Steerable delivery apparatus for implantable medical devices

Abstract

A steerable delivery apparatus for an implantable medical device includes a shaft extending distally from a handle, the shaft having a steering member lumen extending through a length of the shaft, and a steering member extending through the steering member lumen, the steering member having a proximal portion and a distal portion. A pull ring is disposed along a distal portion of the shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter that is less than the first diameter. The distal portion of the steering member is secured to the distal segment of the pull ring, and an adjustment mechanism is further provided in the handle, the mechanism operably coupled to the proximal portion of the steering member and configured to adjust tension in the steering member to adjust a curvature of the shaft.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 007,470, filed April 9, 2020, which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to embodiments of a pull ring assembly for use in implanting medical devices, such as prosthetic heart valves, with a steerable delivery device. Background Technology

[0004] Intravascular delivery devices (e.g., catheters) are used in various procedures to deliver prosthetic medical devices or instruments to locations within the body that are not easily accessible surgically or that are desired to be accessed without surgery. Access to a target location within the body can be achieved by inserting a delivery catheter and guiding it through pathways or cavities within the body—including, but not limited to, blood vessels, esophagus, trachea, any part of the gastrointestinal tract, lymphatic vessels, to name a few.

[0005] In one specific example, the prosthetic heart valve is fitted in a crimped state onto the distal end of the delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, either by inflating a balloon on which the prosthetic valve is mounted, or by deploying the valve from a sheath extending from the prosthetic valve, allowing the prosthetic valve to self-expand to its functional size.

[0006] The usefulness of such delivery devices can be limited by their ability to successfully navigate through small blood vessels and around sharp bends in the vascular system, such as around the aortic arch. Therefore, various techniques have been developed to adjust the curvature of the distal segment of the delivery device. One known technique employs a pull-ring assembly comprising a pull cord and a pull ring. The distal end of the pull cord is fixedly attached via the pull ring to a maneuverable segment at the distal end of the delivery device, while the proximal end of the pull cord is operably connected to a rotatable adjustment knob on the handle of the delivery device. Rotation of the adjustment mechanism applies tension to the pull cord, which in turn causes the maneuverable segment to bend.

[0007] A known method in the art for manufacturing a steerable catheter involves forming the catheter on a mandrel using three main layers: an inner polymer layer, a metal braided layer, and an outer polymer layer. The inner polymer layer is pulled onto the mandrel and tightened. A drawstring is laid axially along the inner layer, typically within a groove present on the surface of the mandrel. A polymeric tie layer can be pulled onto the inner layer and the drawstring. The braided layer is pulled onto or woven into the tie layer or pulled directly above the inner layer and the drawstring. A loop slides onto the distal portion of the braided layer and attaches (e.g., by welding) to the distal portion of the drawstring. To position the distal portion of the drawstring against the loop, an opening can be formed in the braided layer by cutting one or more filaments of the braid and pulling the distal portion of the drawstring through the opening, such that the drawstring extends from the groove of the mandrel through the braided layer and is alongside the loop. After the braided layer is tightened, the entire conduit is encased in an outer polymer layer (typically a thermoplastic material). The outer layer is then encased in a heat-shrinkable material and heated. The heat causes the outer layer to flow, which, combined with pressure from the heat-shrinkable material, causes the thermoplastic outer layer to flow into the braided layer, forming a shaft with a laminated structure.

[0008] Unfortunately, several potential drawbacks exist associated with this technology. For example, the inner diameter of the pull ring must be larger than the outer diameter of the braided layer to allow the pull ring to slide on the braided layer. This creates a relatively long transition section of the pull cord, in which the cord extends radially inward from the pull ring into a groove in the mandrel. This relatively long transition section, coupled with the stiffness of the pull cord, can cause undesirable tilting of the pull ring, which may create a leakage path through the mandrel.

[0009] Furthermore, the filaments in the braided layer may unravel at the cut locations, especially under tensile stress, creating weak points at the ends of the shaft. In some cases, this can impair the shaft's ability to retain pressure, and in rare cases, may lead to unpredictable destructive loads on the delivery device. Additionally, during reflow soldering, the metal ends of the filaments at the cut locations may be pushed into the inner polymer layer of the shaft, creating further leakage paths.

[0010] Therefore, new and improved manipulable catheters and their construction methods are still needed. Summary of the Invention

[0011] This document discloses an improved delivery device for implantable medical devices (e.g., prosthetic heart valves), and embodiments of related methods for delivering (or retrieving) the implantable medical device in a patient's body using such a device. The delivery device includes a pull-ring assembly comprising a pull-ring and an actuating member attached to the pull-ring. In a specific embodiment, the pull-ring has a proximal region with a diameter sufficiently large to extend over a braided layer of the delivery device's axis. The pull-ring has a distal region with a diameter smaller than the proximal region, and an opening where the proximal region transitions to the distal region. The actuating member may extend through the braided layer, the proximal region of the pull-ring, through the opening of the pull-ring, and alongside the outer surface of the distal region of the pull-ring.

[0012] In one representative embodiment, a delivery device for an implantable medical device includes: a handle; a shaft extending distally from the handle, the shaft having an actuation member cavity extending the length of the shaft; an actuation member extending through the actuation member cavity, the actuation member having a proximal portion and a distal portion; and a pull ring disposed along the distal portion of the shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter. The distal portion of the actuation member is secured to the distal segment of the pull ring. Further, the handle includes an adjustment mechanism operatively coupled to the proximal portion of the actuation member and configured to adjust tension in the actuation member to adjust the curvature of the shaft.

[0013] In another representative embodiment, a manipulable delivery device for an implantable medical device includes: a handle; a shaft extending distally from the handle, the shaft having a manipulative member cavity extending between a distal and a proximal portion of the shaft, and a braided layer radially outward of the manipulative member cavity; a manipulative member extending through the manipulative member cavity, the manipulative member having a proximal and a distal portion; and a pull ring coupled to the distal portion of the shaft. Further, the pull ring includes a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein the distal portion of the manipulative member is secured to the distal segment of the pull ring, and wherein the distal portion of the braided layer extends into the proximal segment of the pull ring and terminates at a position proximal to the distal segment of the pull ring. Additionally, the handle includes an adjustment mechanism operatively coupled to the proximal portion of the manipulative member, wherein actuation of the adjustment mechanism changes the tension in the manipulative member to change the curvature of the shaft.

[0014] In another representative embodiment, a manipulable delivery device for an implantable medical device includes: a handle; a shaft extending distally from the handle, the shaft having a manipulative member cavity extending between a distal and a proximal portion of the shaft, a first layer, a second layer coaxially disposed on the first layer, and a third layer coaxially disposed on the second layer; a manipulative member extending through the manipulative member cavity, the manipulative member having a proximal and a distal portion; and a pull ring coupled to the distal portion of the shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein the distal portion of the manipulative member is secured to the distal segment of the pull ring, and wherein the distal portion of the second layer of the shaft extends into the proximal segment of the pull ring and terminates at a position proximal to the distal segment of the pull ring. Further, the handle includes an adjustment mechanism operatively coupled to the proximal portion of the manipulative member, wherein actuation of the adjustment mechanism changes the tension in the manipulative member to change the curvature of the shaft.

[0015] In another representative embodiment, a method of using a catheter device includes: inserting a shaft of the catheter device into a patient's body, the shaft including a manipulator cavity extending therethrough, the manipulator extending through the manipulator cavity, the manipulator having a proximal portion and a distal portion, the distal portion of the manipulator being secured to the distal portion of the shaft via a pull ring, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter, wherein the first diameter is larger than the second diameter; and manipulating the shaft internally in the patient's body via an adjustment mechanism on a handle of an actuating device external to the patient's body, wherein the adjustment mechanism is operatively coupled to the proximal portion of the manipulator, and actuation includes adjusting tension in the manipulator to adjust the curvature of the shaft.

[0016] In another representative embodiment, a method of manufacturing a steerable catheter device includes: placing a first polymer layer on a mandrel; placing a steerable member longitudinally along the first polymer layer; placing a braided layer on the first polymer layer and the steerable member; positioning a pull ring relative to the first polymer layer, the steerable member, and the braided layer such that a distal portion of the braided layer extends into a proximal segment of the pull ring, and a distal portion of the steerable member extends through the proximal segment of the pull ring, distally beyond the braided layer, and alongside the distal segment of the pull ring, wherein the diameter of the proximal segment of the pull ring is larger than the diameter of the distal segment of the pull ring; placing a second polymer layer on the braided layer; and bonding the first polymer layer and the second polymer layer together via an opening in the braided layer.

[0017] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0018] Figure 1 This is a three-dimensional view of a prosthetic heart valve according to one embodiment.

[0019] Figure 2A This is a three-dimensional view of a prosthetic heart valve according to another embodiment.

[0020] Figure 2B yes Figure 2A A three-dimensional view of a prosthetic valve, with components outside the frame shown in transparent lines for illustrative purposes.

[0021] Figure 3 This is a perspective view of a delivery device for a prosthetic heart valve according to one embodiment.

[0022] Figure 4 yes Figure 3 A cross-sectional view of an embodiment of the distal portion of the delivery device.

[0023] Figure 5 This is a side view of an assembly including a prosthetic valve according to one embodiment, the prosthetic valve being folded onto a balloon mounted on the distal portion of a balloon catheter.

[0024] Figure 6 This is a perspective view of a stepped pull ring according to one embodiment.

[0025] Figure 7A yes Figure 6 Side view of the stepped pull ring.

[0026] Figure 7B yes Figure 6 End view of the stepped pull ring.

[0027] Figure 7C It is along Figure 7B A cross-sectional view of the stepped pull ring taken from line 7C-7C.

[0028] Figure 8 This is an enlarged perspective view of a cross-section of the distal portion of the outer shaft of a delivery device according to one embodiment, showing a pull ring with the outer layer of the shaft removed for illustrative purposes.

[0029] Figure 9 yes Figure 8 Another perspective view of the cross-section of the distal portion of the outer shaft, showing the outer layer of the shaft.

[0030] Figure 10 yes Figure 9 A cross-sectional view of the distal portion of the outer shaft.

[0031] Figure 11 It is along Figure 10 The line 11-11 cut Figure 10 A cross-sectional view of the distal portion of the outer shaft.

[0032] Figure 12 It is along Figure 10 The line 12-12 cut Figure 10 A cross-sectional view of the distal portion of the outer shaft.

[0033] Figure 13A This is an example of manufacturing according to one implementation method. Figures 8-12 The flowchart of the method for the axis.

[0034] Figure 13B This is an example of manufacturing according to another embodiment. Figures 8-12 The flowchart of the method for the axis.

[0035] Figure 13C This is an example of manufacturing according to another embodiment. Figures 8-12 The flowchart of the method for the axis.

[0036] Figure 14 It can be used to form Figures 8-12 The cross-section of the inner layer of the shaft being extruded.

[0037] Figure 15 This is an enlarged perspective view of the cross-section of the distal portion of the outer shaft of the delivery device according to another embodiment.

[0038] Figure 16 It is a combination based on one implementation method. Figure 15 A cross-sectional view of the distal portion of the delivery device of the shaft.

[0039] Figure 17 yes Figure 16 The image shows a side view of the distal portion of the delivery device. Detailed Implementation

[0040] This article describes examples of manipulable delivery devices (sometimes referred to as manipulable catheters) that can be used to navigate a subject's vascular system to deliver implantable, expandable medical devices (e.g., prosthetic heart valves), tools, medications, or other therapies to a location within the subject's body. Examples of procedures in which manipulable catheters can be used include neurological, urological, gynecological, reproductive (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transbladder, and transrectal procedures, as well as procedures involving access within any body duct or body cavity. Specific examples include placement of implants, including stents, grafts, embolization coils, etc.; positioning of imaging devices and / or components thereof, including ultrasound transducers; and positioning of energy sources (e.g., for performing lithotripsy), RF sources, ultrasound transmitters, electromagnetic sources, laser sources, heat sources, etc.

[0041] The disclosed device includes a pull ring assembly with a stepped pull ring for securing the distal end of an actuating member, such as a pull cord or traction cable, to the distal end of a shaft of a delivery device. In some embodiments, the stepped pull ring has a larger diameter proximal region and a smaller diameter distal region, as well as an intermediate transition region with an opening through which the distal portion of the actuating member can extend. In some embodiments, the shaft may include a braided layer having a distal portion extending into the larger proximal region of the pull ring.

[0042] Figure 1 A prosthetic heart valve 10 according to one embodiment is shown. The illustrated prosthetic valve is suitable for implantation in a natural aortic valve annulus, but in other embodiments, it may be suitable for implantation in other natural valve annulus of the heart (e.g., pulmonary valve, mitral valve, and tricuspid valve). The prosthetic valve may also be suitable for implantation in other tubular organs or pathways within the body. The prosthetic valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalvular sealing member or outer skirt 18. The prosthetic valve 10 may have an inflow portion 20, a middle portion 22, and an outflow portion 24.

[0043] Valve structure 14 may include three leaflets 40 that together form a leaflet structure, which may be configured to fold in a tricuspid arrangement, but in other embodiments there may be more or fewer leaflets (e.g., one or more leaflets 40). Leaflets 40 may be secured to each other at their adjacent sides to form commissures 22 of leaflet structure 14. The lower edge of valve structure 14 may have an undulating, curved, fan-shaped shape and may be secured to the inner skirt 16 by sutures (not shown). In some embodiments, leaflets 40 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118 (which is incorporated herein by reference).

[0044] The frame 12 may be formed with a plurality of circumferentially spaced slots, or adapted to mount the ferrule portion 22 of the valve structure 14 to the ferrule window 20 of the frame. The frame 12 may be made of any of a variety of suitable malleable expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi), such as Nitinol). When constructed of a malleable expandable material, the frame 12 (and therefore the prosthetic valve 10) can be folded into a radially constricted configuration on the delivery catheter and then expanded in the patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 12 (and therefore the prosthetic valve 10) can be folded into a radially constricted configuration and restrained in the constricted configuration by insertion into a sheath or equivalent mechanism of the delivery catheter. Once in the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0045] Suitable malleable expansion materials for forming the frame 12 include, without limitation, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific embodiment, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy (e.g., ... The alloy (SPS Technologies, Jenkintown, Pennsylvania) is equivalent to UNS R30035 alloy (covered by ASTM F562-02). The alloy / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Further details regarding the prosthetic valve 10 and its components are described in WIPO patent application publication number WO2018 / 222799 (which is incorporated herein by reference).

[0046] Figure 2A This is a perspective view of a prosthetic heart valve 50 according to another embodiment. The valve 50 may have three main components: a stent or frame 52, a valve structure 54, and a sealing member 56. Figure 2B This is a perspective view of the prosthetic valve 50, in which, for illustrative purposes, the components outside the frame 52 (including the sealing member 56) are shown in transparent lines.

[0047] Similar to Figure 1The valve structure 14, valve structure 54 may include three leaflets 60 forming a leaflet structure, which may be configured to fold in a tricuspid arrangement. Each leaflet 60 may be coupled to the frame 52 along its inflow edge 62 (lower edge in the figure; also referred to as the leaflet's "cuspid edge") and at the junction 64 of the valve structure 54—where adjacent portions of two leaflets connect to each other. Reinforcing elements (not shown), such as fabric strips, may be directly attached to the cuspid edge of the leaflet and to struts attached to the frame to connect the cuspid edge of the leaflet to the frame.

[0048] Similar to Figure 1 The frame 12 and frame 52 can be made of any of the various suitable malleable or self-expanding materials known in the art and described above. The frame 52 in the illustrated embodiment includes a plurality of circumferentially extending rows of angled struts 72 defining rows of cells or openings 74 of the frame. The frame 52 may have a cylindrical or substantially cylindrical shape, as shown, having a constant diameter from the inlet end 66 to the outlet end 68 of the frame, or the diameter of the frame may vary along the height of the frame, as disclosed in U.S. Patent 9,155,619 (which is incorporated herein by reference).

[0049] In the illustrated embodiment, the sealing member 56 is mounted on the exterior of the frame 52 and serves to form a seal against surrounding tissue (e.g., natural leaflets and / or natural valve annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 may include an inner layer 76 (which may contact the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be attached to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 can be sutured to the frame 52 via sutures that can extend around the strut 72 and through the inner layer 76. In an alternative embodiment, the inner layer 76 may be mounted on the inner surface of the frame 52, while the outer layer 78 is on the exterior of the frame 52.

[0050] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside the patient's body, the outer layer 78 can expand away from the inner layer 76 to create space between the two layers. Therefore, when implanted in the body, this allows the outer layer 78 to expand to contact the surrounding tissues.

[0051] Further details regarding the prosthetic valve 50 and its components are described in U.S. Patent Publication No. 2018 / 0028310 (which is incorporated herein by reference).

[0052] Figures 3-5 Various embodiments and components of a delivery system, such as a catheter delivery system, are shown, including a delivery device (in one embodiment, which may be a balloon catheter). Figure 3A delivery device (e.g., apparatus) 100 according to one embodiment is shown, which can be used for implanting an expandable prosthetic heart valve (e.g., heart valve 10 or 50) or other types of expandable prosthetic medical devices (such as stents). In some embodiments, the delivery device 100 is specifically adapted for introducing a prosthetic valve into the heart.

[0053] refer to Figure 3 The delivery device 100 in the illustrated embodiment is a balloon catheter, including a handle 102, a steerable outer shaft 104 extending from the handle 102, and an intermediate shaft 105 extending coaxially from the handle 102 through the steerable outer shaft 104 (see [link to original document]). Figure 4 ), and the inner shaft 106, which extends coaxially from the handle 102 through the intermediate shaft 105 and the outer shaft 104. Figure 4 The delivery device 100 further includes an inflatable balloon 108 extending distally from an intermediate shaft 105 and a nasal cone 110 disposed distally at the delivery device 100. The distal portion 112 of the delivery device 100 includes the balloon 108, the nasal cone 110, and a balloon shoulder assembly. Prosthetic medical devices, such as prosthetic heart valves, can be mounted on the valve retention portion of the balloon 108, as referenced below. Figure 4 Further description. The balloon shoulder assembly maintains the prosthetic heart valve or other medical device in a fixed position on the balloon 108 during delivery through the patient's vascular system.

[0054] Handle 102 may include an actuation mechanism configured to adjust the curvature of the operable distal portion 113 of the outer shaft 104 (also referred to herein as the operable section 113 of the outer shaft 104). In one example embodiment, the operable section of the outer shaft comprises approximately one-quarter of the total length of the outer shaft. An actuation member, such as a drawstring or braided cable, is connected to an adjustment member provided in the handle to adjust the curvature of the operable section as the adjustment member rotates. In an example embodiment, handle 102 includes an adjustment member provided in the form of a rotatable knob 134. The rotatable knob 134 is operatively coupled to the proximal portion of the actuation member within the body of handle 102.

[0055] Rotating the knob 134 of the handle 102 effectively increases or decreases the tension in the traction cable 202, thereby adjusting the curvature of the maneuverable segment 113 of the outer shaft. By adjusting the curvature of the maneuverable segment, the operator can guide the delivery device through the patient's vascular system to the selected valve deployment site. In one specific example, the curvature of the maneuverable segment is adjusted when navigating the delivery device through the aortic arch to deliver a prosthetic heart valve.

[0056] Shafts 102, 104, 105 Figure 3It can be formed from any of a variety of suitable materials, such as nylon, braided stainless steel wire, or polyether block amide. Shafts 102, 104, and 105 may also have longitudinal sections formed of different materials to change the flexibility of these shafts along their length.

[0057] In a specific embodiment, the maneuverable segment of the outer axis is substantially straight in its undeflected state. In other embodiments, the maneuverable segment is slightly curved in its undeflected state. In a further embodiment, when fully deflected, the maneuverable segment conforms to the shape of the aortic arch.

[0058] Figure 4 An embodiment of the distal portion 112 of the delivery device 100 is shown. (As...) Figure 4 As shown, the delivery device 100 is configured to mount a prosthetic valve (e.g., a prosthetic heart valve) 114 in a folded state onto a balloon 108 for inserting the delivery device 100 and the prosthetic valve 114 into the patient's vascular system.

[0059] like Figure 4 As shown, at the proximal end of the distal portion 112, the inner shaft 106 extends distally beyond the steerable shaft 104 and the intermediate shaft 105 and through the balloon 108. The balloon 108 can be supported on the balloon shoulder assembly 118. The balloon shoulder assembly 118 includes a proximal shoulder 120 connected to the distal end of the intermediate shaft 105 and a distal shoulder 122 mounted on the inner shaft 106. The balloon 108 includes a proximal portion 126 surrounding and / or folded thereon around the proximal shoulder 120 and a distal portion 128 surrounding and / or folded thereon around the distal shoulder 122. In some embodiments, the proximal portion 126 of the balloon 108 can be secured to the outer surface of the intermediate shaft 105. In some embodiments, the distal portion 128 of the balloon 108 can be secured to the outer surface of the nasal cone 110 (as shown), which can be mounted on or coupled to the inner shaft 106.

[0060] In the illustrated embodiment, the nose cone 110 and the distal shoulder 122 can be a one-piece or integral component; that is, the nose cone 110 is the distal portion of the integral component, and the distal shoulder 122 is the proximal portion of the integral component. In other embodiments, the nose cone 110 and the distal shoulder 122 can be separate components, and each can be mounted on the inner shaft 106 adjacent to each other or axially spaced apart.

[0061] The proximal shoulder 120 and the distal shoulder 122 are spaced apart from each other in the axial direction relative to the central longitudinal axis 124 of the delivery device 100. As a result, the balloon 108 defines a valve retention portion 130 in the space separating the proximal shoulder 120 and the distal shoulder 122 (e.g., between the open ends of the proximal shoulder 120 and the distal shoulder 122). Figure 4 As shown, the prosthetic valve 114 can be folded between the proximal shoulder 120 and the distal shoulder 122 onto the valve holding portion 130 of the balloon 108, thereby preventing or reducing axial movement of the prosthetic valve 114 relative to the balloon 108 during the insertion of the delivery device 100 into the patient and delivery of the prosthetic valve 114 to the target implantation site.

[0062] The outer diameter of the inner shaft 106 can be sized such that the annular space 132 is defined along the entire length of the intermediate shaft 105 between the inner shaft 106 and the intermediate shaft 105. The annular space 132 can be fluidly coupled to one or more fluid passages of the delivery device 100, which can be fluidly connected to a fluid source (e.g., a syringe) that can inject expanding fluid (e.g., saline) into the delivery device. In this way, fluid from the fluid source can flow through one or more fluid passages, through the annular space 132, and into the balloon 108 to inflate and expand the prosthetic valve 114. For example, the handle 102 may have a fluid port 103 configured to be coupled to a fluid source (see...). Figure 3 In use, expansion fluid from a fluid source can be injected into fluid port 103, through one or more fluid passages in handle 102, through annular space 132, and into balloon 108.

[0063] Figure 4 The flow of fluid through the annular space 132 and through channels in the proximal shoulder 120 and distal shoulder 122 is illustrated (indicated by arrow 109). Fluid can then flow into the proximal portion 126 and distal portion 128 of the balloon 108 to dilate the valve 114. Further details of the balloon shoulder assembly, manipulation mechanism, and other components of the delivery device are disclosed in U.S. Patent Nos. 7,780,723; 9,061,119; 9,339,384; and U.S. Publication No. 2017 / 0065415 (which is incorporated herein by reference).

[0064] Figure 5 The image shows an external side view of the distal portion 112 of the delivery device 100, including a prosthetic valve 114 folded onto a balloon 108, which is mounted on the distal portion 112 of the balloon catheter. A balloon shoulder assembly including a proximal shoulder 120 and a distal shoulder 122 (described above) is also shown. Figure 4 (Description) Supporting the balloon 108. (See description) Figure 5As shown, balloon 108 includes a proximal portion 126 surrounding and / or folded over a proximal shoulder 120, a distal portion 128 surrounding and / or folded over a distal shoulder 122, and a valve retaining portion 130 located between the proximal portion 126 and the distal portion 128. A prosthetic valve 114 is folded into and around the balloon catheter, on and around the valve retaining portion 130.

[0065] Figures 6-12 The diagram shows the construction of the distal portion of an operable outer shaft 200, which includes an actuating member in the form of a pull cable 202 attached to a pull ring 210. The pull cable 202 may comprise multiple braided threads or filaments, which may be made of any of a variety of materials, including various metals or metal alloys (e.g., stainless steel), carbon fibers, and / or polymer fibers. Optionally, the actuating member may comprise a single wire, such as a single metal wire. The outer shaft 200 may be implemented in place of the outer shaft 104 in the delivery device 100. It should be understood that the shaft 200 need not be the outermost shaft of the delivery device, but may be an inner or intermediate shaft of the delivery device such as delivery device 100.

[0066] Furthermore, shaft 200 can be implemented in other types of delivery devices or other catheter devices having actuation mechanisms. For example, in some embodiments, shaft 200 can be implemented in a delivery device disclosed in U.S. Provisional Application No. 63 / 138,890, filed January 19, 2021, which is incorporated herein by reference and discloses another example of a delivery device having a balloon for deploying a prosthetic valve. In other embodiments, shaft 200 can be an actuating shaft for a delivery device for a self-expanding prosthetic heart valve, such as those disclosed in U.S. Publication No. 2019 / 0008640, U.S. Publication No. 2014 / 0343670, U.S. Publication No. 2012 / 0239142, or U.S. Publication No. 2010 / 0049313 (which is incorporated herein by reference). In other embodiments, shaft 200 can be an actuating shaft for a delivery device for a mechanically expandable prosthetic heart valve, such as those disclosed in U.S. Application No. 62 / 945,039 (which is incorporated herein by reference).

[0067] The maneuverable shaft 200 can also be implemented in delivery devices for delivering and implanting medical devices other than prosthetic heart valves—such as leaflet repair devices implanted on one or more natural heart valve leaflets, or implantable devices implanted in other organs of the body as described above. Furthermore, in other embodiments, the shaft 200 can be implemented in a maneuverable catheter, which can be configured to perform any of the various medical procedures described above, including but not limited to various neurological, urological, gynecological, reproductive (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transbladder, or transrectal procedures.

[0068] refer to Figure 8 and Figure 9 In the example embodiment, shaft 200 includes a braided layer 212 disposed between an inner polymer layer 214 and an outer polymer layer 216. The braided layer 212 can impart flexibility, tensile strength, torque transmission, and stiffness to the outer shaft while preventing or minimizing kinking. In some embodiments, the braided layer 212 is formed of metal or polymer filaments (e.g., stainless steel filaments) woven together. The braided layer 212 can extend the length of the outer shaft 200—from its proximal end at handle 102 to pull ring 210. Further details regarding the construction of the braided layer are disclosed in U.S. Publication No. 2017 / 0273787 (which is incorporated herein by reference). In alternative embodiments, the braided layer 212 can be replaced with polymer or metal coils (e.g., stainless steel coils).

[0069] The inner layer 214 and the outer layer 216 can be made of any of a variety of suitable polymers, such as nylon, polyether block amide (e.g., PEBA ), polyethylene or polytetrafluoroethylene (e.g., The outer layer 216 may be formed from the same polymer material as the inner polymer layer or from alternative materials (e.g., materials that are more flexible or more rigid than the material of the inner polymer layer).

[0070] The inner layer 214 defines a main cavity 218, which is sized to receive one or more additional shafts of the delivery device (e.g., the intermediate shaft 105 and inner shaft 106 of the delivery device 100). In the example embodiment, the inner layer 214 also defines an actuating member cavity 220 radially offset from the central longitudinal axis A of the shaft 200. The actuating member cavity 220 (e.g., Figure 12 The actuating member cavity 220 (best shown) is sized to receive a pull cable 202 extending the entire length of the cavity 220. The actuating member cavity 220 may be lined with a tubular liner 222 extending the entire length of the cavity 220. The liner 222 may be made of a relatively low-friction polymeric material, such as polytetrafluoroethylene (PTFE) or similar materials, to minimize sliding friction between the pull cable 202 and the surrounding inner surface of the cavity. In some embodiments, the outer surface of the liner is etched to improve the thermal bonding of the liner 222 to the inner layer 214. This thermal bonding prevents or minimizes slippage of the liner 222 during pull cable actuation. In some embodiments, if another shaft (e.g., shaft 105) extends through the main cavity 218, the inner surface of the main cavity 218 may similarly be covered with a relatively low-friction polymeric material, such as PTFE or similar materials.

[0071] The pull cable 202 has a distal portion 226 attached to the pull ring 210, as further described below. The proximal portion of the pull cable 202 is operatively connected to an adjustment mechanism (e.g., a knob 134 of the delivery device 100) on the handle of the delivery device, configured to adjust the tension of the pull cable 202, thereby adjusting the curvature of the shaft 200. Various mechanisms can be used to couple the proximal portion of the pull cable 202 to the knob 134 of the delivery device 100. In one embodiment, the proximal portion of the pull cable 202 is secured to a slidable nut (not shown) within the handle 102. The nut may have external threads that engage with the internal threads of the knob 134. The nut is restricted to rotation with the knob 134 such that rotation of the knob (clockwise and counterclockwise) produces axial movement of the nut within the handle (in the proximal and distal directions).

[0072] Since the distal portion 226 of the pull cable 202 is fixed to the pull ring 210, the tension in the pull cable is changed by longitudinally moving the sliding nut via rotation of the knob. The adjusting knob 134 can be rotated in one direction to apply tension to the pull cable 202 and in the opposite direction to release tension thereon. In some embodiments, the knob 134 is rotated clockwise to apply tension, while in other embodiments, it is rotated counterclockwise to apply tension. In either case, when the tension increases, the pull cable increases the curvature of the distal portion of the shaft 200 (and therefore the distal portion of the delivery device 100). Conversely, when the tension in the pull cable decreases or is released, the elasticity of the distal portion of the shaft causes it to return to its non-flexible configuration. In its non-flexible configuration (in the absence of pull cable force), the distal portion can be substantially straight (e.g., Figure 3 (As shown) or it can be curved.

[0073] Figure 6 and Figures 7A-7C Details of the pull ring 210 are shown. As shown, the pull ring 210 in the example embodiment includes a proximal segment 250 having a first diameter 252 and a distal segment 254 having a second diameter 256 smaller than the first diameter. In a representative embodiment, the first diameter 252 is approximately 0.140 inches, while the second diameter 256 is approximately 0.129 inches. In the example embodiment, the length of the proximal segment 250 is shorter than the length of the distal segment 254. In another embodiment, the length of the proximal segment is longer than the length of the distal segment. In yet another embodiment, the lengths of the proximal and distal segments are equal or substantially equal. In a representative embodiment, the length of the proximal segment 250 is approximately 0.100 inches, while the length of the distal segment is approximately 0.100 inches. When assembled in the shaft 200, the distal portion 228 of the braided layer 212 extends to the proximal segment 250 (see...). Figures 8-10It terminates before reaching the distal segment 254.

[0074] The pull ring 210 may further include a transition segment 258 formed between the proximal segment 250 and the distal segment 254. The transition segment 258 may have an opening 260. As shown, the opening 260 may be provided on only one side of the transition segment 258 such that the remainder of the transition segment 258 forms a continuous connection between the proximal segment 250 and the distal segment 254. In other words, the proximal segment and the distal segment are discontinuous only at the location of the opening 260, as... Figure 6 and Figure 7C As best shown. The opening 260 can have any suitable shape. In the example embodiment, the opening 260 is trapezoidal. In other embodiments, the opening 260 can be circular, oval, elliptical, rectangular, etc. The opening 260 is sized large enough to receive the pull cable 202 passing through it.

[0075] The opening 260 may communicate with a groove 262 on an inwardly V-shaped protrusion 261 formed on the distal segment 254 of the pull ring 210. The groove 262 may extend along the entire length of the distal segment 254 such that when the pull cable 202 is received therein, the distal portion 226 of the pull cable 202 may extend to the distal end 266 of the pull ring 210. Thus, the distal portion 226 of the pull cable 202 extends through the proximal segment 250 of the pull ring, then through the opening 260, and into the groove 262. Further, the distal portion 226 may be attached to the distal segment 254 of the pull ring, for example, by welding, crimping, adhesive, and / or mechanical fasteners. See reference... Figures 8-9 As described, the pull ring 210 can be embedded between the inner layer 214 and the outer layer 216 of the shaft 200, thereby fixing the position of the pull ring 210 at a fixed position along the distal portion of the shaft 200. As a result, the distal portion 226 of the pull cable 202 is fixed at a fixed position relative to the distal portion of the shaft 200.

[0076] In the example embodiment, both the proximal segment 250 and the distal segment 254 are perforated with holes 268. The holes may be evenly distributed across the entire surface of both the proximal and distal segments. In other embodiments, the holes may be unevenly distributed, for example, with more perforations on the proximal segment than on the distal segment, or vice versa. Although the depicted embodiment shows the perforations as circular holes 268, in other embodiments, the perforations may be shaped and sized differently. During assembly, the holes 268 allow the materials forming the inner layer 214 and the outer layer 216 to bond together, which helps to secure the pull ring in place between the layers 214 and 216.

[0077] In one example, the pull ring 210 is manufactured by a stamping process, and then the seam is welded to create a seam 270. For example, see reference... Figure 6 and Figures 7A-7C In the perforated embodiment, a flat sheet of material (e.g., sheet metal) is used as a starting point, and holes 268 and openings 260 are punched into the sheet or laser-cut. The grooves 262 and cylindrical stepped shapes of the pull ring are then produced using stamping and forming processes known in the art. Adjacent longitudinal edges of the fully formed pull ring can be welded together to form a seam 270. In an alternative embodiment, the pull ring 210 can be made of other materials and / or via manufacturing techniques. For example, the pull ring 210 can be made of a suitable polymer, such as… resin, It is molded (e.g., injection molded) from PTFE, FEP or other suitable materials and made.

[0078] Figure 13A A flowchart of a method 300 for manufacturing a shaft 200 according to one embodiment is shown. Figure 13A As shown, at frame 302, the inner polymer layer 214 can be placed on a mandrel that may have longitudinal grooves. The pull cable 202 can be placed within the grooves of the mandrel along the outer side of the inner layer 214. When using a pad 222, the assembly including the pull cable 202 surrounding the pad 222 can be placed within the grooves of the mandrel along the outer side of the inner layer 214, as shown in frame 304. The distal portion 226 of the pull cable 202 can extend outward from the distal end of the pad 222, so that the distal portion 226 is not covered by the pad, for subsequent attachment to the pull ring 210.

[0079] In some embodiments, the inner layer 214 can be compressed into its final or near-final shape before being placed on the mandrel. For example... Figure 14 As shown, the extruded inner layer 214 may have an inwardly projecting portion 224, an actuating member cavity 220, and a slit or groove 276 communicating with the cavity 220 extending the length of the inner layer 214. The slit 276 allows the pull cable 202 and the pad 222 to be inserted into the cavity 220. In some embodiments, the extruded inner layer 214 may be extruded without the slit 276, in which case the slit 276 may be formed by cutting the inner layer longitudinally along the cavity 220. After the inner layer 214 is formed and the pull cable 202 and the pad 222 are placed in the cavity, the inner layer 214 may be positioned on a mandrel, wherein the projecting portion 224 is aligned within a longitudinal groove of the mandrel.

[0080] In some embodiments, an optional polymer adhesive layer may be placed on the liner 222 / pull cable 202 and the inner layer 214, as shown in box 306. The adhesive layer may be made of resin, Made of PTFE, FEP or other suitable materials.

[0081] As shown in box 308, the braided layer 212 is then placed on the adhesive layer, leaving the distal section of the inner layer, the adhesive layer, and the distal portion 226 of the pull cable uncovered by the braided layer 212 for subsequent placement of the pull ring 210. If the adhesive layer is not used, the braided layer can be placed directly on the inner layer 214 and the padding 222 / pull cable 202. In some embodiments, the braided layer 212 may be pre-formed (e.g., braided or woven into a tubular structure) and placed (e.g., pulled onto) the underlying layer. In alternative embodiments, the braided layer 212 may be woven or woven around the underlying layer such that the braided layer is formed when it is placed on the underlying layer.

[0082] As shown in box 310, the pull ring 210 is then slid over the distal portion of a layup comprising an inner layer 214, a pad 222 / pull cable 202, an adhesive layer, and a braided layer 212, such that the larger proximal portion 250 of the pull ring 210 extends over the braided layer 212 and the distal portion 254 of the pull ring 210 extends over the adhesive layer, wherein the distal portion 226 of the pull cable extends through the opening 260 of the pull ring 210 and into the groove 262 (e.g., ...). Figure 10 (As shown). The inward protrusion 261 of the pull ring can be aligned with the groove of the mandrel. The distal portion 226 of the pull cable 202 can be attached to the pull ring, for example, by welding the distal portion 226 of the cable within the groove 262 to the surface of the distal portion 254 of the pull ring. Alternatively, the distal portion of the pull cable 202 can be mechanically attached to the pull ring, for example, by securing an enlarged end member to the distal end of the cable 202. The width of the end member is greater than the width of the opening 260 to prevent the distal end of the cable from being pulled proximally through the opening 260. The end member can be, for example, a ferrule, a ring, or a ball, having a diameter larger than the cable diameter and being sized such that it cannot be pulled proximally through the opening 260. In this way, the distal portion 226 of the cable 202 does not need to be securely attached or secured to the pull ring, but can "float" relative to the pull ring when adjusting the tension in the cable, but not separate from the pull ring in the proximal direction. In an alternative implementation, although less desirable, conventional pull wires can be used instead of pull cables.

[0083] As shown in box 312, the outer layer 216 can then be placed over the braided layer 212, the pull ring 210, and any remaining uncovered sections along the distal portions of the inner layer 214 and the adhesive layer. As shown in box 314, the outer layer 216 can then be encased in a heat-shrinkable material and heated. The heat causes the outer layer to flow through the opening 268 in the pull ring 210 and into and through the braided layer and into contact with the adhesive layer or the inner layer 214, forming a shaft with a laminated structure. The applied heat can also cause the inner layer 214 to flow and seal the slit 276 around the pull cable 202. If the inner layer 214 is initially a cylindrical layer, the inner layer can flow around the liner 222, thereby forming the actuating member cavity 220 entirely within or substantially within the wall thickness of the inner layer 214.

[0084] Figure 13B A flowchart of a method 600 for manufacturing a shaft 200 according to another embodiment is shown. Figure 13B As shown, at frame 602, the inner polymer layer 214 can be placed on a mandrel that may have longitudinal grooves. At frame 604, an assembly including a pad 222 and a second, small-diameter mandrel (not a pull cable) inside the pad is placed along the inner layer 214, for example, aligned with the longitudinal grooves of the mandrel. At frame 606, an adhesive layer can be placed on the inner layer 214 and the pad 222 / small-diameter mandrel. At frame 608, a braided layer 212 can be placed on the adhesive layer. At frame 610, an outer layer 216 can be placed on the braided layer 212, exposing the distal portion 228 of the braided layer. At frame 612, a heat-shrinkable layer is placed on a previously formed laminate, which is heated to laminate these layers. At frame 614, the heat-shrinkable layer is removed from the laminate and the small-diameter mandrel is removed from the liner 222. An assembly including a pull ring 210 and a pull cable 202 (which may be pre-assembled or connected to each other, for example, by welding or other techniques described above) is positioned on the laminate. For example, the pull cable 202 may be inserted through the liner 222 and the pull ring 210 may be placed on the distal portion 228 of the braided layer, for example... Figure 8 As shown. At frame 616, the distal portion of the outer layer 216, or an additional polymer piece for forming the distal portion of the outer layer, is placed on the pull ring 210. At frame 618, a heat-shrinkable layer is placed on the distal portion of the outer layer and heated to delaminate the laminate along the distal end of the outer layer.

[0085] Figure 13C A flowchart of a method 700 for manufacturing a shaft 200 according to another embodiment is shown. Figure 13C As shown, at frame 702, the extruded inner layer 214 (as shown) Figure 14(As shown) is placed on the mandrel. At frame 704, a pad 222 is placed on the pull cable 202, which may have a pre-attached or pre-connected pull loop 210. At frame 706, the pad 222 and the pull cable 202 may be placed within the cavity 220, for example, by pressing these components through the slit 276. At frame 708, a braided layer 212 may be placed on the inner layer 214. At frame 710, the pull loop 210 may slide proximally on the distal portion 228 of the braided layer 212. At frame 712, an outer layer 216 may be placed on the pull loop 210 and the previously formed laminate. At frame 714, a heat-shrinkable layer may be placed on the outer layer and then heated to laminate the laminate.

[0086] The method and arrangement disclosed herein offer several advantages over the prior art methods described above. For example, the distal portion 254 of the pull ring 210 does not need to extend on the braided layer 212, eliminating the need to cut openings in the braided layer for the pull cable 202. Instead, as Figure 10 As shown in the optimal configuration, the pull cable 202 extends distally beyond the distal end of the braided layer 212 and enters the groove 262 of the distal portion 254 of the pull ring.

[0087] Furthermore, the smaller-diameter distal portion 254 of the pull ring and its inward protrusion 261 bring the distal portion 226 of the pull cable close to the groove of the mandrel, thereby reducing the distance the pull cable extends radially inward from the pull ring into the braided layer. This prevents the pull ring from tilting when tension is applied to the pull cable 202 or during heating (when forming the mandrel 200), which could cause the pull ring to perforate the main cavity 218. The proximal portion 250 of the pull ring can be long enough to further resist any residual canting of the pull ring during heating or under relatively high tension applied to the pull cable.

[0088] Furthermore, while conventional pull cords can be used, pull cable 202 is advantageous because it is more flexible than cords of similar size and can easily form a curved transition section extending from pull ring 210 into cavity 220. During heating or when tension is applied to the cable, the more flexible cable is better able to maintain its curved shape along the transition section to prevent pull ring tilting, while a more rigid cord tends to straighten along the transition section, which can cause pull ring tilting.

[0089] In some implementations of the delivery device, such as Figure 9 and Figure 10As best shown, shaft 200 may have a stepped configuration along its distal portion. In the depicted embodiment, outer layer 216 has a distal segment 272 with a smaller diameter than the segment 274 extending proximally from the distal segment 272. The presence of the smaller-diameter stepped region facilitates coupling of delivery device components to the distal end of shaft 200. Additionally, the stepped region may be sized such that, after coupling, the outer surface of the coupled component is flush with the outer surface of shaft 200. In one example, a proximal shoulder (e.g., proximal shoulder 510; see...) Figure 16 It can be installed on the remote segment 274, as further described below.

[0090] Figure 15 The distal portion of a shaft 400 according to another embodiment is shown, which may be incorporated into a delivery device such as delivery device 100 or (discussed below) delivery device 500. Shaft 400 may be identical to shaft 200 described above and may include a pull ring 210, a braided layer 212, an inner polymer layer 214, an outer polymer layer 216, a pull cable 202 (or a pull cord or other actuating member), and a pad 222. Shaft 400 may be formed in the same manner as described above in conjunction with shaft 200, except that the pull ring 210 extends at least partially into the distally segment 272 of shaft 400 with a reduced diameter.

[0091] like Figure 15 As shown, a large portion of the length of the distal segment 254 of the pull ring 210 extends into the distal section 272 of the shaft 400. In some embodiments, the entire distal segment 254 is positioned within the distal section 272 of the shaft 400. Positioning the pull ring 210 at least partially within the distal section 272 of the shaft 400 so that the pull ring 210 and the traction cable 202 are close to the prosthetic valve (which is mounted distal to the distal section 272) enhances the maneuverability of the distal portion of the delivery device and allows control over the positioning of the prosthetic valve within the patient's vascular system.

[0092] Figure 16 and Figure 17 The distal portion of a delivery device 500, incorporating shaft 400 according to one embodiment, is shown. The delivery device 500 also includes an inner shaft 106, but the intermediate shaft 105 of the delivery device 100 is omitted. Therefore, in the example embodiment, the delivery device 500 includes only two shafts. However, it should be understood that in alternative embodiments, additional shafts may also be incorporated into the delivery device, such as the intermediate shaft 105 extending between shafts 106 and 400, or another shaft extending on shaft 400 (in which case shaft 400 is not the outermost shaft of the delivery device).

[0093] The proximal portions of shaft 400 and inner shaft 106 can be connected to handle 102 (e.g., Figure 3As shown, the handle 102 may have an adjustment knob 134 or similar adjustment mechanism for controlling the tension in the traction cable 202 and a fluid port 103. Since the intermediate shaft 105 is omitted, the main cavity 218 of the shaft 400 serves as an expansion cavity for guiding expansion fluid from the fluid port 103 of the handle 102 into the balloon 508.

[0094] The delivery device 500 may include a proximal shoulder 510 mounted to the shaft 400, a distal shoulder 512 mounted to the inner shaft 106, and a nose cone 514 connected to and extending distally from the distal shoulder 512. Figure 16 As shown, the proximal section 516 of the proximal shoulder 510 can be mounted on the distal section 272 of the shaft 400, for example by welding and / or adhesive. The outer diameter of the proximal section 516 can be equal to the outer diameter of the shaft 400 just proximal to the distal section 272 to provide a smooth transition between the shaft and the proximal shoulder.

[0095] The balloon 508 includes a proximal portion 520 surrounding and / or folded over the proximal shoulder 510, a distal portion 522 surrounding and / or folded over the distal shoulder 512, and a middle portion 524 for receiving a prosthetic valve 502 (which may be, for example, valve 10 or 50). The proximal portion 520 may include a leg 526 that abuts against the proximal shoulder 510 and / or shaft 400 for sealing (e.g., by suitable adhesive and / or welding). Similarly, the distal portion 522 may include a leg 528 that abuts against the distal shoulder 512 and / or nasal cone 514 for sealing (e.g., by suitable adhesive and / or welding).

[0096] The proximal shoulder 510 may have an inner bore or cavity 530 communicating with the cavity 218 of the shaft 400 and one or more expansion ports or openings 532. In this way, pressurized expansion fluid within the cavity 218 can flow distally into the proximal shoulder 510 and then radially outward through the ports 532 into the proximal portion 520 of the balloon 508. The expansion fluid within the proximal portion 520 can then flow through the middle portion 524 of the balloon and into the distal portion 522, thereby inflating the balloon 508 and dilating the prosthetic valve 502 mounted on the balloon.

[0097] The proximal shoulder 510 may include an open distal segment, which may include a plurality of winglets or open legs 534 defining a gap therebetween. Similarly, the distal shoulder 512 may include an open proximal segment, which may include a plurality of winglets or open legs 536 defining a gap therebetween. The open segments help to hold the prosthetic valve 502 on the intermediate segment 524 of the balloon 508. The gap between the legs 534, 536 allows the legs to collapse radially and elastically, so that the shoulders 510, 512 can be inserted into the smaller diameter legs 526, 528 of the balloon during assembly. In addition, the gap between the legs 534, 536 facilitates the flow of inflatable fluid from the proximal end of the balloon through the balloon to the distal end.

[0098] like Figure 16 As shown, the delivery device 500 may include a proximal hub 538 mounted on an inner shaft 106 within a leg 534 of the proximal shoulder 510 and a distal hub 540 mounted on an inner shaft 106 within a leg 536 of the distal shoulder 512. The hubs 538 and 540 may be attached to the inner shaft using various techniques and mechanisms, including adhesives, thermal bonding, or overmolding. In some embodiments, one or both of the hubs 538 and 540 form a sliding fit with the inner shaft 106. For example, in some embodiments, the proximal hub 538 forms a sliding fit with the inner shaft 106, while the distal hub 540 is rigidly attached to the inner shaft 106, for example, by adhesives, thermal bonding, or overmolding. When the curvature of the outer axis 400 is adjusted, the sleeve 538 facilitates the transmission of flexural motion of the outer axis 400 to the prosthetic valve 502 by keeping the inner axis 106 concentric with the proximal shoulder 510. The sleeve also minimizes the curvature between the shoulders 510, 512 and the adjacent ends of the prosthetic valve to facilitate crossing the natural aortic valve annulus.

[0099] The delivery device 500 may also include one or more radiopaque markers 542 mounted on the shaft 106 in a region within the intermediate portion 524 of the balloon. The markers 542 can be used to position the prosthetic valve 502 at the natural annulus under fluorescence examination.

[0100] General considerations

[0101] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The described methods, systems, and apparatuses should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of various disclosed embodiments, individually and in various combinations and sub-combinations of each other. The disclosed methods, systems, and apparatuses are not limited to any particular aspect, feature, or combination thereof, nor are they required to address any one or more specific advantages or problems.

[0102] Features, integers, properties, compounds, chemical parts, or groups described in connection with a particular aspect, embodiment, or example of this disclosure should be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings) and / or all steps of any method or process so disclosed may be combined in any way (except that at least some of these features and / or steps are mutually exclusive combinations). This disclosure is not limited to the details of any of the foregoing embodiments. This disclosure extends to any novel single feature or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel single feature or any novel combination of steps of any method or process so disclosed.

[0103] While some operations of the disclosed methods are described in a specific sequential order for ease of presentation, it should be understood that this descriptive approach includes rearrangement unless the specific language used in the following description requires a particular order. For example, the sequentially described operations may be rearranged or performed simultaneously in some cases. Furthermore, for the sake of brevity, the accompanying drawings may not show the various ways in which the disclosed methods, systems, and apparatus can be used in conjunction with other systems, methods, and apparatuses.

[0104] As used herein, the terms “a,” “an,” and “at least one” include one or more of the specified elements. That is, if two specific elements exist, then one of those elements also exists, and therefore there is an “an” element. The terms “a plurality of” and “plural” mean two or more of the specified elements.

[0105] As used herein, the term “and / or” used between the last two elements in an element list means any one or more of the listed elements. For example, the phrase “A, B and / or C” means “A”, “B”, “C”, “A and B”, “A and C”, “B and C”, or “A, B and C”.

[0106] As used in this article, the term “coupled” generally means physically coupled or connected, and does not exclude the existence of intermediate elements between coupled items in the absence of specific opposite language.

[0107] In the context of this application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow”, respectively. Thus, for example, the lower end of the valve is its inflow end, and the upper end of the valve is its outflow end.

[0108] As used herein, the term "proximal" refers to a position, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions.

[0109] Other examples of the disclosed technology

[0110] In view of the above-described embodiments of the disclosed subject matter, this application discloses the following additional examples. It should be noted that a single feature of an example, or more than one feature of an example in combination or optionally combined with one or more features of one or more other examples, are also other examples that fall within the scope of the disclosure of this application.

[0111] Example 1. A delivery device for an implantable medical device, comprising:

[0112] handle;

[0113] A shaft extending distally from the handle, the shaft having a control member cavity extending the length of the shaft;

[0114] An actuating member extending through the actuating member cavity, the actuating member having a proximal portion and a distal portion; and

[0115] A pull ring is arranged along the distal portion of the shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein the distal portion of the actuating member is fixed to the distal segment of the pull ring;

[0116] The handle includes an adjustment mechanism operably coupled to the proximal portion of the actuating member and configured to adjust the tension in the actuating member to adjust the curvature of the shaft.

[0117] Example 2. Any example in this document, particularly the delivery device of Example 1, wherein the pull ring further includes a transition section formed between a proximal segment and a distal segment, the transition section having an opening communicating with a groove formed on the outer surface of the distal segment of the pull ring.

[0118] Example 3. Any example in this document, particularly the delivery device of Example 2, wherein the distal portion of the actuating member extends through the proximal segment of the pull ring, the opening, and into the groove.

[0119] Example 4. Any of the examples in this document, particularly the delivery device of any of Examples 1-3, wherein the shaft includes a braided layer on the radially outer side of the actuating member cavity, wherein the braided layer has a distal portion extending into the proximal segment of the pull ring.

[0120] Example 5. Any example in this document, particularly the delivery device of Example 4, wherein the distal portion of the manipulating member extends distally beyond the distal end of the braided layer.

[0121] Example 6. Any example in this document, particularly a delivery device of any of Examples 4 or 5, wherein the shaft includes an inner polymer layer and an outer polymer layer defining a cavity for an actuating member, wherein the inner polymer layer is radially inside the braided layer and the outer polymer layer is radially outside the braided layer.

[0122] Example 7. Any example in this document, particularly the delivery device of Example 6, wherein a pull ring is embedded in the shaft between an inner polymer layer and an outer polymer layer.

[0123] Example 8. Any of the examples in this document, particularly any of Examples 1-7, of the delivery device, wherein the actuating element comprises a braided cable.

[0124] Example 9. Any of the examples in this document, particularly any of Examples 1-7, of the delivery device, wherein the manipulating element comprises a line.

[0125] Example 10. Any of the examples in this document, particularly the delivery device of any of Examples 1-9, wherein the length of the proximal segment is shorter than the length of the distal segment.

[0126] Example 11. Any of the examples in this document, particularly any of the delivery devices in Examples 1-10, wherein one or both surfaces of the proximal and distal segments of the pull ring are perforated.

[0127] Example 12. Any example in this document, particularly a delivery device of any of Examples 1-11, wherein the shaft is an outer shaft having a central cavity, the delivery device further includes an inner shaft extending coaxially through the central cavity of the outer shaft, and wherein the actuating member cavity is radially offset from the central axis of the central cavity.

[0128] Example 13. A manipulable delivery device for an implantable medical device, comprising:

[0129] handle;

[0130] A shaft extending distally from the handle has an actuation member cavity extending between a distal portion and a proximal portion of the shaft, and a braided layer radially outward of the actuation member cavity.

[0131] An actuating member extending through the actuating member cavity, the actuating member having a proximal portion and a distal portion; and

[0132] A pull ring coupled to a distal portion of a shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein a distal portion of an actuating member is fixed to the distal segment of the pull ring, and wherein a distal portion of a braided layer extends into the proximal segment of the pull ring and terminates at a position proximal to the distal segment of the pull ring.

[0133] The handle includes an adjustment mechanism operably coupled to the proximal portion of the actuating member, wherein actuation of the adjustment mechanism changes the tension in the actuating member to change the curvature of the shaft.

[0134] Example 14. Any example in this document, particularly the delivery device of Example 13, wherein the pull ring further includes a transition section formed between a proximal segment and a distal segment, the transition section having an opening communicating with a groove formed on the outer surface of the distal segment of the pull ring, and wherein a distal portion of an actuating member extends through the proximal segment of the pull ring, the opening, and into the groove.

[0135] Example 15. Any example in this document, particularly the delivery device of Example 14, wherein the transition section gradually tapers from the proximal segment to the distal segment of the pull ring.

[0136] Example 16. Any of the examples in this document, particularly the delivery device of any of Examples 13-15, wherein the distal end of the manipulating member extends distally beyond the distal end of the braided layer.

[0137] Example 17. Any of the examples in this document, particularly the delivery device of any of Examples 13-16, wherein the shaft includes:

[0138] An inner polymer layer defining the cavity of the actuating member, the inner polymer layer being arranged radially inside the braided layer; and

[0139] An outer polymer layer is arranged radially outside the braided layer, and a pull ring is embedded in the distal portion of the shaft between the inner and outer polymer layers.

[0140] Example 18. Any of the examples in this document, particularly any of Examples 13-17, of the delivery device, wherein one or both of the surfaces of the distal and proximal segments of the pull ring include perforations.

[0141] Example 19. Any of the examples in this document, particularly any of Examples 13-18, of the delivery device, wherein the actuating element comprises a braided cable.

[0142] Example 20. Any of the examples in this document, particularly any of Examples 13-18, of the delivery device, wherein the manipulating element comprises a line.

[0143] Example 21. Any example in this document, particularly a delivery device of any of Examples 13 or 16-20, wherein the distal portion of the actuating member extends through the proximal segment of the pull ring, radially outward through an opening in the pull ring, and is adjacent to the outer surface of the distal segment of the pull ring.

[0144] Example 22. Any of the examples in this document, particularly the delivery device of Example 21, wherein the distal portion of the actuating member extends into a groove in the distal segment of the pull ring.

[0145] Example 23. Any example in this document, particularly any of Examples 13-22, of a delivery device, wherein the shaft is a first shaft having a central cavity, and the delivery device further includes a second shaft extending coaxially through the central cavity of the first shaft.

[0146] Example 24. Any of the examples in this document, particularly the delivery device of Example 23, further includes an inflatable balloon mounted on the distal portion of the second axis.

[0147] Example 25. A manipulable delivery device for an implantable medical device, comprising:

[0148] handle;

[0149] A shaft extending distally from the handle, the shaft having an actuation member cavity extending between a distal portion and a proximal portion of the shaft, a first layer, a second layer coaxially arranged on the first layer, and a third layer coaxially arranged on the second layer;

[0150] An actuating member extending through the actuating member cavity, the actuating member having a proximal portion and a distal portion; and

[0151] A pull ring coupled to a distal portion of a shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein a distal portion of an actuating member is fixed to the distal segment of the pull ring, and wherein a distal portion of a second layer of the shaft extends into the proximal segment of the pull ring and terminates at a position proximal to the distal segment of the pull ring.

[0152] The handle includes an adjustment mechanism operably coupled to the proximal portion of the actuating member, wherein actuation of the adjustment mechanism changes the tension in the actuating member to change the curvature of the shaft.

[0153] Example 26. Any example in this document, particularly the delivery device of Example 25, wherein the second layer of the shaft includes a braided layer.

[0154] Example 27. A delivery device in any of the examples in this document, particularly any of Examples 25-26, wherein the first and third layers of the shaft are polymer layers, and a pull ring is embedded between the first and third layers.

[0155] Example 28. Any example in this document, particularly a delivery device of any of Examples 25-27, wherein the pull ring further includes a transition section formed between a proximal segment and a distal segment, the transition section having an opening communicating with a groove formed on the outer surface of the distal segment of the pull ring, and wherein a distal portion of an actuating member extends through the proximal segment of the pull ring, the opening, and into the groove.

[0156] Example 29. Any example in this document, particularly the delivery device of Example 28, wherein the transition section gradually tapers from the proximal segment to the distal segment of the pull ring.

[0157] Example 30. Any of the examples in this document, particularly any of Examples 25-29, of the delivery device, wherein the distal end of the manipulating member extends distally beyond the distal end of the second layer of the axis.

[0158] Example 31. Any of the examples in this document, particularly any of Examples 25-30, of the delivery device, wherein one or both of the surfaces of the distal and proximal segments of the pull ring include perforations.

[0159] Example 32. Any of the examples in this document, particularly any of Examples 25-31, of the delivery device, wherein the actuating element comprises a braided cable.

[0160] Example 33. Any of the examples in this document, particularly any of Examples 25-31, of the delivery device, wherein the manipulating element comprises a line.

[0161] Example 34. A method of using a catheter device, the method comprising:

[0162] The shaft of the catheter device is inserted into the patient's body. The shaft includes a manipulator lumen extending therethrough. The manipulator extends through the manipulator lumen and has a proximal portion and a distal portion. The distal portion of the manipulator is secured to the distal portion of the shaft via a loop. The loop includes a proximal segment having a first diameter and a distal segment having a second diameter, wherein the first diameter is larger than the second diameter.

[0163] An actuation shaft is operated inside the patient's body via an adjustment mechanism on a handle of an external actuation device, wherein the adjustment mechanism is operatively coupled to a proximal portion of the actuation member, and wherein actuation includes adjusting tension in the actuation member to adjust the curvature of the shaft.

[0164] Example 35. Any example in this document, particularly the method of Example 34, wherein the shaft includes a braided layer on the radially outer side of the actuating member cavity, wherein the distal portion of the braided layer extends into the proximal segment.

[0165] Example 36. Any example in this document, particularly any of Examples 34-35, wherein the distal portion of the actuating member extends through a proximal segment, an opening disposed between the proximal and distal segments, and into a groove formed on the outer surface of the distal segment.

[0166] Example 37. Any example in this document, particularly any of the methods in Examples 35-36, where the axes include:

[0167] An inner polymer layer defining the cavity of the actuating member, the inner polymer layer being arranged radially inside the braided layer; and

[0168] An outer polymer layer is arranged radially outside the braided layer, and a pull ring is embedded in the distal portion of the shaft between the inner and outer polymer layers.

[0169] Example 38. Any example in this document, particularly any of the methods in Examples 34-37, wherein the manipulating component includes a braided cable.

[0170] Example 39. Any example in this document, particularly any of the methods in Examples 34-37, wherein the manipulating component includes a line.

[0171] Example 40. A method for manufacturing a maneuverable catheter device, the method comprising:

[0172] Place the first polymer layer on the mandrel;

[0173] The actuating components are placed longitudinally along the first polymer layer;

[0174] The braided layer is placed on the first polymer layer and the manipulating member;

[0175] The pull ring is positioned relative to the first polymer layer, the actuating member, and the braided layer, such that the distal portion of the braided layer extends into the proximal segment of the pull ring, and the distal portion of the actuating member extends through the proximal segment of the pull ring, extends distally beyond the braided layer, and is parallel to the distal segment of the pull ring, wherein the diameter of the proximal segment of the pull ring is larger than the diameter of the distal segment of the pull ring.

[0176] Place the second polymer layer on top of the braided layer; and

[0177] The first polymer layer and the second polymer layer are bonded to each other through openings in the braided layer.

[0178] Example 41. Any example in this document, particularly the method of Example 40, wherein the manipulating component includes a braided cable.

[0179] Example 42. Any example in this document, particularly the method of Example 41, wherein the manipulating component includes a line.

[0180] Example 43. Any example in this document, particularly the method of any one of Examples 40-42, wherein bonding the first polymer layer and the second polymer layer to each other includes applying heat and pressure to at least the second polymer layer.

[0181] Example 44. Any example in this document, particularly the method of Example 43, wherein applying heat and pressure includes placing a heat-shrinkable layer on a second polymer layer and heating the heat-shrinkable layer.

[0182] Example 45. Any example in this document, particularly the method of any one of Examples 40-44, wherein the pull ring includes a plurality of orifices and the first polymer layer and the second polymer layer are bonded to each other via the openings in the pull ring.

[0183] Example 46. Any example in this document, particularly the method of any one of Examples 40-45, wherein the pull ring further includes a transition section formed between a proximal segment and a distal segment, the transition section having an opening communicating with a groove formed on the outer surface of the distal segment of the pull ring, and wherein a distal portion of the actuating member extends through the proximal segment of the pull ring, the opening, and into the groove.

[0184] Example 47. Any example in this document, particularly the method of Example 46, wherein positioning the pull ring includes aligning the groove of the pull ring with the groove of the longitudinal extension of the mandrel.

[0185] Example 48. Any example in this document, particularly the method of any one of Examples 40-47, wherein the actuating member is inside the tubular liner and placing the actuating member comprises placing the tubular liner longitudinally along the first polymer layer, wherein the actuating member is inside the tubular liner.

[0186] Given the many possible implementations to which the principles of this disclosure can be applied, it should be understood that the exemplified embodiments are merely preferred examples of the invention and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is defined by the appended claims.

Claims

1. A delivery device for implantable medical devices, including: handle; A shaft extending distally from the handle, the shaft having an actuating member cavity extending through the length of the shaft; An actuating member extending through the actuating member cavity, the actuating member having a proximal portion and a distal portion; and A pull ring arranged along the distal portion of the axis, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein the distal portion of the actuating member is fixed to the distal segment of the pull ring; The handle includes an adjustment mechanism operatively coupled to the proximal portion of the actuating member and configured to adjust tension in the actuating member to adjust the curvature of the shaft.

2. The delivery device of claim 1, wherein the pull ring further includes a transition section formed between the proximal segment and the distal segment, the transition section having an opening communicating with a groove formed on the outer surface of the distal segment of the pull ring.

3. The delivery device of claim 2, wherein the distal portion of the actuating member extends through the proximal segment of the pull ring, the opening, and into the groove.

4. The delivery device according to any of the preceding claims, wherein the shaft includes a braided layer on the radially outer side of the actuating member cavity, wherein the braided layer has a distal portion extending into the proximal segment of the pull ring.

5. The delivery device of claim 4, wherein the distal portion of the actuating member extends distally beyond the distal end of the braided layer.

6. The delivery device of claim 4, wherein the shaft includes an inner polymer layer and an outer polymer layer defining the actuating member cavity, wherein the inner polymer layer is radially inside the braided layer and the outer polymer layer is radially outside the braided layer.

7. The delivery device of claim 6, wherein the pull ring is embedded in the shaft between the inner polymer layer and the outer polymer layer.

8. The delivery device of claim 1, wherein the actuating member comprises a braided cable.

9. The delivery device of claim 1, wherein the manipulation member comprises a line.

10. The delivery device of claim 1, wherein the length of the proximal segment is shorter than the length of the distal segment.

11. The delivery device of claim 1, wherein one or both of the surfaces of the proximal and distal segments of the pull ring are perforated.

12. The delivery device of claim 1, wherein the shaft is an outer shaft having a central cavity, the delivery device further comprising an inner shaft coaxially extending through the central cavity of the outer shaft, and wherein the actuating member cavity is radially offset from the central axis of the central cavity.

13. A manipulable delivery device for an implantable medical device, comprising: handle; A shaft extending distally from the handle, the shaft having an actuating member cavity extending between a distal portion and a proximal portion of the shaft, and a braided layer radially outside the actuating member cavity; An actuating member extending through the actuating member cavity, the actuating member having a proximal portion and a distal portion; and A pull ring coupled to the distal portion of the shaft, the pull ring including a proximal segment having a first diameter and a distal segment having a second diameter smaller than the first diameter, wherein the distal portion of the actuating member is fixed to the distal segment of the pull ring, and wherein the distal portion of the braided layer extends into the proximal segment of the pull ring and terminates at a proximal position of the distal segment of the pull ring; The handle includes an adjustment mechanism operatively coupled to the proximal portion of the actuating member, wherein actuation of the adjustment mechanism alters the tension in the actuating member to change the curvature of the shaft.

14. The delivery device of claim 13, wherein the pull ring further includes a transition section formed between the proximal segment and the distal segment, the transition section having an opening communicating with a groove formed on the outer surface of the distal segment of the pull ring, and wherein the distal portion of the actuating member extends through the proximal segment of the pull ring, the opening, and into the groove.

15. The delivery device of claim 14, wherein the transition section gradually tapers from the proximal segment to the distal segment of the pull ring.

16. The delivery device according to any one of claims 13-15, wherein the distal end of the actuating member extends distally beyond the distal end of the braided layer.

17. The delivery device according to any one of claims 13-15, wherein the shaft comprises: An inner polymer layer defining the cavity of the actuating member, the inner polymer layer being disposed radially inside the braided layer; and An outer polymer layer is disposed radially outside the braided layer, wherein the pull ring is embedded in the distal portion of the shaft between the inner polymer layer and the outer polymer layer.

18. The delivery device according to any one of claims 13-15, wherein the surface of one or both of the distal and proximal segments of the pull ring includes perforations.

19. The delivery device according to any one of claims 13-15, wherein the actuating member comprises a braided cable.

20. The delivery device according to any one of claims 13-15, wherein the actuating member comprises a line.

21. The delivery device according to any one of claims 13-15, wherein the distal portion of the actuating member extends through the proximal segment of the pull ring, radially outward through an opening in the pull ring, and is parallel to the outer surface of the distal segment of the pull ring.

22. The delivery device of claim 21, wherein the distal portion of the actuating member extends into a groove in the distal segment of the pull ring.

23. The delivery device according to any one of claims 13-15 and 22, wherein the shaft is a first shaft having a central cavity, and the delivery device further includes a second shaft extending coaxially through the central cavity of the first shaft.

24. The delivery device of claim 23, further comprising an inflatable balloon mounted on the distal portion of the second shaft.

25. A method for manufacturing a steerable catheter device, the method comprising: Place the first polymer layer on the mandrel; The actuating components are placed longitudinally along the first polymer layer; The braided layer is placed on the first polymer layer and the actuating member; The pull ring is positioned relative to the first polymer layer, the actuating member, and the braided layer such that a distal portion of the braided layer extends into a proximal segment of the pull ring, and a distal portion of the actuating member extends through the proximal segment of the pull ring, extending distally beyond the braided layer and parallel to the distal segment of the pull ring, wherein the diameter of the proximal segment of the pull ring is larger than the diameter of the distal segment of the pull ring. Place the second polymer layer on the braided layer; and The first polymer layer and the second polymer layer are bonded to each other through openings in the braided layer.

26. The method of claim 25, wherein the actuating member comprises a braided cable.

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