Prosthetic heart valves and delivery devices

Abstract

The present invention relates to prosthetic heart valves and delivery devices. The present disclosure relates to embodiments of catheter-based prosthetic heart valves, and more particularly to embodiments of prosthetic heart valves having a sealing member configured to seal the interface between the prosthetic valve and surrounding tissue of the native annulus, wherein the prosthetic valve is implanted in the interface. The present disclosure also discloses novel methods for making an introducer sheath with an inner liner for percutaneously inserting a medical device into a patient.

Description

[0001] This application is a divisional application of divisional application 2019112167022, entitled “Artificial Heart Valve and Delivery Device,” filed on December 5, 2014. Divisional application 2019112167022 is a divisional application of Chinese patent application 2014800749526 (PCT / US2014 / 068872). Technical Field

[0002] The present disclosure relates to embodiments of prosthetic valves (eg, prosthetic heart valves) and delivery devices for implanting prosthetic valves. Background Art

[0003] For many years, artificial heart valves have been used to treat heart valve diseases. Native heart valves (such as the aortic valve, pulmonary valve and mitral valve) provide important functions in terms of ensuring that sufficient blood supply flows forward through the cardiovascular system. Due to congenital, inflammatory or infectious conditions, these heart valves can be rendered less effective. This damage to the valve can lead to serious cardiovascular damage or death. For many years, the definitive treatment for this disease has been surgical repair or replacement of the valve during open heart surgery, but this surgery is prone to many complications. Recently, transvascular technology has been developed for introducing and implanting artificial heart valves using flexible catheters in a less invasive manner than open heart surgery.

[0004] In this technique, a prosthetic valve is mounted in a crimped state on the end portion of a flexible catheter and advanced through the patient's blood vessels until the prosthetic valve reaches the implantation site. The prosthetic valve at the catheter tip is then expanded to its functional size at the site of the defective native valve, such as by expanding / inflating a balloon on which the prosthetic valve is mounted. Alternatively, the prosthetic valve can have a resilient, self-expanding stent or frame that expands the prosthetic valve to its functional size when the prosthetic valve is advanced from a delivery sheath at the distal end of the catheter.

[0005] The native valve annulus in which an expandable prosthetic valve is deployed often has an irregular shape, primarily due to calcification. As a result, small gaps may exist between the expansion frame of the prosthetic valve and the surrounding tissue. The gaps can allow backflow (leakage) of blood that flows in a direction opposite to the normal flow of blood through the valve. To minimize backflow, various sealing devices have been developed to seal the interface between the prosthetic valve and the surrounding tissue. Summary of the Invention

[0006] The present disclosure relates to embodiments of catheter-based prosthetic heart valves, and in particular, to embodiments of prosthetic heart valves having a sealing member configured to seal the interface between the prosthetic valve and surrounding tissue of the native annulus in which the prosthetic valve is implanted. The present disclosure also discloses novel methods for making an introducer sheath with an inner liner for percutaneously inserting a medical device into a patient.

[0007] In a representative embodiment, the artificial heart valve comprises a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for installation on a delivery device and expanded to a radially expanded state within the body. The frame has an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, and the frame comprises a plurality of struts defining a plurality of cells in a plurality of rows. The artificial heart valve also comprises a collapsible and expandable valve component mounted within the annular frame, and a collapsible and expandable skirt assembly mounted within the annular frame. The skirt assembly comprises an upper skirt, a lower skirt, and a sealing skirt. The upper skirt and the lower skirt prevent the sealing skirt from contacting the valve component and can also couple the valve component to the annular frame. When the annular frame expands to its radially expanded state, portions of the sealing skirt protrude outward through the grid of the frame.

[0008] In certain embodiments, the sealing skirt is made of loop yarn. In further embodiments, the sealing skirt is mounted within the annular frame of the prosthetic heart valve by sutures that secure the sealing skirt and the lower skirt to the frame of the prosthetic heart valve. In additional embodiments, the valve member is positioned radially outward from the lower skirt, the upper skirt is positioned radially outward from the valve member, and the sealing skirt is positioned radially outward from the upper skirt, relative to the longitudinal axis of the prosthetic heart valve. In further embodiments, the outflow portion of the lower skirt is sutured to the inflow portion of the valve member, and the inflow portion of the valve member is sutured to the inflow portion of the upper skirt.

[0009] In another exemplary embodiment, a method for making an introducer sheath with an inner liner for percutaneously inserting a medical device into a patient is provided. The method includes inserting a metal sleeve into a mold, inserting a polymer tube having a closed end and an open end into the metal sleeve, and applying pressure and heat to the polymer tube to cause the polymer tube to expand against an inner surface of the metal sleeve to form the inner liner of the sheath.

[0010] In a particular embodiment of the method, the preformed cylindrical polymer tube is made of nylon-12, polyethylene or fluorinated ethylene propylene copolymer (FEP). In a further embodiment, the liner formed by the polymer tube has a radial wall thickness of from about 0.025 mm (about 0.001 inch) to about 0.075 mm (about 0.003 inch). In more embodiments, the metal sleeve has a radial wall thickness of from about 0.05 mm (about 0.002 inch) to about 0.15 mm (about 0.006 inch). Pressurizing and heating the polymer tube can include injecting heated compressed gas into the polymer tube. Alternatively, pressurizing the polymer tube can include injecting compressed gas into the polymer tube and heating the polymer tube can include heating with a heat source separated from the pressurized gas. In several embodiments, the introducer sheath is configured to be used for percutaneously inserting an artificial heart valve through the patient's femoral artery.

[0011] In several embodiments, the method can include forming an introducer sheath having an inner liner and an outer liner for percutaneously inserting a medical device into a patient. In some embodiments of the method, a preformed cylindrical polymer tube is used to form the outer liner. In certain embodiments, the preformed cylindrical polymer tube used to form the outer liner can be made of nylon-12, polyether block amide, or polyethylene. In further embodiments, the outer liner has a radial wall thickness of from about 0.012 mm (about 0.0005 inches) to about 0.075 mm (about 0.003 inches).

[0012] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a perspective view of a prosthetic valve according to one embodiment that can be used to replace a native heart aortic valve.

[0014] Figure 2 for Figure 1 A perspective view of a portion of a prosthetic valve illustrating the connection of two leaflets to a support frame of the prosthetic valve.

[0015] Figure 3 for Figure 1 Side view of a support frame for a prosthetic valve.

[0016] Figure 4 for Figure 1 Perspective view of the support frame of a prosthetic valve.

[0017] Figure 5A A cross-sectional view of the heart showing a ventricular prosthesis implanted within the aortic valve annulus. Figure 1 artificial valve.

[0018] Figure 5B for Figure 5A , which illustrates an artificial valve implanted within the aortic valve annulus, wherein the leaflet structure of the artificial valve is removed for clarity.

[0019] Figure 6 Shown before being secured to the support frame Figure 1 A perspective view of the leaflet structure of a prosthetic valve.

[0020] Figure 7 for Figure 1 Cross-sectional view of a prosthetic valve.

[0021] Figure 8 is a cross-sectional view of an embodiment of a delivery device that can be used to deliver and implant a prosthetic valve, such as Figure 1 The prosthetic valve shown in .

[0022] Figures 8A to 8C for Figure 8 An enlarged cross-sectional view of a segment.

[0023] Figure 9 for Figure 8 Exploded view of the delivery device.

[0024] Figure 10 for Figure 8 Side view of the guide catheter of the delivery device.

[0025] Figure 11 for Figure 10 Perspective exploded view of the proximal portion of the guide catheter.

[0026] Figure 12 for Figure 10 Perspective exploded view of the distal portion of the guide catheter.

[0027] Figure 13 for Figure 8 Side view of the torque shaft catheter of the delivery device.

[0028] Figure 14 for Figure 13 An enlarged side view of the rotatable screw of the torque shaft catheter.

[0029] Figure 15 FIG. 4 is an enlarged perspective view of a coupling member provided at the distal end of the torque shaft.

[0030] Figure 16 For Figure 13 An enlarged perspective view of the threaded nut used in the torque shaft guide tube.

[0031] Figure 17 for Figure 8An enlarged side view of the distal portion of the nose cone catheter of the delivery device.

[0032] Figure 17A for Figure 17 An enlarged cross-sectional view of the nose cone of a catheter is shown.

[0033] Figure 17B for Figure 8 An enlarged cross-sectional view of the distal portion of the delivery device of FIG. 1 , showing the stent of the prosthetic valve held in a compressed state within the delivery sheath.

[0034] Figure 18 for Figure 8 An enlarged side view of a distal portion of a delivery device of FIG. 1 is shown showing a delivery sheath in a delivery position covering a prosthetic valve in a compressed state for delivery to a patient.

[0035] Figure 19 for Figure 8 An enlarged cross-sectional view of a section of a distal portion of a delivery device showing a valve retaining mechanism securing a stent of a prosthetic valve to the delivery device.

[0036] Figure 20 For similar Figure 19 , showing an enlarged cross-sectional view of the valve retaining mechanism in a released position for releasing a prosthetic valve from a delivery device.

[0037] Figure 21 and Figure 22 for Figure 8 An enlarged side view of the distal portion of a delivery device illustrating the operation of a torque shaft for deploying a prosthetic valve from a delivery sheath.

[0038] Figures 23 to 26 Various views of an embodiment of a motorized delivery device that can be used to operate Figure 8 The torque shaft of the delivery device shown in .

[0039] Figure 27 is a perspective view of an alternative motor that can be used to operate Figure 8 The torque shaft of the delivery device shown in .

[0040] Figure 28A for Figure 10 Magnified view of the distal segment of the guide catheter shaft.

[0041] Figure 28B Shown for forming a metal tube such as by laser cutting Figure 28A The cutting pattern of the portion of the shaft shown.

[0042] Figure 29A is an enlarged view of a distal segment of a guide catheter shaft according to another embodiment.

[0043] Figure 29B Shown for forming a metal tube such as by laser cutting Figure 29A The cutting pattern of the shaft.

[0044] Figure 30 is a perspective view of a prosthetic valve secured to a distal end of a delivery device according to one embodiment.

[0045] Figure 31 is a perspective view of a prosthetic valve according to another embodiment that can be used to replace a native heart aortic valve.

[0046] Figure 32 is a perspective view of the leaflet structure, also shown before being secured to the support frame. Figure 31 The artificial valve comprises an upper skirt and a lower skirt.

[0047] Figure 33 In one embodiment Figure 31 A cross-sectional view of a prosthetic valve of FIG. 1 , illustrating the configuration of the valve frame, leaflets, upper skirt, lower skirt, and sealing skirt.

[0048] Figure 34 is a schematic diagram of the sealing skirt before attachment to the valve frame, in one embodiment.

[0049] Figure 35 is a perspective view of a prosthetic valve including a sealing skirt according to one embodiment, which can be used to replace a native heart aortic valve.

[0050] Figure 36 In one embodiment Figure 35 1 is a perspective view of a portion of a prosthetic valve illustrating a sealing skirt and its connection to a support frame of the prosthetic valve.

[0051] Figure 37 For similar Figure 36 A perspective view illustrating a modification of the sealing skirt.

[0052] Figure 38 For similar Figure 36 A perspective view illustrating a modification of the sealing skirt.

[0053] Figure 39 for Figure 35 A perspective view of a portion of a prosthetic valve illustrating another configuration of the sealing skirt.

[0054] Figure 40A is a perspective view of an introducer sheath according to another embodiment.

[0055] Figure 40B for Figure 40A An enlarged perspective view of the cannula of the introducer sheath.

[0056] Figure 41 is an enlarged perspective view of another embodiment of a sleeve that can be used with Figure 40A Used with an introducer sheath.

[0057] Figure 42 To be able to Figure 40A End view of a cannula used with an introducer sheath.

[0058] Figure 43 is a perspective view of a section of a cannula of an introducer sheath according to another embodiment.

[0059] Figure 44 is a side elevational view of a metal sleeve for an introducer sheath according to another embodiment.

[0060] Figure 45 Shown for forming Figure 43 Cutting pattern of the metal casing.

[0061] Figure 46 Shown for forming Figure 44 Cutting pattern of the metal casing.

[0062] Figure 47 Shows something like Figure 46 But with a cutting pattern with narrower orifices.

[0063] Figure 48 and Figure 49 A cross-sectional view illustrating a method of molding an inner liner of a metal sleeve for an introducer sheath. DETAILED DESCRIPTION

[0064] For the purpose of this description, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. In any case, the methods, systems and devices described should not be interpreted as limiting. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments (whether individually or in various combinations and sub-combinations of each other). The disclosed methods, systems and devices are not limited to any specific aspect, feature or combination thereof, nor do the disclosed methods, systems and devices require the presence of any one or more specific advantages or problems solved.

[0065] Although some of the operations in the disclosed methods are described in a specific, sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a specific order. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings do not illustrate the various ways in which the disclosed methods, systems, and apparatuses can be used in conjunction with other systems, methods, and apparatuses.

[0066] As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, if two of a particular element are present, one of those elements may also be present and therefore, there is "an" element. The terms "plurality" and "multiple" refer to two or more of the specified elements.

[0067] As used herein, the term "and / or" used between the last two elements of a list of elements means any one or more of the listed elements. For example, the phrase "A, B and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0068] As used herein, the term "coupled" generally refers to physically coupled or linked and does not exclude the presence of intervening elements between the coupled items in the absence of specific language to the contrary.

[0069] First refer to Figure 1 , shows a prosthetic aortic heart valve 10 according to one embodiment. The prosthetic valve 10 includes an expandable frame member, or stent 12, that supports an expandable valve component, which in the illustrated embodiment includes flexible leaflet segments 14. The prosthetic valve 10 is radially compressible to a compressed state for delivery through the body to a deployment site and expandable to a Figure 1 1 and 2. The prosthetic valve 10 is shown in its functional size. In certain embodiments, the prosthetic valve 10 is self-expanding; that is, the prosthetic valve is capable of radially expanding to its functional size when the prosthetic valve is advanced from the distal end of the delivery sheath. Devices particularly suitable for percutaneous delivery and implantation of self-expanding prosthetic valves are described in detail below. In other embodiments, the prosthetic valve can be a balloon-expandable prosthetic valve that can be adapted to be mounted in a compressed state on a balloon of a delivery catheter. As is well known in the art, the prosthetic valve can be expanded to its functional size at the deployment site by inflating the balloon.

[0070] Although the artificial valve 10 shown can also be used to replace other native valves (aortic valve, pulmonary valve and mitral valve) of the heart, the artificial valve 10 is suitable for deployment in the native aortic valve ring.In addition, the artificial valve 10 can be suitable for replacing other valves in the body, such as venous valves.

[0071] For illustration purposes, Figure 3 and Figure 4 The support 12 without leaflet section 14 is shown.As shown in the figure, support 12 can be formed by a plurality of longitudinally extending generally sinusoidal framework members or strut 16.Strut 16 is formed with alternating bending, and is welded to each other at the node 18 place formed by the apex of adjacent bending or otherwise fixed to each other so as to form a mesh structure.Strut 16 can be made by suitable shape memory material, described shape memory material is such as the nickel-titanium alloy that is called as nitinol, described shape memory material allows artificial valve to be compressed to the diameter that reduces for delivering in delivery device (such as as described below), and then causes artificial valve to be expanded to its functional size in patient body when artificial valve is deployed from delivery device.If artificial valve is the artificial valve of balloon expandable, support 12 can be made by suitable ductile material, described ductile material is such as stainless steel, and wherein the artificial valve of balloon expandable is suitable for being curled on the dilatable balloon of delivery device and being expanded to its functional size by the expansion of balloon.

[0072] Stent 12 has inflow end 26 and outflow end 27.The meshwork formed by strut 16 comprises substantially cylindrical " on " or outflow end portion 20, outwardly bends into arched or swollen middle section 22, and inwardly bends into arched " down " or inflow end portion 24.Middle section 22 is sized and shaped to extend in the Valsalva sinus (Valsalva sinuses) in the aortic root ideally, thereby once artificial valve is implanted then helps artificial valve to be anchored in proper position.As shown in the figure, meshwork ideally has the curved shape along its overall length, the diameter of meshwork increases gradually from outflow end portion 20 to middle section 22, then diameter reduces gradually from middle section 22 to the position on inflow end portion 24, and then diameter increases gradually to form the flared portion that ends at inflow end 26 places.

[0073] When the prosthetic valve is in its expanded state, the middle section 22 has a diameter D1, the inflow end portion 24 has a minimum diameter D2, the inflow end 26 has a diameter D3, and the outflow end portion 20 has a diameter D4, wherein D2 is smaller than D1 and D3, and D4 is smaller than D2. Moreover, ideally, D1 and D3 are larger than the diameter of the native annulus into which the prosthetic valve is to be implanted. In this way, the overall shape of the stent 12 helps to maintain the prosthetic valve at the implantation site. More specifically, and with reference to Figure 5A and Figure 5B, the artificial valve 10 can be implanted within a native valve (the aortic valve in the illustrated example) such that the lower section 24 is positioned within the aortic valve annulus 28, the middle section 24 extends above the aortic valve annulus into the sinuses of Valsalva 56, and the lower flared end 26 extends below the aortic valve annulus. The artificial valve 10 is retained within the native valve by the lower section 24 resisting the radially outward forces of the surrounding tissue of the aortic valve annulus 28 and the geometric structure of the stent. Specifically, the middle section 24 and the flared lower end 26 extend radially outward beyond the aortic valve annulus 28 to better resist axial displacement of the artificial valve in the downstream and upstream directions (toward and away from the aorta). As Figure 5B As described above, depending on the condition of the native leaflets 58, the artificial valve is typically deployed within the native annulus 28, wherein the native leaflets 58 are folded upward and compressed between the outer surface of the stent 12 and the wall of the sinus of Valsalva. In some cases, it is desirable to remove the leaflets 58 before implanting the artificial valve 10.

[0074] Known artificial valves with self-expanding frames typically have additional anchoring devices or frame portions that extend into and are secured to non-diseased areas of the vasculature. Because the shape of the stent 12 helps to hold the artificial valve, no additional anchoring devices are required, and the overall length L of the stent can be minimized to prevent the upper portion 20 of the stent from extending into, or at least to minimize the extension of the upper portion 20 into, the non-diseased area of ​​the aorta. In the event that future intervention is required, avoiding non-diseased areas of the patient's vasculature helps to avoid complications. For example, because the stent is primarily anchored to the diseased portion of the native valve, the artificial valve can be more easily removed from the patient. In addition, a shorter artificial valve is easier to navigate around the aortic arch.

[0075] In certain embodiments, for a prosthetic valve intended for use in an annulus of 22 mm to 24 mm, diameter D1 is from about 28 mm to about 32 mm, with about 30 mm being a specific example; diameter D2 is from about 24 mm to about 28 mm, with about 26 mm being a specific example; diameter D3 is from about 28 mm to about 32 mm, with about 30 mm being a specific example; and diameter D4 is from about 24 mm to about 28 mm, with about 26 mm being a specific example. Length L in certain embodiments is from about 20 mm to about 24 mm, with about 22 mm being a specific example.

[0076] Reference Figure 1In the embodiment shown, the stent 12 can have a plurality of angularly spaced retaining arms or projections (three in the illustrated embodiment) in the form of posts 30 extending from the stent upper portion 20. Each retaining arm 30 has a respective orifice 32 sized to receive a prong of a valve retaining mechanism that can be used to form a releasable connection between the prosthetic valve and a delivery device (described below). In an alternative embodiment, if a valve retaining mechanism is not used, the retaining arms 30 need not be provided.

[0077] like Figure 6 and Figure 7 As best shown, the leaflet assembly 14 in the illustrated embodiment includes three leaflets 34a, 34b, 34c made of a flexible material. Each leaflet has an inflow end portion 60 and an outflow end portion 62. The leaflets can include any suitable biological material (e.g., pericardial tissue, such as bovine pericardium or equine pericardium), a biocompatible synthetic material, or other such material, such as those described in U.S. Patent No. 6,730,118. The leaflet assembly 14 can include an annular reinforcing skirt 42 secured to the inflow end portions of the leaflets 34a, 34b, 34c at sutures 44 adjacent the inflow end of the prosthetic valve. The inflow end portion of the leaflet assembly 14 can be secured to the stent 12 (e.g., by suturing the skirt 42 to the struts 16 of the lower section 24 of the stent. Figure 1 As best shown). Figure 7 As shown, the leaflet assembly 14 can further include an internal reinforcement band 46 secured to the inner surface of the inflow end portion 60 of the leaflet.

[0078] Reference Figure 1 and Figure 2 The outflow end portion of the leaflet assembly 14 can be secured to the upper portion of the stent 12 at three angularly spaced commissural attachments of the leaflets 34a, 34b, 34c. Figure 2 As best shown, each commissure attachment can be formed by wrapping a reinforcement section 36 around adjacent upper edge portions 38 of a pair of leaflets at the commissure formed by the two leaflets and securing the reinforcement section 36 to the edge portions 38 with sutures 48. The sandwich of reinforcement material and leaflets can then be secured to the struts 16 of the stent 12 adjacent the outflow end of the stent with sutures 50. Thus, the leaflets ideally extend along the entire length, or substantially the entire length, of the stent from the inflow end 26 to the outflow end 27. The reinforcement section 36 reinforces the attachment of the leaflets to the stent so as to minimize stress concentrations at the suture lines and avoid "pinholes" in the leaflet portions that flex during use. The reinforcement section 36, skirt 42, and internal reinforcement band 46 ( Figure 7 ) is ideally made of a biocompatible synthetic material such as polytetrafluoroethylene (PTFE) or a braided polyester (e.g., polyethylene terephthalate (PET), ) fabric material.

[0079] Figure 7 The operation of the prosthetic valve 10 is shown. During diastole, the leaflets 34a, 34b, 34c collapse, effectively closing the prosthetic valve. As shown, the curved shape of the middle section 22 of the stent 12 defines a space between the middle section and the leaflets that simulates the sinuses of Valsalva. Thus, when the leaflets are closed, backflow into the "sinuses" creates turbulent blood flow along the upper surface of the leaflets, as indicated by arrows 52. This turbulent flow helps clean the leaflets and skirt 42, thereby minimizing or reducing clot formation.

[0080] The prosthetic valve 10 can be implanted in a retrograde approach, wherein the prosthetic valve, mounted in a crimped state at the distal end of a delivery device, is introduced into the body via the femoral artery and advanced through the aortic arch to the heart, as further described in US Patent Publication No. 2008 / 0065011.

[0081] Figure 8 and Figure 9 A delivery device 100 is shown according to one embodiment that can be used to deliver a self-expanding prosthetic valve, such as the prosthetic valve 10 described above, through the vasculature of a patient. The delivery device 100 includes a first outermost catheter or main catheter 102 ( Figure 10 ), the distal end of the main catheter 102 is coupled to the delivery sheath 106 ( Figure 18 ; also called a delivery cylinder). The proximal end of the main catheter 102 is connected to the handle of the delivery device. Figures 23 to 26 An embodiment of a handle mechanism having an electric motor for operating the delivery device is shown. The handle mechanism is described in detail below. During delivery of the prosthetic valve, the surgeon can use the handle to advance and retract the delivery device through the patient's vasculature. Although not required, the main catheter 102 can include a guide catheter configured to allow the surgeon to guide or control the amount of bending or flexing of the distal portion of the shaft 104 as the shaft 104 is advanced through the patient's vasculature, such as described further below. Another embodiment of a guide catheter is disclosed in U.S. Patent Publication No. 2008 / 0065011.

[0082] like Figure 9As best shown, the delivery device 100 also includes a second intermediate catheter 108 (also referred to herein as a torque shaft catheter) having an elongated shaft 110 (also referred to herein as a torque shaft) and an elongated screw 112 connected to the distal end of the shaft 110. The shaft 110 of the intermediate catheter 108 extends coaxially through the shaft 104 of the main catheter 102. The delivery device 100 can also include a third front-end tapered catheter 118 having an elongated shaft 120 and a front end piece or front end cone 122 secured to the distal portion of the shaft 120. The front end piece 122 can have a tapered outer surface, as shown, for atraumatic tracking through the patient's vasculature. The shaft 120 of the front-end tapered catheter extends through the prosthetic valve 10 ( Figures 8 and 9 104 and 110. In the illustrated configuration, the innermost shaft 120 is configured to be axially and rotationally movable relative to the shafts 104 and 110, and the torque shaft 110 is configured to be rotatable relative to the shafts 104 and 120, thereby enabling valve deployment and release of the prosthetic valve from the delivery device, as described in detail below. In addition, the innermost shaft 120 can have a lumen for receiving a guidewire so that the delivery device can be advanced over the guidewire into the patient's vasculature.

[0083] like Figure 10 As best shown, the outer catheter 102 can include a flex control mechanism 168 at its proximal end for controlling the amount of bending or flexing of the distal portion of the outer shaft 104 as the distal portion of the outer shaft 104 is advanced through the patient's vasculature, such as described further below. The outer shaft 104 can include a proximal segment 166 and a distal segment 126, wherein the proximal segment 166 extends from the flex control mechanism 168 and the distal segment 126 includes a slotted metal tube that increases the flexibility of the outer shaft at this location. The distal portion of the distal segment 126 can include a valve retaining mechanism 114 ( Figure 8 and Figure 8B ) includes an outer fork 130 that is configured to releasably secure the prosthetic valve 10 to the delivery device 100 during valve delivery, as described in detail below.

[0084] Figure 28A 1 is an enlarged view of a portion of the distal segment 126 of the outer shaft 104 . Figure 28B A cutting pattern that can be used to form the distal segment 126 by laser cutting a pattern in a metal tube is shown. The distal segment 126 includes a plurality of interconnected annular bands or links 160 that form a slotted metal tube. A pull wire 162 can be positioned within the interior of the distal segment 126 and can be pulled from a position 164 ( Figure 10 and Figure 12) extends to the flex control mechanism. The distal end of the pull wire 162 can be fixed to the inner surface of the distal segment 126 at location 164, such as by welding. The proximal end of the pull wire 162 can be operably connected to a flex control mechanism 168, which is configured to apply and release tension to the pull wire to control the bending of the shaft, as further described below. The links 160 of the shaft and the gaps between adjacent links are shaped to allow bending of the shaft when a slight pulling force is applied to the pull wire 162. In the illustrated embodiment, as Figure 12 As best shown, the distal segment 126 is secured to a proximal segment 166 having a different configuration (e.g., one or more layers of polymer tubing). In the illustrated embodiment, the proximal segment 166 extends from the flex control mechanism 168 to the distal segment 126 and, therefore, forms the majority of the length of the outer shaft 104. In alternative embodiments, the entire length or substantially the entire length of the outer shaft 104 can be formed from a slotted metal tube comprising one or more interconnected segments of links 160. In any case, the use of a main shaft having such a configuration can allow for a highly maneuverable delivery device.

[0085] The width of the links 160 can be varied to vary the flexibility of the distal segment along its length. For example, the links within the distal portion of the slotted tube can be relatively narrow to increase the flexibility of the shaft at that location, while the links within the proximal portion of the slotted tube can be relatively wide so that the shaft is relatively less flexible at that location.

[0086] Figure 29A An alternative embodiment of a distal segment is shown indicated at 126', which can be formed, for example, by laser cutting a metal tube. Segment 126' can comprise a distal segment of an outer shaft of a delivery device (e.g., Figure 12 as shown), or substantially the entire length of the outer shaft can have Figure 29A The structure shown. Figure 29B The cutting pattern used to form segment 126' is shown. In another embodiment, the delivery device can include a composite outer shaft comprising a laser cut metal tube laminated with a polymer outer layer fused within gaps in the metal layer. In one example, the composite shaft can include a Figure 29A and Figure 29B In another example, the composite shaft can include a laser cut metal tube having a cutting pattern and a polymer outer layer fused into the gaps between the links 160 of the metal tube. Figure 28A and Figure 28B The composite shaft can also include a laser cut metal tube having a cutting pattern and a polymer outer layer fused into the gaps between the links 160 of the metal tube.

[0087] Reference Figure 8A and Figure 11 The flex control mechanism 168 can include a rotatable housing or handle portion 186 that houses a sliding nut 188 mounted on a guide rail 192. The sliding nut 188 is prevented from rotating within the housing by one or more rods 192, each rod 192 being partially disposed within a corresponding recess within the guide rail 192 and a groove or recess on the inside of the nut 188. The proximal end of the pull wire 162 is secured to the nut 188. The nut 188 has external threads that engage the internal threads of the housing. Thus, depending on the direction of rotation of the housing, rotating the housing 186 causes the nut 188 to move axially within the housing in a proximal or distal direction. Rotating the housing in a first direction (e.g., clockwise) causes the nut to travel in a proximal direction, thereby applying tension to the pull wire 162, which causes the distal end of the delivery device to bend or flex. Rotating the housing in a second direction (eg, counterclockwise) causes the nut to travel in a distal direction, thereby releasing the tension in the pull wire 162 and allowing the distal end of the delivery device to fold back to its pre-flexed configuration under its own elasticity.

[0088] like Figure 13 As best shown, the torque shaft conduit 108 includes an annular protrusion in the form of a ring 128 (also referred to as an anchor disc) that is mounted on the distal portion of the torque shaft 110 adjacent the screw 112. The ring 128 is fixed to the outer surface of the torque shaft 110 so that it cannot move axially or rotationally relative to the torque shaft. The inner surface of the outer shaft 104 is formed with features, such as grooves or recesses, that receive the ring 128 in such a manner that corresponding features on the ring and the inner surface of the outer shaft 104 allow the torque shaft 110 to rotate relative to the outer shaft 104 but prevent the torque shaft from moving axially relative to the outer shaft. The corresponding feature on the outer shaft 104 that receives the ring 128 can be an inwardly extending lug portion formed in the distal segment 126, such as a Figure 12 In the illustrated embodiment (eg Figure 14 As best shown, the ring 128 is an integral part of the screw 112 (ie, the screw 112 and the ring 128 are part of a single component). Alternatively, the screw 112 and the ring are separately formed components but are both securely fixed to the distal end of the torque shaft 110.

[0089] The torque shaft 110 is desirably configured to be rotatable relative to the delivery sheath 106, thereby enabling incremental and controlled advancement of the prosthetic valve 10 from the delivery sheath 106. To achieve this, and according to one embodiment, the delivery device 100 can include a sheath retaining ring in the form of a threaded nut 150 mounted on the external threads of the screw 112. Figure 16As best shown, the nut 150 includes internal threads 152 that engage the external threads of the screw, and axially extending legs 154. Each leg 154 has a raised distal portion that extends into and / or forms a snap-fit ​​connection with an opening 172 in the proximal end of the sheath 106 (e.g., Figure 18 (best shown) to secure the sheath 106 to the nut 150. Figure 17B and Figure 18 As illustrated, the sheath 106 extends over the prosthetic valve 10 and holds the prosthetic valve in a radially compressed state until the sheath 106 is retracted by the user to deploy the prosthetic valve.

[0090] like Figure 21 and Figure 22 As best shown, the outer fork 130 of the valve retaining mechanism includes a plurality of prongs 134, each of which extends through an area defined between two adjacent legs 154 of the nut to prevent the nut from rotating relative to the screw 112 when the screw is rotated. Thus, rotation of the torque shaft 110 (and therefore the screw 112) causes corresponding axial movement of the nut 150. The connection between the nut 150 and the sheath 106 is configured such that axial movement of the nut along the screw 112 (in either the distal or proximal direction) causes axial movement of the sheath 106 relative to the screw and the valve retaining mechanism in the same direction. Figure 21 The nut 150 is shown in a distal position, wherein the sheath 106 ( Figure 21 The nut 150 extends over the prosthetic valve 10 and holds the prosthetic valve 10 in a compressed state for delivery. Figure 21 ) to the proximal position ( Figure 22 ) causes the sheath 106 to move in a proximal direction, thereby deploying the prosthetic valve from the sheath 106. Rotation of the torque shaft 110 to achieve axial movement of the sheath 106 can be accomplished using a motorized mechanism or by manually turning a crank or wheel (as described in U.S. Patent Publication No. 2012 / 0239142).

[0091] Figure 17An enlarged view of the front cone 122 secured to the distal end of the innermost shaft 120 is shown. The front cone 122 in the illustrated embodiment includes a proximal portion 174 sized to fit within the distal end of the sheath 106. An intermediate section 176 of the front cone is positioned proximal to the distal end of the sheath in use and is formed with a plurality of longitudinal grooves or recessed portions 178. The diameter of the intermediate section 176 at its proximal end 180 is ideally slightly larger than the outer diameter of the sheath 106. The proximal end 180 is able to maintain close contact with the distal end of the sheath 106, thereby preventing surrounding tissue from contacting the metal edge of the sheath. As the delivery device is advanced through the introducer sheath, the grooves 178 allow the intermediate section to be radially compressed. This allows the front cone 122 to be slightly oversized relative to the inner diameter of the introducer sheath. Figure 17B 106 in a delivery position with the prosthetic valve retained within the sheath 106 in a compressed delivery state (for illustrative purposes, only the stent 12 of the prosthetic valve is shown). As shown, the proximal end 180 of the intermediate section 176 can abut the distal end of the sheath 106, and the tapered proximal surface 182 of the proximal taper can extend within the distal portion of the stent 12.

[0092] As described above, the delivery device 100 can include a valve retaining mechanism 114 ( Figure 8B ). The valve retaining mechanism 114 can include an outer fork 130 (such as Figure 12 best shown) (also referred to as an "external trident" or "release trident") in the form of a first valve securing member, and an inner fork 132 (e.g., Figure 17 The second valve securing member is in the form of a second prong (also referred to as an "inner trident" or "locking trident"), best shown. An outer prong 130 cooperates with an inner prong 132 to form a releasable connection with the retaining arms 30 of the stent 12.

[0093] The proximal end of the outer fork 130 is connected to the distal segment 126 of the outer shaft 104, and the distal end of the outer fork is releasably connected to the stent 12. In the illustrated embodiment, although these components can be formed separately and then connected to each other, the outer fork 130 and the distal segment 126 can also be integrally formed as a single component (for example, the outer fork and the distal segment can be laser cut or otherwise machined from a single piece of metal tube). The inner fork 132 can be mounted on the front catheter shaft 120 (such as Figure 17 104 ). An inner fork 132 connects the stent to the distal portion of the front catheter shaft 120. As described further below, the front catheter shaft 120 is axially movable relative to the outer shaft 104 to release the prosthetic valve from the valve retaining mechanism.

[0094] like Figure 12As best shown, the outer fork 130 includes a plurality of angularly spaced prongs 134 (three in the illustrated embodiment) that correspond to the retaining arms 30 of the stent 12, with the prongs extending from the distal end of the distal segment 126. The distal portion of each prong 134 includes a respective opening 140. Figure 17 As best shown, the inner fork 132 includes a plurality of angularly spaced prongs 136 (three in the illustrated embodiment) that correspond to the retaining arms 30 of the stent 12, with the prongs extending from a base portion 138 at the proximal end of the inner fork. The base portion 138 of the inner fork is securely fixed to the leading catheter shaft 120 (e.g., with a suitable adhesive) to prevent axial and rotational movement of the inner fork relative to the leading catheter shaft 120.

[0095] Each prong of the outer fork 130 cooperates with a corresponding prong 136 of the inner fork to form a releasable connection with the retaining arm 30 of the stent. In the illustrated embodiment, for example, the distal portion of each prong 134 is formed with an opening 140. When the prosthetic valve is secured to a delivery device (e.g., Figure 19 As best shown, each retaining arm 30 of the stent 12 extends inwardly through the opening 140 of the prongs 134 of the outer fork, and the prongs 136 of the inner fork are inserted through the opening 32 of the retaining arm 30 to retain the retaining arm 30 from retreating out of the opening 140. Figure 30 Also shown is the prosthetic valve 10 secured to the delivery device by the inner and outer forks before the prosthetic valve is loaded into the sheath 106. The threaded nut 150 can be seen positioned between the prongs of the outer fork 130. The prosthetic valve 10 is ready to be compressed and loaded into the sheath 106 of the delivery device. Figure 20 The inner fork 136 is retracted in the direction of arrow 184 to remove the fork from the opening 32, effectively releasing the prosthetic valve 10 from the retaining mechanism. Figure 20 ), the retaining arms 30 of the stent are able to move radially outward from the openings 140 in the outer fork 130 under the resilient force of the stent. In this way, the valve retaining mechanism 114 forms a releasable connection with the prosthetic valve that is sufficiently secure to retain the prosthetic valve relative to the delivery device, thereby allowing the user to fine-tune or adjust the position of the prosthetic valve after it is deployed from the delivery sheath. When the prosthetic valve is positioned at the desired implantation site, the connection between the prosthetic valve and the retaining mechanism can be released by retracting the front catheter shaft 120 relative to the outer shaft 104 (which retracts the inner fork 132 relative to the outer fork 130).

[0096] Once the prosthetic valve 10 is loaded into the delivery sheath 106, the delivery device 100 can be inserted into the patient's body for delivery of the prosthetic valve. In one approach, the prosthetic valve can be delivered in a retrograde procedure, wherein the delivery device is inserted into, for example, the femoral artery and advanced through the patient's vasculature to the heart. Prior to insertion of the delivery device, an introducer sheath can be inserted into the femoral artery, followed by a guidewire that is advanced through the patient's vasculature through the aorta and into the left ventricle. The delivery device 100 can then be inserted through the introducer sheath and advanced over the guidewire until the distal portion of the delivery device housing the prosthetic valve 10 is advanced to a position adjacent to or within the native aortic valve.

[0097] Thereafter, the prosthetic valve 10 can be deployed from the delivery device 100 by rotating the torque shaft 110 relative to the outer shaft 104. As described below, the proximal end of the torque shaft 110 can be operably connected to a manually rotatable handle portion or motorized mechanism that allows the surgeon to rotate the torque shaft 110 relative to the outer shaft 104. Rotation of the torque shaft 110 and screw 112 causes the nut 150 and sheath 106 to move in a proximal direction toward the outer shaft ( Figure 22 ), thereby deploying the prosthetic valve from the sheath. As the prosthetic valve is advanced from the open distal end of the delivery sheath and begins to expand, rotation of the torque shaft 110 causes the sheath to move relative to the prosthetic valve in a precise and controlled manner. Therefore, unlike well-known delivery devices, as the prosthetic valve begins to advance and expand from the delivery sheath, the prosthetic valve is held against uncontrolled movement from the sheath, which is caused by the expansion force of the prosthetic valve resisting the distal end of the sheath. In addition, as the sheath 106 is retracted, the prosthetic valve 10 is held in a stationary position relative to the ends of the inner shaft 120 and the outer shaft 104 by the valve retaining mechanism 114. As such, as the sheath is retracted, the prosthetic valve 10 is able to remain stationary relative to a target location within the body. In addition, after the prosthetic valve is partially advanced from the sheath, it is desirable to retract the prosthetic valve back into the sheath, for example, to reposition the prosthetic valve or to completely withdraw the prosthetic valve from the body. The partially deployed prosthetic valve can be retracted back into the sheath by counter-rotating the torque shaft, thereby causing the sheath 106 to be pushed back in a distal direction over the prosthetic valve.

[0098] In the delivery device known in the art, the surgeon must apply a push-pull force to the shaft and / or sheath to unsheath the artificial valve. Therefore, it is difficult to transmit force to the distal end of the device without twisting the shaft (e.g., axially compressing or stretching the shaft), which in turn leads to uncontrolled movement of the artificial valve during the unsheathing process. In order to alleviate this effect, the shaft and / or sheath can be made more rigid, which is undesirable because the device becomes difficult to manipulate through the vascular system. In contrast, the above-mentioned method of unsheathing the artificial valve eliminates the push-pull force applied to the shaft as required in the known device, so that a relatively large and accurate force can be applied to the distal end of the shaft without compromising the flexibility of the device. In certain embodiments, a force of up to about 90N (20 pounds) can be transmitted to the end of the torque shaft without adversely affecting the unsheathing process. In contrast, during the unsheathing process, the prior art devices utilizing a push-pull mechanism are generally unable to exceed a force of about 20N (5 pounds).

[0099] After the prosthetic valve 10 is advanced from the delivery sheath and expanded to its functional size ( Figure 30 After the expanded prosthetic valve 10 is secured to the delivery device, the prosthetic valve remains connected to the delivery device via the retaining mechanism 114. As a result, after the prosthetic valve is advanced from the delivery sheath, the surgeon is able to reposition the prosthetic valve relative to the desired implantation location in the native valve, such as by moving the delivery device in a proximal and distal direction or side to side, or rotating the delivery device, thereby causing corresponding movement of the prosthetic valve. The retaining mechanism 114 ideally provides a connection between the prosthetic valve and the delivery device that is sufficiently strong and rigid to maintain the position of the prosthetic valve relative to the delivery device against the flow of blood as the position of the prosthetic valve is adjusted relative to the desired implantation location in the native valve. Once the surgeon has positioned the prosthetic valve at the desired implantation location in the native valve, the connection between the prosthetic valve and the delivery device can be released by retracting the innermost shaft 120 in the proximal direction relative to the outer shaft 104, thereby effectively retracting the inner fork 132 to withdraw its prongs 136 from the openings 32 in the retaining arms 30 of the prosthetic valve ( Figure 20 ). Slight retraction of the outer shaft 104 allows the outer forks 130 to exit the retaining arms 30 of the prosthetic valve, which slide outward through openings 140 in the outer forks to completely disengage the prosthetic valve from the retaining mechanism 114. Thereafter, the delivery device can be withdrawn from the body, leaving the prosthetic aortic valve 10 (such as a prosthetic aortic valve) implanted within the native valve. Figure 5A and 5B shown).

[0100] Delivery device 100 has a semi-rigid segment at its distal end, comprised of relatively rigid components, that is used to convert rotation of the torque shaft into axial movement of the sheath. Specifically, the semi-rigid segment in the illustrated embodiment is comprised of a prosthetic valve and screw 112. An advantage of delivery device 100 is that the overall length of the semi-rigid segment is minimized because translation of the sheath is achieved using nut 150 rather than internal threads on the outer shaft. The reduced length of the semi-rigid segment increases overall flexibility along the distal portion of the delivery catheter. Furthermore, the length and position of the semi-rigid segment remain unchanged because the torque shaft does not translate axially relative to the outer shaft. As such, the curved shape of the delivery catheter can be maintained during valve deployment, which improves deployment stability. A further benefit of delivery device 100 is that ring 128 prevents axial loads (compression and tension) from being transferred to the segment of torque shaft 110 distal to the ring.

[0101] In an alternative embodiment, the delivery device can be adapted to deliver a balloon-expandable prosthetic valve. As described above, a valve retaining mechanism 114 can be used to secure the prosthetic valve to the distal end of the delivery device. Because the stent of the prosthetic valve is not self-expanding, the sheath 106 can be optional. The retaining mechanism 114 enhances the pushability of the delivery device and prosthetic valve assembly through the introducer sheath.

[0102] Figures 23 to 26 The proximal portion of a delivery device 100 according to one embodiment is illustrated. The delivery device 100 can include a handle 202 configured to be releasably connectable to a proximal portion of a catheter assembly 204 including catheters 102, 108, 118. For various reasons, it may be desirable to detach the handle 202 from the catheter assembly 204. For example, detaching the handle can allow another device (such as a valve retraction device or a device that assists in manipulating the catheter assembly) to be slid onto the catheter assembly. It should be noted that any of the features of the handle 202 and the catheter assembly 204 can be implemented in any embodiment of the delivery device disclosed herein.

[0103] Figure 23 and Figure 24 The proximal portion of the catheter assembly 204 is shown partially inserted into the distal opening of the handle 202. The proximal portion of the main shaft 104 is formed with an annular groove 212 (e.g., Figure 24 As best shown, the annular groove 212 cooperates with a retaining mechanism or latch mechanism 214 inside the handle. Figure 25 and Figure 26As shown, when the proximal end portion of the catheter assembly is fully inserted into the handle, the engagement portion 216 of the retaining mechanism 214 extends at least partially into the groove 212. One side of the retaining mechanism 214 is connected to a button 218 extending through the housing of the handle. The opposite side of the retaining mechanism 214 contacts a spring 220, which biases the retaining mechanism 214 to the position of engaging the main shaft 104 at the groove 212. The engagement of the retaining mechanism 214 in the groove 212 prevents the catheter assembly from axially separating from the handle. The catheter assembly can be released from the handle by pressing button 218, thereby moving the retaining mechanism 214 from the locking engagement with the main shaft. In addition, the main shaft 104 can be formed with a flat surface portion in the groove 212. The flat surface portion is placed against the corresponding flat surface portion of the engagement portion 216. As the torque shaft is rotated during valve deployment, this engagement keeps the main shaft 104 stationary relative to the torque shaft 110.

[0104] The proximal end portion of the torque shaft 110 can have a driven nut 222 ( Figure 26 ), the driven nut 222 is slidably received in the drive cylinder 224 ( Figure 25 ). By fixing the nut 222 on the connecting member 170 ( Figure 15 ) above, the nut 222 can be secured to the proximal end of the torque shaft 100. Figure 26 2 is a perspective view of the interior of the handle 202 with the drive cylinder and other components removed to show the driven nut and other components housed within the drive cylinder. The cylinder 224 has a through-port (or cavity) extending the length of the cylinder that is shaped to correspond to the flat portion of the nut 222 so that rotation of the drive cylinder effectively rotates the nut 222 and the torque shaft 110. The drive cylinder can have an enlarged distal portion 236 that can accommodate one or more seals (e.g., O-rings 246) that form a seal with the outer surface of the spindle 104 ( Figure 25 ). The handle can also accommodate an accessory 238 having a flush port that communicates with the lumen of the torque shaft and / or the lumen of the main shaft.

[0105] The drive cylinder 224 is operably connected to the electric motor 226 via gears 228 and 230. The handle can also accommodate a battery compartment 232 containing batteries for providing power to the motor 226. Rotation of the motor in one direction causes the torque shaft 110 to rotate, which in turn retracts the sheath 106 and exposes the artificial valve at the distal end of the catheter assembly. Rotation of the motor in the opposite direction causes the torque shaft to rotate in the opposite direction, thereby moving the sheath back over the artificial valve. An operator button 234 on the handle allows the user to activate the motor, which can rotate in either direction to unsheath the artificial valve or retrieve an expanded or partially expanded artificial valve.

[0106] As described above, the distal end portion of the front catheter shaft 120 can be secured to the inner fork 132, which moves relative to the outer fork 130 to release a prosthetic valve secured to the distal end of the delivery device. Movement of the shaft 120 relative to the main shaft 104 (which secures the outer fork 130) can be achieved by a proximal end portion 240 of the handle, which is slidable relative to the main housing 244. The distal end portion 240 is operably connected to the shaft 120 such that movement of the distal end portion 240 effectively translates the shaft 120 axially relative to the main shaft 104 (causing the prosthetic valve to be released from the inner and outer forks). The distal end portion 240 can have flexible side panels 242 on opposite sides of the handle that are normally biased outwardly in a locked position to retain the distal end portion relative to the main housing 244. During deployment of the prosthetic valve, the user can depress the side panels 242, which disengage from corresponding features in the housing and allow the tip portion 240 to be pulled proximally relative to the main housing, thereby causing corresponding axial movement of the shaft 120 relative to the main shaft. The proximal movement of the shaft 120 causes the prongs 136 of the inner fork 132 to disengage from the apertures 32 in the stent 12, which in turn allows the retaining arms 30 of the stent to deflect radially outward from the openings 140 in the prongs 134 of the outer fork 130, thereby releasing the prosthetic valve.

[0107] Figure 27 An alternative embodiment of a motor (indicated at 300) is shown that can be used to drive a torque shaft (e.g., torque shaft 110). In this embodiment, the catheter assembly can be directly connected to one end of a shaft 302 of the motor without gearing. Shaft 302 includes a lumen that allows passage of fluid through the innermost shaft of the catheter assembly (e.g., shaft 120), a pull wire, and / or the lumen for flushing the catheter assembly.

[0108] Alternatively, the power source for rotating the torque shaft 110 can be a hydraulic power source (e.g., a hydraulic pump) or a pneumatic (air-operated) power source configured to rotate the torque shaft. In another embodiment, the handle can have a manually movable joystick or wheel operable to rotate the torque shaft 110.

[0109] In another embodiment, a power source (e.g., an electric power source, a hydraulic power source, or a pneumatic power source) can be operably connected to a shaft that is in turn connected to the prosthetic valve 10. The power source is configured to reciprocate the shaft longitudinally in a distal direction relative to the valve sheath in a precise and controlled manner to advance the prosthetic valve from the sheath. Alternatively, the power source can be operably connected to the sheath to reciprocate the sheath longitudinally in a proximal direction relative to the prosthetic valve to deploy the prosthetic valve from the sheath.

[0110] Reference Figure 31 , shows an aortic heart valve prosthesis 410 according to another embodiment. Similar to the prosthetic valve 10, the prosthetic valve 410 includes an expandable frame member, or stent 412, that supports an expandable valve component, which in the illustrated embodiment includes flexible leaflet segments 414. Likewise, the prosthetic valve 410 is radially compressible to a compressed state for delivery through the body to a deployment site and expandable to a Figure 31 Its functional size is shown. In some embodiments, the artificial valve 410 is self-expanding; that is, when the artificial valve is advanced from the distal end of the delivery sheath, the artificial valve can expand radially to its functional size. In other embodiments, the artificial valve can be a balloon-expandable artificial valve, which can be adapted to be mounted in a compressed state on a balloon of a delivery catheter. As is well known in the art, by inflating the balloon, the artificial valve can expand to its functional size at the deployment site. Devices 10 that are particularly suitable for percutaneous delivery and implantation of artificial valves 10 (such as those described herein) are also suitable for percutaneous delivery and implantation of artificial valves 410. Although the artificial valve 410 illustrated can also be used to replace other native heart valves (mitral valve, tricuspid valve and pulmonary valve), the artificial valve 410 is suitable for being deployed within the native aortic valve annulus. In addition, the artificial valve 410 can be adapted to replace other valves in the body, such as venous valves.

[0111] The frame structure 412 of the prosthetic valve 410 can have the same general shape and configuration as the frame member 12 of the prosthetic valve 10. Thus, similar to the frame member 12, the frame member 412 can be formed from a plurality of longitudinally extending generally sinusoidal frame members or struts 416. Figure 31, the stent 412 has an inflow end 426 and an outflow end 427, and the mesh structure formed by the struts 416 includes a generally cylindrical "upper" or outflow end portion 420, an outwardly curved or bulged middle section 422, and an inwardly curved "lower" or inflow end portion 424. Furthermore, the stent 412 can have a plurality of angularly spaced retaining arms or protrusions (three in the illustrated embodiment) in the form of posts 430 extending from the upper portion of the stent 412. Each retaining arm 430 has a respective orifice 432 sized to receive a prong of a valve retaining mechanism that can be used to form a releasable connection between the prosthetic valve and the delivery device (described above). In an alternative embodiment, if a valve retaining mechanism is not used, the retaining arms 430 need not be provided. In further embodiments, the retaining arms 430 can extend from a lower portion of the stent 424, for example, for applications involving antegrade implantation of the valve (e.g., in a percutaneous approach, the delivery device is inserted through a surgical opening in the wall of the left ventricle of the heart, such as an opening made at a bare spot on the lower anterior side of the ventricular wall).

[0112] The leaflet assembly 414 of the prosthetic aortic heart valve 410 is similar to the leaflet assembly 14 of the prosthetic aortic heart valve 10, although there are some differences described below. Figure 32 and Figure 33 , the leaflet assembly 414 includes three leaflets 434a, 434b, 434c made of a flexible material. Each leaflet has an inflow end portion 460 and an outflow end portion 462. The leaflets can include any suitable biological material (e.g., pericardial tissue, such as bovine pericardium or equine pericardium), biocompatible synthetic material, or other such material, such as those described in U.S. Patent No. 6,730,118. The leaflet assembly 414 can include an annular reinforcing skirt assembly 442 that is secured to the inflow end portions of the leaflets 434a, 434b, 434c at sutures 444 adjacent the inflow end of the prosthetic valve. The inflow end portion of the leaflet assembly 14 can be secured to the stent 412 (e.g., by suturing the skirt assembly 442 to the struts 416 of the lower section 424 of the stent. Figure 31 best shown).

[0113] Reference Figure 33, the skirt assembly 442 can include an upper skirt 443 and a lower skirt 445. The inflow end portions 460 of the leaflets 434a, 434b, and 434c can be positioned between the upper portion 447 of the lower skirt 445 and the lower portion 454 of the upper skirt 443, wherein the upper skirt desirably has an outward arrangement compared to the lower skirt. The upper skirt 443, the inflow end portions 460 of the leaflets 434a, 434b, 434c, and the lower skirt 445 can be secured by sutures along a wave or wavy shaped suture line 444 adjacent the inflow end of the prosthetic valve ( Figure 31 The inflow end portion of the leaflet assembly 414 can be secured to the stent 412 (e.g., via sutures 455) by suturing the upper skirt 443, the lower skirt 445, or both the upper skirt 443 and the lower skirt 445 to the struts 416 of the lower section 424 of the stent. Figure 31 The skirt assembly 442 (including the upper skirt 443 and the lower skirt 445) can desirably be constructed from a biocompatible synthetic material such as polytetrafluoroethylene (PTFE) or a braided polyester (e.g., polyethylene terephthalate (PET), ) fabric material. The upper skirt 443 and the lower skirt 445 can be made of the same or different materials.

[0114] like Figure 32 As best shown, the outflow end portion of the upper skirt 443 can be shaped to substantially align with the wavy or zigzag shape formed by the struts 416 of the lower section 424 of the stent, for example, to facilitate securing the upper skirt to the struts of the stent via sutures. For example, the upper skirt 443 can include an upper edge 456 shaped to correspond to the shape of the grid of the second lowest row of frame members 412. The inflow end portion of the upper skirt 443 can have an undulating lower edge 458 that substantially aligns with the wavy or undulating shape of the undulating suture line 444 and the inflow portions of the leaflets 443a, 443b, and 443c. The outflow end portion of the lower skirt 445 can be shaped to have an undulating shape that substantially corresponds to the undulating suture line 444. The inflow end portion 454 of the upper skirt 443 and the outflow end portion 447 of the lower skirt 445 overlap each other on opposite sides of the leaflet inflow end portion at least enough to secure the upper and lower skirts with sutures along suture lines 444. Although other configurations are possible, the inflow end portion of the lower skirt 445 typically extends to the inflow end 426 of the stent. For example, the inflow end portion of the lower skirt 445 can be shaped to include a lower edge shaped to correspond to the shape of the lowermost row of the frame.

[0115] The outflow end portion of the leaflet assembly 414 can be secured to the upper portion of the stent 12 at the three angularly spaced commissural attachments of the leaflets 34a, 34b, 34c in a manner similar to the configuration used to secure the outflow end portion of the leaflet assembly 14 to the upper portion of the stent 12 (e.g., Figure 2434b, 434c), is secured to the upper portion of the stent 412 at three angularly spaced commissural attachments of the leaflets 434a, 434b, 434c.

[0116] Figure 33 The operation of the prosthetic valve 410 is shown. During diastole, the leaflets 434a, 434b, and 434c collapse, effectively closing the prosthetic valve. As shown, the curved shape of the middle section 422 of the stent 412 defines a space between the middle section and the leaflets that simulates the sinuses of Valsalva. Thus, when the leaflets close, backflow into the "sinuses" creates turbulent blood flow along the upper surface of the leaflets, as indicated by arrows 452. This turbulent flow helps clean the leaflets and skirt assembly 442, thereby minimizing clot formation.

[0117] Reference Figure 33 and Figure 35 , the prosthetic valve 410 can further include a sealing skirt 449 positioned at the lower section 424 of the stent. The sealing skirt 449 provides an additional barrier to prevent paravalvular leakage after the stent is implanted in a subject by providing material at the inflow end portion of the stent that protrudes outward through the lattice openings of the frame and contacts the surrounding tissue of the native annulus, thereby minimizing or reducing paravalvular leakage. The sealing skirt is ideally supported by the upper skirt 443 and the lower skirt 445, thereby preventing the sealing skirt 449 from contacting the leaflets 434a, 434b and 434c of the leaflet assembly 414. The upper skirt 443 and the lower skirt 445 provide additional support to ensure that the material of the sealing skirt 449 extends outward between the lattice formed by the struts 416 of the stent 412 to seal against the surrounding annulus.

[0118] Figure 34 An embodiment of the sealing skirt 449 is depicted prior to attachment to the stent. The outflow end portion 451 of the sealing skirt 449 can have a wavy or sawtooth shape, i.e., have an upper edge shaped to correspond to the shape of the upper boundary of the grid of the lowest row of the frame formed by the struts 416 of the stent 412. In an alternative embodiment, the outflow end portion 451 of the sealing skirt 449 can have a substantially straight edge that is not aligned with the wavy or sawtooth shape formed by the struts 416 of the stent 412; alternatively, the outflow end portion 451 of the sealing skirt 449 can intersect the lowest row of the frame formed by the struts 416 of the stent 412 (see, e.g., FIG. 2 ). Figure 38 ). Although other configurations are possible, the inflow end portion 453 of the sealing skirt 449 typically extends to the inflow end 426 of the stent (see, e.g., Figure 35 and Figure 36For example, the sealing skirt 449 can have an upper edge and a lower edge shaped to correspond to the shape of the lowermost row of mesh formed by the struts 416 of the inflow end 426 of the stent, such that the sealing skirt 449 only blocks the openings in the lowermost row of mesh (see, e.g., Figure 37 In additional embodiments, the inflow end portion of the sealing skirt 449 can be configured to extend beyond the inflow end 426 of the stent (see, e.g., Figure 38 In several embodiments, the inflow end portion 453 of the sealing skirt 449 can be shaped to be substantially aligned with the inflow end portion of the lower skirt 445 .

[0119] Reference Figures 35 to 39 , the sealing skirt 449 can be secured to the struts 416 of the lower portion of the stent 412 using sutures 455. Sutures 455 can secure the sealing skirt 449 to the struts 416 of the lower portion of the stent 412, and optionally can also secure the upper skirt 443 and / or the lower skirt 445 to the struts 416 of the lower portion of the stent 412. The sealing skirt 449 is desirably made of a biocompatible synthetic material such as polytetrafluoroethylene (PTFE) or a braided polyester such as polyethylene terephthalate (PET), ) fabric material. In several embodiments, the sealing skirt comprises a plush or velvet material, such as loop yarn, which acts as a filling material because the fibers of the sealing skirt can extend outward through the opening in the frame and fill the space between the frame and the native annulus. The plush or velvet material is also compressible, thereby minimizing the curl profile of the sealing skirt 449. In some embodiments, the sealing skirt can be made of PET loop yarn or 70 / 20 polyester textured yarn. In additional embodiments, the sealing skirt can be made of partially oriented polyester multifilament yarn (pre-oriented yarn), polyester double-layer multifilament yarn, polyester film, knitted polyester, woven polyester and / or polyester felt. Such materials are commercially available, for example, from Biomedical Structures, Inc. (Warwick, RI) and ATEX Technologies, Inc. (Pinebluff, NC).

[0120] Reference Figure 39, the illustrated embodiment of the sealing skirt 449 can be made of a relatively smaller, non-plush or non-fleece material (e.g., a woven PET fabric) and secured to the frame member 412 (e.g., using sutures 455) such that portions of the sealing skirt protrude radially outward through the mesh of the frame member 412 to seal around the annulus. In such an embodiment, the sealing skirt can be secured by sutures 455 such that loose material of the sealing skirt 449 protrudes or projects through the lowermost mesh formed by the struts 416 of the frame member 412. The lower skirt 445 supports the sealing skirt 449 (and can be secured to the frame member 412 using the same sutures 455 used to secure the sealing skirt 449) to prevent loose material of the sealing skirt from protruding inward toward the longitudinal axis of the valve 410 and contacting the leaflets. In such an embodiment, the length of the sealing skirt 449 is generally greater than the length of the inner circumference of the lower portion of the frame member 412. Figure 39 A perspective view is provided depicting a portion of the frame member 412 and the sealing skirt 449; however, for clarity of illustration, the upper skirt 443, the lower skirt 445, and the leaflet assembly 434 are not depicted.

[0121] Depending on the type of material used for the sealing skirt, the size of the sealing skirt 449 can be adjusted to achieve the desired amount of material protruding from the expanded annular frame. For example, in embodiments where the sealing skirt 449 is constructed of a plush or velvet material (such as loop fleece) having fibers protruding outwardly between the meshes of the frame members 412, the length of the sealing skirt (in the expanded or flattened configuration prior to installation on the frame) can be substantially the same as the circumference of the lower portion of the frame members 412. In other embodiments, the length of the sealing skirt prior to installation on the annular frame is at least about 5% longer (such as at least about 10%, at least about 15%, at least about 20%, at least about 25%) than the circumference of the expanded annular frame of the stent, thereby allowing additional material to protrude between the meshes of the frame members 412.

[0122] Although the above description of the sealing skirt 449 is made with reference to the artificial heart valve 410, the sealing skirt can also be included on the artificial heart valve 10, for example, by modifying the size of the sealing skirt 449 as needed to fix the sealing skirt 449 to the skirt component 42 of the heart valve 10.

[0123] The prosthetic valve 410 can be implanted in a retrograde approach, wherein the prosthetic valve, mounted in a crimped state at the distal end of a delivery device (e.g., delivery device 100), is introduced into the body via the femoral artery and advanced through the aortic arch to the heart, as further described in U.S. Patent Application Publication No. 2008 / 0065011. The prosthetic valve 410 can also be implanted in a retrograde approach, wherein the prosthetic valve, mounted in a crimped state at the distal end of a delivery device (e.g., delivery device 100), is introduced into the body via the left or right subclavian artery and advanced to the heart. In further embodiments, the prosthetic valve 410 can be implanted in an antegrade approach, wherein the prosthetic valve, mounted in a crimped state at the distal end of a delivery device, is introduced into the body and advanced transventricularly (see, e.g., U.S. Patent No. 8,439,970). For transventricular implantation applications, retaining arms 430 can be included on the lower portion of the stent.

[0124] Prior to insertion of the delivery device, an introducer sheath can be inserted into the artery, followed by a guidewire that is advanced through the patient's vasculature through the aorta and into the left ventricle. The delivery device can then be inserted through the introducer sheath and advanced over the guidewire until the distal portion of the delivery device housing the prosthetic valve 410 is advanced to a position adjacent to or within the native aortic valve.

[0125] Known introducer sheaths typically utilize a cannula made from polymer tubing having a radial wall thickness of from about 0.025 mm (about 0.010 inches) to about 0.04 mm (about 0.015 inches). Figure 40A Shown is an embodiment of an introducer sheath indicated at 500 that employs a thin metal tubular layer having a much smaller wall thickness than known equipment. In a particular embodiment, the wall thickness of sheath 500 is from approximately 0.0012 mm (approximately 0.0005 inch) to approximately 0.05 mm (approximately 0.002 inch). Introducer sheath 500 comprises a proximally positioned housing or liner 502 and a distally extending sleeve or cannula 504. As is well known in the art, housing 502 can accommodate a seal or a series of seals to minimize blood loss. Sleeve 504 comprises a tubular layer or sleeve 506 formed of a metal or metal alloy such as nitinol or stainless steel, and is ideally formed with a series of circumferentially extending or spirally extending slots or openings to impart the sleeve desired degree of flexibility.

[0126] like Figure 40BAs shown, for example, the tubular layer 506 is formed (e.g., laser cut) with an "I-beam" pattern of alternating annular strips 507 and openings 508 with axially extending connecting portions 510 connecting adjacent strips 507. As shown in the illustrated embodiment shown, two adjacent strips 507 can be connected by a plurality of angularly spaced connecting portions 510, such as four connecting portions 510 spaced approximately 90 degrees from each other about the cannula axis. The cannula 504 exhibits sufficient flexibility to allow flexing without twisting or buckling as the cannula is advanced through a tortuous path. Figure 41 Another pattern of openings that can be laser cut or otherwise formed in tubular layer 506 is shown. Figure 41 The tubular layer in the embodiment of the present invention has a pattern of alternating strips 512 and openings 514 with connecting portions 516 that connect adjacent strips 512 and openings 514, and each connecting portion 516 is arranged in a spiral pattern along the length of the cannula. In alternative embodiments, the pattern of strips and openings and / or the width of the strips and / or openings can vary along the length of the cannula to change the stiffness of the cannula along its length. For example, the width of the strips can decrease from the proximal end to the distal end of the cannula to provide greater stiffness near the proximal end and greater flexibility near the distal end of the cannula.

[0127] like Figure 42 As shown, the cannula 504 can have a thin outer layer or liner 518 extending over the tubular layer 506, the outer liner 518 being made of a low-friction material to reduce friction between the cannula and the vessel wall into which the cannula is inserted. The cannula 504 can also have a thin inner layer or liner 520 covering the inner surface of the tubular layer 506 and being made of a low-friction material to reduce friction between the cannula and a delivery device inserted therein. The inner and outer layers can be made of suitable polymers such as PET, PTFE, FEP, and / or polyether block amides. The inner and outer liners and tubular layers are appropriately sized for the desired application of the introducer sheath 500. In certain embodiments, the inner liner 520 can have a radial wall thickness in a range from about 0.0012 mm (about 0.0005 in) to about 0.012 mm (about 0.005 in), such as from about 0.025 mm (about 0.001 in) to about 0.075 mm (0.003 in), for example, about 0.06 mm (about 0.0025 in). In certain embodiments, the outer liner 518 has a radial wall thickness in a range from about 0.0012 mm (about 0.0005 in) to about 0.012 mm (about 0.005 in), such as from about 0.012 mm (about 0.0005 in) to about 0.075 mm (0.003 in), for example, about 0.025 mm (about 0.001 in). In particular embodiments, the tubular layer 506 can have a radial wall thickness in a range from about 0.0012 mm (about 0.0005 inches) to about 0.025 mm (about 0.01 inches), such as from about 0.05 mm (about 0.002 inches) to about 0.15 mm (about 0.006 inches), for example, about 0.05 mm (about 0.002 inches) or about 0.1 mm (about 0.004 inches).

[0128] In concert, the wall thickness of the liner 520, tubular layer 506, and outer layer can vary based on the desired end product. In some embodiments, the liner 520, tubular layer 506, and outer layer can uniformly have a radial wall thickness ranging from about 0.05 mm (about 0.002 inches) to about 0.5 mm (about 0.02 inches), such as from about 0.09 mm (about 0.0035 inches) to about 0.3 mm (about 0.012 inches). Thus, the cannula 504 can be provided with an outer diameter that is about 1 Fr to 2 Fr smaller than known devices. The relatively small profile of the cannula 504 improves ease of use, reduces the risk of patient injury via tearing of the arterial wall, and increases potential use for minimally invasive procedures in patients with highly calcified arteries, tortuous pathways, or small vessel diameters.

[0129] The liner 520 can be applied to the interior of the tubular layer 506, for example, using a two-stage molding process. In one step, a preformed cylindrical polymer tube or parison 522 ( 524 ) with an open end 524 and a closed end 526 is formed, for example, by an injection molding or extrusion process. Figure 48). The tube 522 has an outer diameter and a wall thickness, wherein the outer diameter of the tube 522 is smaller than the inner diameter of the tubular layer 506, and the wall thickness of the tube 522 is designed to provide a suitable wall thickness for the inner liner 520 of the tubular layer 506, followed by blow molding. In one embodiment, the tube 522 can have a wall thickness of from about 0.025 mm (about 0.001 inches) to about 0.1 mm (about 0.004 inches) (such as from about 0.05 mm (about 0.002 inches) to about 0.075 mm (about 0.003 inches), such as about 0.06 mm (about 0.0025 inches)). Suitable materials for the polymeric tube can be selected based on the desired finished product. In some embodiments, the polymeric tube 522 is made of nylon-12, polyethylene or fluorinated ethylene propylene and / or polyether block amide (for example, The length of the tube 522 can vary depending on the length of the tubular layer 506 and is typically longer than the length of the tubular layer 506. In another step, heat and pressure are applied to the tube 522 to form the liner 520 by blow molding.

[0130] Figure 48 and Figure 49 An exemplary method using blow molding to apply a tube 522 to a tubular layer 506 to form a liner 520 is depicted. The tubular layer 506 is inserted into a mold 528. The mold 528 has an inner diameter slightly larger than the tubular layer 506 so that the sleeve can be easily inserted into and removed from the mold, and during the pressurization step (described below), the mold 528 prevents any appreciable radial expansion of the sleeve. The mold 528 can be constructed to be non-expandable during the blow molding of the tube 522. The mold 528 can have a cylindrical inner surface 529 that corresponds to the shape of the outer surface of the tubular layer 506. Thus, when the tube 522 is pressurized (discussed in detail below), the inner surface of the mold prevents the tubular layer 506 from expanding / deforming under the pressure from the expanded tube 522 and prevents portions of the tube 522 from expanding radially outward through the opening 508 in the tubular layer 506.

[0131] like Figure 48 As shown, a tube 522 with an open end 524 and a closed end 526 is inserted into the tubular layer 506. The closed end 526 can extend beyond one end of the tubular layer 506, and the open end 524 can extend beyond the other end of the tubular layer 506.

[0132] Heat and pressure are applied to the tube 522 to cause the tube to expand against the inner surface of the tubular layer 506 to form an expanded polymer tube 530. Heat and pressure can be applied sequentially (e.g., first apply heat, then apply pressure) or simultaneously. For example, by injecting heated compressed gas or fluid into the open end 524 of the tube 522, heat and pressure can be applied simultaneously. Alternatively, heat can be applied by heating the mold 528, and the tube 522 can be pressurized by injecting compressed gas or fluid into the open end 524 of the tube 522. For example, the entire assembly including the mold 528, the tubular layer 506 and the tube 522 can be immersed in the heated fluid. In this regard, the wall of the mold can have one or more orifices, so that the heated fluid (e.g., a heated fluid such as water) is allowed to flow through the orifice and contact the tube 522, thereby facilitating the heating of the tube. Various other types of heat sources, such as resistive heat sources, conductive heat sources, convection heat sources and infrared heat sources, can be used to apply heat to the tube 522. Alternatively, the tube 522 can be axially stretched while being heated and / or pressurized, or in one or more separate stretching steps performed at a separate time from the heating and / or pressurization.

[0133] The portion of the expanded tube 530 that extends beyond either end of the tubular layer 506 can be trimmed to form the liner 520 of the tubular layer 506. In some embodiments, the liner 520 can expand into the opening 508 of the tubular layer 506 during the molding process and remain in the opening after the molding process. In other embodiments, the liner 520 does not expand into and / or remain in the opening 508 of the tubular layer 506 during the molding process. The specific heat and pressure conditions (including the duration for which heat and pressure should be applied, as well as the cooling conditions) used to blow mold the liner 520 of the tubular layer 506 can be varied as desired and will generally depend on the starting material and the desired finished product. In some embodiments, the tube 522 is heated to approximately 125 degrees Celsius (approximately 255 degrees Fahrenheit) and pressurized to approximately 80 kilopascals (approximately 12 pounds per square inch) for a period of time sufficient to form the liner 520. Further, general methods of blow molding are well known to those of ordinary skill in the art (see, for example, US Patent Application Publication No. 2011 / 0165284).

[0134] The outer layer of the sheath can be applied to and secured to the outer surface of the tubular layer 506 using conventional techniques or mechanisms (e.g., using adhesives or by heat welding). In one embodiment, the outer layer is formed by shrink wrapping a polymer tubular layer onto the tubular layer 506. Suitable materials for the outer layer can be selected based on the desired finished product. In some embodiments, the outer layer is comprised of nylon-12, polyether block amide ( For example, 72D) and / or polyethylene. The outer layer can be applied to the tubular layer 506 before or after the inner layer is formed using the molding process described above.

[0135] In a modification of the introducer sheath 500, the sheath can have an inner layer and an outer layer, respectively, which are fixed to the metal sleeve (e.g., sleeve 504) only at the proximal and distal ends of the metal sleeve. The inner polymer layer and the outer polymer layer can be bonded to the metal sleeve (or bonded to each other through gaps in the metal sleeve), for example, by using a suitable adhesive or by heat welding. In this way, the metal sleeve is not attached to the inner polymer layer and the outer polymer layer between the proximal and distal ends of the sleeve along most of the length of the sleeve, and thus the metal sleeve is "free floating" relative to the polymer layer along most of the length of the sleeve. This configuration allows adjacent metal strips to bend more easily relative to the inner layer and the outer layer, providing the sheath with greater flexibility and resistance to twisting than if the inner layer and the outer layer were bonded along the entire length of the sleeve.

[0136] Figure 43 600 that can be used in the introducer sheath 500. The sheath 500 in this embodiment desirably comprises an inner polymer layer and an outer polymer layer that are desirably secured to the metal cannula only at its proximal and distal ends as described above. The cannula 600 comprises a plurality of circular strips or rings 602 interconnected by two links or connecting portions 604 extending between each pair of adjacent rings. Each pair of links connecting two adjacent strips 602 is desirably spaced approximately 180 degrees apart from each other and is desirably rotationally offset approximately 90 degrees from the adjacent pair of connecting links to allow for multi-axial bending.

[0137] Figure 44 A side view of a segment of another embodiment of a metal cannula, indicated at 700, which can be used in the introducer sheath 500 is shown. The cannula 700 has the same cut pattern as the cannula 600 and thus has circular strips 702 and two links 704 connecting adjacent strips, and further includes two cutouts or apertures 706 formed in each strip 702 to increase the flexibility of the cannula. The cutouts 706 ideally have a generally elliptical or oval shape, but can also have other shapes. Each cutout 706 ideally extends approximately 180 degrees in the circumferential direction of the cannula and is ideally rotationally offset approximately 90 degrees from the cutout 706 in the adjacent strip 702.

[0138] In certain embodiments, the metal sleeve of the introducer sheath has a wall thickness ranging from about 0.05 mm (about 0.002 in) to about 0.015 mm (about 0.006 in). In one implementation, the sheath has a metal sleeve with a wall thickness of about 0.05 mm (about 0.002 in) and an inner diameter of about 5.8 mm (about 0.229 in), an inner polymer layer with a wall thickness of about 0.06 mm (about 0.0025 in), an outer polymer layer with a wall thickness of about 0.025 mm (about 0.001 in), and a total wall thickness (throughout all three layers) of about 0.14 mm (about 0.0055 in). In another embodiment, the sheath has a metal sleeve having a wall thickness of about 0.1 mm (about 0.004 inches) and an inner diameter of about 5.8 mm (about 0.229 inches), an inner polymer layer having a wall thickness of about 0.06 mm (about 0.0025 inches), an outer polymer layer having a wall thickness of about 0.025 mm (about 0.001 inches), and a total wall thickness (throughout all three layers) of about 0.2 mm (about 0.0075 inches). Figure 45 Shown for forming Figure 43 The cutting pattern of the metal sleeve 600. Figure 46 Shown for forming Figure 44 The cutting pattern of the metal sleeve 700. Figure 47 Shows something like Figure 46 The cutting pattern of the cutting pattern, but including the cut 706, the cut 706 is larger than that in Figure 46 The incision is shown in Figure 4.

[0139] Table 1

[0140]

[0141] Table 1 above shows the bending properties of several metal sleeves. Each metal sleeve has an inner diameter of about 5.8 mm (about 0.229 inches). Figure 43 With the exception of the final sleeve of the cutting pattern shown in FIG, each sleeve is formed with Figure 44 All of the cannulas in Table 1 provided device delivery capabilities at a relatively small bend diameter (2.5 cm, 1 inch). Furthermore, it was found that the metal cannulas recovered their annular cross-sectional shape even after passing the delivery device through the visible twisted section of the cannula.

[0142] In view of the many possible embodiments to which the principles of the present invention may be applied, it should be appreciated that the illustrated embodiments are merely preferred examples and should not be considered to limit the scope of the present disclosure. Furthermore, additional embodiments are disclosed in U.S. Patent Application No. 2010 / 0049313 (U.S. Patent Application No. 12 / 429,040) and U.S. Patent Application Publication No. 2012 / 0239142 (U.S. Patent Application No. 13 / 405,119). Applicants therefore claim all aspects that fall within the scope and spirit of the appended claims.

Claims

1. An artificial heart valve, comprising: a collapsible and expandable annular frame configured to be collapsed to a radially collapsed state for mounting on a delivery device and expanded to a radially expanded state within the body, the frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, the frame comprising a plurality of struts defining a plurality of rows of a plurality of grids; a collapsible and expandable valve component mounted within the annular frame, the valve component comprising a leaflet assembly including leaflets; A collapsible and expandable skirt assembly is mounted within the annular frame and comprises an upper skirt, a lower skirt and a sealing skirt, wherein the sealing skirt is supported by the upper skirt and the lower skirt to prevent the sealing skirt from contacting the leaflets of the leaflet assembly and to provide support to ensure that the material of the sealing skirt extends outwardly between the grid of the frame to seal against the surrounding valve annulus.

2. An artificial heart valve according to claim 1, wherein the sealing skirt is made of loop yarn.

3. An artificial heart valve according to claim 1, wherein the sealing skirt is mounted within the annular frame of the artificial heart valve by sutures, and the sutures fix the sealing skirt and the lower skirt to the frame of the artificial heart valve.

4. The prosthetic heart valve according to any one of claims 1 to 3, wherein the sealing skirt extends beyond the inflow end of the prosthetic heart valve.

5. The prosthetic heart valve according to any one of claims 1 to 3, wherein the sealing skirt comprises an upper edge and a lower edge shaped to correspond to the shape of the lowermost row of meshes of the frame.

6. The prosthetic heart valve of any one of claims 1 to 3, wherein the upper skirt comprises an upper edge shaped to correspond to the shape of an upper boundary of the second lowermost row of meshes of the frame.

7. The prosthetic heart valve according to any one of claims 1 to 3, wherein with reference to the longitudinal axis: The valve component is disposed radially outward from the lower skirt, the upper skirt is disposed radially outward from the valve component; and the sealing skirt is disposed radially outward from the upper skirt.

8. The artificial heart valve according to any one of claims 1 to 3, wherein the lower skirt, the valve member and the upper skirt are coupled to each other by sutures.

9. The prosthetic heart valve according to any one of claims 1 to 3, wherein the outflow portion of the lower skirt is sewn to the inflow portion of the valve member; and The inflow portion of the valve component is sewn to the inflow portion of the upper skirt.

10. The prosthetic heart valve of any one of claims 1 to 3, wherein the outflow end portion of the sealing skirt has a substantially straight edge that is not aligned with the shape formed by the struts of the frame.

11. The prosthetic heart valve of claim 10, wherein the outflow end portion of the sealing skirt intersects a lowermost row of the grid of the frame formed by the struts of the frame.

12. The prosthetic heart valve according to any one of claims 1 to 3, wherein the inflow end portion of the sealing skirt extends beyond the inflow end of the frame.

13. The prosthetic heart valve of claim 12, wherein the inflow end portion of the sealing skirt is substantially aligned with the inflow end portion of the lower skirt.

14. The prosthetic heart valve of claim 13, wherein sutures secure the sealing skirt to the struts at the inflow end of the frame.

15. The prosthetic heart valve of claim 14, wherein the sutures secure the upper skirt and / or the lower skirt to the struts at the inflow end of the frame.

16. The prosthetic heart valve of claim 14, wherein the sutures secure the sealing skirt such that loose material of the sealing skirt protrudes or projects through a lowermost grid formed by the struts of the frame.

17. An artificial heart valve according to claim 16, wherein the lower skirt supports the sealing skirt to prevent the loose material of the sealing skirt from protruding inwardly toward the longitudinal axis of the valve and to prevent the loose material of the sealing skirt from contacting the valve component.

18. The prosthetic heart valve of claim 17, wherein the lower skirt is secured to the frame using the same sutures used to secure the sealing skirt.

19. An artificial heart valve according to claim 17 or claim 18, wherein the length of the sealing skirt is longer than the length of the inner circumference of the inflow end of the frame.

20. The prosthetic heart valve of claim 19, wherein the length of the sealing skirt is at least 5% longer than the circumference of the expanded annular frame prior to mounting on the frame.

21. The prosthetic heart valve of claim 20, wherein the length of the sealing skirt is at least 10% longer than the circumference of the expanded annular frame prior to mounting on the frame.

22. The prosthetic heart valve of claim 20, wherein the length of the sealing skirt is at least 15% longer than the circumference of the expanded annular frame prior to mounting on the frame.

23. The prosthetic heart valve of claim 20, wherein the length of the sealing skirt is at least 20% longer than the circumference of the expanded annular frame prior to mounting on the frame.

24. The prosthetic heart valve of claim 20, wherein the length of the sealing skirt is at least 25% longer than the circumference of the expanded annular frame prior to mounting on the frame.

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