Prosthetic valve delivery system

Abstract

A delivery system includes an outer shaft assembly including an outer shaft and an outer distal hinge component, an inner shaft assembly including an inner shaft and an inner shaft distal hinge component, the inner shaft slidingly and rotationally disposed within the outer shaft, and a capsule shaft assembly including a capsule shaft and a capsule coupled to the capsule shaft, the capsule shaft slidingly and rotationally disposed within the inner shaft, the capsule configured to receive a prosthetic heart valve therein. The capsule shaft assembly is configured to be selectively rotated and longitudinally translated independent of the inner shaft assembly and the outer shaft assembly. The inner shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the outer shaft assembly. The inner distal hinge component and the outer distal hinge component are each configured to pivot independently.

Description

PROSTHETIC VALVE DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No.63 / 712,392, filed October 25, 2024, the entire contents of which is incorporated herein by reference.FIELD OF THE INVENTION

[0002] The present technology is generally related to prosthetic valve delivery devices.BACKGROUND OF THE INVENTION

[0003] Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of leaflets of a heart valve may be treated with a heart valve replacement procedure. A traditional surgical valve replacement procedure requires a sternotomy and a cardiopulmonary bypass, which creates significant patient trauma and discomfort. Traditional surgical valve procedures may also require extensive recuperation times and may result in life-threatening complications.

[0004] One alternative to a traditional surgical valve replacement procedure is delivering implantable medical devices using minimally-invasive techniques. For example, a prosthetic valve can be percutaneously and transluminally delivered to an implant location. In such methods, the prosthetic valve can be compressed within a delivery catheter for insertion within a patient’s vasculature and once inserted may be expanded at a target location. Among devices commonly used to access vascular and other locations within a body and to perform various functions at those locations are medical catheter, or delivery catheters, adapted to deliver and deploy medical devices such as prosthetic valves, stentgrafts, and stents to selected targeted sites in the body. Such medical devices typically are releasably carried within a distal region of the delivery catheter in a radially compressed delivery configuration as the catheter is navigated to and positioned at a target treatment / deployment site.

[0005] Typically, a delivery catheter will deploy the prosthetic valve using a mechanical or hydraulic systems and the forces created by these systems will expel the prosthetic valveinto the target treatment site. Achieving the desired trajectory, position, and depth, particularly in a tricuspid valve may be particularly challenging for both repair and replacement due to the access path to the tricuspid valve anatomy. Therefore, a need exists for improved delivery systems configured to provide a consistent and reliable delivery process within a patient’s anatomy.BRIEF SUMMARY OF THE INVENTION

[0006] According to examples hereof, the present disclosure is directed to a system for delivering and positioning a prosthetic heart valve. The system includes an outer shaft an outer shaft assembly including an outer shaft and an outer distal hinge component, an inner shaft assembly including an inner shaft and an inner shaft distal hinge component, the inner shaft slidingly and rotationally disposed within the outer shaft, and a capsule shaft assembly including a capsule shaft and a capsule coupled to a distal portion of the capsule shaft, the capsule shaft slidingly and rotationally disposed within the inner shaft, the capsule configured to receive the prosthetic heart valve therein. The capsule shaft assembly is configured to be selectively rotated and longitudinally translated independent of the inner shaft assembly and the outer shaft assembly. The inner shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the outer shaft assembly. The inner distal hinge component and the outer distal hinge component are each configured to pivot independently.

[0007] In another example hereof, in the system of any of the preceding or following examples, pivoting the inner distal hinge component bends the capsule shaft relative to the inner shaft.

[0008] In another example hereof, in the system of any of the preceding or following examples, pivoting the outer distal hinge component bends the inner shaft relative to the outer shaft.

[0009] In another example hereof, in the system of any of the preceding or following examples, the outer shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the inner shaft assembly.

[0010] In another example hereof, in the system of any of the preceding or following examples, the inner distal hinge component includes a first hinge portion coupled to a distal end of the inner shaft of the inner shaft assembly and a second hinge portion pivotably coupled to the first hinge portion.

[0011] In another example hereof, in the system of any of the preceding or following examples, the outer distal hinge component includes an outer first hinge portion coupled to a distal end of the outer shaft of the outer shaft assembly and an outer second hinge portion pivotably coupled to the outer first hinge portion.

[0012] In another example hereof, the system of any of the preceding or following examples further includes a handle, wherein the handle includes a first pivot actuator operably coupled to the second hinge portion of the inner distal hinge component to selectively pivot the second hinge portion.

[0013] In another example hereof, in the system of any of the preceding or following examples, the pivot actuator is a rotatable knob.

[0014] In another example hereof, in the system of any of the preceding or following examples, the handle includes a second pivot actuator operably coupled to the outer second hinge portion of the outer distal hinge component to selectively pivot the outer second hinge portion.

[0015] In another example hereof, in the system of any of the preceding or following examples, the second pivot actuator is a rotatable knob.

[0016] In another example hereof, the system of any of the preceding or following examples further includes a first belt and pulley system configured to pivot the second hinge portion of the inner distal hinge component.

[0017] In another example hereof, in the system of any of the preceding or following examples, the first belt and pulley system includes a first drive pulley operably coupled the first pivot actuator, a first pivot pulley operably coupled to the second hinge portion of the inner distal hinge component, and a belt extending between the first drive pulley and the first pivot pulley.

[0018] In another example hereof, in the system of any of the preceding or following examples, the inner shaft assembly includes a belt sleeve disposed within a lumen of the inner shaft of the inner shaft assembly, wherein the belt is routed through the belt sleeve.

[0019] In another example hereof, in the system of any of the preceding or following examples, the first belt and pulley system includes a plurality of first drive pulleys, a plurality of first pivot pulleys, and a plurality of first belts.

[0020] In another example hereof, the system of any of the preceding or following examples further includes a second belt and pulley system configured to pivot the outer second hinge portion of the outer distal hinge component.

[0021] In another example hereof, in the system of any of the preceding or following examples, the second belt and pulley system includes a second drive pulley operably coupled the second pivot actuator, a second pivot pulley operably coupled to the outer second hinge portion of the outer distal hinge component, and a second belt extending between the second drive pulley and the second pivot pulley.

[0022] In another example hereof, in the system of any of the preceding or following examples, the outer shaft assembly includes a second belt sleeve disposed within a lumen of the outer shaft of the outer shaft assembly, wherein the second belt is routed through the second belt sleeve.

[0023] In another example hereof, in the system of any of the preceding or following examples, the second belt and pulley system includes a plurality of second drive pulleys, a plurality of second pivot pulleys, and a plurality of second belts.

[0024] In another example hereof, the system of any of the preceding or following examples further includes a first actuator operably coupled to a proximal end of the capsule shaft, the first actuator configured to translate the capsule shaft assembly proximally and distally.

[0025] In another example hereof, in the system of any of the preceding or following examples, the first actuator is configured to rotate the capsule shaft about a capsule shaft assembly central axis.

[0026] In another example hereof, the system of any of the preceding or following examples further includes a second actuator operably coupled to a proximal end of the inner shaft, the second actuator configured to translate the inner shaft assembly proximally and distally.

[0027] In another example hereof, in the system of any of the preceding or following examples, the second actuator is configured to rotate the inner shaft about an inner shaft assembly central axis.

[0028] In another example hereof, the system of any of the preceding or following examples further includes an anchor configured to stabilize the delivery system within a native vessel or cavity.

[0029] In another example hereof, in the system of any of the preceding or following examples, the anchor includes a plurality of expandable members configured to selectively extend radially outward from an outer surface of the outer shaft of the outer shaft assembly. BRIEF DESCRIPTION OF DRAWINGS

[0030] The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments thereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the art to make and use the invention. The drawings are not to scale.

[0031] FIG. 1 depicts a perspective view of a prosthetic heart valve in accordance with an aspect of the disclosure.

[0032] FIG. 2 depicts a side view of a delivery system according to an embodiment hereof.

[0033] FIG. 3 depicts a cross-sectional view taken along line A-A of FIG. 2.

[0034] FIG. 4 depicts an exploded view of the delivery system of FIG. 2.

[0035] FIG. 5 depicts an enlarged view of a distal portion of an inner shaft assembly of the delivery system of FIG. 2 according to embodiments hereof.

[0036] FIG. 6 depicts an exploded view of a distal portion of the inner shaft assembly of FIG. 5 according to embodiments hereof.

[0037] FIG. 7 depicts a simplified view of a belt and pulley system of the inner shaft assembly of FIG. 5 according to embodiments hereof.

[0038] FIG. 8 depicts an enlarged view of a distal portion of an outer shaft assembly of the delivery system of FIG. 2 according to embodiments hereof.

[0039] FIG. 9 depicts an exploded view of a distal portion of the outer shaft assembly of FIG. 8 according to embodiments hereof.

[0040] FIG. 10 depicts a simplified view of a belt and pulley system of the outer shaft assembly of FIG. 8 according to embodiments hereof.

[0041] FIG. 11 depicts an anchor of the delivery system of FIG. 2 according to embodiments hereof.

[0042] FIG. 12 depicts omnidirectional steering capabilities of the delivery system of FIG.2 according to embodiments hereof.

[0043] FIGS. 13A-13F depict illustrations of examples directional positions of the delivery system of FIG. 2.

[0044] FIGS. 14-17 depict illustrations of several of the steps for delivering a prosthetic valve to a native tricuspid valve with the delivery system of FIG. 2, according to embodiments hereof.DETAILED DESCRIPTION OF THE INVENTION

[0045] Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” when used in the following description to refer to a delivery system or catheter are with respect to a position or direction relative to the treating clinician or the handle of the device. Thus, “distal” and “distally” refer to positioned distant from, or in a direction away from the treating clinician or handle, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the clinician or handle.

[0046] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and use of the invention. Although the description of the invention is in the context of the treatment and navigation of a tricuspid heart valve, the invention may be used where it is deemed useful in other anatomical sites. For example, the present invention may be applied to other heart valves, such as but not limited to mitral valve, or venous valves. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description.

[0047] FIG. 1 illustrates an exemplary prosthetic heart valve 100 for which the delivery systems described herein may be used to deliver. Prosthetic heart valve 100 is illustrated herein in order to facilitate description of the interaction between the prosthetic heart valve 100 and a delivery system to be utilized in conjunction therewith according to embodiments hereof. It is understood that any number of alternate heart valve prostheses can be used with the delivery systems and methods described herein. The prosthetic heart valve 100 is presented by way of example only, and other shapes and designs of prosthetic heart valves are also consistent with embodiments hereof. Other non-limiting examples of prosthetic heart valves that can be delivered via the delivery devices and methods described herein are described in U.S. Patent No. 9,034,032 assigned to Medtronic, Inc., U.S. Patent No.11,318,013 assigned to Twelve, Inc., and International Publication No. WO 2014 / 144937 assigned to Twelve, Inc., each of which is incorporated by reference herein in its entirety. Itis understood that any number of alternate heart valve prostheses may be used with the methods and devices described here in. The prosthetic heart valve 100 is presented by way of example only, and the existing components illustrated in FIG. 1 may be removed and / or additional components may be added to the prosthetic heart valve 100.

[0048] The prosthetic heart valve 100 is configured to be radially compressed into a reduced-diameter configuration (not shown) for delivery within a vasculature and to return to an expanded, deployed configuration, which is shown in FIG 1. In accordance with embodiments hereof, when in the radially compressed or reduced-diameter configuration, the prosthetic heart valve 100 has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery system that may be tracked to the deployment site of the native heart valve of a heart. The prosthetic heart valve 100 includes a stent or frame 102 and a valve component 104 including at least one leaflet 106 configured to regulate flow through the prosthetic heart valve 100.

[0049] In the example prosthetic heart valve 100, the frame 102 of the prosthetic heart valve 100 includes a valve support 108 and an anchoring member 110. The valve support 108 is configured to support the valve component 104 therein. When positioned in situ within a native tricuspid or mitral valve, a first end 114 is an inflow or upstream end and a second end 116 is an outflow or downstream end. The valve support 108 is attached to the anchoring member 110 at the second end 116. The anchoring member 110 is a stent-like structure that functions as an anchor for the prosthetic heart valve 100 to secure its deployed position within a native annulus. The anchoring member 110 is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native tricuspid valve. The anchoring member 110 includes one or more fixation elements 122 that extend outward from an exterior side thereof to engage heart tissue.

[0050] The valve component 104 of the prosthetic heart valve 100 is capable of regulating flow via valve leaflets 106 that may form a replacement valve. FIG. 1 illustrates an exemplary valve component 104 having three leaflets, although a bicuspid leaflet configuration may alternatively be used.

[0051] In embodiments herein, a delivery system 200 includes a capsule shaft assembly, an inner shaft assembly, and an outer shaft assembly configured to provide improved trajectory, positioning, and depth control of a prosthetic heart valve within a heart valve for repair or replacement thereof. In embodiments, the capsule shaft assembly, the inner shaft assembly,and the outer shaft assembly may each be rotated and longitudinally translated independently. In embodiments, a distal portion of each of the inner shaft assembly and the capsule shaft assembly may each be bent or angled independently.

[0052] The delivery system 200, which may be used for transcatheter delivery and deployment of an implant, such as the non-limiting example of the prosthetic heart valve 100 of FIG. 1, is shown in FIGS. 2-16. In general terms, the delivery system 200 is arranged and configured for percutaneously delivering an implant (e.g., prosthetic heart valve 100) in a delivery configuration to a patient’s native defective heart valve or other portion of a patient’s anatomy via transcatheter delivery. FIG. 2 illustrates a side view of the delivery system 200 and FIG. 3 is a cross-sectional view taken along line A-A of FIG. 2. FIG. 4 is an exploded view of the delivery system 200. FIGS. 5-12 are detailed illustrations of components of the delivery system 200. FIGS. 13-16 illustrate the interaction of the components of the delivery system 200 to deliver and position a prosthetic heart valve within a native heart valve.

[0053] In embodiments, the delivery system 200 includes a capsule shaft assembly 210, an inner shaft assembly 230 disposed over the capsule shaft assembly 210, and an outer shaft assembly 330 disposed over the inner shaft assembly 230, and a handle 202, as shown in FIG. 2. The capsule shaft assembly 210 includes a capsule 212 coupled thereto for housing at least a portion of the prosthetic heart valve 100 during delivery thereof. In embodiments herein, the capsule shaft assembly 210 is configured for manipulation in situ, the inner shaft assembly 230 is configured for manipulation in situ, and the outer shaft assembly 330 is configured for manipulation in situ, such that during delivery the prosthetic heart valve 100 contained within the capsule 212 of the innermost shaft assembly 210 may be steered into alignment within the native heart valve for which the prosthetic heart valve 100 serves as a replacement. The capsule shaft assembly 210, the inner shaft assembly 230, and the outer shaft assembly 330 may each be controlled or manipulated independently to provide the delivery system 200 with omnidirectional steering capabilities to direct the capsule 212. The handle 202 of the delivery system 200 may have any shape or size appropriate for convenient handling by a user. In embodiments, the handle 202 may include one or more actuators for manipulation of the capsule shaft assembly 210, the inner shaft assembly 230, and the outer shaft assembly 330 during delivery and deployment, as described below.

[0054] Components of the delivery system 200 will now be described in more detail. In embodiments shown in FIGS. 2-12, the capsule shaft assembly 210 includes a flexible or capsule shaft 216 and the capsule 212 at a distal end thereof. The capsule shaft assembly 210 is coupled to the handle 202 at a proximal end thereof. The capsule shaft 216 is a flexible elongated tubular body that may include, for example, a flexible metal tetris or spring disposed within a polymer jacket. The capsule shaft 216 is of sufficient flexibility to permit selective bending of a distal portion thereof by the inner shaft assembly 230, as described below. A lumen 218 is defined within the capsule shaft 216 between a proximal end 220 and a distal end 222 of the capsule shaft 216 of the capsule shaft assembly 210, as shown in FIGS. 3-4. The capsule 212 is concentrically disposed over a distal end of the capsule shaft 216, and an annular cavity (not shown) is defined between an inner surface of the capsule 212 and an outer surface of the capsule shaft 216. The capsule shaft 216 and the capsule 212 together may house a hydraulic deployment system (not shown) that is configured to cause proximal and distal translation of the capsule 212 with respect to the prosthetic heart valve 100 for deployment. The capsule shaft 216 contains or houses a hydraulic tube or lumen (not shown) that is in fluid communication with the annular cavity and functions to deliver a fluid to hydraulically actuate the capsule 212. The distal sheath capsule 212 is configured to be distally advanced relative to the capsule shaft 216 to release and deploy the prosthetic heart valve 100 from the capsule 212. Via a manifold (not shown), fluid is injected through the capsule shaft 216 in order to drive the capsule 212 distally. The prosthetic heart valve 100 may remain in a stationary longitudinal position relative to the native valve while the capsule 212 is driven distally, thereby increasing the precision of deployment. Hydraulic valve delivery systems consistent with embodiments hereof include, for example, those described in U.S. Pat. No. 9,034,032 assigned to Medtronic, Inc., International Publication No. WO 2014 / 144937 assigned to Twelve, Inc, and U.S. Pat. No.10,561,497 assigned to Medtronic, Inc., which are hereby incorporated by reference in their entirety. In other embodiments, the capsule 212 may be coupled to a shaft (not shown) disposed within the lumen 218 of the capsule shaft 216 and translation of such a shaft (not shown) moves the capsule relative to the capsule shaft 216.

[0055] In embodiments, the capsule shaft 216 of the capsule shaft assembly 210 may be coupled to a first actuator 214 at the handle 202. In an embodiment the first actuator 214 may manipulate the capsule shaft 216 circumferentially about the central longitudinal axisCL A of the delivery system 200, in a first circumferential direction CD1 or a second circumferential direction CD2 opposite the first circumferential direction CD1 relative to the inner shaft assembly 230 and the outer shaft assembly 330. In a non-limiting example, the first actuator 214 may be rotated circumferentially within a groove 214A to rotate the capsule shaft 216. In embodiments, the first actuator 214 may also be manipulated longitudinally to control longitudinal translation of the capsule shaft 216 in a first longitudinal direction LD1 and a second longitudinal direction LD2 opposite the first longitudinal direction LD1 relative to the inner shaft assembly 230 and the outer shaft assembly 330. In an embodiment, the first actuator 214 may engage a proximal portion of the capsule shaft 216 and is constructed to provide selective longitudinal translation of the capsule shaft 216 in a first (z.e., proximal) or a second (z.e., distal) direction and to provide selective circumferential rotation of the capsule shaft 216. However, this is not meant to be limiting, and the first actuator 214 may assume any construction that is capable of providing the desired functionality. In an embodiment, the first actuator 214 is configured as a lever that may be manipulated in the first (z.e., proximal) direction to retract the capsule shaft 216 in the first or proximal direction LD1, may be manipulated in the second (i.e., distal) direction to distally advance the capsule shaft 216 in the second or distal direction LD2, may be manipulated in the first circumferential direction CD1 to rotate the capsule shaft 216 in the first circumferential direction CD1, and may be manipulated in the second circumferential direction CD2 to rotate the capsule shaft 216 in the first circumferential direction CD1. In embodiments, the first actuator 214 may be configured as a button, a rotatable knob, and / or may be configured as two actuators (one for longitudinal translation and one for rotation).

[0056] FIGS. 2-7 illustrate the inner shaft assembly 230. The inner shaft assembly 230 includes a flexible, tubular component or inner shaft 236 and an inner distal hinge component 240 extending distally from a distal end 242 of the inner shaft 236. The inner shaft 236 includes a proximal end 238 and the distal end 242, as shown in FIG. 4. In embodiments, the inner shaft assembly 230 is disposed over the capsule shaft assembly 210 such that an annular lumen 234, shown in FIG. 3, is defined between an outer surface of the capsule shaft 216 of the capsule shaft assembly 210 and an inner surface of the inner shaft 236. The lumen 234 is configured to slidingly and rotationally receive the capsule shaft assembly 210 (specifically the capsule shaft 216). The capsule shaft 216 of the capsule shaftassembly 210 is slidingly and rotationally disposed within the inner shaft 236 of the inner shaft assembly 230 such that relative axial or longitudinal and rotational movement is permitted therebetween. As used herein, “slidingly” generally denotes back and forth movement in a longitudinal direction along or generally parallel to a central longitudinal axis CLA of the delivery system 200 and “rotationally” generally denotes rotational movement in a first rotational direction (z.e., clockwise) or a second rotational direction (z.e., counter-clockwise) around the central longitudinal axis CLA of the delivery system 200. In embodiments herein, a distal portion of the inner shaft 236 is of sufficient flexibility to permit selective bending thereof by the outer shaft assembly 330, as described below. A proximal portion of the inner shaft 236 is operably coupled to a second portion 202B of the handle 202. In embodiments herein, the inner shaft 236 can assume various forms conventionally employed, and in some embodiments can be a braided catheter surrounded by a polymer outer layer or jacket. In embodiments, the inner shaft assembly 230 further includes a first belt 244, a second belt 246, a first belt sleeve 248, and a second belt sleeve 250 as shown in FIGS. 6-7 and described below.

[0057] The inner distal hinge component 240 is configured to permit selective bending or angular deflection of a distal portion of the capsule shaft assembly 210 relative to the inner shaft assembly 230, as described below. In an embodiment shown in FIG. 5, the inner distal hinge component 240 includes a first hinge portion 252 and a second hinge portion 254. The first hinge portion 252 and the second hinge portion 254 form a pivot hinge that permits the second hinge portion 254 to pivot relative to the distal end 242 of the inner shaft 236 of the inner shaft assembly 230 and the first hinge portion 252 coupled thereto.

[0058] In an embodiment, the first hinge portion 252 includes a body 256, a first pivot knuckle 258, a second pivot knuckle 260, and a proximal collar 262, as shown in FIG. 6. The body 256 is a tubular component and defines a distal portion of the lumen 234. The first pivot knuckle 258 extends distally from a distal end 264 of the body 256. The first pivot knuckle 258 is disposed on a first side of the body 256. The second pivot knuckle 260 extends distally from the distal end 264 on a second side of the body 256, opposite the first pivot knuckle 258. A gap or channel 266 is defined between the first pivot knuckle 258 and the second pivot knuckle 260. The channel 266 is sized to pivotably receive the corresponding second hinge portion 254 therein. In embodiments, the first pivot knuckle 258 includes a first pivot bore 268 and the second pivot knuckle 260 includes a second pivotbore 270 opposite the first pivot bore 268 of the first pivot knuckle 258. The first pivot bore 268 and the second pivot bore 270 each extend transversely through the corresponding first pivot knuckle 258 and the second pivot knuckle 260 around a first transverse pivot axis PAI. The first pivot bore 268 and the second pivot bore 270 are each configured to receive a corresponding pivot shaft 294, 284 of the second hinge portion 254 such that the second hinge portion 254 may pivot relative to the first hinge portion 252 around the first transverse pivot axis PAI . The proximal collar 262 extends proximally from a proximal end 272 of the body 256. The proximal collar 262 is a tubular component configured to receive a distal portion of the inner shaft 236 and to couple the first hinge portion 252 to the inner shaft 236.

[0059] In an embodiment, the second hinge portion 254 includes a body 274, a first pivot pulley 276, a second pivot pulley 278, and a collar 280. The body 274 is a tubular component and defines a lumen 235 configured to slidingly and rotationally receive a distal portion of the capsule shaft assembly 210 such that the distal portion of the capsule shaft assembly 210 may be pivoted relative to the inner shaft 236 of the inner shaft assembly 230 by the inner distal hinge component 240, as described below.

[0060] The first pivot pulley 276 extends generally proximally from a first side of the body 274, as best shown in FIG. 6. The second pivot pulley 278 extends generally proximally from a second side of the body 274 opposite the first pivot pulley 276. However, this is not meant to be limiting such that the first and second pivot pulleys 276, 278 may extend distally from the body 274 or may be disposed laterally with respect to the body 274. A channel 282 is defined between the first pivot pulley 276 and the second pivot pulley 278. The channel 282 is sized to slidingly receive a portion of the capsule shaft assembly 210. In embodiments, the first pivot pulley 276 includes a first pivot shaft 284 (not visible in FIG.6) extending radially outward from an outer surface of the first pivot pulley 276. The first pivot shaft 284 is configured to be disposed within the first pivot bore 268 of the first pivot knuckle 258 of the first hinge portion 252. Similarly, the second pivot pulley 278 includes a second pivot shaft 294 extending radially outward from an outer side of the second pivot pulley 278. The second pivot shaft 294 is configured to be disposed within the second pivot bore 270 of the first pivot knuckle 258 of the first hinge portion 252. In embodiments, the first pivot pulley 276 and the second pivot pulley 278 each includes a respective belt channel 288, 298 located at a circumferential edge of the first and second pivot pulleys 276, 278, respectively. The belt channels 288, 298 are configured to receive respective first andsecond belts 244, 246 (FIG. 7). A portion of each belt channel 288, 298 may include a cover configured to prevent disengagement of the first and second belts 244, 246 (FIG. 7) disposed within the belt channels 288, 298, respectively.

[0061] In an embodiment, the first pivot shaft 284 and / or the second pivot shaft 294 may be installed within the corresponding first and second pivot bores 268, 270 with a bearing assembly to permit smooth rotation of the first pivot shaft 284 within the first pivot bore 268 and the second pivot shaft 294 within the second pivot bore 270.

[0062] The collar 280 extends distally from the body 274. The collar 280 is a tubular component configured to slidingly and rotationally receive a portion of the capsule shaft assembly 210. The collar 280 defines a distal portion of the lumen 235 of the second hinge portion 254. The collar 280 rotates with the second hinge portion 254 to bend the portion of the capsule shaft assembly 210 disposed therein.

[0063] In embodiments herein, the first hinge portion 252 and the second hinge portion 254 may each be formed of materials such as, but not limited to stainless steel. The first hinge portion 252 may be coupled to the distal end 242 of the inner shaft 236 of the inner shaft assembly 230 for example, and not by way of limitation, adhesives, fusing, welding, or any other method suitable for the purposes described herein. The first and the second pivot pulleys 276, 278 may be formed integrally as a part of the body 274 or may be coupled to the body 274 of the second hinge portion 254 of the inner distal hinge component 240 by methods including, but not limited to adhesives, fusing, or any other method suitable for the purposes described herein.

[0064] In embodiments, the inner shaft assembly 230 includes the first belt sleeve 248 and the second belt sleeve 250 configured to receive the first and second belts 244, 246, respectively, as shown in FIGS. 6-7. The first and second belt sleeves 248, 250 are elongate components including proximal ends 304, 310, distal ends 306, 312, two first belt lumens 308A, 308B of the first belt sleeve 248 and two second belt lumens 314A, 314B of the second belt sleeve 250, which extend from the respective proximal ends 304, 310 to the respective distal ends 306, 312. Each of the first belt lumens 308A, 308B and second belt lumens 314 A, 314B are configured to slidingly receive a portion of the first belt 244 and the second belt 246, respectively, as shown in FIG. 7. Routing of the first belt 244 through the first belt lumens 308 A, 308B of the first belt sleeve 248 and the second belt 246 through the second belt lumens 314A, 314B prevents entanglement or twisting of the first belt 244and / or the second belt 246 within the inner shaft assembly 230 and ensures that the first and second belts 244, 246 may move freely. The first and second belt sleeves 248, 250 are coupled to an inner surface of the inner shaft 236 of the inner shaft assembly 230 on opposite sides from each other, and are generally longitudinally aligned with the respective first and second pivot pulleys 276, 278.

[0065] The first and the second belt sleeves 248, 250 may each be formed of various materials, non-limiting examples including polymers or stainless steel. The first and the second belt sleeves 248, 250 may each be coupled to the inner surface of the inner shaft 236 of the inner shaft assembly 230 by methods including, but not limited to adhesives, fusing, welding, or any other method suitable for the purposes described herein.

[0066] When assembled, the first pivot shaft 284 is disposed within the first pivot bore 268 of the first pivot knuckle 258 of the first hinge portion 252 and the second pivot shaft 294 is disposed within the second pivot bore 270 of the second pivot knuckle 260 of the first hinge portion 252 such that the second hinge portion 254 may selectively pivot around the first transverse pivot axis PAI relative to the first hinge portion 252. Accordingly, a distal portion of the capsule shaft assembly 210 may selectively pivot relative to the inner shaft assembly 230, as shown in FIG. 7. In greater detail, a portion of the capsule shaft 216 of the capsule shaft assembly 210 distal of the inner shaft 236 of the inner shaft assembly 230 may be selectively bent or angled in a first angular direction ADI or a second angular direction AD2 opposite the first angular direction ADI relative to a second central longitudinal axis CLA2 of the inner shaft assembly 230. In an embodiment, the second hinge portion 254 may pivot relative to the second central longitudinal axis CLA2 of the inner shaft assembly 230, for example, and not by way of limitation, in a range of 0° to 110° or in a range of -15° to 100°.

[0067] In embodiments, the handle 202 of the delivery system 200 includes a second actuator 224 and a first pivot actuator 225, as shown in FIG. 2. A proximal portion of the inner shaft assembly 230 may be coupled to the second actuator 224 at the handle 202. In an embodiment the second actuator 224 may manipulate the inner shaft 236 circumferentially about the central longitudinal axis CLA of the delivery system 200, in a first circumferential direction CD3 or a second circumferential direction CD4 opposite the first circumferential direction CD1 relative to the outer shaft assembly 330. In a non-limiting example, the second actuator 224 may be rotated circumferentially within a groove 224A torotate the inner shaft 236. In embodiments, the second actuator 224 may also be manipulated longitudinally to control longitudinal translation of the inner shaft 236 in a first longitudinal direction LD1 and a second longitudinal direction LD2 opposite the first longitudinal direction LD1 relative to the outer shaft assembly 330. In an embodiment, the second actuator 224 may engage a proximal portion of the inner shaft 236 and is constructed to provide selective longitudinal translation of the inner shaft 236 in a first (z.e., proximal) or a second (z.e., distal) direction and to provide selective circumferential rotation of the inner shaft 236. However, this is not meant to be limiting, and the second actuator 224 may assume any construction that is capable of providing the desired functionality. In an embodiment, the second actuator 224 is configured as a lever that may be manipulated in the first (i.e., proximal) direction to retract the inner shaft 236 in the first or proximal direction LD1, may be manipulated in the second (i.e., distal) direction to distally advance the inner shaft 236 in the second or distal direction LD2, may be manipulated in the first circumferential direction CD1 to rotate the inner shaft 236 in the first circumferential direction CD1, and may be manipulated in the second circumferential direction CD2 to rotate the capsule shaft 216 in the first circumferential direction CD1. In embodiments, the first actuator 214 may be configured as a button, a rotatable knob, and / or may be configured as two actuators (one for longitudinal translation and one for rotation).

[0068] The first pivot actuator 225 is accessible to the user and may be manipulated to control pivoting or bending of the second hinge portion 254 of the inner distal hinge component 240 of the inner shaft assembly 230. The first pivot actuator 225 is constructed to provide selective pivoting of the second hinge portion 254 in a first or a second angular direction ADI, AD2, as shown in FIG. 7. The first pivot actuator 225 may assume any construction that is capable of providing the desired pivoting of the second hinge portion 254 of the inner distal hinge component 240. In embodiments, the first pivot actuator 225 is configured as a rotatable knob. The first pivot actuator 225 is rotated in a first direction (i.e., clockwise) CW1 to pivot the second hinge portion 254 in the first angular direction ADI. The first pivot actuator 225 is rotated in a second direction (i.e., counter-clockwise) CW2 to pivot the second hinge portion 254 in the second angular direction AD2, as described below.

[0069] In an embodiment, the handle 202 includes a first drive pulley 316, a second drive pulley 318, and a drive shaft 320 coupling the first drive pulley 316 to the second drivepulley 318. The first and second drive pulleys 316, 318 and the drive shaft 320 are operably coupled to the first pivot actuator 225 such that actuation of the first pivot actuator 225 rotates the first and the second drive pulleys 316, 318 simultaneously or in unison. In embodiments, the first drive pulley 316 includes a drive channel 322 located in a circumferential edge thereof. The drive channel 322 is configured to receive a proximal portion of the first belt 244. The second drive pulley 318 includes a drive channel 326 in a circumferential edge thereof. The drive channel 326 of the second drive pulley 318 is configured to receive a proximal portion of the second belt 246.

[0070] In embodiments, the first belt 244 and the second belt 246 are each a flexible loop of material or wire configured to connect the corresponding drive pulley with the corresponding pivot pulley. In embodiments, a radius of the first and the second drive pulleys 316, 318 may be larger than a radius of the corresponding first and the second pivot pulleys 276, 278. In such an embodiment, rotation of the first and the second drive pulleys 316, 318, for example, 1° of rotation at the handle 202 would rotate or pivot the corresponding first and the second pivot pulleys 276, 278 and the second hinge portion 254 coupled thereto an amount greater than 1°. The ratio of the radius of the first and second drive pulleys 316, 318 to the corresponding first and second pivot pulleys 276, 278 may be selected to optimize pivoting of the inner distal hinge component 240 and its bending of the capsule shaft assembly 210 for specific anatomies. It shall be understood that the first belt 244 and the second belt 246 are optimally installed with sufficient tension such that the first and second belts 244, 246 rotate the first and the second pivot pulleys 276, 278 without belt slippage. The first belt 244 and the second belt 246 may each be formed of a flexible, durable material such as, but not limited to rubber, various polymers, and / or metals.

[0071] With the inner shaft assembly 230 assembled, the first belt 244 forms a loop extending between the first drive pulley 316 of the handle 202 and the first pivot pulley 276 of the second hinge portion 254 of the inner distal hinge component 240. Similarly, the second belt 246 forms a loop extending between the second drive pulley 318 of the handle 202 and the second pivot pulley 278 of the second hinge portion 254. Actuation of the first pivot actuator 225 of the handle 202 in the first direction (z.e., clockwise) CW1 turns or rotates the first and second drive pulleys 316, 318 in the first or clockwise direction CW1, which drives the first and second belts 244, 246 in a clockwise direction, which rotates the first and the second pivot pulleys 276, 278 of the second hinge portion 254 of the inner shaftassembly 230 in the first or clockwise direction CW 1. Rotation of the first and second pivot pulleys 276, 278 in the first or clockwise direction CW1 pivots the second hinge portion 254 and a distal portion of the innermost shaft assembly 210 in the first angular direction ADI, as shown in FIG. 7. Actuation of the first pivot actuator 225 of the handle 202 in the second direction (z.e., counter-clockwise) CW2 rotates the first and second drive pulleys 316, 318 in the second or counter-clockwise direction CW2, driving the first and second belts 244, 246, in the second or counterclockwise rotation CW2, which rotates the first and the second pivot pulleys 276, 278 in the second or counterclockwise direction CW2. . Rotation of the first and second pivot pulleys 276, 278 in the second or counter-clockwise direction CW2 pivots the second hinge portion 254 and a distal portion of the innermost shaft assembly 210 in the second angular direction AD2, as shown in FIG. 7.

[0072] The outer shaft assembly 330 will now be described with reference to FIGS. 2-4 and 8-11. The outer shaft assembly 330 is similar to the inner shaft assembly 230, except as described herein. The outer shaft assembly 330 includes a flexible, tubular component or outer shaft 336 and an outer distal hinge component 340. The outer shaft 336 includes a proximal end 338, a distal end 342, and a lumen 334 extending from the proximal end 338 to the distal end 342, as shown in FIG. 4. The outer shaft assembly 330 is disposed over the inner shaft assembly 230 as shown in FIG. 3. The lumen 334 is configured to slidingly and rotationally receive the inner shaft 236 of the inner shaft assembly 230 such that relative axial or longitudinal and rotational movement is permitted between the outer shaft assembly 330 and the inner shaft assembly 230. A proximal portion of the outer shaft 336 is coupled to the handle 202. The outer shaft 336 may assume various forms conventionally employed, and in some embodiments can be a braided catheter surrounded by a polymer outer layer or jacket. In embodiments herein, the outer shaft assembly 330 further includes a third belt 344, a fourth belt 346, a third belt sleeve 348, and a fourth belt sleeve 350.

[0073] As shown in FIG. 8, the outer distal hinge component 340 distally extends from the distal end 342 of the shaft 336. The outer distal hinge component 340 is configured to permit selective bending or angular deflection of a distal portion of the inner shaft 236 of the inner shaft assembly 230 relative to the outer shaft 336 of the outer shaft assembly 330. Further, because the capsule shaft 216 of the capsule shaft assembly 210 is disposed within the inner shaft 236, the outer distal hinge component 340 will also bend the capsule shaft 216 at the location of the outer distal hinge component 340. In an embodiment, the outer distal hingecomponent 340 includes a first hinge portion 352 and a second hinge portion 354. The first hinge portion 352 and the second hinge portion 354 form a pivot hinge that permits the second hinge portion 354 to pivot relative to the distal end 342 of the shaft 336 and the first hinge portion 352.

[0074] In an embodiment, the first hinge portion 352 includes a body 356, a first pivot knuckle 358, and a second pivot knuckle 360, as shown in FIG. 9. The body 356 is a tubular component and defines a distal portion of the lumen 334. The first pivot knuckle 358 extends distally from a distal end 364 on a first side of the body 356, and the second pivot knuckle 360 extends distally from the distal end 364 on a second side of the body 356, opposite the first pivot knuckle 358. A gap or channel 366 is defined between the first pivot knuckle 358 and the second pivot knuckle 360 and is sized to pivotably receive the corresponding second hinge portion 354 therein. The first pivot knuckle 358 includes a first pivot bore 368 and the second pivot knuckle 360 includes a second pivot bore 370 opposite the first pivot bore 368 of the first pivot knuckle 358. The first pivot bore 368 and the second pivot bore 370 each extend transversely through the corresponding first and second pivot knuckle 358, 360 on a second transverse pivot axis PA2. The first pivot bore 368 and the second pivot bore 370 are each configured to receive a corresponding pivot shaft of the second hinge portion 354.

[0075] In an embodiment, the second hinge portion 354 includes a body 374, a third pivot pulley 376, a fourth pivot pulley 378, and a collar 380. The body 374 is a tubular component and defines a lumen 335 configured to slidingly and rotationally receive a distal portion of the inner shaft assembly 230 such that the distal portion of the inner shaft assembly 230 may be pivoted relative to the outer shaft 336 of the outer shaft assembly 330 by the outer distal hinge component 340, as described below.

[0076] The third pivot pulley 376 extends generally proximally from a first side of the body 374 and the fourth pivot pulley 378 extends generally proximally from a second side of the body 374 opposite the third pivot pulley 376. However, this is not meant to be limiting such that the third and fourth pivot pulleys 376, 378 may extend distally from the body 374 or may be disposed laterally with respect to the body 374. A channel 382 is defined between the third pivot pulley 376 and the fourth pivot pulley 378. The channel 382 is sized to slidingly and rotationally receive a portion of the inner shaft assembly 230. The third pivot pulley 376 includes a third pivot shaft 384 (not visible in FIG. 9) extending radially outward from an outer surface of the third pivot pulley 376. The third pivot shaft 384 is configuredto be disposed within the first pivot bore 368 of the first pivot knuckle 358 of the first hinge portion 352. In an embodiment, a circumferential edge of the third pivot pulley 376 includes a belt channel 388. The belt channel 388 is configured to receive the third belt 344 (FIG.10) of the outer shaft assembly 330. A portion of the belt channel 388 may include a cover configured to prevent disengagement of the third belt 344 (FIG. 10) and the belt channel 388. The fourth pivot pulley 378 includes a fourth pivot shaft 394 extending radially outward from an outer side of the fourth pivot pulley 378. The fourth pivot shaft 394 is configured to be disposed within the fourth pivot bore 370 of the second pivot knuckle 360 of the first hinge portion 352. The fourth pivot pulley 378 includes a belt channel 398 located in a circumferential edge of the fourth pivot pulley 378. The belt channel 398 is configured to receive the fourth belt 346 (FIG. 10). A portion of the belt channel 398 may include a cover configured to prevent disengagement of the fourth belt 346 (FIG. 10) disposed within the belt channel 398.

[0077] The third pivot shaft 384 and / or the fourth pivot shaft 394 may be installed within the corresponding first and second pivot bores 368, 370 with a bearing assembly to permit smooth rotation of the third and fourth pivot shafts 384, 394 within the corresponding first and second pivot bores 368, 370.

[0078] The collar 380 is a tubular component extending distally from the body 374 and configured to slidingly and rotationally receive a portion of the inner shaft assembly 230. The collar 380 defines a distal portion of the lumen 335 of the second hinge portion 354. The collar 380 rotates with the second hinge portion 354 to bend the portion of the inner shaft assembly 230 disposed therein.

[0079] In embodiments, the third pivot shaft 384 is disposed within the first pivot bore 368 of the first pivot knuckle 358 and the fourth pivot shaft 394 is disposed within the second pivot bore 370 of the second pivot knuckle 360 of the first hinge portion 352. The second hinge portion 354 may selectively pivot along the second transverse pivot axis PA2 relative to the first hinge portion 352. Accordingly, a distal portion of the inner shaft 236 of the inner shaft assembly 230 may be selectively pivoted relative to the outer shaft 336 of the outer shaft assembly 330, as shown in FIG. 10. Stated another way, a portion of the inner shaft 236 of the inner shaft assembly 230 distal of the body 356 of the first hinge portion 352 of the outer distal hinge component 340 may be selectively bent or angled relative to a third central longitudinal axis CLA3 of the outer shaft 336 of the outer shaft assembly 330, asshown in FIG. 10. In a non-limiting example, the second hinge portion 354 may pivot relative to the third central longitudinal axis CLA3 of the outer shaft 336, in a range of 0° to 100° or in a range of -15° to 90°.

[0080] The first hinge portion 352 and the second hinge portion 354 may each be formed of materials such as, but not limited to stainless steel. The first hinge portion 352 may be coupled to the distal end 342 of the shaft 336 of the outer shaft assembly 330 by various methods, non-limiting examples including adhesives, fusing, welding, or any other method suitable for the purposes described herein. The third and the fourth pivot pulleys 376, 378 may each be formed integrally as a part of the body 374 or may be coupled to the body 374 of the second hinge portion 354 of the outer distal hinge component 340 by methods including, but not limited to adhesives, fusing, or any other method suitable for the purposes described herein.

[0081] In embodiments, the outer shaft assembly 330 may include the third belt sleeve 348 and the fourth belt sleeve 350 configured to receive the third and fourth belts 344, 346, as shown in FIGS. 9-10. The third and fourth belt sleeves 348, 350 are each elongate components including proximal ends 404, 410, distal ends 406, 412, two third belt lumens 408A, 408B of the first belt sleeve 348 and two second belt lumens 414A, 414B of the second belt sleeve 350, which extend from the respective proximal ends 404, 410 to the respective distal ends 406, 412. Each of the third belt lumens 408A, 408B and fourth belt lumens 414A, 414B are configured to slidingly receive a portion of the third belt 344 and the fourth belt 346, respectively, as shown in FIG. 10. Routing of the third belt 344 through the third belt lumens 408A, 408B of the third belt sleeve 348 and the fourth belt 346 through the fourth belt lumens 414A, 414B prevents entanglement or twisting of the third belt 244 and / or the fourth belt 246 within the outer shaft assembly 330 and ensures that the third and fourth belts 344, 346 may move freely. The third and fourth belt sleeves 348, 350 are coupled to an inner surface of the outer shaft 336 of the outer shaft assembly 330 on opposite sides from each other, and are generally longitudinally aligned with the respective third and fourth pivot pulleys 376, 378.

[0082] The third and the fourth belt sleeves 348, 350 may each be formed of various materials including, but not limited to polymers or stainless steel. The third and the fourth belt sleeves 348, 350 may each be coupled to the inner surface of the shaft 336 of the outershaft assembly 330 by, for example, and not by way of limitation with adhesives, fusing, welding, or any other method suitable for the purposes described herein.

[0083] In embodiments, outer shaft 336 is attached to the handle 202 such that longitudinal movement of the handle 202 moves the outer shaft 336 distally and proximally, and rotation of the handle 202 rotates the outer shaft 336. However, in other embodiments, the outer shaft 336 may be coupled to an actuator (not shown) similar to the actuators 214, 224 described above or other actuators to longitudinally and rotationally adjust the outer shaft 336.

[0084] A second pivot actuator 362 is coupled to the handle 202. The second pivot actuator 362 is accessible to the user and may be manipulated to control pivoting or bending of the second hinge portion 354 of the outer distal hinge component 340 of the outer shaft assembly 330 in a third angular direction AD3 or a fourth angular direction AD4 opposite the third angular direction AD3, as shown in FIG. 10. The second pivot actuator 362 may assume any construction that is capable of providing the desired functionality. In embodiments, the second pivot actuator 362 is configured as a rotatable knob that may be rotated in a first direction (z.e., clockwise) CW1 or a second direction (z.e., counterclockwise) CW2 to pivot the second hinge portion 354 of the outer distal hinge component 340 as described below.

[0085] In an embodiment, the handle 202 includes a third drive pulley 416, a fourth drive pulley 418, and a drive shaft 420 coupling the third drive pulley 416 to the fourth drive pulley 408. The third and the fourth drive pulleys 416, 418 and the drive shaft 420 are operably coupled to the second pivot actuator 362 such that actuation of the second pivot actuator 362 rotates the third and the fourth drive pulleys 416, 418 in unison. The third drive pulley 416 includes a drive channel 422 located in a circumferential edge thereof. The drive channel 422 is configured to receive a proximal portion of the third belt 344. The fourth drive pulley 418 includes a drive channel 426 in a circumferential edge thereof and is configured to receive a proximal portion of the fourth belt 346.

[0086] In embodiments, the third and fourth belts 344, 346 are each a flexible loop of belt or wire configured to connect the corresponding drive pulley with the corresponding pivot pulley of the outer shaft assembly 330. In embodiments, a radius of the third and the fourth drive pulleys 416, 418 may be larger than a radius of the corresponding third and the fourth pivot pulleys 376, 378. In embodiments, rotation of the third and the fourth drive pulleys416, 418, will rotate the corresponding third and fourth pivot pulleys 376, 378 an amount greater than an arc of rotation of the third and the fourth drive pulleys 416, 418. Accordingly, the second hinge portion 354 will pivot an amount greater than the arc of rotation of the third and the fourth drive pulleys 416, 418. In a non-limiting example, the third and fourth drive pulleys 416, 418 are rotated 1°, resulting in the third and fourth pivot pulleys 376, 378 rotating more than 1° and the second hinge portion 354 pivoting greater than 1°. The ratio of the radius of the third and fourth drive pulleys 416, 418 to the radius of the corresponding third and fourth pivot pulleys 476, 478 may be selected to optimize pivoting of the outer distal hinge component 340 and the distal portion of the inner shaft assembly 230 for specific anatomies. In embodiments, the third belt 344 and the fourth belt 346 are installed with sufficient tension such to prevent belt slippage of the third and fourth belts 344, 346. The third and fourth belts 344, 346 may each be formed of a flexible, durable material such as, but not limited to rubber or various polymers.

[0087] With components of the outer shaft assembly 330 assembled, the third and fourth belts 344, 346 extend between the corresponding third and fourth drive pulleys 416, 418 and the corresponding third and fourth pivot pulleys 376, 378 of the second hinge portion 354, as shown in FIG. 10. Actuation of the second pivot actuator 362 of the handle 202 in the first or clockwise direction CW1 turns or rotates the third and fourth drive pulleys 416, 418 in the first or clockwise direction CW1, which moves or drives the third and fourth belts 344, 346 in the first or clockwise direction CW1, which rotates the third and the fourth pivot pulleys 376, 378 in the first or clockwise direction CW1, which pivots the second hinge portion 354 of the outer shaft assembly 330 in the third angular direction AD3, which bends a distal portion of the inner shaft assembly 230 in the third angular direction AD3. When the second pivot actuator 362 is rotated in the second or counter-clockwise direction CW2, the third and fourth drive pulleys 416, 418 rotate in the second or counter-clockwise direction CW2, which drives the third and fourth belts 344, 346 in the second or counterclockwise direction CW2, which rotates the third and fourth pivot pulleys 376, 378, in the second or counter-clockwise direction CW2, which pivots the second hinge portion 354 and a distal portion of the inner shaft assembly 230 in the fourth angular direction ALM.

[0088] In embodiments, the outer shaft assembly 330 may include an anchor 500, as shown in FIG. 11. The anchor 500 is configured to anchor and / or stabilize the delivery system 200 within a native vessel or cavity during delivery, positioning, and deployment ofa prosthetic heart valve. In embodiments, the anchor 500 includes a compressed state for delivery and an expanded state when deployed to stabilize and / or anchor the delivery system 200 within a native vessel. In embodiments the anchor 500 may be configured to extend from an outer surface of the outer shaft 336 of the outer shaft assembly 330. In an embodiment, the anchor 500 may be a plurality of longitudinal expandable members 502 radially expanding from the outer shaft 336, proximal of the outer distal hinge component 340. Each expandable member 502 includes a pre-set shape in the expanded state. In the compressed state, the anchor 500 has a first diameter DI, which may be essentially equal to the diameter of the outer shaft 336. The anchor 500 may be retained in the compressed state by, for example, an outer sheath slidably disposed over the expandable members 502 of the anchor 500. In the expanded state, the anchor 500 has a second diameter D2 wherein the second diameter D2 is greater than the first diameter DI . Thus, the anchor 500 is configured to self-expand from the compressed state to the expanded state to releasably anchor the outer shaft 336 of the delivery system 200 to adjacent tissue, for example within the inferior vena cava. In an embodiment, the anchor 500 may radially expand to the expanded state by proximally retracting the outer sheath to release and permit self-expansion of the plurality of expandable members 502. In an embodiment, the plurality of expandable members are portions of the outer surface of the outer shaft 336. In another embodiment, the plurality of expandable members may be separate from the outer shaft 336 and may extend though slots in the outer surface of the outer shaft 336. The anchor 500 may be formed of various materials, such as, but not limited to nickel -titanium alloys (e.g., Nitinol), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35N), stainless steel, high spring temper steel, or any other conductive and / or sufficiently stiff material suitable for the purposes describe herein.

[0089] While the anchor 500 has been described herein as self-expanding and in a single or one location along the outer shaft 336, this is not meant to be limiting. In embodiments herein, the anchor 500 may include a plurality of anchors 500 disposed in various locations and of a variety of configurations, in any combination, to anchor the delivery system 200 within a native vessel or cavity such that the outer shaft 336 of the outer shaft assembly 330 is supported and stabilized.

[0090] With the delivery system 200 assembled, the omnidirectional steering capabilities of the delivery system 200 are illustrated in FIGS. 11-12. In embodiments herein, thedelivery system 200 permits independent rotation and longitudinal movement of each of the capsule, inner, and outer shaft assemblies 210, 230, 330. Stated another way, the capsule shaft assembly 210, the inner shaft assembly 230, and the outer shaft assembly 330 may each be circumferentially rotated and advanced or retracted independently. The delivery system 200 further permits the independent pivoting of the inner distal hinge component 240 and the outer distal hinge component 340. Pivoting of the inner distal hinge component 240 bends or deflects a distal portion of the capsule shaft 216 of the capsule shaft assembly 210 and pivoting of the outer distal hinge component 340 bends or deflects a distal portion of the inner shaft 236 of the inner shaft assembly 230. In an embodiment, the inner and outer distal hinge components 240, 340 permit up to, for example, and not by way of limitation, 210°of total angular deflection or bending of the capsule 212 in one direction relative to the outer shaft assembly 330. The omnidirectional steering capabilities of the delivery system 200 may be utilized to achieve an optimal desired trajectory, position, and depth in challenging heart valves, for example, a native tricuspid valve and provide a stable and predictable deployment of a prosthetic heart valve therein.

[0091] The capsule shaft assembly 210 permits rotational orientation of the capsule 212 relative to the outer shaft assembly 330 and the inner shaft assembly 230. The capsule shaft assembly 210 may be circumferentially rotated around the central longitudinal axis CLA of the delivery system 200 in the first or second circumferential directions CD1, CD2 as shown in FIG. 11. The capsule shaft assembly 210 may be longitudinally translated in the first or second longitudinal direction LD1, LD2 to adjust the longitudinal position of the capsule 212 relative to the inner shaft assembly 230 and the outer shaft assembly 330. In embodiments, the innermost shaft assembly 210 may be translated in the first or second longitudinal direction LD1, LD2 by actuating the first longitudinal actuator 214 of the handle 202.

[0092] As shown in FIG. 11, the inner shaft assembly 230 may be rotated around the central longitudinal axis CLA of the delivery system 200 in the third or fourth circumferential directions CD3, CD4, independent of the capsule shaft assembly 210 and the outer shaft assembly 330. Accordingly, the inner distal hinge component 240 of the inner shaft assembly 230 may be rotated relative to the outer shaft assembly 330 and the innermost shaft assembly 210. The longitudinal position of the inner distal hinge component 240 of the inner shaft assembly 230 may be adjusted in the third or fourth longitudinal directionsLD3, LD4 relative to the outer distal hinge component 340 of the outer shaft assembly 330. In embodiments, the longitudinal movement of the inner shaft assembly 230 in the third or fourth longitudinal direction LD3, LD4 may be accomplished by actuation of the second longitudinal actuator 224 (FIG. 2) of the handle 202 (FIG. 2). In embodiments, the pivot angle of the second hinge portion 254 of the inner distal hinge component 240 may be selected or adjusted in the first or second angular direction ADI, AD2 to bend or deflect a distal portion of the capsule shaft 216 of the capsule shaft assembly 210 as previously described.

[0093] In embodiments herein, the outer shaft assembly 330 may be rotated around the central longitudinal axis CLA of the delivery system 200 in the fifth or sixth circumferential directions CD5, CD6. Rotation of the outer shaft assembly 330 in the fifth or sixth circumferential direction CD5, CD6 may be independent of the capsule shaft assembly 210 and the inner shaft assembly 230. The longitudinal position of the outer distal hinge component 340 may be adjusted independent of the inner shaft assembly 230 and the capsule shaft assembly 210. In embodiments, the outer shaft assembly 330 may be translated in the fifth or sixth longitudinal directions LD5, LD6 by movement of the handle 202 or by actuation of an actuator (not shown). The pivot angle of the second hinge portion 354 of the outer distal hinge component 340 may be selected in the third or fourth angular direction AD3, AD4 to bend or deflect a distal portion of the inner shaft 236 of the inner shaft assembly 230 by actuation of the second pivot actuator 362 of the handle 202 as previously described.

[0094] Thus, the delivery system 200 offers multiple independent movements or adjustments along or about multiple axes to achieve an optimal desired trajectory, position, and depth for the capsule 212 of the delivery system 200 within a native heart valves to provide improved stability and deployment of prosthetic heart valve therein.

[0095] FIGS. 13A-13F show examples of bending, translation, and rotation of the components of the delivery system 200. It should be understood that these are merely a few examples of the nearly limitless positions possible via combinations of translation, rotation, and bending of the components of the delivery system 200.

[0096] In the example of FIG. 13 A, the inner distal hinge component 240 is actuated such that the capsule shaft assembly 210 is bent with respect to the inner shaft assembly 230. In the example shown in FIG. 13B, the inner distal hinge component 240 and the outer distalhinge component 340 are actuated such that the capsule shaft assembly 210 is bent with respect to the inner shaft assembly 230 by the inner distal hinge component 240 and the inner shaft assembly 230 is bent with respect to the outer shaft assembly 330 by the outer distal hinge component 340. In the example shown in FIG. 13C, an example of a maximum bending is shown wherein capsule shaft 216 is bent 110° relative to the inner shaft 136 by the inner distal hinge component 240 and the inner shaft 236 is bent 100° relative to the outer shaft 336 by the outer distal hinge component 340. As noted above, these maximum angle are only examples.

[0097] In the example of FIG. 13D, the inner shaft 236 has been translated distally relative to the outer shaft 336 and the capsule shaft 216 has been translated distally with respect to the inner shaft 236 and the outer shaft 336. In the example of FIG. 13E the inner distal hinge component 240 has been rotated in a first angular direction ADI to bend the capsule shaft 216 relative to the inner shaft 236 in the first angular direct ADI, and the outer distal hinge component 340 has been rotated in a fourth angular direction AD4 (opposite the first angular direction ADI) to bend the inner shaft 236 relative to the outer shaft 336. In the example of FIG. 13F, rotation of the inner shaft assembly 230, and hence the inner distal hinge component 240 coupled thereto, relative to the outer shaft assembly 330 is shown. With the various rotations, bending, and translations available as described herein, precise tracking a positioning of the capsule 212 with the heart valve prosthesis 100 disposed therein may be achieved to enhance positioning of the heart valve prosthesis 100 when deployed from the capsule 212.

[0098] FIGS. 14-17 illustrate the interactions of the various components of the delivery system 200 to deliver a prosthetic heart valve, such as the prosthetic heart valve 100, to a tricuspid valve TV. One skilled in the art will realize that FIGS. 14-17 illustrate one example of a method of using the delivery system 200 and that certain steps may be removed or combined, and that additional steps may be performed in keeping with scope of the present disclosure.

[0099] In a step, the delivery system 200 is tracked through the vasculature of a patient and positioned with a distal end of the outer shaft assembly 330 disposed within a right atrium RA of a heart HE, as shown in FIG. 14. The delivery system 200 may be tracked to the right atrium RA utilizing established. In the embodiment of FIGS. 14-17, the delivery system 200 is tracked through the inferior vena cava IVC and into the right atrium RA adjacent to anative tricuspid valve TV. However, it will be understood that the delivery system 200 may instead be tracked through other vessels and disposed adjacent to other native heart valves.

[0100] In another step, the capsule 212 of the delivery system 200 is steered towards an annulus AN of the tricuspid valve TV. In a non-limiting example shown in FIGS. 15 and 16, similar to FIGS. 13E and 13B, the outer distal hinge component 340 and the inner distal hinge component 240 are rotated to bend the inner shaft 236 and the capsule shaft 216, respectively, to position the capsule 212 in the annulus AN of the tricuspid valve TV. For example, in FIG. 15 the outer distal hinge component is rotated in the fourth angular direction AD4 to bend the inner shaft 230 away from the tricuspid valve TV and the inner distal hinge component 240 is rotated in the first annular direction ADI to bend the capsule shaft 216 toward the tricuspid valve. In FIG. 16, the outer distal hinge component 340 has been rotated in the third angular direction AD3 to bend the inner shaft 236 towards the tricuspid valve TV and the inner distal hinge component 230 has been rotated in the first angular direction AD 1 to bend the capsule shaft 216 toward the tricuspid valve TV to located the capsule 212 within the annulus AN of the tricuspid valve TV.

[0101] Manipulation of the various components by rotation and translation as described above may be utilized to track and position the capsule 212 at the desired location. For example, as shown in FIG. 17, translation of the capsule shaft 216 and / or the inner shaft 236 may assist in proper depth positioning of the capsule 212 within the annulus AN. Further, in preparation for deployment, the anchor 500 may be deployed from the outer shaft assembly 330. The anchor 500 is deployed within the inferior vena cava IVC to stabilize the delivery system 200 to maintain the precise positioning of the capsule 212 and the prosthetic heart valve 100 disposed therein during deployment of the prosthetic heart valve 100 from the capsule 212.

[0102] The omnidirectional steering capabilities of the delivery system 200 embodiments described herein permit precise and optimal positioning, of the capsule 212 of the delivery system 200 and the prosthetic heart valve disposed therein including desired angular, rotational, and longitudinal (depth) alignment within the native tricuspid valve TV. The description of positioning the capsule 212 within a native tricuspid valves has been presented by way of example only. Steps may be added, deleted, or rearranged as desired to precisely maneuver and position the capsule 212 of the delivery system 200 at a desired treatment location.

[0103] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0104] The following examples are illustrative of the techniques described herein.

[0105] Example 1. A system for delivering and positioning a prosthetic heart valve comprising: an outer shaft assembly including an outer shaft and an outer distal hinge component; an inner shaft assembly including an inner shaft and an inner shaft distal hinge component, the inner shaft slidingly and rotationally disposed within the outer shaft; and a capsule shaft assembly including a capsule shaft and a capsule coupled to a distal portion of the capsule shaft, the capsule shaft slidingly and rotationally disposed within the inner shaft, the capsule configured to receive the prosthetic heart valve therein; wherein the capsule shaft assembly is configured to be selectively rotated and longitudinally translated independent of the inner shaft assembly and the outer shaft assembly; wherein the inner shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the outer shaft assembly; and wherein the inner distal hinge component and the outer distal hinge component are each configured to pivot independently.

[0106] Example 2. The system of Example 1, wherein pivoting the inner distal hinge component bends the capsule shaft relative to the inner shaft.

[0107] Example 3. The system of Example 1 or Example 2, wherein pivoting the outer distal hinge component bends the inner shaft relative to the outer shaft.

[0108] Example 4. The system of any one of Examples 1 to 3, wherein the outer shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the inner shaft assembly.

[0109] Example 5. The system of any one of Examples 1 to 4, wherein the inner distal hinge component includes a first hinge portion coupled to a distal end of the inner shaft of the inner shaft assembly and a second hinge portion pivotably coupled to the first hinge portion.

[0110] Example 6. The system of any one of Examples 1 to 5, wherein the outer distal hinge component includes an outer first hinge portion coupled to a distal end of the outer shaft of the outer shaft assembly and an outer second hinge portion pivotably coupled to the outer first hinge portion.

[0111] Example 7. The system of any one of Examples 1 to 6, further comprising a handle, wherein the handle includes a first pivot actuator operably coupled to the second hinge portion of the inner distal hinge component to selectively pivot the second hinge portion.

[0112] Example 8. The system of Example 7, wherein the pivot actuator is a rotatable knob.

[0113] Example 9. The system of any one of Examples 1 to 8, wherein the handle includes a second pivot actuator operably coupled to the outer second hinge portion of the outer distal hinge component to selectively pivot the outer second hinge portion.

[0114] Example 10. The system of Example 9, wherein the second pivot actuator is a rotatable knob.

[0115] Example 11. The system of any one of Examples 5 to 10, further comprising a first belt and pulley system configured to pivot the second hinge portion of the inner distal hinge component.

[0116] Example 12. The system of Example 11, wherein the first belt and pulley system includes a first drive pulley operably coupled the first pivot actuator, a first pivot pulley operably coupled to the second hinge portion of the inner distal hinge component, and a belt extending between the first drive pulley and the first pivot pulley.

[0117] Example 13. The system of Example 12, wherein the inner shaft assembly includes a belt sleeve disposed within a lumen of the inner shaft of the inner shaft assembly, wherein the belt is routed through the belt sleeve.

[0118] Example 14. The system of any one of Examples 11 to 13, wherein the first belt and pulley system includes a plurality of first drive pulleys, a plurality of first pivot pulleys, and a plurality of first belts.

[0119] Example 15. The system of any one of Examples 6 to 14, further comprising a second belt and pulley system configured to pivot the outer second hinge portion of the outer distal hinge component.

[0120] Example 16. The system of Example 15, wherein the second belt and pulley system includes a second drive pulley operably coupled the second pivot actuator, a second pivot pulley operably coupled to the outer second hinge portion of the outer distal hinge component, and a second belt extending between the second drive pulley and the second pivot pulley.

[0121] Example 17. The system of Example 16, wherein the outer shaft assembly includes a second belt sleeve disposed within a lumen of the outer shaft of the outer shaft assembly, wherein the second belt is routed through the second belt sleeve.

[0122] Example 18. The system of any one of Examples 15 to 17, wherein the second belt and pulley system includes a plurality of second drive pulleys, a plurality of second pivot pulleys, and a plurality of second belts.

[0123] Example 19. The system of any one of Examples 1 to 18, further comprising a first actuator operably coupled to a proximal end of the capsule shaft, the first actuator configured to translate the capsule shaft assembly proximally and distally.

[0124] Example 20. The system of Example 19, wherein the first actuator is configured to rotate the capsule shaft about a capsule shaft assembly central axis.

[0125] Example 21. The system of any one of Examples 1 to 20, further comprising a second actuator operably coupled to a proximal end of the inner shaft, the second actuator configured to translate the inner shaft assembly proximally and distally.

[0126] Example 22. The system of Example 21, wherein the second actuator is configured to rotate the inner shaft about an inner shaft assembly central axis.

[0127] Example 23. The system of any one of Examples 1 to 22, further comprising an anchor configured to stabilize the delivery system within a native vessel or cavity.

[0128] Example 24. The system of Example 23, wherein the anchor includes a plurality of expandable members configured to selectively extend radially outward from an outer surface of the outer shaft of the outer shaft assembly.

Claims

CLAIMS1. A system for delivering and positioning a prosthetic heart valve comprising:an outer shaft assembly including an outer shaft and an outer distal hinge component;an inner shaft assembly including an inner shaft and an inner shaft distal hinge component, the inner shaft slidingly and rotationally disposed within the outer shaft; and a capsule shaft assembly including a capsule shaft and a capsule coupled to a distal portion of the capsule shaft, the capsule shaft slidingly and rotationally disposed within the inner shaft, the capsule configured to receive the prosthetic heart valve therein;wherein the capsule shaft assembly is configured to be selectively rotated and longitudinally translated independent of the inner shaft assembly and the outer shaft assembly;wherein the inner shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the outer shaft assembly; andwherein the inner distal hinge component and the outer distal hinge component are each configured to pivot independently.

2. The system of claim 1, wherein pivoting the inner distal hinge component bends the capsule shaft relative to the inner shaft.

3. The system of claim 1 or claim 2, wherein pivoting the outer distal hinge component bends the inner shaft relative to the outer shaft.

4. The system of any one of claims 1 to 3, wherein the outer shaft assembly is configured to be selectively rotated and longitudinally translated independent of the capsule shaft assembly and the inner shaft assembly.

5. The system of any one of claims 1 to 4, wherein the inner distal hinge component includes a first hinge portion coupled to a distal end of the inner shaft of the inner shaft assembly and a second hinge portion pivotably coupled to the first hinge portion.

6. The system of any one of claims 1 to 5, wherein the outer distal hinge component includes an outer first hinge portion coupled to a distal end of the outer shaft of the outer shaft assembly and an outer second hinge portion pivotably coupled to the outer first hinge portion.

7. The system of any one of claims 1 to 6, further comprising a handle, wherein the handle includes a first pivot actuator operably coupled to the second hinge portion of the inner distal hinge component to selectively pivot the second hinge portion.

8. The system of any one of claims 1 to 7, wherein the handle includes a second pivot actuator operably coupled to the outer second hinge portion of the outer distal hinge component to selectively pivot the outer second hinge portion.

9. The system of any one of claims 5 to 8, further comprising a first belt and pulley system configured to pivot the second hinge portion of the inner distal hinge component.

10. The system of claim 9, wherein the first belt and pulley system includes a first drive pulley operably coupled the first pivot actuator, a first pivot pulley operably coupled to the second hinge portion of the inner distal hinge component, and a belt extending between the first drive pulley and the first pivot pulley.

11. The system of claim 10, wherein the inner shaft assembly includes a belt sleeve disposed within a lumen of the inner shaft of the inner shaft assembly, wherein the belt is routed through the belt sleeve.

12. The system of any one of claims 6 to 11, further comprising a second belt and pulley system configured to pivot the outer second hinge portion of the outer distal hinge component.

13. The system of claim 12, wherein the second belt and pulley system includes a second drive pulley operably coupled the second pivot actuator, a second pivot pulley operably coupled to the outer second hinge portion of the outer distal hinge component, and a second belt extending between the second drive pulley and the second pivot pulley.

14. The system of claim 13, wherein the outer shaft assembly includes a second belt sleeve disposed within a lumen of the outer shaft of the outer shaft assembly, wherein the second belt is routed through the second belt sleeve.

15. The system of any one of claims 1 to 14, further comprising an anchor configured to stabilize the delivery system within a native vessel or cavity, wherein the anchor includes a plurality of expandable members configured to selectively extend radially outward from an outer surface of the outer shaft of the outer shaft assembly.

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