Transcatheter deliverable prosthetic heart valves and methods of delivery

Abstract

To provide transcatheter deliverable prosthetic hart valves, and devices and methods for use in the delivery and deployment of such valves.SOLUTION: A prosthetic valve 102 includes a frame 110 and a flow control component 150. The frame 110 has an aperture 114 extending through the frame about a central axis. The flow control component 150 is mounted within the aperture 114 and is configured to permit blood flow in a first direction approximately parallel to a vertical axis from an inflow end to an outflow end of the flow control component 150 and to block blood flow in a second direction, opposite the first direction. The frame 110 has an expanded configuration with a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and a first longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis. The frame 110 has a compressed configuration with a second height less than the first height and a second lateral width less than the first lateral width.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of the following documents: U.S. Provisional Patent Application No. 62 / 766,611, entitled "Side-Loading Transcatheter Heart Valve Replacement," filed September 20, 2018; U.S. Provisional Patent Application No. 62 / 737,343, entitled "Side-Loading Transcatheter Heart Valve Replacement," filed September 27, 2018; U.S. Patent Application No. 16 / 155,890, entitled "Orthogonally Delivered Transcatheter Heart Valve Replacement," filed October 10, 2018; U.S. Provisional Patent Application No. 62 / 749,121, entitled "Guidewire Delivery of Tricuspid Valve," filed October 22, 2018; U.S. Patent Application No. 16 / 163,577, entitled "Orthogonally Delivered Transcatheter Heart Valve Frame for Valve in Valve" No. 62 / 777,070, entitled "Compression Capable Annular Frames for Orthogonal Delivery of Transcatheter Heart Valve Replacement," filed on December 8, 2018, the disclosures of each of which are incorporated herein by reference in their entireties. [Background technology]

[0002] Described herein are embodiments of prosthetic heart valves, as well as devices and methods for use in delivering and deploying such valves.

[0003] Prosthetic heart valves can pose problems during delivery and placement within the heart, especially when delivered with a catheter through the patient's vasculature rather than through a surgical approach. Conventional valves have a central cylindrical axis parallel to the longitudinal axis of the delivery catheter and are deployed from the end of the delivery catheter. They then expand radially outward from the central annular axis in a manner similar to the way a closed spring-loaded umbrella is forced open from a sleeve. Conventional valves can only expand to as much as allowed by the inner diameter of the delivery catheter. Efforts to increase the expanded diameter of conventional valves have run into problems trying to compress many materials and structures into spaces that are too small.

[0004] There is a need for a valve that can be delivered through a small diameter delivery catheter, particularly to a native valve such as the tricuspid valve.

[0005] The embodiments described herein generally relate to transcatheter prosthetic valves and methods for delivering transcatheter prosthetic valves. In some embodiments, the prosthetic valve includes a frame and a flow control component. The frame has an aperture extending through the frame about a central axis. The flow control component is configured to mount within the aperture to allow blood flow in a first direction generally parallel to the central axis from an inflow end to an outflow end of the flow control component and block blood flow in a second direction opposite the first direction. The frame has an expanded configuration with a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and a first longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis. The frame has a compressed configuration with a second height less than the first height along the central axis and a second lateral width less than the first lateral width along the lateral axis. [Brief description of the drawings]

[0006] [Figure 1A] FIG. 1 is a schematic diagram of a transcatheter prosthetic valve according to one embodiment. [Figure 1B] FIG. 1 is a schematic diagram of a transcatheter prosthetic valve according to one embodiment. [Figure 1C] FIG. 1 is a schematic diagram of a transcatheter prosthetic valve according to one embodiment. [Figure 1D] FIG. 1 is a schematic diagram of a transcatheter prosthetic valve according to one embodiment. [Figure 1E] FIG. 1 is a schematic diagram of a transcatheter prosthetic valve according to one embodiment. [Figure 1F] FIG. 1 is a schematic diagram of a transcatheter prosthetic valve according to one embodiment. [Diagram 2] FIG. 1 illustrates a transcatheter prosthetic valve delivered to a target tissue within a delivery catheter, according to one embodiment. [Diagram 3] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment, inserted within a native annulus of a target tissue. [Figure 4A] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment, positioned within a native annulus of a target tissue. [Figure 4B] FIG. 1 is a partial cutaway view of a transcatheter prosthetic valve showing the internal valve sleeve, according to one embodiment. [Diagram 5] FIG. 1 is a side view of a transcatheter prosthetic valve according to one embodiment. [Figure 6] 6 illustrates a process of delivering the transcatheter prosthetic valve of FIG. 5 to the native annulus of a target tissue. [Figure 7] 6 illustrates a process of delivering the transcatheter prosthetic valve of FIG. 5 to the native annulus of a target tissue. [Figure 8] 6 illustrates a process of delivering the transcatheter prosthetic valve of FIG. 5 to the native annulus of a target tissue. [Figure 9] 6 illustrates a process of delivering the transcatheter prosthetic valve of FIG. 5 to the native annulus of a target tissue. [Figure 10] 1A-1D are various views of a transcatheter prosthetic valve in a compressed configuration within a delivery catheter, according to one embodiment. [Figure 11] 1A-1D are various views of a transcatheter prosthetic valve in a compressed configuration within a delivery catheter, according to one embodiment. [Figure 12]1A-1D are various views of a transcatheter prosthetic valve in a compressed configuration within a delivery catheter, according to one embodiment. [Figure 13] FIG. 11 is a partial cross-sectional view of the transcatheter prosthetic valve of FIG. [Figure 14] 14A-C illustrate a transcatheter prosthetic valve being transitioned from an expanded configuration (FIG. 14A) to a compressed configuration (FIG. 14C) according to one embodiment. [Figure 15] FIG. 14B is a perspective view of the transcatheter prosthetic valve of FIG. 14A in a compressed configuration within a delivery catheter. [Figure 16] 1A-D illustrate a transcatheter prosthetic valve being transitioned from an expanded configuration (A) to a compressed configuration (D) according to one embodiment. [Figure 17] 5A-5E illustrate a transcatheter prosthetic valve being transitioned from an expanded configuration (A) to a compressed configuration (E) according to one embodiment. [Figure 18] 1A-D illustrate a transcatheter prosthetic valve being transitioned from an expanded configuration (A) to a compressed configuration (D) according to one embodiment. [Figure 19] 19A-D illustrate a transcatheter prosthetic valve being transitioned from a compressed configuration (FIG. 19A) to an expanded configuration (FIG. 19D) according to one embodiment. [Figure 20] FIG. 1 is a side perspective view of a transcatheter prosthetic valve according to one embodiment. [Figure 21] FIG. 21 is a partial cross-sectional view of the transcatheter prosthetic valve of FIG. [Figure 22] FIG. 1 is an exploded view of a two-panel transcatheter prosthetic valve according to one embodiment. [Diagram 23] FIG. 23 is a side view of the two-panel transcatheter prosthetic valve of FIG. [Figure 24] FIG. 23 is a side view of the two-panel transcatheter prosthetic valve of FIG. 22 in a compressed configuration. [Diagram 25] FIG. 1 is an exploded view of a two-panel transcatheter prosthetic valve according to one embodiment. [Figure 26] FIG. 26 is a side view of the two-panel transcatheter prosthetic valve of FIG. [Figure 27]FIG. 26 is a side view of the two-panel transcatheter prosthetic valve of FIG. 25 in a compressed configuration. [Figure 28] FIG. 1 is a side perspective view of a transcatheter prosthetic valve according to one embodiment. [Figure 29] FIG. 1 is a plan view of a transcatheter prosthetic valve according to one embodiment. [Diagram 30] FIG. 1 is a side perspective view of a transcatheter prosthetic valve according to one embodiment. [Diagram 31] FIG. 1 is a plan view of a transcatheter prosthetic valve according to one embodiment. [Diagram 32] 1A-B are side perspective views of a transcatheter prosthetic valve according to one embodiment in an expanded configuration. [Diagram 33] 5A-5E illustrate a transcatheter prosthetic valve being transitioned from an expanded configuration (A) to a compressed configuration (E) according to one embodiment. [Figure 34A] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment in a collapsed configuration. [Figure 34B] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment in an expanded configuration. [Figure 35A] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment. [Figure 35B] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment. [Figure 36A] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment. [Figure 36B] FIG. 1 illustrates a transcatheter prosthetic valve according to one embodiment. [Figure 37A] FIG. 1 is a side perspective view of a transcatheter prosthetic valve according to one embodiment. [Figure 37B] FIG. 1 is a top perspective view of a transcatheter prosthetic valve according to one embodiment. [Figure 37C] FIG. 37B is a perspective view of the transcatheter prosthetic valve of FIG. 37A being transitioned to a collapsed configuration. [Figure 37D] FIG. 37B is a perspective view of the transcatheter prosthetic valve of FIG. 37A being transitioned to a collapsed configuration. [Figure 38]1A-C are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 39] 1A-1D are side perspective views of transcatheter prosthetic valves according to different embodiments. [Diagram 40] 1A-1D are side perspective views of transcatheter prosthetic valves according to different embodiments. [Diagram 41] AG show various views of one or more portions of a transcatheter prosthetic valve, according to embodiments. [Diagram 42] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Diagram 43] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Diagram 44] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Diagram 45] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Figure 46] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Figure 47] 1A and 1B are side perspective views of an etched metal alloy sheet used to form the frame of a transcatheter prosthetic valve according to different embodiments. [Figure 48] 1A-1D are side views of a transcatheter prosthetic valve positioned within a native annulus of a target tissue according to different embodiments. [Figure 49] 1A-1D are side views of a transcatheter prosthetic valve positioned within a native annulus of a target tissue according to different embodiments. [Figure 50] FIG. 1 is a side view of a transcatheter prosthetic valve positioned and secured within a native annulus of the heart. [Figure 51A] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 51B] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 51C] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Fig. 51D] FIG. 51B illustrates the transcatheter prosthetic valve of FIG. 51A at least partially disposed within a delivery catheter. [Figure 51E] FIG. 51B illustrates the transcatheter prosthetic valve of FIG. 51A at least partially disposed within a delivery catheter. [Figure 52] 1A and 1B illustrate a transcatheter prosthetic valve partially and completely deployed, respectively, within the native annulus of a target tissue. [Figure 53A] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 53B] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 53C] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Fig. 53D] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 53E] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Fig. 53F] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 54A] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 54B] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Fig. 54C] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Fig. 54D] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 54E] 1A-1D are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 55A] FIG. 1 is a side perspective view of a transcatheter prosthetic valve according to one embodiment. [Figure 55B] FIG. 55B is a cross-sectional view of the transcatheter prosthetic valve of FIG. [Figure 56] 1A-B are side views of a transcatheter prosthetic valve according to one embodiment in an expanded configuration. [Figure 57]1A-B are side views of a transcatheter prosthetic valve according to one embodiment in an expanded configuration. [Figure 58] 1A-B are side perspective views of a transcatheter prosthetic valve according to one embodiment. [Figure 59] 1A-1D are side perspective views of transcatheter prosthetic valves according to different embodiments. [Figure 60] 1A-1D are side perspective views of transcatheter prosthetic valves according to different embodiments. [Figure 61] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Figure 62] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Figure 63] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Figure 64] 1A-1D are various views of one or more portions of a wire frame of a transcatheter prosthetic valve, according to an embodiment. [Figure 65A] FIG. 2 is a plan view of a transcatheter prosthetic valve shown in cross-section of the atrial floor and positioned within the native valve annulus. [Figure 65B] FIG. 2 is a bottom view of a transcatheter prosthetic valve shown in cross section at the roof of the ventricle, positioned within the native annulus. [Figure 66] FIG. 1 is a side perspective view of a wire frame of a transcatheter prosthetic valve according to one embodiment. [Figure 67] FIG. 1 is a side perspective view of a valve sleeve of a transcatheter prosthetic valve according to one embodiment. [Figure 68A] FIG. 1 is a side perspective view of a valve sleeve of a transcatheter prosthetic valve according to one embodiment. [Figure 68B] FIG. 68B is a cross-sectional view of the valve sleeve of FIG. 68A positioned within the frame of a transcatheter prosthetic valve. [Figure 69] FIG. 1 is a side perspective view of a valve sleeve of a transcatheter prosthetic valve according to one embodiment. [Figure 70A] FIG. 1 is a side perspective view of a valve sleeve of a transcatheter prosthetic valve according to one embodiment. [Figure 70B] FIG. 70B is a cross-sectional view of the valve sleeve of FIG. 70A positioned within the frame of a transcatheter prosthetic valve. [Figure 71] 1A-C are various views of a transcatheter prosthetic valve according to one embodiment. [Figure 72A] FIG. 1 is a schematic diagram of a delivery system for delivering a transcatheter prosthetic valve according to one embodiment. [Fig. 72B] FIG. 1 is a schematic diagram of a delivery system for delivering a transcatheter prosthetic valve according to one embodiment. [Fig. 72C] FIG. 1 is a schematic diagram of a delivery system for delivering a transcatheter prosthetic valve according to one embodiment. [Fig. 72D] 1 is a flow chart illustrating a method for delivering a transcatheter prosthetic valve according to one embodiment. [Figure 73] AB are diagrams of human cardiac anatomy. [Figure 74] FIG. 73C is a diagram of a transcatheter prosthetic valve positioned within the native annulus of the human heart of FIGS. 73A and 73B in accordance with one embodiment. [Fig. 75A] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to different embodiments. [Fig. 75B] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to different embodiments. [Fig. 75C] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to different embodiments. [Fig. 75D] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to different embodiments. [Figure 76] 1A-C illustrate the process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to different embodiments. [Figure 77] 1A-D illustrate the process of placing a transcatheter prosthetic valve within the native annulus of the human heart according to different embodiments. [Figure 78]1A-D illustrate the process of placing a transcatheter prosthetic valve within the native annulus of the human heart according to different embodiments. [Figure 79] 5A-5E illustrate a transcatheter prosthetic valve being transitioned from a compressed configuration (A) to an expanded configuration (D and E) according to one embodiment. [Figure 80A] 1A-1D illustrate a transcatheter prosthetic valve being transitioned from a compressed configuration (A) to an expanded configuration (D) in accordance with one embodiment. [Figure 80B] 1A-1D illustrate a transcatheter prosthetic valve being transitioned from a compressed configuration (A) to an expanded configuration (D) in accordance with one embodiment. [Fig. 80C] 1A-1D illustrate a transcatheter prosthetic valve being transitioned from a compressed configuration (A) to an expanded configuration (D) in accordance with one embodiment. [Fig. 80D] 1A-1D illustrate a transcatheter prosthetic valve being transitioned from a compressed configuration (A) to an expanded configuration (D) in accordance with one embodiment. [Figure 80E] FIG. 1 illustrates a side view of a transcatheter prosthetic valve in a compressed configuration within a delivery catheter, according to one embodiment, showing a secondary catheter configured to move the valve through the delivery catheter. [Figure 81] 1A-D are side views of a portion of a secondary catheter including a guidewire collar according to different embodiments. [Fig. 82A] FIG. 1 is a schematic diagram of a delivery system for delivering a transcatheter prosthetic valve according to one embodiment. [Fig. 82B] FIG. 1 is a schematic diagram of a delivery system for delivering a transcatheter prosthetic valve according to one embodiment. [Fig. 82C] FIG. 1 is a schematic diagram of a delivery system for delivering a transcatheter prosthetic valve according to one embodiment. [Fig. 82D] 1 is a flow chart illustrating a method for delivering a transcatheter prosthetic valve according to one embodiment. [Figure 83A] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 83B] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 83C] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 83D] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 83E] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 83F] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84A] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84B] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84C] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84D] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84E] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84F] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84G] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 84H] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 85]5A-5F illustrate a process for placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 86A] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 86B] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 86C] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 86D] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 86E] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 86F] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 87] 1A-E illustrate a process for placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 88] 1A-B illustrate a process for placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 89] 1A-C illustrate a process for placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 90] 1A-C illustrate a process of anchoring a transcatheter prosthetic valve to a target tissue via tissue anchors according to one embodiment. [Figure 91] 5A-D are side views of tissue anchors according to different embodiments. [Figure 92] 5A-D illustrate the process of placing and anchoring a transcatheter prosthetic valve within the native annulus of a target tissue. [Figure 93]5A-5E illustrate the process of placing and anchoring a transcatheter prosthetic valve within the native annulus of a target tissue. [Figure 94] 1 is a flow chart illustrating a method for delivering a transcatheter prosthetic valve according to one embodiment. [Figure 95] 1 is a flow chart illustrating a method for loading a transcatheter prosthetic valve into a delivery catheter according to one embodiment. [Figure 96A] FIG. 1 is a cross-sectional view of a transcatheter prosthetic valve illustrating a valve sleeve disposed within a frame, according to one embodiment. [Figure 96B] FIG. 96B is a side view of the transcatheter prosthetic valve of FIG. 96A in an expanded configuration. [Figure 96C] 96B illustrates a process of placing the transcatheter prosthetic valve of FIG. 96A within the native annulus of a target tissue. [Figure 96D] 96B illustrates a process of placing the transcatheter prosthetic valve of FIG. 96A within the native annulus of a target tissue. [Figure 96E] 96B illustrates a process of placing the transcatheter prosthetic valve of FIG. 96A within the native annulus of a target tissue. [Fig. 96F] 96B illustrates a process of placing the transcatheter prosthetic valve of FIG. 96A within the native annulus of a target tissue. [Figure 97] 1A-C illustrate a process of deploying a transcatheter prosthetic valve in a target tissue via a tissue anchor according to one embodiment. [Figure 98] 1A-C illustrate a process of deploying a transcatheter prosthetic valve in a target tissue via a tissue anchor according to one embodiment. [Figure 99] 1A-D are diagrams illustrating at least a portion of a transcatheter prosthetic valve according to one embodiment. [Figure 100] FIG. 1 illustrates a human heart, showing the approximate locations of the valves, atria, ventricles, and associated blood vessels entering and exiting the heart chambers. [Figure 101A] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 101B] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 101C] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 101D] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 101E] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Fig. 101F] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 101G] 1A-1C illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 102] 1A-D illustrate a process for deploying a transcatheter prosthetic valve within a native annulus of a target tissue according to one embodiment. [Figure 103A] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 103B] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 103C] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 103D] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 103E] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 103F] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 103G]1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 104A] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 104B] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 104C] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 104D] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Figure 104E] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. [Fig. 104F] 1A-1D illustrate a process of placing a transcatheter prosthetic valve within a native annulus of a human heart according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Disclosed embodiments are directed to orthogonally delivered transcatheter prosthetic valves and / or components thereof, and methods of manufacturing, mounting, delivering, and positioning the transcatheter prosthetic valves and / or components thereof. The transcatheter prosthetic valves have a tubular frame and a flow control component mounted within a central lumen of the tubular frame. The flow control component is configured to allow blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction opposite the first direction through an outflow end of the valve. The valve is compressible and expandable along a longitudinal axis substantially parallel to a longitudinal cylindrical axis of a delivery catheter. The valve is configured to transition between a compressed configuration for introduction into the body with a delivery catheter and an expanded configuration for implantation at a desired location within the body. The valve is configured to allow blood flow in a first direction through the inflow end of the valve and block blood flow in a second direction opposite the first direction through an outflow end of the valve.

[0008] In some embodiments, the transcatheter prosthetic valve has a compressible configuration longitudinally or orthogonally to the central axis of the flow control component, allowing large diameter valves (e.g., about 5-60 mm in height and about 20-80 mm in diameter) to be delivered and deployed directly from the inferior vena cava into the mitral or tricuspid valve, for example, with a 24-36 Fr delivery catheter, and without the need for delivery and deployment from a delivery catheter at an acute angle of approach.

[0009] In some embodiments, the transcatheter prosthetic valve has a central axis that is coaxial or at least substantially parallel to a first direction (e.g., blood flow direction) when in a compressed configuration. In some embodiments, the compressed configuration of the valve is orthogonal to the first direction. In some embodiments, the long axis is oriented at an intersection angle of 45 to 135 degrees relative to the first direction when in the compressed and / or expanded configuration.

[0010] In some embodiments, the transcatheter prosthetic valve includes a tension arm extending distally from a tubular frame. The tension arm can be used, for example, as a right ventricular outflow tract ("RVOT") tab. The tension arm can include a wire loop or wire frame, an integrated frame section, or a stent that extends approximately 10-40 mm away from the tubular frame.

[0011] In some embodiments, the transcatheter prosthetic valve includes (i) an upper tensioning arm attached to the distal upper edge of the tubular frame, the upper tensioning arm being comprised of a wire loop or wire frame that extends away from the tubular frame approximately 2-20 mm, and (ii) a lower tensioning arm (e.g., for use as an RVOT tab) extending from the distal side of the tubular frame, the lower tensioning arm being comprised of a wire loop or wire frame that extends away from the tubular frame approximately 10-40 mm.

[0012] In some embodiments, the transcatheter prosthetic valve includes at least one tissue anchor connected to the tubular frame for mating with valve annulus tissue.

[0013] In some embodiments, the transcatheter prosthetic valve is one of a balloon-expandable valve or a self-expanding valve.

[0014] In some embodiments, the tubular frame comprises a two-part framework: a first part includes a flared atrial cuff that is attached to a second part that includes a cylindrical member / segment, the cuff being attached to the cylindrical member / segment around the upper end of the cylindrical member / segment.

[0015] In some embodiments, the tubular frame has a flattened conical side profile with a diameter R of 40-80 mm, a diameter r of 20-60 mm, and a height of 5-60 mm. In some embodiments, the tubular frame has an hourglass-shaped flattened conical side profile with a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an inner diameter r of 20-30 mm, and a height of 5-60 mm. In some embodiments, the tubular frame has an outer diameter of 20-80 mm and an inner diameter of 21-79 mm.

[0016] In some embodiments, the tubular frame is formed of braided wire, laser cut wire, photolithographically formed wire cells, 3D printed wire cells, wire cells formed from a single stranded wire intermittently connected in a corrugated, zigzag, or helical shape, and / or combinations thereof, and is covered with a biocompatible material. In some embodiments, the tubular frame is formed of a plurality of compressible wire cells having an orientation and cell shape substantially perpendicular to the central vertical axis of the valve to minimize wire cell distortion when the tubular frame is configured in a vertically compressed configuration, a rolled compressed configuration, or a folded compressed configuration.

[0017] In some embodiments, the tubular frame has a central groove and a perimeter wall surrounding a central vertical axis in the expanded configuration. The perimeter wall has a front wall portion and a rear wall portion connected to a proximal folding region along a proximal side and to a distal folding region along a distal side. The front wall portion has a front upper collar portion and a front lower body portion. The rear wall portion has a rear upper collar portion and a rear lower body portion. In some embodiments, the front lower body portion and the rear lower body portion in the expanded configuration form a shape selected from a funnel, a cylinder, a flattened cone, or a circular hyperboloid. In some embodiments, the proximal folding region and the distal folding region each include a sewn seam, a woven panel, or a rigid hinge. In some embodiments, the proximal folding region and the distal folding region each include a flexible woven span without any wire cells.

[0018] In some embodiments, the tubular frame has an inner surface covered with a biocompatible material that includes pericardial tissue and an outer surface covered with a biocompatible material that includes a woven synthetic polyester material.

[0019] In some embodiments, the flow control component has an inner diameter of 20-35 mm, a height of 5-40 mm, and includes multiple leaflets of pericardial material joined to form a rounded cylinder at the inflow end and having a flat, closable aperture at the outflow end. For example, the flow control component can include 2-4 leaflets of pericardial material.

[0020] In some embodiments, the flow control component is supported by one or more longitudinal support members incorporated within or mounted on the flow control component, The one or more longitudinal support members are selected from rigid or semi-rigid struts, rigid or semi-rigid ribs, rigid or semi-rigid battens, rigid or semi-rigid panels, and combinations thereof.

[0021] In some embodiments, a delivery system for deploying a transcatheter prosthetic valve includes: (i) a delivery catheter including an elongated tube with a central lumen; (ii) a hypotube covered guidewire assembly having an outer sheath and an inner guidewire shaft configured to push against a guidewire collar on a tension arm of the compressed transcatheter prosthetic valve to deliver the valve; and (iii) a transcatheter prosthetic valve having a tension arm extending from a distal side of a tubular frame. The tension arm is comprised of a wire loop or wire frame, an integrated frame section, or a stent that extends approximately 10-40 mm away from the tubular frame. A guidewire collar element is attached to the tension arm. The guidewire collar element is sized by a guidewire aperture and configured to allow the inner guidewire shaft of the hypotube covered guidewire assembly to pass through the guidewire aperture and to block the outer sheath of the guidewire assembly from passing through the guidewire aperture.

[0022] In some embodiments, a method for manufacturing a transcatheter prosthetic valve includes: (i) manufacturing a tubular frame using additive or subtractive metal or metal alloy manufacturing, where additive metal or metal alloy manufacturing is 3D printing or direct metal laser sintering (powder fusion), and subtractive metal or metal alloy manufacturing is photolithography, laser sintering / cutting, CNC machining, or electrical discharge machining, (ii) mounting flow control components within the tubular frame, and (iii) covering an exterior surface of the tubular frame with a pericardial material or similar biocompatible material.

[0023] In some embodiments, a method for orthogonal delivery of a transcatheter prosthetic valve to a desired location within the body includes (i) advancing a delivery catheter to a desired location within the body, and (ii) delivering the transcatheter prosthetic valve to the desired location within the body by releasing the valve from the delivery catheter. The valve is in a compressed configuration while in the delivery catheter. The valve transitions to an expanded configuration upon release from the delivery catheter.

[0024] In some embodiments, the method further includes attaching a puller wire (e.g., a rigid elongated pull / push rod or pull wire) to a sidewall of the transcatheter prosthetic valve and pulling the valve into a tapered fixture or funnel (e.g., attached to the proximal end of the delivery catheter) such that the tapered fixture or funnel compresses or spirals the valve into a compressed configuration and seats within the delivery catheter.

[0025] In some embodiments, the method includes releasing the valve from the delivery catheter by: (i) pulling the valve from the delivery catheter using a puller wire removably connected to a distal side of the valve, whereby the compressed valve is pulled / pulled out of the delivery catheter by advancing a push rod away from the delivery catheter; or (ii) pushing the valve from the delivery catheter using a puller wire removably connected to a proximal side of the valve, whereby the compressed valve is pushed / pushed out of the delivery catheter by advancing a push rod away from the delivery catheter.

[0026] In some embodiments, the method includes increasing blood flow during deployment of the valve while releasing the valve from the delivery catheter by: (i) partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and through the flow control component; (ii) fully releasing the valve from the delivery catheter while maintaining attachment to the valve with a positioning catheter or puller wire to transition to a state of increased blood flow through the flow control component and decreased blood flow around the valve; (iii) deploying the valve in a final mounted position to transition to a state of full blood flow through the flow control component and minimal or no blood flow around the valve; and (iv) removing and withdrawing the positioning catheter or puller wire from the valve.

[0027] In some embodiments, the method further includes inserting a tension arm (eg, an RVOT tab) into the RVOT during the transition from partial release of the valve to full release of the valve.

[0028] In some embodiments, the method further includes rotating the transcatheter prosthetic valve with the steerable catheter along an axis parallel to the plane of the annulus such that (i) the upper tension arm is conformationally pressure locked against the supra-annular tissue, and (ii) the lower tension arm is conformationally pressure locked against the sub-annular tissue.

[0029] In some embodiments, the method further includes anchoring one or more tissue anchors attached to the valve within the annulus tissue.

[0030] In some embodiments, a method for orthogonal delivery of a transcatheter prosthetic valve to a desired location within a body includes (i) advancing a first delivery catheter to a desired location within the body, (ii) delivering a tubular frame to a desired location within the body by releasing the tubular frame from the delivery catheter, (iii) advancing a second delivery catheter to a desired location within the body, and (iv) delivering a flow control component within a central lumen of the tubular frame. The tubular frame is in a compressed configuration when within the first delivery catheter and the flow control component is in a compressed configuration when within the second delivery catheter. The tubular frame transitions to an expanded configuration when released from the first delivery catheter and the flow control component transitions to an expanded configuration when released from the second delivery catheter and mounted within the tubular frame.

[0031] In some embodiments, a method for compressing a transcatheter prosthetic valve for orthogonal longitudinal release from a delivery catheter includes (i) flattening, rolling, or folding the valve into a compressed configuration, where the long axis of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter. In some embodiments, the method includes one of: (i) rolling the valve in only one direction from one side of a tubular frame into the compressed configuration, (ii) rolling the valve symmetrically from two opposite sides of a tubular frame into the compressed configuration, (iii) flattening the tubular frame into two parallel panels substantially parallel to the long axis and rolling the flattened tubular frame into the compressed configuration, or (iv) flattening the tubular frame along a vertical axis to reduce the vertical dimension of the valve from top to bottom.

[0032] In some embodiments, a method for orthogonal delivery of a transcatheter prosthetic valve to a desired location within the body includes: (i) advancing a guidewire to a desired location within the body, the guidewire having an outer sheath and an inner shaft; (ii) advancing a delivery catheter over the guidewire to the desired location; (iii) mounting a valve capsule on a proximal end of the guidewire, the valve capsule including a compressed valve having a threaded guidewire collar having an aperture sized to allow the inner shaft of the guidewire to extend through the aperture and to block the outer sheath of the guidewire from extending through the aperture; (iv) loading the valve capsule into a proximal end of the delivery catheter; and (v) advancing the outer sheath over the inner shaft to advance the compressed valve from the valve capsule into a lumen of the delivery catheter and through the lumen to the desired location within the body, placing the valve at the desired location.

[0033] In some embodiments, a method for orthogonal delivery of a transcatheter prosthetic valve to a native annulus of a human heart can include at least one of: (i) advancing a delivery catheter via the femoral vein through the inferior vena cava (IVC) to the tricuspid valve or pulmonary artery of the heart; (ii) advancing via the jugular vein through the superior vena cava (SVC) to the tricuspid valve or pulmonary artery of the heart; or (iii) advancing via an IVC femoral or SVC jugular approach through a transatrial approach (e.g., at or below the fossa ovalis) to the mitral valve of the heart; and (iv) delivering the transcatheter prosthetic valve to the native annulus by releasing the valve from the delivery catheter.

[0034] In some embodiments, the method further includes positioning a tension arm of the transcatheter prosthetic valve in the RVOT of the right ventricle of the human heart. For example, the method can further include (i) positioning a lower tension arm of the valve in the RVOT of the right ventricle, and (ii) positioning an upper tension arm (connected to the lower tension arm) in a supra-annular location such that the upper tension arm exerts a downward force on the supra-annular location toward the right ventricle and the lower tension arm exerts an upward force on the supra-annular location toward the right atrium.

[0035] In some embodiments, the prosthetic valve includes a tubular frame, a distal subannular fixation tension arm, and a flow control component. The tubular frame has a sidewall and an atrial collar attached around an upper end of the sidewall. The distal subannular fixation tension arm is attached to a lower distal wall of the tubular frame and extends away from the lower distal wall of the tubular frame. The flow control component is mounted within the tubular frame and configured to allow blood flow in a first direction through the inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through the outflow end of the prosthetic valve. The prosthetic valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired location within the body. In the compressed configuration, the prosthetic valve has a major axis oriented at an intersection angle of 45 to 135 degrees relative to the first direction and substantially parallel to a longitudinal cylindrical axis of the lumen of the delivery catheter. The prosthetic valve is expandable to an expanded configuration having a major axis oriented at an intersection angle of 45 to 135 degrees relative to the first direction.

[0036] In some embodiments, the prosthetic valve includes a valve frame and a flow control component. The valve frame has an aperture extending through the valve frame along a central axis. The flow control component is configured to mount within the aperture to permit blood flow in a first direction generally parallel to the central axis from an inflow end to an outflow end of the flow control component and block blood flow in a second direction opposite the first direction. The valve frame has an expanded configuration with a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and a first longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis. The valve frame has a compressed configuration with a second height less than the first height along the central axis and a second lateral width less than the first lateral width along the lateral axis.

[0037] In some embodiments, the frame for the prosthetic valve includes a tubular frame having a central lumen defined by an inner circumferential surface of the tubular frame and defining a vertical axis of the tubular frame. The tubular frame has an outer circumferential surface capable of mating with native annulus tissue. The tubular frame is compressible to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired location within the body. In the compressed configuration, the valve has a horizontal major axis oriented at an intersection angle of 45-135 degrees relative to the vertical axis of the tubular frame and substantially parallel to the longitudinal cylindrical axis of the lumen of the delivery catheter when positioned therein. The valve is expandable to an expanded configuration having a horizontal major axis oriented at an intersection angle of 45-135 degrees relative to the vertical axis of the tubular frame.

[0038] In some embodiments, a method for delivering a prosthetic valve to a native valve between a ventricle and an atrium of a heart includes advancing a delivery catheter containing the prosthetic valve into the atrium. The prosthetic valve has a tubular frame having a sidewall and an atrial collar attached around an upper end of the sidewall, a distal annulus subfixation tension arm attached to a lower distal sidewall of the tubular frame and extending distally away from the lower distal sidewall of the tubular frame, and a flow control component mounted within the tubular frame. The flow control component is configured to allow blood flow in a first direction through the inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through the outflow end of the prosthetic valve. The prosthetic valve is disposed within the delivery catheter in a compressed configuration having a major axis oriented at an intersection angle of 45-135 degrees relative to the first direction and substantially parallel to a longitudinal cylindrical axis of the delivery catheter, and is expandable to an expanded configuration having a major axis oriented at an intersection angle of 45-135 degrees relative to the first direction. The method includes releasing a distal sub-annular fixation tension arm of the prosthetic valve from the delivery catheter by pushing a rigid elongated push rod removably connected to the tension arm away from the delivery catheter, thereby withdrawing the tension arm from the delivery catheter. The distal sub-annular fixation tension arm is delivered to the ventricular side of the native valve annulus. The remaining portion of the prosthetic valve is then released from the delivery catheter to an expanded configuration such that the tubular frame is positioned within the native valve annulus.

[0039] In some embodiments, a method of delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart includes placing a distal portion of a delivery catheter having a lumen and a longitudinal axis in the atrium with a distal end of the delivery catheter oriented toward the annulus of the native valve. The prosthetic valve is disposed in a compressed configuration within the distal portion of the delivery catheter. The prosthetic valve has a tubular frame with tension arms coupled thereto, a flow control component mounted within the tubular frame, and an expanded configuration, wherein the prosthetic valve is configured to permit blood flow in a first direction through an inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through an outflow end of the prosthetic valve. The tension arms extend laterally from the tubular frame and are disposed on the ventricular side of the annulus of the native valve when the tubular frame is disposed within the annulus. When in the expanded configuration, the prosthetic valve has an extent in any direction transverse to the first direction that is greater than a diameter of the lumen of the distal portion of the delivery catheter. When the prosthetic valve is in the compressed configuration, the prosthetic valve is disposed within a distal portion of the delivery catheter and is longitudinally stretched and transversely compressed relative to the dimensions of the prosthetic valve in the expanded configuration. The prosthetic valve has a longitudinal axis oriented parallel to the longitudinal axis of the delivery catheter and at an intersection angle of 45 to 135 degrees relative to the first direction, and the tension arm is longitudinally disposed distally toward the distal end of the delivery catheter. The method further includes releasing the tension arm from the lumen of the catheter. At least a distal portion of the tension arm is positioned on the ventricular side of the native valve annulus while the distal end of the delivery catheter remains on the atrial side of the annulus. The remaining portion of the prosthetic valve is released from the lumen of the delivery catheter such that the tubular frame is positioned within the native valve annulus.

[0040] In some embodiments, a method of delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart includes placing a distal portion of a delivery catheter having a lumen and a longitudinal axis in the atrium with a distal end of the delivery catheter pointing toward the annulus of the native valve. The prosthetic valve is disposed in a compressed configuration within the distal portion of the delivery catheter. The prosthetic valve has a tubular frame with tension arms coupled thereto, a flow control component mounted within the tubular frame, and an expanded configuration, wherein the prosthetic valve is configured to allow blood flow in a first direction through an inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through an outflow end of the prosthetic valve. The tension arms extend laterally from the tubular frame and are disposed on the ventricular side of the annulus of the native valve when the tubular frame is disposed within the annulus. The tubular frame is disposed within the lumen of the delivery catheter with the tension arms disposed toward the distal end of the delivery catheter. The method further includes releasing the tension arms from the lumen of the delivery catheter. While the distal end of the delivery catheter remains on the atrial side of the annulus, at least a distal portion of the tension arm is positioned on the ventricular side of the native valve annulus. The remainder of the prosthetic valve is released from the lumen of the delivery catheter. The prosthetic valve is held at an oblique angle to the native valve annulus, allowing blood to flow from the atrium to the ventricle through both the native and prosthetic valves, and function of the native and prosthetic valves can be assessed.

[0041] In some embodiments, a method for delivering a prosthetic valve includes advancing a delivery catheter over a guidewire having a diameter to position a distal end of the delivery catheter at a desired location within the body. A proximal end of the guidewire is mounted over a valve capsule containing the prosthetic valve in a compressed configuration. The prosthetic valve has a guidewire collar having an aperture therethrough with an inner diameter larger than the diameter of the guidewire. The guidewire is placed through the aperture in the guidewire collar. The valve capsule is mounted within a proximal end of the delivery catheter. A pusher is placed over the guidewire proximal to the prosthetic valve. The pusher has an outer diameter larger than the inner diameter of the aperture in the guidewire collar. Advancing the pusher over the guidewire advances the prosthetic valve from the valve capsule into and through a lumen of the delivery catheter to its distal end, positioning the prosthetic valve from the distal end of the delivery catheter to a desired location.

[0042] In some embodiments, a method of delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of the heart includes placing a distal portion of a delivery catheter having a lumen and a longitudinal axis within the atrium of the heart with a distal end of the delivery catheter oriented toward the annulus of the native valve. A tubular frame for the prosthetic valve is disposed within the lumen of the delivery catheter in a compressed configuration. The tubular frame defines a central lumen having a central axis, and a tensioning arm is coupled to the tubular frame. The tubular frame has an expanded configuration in the tubular frame. When in the expanded configuration, the tubular frame has an extent in any direction transverse to the central axis that is greater than a diameter of the lumen of the distal portion of the delivery catheter. When in the compressed configuration, the tubular frame is disposed within the distal portion of the delivery catheter and is longitudinally stretched and compressed transversely relative to a dimension of the tubular frame in the expanded configuration. The tubular frame has a longitudinal axis oriented longitudinally parallel to the longitudinal axis of the delivery catheter and at an intersection angle of 45 to 135 degrees relative to the central axis, with tension arms disposed longitudinally distally toward the distal end of the delivery catheter. The method further includes releasing the tension arms from the lumen of the catheter. While the distal end of the delivery catheter remains on the atrial side of the annulus, at least a distal portion of the tension arms is disposed on the ventricular side of the native valve annulus, and a remaining portion of the tubular frame is released from the lumen of the delivery catheter such that the tubular frame is disposed within the native valve annulus.

[0043] In some embodiments, the prosthetic valve has an annular valve frame defining a central axis and has an expanded configuration with a vertical height along the central axis, a lateral width along a lateral axis perpendicular to the central axis, and a longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis. A method for preparing the prosthetic valve for delivery to a patient by a delivery catheter having a lumen with a lumen diameter includes compressing the annular support frame vertically by reducing a dimension of the annular support frame along the central axis from the expanded configuration to a dimension smaller than the lumen diameter. The annular support frame is compressed laterally by reducing a dimension of the annular support frame along the lateral axis from the expanded configuration to a dimension smaller than the lumen diameter. The vertical compression of the annular support frame and the lateral compression of the annular support frame are combined to place the annular support frame in a compressed configuration. When the annular support frame is in the compressed configuration, it is inserted within the lumen of the delivery catheter.

[0044] In some embodiments, a method of delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart includes positioning a distal portion of a delivery catheter having a lumen and a longitudinal axis in an atrium of the heart with a distal end of the delivery catheter facing the annulus of the native valve. The prosthetic valve is positioned within the distal portion of the delivery catheter in a compressed configuration. The prosthetic valve has a tubular frame with a distal lower tension arm and a distal upper tension arm coupled to a distal sidewall thereof and a flow control component mounted within the tubular frame. The prosthetic valve has an expanded configuration, the flow control component permits blood flow in a first direction through the prosthetic valve and blocks blood flow in a second direction opposite the first direction through the prosthetic valve. The prosthetic valve is positioned within the lumen of the delivery catheter with the distal lower tension arm and the distal upper tension arm positioned toward the distal end of the delivery catheter. The method further includes releasing the distal lower tension arm from the lumen of the delivery catheter and releasing the distal upper tension arm from the lumen of the delivery catheter, wherein the distal upper tension arm remains on the atrial side of the annulus while a portion of the distal lower tension arm is positioned on the ventricular side of the native valve annulus, and after releasing the distal lower tension arm and releasing the distal upper tension arm, a remaining portion of the prosthetic valve is released from the lumen of the delivery catheter to position the prosthetic valve within the native valve annulus and secure thereto while during positioning the distal upper tension arm contacts supra-annular tissue on the atrial side of the annulus and the distal lower tension arm contacts sub-annular tissue on the ventricular side of the annulus.

[0045] The embodiments herein and various features and advantageous details thereof will be more fully described with reference to the non-limiting embodiments illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments herein. The examples used herein are merely intended to facilitate an understanding of how the embodiments herein may be implemented and to further enable those skilled in the art to implement the embodiments herein. Thus, the examples should not be construed as limiting the scope of the embodiments herein. Rather, these embodiments are presented so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like elements throughout.

[0046] The terminology used herein is for the purpose of describing certain embodiments only and is not intended to limit the full scope of the claims. As used herein, the singular forms "a", "an" and "the" are intended to include the plural, unless the context clearly indicates otherwise. With respect to the use of substantially any plural and / or singular terminology herein, those skilled in the art can convert from the plural to the singular and / or from the singular to the plural as appropriate to the context and / or application. For clarity, various singular / plural permutations may be expressly stated herein.

[0047] As will be appreciated by those skilled in the art, in general, the terms used in this specification, and particularly in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including without limitation," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "including without limitation," etc.).

[0048] It is further understood that the terms "comprises" and / or "comprising" as used herein specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used in this document, the term "comprising" means "including, but not limited to."

[0049] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0050] Those skilled in the art will further appreciate that virtually any disjunction and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the inclusion of one of the terms, either of the terms, or both terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0051] As will be appreciated by those skilled in the art, for all purposes, e.g., in relation to providing a written description, all ranges disclosed herein include all possible subranges and combinations of subranges. Any recited ranges can be readily understood to fully describe and allow for the same range to be broken down into at least equal subdivisions. As will be appreciated by those skilled in the art, a range includes each individual member.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention.

[0053] The term "valve prosthesis" or "artificial valve" can refer to a combination of a frame and leaflets or flow control structures or components, and can encompass both the complete replacement of an anatomical site (e.g., a new mechanical valve replaces the native valve), as well as medical devices that replace and / or aid, repair, or improve an existing anatomical site (e.g., the native valve remains in place).

[0054] The disclosed valves include members (e.g., frames) that can be seated within the native annulus and can be used as leaflet structures, flow control components, or mounting elements for a flexible reciprocating sleeve or sleeve valve, which may or may not include such leaflet structures or flow control components depending on the embodiment. Such members may be referred to herein as "annular support frames," "tubular frames," "wire frames," "flanges," "collars," and / or any other similar term.

[0055] The term "flow control component" may refer, in a non-limiting sense, to a leaflet structure having two, three or four leaflets of a flexible biocompatible material (e.g., treated or untreated pericardium sewn or bonded to an annular support frame to function as a prosthetic heart valve). Such a valve may be a heart valve, e.g., tricuspid, mitral, aortic or pulmonary (open to blood flowing from the atrium to the ventricle during diastole and closed from systolic intraventricular pressure applied to the outer surface). The sequential opening and closing may be described as "shutting down". Flow control components are considered to include a wide range of (bio)prosthetic artificial heart valves, e.g., ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g., Bjork-Shiley), stented pericardial heart valve prostheses (bovine, porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic valve), as well as allogeneic and autologous valves. Bioprosthetic pericardial valves can include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0056] In some embodiments, the frame and the flow control components can be separate structures and delivered simultaneously or separately. The term "valve frame" or "prosthetic valve frame" or "valve-in-valve" can refer to a three-dimensional structural component, usually tubular, cylindrical, or oval or annular, that can be seated in the native valve annulus and used as a mounting element for a commercially available valve, such as Sapien, Sapien3, or SapienXT (Edwards Lifesciences), Inspiris Resilia aortic valve (Edwards Lifesciences), Masters HP15mm valve (Abbott), Lotus Edge valve (Boston Scientific), Crown PRT leaflet structure (Livanova / Sorin), Carbomedics family of valves from Sorin, or other flow control components, or flexible reciprocating sleeve or sleeve valves.

[0057] The term "expandable" as used herein may refer to a component of a heart valve that can expand from a first delivery diameter to a second implantation diameter. Thus, an expandable structure does not mean one that may undergo slight expansion resulting from temperature increase or other such incidental causes. Conversely, "non-expandable" should not be interpreted to mean completely rigid or dimensionally stable, since, for example, some slight expansion of a conventional "non-expandable" heart valve may be observed.

[0058] The terms "side-delivered," "side delivery," "orthogonal," "orthogonally delivered," and the like, are used to describe valves that are compressed and delivered at approximately a 90 degree angle compared to conventional transcatheter heart valves. Orthogonal delivery is a transverse delivery in which the peripheral distal sidewall exits the delivery catheter first, followed by the central aperture, followed by the proximal sidewall.

[0059] Mathematically, the term "orthogonal" refers to a 90 degree intersection angle between two lines or planes. As used herein, the term "substantially orthogonal" refers to an intersection angle or 90 degrees plus or minus a suitable tolerance. For example, "substantially orthogonal" can refer to an intersection angle in the range of 75 to 105 degrees.

[0060] The disclosed valve embodiments may be delivered by a transcatheter approach. The term "transcatheter" is used to define the process of accessing, controlling, and delivering a medical device or instrument within the lumen of a catheter placed within a heart chamber (or other desired location within the body), as well as the item delivered or controlled by such a process. Transcatheter access is known to include via the femoral artery and femoral vein, via the brachial artery and vein, via the carotid artery and jugular vein, via the intercostal (rib) space, and via the subxiphoid. Transcatheter can be synonymous with transluminal and is functionally related to the term "percutaneous" with respect to delivery of heart valves.

[0061] In some of the disclosed embodiments, the prosthetic valve is secured to the native tissue in part by tissue anchors. The terms "tissue anchor" or "plica tissue anchor" or "secondary tissue anchor" or "dart" or "pin" refer to a fastening device that connects the upper atrial frame to the native annulus tissue, usually at or near the collar periphery. The anchor may be based on the compressive force of two plate-like collars onto the captured tissue, positioned to avoid tissue penetration, or the anchor may penetrate and secure the native tissue, either by itself or with an integrated fastening wire, or a combination of both. The anchor may have a dedicated fastening mechanism (e.g., a tip with a groove and a flanged shoulder that is inserted or popped into a mating aperture or a series of mating apertures). The series of mating apertures allows the attachment of the anchor but prevents dislodgement when the aperture periphery is secured in the groove near the flanged shoulder. The retaining wire may be attached or secured to the collar opposite the pin by any attachment or securing mechanism (eg, knots, sutures, wire crimps, wire locks with cam mechanisms, or combinations).

[0062] Some disclosed embodiments include struts. The term "strut" refers to a rigid or semi-rigid length of material, such as nickel titanium alloy (Nitinol™) or polyetheretherketone (PEEK), which may be mounted on a spoked frame and may have a flexible sleeve running axially, down its center, or within its sewn seams. The sleeve may be unattached to the strut, or the sleeve may be attached directly or indirectly to the strut.

[0063] The term "body channel" may be used to define a blood conduit or vessel within the body. The particular application of the disclosed embodiments of the prosthetic valve will determine the body channel at issue. For example, an aortic valve replacement is implanted in or adjacent to the aortic annulus. Similarly, a tricuspid or mitral valve replacement is implanted in the tricuspid or mitral annulus. Certain features are particularly advantageous for one implantation site or another. However, unless the combination is structurally impossible or excluded by claim language, any of the valve embodiments described herein may be implanted in any body channel.

[0064] As used herein, the term "lumen" can refer to the interior of a cylinder or tube. The term "bore" can refer to the inside diameter of the lumen.

[0065] In some embodiments, the components may be made from synthetic materials (e.g., polyurethane or polytetrafluoroethylene). When thin and durable synthetic materials are considered, for example for covering, synthetic polymeric materials (e.g., expanded polytetrafluoroethylene (PTFE) or polyester) may optionally be used. Other suitable materials may optionally include: thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, polyether ether ketone (PEEK), silicone polycarbonate urethane, polypropylene, polyethylene, low density polyethylene, high density polyethylene, and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include: Elastomers, polyolefins, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylons), PTFE, expanded PTFE, expanded PTFE, polyurethanes, siloxane polymers and / or oligomers, and / or polylactones, and block copolymers using these.

[0066] The annular support frame is optionally partially or completely covered internally or externally by a biocompatible material (e.g., pericardium). The annular or tubular frame may also be optionally partially or completely covered externally by a second biocompatible material (e.g., polyester or Dacron®). In the disclosed embodiments, tissues such as biological tissues that are chemically stabilized pericardial tissues from animals such as cows (bovine pericardium), sheep (ovine pericardium), pigs (porcine pericardium), or horses (equine pericardium) may be used. Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissues include those used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®. All products are currently used in surgical procedures and are generally sold as harvested from cattle under 30 months of age. Other patents and publications disclose the surgical use of harvested biocompatible thin animal tissues suitable herein as biocompatible "jackets" or sleeves for implantable stents. For example: No. 5,554,185 (Block), U.S. Pat. No. 7,108,717 (Design & Performance-Cyprus Limited) (disclosing a covered stent assembly), U.S. Pat. No. 6,440,164 (Scimed Life Systems, Inc.) (disclosing a biological valve for implantation), and U.S. Pat. No. 5,336,616 (LifeCell Corporation) (disclosing an acellular collagen-based tissue matrix for implantation).

[0067] In some embodiments, the frame components may include a drug-eluting wire frame. The drug-eluting wire frame may consist of three parts: a wire frame platform, a coating, and a drug. Some examples for polymer-free coated frames are: Amazon Pax (MINVASYS), which uses an Amazonia CroCo (L605) cobalt-chromium (Co-Cr) wire frame with paclitaxel as the antiproliferative agent and an abluminal coating as the drug carrier; BioFreedom (Biosensors Inc.), which uses a stainless steel base with a modified abluminal coating as the carrier surface for the antiproliferative agent Biolimus A9; Optima (CIDS.rI), which uses a 316L stainless steel wire frame as the base for the drug tacrolimus and an integrated turbostratic carbofilm as the drug carrier; VESTA sync (MIV Therapeutics), which uses a GenX stainless steel (316L) base with a microporous hydroxyapatite coating as the carrier for the drug sirolimus. YUKON SELECT (Translumina). 316L stainless steel is used as the base for the sirolimus drug in combination with probucol.

[0068] Bioabsorbable polymers may also be used herein as carrier matrices for drugs. Cypher, Taxus, and Endeavour are the three basic types of bioabsorbable DES. Cypher (J&J, Cordis): 316L stainless steel coated with polyethylene vinyl acetate (PEVA) and polybutyl methacrylate (PBMA) is used to hold the drug sirolimus. Taxus (Boston Scientific): 316L stainless steel wire frame coated with translute styrene isoprene butadiene (SIBS) copolymer is used to hold paclitaxel (elutes over about 90 days). Endeavour (Medtronic): Cobalt chrome driver wire frame is used to hold zotarolimus and phosphorylcholine is used as the drug carrier. BioMatrix: S-wire frame (316L) stainless steel is used as the base with a polylactic acid surface to hold the antiproliferative drug Biolimus. ELIXIR-DES program (Elixir Medical Corp). JACTAX (Boston Scientific Corp.), which uses a cobalt-chromium (Co-Cr) based wire frame with both polyester and polylactide coatings to hold the drug novolimus; DLPLA (D-lactide polylactide) coated (316L) stainless steel wire frame to hold paclitaxel; NEVO (Cordis Corporation, Johnson & Johnson), which uses a polylactide-co-glycolide (PLGA) coated cobalt-chromium (Co-Cr) wire frame to hold the drug sirolimus;

[0069] 1A-1F are various schematic diagrams of a transcatheter prosthetic valve 102 according to one embodiment. The transcatheter prosthetic valve 102 is configured to be placed at a desired location within the body (e.g., of a human patient) and to allow blood flow in a first direction through an inflow end of the transcatheter prosthetic valve 102 and block blood flow in a second direction opposite the first direction through an outflow end of the transcatheter prosthetic valve 102. For example, the transcatheter prosthetic valve 102 can be a transcatheter prosthetic heart valve configured to be placed within the annulus of a native tricuspid or native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0070] The transcatheter prosthetic valve 102 (also referred to herein as the "valve") is compressible and expandable in at least one direction perpendicular to a major axis 111 (also referred to herein as the "horizontal axis," "longitudinal axis," or "lengthwise axis") of the valve 102. The valve 102 is configured to be compressible and expandable between an expanded configuration (FIGS. 1A, 1B, 1C, and 1E) for implantation at a desired location within the body (e.g., the human heart) and a compressed configuration (FIGS. 1D and 1F) for introduction into the body using a delivery catheter (not shown).

[0071] In some embodiments, the valve 102 may be centric or radially symmetric. In other embodiments, the valve 102 may be eccentric or radially (y-axis) asymmetric. In some eccentric embodiments, the valve 102 (or its external frame) may have a D-shape (as viewed from the top) and a flat portion may be adapted to the anatomy in which the valve 102 is to be placed. For example, in some cases, the valve 102 may be placed in the tricuspid annulus and may have a complex shape determined by the anatomy in which the valve 102 is to be mounted. In the tricuspid annulus, the circumference of the tricuspid valve may be a round ellipse, the septum is known to be substantially vertical, and the tricuspid valve is known to expand along an anterior-posterior line in pathological conditions. In other cases, the valve 102 may be placed in the mitral annulus (e.g., near the anterior leaflet) and may have a complex shape determined by the anatomy in which the valve 102 is to be mounted. For example, in the mitral annulus, the circumference of the mitral valve may be a round ellipse, the septum is known to be substantially vertical, and the mitral valve is known to expand in pathological conditions.

[0072] As shown, the valve 102 generally includes an annular support frame 110 and a flow control component 150. Additionally, the valve 102 and / or at least the annular support frame 110 of the valve 102 may optionally include one or more of a distal upper tensioning arm 131, a distal lower tensioning arm 132, a proximal upper tensioning arm 133, a proximal lower tensioning arm 134, a guidewire collar 140, and / or an anchor delivery conduit 145.

[0073] An annular support frame 110 (also referred to herein as a "tubular frame," "valve frame," "wire frame," or "feature") can have or define an aperture 114 extending along a central axis 113. The aperture 114 (e.g., a central axial lumen) can be sized and configured to receive a flow control component 150 across the diameter of the aperture 114. The frame 110 can have an outer circumferential surface to mate with the native annulus tissue, which can be tensioned against the inner surface of the native annulus, to provide structural patency to a weakened native annulus.

[0074] The frame 110 includes a cuff or collar 120 and a tubular section 112. The cuff or collar 120 (referred to herein as a "cuff") can be attached to and / or form the upper edge of the frame 110. When the valve 102 is placed in the human heart, the cuff 120 can be an atrial cuff or collar. The atrial collar 120 can be shaped to fit the native placement site. In a mitral valve replacement, for example, the atrial collar 120 is configured with various portions to fit the native valve. In one embodiment, the collar 120 has distal and proximal upper collar portions. The distal collar portion can be larger than the proximal upper collar portion to account for the geometry of the valve annulus or sub-annulus.

[0075] Frame 110 may optionally have a separate atrial collar attached to its upper (atrial) edge for placement on the atrial floor to direct blood from the atrium into flow control component 150 and to seal against blood leaking around frame 110 (perivalvular leak). Frame 110 may also optionally have a separate ventricular collar attached to its lower (ventricular) edge for placement in the ventricle just below the native valve annulus to prevent backflow leak during systole, to prevent movement of valve 102 during systole, to pinch or compress the native valve annulus or adjacent tissue against atrial collar or cuff 120, and / or to optionally attach and support flow control component 150. Some embodiments may have both an atrial collar and a ventricular collar. Other embodiments may include a single atrial collar, a single ventricular collar, or no additional collar structures.

[0076] In some embodiments, the frame 110 can have a peripheral wall that surrounds the aperture 114 and the central axis 113 in the expanded configuration. The peripheral wall can encompass both the collar 120 and the tubular section 112. In some embodiments, the peripheral wall can be further defined as having a front wall portion and a rear wall portion that are connected along a proximal side (e.g., relative to the inferior vena cava ("IVC")) or proximal to the fold region, and along a distal side or distal to the fold region. The front wall portion can be further defined as having a front upper collar portion and a front lower body portion. The rear wall portion can be further defined as having a rear upper collar portion and a rear lower body portion. The front upper collar portion and the rear upper collar portion can collectively form the collar or cuff 120. The front lower body portion and the rear lower body portion can collectively form the tubular section 112.

[0077] The frame 110 can be a ring or a cylinder or conical tube, but may also have a flattened conical side profile, an inverted flattened cone (narrower at the top and wider at the bottom), a concave (concave wall), a convex cylinder (bulging wall), an angular hourglass, a curved graduated hourglass, a ring or cylinder with a flared top, a flared bottom, or both.

[0078] Taking into account the thickness of frame 110 (e.g., the wire material forming frame 110), frame 110 may have a height in the range of approximately 5 to 60 mm, an outer diameter dimension R in the range of approximately 20 to 80 mm, and an inner diameter dimension in the range of approximately 21 to 79 mm.

[0079] The design of the frame 110 is preferably compressible and has the proposed property of returning to its original (uncompressed) shape upon release. The frame 110 may be compressed for transcatheter delivery or may be expandable using a transcatheter dilatation balloon or as a self-expandable shape memory element. In some cases, suitable shape memory materials may include metals and plastics that are durable and biocompatible. For example, the frame 110 may be formed from superelastic metal wire, such as Nitinol wire, or other similarly performing materials. Nitinol may be useful and desirable because it can be processed to be austenitic, martensite, or superelastic. Martensite and superelastic alloys can be processed to exhibit the desired compression. Materials may be used for the frame 110 or any portion thereof. Other shape memory alloys, such as Cu-Zn-Al-Ni alloys, Cu-Al-Ni alloys, as well as polymeric composites (e.g., composites including carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers) are also contemplated.

[0080] The frame 110 may be configured as a braid, wire, or laser cut wire frame. Such materials are available from any number of commercial manufacturers (e.g., Pulse Systems). One possible configuration of the wire frame 110 may be laser cutting of a thin, equal diameter Nitinol tube. The laser cutting creates regular cutouts in the thin Nitinol tube. In one embodiment, the Nitinol tube is expanded to create a three-dimensional structure formed from diamond-shaped cells. The structure may also have additional functional elements (e.g., loops, anchors, etc.) for attaching accessory components (e.g., biocompatible covers, tissue anchors, releasable placement and retrieval control guides, knobs, attachments, rigging, etc.). Secondarily, the frame 110 may be placed on a mold of the desired shape, heated to the corresponding martensite temperature, and quenched. The frame 110 formed by treating the wire frame in this way has shape memory properties and easily returns to the memory shape at a calibrated temperature. The laser cut wire frame is preferably formed from Nitinol, but may also be formed from, without limitation, stainless steel, cobalt chrome, titanium, and other functionally equivalent metals and alloys.

[0081] Alternatively, the frame 110 can be constructed using simple braiding techniques. Using Nitinol wire (e.g., 0.012" wire) and a simple braid fixture, the wire can be wrapped in a simple over / under braid pattern on the braid fixture until an equal diameter tube is formed from a single wire (e.g., the frame 110). The two free ends of the wire are joined using a stainless steel or Nitinol connecting tube onto which the free ends are placed and crimped. In some embodiments, an angled braid of about 60 degrees may be desired. Secondarily, the braided wire frame 110 is placed on a forming fixture and placed in a muffle furnace at a specific temperature to set the wire frame 110 into the desired shape and form the desired martensite or superelastic properties.

[0082] Frame 110 is formed of a superelastic metal or alloy (e.g., Nitinol) such that frame 110 is compressible. Preferably, frame 110 is constructed of a plurality of compressible wire cells having an orientation and cell shape substantially perpendicular to central axis 113 to minimize wire cell strain within frame 110 when configured in a vertically compressed configuration, a rolled compressed configuration, or a folded compressed configuration.

[0083] First, the annular prosthesis is heat-formed to provide an upper atrial cuff or flange (e.g., cuff 120) for atrial sealing and a lower transannular tubular or cylindrical section having an hourglass cross-section for approximately 60-80% of the circumference that fits into the native annulus along the posterior and anterior annular segments, while remaining substantially vertically flat along 20-40% of the annular circumference that fits into the septal annular segment.

[0084] Flow control component 150 may refer, in a non-limiting sense, to a device for controlling fluid flow therethrough. In some embodiments, flow control component 150 may be a leaflet structure having two, three, four or more leaflets formed of a flexible biocompatible material (e.g., treated or untreated pericardium). The leaflets may be sewn or bonded to a support structure and / or may be sewn or bonded to frame 110. Flow control component 150 may be mounted within frame 110 and configured to allow blood flow in a first direction through the inflow end of the valve and block blood flow in a second direction opposite the first direction through the outflow end of the valve. For example, flow control component 150 may be configured such that valve 102 functions as a heart valve (e.g., tricuspid, mitral, aortic, or pulmonary valve) that can open to blood flowing from the atrium to the ventricle during diastole and close from systolic intraventricular pressure applied to the exterior surface. The sequential opening and closing may be described as "shutting down." The flow control component 150 is contemplated to include a wide range of (bio)prosthetic artificial valves, such as ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disk valves (e.g., Bjork-Shiley), stented pericardial heart valve prostheses (bovine, porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic valves), as well as allogeneic and autologous valves. Bioprosthetic pericardial valves can include the bioprosthetic aortic valve, the bioprosthetic mitral valve, the bioprosthetic tricuspid valve, and the bioprosthetic pulmonary valve.

[0085] The arrangement of the valve 102 can be such that a commercially available valve (flow control component 150) is received or accommodated in the frame 110 and / or otherwise mounted within the frame 110. The commercially available valve (flow control component 150) may include, for example, Sapien, Sapien3, or SapienXT (Edwards Lifesciences), Inspiris Resilia aortic valve (Edwards Lifesciences), Masters HP15mm valve (Abbott), Lotus Edge valve (Boston Scientific), CrownPRT leaflet structure (Livanova / Sorin), a valve from the Carbomedics family of valves from Sorin, or other flow control component(s), or a flexible reciprocating sleeve or sleeve valve.

[0086] As previously discussed, the valve 102 and / or at least the frame 110 of the valve 102 can optionally include one or more of the distal upper tensioning arm 131, the distal lower tensioning arm 132, the proximal upper tensioning arm 133, the proximal lower tensioning arm 134, the guidewire collar 140, and / or the anchor delivery conduit 145. The tensioning arms 131, 132, 133, and 134 can be configured to mate with a portion of the annulus tissue to mount the frame 110 to the annulus of the native valve in which the valve 102 is to be placed. The tensioning arms 131, 132, 133, and / or 134 can be of any suitable configuration, such as those described below for certain embodiments. The anchor delivery conduit 145 can be attached to the frame 110 and configured to receive a tissue anchor 190 (FIG. 1B) therethrough. The tissue anchor 190 can then secure the valve 102 and / or at least the frame 110 to the annulus tissue.

[0087] The valve 102 can be delivered to a desired location within the body by a procedure that generally includes advancing a delivery catheter over a guidewire (not shown in FIGS. 1A-1F) and positioning a distal end of the delivery catheter at or near the desired location. Thus, the guidewire may be disposed within a lumen of the delivery catheter. The valve 102 can be disposed within a lumen of the delivery catheter (e.g., in a compressed configuration) and advanced over the guidewire through the delivery catheter. More specifically, in embodiments that include a guidewire collar 140, the guidewire can extend through an aperture in the guidewire collar 140 such that the valve 102 can be advanced over or along the guidewire. The guidewire collar 140 can be attached to the frame 110 and / or to at least one of the tension arms 131, 132, 133, and / or 134. The guidewire collar 140 can be configured to selectively mate with a portion of the guidewire or a portion of the guidewire assembly and / or can have any suitable configuration as described below for specific embodiments.

[0088] The valve 102 is compressible and expandable between an expanded configuration and a compressed configuration. The valve 102 is in the expanded configuration when it is placed or implanted (or ready to be placed or implanted) in a desired location in the body (e.g., in the annulus of a native valve). When the valve 102 is in the expanded configuration as shown in FIG. 1C, it has an extent in any direction along or transverse to the central axis 113 that is greater than the diameter of the lumen of a delivery catheter used to deliver the valve 102 to a desired location in the body. Stated another way, the valve 102 has an extent in any direction perpendicular to the valve's longitudinal axis 111 that is greater than the diameter of the lumen of the delivery catheter.

[0089] The valve 102 is in a compressed configuration when it is delivered to a desired location within the body via a delivery catheter. When in the compressed configuration shown in FIG. 1D, the valve 102 can be placed within a delivery catheter and compressed transversely relative to the dimensions of the valve 102 in the expanded configuration and stretched longitudinally along a longitudinal axis 111. The longitudinal axis 111 can be parallel to the longitudinal axis of the delivery catheter and oriented at an intersection angle of 45-135 degrees relative to a central axis 113 (e.g., perpendicular or about 90 degrees). In some embodiments, the horizontal x-axis (e.g., longitudinal axis 111) of the valve 102 when in the expanded configuration is orthogonal (90 degrees), or substantially orthogonal (75-105 degrees), or substantially oblique (45-135 degrees) to a central vertical y-axis (e.g., central axis 113). In some embodiments, the horizontal x-axis (eg, longitudinal axis 111) of the valve 102 in the compressed configuration is substantially parallel to the longitudinal cylindrical axis of the delivery catheter.

[0090] As used herein, the terms "angle of intersection" and / or "orthogonal angle" can refer to both (i) the relationship between the longitudinal cylindrical axis of the delivery catheter and the long axis 111 of the compressed valve 102, where the long axis 111 is perpendicular to the central axis 113 of a conventional valve, and (ii) the relationship between the long axis 111 of the compressed or expanded valve 102 and the axis defined by the blood flow through the prosthetic valve 102 (e.g., from one portion of the body or heart chamber to another downstream portion of the body or heart chamber, e.g., from the atrium to the ventricle through the native annulus).

[0091] 1C and 1D , when the valve 102 is in the expanded configuration, it can have a first height or size along the central axis 113, and when the valve 102 is in the compressed configuration, it can have a second height or size (smaller than the first height or size) along the central axis 113. The second height or size of the valve 102 when in the compressed configuration is smaller than the diameter of the lumen of a delivery catheter through which the valve 102 can be delivered.

[0092] The valve 102 may also be compressed in additional directions. For example, Figures 1E and 1F are plan views of the valve 102 in expanded and compressed configurations, respectively. The lateral axis 115 of the valve 102 is perpendicular to the longitudinal axis 111 and the central axis 113. When the valve 102 is in the expanded configuration, it has an extent along the lateral axis 115 or in any direction transverse to the lateral axis 115 that is greater than the diameter of the lumen of a delivery catheter used to deliver the valve 102. In other words, the valve 102 may have a first width or size along the lateral axis 115 when in the expanded configuration, as shown in Figure 1E, and a second width or size (smaller than the first width or size) along the lateral axis 115 when in the compressed configuration, as shown in Figure 1F.

[0093] The valve 102 may be compressed (as described above) and delivered in a transverse or orthogonal manner such that the longitudinal axis 111 is substantially parallel to the delivery axis (e.g., the length axis of the delivery catheter). The shape of the expanded valve 102 may be that of a large diameter shortened cylinder with an extended collar or cuff (e.g., cuff 120). In some embodiments, the valve 120 may be compressed such that the central axis 113 of the valve 102 is generally perpendicular (orthogonal) to the length axis of the delivery catheter. In some embodiments, the valve 102 may be compressed vertically (e.g., along the central axis 113), similar to collapsing the height of a cylindrical accordion from tall to short. Additionally or alternatively, the valve 102 may be compressed laterally (e.g., along the transverse axis 115), similar to folding or compressing a front panel against a rear panel. In other embodiments, the valve 102 may be compressed by rolling. In other embodiments, the valve 102 may be compressed using a combination of compressing, folding, and / or rolling. The compression along the central axis 113 (e.g., vertical compression) and the compression along the transverse axis 115 (e.g., lateral or widthwise compression) is in contrast to the compression of a conventional coaxially delivered prosthetic valve, which is typically compressed along the transverse axis (e.g., transverse axis 115) and the longitudinal axis (e.g., longitudinal axis 111) and elongated along the central axis (e.g., central axis 113).

[0094] In some embodiments, the valve 102 can have an expanded height (y-axis) between 5 and 60 mm. In some embodiments, the valve 102 can have an expanded diameter length and width between 20 and 80 mm, preferably between 40 and 80 mm, and in some embodiments, the length and / or width can vary, having lengths of 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm in combination with widths that are the same or different from the lengths.

[0095] In some embodiments, the valve 102 can have a compressed height (y-axis) and / or width (z-axis) of 6-15 mm, preferably 8-12 mm, more preferably 9-10 mm, and an expanded deployed height of about 5-60 mm, preferably about 5-30 mm, more preferably about 5-20 mm, or even 8-12 mm or 8-10 mm. In some embodiments, the length of the valve 102 (x-axis) does not require compression because, when deployed within a delivery catheter, the valve 102 can extend along the length of the central cylindrical axis of the delivery catheter.

[0096] In some embodiments, the valve 102 can be positioned such that, for example, the internal frame or structure of the flow control component 150 that retains the leaflet tissue has a diameter of 25-29 mm, the frame 110 or a portion thereof has a diameter of 50-70 mm, and the collar structure (cuff 120) of the frame 110 extends 10-30 mm beyond the top end of the frame 110 to provide a seal against paravalvular leak (PVL) on the atrial floor.

[0097] Referring again to FIG. 1B, the valve 102 can be placed in the annulus of a native valve in a human heart (e.g., pulmonary valve (PV) or mitral valve (MV), or aortic valve or tricuspid valve, not shown in FIG. 1B). As previously described, the valve 102 can be delivered to the annulus via a delivery catheter in a compressed configuration. The valve 102 can be released from the delivery catheter to expand to an expanded configuration shown in FIG. 1B. Placement of the valve 102 can include placing the distal lower tension arm 132 in the ventricle below the annulus, while the remainder of the valve 102 is placed in the atrium. The valve 102 can be placed in the annulus of a native valve (PV or MV), with at least a portion of the distal lower tension arm 132 positioned in the ventricular outflow tract (e.g., RVOT, as shown in FIG. 1B). In embodiments in which valve 102 includes additional tension arms, distal upper tension arm 131 and proximal upper tension arm 133 can be positioned in the atrium above the native valve, and proximal lower tension arm 134 can be positioned in the ventricle below the native valve. Thus, one or more of optional tension arms 131, 132, 133, 134 included in valve 102 can exert a force on the native valve structure or tissue to mount valve 102 within the annulus of the native valve. For example, upper tension arms 131 and / or 133 can exert a downward force on the upper portion of the annulus toward the right ventricle, and lower tension arms 132 and / or 134 can exert an upward force on the lower portion of the annulus toward the right atrium.

[0098] Mounting the valve 102 in the annulus can optionally include securing the valve 102 to the native valve via tissue anchors 190. The tissue anchors 190 can be, for example, teeth or barbs arranged to provide attachment to tissue adjacent the annulus. The tissue anchors 190 can be forced into the annulus tissue by mechanical means (e.g., with a balloon catheter). In one non-limiting embodiment, the tissue anchors 190 can optionally be semicircular hooks that securely penetrate, rotate into, and hold the annulus tissue as the frame 110 (or valve 102) expands. The tissue anchors 190 can be deployed by over-the-wire delivery through a delivery catheter (e.g., via the anchor delivery conduit 145). The delivery catheter can have multiple axial lumens for delivery of various fixation tools (e.g., anchor setting tools, force application tools, hooks, snaring tools, cutting tools, radio frequency and radiological visualization tools and markers, suture / thread manipulation tools). Once the tissue anchor(s) 190 are attached to the valve, a tensioning tool may be used to adjust the length of one or more tethers or the like that connect to the implanted valve 102 and securely adjust the implanted valve 102 as necessary for proper function. It is also contemplated that the tissue anchor(s) 190 may be spring loaded, or that a tether attachment or tether capture mechanism may be incorporated into the tethering surface of the anchor(s) 190. The anchors 190 or tethers may be routed through an anchor delivery conduit 145 of the valve 102 or frame 110. The anchors 190 may also have an ingrowth material (e.g., polyester fibers) that promotes ingrowth of the anchor into cardiac tissue. In one embodiment, where the valve 102 may or may not include a ventricular collar, the anchors 190 (e.g., darts, teeth, or barbs) are not attached to the underlying ventricular collar, but are attached directly into the annulus tissue or other tissue useful for fixation.

[0099] In some embodiments, the frame 110 and the flow control component 150 can be separate structures and delivered simultaneously or separately to a desired location in the body. For example, the flow control component 150 can be positioned within the aperture 114 of the frame 110 to form the complete valve 102, which can be compressed and delivered to a desired location in the body via a delivery catheter, as described in detail above. In other embodiments, the frame 110 and the flow control component 150 can be delivered separately to a desired location in the body. For example, the frame 110 can be compressed and delivered to a desired location in the body via a delivery catheter. The frame 110 can be released from the delivery catheter and positioned, for example, within the annulus of a native valve. The frame 110 is in an expanded configuration once released from the delivery catheter, and is thus positioned in the annulus of the native valve in an expanded configuration. The flow control component 150 can then be delivered separately (e.g., via a delivery catheter) and mounted within the positioned frame 110.

[0100] Set forth below are descriptions of particular aspects or embodiments of transcatheter prosthetic valves. The transcatheter prosthetic valves (or aspects or portions thereof) described below for particular embodiments can be substantially similar, at least in form and / or function, to valve 102 and / or corresponding aspects of valve 102 described above with reference to Figures 1A-1F. Accordingly, particular aspects of particular embodiments will not be described in greater detail herein.

[0101] Figure 2 is a diagram of a low profile (e.g., 8-20 mm), side-loaded prosthetic valve 1102 according to one embodiment. The valve 1102 can be substantially similar to the valve 102 shown in Figures 1A-1F. The valve 1102 shown in Figure 2 is in an expanded configuration and is positioned within the native annulus.

[0102] FIG. 3 is a diagram of a valve 1102 having a frame 1110 and a flow control component 1150 , illustratively compressed or housed within a delivery catheter 1172 .

[0103] 4A shows the valve 1102, illustratively projected from a delivery catheter 1172 and positioned against the anterior side of the native annulus. While the valve 1102 is held at this oblique angle by a secondary catheter 1180, valve function and patient status are assessed (described in more detail below), and if appropriate, the valve is fully positioned within the native annulus and secured using conventional fixation elements (e.g., tissue anchors 190).

[0104] 4B shows an open cross-sectional view of a low-profile, side-loaded prosthetic valve 1202 according to one embodiment. Valve 1202 includes an internal valve sleeve or flow control component 1250 and a frame 1210. Valve 1202 can be similar to valve 1102.

[0105] Figure 5 is a diagram of a low-profile side-loaded heart valve prosthesis 1302 according to one embodiment. The valve 1302 has a braided or laser cut configuration to a tubular frame 1310 with a valve sleeve or flow control component 1350 that extends beyond the bottom of the tubular frame 1310. Figure 5 shows a longer lower tensioning arm 1332 to extend below the annulus towards the RVOT and a shorter upper tensioning arm 1331 to extend over the atrial floor.

[0106] Figure 6 is a diagram of the valve 1302 in a compressed configuration within a delivery catheter 1372. The valve 1302 shown in Figure 6 is attached to a secondary steerable catheter 1380 for projecting, positioning, and securing the valve 1302. The secondary catheter 1380 can also be used to repair a failed placement of the valve 1302.

[0107] 7 shows the valve 1302 in a partially compressed configuration, partially within the delivery catheter 1372, and partially protruding from the delivery catheter 1372. FIG 7 illustrates that while the valve 1302 is still compressed, the lower tension arm 1332 can be manipulated through the leaflets and chordae tendineae of the native valve to find a stable anterior anchorage against the distal side of the valve 1302.

[0108] Figure 8 shows the valve 1302 mating with tissue anterior to the native valve annulus, with the curved distal wall of the tubular frame 1310 sealing around the native annulus. The valve 1302 shown in Figure 8 is held by a steerable secondary catheter 1380 at an oblique angle that allows valve function to be assessed.

[0109] 9 is a diagram of the valve 1302 fully positioned within the native valve annulus. The distal side of the valve 1350 is shown mating with tissue anterior to the native annulus, with the curved distal sidewall of the tubular frame 1310 sealing around the native annulus and the proximal sidewall tension mounted within the posterior side of the native annulus.

[0110] Figure 10 shows a top view of one embodiment of a prosthetic valve 1402 shown in a compressed configuration within a delivery catheter 1472. Figure 10 shows that flipping the tubular frame 1410 outwards results in a 50% reduction in the height of the valve 1402 housed within the catheter. The low-profile side-loaded valve 1402 does not require the aggressive, strut-breaking, tissue-tearing, suture-pulling forces that traditional transcatheter valves are designed to mitigate.

[0111] 11 illustrates a cross-sectional view of the compressed valve 1402 within a delivery catheter 1472. This cross-sectional end view shows one embodiment of a single-fold compressed configuration in which the tubular frame 1402 and attached two-panel sleeve or flow control component 1450 are flipped outward five times, resulting in a 50% reduction in height, allowing it to fit within a delivery catheter 1472 with an inner diameter of 1 cm (10 mm).

[0112] 12 shows a cross-sectional view of another embodiment of a compressed valve 1402 folded into a delivery catheter 1472. The cross-sectional end view shows another embodiment of a single-fold compressed configuration in which the tubular frame 1410 and attached two-panel sleeve or flow control component 1450 are folded outward four times, resulting in a 50% reduction in height, allowing it to fit within a 1 cm (10 mm) inner diameter delivery catheter 1472.

[0113] FIG. 13 shows a cross-sectional view of a valve 1402 to further illustrate how the folded and rolled configuration can be achieved with minimal material requirements for a low profile, side-loaded valve 1402.

[0114] 14A-14C show a series of low profile valves 1502 rolled into a compressed configuration for placement within a delivery catheter 1572. The valves 1502 include a tubular frame 1510 having an aperture 1514 and supporting a sleeve or flow control component 1550.

[0115] FIG. 15 shows the valve 1502 rolled longitudinally and mounted within a delivery catheter 1572 , showing an end view of the frame 1510 and sleeve flow control components 1550 .

[0116] 16A-16D illustrate one embodiment showing a four step process for compressing a prosthetic valve 1602 to provide a long axis (e.g., similar to long axis 111 shown in FIGS. 1A-1F) that is coplanar or parallel to a longitudinal axis of a delivery catheter (not shown). These figures show that a valve 1602 (having a tubular frame 1610 formed of cuff and transannular tubular sections and having a flow control component 1610 mounted within the tubular frame 1610, the flow control component 1610 configured to allow blood flow in a first direction through the inflow end of the valve and block blood flow in a second direction opposite the first direction through the outflow end of the valve 1602) is compressible about a long axis that is parallel to the longitudinal axis of the delivery catheter. These figures show that the valve 1602 can be compressed into a compressed configuration for introduction into the body using a delivery catheter, the compressed configuration having a long axis perpendicular to the blood flow axis (e.g., oriented at an intersecting angle (perpendicular angle) of 45 to 135 degrees (e.g., 90 degrees) relative to the first (blood flow) direction), the long axis of the compressed configuration of the valve 1602 is substantially parallel to the longitudinal axis of the delivery catheter, and the valve 1602 is approximately 5 to 60 mm in height and approximately 25 to 80 mm in diameter.

[0117] FIG. 16A shows a view of the valve 1602 in an uncompressed configuration. FIG. 16B shows a view of the initial rolling or folding of the cuff of the frame 1610. The rolling or rolling can be inward as shown here, or outward, or can be simultaneously flattened to roll the entire valve 1602 from bottom to top. FIG. 16C shows a view of the valve 1602 that has been rolled or folded using multiple folds or rolling into a tubular shape along its long axis. FIG. 16D shows a view of the fully compressed valve 1602 that can be folded or rolled into a compressed configuration using, for example, a compression accessory and then loaded into a delivery catheter (not shown). The compressed valve 1602 can self-expand using a shape memory alloy when released from the delivery catheter, or the valve 1602 can be balloon expanded in a secondary process once the valve 1602 is released from the delivery catheter.

[0118] 17A shows a side perspective view of a side-delivered transcatheter prosthetic valve 1702 in an expanded configuration with at least one fold region according to one embodiment. FIG 17A shows a distal fold region 1723A within the collar portion 1720 of the annular frame 1710 that allows compression of the valve 1702 without exposing the annular frame 1710 or internal flow control components 1750 to damaging compressive forces.

[0119] FIG. 17B shows a side perspective view of the valve 1702, showing that the front side 1721 of the collar portion 1720 of the valve 1702 begins a rolling process (indicated by arrow 1763) in only one direction. FIG. 17B shows two folding regions, a proximal (near) folding region 1723A and a distal (far) region 1723B. The folding regions 1723A and 1723B may be free of wire cells (wire frame portions) or may be made of cells that are large or oriented to minimize damage from folding or rolling from the compression process. The leaflets 1753 of the flow control component 1750 are visible from this angle.

[0120] 17C shows a side perspective view of valve 1702 illustrating the second rolling step of the unidirectional rolling process 1763. Anterior collar 1721 has been everted into central distal fold region 1723B and proximal fold region 1723A, and posterior septal collar 1722 is in an unrolled, expanded configuration.

[0121] 17D shows a side perspective view of the valve 1702 illustrating the third rolling step of the unidirectional rolling process 1763. The valve 1702 continues to be rolled and compressed towards the posterior septal collar 1722.

[0122] FIG. 17E shows a side perspective view of the valve 1702 showing the one-way rolling process 1763 completed to achieve the compressed configuration.

[0123] 18A shows a side perspective view of the valve 1802 in an expanded configuration, with the two sides of the valve 1802 beginning a symmetrical rolling process 1864 with distal fold region 1823B and a second distal fold region 1824B, two of the four (shown) fold regions. The anterior collar 1821 of the frame 1810 of the valve 1802 and the posterior septal collar 1822 of the frame 1810 are shown along with the exterior frame wall 1816, with the leaflets 1853 shown in dashed lines for reference.

[0124] 18B shows a side perspective view of valve 1802 illustrating a second rolling step of a symmetrical rolling process 1864. The edges of annular support frame 1810 are shown rolled inward toward a central axis 1811. Distal fold 1823B and second distal fold 124B are shown opposite proximal fold region 1823A and second proximal fold region 1824A, respectively. Flow control leaflets 1853 of flow control component 1850 of valve 1802 are shown for reference.

[0125] 18C shows a side perspective view of the valve 1802 illustrating the third rolling step of the symmetrical rolling process 1864, where the rolled edge is now rolled further inward towards the central axis 1811.

[0126] 18D shows a side perspective view of the valve 1802, showing that the symmetrical rolling compression process 1864 has been completed, shown rolled inward toward the central axis 1811. The valve 1802 shown in FIG. 18D will appear in a compressed configuration within a delivery catheter (not shown).

[0127] 19A shows a side perspective view of the valve 1902 in a compressed configuration. The valve 1902 has been compressed using a rolling and folding process 1965. The lower portion of the valve 1902 is rolled and the upper collar portion of the valve 1902 is folded lengthwise about the central longitudinal axis 1911.

[0128] Figure 19B shows a side perspective view of valve 1902 partially uncompressed, with the lower body portion unrolled and the flattened upper collar portion unfolded. Figure 19B shows folded areas 1923A and 1923B in the collar portion.

[0129] 19C shows a side perspective view of the valve 1902 in a further uncompressed state, showing the lower body portion unrolled and the upper collar portion unfolded. As the valve 1902 assumes its expanded configuration, the fold area at the collar is wider.

[0130] FIG. 19D shows a side perspective view of valve 1902 in an expanded configuration, but at a different side / orientation (90 degrees from the previous view).

[0131] 20 shows a side perspective view of a valve 2002 having a circular hyperboloid (hourglass) shape. Wire frame details are not shown because, in practice, the exterior surface is preferably covered with, for example, Dacron polyester to facilitate ingrowth. According to one embodiment, proximal and distal folding regions 2023A and 2023B are shown at either end of the anterior collar 2021 and posterior septal collar 2022 of the frame 2010 along a horizontal axis 2011, showing the anterior wall 2016 and central groove or aperture 2014.

[0132] Figure 21 shows a cut away view of valve 2002. Figure 21 shows the inner leaflets 2053 and inner frame of the flow control component attached to the inner surface of the annular frame 2010, with the collar portion 2020 attached to the lower annular anchor portion 2032 via the wall portion 2012. Here, only the flow control component is attached to the upper end of the frame 2010, although other non-limiting attachments are contemplated (e.g., mid-wall, multiple attachment points, etc.).

[0133] FIG 22 shows an exploded view of a valve or valve frame 2110 according to one embodiment, having a funnel-shaped anterior collar 2121, a funnel-shaped posterior septal collar 2122, anterior cylindrical body portion 2112A, and posterior septal cylindrical body portion 2112B. Shown in FIG 22 is one variation in which the valve frame 2110 includes wire cells used to form opposing panels that are joined using woven strain-minimizing panels in the proximal fold region 2123A and distal flow region 2123B. FIG 22 also shows a flow control component 2150 having a tri-leaflet valve 2153 mounted on an internal U-shaped wire frame 2152.

[0134] FIG. 23 shows a side view of a valve or valve frame 2110 showing two (2) panels or walls 2116A and 2116B of the valve frame 2110. The panel or wall 2116A can include a front collar portion 2121 and a front cylindrical body portion 2112A, and the panel or wall 2116B can include a rear septal collar portion 2122 and a rear septal cylindrical body portion 2112B. FIG. 23 shows that the diamond shaped wire cell 2125A of the frame 2110 for the collar portion 2121 can be one large diamond in height, while the lower body portion 2112A can be constructed with two smaller diamond shaped wire cells in height. The dashed lines illustrate where the internal flow control components would be attached, but are not shown.

[0135] FIG. 24 shows a side view of a two-panel embodiment of the valve or valve frame 2110 in a compressed configuration.

[0136] FIG. 25 shows an exploded view of a valve or valve frame 2110 according to one embodiment, including a funnel-shaped anterior collar 2221, a funnel-shaped posterior septal collar 2222, an anterior cylindrical body portion 2212A, and a posterior septal cylindrical body portion 2212B. Shown in FIG. 25 is one variation in which the valve frame 2210 includes wire cells that are used to form the entire opposing panels. Also shown in FIG. 25 is a flow control component 2250 having a tri-leaflet valve 2253 mounted on an internal U-shaped wire frame 2252. Also shown in FIG. 25 is a subannular tab 2230 that can be used to secure the frame 2210 within the annulus of the native valve.

[0137] Figure 26 shows a side view of the valve or valve frame 2210 showing two (2) panels or walls 2216A and 2216B of the valve frame 2210. Figure 26 also shows that the corrugated wire cell 2225B of the frame 2210 for the collar portion 2221 may be one large corrugated cell in the height direction, while the lower body portion 2212A may be constructed with one or two smaller corrugated wire cells in the height direction. The dashed lines illustrate where internal flow control components would be attached, but are not shown.

[0138] FIG. 27 shows a side view of a two-panel embodiment of the valve or valve frame 2210 in a compressed configuration.

[0139] 28 shows a side perspective view of a prosthetic valve frame 2310 formed by undulating wire cells 2325B. Frame 2310 has proximal fold regions 2323A and distal fold regions 2323B within undulating wire cells 2325B. Dashed lines illustrate where internal flow control components would be attached, but are not shown.

[0140] 29 shows a plan view of the valve frame 2310, illustrating the proximal and distal fold regions or gaps 2323A and 2323B in the wavy wire cells 2325B. The opening of the central flow control component is shown as a horizontal linear gap 2354.

[0141] 30 shows a side perspective view of a prosthetic valve frame 2410 formed by diamond-shaped wire cells 2425A. The frame 2310 has a set of fold regions or gaps 2419 within the diamond-shaped wire cells 2425A. The dashed lines illustrate where internal flow control components would be attached, but are not shown. Details of the wire frame are not shown because, in practice, the exterior surface is preferably covered with, for example, a Dacron polyester covering 2417 to facilitate ingrowth.

[0142] 31 shows a plan view of the valve showing the folded areas or gaps 2419 in the overall annular supporting wire frame with diamond shaped wire cells 2425A. The central flow control component opening is shown as a tri-leaflet structure 2455.

[0143] 32A shows a side perspective view of a frame 2510 of a prosthetic valve according to one embodiment. The frame 2510 has a set of fold regions or gaps 2519 within an overall wire cell structure that are covered by a woven mesh that spans the gaps 2519. Woven fold panels 2519A are illustrated on the proximal and distal sides of the lower body portion of the frame 2510. A polyester cover 2517 for the lower body portion of the frame 2510 is also shown.

[0144] Figure 32B shows a side view of frame 2510, showing the lower body portion in a partially rolled configuration, where it flares out towards the septal leaflet of the native valve.

[0145] Figure 33A shows a side perspective view of a prosthetic valve frame 2610 in accordance with one embodiment. The valve 2610 has a flat collar portion 2620 and a cylindrical body portion 2612. Figure 33A shows proximal and distal fold regions 2623A, 2623B in the collar portion 2620 of the frame 2610, as well as a fold region 2626 in the lower body portion 2612.

[0146] Figure 33B shows a side perspective view of the illustratively flattened and partially compressed frame 2610. Figure 33B shows the folding regions 2623A, 2623B on two sides of the collar slide 2620 compressed inwardly to crush the central axial opening or aperture, while the lower body portion 2612 is flattened along the folding region or seam 2626.

[0147] FIG. 33C shows a side perspective view of frame 2610 with collar portion 2620 folded, flattened and partially compressed, and lower body portion 2612 rolled, flattened and partially compressed.

[0148] FIG. 33D shows a side perspective view of frame 2610 with collar portion 2620 partially compressed by folding and flattening, and lower body portion 2612 fully compressed by rolling up onto collar portion 2620.

[0149] FIG. 33E shows a side perspective view of the flattened and compressed valve frame 2610 in its compressed configuration, with the lower body portion 2612 compressed by rolling and folding onto the flattened upper collar portion 2620.

[0150] Figure 34A shows a side perspective view of the composite laser cut workpiece prior to expansion into the valve frame 2710. Figure 34A shows that the wire loop portion 2725C and the wire mesh or wire braid portion 2725A can be combined and joined into a single wire frame structure.

[0151] Figure 34B shows a side perspective view of the valve 2710, showing the composite laser cut workpiece after expansion into the valve wire frame in an expanded configuration. Figure 34B shows the collar portion of the frame 2710 with the braided or laser cut wire cell structure 2725B, and the lower body portion with the wire loop structure 2725C.

[0152] Figure 35A shows a side perspective view of the laser cut orthogonal cell work piece prior to expansion into a set of valve frame panels or walls 2816A and 2816B. Figure 35A illustrates an asymmetric irregular round wire cell 2825D.

[0153] Figure 35B shows a side perspective view of the laser cut orthogonal work pieces after expansion into the valve wire frame panels or walls 2816A and 2816B prior to assembling the frame. Figure 35B shows round horizontally oriented wire cells 2825D to minimize wire distortion during folding, rolling, and compressing the assembled frame.

[0154] FIG. 36A shows a side perspective view of the laser cut orthogonal cell work piece with zigzag / diamond shaped cells 2925A prior to expansion into valve frame panels or walls 2916A and 2916B.

[0155] Figure 36B shows a side perspective view of the laser cut orthogonal workpiece with zigzag / diamond shaped cells 298 after expansion into the valve wire frame panels 280, 282 prior to assembly. Figure 36B illustrates the diamond shaped horizontally oriented wire cells 298 to minimize wire distortion during folding, rolling and compression.

[0156] FIG. 37A shows a side perspective view of valve wire frame panels or walls 3016A and 3016B in a collapsed or folded configuration joined together along a lateral edge 3026A to form a three-dimensional valve frame 3010 having arched collar portions 3021, 3022 and a cylindrical body portion with an internal flow control component 3050 mounted within the cylindrical body portion.

[0157] FIG. 37B shows a top perspective view of valve wire frame panels or walls 3016A and 3016B in an expanded configuration joined together along side edge 3026A to form a three-dimensional valve frame 3010 having arched collar portions 3021, 3022 and a cylindrical body portion with an internal flow control component 3050 mounted within the cylindrical body portion.

[0158] Figure 37C shows a side perspective view of the two panel valve frame 3010 being compressed by rolling. Figure 37C shows the two panels sewn along the joined (joined, joined) edges 3026.

[0159] FIG. 37D shows a side perspective view of the two-panel valve frame 3010 in a wrapped compressed configuration with at least 1 turn and up to 1.5 turns or at least 360 degrees and up to at least 540 degrees.

[0160] Figure 38A shows a plan view of a single sheet of metal or metal alloy with compressible cells cut or formed into first and second collar panels and first and second body portions to form a wire valve frame 3110. Figure 38A shows a cut and fold design. Figure 38A shows that the collar can be folded so that two points A on the collar meet and the bottom can be folded so that two points B on the bottom meet to form a three dimensional valve frame structure 3110 with partial folds to minimize the requirement for extensive sewing.

[0161] FIG. 38B shows a top perspective view of the single seat valve frame 3110 after folding along the open seams, assembly, and installation.

[0162] FIG. 38C shows a side perspective view of the single seat valve frame 3110 in its expanded configuration after folding along the open seams, assembling and installation.

[0163] 39 shows a side perspective view of a valve frame 3210 in its expanded configuration formed from a series of horizontally undulating wires 3225E connected at connection points, with an upper collar portion and an hourglass shape for the lower body portion, showing stitching features along the joining edges.

[0164] 40 shows a side perspective view of a valve frame 3310 in its expanded configuration formed from a series of (vertical) zigzag shaped wires 3325B connected at connection points, with an hourglass shape for the upper collar portion and body portion, showing stitching features along the joining edges.

[0165] 41A shows a top perspective view of a valve frame 3410 in its expanded configuration according to one embodiment. The valve frame 3410 is formed from a series of fan-shaped, asymmetric, irregular, round cells / wires 3425D whose upper collar portion is circumferentially connected to the top peripheral edge of the lower body portion of the frame 3410.

[0166] FIG. 41B shows a cutaway view of the valve frame 3410 showing an upper collar portion formed from a series of fan-shaped asymmetric and irregular round cells / wires 3425D circumferentially connected to the top peripheral edge of the lower body portion, and shows one half of a flow control component 3450 mounted by the lower body portion.

[0167] FIG. 41C shows a side perspective view of the upper cuff or collar portion of the frame 3410 in a partially expanded configuration, illustrating how the elongated fan-shaped asymmetrical irregular round cells / wires 3425D allow for stretching and radial compression.

[0168] FIG. 41D shows a side perspective view of a two-panel embodiment of the flow control component 3450.

[0169] FIG. 41E shows a side perspective view of one embodiment of a lower body portion of a frame 3410 having a braided wire cell configuration 3425B.

[0170] FIG. 41F shows a side perspective view of one embodiment of a lower body portion of a frame 3410 having a diamond shaped laser cut wire cell configuration 3425A.

[0171] FIG. 41G shows a side perspective view of one embodiment of a lower body portion of a frame 3410 having a connecting corrugated wire cell configuration 3425E.

[0172] FIG. 42 shows a plan view of a flat wire frame of metal or metal alloy with compressible wire cells configured in a strain-minimizing orientation to facilitate orthogonal loading and delivery of the prosthetic valve. The arrangement and / or configuration of the compressible wire cells allows the cells to compress, deform, or reconfigure when the prosthetic valve is compressed into a compressed configuration while minimizing strain in the wire valve frame. FIG. 42 shows internal diamond-shaped cells 3525A for use on the lower body portion of the wire frame along with external corrugated cells 3525B for use on the collar portion of the wire frame.

[0173] Figure 43 shows a plan view of a smaller sized flat wire frame of metal or metal alloy with compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of the prosthetic valve. Figure 43 shows internal diamond shaped cells 3525A used for the lower body portion of the wire frame along with external corrugated cells 3525B used for the collar portion of the wire frame.

[0174] Figure 44 shows a side perspective view of a portion of a wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain-minimizing orientation that facilitates orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 44 shows an outer diamond-shaped cell 3525A for use with the collar portion of the wire frame and an inner diamond-shaped cell 3525A for use with the lower body portion of the wire frame.

[0175] Figure 45 shows a side perspective view of a portion of a wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain-minimizing orientation that facilitates orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 45 shows an outer diamond-shaped cell 3525A for use with the collar portion of the wire frame and an inner diamond-shaped cell 3525A for use with the lower body portion of the wire frame.

[0176] Figure 46 shows a plan view looking down the central axis of the wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain-minimizing orientation that facilitates orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 46 shows the outer corrugated cells 3525B used for the collar portion of the wire frame and the inner diamond-shaped cells 3525A used for the lower body portion of the wire frame.

[0177] One benefit of the two (or more) panel valve frame configuration described with some of the previous embodiments is that each frame panel can be formed as a flat sheet rather than braided, laser cut tubes, etc. The manufacturing process for such flat sheet components can be substantially cheaper than other techniques. For example, rather than using a laser to cut apertures in a sheet to form a wire frame structure, the sheet can be etched, for example, using photolithography and a resistive mask. This technique also allows the sheet to be selectively etched to different thicknesses in different areas of the sheet, allowing more design control over the mechanical or structural properties of different sections of the sheet (and thus the valve frame formed from the sheet). FIG. 47A shows a side perspective view of a metal alloy sheet 3605A partially etched on a single side using photolithography and a resistive mask. The metal alloy sheet 3605A can be used to form a wire valve frame.

[0178] Figure 47B shows a side perspective view of metal alloy sheet 3605B that has been partially etched in a double-sided configuration using photolithography and a resistive mask. Metal alloy sheet 3605B can be used to form a wire valve frame.

[0179] As described above with reference to Figures 1A and 1B, the valve and / or valve frame may include any number of tension arms and / or fixation members configured to mount, secure, or fix the valve and / or valve frame within the annulus of a native valve. The tension arms may extend from the valve frame, for example, and may engage with supranulus or subannulus tissue. The tension arms included within the valves and / or valve frames described herein may be substantially similar at least in form and / or function to at least one of tension arms 131, 132, 133, and / or 134 described above with reference to Figures 1A and 1B. The valve and / or valve frame may include and / or be coupled to fixation members that can be used to mount or fix the valve or valve frame within the annulus of a native valve. The fixation members included within and / or used with the valves and / or valve members described herein may be substantially similar at least in form and / or function to tissue anchor 190 described above with reference to Figures 1A and 1B.

[0180] FIG. 48 shows a plan view of one embodiment of a prosthetic valve with a valve frame 3710 having a distal upper tension arm 3731 and a distal lower tension arm 3732 mounted and secured to the anterior leaflet side of the native annulus. The frame 3710 includes a mechanical anchoring element (such as a proximal sealing cuff 3720) for securing to the posterior septal side of the native annulus. The sealing cuff 3720 may be a short tab on the posterior side of the valve frame 3710 or may be a semicircular or circular collar or cuff (such as the cuff 120 described above with reference to FIGS. 1A-1F) that mates with the atrial floor to seal the annulus from paravalvular regurgitation. Valve placement may include placing the valve frame 3710 at or near the native valve annulus and positioning the distal lower tension arm 3732 at a subannular location (such as the RVOT). The distal upper tensioning arm 3731 can be positioned at a supra-annular location (e.g., atrium, etc.). Thus, the distal upper tensioning arm 3731 can exert a supra-annular downward force on the annular tissue and the distal lower tensioning arm 132 can exert an opposing supra-annular upward force on the opposite side of the annular tissue. The forces act to mount or secure the valve frame 3710 within the annulus of the native valve.

[0181] 49 shows a plan view of an embodiment of a prosthetic valve with a valve frame 3810 having a distal upper tension arm 3831 and a distal lower tension arm 3832 mounted and secured to the anterior leaflet side of the native annulus. The frame 3810 includes a mechanical anchoring element (e.g., an hourglass annulus seal 3820) for securing to the posterior septal side of the native annulus. The hourglass or concave sealing cuff 3820 may simply be a short segment of the posterior side of the valve or may be a semicircular or circular combined upper and lower collar or cuff that mates with the atrial floor and ventricular roof to seal the annulus from paravalvular regurgitation. The hourglass or concave sealing cuff 3820 may be formed, for example, by a proximal upper tension arm 3833 and a proximal lower tension arm 3834. The proximal upper tensioning arm 3833 and the proximal lower tensioning arm 3834 can exert opposing forces on the annulus tissue as described for the distal tensioning arms 3831 and 3832. This embodiment may also include an embodiment having a partial collar. This embodiment may be used with other fixation elements (e.g., tissue anchors) described herein.

[0182] FIG 50 shows a plan view of a prosthetic valve 3902 according to one embodiment. The valve 3902 includes a valve frame 3910 having a distal upper tension arm 3931 and a distal lower tension arm 3932 that are mounted and secured to the valve annulus. FIG 50 shows the distal lower tension arm 3932 extending into the RVOT. Lateral or side-loaded delivery of the valve 3902 through the inferior vena cava provides direct access to the native annulus without the need to deliver a compressed valve through a right angle bend, as is done for IVC delivery of conventional transcatheter prosthetic valves that are axially or vertically loaded. FIG. 50 shows one embodiment in which tissue anchors 3990, such as screws or other anchoring devices, are used in conjunction with the tension mounting methods described herein, where distal upper and lower tension arms 3931 and 3932 on the anterior leaflet anchor the valve 3902 in place, and a secondary anchor element (e.g., tissue anchor 3990) completes the secure retention of the valve 3902 at the annulus site.

[0183] Figure 50 shows a polyester mesh cover 3917 that covers the valve frame 3910 and encloses a collapsible flow control sleeve of a flow control component (not shown). Figure 50 also shows the frame 3910 with a nitinol wire frame within diamond shaped cells 3925A that are within or covered by the biocompatible cover 3917. In one embodiment, the frame has a pericardial material on top and a polyester material (e.g., surgical Dacron) underneath to contact the native annulus and promote ingrowth.

[0184] FIG. 51A shows a plan view of a low profile (e.g., 10 mm) prosthetic valve 4002 in an expanded configuration according to one embodiment. The valve 4002 includes a frame 4010 that includes and / or forms a wire annulus support loop. The frame 4010 includes and / or forms (or wire loops include and / or form) a distal upper tension arm 4031 and a distal lower tension arm 4032 that can be formed as a single or integral part and covered with a biocompatible material. This embodiment shows how a low profile side-loaded valve 4002 can have a very large diameter (40-80 mm) without the need to deliver the valve 4002 using an undesirably large delivery catheter. Large delivery catheters are used to deliver larger diameter valves that would otherwise be delivered using a traditional vertical or axial orientation.

[0185] FIG. 51B shows a plan view of the valve 4002, showing an internal two-panel sleeve or flow control component 4050 and a reciprocating collapsible aperture 4054 at the lower end to deliver blood to the ventricle.

[0186] FIG. 51C shows a bottom side view of the valve 4002, showing a top view of the internal two-panel sleeve or flow control component 4050 and the collapsible distal aperture 4054 on the ventricular side.

[0187] Figure 51D is a diagram of the valve 4002 in a compressed configuration and disposed within a delivery catheter 4072. Figure 51D illustrates how a large diameter valve 4002 can be delivered through a delivery catheter 4072 using side loading.

[0188] Figure 51E is a diagram of the valve 4002 in a compressed configuration, partially ejected and partially deployed within the delivery catheter 4072. Figure 51E illustrates how the valve 4002 can be partially delivered for positioning within the valve annulus. The distal lower tension arm 4034 can be used to move through the native tricuspid valve leaflets and chordae tendineae while the valve body, tubular frame 4010, remains within the steerable delivery catheter 4072.

[0189] FIG. 52A shows a plan view of the prosthetic valve 4102 partially mounted within the native annulus. With the side-loaded valve 4102 of the disclosed embodiments, the distal upper tension arm 4133 and the distal lower tension arm 4132 can be mounted against an anterior aspect of the native annulus, and valve function can be evaluated before the valve 4102 is fully seated. By allowing two paths for blood flow, the first through the native valve near the posterior leaflet and the second through a central aperture in the prosthetic valve 4102, the practitioner can determine whether the heart is decompensating or whether valve function is suboptimal. FIG. 52A also shows the proximal upper tension arm 4133, which can operate with the distal tension arms 4131 and 4132 to mount, seat, and / or secure the valve 4102 within the native annulus.

[0190] Figure 52B shows a plan view of the prosthetic valve 4102 fully seated within the annulus. Figure 52B shows that the valve 4102 can be securely fastened in place once valve function assessment indicates successful deployment. Importantly, because the valve 4102 is a low profile valve and easily fits within a standard (e.g., 8-12 mm) delivery catheter without the need for force-fitting of typical transcatheter valves, the side-loaded valve 4102 can be easily retrieved using the same delivery catheter used to deploy the valve.

[0191] FIG. 53A is a diagram of a prosthetic valve 4202 according to one embodiment in a compressed configuration within a delivery catheter 4272. The valve 4202 includes a frame 4210 that includes and / or forms wire annulus support loops. The frame 4210 includes and / or forms (or wire loops include and / or form) a distal upper tension arm 4231 and a distal lower tension arm 4232 that can be formed as a single or integral part and covered with a biocompatible material. The lower and upper tension arms 4231 and 4232 are stretched to the right and the prosthetic valve 4202 is shown laterally compressed within the delivery catheter 4272. The lateral compression is a function of using minimal structural material, e.g., a minimal internal valve sleeve of the flow control component 4250 (FIG. 53C), and a relatively low height of the frame 4210. Such lateral delivery can result in very large prosthetic valves (e.g., up to 80 mm or more). Lateral delivery also avoids making the 90 degree right turn required when using the IVC femoral route to deliver the valve 4202. This sharp delivery angle when delivering conventional valves limits the size and configuration of conventional valve prostheses, and side delivery of the valve 4202 avoids such limitations.

[0192] Figure 53B shows a profile or plan view of the wire frame 4210 of the valve 4202 in an expanded configuration. Figure 53B shows that the distal upper tensioning arm 4231 is attached to the tubular frame 4210, while the distal lower tensioning arm 4232 is shaped in an S-shape and is only connected to the distal upper tensioning arm 4231.

[0193] Figure 53C shows a plan view of the valve 4202 positioned within the native tricuspid valve. Figure 53C shows the tubular frame 4210 and inner sleeve or flow control component 4250 sewn within the central aperture 4214 of the frame 4210, with two (2) panels extending downward (into the page) in the ventricular direction. Figure 53C shows the distal upper tension arm 4231 oriented toward the anterior leaflet side (shown in dashed outline) of the atrial floor around the native tricuspid valve.

[0194] FIG. 53D shows a plan view of the valve 4202, and FIG. 53E shows a cut-away plan view of the valve 4202. FIG. 53E shows an internal panel valve sleeve or flow control component 4250 mounted within an internal space or aperture 4214 defined by a tubular frame 4210. FIG. 53E shows an elongated two-panel valve sleeve or flow control component 4250 extending into the sub-annular leaflet space. The tubular frame 4210 shown in FIG. 53E is approximately 10 mm in height, and the valve sleeve or flow control component 4250 extends approximately 10 mm below the bottom of the tubular frame 4210, resulting in an overall height of the valve 4202 of 20 mm.

[0195] Figure 53F shows a bottom view of the valve 4202 showing the tubular frame 4210 with an internal sleeve or flow control component 4250 sewn within the central aperture 4214, with two panels extending upward (off the page) in the direction of the ventricle. Figure 53F shows the distal lower tension arm 4242 oriented towards the anterior leaflet side (shown in dashed outline) of the roof of the ventricle of the native tricuspid valve.

[0196] Figure 54A shows a profile or plan view of a prosthetic valve 4302 according to one embodiment in an expanded configuration. The valve 4302 has a braided or laser cut frame 4310. Figure 54A shows a distal upper tensioning arm 4331 attached to the top edge of the tubular frame 4310 and a distal lower tensioning arm 4332 attached to the bottom edge of the tubular frame 4310.

[0197] Figure 54B shows a plan view of the valve 4302 positioned within the native tricuspid valve. Figure 54B shows a tubular frame 4310 with an internal sleeve or flow control component 4350 sewn into a central aperture of the frame 4310 with two panels extending downward (into the page) in the ventricular direction. Figure 54B shows the distal upper tension arm 4331 oriented toward the anterior leaflet side (shown in dashed outline) of the atrial floor of the native tricuspid valve.

[0198] Figure 54C shows a plan view of the valve 4302 and Figure 54D shows a cutaway plan view of the valve 4302. Figure 54D shows an internal panel valve sleeve or flow control component 4350 mounted within the interior space or central aperture defined by the tubular frame 4310.

[0199] Figure 54E shows a bottom view of the valve 4302 showing the tubular frame 4210 with an internal sleeve or flow control component 4350 sewn within a central aperture, with two (2) panels extending upward (off the page) in the direction of the ventricle. Figure 54E shows the distal lower tension arm 4334 oriented towards the anterior leaflet side (shown in dashed outline) of the roof of the ventricle.

[0200] FIG. 55A shows a side perspective view of a valve 4402 in an expanded configuration according to one embodiment having a circular hyperboloid (hourglass) shape. The valve 4402 includes a frame 4410 having an extended RVOT tab 4430. The RVOT tab 4430 can be similar to the distal lower tension arm described herein. The details of the wire frame are not shown because, in practice, the exterior surface is preferably covered with, for example, Dacron polyester to facilitate ingrowth. The frame 4410 includes proximal and distal fold regions 4423A and 4423B shown at either end of the anterior collar 4421 and posterior septal collar 4422 along the horizontal major axis 4411. The frame 4410 defines a central groove or aperture that receives a flow control component.

[0201] FIG 55B shows a cut away view of the valve 4402, showing its circular hyperboloid (hourglass) shape and the RVOT tabs 4430 (e.g., distal lower tension arms). FIG 55B shows that the internal leaflets 4453 and flow control component internal frame (not visible) are attached to the inner surface of the annular frame 4410, and the collar portion 4420 is attached to the RVOT tabs or lower annular fixation portion 4430 via wall portion 4412. Here, only the flow control component is attached at the top end, although other non-limiting attachments are contemplated (e.g., mid-wall, multiple attachment points, etc.).

[0202] FIG. 56A shows a side view of a vertically compressible valve 4502 with an internal set of non-extended leaflets (e.g., flow control components) and compressible orthogonal (wide) wire cells in an expanded configuration for implantation within a desired location within the body.

[0203] FIG. 56B shows a side view of the vertically compressible valve 4502 in a compressed configuration for delivery of the compressed valve 4502 to a desired location within the body.

[0204] FIG. 57A shows a side view of a vertically compressible valve 4602 with extended leaflets 4653 (e.g., flow control components) and compressible orthogonal (wide) wire cells in an expanded configuration for implantation within a desired location within the body.

[0205] 57B shows a side view of the vertically compressible valve 4602 in a compressed configuration for delivery of the compressed valve 4602. The wire frame is reduced in height (vertically compressed) and the elongated leaflets are rolled.

[0206] 58A and 58B show a side perspective view and a top view, respectively, of a valve 4702 having a wire frame 4710 formed from a single continuous wire with an upper collar portion, a lower body portion having an hourglass shape, and an RVOT tab or distal lower tension arm extending away from the lower edge of the lower body portion of the frame 4710. The valve 4702 is shown in an expanded configuration.

[0207] 59 shows a side perspective view of a valve frame 4810 formed from a series of undulating wires 4825E connected at connection points with an upper collar portion, a lower body portion having an hourglass shape, and an RVOT tab or distal lower tension arm extending away from the lower edge of the lower body portion of the frame 4810. The valve frame 4810 is shown in an expanded configuration. Stitching features are shown along the joining edges.

[0208] 60 shows a side perspective view of a valve frame 4910 formed from a series of horizontally undulating wires 4925F connected at connection points, with an upper collar portion, a lower body portion having an hourglass shape, and an RVOT tab or distal lower tension arm extending away from the lower edge of the lower body portion of the frame 4910. The valve frame 4910 is shown in an expanded configuration. Stitching features are shown along the joining edges.

[0209] Figure 61 shows a plan view of a flat wire frame of metal or metal alloy with compressible wire cells configured in a strain-minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 61 shows external diamond-shaped cells 5025A for use with the collar portion 5025B of the wire frame, internal corrugated cells 5025B for use with the lower body portion of the wire frame, and diamond-shaped cells 5025A for use with the sub-annular tabs 5030 (e.g., distal lower tension arms).

[0210] Figure 62 shows a plan view of a portion of the wire frame in a funnel configuration (heat set), showing compressible wire cells configured in a strain-minimizing orientation that facilitates orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 62 shows outer diamond-shaped cells 5025A for use with the collar portion of the wire frame, and inner diamond-shaped cells 5025A for use with the lower body portion of the wire frame and sub-annular tabs 5030 (e.g., distal lower tension arms).

[0211] Figure 63 shows a side view of a portion of the wire frame in a funnel configuration (heat set), showing compressible wire cells configured in a strain-minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 63 shows outer diamond-shaped cells 5025A for use with the collar portion of the wire frame, and inner diamond-shaped cells 5025A for use with the lower body portion of the wire frame and sub-annular tabs 5030 (e.g., distal lower tension arms).

[0212] Figure 64 shows a side perspective view of a portion of a wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain-minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve. Figure 64 shows exterior diamond-shaped cells 5025A used for the collar portion of the wire frame, interior diamond-shaped cells 5025A used for the lower body portion of the wire frame, and irregularly shaped cells used for the sub-annular tabs 5030 (e.g., distal lower tension arms).

[0213] FIG. 65A shows a plan view of a prosthetic valve 5102 according to one embodiment having a braided or laser cut wire frame 5110 mounted within a cross section of the atrial floor at the annulus of a native tricuspid valve.

[0214] FIG 65B shows a bottom view of a valve 5102 with a braided or laser cut wire frame 5110 including and / or forming a distal lower tension arm 5132 mounted within a cross section of the roof of the ventricle, shown at the annulus of a native tricuspid valve. FIG 65B shows a two panel valve sleeve or flow control component 5150 in an open position positioned within a central aperture 5114 of the frame 5110. The flow control component 5150 can be in the open position, for example, during atrial systole and ventricular diastole.

[0215] FIG. 66 is a diagram of an embodiment of a prosthetic valve 5202 in an expanded configuration. The valve 5202 includes a frame 5210 having and / or forming a wire annulus support loop and two vertical struts 5252 that extend down to the edges of opposite sides of an inner sleeve or flow control component 5250. The posts 5252 are designed to fold horizontally during compression into a delivery catheter and resiliently open during ejection to position the valve sleeve or flow control component 5252. FIG. 66 also illustrates the frame 5210 with a distal upper tension arm 5231 and a distal lower tension arm 5232, which can be formed as a single or integral part and covered with a biocompatible material. FIG. 66 also illustrates a proximal tab 5230, which can be, for example, a tension arm and / or a fixation post or point.

[0216] 67 is a diagram of a two-panel embodiment of an internal valve sleeve or flow control component 5350. In some embodiments, the frame 5210 shown in FIG.

[0217] Figures 68A and 68B show a side perspective view and a cutaway top view, respectively, of a flow control component 5450 having two rigid posts 5452. Figure 68B shows the flow control component 5450 having two rigid posts 5452 mounted within an interior space or central aperture defined by a tubular frame 5410. The frame 5410 includes a distal upper tensioning arm 5431 and a distal lower tensioning arm 5432 that extend away from the frame 5410.

[0218] FIG. 69 is a diagram of a three-panel embodiment of a valve sleeve within a flow control component 5550 according to one embodiment.

[0219] FIG. 70A is a diagram of a three-panel embodiment of an internal valve sleeve or flow control component 5550 having three rigid struts 5552 according to one embodiment.

[0220] 70B shows a cutaway plan view of a three panel, three post valve sleeve, or flow control component 5550 mounted within an interior space or central aperture defined by a tubular frame 5510. The frame 5510 includes a distal upper tensioning arm 5531 and a distal lower tensioning arm 5532 that extend away from the frame 5510.

[0221] 71A is a diagram of one embodiment of a partial cutaway internal view of a tri-leaflet embodiment of a low profile (e.g., 8-20 mm), side-loaded prosthetic valve 5702 having a frame 5710 and a flow control component 5750. The frame 5710 includes a distal lower tension arm 5732. The flow control component 5750 is a tri-leaflet flow control component with three rigid struts 5752.

[0222] FIG. 71B is a diagram of another embodiment of a partially cut-away internal view of a tri-leaflet embodiment of a low profile (eg, 8-20 mm), side-loaded prosthetic valve 5702 showing the flow control component 5750 in a non-cutaway view.

[0223] FIG. 71C shows a plan view of a tri-leaflet embodiment of a low profile (eg, 8-20 mm) side-loaded prosthetic valve 5702.

[0224] 72A-72C are various schematic diagrams of a delivery system 270 for delivering a transcatheter prosthetic valve 202 according to one embodiment. The transcatheter prosthetic valve 202 is configured to be placed at a desired location within the body (e.g., of a human patient) and to allow blood flow in a first direction through an inflow end of the transcatheter prosthetic valve 202 and block blood flow in a second direction opposite the first direction through an outflow end of the transcatheter prosthetic valve 202. For example, the transcatheter prosthetic valve 202 can be a transcatheter prosthetic heart valve configured to be placed within the annulus of a native tricuspid or native mitral valve of a human heart to supplement and / or replace the function of the native valve.

[0225] The transcatheter prosthetic valve 202 is compressible and expandable in at least one direction perpendicular to the valve's longitudinal axis 202. The valve 202 is configured to be compressible and expandable between an expanded configuration for implantation at a desired location within the body (e.g., the human heart) and a compressed configuration for introduction into the body via a delivery system 270.

[0226] In some embodiments, the prosthetic valve 202 can be similar or substantially the same as the valve 102 described above with reference to FIGS. 1A-1F. For example, FIG. 72B shows that the valve 202 can include an annular support frame 210 and a flow control component 250. The annular support frame 210 can be similar to the frame 110 and can include a cuff or collar portion 220, and a tubular section (e.g., a lower tubular body portion) 212, and a guidewire collar 240. In addition, the annular support frame 210 defines an aperture 214 extending along or in the direction of a central axis 213 of the frame 210. Although not shown, the frame 210 and / or the valve 202 can also include one or more tension arms, fixation tabs, and the like. The flow control component 250 can be similar to the flow control component 150 described above with reference to FIGS. 1A-1F. The valve 202, which is substantially similar to the valve 102, will not be described in greater detail here.

[0227] As shown in FIGS. 72A-72C, the delivery system 270 includes a delivery catheter 272, a secondary catheter 280, and a guidewire 285. The delivery system 270 can be configured to deliver the compressed valve 202 and / or a portion of the valve 202 (e.g., the compressed frame 210 or the compressed flow control component 250) orthogonally to a desired location in the body (e.g., the annulus of the native tricuspid valve and / or the native mitral valve of a human heart, etc.). As already described in detail with reference to the valve 102, the delivery system 270 can deliver the valve 202 orthogonally. The valve 202 is compressed into a compressed configuration by being compressed along a central axis 213 (FIG. 72B) or compressed laterally (e.g., orthogonal to the central axis 213 and the central longitudinal axis 275 of the delivery catheter 272). Such compression can result in the valve 202 stretching along a longitudinal axis (not shown in FIGS. 72A-72C). The longitudinal axis is substantially parallel to the central longitudinal axis 275 of the delivery catheter 272 .

[0228] The delivery catheter 272 defines a lumen 274 extending along or in the direction of a central longitudinal axis 275. The lumen 274 of the delivery catheter 272 can have a diameter sufficient to receive the compressed valve 202 therethrough. For example, the delivery catheter 272 can be 22-34 Fr with any suitable corresponding internal lumen diameter and / or an internal lumen diameter sufficient to receive the prosthetic valve 202 in the compressed configuration.

[0229] A guidewire 285 extends through or penetrates the secondary catheter 280, the valve 202, and the delivery catheter 272. The guidewire 285 can be, for example, a covered guidewire that is at least partially covered by the secondary catheter 280. The guidewire 285 is configured to be advanced through the anatomy of the body to be positioned at a desired location relative to the native tissue (e.g., the native valve). In some cases, the guidewire 285 can be advanced to provide a wire path (e.g., to the delivery catheter 272, the valve 202, etc.) to the RVOT. The guidewire 285 extends through the guidewire collar 240 of the valve 202 to provide a wire path along which the valve 202 is advanced.

[0230] The secondary catheter 280 can be a sheath, tube, circular rod, wire, or the like. In some embodiments, the secondary catheter 280 is a hypotube sheath disposed around a portion of the guidewire 285 (e.g., the secondary catheter 280 and the guidewire 285 collectively form a covered guidewire or a covered guidewire assembly). The secondary catheter 280 is sized relatively small to allow the secondary catheter 280 to advance through the delivery catheter 272 and / or to be at least partially disposed within or otherwise mated with the guidewire collar 240. As shown in FIGS. 72A-72C, the inner diameter of the lumen of the secondary catheter 280 is larger than the guidewire 285 to allow the guidewire 285 to pass therethrough.

[0231] A pusher 281 is disposed within the secondary catheter 280 and is configured to push a portion of the valve 202 to advance the valve 202 through and / or out of the delivery catheter 272. In some implementations, the pusher 281 is configured to push against a portion of the guidewire collar 240 of the valve 202. For example, the guidewire collar 240 can advance the guidewire 285 through the guidewire collar 240 and can block and / or substantially prevent the pusher 281 from advancing beyond the guidewire collar 240 (or at least a portion thereof). Although the pusher 281 is illustrated disposed within the secondary catheter 280, in some embodiments, the secondary catheter 280 can be used as the pusher 281. In such embodiments, the delivery system 270 need not include a separate pusher 281.

[0232] The guidewire collar 240 of the valve (FIG. 72B) can be any suitable element that selectively allows the guidewire 285 to pass therethrough while blocking or preventing the secondary catheter 280 and / or pusher 281 from passing over the guidewire collar 240. In some embodiments, the guidewire collar 240 can be included within, formed by, and / or attached to the cuff 220 of the frame 210. In some embodiments, the guidewire collar 240 can be included within, formed by, and / or attached to a tension arm (e.g., a distal upper tension arm, a distal lower tension arm, etc.). In some embodiments, the distal lower tension arm can form and / or include features that form the guidewire collar 240. It may be desirable to attach the guidewire collar 240 to the distal lower tension arm because both the guidewire 285 and the distal lower tension arm are inserted into or routed toward the RVOT.

[0233] In some embodiments, the guidewire collar 240 can be a ball or feature of a tension arm that defines an aperture or lumen large enough for the guidewire 285 to pass through, but not large enough for the secondary catheter 280 and / or pusher 281 to advance through. Thus, the secondary catheter 280 and / or pusher 281 can be stopped against the guidewire collar 240 by the outer circumference of the secondary catheter 280 and / or pusher 281, which is large compared to the aperture or lumen of the guidewire collar 240. Such an arrangement allows the secondary catheter 280 and / or pusher 281 to push against the guidewire collar 240, and thus the tension arm to which the guidewire collar 240 is attached (e.g., the distal lower tension arm). When the guidewire collar 240 is attached to the distal tension arm, pushing the guidewire collar 240 serves to pull the valve 202 through and / or out of the delivery catheter 272. It is contemplated that guidewire collar 240 may have any suitable configuration that allows guidewire collar 240 to allow advancement of guidewire 285 while limiting, blocking, or preventing advancement of secondary catheter 280 and / or pusher 281. Release mechanism 282 may also be configured to release guidewire 285, secondary catheter 280, and / or pusher 281 from guidewire collar 240, for example, after valve 202 has been deployed.

[0234] FIG. 72C illustrates a delivery system 270 for delivering a valve 202 to a native valve, such as the mitral or pulmonary valve (or tricuspid or aortic valve). A guidewire 285 is advanced through the annulus of the native valve and positioned within the ventricle (e.g., in the RVOT). A delivery catheter 272 can be advanced over the guidewire 285 to deliver to a desired location at or near the annulus. Once the delivery catheter 272 is in the desired location, the valve 202 can be advanced over the guidewire 285 and within the delivery catheter 272 by pushing a secondary catheter 280 and / or a pusher 281. When the guidewire collar 240 is attached distally or anteriorly to the valve 202 or frame 210, pushing the secondary catheter 280 and / or the pusher 281 acts like a pulling force, for example, on the tubular section 212 of the valve frame 210 and / or the flow control component 250 of the valve 202. Additionally, the secondary catheter 280 and / or the pusher 281 can be used to eject the valve 202 from the delivery catheter 272. Once ejected from the delivery catheter 272, the valve 202 can be expanded to an expanded configuration and seated within the annulus of the native valve. In some embodiments, the secondary catheter 280, the pusher 281, and / or the guidewire 285 can be released from the guidewire collar 240 to allow the secondary catheter 280, the pusher 281, and / or the guidewire 285 to be retracted and / or withdrawn. In some embodiments, the secondary catheter 280 and / or the pusher 281 can be used to push at least the proximal side of the valve 202 or the valve frame 210 into the valve annulus, thereby fully seating and / or positioning the valve 202. 72A-72C, in some embodiments, a secondary catheter 280 and / or pusher 281 can further be used to deliver and / or secure tissue anchors proximally to the valve 202 or valve frame 210. Thus, the delivery system 270 can deliver a conventionally compressed valve or orthogonally deliver a vertically and / or laterally compressed valve 202.

[0235] FIG. 72D is a flow chart illustrating a method 300 for delivering a low-profile side-loaded prosthetic valve (e.g., any of the valves disclosed herein) according to one embodiment. The method 300 includes positioning a distal portion of a delivery catheter including a frame of the prosthetic valve in a compressed configuration within the atrium toward the annulus of a native valve of the heart (302). The valve can be any of the valves disclosed herein. For example, the valve can be similar in form and / or function to valves 102 and / or 202 described above. In some embodiments, the valve can be a valve that: (i) the valve has a tubular frame with a flow control component mounted within the tubular frame; (ii) the valve or flow control component is configured to allow blood flow in a first direction through the inflow end of the valve and block blood flow in a second direction opposite the first direction through the outflow end of the valve; (iii) the valve is compressible and expandable and has a major axis oriented at an intersection angle of 45 to 135 degrees relative to the first direction; and (iv) the major axis is parallel to a longitudinal cylindrical axis of a delivery catheter used to deliver the valve.

[0236] The tension arms of the prosthetic valve frame are released from the delivery catheter (304). The tension arms can be, for example, the distal valve lower tension arm frame. The placement of the valve within the delivery catheter can be such that the distal lower tension arms are distal to the valve body. In other words, the compressed valve is placed within the delivery catheter such that the major axis (longitudinal axis) is substantially parallel to the major or longitudinal axis of the delivery catheter with the distal lower tension arms extending distally from the valve body. Thus, the distal lower tension arms typically release from the delivery catheter before the valve body.

[0237] A distal portion of the tension arm is positioned on the ventricular side of the native valve annulus while the distal end of the delivery catheter remains on the atrial side of the annulus (306). The tension arm (e.g., the distal lower tension arm) can extend through the native annulus and can be positioned at least partially within the RVOT. In some cases, the tension arm can engage with sub-annular tissue to securely anchor the distal portion of the valve at least partially to the native annular tissue while maintaining the remainder of the valve in a supra-annular position within the atrial side of the annulus.

[0238] The remaining portion of the prosthetic valve frame is released from the delivery catheter 308. As previously detailed for certain embodiments, releasing the remaining portion of the prosthetic valve allows the prosthetic valve to expand from a compressed configuration within the delivery catheter to an expanded configuration outside of the delivery catheter suitable for placement within the native valve annulus.

[0239] Method 300 may optionally include holding the prosthetic valve frame at an angle relative to the native annulus (310). The angle may be, for example, an oblique angle relative to the native annulus. In some embodiments, the delivery system or the like may include a secondary catheter or push / pull rod that may be used to (1) advance the valve through the delivery catheter and (2) temporarily hold the prosthetic valve at an angle relative to the native annulus. When the prosthetic valve is held at the angle, blood may be allowed to flow from the atrium to the ventricle, partially through the native annulus around the prosthetic valve frame and partially through the prosthetic valve (312). Blood flow may optionally be used to assess valve function (314). If the prosthetic valve does not appear to be functioning properly, the valve may be replaced without having to remove the fully deployed valve.

[0240] The tubular portion of the frame is positioned (316) within the annulus of the native valve. For example, in some embodiments, a secondary catheter or a push / pull rod can be used to push at least a proximal end portion of the valve into the native annulus. In some implementations, one or more walls of the valve and / or one or more proximal or distal tension arms can be used to seat the prosthetic valve within the native annulus. For example, the tension arms can exert opposing forces that can securely fasten the prosthetic valve at least partially to the annulus tissue. In some embodiments, the tension arms and / or any other portion of the frame can form a rotational or pressure lock against the annulus tissue. With the tubular portion of the frame within the annulus of the native valve, the prosthetic valve can be fully positioned.

[0241] Method 300 may optionally include securing a proximal portion of the prosthetic valve frame to tissue surrounding the native valve (318). For example, the proximal portion of the frame may be secured using any of the tissue anchors and / or securing methods described herein. In some embodiments, the proximal portion of the frame may be secured using tissue anchors that mate with a portion of the frame and are inserted into the tissue surrounding the native valve.

[0242] Method 300 may optionally include delivering a flow control device to an aperture of the prosthetic valve frame (320). For example, as described above with reference to valve 102 shown in FIGS. 1A-1F, the valve may be positioned within the annulus of the native valve as a single integrated part. The valve includes a valve frame and a flow control component positioned within an aperture of the valve frame. However, in other embodiments, the valve may be positioned within the annulus of the native valve as two or more independent or separate processes. In some cases, delivering the valve in two or more parts may compress the separately delivered components into a smaller or tighter compressed configuration. In some such circumstances, the valve frame may be compressed and delivered to the annulus of the native valve as described in method 300 above. After the valve frame is fully seated or positioned within the annulus of the native valve, the flow control component may be compressed and delivered to the valve frame. The flow control component may be a self-expanding valve component or may be balloon-expanded once positioned in the desired location within the valve frame.

[0243] Set forth below are descriptions of particular aspects or embodiments of transcatheter prosthetic valves, delivery systems, and / or delivery methods. The transcatheter prosthetic valves (or aspects or portions thereof), delivery systems, and / or delivery methods described below for particular embodiments can be substantially similar, at least in form and / or function, to the valve 202 and / or corresponding aspects of the valve 202, delivery system 270, and / or delivery method 300 described above with reference to Figures 72A-72D. Accordingly, certain aspects of particular embodiments will not be described in greater detail herein.

[0244] Figure 73A shows a lateral view of the human cardiac anatomy. Figure 73B shows an enlarged view of a portion of the human cardiac anatomy of Figure 73A, illustrating the geometric relationships between the inferior vena cava (IVC), the three leaflet cusps of the tricuspid valve (anterior, posterior, septal), the RVOT, and the pulmonary artery (PA).

[0245] FIG. 74 shows a side perspective view of a side-delivered valve 5802 seated in the native tricuspid annulus, with the collar portion 5820 of the valve, 5802 (or valve frame) positioned in the atrium above the tricuspid annulus and leaflets, and the lower body portion extending into and through the annulus to provide modified hemodynamic flow from the flow control component.

[0246] FIG. 75A shows a plan view of the native right atrium of a human heart, showing the superior vena cava (SVC), inferior vena cava (IVC), right atrium (RA), tricuspid valve and annulus (TCV), anterior leaflet (), posterior leaflet (P), septal leaflet (S), right ventricle (RV), and right ventricular outflow tract (RVOT).

[0247] Figure 75B illustrates a prosthetic valve 5902 being delivered to the tricuspid annulus according to one embodiment. Figure 75B shows the valve 5902 with a braided / laser cut frame 5910 with a distal lower tension arm 5932 projecting from a delivery catheter 5972 through the annulus toward the right ventricular outflow tract.

[0248] FIG. 75C is a diagram of the valve 5902 showing the braided / laser cut frame 5910 with the distal lower tension arm 5932 and distal upper tension arm 5931 protruded from the delivery catheter 5972 via a secondary catheter and / or pusher 5980, the distal lower tension arm 5932 delivered through the annulus into the RVOT, and the distal upper tension arm 5931 remaining in a supra-annular position, causing passive structural fixation of the distal side of the valve 5902 around the annulus.

[0249] FIG. 75D is a diagram of the valve 5902 showing the entire braided / laser cut frame 5910 extruded from the delivery catheter 5972, with the distal lower tension arm 5932 routed through the annulus and into the RVOT, and the distal upper tension arm 5931 remaining in a supra-annular position to create passive structural fixation of the distal side of the valve around the annulus, and at least one tissue anchor (not shown) securing the proximal side of the prosthesis within the annular tissue.

[0250] Figure 76A illustrates the delivery of a prosthetic valve 6002 to the tricuspid annulus according to one embodiment. Figure 76A shows the distal lower tension arm 6032 of the valve 6002 being ejected from the delivery catheter and sent through the annulus to the RVOT. In this example, delivery of the valve 6002 can include a valve evaluation process.

[0251] FIG. 76B shows the distal lower tension arm 6032 and the distal upper tension arm 6031 being pushed out of the delivery catheter such that the distal lower tension arm 6032 is sent through the annulus into the RVOT and the distal upper tension arm 6031 remains in a supra-annular position, causing passive structural fixation of the distal side of the valve 6002 around the annulus. FIG. 76B shows that the valve 6002 can be held at an oblique angle in a pre-attached position (e.g., by a secondary catheter (not shown)) so that it can be evaluated, and once the valve function and patient condition are corrected, the secondary catheter can push the proximal side of the valve 6002 down from the oblique angle into the annulus. By allowing two paths for blood flow (first through the native valve near the posterior leaflet and second through a central aperture in the prosthetic valve 6002), the practitioner can determine whether the heart is decompensating or whether valve function is suboptimal. The secondary catheter can then be fitted with one or more fixation elements or otherwise secure the valve 6002 within the native valve.

[0252] FIG. 76C is a diagram of the entire braided / laser cut frame valve 6002 extruded from the delivery catheter with the distal lower tension arm 6032 routed through the annulus and into the RVOT and the distal upper tension arm 6031 remaining in a supra-annular position to create passive structural fixation of the distal side of the valve 6002 around the annulus, and optionally at least one tissue anchor (not shown) anchoring the proximal side of the valve 6002 within the annulus tissue.

[0253] FIG. 77A shows a side perspective view of the valve 6102 vertically compressed without folding into a compressed configuration and loaded into a delivery catheter 6172. By using a horizontal diamond-shaped cell rather than the traditional vertical orientation, the frame 6110 of the valve 6102 can be compressed from top to bottom. This allows for orthogonal delivery of a much larger diameter valve than can be delivered using traditional axial compression. Additionally, orthogonal delivery allows for access to the tricuspid annulus from the IVC using the distal fixation tabs on the lower annulus or the distal lower tensioning arm 6132. Typically, the delivery catheter must make a 90-120 degree right turn before delivering a traditional transcatheter axially compressed valve. In contrast, a vertically compressed (e.g., compressed toward the center aperture or toward blood flow through the valve 6102) valve 6102 can be delivered directly into the distal side of the tricuspid annulus.

[0254] FIG. 77B shows a side perspective view of the valve 6102 being partially expelled or released from the delivery catheter 6172, allowing a transition from the native blood flow through the native tricuspid valve and the partial flow around the prosthetic valve 6102 and into the native annulus to the partial flow through the inflow end of the prosthetic valve 6102 (indicated by the arrow labeled "INFLOW" in FIG. 77B) and out the outflow end (indicated by the arrow labeled "OUTFLOW" in FIG. 77B) and into the native annulus. The guidewire 6185 is shown pigtailed to enter the pulmonary artery of the heart. The stiff pull rod / wire, pusher, and / or secondary catheter 6180 in some embodiments are designed to ride over the guidewire 6185 to precisely deliver the valve 6102 to the intended location. The distal annular subtab or distal subtension arm 6132 are configured to be delivered into the RVOT to provide fixation to the valve 6102 while it is positioned and evaluated.

[0255] FIG. 77C shows a side perspective view of the valve 6102 in an expanded configuration after being fully expelled or released from the delivery catheter 6172. The valve 6102 is attached using a distal tab or a distal lower tension arm 6132 against the distal surface of the annulus and held at an elevation angle above the native annulus using a rigid pull rod / wire or pusher 6180 before the valve 6102 is fully deployed. This allows for a further transition from native blood flow through the native tricuspid valve and partial flow passing around the prosthetic valve 6102 into the native annulus to an increased partial flow through the inflow end of the prosthetic valve 6102 and out the outflow end into the native annulus. FIG. 77C also shows a guidewire 6185 pigtailed into the pulmonary artery of the heart (through the LVOT). FIG. 77C further shows a proximal subannular fixation tab or a proximal lower tension arm (proximal tab) 6134 shown. This may facilitate mounting or fixation to the valve 6102 once generally positioned within the native annulus.

[0256] FIG. 77D shows a side perspective view of the valve 6102 fully discharged or released from the delivery catheter 6172 and fully seated within the native annulus. Delivery of the valve 6102 as described above allows for a smooth transition from native blood flow to full and complete flow through the prosthetic valve 6102 (and thus into the native annulus). The valve 6102 is secured using a distal tab (distal lower tension arm) 6132 at the subannulus, a proximal tab (proximal lower tension arm) 6134 at the subannulus, and an (atrial) upper tension arm (distal upper tension arm) 6131 at the supraannulus. A modified alternative flow using the valve 6102 is shown by flow in through the inflow end and out through the outflow end of the prosthetic valve 6102 (and thus into the native annulus).

[0257] 78A shows a side perspective view of the valve 6202 vertically compressed without folding into a compressed configuration and loaded into a delivery catheter 6272, showing the flow control component 6250 in a rolled configuration. The guidewire 6285 and RVOT tab or distal lower tension arm 6232 are shown extended into the pulmonary artery, allowing for precise delivery of the valve 6202.

[0258] FIG. 78B shows a side perspective view of the valve 6202 being partially expelled or released from the delivery catheter 6272, with the leaflets 6253 of the internal flow control component 6250 partially unfolded and stretched. FIG. 78B shows the transition from the natural flow through the native tricuspid valve, passing around the prosthetic valve 6202 and into the native annulus, to the partial flow passing through the inflow end of the prosthetic valve 6202 (indicated by the arrow labeled "inflow" in FIG. 78B), out the outflow end (indicated by the arrow labeled "outflow" in FIG. 78B), and into the native annulus. The rigid pull rod / wire, pusher, and / or secondary catheter 6280 in some embodiments is designed to ride over the guidewire 6285. The RVOT tab or distal lower tension arm 6232 is routed into the RVOT and configured to provide fixation to the valve 6202 while the valve 6202 is positioned and evaluated. The valve 6202 has a distal mid-wall arch above the RVOT tabs or distal lower tension arms 6232 for mating with the native annulus.

[0259] 78C shows a side perspective view of the valve 6202 in an expanded configuration having been fully expelled or released from the delivery catheter 6272, with the leaflets 6253 of the internal flow control component 6250 fully unfolded and extended. The valve 6202 is attached using distal tabs or distal lower tension arms 6232 against the distal surface of the annulus and held in an elevated position using a rigid puller / pusher or secondary catheter 6280 at an angle above the native annulus prior to being fully deployed. This allows for a further transition from native flow through the native tricuspid valve and partial flow passing around the prosthetic valve 6202 and into the native annulus to an increased partial flow through the inflow end of the prosthetic valve 6202 and out the outflow end into or through the native annulus. FIG. 78C shows a distal mid-wall arch mating with the distal native annulus and a proximal mid-wall arch elevated above the native annulus to provide a smooth transition to prosthetic flow when the valve 6202 is fully seated within the native annulus.

[0260] 78D shows a side perspective view of the valve 6202 fully expelled or released from the delivery catheter 6272 and fully seated within the native annulus. Delivery of the valve 6202 as described above allows for a smooth transition from native blood flow to full and complete flow through the prosthetic valve 6202 (and thus into the native annulus). The valve 6202 is secured using a distal tab or distal lower tension arm 6232 at the subannulus, a proximal tab or proximal lower tension arm 6234 at the subannulus, and an (atrial) tab or distal upper tension arm 6231 at the subannulus. The modified alternative flow through the unfolded and stretched leaflets 6253 is shown by flow in through the inflow end of the prosthetic valve 6202 and out through the outflow end (and thus into the native annulus).

[0261] FIG. 79A shows a side view of the valve 6302 in a compressed configuration within a delivery catheter 6372 according to one embodiment. FIG. 79A shows how a central tube / wire or secondary catheter 6380 can be attached distally to the distal edge, RVOT tab, or distal lower tension arm 6332, and by pushing on the stiff tube / wire or secondary catheter 6332, the compressed valve 6202 can be pulled from the proximal end of the catheter 6372 to the distal deployment end of the delivery catheter 6372. This pulling action avoids pushing the valve 6302 out of the delivery catheter 6302, which may result in further radial expansion and radial forces that may damage the valve 6302 when compressed within the delivery catheter 6372.

[0262] FIG. 79B shows a side view of the valve 6302 partially compressed and partially released from the delivery catheter 6372, illustrating how blood flow can begin to transition. Pulling the valve 6302 with a rigid pusher or secondary catheter 6380 attached to the distal sub-annular fixation tab or distal lower tension arm 6332 creates a gradual and smooth transition from native flow to flow through the prosthetic valve 6302, avoiding the sphincter effect, which can result in dry pumping and heart failure, as the heart is cut off from flow. When the valve 6302 is partially open (partially released) exposing only a portion of the collar portion 6320 of the frame of the valve 6302 to a small portion of the right atrial blood flow passing through the prosthetic valve 6302, a flushing effect creates a smooth transition to an increased volume passing through the valve 6302.

[0263] FIG. 79C shows a side view of the valve 6302 being partially compressed and partially released from the delivery catheter 6372, illustrating how blood flow can begin its transition.

Claims

1. An artificial valve, a tubular frame having a sidewall and an atrial collar attached around an upper end of the sidewall; a distal sub-annulus fixation tension arm attached to a lower distal sidewall of the tubular frame, the distal sub-annulus fixation tension arm extending away from the distal sidewall of the tubular frame; a flow control component mounted within the tubular frame, the flow control component configured to allow blood flow in a first direction through the inflow end of the prosthetic valve and to block blood flow in a second direction opposite the first direction through the outflow end of the prosthetic valve; the prosthetic valve is compressible to a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration having a major axis oriented at an angle of 45-135 degrees relative to the first direction, and expandable to an expanded configuration having a major axis oriented at an angle of 45-135 degrees relative to the first direction; the prosthetic valve is disposed within a lumen of the delivery catheter, and the major axis of the compressed configuration of the prosthetic valve is substantially parallel to a longitudinal cylindrical axis of the lumen of the delivery catheter. The artificial valve.

2. the tubular frame includes a transannular tubular segment; 2. The prosthetic valve of claim 1, wherein the atrial collar includes a flared atrial cuff coupled to the transannular tubular segment around a superior end of the transannular tubular segment.

3. the tubular frame being formed from one or more of braid, wire, or laser cut wire frame; The artificial valve according to claim 1 or 2, wherein the tubular frame has an inner surface and an outer surface, the inner surface and the outer surface being covered with a biocompatible material.

4. The prosthetic valve of claim 3 , wherein the biocompatible material comprises one or more of pericardial tissue and a woven synthetic polyester material.

5. The prosthetic valve of claims 1-4, wherein the tubular frame has a flattened conical or hourglass shaped side profile.

6. the flow control component having a plurality of leaflets of pericardial material; The prosthetic valve of claims 1-5, wherein the leaflets are joined to form a rounded cylinder at the inflow end and have a flat, closable aperture at the outflow end.

7. the flow control component is supported by one or more longitudinal support members embedded or mounted within or on the flow control component; 7. The prosthetic valve of claims 1-6, wherein the one or more longitudinal support members comprise one or more of rigid or semi-rigid struts, rigid or semi-rigid ribs, rigid or semi-rigid battens, rigid or semi-rigid panels, and combinations thereof.

8. The prosthetic valve of claims 1-7, wherein the distal subannular fixation tension arm is a wire loop or wire frame, an integrated frame section, or a stent.

9. The prosthetic valve of claims 1-8, wherein the distal subannular fixation tension arm has a length of 10-40 mm.

10. a distal supra-annular tensioning arm attached to a distal upper edge of the tubular frame; The prosthetic valve of any one of claims 1 to 8, wherein the distal supra-annular tensioning arm is comprised of a wire loop or wire frame that extends approximately 2-20 mm away from the tubular frame.

11. The prosthetic valve of claim 10, wherein the distal supranulus tension arm is 2-20 mm in length.

12. a proximal sub-annulus fixation tension arm attached to a lower proximal sidewall of the tubular frame; at least one tissue anchor connected to the tubular frame for engaging natural tissue; The artificial valve according to claim 1 to 11, further comprising:

13. The artificial valve according to any one of claims 1 to 12, wherein the side wall has a height of 8 to 20 mm and a diameter of 40 to 80 mm.

14. An artificial valve, a valve frame having a central axis and defining an aperture extending along said central axis; a flow control component mounted within the aperture, the flow control component configured to permit blood flow in a first direction generally parallel to the central axis from an inflow end to an outflow end of the flow control component and to block blood flow in a second direction opposite the first direction; the frame has an expanded configuration with a first height along the central axis, a first lateral width along a lateral axis perpendicular to the central axis, and a first longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis; the frame has a compressed configuration with a second height along the central axis that is less than the first height and a second lateral width along the lateral axis that is less than the first lateral width. The artificial valve.

15. 15. The prosthetic valve of claim 14, wherein the compressed configuration of the valve frame has a second longitudinal length that is longer than the first longitudinal length along the longitudinal axis.

16. 16. The prosthetic valve of claim 14 or 15, wherein the valve frame is capable of being transformed from the expanded configuration to the compressed configuration by compressing the valve frame vertically by one or more of flattening, rolling, or folding the valve frame, and by compressing the valve frame laterally by one or more of flattening, rolling, or folding the valve frame.

17. 17. The prosthetic valve of claims 14-16, wherein the valve frame includes two panels, and the valve frame can be transformed from the expanded configuration to the compressed configuration by compressing the valve frame laterally by flattening the valve frame along the lateral axis so that the two panels are approximately parallel, and by compressing the valve frame vertically by rolling the flattened valve frame about the longitudinal axis along the central axis.

18. A system including the artificial valve according to any one of claims 14 to 17, a delivery catheter having a lumen, the lumen having a diameter less than the first height of the valve frame, less than the first lateral width of the valve frame, greater than the second height of the valve frame, and greater than the second lateral width of the valve frame; The system, wherein the valve frame is in the compressed configuration and the prosthetic valve is disposed within the lumen of the delivery catheter.

19. A capsule having an outer diameter and a lumen having an inner diameter, the capsule further comprising: an outer diameter of the capsule smaller than the inner diameter of the lumen of the delivery catheter, the inner diameter of the lumen of the capsule smaller than the first height of the valve frame, smaller than the first lateral width of the valve frame, greater than the second height of the valve frame, and greater than the second lateral width of the valve frame; the prosthetic valve is positionable within the lumen of the capsule; The system of claim 18 , wherein the capsule is positionable within the lumen of the delivery catheter.

20. the valve frame includes a guide collar having an aperture therethrough, the aperture in the guide collar having an inner diameter; 20. The system of claim 18 or 19, further comprising a pusher having a distal end and a diameter larger than the inner diameter of the aperture of the guidewire collar, the pusher being positionable over a guidewire positionable through the aperture of the guidewire collar and the lumen of the delivery catheter, the distal end of the pusher being matable with the guidewire collar.

21. 1. A frame for an artificial valve, comprising: a tubular frame having a central lumen defined by an inner circumferential surface of the tubular frame defining a vertical axis of the tubular frame, the tubular frame having an outer circumferential surface capable of mating with native annulus tissue; the tubular frame is compressible into a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration having a horizontal major axis oriented at an angle of 45-135 degrees relative to the vertical axis of the tubular frame, and expandable into an expanded configuration having a horizontal major axis oriented at an angle of 45-135 degrees relative to the vertical axis of the tubular frame; when the tubular frame is disposed within the lumen of the delivery catheter, the horizontal major axis of the compressed configuration of the tubular frame is substantially parallel to a longitudinal cylindrical axis of the lumen of the delivery catheter. The frame.

22. the tubular frame includes a flared atrial cuff; 22. The frame of claim 21, wherein the flared atrial cuff is coupled to the transannular tubular segment around a superior end of the transannular tubular segment.

23. 23. The frame of claim 21 or 22, wherein the tubular frame is formed of braid, wire, or laser cut wire frame and is covered with a biocompatible material.

24. 24. The frame of claims 21-23, further comprising a flow control component connectable to the inner circumferential surface of the tubular frame, the flow control component having a plurality of leaflets of pericardial material that join to form a rounded cylinder at an inflow end and having a closable aperture at an outflow end.

25. 25. The frame of claims 21-24, further comprising a tensioning arm extending away from one side of the tubular frame, the tensioning arm being formed of a wire loop or wire frame, an integrated frame section, or a stent.

26. an upper tensioning arm attached to and extending away from an upper edge of the tubular frame, the upper tensioning arm being formed of a wire loop or wire frame; 25. The frame of claims 21-24, further comprising a lower tensioning arm attached to and extending away from a lower edge of the tubular frame, the lower tensioning arm being formed of a wire loop or wire frame, an integrated frame section, or a stent.

27. 1. A method for delivering a prosthetic valve to a native valve between a ventricle and an atrium of a heart, comprising: advancing a delivery catheter including the prosthetic valve into the atrium of the heart, the prosthetic valve comprising: a tubular frame having a sidewall and an atrial collar attached around an upper end of the sidewall; a distal sub-annular fixation tension arm attached to a lower, distal wall of the tubular frame, the sub-annular fixation tension arm extending distally away from the lower, distal wall; and a flow control component mounted within the tubular frame, the flow control component configured to allow blood flow in a first direction through an inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through an outflow end of the prosthetic valve, the prosthetic valve being disposed within the delivery catheter in a compressed configuration having a major axis oriented at an angle of 45-135 degrees relative to the first direction and expandable to an expanded configuration having a major axis oriented at an angle of 45-135 degrees relative to the first direction, the major axis of the prosthetic valve when in the compressed configuration being substantially parallel to a longitudinal cylindrical axis of the delivery catheter; releasing the distal subannular fixation tension arm of the valve from the delivery catheter by pushing a rigid elongated push rod removably connected to the tension arm away from the delivery catheter, thereby withdrawing the tension arm from the delivery catheter; delivering the distal subannular fixation tension arm to a ventricular side of the annulus of the native valve; expelling a remaining portion of the prosthetic valve from the delivery catheter to the expanded configuration such that the tubular frame is disposed within the annulus of the native valve; The method comprising:

28. anchoring one or more tissue anchors attached to the prosthetic valve within native tissue; 28. The method of claim 27, further comprising:

29. positioning the distal subannular fixation tension arm of the prosthetic valve within a right ventricular outflow tract of a right ventricle; positioning an upper tension arm of the prosthetic valve in a supra-annular position, the upper tension arm exerting a supra-annular downward force toward the ventricle and the distal sub-annular fixation tension arm exerting a sub-annular upward force toward the atrium; The method of claims 27 to 28, further comprising:

30. rotating the prosthetic valve with a steerable catheter along an axis parallel to the plane of the annulus of the native valve, wherein an upper tension arm mounted on the prosthetic valve is conformationally pressure-locked against the supra-annular tissue on the atrial side of the native valve and the distal sub-annular fixation tension arm mounted on the valve is conformationally pressure-locked against the sub-annular tissue on the ventricular side of the native valve; The method of claims 27 to 28, further comprising:

31. 1. A method for delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart, comprising: positioning a distal portion of a delivery catheter within the atrium of the heart, the delivery catheter having a lumen and a longitudinal axis; the distal portion of the delivery catheter positions the prosthetic valve in a compressed configuration within the lumen with a distal end of the delivery catheter toward the annulus of the native valve; the prosthetic valve having a tubular frame coupled to the tension arms and a flow control component mounted within the tubular frame, the prosthetic valve having an expanded configuration, the prosthetic valve being configured to allow blood flow in a first direction through an inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through an outflow end of the prosthetic valve, the tension arms extending laterally from the tubular frame and configured to be positioned on the ventricular side of the annulus of the native valve when the tubular frame is positioned within the annulus; the prosthetic valve in the expanded configuration has an extent in any direction transverse to the first direction that is greater than a diameter of the lumen of the distal portion of the delivery catheter; the prosthetic valve in the compressed configuration is disposed within the distal portion of the delivery catheter and longitudinally stretched and transversely compressed relative to the dimensions of the prosthetic valve in the expanded configuration; the artificial valve has a long axis in the longitudinal direction that is parallel to the longitudinal axis of the delivery catheter and oriented at an intersection angle of 45 to 135 degrees with respect to the first direction; The placing, releasing the tension arm from the lumen of the delivery catheter while the tension arm is positioned distally in the longitudinal direction toward the distal end of the delivery catheter; positioning at least a distal portion of the tension arm on the ventricular side of the annulus of the native valve while the distal end of the delivery catheter remains on the atrial side of the annulus; expelling a remaining portion of the prosthetic valve from the lumen of the delivery catheter such that the tubular frame is positioned within the annulus of the native valve; The method comprising:

32. fixing a portion of the prosthetic valve opposite the tension arm to the annulus of the native valve; 32. The method of claim 31 , further comprising:

33. between positioning at least a distal portion of the tension arm and expelling a remainder of the prosthetic valve from the lumen, The method of claims 31-32, further comprising allowing blood to flow from the atrium to the ventricle through both the native valve and the artificial valve.

34. the delivery catheter includes an elongate pusher disposed within the lumen of the delivery catheter, the elongate pusher having a distal end that mates with the tension arm of the prosthetic valve; 34. The method of claim 31, wherein releasing the tension arm from the lumen of the delivery catheter comprises advancing the pusher distally through the lumen of the delivery catheter to withdraw the tension arm from the lumen of the delivery catheter.

35. the native valve is a tricuspid valve, the atrium is a right atrium, and the ventricle is a right ventricle; The method of any one of claims 31 to 34, wherein positioning at least a distal portion of the tension arm comprises positioning the at least a distal portion of the tension arm within a right ventricular outflow tract of the right ventricle.

36. the tension arm is a lower tension arm, and the prosthetic valve further includes an upper tension arm coupled to the tubular frame and extending laterally from the tubular frame; positioning at least a distal portion of the upper tension arm on the right atrial side of the annulus of the tricuspid valve, the upper tension arm exerting a downward force on an upper portion of the annulus toward the right ventricle and the lower tension arm exerting an upward force on a lower portion of the annulus toward the right atrium; 36. The method of claim 35, further comprising:

37. the native valve is the mitral valve, the atrium is the left atrium, and the ventricle is the left ventricle; 35. The method of claim 31, wherein positioning at least a distal portion of the tension arm comprises positioning the at least a distal portion of the tension arm below an anterior portion of the annulus of the mitral valve.

38. the delivery catheter includes an elongate pusher disposed within the lumen of the delivery catheter and having a distal end that mates with a proximal end of the prosthetic valve; 34. The method of claim 31, wherein releasing the tension arm from the lumen of the delivery catheter comprises advancing the pusher distally through the lumen of the delivery catheter to push the valve distally and release the tension arm from the lumen of the delivery catheter.

39. 1. A method for delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart, comprising: positioning a distal portion of a delivery catheter within the atrium of the heart, the delivery catheter having a lumen and a longitudinal axis; the distal portion of the delivery catheter positions the prosthetic valve in a compressed configuration within the lumen with a distal end of the delivery catheter toward the annulus of the native valve; The prosthetic valve has a tubular frame having tension arms coupled thereto and a flow control component mounted within the tubular frame, the prosthetic valve being configured to allow blood flow in a first direction through an inflow end of the prosthetic valve and block blood flow in a second direction opposite the first direction through an outflow end of the prosthetic valve, the tension arms extending laterally from the tubular frame and configured to be positioned on the ventricular side of the annulus of the native valve when the tubular frame is positioned within the annulus, the tubular frame being positioned within the lumen of the delivery catheter and the tension arms being positioned toward the distal end of the delivery catheter. The placing, Releasing the tension arm from the lumen of the delivery catheter; positioning at least a distal portion of the tension arm on the ventricular side of the annulus of the native valve while the distal end of the delivery catheter remains on the atrial side of the annulus; releasing a remaining portion of the prosthetic valve from the lumen of the delivery catheter; and holding the prosthetic valve at an oblique angle relative to the annulus of the native valve; allowing blood to flow from the atrium to the ventricle through both the native valve and the artificial valve to allow evaluation of the function of the native valve and the artificial valve; The method comprising:

40. completely positioning the tubular frame of the prosthetic valve within the annulus of the native valve; 40. The method of claim 39, further comprising:

41. 1. A method for delivering a prosthetic valve, comprising: advancing a delivery catheter over a guidewire having a diameter such that a distal end of the delivery catheter is positioned at a desired location within the body; mounting a valve capsule containing the prosthetic valve in a compressed configuration onto a proximal end of the guidewire, the prosthetic valve having a guidewire collar with an aperture therethrough, the inner diameter of the aperture being larger than a diameter of the guidewire, the guidewire being disposed through the aperture of the guidewire collar; mounting the valve capsule within a proximal end of the delivery catheter; placing a pusher over the guidewire proximal to the prosthetic valve, the pusher having an outer diameter greater than the inner diameter of the aperture of the guidewire collar; advancing the pusher over the guidewire to advance the prosthetic valve from the valve capsule into a lumen of the delivery catheter and through the lumen to the distal end; deploying the prosthetic valve from the distal end of the delivery catheter to the desired location; The method comprising:

42. the prosthetic valve having a flow control component configured to permit blood flow in a first direction through an inflow end of the prosthetic valve and to block blood flow in a second direction opposite the first direction through an outflow end of the prosthetic valve; 42. The method of claim 41, wherein the compressed configuration of the prosthetic valve is coaxial with the first direction.

43. 43. The method of claim 41 or 42, wherein the prosthetic valve has a self-expanding frame, and wherein the deploying the prosthetic valve comprises allowing the frame to expand to an expanded configuration.

44. the desired location is a tricuspid valve of the patient's heart; The prosthetic valve includes a frame and a tension arm extending distally from the frame, the guidewire collar being disposed on the tension arm; positioning the tension arm within a right ventricular outflow tract of the right ventricle of the heart; 43. The method of claim 41 or 42, further comprising:

45. the tension arm is a lower tension arm, and the prosthetic valve further includes an upper tension arm extending from the frame of the prosthetic valve; positioning the upper tension arm over the tricuspid valve annulus, the upper tension arm exerting a downward force on the annulus toward the ventricle and the lower tension arm exerting an upward force on the annulus toward the atrium; 45. The method of claim 44, further comprising:

46. rotating the prosthetic valve with a steerable catheter along an axis parallel to the plane of the annulus such that the upper tension arm is conformationally pressure locked against the atrial side of the annulus and the lower tension arm is conformationally pressure locked against the ventricular side of the annulus; 46. ​​The method of claim 45, further comprising:

47. 1. A method for delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart, comprising: positioning a distal portion of a delivery catheter within the atrium of the heart, the delivery catheter having a lumen and a longitudinal axis; the distal portion of the delivery catheter is disposed within the lumen in a compressed configuration over a tubular frame for the prosthetic valve with the distal end of the delivery catheter directed toward the annulus of the native valve; the tubular frame defining a central lumen and having a central axis, tension arms coupled thereto, the tubular frame having an expanded configuration configured to be positioned within the native valve annulus with the tension arms extending laterally from the tubular frame; the tubular frame in the expanded configuration has an extent in any direction transverse to a central axis that is greater than a diameter of the lumen of the distal portion of the delivery catheter; placing the tubular frame in the compressed configuration disposed within the distal portion of the delivery catheter, stretched longitudinally and compressed transversely relative to the dimensions of the tubular frame in the expanded configuration, with the tubular frame having a major axis in the longitudinal direction parallel to the longitudinal axis of the delivery catheter and oriented at an intersection angle of 45-135 degrees relative to the central axis, the tensioning arm disposed distally in the longitudinal direction toward the distal end of the delivery catheter; Releasing the tension arm from the lumen of the catheter; positioning at least a distal portion of the tension arm on the ventricular side of the annulus of the native valve while the distal end of the delivery catheter remains on the atrial side of the annulus; expelling a remaining portion of the tubular frame from the lumen of the delivery catheter such that the tubular frame is positioned within the annulus of the native valve; The method comprising:

48. advancing a distal end of a second delivery catheter to the annulus of the native valve; delivering an expandable flow control component of the prosthetic valve from the distal end of the delivery catheter to the central lumen of the tubular frame; expanding the expandable flow control component within the central lumen and mounting the expandable flow control component within the tubular frame; 48. The method of claim 47, further comprising:

49. 1. A method for preparing a prosthetic valve for delivery to a patient via a delivery catheter having a lumen with a lumen diameter, the method comprising: The prosthetic valve has an annular valve frame defining a central axis, the prosthetic valve having an expanded configuration with a vertical height along the central axis, a lateral width along a lateral axis perpendicular to the central axis, and a longitudinal length along a longitudinal axis perpendicular to the central axis and the lateral axis; vertically compressing the valve frame by reducing a dimension of the valve frame along the central axis from the expanded configuration to a dimension smaller than the lumen diameter; compressing the valve frame laterally by reducing a dimension of the valve frame along the lateral axis from the expanded configuration to a dimension smaller than the lumen diameter, wherein the compressing of the valve frame vertically and the compressing of the valve frame laterally combine to place the valve frame in a compressed configuration; inserting the valve frame in the compressed configuration into the lumen of the delivery catheter; The method comprising:

50. 50. The method of claim 49, wherein the compressing the valve frame vertically comprises one or more of flattening, rolling, or folding the valve frame.

51. The valve frame includes two panels; said compressing said valve frame laterally includes flattening said valve frame along said lateral axis such that said two panels are generally parallel; 51. The method of claim 50, wherein the compressing the valve frame in a vertical direction comprises rolling the flattened valve frame along the vertical axis.

52. 51. The method of claim 49 or 50, wherein the compressing the valve frame laterally comprises one or more of flattening, rolling, or folding the valve frame.

53. The compressing the valve frame laterally may comprise rolling the valve frame unidirectionally from one side of the valve frame or rolling the valve frame symmetrically from both sides of the valve frame along the lateral axis; 53. The method of claim 52, comprising any one of the following:

54. The inserting of the valve frame includes inserting the valve frame into a capsule and inserting the capsule into the lumen of the delivery catheter. The method of any one of claims 49 to 53, comprising:

55. the valve frame includes a guidewire collar having an aperture therethrough, the aperture having an inner diameter; placing the valve frame over a guidewire having a diameter smaller than the inner diameter of the aperture of the guidewire collar; placing a pusher over the guidewire having a distal end and a diameter larger than the inner diameter of the aperture of the guidewire collar, the distal end of the pusher mating with the guidewire collar; The method of claims 49 to 54, further comprising:

56. 1. A method for delivering a prosthetic valve to an annulus of a native valve between a ventricle and an atrium of a heart, comprising: positioning a distal portion of a delivery catheter within the atrium of the heart, the delivery catheter having a lumen and a longitudinal axis; the distal portion of the delivery catheter positions the prosthetic valve in a compressed configuration within the lumen with a distal end of the delivery catheter toward the annulus of the native valve; The prosthetic valve includes a tubular frame with a distal lower tension arm and a distal upper tension arm coupled to a distal sidewall thereof, and a flow control component mounted within the tubular frame, the prosthetic valve having an expanded configuration, the flow control component allowing blood flow in a first direction through the prosthetic valve and blocking blood flow in a second direction opposite the first direction through the prosthetic valve, the prosthetic valve being disposed within the lumen of the delivery catheter with the distal lower tension arm and the distal upper tension arm disposed toward the distal end of the delivery catheter. The placing, Releasing the distal lower tension arm from the lumen of the delivery catheter; Releasing the distal upper tension arm from the lumen of the delivery catheter; placing a portion of the distal lower tension arm on the ventricular side of the native valve annulus while the distal upper tension arm remains on the atrial side of the annulus; After releasing the distal lower tensioning arm and the distal upper tensioning arm, releasing a remaining portion of the prosthetic valve from the lumen of the delivery catheter; and placing the prosthetic valve within the annulus of the native valve and securing the prosthetic valve to the annulus of the native valve, wherein during the placing, the distal upper tension arm contacts supra-annular tissue on the atrial side of the annulus and the distal lower tension arm contacts sub-annular tissue on the ventricular side of the annulus; The method comprising:

57. contacting a proximal tension arm attached to a proximal sidewall of the tubular frame with proximal annular tissue of the native valve; anchoring the proximal tension arm to the annulus tissue proximal to the native valve via at least one tissue anchor; 57. The method of claim 56, further comprising:

58. rotating the prosthetic valve with a steerable catheter along an axis parallel to the plane of the annulus of the native valve so that the distal upper tension arm is conformationally pressure locked against the supra-annular tissue on the atrial side of the annulus and the distal lower tension arm is conformationally pressure locked against the sub-annular tissue on the ventricular side of the annulus; 58. The method of claim 56 or 57, further comprising:

59. the native valve is a tricuspid valve, the atrium is a right atrium, and the ventricle is a right ventricle; 59. The method of claims 56-58, wherein said positioning said portion of said distal lower tension arm comprises positioning said portion of said tension arm within a right ventricular outflow tract of said right ventricle.

60. 60. The method of claims 56-59, wherein during said positioning, the distal upper tension arm applies a force on the upper annulus tissue in a direction towards the ventricle and the distal lower tension arm applies a force on the lower annulus tissue in a direction towards the atrium.

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