Delivery device with controlled release shaft for improved positioning of a transcatheter heart valve

Abstract

The present invention relates to a delivery device comprising a control release shaft and a pusher shaft disposed within the control release shaft. A distal end of the control release shaft comprises a collar having a beveled distal edge. The control release shaft is rotatable so as to rotate the collar. The pusher shaft has a distal end having a mandrel coupled thereto. The mandrel is configured to receive at least one connector extending from at least one terminal crown of a self-expanding prosthesis so as to releasably attach the self-expanding prosthesis to the pusher shaft. The collar is configured to radially constrain the terminal crown and the connector of the self-expanding prosthesis when disposed over the terminal end of the self-expanding prosthesis. Actuation of an actuator of the delivery device rotates the collar relative to the mandrel and proximally retracts the collar to effect incremental release of the terminal crown and the connector of the self-expanding prosthesis.

Description

Technical Field

[0001] This invention relates to a delivery apparatus and method for delivering self-expanding prostheses. Background Technology

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

[0003] Generally, prostheses are not deployed through potentially invasive open surgery, but rather preferably via a less invasive endovascular delivery procedure. More specifically, the prosthesis is percutaneously entered into the lumen or vascular system at a convenient and less invasive access point and guided through the vascular system to the site of deployment. Intraluminal deployment is typically performed using a delivery catheter device with a coaxial inner and outer cannula arranged for relative axial movement. For example, a heart valve prosthesis may be compressed and positioned distal to the outer cannula or sheath. The delivery catheter is then manipulated, typically through the body cavity, until the distal end of the delivery catheter and the prosthesis are positioned at the intended treatment site. The inner cannula or axis is then held stationary while the outer cannula of the delivery catheter is withdrawn. A stop or prosthesis retainer may be used to prevent the prosthesis from being withdrawn along with the outer cannula. As the outer cannula is withdrawn, the prosthesis is released from the constraints of the outer cannula and self-expands radially, such that at least a portion of the prosthesis contacts and substantially conforms to a portion of the interior surrounding the body cavity (e.g., a vessel wall or anatomical catheter).

[0004] While transcatheter delivery methods have provided a safer and less invasive way to replace defective natural heart valves, complications can occur, including vascular trauma due to percutaneous delivery within highly curved anatomy and / or due to the large delivery profile of the prosthesis, inaccurate placement of the heart valve prosthesis, conduction disturbances, coronary artery obstruction, and / or undesirable paravalvular leakage and / or regurgitation at the implantation site. More specifically, for example, a prosthesis positioned too deep relative to the natural valve annulus or placed unevenly within the natural valve annulus in terms of depth can cause conduction disturbances. In another example, if the prosthesis is not centered relative to the natural valve annulus, the deployed prosthesis may displace from the implantation site and / or undesirable paravalvular leakage and / or regurgitation may occur. Therefore, after the prosthesis is fully deployed, it must be accurately positioned relative to the natural valve annulus.

[0005] Embodiments of the present invention relate to a delivery device for a transcatheter valve prosthesis, the delivery device being used to position the valve prosthesis in situ with improved accuracy to address one or more of the aforementioned complications. Summary of the Invention

[0006] Embodiments of the present invention relate to a delivery device for percutaneous delivery of a self-expanding prosthesis, the delivery device comprising a handle having at least one actuator thereon, a control release shaft, and a push rod shaft disposed within the control release shaft. The self-expanding prosthesis has a first end and a second end, the second end being proximal to the first end when the self-expanding prosthesis is loaded onto the delivery device. The control release shaft has a proximal end operably coupled to the handle and a distal end including a collar with a sloping distal edge. The control release shaft is rotatable via actuation of at least one actuator of the handle to rotate the collar. The push rod shaft has a proximal end operably coupled to the handle and a distal end having a prosthesis retaining member or mandrel coupled thereto. The prosthesis retaining member or mandrel is configured to receive at least one connector extending from at least one distal coronal portion of the self-expanding prosthesis for releasably attaching the self-expanding prosthesis to the push rod shaft. When disposed over the second end of the self-expanding prosthesis, the collar is configured to radially restrict the distal coronal portion of the self-expanding prosthesis and at least one connector. Actuation of at least one actuator of the handle causes the collar to rotate relative to the mandrel and retract proximally to achieve incremental release of the distal coronal portion of the self-expanding prosthesis and at least one connector.

[0007] The embodiments also relate to a system including a self-expanding prosthesis and a delivery device configured for percutaneous delivery of the self-expanding prosthesis. The self-expanding prosthesis has a first end and a second end, the second end being adjacent to the first end when the self-expanding prosthesis is loaded onto the delivery device. The self-expanding prosthesis includes a plurality of distal crowns at the second end and at least one connector extending from at least one distal crown. The delivery device includes a handle having at least one actuator thereon, a control release shaft, and a push rod shaft disposed within the control release shaft. The control release shaft has a proximal end operably coupled to the handle and a distal end including a collar with a sloped distal edge. The control release shaft is rotatable via actuation of at least one actuator of the handle to rotate the collar. The push rod shaft has a proximal end operably coupled to the handle and a distal end having a prosthesis holding member or mandrel coupled thereto. The prosthesis holding member or mandrel is configured to receive at least one connector extending from at least one distal crown of the self-expanding prosthesis to releasably attach the self-expanding prosthesis to the push rod shaft. When positioned above the second end of the self-expanding prosthesis, the collar is configured to radially restrict the distal coronal portion of the self-expanding prosthesis and at least one connector. Actuation of at least one actuator of the handle causes the collar to rotate relative to the mandrel and retract proximally, thereby achieving incremental release of the distal coronal portion of the self-expanding prosthesis and at least one connector.

[0008] Embodiments of the present invention also relate to a delivery device for percutaneous delivery of a self-expanding prosthesis, the delivery device comprising a handle having at least one actuator thereon, an outer sheath, a control release shaft disposed within the outer sheath, a push rod shaft disposed within the control release shaft, and an inner shaft disposed within the push rod shaft, the inner shaft having a distal portion configured to receive the self-expanding prosthesis thereon. The self-expanding prosthesis has a first end and a second end, the second end being adjacent to the first end when the self-expanding prosthesis is loaded onto the delivery device. The outer sheath includes a proximal end operably coupled to the handle and a distal portion configured to compressively restrict the self-expanding prosthesis during delivery. The outer sheath is retractable relative to the self-expanding prosthesis. The control release shaft has a proximal end operably coupled to the handle and a distal end including a collar having a sloped distal edge. The control release shaft is rotatable via actuation of at least one actuator of the handle to rotate the collar. The push rod shaft has a proximal end operably coupled to the handle and a distal end having a prosthesis holding member or mandrel coupled thereto. The prosthesis retaining member or mandrel is configured to receive at least one connector extending from at least one distal coronal portion of the self-expanding prosthesis for releasable attachment of the self-expanding prosthesis to the pushrod shaft. When positioned above a second end of the self-expanding prosthesis, a collar is configured to radially restrict the distal coronal portion of the self-expanding prosthesis and at least one connector. Actuation of at least one actuator of the handle causes the collar to rotate relative to the mandrel and retract proximally to achieve incremental release of the distal coronal portion of the self-expanding prosthesis and at least one connector.

[0009] Embodiments of the invention also relate to a method of delivering a heart valve prosthesis to a treatment site within a body cavity. A delivery device, on which the heart valve prosthesis is loaded, is advanced through a vascular system. The heart valve prosthesis has a first end and a second end, the second end being adjacent to the first end when the heart valve prosthesis is loaded onto the delivery device. The delivery device includes a control release shaft having a distal end comprising a collar with a sloping distal edge. The heart valve prosthesis includes a plurality of distal coronals at its second end, a first connector extending from at least one of the distal coronals, and a second connector extending from another distal coronal. The first and second connectors are coupled to a prosthesis holding member or spindle of the delivery device, and the heart valve prosthesis is held in a radially compressed configuration within an outer sheath of the delivery device. The heart valve prosthesis is positioned at the treatment site. The outer sheath of the delivery device is retracted to expose the first end of the heart valve prosthesis, thereby allowing the first end of the heart valve prosthesis to expand radially. The outer sheath of the delivery system is further retracted to expose the second end of the heart valve prosthesis. A collar controlling the release axis radially restricts the distal coronary portion of the heart valve prosthesis and the first and second connectors, such that the first and second connectors of the heart valve prosthesis remain engaged with the heart axis of the delivery device after the outer sheath is retracted. At least one actuator of the delivery device is rotated to retract the collar proximally relative to the heart axis to release the first connector of the heart valve prosthesis from the delivery device. After the first connector is released, the collar controlling the release axis radially restricts at least the second connector of the heart valve prosthesis, such that the second connector of the heart valve prosthesis remains engaged with the heart axis of the delivery device after the first connector is released. At least one actuator of the delivery device is further rotated to retract the collar proximally relative to the heart axis to release the second connector of the heart valve prosthesis from the delivery device, thereby allowing the second end of the heart valve prosthesis to expand radially. Attached Figure Description

[0010] The accompanying drawings, incorporated herein, form part of the specification and illustrate embodiments of the delivery system. Together with the specification, the drawings further explain, in conjunction with the specification, the principles by which those skilled in the art can manufacture, use, and implant the prostheses described herein. In the drawings, the same reference numerals denote the same or similarly functional elements.

[0011] Figure 1 This is a side view of a delivery system according to an embodiment of the present invention, wherein the delivery system includes a delivery device and a self-expanding prosthesis, the self-expanding prosthesis being shown in a delivery configuration.

[0012] Figure 1A It is along Figure 1 The line AA is intercepted Figure 1 A cross-sectional view of the delivery system.

[0013] Figure 1B yes Figure 1 A perspective view of the distal portion of the delivery system, in which the self-expanding prosthesis is in the delivery configuration and the outer sheath of the delivery device and the control release shaft are not shown for illustrative purposes only.

[0014] Figure 2 yes Figure 1 A side view of the delivery system, in which the self-expanding prosthesis is in the deployment configuration.

[0015] Figure 3 This is a side perspective view of a heart valve prosthesis used in an embodiment of the present invention.

[0016] Figure 4 for Figure 3 End view of a heart valve prosthesis.

[0017] Figure 5 yes Figure 1 A perspective side view of the control release axis of the delivery device, wherein the control release axis is shown as being removed from the delivery device for illustrative purposes only.

[0018] Figure 6 This is an illustration shown for illustrative purposes only, depicting the distal end of the control release shaft removed from the delivery system and the end of the self-expanding prosthesis, wherein the control release shaft is positioned above all the distal coronal portions of the self-expanding prosthesis.

[0019] Figure 7 This is an illustration shown for illustrative purposes only, depicting the distal end of the control release shaft removed from the delivery system and the end of the self-expanding prosthesis, wherein rotation of the control release shaft has been initiated, exposing some of the distal coronal portion of the self-expanding prosthesis.

[0020] Figure 8 This is an illustration shown for illustrative purposes only, depicting the distal end of the control release shaft removed from the delivery system and the end of the self-expanding prosthesis, wherein rotation of the control release shaft continues, exposing all the distal coronal portions of the self-expanding prosthesis.

[0021] Figure 9 This is an illustration shown for illustrative purposes only, depicting the distal end of the control release shaft removed from the delivery system and the end of the self-expanding prosthesis, wherein rotation of the control release shaft continues, causing one connector of the self-expanding prosthesis to be exposed and released from the mandrel.

[0022] Figure 10 It shows the use of Figure 1 Delivery device for deployment Figure 3 The first step of the method for the delivery of a heart valve prosthesis, wherein the heart valve prosthesis is positioned in a delivery or compression configuration at the target treatment site.

[0023] Figure 11It shows the use of Figure 1 Delivery device for deployment Figure 3 The second step of the method for a heart valve prosthesis, wherein the heart valve prosthesis is shown to change from a delivery or compression configuration to a deployment or expansion configuration at the target treatment site.

[0024] Figure 12 It shows the use of Figure 1 Delivery device for deployment Figure 3 The third step of the method for the heart valve prosthesis involves exposing the full length of the heart valve prosthesis and setting the control release axis above all the distal coronary portions of the self-expanding prosthesis.

[0025] Figure 13 It shows the use of Figure 1 Delivery device for deployment Figure 3 The fourth step of the method for the implantation of a heart valve prosthesis involves the exposure and release of a connector of the self-expanding prosthesis from the heart axis due to the rotation of the control release axis.

[0026] Figure 14 It shows the use of Figure 1 Delivery device for deployment Figure 3 The fifth step of the method for the heart valve prosthesis involves the exposure and release of both connectors of the self-expanding prosthesis from the heart axis due to the rotation of the control release axis.

[0027] Figure 15 It shows the use of Figure 1 Delivery device for deployment Figure 3 The sixth step of the method for the delivery of a heart valve prosthesis, wherein the heart valve prosthesis is shown in a fully deployed or expanded configuration after deployment at the target treatment site and the delivery device is removed.

[0028] Figure 16 This is a side perspective view of the handle used in an embodiment of the present invention.

[0029] Figure 17 yes Figure 16 An enlarged perspective view of the first actuator of the handle, wherein the first actuator has been removed from the handle housing for illustrative purposes only.

[0030] Figure 18 yes Figure 17 The first actuator is shown in a top view before its actuation.

[0031] Figure 19 yes Figure 17 The first actuator is shown in a top view after its actuation. Detailed Implementation

[0032] Specific embodiments of the invention will now be described with reference to the accompanying drawings, wherein like reference numerals indicate like or functionally similar elements. Unless otherwise stated, the terms “distal” and “proximal” are used in the following description with respect to position or orientation relative to the treating clinician. “Distal” and “distally” are positions away from or in a direction away from the clinician, and “proximal” and “proximally” are positions close to or toward the clinician. Additionally, the term “self-expanding” is used in the following description with reference to one or more scaffold structures of the prosthesis of the invention and is intended to convey that these structures are shaped or formed of a material that can provide mechanical memory so that the structure returns from a compressed or contracted delivery configuration to an expanded, unfolded configuration. Non-exhaustive illustrative self-expanding materials include stainless steel, pseudoelastic metals such as nickel-titanium alloys or nitinol, various polymers, or so-called superalloys that may have a base metal of nickel, cobalt, chromium, or other metals. Mechanical memory can be imparted to wire or support structures through heat treatment, for example, to achieve spring tempering in stainless steel or to set shape memory in sensitive metal alloys such as nickel-titanium. A variety of polymers that can be formulated to have shape memory properties are also suitable for embodiments of the invention, including polymers such as polynorbornene, trans-polyisoprene, styrene-butadiene, and polyurethane. PolyLD lactic acid copolymers, oligomeric caprolactone copolymers, and polycyclooctane can also be used alone or in combination with other shape memory polymers.

[0033] The following detailed description is illustrative in nature and is not intended to limit the invention or its application and use. Although the embodiments of the invention are described in the context of a delivery system for delivering a heart valve prosthesis within a natural aortic valve, the delivery system of the invention can also be used in other areas of the body, such as for delivering a heart valve prosthesis within a natural mitral valve, for delivering a heart valve prosthesis within a natural pulmonary valve, for delivering a heart valve prosthesis within a natural tricuspid valve, for delivering a venous valve, or for delivering a heart valve prosthesis within a failed previously implanted prosthesis. Furthermore, it is not intended that one be bound by any express or implied theory presented in the foregoing technical field, background art, summary of the invention, or the following detailed description.

[0034] Embodiments of the present invention relate to a delivery device for percutaneously delivering a self-expanding prosthesis with improved positioning accuracy. The self-expanding prosthesis has a first end and a second end, the second end being adjacent to the first end when the self-expanding prosthesis is loaded onto the delivery device. The delivery device includes a control release shaft that controls the release or deployment of the second end of the self-expanding prosthesis. The additional constraint on the second end of the self-expanding prosthesis improves positioning accuracy because the self-expanding prosthesis can be moved away from the target location in situ when the second end of the self-expanding prosthesis is released from the delivery device after being positioned in the target location by a clinician. In particular, the self-expanding prosthesis can move or tilt during full deployment or release from the delivery device due to kinetic energy stored within the second end of the self-expanding prosthesis upon release, which is undesirable. Embodiments of the present invention relate to controlling the release of a connector attached to the second end of the self-expanding prosthesis such that the connector is released gradually or incrementally. The control release shaft is configured to release the connector gradually and incrementally to counteract the effect of the frame expansion force. As will be explained in more detail herein, the control release shaft is rotatable such that when the control release shaft rotates or turns, it retracts simultaneously due to the actuator of the handle at the proximal end of the delivery device, resulting in the connector disengaging or separating individually and sequentially from the delivery device. The speed at which the connector is released from the delivery device is controlled by the rotational rate of the control release shaft, thus slowing down the final step of the self-expanding prosthesis deployment and further preventing uncontrolled release of the self-expanding prosthesis from the delivery device. Therefore, the second end of the self-expanding prosthesis is selectively held, restricted, or otherwise controlled by the control release shaft to ensure accurate positioning of the self-expanding prosthesis when the second end is released from the delivery device during the final step of deployment.

[0035] The delivery system will be described in more detail with reference to the accompanying drawings. The delivery system 100 includes a self-expanding prosthesis 101 and a delivery device 110 configured to percutaneously deliver the self-expanding prosthesis 101 with improved positioning accuracy. The self-expanding prosthesis 101 has a first end 102 and a second end 104, the second end 104 being close to the first end 102 when the self-expanding prosthesis 101 is loaded onto the delivery device 110. More specifically, the delivery system 100 in… Figure 1 , 1A As shown in 1B and 2. Figure 1 This is a side view of the delivery system 100, wherein its outer sheath 112 surrounds and constrains the self-expanding prosthesis 101 in a radial compression or delivery configuration. Figure 1A (Not shown in the image). Figure 1A It is along Figure 1A The sectional view taken by line AA. Figure 1B This is a perspective view of the distal portion of the delivery system 100, but the outer sheath 112 and control release shaft 152 of the delivery device 110 are not shown for illustrative purposes only. Figure 2This is a side view of the delivery system 100 after the outer sheath 112 has retracted to allow the self-expanding prosthesis 101 to self-expand and the self-expanding prosthesis 101 has been released from the control release shaft 152 into its fully deployed or expanded configuration. The delivery device 110 includes a handle 140 having a first actuator 142 and a second actuator 144. The first actuator is used to rotate the control release shaft 152, as will be explained in more detail herein, and the second actuator is used to manipulate the outer sheath 112, as will be explained in more detail herein. The handle 140 may have any shape or size suitable for convenient operation by the user.

[0036] In addition to the outer sheath 112 operably connected to the handle 140, the delivery device 110 also includes a control release shaft 152 disposed within the outer sheath 112, a push rod shaft 122 disposed within the control release shaft 152, and an inner shaft 132 disposed within the push rod shaft 122. The outer sheath 112, the control release shaft 152, the push rod shaft 122, and the inner shaft 132 each extend distally from within the handle 140.

[0037] The outer sheath 112 has a proximal end (not shown) and a distal end 116, the proximal end terminating within and operably coupled to the handle 140. For example... Figure 1A As best shown, the outer sheath 112 defines the inner cavity 118 and is slidably and concentrically positioned above the control release shaft 152. As used herein, "slidably" means along or substantially parallel to the central longitudinal axis L of the delivery system 100 in the longitudinal direction. A The outer sheath 112 extends back and forth. The distal portion of the outer sheath 112 defines the capsule 120. The capsule 120 is configured to compressively hold the self-expanding prosthesis 101 in a collapsed configuration for delivery to the desired treatment location. Although the capsule 120 is described herein as the distal portion of the outer sheath 112, the capsule 120 may be a separate component attached to the distal end of the outer sheath 112. Furthermore, although the outer sheath 112 is described herein as a single component, this does not imply limitation to the design, and the outer sheath 112 may contain components such as, but not limited to, a proximal axis or other components suitable for the purposes described herein.

[0038] A second actuator 144 of the handle 140 is configured for retracting the capsule 120. The second actuator 144 is coupled to the outer sheath 112 and is generally configured to provide selective proximal retraction and distal advance of the capsule 120, attached to the outer sheath, relative to the self-expanding prosthesis 101 held therein in a radially compressed delivery configuration, to cover and expose the self-expanding prosthesis 101. The second actuator 144 may employ any configuration capable of providing the desired sheath actuation function, such as those described in U.S. Patent No. 8,579,963 to Tabor, assigned to the same assignee as this disclosure, which is incorporated herein by reference in its entirety.

[0039] For further reference Figure 5 This figure is a perspective side view of a control release shaft 152, shown for illustrative purposes only, removed from the delivery device 110. The control release shaft 152 has a proximal end 154 and a distal end 156, the proximal end terminating within and operatively coupled to the handle 140, and the distal end positioned inside the outer sheath 112 when it is positioned above the self-expanding prosthesis 101. Figure 1A As best shown, the control release shaft 152 defines an inner cavity 158 and is concentrically positioned above the push rod shaft 122. The distal portion of the control release shaft 152 defines a collar 157 having an inclined or angled distal edge 160. The inclined distal edge 160 of the collar 157 is helical and includes a first or distal end 162 and a second or proximal end 164. More specifically, the inclined distal edge 160 of the collar 157 extends proximally from the distal end 162 along a helical path to the proximal end 164, such that the proximal end 164 is axially spaced from the distal end 162, thereby forming or defining an axial edge 166 extending between the proximal end 164 and the distal end 162. The axial edge 166 is along or substantially parallel to the central longitudinal axis L of the delivery system 100. A A straight or linear edge extending in the longitudinal direction. The inclined distal edge 160 surrounds the central longitudinal axis L of the delivery system 100. A It bends or coils in a spiral path. (As will be discussed in this article...) Figures 6 to 9 To explain in more detail, collar 157 is configured to radially restrict the second end 104 of the self-expanding prosthesis 101 until the operator selects to fully deploy and release the self-expanding prosthesis 101 from delivery device 110. While collar 157 is described herein as the distal portion of control release shaft 152, collar 157 may be a separate component coupled to the distal end of control release shaft 152. Furthermore, although control release shaft 152 is described herein as a single component, this does not imply limitation to the design, and control release shaft 152 may include components such as, but not limited to, a proximal shaft or other components suitable for the purposes described herein.

[0040] The first actuator 142 of the handle 140 is configured to rotate and simultaneously retract proximally the control release shaft 152. The first actuator 142 is coupled to the proximal end 154 of the control release shaft 152 and provides rotation or torsion of the control release shaft 152, particularly the collar 157 attached to it, relative to the self-expanding prosthesis 101 to expose the second end 104 of the self-expanding prosthesis 101. Figures 16 to 19 An exemplary first actuator 142 is shown and described in more detail below.

[0041] To improve the torsion flexibility of the control release shaft 152, a coil 168 may be embedded in the polymeric material of the control release shaft 152. The control release shaft 152 may be formed of one or more polymeric materials, non-exhaustive examples of which include laminated, blended, or co-extruded polyethylene, polyethylene block amide copolymers (PEBA), polyamides, and / or combinations thereof. The coil 168 is a reinforcing layer incorporated within the polymeric material to enhance the torsion flexibility of the control release shaft 152. A collar 157 is disposed distal to the distal end of the coil 168, and the collar 157 may be formed of the same polymeric material as the control release shaft 152. In another embodiment, in which the collar 157 is a separate component attached to the distal end of the control release shaft 152, the collar 157 may be formed of a material different from the polymeric material of the control release shaft. In one embodiment, the angled distal edge 160 of the collar 157 is formed of reflow polymeric material, but other manufacturing methods may also be used to shape the angled distal edge 160.

[0042] The push rod shaft 122 is positioned between the control release shaft 152 and the inner shaft 132. For example... Figure 1A As best shown, the push rod shaft 122 defines an inner cavity 128 and is concentrically disposed on an inner shaft 132. When the outer sheath 112 is disposed above the self-expanding prosthesis 101, the push rod shaft 122 has a proximal end (not shown) terminating within a handle 140 and a distal end 126 disposed within the outer sheath 112. The distal end 126 of the push rod shaft 122 includes a prosthesis retaining member or mandrel 108, which is releasably coupled to the end of the self-expanding prosthesis 101. Figure 1B The perspective view is best shown, with the outer sheath 112 removed for illustrative purposes only. The mandrel 108 is a tubular component having at least one recess 111A formed on its outer surface, configured to receive a connector 107 extending proximally from the distal crown of the self-expanding prosthesis 101. In embodiments, the connector 107 is a planar or flat component comprising a rod 115 and a blade 117. The rod 115 extends between the distal crown of the self-expanding prosthesis 101 and the blade 117. The blade 117 is relatively wider or has a greater width than the rod 115 and is configured or shaped to fit within or mate with the recess 111A of the mandrel 108. Although shown in a generally semi-circular configuration, the blade 117 may have other shapes, including circular, rectangular, triangular, or other suitable shapes, as long as it is configured to fit within or mate with the recess 111A of the mandrel 108. Figures 6 to 9As shown, the mandrel 108 includes a first recess 111A and a second recess 111B at opposite locations for receiving opposing connectors 107 of the self-expanding prosthesis 101. In another embodiment (not shown), those skilled in the art will understand that the mandrel 108 may include more or fewer than two recesses for receiving a corresponding number of connectors of the self-expanding prosthesis 101. The self-expanding prosthesis 101 includes at least one connector, but may include two or more connectors, as described herein. Figures 3 to 4 Described in more detail. Before the self-expanding prosthesis 101 is fully deployed, the collar 157 controlling the release shaft 152 radially restricts the distal crown of the self-expanding prosthesis and the connector 107. As will be discussed in this article regarding... Figures 6 to 9 To explain in more detail, the rotation of the control release shaft 152 relative to the spindle 108 causes the collar 157 to rotate and retract proximally, thereby achieving incremental release of the distal crown of the self-expanding prosthesis 101 and the connector 107.

[0043] The inner shaft 132 has a proximal end (not shown) and a distal end 136 that terminate within the handle 140. For example... Figure 1 and 2 As shown, the tapered flexible front cone or distal end 133 can be connected to the distal end 136 of the inner shaft 132. Figure 1A As shown in the best view, this diagram is along Figure 1 The image shows a cross-sectional view of the delivery system 100 taken from line AA. The inner shaft 132 defines an inner cavity 138, allowing the delivery system 100 to be slidably positioned and to travel along the guide wire 109. The inner shaft 132 can be coupled to the push rod shaft 122 at the spindle 108, such that the inner shaft 132 and the push rod shaft 122 are components.

[0044] The inner shaft 132 is configured to receive the self-expanding prosthesis 101 on its distal portion, and the outer sheath 112 is configured to compress and hold the self-expanding prosthesis 101 on the distal portion of the inner shaft 132 during delivery, as... Figure 1 As shown. In other words, the outer sheath 112 surrounds and radially constrains the self-expanding prosthesis 101 in a radially compressed or delivered configuration. As previously described, the distal end 126 of the pushrod shaft 122 includes a mandrel 108 to which the self-expanding prosthesis 101 is releasably coupled. The self-expanding prosthesis 101 in Figure 2 As shown in the view, but Figure 1 The self-expanding prosthesis 101 is concealed by an outer sheath 112. During in-situ deployment of the self-expanding prosthesis 101, the outer sheath 112 retracts proximally relative to the self-expanding prosthesis 101, thereby incrementally exposing the self-expanding prosthesis 101 until its entire length is fully exposed. However, during this deployment phase, as will be discussed herein... Figures 10 to 15As described in more detail, the second end 104 of the self-expanding prosthesis 101 remains connected to the delivery device 110 because the collar 157 of the control release shaft 152 is positioned above the distal crown of the self-expanding prosthesis 101 and the connector 107. Therefore, the connector 107 of the self-expanding prosthesis 101 is positioned within and connected to the mandrel 108 of the push rod shaft 122. Once the positioning of the self-expanding prosthesis 101 is confirmed, the control release shaft 152 rotates and retracts simultaneously due to the operation of the first actuator 142, to release the connector 107 from the mandrel 108 individually and incrementally. More specifically, after the inclined distal edge 160 is positioned proximal to the recesses 111A, 111B of the mandrel 108, the connector 107 of the self-expanding prosthesis 101 is no longer retained within the recesses 111A, 111B of the mandrel 108, and the self-expanding prosthesis 101 is allowed to self-expand to its deployment configuration. Therefore, once the control release shaft 152 rotates and retracts to the point where the two connectors 107 of the self-expanding prosthesis 101 are released from the mandrel 108, the self-expanding prosthesis 101 is fully deployed and released from the delivery device 110. Due to the gradual and controlled release of the second end 104 of the self-expanding prosthesis 101, the self-expanding prosthesis does not move or tilt when the second end 104 of the self-expanding prosthesis 101 is released from the delivery device 110.

[0045] Figure 3 and Figure 4 Side perspective and end views of a heart valve prosthesis 301, which can be used as a self-expanding prosthesis 101 according to an embodiment of the invention, are shown respectively. The heart valve prosthesis 301 is merely exemplary and is described in more detail in U.S. Patent Application Publication 2011 / 0172765 by Nguyen et al., the entire contents of which are incorporated herein by reference. It should be understood that any number of alternative heart valve prostheses can be used with the delivery device and method described herein. Furthermore, the delivery device 110 can also be used with other self-expanding prostheses, such as stent grafts, uncovered stents, bare metal stents, drug-eluting stents, and any self-expanding structure that can be moved or tilted during deployment when the second end of the delivery device is released from the delivery device.

[0046] The heart valve prosthesis 301 includes an expandable stent or frame 306 that internally supports the prosthetic valve component 313. In its embodiments, the frame 306 is self-expanding to return from a compressed or contracted delivery state to an expanded state. Figure 3 and Figure 4In the depicted embodiment, frame 306 has an expanded, longitudinally asymmetrical hourglass configuration, comprising a first end or portion 302 and a relatively enlarged second end or portion 304. Each portion of frame 306 can be designed with a variety of different configurations and sizes to meet different requirements for its implantation location. When constructing a replacement for the aortic valve, such as as described in more detail herein... Figures 10 to 15 As shown, the first end 302 serves as the inflow end of the heart valve prosthesis 301, while the enlarged second end 304 serves as the outflow end of the heart valve prosthesis 301 and is located in the patient's ascending aorta. When the heart valve prosthesis 301 is configured as a replacement for the aortic valve and is loaded onto a retrograde delivery system (such as delivery system 110, e.g., a femoral artery delivery system, a direct or aortic delivery system, or a subclavian delivery system), the second end 304 is positioned close to the first end 302, and the deployment of the second end 304 is controlled by a control release cannula 152. When the heart valve prosthesis 301 is configured as a replacement for the aortic valve and is loaded onto an antegrade delivery system, for example, for a transapical delivery system configured to deliver a replacement for the aortic valve, the second end serves as the inflow end and is positioned close to the first end, which serves as the enlarged outflow end. The deployment of the second end is controlled by a control release cannula 152.

[0047] When configured as a mitral valve replacement, the inflow end of the heart valve prosthesis 301 is enlarged and positioned in the patient's left atrium, while the outflow end of the heart valve prosthesis 301 extends into and is anchored within the mitral annulus of the patient's left ventricle. When the heart valve prosthesis 301 is configured as a mitral valve replacement and loaded onto a retrograde delivery system such as delivery system 110, a second end 304, serving as the outflow end, is positioned close to a first end 302, serving as the inflow end. The deployment of the second end 304 is controlled by a control release cannula 152. When the heart valve prosthesis 301 is configured as a mitral valve replacement and loaded onto an antegrade delivery system, such as a transseptal delivery system or a transatrial delivery system, configured to deliver a mitral valve replacement prosthesis, the second end 304 serves as an enlarged inflow end and is positioned close to the first end 302, which serves as the outflow end. The deployment of the second end 304 is controlled by a control release cannula 152. For example, U.S. Patent Application Publication No. 2012 / 0301572, granted to Kovalsky et al., and U.S. Patent Application Publication No. 2012 / 0035722, granted to Tuval, describe heart valve prostheses configured for placement 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, elliptical, rectangular, hexagonal, square, or other polygonal shapes, although it is currently considered that circular or elliptical shapes may be preferred when providing heart valve prostheses to replace the aortic or mitral valve. Figure 3and 4 As an alternative to the unfolded asymmetric hourglass configuration, frame 306 may have a symmetrical hourglass configuration, a generally tubular configuration, or other stent configurations or shapes known in the art for valve replacement.

[0048] Frame 306 includes a plurality of diamond-shaped openings formed by a plurality of crowns 303 and a plurality of struts 305, wherein each crown 303 is formed between a pair of opposing struts 305. Each crown 303 is a curved segment or bend extending between opposing struts 305. The plurality of crowns 303 and the plurality of struts 305 define a plurality of side openings. A series of terminal crowns 303A are formed at the inflow end or first end 302 of frame 306. The number of terminal crowns 303A can vary depending on size and application, and can be, for example, between 5 and 20 crowns. Similarly, a series of terminal crowns 303B are formed at the second end 304 of frame 306. The number of terminal crowns 303B can also vary depending on size and application, and can be, for example, between 5 and 20 crowns. Figures 3 to 4 In one embodiment, the first connector 307A extends proximally from the first distal coronary portion 303B of the heart valve prosthesis 301, and the second connector 307B extends proximally from the second distal coronary portion 303B of the heart valve prosthesis 301. The first connector 307A and the second connector 307B are located at opposite positions on the heart valve prosthesis 301 and are configured to be received within opposing recesses 111A, 111B of the heart axis 108, as described above. Figure 1B As stated above.

[0049] Although the heart valve prosthesis 301 includes a first connector 307A and a second connector 307B, those skilled in the art will understand that a heart valve prosthesis may include more or fewer than two connectors. For example, in one embodiment, the self-expanding prosthesis may include only a single connector extending from its distal coronary portion. In another embodiment, the self-expanding prosthesis may include three connectors extending from its three distal coronary portions, wherein the connectors are circumferentially equidistant around the second end of the prosthesis. In yet another embodiment, the self-expanding prosthesis may include four connectors extending from its four distal coronary portions, wherein the connectors are circumferentially equidistant around the second end of the prosthesis. A greater number of connectors can further control the final or complete release of the distal coronary portion. The number of recesses formed on the axial section 108 of the delivery device 110 is equal to the number of connectors extending from the second end of the self-expanding prosthesis.

[0050] As previously described, the heart valve prosthesis 301 includes a prosthetic valve component 313 within a frame 306. The prosthetic valve component 313 is capable of blocking flow in one direction to regulate flow through it via valve leaflets, which may form a mitral or tricuspid valve replacement valve. Figure 4 yes Figure 3 The diagram shows an end view and illustrates an exemplary tricuspid valve with three leaflets, although a mitral valve leaflet configuration may alternatively be used in embodiments of the invention. Furthermore, more than three leaflets may be used. As known to those skilled in the art of prosthetic tissue valve construction, the leaflets are sutured or otherwise securely and sealingly attached to the frame 306 and / or surrounding or lining the inner surface of the graft material 311 of the frame 306. For example, the leaflets are attached to the graft material 311 along their base using sutures or a suitable biocompatible adhesive. Adjacent pairs of leaflets are joined together at their lateral ends to form a commissure. 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 cardiac tube valve prosthesis 301 is the outflow end, thereby ensuring unidirectional blood flow through the heart valve prosthesis 301.

[0051] The leaflet can be made from pericardial material; however, it can be alternatively made from another material. Natural tissues used for valve replacement leaflets can be obtained from, for example, heart valves, aortic root, aortic wall, aortic leaflets, pericardial tissues such as pericardial patches, bypass grafts, blood vessels, submucosal intestinal tissue, umbilical tissue, and human or animal analogs. Suitable synthetic materials for use as leaflets include those commercially available from Invista North America SARL of Wilmington, DE. Polyester, other fabric materials, nylon blends, polymeric materials, and vacuum-deposited nickel-titanium alloys are used to manufacture leaflets. One polymeric material that can be used to make leaflets is ultra-high molecular weight polyethylene (UHMWPE), commercially available from Royal DSM, Netherlands, under the trade name DYNEEMA. For some 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 resistant to stretching, deformation, or fatigue.

[0052] The graft material 311 may also be a natural or biological material, such as the pericardium or another membranous tissue, such as the submucosa of the intestine. Alternatively, the graft material 311 may be a low-porosity woven fabric, such as polyester, polyester fabric, or PTFE, which forms a unidirectional fluid channel when attached to the stent. In one embodiment, the graft material 311 may 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 inward growth and to allow the fabric to stretch to conform to a curved surface. Alternatively, polyester velvet fabric may be used, for example, when it is necessary to provide a medium for tissue inward growth on one side and a smooth surface on the other side. These and other suitable cardiovascular fabrics are commercially available, for example, from Bard Peripheral Vascular, Inc. of Tempe, Arizona.

[0053] Now go to Figures 6 to 9 The deployment of the second end 304 of the heart valve prosthesis 301 will be described in more detail, along with the operation of the control release shaft 152 and the collar 157. Figure 6 This is an illustration shown for illustrative purposes only, depicting the distal end 156 of the control release shaft 152 removed from the delivery system, the prosthesis retaining member or spindle 108, and the second end 304 of the heart valve prosthesis 301. During this delivery phase, the outer sheath 112 and capsule 120 have been retracted proximally beyond the spindle 108. The control release shaft 152 remains positioned over and radially restricts all distal coronary portions 303B of the second end 304 of the heart valve prosthesis 301 until the operator selects to fully deploy and release the distal coronary portions 303B from the delivery device 110. The second end 304 of the heart valve prosthesis 301 remains coupled to the delivery device 110 because the collar 157 of the control release shaft 152 is positioned over the distal coronary portions 303B of the heart valve prosthesis 301 and the connectors 307A, 307B. The connectors 307A and 307B of the heart valve prosthesis 301 are located in the recesses 111A and 111B of the spindle 108.

[0054] Once the positioning of the self-expanding prosthesis 101 is confirmed, the first actuator 142 is rotated to initiate the deployment process. Figure 7 As shown, when the operator rotates or turns the first actuator 142, the control release shaft 152 rotates and simultaneously retracts axially in the proximal direction, and the tilted distal edge 160 rotates relative to the distal coronary portion 303B of the heart valve prosthesis 301. In other words, rotation of the first actuator 142 causes the control release shaft 152 to rotate and retract, as per [reference to...]. Figures 16 to 19To explain in more detail. Due to the operation of the first actuator 142, the control release shaft 152 moves axially or longitudinally during rotation to incrementally expose the distal coronary portion 303B of the second end 304 of the heart valve prosthesis 301 by tilting the distal edge 160. As rotation and proximal retraction occur, the distal coronary portions 303B of the second end 304 of the heart valve prosthesis 301 will be exposed as the tilted distal edge 160 passes over each distal coronary portion 303B, thereby exposing them and allowing them to self-expand. Figure 7 The diagram shows the stage where the control release shaft 152 has begun to rotate and some of the distal coronary portion 303B of the second end 304 of the heart valve prosthesis 301 is exposed. However, the tilted distal edge 160 remains positioned above and radially restrains most of the distal coronary portion 303B of the second end 304 of the heart valve prosthesis 301. The two connectors 307A, 307B of the heart valve prosthesis 301 are positioned within the recesses 111A, 111B of the shaft 108 and remain covered and radially restrained by the control release shaft 152.

[0055] exist Figure 8 In this embodiment, the rotation and proximal retraction of the control release shaft 152 continue, such that all the distal coronaries 303B of the second end 304 of the heart valve prosthesis 301 are exposed or revealed when the tilted distal edge 160 passes over the respective distal coronaries 303B. However, in this embodiment, the two connectors 307A, 307B of the heart valve prosthesis 301 are disposed within the recesses 111A, 111B of the shaft 108 and are still covered and radially restrained by the control release shaft 152. Although Figure 8 The image depicts the exposure of all distal coronary segments 303B while the two connectors 307A and 307B of the heart valve prosthesis 301 are still covered by the control release shaft 152. However, one of the connectors 307A and 307B may be exposed and allowed to self-expand before all distal coronary segments 303B are exposed. The specific order of deployment of the distal coronary segments 303B and the connectors 307A and 307B depends on the placement of the tilted distal edge 160.

[0056] Connectors 307A and 307B detach or separate individually and sequentially from the delivery device 110. Figure 9 In this process, the rotation of the control release shaft 152 and proximal retraction continue until the first connector 307A is exposed or revealed as the inclined distal edge 160 passes over it. Once exposed, the first connector 307A is released from the shaft 108 and allowed to self-expand. Self-expanding or partial self-expanding of the distal coronal portion 303B adjacent to the first connector 307A is also permitted. Although not in Figure 9As shown, the control release shaft 152 rotates until the two connectors 307A, 307B are released from the mandrel 108, thereby also releasing all distal coronals 303B and allowing all released distal coronals 303B to self-expand. The energy release that occurs when the distal coronals 303B are allowed to self-expand is staggered or dispersed, by incrementally and individually exposing the distal coronals 303B and connectors 307A, 307B. Although Figure 9 The diagram shows the first connector 307A being released before the second connector 308B is released, but the order of connector release can be reversed depending on the placement of the tilted distal edge 160.

[0057] The method of delivering and deploying the heart valve prosthesis 301 using the delivery device 110 Figures 10 to 15 As depicted in the text. For example... Figure 10 As shown, according to techniques known in the fields of interventional cardiology and / or interventional radiology, a delivery system 100, including a delivery device 110, is advanced retrogradely through the vascular system to reach a treatment site, in this case, the target of the diseased natural aortic valve AV extending between the patient's left ventricle (LV) and aorta (A). Delivery of the delivery system 100 to the natural aortic valve AV is achieved via a percutaneous transfemoral approach, wherein the delivery system follows through the femoral artery, upward along the aorta, and around the aortic arch to reach the natural aortic valve AV. The delivery system 100 can also be positioned within the desired area of ​​the heart using various delivery methods known in the art for accessing heart valves, such as direct aortic delivery or subclavian artery delivery. As shown, the delivery system 100 travels along a guidewire 109 previously inserted into the patient's vascular system. During delivery, because 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 end 133 is distal to the natural aortic valve AV and positioned within the left ventricle LV, as... Figure 10 As shown, the first end 302 of the heart valve prosthesis 301 (which is the inflow end of the heart valve prosthesis 301 when the heart valve prosthesis 301 is configured for placement in the natural aortic valve) is positioned at the annulus of the natural aortic heart valve.

[0058] like Figure 11As shown, this figure is a cross-sectional view of a natural aortic heart valve AV, with the inlet end 302 of the heart valve prosthesis 301 deployed at the annulus of the natural aortic heart valve AV via the proximal retraction of the outer sheath 112 and capsule 120. The outer sheath 112 and capsule 120 retract proximally via a second actuator 144 of the handle 140. During this deployment phase, the positioning of the delivery system 100 can still be adjusted, and / or the outer sheath 112 and capsule 120 can be advanced distally to recapture the heart valve prosthesis 301. For example, in one embodiment, the outer sheath 112 and capsule 120 can be advanced distally to recapture the heart valve prosthesis 301 until one or more connectors 307A, 307B of the heart valve prosthesis 301 have been released from the spindle 108 of the delivery device 110.

[0059] exist Figure 12 In this delivery phase, the outer sheath 112 and capsule 120 are fully retracted to expose the entire length of the heart valve prosthesis 301, and the second end 304 of the heart valve prosthesis 301 remains engaged or attached to the spindle 108 of the delivery device 110. More specifically, during this delivery phase, the outer sheath 112 and capsule 120 have been retracted proximally beyond the spindle 108. The outer sheath 112 and capsule 120 are retracted proximally via the second actuator 144 of the handle 140. The collar 157 controlling the release shaft 152 remains positioned above and radially restricts all the distal coronary portions 303B of the second end 304 of the heart valve prosthesis 301. Connectors 307A and 307B of the heart valve prosthesis 301 are positioned within the recesses 111A and 111B of the spindle 108, and the collar 157 is positioned above the connectors 307A and 307B and the distal coronary portion 303B. During this deployment phase, the outer sheath 112 and capsule 120 can be advanced distally to recapture the heart valve prosthesis 301.

[0060] When the control release shaft 152 rotates and retracts, connectors 307A and 307B individually and sequentially disengage or separate from the delivery device 110. Figure 13 In this deployment phase, the control release shaft 152 has been rotated and retracted, causing its tilted distal edge 160 to have passed over and exposed the first connector 307A of the heart valve prosthesis 301. The control release shaft 152 and the collar 157 are rotated and retracted via the first actuator 142 of the handle 140. Once exposed, the first connector 307A is released from the shaft 108. This allows the first connector 307A and the distal coronary portion 303B adjacent to the first connector 307A to self-expand or partially self-expand. During this deployment phase, the outer sheath 112 and the capsule 120 may no longer be advanced distally to recapture the heart valve prosthesis 301.

[0061] like Figure 14As shown, the control release shaft 152 rotates and retracts until both connectors 307A, 307B are released from the spindle 108. The control release shaft 152 and collar 157 rotate and retract via the first actuator 142 of the handle 140. When both connectors 307A, 307B are exposed or exposed, all distal coronary portions 303B are released from the delivery device 110 and allowed to self-expand. More specifically, when the tilted distal edge 160 is positioned proximal to the recesses 111A, 111B of the spindle 108, the connectors 307A, 307B of the heart valve prosthesis 301 are no longer retained within the recesses 111A, 111B of the spindle 108, and the second end 304 of the heart valve prosthesis 301 is allowed to self-expand to its deployment configuration. Therefore, once the control release shaft 152 rotates and retracts to the point where the two connectors 307A, 307B of the self-expanding prosthesis 101 are released from the axis 108, the heart valve prosthesis 301 is fully deployed and released from the delivery device 110. By incrementally and individually exposing the distal coronary portion 303B and connectors 307A, 307B, the energy release that occurs when the distal coronary portion 303B is allowed to self-expand is staggered or dispersed, and the self-expanding prosthesis 101 does not move or tilt when fully released from the delivery device 110. Figure 15 As shown, after the deployment of the heart valve prosthesis 301 is completed, the delivery device 110 is then removed and the heart valve prosthesis 301 remains deployed within the natural target heart valve.

[0062] Figures 16 to 19 An exemplary first actuator 142 is shown, which is configured to rotate and simultaneously retract proximally the control release shaft 152 to expose the second end 104 of the self-expanding prosthesis 101. Figure 16 An exemplary handle 1640 that can be used as a handle 140 is shown. The handle 1640 includes a first actuator 142 and a second actuator 144. Figure 17 This is an enlarged perspective view of the first actuator 142, with the housing 1641 of the handle 1640 removed for illustrative purposes. The first actuator 142 includes a rotatable knob 1670 accessible to a user for rotation, a first gear 1672 attached to the rotatable knob 1670 to rotate it therewith, a second gear 1674 cooperating with the first gear 1672 and disposed within the housing 1641 of the handle 1640, and a housing 1676 coupled to the first gear 1672 and further constrained to the housing 1641 of the handle 1640. The control release shaft 152 includes a cam slot or recess 1678 formed on its outer surface, extending through the housing 1676. In an embodiment, the cam slot 1678 is helical. The housing 1676 houses the first gear 1672 and an internal cam actuator (not shown) configured to engage with the cam slot 1678.

[0063] A rotatable knob 1670 protrudes from the housing 1641 of the handle 1640 at an angle of approximately ninety degrees. In operation, the rotatable knob 1670 is turned or rotated to rotate the first gear 1672 attached or fixed thereto. Consequently, as the first gear 1672 rotates, the second gear 1674, due to its relatively large size, also rotates at a reduced rate or speed compared to the first gear 1672. The proximal end 154 of the control release shaft 152 is attached to the first gear 1672 and rotates with it.

[0064] To allow the control release shaft 152 to retract proximally during rotation, a cam driver of housing 1676 interacts with or engages with a cam slot 1678 of control release shaft 152. Housing 1676 is attached or secured to housing 1641 of handle, thereby restricting its movement relative to control release shaft 152. As control release shaft 152 rotates with second gear 1674, cam slot 1678 engages with cam driver of housing 1676. More specifically, cam driver extends radially inward from the inner surface of housing 1676 and into a foot or protrusion in cam slot 1678. As control release shaft 152 and its cam slot 1678 rotate, cam driver of housing 1676 extends within cam slot 1678. Because the housing 1676 is attached or fixed to the housing 1641 of the handle, and thus prevents the housing from rotating with the control release sleeve 152, the rotation of the cam slot 1678 formed on the control release shaft 152 causes linear movement of the control release shaft 152, such as... Figures 18 to 19 As best shown. More specifically, Figure 18 A top view of the first actuator 142 prior to its actuation is shown, wherein the cam slot 1678 extends distally from the housing 1676. When the rotatable knob 1670 is turned, the control release shaft 152 rotates, and when the cam slot 1678 is pulled into the housing 1676 (due to the cam driver of the housing 1676 extending into the cam slot 1678 during the rotation of the control release shaft 152), the control release shaft retracts proximally, as... Figure 19 As shown in the top view. The control release shaft 152 and the second gear 1674 retract proximally relative to the housing 1676, the first gear 1672, and the rotatable knob 1670. Therefore, actuation of the first actuator 142 causes the control release sleeve 152 to rotate and retract proximally simultaneously.

[0065] The above-described embodiment includes an additional intermediate shaft, namely a control release shaft 152, which includes a collar 157 having a sloping distal edge 160 thereon for controlled, gradual release of the second end of the self-expanding prosthesis. The control release shaft 152 is rotatable and is positioned between the outer sheath 112 and a push rod shaft 122 having a mandrel 108 at its distal end. However, the collar 157 having the sloping distal edge 160 can be incorporated into different components of the delivery device 110. For example, in another embodiment, the collar 157 having the sloping distal edge 160 can be incorporated into the outer sheath 112 and the capsule 120. The outer sheath 112 can be configured to retract proximally to expose most of the length of the self-expanding prosthesis and can be configured to rotate once only the collar 157 having the sloping distal edge 160 covers the second end of the self-expanding prosthesis.

[0066] The foregoing description has been presented for illustrative and implementation purposes and is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Other modifications and variations are possible in accordance with the foregoing teachings. For the best explanation of the principles of the invention and its practical application, embodiments and examples have been selected and described, thereby enabling others skilled in the art to best utilize the invention in various embodiments and modifications suited to the particular intended use. The appended claims are intended to be construed as including other alternative embodiments of the invention.

Claims

1. A delivery device for percutaneous delivery of a self-expanding prosthesis, the self-expanding prosthesis having a first end and a second end, wherein when the self-expanding prosthesis is loaded onto the delivery device, the second end is proximate to the first end, the delivery device comprising: A handle having at least one actuator; A control release shaft having a proximal end operably coupled to the handle and a distal end including a collar with a sloping distal edge, wherein the control release shaft is rotatable via actuation of the at least one actuator of the handle to rotate the collar. and A push rod shaft, disposed within the control release shaft, has a proximal end operably coupled to the handle and a distal end having a mandrel coupled thereto, the mandrel being configured to receive at least one connector extending from at least one distal coronal portion of the self-expanding prosthesis for releasably attaching the self-expanding prosthesis to the push rod shaft. Wherein, when positioned above the second end of the self-expanding prosthesis, the collar is configured to radially restrict the distal crown portion of the self-expanding prosthesis and the at least one connector, and Actuation of at least one actuator of the handle causes the collar to rotate relative to the mandrel and retract proximally to achieve incremental release of the distal crown of the self-expanding prosthesis and the at least one connector.

2. The delivery device according to claim 1, further comprising: An outer sheath, the outer sheath including a proximal end operably coupled to the handle and a distal portion configured to compressively restrict the self-expanding prosthesis during delivery, wherein the control release shaft is disposed within the outer sheath and the outer sheath is retractable relative to the control release shaft.

3. The delivery device of claim 2, wherein the handle includes a first actuator and a second actuator, the first actuator being configured to rotate the control release shaft, and the second actuator being configured to retract the outer sheath proximally.

4. The delivery device of claim 2, wherein the at least one actuator of the handle is configured to rotate and simultaneously retract the control release shaft proximally.

5. The delivery device according to claim 1, further comprising: An inner shaft is disposed within the push rod shaft, the inner shaft having a distal portion configured to receive the self-expanding prosthesis thereon.

6. The delivery device of claim 5, wherein the inner shaft is configured to travel along the guide wire.

7. The delivery device of claim 1, wherein the inclined distal edge of the collar is helical.

8. The delivery device of claim 1, wherein the at least one connector comprises a first connector and a second connector, the first connector and the second connector being disposed at relative positions of the self-expanding prosthesis, and wherein the mandrel comprises a first recess configured to receive the first connector and a second recess configured to receive the second connector.

9. The delivery device of claim 1, wherein the control release shaft comprises a coil embedded in a polymer material.

10. The delivery device of claim 9, wherein the collar is disposed on the distal side of the coil.

11. The delivery device of claim 10, wherein the collar is formed of the polymer material.

12. The delivery device of claim 10, wherein the collar is formed of a material different from the polymer material.

13. The delivery device of claim 1, wherein the self-expanding prosthesis is a heart valve prosthesis.

14. A delivery device for percutaneous delivery of a self-expanding prosthesis, the self-expanding prosthesis having a first end and a second end, wherein when the self-expanding prosthesis is loaded onto the delivery device, the second end is proximate to the first end, the delivery device comprising: A handle having at least one actuator; An outer sheath, the outer sheath including a proximal end operably coupled to the handle and a distal portion configured to compressively restrict the self-expanding prosthesis during delivery, wherein the outer sheath is retractable relative to the self-expanding prosthesis; A control release shaft is disposed within the outer sheath, the control release shaft having a proximal end operably coupled to the handle and a distal end including a collar with an inclined distal edge, wherein the control release shaft is rotatable via actuation of the at least one actuator of the handle to rotate the collar. A push rod shaft, disposed within the control release shaft, the push rod shaft having a proximal end operably coupled to the handle and a distal end having a mandrel coupled thereto, the mandrel being configured to receive at least one connector extending from at least one distal coronal portion of the self-expanding prosthesis for releasably attaching the self-expanding prosthesis to the push rod shaft; and An inner shaft, disposed within the push rod shaft, having a distal portion configured to receive the self-expanding prosthesis thereon. Wherein, when positioned above the second end of the self-expanding prosthesis, the collar is configured to radially restrict the distal crown portion of the self-expanding prosthesis and the at least one connector, and Actuation of at least one actuator of the handle causes the collar to rotate relative to the mandrel and retract proximally to achieve incremental release of the distal crown of the self-expanding prosthesis and the at least one connector.

15. The delivery device of claim 14, wherein the inclined distal edge of the collar is helical.

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