WO2024246750A1

WO2024246750A1 - Transcatheter valve delivery system with a telescopic capsule assembly and methods of use thereof

Info

Publication number: WO2024246750A1
Application number: PCT/IB2024/055178
Authority: WO
Inventors: Lijin Rajendran NANU
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2023-06-02
Filing date: 2024-05-28
Publication date: 2024-12-05
Anticipated expiration: 2025-12-02
Also published as: EP4719271A1

Abstract

A delivery system for delivering a prosthetic valve into a heart of a patient includes a telescopic capsule assembly having a primary capsule configured to contain a first longitudinal portion of the prosthetic valve and a secondary capsule configured to contain a second longitudinal portion of the prosthetic valve. During a first deployment stage, the primary capsule moves in a distal direction with respect to the secondary capsule to release the first longitudinal portion of the prosthetic valve. During a second deployment stage, the secondary capsule and the primary capsule move together in a distal direction to release the second longitudinal portion of the prosthetic valve. Tethers are utilized to move the primary capsule during the first deployment stage, and the tethers extend through tether lumens formed within the secondary capsule. A hydraulic system is utilized to move the primary capsule and the secondary capsule during the second deployment stage.

Description

TRANSCATHETER VALVE DELIVERY SYSTEM WITH A TELESCOPIC CAPSULE ASSEMBLY AND METHODS OF USE THEREOF

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/505,836, filed June 2, 2023, the entire content of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention is related to systems and methods for transcatheter valve delivery and deployment.

BACKGROUND

[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 and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses can be delivered while in a low-profile or compressed/contracted configuration so that the valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the valve prosthesis in position. While these valve prostheses offer minimally invasive methods for heart valve repair and/or replacement, challenges remain to providing effective, less invasive prosthetic delivery systems, particularly for mitral valve and/or tricuspid valve replacement. For example, catheter delivery approaches and techniques for mitral and/or tricuspid valve replacement may require a capsule of the delivery system to be advanced into the left and/or right ventricle, respectively, to deploy the valve prosthesis. Capsule travel within the confined space of the left and/or right ventricle may limit positioning of a heart valve prosthesis. The present disclosure relates to improvements relating to such delivery systems.

BRIEF SUMMARY OF THE INVENTION

[0005] In a first example, a system for delivering a prosthetic heart valve into a heart of a patient includes an elongated catheter body having a distal end and a proximal end, a handle disposed at the proximal end of the catheter body, a telescopic capsule assembly disposed at the distal end of the catheter body, at least one tether, and a hydraulic system. The catheter body includes a lumen extending a length of the catheter body. The telescopic capsule assembly comprises a primary capsule configured to contain a first longitudinal portion of the prosthetic heart valve and a secondary capsule configured to contain a second longitudinal portion of the prosthetic heart valve. During a first deployment stage, the primary capsule moves in a distal direction with respect to the secondary capsule to release the first longitudinal portion of the prosthetic heart valve. During a second deployment stage, the secondary capsule and the primary capsule move together in a distal direction to release the second longitudinal portion of the prosthetic heart valve. The tether extends between the handle and the primary capsule. The tether attached to a proximal end of the primary capsule and extends from the primary capsule through at least one tether lumen formed within the secondary capsule and through the elongated catheter body. The tether is configured to move the primary capsule during the first deployment stage via tensioning of the tether. The hydraulic system is fluidly connected to the telescopic capsule assembly and the lumen of the catheter body. The hydraulic system is configured to move the primary capsule and the secondary capsule during the second deployment stage via delivery of a hydraulic fluid into the secondary capsule through the lumen.

[0006] In a second example, in the system according to any of the previous or subsequent examples herein, the system also includes a tension cable disposed within the catheter body and attached to the secondary capsule. The tension cable includes at least one tether lumen in fluid communication with the at least one tether lumen of the secondary capsule. [0007] In a third example, in the system according to any of the previous or subsequent examples herein, the system also includes a deployment piston, The primary capsule and the secondary capsule move axially relative to the deployment piston during the second deployment stage.

[0008] In a fourth example, in the system according to any of the previous or subsequent examples herein, an annular chamber is defined between the secondary capsule and the deployment piston. The annular chamber is configured to fill with hydraulic fluid during the second deployment stage.

[0009] In a fifth example, in the system according to any of the previous or subsequent examples herein, the at least one tether includes a first tether, a second tether, and a third tether, and the at least one tether lumen includes a first tether lumen, a second tether lumen, and a third tether lumen. The first tether is slidingly disposed in the first tether lumen, the second tether is slidingly disposed in the second tether lumen, and the third tether is slidingly disposed in the third tether lumen.

[0010] In a sixth example, in the system according to any of the previous or subsequent examples herein, the first tether lumen, the second tether lumen, and the third tether lumen are disposed at circumferentially spaced-apart equal intervals around the secondary capsule. [0011] In a seventh example, in the system according to any of the previous or subsequent examples herein, the at least one first tether includes a first end and a second end opposing the first end, the first end being attached to an inner surface of the primary capsule at a proximal end thereof.

[0012] In an eighth example, in the system according to any of the previous or subsequent examples herein, the secondary capsule includes a capsule cap at a distal end thereof. The capsule cap includes at least one tether lumen in fluid communication with the at least one tether lumen of the secondary capsule.

[0013] In a nineth example, in the system according to any of the previous or subsequent examples herein, the at least one tether is disposed completely internal to the secondary capsule.

[0014] In a tenth example, in the system according to any of the previous or subsequent examples herein, the system also includes a tension cable disposed within the catheter body. The tension cable attached to the capsule cap. The tension cable includes at least one tether lumen in fluid communication with the at least one tether lumen of the capsule cap.

[0015] In an eleventh example, in the system according to any of the previous or subsequent examples herein, the system also includes a spring component disposed within at least one spring channel formed within the secondary capsule. The spring component is configured to bias the primary capsule toward the delivery state. The primary capsule includes at least one pin axially extending from a proximal end of the primary capsule to a distal end of the primary capsule, the at least one pin aligned for advancement into the at least one spring channel during the first deployment stage.

[0016] In a twelfth example, in the system according to any of the previous or subsequent examples herein, the spring component is configured to be axially compressed by the at least one pin during the first deployment stage and the spring component is biased to return to a non-compressed state absent force applied by the at least one pin.

[0017] In a thirteenth example, in the system according to any of the previous or subsequent examples herein, the proximal end of the primary capsule includes an anchor which extends radially inwards and a proximal end of the at least one pin is attached to the anchor.

[0018] In a fourteenth example, in the system according to any of the previous or subsequent examples herein, when the telescopic capsule assembly is in a delivery state, a distal end of the primary capsule overlaps a proximal end of the secondary capsule and a distal end of the at least one pin is disposed within a proximal end of the at least one spring channel.

[0019] In a fifteenth example, in the system according to any of the previous or subsequent examples herein, the at least one pin includes a first pin, a second pin, and a third pin, and the at least one spring channel includes a first spring channel, a second spring channel, and a third spring channel. The first pin is slidingly disposed in the first spring channel, the second pin is slidingly disposed in the second spring channel, and the third pin is slidingly disposed in the third spring channel.

[0020] In a sixteenth example, in the system according to any of the previous or subsequent examples herein, the first spring channel, the second spring channel, and the third spring channel are spaced at circumferentially spaced-apart equal intervals around the secondary capsule and the first pin, the second pin, and the third pin are spaced at circumferentially spaced-apart equal intervals around the primary capsule.

[0021] In a seventeenth example, in the system according to any of the previous or subsequent examples herein, the at least one tether includes a first tether, a second tether, and a third tether, and the at least one tether lumen includes a first tether lumen, a second tether lumen, and a third tether lumen. The first tether is slidingly disposed in the first tether lumen, the second tether is slidingly disposed in the second tether lumen, and the third tether is slidingly disposed in the third tether lumen. The first spring channel, the second spring channel, and the third spring channel are interspersed between the first tether lumen, the second tether lumen, and the third tether lumen.

[0022] In an eighteenth example, in the system according to any of the previous or subsequent examples herein, proximal retraction of the at least one tether slides the primary capsule over the secondary capsule in a distal direction to unsheathe the first longitudinal portion of the prosthetic heart valve from the primary capsule.

[0023] In a nineteenth example, a method for delivering a prosthetic heart valve to a native valve of a heart of a human patient includes positioning a telescopic capsule assembly at a distal portion of an elongated catheter body within the heart. A primary capsule of the telescopic capsule assembly houses a first longitudinal portion of the prosthetic heart valve and a secondary capsule of the telescopic capsule assembly houses a second longitudinal portion of the prosthetic heart valve. At least one tether is attached to a proximal end of the primary capsule and extends from the primary capsule through at least one tether lumen formed within the secondary capsule and through the elongated catheter body. A hydraulic system is fluidly connected to the telescopic capsule assembly and a lumen of the catheter body. The method further includes tensioning the at least one tether to move the primary capsule in a distal direction with respect to the secondary capsule to deploy the first longitudinal portion of the prosthetic heart valve. The method further includes delivering hydraulic fluid via the hydraulic system into the secondary capsule through the lumen of the elongated catheter to move the secondary capsule and the primary capsule together in a distal direction to deploy the second longitudinal portion of the prosthetic heart valve. [0024] In a twentieth example, in the method according to any of the previous or subsequent examples herein, positioning the telescopic capsule assembly includes positioning the telescopic capsule assembly at a native tricuspid valve.

[0025] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

[0026] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof 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 present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings may not be to scale.

[0027] FIG. 1 depicts a perspective view of a prosthetic heart valve in accordance with an aspect of the disclosure.

[0028] FIG. 2 depicts an inflow end view of the prosthetic heart valve shown in FIG. 1 in accordance with an aspect of the disclosure.

[0029] FIG. 3 depicts a side view of a delivery system according to an embodiment hereof, wherein the delivery system is configured for delivering the prosthetic heart valve of FIG. 1 within a telescopic capsule assembly of the delivery system according to an embodiment hereof.

[0030] FIG. 4 depicts a side sectional view of the delivery system of FIG. 3, the delivery system being fluidly coupled to a hydraulic system and a deployment assist being disposed over a proximal end of the delivery system.

[0031] FIG. 5 is a cross-sectional view taken along line A-A of FIG. 3.

[0032] FIG. 6 is an exploded view of the delivery system of FIG. 3.

[0033] FIG. 7A is an enlarged view of a distal portion of an innermost shaft assembly of the delivery system of FIG. 3, wherein the innermost shaft assembly includes a flexible shaft, a piston mount, a piston, a tension cable, a distal shaft, the telescopic capsule assembly, tethers, and a capsule cap.

[0034] FIG. 7B is an enlarged view of a first subassembly of the inner most shaft assembly of FIG. 7A, wherein the first subassembly includes the flexible shaft, the piston mount and the deployment piston.

[0035] FIG. 7C is an enlarged view of a second subassembly of the innermost shaft assembly of FIG. 7A, wherein the second subassembly includes the tension cable, the distal shaft, the telescopic capsule assembly, the tethers, and the capsule cap.

[0036] FIG. 7D is a sectional view of the distal shaft and the capsule cap of FIG. 7C.

[0037] FIG. 7E is a side sectional view of the telescopic capsule assembly and tethers, wherein the telescopic capsule assembly and tethers are removed from the delivery system for sake of illustration only and the telescopic capsule assembly is in a delivery state.

[0038] FIG. 7F is a cross-sectional view taken along line F-F of FIG. 7E.

[0039] FIG. 7G is a cross-sectional view taken along line G-G of FIG. 7E.

[0040] FIG. 7H is a cross-sectional view taken along line H-H of FIG. 7C.

[0041] FIG. 8 is a perspective view of the deployment piston of the delivery system of FIG.

3, wherein the deployment piston is shown removed from the delivery system for sake of illustration only.

[0042] FIG. 9 is a side view of a distal portion of the delivery system of FIG. 3, wherein the distal portion includes the telescopic capsule assembly and the deployment piston, the telescopic capsule assembly being shown in the delivery state and the prosthetic heart valve of FIG. 1 being loaded into the telescopic capsule assembly.

[0043] FIG. 10 is a side view of the distal portion of FIG. 9, the prosthetic heart valve of FIG. 1 being omitted for sake of clarity, wherein a primary capsule of the telescopic capsule assembly is being distally advanced and the deployment piston is disposed adjacent to the capsule cap.

[0044] FIG. 11 is a side view of the distal portion of FIG. 9, the prosthetic heart valve of FIG. 1 being omitted for sake of clarity, wherein the primary capsule of the telescopic capsule assembly has been distally advanced to be disposed over a secondary capsule of the telescopic capsule assembly and the deployment piston is disposed adjacent to the capsule cap. [0045] FIG. 12 is a side view of the distal portion of FIG. 9, the prosthetic heart valve of FIG. 1 being omitted for sake of clarity, wherein the primary and secondary capsules of the telescopic capsule assembly are being distally advanced relative the deployment piston.

[0046] FIG. 13 is a side view of the distal portion of FIG. 9, the prosthetic heart valve of FIG. 1 being omitted for sake of clarity, wherein a proximal end of the deployment piston is unsheathed.

[0047] FIG. 14 is a side sectional view of atelescopic capsule assembly according to another embodiment hereof, the telescopic capsule assembly including a recapture mechanism, wherein the telescopic capsule assembly is removed from the delivery system for sake of illustration only and the telescopic capsule assembly is in a delivery state.

[0048] FIG. 14A is a cross-sectional view taken along line A-A of FIG. 14.

[0049] FIG. 14B is a cross-sectional view taken along line B-B of FIG. 14.

[0050] FIG. 15 is a side sectional view of the telescopic capsule assembly of FIG. 14, wherein the telescopic capsule assembly is removed from the delivery system for sake of illustration only and a primary capsule of the telescopic capsule assembly has been distally advanced to be disposed over a secondary capsule of the telescopic capsule assembly.

DETAILED DESCRIPTION

[0051] It should be understood that various embodiments 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 device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components associated with, for example, a delivery system. The following detailed description is merely exemplary in nature and is not intended to limit the invention of the application and uses of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding field of the invention, background, summary or the following detailed description. [0052] As used in this specification, the singular forms “a”, “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise. Further, numerical terms such as “first”, “second”, “third”, etc. used herein are not meant to be limiting such that use of the term “second” when referring to a part in the specification does not mean that there necessarily is a “first” of part in order to fall within the scope of the invention. Instead, such numbers are merely describing that the particular embodiment being described has a “first” part and a “second” part. The invention is instead defined by the claims, in which one or more of the numbered parts may be claimed. [0053] 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. Thus, “distal” and “distally” refer to positioned distant from, or in a direction away from the treating clinician, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the clinician.

[0054] FIG. 1 and FIG. 2 illustrate an exemplary prosthetic heart valve 100 for use in embodiments hereof. Prosthetic heart valve 100 is illustrated herein 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 methods and devices 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. Although the prosthetic heart valve 100 is configured for placement within a tricuspid heart valve or a mitral heart valve, embodiments of delivery systems and techniques described herein may be used in conjunction with any transcatheter valve prostheses. For example, embodiments described herein may be utilized with a transcatheter prosthetic heart valve configured for placement within a pulmonary, aortic, mitral, or tricuspid valve. There is no intention of being bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

[0055] 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. Stated another way, the prosthetic heart valve 100 has a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. 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 via any one of a transatrial, antegrade, or transapical approach. The prosthetic heart valve 100 includes a stent or frame 102 and a valve component 101 including at least one leaflet 107 disposed within and secured to the frame 102. The valve component 101 of the prosthetic heart valve 100 is capable of regulating flow therethrough via valve leaflets that may form a replacement valve.

[0056] Any portion of the frame 102 described herein as an element of the prosthetic heart valve 100 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as Nitinol™, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials. A suitable biocompatible material would be selected to provide the prosthetic heart valve 100 to be configured to be compressed into a reduced-diameter crimped configuration for transcatheter delivery to a native valve, whereby release from a delivery catheter returns the prosthesis to an expanded, deployed configuration. Alternatively, the prosthetic heart valve 100 may be balloon expandable as would be understood by one of ordinary skill in the art.

[0057] In an aspect of the disclosure, the frame 102 of the prosthetic heart valve 100 includes a valve support 102 A at least partially surrounded by and attached to an anchoring member 102B. The valve support 102A is configured to support the valve component 101 therein. The valve support 102A is a tubular stent-like or frame structure that defines a central lumen from a first end 108 of the valve support 102A to a second end 109 of the valve support 102A. When positioned in situ within a native tricuspid or mitral valve, the first end 108 is an inflow or upstream end and the second end 109 is an outflow or downstream end. At the second end 109, the valve support 102A is attached to the anchoring member 102B via a plurality of connector components 104. In an embodiment, the plurality of connector components are rivets. In addition, at the second end 109, the valve support 102A also includes a plurality of attachment bars 112 extending therefrom that function to releasably couple the prosthetic heart valve 100 to a delivery system.

[0058] The anchoring member 102B is a stent-like or frame structure that functions as an anchor for the prosthetic heart valve 100 to secure its deployed position within a native annulus. The anchoring member 102B is a substantially cylindrically shaped structure that is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve. At the first end 108 of the valve support 102 A, the anchoring member 102B is radially spaced a distance S from the valve support 102A to mechanically isolate the inflow end 108 of the valve support 102A from the anchoring member 102B. The anchoring member 102B includes one or more fixation elements 105 that extend outward from an exterior side thereof to engage heart tissue. The fixation elements 105 project radially outward and are inclined toward an upstream direction. The fixation elements 105, for example, can be prongs, cleats, barbs, hooks, or other elements that are inclined only in the upstream direction (e.g., a direction extending away from the downstream portion of the prosthetic heart valve 100.

[0059] The anchoring member 102B includes a plurality of crowns 113A and a plurality of struts 113B with each crown 113A being formed between a pair of opposing struts 113B. Each crown 113A is a curved segment or bend extending between opposing struts 113B. The anchoring member 102B is tubular, with a plurality of side openings 114 being defined by edges of the plurality of crowns 113A and the plurality of struts 113B. In an embodiment, the plurality of side openings 114 may be substantially diamond-shaped. The anchoring member 102B includes a plurality of nodes 113C. A node 113C is defined as a region where two crowns of the plurality of crowns 113A within the anchoring member 102B meet or connect. When attached to the valve support 102A via the plurality of connecting components 104, the anchoring member 102B forms an outer frame portion of the frame 102 and the valve support 102A forms an inner frame portion of the frame 102 with the anchoring member 102B circumferentially surrounding the valve support 102 disposed therein.

[0060] Each of the valve support 102A and the anchoring member 102B include a skirt or graft material 103 A, 103B, respectively, secured thereto. More particularly, the graft material 103 A is coupled to an inner surface of the valve support 102A to line a portion thereof. Alternatively, the graft material 103 A may be coupled to an outer surface of the valve support 102A to enclose a portion thereof as would be known to one of ordinary skill in the art of prosthetic valve construction. The graft material 103B is coupled to an inner surface of the anchoring member 102B to line a portion thereof. The outer engagement surface of the anchoring member 102 is not covered with any sealing or graft material so that the outer engagement surface directly contacts the tissue of the native annulus. The graft material 103 A, 103B may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa. Alternatively, the graft material 103A, 103B may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent.

[0061] The valve component 101 of the prosthetic heart valve 100 is capable of regulating flow therethrough via valve leaflets 107 that may form a replacement valve. FIGS. 1 and 2 illustrate an exemplary valve component having three leaflets, although a bicuspid leaflet configuration may alternatively be used in embodiments hereof. When deployed in situ, the valve component 101 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the valve support 102A. The valve component 101 includes valve leaflets 107, e.g., three valve leaflets 107, that are disposed to coapt within an upstream portion of the valve support 102A with leaflet commissures of the valve leaflets 107 being secured within a downstream portion of the valve support 102A, such that the valve leaflets 107 open during diastole. Leaflets 107 are attached along their bases to the valve support 102A, for example, using sutures or a suitable biocompatible adhesive. Adjoining pairs of leaflets 107 are attached to one another at their lateral ends to form leaflet commissures. The orientation of the leaflets 107 within the valve support 102A depends upon on which end of the prosthetic heart valve 100 is the inflow end and which end of the prosthetic heart valve 100 is the outflow end, thereby ensuring oneway flow of blood through the prosthetic heart valve 100.

[0062] The valve leaflets 107 are attached to the graft material 103 A to form the valve component 101. The valve leaflets 107 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials. With certain prosthetic leaflet materials, it may be desirable to coat one or both sides of the replacement valve leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the prosthetic leaflet material is durable and not subject to stretching, deforming, or fatigue.

[0063] Embodiments hereof relate to delivery systems for and methods of delivering a prosthetic heart valve such as the non-limiting example of the prosthetic heart valve 100 of FIGS. 1 and 2. In embodiments hereof, as will be described in more detail herein, the delivery system includes a telescopic capsule assembly including a primary capsule and a secondary capsule for deployment of the prosthetic heart valve in two stages. In an initial or delivery state, the primary capsule and the secondary capsule are positioned longitudinally adjacent to one another. In a first deployment stage, to deploy a first longitudinal portion of the prosthetic heart valve, the primary capsule is moved to be positioned or disposed over the secondary capsule and thereby exposes the first longitudinal portion of the prosthetic heart valve. In a second deployment stage, to deploy a second longitudinal portion of the prosthetic heart valve, the primary and secondary capsules are moved together or simultaneously and thereby expose the second longitudinal portion of the prosthetic heart valve.

[0064] Relative to a single or unitary capsule, during the second deployment stage, the telescopic capsule assembly of embodiments herein has a compact or reduced length and a relatively short overall longitudinal translation to deploy the prosthetic heart valve to thereby facilitate delivery of the prosthetic heart valve to the tricuspid valve, the mitral valve, or other regions of the body that benefit from the short axial deployment paths. For example, with respect to the tricuspid valve, the capsule of a delivery system is advanced into the right ventricle during the deployment procedure of a prosthetic tricuspid valve. Physicians have identified capsule interaction with the right ventricle during a tricuspid valve replacement as a major criteria of patient exclusion and procedural complication. Due to length restrictions of single or unitary capsules, current procedures require patients to be screened for allowable right ventricle depth and a very high percentage of patients are not considered candidates for tricuspid valve replacement due to limited right ventricular depths. The telescopic capsule assembly described herein decreases or reduces the length of the capsule advanced into the right ventricle, thereby decreasing interaction with the right ventricle during deployment, while maintaining the procedural steps of the delivery system to increase treating patient population. In addition, the components (i.e., tethers) utilized for moving the telescopic capsule assembly described herein are entirely internal to the delivery system to avoid unnecessary interaction of the components with the right ventricle.

[0065] Turning now to FIGS. 3-8, a delivery system 320 having a telescopic capsule assembly 322 according to an embodiment hereof is shown. The telescopic capsule assembly 322 includes a primary capsule 322A and a secondary capsule 322B. In general terms, the delivery system 320 is arranged and configured for percutaneously delivering an implant (e.g., prosthetic heart valve 100) in a radially compressed or delivery configuration to a patient’s native defective heart valve or other portion of a patient’s anatomy via transcatheter delivery. FIG. 3 illustrates a side view of the delivery system 320, and FIG. 4 is a sectional view of a system 319 that includes the delivery system 320 operably coupled to a hydraulic system 470. FIG. 5 is a cross-sectional view taken along line A-A of FIG. 3. FIG. 6 is an exploded view of the delivery system 320.

[0066] With reference to the exploded view of FIG. 6, the delivery system 320 includes an innermost shaft assembly 324, an inner steerable catheter 326 disposed over the innermost shaft assembly 324, and an outer steerable catheter 328 disposed over the inner steerable catheter 326. The innermost shaft assembly 324 includes the telescopic capsule assembly 322 for housing at least a portion of the prosthetic heart valve 100 during delivery thereof. During delivery, the prosthetic heart valve 100 contained within the telescopic capsule assembly 322 is steered by the inner steerable catheter 326 and the outer steerable catheter 328 into alignment within the native heart valve for which the prosthetic heart valve 100 serves as a replacement. The inner steerable catheter 326 includes a handle 327 at a proximal portion thereof for manipulation in situ, and the outer steerable catheter 328 includes a handle 329 at a proximal portion thereof for manipulation in situ. The inner steerable catheter 326 may be controlled or steered independently from the outer steerable catheter 328 and provides the delivery system 320 with omnidirectional steering capabilities to direct the telescopic capsule assembly 322, as described in more detail in U.S. Patent Pub. 2023/0016149A1 to Griswold et al., which is assigned to the same assignee as the present application and herein incorporated by reference in its entirety. [0067] While the delivery system 320 includes the inner steerable catheter 326 and the outer steerable catheter 328 for steering functionality, these catheters are not required to be utilized with innermost shaft assembly 324, which includes the telescopic capsule assembly 322. The innermost shaft assembly 324, and the telescopic capsule assembly 322 thereof, may be utilized with other components for steerability and/or modified to include steering capability therein. However, the inner steerable catheter 326 and the outer steerable catheter 328 are described herein as exemplary structures for providing steering functionality.

[0068] The inner steerable catheter 326 is disposed over the innermost shaft assembly 324 such that an annular lumen 332 (shown on FIG. 5) is defined between an outer surface of the innermost shaft assembly 324 and an inner surface of the inner steerable catheter 326 along an entire length of the inner steerable catheter 326. The innermost shaft assembly 324 is slidingly disposed within the inner steerable catheter 326 such that relative axial movement is permitted therebetween as will be described in more detail below. As used herein, “slidably” generally denotes back and forth movement in a longitudinal direction along or generally parallel to a central longitudinal axis LA of the delivery system 320. The inner steerable catheter 326 includes a flexible, steerable tubular component or shaft 334, the handle 327 fixedly secured to a proximal end 336 of the shaft 334, an inner distal flex component 340 extending distally from a distal end 338 of the shaft 334, and a first pullwire 342. The shaft 334 can assume various forms conventionally employed, and in some embodiments can be a braided catheter surrounded by a polymer outer layer or jacket. The inner distal flex component 340 is secured to and extends distally from the shaft 334 and can be configured to exhibit flexibility and/or hoop strength characteristics differing from that of the shaft 334. In an embodiment, the inner distal flex component 340 is a metal tube with a laser cut pattern that facilitates flexing or bending of the inner distal flex component 340. A cap 341 (shown on FIG. 3) is attached to a distal end of the inner distal flex component 340. The cap 341 is an annular component that permits the innermost shaft assembly 324 to slide therethrough. The handle 327 includes an actuator 327A that is accessible to the user and may be manipulated to control flexing or bending of the inner distal flex component 340 of the shaft 334. More particularly, as will be explained in more detail herein, the first pullwire 342 is attached to and extends between the handle 327 and the cap 341 attached to the inner distal flex component 340. The first pullwire 342 is selectively tensioned by the user to bend the inner distal flex component 340. The inner steerable catheter 326 is configured to transition between a non-flexed configuration when the first pullwire 342 is not tensioned and a flexed configuration in which the first pullwire 342 is tensioned.

[0069] The handle 327 includes the actuator 327A for tensioning the first pullwire 342. The handle 327 can have any shape or size appropriate for convenient handling by a user. The actuator 327A is coupled to the proximal end of the first pullwire 342 and is constructed to provide selective proximal retraction and distal advancement of the first pullwire 342. Stated another way, the actuator 327A is coupled to the proximal end of the first pullwire 342 and is constructed to selectively push or pull the first pullwire 342. The actuator 327A may assume any construction that is capable of providing the desired pullwire actuation functionality. In an embodiment, the actuator 327A is configured as a rotatable knob that is rotated in a first direction (i.e., clockwise) to proximally retract the first pullwire 342 and apply tension thereto, and is rotated in a second, opposing direction (i.e., counter-clockwise) to distally advance the first pullwire 342 and remove or release tension therefrom, such as the rotatable knob described in U.S. Patent No. 10,188,833 to Bolduc et al., filed December 8, 2015, or the rotatable knob described in U.S. Patent No. 6,607,496 to Poor et al., filed on September 12, 2000, each of which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety. In another embodiment, the actuator 327A may be configured as a button such as those described in U.S. Patent No. 10,278,852 to Griffin, filed on March 10, 2016, which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety.

[0070] The outer steerable catheter 328 is slidably disposed over the inner steerable catheter 326 such that an annular lumen 343 (shown on FIG. 5) is defined between an outer surface of the inner steerable catheter 326 and an inner surface of the outer steerable catheter 328 along an entire length of the outer steerable catheter 328. The outer steerable catheter 328 includes a flexible, steerable tubular component or shaft 344, the handle 329 fixedly secured relative to a proximal end 346 of the shaft 344, an outer distal flex component 350 extending distally from a distal end 348 of the shaft 344, and a second pullwire 352. The shaft 344 can assume various forms conventionally employed, and in some embodiments can be a braided catheter surrounded by a polymer outer layer or jacket. The outer distal flex component 350 is secured to and extends distally from the shaft 344 and can be configured to exhibit flexibility and/or hoop strength characteristics differing from that of the shaft 344. In an embodiment, the outer distal flex component 350 is formed from a metal tube with a laser cut pattern that facilitates flexing or bending of the outer distal flex component 350. A cap 351 is attached to a distal end of the outer distal flex component 350. The cap 351 is an annular component that permits the inner steerable catheter 326 to slide therethrough. The handle 329 includes an actuator 329A that is accessible to the user and may be manipulated to control steering of the outer distal flex component 350 of the shaft 344. More particularly, as will be explained in more detail herein, the second pullwire 352 is attached to and extends between the handle 329 and the cap 351 of the outer distal flex component 350. The second pullwire 352 is selectively tensioned by the user to bend the outer distal flex component 350. The outer steerable catheter 328 is configured to transition between a non-flexed configuration when the second pullwire 352 is not tensioned and a flexed configuration in which the second pullwire 352 is tensioned.

[0071] The handle 329 includes the actuator 329A for tensioning the second pullwire 352. The handle 329 can have any shape or size appropriate for convenient handling by a user. The actuator 329A is coupled to the proximal end of the second pullwire 352 and is constructed to provide selective proximal retraction and distal advancement of the second pullwire 352. Stated another way, the actuator 329A is coupled to the proximal end of the second pullwire 352 and is constructed to selectively push or pull the second pullwire 352. The actuator 329A may assume any construction that is capable of providing the desired pullwire actuation functionality. In an embodiment, the actuator 329A is configured as a rotatable knob that is rotated in a first direction (i.e., clockwise) to proximally retract the second pullwire 352 and apply tension thereto, and is rotated in a second, opposing direction (i.e., counter-clockwise) to distally advance the second pullwire 352 and remove or release tension therefrom, such as the rotatable knob described in U.S. Patent No. 10,188,833 to Bolduc et al., filed December 8, 2015, or the rotatable knob described in U.S. Patent No. 6,607,496 to Poor et al., filed on September 12, 2000, each of which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety. In another embodiment, the actuator 329A may be configured as a button such as those described in U.S. Patent No. 10,278,852 to Griffin, filed on March 10, 2016, which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety.

[0072] The innermost shaft assembly 324, which includes the telescopic capsule assembly 322, will now be described in more detail with reference to FIGS. 7A-7H. The innermost shaft assembly 324 includes a flexible shaft 324A, a piston mount 324B, a deployment piston 354, a tension cable 330, a distal shaft 324C, the telescopic capsule assembly 322 including the primary capsule 322A and the secondary capsule 322B, a plurality of tethers 380 operatively coupled to the telescopic capsule assembly 322, and a capsule cap 353. At a proximal end thereof, as best shown in the exploded view of FIG. 6, the innermost shaft assembly 324 is fixedly secured to a manifold 325. As will be described in more detail herein, the manifold 325 is connected to the hydraulic system 470 for delivery of hydraulic fluid to the telescopic capsule assembly 322.

[0073] The innermost shaft assembly 324 is configured to permit mechanical actuation of the primary capsule 322A during the first deployment stage of the prosthetic heart valve 100 and hydraulic actuation of the secondary capsule 322B with the primary capsule 322A disposed thereover during the second deployment stage of the prosthetic heart valve 100. More particularly, the tethers 380 are selectively tensioned to move the primary capsule 322A in a distal direction during the first deployment stage of the prosthetic heart valve 100 and the delivery of hydraulic fluid from the hydraulic system 470 moves the secondary capsule 322B with the primary capsule 322A disposed thereover in a distal direction during the second deployment stage of the prosthetic heart valve 100.

[0074] FIG. 7A is an enlarged view of a distal portion of the innermost shaft assembly 324, with primary and secondary capsules 322A, 322B of the telescopic capsule assembly 322 shown in phantom for illustrative purposes only. The innermost shaft assembly 324 may be considered to include a first subassembly, shown in FIG. 7B and which includes the flexible shaft 324A, the piston mount 324B and the deployment piston 354, and a second subassembly, shown in FIG. 7C and which includes the tension cable 330, the distal shaft 324C, the telescopic capsule assembly 322, the tethers 380, and the capsule cap 353. The first and second subassemblies are coupled together in that the distal shaft 324C of the second subassembly slides or telescopes within the piston mount 324B of the first subassembly during the second deployment stage of the prosthetic heart valve 100. In addition, the first and second subassemblies are coupled together via the manifold 325.

[0075] With respect to the first subassembly shown in FIG. 7B, the flexible shaft 324A is a flexible elongated tubular body that may include, for example, a flexible metal tetris or spring disposed within a polymer jacket. A distal end of the flexible shaft 324A is attached and fixed relative to a proximal end of the piston mount 324B, which is a rigid, tubular body that distally extends from the flexible shaft 324A. The deployment piston 354 is attached and fixed relative to the piston mount 324B. More particularly, the deployment piston 354 is disposed over and mounted to a distal end of the piston mount 324B.

[0076] With respect to the second subassembly shown in FIG. 7C, the tension cable 330 extends from the manifold 325 to the distal shaft 324C through the lumens of the flexible shaft 324A and the piston mount 324B. Reference number 331 is utilized in the cross- sectional view of FIG. 5 to designate the lumen of the flexible shaft 324A. The lumens of the flexible shaft 324 A and the piston mount 324B are in fluid communication with each other. A distal end of the tension cable 330 is secured or mounted within a proximal portion 337 (shown on FIG. 7D) of the distal shaft 324C. The tethers 380, which is utilized for moving the primary capsule 322A of the telescopic capsule assembly 322 as described in more detail below, extend through the tension cable 330 and the distal shaft 324C to operatively couple to the telescopic capsule assembly 322.

[0077] As best shown on FIGS. 7E, 7F, and 7G, the telescopic capsule assembly 322 includes the primary capsule 322A and the secondary capsule 322B. FIG. 7E is a sectional view of the telescopic capsule assembly 322, removed from the delivery system 320 for sake of illustration only, and FIGS. 7F and 7G are cross-sectional views taken along lines F-F and G-G, respectively, of FIG. 7E. Each of the primary capsule 322A and the secondary capsule 322B is a tubular component that is configured to house at least a portion of the prosthetic heart valve 100 in a radially compressed state during delivery. Each of the primary capsule 322A and the secondary capsule 322B is rigid and may be made of metal or a rigid polymeric material. The primary capsule 322A has an inner diameter DI which is slightly greater than an outer diameter D2 of the secondary capsule 322B, so that primary capsule 322A is configured to slide or translate over the secondary capsule 322B during deployment of the prosthetic heart valve 100. [0078] The primary capsule 322A has an open proximal end 355A and an open distal end 355AA, while the secondary capsule 322B has an open proximal end 355B and a closed distal end 355BB. The distal end 355BB of the secondary capsule 322B is closed via the capsule cap 353. The capsule cap 353 may be integrally formed with the secondary capsule 322B or may be a separate component attached thereto to form the closed distal end 355A. The distal shaft 324C is further attached to the capsule cap 353. FIG. 7D is a sectional view of the distal shaft 324C and the capsule cap 353. As shown in FIG. 7D, the distal shaft 324C may be integrally formed with the capsule cap 353, or in another embodiment, the distal end of the distal shaft 324C may be welded or otherwise attached to the capsule cap 353.

[0079] In the delivery state of the telescopic capsule assembly 322 depicted in FIG. 7C and FIG. 7E, the primary capsule 322A and the secondary capsule 322B are coaxially aligned with the primary capsule 322A disposed proximal to the secondary capsule 322B. In this embodiment, in the delivery state, the primary capsule 322A is disposed longitudinally adjacent to the secondary capsule 322B with the distal end 355AA of the primary capsule 322A being disposed directly adjacent to the proximal end 355B of the secondary capsule 322B, with no gaps or spaces therebetween. In another embodiment, in the delivery state, the primary capsule 322A may be disposed longitudinally adjacent to the secondary capsule 322B with a relatively short length of the distal end 355 AA of the primary capsule 322A overlapping or overlaying the proximal end 355B of the secondary capsule 322B.

[0080] During the first deployment stage of the prosthetic heart valve 100, which is described in more detail below with respect to FIGS. 10-11, the primary capsule 322A moves in a distal direction over the outer surface of the secondary capsule 322B to release a first longitudinal portion of the prosthetic heart valve 100. As previously stated, the innermost shaft assembly 324 is configured to permit mechanical actuation of the primary capsule 322A during the first deployment stage of the prosthetic heart valve 100. More particularly, the tethers 380 extends between the manifold 325 and the primary capsule 322A and is configured to move the primary capsule 322A during the first deployment stage via tensioning of the tethers 380. Each tether 380 includes a first end 381 and a second end (not shown) opposing the first end 318, with the first end 381 being attached to an inner surface of the primary capsule 322A at the proximal end 355A thereof and the second end being operatively attached to the manifold 325. The first end 381 of the tether 380 is shown secured to the inner surface of the primary capsule 322A via a weld 385 in FIG. 7E, but may alternatively be secured via an adhesive, interlocking components, and/or other suitable fasteners.

[0081] The tethers 380 extend from the proximal end 355A of the primary capsule 322A to the manifold 325. The tethers 380 are housed within or extend through the tension cable 330, the distal shaft 324, the capsule cap 353, and the secondary capsule 322B in order to access the primary capsule 322A. More particularly, each tether 380 is slidingly disposed within a tether lumen or passageway 382A (shown on FIG. 5) formed through the tension cable 330, within a tether lumen or passageway 382B formed through the distal shaft 324 (shown on FIG. 7D), within a tether lumen or passageway 382C formed through the capsule cap 353 (shown on FIGS. 7D and 7H), and within a tether lumen or passageway 382D formed within the secondary capsule 322B (shown on FIGS. 7E and 7G). The tether lumens 382A, 382B, 382C, 382D are in fluid communication with each other and collectively form a continuous lumen or passageway (herein referred to as continuous lumen 382) for housing a tether 380 within the delivery system 320. Each tether 380 is entirely internal or disposed within the delivery system 320, including the secondary capsule 322B, to avoid ventricular interaction in vivo. Stated another way, each tether 380 is not disposed external to the secondary capsule 322B bur rather is disposed completely internal thereto so that the tethers 380 do not interfere with the native valve anatomy. While the inner circumferential surface of the secondary capsule 322B compressively contains the second longitudinal portion of the prosthetic heart valve 100, the tether lumens 382B are formed within the tubular wall of the secondary capsule 322B as best shown in the cross-sectional view of FIG. 14B. As such, the tethers 380 are isolated from and do not interact with the native valve anatomy in vivo.

[0082] While at least one tether 380 is required, the delivery system 320 includes a plurality of tethers 380. Each tether 380 is slidingly disposed in an individual or separate continuous lumen 382, such that the number of continuous lumens 382 formed within the delivery system 320 corresponds to the number of tethers utilized in the delivery system 320. For example, the delivery system 320 includes three tethers and three continuous lumens 382 for housing the tethers. As best depicted in the cross-sectional view of the secondary capsule 322B in FIG. 7G, the secondary capsule 322B includes three tether lumens 382D with a first tether being slidingly disposed in a first tether lumen, a second tether being slidingly disposed in a second tether lumen, and a third tether being slidingly disposed in a third tether lumen. The three tether lumens of the secondary capsule 322B are disposed at circumferentially spaced-apart equal intervals around the secondary capsule 322B. The tethers 380 can be wires, cables, sutures, and/or other suitable structures for moving the primary capsule 322A.

[0083] At a proximal portion of the delivery system 320, the second ends of the tethers 380 are attached to an actuator 325A of the manifold 325 and/or otherwise accessible to allow a clinician to tension, pull or otherwise proximally retract the tethers 380. The actuator 325A is configured to provide selective proximal retraction and distal advancement of the tethers 380. Stated another way, the actuator 325A is coupled to the second ends of the tethers and is constructed to selectively apply tension to the tethers 380. The actuator 325A may assume any construction that is capable of providing the desired actuation functionality. In an embodiment, the actuator 325A is configured as a rotatable knob that is rotated in a first direction (i.e., clockwise) to proximally retract the tethers and apply tension thereto, and is rotated in a second, opposing direction (i.e., counter-clockwise) to distally advance the tethers and remove or release tension therefrom, such as the rotatable knob described in U.S. Patent No. 10,188,833 to Bolduc et al., filed December 8, 2015, or the rotatable knob described in U.S. Patent No. 6,607,496 to Poor et al., filed on September 12, 2000, each of which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety. In another embodiment, the actuator 325A may be configured as a button such as those described in U.S. Patent No. 10,278,852 to Griffin, filed on March 10, 2016, which is assigned to the same assignee as the present disclosure and which is herein incorporated by reference in its entirety.

[0084] When tension is applied to the tethers 380 at the manifold 325 during the first deployment stage, causing proximal retraction of the tethers 380, the capsule cap 353 and the secondary capsule 322B serve as a pulley to change the direction of motion, and thus the primary capsule 322B moves in a distal direction, i.e., towards the secondary capsule 322B. Distal advancement of the primary capsule 322A causes the primary capsule 322A to slide over the secondary capsule 322B and a first longitudinal portion of the prosthetic heart valve 100 is unsheathed or uncovered from the primary capsule 322A, which is described in more detail below with respect to FIGS. 9 and 10.

[0085] After the first deployment stage, as will be described in more detail with respect to FIG. 11, the primary capsule 322A and the secondary capsule 322B are coaxially aligned with the primary capsule 322A disposed over the secondary capsule 322B. Stated another way, the primary capsule 322A overlaps or overlays the secondary capsule 322B such that the secondary capsule 322B is disposed within the primary capsule 322A.

[0086] During the second deployment stage of the prosthetic heart valve 100, which is described in more detail below with respect to FIGS. 12 and 13, the primary and secondary capsules 322A, 322B move together in a distal direction to unsheathe the second longitudinal portion of the prosthetic heart valve 100 and thereby fully deploy the prosthetic heart valve 100. As previously stated, the innermost shaft assembly 324 is configured to permit hydraulic actuation of the primary and secondary capsules 322A, 322B during the second deployment stage of the prosthetic heart valve 100.

[0087] To permit hydraulic actuation of the primary and secondary capsules 322A, 322B, the distal shaft 324C is received within the lumen of the piston mount 324B and may move or slide relative thereto in an axial or longitudinal direction as best shown on FIG. 7A. Stated another way, the distal shaft 324C telescopes within the piston mount 324B. The secondary capsule 322B is concentrically disposed over the distal shaft 324C, and an annular chamber 357 is defined between an inner surface of the secondary capsule 322B, an outer surface of the distal shaft 324C, the deployment piston 354 and the capsule cap 353. The annular chamber 357 is a sealed cavity into which fluid can be introduced to increase fluid pressure therein and thereby moves the secondary capsule 322B away from the deployment piston 354, which remains stationary during fluid delivery. The primary capsule 322A moves with the secondary capsule 322B during the second deployment stage, because the tethers 380 (housed within tether lumens 382A, 382B, 382C, 382D as described above) are distally advanced during hydraulically driven distal advancement of the tension cable 330, the distal shaft 324C, the capsule cap 353, and the secondary capsule 322B.

[0088] The deployment piston 354 is shown removed from the delivery system 320 in FIG. 8. The deployment piston 354 is an annular component that defines an opening or central bore 333 such that the deployment piston 354 is configured to be disposed over and atached to a distal end of the piston mount 324B. The deployment piston 354 includes a plurality of slots or recesses 358 configured to receive the atachment bars 112 of the prosthetic heart valve 100. The deployment piston 354 also includes an annular groove 360 on an outer surface thereof. A seal 356 (shown in FIGS. 9-13) is disposed within the annular groove 360. The seal 356 is thus coupled to the deployment piston 354 and functions to provide a fluid seal between the deployment piston 354 and an inner surface of the telescopic capsule assembly 322. The seal 356 may be, for example, an O-ring. When fluid is present in the annular chamber 357, the seal 356 prevents fluid from leaking out between the outer surface of the deployment piston 354 and the inner surface of the telescopic capsule assembly 322.

[0089] In an embodiment, the tension cable 330 is configured to be selectively tensioned (proximally or distally) by hydraulic force to enable translation of the secondary capsule 322B either proximally or distally with respect to the piston mount 324B and the deployment piston 354 atached thereto. Depending on which hydraulic system is engaged (deployment or recapture), the tension cable 330 will translate under tension through the innermost shaft assembly 324, with the secondary capsule 322B moving in a distal direction during deployment or moving in a proximal direction during recapture.

[0090] More particularly, as stated above, the delivery system 320 is operatively coupled to the hydraulic system 470 (see FIG. 4). The hydraulic system 470 is utilized to axially or longitudinally move or translate the secondary capsule 322B relative to the deployment piston 354 and the prosthetic heart valve 100 coupled thereto. The hydraulic system 470 includes a deployment pressure delivery system 472 and a recapture pressure delivery system 473. The deployment pressure delivery system 472 is configured to deliver hydraulic fluid to the annular chamber 357 of the delivery system 320 to drive the telescopic capsule assembly 322 in a distal direction, thereby deploying the prosthetic heart valve 100, as will be described in more detail herein. The deployment pressure delivery system 472 is configured to be fluidly coupled to a deployment valve 463 of the manifold 325.

[0091] The recapture pressure delivery system 473 is configured to deliver hydraulic fluid to a recapture chamber 461 of the delivery system 320 to drive the telescopic capsule assembly 322 in a proximal direction, thereby recapturing the prosthetic heart valve 100, as will be described in more detail herein. The recapture pressure delivery system 473 is configured to be fluidly coupled to a recapture valve 464 of the manifold 325. The recapture chamber 461 is disposed within the manifold 325 and is configured to house a recapture piston 460 therein. The recapture chamber 461 is fluidly coupled to the recapture valve 464 and is configured to fill with hydraulic fluid from the recapture pressure delivery device 473. As the hydraulic fluid from the recapture pressure delivery device 473 flows into and/or exits from the recapture chamber 461 , the recapture piston 460 is configured to move axially within the recapture chamber 461. In an embodiment, the movement of the recapture piston 460 may be supplemented by a spring 466. The spring 466 pushes against the recapture piston 460 and biases the recapture piston 460 towards a proximal end of the recapture chamber 461. The recapture piston 460 and the spring 466 provide an opposing or dampening force during deployment of the prosthetic heart valve 100.

[0092] In an embodiment, the deployment pressure delivery system 472 and the recapture pressure delivery system 473 are inversely related to each other. For example, when the delivery system 320 is in the delivery configuration, the deployment pressure delivery system 472 is full (as the annular chamber 357 is empty), while the recapture pressure delivery system 473 is empty (as the recapture chamber 461 is full). Conversely, when the delivery system 320 is in the deployed configuration, the deployment pressure delivery system 472 is empty (as the annular chamber 357 is full), while the recapture pressure delivery system 473 is full (as the recapture chamber 461 is empty). The fluid paths of the recapture chamber 461 and the annular chamber 357 are independent of one another. However, it is envisioned that in some embodiments, the recapture chamber 461 and the annular chamber 357 are fluidly connected to one another, allowing for the recapture chamber 461 and the annular chamber 357 to change volume inversely based on a single source of hydraulic fluid. In an embodiment, each of the pressure delivery systems 472, 473 may be a pump or a syringe-type inflator. In another embodiment, the pressure delivery systems 472, 473 may be integrated into an inflation device that is configured to be coupled to a flow reverser that selects which hydraulic cylinder or chamber 461, 357 to pressurize, while venting the opposing or non-selected cylinder or chamber 461, 357.

[0093] Turning now to FIGS . 9- 13, the first and second deployment stages of deploying an implant such as prosthetic heart valve 100 will be described in more detail. FIG. 9 illustrates a delivery configuration of the prosthetic heart valve 100 after being loaded onto the deployment piston 354 and disposed within the telescopic capsule assembly 322 for delivery thereof. FIGS. 10 and 11 illustrate movement of the primary capsule 322A relative to the secondary capsule 322B during the first deployment stage of the prosthetic heart valve 100. FIGS. 12 and 13 illustrate movement of the telescopic capsule assembly 322 relative to the deployment piston 354 during the second deployment stage of the prosthetic heart valve 100. The prosthetic heart valve 100 is depicted in FIG. 9 but is not shown in FIGS. 10-13 for sake of clarity, as these figures are primarily provided to illustrate the movement of the telescopic capsule assembly 322.

[0094] Referring now to FIG. 9, the prosthetic heart valve 100 is loaded onto the deployment piston 354 and disposed within the telescopic capsule assembly 322 for delivery thereof. The telescopic capsule assembly 322 compressively retains at least a portion of the prosthetic heart valve 100. A first longitudinal portion 986 of the prosthetic heart valve 100 (adj acent to the first end 108 of the prosthetic heart valve 100) is disposed within the primary capsule 322A and a second longitudinal portion 988 of the prosthetic heart valve 100 (adjacent to the second end 109 of the prosthetic heart valve 100) is disposed within the secondary capsule 322B. It will be understood by one of ordinary skill in the art that other delivery configurations of the prosthetic heart valve 100 are contemplated and the illustrated configuration is only exemplary. In the depicted embodiment, the telescopic capsule assembly 322 in the delivery state has a length that is greater than or substantially equal to a length of the prosthetic heart valve 100 such that the full length of the prosthetic heart valve 100 is radially compressed by the telescopic capsule assembly 322. However, in another embodiment (not shown), the telescopic capsule assembly 322 may have a length that is shorter than a length of the prosthetic heart valve 100 such that a proximal portion of the prosthetic heart valve 100 extends proximally out of the proximal end 355 A of the primary capsule 322A.

[0095] In the delivery configuration depicted in FIG. 9, the deployment piston 354 abuts against or is disposed directly adjacent to the capsule cap 353. The prosthetic heart valve 100 is coupled to the deployment piston 354 via the attachment bars 112 being disposed within the plurality of slots 358. In FIG. 9, the distal shaft 324C is concealed from view since the piston mount 324B extends thereover. In this delivery configuration of FIG. 9, the clinician may then insert the distal end of the delivery system 320 into the patient and navigate the telescopic capsule assembly 322 through the vasculature of the patient to the desired location within the patient’s heart.

[0096] The telescopic capsule assembly 322 is depicted in its delivery state in FIG. 9, with the primary capsule 322A and the secondary capsule 322B coaxially aligned and the primary capsule 322A disposed proximal to the secondary capsule 322B. Once the telescopic capsule assembly 322 is positioned at the native heart valve as desired, the clinician executes the first deployment stage of the prosthetic heart valve 100. FIGS. 10 and 11 illustrate movement of the primary capsule 322A relative to the secondary capsule 322B during the first deployment stage of the prosthetic heart valve 100. The tethers 380 are proximally retracted to cause the primary capsule 322A to move in a distal direction over the outer surface of the secondary capsule 322B, as shown in FIG. 10. Once the primary capsule 322A overlaps or overlays the secondary capsule 322B such that the secondary capsule 322B is disposed within the primary capsule 322A, as shown in FIG. 11, the first longitudinal portion 986 of the prosthetic heart valve 100 is unsheathed or uncovered from the primary capsule 322A and the first longitudinal portion 986 of the prosthetic heart valve 100 thereby deploys and is permitted to radially self-expand towards the expanded configuration of FIG. 1.

[0097] FIGS. 12 and 13 illustrate movement of the telescopic capsule assembly 322 (shown in phantom) relative to the deployment piston 354 during the second deployment stage of the prosthetic heart valve 100. During the second deployment stage of the prosthetic heart valve 100, the overlapping primary and secondary capsules 322A, 322B are hydraulically driven together in a distal direction to unsheathe the second longitudinal portion 988 of the prosthetic heart valve 100 and thereby fully deploy the prosthetic heart valve 100. The deployment pressure delivery system 472 is utilized to begin to fill the annular chamber 357, moving the overlapping primary and secondary capsules 322A, 322B axially relative to the deployment piston 354. More particularly, the overlapping primary and secondary capsules 322A, 322B are configured to be distally advanced relative to the deployment piston 354 to incrementally release and deploy the second longitudinal portion 988 of the prosthetic heart valve 100. Via the manifold 325, fluid is injected from the deployment pressure delivery system 472 into the innermost shaft assembly 324 in order to drive the overlapping primary and secondary capsules 322A, 322B distally. The prosthetic heart valve 100 remains in a stationary longitudinal position relative to the native valve while the overlapping primary and secondary capsules 322A, 322B are driven distally, thereby increasing the precision of deployment.

[0098] More particularly, the manifold 325 is connected to the deployment pressure delivery system 472 of the hydraulic system 470 via the deployment valve 463. The deployment pressure delivery system 472 is fluidly connected to the annular chamber 357 within the telescopic capsule assembly 322 via the lumens of the flexible shaft 324A and the piston mount 324B (which are in fluid communication with each other). Fluid enters the annular chamber 357 via the outlet of the piston mount 324B, around the distal shaft 324C through the annular space or lumen defined between the outer surface of the distal shaft 324C and the inner surface of the piston mount 324B. As shown by the directional arrow 1264 in FIG. 12, as the annular chamber 357 fills with fluid, the overlapping primary and secondary capsules 322A, 322B are distally advanced with respect to the deployment piston 354. FIG. 12 illustrates the deployment piston 354 disposed within the telescopic capsule assembly 322 at approximately a midportion thereof. The annular chamber 357 between the deployment piston 354 and the capsule cap 353 is filled with fluid from the deployment pressure delivery system 472. The deployment piston 354, which is attached and fixed to the piston mount 324B and the flexible shaft 324A, remains stationary as the telescopic capsule assembly 322 and distal shaft 324C move in an axial direction. The deployment piston 354 (and piston mount 324B and flexible shaft 324A) may be held in place by holding the manifold 325 stationary during fluid delivery.

[0099] The fluid continues to fill the annular chamber 357 until the deployment piston 354 is partially disposed within the telescopic capsule assembly 322 and is directly adjacent to the proximal end 355B of the secondary capsule 322B, as shown on FIG. 13. The annular chamber 357 between the deployment piston 354 and the capsule cap 353 is filled with fluid from the deployment pressure delivery system 472. As shown on FIG. 13, the plurality of slots 358 of the deployment piston 354 are no longer covered by the telescopic capsule assembly 322. With the plurality of slots 358 exposed, the attachment bars 112 of the prosthetic heart valve 100 are permitted to decouple from the deployment piston 354. Accordingly, via movement of the overlapping primary and secondary capsules 322A, 322B, the second longitudinal portion 988 of the prosthetic heart valve 100 is unsheathed from the overlapping primary and secondary capsules 322A, 322B. When the overlapping primary and secondary capsules 322A, 322B no longer cover or extend over the attachment bars 112, the attachment bars 112 are free or permitted to pop out of the slots 358 of the deployment piston 354 to decouple the prosthetic heart valve 100 from the deployment piston 354. Thus, once the prosthetic heart valve 100 is no longer covered by the telescopic capsule assembly 322, the full length of the prosthetic heart valve 100 is permitted to radially self-expand towards the expanded configuration of FIG. 1.

[0100] The telescopic capsule assembly 322 is configured to allow for recapturing or resheathing a partially deployed device by moving the telescopic capsule assembly 322 back towards its delivery state. Particularly, in an embodiment, the tethers 380 are formed from semi-rigid or rigid materials that do not buckle when distally advanced such that a clinician may distally advance the tethers 380, thereby moving the primary capsule 322A in a proximal direction to allow for recapturing or resheathing a partially deployed device.

[0101] FIGS. 14, 14A, 14B, and 15 illustrate a telescopic capsule assembly 1422 according to another embodiment hereof. The telescopic capsule assembly 1422 includes a primary capsule 1422A and a secondary capsule 1422B. The telescopic capsule assembly 1422 is the same as the telescopic capsule assembly 322 except that the telescopic capsule assembly 1422 includes an integral recapture mechanism which acts on the primary capsule 1422A to bias it in its delivery state. By biasing the primary capsule 1422A in its delivery state, the primary capsule 1422A resheathes the first portion of the heart valve prosthesis 100 when tension on the tethers 380 is removed or released to recapture a partially deployed heart valve prosthesis 100. Stated another way, when a clinician wants to recapture a partially deployed heart valve prosthesis 100, tension on the tethers 380 is removed and the integral recapture mechanism drives the primary capsule 1422A in a proximal direction, towards its initial delivery state. As such, the tethers 380 are not required to be formed from a semi-rigid or rigid material that permit distal advancement of the tethers but rather the recapture mechanism functions to move the primary capsule 1422A in a proximal direction to allow for recapturing or resheathing a partially deployed device.

[0102] With reference to FIG. 14, 14A, and 14B, the recapture mechanism includes spring components 1490 disposed within spring channels 1492 formed within the secondary capsule 1422B, and corresponding pins 1494 axially extending from a proximal end 1455A of the primary capsule 1422A to a distal end 1455AA of the primary capsule 1422A. Each spring component 1490 is a compressive spring pre-formed in a non-compressed state, shown in FIG. 14. Stated in another way, absent the force applied by the pin 1494, the spring component 1490 is biased to return to its non-compressed state. The profde or shape of the spring lumens 1492 may vary from the circular profile shown. For example, the profile of the spring lumens 1492 may be configured to accommodate two or more parallel springs. [0103] Each pin 1494 is aligned with a spring channel 1492. The proximal end 1455A of the primary capsule 1422A includes an anchor 1496 which extends radially inwards, and a proximal end 1493 of the pin 1494 is attached to the anchor 1496. When the telescopic capsule assembly 1422 is in a delivery state, as shown in FIG. 14, the distal end 1455AA of the primary capsule 1422AA overlaps a proximal end 1455B of the secondary capsule 1422B and a distal end 1495 of the pin 1494 is disposed within a proximal end of the spring channel 1492. Each pin 1494 is thus constrained within the spring channel 1492 and the anchor 1496. During the first deployment stage, as the primary capsule 1422A is distally advanced, each pin 1494 is further distally advanced into its respective spring channel 1492. The spring component 1490 axially compresses as the primary capsule 1422A (and the pin 1494) moves in the distal direction, as shown in FIG. 15. Conversely, when tension on the tethers 380 is released, the spring components 1490 decompress and restore or revert to the non-compressed state and thereby push the pins 1494 and thereby the primary capsule 1422A in a proximal direction to resheathe the first longitudinal portion of the prosthetic heart valve 100.

[0104] While at least one spring component 1490 is required in the integral recapture mechanism, the telescopic capsule assembly 1422 includes a plurality of spring components 1490. Each spring component 1490 is disposed in an individual or separate spring lumen 1492, such that the number of spring lumens 1492 formed within the secondary capsule 1422B corresponds to the number of spring components 1490 utilized in the integral recapture mechanism. Similarly, the number of pins 1494 also corresponds to the number of spring components 1490 and the spring lumens 1492 utilized in the integral recapture mechanism. For example, the telescopic capsule assembly 1422 is shown with three spring components 1490, three spring lumens 1492 for housing the spring components 1490, and three pins 1494 for axially compressing the spring components 1490. As best depicted in the cross-sectional view of the secondary capsule 1422B in FIG. 14B, the secondary capsule 1422B includes three spring lumens 1492 with a first spring component being disposed in a first spring lumen, a second spring component being disposed in a second spring lumen, and a third spring component being slidingly disposed in a third spring lumen. The three spring lumens 1492 of the secondary capsule 1422B are disposed at circumferentially spaced-apart equal intervals around the secondary capsule 1422B. Further, as shown on FIG. 14B, the spring channels 1492 (i.e., the first spring channel, the second spring channel, and the third spring channel) are interspersed between the tether lumens 382D (i.e., the first tether lumen, the second tether lumen, and the third tether lumen) at circumferentially spaced-apart equal intervals around the secondary capsule 1422B. Similarly, the three pins 1494 of the primary capsule 1422A are spaced at circumferentially spaced-apart equal intervals around the primary capsule 1422A, with a first pin being slidingly disposed in the first spring channel of the secondary capsule 1422B, a second pin being slidingly disposed in the second spring channel of the secondary capsule 1422B, and a third pin being slidingly disposed in the third spring channel of the secondary capsule 1422B. Further, as shown on FIG. 14A, the pins 1494 (i.e., the first pin, the second pin, and the third pin) are interspersed between the tethers 380 (i.e., the first tether, the second tether, and the third tether) at circumferentially spaced- apart equal intervals around the primary capsule 1422A.

[0105] It should be understood that various embodiments 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 device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components.

Claims

WHAT IS CLAIMED IS:

1. A system for delivering a prosthetic heart valve into a heart of a patient, the system comprising: an elongated catheter body having a distal end and a proximal end, the catheter body further including a lumen extending a length of the catheter body; a handle disposed at the proximal end of the catheter body; a telescopic capsule assembly disposed at the distal end of the catheter body, wherein the telescopic capsule assembly comprises a primary capsule configured to contain a first longitudinal portion of the prosthetic heart valve and a secondary capsule configured to contain a second longitudinal portion of the prosthetic heart valve, wherein, during a first deployment stage, the primary capsule moves in a distal direction with respect to the secondary capsule to release the first longitudinal portion of the prosthetic heart valve, and wherein, during a second deployment stage, the secondary capsule and the primary capsule move together in a distal direction to release the second longitudinal portion of the prosthetic heart valve; at least one tether extending between the handle and the primary capsule, the at least one tether attached to a proximal end of the primary capsule and extending from the primary capsule through at least one tether lumen formed within the secondary capsule and through the elongated catheter body, wherein the at least one tether is configured to move the primary capsule during the first deployment stage via tensioning of the tether; and a hydraulic system fluidly connected to the telescopic capsule assembly and the lumen of the catheter body, wherein the hydraulic system is configured to move the primary capsule and the secondary capsule during the second deployment stage via delivery of a hydraulic fluid into the secondary capsule through the lumen.

2. The system of claim 1, further comprising a tension cable disposed within the catheter body and attached to the secondary capsule, the tension cable including at least one tether lumen in fluid communication with the at least one tether lumen of the secondary capsule.

3. The system of claim 1, further comprising a deployment piston and wherein the primary capsule and the secondary capsule move axially relative to the deployment piston during the second deployment stage.

4. The system of claim 3, wherein an annular chamber is defined between the secondary capsule and the deployment piston, the annular chamber being configured to fill with hydraulic fluid during the second deployment stage.

5. The system of claim 1, wherein the at least one tether includes a first tether, a second tether, and a third tether, and wherein the at least one tether lumen includes a first tether lumen, a second tether lumen, and a third tether lumen, the first tether being slidingly disposed in the first tether lumen, the second tether being slidingly disposed in the second tether lumen, and the third tether being slidingly disposed in the third tether lumen.

6. The system of claim 5, wherein the first tether lumen, the second tether lumen, and the third tether lumen are disposed at circumferentially spaced-apart equal intervals around the secondary capsule.

7. The system of claim 1 , wherein the at least one first tether includes a first end and a second end opposing the first end, the first end being attached to an inner surface of the primary capsule at a proximal end thereof.

8. The system of claim 1, wherein the secondary capsule includes a capsule cap at a distal end thereof, the capsule cap including at least one tether lumen in fluid communication with the at least one tether lumen of the secondary capsule.

9. The system of claim 8, wherein the at least one tether is disposed completely internal to the secondary capsule.

10. The system of claim 8, further comprising a tension cable disposed within the catheter body, the tension cable attached to the capsule cap, the tension cable including at least one tether lumen in fluid communication with the at least one tether lumen of the capsule cap.

11. The system of claim 1, further comprising a spring component disposed within at least one spring channel formed within the secondary capsule, the spring component configured to bias the primary capsule toward the delivery state, wherein the primary capsule includes at least one pin axially extending from a proximal end of the primary capsule to a distal end of the primary capsule, the at least one pin aligned for advancement into the at least one spring channel during the first deployment stage.

12. The system of claim 11, wherein the spring component is configured to be axially compressed by the at least one pin during the first deployment stage and the spring component is biased to return to a non-compressed state absent force applied by the at least one pin.

13. The system of claim 11, wherein the proximal end of the primary capsule includes an anchor which extends radially inwards and a proximal end of the at least one pin is attached to the anchor.

14. The system of claim 11, wherein, when the telescopic capsule assembly is in a delivery state, a distal end of the primary capsule overlaps a proximal end of the secondary capsule and a distal end of the at least one pin is disposed within a proximal end of the at least one spring channel.

15. The system of claim 11, wherein the at least one pin includes a first pin, a second pin, and a third pin, and wherein the at least one spring channel includes a first spring channel, a second spring channel, and a third spring channel, the first pin being slidingly disposed in the first spring channel, the second pin being slidingly disposed in the second spring channel, and the third pin being slidingly disposed in the third spring channel.

16. The system of claim 15, wherein the first spring channel, the second spring channel, and the third spring channel are spaced at circumferentially spaced-apart equal intervals around the secondary capsule and the first pin, the second pin, and the third pin are spaced at circumferentially spaced-apart equal intervals around the primary capsule.

17. The system of claim 16, wherein the at least one tether includes a first tether, a second tether, and a third tether, and wherein the at least one tether lumen includes a first tether lumen, a second tether lumen, and a third tether lumen, the first tether being slidingly disposed in the first tether lumen, the second tether being slidingly disposed in the second tether lumen, and the third tether being slidingly disposed in the third tether lumen and wherein the first spring channel, the second spring channel, and the third spring channel are interspersed between the first tether lumen, the second tether lumen, and the third tether lumen.

18. The system of claim 1, wherein proximal retraction of the at least one tether slides the primary capsule over the secondary capsule in a distal direction to unsheathe the first longitudinal portion of the prosthetic heart valve from the primary capsule.

19. A method for delivering a prosthetic heart valve to a native valve of a heart of a human patient, the method comprising: positioning a telescopic capsule assembly at a distal portion of an elongated catheter body within the heart, a primary capsule of the telescopic capsule assembly housing a first longitudinal portion of the prosthetic heart valve and a secondary capsule of the telescopic capsule assembly housing a second longitudinal portion of the prosthetic heart valve, wherein at least one tether is attached to a proximal end of the primary capsule and extends from the primary capsule through at least one tether lumen formed within the secondary capsule and through the elongated catheter body, and wherein a hydraulic system is fluidly connected to the telescopic capsule assembly and a lumen of the catheter body; tensioning the at least one tether to move the primary capsule in a distal direction with respect to the secondary capsule to deploy the first longitudinal portion of the prosthetic heart valve; and delivering hydraulic fluid via the hydraulic system into the secondary capsule through the lumen of the elongated catheter to move the secondary capsule and the primary capsule together in a distal direction to deploy the second longitudinal portion of the prosthetic heart valve.

20. The method of claim 19, wherein positioning the telescopic capsule assembly includes positioning the telescopic capsule assembly at a native tricuspid valve.