Valve delivery system including shortened compensator to improve positioning accuracy

Abstract

A system includes a self-expanding prosthesis configured to shorten during deployment thereof and a delivery device configured to deliver the self-expanding prosthesis percutaneously. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle, and a push rod slidably disposed within the outer sheath. The push rod has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis to allow axial movement of the self-expanding prosthesis therewith. The inner shaft has a distal portion of the inner shaft configured to receive the self-expanding prosthesis thereon. The outer sheath and the push rod are configured to move simultaneously in opposite axial directions upon actuation of the actuator on the handle to compensate for shortening of the self-expanding prosthesis during deployment.

Description

Technical Field

[0001] The present invention relates to delivery systems and methods for delivering a self-expanding prosthesis. Background Art

[0002] Prostheses for implantation in blood vessels or other similar organs of living bodies are generally well known in the medical field. For example, artificial vascular stent grafts composed of biocompatible materials have been used to replace or bypass damaged or occluded natural blood vessels. In general, artificial vascular stent grafts generally include a graft anchoring component that is used to maintain a tubular graft component of a suitable graft material in its intended position within a blood vessel. Most commonly, the graft anchoring component is one or more radially compressible stents that radially expand in situ to anchor the tubular graft component to the wall of a blood vessel or anatomical conduit. Therefore, artificial vascular stent grafts are generally maintained in place by mechanical engagement and frictional forces generated by the reaction force provided by the radially expandable stent. In another example, the expandable stent can be deployed without adding a covering graft component. In addition, artificial valves supported by stent structures have also been developed for heart and venous valve replacement.

[0003] In general, the prosthesis is not subjected to an open surgical procedure that may be traumatic and invasive, but is preferably deployed through a less invasive intraluminal delivery procedure. More specifically, the lumen or vascular system is percutaneously entered at a convenient and less traumatic entry point, and the prosthesis is guided through the vascular system to the site where the prosthesis is to be deployed. Intraluminal deployment is usually carried out using a delivery catheter with a coaxial inner tube and an outer tube, which are arranged for relative axial movement. For example, a self-expanding prosthesis can be compressed and arranged in the distal end of an outer catheter. The catheter is then manipulated, usually through the body cavity, until the catheter end and the prosthesis are positioned at the intended treatment site. The inner member is then kept stationary while the outer tube of the delivery catheter is withdrawn. A stopper can be used to prevent the prosthesis from being withdrawn together with the sheath. As the sheath is withdrawn, the prosthesis is released from the restrictions of the sheath and radially self-expanded, so that at least a portion of the prosthesis contacts and substantially fits a portion of the inner cavity such as a blood vessel wall or an anatomical catheter surrounding the inner portion.

[0004] Self-expanding prostheses often shorten or contract longitudinally during deployment, and this shortening can make it difficult to accurately position the self-expanding prosthesis. Embodiments of the present invention are directed to a delivery system configured to compensate for shortening of a self-expanding prosthesis during deployment to ensure accurate positioning thereof. Summary of the invention

[0005] Embodiments of the present invention generally relate to delivery systems, and more specifically to a delivery device for percutaneously delivering a self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end operably coupled to the handle, a push rod slidably disposed within the outer sheath, and an inner shaft disposed within the push rod. The push rod has a proximal end operably coupled to the handle. The inner shaft has a distal portion of the inner shaft configured to receive the self-expanding prosthesis thereon. The outer sheath and the push rod are configured to be simultaneously moved in opposite axial directions by actuation of the actuator on the handle.

[0006] Embodiments of the present invention also relate to a system comprising a self-expanding prosthesis configured to shorten during its deployment and a delivery device configured to deliver the self-expanding prosthesis percutaneously. The delivery device comprises a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle, a push rod slidably disposed within the outer sheath, and an inner shaft disposed within the push rod. The push rod has a proximal end coupled to the handle and a distal end configured to be releasably coupled to the self-expanding prosthesis so that the self-expanding prosthesis moves axially therewith. The inner shaft has a distal portion of the inner shaft configured to receive the self-expanding prosthesis thereon. The outer sheath and the push rod are configured to move simultaneously in opposite axial directions by actuation of the actuator on the handle to compensate for shortening of the self-expanding prosthesis during deployment.

[0007] Embodiments of the present invention also relate to a method for delivering a self-expanding heart valve prosthesis to a treatment site within a patient's vasculature using a delivery device including an outer sheath, a push rod, and an inner shaft. The delivery device is delivered to the treatment site so that the proximal end of the self-expanding heart valve prosthesis is positioned at the annulus of a native heart valve. The self-expanding heart valve prosthesis is deployed at the annulus of the native heart valve. The self-expanding heart valve prosthesis shortens during deployment. As the self-expanding heart valve prosthesis is deployed, the outer sheath is retracted proximally and the push rod is simultaneously advanced distally to compensate for the shortening of the self-expanding heart valve prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The accompanying drawings incorporated herein form a part of the specification and illustrate embodiments of the delivery system. Together with the specification, the accompanying drawings further explain the principles by which a person skilled in the relevant art can make, use and implant the prosthesis described herein. In the accompanying drawings, the same reference numerals represent the same or functionally similar elements.

[0009] Figure 1 is a side view of a delivery system according to an embodiment of the present invention, wherein the delivery system is in a delivery configuration.

[0010] Figure 1A For along Figure 1 The line AA intercepts Figure 1 Cross-sectional view of the delivery system.

[0011] Figure 1B yes Figure 1 A perspective view of a distal portion of a delivery system of FIG. 1 , wherein the delivery system is in a delivery configuration and an outer sheath of the delivery system is not shown for illustrative purposes only.

[0012] Figure 2 yes Figure 1 Side view of a delivery system in which the delivery system is in a deployed configuration.

[0013] Figure 3 is a side perspective view of a heart valve prosthesis for use in an embodiment thereof.

[0014] Figure 4 for Figure 3 End view of a heart valve prosthesis.

[0015] Figure 5A yes Figure 3 A side view of a heart valve prosthesis in a delivery or compressed configuration with the proximal or inflow end of the heart valve prosthesis aligned along the plane of the native valve annulus.

[0016] Figure 5B yes Figure 3 A side view of a heart valve prosthesis in a deployed or expanded configuration wherein the proximal or inflow end of the heart valve prosthesis is spaced from the plane of the native valve annulus.

[0017] Fig. 6A yes Figure 3 A side view of a heart valve prosthesis in a delivery or compressed configuration with the proximal or inflow end of the heart valve prosthesis aligned along the plane of the native valve annulus.

[0018] Figure 6B yes Figure 3 A side view of a heart valve prosthesis in a deployed or expanded configuration wherein the proximal or inflow end of the heart valve prosthesis remains aligned along the plane of the native valve annulus.

[0019] Figure 7 yes Figure 1 An enlarged cross-sectional view of the handle of the delivery system.

[0020] Figure 8 yes Figure 1 A perspective view of the internal components of a handle of a delivery system of FIG. 1 , with the internal components removed from the handle for illustration purposes only.

[0021] Fig. 9 yes Figure 1 Another enlarged cross-sectional view of the handle of the delivery system.

[0022] Fig.10 yes Figure 1A perspective view of a first bracket and a fixed frame of a handle of a delivery system of FIG. 1 , wherein the first bracket and the fixed frame are removed from the handle for illustration purposes only.

[0023] Fig.11 yes Figure 1 A perspective view of a first bracket of a handle of a delivery system of FIG. 1 , wherein the first bracket is removed from the handle for illustration purposes only.

[0024] Fig.12 yes Figure 1 A perspective view of a cap assembly of a handle of a delivery system of FIG. 1 , wherein the cap assembly is removed from the handle for illustration purposes only.

[0025] Fig.13 yes Figure 1 A perspective view of the internal components of a handle of a delivery system of FIG. 1 , wherein the internal components are removed from the handle for illustration purposes only and some internal components are shown in phantom lines for illustration purposes only.

[0026] Fig.14 yes Figure 1 Another enlarged cross-sectional view of the handle of the delivery system.

[0027] Fig.15 Illustration of the use Figure 1 The first step in the delivery system approach to deploy Figure 3 A heart valve prosthesis is shown in a delivery or compressed configuration at a target treatment site.

[0028] Fig.16 Illustration of the use Figure 1 The second step of the method of delivery system is to deploy Figure 3 A heart valve prosthesis is provided in which the heart valve prosthesis is shown transitioning from a delivery or compressed configuration to a deployed or expanded configuration at a target treatment site.

[0029] Fig.17 Illustration of the use Figure 1 The third step of the method of delivery system is to deploy Figure 3 A heart valve prosthesis is shown in a deployed or expanded configuration after deployment at a target treatment site. DETAILED DESCRIPTION

[0030] Specific embodiments of the present invention are now described with reference to the accompanying drawings, wherein the same reference numerals indicate the same or functionally similar elements. Unless otherwise noted, for delivery systems, in the following description, the terms "distal" and "proximal" are used with respect to the position or direction relative to the treating clinician. "Distal" and "distally" are positions away from the clinician or in the direction away from the clinician, and "proximal" and "proximally" are positions close to the clinician or in the direction toward the clinician. For prosthesis, "proximal" refers to the part closer to the heart through the blood flow path, and "distal" refers to the part of the prosthesis further away from the heart through the blood flow path. In addition, the term "self-expanding" is used in the following description with reference to one or more stent structures of the prosthesis of the present invention, and is intended to convey that these structures are formed or formed by materials that can provide mechanical memory so that the structure is returned to the expanded deployment configuration from a compressed or contracted delivery configuration. Non-exhaustive illustrative self-expanding materials include stainless steel, pseudo-elastic metals such as nickel titanium alloy or nitinol, various polymers or so-called superalloys, which may have a base metal of nickel, cobalt, chromium or other metals. Mechanical memory may be imparted to a wire or stent structure by heat treatment, such as to achieve spring tempering in stainless steel, or to set shape memory in sensitive metal alloys such as nitinol. Various polymers that can be made to have shape memory properties may also be suitable for use in embodiments of the present invention, to include polymers such as polynorbornene, trans-polyisoprene, styrene-butadiene, and polyurethane. Poly LD lactic acid copolymers, oligocaprolactone copolymers, and polycyclooctane may also be used alone or in combination with other shape memory polymers.

[0031] The following detailed description is merely illustrative in nature and is not intended to limit the invention or the application and use of the invention. Although the invention is described primarily in the context of heart valve treatment, the invention may also be used in any body passageway where it is considered useful. For example, the present invention may be used with any self-expanding prosthesis configured to shorten during deployment, and may be used in any body passageway where such a self-expanding prosthesis is considered useful. As used herein, "prosthesis" or "prostheses" may include any prosthesis, including one or more self-expanding structures, including but not limited to heart valve prostheses, stents, stent-graft prostheses, uncovered stents, bare metal stents, drug-eluting stents, and any self-expanding structure configured to shorten during deployment.

[0032] Embodiments of the present invention relate to a delivery device with improved positioning accuracy for percutaneous delivery of a self-expanding prosthesis. A self-expanding prosthesis typically shortens during deployment. In other words, the length of a self-expanding prosthesis in a delivery or compressed configuration is typically longer than the length of a self-expanding prosthesis in a deployed or expanded configuration. Since the self-expanding prosthesis may move away from the target position in situ during its deployment after being positioned at the target position by the clinician, such shortening may result in difficulty in accurately positioning the self-expanding prosthesis. Embodiments of the present invention relate to a delivery system configured to compensate for the shortening of the self-expanding prosthesis during deployment to ensure its accurate positioning. The clinician does not need to adjust the position of the self-expanding prosthesis during deployment, so the delivery system reduces the reliance on the experience and ability of the clinician. In addition, embodiments of the delivery system described herein reduce the force applied to the interface between the delivery device and the self-expanding prosthesis because the self-expanding prosthesis does not remain stationary at such an interface. More specifically, when the self-expanding prosthesis is configured to shorten during deployment, a force of up to 9N may be applied to the interface between the delivery device and the self-expanding prosthesis when the self-expanding prosthesis is forced to remain stationary during deployment. However, in embodiments of the present invention, the self-expanding prosthesis is advanced distally during deployment to compensate for its shortening and the forces at the interface between the delivery device and the self-expanding prosthesis are reduced or minimized.

[0033] The delivery system 100 will be described in more detail with reference to the accompanying drawings. The delivery system 100 includes a self-expanding prosthesis 101 configured to shorten during its deployment and a delivery device 110 configured to percutaneously deliver the self-expanding prosthesis 101. More specifically, the delivery system 100 is Figure 1 , 1A , 1B and 2. Figure 1 1 is a side view of the delivery system 100 with the outer sheath 112 shown in the delivery configuration, wherein the outer sheath 112 surrounds and constrains the self-expanding prosthesis 101 in the compressed or delivery configuration ( Figure 1A not shown). Figure 1A It is along Figure 1 A cross-sectional view taken along line AA. Figure 1B is a perspective view of the distal portion of the delivery system 100 in a delivery configuration, but without the outer sheath 112 for illustrative purposes only. Figure 2 1 is a side view of the delivery system 100 after the outer sheath 112 has been retracted to allow the prosthesis 101 to self-expand to the deployed or expanded configuration. The delivery device 110 includes a handle 140 having an actuator 142 thereon. The components of the handle 140 will be referred to herein as Figure 7-14 Describe in detail.

[0034] In addition to the outer sheath 112 operably coupled to the handle 140, the delivery device 110 also includes a push rod 122 slidably disposed within the outer sheath 112 and operably coupled to the handle 140, and an inner shaft 132 disposed within the push rod 122. The outer sheath 112, the push rod 122, and the inner shaft 132 all extend distally from within the handle 140. As will be explained in more detail herein, the outer sheath 112 and the push rod 122 are configured to be actuated by an actuator 142 on the handle 140 along the central longitudinal axis L of the delivery device 110. A The outer sheath 112 and the push rod 122 are simultaneously moved or translated in opposite axial directions to compensate for the shortening of the self-expanding prosthesis 101 during deployment. In other words, to deploy the self-expanding prosthesis 101, the outer sheath 112 is retracted proximally to expose the self-expanding prosthesis 101, and the push rod 122 is simultaneously advanced distally to push the self-expanding prosthesis 101. The outer sheath 112 and the push rod 122 are configured to move at different rates, so that the push rod 122 is configured to be advanced distally by a predetermined distance that compensates for the shortening of the self-expanding prosthesis 101.

[0035] The outer sheath 112 has a proximal end 114 and a distal end 116 disposed within the handle 140. Figure 1A As best shown, the outer sheath 112 defines an inner lumen 118 and is slidably and concentrically disposed on a push rod 122. The distal portion of the outer sheath 112 defines a capsule 120. The capsule 120 is configured to retain the self-expanding prosthesis 101 in a folded configuration for delivery to a desired treatment location, as will be described in greater detail herein. Although the capsule 120 is described herein as a distal portion of the outer sheath 112, the capsule 120 may be a separate component coupled to the distal end of the outer sheath 112. Furthermore, although the outer sheath 112 is described herein as a single component, this is not meant to limit the design, and the outer sheath 112 may include components such as, but not limited to, a proximal shaft or other components suitable for the purposes described herein.

[0036] When the outer sheath 112 is disposed on the self-expanding prosthesis 101, the push rod 122 has a proximal end 124 disposed within the handle 140 and a distal end 126 disposed within the outer sheath 112. The distal end 126 of the push rod 122 includes a mandrel 108 that is releasably coupled to one end of the self-expanding prosthesis 101 so that the self-expanding prosthesis moves axially with the push rod 122. Figure 1B As best shown in a perspective view of FIG. 1 , with outer sheath 112 removed for illustration purposes only, mandrel 108 is a tubular member having at least one recess 107A formed on its outer surface that is configured to receive a paddle 107B extending proximally from self-expanding prosthesis 101. Paddle 107B fits within or cooperates with recess 107A of mandrel 108, allowing self-expanding prosthesis 101 to move axially simultaneously with push rod 122. Although in FIG. Figure 1BOnly one recess 107A is visible in the figure, but a person skilled in the art will understand that the mandrel 108 may include two or more recesses for receiving the mating paddles of the self-expanding implant 101, such as first and second recesses in opposite positions on the mandrel 108. Figure 1A As best shown, the push rod 122 defines an inner cavity 128 and is concentrically disposed on an inner shaft 132. The inner shaft 132 has a proximal end 134 extending proximally from the handle 140 and a distal end 136. Figure 1 and 2 As shown, a tapered flexible nose cone or distal tip 133 can be coupled to the distal end 136 of the inner shaft 132. Figure 1A As best shown, the inner shaft 132 defines a lumen 138 so that the delivery system 100 can be slidably disposed and advanced over the guidewire 109. The inner shaft 132 can be coupled to the push rod 122 at the mandrel 108 so that the inner shaft 132 and the push rod 122 move axially as an assembly.

[0037] The inner shaft 132 is configured to receive the self-expanding prosthesis 101 on a distal portion thereof, and the outer sheath 112 is configured to compress and retain the self-expanding prosthesis 101 on the distal portion of the inner shaft 132 during delivery, such as Figure 1 In other words, the outer sheath 112 surrounds and constrains the self-expanding prosthesis 101 in a compressed or delivery configuration. As previously described, the distal end 126 of the push rod 122 includes the mandrel 108 to which the self-expanding prosthesis 101 is releasably coupled. The self-expanding prosthesis 101 moves axially with the push rod 122. The self-expanding prosthesis 101 is Figure 2 , but in Figure 1 During in situ deployment of the self-expanding prosthesis 101, the outer sheath 112 is proximally retracted relative to the prosthesis 101, thereby gradually exposing the self-expanding prosthesis 101 until the self-expanding prosthesis 101 is fully exposed and thereby released from the delivery device 110. More specifically, when the outer sheath 112 is proximally retracted beyond the mandrel 108, the paddles 107B of the self-expanding prosthesis 101 are no longer retained within the recesses 107A of the mandrel and the self-expanding prosthesis 101 is allowed to self-expand to its deployed configuration.

[0038] Figure 3 and Figure 4A side perspective view and an end view, respectively, of a heart valve prosthesis 301 that can be used as a self-expanding prosthesis 101 according to an embodiment of the present invention are shown. The heart valve prosthesis 301 is merely exemplary and is described in more detail in U.S. Patent Application Publication 2011 / 0172765 to Nguyen et al., the entire contents of which are incorporated herein by reference. It should be understood that a variety of alternative heart valve prostheses can be used with the delivery devices and quantities described herein. In addition, the delivery device 110 can also be used with other self-expanding prostheses, such as stent graft prostheses, uncovered stents, bare metal stents, drug eluting stents, and any self-expanding structure configured to shorten during deployment.

[0039] Heart valve prosthesis 301 includes an expandable stent or frame 306 that supports a prosthetic valve component 308 within the interior of frame 306. In an embodiment thereof, frame 306 is self-expanding to return from a compressed or contracted delivery state to an expanded state. Figure 3 and Figure 4 In the illustrated embodiment, the frame 306 has an expanded, longitudinally asymmetric hourglass configuration including a first end or portion 302 and a relatively enlarged second end or portion 304. Each portion of the frame 306 can be designed to have a variety of different configurations and sizes to meet the different requirements of the location where it can be implanted. When configured as an aortic valve replacement, for example as described in more detail herein Figure 15-17 As shown, the first end 302 serves as the inflow end of the heart valve prosthesis 301 and extends into and is anchored in the aortic annulus of the patient's left ventricle, while the enlarged second end 304 serves as the outflow end of the heart valve prosthesis 301 and is located in the ascending aorta of the patient. When configured as a replacement for the mitral valve, the enlarged second end 304 serves as the inflow end of the heart valve prosthesis 301 and is positioned in the patient's left atrium, while the first end 302 serves as the outflow end of the heart valve prosthesis 301 and extends into and is anchored in the mitral annulus of the patient's left ventricle. For example, U.S. Patent Application Publication 2012 / 0101572 to Kovalsky et al. and U.S. Patent Application Publication 2012 / 0035722 to Tuval describe heart valve prostheses configured to be placed in the mitral valve, each of which is incorporated herein by reference in its entirety. Each portion of frame 306 may have the same or different cross-sections, such as circular, oval, rectangular, hexagonal, rectangular, square, or other polygonal shapes, although it is presently believed that circular or oval shapes may be preferred when providing a valve prosthesis to replace an aortic valve or a mitral valve. Figure 3 and 4 As an alternative to the deployed asymmetric hourglass configuration of the valve, the frame 306 can have a symmetrical hourglass configuration, a generally tubular configuration, or other support configurations or shapes known in the art for valve replacement.

[0040] As previously described, heart valve prosthesis 301 includes a prosthetic valve component 308 within a frame 306. Prosthetic valve component 308 is capable of blocking flow in one direction to regulate flow through valve leaflets, which may form a mitral or tricuspid replacement valve. Figure 4 yes Figure 3 , and illustrates an exemplary tricuspid valve having three leaflets, although a mitral valve leaflet configuration may alternatively be used in embodiments of the present invention. More specifically, if the heart valve prosthesis 301 is configured to be placed within a native valve having three leaflets, such as an aortic valve, a tricuspid valve, or a pulmonary valve, the heart valve prosthesis 301 may include three leaflet leaflets. If the heart valve prosthesis 301 is configured to be placed within a native valve having two leaflets, such as a mitral valve, the heart valve prosthesis 301 may include two valve leaflets. As known to those of ordinary skill in the art of prosthetic tissue valve construction, the leaflets are sutured or otherwise securely and sealingly attached to the inner surface of a frame 306 and / or a graft material 307 surrounding or lining the frame 306. The leaflets are attached to the graft material 307 along their bases, for example, using sutures or a suitable biocompatible adhesive. Adjacent pairs of leaflets are attached to each other at their lateral ends to form commissures. The orientation of the leaflets within the frame 306 will vary depending on which end of the heart valve prosthesis 301 is the inflow end and which end of the heart tube valve prosthesis 301 is the outflow end, thereby ensuring unidirectional blood flow through the heart valve prosthesis 301 .

[0041] The leaflets may be made of pericardial material; however, the leaflets may also be made of another material. Natural tissue for replacement leaflets may be obtained, for example, from heart valves, aortic roots, aortic walls, aortic valve leaflets, pericardial tissue such as pericardial patches, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue, and the like from humans or animals. Synthetic materials suitable for use as leaflets include those commercially available from Invista North America SARL of Wilmington, Delaware. Polyester, other cloth materials, nylon blends, polymeric materials, and vacuum deposited nitinol manufacturing materials. One polymeric material from which the leaflets can be made is an ultra high molecular weight polyethylene material commercially available from Royal DSM of the Netherlands under the trade name DYNEEMA. For certain leaflet materials, it may be desirable to coat one or both sides of the leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the leaflet material be durable and not subject to stretching, deformation, or fatigue.

[0042] The graft material 307 can also be a natural or biological material, such as pericardium or another membranous tissue, such as intestinal submucosa. Alternatively, the graft material 307 can be a low-porosity woven fabric, such as polyester, Dacron fabric or PTFE, which forms a one-way fluid channel when attached to the support. In one embodiment, the graft material 307 can be a knitted or woven polyester, such as polyester or PTFE knitted fabric, which can be used when it is necessary to provide a medium for tissue ingrowth and to enable the fabric to stretch to conform to a curved surface. Polyester velvet fabric can be used alternatively, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. For example, these and other suitable cardiovascular fabrics can be commercially available from Bard Peripheral Vascular, Inc. of Tempe, Ariz., Tempe, Arizona, USA.

[0043] Heart valve prosthesis 301 is designed or configured to have a specific amount of shortening or contraction that reduces its length when radially expanded. As heart valve prosthesis 301 radially expands, the diameter of heart valve prosthesis 301 increases and the length decreases. In other words, heart valve prosthesis 301 is configured to shorten as heart valve prosthesis 301 transitions between a delivery or compressed configuration to a deployed or expanded configuration.

[0044] Figure 5A-5B The in-situ displacement or movement of a heart valve prosthesis 301 when deployed using a standard delivery system that does not compensate for foreshortening is shown. Figure 5A-5B , a plane representing the native annulus AN is depicted adjacent a first end or inflow end 302 of a heart valve prosthesis 301 . Figure 5A is a side view illustration of a heart valve prosthesis 301 in a delivery or compressed configuration, wherein a first end or inflow end 302 is shown aligned with or positioned at the native annulus AN. Although the heart valve prosthesis 301 is removed from the delivery device for illustration purposes only, it should be understood that at this stage of deployment, the outer sheath of the standard delivery system is disposed over the entire length of the heart valve prosthesis 301 and constrains or compresses the heart valve prosthesis 301 into the delivery or compressed configuration.

[0045] Figure 5B 301 is a side view of a heart valve prosthesis 301 in a deployed or expanded configuration after the outer sheath of a standard delivery system has been fully proximally retracted to expose the entire length of the heart valve prosthesis 301. When the heart valve prosthesis 301 is deployed, as shown in FIG. Figure 5BAs shown, it shortens or contracts from a first length L1 to a second length L2, and due to the shortening, a first end or inflow end 302 of the prosthetic heart valve 301 moves away from the native annulus AN such that the prosthetic heart valve 301 is a distance D1 from the target position.

[0046] The delivery device 110 is configured to compensate for the shortening of the heart valve prosthesis 301 so that the first end or inflow end 302 is accurately positioned at the native valve annulus AN. More specifically, the distal advancement or movement of the push rod 122 during the deployment of the heart valve prosthesis 301 ensures that the first end or inflow end 302 of the heart valve prosthesis 301 remains positioned at the native valve annulus AN during deployment. In one embodiment, the heart valve prosthesis 301 is configured to shorten by a distance D1 during its deployment, and the push rod 122 (whose distal end is releasably coupled to the heart valve prosthesis 301) is configured to distally advance the heart valve prosthesis 301 by the same amount, i.e., the distance D1, during deployment. For example, the heart valve prosthesis 301 can be configured to shorten by a distance of 8 mm during its deployment, and then the push rod 122 is configured to distally advance the heart valve prosthesis 301 by a distance of 8 mm during deployment to compensate for the shortening of the heart valve prosthesis 301.

[0047] Figure 6A-6B The transition of the heart valve prosthesis 301 when deployed using the delivery system 110 configured to compensate for the shortening of the heart valve prosthesis 301 is shown. Figure 6A-6B , a plane representing the native annulus AN is depicted adjacent a first end or inflow end 302 of a heart valve prosthesis 301 . Fig. 6A is a side view illustration of a heart valve prosthesis 301 in a delivery or compressed configuration, wherein a first end or inflow end 302 is shown aligned with or positioned at the native annulus AN. Although the heart valve prosthesis 301 is removed from the delivery device 110 for illustration purposes only, it should be understood that at this stage of deployment, the outer sheath 112 of the delivery system 110 is disposed over the entire length of the heart valve prosthesis 301 and constrains or compresses the heart valve prosthesis 301 into the delivery or compressed configuration.

[0048] Figure 6B 1 is a side view of heart valve prosthesis 301 in a deployed or expanded configuration after outer sheath 112 of delivery system 110 is fully proximally retracted to expose the entire length of heart valve prosthesis 301. When heart valve prosthesis 301 is deployed, as shown in FIG. Figure 6B As shown, it shortens or contracts from the first length L1 to the second length L2. However, due to the distal advancement of the push rod 122, the first end or inflow end 302 of the heart valve prosthesis 301 remains aligned or positioned at the native valve annulus AN, as shown in FIG. Figure 6B shown.

[0049] Steering Figure 7 and 8 , the handle 140 will now be described in more detail. Figure 7 is an enlarged cross-sectional view of the handle 140, Figure 8 1 is a perspective view of some of the internal components of the handle 140. The handle 140 includes an actuator 142, a cap assembly 148 having a screw 154, a fixed grip 156, a fixed frame 164, a first bracket 160 attached to the proximal end 114 of the outer sheath 112, and a second bracket 166 attached to the proximal end 124 of the push rod 122. The inner shaft 132 passes through the push rod 122 and through the lumen of the screw 154, and its proximal end 134 extends proximally to the outside of the handle 140. As described above, although in Figure 7 Not shown, the guide wire 109 may be slidably disposed through the inner shaft 132 .

[0050] The actuator 142 is Figure 7 144, but may have alternative configurations as would be appreciated by one of ordinary skill in the art. The handle 140 is configured such that actuation of the actuator 142 in a first direction causes the outer sheath 112 to retract proximally and the push rod 122 to simultaneously advance distally. In other words, when the rotatable housing 144 is rotated in a first or clockwise direction, the outer sheath 112 is retracted proximally and the push rod 122 is simultaneously advanced distally. Actuation of the actuator 142 in a second or opposite direction causes the outer sheath 112 to advance distally and the push rod 122 to retract proximally. In other words, when the rotatable housing 144 is rotated in a second or counterclockwise direction, the outer sheath 112 is advanced distally and the push rod 122 is simultaneously retracted proximally.

[0051] like Figure 7 As best shown, the rotatable housing 144 is a generally tubular structure having a threaded inner wall, i.e., a second set of threads 146 is formed or disposed on its inner surface, which will be described in more detail below. The fixed frame 164 is a generally tubular structure disposed within the rotatable housing 144 and is further fixed or attached to a fixed grip 156 disposed at the distal end of the handle 140. The fixed grip 156 may include a textured outer surface 158 and is configured to be held fixed by a clinician during rotation of the rotatable housing 144 and operation of the handle 140. Similarly, the fixed frame 164 is fixedly attached to the fixed grip 156 and remains fixed during rotation of the rotatable housing 144 and operation of the handle 140.

[0052] The interaction between the handle 140 and the outer sheath 112 will be further described with reference to Figure 9-11 Describe in more detail. Fig. 9 is another enlarged cross-sectional view of the handle 140, and Fig.10 is a perspective view showing the first bracket 160 and the fixing frame 164 removed from the handle 140 for illustration purposes. Fig.11 1 is a perspective view of the first bracket 160 removed from the handle 140 for illustration purposes only. The proximal end 114 of the outer sheath 112 is disposed within the first bracket 140 and is fixedly attached to the first bracket such that the outer sheath 112 moves axially with the first bracket 140 disposed within a fixed frame 164. The first bracket 160 includes a first set of threads 162 on its outer surface that are configured to mate with a second set of threads 146 on the inner surface of the rotatable housing 144. Due to the threaded relationship between the first bracket 160 and the rotatable housing 144, and also because the first bracket 160 is prevented from rotating, as described in more detail below, the outer sheath 112 translates longitudinally with the first bracket 160 when the rotatable housing 144 rotates.

[0053] More specifically, as in Figure 9-11 As best shown in FIG. 1 , the first bracket 160 is provided with a threaded outer wall, i.e., a first set of threads 162 on its outer surface. The threaded outer wall of the first bracket 160 extends through two opposing slots 165A, 165B of the fixed frame 164. Each slot 165A, 165B is a slot, channel, gap, window or opening formed in or through the side wall of the fixed frame 164. In this way, the first set of threads 162 on the first bracket 160 extends or is positioned through the opposing slots 165A, 165B of the fixed frame 164 and cooperates with the second set of threads 146 on the inner surface of the rotatable housing 144. In addition, because the first bracket 160 is disposed within the fixed frame 164 and the first set of threads 162 on the first bracket 160 extends or is positioned through the opposing slots 165A, 165B of the fixed frame 164, the first bracket 160 is prevented from rotating with the rotatable housing 144. In other words, the wall of each slot 165A, 165B of the fixing frame 164 is disposed adjacent to each side of the first set of threads 162 on the first bracket 160 to prevent the first bracket 160 from rotating.

[0054] As the rotatable housing 144 rotates, the rotatable housing 144 does not move axially due to mechanical engagement with the fixed grip 156 and the fixed frame 164 attached thereto. More specifically, the fixed grip 156 and the fixed frame 164 attached thereto are configured to remain stationary during rotation of the rotatable housing 144 and operation of the handle 140. As the rotatable housing 144 rotates, the rotatable housing 144 rotates without translational or axial movement because the rotatable housing 144 abuts the fixed grip 156 and the fixed frame 164 attached thereto.

[0055] When the rotatable housing 144 rotates, the threaded engagement between the first set of threads 162 of the first bracket 160 and the second set of threads 146 of the rotatable housing 144 causes axial movement or translation of the first bracket 160 and the outer sheath 112 attached thereto. The threads 146, 162 are used to convert rotational motion into translational or linear motion. More specifically, because the first bracket 160 is prevented from rotating therewith due to engagement with the walls of each slot 165A, 165B of the fixed frame 164 as described above, and because the rotatable housing 144 does not move axially due to the fixed grip 156 and the fixed frame 164 attached thereto, the rotational motion of the rotatable housing 144 and the first bracket 160 is converted into translational or linear motion of the first bracket 160 due to the threaded relationship between the first bracket 160 and the rotatable housing 144.

[0056] The interaction between the handle 140 and the push rod 122 will be further referred to. Figure 12-14 Describe in more detail. Fig.12 is a perspective view of the cap assembly 148 removed from the handle 140 for illustration purposes only, and Fig.13 is a perspective view showing the second bracket 166 and the cap assembly 148 removed from the handle 140 for illustration purposes. Fig.14 1 is an enlarged cross-sectional view of a portion of the handle 140, illustrating the interaction between the second bracket 166 and the fixed frame 164. The proximal end 124 of the push rod 122 is attached to the second bracket 166 disposed within the fixed frame 164. The second bracket 166 includes a third set of threads 168 on its inner surface, which are configured to mate with a fourth set of threads 154 on the outer surface of the screw 152 of the cap assembly 148. Due to the threaded relationship between the second bracket 166 and the cap assembly 148, when the clinician rotates the rotatable housing 144, the push rod 122 and the second bracket 166 translate longitudinally.

[0057] More specifically, refer to Fig.12 , the cap assembly 148 includes a cap 150 and a screw 152 having a fourth set of threads 154 formed on an outer surface thereof. The cap assembly 148 forms the proximal end of the handle 140 and is fixedly attached to the rotatable housing 144 so that the cap assembly 148 rotates therewith. Fig.13 and 14As shown, the second bracket 166 includes a second bracket bracket 170 and a second bracket retainer 172. The second bracket bracket 170 is provided with a threaded inner wall, that is, a third set of threads 168 formed on its inner surface. The third set of threads 168 is configured to mate or engage with the fourth set of threads 154 formed on the outer surface of the screw 152. The second bracket retainer 172 is attached to the second bracket bracket 170 so that they move in the axial direction as an assembly. The second bracket retainer 170 is configured to receive and fixedly attach to the proximal end 124 of the push rod 122 so that the push rod 122 moves axially with the second bracket retainer 170. In addition, the second bracket retainer 170 is disposed in the fixed frame 164, and its shape is configured to prevent the second bracket 166 from rotating with the screw 152. In other words, the second bracket holder 170 has a non-circular cross-section that abuts the inner wall of the fixed frame 164 having a circular cross-section to prevent the second bracket holder 170 from rotating therein, thereby similarly preventing rotation of the second bracket 166 .

[0058] When the rotatable housing 144 rotates, the cap assembly 150 having the screw 152 rotates therewith, and the threaded engagement between the third set of threads 168 of the second bracket 166 and the fourth set of threads 154 of the screw 152 causes the second bracket 166 and the push rod 122 attached thereto to move axially or translate. The threads 168, 154 are used to convert rotational motion into translational or linear motion. More specifically, because the second bracket 166 is prevented from rotating due to the engagement of the second bracket retainer 172 with the inner wall of the fixed frame 164 as described above, the rotational motion of the rotatable housing 144 / cap assembly 150 and the second bracket 166 is converted into translational or linear motion of the second bracket 166 due to the threaded relationship between the second bracket 166 and the screw 152 of the cap assembly 150.

[0059] It is noteworthy that the first set of threads 162 on the first bracket 160 are oppositely inclined (i.e., have different hand directions) from the third set of threads 168 on the second bracket 166 to provide axial translation of the outer sheath 112 and the push rod 122 in opposite directions. In other words, because the first set of threads 162 on the first bracket 160 has an opposite pitch to the third set of threads 168 on the second bracket 166, the outer sheath 112 and the push rod 122 are configured to axially translate in opposite directions. In order to allow the outer sheath 112 and the push rod 122 to move in opposite directions by rotation of a single actuator (i.e., the rotating housing 144), the mating threads 162, 146 are oppositely inclined (i.e., have different hand directions) to mate with the threads 154, 168. When the rotatable housing 144 rotates, the threaded engagement between the first set of threads 162 of the first bracket 160 and the second set of threads 146 of the rotatable housing 144, and the threaded engagement between the third set of threads 168 of the second bracket and the fourth set of threads 154 of the screw 152 of the cap assembly 148 cause axial movement or translation of the outer sheath 112 and the push rod 122 in opposite or relative axial directions.

[0060] In addition, the outer sheath 112 and the push rod 122 are configured to move simultaneously in opposite axial directions at different rates, wherein the push rod 122 is configured to move at a lower rate than the outer sheath 112. The meshing thread pairs may include different pitches such that the first bracket 160 and the second bracket 166 move at different rates. More specifically, the first group of threads 162 on the first bracket 160 has a first pitch and the third group of threads 168 on the second bracket 166 has a second pitch. The first pitch of the first group of threads 162 is higher than the second pitch of the third group of threads 168, such that the push rod 122 is configured to move or translate at a lower rate than the outer sheath 112. In one embodiment, the outer sheath 112 is configured to move at least 50% faster than the push rod 122. In addition, in one embodiment, the push rod 122 is configured to advance at a rate distribution corresponding to the shortening rate of the self-expanding prosthesis 101. As described above with respect to Figure 6A-6B As described, the self-expanding prosthesis 101 is configured to shorten the distance D1 during its deployment, and the push rod 122 is configured to advance the self-expanding prosthesis 101 distally by the same amount during deployment. The rate profile of the push rod 122 can be configured so that the push rod 122 advances the self-expanding prosthesis 101 distally by the same amount as the self-expanding prosthesis 101 shortens, while the rate profile of the outer sheath 112 can be configured to retract the full length of the self-expanding prosthesis 101 proximally to fully deploy the self-expanding prosthesis 101. Although the different retraction rates of the outer sheath 112 and the advancement of the push rod 122 are described herein as being achieved by different pitches of the first set of threads 162 and the third set of threads 168, this is not meant to be limiting, and other means may be used to achieve the different rates.

[0061] Methods of delivering and deploying a heart valve prosthesis 301 using a delivery device 110 are described in Figure 15-17 As described in Fig.15 As shown, according to techniques known in the field of interventional cardiology and / or interventional radiology, a delivery system 100 including a delivery device 110 is advanced transluminally through the vascular system in a retrograde manner to a treatment site, in this case a diseased native aortic valve AV target extending between the patient's left ventricle LV and the patient's aorta A. Delivery of the delivery system 100 to the native aortic valve AV is achieved through a percutaneous transfemoral approach, wherein the delivery system tracks through the femoral artery, up the aorta and around the aortic arch to reach the native aortic valve AV. The delivery system 100 can also be positioned in a desired area of ​​the heart by different delivery methods known in the art for approaching a heart valve. As shown, the delivery system 100 travels along a guidewire 109 that has been previously inserted into the patient's vascular system. During delivery, since the heart valve prosthesis 301 is self-expanding, the heart valve prosthesis 301 remains compressed within the sac 120 of the outer sheath 112 as the delivery system 100 is manipulated and navigated through the vascular system. The delivery system 100 is advanced until its distal tip 133 is distal to the native aortic valve AV and disposed within the left ventricle LV, as shown in FIG. Fig.15 As shown, a first end 302 of the heart valve prosthesis 301 (which is the inflow end and the proximal end of the heart valve prosthesis 301 when the heart valve prosthesis 301 is configured for placement in the native aortic valve) is positioned at the annulus of the native aortic heart valve.

[0062] like Fig.16 , which is a cross-sectional view of a native aortic heart valve AV, with a heart valve prosthesis 301 deployed at the annulus of the native aortic heart valve AV and the heart valve prosthesis 301 shortening during deployment. During deployment of the heart valve prosthesis 301, the outer sheath 112 (and the sac 120 forming the distal portion of the outer sheath 112) are proximally retracted and the push rod 122 is simultaneously advanced distally. Because the distal end 126 of the push rod 122 is releasably coupled to the thermal valve prosthesis 301, the distal advancement of the push rod 122 pushes the heart valve prosthesis 301 to compensate for the shortening of the heart valve prosthesis 301. More specifically, the rotatable housing 144 ( Fig.16160 is rotated in a first direction (i.e., clockwise) to cause the second bracket 166 to translate distally as indicated by directional arrow 1680A and the first bracket 160 to translate proximally as indicated by directional arrow 1680B. Movement of the first bracket 160 in the proximal direction indicated by directional arrow 1680B causes the outer sheath 112 fixed thereto to move with the first bracket 160. Movement of the second bracket 166 in the distal direction indicated by directional arrow 1680A causes the push rod 122 fixed thereto to move with the second bracket 166. Thus, rotation of the rotatable housing 144 causes the outer sheath 112 to retract proximally while causing the push rod 122 to advance distally. When the heart valve prosthesis 301 is deployed, the distal advancement of the push rod 122 pushes the outflow end or second end 304 of the heart valve prosthesis 301, ensuring that the inflow end or first end 302 of the heart valve prosthesis 301 remains positioned at the annulus of the native aortic heart valve throughout the deployment process, and further ensuring that the inflow end or first end 302 of the heart valve prosthesis 301 is positioned at the annulus of the native aortic heart valve after deployment is completed. When the outer sheath 112 is retracted so that all of the heart valve prosthesis 301 is uncovered, the heart valve prosthesis 301 is released from the push rod 122, for example by releasing it from the spindle 108 on the distal end 126 of the push rod 122. Fig.17 As shown, after deployment of heart valve prosthesis 301 is complete, delivery device 110 is then removed and heart valve prosthesis 301 remains deployed within the native target heart valve.

[0063] The above description has been presented for the purpose of illustration and implementation, and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Based on the above teachings, other modifications and variations are possible. In order to best explain the principles of the present invention and its practical application, embodiments and examples are selected and described, and the embodiments and examples thus enable other technical personnel in the field to best utilize the present invention in various embodiments and various modifications suitable for the specific purpose envisioned. The attached claims are intended to be interpreted as including other alternative embodiments of the present invention.

Claims

1. A delivery device for percutaneously delivering a self-expanding prosthesis, the delivery device comprising: a handle having an actuator; an outer sheath including a proximal end coupled to the handle; a push rod slidably disposed within the outer sheath, the push rod having a proximal end coupled to the handle; and an inner shaft disposed within and coupled to the push rod, the inner shaft including a distal portion configured to receive the self-expanding prosthesis thereon, the distal end of the distal portion of the inner shaft being provided with a distal tip, wherein the distal tip, the inner shaft, and the push rod are configured to move axially as an assembly from a delivery orientation, wherein in the delivery orientation, the distal portion of the inner shaft is disposed within the outer sheath, the distal tip being engaged with and distal to the distal end of the outer sheath in the delivery orientation, and in the deployment orientation, the distal portion of the inner shaft is disposed outside of the outer sheath, and the distal tip is distally spaced from the distal end of the outer sheath in the deployment orientation, Wherein the outer sheath and the push rod are configured to be simultaneously moved in opposite axial directions between the delivery orientation and the deployment orientation by actuation of an actuator.

2. The delivery device of claim 1, wherein the outer sheath and the push rod are configured to move simultaneously in opposite axial directions at different rates, the push rod being configured to move at a lower rate than the outer sheath.

3. The delivery device of claim 2, wherein the outer sheath is configured to move at least 50% faster than the push rod.

4. The delivery device of claim 1 , wherein actuation of the actuator in a first direction causes the outer sheath to retract proximally and the push rod to advance distally and actuation of the actuator in a second direction causes the outer sheath to advance distally and the push rod to retract proximally.

5. The delivery device of claim 1, wherein the actuator is a rotatable housing of the handle.

6. A delivery device according to claim 5, wherein the proximal end of the outer sheath is attached to a first bracket arranged within the rotatable housing of the handle so that the outer sheath translates longitudinally with the first bracket, and the first bracket includes a first set of threads on its outer surface, which is configured to cooperate with a second set of threads on the inner surface of the rotatable housing.

7. The delivery device of claim 6, wherein the proximal end of the push rod is attached to a second bracket disposed within the housing of the handle such that the push rod translates longitudinally with the second bracket, the second bracket comprising a third set of threads on an inner surface thereof configured to cooperate with a fourth set of threads on an outer surface of a cap assembly configured to rotate with the rotatable housing.

8. The delivery device of claim 7, wherein the first set of threads and the third set of threads comprise opposite pitch directions.

9. The delivery device of claim 8, wherein the first set of threads has a first pitch and the third set of threads has a second pitch, the first pitch being higher than the second pitch.

10. A system comprising: a self-expanding prosthesis configured to shorten during its deployment; A delivery device configured to percutaneously deliver the self-expanding prosthesis, the delivery device comprising a handle having an actuator; an outer sheath including a proximal end coupled to the handle; a push rod slidably disposed within the outer sheath, the push rod having a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis so that the self-expanding prosthesis moves axially therewith when coupled thereto, an inner shaft disposed within and coupled to the push rod, wherein the self-expanding prosthesis is disposed on a distal portion of the inner shaft during delivery thereof, the distal end of the distal portion of the inner shaft being provided with a distal tip, wherein the distal tip, the inner shaft, and the push rod are configured to move axially as an assembly from a delivery orientation, wherein in the delivery orientation, the distal portion of the inner shaft is disposed within the outer sheath, the distal tip being engaged with and distal to the distal end of the outer sheath in the delivery orientation, and in the deployment orientation, the distal portion of the inner shaft is disposed outside of the outer sheath, and the distal tip is distally spaced from the distal end of the outer sheath in the deployment orientation, and Wherein the outer sheath and the push rod are configured to be simultaneously moved in opposite axial directions between the delivery orientation and the deployed orientation by actuation of an actuator to compensate for shortening of the self-expanding prosthesis during deployment.

11. The system of claim 10, wherein the self-expanding prosthesis is a heart valve prosthesis.

12. The system of claim 10, wherein the self-expanding prosthesis is configured to shorten a first distance during deployment thereof, and the push rod is configured to advance the self-expanding prosthesis distally the first distance during deployment.

13. The system of claim 10, wherein the outer sheath and the push rod are configured to move simultaneously in opposite axial directions at different rates, the push rod being configured to move at a lower rate than the outer sheath.

14. The system of claim 10, wherein the pushrod is configured to advance at a rate profile corresponding to a shortening rate of the self-expanding prosthesis.

15. The system of claim 10, wherein actuation of the actuator in a first direction causes the outer sheath to retract proximally and the push rod to advance distally and actuation of the actuator in a second direction causes the outer sheath to advance distally and the push rod to retract proximally.

16. The system of claim 10, wherein the actuator is a rotatable housing of the handle.

Images