implementing support portion 524, the distal restraint 182 passes through and exits from the third restraint cavity 58, enters and passes through one of the channels 566 of the support guide 562 (e.g., the second restraint channel 572). The distal restraint 182 then exits from the proximal guide 582, then enters and passes through one of the multiple channels 612 of the intermediate guide 586 (e.g., the second restraint channel 618), then enters and passes through one of the multiple channels 602 of the distal guide 584 (e.g., the second restraint channel 608), extending radially away from the central longitudinal axis Xs of the support portion 524. The distal restraint 182 loops around the support portion 524, crosses itself, and is secured to the post member 30, which is received through the capture member 192 of the distal restraint 182 to define the distal restraint ring 196. For example, utilizing the first spindle 36 of the actuation portion 20 ( Figure 2 Tensioning the distal restraint 182 proximally causes the distal restraint ring 196 to contract, thus causing collapse or restraint force within the proximal restraint ring 196, thereby reducing the diameter of the distal restraint ring 196. Subsequently, releasing the tension allows the distal restraint ring 196 to expand.

[0218] Contrary to the configuration having support portion 24, in some embodiments implementing support portion 524, intermediate constraint member 184 extends from the second constraint cavity 56 ( Figure 3 The intermediate constraint 184 then passes through the outside of the proximal guide 582 to reach the intermediate guide 586 and enters one of the multiple channels 612 of the intermediate guide 586 (e.g., the first constraint channel 616 as shown). The intermediate constraint 184 then extends radially away from the central longitudinal axis Xs of the support portion 524, then loops around the support portion 524, crosses itself, and is secured to the pile member 30, wherein the pile member 30 is received through the capture member 194 of the intermediate constraint 184 to define the intermediate constraint ring 197. For example, using the third spindle 38 of the actuation portion 20 ( Figure 2 Tensing the intermediate constraint member 184 proximally causes the intermediate constraint ring 197 to contract, thus causing collapse or constraint force within the intermediate constraint ring 197, thereby reducing the diameter of the intermediate constraint ring 197. Subsequently, releasing the tension allows the distal constraint ring 196 to expand.

[0219] Various methods for assembling and operating the transcatheter delivery system 10 are conceivable. Whether using support portion 24 or support portion 524, the same method can be used substantially optionally. Furthermore, the substantially same method can be used for the transcatheter delivery system 510 or other exemplary transcatheter delivery systems (e.g., transcatheter delivery system 1010) described below for the assembly and operation methods described below.

[0220] In some examples, the method of assembling the transcatheter delivery system 10 includes positioning a prosthetic valve 16 on a support portion 24 of the delivery catheter 14 such that the central longitudinal axis Xv of the prosthetic valve 16 is laterally offset from the central longitudinal axis Xs of the support portion 24, and the leaflet region 262 of the prosthetic valve 16 is located between the proximal guide 82 and the distal guide 84 of the support portion 24, as previously described. The method also includes compressing the prosthetic valve 16 into a radially compressed delivery configuration such that the leaflet region 262 is received on the intermediate guide 86 and between the proximal guide 82 and the distal guide 84. As previously described, the proximal restraint 180, the distal restraint 182, and the intermediate restraint 184 are secured around the prosthetic valve 16 and fixed to the delivery catheter 14 using a post member 30. The prosthetic valve 16 is constrained in a radially compressed delivery configuration, wherein a proximal restraint ring 195 is defined by a proximal restraint member 180, a distal restraint ring 196 is defined by a distal restraint member 182, and an intermediate restraint ring 197 is defined by an intermediate restraint member 184. The prosthetic valve 16, in its compressed delivery configuration, can be received within a sheath 12 and then extended from the sheath 12 during a medical procedure for delivering the prosthetic valve 16 into the patient. For reference, Figure 17 This shows the prosthetic valve 16 partially retracting into the cannula 12.

[0221] Various methods are conceivable for replacing a patient's natural valve with a transcatheter delivery system 10. Some examples include using the transcatheter delivery system 10 to position a prosthetic valve 16 in a desired location within the patient, wherein the prosthetic valve 16 is mounted on a support portion 24 of the transcatheter delivery system 10 and held in a collapsed delivery configuration by a proximal bundle ring 195, a distal restraint ring 196, and an intermediate restraint ring 197. In some examples, the method includes releasing the proximal restraint ring 195 by reducing tension on the proximal restraint member 180, as previously described, causing the proximal portion 200 of the prosthetic valve 16 to self-expand; releasing the distal restraint ring 196 by reducing tension on the distal restraint member 182, as previously described, causing the distal portion 202 of the prosthetic valve 16 to self-expand; and releasing the intermediate restraint ring 197 by reducing tension on the intermediate restraint member 184, as previously described, causing the intermediate portion 204 of the prosthetic valve 16 to self-expand.

[0222] In some examples, the proximal restraint ring 195, the distal restraint ring 196, and / or the intermediate restraint ring 197 are released simultaneously. In some examples, the proximal restraint ring 195, the distal restraint ring 196, and / or the intermediate restraint ring 197 are released sequentially. As previously described, the release of the proximal restraint ring 195, the distal restraint ring 196, and the intermediate restraint ring 197 allows the prosthetic valve 16 to self-expand to... Figure 12 The enlarged diameter is shown. After expansion, the post member 30 can slide proximally, releasing the capture 190 of the proximal restraint 180, the capture 192 of the distal restraint 182, and the capture 194 of the intermediate restraint 184. Then, according to some embodiments, the proximal restraint 180, the distal restraint 182, and the intermediate restraint 184 can be tensioned and pulled back from around the prosthetic valve 16 and returned to the delivery catheter 14 to release the proximal restraint 180, the distal restraint 182, and the intermediate restraint 184 from the prosthetic valve 16, and thus release the prosthetic valve 16 from the delivery catheter 14.

[0223] In some other examples, similar to the multiple restraints 28, additionally or alternatively, the stud member 30 is releasably received (e.g., through) by one or more of the frame portions 210 and / or coverings 212 of the prosthetic valve 16 to help secure the prosthetic valve 16 to the delivery catheter 14 before release from the delivery catheter 14. The prosthetic valve 16 is then released from the delivery catheter 14 by pulling the stud member 30 through the proximal guide 82, distal guide 84, and intermediate guide 86, as well as the portions of the prosthetic valve 16 into which the stud member 30 is inserted to release the prosthetic valve 16.

[0224] Figure 19 and 20 A partial side view of another transcatheter delivery system 1010 is shown, which has features and components that can be used interchangeably with (and vice versa) any component of the transcatheter delivery system 1010. For ease of understanding, features of the transcatheter delivery system 1010 that are similar to those of the transcatheter delivery system 1010 are prefixed with "1000" on the corresponding feature reference numerals. From the preceding examples, it should be apparent that the transcatheter delivery system 10 can be modified for use with built-in prostheses such as stent grafts, as Figure 20 As shown.

[0225] The transcatheter delivery system 1010 may include a cannula (not shown) such as cannula 12, a delivery catheter 1014 that may be similar to delivery catheter 14, and may be as follows: Figure 20The implantable device 1016 of the stent graft shown, or another implantable device, such as a prosthetic valve 16, has one or more portions held in the collapsed structure by a delivery catheter 1014. It should be noted that cannulas (not shown) or other features, such as restraint sleeves or sheaths (not shown), may be additionally or alternatively employed along one or more portions of the implantable device 1016 to assist in holding the implantable device 1016 in the collapsed structure.

[0226] Similar to delivery conduit 14, delivery conduit 1014 includes an actuation portion (not shown) that may be similar to actuation portion 20, a body portion 1022, a support portion 1024, an end portion 1026, one or more constraint members 1028 that may be similar to a plurality of constraints 1028, and a post member 1030, which may also be described as a locking wire and may be similar to post member 30. As shown, the conduit delivery system 1010 includes a single constraint member 1028, but more constraint members are conceivable.

[0227] As shown, the support portion 1024 is typically configured to be received within the implantable device 1016 and to support the implantable device 1016 by delivery into the patient's body (not shown) and deployment at the desired treatment location. As shown, the support portion 1024 includes a shaft 1080, which may resemble shaft 80; a proximal guide 1082, which may resemble proximal guide 82; and a distal guide 1084, which may resemble distal guide 84. As shown, the support portion 1024 does not include an intermediate guide, such as intermediate guide 86, but such an option is contemplated. The proximal guide 1082 may optionally include a tapered portion, such as a sloped portion 1082a, which facilitates retraction of the proximal guide 1082 into a cannula 12 (…). Figure 1 In the casing, such as )

[0228] As shown, the first reduced profile segment 1154 (e.g., similar to the first reduced profile segment 154) is located in the middle or between the proximal guide 1082 and the distal guide 1084, and can provide additional area for the implantable device 1016 and / or assist in ensuring that the post member 1030 has sufficient bending strength to help anchor the restraint 1028 to the post member 1030, while tensioning the restraint 1028 in a manner similar to the plurality of restraints 28.

[0229] like Figure 20As shown, similar to a plurality of constraint members 28, constraint member 1028 is received through various portions of implantable device 1016 (e.g., through the distal row 1250 of the closed cell at the distal end 1220 of the frame portion 1210 of implantable device 1016). As shown, constraint member 1028 may optionally be guided in an "under-frame" configuration, wherein constraint member 1028 is guided under the frame portion 1210 of implantable device 1016. In some examples, this guidance pattern may help reduce frictional forces encountered by constraint member 1028 and help reduce the tension force used by constraint member 1028.

[0230] Although not described in more detail, it should be readily understood that the operation of the transcatheter delivery system 1010 and the components for such operation can be taken from any examples and options described with respect to the transcatheter delivery system 10, and vice versa.

[0231] Figure 21A This is a side view of a catheter delivery system 3500, including a delivery catheter 3510 for delivering and deploying a multi-frame implantable device 3000. The multi-frame implantable device 3000 is shown, comprising an outer frame 3100, an inner frame 3200, and a flexible interconnection 3300 between the outer frame 3100 and the inner frame 3200. The inner frame 3200 is longitudinally offset from the outer frame after delivery and optionally nestable within the outer frame. The flexible interconnection is reversible when the inner frame is nested within the outer frame; however, this is merely an example and nesting is not required in all examples. In some examples, the multi-frame implantable device is configured for repairing or replacing a prosthetic valve of the mitral valve; however, various implantable devices are contemplated. The inner frame 3200 is optionally a leaflet frame (i.e., configured to support the leaflet structure), and the outer frame 3200 is optionally a reinforcing frame (e.g., configured to reinforce or otherwise support the inner frame). In other examples, the inner frame is used as a reinforcing frame, and the outer frame is used as a leaflet frame.

[0232] In a manner similar to the previously described example (e.g., delivery catheter 14), delivery catheter 3510 includes a body portion 3510, a support portion 3512, a distal portion 3514, and one or more restraints, such as a first pair of restraints 3536 and a second pair of restraints 3538, wherein the first pair of restraints 3536 is associated with a first pair of guides 3522, and the second pair of restraints 3538 is associated with a second pair of guides 3524.

[0233] In various examples, each pair of restraints is adapted and arranged to interface with a corresponding one of the outer frame 3100 and the inner frame 3200. The first pair of restraints 3536 typically includes a proximal restraint 3540 and a distal restraint 3542. It will be understood that the first pair of restraints 3536 may additionally include an intermediate restraint located between the proximal restraint 3540 and the distal restraint 3542, though this intermediate restraint is not shown. The body portion 3510 defines a central longitudinal axis Xa and has a proximal segment (not shown, but may be similar to other examples, such as proximal segment 40) and a distal segment 3520. The body portion 3510 has an appropriate length to allow a user (not shown) to manipulate the delivery device 3500 from outside the patient's body, which can be implanted with the device ( Figure 21A (Not shown) is implanted into the patient's body. Typically, the main body 3510 has sufficient flexibility, length, and column strength to be suitable for traversing the vascular system or other body cavities and catheters within the patient's body.

[0234] Figure 21B According to some embodiments Figure 21A The sectional view taken by line BB in the diagram. For example... Figure 21B As shown, the body portion 3510 has a plurality of lumens 3511 extending within the body portion 3510, which can also be described as pathways or channels. In the same manner as in the previous example, the plurality of lumens 3511 extend the length of the body portion 3510 through the proximal and distal segments of the delivery conduit. In some embodiments, the lumens 3511 include two or more post member lumens, such as a first post member lumen 3513 and a second post member lumen 3515. Furthermore, in some embodiments, the plurality of lumens 3511 include a first constrained lumen 3517, a second constrained lumen 3519, a third constrained lumen 3521, and a fourth constrained lumen 3523; however, multiple additional lumens (e.g., eight, ten, twelve, etc.) are contemplated. In some embodiments, the lumen 3511 also includes a central lumen 3525. In various examples, the first pile member cavity 3513 and the second pile member cavity 3515, as well as the first constraint cavity 3517, the second constraint cavity 3519, the third constraint cavity 3521 and the fourth constraint cavity 3523, are each optionally located at a desired angular position around the central longitudinal axis Xa of the main body portion 3510.

[0235] As shown in the figure, the inner cavity 3513 of the first pile member is located at the position corresponding to 12 o'clock or 0 degrees, the inner cavity 3515 of the second pile member is located at the position corresponding to 2 o'clock or 60 degrees, the first constraint inner cavity 3517 is located at the position corresponding to 4 o'clock or 120 degrees, the second constraint inner cavity 3519 is located at the position corresponding to 6 o'clock or 180 degrees, the third constraint inner cavity 3521 is located at the position corresponding to 8 o'clock or 240 degrees, and the fourth constraint inner cavity 3523 is located at the position corresponding to 10 o'clock or 270 degrees. Although some examples of angular positions are provided, any number of positions can be used as desired. As shown in the figure, the central inner cavity 3525 can be positioned coaxially with the longitudinal axis Xa of the main body 3510; however, again, any number of positions can be used as desired.

[0236] The distal segment 3520 of the main body portion 3510 is coupled to the support portion 3512 and optionally includes one or more features to facilitate entry, exit, and / or passage of the distal segment 3520 through the restraint cannula. For example, the distal segment may include a flare, flange, or taper to provide an increased diameter profile to the distal segment 3520 adjacent to the support portion 3512. This increased diameter profile, also referred to as the external lateral profile, has a relatively smooth transition to reduce entanglement or mechanical friction between the restraint cannula and the distal segment 3520 as the distal segment 3520 slides through, extends from, and / or retracts into such a restraint cannula and passes through the vascular system or other catheters (not shown) within the patient's body.

[0237] The support portion 3512 is typically configured to be received within an implantable device 3000 and to support the implantable device 3000 by delivery to and deployment at a desired treatment location in the patient's body (not shown). As shown, the support portion 3512 extends from a distal segment 3520 of the body portion 3510 and has a central longitudinal axis Xb. In various examples, the central longitudinal axis Xb of the support portion 3512 is parallel to the central longitudinal axis Xa of the body portion 3510. In some examples, the central longitudinal axis Xb is coaxial with the central longitudinal axis Xa. The support portion 3512 includes a shaft 3526. In some examples, the shaft 3526 supports one or more of a plurality of restraints 3516. The shaft 3526 may be substantially identical to features similar to those of the shaft 80 previously described or subsequently described (e.g., including a reinforced flexible portion). In various embodiments, as those skilled in the art will understand, the shaft 3526 is a flexible, elongated element and may optionally include a central lumen, such as for receiving a guidewire.

[0238] In various examples, the support portion 3512 also includes a first pair of guides 3522 and a second pair of guides 3524, as discussed further below.

[0239] In various embodiments, shaft 3526 is formed as a hollow tube (e.g., a hypo tube), such as using a nickel-titanium alloy, stainless steel, or other metal or polymeric material. In various examples, shaft 3526 is configured to receive a guidewire (not shown) for guiding delivery device 3500 to a desired treatment location within the patient's anatomy. However, shaft 3526 may also be formed as a solid member without any lumen, if desired. Shaft 3526 is optionally coupled to distal portion 3514 (e.g., inserted and press-fitted or coupled to distal portion 3514), extending the length of support portion 3512, and coupled to body portion 3510 (e.g., extending through central lumen 3525 and extending proximally from body portion 3510). Shaft 3526 may optionally be a single integral member, although separate connecting parts are also contemplated.

[0240] In various examples, each pair of guides 3522 and 3524 is adapted and arranged to interface with one or more of the constraint members 3516. The first pair of guides 3522 typically includes a proximal guide 3528 and a distal guide 3530. It will be understood that the first pair of guides 3522 may additionally include, as desired, an intermediate guide located between the proximal guide 3528 and the distal guide 3530, although this intermediate guide is not shown. In some examples, the second pair of guides 3524 typically includes a proximal guide 3532 and a distal guide 3534. It will be understood that the second pair of guides 3524 may also additionally include, as desired, an intermediate guide located between the proximal guide 3532 and the distal guide 3534.

[0241] like Figure 21C and 21D As shown, the proximal guide 3528 and distal guide 3530 of the first pair of guides 3522 are generally cylindrical, having a cylindrical lateral outer profile that also corresponds to a lateral outer profile segment with a circular cross-section. It will be understood that while a cylindrical profile is envisioned, various taper, steps, chamfers, and other features are also conceivable. In some examples, the proximal guide 3528 and distal guide 3530 are configured to support the inner frame 3200.

[0242] In various examples, each of the proximal guide 3528 and the distal guide 3530 of the first pair of guides 3522 defines a central longitudinal axis (not separately labeled) that is coaxial with the central longitudinal axis Xa of the support portion 3512, and according to some examples, it is coaxial with the central longitudinal axis of the shaft 3526 in accordance with the transmission principle.

[0243] like Figure 21CAs shown, in some embodiments, the proximal guide 3528 includes a central cavity 3527 through which the shaft 3526 is received to couple the proximal guide 3528 to the shaft 3526. As also shown, the proximal guide 3528 includes a plurality of channels 3529, also referred to as pathways or cavities. In various examples, the plurality of channels 3529 include one or more pile member channels, such as a first pile member channel 3533 and a second pile member channel 3535. Furthermore, in some embodiments, the plurality of channels 3529 includes a first constraint channel 3537, a second constraint channel 3539, a third constraint channel 3541, and a fourth constraint channel 3543; however, multiple additional channels (e.g., eight, ten, twelve, etc.) are contemplated. In various examples, the first pile member channel 3533 and the second pile member channel 3535, as well as the first constraint channel 3537, the second constraint channel 3539, the third constraint channel 3541 and the fourth constraint channel 3543, are each optionally located at a desired angular position around the central longitudinal axis Xb of the support portion 3512.

[0244] As shown in the figure, the pile member channel and the constraint member channel correspond to the pile member cavity and the constraint member cavity of the main body 3510 in terms of angle and offset, as described above. For example, the first pile member channel 3533 corresponds to the first pile member cavity 3513, such that the first pile member channel 3533 is at an angle position corresponding to 12 o'clock or 0 degrees.

[0245] As in Figure 21C and 21D As can be seen by reference, the distal guide 3530 is substantially similar to the proximal guide 3528. In some examples, the distal guide 3530 is also generally cylindrical, with a cylindrical lateral outer profile, which also corresponds to a lateral outer profile with a circular cross-section; however, as mentioned above, any of various taper, steps, chamfers, and other features can also be envisioned.

[0246] According to some examples, the distal guide 3530 also defines a central longitudinal axis (not separately marked), which is coaxial with the central longitudinal axis Xa of the support portion 3512, and, according to the transmission principle, is coaxial with the central longitudinal axis of the shaft 3526 (and the proximal guide 3528).

[0247] like Figure 21DAs shown, in some embodiments, the distal guide 3530 includes a central cavity 3545 through which the shaft 3526 is received to couple the distal guide 3530 to the shaft 3526. As also shown, the distal guide 3530 includes a plurality of channels 3547, also referred to as pathways or cavities. In various examples, the plurality of channels 3547 includes one or more pile member channels, such as a first pile member channel 3553 and a second pile member channel 3555. Furthermore, in some embodiments, the plurality of channels 3547 includes a first constraint channel 3557, a second constraint channel 3559, a third constraint channel 3561, and a fourth constraint channel 3563; however, multiple additional channels (e.g., eight, ten, twelve, etc.) are contemplated. In various examples, the first pile member channel 3553 and the second pile member channel 3555, as well as the first constraint channel 3557, the second constraint channel 3559, the third constraint channel 3561 and the fourth constraint channel 3563, are each optionally located at a desired angular position around the central longitudinal axis Xb of the support portion 3512.

[0248] As shown in the figure, the pile member channel and the constraint member channel correspond to the pile member cavity and the constraint member channel of the proximal guide 3528 in terms of angle and offset, as described above. For example, the first pile member channel 3553 corresponds to the first pile member channel 3533, such that the first pile member channel 3553 is at an angle position corresponding to 12 o'clock or 0 degrees.

[0249] In various embodiments, each channel 3529 of the proximal guide 3528 is aligned with a corresponding channel among the plurality of channels 3547 of the distal guide 3530. In other words, the first post member channel 3533 is angularly aligned with the first post member channel 3553, and the first constraint channel 3537 is angularly aligned with the first constraint channel 3557, and so on, as described above. However, it will be understood that one or more of the plurality of channels 3529 and the plurality of channels 3547 may be angularly misaligned or misaligned with each other. Furthermore, as described below, the distal guide 3530 need not have the same number of channels as the proximal guide 3528.

[0250] like Figure 21E and 21FAs shown, the proximal guide 3532 and distal guide 3534 of the second pair of guides 3524 are generally cylindrical, having a cylindrical lateral outer profile that also corresponds to a lateral outer profile segment with a circular cross-section. It will be understood that while a cylindrical profile is envisioned, various taper, step, chamfer, and other features are also conceivable. In some examples, the diameters of the proximal guide 3532 and distal guide 3534 of the second pair of guides 3524 are typically smaller than the diameters of the proximal guide 3528 and distal guide 3530 of the second pair of guides 3524. In some examples, this configuration provides an inner frame 3200 that can be retracted proximally (e.g., extended) into the internal region defined by the outer frame 3100. That is, by providing the proximal guide 3532 and distal guide 3534 with smaller diameters, the inner frame 3200 can be reduced to a smaller cross-section suitable for reception within the outer frame 3100. In some examples, the proximal guide 3532 and the distal guide 3534 are configured to support the inner frame 3200.

[0251] In various examples, each of the proximal guide 3532 and the distal guide 3534 of the second pair of guides 3524 defines a central longitudinal axis (not individually labeled) that is coaxial with the central longitudinal axis Xa of the support portion 3512, and according to some embodiments, it is coaxial with the central longitudinal axis of the shaft 3526 in accordance with the transmission principle.

[0252] like Figure 21E As shown, in some embodiments, the proximal guide 3532 includes a central cavity 3565 through which the shaft 3526 is received to couple the proximal guide 3532 to the shaft 3526. As also shown, the proximal guide 3532 includes a plurality of channels 3567, also referred to as pathways or cavities. These channels 3567 include a second post member channel 3575, a first constraint channel 3577, and a second constraint channel 3579, but many additional channels (e.g., eight, ten, twelve, etc.) are contemplated. In various examples, the second post member channel 3575 and the first and second constraint channels 3577 and 3579 are each optionally located at a desired angular position around the central longitudinal axis Xb of the support portion 3512.

[0253] As shown in the figure, the pile member channel and the constraint member channel correspond to the pile member channel and the constraint member channel of the distal guide 3530 in terms of angle and offset, as described above. For example, the second pile member channel 3575 corresponds to the second pile member channel 3555, such that the second pile member channel 3575 is at an angle position corresponding to 2 o'clock or 60 degrees.

[0254] As in Figure 21E and 21F As can be seen by reference, the distal guide 3534 is substantially similar to the proximal guide 3532. In some examples, the distal guide 3534 is also generally cylindrical, having a cylindrical lateral outer profile, which also corresponds to a lateral outer profile with a circular cross-section; however, as mentioned above, any of various taper, steps, chamfers, and other features can also be envisioned.

[0255] According to some examples, the distal guide 3534 also defines a central longitudinal axis (not separately marked), which is coaxial with the central longitudinal axis Xa of the support portion 3512, and according to the transmission principle, it is coaxial with the central longitudinal axis of the shaft 3526 (and the proximal guide 3532).

[0256] like Figure 21F As shown, in some embodiments, the distal guide 3534 includes a central cavity 3581 through which the shaft 3526 is received to connect the distal guide 3534 to the shaft 3526. As shown, the distal guide 3534 also includes a plurality of channels 3583, also referred to as pathways or cavities. As shown, the plurality of channels 3583 include a second post member channel 3585, a first constraint channel 3587, and a second constraint channel 3589, but many additional channels (e.g., eight, ten, twelve, etc.) are contemplated. In various examples, the second post member channel 3585 and the first constraint channel 3587 and the second constraint channel 3589 are each optionally located at a desired angular position around the central longitudinal axis Xb of the support portion 3512.

[0257] As shown in the figure, the pile member channel and the restraint member channel correspond to the pile member channel and the restraint member channel of the proximal guide 3532 in terms of angle and offset, as described above. For example, the second pile member channel 3585 corresponds to the second pile member channel 3575, such that the second pile member channel 3585 is at an angle position corresponding to 2 o'clock or 60 degrees.

[0258] like Figure 21AAs shown, the plurality of constraint members 3516 includes a first pair of constraint members 3536 and a second pair of constraint members 3538, wherein the first pair of constraint members 3536 is associated with a first pair of guide members 3522, and wherein the second pair of constraint members 3538 is associated with a second pair of guide members 3524. In various examples, each pair of constraint members is adapted and arranged to interface with a corresponding one of the outer frame 3100 and the inner frame 3200. The first pair of constraint members 3536 typically includes a proximal constraint member 3540 and a distal constraint member 3542. It will be understood that the first pair of constraint members 3536 may additionally include an intermediate constraint member located between the proximal constraint member 3540 and the distal constraint member 3542, although this intermediate constraint member is not shown. The second pair of constraint members 3538 typically includes a proximal constraint member 3544 and a distal constraint member 3546. It will be understood that the second pair of constraint members 3538 may also additionally include an intermediate constraint member located between the proximal constraint member 3544 and the distal constraint member 3546, although this intermediate constraint member is not shown.

[0259] In some embodiments, each of the plurality of restraints 3516 is formed as fibers, strands, wires, combinations thereof, etc., and may be woven, wound, extruded, or otherwise formed from metallic or polymeric materials. For example, each of the restraints 3516 may be formed from woven strands of materials such as UHMWPE or ePTFE. Although three restraints are shown, any number of restraints (e.g., one, two, four, nine, etc.) is contemplated. In some embodiments, the proximal restraint 3540 includes a catch 3548 in the form of, for example, a terminal, a closed loop, or an eyelet. The catch 3548 may optionally be formed using a weaving method (e.g., by twisting the braid into itself or by a continuous weaving method that branches a single strand into two separate strands and then re-weaves them into a single strand to form an eyelet). The distal restraint 3542 similarly includes a catch 3550, as does the proximal restraint 3544, which includes a catch 3552. The distal restraint 3546 includes a catch 3554.

[0260] The transcatheter delivery system 3510 may include a cannula (not shown), such as cannula 12, a delivery catheter 3514, which may be similar to delivery catheter 14, and an implantable device, which may be a valve or another implantable device, having one or more portions held in a collapsed configuration by delivery catheter 3514. It should be noted that a cannula (not shown) or other features, such as restraint sleeves or sheaths (not shown), may be additionally or alternatively employed along one or more portions of the implantable device (not shown) to assist in holding the implantable device in a collapsed configuration. Delivery catheter 3514 also includes two or more post members, which may also be described as locking sutures, and each may be similar to post member 30.

[0261] In various examples, the pile member includes a first pile member 3556 and a second pile member 3558. The first pile member 3556 is typically associated with a first pair of restraints (not shown) and a first pair of guides 3522, either fixedly or otherwise engaged, while the second pile member 3558 is typically associated with a second pair of restraints (not shown) and a second pair of guides 3084, either fixedly or otherwise engaged. For example, as... Figure 21G As shown, the first pile member 3556 extends through the first pile member cavity 3513 of the main body portion 3510 and enters the first pile member channels 3533 and 3553 of the proximal guide 3528 and distal guide 3530 of the first pair of guides 3522. Similarly, as Figure 21G As shown, the second pile member 3558 extends through the second pile member cavity 3515 of the main body portion 3510, through the second pile member channels 3535 and 3555 of the proximal guide 3528 and the distal guide 3530 of the first pair of guides 3522, and enters the second pile member channels 3575 and 3585 of the proximal guide 3532 and the distal guide 3530 of the second pair of guides 3524.

[0262] Now go to Figure 21H The figure illustrates and describes a non-limiting delivery operation according to the examples and embodiments described above. As shown, for example, a first pair of restraints 3536 (e.g., proximal restraint 3540 and distal restraint 3542) has been released from the first post member 3556, such that the outer frame 1100 is operable to expand and engage the mitral valve annulus. However, as shown, the proximal restraint 3544 and distal restraint 3546 remain connected to the second post member 3558 and the leaflet frame 3200.

[0263] Despite Figure 21H Not shown in this document, but it will be understood that, in practice, each of the proximal restraint 3544 and the distal restraint 3546 connects (e.g., weaves or otherwise passes through) the portions of the internal frame 3200.

[0264] With the outer frame 3100 unconstrained and the leaflet frame 3200 at least partially constrained by the proximal constraint 3544 and the distal constraint 3546, the delivery device 3500 can be retracted proximally (e.g., translated proximally) relative to the leaflet and outer frame 3100 in the direction of arrow 3560, such that the inner frame 3200 is retracted proximally into the internal region defined by the outer frame 3100, as discussed herein. In various examples, the delivery device 3500 is retracted proximally until the inner frame 3200 becomes nested within the outer frame 3100, as discussed herein.

[0265] In some examples, after the first pair of restraints 3536 are released from the first pile member 3556 and the outer frame 1100, and before the delivery device 3500 and the inner frame 3200 are withdrawn proximally, the tension in one or more of the proximal restraints 3544 and the distal restraints 3546 can be reduced, thereby enabling the partial deployment of one or more of the inner frames 3200. Thus, in such examples, the delivery device 3500 is operable to partially deploy the inner frame 3200 before the delivery device 3500 and the inner frame 3200 are withdrawn proximally.

[0266] It should be understood that while the delivery system included in the examples and embodiments discussed above comprises multiple piling members, the delivery system can operate using a single piling member. For example, in some examples, the piling member may engage and hold each of a first constraint extending around the outer frame 3100 and a second constraint extending around the inner frame 3200. In such examples, the piling member is typically guided through one or more guides such that retracting the proximal end of the piling member proximally causes the distal end of the piling member to advance proximally along the support of the delivery system, such that the constraint extending around the outer frame 1100 can be released before releasing the constraint extending around the leaflet frame 1200.

[0267] Figures 22A-22D Additional design concepts for proximal guides 82, distal guides 84, and / or intermediate guides 86 in the form of guides 2082, and proximal guides 1082 and / or distal guides 1084 are shown. In various examples, guide 2082 includes a filament formed into at least one loop adapted to wrap around and engage with the outer periphery of shaft 2080 (e.g., a support portion), and defines at least one constraint channel between shaft 2080 and the filament. Similar to the guide designs previously described, the constraint channel of guide 2082 is configured to receive a constraint member (e.g., a fiber) extending longitudinally through the constraint channel and then guided laterally / radially outward to form a releasable loop configuration to define a constraint ring (e.g., a proximal constraint ring 195). In various examples, the looped filament design of guide 2082 can help provide easy manufacturability, a reduced overall guide profile for achieving a higher level of diameter clamping of the device on the guide, and resistance to deflection of the pile member when loads are applied by the constraint (e.g., when the constraint is tensioned).

[0268] Figure 22A This is a perspective view of a guide 2082 mounted on a section (e.g., support portion 24 of shaft 80 or support portion 1024 of shaft 1080) of a transcatheter delivery system (e.g., transcatheter delivery system 10 or transcatheter delivery system 1010).

[0269] Figure 22B This is a bottom view of a guide 2082 mounted on shaft 2080. As shown, guide 2082 comprises one or more turns of filament (e.g., wire, fiber, braid, bead, or hyaluronic acid tube) wrapped around or otherwise arranged around shaft 80. In various examples, the filament forming any guide may elastically retain its shape, although less elastic and more flexible filaments may be used as desired.

[0270] Figure 22C This is an end view of guide 2082 according to some embodiments. As shown, according to some examples, guide 2082 defines a central longitudinal axis (not separately labeled) that is coaxial with the central longitudinal axis of shaft 2080. As shown, guide 2082 includes a central cavity 2088 through which shaft 2080 is received to connect guide 2082 to shaft 2080.

[0271] like Figure 22A and 22B As shown, guide 2082 defines a plurality of loops around or around shaft 2080, including a first base loop 2090 (also referred to as a retaining ring), a first eyelet loop 2092 (also referred to as a guide ring), a second eyelet loop 2094 (also referred to as a guide ring), and a second base loop 2096 (also referred to as a retaining ring). However, any number of loops, turns, rings, or passes around shaft 2080 can be contemplated. Although guide 2082 is shown as a single continuous length of material extending multiple times around guide 2082 along a helical path or other longitudinal and circumferential path, in other examples, individual loops (e.g., individual turns or rings) can also be contemplated for each loop 2090, 2092, 2094, 2096. As shown, the first base loop 2090 and the second base loop 2096 are each generally cylindrical and can engage relatively tightly with the outer periphery of shaft 80 (e.g., to help secure guide 2082 to shaft 2080).

[0272] The first eyelet 2092 has an eccentric profile relative to the axis 2080 and defines a pile member channel 2092A, also referred to as pile member channel 2092A. The second eyelet 2094 has an eccentric profile relative to the axis 2080 and defines a constraint channel 2094A. Similar to any of the aforementioned proximal, intermediate, or distal guides, the pile member channel 2092A is configured to receive a pile member, such as pile member 30 or pile member 1030. Similar to any of the aforementioned proximal, intermediate, or distal guides, the constraint channel 2094A is configured to receive a constraint, such as one of one or more constraint members 1028 among a plurality of constraint members 28.

[0273] The pile component channel 2092A and the constraint channel 2094A are each optionally located at a desired angular position around the central longitudinal axis of the shaft 2080. For example, the pile component channel 2092A and the constraint channel 2094A may optionally be located at the same angular position as the pile component channel 92 and the first constraint channel 94 of the transconduit delivery system 10 or a similar feature of the transconduit delivery system 1010, and serve a similar function.

[0274] As shown in the figure, the pile member channel 2092A is located at an angle corresponding to 12 o'clock or 0 degrees, and the first constraint channel 2094A is located at an angle corresponding to 11 o'clock or -15 degrees. Although some examples of angle positions are provided, any number of angle positions can be used as desired.

[0275] Guide 2082 has a maximum lateral outer profile at one or more cross-sections along its length and a minimum lateral outer profile at one or more cross-sections along its length. For example, guide 2082 may optionally define a maximum lateral outer profile at a first eyelet 2092 and / or a second eyelet 2094 and a minimum lateral outer profile at a first base ring 2090 and / or a second base ring 2096, though any of a variety of outer profiles is contemplated, including tapers, steps, chamfers, and other features. Typically, the arrangement of the first eyelet 2092 and the second eyelet 2094 is chosen to minimize the overall profile, thereby facilitating clamping of the device around the maximum diameter of guide 2082.

[0276] The configuration associated with guide 2082 can be used for proximal guide 82 and / or intermediate guide 86 as desired. For example, a second guide with the same or similar design as guide 2082 can be implemented, such that both proximal guide 82 and intermediate guide 86 have a design corresponding to that of guide 2082. In use, in situations such as Figure 22C In the case of the proximal guide 82 of the transcatheter delivery system 10, instead of a second constraint channel such as a second constraint channel 96, the distal constraint 182 can simply bypass the guide 2082 or extend alongside the guide 2082, thus extending side by side with the pile member channel 2092A.

[0277] Figure 22D An end view of the guide 2082 in a variant configuration is shown, wherein the position of the pile member channel 2092A is relative to... Figure 22C The examples show similar angular positions, but constraint channel 2094A is located at an angular position corresponding to 1 o'clock or +15 degrees. Although some examples of angular positions are provided, any number of angular positions can be used as desired. Figure 22D The arrangement shown can be used as an alternative to the previously described arrangement of the distal guide 84 of the transcatheter delivery system 10. Figure 22D The constraint channel 2094A shown may optionally be used in a similar manner to the second constraint channel 108 of the distal guide 84.

[0278] Guide 2082 may optionally be formed and attached to shaft 2080 using any of a variety of methods, including wrapping or winding a filament (e.g., wire) around shaft 2080 with sufficient tension such that guide 2082 is held in a desired position on shaft 2080 with a desired orientation. Heat treatment, adhesives, or other methods may be used, if desired, to facilitate attachment of guide 2082 to shaft. Alternatively, guide 2082 may be formed separately from shaft 2080, with an inner diameter smaller than the outer diameter of shaft 2080, then expanded, placed on shaft, and recoiled such that a biasing force / elasticity assists in engaging guide 2082 and shaft 2080. Multiple guides, such as guide 2082, may be attached to shaft 2080 using any of these techniques. Guide 2082 may be formed from any of a variety of metallic or polymeric materials, including shape memory materials, nickel-titanium alloys, stainless steel alloys, fluoropolymers, etc.

[0279] Figures 22A-22D Further design concepts are shown for the proximal guide 82, the distal guide 84 and / or the intermediate guide 86 in the form of guide 2182, and the proximal guide 1082 and / or the distal guide 1084.

[0280] In the example shown, guide 2182 is typically described in connection with the use of a proximal guide 82 in place of transcatheter delivery system 10. From this example, it should be readily understood that any proximal, intermediate, or distal guide previously associated with transcatheter delivery system 10 or transcatheter delivery system 1010 can be constructed in the same or similar manner as guide 2182. Like other guide constructions, guide 2182 is configured to receive restraints (e.g., as...). Figure 23B The proximal constraint 180 shown extends longitudinally through the constraint channel and is then laterally / radially redirected outward by the guide 2182 to form a releasable loop configuration to define a constraint loop (e.g., as shown). Figures 23A-23C The proximal constraint ring 195 is shown.

[0281] Figure 23A This illustrates the ability to position guide 2182 relative to the transcatheter delivery system 10 (in... Figure 23A The area (hidden in the middle) (e.g., as a proximal guide located below the prosthetic valve 16 to retain the proximal restraint ring 195). Figure 23B and Figure 22AThe arrangement is the same, but viewed from opposite angles. Figure 23C Guide 2182 is shown, which has a prosthetic valve 16 (not shown) to make the interaction between guide 2182 and proximal restraint ring 195 and the interaction between guide 2182 and post member 30 in use visible.

[0282] Figure 23D This is a top view of the area of ​​the support portion 24 near the guide 2182. Figure 23E This is an end view of the support portion 24 near the guide 2182, showing the distal section 42 of the main body portion 22, and Figure 23F Is with Figure 23D Side views of roughly the same area. Figure 23E In the diagram, for ease of reference, the lateral angular position corresponding to "12 o'clock" relative to the top of the support portion 24 is marked. For reference, and for ease of observation, in... Figure 23D-23F The proximal restraint 180 is not shown in the diagram.

[0283] As shown in the figure, guide 2182 includes a fiber guide tube 2192 and optionally a post guide tube 2193, which can also be described as a wire-locking guide tube 2193. As shown, the fiber guide tube 2192 and post guide tube 2193 are optionally formed separately and positioned close to each other. Each of the fiber guide tube 2192 and post guide tube 2193 is optionally formed individually as a continuous tubular member, such as a hyaluronic acid tube. The fiber guide tube 2192 and post guide tube 2193 are optionally formed from similar or dissimilar materials, including any of a variety of metals or polymeric materials. In some examples, the fiber guide tube 2192 and post guide tube 2193 are formed from hyaluronic acid tube material. The fiber guide tube 2192 and post guide tube 2193 can be integrally formed with shaft 80, or they can be formed separately and connected to shaft 80 using any of a variety of fastening mechanisms, including welding, adhesives, fasteners, etc.

[0284] As shown in the figure, the fiber guide tube 2192 includes a receiving portion 2194, a transition portion 2196, and an exit portion 2198, wherein the receiving portion 2194 is located proximal to the exit portion 2198, and the transition portion 2196 is located along the axis 80 between the receiving portion 2194 and the exit portion 2198. As shown, the receiving portion 2194 extends along the outer periphery or surface of the axis 80 at a first lateral angular position relative to the top of the support portion 24, and extends at a first longitudinal angle relative to the longitudinal axis of the axis 80 and the support portion 24. For example, the receiving portion 2194 may optionally extend at a first longitudinal angle equal to or close to zero degrees (±15 degrees), which is measured relative to the longitudinal axis of the axis 80. The receiving portion 2194 is located at a first lateral angular position around the outer surface of the axis 80. For example, the receiving portion 2194 may optionally be at a first lateral angular position at zero degrees or 6 o'clock relative to a coordinate system in which the top of the axis 80 is at zero degrees or 12 o'clock.

[0285] The transition portion 2196 of the fiber guide tube 2192 extends or wraps around a portion of the outer periphery of the shaft 80 in a longitudinal and circumferential manner (e.g., spirally, substantially spirally, or otherwise bent / extended along the surface of the support portion 24), thereby changing the longitudinal and lateral angular position of the fiber guide tube 2192 between the receiving portion 2194 and the exit portion 2198.

[0286] The departure portion 2198 extends along the outer periphery or surface of the shaft 80 at a second lateral angular position and extends at a second longitudinal angular position. For example, the departure portion 2198 may optionally be located at a second longitudinal angular position of 90 degrees or close to 90 degrees (±15 degrees) relative to the longitudinal axis of the shaft 80. The departure portion 2198 is located at a second lateral angular position of 135 degrees about the outer surface of the shaft 80, or at a 9 o'clock position in a coordinate system with zero degrees or 12 o'clock relative to the top of the shaft 80.

[0287] In some examples, the first longitudinal angle and the second longitudinal angle are offset by 45 degrees or more, such as 90 degrees, and the first lateral angle position and the second lateral angle position are offset by 45 degrees or more, such as 90 degrees.

[0288] In operation, the fiber guide tube 2192 is configured to receive a constraint (e.g., proximal constraint 180) at a first longitudinal extension angle at a first lateral angular position around the periphery of the shaft 80 (e.g., at or near the first longitudinal angle of the receiving portion 2194). The fiber guide tube 2192 then guides or transforms the extension direction of the constraint at a second lateral angular position around the periphery of the shaft 80 to a second longitudinal extension angle corresponding to the second longitudinal angle of the exit portion 2198.

[0289] In some examples, as the constraint passes through the fiber guide tube 2192, the first longitudinal extension angle and the second longitudinal extension angle of the constraint are offset by 45 degrees or more, for example, 90 degrees, and similarly, the first lateral angle position and the second lateral angle position are offset by 45 degrees or more, for example, 90 degrees.

[0290] exist Figure 22C-22D In the example, fiber guide tube 2192 is configured to receive the constraint at a first longitudinal extension angle of zero degrees or within 15 degrees of zero, in a generally longitudinally extending direction, at a first lateral angular position corresponding to 90 degrees or 6 o'clock. Fiber guide tube 2192 transitions or guides the extension direction of the constraint to a generally perpendicular extension direction at a second lateral angular position corresponding to 135 degrees or 9 o'clock, at a second longitudinal extension angle of 90 degrees or within 15 degrees of that position. However, fiber guide tube 2192 can be readily modified to provide any of a variety of variations in the longitudinal extension angle and lateral angular position of the constraint (e.g., proximal constraint 180) as the constraint passes through fiber guide tube 2192.

[0291] In some examples, the exit portion 2198 defines an outlet 2198A for the outwardly flared fiber guide tube 2192. This flared configuration helps prevent friction and facilitates smooth actuation of the constraint passing through the fiber guide tube 2192. Similarly, the receiving portion 2194 optionally defines an inlet 2194A for the outwardly flared fiber guide tube 2192. Likewise, the flared configuration of the inlet 2194A helps prevent friction and facilitates smooth actuation of the constraint passing through the fiber guide tube 2192.

[0292] Similarly, the pile guide tube 2193 extends along the surface of the outer periphery or axis 80 at a desired second lateral angular position and at a desired second longitudinal angle. In the example shown, the lateral angular position is zero degrees or 12 o'clock, and the longitudinal angle is zero degrees, but various lateral angular positions and longitudinal angles are conceivable. Like the pile member channels of the previously described guides (e.g., the pile member channel 92 of the proximal guide 82), the pile guide tube 2193 is configured to receive the pile member 30 and will typically be positioned where this is done.

[0293] like Figure 23D As shown, the pile guide tube 2193 can optionally be offset distally from the fiber guide tube 2192 by a desired amount (e.g., between 1 mm and 10 mm). This helps to avoid overlap or self-interference of the constraints (e.g., proximal constraint 180) when the constraints (e.g., proximal constraint 180) form a constraint loop (e.g., proximal constraint loop 195). The operation of the previously provided examples of proximal, distal, and intermediate guides also applies to guide 2182, and it should be understood that... Figures 23A-23FThe construction can optionally be used as an alternative to the previously described construction.

[0294] Figures 24A-24C Figures 24 and 25 illustrate various options for one or more of a plurality of constraint members 28 according to some embodiments. As shown, one of the plurality of constraint members 28 may be secured in a loop manner (e.g., secured to an eye loop knot) to form a capture member 28A (e.g., capture member 190). Figure 24A An example of an eye loop knot is shown, in which the first number of strands have looped back and woven into themselves. Figure 24B Another example is shown, featuring more strands that have looped back and woven into themselves. Figure 24C Another example is shown, in which the capture element 28A is formed via a continuous weaving method that splits a single strand into two separate strands, and then re-weaves them into a single strand to form the capture element 28A, wherein the strands have been separated. Figure 25 As shown, in Figure 24A and 24B In the example, the capture element 28A may optionally be formed using an eye-knot method, wherein the desired length of a corresponding constraint among the plurality of constraints 28 is re-woven or “embedded” in itself to form an embedded length 28B of material. As previously described, the constraint element 1028 may take a form similar to one or more of the plurality of constraints 28. It has been found that these types of forming techniques not only provide strong constraints and capture elements, but also provide the small-diameter profile typically required in delivery systems for implantable devices.

[0295] Figures 26-31 show additional examples of features of the frame portion 210 that can be used to secure one of a plurality of restraints 28 to the frame portion 210 of the prosthetic valve 16. Consistent with the previously described concept, the frame portion 1210 may include similar features, and the restraint 1028 may be similarly secured to the frame portion 1210 as desired. Figure 26A As shown, one or more rows of the multi-row frame members 224 (e.g., Figure 12The distal row 230 and / or proximal row 232 shown may optionally include a plurality of circumferentially oriented eyelets 224A. In some examples, the plurality of circumferentially oriented eyelets 224A are formed in the proximal row 232 of the proximal vertices 228 at the proximal end 222 of the frame portion 210. Similarly, these features may additionally or alternatively be located at other locations in the frame design (e.g., near the distal end 220). Additionally, although a plurality of circumferentially oriented eyelets 224A are shown in each proximal vertices 226, this arrangement need not always be so (e.g., there may be fewer circumferentially oriented eyelets 224A than in all the proximal vertices 226 in a particular row). Various methods can be used to form the plurality of circumferentially oriented eyelets 224A. For example, the plurality of circumferentially oriented eyelets 224A may optionally be formed using transverse laser processes, transverse drilling processes, casting processes, combinations thereof, and other techniques as desired.

[0296] Figure 26B A plurality of radially oriented eyelets 224R are shown formed at the proximal end 222 of the frame portion 210 (e.g., in the joining attachment region 224P (e.g., the joining post) of the frame portion 210). As shown, the radially oriented eyelets 224R have smooth edges (e.g., via electropolishing). In some examples, one of the plurality of constraint members 28 can be woven through the radially oriented eyelets 224R to help provide guidance as the constraint member 28 extends around the frame portion 210. The radially oriented eyelets 224R may optionally be formed via laser processing or other manufacturing options as desired.

[0297] Figure 26C A frame portion is shown, which has a plurality of constraint retainers 224C (also described as constraint guides) fixed to the frame portion 210. Figure 26D A prosthetic valve 16 with a restraint retainer 224C is shown, and Figure 26E It is made from manufacturing auxiliary parts M 辅助件 An enlarged view of the formed restraint retainer 224C. As shown, the prosthetic valve 16 includes one or more restraint retainers 224C formed as loops of material attached to the frame portion 210. In some embodiments, each restraint retainer 224C is formed from one or more loops of material, such as polymeric materials (e.g., ePTFE fibers), metallic materials (e.g., nitinol), or any other biocompatible material suitable for implantation with the prosthetic valve 16. In some examples, the restraint retainer 224C is formed from a filamentous material, such as filaments, strands, or wires (e.g., polymeric or metallic). The restraint retainer 224C may optionally be wound around the frame portion 210 to attach the restraint retainer 224C to the frame portion 210.

[0298] In some examples, one or more of the restraint retainers 224C are formed of a biodegradable or biocorrosive material that is biocorrosive or bioabsorbable over time after implantation. Similar to the foregoing features, the restraint retainers 224C may optionally be used to help secure one or more of the plurality of restraints 28 in place and help prevent slippage from the proximal end of the frame portion 210.

[0299] Figure 26E Two restraint retainers 224C are shown, which are formed as follows: by wrapping a filament around a frame member 224 multiple times to secure the filament to the frame member 224 and form one or more loops suitable for receiving one of the restraint members 28. As previously described, the filament forming the restraint retainer 224C can be a metal (e.g., nitinol), a polymer (e.g., ePTFE), or any other biocompatible material. In some examples, the filament is formed of a biocompatible, biodegradable / biodegradable material, such that the filament degrades and is absorbed or excreted from the body after a desired timeframe. If desired, the loops of the restraint retainer 224C can also be bonded (e.g., to or as an addition to the wrapping fixation mechanism) to specific points on the frame member 224 using, for example, a suitable adhesive or other bonding agent.

[0300] Figure 26F A restraint retainer 224C is shown, which is formed by wrapping a filament around a frame portion 210 at an intersection or point of intersection, such as intersection P. The restraint retainer 224C is formed by wrapping the filament around the frame member 224 once or multiple times at intersection P to secure the filament to the frame member 224 and form one or more loops suitable for receiving one of the restraint members 28. As previously described, the restraint retainer 224C can be a metal (e.g., nitinol), a polymer (e.g., ePTFE), or other materials. In some examples, the restraint retainer 225C is formed of a biocompatible, biodegradable / biodegradable material, such that the restraint retainer 224C degrades and is absorbed or excreted from the body after a desired timeframe. If desired, the restraint retainer 224C can also be wrapped and bonded to specific points on the frame member 224 using, for example, a suitable adhesive or other bonding agent (e.g., as an addition to or alternative to a wrapping fixation mechanism).

[0301] In some examples, the method of forming a prosthetic valve 16 with a constraint retainer 224C includes the following steps:

[0302] Obtain manufacturing aid M for placement via each ring of constraint retainer 224C. 辅助件 Among them, manufacturing auxiliary parts M 辅助件 It should have the desired diameter for removing manufacturing aid M. 辅助件The constraint member 28 and the constraint retainer 224C should achieve an appropriate level of interference, be able to withstand the bonding temperature of any adhesive used with the filaments forming the constraint retainer 224C, and should not bond to the material forming the constraint retainer 224C, or should be otherwise constructed to allow for the efficient removal of the manufacturing aid M from the constraint retainer 224C. 辅助件 (For example, potential manufacturing aids M) 辅助件 (It could be a PEEK rod);

[0303] The filament is wrapped around the frame member 224 once or multiple times to secure the filament to the frame member 224, and in the manufacturing auxiliary part M 辅助件 The constraint retainer 224C is formed on it;

[0304] For optional bonding (e.g., by heating in an oven to reflow (one or more) adhesives and / or sinter (one or more) windings), prepare the frame portion 210, filaments, and manufacturing aids M. 辅助件 ;as well as

[0305] Remove manufacturing aid M from constraint retainer 224C. 辅助件 In some examples, when manufacturing auxiliary parts M... 辅助件 Before pulling it out of the constraint retainer 224C (e.g., with tweezers), the manufacturing aid M can be traced using a thin rod (or needle). 辅助件 The outer diameter makes the manufacturing auxiliary part M 辅助件 It separates from the filament, thereby enabling the manufacturing of auxiliary part M. 辅助件 Release or detach from the constraint retainer 224C. Typically, any number of constraint retainers 224C can be formed using the same process as desired.

[0306] Although the constraint retainer 224C is shown in a position corresponding to the proximal constraint 180, the constraint retainer 224C can be positioned on the frame portion 210 as desired, and can be used as desired with any of the plurality of constraints 28.

[0307] Figure 26D and 26G The illustration shows constraint guidance or constraint retention features for a prosthetic valve 16, provided according to some examples, which can be attached to or replace the rows of orifices 270 and constraint retention elements 224C. For example, as Figure 26D As shown, the prosthetic valve 16 optionally includes a plurality of restraint guides 1270, which can operate similarly to the restraint retaining member 224C to receive the restraints 28 for delivery and deployment of the prosthetic valve 16. It should also be understood that any combination of restraint retaining features, as desired, and as... Figure 26DAs shown, the prosthetic valve 16 may also optionally include one or more restraint retaining members 224C, which, as previously described, are formed as a ring of material connected to the frame portion 210 (e.g., fixed to one or more of the plurality of frame members 224).

[0308] Like the restraint retainer 224C, the restraint guide 1270 helps retain one or more restraints 28 surrounding the prosthetic valve 16. The restraint guide 1270 can be described as a tunnel, external band, or belt loop through which the restraints 28 can be slidably or otherwise received. As shown, the restraint guide 1270 is formed of a band or layer of material defining spaces, gaps, or tunnels between material layers (e.g., between the layers of the covering 212). The restraints 28 pass through these gaps and are held between the material layers. This type of arrangement can differ from an arrangement where the restraints 28 pass through the rows of holes 270 from the inside to the outside of the prosthetic valve 16. In other words, as... Figure 26D As shown, the constraint guide 1270 does not cause the constraint 28 to extend into the interior of the prosthetic valve 16 behind the cover 212.

[0309] Typically, the method implemented by the restraint guide 1270 is to embed or retain one of the restraints 28 within the portions of the cover 212, rather than having the restraints 28 merely wrap around the perimeter of the prosthetic valve 16 or pass through the internal and external paths of the prosthetic valve 16 via the perforations 28.

[0310] The restraint guide 1270 can provide various desired features, including one or more of the following: reduced paravalvular leakage due to the elimination of biopsy tissue (e.g., opening or hole) through the covering 212 of the prosthetic valve 16 (e.g., unlike some examples using the hole 270); improved durability of the prosthetic valve 16 due to fewer perforations; improved deployment reliability (e.g., release and / or tensioning of the restraint 28) due to reduced friction between the restraint 28 and the prosthetic valve 16; and reduced interference / interaction between the vessel wall and the restraint 28. This results in improved compatibility and reliability of the prosthetic valve 16; a reduced likelihood of the constraint 28 getting caught / clamped (e.g., when the constraint 1272 enters and exits the hole 270 and / or the frame 210) due to the absence of trapping or otherwise causing the constraint 28 to fall between the frame members 224 of the frame portion 210; and improved durability of the constraint 28 due to less wear on the frame portion 210 engaging with the constraint 28 when the prosthetic valve 16 is compressed or radially pressed (e.g., when the constraint 28 is clamped). These are merely some examples of the optional advantages according to various embodiments.

[0311] Typically, the constraint guide 1270 receives one or more constraint members 1272 that enter and exit the constraint guide 1270 in a circumferential path extending around the frame portion 210. Thus, one or more constraint members 28 can be used to hold the frame portion 210 and thus the prosthetic valve 16 in a radially compressed delivery configuration, and then allow the prosthetic valve 16 to be transformed into a radially enlarged, deployed configuration when the tension in the one or more constraint members 1272 is released using an associated delivery system (such as those described previously or subsequently).

[0312] like Figure 26D As shown, the prosthetic valve 16 includes multiple rows of restraint guides 1270, such as a proximal row 1270A of restraint guides, one or more intermediate rows 1270B of restraint guides, and a distal row 1270C of restraint guides. Each row of restraint guides 1270 is positioned as desired for a corresponding restraint 28 to form a loop along the prosthetic valve 16 at a desired level. For example, the cover 212 may optionally include a plurality of individual restraint guides 1270, each restraint guide arranged in rows circumferentially spaced from each other around the periphery of the frame portion 210, wherein one of the restraints 28 passes through each of the plurality of restraint guides 1270, thereby forming a circumferentially aligned row. Although in some examples each of the plurality of individual restraint guides 1270 in the row is circumferentially aligned around the periphery of the frame portion 210, in other examples a row is not circumferentially oriented (aligned), but rather helically oriented (aligned) or defines another path around the periphery of the frame portion 210 and the cover 212 as desired.

[0313] Typically, the proximal row 5270a of the restraint guide slidably receives the proximal restraint member 1272a, which passes through the proximal row 5270a of the restraint guide, and can be tensioned to collapse or radially compress the prosthetic valve 16 onto the delivery catheter, as previously described. Similarly, the intermediate restraint guide 5270b and the distal restraint guide 5270c slidably receive the intermediate restraint member 1272b and the distal restraint member 1272c, respectively, which each pass through the restraint guide 5272 and can be tensioned to collapse or radially compress the prosthetic valve 16. For example, as shown, the proximal restraint member 1272a may optionally pass through the restraint retainer 224C associated with the frame portion 210. For reference, a single row may include a design with multiple restraint guides, such as a design consistent with the restraint guide 1270, the restraint retainer 224C, or the orifice 270.

[0314] Figure 26G This is an enlarged view of a portion of a prosthetic valve 16, including one of the restraint guides 1270. (See image.) Figure 26G As shown, manufacturing auxiliary component M 辅助件Passing through constraint guide 1270. Each constraint guide 1270 can optionally form terrain similar to... Figure 26G The constraint guide 1270 is shown. Figure 26G As shown, the constraint guide 1270 includes an outer layer 212A and a base layer 212B of material, which are combined to form a ring and define a tunnel 212C or gap extending between the outer layer 212A and the base layer 212B within the thickness of the cover 212. The tunnel 212C extends between a first opening 212D and a second opening 212E in the outer surface of the cover 212.

[0315] As described below, the outer layer 212A and the base layer 212B can optionally be topographically formed as layers of the covering 1104, wherein some methods of forming the restraint guide 1270 include creating a cutting line C through the outer layer 212A on either side of the tunnel 212C. 线 In other embodiments, the outer layer 212A is formed as discrete sheets or flaps of material, which are then fixed to the cover 212 to define the channel 212C and a portion of the outer surface of the cover 1104.

[0316] Figure 26D Also shown is a potentially preferred location for the support portion of any example of the prosthetic valve described herein. Specifically, the support portion (e.g., any of support portions 24, 524, 1024 and 3512, 4024, 5024, 6024 described subsequently) is shown positioned at a location adjacent to the frame portion 210 between adjacent leaflets 260 of leaflet configuration 214 (next to the synaptic post or other synaptic engagement region 224P). The location between adjacent leaflets 260 may optionally be referred to as the “synaptic line” location. As shown, due to tension on the restraints, the support portion is pinned, secured, or otherwise held by the delivery catheter on the synaptic line adjacent to one of the synaptic attachment regions 224P (e.g., the synaptic post) (whether in a collapsed delivery configuration or an expanded deployment configuration).

[0317] Additional reference Figure 26D The frame portion 210 generally defines a periphery extending along a transverse path surrounding the central longitudinal axis Xv of the prosthetic valve 16. As previously described, the cover 212 is coupled to the frame portion 210 and includes constraint guides 1270. In some examples, each constraint guide 1270 defines a tunnel 212C, such as... Figure 26A As shown, the first opening 212D and the second opening 212E in the outer surface of the cover 212 extend transversely to the central longitudinal axis Xv of the prosthetic valve 16.

[0318] Some methods for forming a prosthetic valve 16 with a restraint retainer 224C include one or more of the following steps:

[0319] One or more layers of inner covering material are applied to the mandrel to form a base layer 212B, wherein the inner covering material includes an outward-facing adhesive;

[0320] Position the frame portion 210 on the base layer 212B;

[0321] Prepare one or more layers of outer covering material to form outer layer 212A, wherein the outer covering material optionally includes an inward-facing adhesive;

[0322] Along the cutting line C on either side of tunnel 212C 线 Cut the outer layer 212A, and the channel will be formed at a position corresponding to each constraint guide 1270;

[0323] The outer layer 212A is positioned on the frame portion 210, and the base layer 212B and the outer layer 212A are joined to form a cover 212, wherein a cut line C passes through the outer layer 212A. 线 The hole may be positioned at the desired location for the constraint guide 1270;

[0324] Obtain the manufacturing aid M for placement through each tunnel 212C. 辅助件 (That is, through the cutting line C on either side of tunnel 212C) 线 ), including manufacturing auxiliary parts M 辅助件 It should have the desired diameter for removing manufacturing aid M. 辅助件 To achieve an appropriate level of interference between the constraint member 28 and the constraint guide 1270, its length may correspond to the length of each tunnel 212C or be a longer continuous element placed through multiple tunnels 212C. It should be able to withstand the bonding temperature of the base layer 212B and the outer layer 212A, and should not bond to the base layer 212B and / or the outer layer 212A, or should be otherwise constructed such that the manufacturing aid M... 辅助件 Capable of being effectively removed from tunnel 212C (e.g., potential manufacturing aids M) 辅助件 (It can be a PEEK stick);

[0325] Manufacturing auxiliary component M 辅助件 Tunnel 212C passes through the base layer 212B and the outer layer 212A;

[0326] Prepare the frame section 210, the base layer 212B, the outer layer 212A, and the manufacturing auxiliary parts M. 辅助件 Used for bonding, and bonding one or more of the aforementioned (e.g., by wrapping with a sacrificial compression layer and heating in an oven to reflow one or more adhesives and / or sintering one or more layers); and

[0327] Remove manufacturing aid M from channel 212C.辅助件 In some examples, when manufacturing auxiliary parts M... 辅助件 Before pulling it out of tunnel 212C (e.g., with tweezers), the manufacturing aid M can be traced using a thin rod (or needle). 辅助件 The outer diameter makes the manufacturing auxiliary part M 辅助件 Separating from the base layer 212B and / or the outer layer 212A, thereby enabling the manufacturing auxiliary component M 辅助件 Release or detach from tunnel 212C. Typically, any number of tunnels 212C can be formed using the same process as desired.

[0328] Although some examples have been provided, it is expected that any of the aforementioned constraint-guided features can be used alone or combined into a single prosthetic valve design.

[0329] It should also be understood that various modifications can be envisioned to the features of various frame portions that can be used to secure one of the multiple constraints 28 to the frame portion. For example, Figures 26-30 show additional features for securing one of the multiple constraints 28 to the frame portion 210. As shown, radially oriented eyelets can be formed and then transitioned to circumferentially oriented eyelets. Figures 26-30 show multiple circumferentially oriented eyelets 224A formed using this technique. Figure 27 This is an axonometric view of the proximal portion of frame section 210. Figure 28 This is a front view of the proximal portion of frame part 210. Figure 29 This is an end view of the proximal portion of frame section 210. Figure 29 This is a side view of the proximal portion of frame part 210, and Figure 30 and Figure 31 It shows according to Figure 27-31 One of the multiple circumferentially oriented apertures 224A is formed in a certain manner. For example, as shown in the figure, the multiple circumferentially oriented apertures 224A can be optionally formed by: firstly forming a radially formed aperture 224R in the radial direction. Figure 30 Then, the frame portion 210 (e.g., the distal vertex 226) is twisted to circumferentially reorient the radially formed eyelet 224R to define one of a plurality of circumferentially oriented eyelets 224A. Figure 31 This twisting form can be heat-set, cold-set, or shaped by any of a variety of methods as desired, depending on the application and the materials used.

[0330] Various advantages can be achieved by using circumferentially oriented eyelets 224A, such as any of the aforementioned examples, to secure one or more of the plurality of constraint members 28 (or constraint members 1028). As a potential advantage, tension can be reduced by decreasing friction (e.g., by reducing the size of the surface area contacted by the constraint members), which can be achieved otherwise by securing the constraint members to the features of the prosthetic valve. Furthermore, the surface profile can be reduced by making the constraint pass "within" the body of the frame 210, and the reliability of deployment and clamping can be improved.

[0331] As described above, delivery conduit 14 and delivery conduit 1014 can be used with various actuating parts or actuators. Figures 31-42 Possible features of another actuating part 2020, which may be used as a delivery catheter 14 or delivery catheter 1014, are shown. Figure 32 This is a 3D view of the actuator in its assembled state from 2020. Figure 33 This is a perspective view of the actuation portion 2020 in an exploded state, and is typically described as an exploded view. In other words, according to various embodiments, the actuation portion 2020 can also be described as a deployment handle or a deployment handle assembly.

[0332] like Figure 31 and 32 As shown, the actuation part 2020 includes a housing assembly 2100 and a shelf assembly 2102. Figure 33 ), drive assembly 2104, actuation assembly 2106, release assembly 2108, and conduit subassembly 2110. Generally, the actuation part 2020 is configured to allow multiple constraint elements 28 ( Figure 2 The actuation (tensioning and detensioning or releasing) of the pile member 30 releases and retracts multiple restraints 28. Figure 2 ) from the prosthetic valve 16 ( Figure 14A The actuator 2020 can release and retract multiple constraints 28, and can also optionally include the complete release of the body portion 22 of the delivery conduit 14 from the actuation portion 2020. In various examples, the actuation portion 2020 is configured to actuate simultaneously at one time (tightening or de-tensioning multiple constraints 28 at the same time), although it is also contemplated to actuate separately and / or sequentially (e.g., as described with respect to the actuation portion 20).

[0333] like Figure 33As shown, the housing assembly 2100 includes a body portion 2200 extending from a proximal end 2202 to a distal end 2204, defining an outer surface 2206, an inner surface 2208, a proximal section 2210 near the proximal end 2202, a distal section 2212 near the distal end 2204, a distal groove 2214 near the distal end 220, and a proximal groove 2216 near the proximal end 2202, and forming a cavity 2220 for receiving various components of the actuating portion 2020. As shown, the body portion 2200 may optionally be a flip-top design for ease of manufacture and assembly. For example, the body portion 2200 may include two halves or longitudinal sections that can be assembled together (e.g., using fasteners such as screws), although various configurations are contemplated.

[0334] As shown in the figure, the proximal section 2210 defines the release component track 2230. Figure 32 The release assembly track 2230 is formed by a first elongated slot 2232 and a second elongated slot 2234 formed opposite to the first elongated slot 2232, and each slot extends longitudinally along the proximal section 2210. Each of the first elongated slot 2232 and the second elongated slot 2234 has a proximal enlarged end 2236 and a distal enlarged end 2238. Subsequently, the distal section 2212 defines an actuator support 2240 and an actuator window 2242 on the outer surface 2206 in the form of an opening through the body portion 2200 (e.g., on the underside of the body portion 2200).

[0335] like Figure 33 As shown, the housing assembly 2100 may also optionally include a knob support 2260 coaxially received on the distal section 2212 and fixed to the body portion 2200 (e.g., using fasteners such as screws), a proximal locking clamp 2262 insertable into the body portion 2200 at the proximal end 2202 of the body portion 2200, a distal locking clamp 2264 insertable into the body portion 2200 at the distal end 2204 of the body portion 2200, and a front end cone 2266 having a groove 2268 and being received in the distal end 2204 of the body portion 2200.

[0336] According to some embodiments, Figure 34 It is an isometric drawing of shelving assembly 2102, and Figure 35 yes Figure 34An enlarged view of the circled portion. As shown, the shelf assembly 2102 includes a slide rail 2300 and a slider 2302. As shown, the slide rail 2300 extends from a proximal end 2310 to a distal end 2312, forming a stop 2320 at the distal end 2312, and a retractable feature 2322 at the proximal end 2310. The distal end 2312 may also optionally include a slot 2324, which is further described as a recess, for the post member 30 ( Figure 2 The proximal end 30a of the ) can be fixed in the slot 2324. The slot 2324 can also be configured to receive and allow multiple constraint members 28 as desired. Figure 2 (Passes through slot 2324.) The slide rail 2300 has an upper rail 2330 and a lower rail 2332 extending between the stop 2320 and the retraction feature 2322, the upper rail 2330 and the lower rail 2332 being separated by a gap 2334.

[0337] As shown, a slider 2302 is slidably received between an upper track 2330 and a lower track 2332 within a gap 2334, allowing the slider 2302 to move proximally and distally within the gap 2334. The slider 2302 includes a carrier 2338 and a clamp 2340, the clamp 2340 including a plurality of holes 2342 configured to receive and secure a plurality of restraints 28. The slider 2302, and specifically the carrier 2338, also defines a distal engagement surface 2344 for proximally and distally moving the slider 2302 within the gap 2334. As shown, the clamp 2340 is removably secured to the carrier 2338 (e.g., using a sliding fit, friction fit, interference fit, or other attachment mechanism).

[0338] Figure 36 This is an isometric view of a drive assembly 2104 according to some embodiments. In some embodiments, the drive assembly 2104 includes a drive member 2400 extending from a proximal end 2402 to a distal end 2404, defining a proximal segment 2406, a distal segment 2408, an outer surface 2410, an inner surface 2412, and a lumen 2414 extending from the proximal end 2402 to the distal end 2404. As shown, the proximal segment 2406 is longitudinally slotted to define a slot 2416. The outer surface 2410 is threaded or includes external threads 2418 between the proximal end 2402 and the distal end 2404. In some embodiments, the lumen 2414 is configured to receive a body portion 22 of a delivery conduit 14 such that the body portion 22 can pass through the drive member 2400. The cavity 2414 may also optionally define a first diameter passing through the proximal section 2406 and at a position 2430 along the distal section 2408, the distal section 2408 defining a reduced diameter or engagement feature 2432 (FIG. 38).

[0339] like Figure 33As shown, in some embodiments, the actuation assembly 2106 includes a deployment knob 2500, a nut portion 2502, a gear portion 2504, a spring retainer 2506, a biasing member 2508, and a retainer 2510.

[0340] like Figure 33 As shown, the deployment knob 2500 is optionally cylindrical and has an extended outer surface 2600, an inner surface 2602 (FIG. 38), a proximal end 2604, a distal end 2606, an inner cavity 2608 (FIG. 38) extending from the proximal end 2604 to the distal end 2606, and a plurality of engagement features 2610 (e.g., gear teeth) extending from the inner surface 2602 into the inner cavity 2608 around the periphery of the inner cavity 2608.

[0341] exist Figure 33 The image shows a nut portion 2502 threadedly connected to a drive member 2400. Figure 37 An isometric view of the nut portion 2502 and gear portion 2504 in their assembled state is shown, with the drive member 2400 removed from the nut portion 2502. Figure 37 As shown, the nut portion 2502 has an outer surface 2630, an inner surface 2632 (FIG. 38), a proximal end 2634, a distal end 2636, an inner cavity 2638 (FIG. 38) extending from the proximal end 2634 to the distal end 2636, a plurality of internal threads 2639 extending from the inner surface 2632 into the inner cavity 2638, and a ratchet shoulder 2640 defining a ratchet surface 2642.

[0342] like Figure 33 As shown, and as further described, the gear portion 2504 is configured to be rotatably received on the nut portion 2502. Figure 37 As shown, the gear portion 2504 has an outer surface 2660, an inner surface 2662 (FIG. 38), a proximal end 2664, a distal end 2666, an inner cavity 2668 (FIG. 38) extending from the proximal end 2664 to the distal end 2666, a plurality of engagement features 2669 (e.g., gear teeth) extending from the outer surface 2660, and a ratchet shoulder 2640 defining a ratchet surface 2642 configured to engage with the ratchet surface 2642 of the nut portion 2502.

[0343] In some embodiments, the biasing member 2508 may optionally be one or more springs (e.g., one or more wave springs) or other biasing devices, as desired. The spring retainer 2506 may optionally be one or more washers, and the retainer 2510 may optionally be one or more spring clamps, but various configurations are possible.

[0344] Figure 38 is a longitudinal sectional view of the actuation portion 2020, showing the actuation assembly 2106 in more detail. As shown, the actuation assembly 2106 is held by the housing assembly 2100, wherein the deployment knob 2500 is rotatably received on the outer surface 2206 and fixed to prevent longitudinal translation. As shown, a knob support 2260 is positioned at the proximal end 2202 of the body portion 2200 to help fix the deployment knob 2500 and prevent its longitudinal translation, and provides a gap 2706 between the outer surface 2206 of the body portion 2200 and the inner surface 2602 of the deployment knob 2500, such that the plurality of engagement features 2610 have space to rotate about a portion of the outer surface 2006 of the body portion 2200. As shown, the deployment knob 2500 is axially offset from the nut portion 2502 and the gear portion 2504. The plurality of engagement features 2610 of the deployment knob 2500 pass through the actuation assembly window 2242 ( Figure 33 Multiple engagement features 2669 exposed on the nut portion 2502 are actuated by an assembly window 2242 formed as an opening passing through the body portion 2200 on the underside of the body portion 2200. Therefore, rotation of the deployment knob 2500 causes engagement features 2610 to engage with engagement features 2669, resulting in positive or negative angular rotation of the gear portion 2504.

[0345] As shown in Figure 38, the gear portion 2504 and the nut portion 2502 are rotatably received by the housing assembly 2100, wherein the nut portion 2502 is fixed to prevent longitudinal translation by the housing assembly 2100. The gear portion 2504 is slidably and rotatably received on the nut portion 2502 and is allowed a limited amount of longitudinal travel by the housing assembly 2100. The gear portion 2504 is fixed to the main body portion 2200 of the housing assembly 2100 by a retainer 2510 that holds the biasing member 2508 against the gear portion 2504 and a spring retainer 2506 to bias the gear portion 2504 distally. In this way, once the biasing force of the biasing member 2508 (e.g., spring constant) is overcome, the gear portion 2504 can be displaced a limited amount in the proximal direction. With such biasing, the ratchet surface 2672 and the ratchet surface 2642 of the nut portion 2502 ( Figure 37 The engagement of the gear portion 2504 causes the nut portion 2502 to rotate until the torsional limit is exceeded, thus overcoming the bias force, and causing the ratchet surfaces 2672 and 2642 to slip or the ratchet teeth to overlap each other. In this way, the actuation assembly 2106 defines a clutch, and more specifically a ratchet or slip clutch, although other clutch mechanisms (e.g., magnetic) may also be considered and adapted for use.

[0346] As previously described, once there is sufficient resistance to the rotation of the nut portion 2502, the rotation of the deployment knob 2500 causes the nut portion 2502 to rotate at a positive or negative angle, with a clutch mechanism defined between the deployment knob 2500 and the nut portion 2502. As will be described later, the rotation of the nut portion 2502 (and therefore the rotation of the deployment knob 2500) is used to drive the drive assembly 2104, and more specifically, to longitudinally translate the drive member 2400 in the proximal and distal directions within the housing assembly 2100.

[0347] Figure 39 This is an isometric view of the release component 2108 according to some embodiments. For example... Figure 39 As shown, in some embodiments, the release assembly 2108 includes a locking flexibility 2700, a first button 2702, and a second button 2704. In some embodiments, the locking flexibility 2700 includes a first flexible arm 2710 and a second flexible arm 2712. Each of the first flexible arm 2710 and the second flexible arm 2712 includes a gripping portion 2720 configured to engage and grip the slide rail 2300 when the first flexible arm 2710 and the second flexible arm 2712 flex inward. Figure 34 The retractable feature 2322 is located at the proximal end 2310 of the slide rail 2300. The first button 2702 and the second button 2704 are fixed to the first flexible arm 2710 and the second flexible arm 2712, and are such that the first button 2702 and the second button 2704 can be pressed down to flex the first flexible arm 2710 and the second flexible arm 2712 inwards. In some examples, the release assembly 2108 includes a first stop feature 2730 formed on the first button 2702 and a similar second stop feature (not shown) formed on the second button 2704. Each of the first stop feature 2730 and the second stop feature is optionally configured to help prevent the slide rail 2300 ( Figure 34 Unintentional longitudinal retraction along the proximal direction. The release assembly 2108 may also optionally include a first locking feature 2740 (e.g., a channel) and a second locking feature 2742 (e.g., a channel) formed by the first button 2702 and the second button 2704, such that the release assembly 2108 is longitudinally fixed to the housing assembly 2100 until the first button 2702 and the second button 2704 are pressed.

[0348] like Figure 33 As shown, in some embodiments, the catheter subassembly 2110 is coupled to the delivery catheter 14 ( Figure 2 The main body of 22 () Figure 2For example, the catheter subassembly 2110 may optionally include a tube extension 2800 (e.g., for receiving a guidewire that can pass through the actuation portion 2020 to the body portion 22 of the delivery catheter 14), a proximal coupling 2802, and a distal coupling 2804. The distal coupling 2804 is optionally secured to the coupling interface 46 of the body portion 22, and the proximal coupling 2802 is optionally secured to a portion of the housing assembly 2100, as described in further detail below. In some examples, the proximal coupling 2802 includes a clamping groove 2806. Typically, a plurality of restraints 28 and a post member 30 ( Figure 2 It is permitted to bypass the conduit subassembly 2110 to be secured to the shelf assembly 2102, as described in further detail below.

[0349] Some methods of assembling the actuation portion 2020 include assembling the catheter subassembly 2110 to the body portion 22 of the delivery catheter 14 by securing the distal coupling 2804 to the coupling interface 46 of the body portion 22. The tip cone 2266 is received on the body portion 22 of the delivery catheter 14 (e.g., coaxially received on the body portion 22) such that the coupling interface 46 and / or the distal coupling 2804 engage (e.g., are received therein) with and abut against the tip cone 2266. The tube extension 2800 of the catheter subassembly 2110 is received in the slide rail 2300 and the slide member 2302 of the shelf assembly 2102. Figure 34 The slide rail 2300 and the slider 2302 are coaxially received within the slide rail 2300 and the slider 2302, such that the slide rail 2300 and the slider 2302 can slide longitudinally on the tube extension 2800 (e.g., can slide along the tube extension 2800 between the proximal connector 2802 and the distal connector 2804).

[0350] The drive assembly 2104, and specifically the drive member 2400, is slidably received on the shelf assembly 2102 (e.g., coaxially received on the shelf assembly 2102). Figure 38 shows a portion of this interaction between the drive assembly 2104 and the shelf assembly 2102, wherein the drive member 2400 is slidable on and along the slide rail 2300 until the distal engagement surface 2344 of the slide member 2302 is proximally engaged by an engagement feature 2432 formed inside the drive member 2400. Once the drive member 2400 has moved sufficiently proximal, such that the engagement feature 2432 engages with the distal engagement surface 2344 of the slide member 2302 (… Figure 34 When the drive member 2400 slides on the slide rail 2300, the slider 2302 moves proximally within the slide rail 2300, or translates longitudinally along the proximal direction. Reference will be made to some examples. Figures 40-43 To describe this interaction in more detail, Figures 40-43The operation of the actuator 2020 is shown.

[0351] As shown in Figure 38, the nut portion 2502 of the actuation assembly 2106 is threadedly connected to the drive member 2400, with the internal thread 2639 engaging the external thread 2418. As previously described, the gear portion 2504 is slidably and rotatably received on the nut portion 2502 and engaged in the clutch mechanism, such that rotation of the gear portion 2504 causes rotation of the nut portion 2502 until a torsional limit is reached, at which point the gear portion 2504 is allowed to slide relative to the nut portion 2502. Although the clutch arrangement is defined by the nut portion 2502 and the gear portion 2504 according to various examples, it should also be understood that the two can simply be rotated together (e.g., integrally formed with each other, or simply by being separate but fixedly connected parts).

[0352] As previously described, the actuation assembly 2106 is held by the housing assembly 2100, wherein the deployment knob 2500 is rotatably received on the outer surface 2206 of the body portion 2200 and secured to prevent longitudinal translation. A knob support 2260 is located at the proximal end 2604 of the deployment knob 2500 to help secure the deployment knob 2500 to prevent its longitudinal translation, and also provides a gap 2706 between the outer surface 2206 of the body portion 2200 and the inner surface 2602 of the deployment knob 2500, in which the engagement feature 2610 has rotational space. Multiple engagement features 2610 of the deployment knob 2500 are exposed to multiple engagement features 2669 of the nut portion 2502 through the actuation component window 2242, such that rotation of the deployment knob 2500 causes engagement features 2610 to mesh with engagement features 2669, thereby causing rotation of the gear portion 2504 at a positive or negative angle, which is converted into longitudinal translation of the drive member 2400 (depending on whether the rotation direction of the deployment knob 2500 is proximal or distal).

[0353] For reference Figure 33 As understood, the locking flexible element 2700 is configured to be slidably received in the release component track 2230. Figure 32 In the first elongated slot 2232 and the second elongated slot 2234, the first button 2702 and the second button 2704 are received in the distal enlarged end 2238 of each of the first elongated slot 2232 and the second elongated slot 2234. The distal enlarged end 2238 engages with the first button 2702 and the second button 2704 to “lock” the release assembly 2108 to the housing assembly 2100. When the first button 2702 and the second button 2704 are pressed, the first flexible arm 2710 and the second flexible arm 2712 are flexed inward. Figure 39 When the first locking feature 2740 and the second locking feature 2742 are engaged, Figure 39The first elongated slot 2232 and the second elongated slot 2234 move inward and receive the edges. This "unlocks" the release assembly 2108 and allows the first button 2702 and the second button 2704, and thus the locking flexure 2700, to slide proximally from the distal enlarged end 2238 of each of the first elongated slot 2232 and the second elongated slot 2234, and to slide proximally along the release assembly track 2230.

[0354] Figure 40 This is an enlarged view of the distal connector 2804 of the catheter subassembly 2110, which is fixed side-by-side with the distal end 2312 of the slide rail 2300 to the delivery catheter 14. Figure 2 The main body portion 22 of the slide rail 2300 has a connecting interface 46. The distal end 2312 of the slide rail 2300 receives the abutment of the distal connecting member 2804 and / or the connecting interface 46 to stop the distal movement of the slide rail 2300 (unless intentionally released to remove it from the housing assembly 2100, as described below). The distal end 2312 of the slide rail 2300, particularly the slot 2324, receives and secures the proximal end 30a of the post member 30 to the slide rail 2300. Although in Figure 40 Not shown, but slot 2324 also allows multiple restraints 28 to pass through slot 2324 from connector interface 46 of body portion 22 to attach to clamp 2340 of slider 2302, and specifically to be fixed in multiple holes 2342 of clamp 2340. Figure 34 ).

[0355] Figures 40-42 This is a longitudinal sectional view of the actuation portion 2020 at various operational stages according to some embodiments. For example... Figure 41 As shown, the front cone 2266 is received on the connector interface 46 and inserted into the distal end 2204 of the body portion 2200 of the housing assembly 2100, and the front cone 2266 and the connector interface 46 use a distal clamping groove 2214 through the body portion 2200. Figure 33 The distal locking clamp 2264 and the clamping groove 2268 in the front cone 2266 () Figure 33 ) to be fixed to the main body 2200, and fixed in the clamping groove 2808 in the connector interface 46 ( Figure 40 The connector interface 46 and the front cone 2266 are then secured to the housing assembly 2100. Subsequently, the proximal locking clamp 2262 passes through the proximal clamping groove 2216 in the main body portion 2200. Figure 33 The conduit is received and held in the groove 2806 in the proximal connector 2802 of the conduit subassembly 2110 to secure the proximal connector 2802 and thus the conduit assembly 22110 to the housing assembly 2100.

[0356] The following is for reference Figures 40-43 This describes some examples of methods used to operate the actuator section 2020. For example... Figure 41 As shown, the deployment knob 2500 has been rotated, causing the drive member 2400 to move proximally, thereby causing the slider 2302 to move proximally and pulling the multiple constraint members 28 proximally. Figure 2 ).like Figure 14A As shown, by pulling multiple restraints 28 proximally, the proximal restraint ring 195, the distal restraint ring 196, and the intermediate restraint ring 197 contract around the prosthetic valve 16 to bring the valve into a compact delivery state. The prosthetic valve 16 can then be retracted into the cannula 12 to deliver the valve intracavitarily to the desired treatment site or location.

[0357] The prosthetic valve 16 (or other implantable device) may extend from the cannula 12, and when the actuating member 2400 moves distally to... Figure 42 When positioned as shown, the deployment knob 2500 can be rotated on the multiple restraints 28 or in the opposite direction to release tension or remove stress. In some examples, the bias of the prosthetic valve 16 into an expanded state results in distal tension being provided on the multiple restraints 28, thereby causing the slider 2302 to move distally together with the drive member 2400 as previously described.

[0358] When the tension applied to the constraint member 28 by the actuating part 2020 is reduced or removed, a release operation can be performed to allow the release assembly 2108 to transition to... Figure 43 The positions shown. Specifically, the first button 2702 and the second button 2704 ( Figure 33 ) is pressed, thereby causing the first locking feature 2740 and the second locking feature 2742 ( Figure 39 The first flexible arm 2710 and the second flexible arm 2712 are moved to the appropriate position to allow the locking flexible member 2700 to move proximally. Simultaneously, the first flexible arm 2710 and the second flexible arm 2712... Figure 39 The first flexible arm 2710 and the second flexible arm 2712 flex inwards, causing the gripping portion 2720 of each of them to engage and grip the retracted feature 2322 at the proximal end 2310 of the slide rail 2300. With the first locking feature 2740 and the second locking feature 2742 engaging with the edge of the release assembly track 2230, the release assembly 2108 locks in the inwardly deflected position and is thus locked to the slide rail 2300 via the gripping portion 2720. The release assembly 2108 then slides proximally within the release assembly track 2230, thereby pulling the slide rail 2300 proximally within the housing assembly 2100.

[0359] When the slide rail 2300 is pulled to the proximal side, the proximal end 30a of the pile member 30 ( Figure 2The slide rail 2300 retracts proximally, and the distal restraint ring 196, intermediate restraint ring 197, and proximal restraint ring 195, specifically the corresponding capture elements 192, 194, and 190, are released from the post member 30. Once the slide rail 2300 has been fully retracted, the stop 2320 at the distal end 2312 of the slide rail 2300 engages the slide element 2302, and begins to retract proximally along with the slide rail 2300. At this point, the plurality of restraint elements 28, now released from the post member 30, retract from around the prosthetic valve 16, thereby releasing the prosthetic valve (or other implantable device) from the delivery catheter 14 (e.g., at the desired delivery site).

[0360] Figure 44 Another method of operation for the actuation part 2020 is shown. For example, if a user (not shown) wishes to bypass the function of the actuation part 2020, the user can remove the distal locking clamp 2264 and the proximal locking clamp 2262 from the housing assembly 2100, thereby freeing the front cone 2266, the connector interface 46, and the conduit sub-assembly 2110 from the housing assembly 2100. The deployment knob 2500 can then be rotated in a direction that moves the drive member 2400 distally until the drive member 2400 is driven distally out of the nut portion 2502 (FIG. 38), and thus released from the actuation assembly 2106. The shelf assembly 2102 and the drive assembly 2104, together with the body portion 22 of the delivery conduit 14, can then be used. Figure 2 Together, they are pulled distally from the housing assembly 2100. The user can then directly access the multiple restraints 28 and the pile member 30 as desired. Figure 2 This allows for manual operation. This may be expected if delivery problems arise or if the user wishes to take other diagnostic or remedial measures. As previously stated, the aforementioned actuation portion 2020 and associated methods are interchangeable with the delivery catheter 1014, including for use with different implantable devices (e.g., stent grafts) as desired.

[0361] Figures 45 to 47 Various additional optional positions of various guides (e.g., proximal guides, distal guides, and / or intermediate guides) relative to various leaflet configurations of the prosthetic valve are schematically illustrated according to various examples. For ease of reference, only the frame of an exemplary prosthetic valve is shown. With regard to these additional examples, it should be understood that any leaflet configuration (and associated prosthetic valve) previously described can be used with... Figures 45 to 47 The positions shown are located relative to each guide position in a similar manner.

[0362] Figure 45This is a side view of another transcatheter delivery system 4010 according to one embodiment. The delivery catheter 4014 includes a body portion 4022, a support portion 4024, a distal portion 4026, and a plurality of restraints (not shown). As shown, the implantable device 4016 may be a prosthetic valve including a leaflet configuration (not shown) located internally and supported by the support portion 4024 within the boundary of a leaflet region 4018. In some embodiments, the leaflet region 4018 is positioned along the support portion 4024 between a proximal guide 4082 and a distal guide 4084. For example, in some embodiments, the leaflet region 4018 does not extend longitudinally beyond the proximal guide 4082 and the distal guide 4084. In some embodiments, the leaflet region 4018 may be located between an intermediate guide 4086 and a proximal guide 4082, which may reduce or eliminate the volume of one or more guides in the leaflet region 4018 when the implantable device 4016 is pressed into a delivery state onto the support portion 4024.

[0363] Figure 46 This is a side view of another transcatheter delivery system 5010 according to one embodiment. The delivery catheter 5014 includes a body portion 5022, a support portion 5024, a distal portion 5026, and a plurality of restraints (not shown). As shown, the support portion 5024 is generally configured to be received in an implantable device 5016 and to support the implantable device 5016 by delivery into the patient's body (not shown) and deployment at the desired treatment location. As shown, the support portion 5024 includes a shaft 5080, a proximal guide 5082, a first intermediate guide 5086, a second intermediate guide 5088, and a distal guide 5084.

[0364] As shown, the implantable device 5016 may be a prosthetic valve comprising a leaflet structure (not shown) located internally and supported by a support portion 5018 within the boundary of the leaflet region 4018. In some embodiments, the leaflet region 5018 is positioned on the support portion 5024 between a proximal guide 5082 and a second intermediate guide 5088. For example, in some embodiments, the leaflet region 5018 is positioned on a first intermediate guide 5086. In some embodiments, the first intermediate guide 5086 is typically smaller than the proximal guide 5082 and the second intermediate guide 5088, such that the volume of the first intermediate guide 5086 in the leaflet region 5018 is reduced when the implantable device 4016 is pressed into a delivery state onto the support portion 5024.

[0365] Figure 47This is a side view of another transcatheter delivery system 6010 according to one embodiment. The delivery catheter 6014 includes a body portion 6022, a support portion 6024, a distal portion 6026, and a plurality of restraints (not shown). As shown, the support portion 6024 is generally configured to be received in an implantable device 6016 and to support the implantable device 6016 by delivery into the patient's body (not shown) and deployment at the desired treatment location. As shown, the support portion 6024 includes a shaft 6080, a proximal guide 6082, an intermediate guide (not shown), and a distal guide (not shown).

[0366] As shown, the implantable device 6016 may include a frame portion and a valve including a leaflet structure (not shown) supported by a support portion 6024 at a location within the support portion 6024 corresponding to the boundary of the leaflet region 6018. In some embodiments, the leaflet region 6018 is positioned on the support portion 6024 between a proximal guide 6082 and a distal guide 6084. For example, in some embodiments, the leaflet region 6018 does not extend longitudinally beyond the proximal guide 6082 and the distal guide 6084. In some embodiments, the leaflet region 6018 may be located between an intermediate guide 6086 and a proximal guide 6082, which may reduce or eliminate the volume of one or more guides in the leaflet region 6018. As shown, the implantable device 6016 may include a plurality of posts and through-hole features (e.g., such as... Figure 25 and 26A (Those up to 30), when the implantable device 4016 is pressed into a delivery state onto the support portion 6024, these features can help allow the proximal guide 6082 to move out of the leaflet region 6018.

[0367] Figure 48 A shaft 80 according to various embodiments is shown. Figure 4 The shaft 80 has an enhanced flexible portion 7080, which can be implemented for any of the other shafts described above. As previously described, the shaft 80 is formed as a hollow tube (e.g., a hypo tube), for example using a nickel-titanium alloy, stainless steel, or other metal or polymeric material. In various examples, the shaft 80 is configured to receive a guidewire (not shown) for guiding the delivery catheter 80, wherein the shaft 80 is assembled to the desired treatment location. If desired, a liner of polymeric or other low-friction material (not shown) may be incorporated into the shaft 80 to reduce wear or interference to the guidewire (not shown) received within the shaft 80.

[0368] In some examples, the reinforced flexible portion 7080 includes a cut pattern (e.g., laser cutting) formed through the wall of shaft 80. Although the pattern is described as a "cut" pattern, any forming technique (e.g., etching) can be used to form the "cut" pattern. Figure 48In the example, the cutting pattern is a discontinuous spiral pattern, leaving a continuous longitudinal segment 7082 of the shaft 80. In different terms, the cutting pattern comprises discontinuous spiral cuts interlaced along the longitudinal length of the reinforced flexible portion 7080. Cuts or turns define a period or pitch P between adjacent cut lines in each of the proximal segment 7080P and distal segment 7080D of the reinforced flexible portion 7080. Figure 48 As shown, the pitch P can vary along the length of the reinforced flexible portion 7080. For example, the pitch P of the helical cut pattern can be larger in the proximal section 7080P and then smaller in the distal section 7080D. If desired, the pitch can be increased again at the end of the distal section 7080D to provide another transition to the continuous or uncut portion in or near the distal section 42 of the main body portion 22. Figure 4 ).

[0369] Regarding the starting and ending positions of the reinforcing flexible portion 7080 along the length of the shaft 80, this portion 7080 may form the entire length of the shaft 80. However, in various examples, the reinforcing flexible portion 7080 begins at or near the distal segment 42 of the main body portion 22. In one example, the total length of the reinforcing flexible portion extends, for example, 11 cm and begins approximately 2 mm proximal to the distal segment 42 of the main body portion 22. Regarding the pitch P, in one example, the distal segment 7080D has a pitch of 0.008 inches and has an intermittent slit pattern of 3.5 slits per revolution. Regarding the proximal portion 7080P, in one example, the pitch P transitions from 0.008 inches in the distal segment 7080D to 0.016 inches in the proximal segment 7080P, with 3.5 slits per revolution, exceeding 25 mm.

[0370] In another example, the reinforced flexible portion extends 25 cm (e.g., starting from a position similar to the one described above), wherein the initial transition in the distal segment 7080D extends 25 mm with a pitch P varying from 0.016 inches to 0.008 inches, with 3.5 slits per revolution, then extends 150 mm through the distal segment 7080P with a pitch P of 0.008 inches, with 3.5 slits per revolution, and then extends 25 mm with a pitch P varying from 0.008 inches to 0.016 inches, with 3.5 slits per revolution. Another example includes an initial transition portion in the distal segment 7080P that extends 25 mm with a pitch P varying from 0.016 inches to 0.008 inches, with 3.5 slits per revolution, and then extends 150 mm with a pitch P of 0.008 inches, with 3.5 slits per revolution. Then the proximal portion 7080P extends 25 mm with a pitch P varying from 0.008 inches to 0.016 inches, with 3.5 slits per revolution.

[0371] While some specific examples of cut pattern dimensions are provided, it should be understood that these dimensions are provided for illustrative purposes and should not be construed as limiting the design to a specific length, start point, or end point of the reinforced flexible portion 7080. The foregoing dimensions are provided as examples for illustrative purposes, and while each of the foregoing dimensions, any combination of those dimensions, and any range between and including those dimensions are within the scope of the inventive concept described herein, additional dimensions are contemplated and do not exceed the scope of such concept.

[0372] In some examples, shaft 7080 may include a liner (not shown) of a desired material (e.g., polyimide or fluoropolymer) lining the inner surface of shaft 7080. In other examples, shaft 7080 may be characterized by the absence of any liner and a continuous topography consisting of monolithic units (e.g., entirely made of thiourea tube). Figure 48 The spiral cutting pattern may be particularly advantageous because there is no wear or other abrasion on the guide wire received within the shaft 7080 when using the spiral cutting pattern disclosed herein.

[0373] Leaflet material

[0374] In various embodiments, the leaflet structure may be formed from biocompatible synthetic materials (e.g., including ePTFE and ePTFE composites, or other materials as desired). Other biocompatible polymers suitable for synthesizing leaflets include, but are not limited to, urethanes, silicones (organopolysiloxanes), silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the foregoing.

[0375] In other examples, such leaflet structures can be formed from natural materials such as repurposed tissues, including bovine tissue, porcine tissue, etc.

[0376] As used herein, the term "elastomer" refers to a polymer or mixture of polymers having the ability to stretch to at least 1.3 times its original length and rapidly return to its original length upon release. The term "elastomer material" refers to a polymer or mixture of polymers exhibiting tensile and recovery properties similar to those of an elastomer, but not necessarily to the same degree. The term "non-elastomer material" refers to a polymer or mixture of polymers exhibiting tensile and recovery properties different from those of an elastomer or elastomer material, i.e., not considered an elastomer or elastomer material.

[0377] According to some embodiments herein, the leaflet structure includes a composite material having at least one porous synthetic polymer diaphragm layer having a plurality of pores and / or spaces, and an elastomeric and / or elastomeric material and / or non-elastomeric material filling the pores and / or spaces of the at least one synthetic polymer diaphragm layer. According to other examples, the leaflet structure further includes layers of elastomeric and / or elastomeric material and / or non-elastomeric material on the composite material. According to some examples, the composite material includes a porous synthetic polymer diaphragm ranging from about 10% to 90% by weight.

[0378] Examples of porous synthetic polymer diaphragms include expandable fluoropolymer diaphragms having nodular and fibrillary structures defining pores and / or spaces. In some examples, the expandable fluoropolymer diaphragm is an expandable polytetrafluoroethylene (ePTFE) diaphragm. Another example of porous synthetic polymer diaphragms includes microporous polyethylene diaphragms.

[0379] Examples of elastomers and / or elastomeric materials and / or non-elastomeric materials include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE / PMVE copolymer), (per)fluoroalkyl vinyl ether (PAVE), urethanes, silicones (organopolysiloxanes), silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the foregoing. In some examples, the TFE / PMVE copolymer is an elastomer that is substantially composed of 60 to 20 weight percent tetrafluoroethylene and 40 to 80 weight percent perfluoromethyl vinyl ether. In some examples, the TFE / PMVE copolymer is an elastomeric material that is substantially composed of 67 to 61 weight percent tetrafluoroethylene and 33 to 39 weight percent perfluoromethyl vinyl ether. In some examples, the TFE / PMVE copolymer is a non-elastomeric material that is substantially composed of 73 to 68 weight percent tetrafluoroethylene and 27 to 32 weight percent perfluoromethyl vinyl ether. The TFE and PMVE components of the TFE-PMVE copolymer are expressed as weight percent (%). For reference, 40, 33-39, and 27-32% by weight of PMVE correspond to 29, 23-28, and 18-22 mol%, respectively.

[0380] In some examples, TFE-PMVE copolymers exhibit elastomeric, elastomeric, and / or non-elastomeric properties.

[0381] In some examples, the composite material also includes a layer or coating of TFE-PMVE copolymer containing about 73 to about 68 weight percent of tetrafluoroethylene and correspondingly from about 27 to about 32 weight percent of perfluoromethyl vinyl ether.

[0382] In some examples, the leaflet configuration is an expanded polytetrafluoroethylene (ePTFE) membrane that has absorbed a TFE-PMVE copolymer comprising about 60 to about 20% by weight of tetrafluoroethylene and correspondingly about 40 to about 80% by weight of perfluoromethyl vinyl ether. The leaflet configuration also includes a coating of TFE-PMVE copolymer on the blood contact surface, the TFE-PMVE copolymer comprising about 73 to about 68% by weight of tetrafluoroethylene and correspondingly about 27 to about 32% by weight of perfluoromethyl vinyl ether.

[0383] As described above, elastomers and / or elastomeric materials and / or non-elastomeric materials can be combined with an expanded fluoropolymer membrane such that the elastomers and / or elastomeric materials and / or non-elastomeric materials occupy substantially all the spaces or pores within the expanded fluoropolymer membrane.

[0384] According to one embodiment, the composite material may include an expandable fluoropolymer material made of a porous ePTFE diaphragm, such as that generally described in U.S. Patent No. 7,306,729 to Bacino.

[0385] The expanded fluoropolymer diaphragm used to form certain of the aforementioned composites may include a PTFE homopolymer. In alternative embodiments, a mixture of PTFE, expanded modified PTFE, and / or expanded copolymers of PTFE may be used. For example, non-limiting examples of suitable fluoropolymer materials are described in U.S. Patent No. 5,708,044 to Branca, U.S. Patent No. 6,541,589 to Ballie, U.S. Patent No. 7,531,611 to Sabol et al., U.S. Patent Application No. 11 / 906,877 to Ford, and U.S. Patent Application No. 12 / 410,050 to Xu et al.

[0386] Frame materials

[0387] Various frames can be formed primarily by etching, cutting, laser cutting, stamping, 3D printing, or wire winding (wire wrapping), and other suitable processes. Frames can be self-expanding or capsularly expandable (e.g., when configured for transcatheter implantation) or non-expandable (e.g., when configured for surgical implantation). Various frames can include, but are not limited to, any metallic or polymeric material, such as generally biocompatible, elastically deformable (e.g., nitinol) or plastically deformable (e.g., stainless steel) metallic or polymeric materials. Other materials suitable for any of the frames described herein include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloys, polypropylene, acetyl homopolymers, acetyl copolymers, drawn filler tubes (e.g., nitinol wire with a platinum core), other alloys or polymers, or any other material with sufficient physical and mechanical properties to be substantially biocompatible for use as the frames described herein.

[0388] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0389] The inventive concept has been described above in a general sense and with respect to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Therefore, this disclosure is intended to include modifications and variations that fall within the scope of the appended claims.

Claims

1. A transcatheter delivery system, the transcatheter delivery system comprising a delivery catheter, the delivery catheter comprising: Main body, A support portion extending from the main body portion, the support portion being configured to support an implantable device; Pile and column components; At least one constraint member, the at least one constraint member being configured to: be tensioned to the post member to hold the implantable device in a compact delivery configuration, be detensioned from the post member to allow the implantable device to transition to an expanded deployment configuration, and be released from the post member to release the implantable device from the delivery conduit; as well as An actuating portion, the actuating portion being configured to: tension the at least one constraint, release the at least one constraint from tension, and release the at least one constraint from the pile member, the actuating portion comprising: A housing assembly, which is connected to the main body portion. A shelf assembly, received within the housing assembly, includes a slide rail fixed to the post member and slidably receiving a sliding member fixed to the at least one constraint member. A drive assembly, slidably received on the slide rail and capable of engaging the slider to longitudinally translate the slider within the slide rail, and An actuation component, the actuation component including a rotatable deployment knob and configured to longitudinally translate the drive component along the slide rail.

2. The transcatheter delivery system as claimed in claim 1, characterized in that, The actuation part further includes a release component configured to longitudinally translate the slide rail to cause longitudinal translation of the pile member.

3. The transcatheter delivery system as described in claim 2, characterized in that, The at least one constraint includes a catch that is releasably fixed to the pile member.

4. The transcatheter delivery system as described in any one of claims 1 to 3, characterized in that, The drive assembly includes a clutch.

5. The transcatheter delivery system as claimed in claim 4, characterized in that, The clutch is a ratchet clutch.

6. The transcatheter delivery system as claimed in any one of claims 1 to 3, characterized in that, The main body portion, the shelf assembly, and the drive assembly are releasably secured to the housing assembly by one or more clamps, such that the shelf assembly and the drive assembly are configured to be released from the drive assembly and the housing and slide longitudinally out from the distal end of the housing assembly.

7. The transcatheter delivery system as claimed in any one of claims 1 to 3, characterized in that, It also includes an implantable device that is held in a compact delivery configuration on the support portion by the at least one constraint.

8. The transcatheter delivery system as claimed in claim 7, characterized in that, The implantable device is a prosthetic valve.

9. The transcatheter delivery system as claimed in any one of claims 1 to 3, characterized in that, The delivery conduit includes at least two restraints, each constrained to be tensioned to the post member to hold the implantable device in the compact delivery configuration, to be detensioned from the post member to allow the implantable device to transition to the expanded deployment configuration, and to be released from the post member to release the implantable device from the delivery conduit.

10. The transcatheter delivery system as claimed in any one of claims 1 to 3, characterized in that, The actuation assembly further includes a nut portion and a gear portion defining the clutch device, such that rotation of the gear portion causes the nut portion to rotate until a torsional limit is reached, and when the torsional limit is reached, the gear portion is allowed to slide against the nut portion.

11. The transcatheter delivery system as claimed in claim 10, characterized in that, The nut portion is threaded onto the drive assembly.

12. The transcatheter delivery system as claimed in claim 10, characterized in that, The gear portion includes multiple teeth that engage with the multiple teeth of the deployment knob.

13. The transcatheter delivery system as claimed in any one of claims 1 to 3, characterized in that, It also includes a shaft extending through the main body portion and the support portion, the shaft including an enhanced flexible portion proximal to the support portion, the enhanced flexible portion including a distal segment having a cutting pattern characterized by a first pitch and a proximal segment having a cutting pattern characterized by a second pitch greater than the first pitch.

14. The transcatheter delivery system as claimed in claim 13, characterized in that, The distal segment of the enhanced flexible portion includes a distal transition portion having a cutting pattern characterized by a third pitch greater than the first pitch.

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