Stent graft with low profile passive sealing skirt and method

Abstract

The technology of the present disclosure generally relates to a method that includes providing a sealed stent graft. A sealing stent graft includes a graft material, a stent coupled to the graft material, a sealing skirt of graft material placed flat on the stent, and a collapse suture coupled to the graft material. The method further includes expanding the stent to cause the collapse suture to collapse the sealing skirt. Accordingly, when in the delivery configuration, the sealing skirt is placed flat and does not affect the packing density of the sealing stent graft. During deployment, collapse of the sealing skirt causes the sealing skirt to project radially outward. This thickening of the sealing skirt improves the sealing of the sealing stent graft from other structures (e.g., vessels).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 407,001 filed on September 15, 2022, U.S. Provisional Application Serial No. 63 / 538,460 filed on September 14, 2023, and U.S. Provisional Application Serial No. 63 / 538,462 filed on September 14, 2023, the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0002] The present application generally relates to an intravascular device and method. For example, the present application relates to a device for treating intravascular diseases. The present application also generally relates to a cardiac implant device (e.g., a transcatheter aortic valve replacement (TAVR) device) having an invertible sealing skirt or a sealing skirt having an expanded axial pleating. Background Art

[0003] Conventional stent grafts typically include a radially expandable reinforcement structure formed of a plurality of annular stent rings, and a cylindrical layer of graft material defining an inner lumen to which the stent rings are coupled.Stent grafts are well known for use in tubular vessels of the human body.

[0004] For purposes of illustration, endovascular aneurysm isolation is a method of using a stent graft to isolate a pressurized fluid flow from the interior of an aneurysm, thereby reducing the risk of aneurysm rupture and the associated invasive surgical intervention. However, challenges exist in certain anatomies in providing an adequate seal between the stent graft and the vessel to effectively isolate the aneurysm from the pressurized fluid flow.

[0005] Diseased or otherwise defective heart valves can be repaired or replaced using a variety of heart valve surgeries. One type of heart valve surgery is an open-heart surgical procedure performed under general anesthesia. During an open-heart surgical procedure, the heart stops pumping blood and blood flow is controlled by a heart-lung bypass machine. Due to its highly invasive nature, an open-heart surgical procedure exposes the patient to one or more potentially serious risks (e.g., infection, stroke, kidney failure, and adverse effects of the heart-lung machine).

[0006] In view of the invasiveness and serious risks associated with open-heart surgical procedures, less invasive percutaneous replacement of heart valves has been proposed and implemented. One type of such procedure is known as a transcatheter heart valve procedure, in which a valve component is inserted through a relatively small opening in the skin and delivered into the heart via a delivery system (e.g., a catheter) to access the patient's vasculature.

[0007] Artificial heart valve designs are intended to mimic the function of natural heart valve designs. One type of artificial heart valve design is called a self-expanding valve (e.g., an supra-annular design). A self-expanding valve design includes an expandable stent frame formed of a self-expanding material (e.g., nickel-titanium alloy or nitinol). Leaflets can be mounted on the expandable stent frame to replicate a natural heart valve. A wrap can be sutured to the expandable stent frame to reduce paravalvular leakage (PVL). PVL is a leak caused by a gap between the natural heart tissue and the replacement valve replacement.

[0008] Although the wrap can reduce or resist PVL, the wrap may increase the profile of the self-expanding valve in the delivery position (e.g., compressed position). This increased profile may pose a challenge to delivering the self-expanding valve to the deployment position (e.g., aortic valve position) to expand to the deployment position. Summary of the invention

[0009] The technology of the present disclosure generally relates to a method, which includes providing a sealing stent graft. The sealing stent graft includes a graft material, a stent coupled to the graft material, a sealing skirt of the graft material placed flatly on the stent, and a collapse suture coupled to the graft material. The method further includes expanding the stent to cause the collapse suture to collapse the sealing skirt. In one or more embodiments, when in a delivery configuration, the sealing skirt is placed flatly and does not affect the packing density of the sealing stent graft. During deployment, the collapse of the sealing skirt causes the sealing skirt to protrude radially outward. This thickening of the sealing skirt improves the sealing of the sealing stent graft with other structures (e.g., a vessel). The collapse of the sealing skirt can produce wrinkles in the sealing skirt. The method may further include: before the expansion step, positioning the sealing stent graft in the vessel, and deploying the sealing stent graft in the vessel. In one or more embodiments, the sealing skirt forms a seal with the vessel. The method may further include forming a seal between the sealing stent graft and the first component by the sealing skirt.

[0010] In one aspect, the present disclosure provides an assembly including a sealed stent graft. The sealed stent graft includes a graft material, a stent coupled to the graft material, and a collapse suture coupled to the graft material. When the sealed stent graft is in a delivery configuration, a sealing skirt of the graft material is placed flat on the stent. When the sealed stent graft is in an expanded configuration, the sealing skirt collapses and protrudes from the stent by the collapse suture. The graft material may further include an exclusion section. The stent may further include a first crown, a second crown, and a pillar extending between the first crown and the second crown. The second crown may be attached to the graft material at an anchor point. The sealing skirt and the barrier section may meet at the anchor point. The graft material may include an edge that defines an opening and overlaps the pillar. The stent may extend from the second crown through the edge to the first crown.

[0011] On the other hand, the present disclosure provides an assembly including a graft material, a stent, and a collapse suture. The graft material has an edge. The stent is coupled to the graft material at an anchor point. The graft material has a sealing skirt between the anchor point and the edge. The collapse suture is coupled to the sealing skirt and the graft material at periodic points in an alternating repeating pattern. The periodic points may include a first periodic point defining a first suture trace and a second periodic point defining a second suture trace. When the stent is expanded, the longitudinal distance between the first suture trace and the second suture trace may be reduced. When the stent is expanded, the circumferential distance between the first suture points may increase, and the circumferential distance between the second suture points may increase. When the stent is expanded, the collapse suture may collapse the sealing skirt. The sealing skirt may protrude radially outward when collapsed. The assembly may further include: a sealing stent graft including the graft material, the stent, and the collapse suture; and a first component. The sealing skirt may be located within the first component. Alternatively, the first component may be located within the sealing skirt. The sealing skirt may protrude radially inwardly when collapsed. The sealing skirt may be placed flat on the stent before the stent is expanded.

[0012] In one embodiment, a cardiac implant device is disclosed. The cardiac implant device includes a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device further includes a skirt anchored to the inflow section of the frame. The cardiac implant device also includes a collapse suture anchored to the skirt and the inflow section of the frame. The collapse suture has a repeating shape having a delivery amplitude in a delivery state of the frame and an expanded amplitude in an expanded state of the frame. The reduced amplitude from the delivery amplitude to the expanded amplitude generates a force that causes a portion of the skirt to rotate outward at a hinge trace to form an overlap between this portion of the skirt and a portion of the inflow section of the frame. The overlap is configured to enhance the sealing of the cardiac implant device in the expanded state and / or reduce paravalvular leakage (PVL).

[0013] The skirt can be anchored to the inflow section of the frame at the skirt / frame anchoring point forming the skirt / frame anchoring trace. The collapse suture can be anchored to the inflow section of the frame at the suture / frame anchoring point forming the suture / frame anchoring trace. The collapse suture can be anchored to the skirt at the suture / skirt anchoring point forming the suture / skirt anchoring trace. The skirt / frame anchoring trace can be longitudinally positioned between the suture / frame anchoring trace and the suture / skirt anchoring trace. The skirt / frame anchoring point can be offset from the suture / frame anchoring point and the suture / skirt anchoring point. The frame can have an inner surface and an outer surface, and the skirt can have an inner surface and an outer surface. The suture / frame anchoring point can be anchored to the outer surface of the frame. The suture / skirt anchoring point can be anchored to the outer surface of the skirt. In the expanded state, the outer surface of the frame and the outer surface of the skirt can be in contact. The articulation trace may be spaced apart from the skirt / frame anchoring trace toward the suture / skirt anchoring trace. The repeating shape may be a sinusoidal shape. The force includes a radial component. The skirt may include a first segment and a second segment. In the delivery state, the first segment and the second segment of the skirt may be aligned with the inflow segment of the frame. In the deployed state, the first segment of the skirt may be aligned with the inflow segment. In the deployed state, the second segment of the skirt may contact the inflow segment of the frame.

[0014] Another embodiment discloses a cardiac implant device, which includes a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device further includes a skirt having a first end section and a second end section. The first end section of the skirt is anchored to the inflow section of the frame at a skirt / frame anchoring point forming a skirt / frame anchoring trace. The cardiac implant device also includes a collapse suture, which is anchored to the inflow section of the frame at a suture / frame anchoring point forming a suture / frame anchoring trace, and is anchored to the second end section of the skirt at a suture / skirt anchoring point forming a suture / skirt anchoring trace. The collapse suture has a repeating shape, which has a delivery amplitude in a delivery state of the cardiac implant device and has an expanded amplitude in an expanded state of the cardiac implant device. The reduced amplitude from the delivery amplitude to the expanded amplitude generates a force that causes the skirt to flip around the skirt / frame anchoring trace and form a sealing portion of the skirt.

[0015] In the deployed state, the sealing portion of the skirt may be pleated. The collapse suture may include a first set of legs extending in a first direction and a second set of legs extending in a second direction intersecting the first direction to form a scissor arm. The suture / skirt anchoring trace may be longitudinally located between the outflow section of the frame and the skirt / frame anchoring trace in the delivery state, and between the skirt / frame anchoring trace and the suture / frame anchoring trace in the deployed state. In the delivery state, a portion of the skirt may be longitudinally aligned with the contraction section of the frame.

[0016] Yet another embodiment discloses a cardiac implant device, the cardiac implant device comprising a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device also includes a skirt, the skirt being anchored to the inflow section of the inflow section of the frame at a first skirt / frame anchoring point forming a first skirt / frame anchoring trace and at a second skirt / frame anchoring point forming a second skirt / frame anchoring trace. The cardiac implant device also includes a collapse suture, the collapse suture being anchored to the inflow section of the frame at a suture / frame anchoring point forming a suture / frame anchoring trace, and being anchored to the skirt at a suture / skirt anchoring trace. The collapse suture has a repeating shape, the repeating shape having a delivery amplitude in a delivery state of the cardiac implant device and having an expanded amplitude in an expanded state of the cardiac implant device. The reduced amplitude from the delivery amplitude to the expanded amplitude generates a force, which causes a portion of the skirt to flip around the first skirt / frame anchoring trace and form a sealing portion of the skirt.

[0017] The skirt can be anchored to the inflow section of the frame at a third skirt / frame anchoring point forming a third skirt / frame anchoring trace. The third skirt / frame anchoring trace can be longitudinally located between the first skirt / frame anchoring trace and the second skirt / frame anchoring trace. The skirt can have a first end section and a second end section. The first end section and the second end section can be placed flat in the delivery state. In the deployed state, the first end section can be pleated. In the deployed state, the second end section can be placed flat. The suture / skirt anchoring trace can be longitudinally located between the outflow section of the frame and the first skirt / frame anchoring trace in the collapsed state, and between the first skirt / frame anchoring trace and the second skirt / frame anchoring trace in the deployed state. The suture / frame anchoring trace can be located on or near the inflow end of the frame.

[0018] In one embodiment, a cardiac implant device is disclosed. The cardiac implant device includes a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device further includes a skirt anchored to the inflow section of the frame. The cardiac implant device also includes an extensible suture anchored to the inflow section of the frame and extending through a sealing portion of the skirt. The extensible suture is configured to pleat the sealing portion in the expanded state of the frame to form a pleated sealing portion, which, in the expanded state, enhances the sealing and / or reduced paravalvular leakage (PVL) of the cardiac implant device.

[0019] The stretchable suture may be aligned with the longitudinal axis. The sealing portion defines an eyelet for receiving the stretchable suture. The stretchable suture may be woven through the frame nodes of the frame in the woven structure. The woven structure may be an over / under woven structure.

[0020] In another embodiment, a cardiac implant device is disclosed. The cardiac implant device includes a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device further includes a skirt anchored to the inflow section of the frame. The cardiac implant device also includes a collapse suture anchored to the inflow section of the frame at a suture / frame anchoring point forming a suture / frame anchoring trace. The collapse suture is anchored to the skirt at a suture / skirt anchoring point forming a suture / skirt anchoring trace, and the suture / skirt anchoring trace coincides with the suture / frame anchoring trace. The collapse suture is configured to collapse to form a sealing portion of the skirt, which, in the expanded state, enhances the seal and / or reduces leakage (PVL) of the cardiac implant device.

[0021] The suture / skirt anchoring points may include an upper suture / skirt anchoring point forming an upper suture / skirt anchoring trace, a lower suture / skirt anchoring point forming a lower suture / skirt anchoring trace, and an intermediate suture / skirt anchoring point forming an intermediate suture / skirt anchoring trace longitudinally located between the upper suture / skirt anchoring trace and the lower suture / skirt anchoring trace. The suture / frame anchoring trace may coincide with the lower suture / skirt anchoring trace. The suture / frame anchoring trace may coincide with the upper suture / skirt anchoring trace. The suture / frame anchoring piece may be spaced apart from the suture / skirt anchoring piece.

[0022] In yet another embodiment, a cardiac implant device is disclosed. The cardiac implant device includes a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device further includes a skirt anchored to the inflow section of the frame. The cardiac implant device includes a collapse suture, which includes a first collapse suture and a second collapse suture separated from each other. The first collapse suture has a first end and a second end. The second collapse suture has a first end and a second end. The first ends of the first collapse suture and the second collapse suture are anchored to the skirt. The second ends of the first collapse suture and the second collapse suture are anchored to the frame. The first end has a compression offset in the delivery state of the frame and has an expansion offset in the expanded state of the frame. The expansion offset is greater than the compression offset, thereby causing the skirt to gather to enhance the sealing of the cardiac implant device and / or reduce paravalvular leakage (PVL) in the expanded state.

[0023] The second ends of the first and second collapse sutures can be anchored to the inflow section of the frame. The first and second collapse sutures can have a curved shape in the compressed state and the expanded state. The second ends of the first and second collapse sutures are anchored to the outflow section of the frame. The first and second collapse sutures have a spiral shape in the compressed state and the expanded state.

[0024] In yet another embodiment, a cardiac implant device is disclosed. The cardiac implant device includes a frame extending along a longitudinal axis and having an inflow section, an outflow section, and a contraction section extending between the inflow section and the outflow section. The cardiac implant device further includes a skirt anchored to the inflow section of the frame at a first skirt / frame anchoring point forming a first skirt / frame anchoring trace and at a second skirt / frame anchoring point forming a second skirt / frame anchoring trace. The cardiac implant device further includes a collapse suture anchored to the skirt at a suture / skirt anchoring point forming a suture / skirt anchoring trace. The collapse suture is anchored to the inflow section of the frame at a suture / frame anchoring point forming a suture / frame anchoring trace. The collapse suture has a repeating shape having a delivery amplitude in a delivery state of the cardiac implant device and an expanded amplitude in an expanded state of the cardiac implant device. The reduced amplitude from the delivery amplitude to the deployed amplitude creates a force that causes a portion of the skirt to move closer to the inflow section of the frame in the deployed position.

[0025] In the delivery state, at least a portion of the skirt may coincide with the contraction section. The skirt may have a first end section and a second end section. The cardiac implant device may further include a skirt suture anchored to the first end section and the second end section of the skirt at a first suture / skirt anchor point and a second suture / skirt anchor point, respectively. The suture / frame anchoring trace may coincide with the inflow end of the frame. This portion of the skirt may be moved closer to the inflow section of the frame and is pleated in the deployed position.

[0026] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in the disclosure will become apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a perspective view of a sealed stent-graft in a delivery configuration according to one embodiment.

[0028] Figure 2 is in an expanded configuration according to one embodiment Figure 1 Stereoscopic view of a sealed stent graft.

[0029] Figure 3 According to an embodiment Figure 1 An enlarged plan view of region III of the sealed stent-graft.

[0030] Figure 4 According to one embodiment, Figure 2 An enlarged plan view of region IV of a sealed stent graft in the expanded configuration.

[0031] Figure 5 is a cross-sectional view of a vascular assembly according to one embodiment, the vascular assembly including a delivery system, the delivery system including a Figure 1 and Figure 3 A sealed stent graft in a delivery configuration.

[0032] Figure 6 According to an embodiment Figure 5 A cross-sectional view of a vascular assembly comprising a Figure 2 and Figure 4 A sealed stent graft in an expanded configuration.

[0033] Figure 7 is a cross-sectional view of a modular assembly according to one embodiment, the modular assembly comprising Figure 2 and Figure 4 A sealed stent graft in an expanded configuration.

[0034] Figure 8 is a cross-sectional view of a sealed stent-graft in a delivery configuration according to one embodiment.

[0035] Fig. 9 is in an expanded configuration according to one embodiment Figure 8 Cross-sectional view of a sealed stent graft.

[0036] Fig. 10A A schematic side view of a transcatheter aortic valve replacement (TAVR) device is depicted.

[0037] Fig. 10B Depicted Fig. 10A Schematic perspective view of the TAVR device shown in .

[0038] Fig. 10C Depicting a cross-sectional view of a patient's anatomy and a delivery system and a Fig. 10A and Fig. 10B Schematic side view of a TAVR device.

[0039] Fig. 10D Depicting a cross-sectional view of a patient's anatomy and a delivery system and a Fig. 10A and a schematic side view of a TAVR device in FIG. A10B .

[0040] Fig.11A Depicted is a cross-sectional view of a portion of a cardiac implant device (e.g., a TAVR device) in a compressed state (e.g., a delivery state), the cardiac implant device having a frame (e.g., an expandable frame of a TAVR device), a skirt anchored to the frame, and sutures anchored to the frame and the skirt.

[0041] Fig. 11B Depicts the compressed state Fig.11A Side view of a cardiac implant device.

[0042] Fig. 11C Depicts an expanded state (eg, partially deployed state) Fig.11A A cross-sectional view of a portion of a cardiac implant device.

[0043] Fig.11D Depicted is a side view of a cardiac implant device in an expanded state.

[0044] Fig.11E Depicted is a cross-sectional view of a portion of a cardiac implant device in an expanded state (eg, a fully deployed state).

[0045] Fig.11F Depicted is a side view of a cardiac implant device in an expanded state.

[0046] Fig. 12A Depicted is a side view of a cardiac implant device in a compressed state (e.g., a delivery state) according to another embodiment, the cardiac implant device having a frame (e.g., an expandable frame of a TAVR device), a skirt anchored to the frame, and sutures anchored to the frame and the skirt.

[0047] Fig. 12B Depicts an expanded state (eg, partially deployed state) Fig. 12A Side view of a cardiac implant device.

[0048] Fig. 12C Depicts an expanded state (eg, fully deployed state) Fig. 12A Side view of a cardiac implant device.

[0049] Fig.13A Depicted is a side view of a cardiac implant device in a compressed state (e.g., a delivery state) according to yet another embodiment, the cardiac implant device having a frame (e.g., an expandable frame of a TAVR device), a skirt anchored to the frame, and sutures anchored to the frame and the skirt.

[0050] Fig. 13B Depicts an expanded state (eg, partially deployed state) Fig.13A Side view of a cardiac implant device.

[0051] Fig. 13C Depicts an expanded state (eg, fully deployed state) Fig.13A Side view of a cardiac implant device.

[0052] Fig.14AA schematic side view of a TAVR device is depicted.

[0053] Fig. 14B Depicted is a schematic side view of a TAVR device having a pleated section and an extendable suture.

[0054] Fig. 14C Depicted Fig. 14C Isolated side view of the pleated segment and extendable suture of a TAVR device.

[0055] Fig.15A A schematic side view of a frame and skirt of a cardiac implant device in a compressed state is depicted.

[0056] Fig. 15B Depicts the expansion Fig.15A A side view schematic diagram of the frame and skirt of a cardiac implant device.

[0057] Fig. 15C is a description of cardiac implantable devices (e.g. Fig.15A Schematic diagram of the frame nodes of a frame of a cardiac implant device).

[0058] Fig.15D A schematic diagram depicting the rivets connecting the frame nodes to the collapse sutures.

[0059] Fig.15E A schematic diagram depicting the sutures connecting the framework nodes to the collapse sutures.

[0060] Fig.15F Depicts depicting cardiac implantable devices (e.g., Fig.15A Schematic diagram of the straight struts of a frame of a cardiac implant device.

[0061] Figure 15G A schematic diagram of the rivets connecting the straight struts to the collapsing sutures is depicted.

[0062] Fig.15H A schematic diagram of the sutures connecting the straight struts to the collapsing sutures is depicted.

[0063] Fig.16A A schematic side view of a frame and skirt of a cardiac implant device in a compressed state is depicted.

[0064] Fig. 16B Depicts the expansion Fig.16A A side view schematic diagram of the frame and skirt of a cardiac implant device.

[0065] Fig.17A A schematic side view of a frame and skirt of a cardiac implant device in a compressed state is depicted.

[0066] Fig. 17BDepicts the expansion Fig.17A A side view schematic diagram of the frame and skirt of a cardiac implant device.

[0067] Fig.18A A schematic side view of a frame and skirt of a cardiac implant device in a compressed state is depicted.

[0068] Fig.18B Depicts the expansion Fig.18A A side view schematic diagram of the frame and skirt of a cardiac implant device.

[0069] Fig.19A A schematic side view of a cardiac implant device and skirt is depicted in a compressed state.

[0070] Fig.19B Depicts the expansion Fig.19A Schematic side view of a cardiac implant device and skirt.

[0071] Fig. 20A Depicted is a schematic side view of an inflow segment of a cardiac implant device in a fully deployed state.

[0072] Fig. 20B Depicts an expanded state (eg, partially deployed state) Fig. 20A Schematic side view of the inflow section of a cardiac implant device.

[0073] Fig. 20C Depicts an expanded state (eg, fully deployed state) Fig. 20A Schematic side view of the inflow section of a cardiac implant device.

[0074] Fig.20D Depicts relative to Fig. 20A A schematic diagram of the stretchable sutures woven axially cross-braided at the frame nodes of the frame of the cardiac implant device is shown.

[0075] Fig.21A Depicted is a side view of a cardiac implant device in a compressed state.

[0076] Fig.21B Depicts the expanding Fig.21A Side view of the inflow section of a cardiac implant device.

[0077] Fig. 21C Depicted is a side view of an inflow segment of a cardiac implant device in an expanded state.

[0078] Fig.22A Depicted is a side view of a cardiac implant device in a compressed state.

[0079] Fig. 22BDepicts the expansion Fig.22A Side view of the inflow section of a cardiac implant device.

[0080] Fig.23A A side view of a cardiac implant device compressed within a capsule is depicted.

[0081] Fig. 23B Depicts the expanding Fig.23A Side view of the inflow section of a cardiac implant device.

[0082] Fig.23C Depicted is a side view of a cardiac implant device in an expanded state wherein the balloon has been released from the cardiac implant device. DETAILED DESCRIPTION

[0083] Embodiments of the present disclosure are described herein. However, it should be understood that the disclosed embodiments are merely examples, and other embodiments may take various forms and alternative forms. The drawings are not necessarily to scale; some features may be exaggerated or minimized to show the details of a particular component. Therefore, the specific structural details and functional details disclosed herein should not be interpreted as being restrictive, but only as a representative basis for teaching those skilled in the art to adopt the embodiments in various ways. It will be understood by those skilled in the art that the various features shown and described with reference to any one of the figures in the accompanying drawings may be combined with the features shown in one or more other figures to produce embodiments that are not explicitly shown or described. The combination of the features shown provides representative embodiments for typical applications. However, for specific applications or embodiments, various combinations and modifications of features consistent with the teachings of the present disclosure may be desired.

[0084] Directional terms used herein are given with reference to the views and orientations shown in the exemplary drawings. A central axis is shown in the drawings and described below. Terms such as "outer" and "inner" are relative to the central axis. For example, "outer" surfaces refer to those surfaces facing away from the central axis, or on the outside of another "inner" surface. Terms such as "radial", "diameter", "circumference" are also relative to the central axis. The terms "front", "rear", "upper" and "lower" represent directions in the drawings to which reference is made.

[0085] Unless otherwise indicated, for the delivery system, in the following description, the terms "distal" and "proximal" are used relative to the position or direction of the treating clinician. "Distal" and "distalwardly" are positions away from the clinician or in a direction away from the clinician, and "proximal" and "proximalwardly" are positions close to the clinician or in a direction toward the clinician. For stent-graft prostheses, "proximal" is the portion closer to the heart in the blood flow path, while "distal" is the portion of the stent-graft that is farther from the heart in the blood flow path.

[0086] Figure 1 is a perspective view of sealing stent-graft 100 in a delivery configuration according to one embodiment. Figure 2 is in an expanded configuration according to one embodiment Figure 1 A perspective view of a sealed stent graft 100 is shown.

[0087] Now let’s refer to Figure 1 and Figure 2 , the sealed stent graft 100 includes a proximal stent 102, a distal stent 104, a graft material 106, and a collapse suture 108. Illustratively, the stents 102, 104 (sometimes referred to as annular stent rings 102, 104) are self-expanding stents, such as nickel titanium alloy (NiTi), sometimes referred to as Nitinol. In another embodiment, the stents 102, 104 are balloon expandable. In various embodiments, one or more additional stents are included between the stents 102, 104, or only the proximal stent 102 is provided, such as a suprarenal stent.

[0088] exist Figure 1 In the embodiment, the sealing stent graft 100 is in a delivery configuration (eg, in a collapsed or constrained configuration) when the sealing stent graft 100 is loaded into a delivery system for delivery to a target location, such as to a vessel. Figure 2 In the embodiment, the sealed stent graft 100 is in a deployed configuration (e.g., in an expanded configuration) in which the sealed stent graft 100 is deployed at a target location. The expansion of the stents 102, 104 (e.g., by self-expansion or balloon expansion) causes the sealed stent graft 100 to expand from Figure 1 The delivery configuration changes to Figure 2 The expanded configuration.

[0089] According to various embodiments, the graft material 106 is a fabric or a biological tube. Synthetic materials suitable for use as the graft material 106 include DACRON polyester, PTFE, other cloth materials, nylon blends, and polymer materials. Natural tissues for the graft material 106 can be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue (e.g., pericardial patches), bypass grafts, blood vessels, intestinal submucosal tissue, umbilical cord tissue, etc. from humans or animals.

[0090] According to this embodiment, graft material 106 includes a proximal opening 110 at a proximal end 112 of graft material 106 and a distal opening 114 at a distal end 116 of graft material 106. Further, sealing stent-graft 100 includes a longitudinal axis L. An inner lumen 118 is defined by graft material 106, and generally by sealing stent-graft 100. Lumen 118 extends generally parallel to longitudinal axis L between proximal opening 110 and distal opening 114 of sealing stent-graft 100.

[0091] As used herein, the proximal end of a prosthesis, such as sealing stent graft 100, is the end closest to the heart in the blood flow path during deployment, while the distal end is the end farthest from the heart. In contrast and of note, the distal end of a catheter is typically identified as the end farthest from the operator (handle), while the proximal end of the catheter is the end closest to the operator (handle).

[0092] For clarity of discussion, as used herein, the distal end of the catheter is the end farthest from the operator (the end farthest from the handle), and the distal end of the prosthesis is the end closest to the operator (the end closest to the handle), i.e., the distal end of the catheter and the proximal end of the stent graft are the ends farthest from the handle, while the proximal end of the catheter and the distal end of the stent graft are the ends closest to the handle. However, those skilled in the art will appreciate that the description of the stent graft and delivery system may be consistent or opposite in actual use, depending on the entry location.

[0093] Figure 3 According to an embodiment Figure 1 FIG. 1 is an enlarged plan view of region III of the sealed stent graft 100. Referring now to FIG. Figure 1 and Figure 3, the proximal stent 102 is located on the inner surface 302 of the graft material 106, and the collapse suture 108 is located on the outer surface 304 of the graft material 106. The proximal stent 102 includes a proximal crown 306, a distal crown 308, and struts 310 extending in an alternating repeating arrangement of sinusoidal loops between the crowns 306, 308. The proximal crown 306 and the distal crown 308 are sometimes referred to as the first crown 306 and the second crown 308.

[0094] The proximal stent 102 protrudes proximally beyond the proximal edge 112 of the graft material 106. In one or more embodiments, the proximal crown 306 is proximal to the proximal edge 112 and the distal crown 308 is distal to the proximal edge 112, such that the proximal stent 102 extends proximally from the distal crown 308 beyond the proximal edge 112 of the graft material 106 to the proximal crown 306. Accordingly, the proximal edge 112 of the graft material 106 overlaps the struts 310. In another embodiment, the proximal edge 112 of the graft material 106 extends proximally beyond the entire proximal stent 102. For example, in the delivery configuration, the graft material 106 can cover at least 25%, 33%, 50%, 67%, or 75%, typically 20% to 150%, of the height of the proximal stent 102 (e.g., from the distal crown 308 to the proximal crown 306).

[0095] The distal crown 308 is attached to the graft material 106 at anchor points 314, for example, by sutures 312. In other words, at each specific location where the distal crown 308 is sutured to the graft material 106 by sutures 312, an anchor point 314 is defined. Accordingly, the anchor points 314 are circumferentially positioned around the entire circumference of the graft material 106 at a specific longitudinal distance from the proximal edge 112 of the graft material 106. An anchor trace 316 is defined as a circle extending through and connecting the anchor points 314.

[0096] The graft material 106 is divided into a sealing skirt 318 and a stand-off section 320 by the anchor trace 316. More specifically, the sealing skirt 318 is defined as the section of the graft material 106 proximal to the anchor trace 316, and the stand-off section 320 is defined as the section of the graft material 106 distal to the anchor trace 316. The sealing skirt 318 and the stand-off section 320 meet at the anchor trace 316. The sealing skirt 318 is the excess or loose graft material 106 extending between the anchor trace 316 and the proximal edge 112.

[0097] The collapse suture 108 (e.g., suture) is attached to the graft material 106 at proximal suture points 322 and distal suture points 324 (sometimes referred to as first periodic points 322 and second periodic points 324, respectively) in an alternating repeating pattern. For example, at each suture point 322, 324, the collapse suture 108 passes from the outer surface 304 through the graft material 106 to the inner surface 302, and then from the inner surface 302 back to the outer surface 304. Although referred to herein as a suture, the collapse suture 108 can be any filamentary or thread-like material, such as a polymer, metal, or natural material, and is not limited to a surgical suture.

[0098] The proximal suture points 322 are located on the sealing skirt 318, on or near the proximal end 112 of the graft material 106. The proximal suture points 322 are circumferentially positioned around the entire circumference of the graft material 106. A first or proximal suture trace 326 is defined as a circle extending through and connecting the proximal suture points 322. In this embodiment, the proximal suture points 322 overlap the proximal stent 102.

[0099] In this embodiment where the proximal suture point 322 is located on the proximal end 112 of the graft material 106, the proximal suture trace 326 is located on the proximal end 112. However, in another embodiment, the proximal suture point 322 is proximal to the proximal end 112, but not exactly on the proximal end, so there is a small longitudinal space between the proximal suture trace 326 and the proximal end 112.

[0100] The distal suture points 324 are located on the graft material 106, on or near the anchoring trace 316. The distal suture points 324 are circumferentially positioned around the entire circumference of the graft material 106. A second or distal suture trace 328 is defined as a circle extending through and connecting the distal suture points 324.

[0101] In the present embodiment, the distal suture trace 328 is located on the isolation section 320, adjacent to and distal to the anchoring trace 316. However, in other embodiments, the distal suture point 324 and therefore the distal suture trace 328 are placed directly on the anchoring trace 316 or adjacent to and proximal to the anchoring trace.

[0102] There is a circumferential distance D1 between each adjacent proximal suture point 322 or adjacent distal suture point 324. The circumferential distance D1 is the distance along the circumference of the graft material 106. Further, there is a longitudinal distance L1 between the proximal suture point 322 and the distal suture point 324. The longitudinal distance L1 is the distance in the longitudinal direction, that is, the distance in the direction parallel to the longitudinal axis L of the graft material 106. The distance D1, L1, and the number of suture points 322, 324 define a fixed length of the collapsed suture 108, which in this embodiment is a long suture loop.

[0103] Further, in order to selectively control the amount of collapse of the sealing skirt 318, the number of suture points 322, 324 and the positioning of the suture points 322, 324 can be customized. Figure 3 and Figure 4 A one-to-one relationship between the number of distal suture points 324 and the number of anchor points 314 is shown, i.e., there is one distal suture point 324 for each anchor point 314. However, in other embodiments, more or less than a one-to-one relationship between the number of distal suture points 324 and the number of anchor points 314 is used, for example, to produce more / less collapse of the sealing skirt 318. For example, the ratio of distal suture points 324 to anchor points 314 can be 2:1 or 3:1, or vice versa.

[0104] Further, Figure 3 and Figure 4 The distal suture point 324 is shown aligned with the anchor point 314, i.e., directly below the anchor point 314 and having the same clockwise or radial orientation. However, in other embodiments, the distal suture point 324 has other radial orientations relative to the anchor point 314, such as being located between the anchor points 314. In yet another embodiment, the distal suture point 324 has no particular radial orientation relative to the anchor point 314.

[0105] The sealing skirt 318 is the excess or loose graft material 106 extending proximally of the anchoring trace 316. Figure 1 and Figure 3 As shown, in the delivery configuration, the sealing skirt 318 is placed flat on the proximal stent 102 as a cylinder (i.e., tube) in the same or identical state as the state of the barrier section 320. Therefore, when the proximal stent 102 is collapsed or compressed, the sealing skirt 316 does not affect the packing density of the sealing stent graft 100, thereby maximizing the range of anatomical applications and reducing the complexity of the procedure. The addition of the collapse suture 108 negligibly or at most slightly increases the packing density.

[0106] Figure 4 According to one embodiment, Figure 2 100 is an enlarged plan view of region IV of the sealed stent graft 100 in the deployed configuration. During deployment, the expansion of the proximal stent 102 causes the sealed stent graft 100 to expand from Figure 1 , 3 The delivery configuration changes to Figure 2 , 4More specifically, the expansion of the proximal stent 102 causes the collapse suture 108 to pull the sealing skirt 318 downward toward the distal crown 308, thereby causing the sealing skirt 318 to bulge outward, thereby increasing the diameter of the sealing skirt 318 relative to the isolation section 320.

[0107] In more detail, when the proximal stent 102 expands and the circumference of the graft material 106 increases, the circumferential distance D1 between the adjacent proximal suture points 322 and the adjacent distal suture points 324 increases to a larger circumferential distance D2. Since the collapsed suture line 108 has a fixed length, the increase in the circumferential distance D1 to the circumferential distance D2 causes the longitudinal distance L1 between the proximal suture point 322 and the distal suture point 324 to be relatively reduced to the longitudinal distance L2, which is less than the longitudinal distance L1. Generally, the expansion of the proximal stent 102 causes the longitudinal distance L1 between the proximal suture trace 326 and the distal suture trace 328 to be reduced to the longitudinal distance L2.

[0108] The distal suture point 324 is fixed in position on the graft material 106 due to its proximity to the anchor point 314. More specifically, the graft material 106 is attached to the distal crown 308 at the anchor point 314 and, therefore, cannot move along the anchor trace 316 relative to the proximal stent 102. When the distal suture point 324 is on or near the anchor trace 316, the distal suture point 324 also cannot move relative to the proximal stent 102.

[0109] In contrast, the proximal suture point 322, together with the attached sealing skirt 318, is free to move distally relative to the proximal stent 102 and the anchoring trace 316. Thus, when the longitudinal distance between the proximal suture point 322 and the distal suture point 324 is increased from the longitudinal distance L1 ( Figure 3 ) is reduced to the longitudinal distance L2( Figure 4 ), the proximal suture point 322 and the attached sealing skirt 318 move distally. This collapses and compresses the sealing skirt 318 on the proximal stent 102 longitudinally between the proximal suture point 322 and the anchoring trace 316. For example, when longitudinally collapsed and compressed, the length of the sealing skirt 318 can be reduced by 10% to 90%, and the sealing skirt can overlap 5% to 90% of the height of the proximal stent 102 (e.g., from the distal crown 308 to the proximal crown 306).

[0110] The collapse of the sealing skirt 318 causes the sealing skirt 318 to become wrinkled / folded / pleated and protrude radially outward. For example, the sealing skirt 318 has longitudinal corrugations, such as a series of peaks and valleys, protruding outward from the proximal stent 102. This thickening of the sealing skirt 318 improves the sealing of the sealing skirt 318 (and more generally, the sealing stent graft 100) with the vascular or other prosthesis in which the sealing stent graft 100 is deployed. For example, the excess fabric of the sealing skirt 318 can help achieve a short sealing length and a seal at a non-circular aortic tube (e.g., reducing type 1a internal leakage). This enhanced sealing is achieved without the need for new materials, new stent designs, new manufacturing processes, or different catheter systems.

[0111] As described above, the collapse suture 108, graft material 106, and proximal stent 102 are used to provide a passive mechanism that maintains a low profile transcatheter system for delivery and improves the sealing features on the stent graft 100 (sometimes referred to as an implant) during deployment. This reduces surgical complexity and improves in vivo performance. The sealing skirt 318 improves sealing performance in normal anatomical structures and complex anatomical structures (such as non-circular, calcified, and short landing zone anatomical structures).

[0112] Figure 5 is a cross-sectional view of a vascular assembly 500 according to one embodiment, the vascular assembly including a delivery system 502, the delivery system including a Figure 1 and Figure 3 The sealed stent graft 100 is in a delivery configuration. Figure 6 According to an embodiment Figure 5 A cross-sectional view of a vascular assembly 500 comprising a Figure 2 and Figure 4 Sealing stent graft 100 is positioned within vessel 504 using delivery system 502 ( Figure 5 ) and deployed into vessel 504 to isolate aneurysm 506 using any of a variety of techniques known to those skilled in the art ( Figure 6 ).

[0113] More specifically, vessel 504 (e.g., the aorta) includes an aneurysm 506. Branching from vessel 504 are first branch vessels 508 and second branch vessels 510, sometimes referred to as visceral branches of the abdominal aorta. The locations of branch vessels 508, 510 vary from patient to patient. Examples of branch vessels include the renal artery (RA) and the superior mesenteric artery (SMA).

[0114] Sealed stent graft 100 Figure 1 and Figure 3The delivery configuration is delivered within the delivery system 502 to a deployment location in the vessel 504, such as Figure 5 The sealed stent graft 100 is deployed from the delivery system 502 just distal to the branch vessels 508, 510, and the delivery system 502 is removed, as shown. Figure 6 shown.

[0115] The sealing skirt 318 is deployed in the landing zone 512 between the branch vessels 508, 510 and the aneurysm 506. In one embodiment, the landing zone 512 is short, thus providing a minimal area for sealing. However, due to the outward bulge and folds of the sealing skirt 318, the sealing skirt 318 forms a good seal with the short landing zone 512.

[0116] although Figure 5 and Figure 6 The sealing skirt 318 is shown as forming a seal with the vessel 504, but in another embodiment, the sealing skirt 318 is used to form an enhanced seal with other vessels or structures. Illustratively, the sealing stent graft 100 is used with a transcatheter cardiovascular therapy (e.g., endovascular repair, heart valve repair, etc.) that requires sealing. In another embodiment, the sealing stent graft 100 is used with another prosthesis (such as a stent graft) to form a modular assembly. Figure 7 Discuss such examples.

[0117] Figure 7 is a cross-sectional view of a modular assembly 700 according to one embodiment, the modular assembly comprising Figure 2 and Figure 4 The sealed stent graft 100 in the expanded configuration. Figure 7 , modular assembly 700 includes a first component 702 and a sealing stent graft 100 deployed within first component 702. Illustratively, first component 702 (e.g., stent graft) is deployed first. Sealing stent graft 100 is then positioned within first component 702 and then deployed. Sealing skirt 318 bulges outwardly and extends into first component 702, thereby providing a secure seal between first component 702 and sealing stent graft 100.

[0118] Although the sealing stent-graft 100 is discussed and illustrated as having the sealing skirt 318 at the proximal end of the sealing stent-graft 100, in another embodiment, the sealing skirt 318 is disposed at the distal end of the sealing stent-graft 100. According to this embodiment, the terms "proximal" and "distal" used above to describe the sealing stent-graft 100 are replaced with "distal" and "proximal," respectively. In this embodiment, the distal end of the stent-graft is pulled proximally by collapsing the sutures to form the sealing skirt 318. Forming the distal sealing skirt may improve the seal with the vessel wall at the distal end of the stent-graft (e.g., reducing type 1b endoleak), or it may improve the seal with the proximal end of another stent-graft component (similar to Figure 7 , but wherein the sealing stent-graft 100 is proximal to the first component 702). In another embodiment, the sealing stent-graft 100 may have a sealing skirt 318 at both the proximal end and the distal end.

[0119] Further, although in the above-described embodiment the sealing skirt 318 bulges outwardly when collapsed, in another embodiment the sealing skirt 318 bulges inwardly when collapsed. Figure 8 and Fig. 9 Such an example is described in .

[0120] Figure 8 is a cross-sectional view of a sealing stent-graft 800 in a delivery configuration according to one embodiment. Fig. 9 is in an expanded configuration according to one embodiment Figure 8 A cross-sectional view of a sealed stent graft 800 is provided. Figure 8 and Fig. 9 In the view of FIG. 8 , stent graft 800 has been cut in half longitudinally to allow visualization of collapsed sutures 108 located on inner surface 302 of graft material 106 . Figure 8 and Fig. 9 The stent graft 800 is similar to Figures 1 to 4 The present invention relates to a stent graft 100 of the present invention, and only the significant differences are discussed below.

[0121] According to this embodiment, the proximal stent 102 is located on the outer surface 304 of the graft material 106, while the collapse suture 108 is located on the inner surface 302 of the graft material 106. Therefore, during deployment, the sealing skirt 318 is pulled downward by the collapse suture 108 on the inner side of the proximal stent 102 and thus bulges inwardly, as shown in FIG. Fig. 9 shown.

[0122] Inwardly protruding sealing skirt 318 provides an enhanced seal with structures located within sealing stent-graft 800. In one embodiment, modular assembly includes first component 902, shown in phantom, coupled within sealing stent-graft 800. For example, sealing stent-graft 800 is initially deployed such that sealing skirt 318 is protruding inwardly. First component 902 is then positioned within sealing stent-graft 800, protrudes proximally from sealing stent-graft 800, and then deployed. Sealing skirt 318 protrudes inwardly and enters first component 902, thereby providing a secure seal between sealing stent-graft 800 and first component 902. Similar to outwardly protruding sealing skirt 318, the inwardly protruding sealing skirt may be positioned at the proximal end and / or distal end of sealing stent-graft 800.

[0123] Although the embodiments of the present invention have been described with respect to stent grafts such as for treating aortic aneurysms, the passive sealing skirt can be applied to any device based on an expansion catheter, such as a transcatheter heart valve replacement or repair device. For example, the sealing skirt can be used with a transcatheter aortic valve replacement (TAVR) device (such as a self-expanding TAVR device). Such devices generally include a frame (e.g., a stent frame) and an artificial valve, and can optionally include a skirt material to reduce paravalvular leakage (PVL). These skirts are typically sutured to the frame in a static manner, however, the passive sealing skirt disclosed herein can be incorporated into such a device. The passive sealing skirt can provide the same advantages described herein to the TAVR device or other heart valve devices, such as improved sealing and reduced profile in the delivery configuration. For a TAVR device, the skirt can be positioned at the inflow end or proximal end of the device. As used herein, the term graft material can also be applied to a sealing skirt material for a heart valve replacement or repair device. The passive sealing skirt can replace an existing skirt on a transcatheter heart valve replacement or repair device, or can be added thereto to improve sealing.

[0124] Fig. 10A A schematic side view of a transcatheter aortic valve replacement (TAVR) device 1000 is depicted. Fig. 10B A schematic perspective view of a TAVR device 1000 is depicted. Fig. 10A and Fig. 10BAs shown, the TAVR device 1000 includes an expandable frame 1002 and a valve body 1004. The valve body 1004 can be fastened to the inner surface of the expandable frame 1002 via sutures 1006 or other types of fasteners. The valve body 1004 can be formed from natural or synthetic materials. Non-limiting examples of such materials include mammalian tissue (e.g., porcine, equine, or bovine pericardium), synthetic materials, or polymer materials. The expandable frame 1002 can be a self-expanding structure formed by laser cutting or etching a tube formed from a metal alloy (e.g., a stainless steel alloy, a nickel-titanium alloy, nitinol, or other shape memory material). Alternatively, the expandable frame 1002 can be a balloon-expandable frame. As Fig. 10A and Fig. 10B As shown, TAVR device 1000 is in an expanded deployed state (eg, when TAVR device 1000 is deployed at a target location).

[0125] The expandable frame 1002 can include an outflow segment 1008, an inflow segment 1010, and a contraction region 1012 extending between the outflow segment 1008 and the inflow segment 1010. The expandable frame 1002 can include cells whose size can vary along the length of the prosthesis. When the TAVR device 1000 is deployed within the patient's vasculature, the inflow segment 1010 can extend into and anchor within the aortic annulus of the patient's left ventricle, and the outflow segment 1008 can be positioned in the patient's ascending aorta. The expandable frame 1002 can also include a paddle or eyelet 1014, which is configured to load the TAVR device 1000 into a delivery system as described herein.

[0126] The valve body 1004 may include a skirt 1016. Fig. 10A and Fig. 10BAs shown, the skirt 1016 is sutured to the expandable frame 1002 in a static manner. The valve body 1004 can further include a first leaflet 1018, a second leaflet 1020, and a third leaflet 1022, which can be attached to the skirt 1016 along their bases with fasteners (e.g., sutures or biocompatible adhesives). The first leaflet 1018, the second leaflet 1020, and the third leaflet 1022 form three pairs of adjacent leaflets (i.e., the first leaflet 1018 and the second leaflet 1020; the second leaflet 1020 and the third leaflet 1022; and the third leaflet 1022 and the first leaflet 1018). Each pair of adjacent leaflets can be attached to each other at their side ends to form a first commissure 1024, a second commissure 1026, and a third commissure 1028, respectively. A first free edge 1030 between the first leaflet 1018 and the second leaflet 1020 , a second free edge 1032 between the second leaflet 1020 and the third leaflet 1022 , and a third free edge 1034 between the third leaflet 1022 and the first leaflet 1018 form coapted edges that meet in a coaptation region 1036 .

[0127] Fig. 10C Depicted are a cross-sectional view of a patient's anatomy 1050 and a schematic side view of a delivery system 1052 and TAVR device 1000 in a partially deployed position. Fig. 10D Depicted are a cross-sectional view of a patient's anatomy 1050 and a schematic side view of a delivery system 1052 and TAVR device 1000 in a fully deployed position. Delivery system 1052 includes a delivery sheath assembly 1054, a balloon 1056, an inner shaft assembly 1058, a retention hub 1060, and a tip 1062.

[0128] The delivery system 1052 is configured to hold the TAVR device 1000 in a delivery state in which the TAVR device 1000 is loaded in a constrained position within the delivery system 1052. In the delivery state, the TAVR device 1000 is coupled to the inner shaft assembly 1058 via the retainer 1060 (e.g., the eyelet 1014 of the TAVR device 1000 is captured by the retainer 1060) and is compressively retained within the capsule 1056 of the delivery sheath assembly 1054. The loaded delivery system 1052 can be configured to deliver the TAVR device 1000 percutaneously to an implantation site (e.g., a defective heart valve). Fig. 10C and Fig. 10DAs shown, the loaded delivery system 1052 can be advanced in a retrograde manner toward the implantation site 1064, through the patient's femoral artery into the descending aorta 1066, across the aortic arch 1068, through the ascending aorta 1070, and across the defective heart valve at the implantation site 1064 (e.g., approximately midway along the defective heart valve).

[0129] For self-expanding embodiments, delivery sheath assembly 1054 is configured to withdraw balloon 1056 proximally from TAVR device 1000 via manipulation of a handle (not shown) on delivery system 1052, thereby allowing TAVR device 1000 to expand from a restricted position to a Fig. 10C Partially expanded position shown and Fig. 10D 1056 and implanted in the native valve. The release sheath assembly of the delivery system 1052 can be configured to fully release the TAVR device 1000 from the balloon 1056. The handle can be configured to manipulate the balloon 1056 to a position that is substantially as close to the TAVR device 1000 as possible. Fig. 10C The partially deployed position is shown in which the distal region of the TAVR device 1000 is permitted to self-expand at the distal end 1057 of the retainer 1056 while the proximal region of the TAVR device 1000 remains coupled to the retainer 1056 .

[0130] Fig.11A Depicted is a cross-sectional view of a portion of a cardiac implant device 1100 (eg, a TAVR device) in a compressed state (eg, a delivery state). Fig. 11B A side view of a cardiac implant device 1100 in a compressed state (e.g., a delivery state) is depicted. The cardiac implant device 1100 includes a frame 1102 (e.g., an expandable frame of a TAVR device), a skirt 1104 anchored to the frame 1102, and a collapse suture 1106 anchored to the frame 1102 and the skirt 1104. The skirt 1104 may replace Fig. 10A The skirt 1016 shown in FIG. 10A , or may be an additional skirt on top of the skirt 1016 (eg, outward).

[0131] The frame 1102 includes an outflow end 1110, an inflow end 1112, and a frame body 1114 extending therebetween. The skirt 1104 includes a first end 1116, a second end 1118, and a skirt body 1122 extending therebetween. The skirt body 1122 can be formed by a cylindrical body (e.g., a tube). The collapse suture 1106 can be formed by any filamentous or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures.

[0132] The inflow end 1112 of the frame 1102 is fastened to the first end 1116 of the skirt 1104 via the anchor points 1120 to form a seam 1121 circumferentially around the circumference (e.g., the entire circumference) of the cardiac implant device 1100. The anchor points 1120 may include sutures that fasten the frame 1102 and the skirt 1104 together. The seam 1121 may form a circle extending through the anchor points 1120. The anchor points 1120 may be evenly spaced from each other around the circumference (e.g., the entire circumference) of the frame 1102 to strengthen the connection between the frame 1102 and the skirt 1104. Fig.11A and Fig. 11B As shown, the skirt body 1122 extends away from the inflow end 1112 and is aligned with the inflow section 1115 of the frame body 1114 so that the skirt 1104 does not affect the packing density of the cardiac implant device 1100 in the compressed state, wherein the collapse suture line 1106 can negligibly or at most slightly increase the packing density.

[0133] The collapse suture 1106 is fastened to the frame body 1114 at the anchor point 1124 and is fastened to the second end 1118 of the skirt 1104 at the anchor point 1126 in a periodic alternating repeating pattern. In one or more embodiments, the anchor points 1124 and the anchor points 1126 fasten the collapse suture 1106 to the outer surfaces of the frame body 1114 and the skirt 1104, respectively, so that the collapse suture 1106 is located outside these outer surfaces. The anchor points 1124 can be circumferentially positioned around the circumference (e.g., the entire circumference) of the frame body 1114 to form a circle 1125 including the anchor points 1124. The circle 1125 is spaced apart from the inflow end 1112 of the frame 1102 toward the outflow end 1110 of the frame 1102, and the distance of the spacing can be greater than the length of the skirt 1104. The anchor points 1126 may be positioned circumferentially around a circumference (eg, an entire circumference) of the second end 1118 of the skirt 1104 to form a second circle 1127 that includes the anchor points 1126 .

[0134] like Fig. 11B As shown, in the delivery state, the collapsed suture 1106 forms a sinusoidal loop having a delivery amplitude and a delivery period. In other embodiments, the collapsed suture 1106 may have a sawtooth shape with alternating peaks and valleys, with legs between them. The delivery amplitude may refer to the distance between the seam 1121 and the peak at the anchor point 1124 of the collapsed suture 1106 or the valley at the anchor point 1126. The delivery period may refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 1124) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 1126) of the collapsed suture 1106. In the delivery state, the cardiac implant device 1100 has a compressed nominal diameter and a compressed length.

[0135] Fig. 11C A cross-sectional view of a portion of a cardiac implant device 1100 is depicted in an expanded state (eg, a partially deployed state). Fig.11D A side view of a cardiac implant device 1100 is depicted in an expanded state. Fig.11D As shown, the frame 1102 has been partially expanded from a delivery state to a partially expanded nominal diameter and a partially expanded length. The partially expanded nominal diameter is greater than the compressed nominal diameter. The partially expanded length is less than the compressed length (e.g., due to shortening caused by radial expansion). The increased nominal diameter and decreased length of the frame 1102 between the compressed state and the partially expanded state reduces the amplitude of the sinusoidal loops of the collapsed suture 1106 to the partially expanded amplitude, and increases the period of the sinusoidal loops of the collapsed suture 1106 to the partially expanded period. These changes in the amplitude and period of the sinusoidal loops of the collapsed suture 1106 cause the collapsed suture 1106 to bulge outward because the collapsed suture 1106 is connected at its ends to anchor points 1124 and 1126. This outward bulging movement causes the skirt 1104 to rotate at the hinge trace 1128. As shown Fig. 11C As shown, articulation trace 1128 is spaced apart from seam 1121 because anchor point 1120 reinforces seam 1121 such that articulation trace articulates at a point spaced apart from seam 1121. In other embodiments, articulation trace 1128 may coincide with anchor point 1120, or articulation trace 1128 may be further spaced apart from seam 1121.

[0136] The articulation trace 1128 divides the skirt 1104 into a first section 1130 extending between the seam 1121 and the articulation trace 1128 and a second section 1132 extending between the articulation trace 1128 and the second end 1118 of the skirt 1104. In this partially deployed state, the first section 1130 is aligned with the inflow section 1115 of the frame body 1114, and the second section 1132 causes the first section 1130 and the frame body 1114 to bulge or rotate outwardly about the articulation trace 1128.

[0137] Fig.11E A cross-sectional view of a portion of a cardiac implant device 1100 is depicted in an expanded state (eg, a fully deployed state). Fig.11F A side view of a cardiac implant device 1100 is depicted in an expanded state. Fig.11FAs shown, the frame 1102 has been fully expanded from the partially expanded state to a fully expanded nominal diameter and a fully expanded length. The fully expanded nominal diameter is larger than the other nominal diameters. The fully expanded length is smaller than the other lengths. The increase in the nominal diameter and the decrease in the length of the frame 1102 further reduce the amplitude of the sine loop and increase the period of the sine loop. These changes in the amplitude and period of the sine loop of the collapse suture 1106 cause the collapse suture 1106 to be pulled inward from its position in the partially expanded state, thereby causing the skirt 1104 to further rotate at the hinge trace 1128, so that the surface of the second section 1132 contacts the outer surface of the frame 1102. In the fully expanded state, the second section 1132 and a portion of the frame 1102 overlap to form an area of ​​increased radial thickness, which is configured to enhance the sealing of the cardiac implant device 1100 and / or reduce paravalvular leakage (PVL). There may also be an area where the second section 1132 and the first section 1130 of the skirt contact each other to form a doubled section of the skirt having an increased (eg, 2X) thickness.

[0138] Fig. 12A A side view of a cardiac implant device 1200 is depicted in a compressed state (eg, a delivery state). Fig. 12A As shown, cardiac implant device 1200 is compressed within capsule 1202. Cardiac implant device 1200 includes frame 1204 (e.g., an expandable frame of a TAVR device), skirt 1206 anchored to frame 1204, and collapse suture 1208 anchored to frame 1204 and skirt 1206. Skirt 1204 may replace Fig. 10A The skirt 1016 shown in FIG. 10A , or may be an additional skirt on top of the skirt 1016 (eg, outward).

[0139] The frame 1204 includes an outflow end 1210, an inflow end 1212, and a frame body 1214 extending therebetween. The skirt 1206 includes a first end 1216, a second end 1218, and a skirt body 1220 extending therebetween. The skirt body 1220 can be formed by a cylindrical body (e.g., a tube). The collapse suture 1208 can be formed by any filamentous or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures.

[0140] The first end 1216 of the skirt 1206 is secured to the frame body 1214 of the frame 1204 via anchor points 1222 in a repeating pattern. The anchor points 1222 may include sutures that secure the skirt 1206 and the frame 1204 together. The anchor points 1222 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the frame body 1214 to form a circle 1223 including the anchor points 1222 at the first end 1216 of the skirt 1206. The anchor points 1222 may be evenly spaced from one another around the circumference (e.g., the entire circumference) of the frame body 1214 to strengthen the connection between the frame 1204 and the skirt 1206. Fig. 12A As shown, the skirt body 1220 extends away from the first circle 1223 toward the contraction portion 1225 of the frame 1204, thereby occupying the portion of the frame body 1214 with reduced diameter, so that the skirt 1206 has no effect or only a negligible effect on the packing density of the cardiac implant device 1200 in a compressed state within the capsule 1202.

[0141] The collapse sutures 1208 are secured to the inflow end 1212 of the frame 1204 at anchor points 1224 and to the second end 1218 of the skirt 1206 at anchor points 1226 in a periodic, alternating, repeating pattern. Fig. 12A As shown, anchor points 1224 and 1226 respectively fasten the collapse suture 1208 to the outer surface of the frame 1204 and the outer surface of the skirt 1206, so that the collapse suture 1206 is located outside the skirt 1206. In another embodiment, anchor points 1224 and 1226 respectively fasten the collapse suture 1208 to the outer surface of the frame 1204 and the inner surface of the skirt 1206, so that the collapse suture 1206 is located between the frame 1204 and the skirt 1206.

[0142] The anchor points 1224 can be positioned circumferentially around the circumference (e.g., the entire circumference) of the inflow end 1212 of the frame 1204 to form a circle 1227 that includes the anchor points 1224. The anchor points 1226 can be positioned circumferentially around the circumference (e.g., the entire circumference) of the second end 1218 of the skirt 1206 to form a circle 1229 that includes the anchor points 1226.

[0143] In one or more embodiments, the collapsing suture includes a first suture having a repeating shape and a second suture having a repeating shape. Fig. 12AThe collapse suture 1208 is schematically illustrated having a first sinusoidal suture 1209 and a second sinusoidal suture 1211 (although in other embodiments, the first and second sutures may be zigzag loops forming an annular scissor arm). The alternating peaks and valleys of the first sinusoidal suture 1209 are secured via alternating anchor points 1224 and 1226, and the alternating peaks and valleys of the second sinusoidal suture 1211 are secured via alternating anchor points 1226 and 1224, such that the first and second sinusoidal sutures 1209 and 1211 are out of phase with each other (e.g., the peaks of one sinusoidal suture are aligned with the valleys of the other). Although Fig. 12A The first sinusoidal suture 1209 and the second sinusoidal suture 1211 are shown to be 180 degrees out of phase, but the two or more sutures may be out of phase by a different number of degrees, such as 60 degrees or 120 degrees.

[0144] The use of two or more sutures provides a longer axial stroke than a single suture with the same number of total anchoring points, thereby allowing a greater distance from the inflow end 1212 to the attachment portion of the second end 1218 of the skirt 1206 during loading (e.g., delivery state). The use of two or more sutures can also increase strength when the skirt 1206 is pulled toward the inflow end 1212.

[0145] The first sinusoidal suture 1209 and the second sinusoidal suture 1211 can have a delivery amplitude and a delivery period in the delivery state (in other embodiments, the first sinusoidal suture 1209 and the second sinusoidal suture 1211 can have different amplitudes and periods). The delivery amplitude can refer to the distance between the inflow end 1212 of the frame 1204 at the first anchor point 1224 and the second end 1218 of the skirt 1206 at the second anchor point 1226. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 1224) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 1226) of the first sinusoidal suture 1209 or the second sinusoidal suture 1211 of the collapsed suture 1208.

[0146] Fig. 12B A side view of cardiac implant device 1200 is depicted in an expanded state (e.g., partially deployed state) wherein balloon 1202 is partially retracted as indicated by arrow 1228 to partially deploy cardiac implant device 1200. Fig. 12B, the inflow segment 1230 has been deployed from a delivery state to increase the nominal diameter of the inflow segment 1230 and reduce the length of the inflow segment 1230. The increased nominal diameter and reduced length of the inflow segment 1230 between the compressed state and the partially deployed state reduces the amplitude and increases the period of the first sinusoidal suture 1209 and the second sinusoidal suture 1211, thereby causing the collapsed suture 1208 to pull the skirt 1206 downward toward the inflow end 1212 and outward to cause the skirt 1206 to flip outward as depicted by arrow 1232 (e.g., around the anchor point 1222). The downward / outward pulling force can have a longitudinal direction component and a radial direction component. In one or more embodiments, although there is some shortening in the longitudinal direction, the greater effect on the suture is in the radial direction (e.g., diameter), which pulls the suture attachment points apart. The downward / outward pulling force can form wrinkles, folds, and / or pleats in the skirt 1206 (e.g., Fig. 12B ).

[0147] Fig. 12C A side view of a cardiac implant device 1200 is depicted in an expanded state (e.g., a fully deployed state) wherein the balloon 1202 has been released from the cardiac implant device 1200. Fig. 12C , the inflow segment 1230 has been fully deployed to further increase the nominal diameter of the inflow segment 1230 and reduce the length of the inflow segment 1230. The further increased nominal diameter and further reduced length of the inflow segment 1230 between the partially deployed state and the fully deployed state further reduce the amplitude of the first sinusoidal suture 1209 and the second sinusoidal suture 1211 and further increase their period, thereby causing the collapse suture 1208 to pull the skirt 1206 further downward toward the inflow end 1212 to increase the coverage of the inflow segment 1230 by the skirt 1206. In the fully deployed state, a portion of the inflow segment 1230 and the skirt 1206 overlap to form an area of ​​increased radial thickness, which is configured to enhance the seal of the cardiac implant device 1200 and / or reduce PVL.

[0148] Fig.13A A side view of a cardiac implant device 1300 is depicted in a compressed state (eg, a delivery state). Fig.13A As shown, cardiac implant device 1300 is compressed within capsule 1302. Cardiac implant device 1300 includes frame 1304 (e.g., an expandable frame of a TAVR device), skirt 1306 anchored to frame 1304, and collapse suture 1308 anchored to frame 1304 and skirt 1306. Skirt 1304 may replace Fig. 10A The skirt 1016 shown in FIG. 10A , or may be an additional skirt on top of the skirt 1016 (eg, outward).

[0149] The frame 1304 includes an outflow end 1310, an inflow end 1312, and a frame body 1314 extending therebetween. The skirt 1306 includes a first end 1316, a second end 1318, and a skirt body 1320 extending therebetween. The skirt body 1320 can be formed by a cylindrical body (e.g., a tube). The collapse suture 1308 can be any filamentous or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures.

[0150] The middle portion of the skirt 1306 is secured to the frame body 1314 via anchor points 1322. The anchor points 1322 may be circumferentially positioned around the circumference (e.g., the entire circumference) of the frame body 1314, thereby forming a circle 1315 that includes the anchor points 1322. The anchor points 1322 may be evenly spaced from one another around the circumference (e.g., the entire circumference) of the frame body 1314 to strengthen the connection between the frame 1304 and the skirt 1306.

[0151] The first end 1316 of the skirt 1306 is secured to the frame body 1314 via anchor points 1324. The anchor points 1324 can be circumferentially positioned around the circumference (e.g., the entire circumference) of the frame body 1314, thereby forming a circle 1317 that includes the anchor points 1324. The anchor points 1324 can be evenly spaced from one another around the circumference (e.g., the entire circumference) of the frame body 1314 to strengthen the connection between the frame 1304 and the skirt 1306. Although FIG. 13A to FIG. 13C Two sets of anchor points are depicted (ie, a top set of anchor points 1322 and a bottom set of anchor points 1324), but in other embodiments there may be three or more sets of anchor points, with additional sets of anchor points located between the top and bottom sets.

[0152] The skirt 1306 includes a first section 1326 and a second section 1328. The first section 1326 extends between the second end 1318 and the first circle 1315. The first section 1326 of the skirt 1306 has a free end at the second end 1318 relative to the frame 1304, thereby allowing the end to move toward the second section 1328. The second section 1328 extends between the circle 1317 at the first end 1316 and the first circle 1315 and is fixed at the circles 1315 and 1317, thereby forming a fixed portion of the skirt 1306. A portion of the skirt body 1320 occupies a portion of the reduced diameter of the frame body 1314 to reduce the packing density of the cardiac implant device 1300 in a compressed state.

[0153] The collapse sutures 1308 are secured to the inflow end 1312 of the frame 1304 at anchor points 1330 and to the second end 1318 of the skirt 1306 at anchor points 1332 in a periodic, alternating, repeating pattern. Fig.13AAs shown, anchor point 1330 and anchor point 1332 respectively secure the collapse suture 1308 to the outer surface of the frame 1304 and the outer surface of the skirt 1306, so that the collapse suture 1308 is located outside the skirt 1306.

[0154] The anchor points 1330 can be positioned circumferentially around the circumference (e.g., the entire circumference) of the inflow end 1312 of the frame 1304 to form a circle 1319 that includes the anchor points 1330. The anchor points 1332 can be positioned circumferentially around the circumference (e.g., the entire circumference) of the second end 1318 of the skirt 1306 to form a circle 1321 that includes the anchor points 1332.

[0155] In one or more embodiments, the collapsing suture includes a first suture having a repeating shape and a second suture having a repeating shape. Fig.13A The collapse suture 1308 is schematically illustrated having a first sinusoidal suture 1334 and a second sinusoidal suture 1336 (although in other embodiments, the first and second sutures may be zigzag loops forming an annular scissor arm). The alternating peaks and valleys of the first sinusoidal suture 1334 are secured via alternating anchor points 1330 and 1332, and the alternating peaks and valleys of the second sinusoidal suture 1336 are secured via alternating anchor points 1332 and 1330, such that the first sinusoidal suture 1334 and the second sinusoidal suture 1336 are out of phase with each other (e.g., the peaks of one sinusoidal suture are aligned with the valleys of the other). Although Fig.13A The first sinusoidal suture 1334 and the second sinusoidal suture 1336 are shown to be 180 degrees out of phase, but the two or more sutures may be out of phase by a different number of degrees, such as 60 degrees or 120 degrees.

[0156] The use of two or more sutures provides a longer axial stroke than a single suture with the same number of total anchoring points, thereby allowing a greater distance from the inflow end 1312 to the attachment portion of the skirt 1306 during loading (e.g., delivery state). The use of two or more sutures can also increase strength when the skirt 1306 is pulled toward the inflow end 1312.

[0157] The first sinusoidal suture 1334 and the second sinusoidal suture 1336 can have a delivery amplitude and a delivery period in the delivery state (in other embodiments, the first sinusoidal suture 1334 and the second sinusoidal suture 1336 can have different amplitudes and periods). The delivery amplitude can refer to the distance between the inflow end 1312 of the frame 1304 at the anchor point 1330 and the second end 1318 of the skirt 1306 at the second anchor point 1332. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 1330) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 1332) of the first sinusoidal suture 1334 or the second sinusoidal suture 1336 of the collapsed suture 1308.

[0158] Fig. 13B A side view of cardiac implant device 1300 is depicted in an expanded state (e.g., partially deployed state) wherein balloon 1302 is partially retracted as indicated by arrow 1338 to partially deploy cardiac implant device 1300. Fig. 12B , the inflow segment 1340 has been deployed from the delivery state to increase the nominal diameter of the inflow segment 1340 and reduce the length of the inflow segment 1340. The increased nominal diameter and reduced length of the inflow segment 1340 between the compressed state and the partially deployed state reduces the amplitude of the first sinusoidal suture 1334 and the second sinusoidal suture 1336 and increases its period, thereby causing the collapse suture 1308 to pull the first segment downward toward the second segment 1328 by flipping the first segment 1326 outward (e.g., around the anchor point 1322) as depicted by arrow 1342. The downward / outward pulling force can have a longitudinal direction component and a radial direction component. Therefore, there can be a longitudinal region where the first segment 1326 and the second segment 1328 overlap and have an increased radial thickness (e.g., 2X). There can also be a longitudinal region toward the inflow end where only the second segment 1328 exists.

[0159] Fig. 13C A side view of a cardiac implant device 1300 is depicted in an expanded state (e.g., a fully deployed state) wherein a balloon 1302 has been released from the cardiac implant device 1300. Fig. 13C, the inflow segment 1340 has been fully deployed to further increase the nominal diameter of the inflow segment 1340 and reduce the length of the inflow segment 1340. The further increased nominal diameter and further reduced length of the inflow segment 1340 between the partially deployed state and the fully deployed state further reduce the amplitude and further increase the period of the first sinusoidal suture 1334 and the second sinusoidal suture 1336, thereby causing the collapsing suture 1308 to pull the first segment 1326 further downward on the second segment 1328. This movement of the skirt 1306 is configured to repeatedly help control the height of the skirt while introducing the body and / or diameter of the skirt 1306 into the inflow segment 1340 in the fully deployed state. In the fully deployed state, a portion of the inflow segment 1340 and the skirt 1306 overlap to form an area of ​​increased radial thickness, which is configured to enhance the sealing and / or reduce PVL of the cardiac implant device 1300.

[0160] Fig.14A A schematic side view of a transcatheter aortic valve replacement (TAVR) device 1400 is depicted. Fig.14A As shown, TAVR device 1400 includes an expandable frame 1402, a valve body 1404, and a skirt 1405. Expandable frame 1402 may include an outflow section 1406 and an inflow section 1408. Expandable frame 1402 may be a balloon expandable structure or a self-expanding structure formed by laser cutting or etching a tube formed of a metal alloy (e.g., a stainless steel alloy, a nickel titanium alloy, nitinol, or other shape memory material). In other embodiments, expandable frame 1402 may be a linear or braided frame. Fig.14A As shown, TAVR device 1400 is in an expanded, deployed state (eg, when TAVR device 1400 is deployed at a target location).

[0161] The expandable frame 1402 includes units 1419 formed as a diamond-shaped structure and nodes 1421 formed as single points on the frame 1402. The units 1419 are interconnected by struts 1423. A combination of four adjacent nodes and struts can form a unit.

[0162] The skirt 1405 includes an inner section 1410 secured to the inner surface of the expandable frame 1402, wherein a first suture 1412 is at a first end of the skirt 1405, and an outer section 1414 is not secured to the frame 1402 to form a free end 1416 at a second end of the skirt 1405. The skirt 1405 can be formed of a single piece of material (e.g., a synthetic material or a polymer material) wrapped around the inflow end 1418 of the expandable frame 1402. In one or more embodiments, the skirt 1405 can be formed of a non-stretchable material. Sutures 1420 following a fan-shaped path can be sutured to the outer surface of the outer section 1414. In one or more embodiments, the sutures 1420 following a fan-shaped path are attached to the skirt inner section 1410 (and optionally also to the frame), but not to the outer section 1414, to allow the entire outer section 1414 and 1422 to be curled / folded to produce an improved PVL seal. In another embodiment, the outer section 1414 is crimped / pleated, but the middle section 1422 is not, which can minimize changes to the existing implant configuration.

[0163] Fig. 14B A schematic side view of a TAVR device 1400 having a pleated section 1424 and a stretchable suture 1426 is depicted. Fig. 14C An isolated side view of a pleated section 1424 and an extensible suture 1426 of a TAVR device 1400 is depicted. The skirt 1405 can include a middle portion 1422 between the suture 1420 and the free end 1416, wherein the outer section 1414 is pleated but the middle portion 1422 is not pleated. A portion of the outer section 1414 of the skirt 1405 can be sutured or otherwise secured to the expandable frame 1402 to form a pleated section 1424 extending along a portion of the length of the outer section 1414 when the expansion frame 1402 is in a fully expanded state.

[0164] When the expansion frame 1402 is loaded in a constrained position on / inside the delivery system, the expandable frame 1402 can be in a compressed state. Due to the radial compression of the expansion frame 1402 when transitioning from the fully expanded state to the compressed state, the pleated sections 1424 can be expanded and laid flat or substantially flat so as not to increase the packing density of the TAVR device 1400.

[0165] The stretchable suture 1426 can extend in the axial direction along the skirt 1405 and pass through the pleated section 1424. The stretchable suture 1426 can be formed of any filamentary or linear material having stretchable, extensible or stretchable properties, such as polymers, metals, or natural materials, not limited to surgical sutures. The stretchable suture 1426 can be fastened to the first end and the second end of the node 1421 and extend between the first end and the second end. The stretchable suture 1426 can pass through the pleated section 1424 two or more times. In one or more embodiments, the stretchable suture 1426 can pass through the pleated section 1424 at any of the following times or within the range of any two of the following times: 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, and 20.

[0166] like Fig. 14C As shown, the stretchable suture 1426 passes through the pleated section eight (8) times, through the eyelet 1428 defined by the pleated section 1424. The eyelet 1428 can be reinforced (e.g., with a grommet) or can be a small, unreinforced opening in the skirt. In other embodiments, the suture can pass through the skirt material without an enlarged eyelet. The stretchable suture 1426 can be connected to the node 1421 at a first end 1430 and a second end 1432 of the node 1421. The stretchable suture 1426 can be configured to maintain alignment of the outer section 1414 of the skirt 1405 when it is pleated with the pleated section 1424 in the fully expanded state, and when it is flat in the delivery state. The extensible suture 1426 is configured to extend from a fully expanded length in a fully expanded state to a delivery length in a delivery state while remaining secured to the first end 1430 and the second end 1432 of the node 1421 so that the fully expanded length is less than the delivery length. The extensible suture 1426 is configured to contract from the delivery length to the fully expanded length when the TAVR device 1400 is deployed, thereby forming a pleated section 1424. The extensible suture 1426 can be configured so that they are under tension in the delivery state, but do not plastically deform when stretched. In the fully expanded state, the extensible suture 1426 can be in a neutral state (e.g., minimal relaxation, but no active tension). In the fully expanded state, the pleated section 1424 forms an area of ​​increased radial thickness that is configured to enhance the sealing of the TAVR device 1400 and / or reduce paravalvular leakage (PVL).

[0167] Fig.15A A schematic side view of a frame 1502 and skirt 1504 of a cardiac implant device 1500 is depicted in a compressed state (eg, a delivery state). Fig. 15BA schematic side view of a frame 1502 and skirt 1504 of a cardiac implant device 1500 in an expanded state (e.g., a delivery state) is depicted. The cardiac implant device 1500 includes a frame 1502 (e.g., an expandable frame of a balloon-expandable TAVR device) terminating at an inflow end 1510 and a collapse suture 1508 anchored to the frame 1506 and the skirt 1504, as described herein. The collapse suture 1508 can be formed of any filamentous or linear material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 1604 can replace an existing skirt or can be an additional skirt on the top (e.g., outward) of the skirt. The skirt 1504 includes a first end 1512 and a second end 1514, which are aligned with the middle section of the frame 1502. The skirt 1504 can be formed by a cylindrical body (e.g., a tube). In at least one embodiment, in the compressed state, the first end 1512 extends beyond the inflow end 1510 of the frame.

[0168] like Fig.15A and Fig. 15B As shown, the collapse suture 1508 forms a sinusoidal ring having peaks, valleys, and a central portion extending between the peaks and valleys. In other embodiments, the collapse suture 1508 can have a sawtooth shape with alternating peaks and valleys, with legs extending between them. The collapse suture 1508 can be fastened to the frame 1502 in a repeating pattern at the anchor points 1516. The anchor points 1516 can be positioned circumferentially around the circumference (e.g., the entire circumference) of the frame 1502 to form a circle 1518 that includes the anchor points 1516. The circle 1518 is spaced apart from the inflow end 1510 of the frame 1502.

[0169] Fig. 15C 15 is a schematic diagram depicting a frame node 1520 of a frame 1502. Fig.15D As shown, some anchor points 1516 may connect the collapse suture 1508 to the frame node 1520 via rivets 1522. Fig.15E As shown, anchor point 1516 may connect collapse suture 1508 to framework node 1520 via suture 1524 . Fig.15F is a schematic diagram depicting the straight support 1526 of the frame 1502. Figure 15G As shown, some of the anchor points 1516 may connect the collapse suture 1508 to the straight strut 1526 via rivets 1528. Fig.15H As shown, some of the anchor points 1516 can connect the collapse sutures 1508 to the straight struts 1526 via sutures 1530.

[0170] In one or more embodiments, the skirt 1504 is secured to the collapse suture 1508 in a periodic, alternating, repeating pattern at the following locations: an anchor point 1532 at the first end 1512 of the skirt 1504, an anchor point 1534 at the mid-section of the skirt 1504, and an anchor point 1536 at the second end 1514 of the skirt 1504. The anchor points 1532, 1534, and 1536 can be configured to secure the collapse suture 1508 to the outer surface of the skirt 1504. Alternatively, the anchor points 1532, 1534, and 1536 can be configured to secure the collapse suture 1508 to the inner surface of the skirt 1504 (e.g., such that the collapse suture is located between the frame 1502 and the skirt 1504).

[0171] The anchor points 1532 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the first end 1512 of the skirt 1504 to form a circle 1538 that includes the anchor points 1532. The anchor points 1534 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the middle section of the skirt 1504 to form a circle 1540 that includes the anchor points 1534. The anchor points 1536 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the second end 1514 of the skirt 1504 to form a circle 1542 that includes the anchor points 1536.

[0172] In the delivery state, the sinusoidal loop of collapsed suture 1508 can have a delivery amplitude and a delivery period. The delivery amplitude can refer to the distance between circle 1540 and circle 1542 or circle 1540 and circle 1538. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 1532) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 1536).

[0173] exist Fig. 15B 15, the frame 1502 has been expanded to increase the nominal diameter of the frame 1502 and decrease the length of the frame 1502 from the delivery state. The increased nominal diameter and decreased length of the frame 1502 between the compressed state and the expanded state decreases the amplitude of the sinusoidal loop of the collapsed suture 1508 and increases its period, thereby causing the collapsed suture 1608 to pull the skirt 1504 inwardly in the axial direction and outwardly in the radial direction about the anchor point 1516. In at least one embodiment, in the expanded state, the skirt end 1512 can be aligned or substantially aligned with the inflow end 1510 after expansion. The sinusoidal loop can be formed of a shape memory material (e.g., nitinol) that is configured to expand by shortening the amplitude of the sinusoidal loop with body temperature, wherein such shortening of the amplitude increases by expansion of the valve frame to the expanded state.

[0174] The skirt 1504 can have annular seams extending around circles 1538, 1540 and 1542 and locations therebetween (e.g., circles 1544 and 1546). The annular seams can be configured to reinforce portions of the skirt 1504, which can facilitate pleating of the skirt at the annular seams. These annular seams can be formed of elastic or inelastic thread material. In one or more embodiments, the annular seams are not connected to the frame 1506 or the collapse sutures 1508, such that the shortening of the amplitude and the lengthening of the period cause the skirt 1504 to pleat. In the expanded state, the pleated skirt forms an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 1500 and / or reduce PVL while maintaining a lower profile in the delivery state.

[0175] Fig.16A A schematic side view of a frame 1602 and skirt 1604 of a cardiac implant device 1600 is depicted in a compressed state (eg, a delivery state). Fig. 16B A schematic side view of a frame 1602 and a skirt 1604 of a cardiac implant device 1600 in an expanded state (e.g., a delivery state) is depicted. The cardiac implant device 1600 includes a frame 1602 (e.g., an expandable frame of a balloon-expandable TAVR device) terminating at an inflow end 1610 and a collapse suture 1608 anchored to the frame 1606 and the skirt 1604, as described herein. The collapse suture 1608 can be formed of any filamentous or linear material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 1604 can replace an existing skirt or can be an additional skirt on the top (e.g., outward) of the skirt. The skirt 1604 includes a first end 1612 and a second end 1614, which are aligned with the middle section of the inflow section 1602. The skirt 1604 can be formed by a cylindrical body (e.g., a tube).

[0176] like Fig.16A and Fig. 16B 16, the collapsing suture 1608 forms a sinusoidal ring having peaks, valleys, and a central portion extending between the peaks and valleys. In other embodiments, the collapsing suture 1608 may have a sawtooth shape with alternating peaks and valleys, with legs extending between them. The collapsing suture 1608 may be fastened to the frame 1602 in a repeating pattern at anchor points 1616. The anchor points 1616 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the frame 1602 to form a circle 1618 including the anchor points 1616. The circle 1618 may coincide with the inflow end 1610 of the frame 1602.

[0177] In one or more embodiments, the skirt 1606 is secured to the collapse suture 1608 in a periodic, alternating, repeating pattern at anchor points 1620 at the first end 1612 of the skirt 1604, at anchor points 1622 at the midsection of the skirt 1604, and at anchor points 1624 at the second end 1614 of the skirt 1604. The anchor points 1620, 1622, and 1624 can be configured to secure the collapse suture 1608 to the outer surface of the skirt 1604. Alternatively, the anchor points 1620, 1622, and 1624 can be configured to secure the collapse suture 1608 to the inner surface of the skirt 1604 (e.g., such that the collapse suture is located between the frame 1602 and the skirt 1604).

[0178] The anchor points 1620 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the first end 1612 of the skirt 1604 to form a circle 1626 that includes the anchor points 1620. The anchor points 1622 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the middle section of the skirt 1604 to form a circle 1628 that includes the anchor points 1622. The anchor points 1624 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the second end 1614 of the skirt 1604 to form a circle 1630 that includes the anchor points 1624.

[0179] In the delivery state, the sinusoidal loop of collapsed suture 1608 can have a delivery amplitude and a delivery period. The delivery amplitude can refer to the distance between circle 1626 and circle 1628 or circle 1628 and circle 1630. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 1620) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 1624).

[0180] exist Fig. 16B 16, the frame 1602 has been expanded to increase the nominal diameter of the frame 1602 and decrease the length of the frame 1602 from the delivery state. The increased nominal diameter and decreased length of the frame 1602 between the compressed state and the expanded state decreases the amplitude of the sinusoidal loop of the collapsed suture 1608 and increases its period, thereby causing the collapsed suture 1608 to pull the skirt 1604 inwardly in the axial direction and outwardly in the radial direction around the anchor point 1616. This causes the skirt 1604 to drop toward the inflow end 1610 (e.g., toward the anchor point 1616). The sinusoidal loop can be formed of a shape memory material (e.g., nitinol) that is configured to self-expand by shortening the amplitude of the sinusoidal loop with body temperature, wherein such shortening of the amplitude is increased by expansion of the valve frame to the expanded state.

[0181] The skirt 1604 can have annular seams extending around circles 1626, 1628, and 1630 and locations therebetween (e.g., circles 1632 and 1634). The annular seams can be configured to reinforce portions of the skirt 1604, which can facilitate pleating of the skirt at the annular seams. These annular seams can be formed of elastic or inelastic thread material. In one or more embodiments, the annular seams are not connected to the frame 1602 or the collapse sutures 1608, such that the shortening of the amplitude and the lengthening of the period cause the skirt 1604 to pleat. In the expanded state, the pleated skirt forms an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 1600 and / or reduce PVL while maintaining a lower profile in the delivery state.

[0182] Fig.17A A schematic side view of a frame 1702 and skirt 1704 of a cardiac implant device 1700 is depicted in a compressed state (eg, a delivery state). Fig. 17B A schematic side view of a frame 1702 and a skirt 1704 of a cardiac implant device 1700 in an expanded state (e.g., a delivery state) is depicted. The cardiac implant device 1700 includes: a frame 1702 (e.g., an expandable frame of a balloon-expandable TAVR device) including a frame 1702 terminating at an inflow end 1710, and a collapse suture 1708 anchored to the frame 1702 and the skirt 1704, as described herein. The collapse suture 1708 can be formed of any filamentous or linear material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 1704 can replace the skirt or can be an additional skirt on the top (e.g., outward) of the existing skirt. The skirt 1704 includes a first end 1712 and a second end 1714, which are aligned with the middle section of the inflow section 1702. The skirt 1704 can be formed by a cylindrical body (e.g., a tube). In at least one embodiment, in the compressed state, the first end 1712 extends beyond the inflow end 1710 of the frame.

[0183] like Fig.17A and Fig. 17B As shown, the collapse suture 1708 forms a sinusoidal ring having peaks, valleys, and a central portion extending between the peaks and valleys. In other embodiments, the collapse suture 1708 can have a sawtooth shape with alternating peaks and valleys, with legs extending between them. The collapse suture 1708 can be fastened to the frame 1706 in a repeating pattern at the anchor points 1716. The anchor points 1716 can be positioned circumferentially around the circumference (e.g., the entire circumference) of the frame 1706 to form a circle 1718 including the anchor points 1716. The circle 1718 can coincide with the inflow end 1710 of the frame 1704.

[0184] In one or more embodiments, the skirt 1706 is secured to the collapse suture 1708 in a periodic, alternating, repeating pattern at anchor points 1720 at the first end 1712 of the skirt 1704, at anchor points 1722 at the midsection of the skirt 1704, and at anchor points 1724 at the second end 1714 of the skirt 1704. The anchor points 1720, 1722, and 1724 can be configured to secure the collapse suture 1708 to the outer surface of the skirt 1704. Alternatively, the anchor points 1720, 1722, and 1724 can be configured to secure the collapse suture 1708 to the inner surface of the skirt 1704 (e.g., such that the collapse suture is located between the frame 1706 and the skirt 1704).

[0185] The anchor points 1720 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the first end 1712 of the skirt 1704 to form a circle 1726 that includes the anchor points 1620. The anchor points 1722 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the middle section of the skirt 1704 to form a circle 1728 that includes the anchor points 1722. The anchor points 1724 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the second end 1714 of the skirt 1704 to form a circle 1730 that includes the anchor points 1724.

[0186] In the delivery state, the sinusoidal loop of collapsed suture 1708 can have a delivery amplitude and a delivery period. The delivery amplitude can refer to the distance between circle 1726 and circle 1728 or circle 1728 and circle 1730. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 1720) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 1724).

[0187] exist Fig. 17B 1702 has been deployed to increase the nominal diameter of the inflow segment 1702 and reduce the length of the frame 1702 from the delivery state. The increased nominal diameter and reduced length of the frame 1702 between the compressed state and the deployed state reduces the amplitude of the sinusoidal loop of the collapsed suture 1708 and increases its period, thereby causing the collapsed suture 1708 to pull the skirt 1704 inwardly in the axial direction and outwardly around the anchor point 1716 in the radial direction. This causes the skirt 1704 to be pulled upwardly (e.g., toward the anchor point 1716) away from the inflow end 1710. In at least one embodiment, in the expanded state, the skirt end 1712 can be aligned or substantially aligned with the inflow end 1710 after expansion. The sinusoidal loop can be formed of a shape memory material (e.g., nitinol) that is configured to expand by shortening the amplitude of the sinusoidal loop with body temperature, wherein such shortening of the amplitude increases by expansion of the valve frame to the deployed state.

[0188] The skirt 1704 can have annular seams extending around circles 1726, 1728, and 1730 and locations therebetween (e.g., circles 1732 and 1734). The annular seams can be configured to reinforce portions of the skirt 1704, which can facilitate pleating of the skirt at the annular seams. These annular seams can be formed of elastic or inelastic thread material. In one or more embodiments, the annular seams are not connected to the frame 1706 or the collapse sutures 1708, such that the shortening of the amplitude and the lengthening of the period cause the skirt 1704 to pleat. In the expanded state, the pleated skirt forms an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 1700 and / or reduce PVL while maintaining a lower profile in the delivery state.

[0189] Fig.18A A schematic side view of a frame 1802 and skirt 1804 of a cardiac implant device 1800 is depicted in a compressed state (eg, a delivery state). Fig.18B A schematic side view of a frame 1802 and skirt 1804 of a cardiac implant device 1800 in an expanded state (e.g., a delivery state) is depicted. The cardiac implant device 1800 includes a frame 1802 (e.g., an expandable frame of a balloon-expandable TAVR device) terminating at an inflow end 1810 and a collapse suture 1808 anchored to the frame 1806 and the skirt 1804, as described herein. The collapse suture 1808 can be formed of any filamentous or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 1804 can replace an existing skirt or can be an additional skirt on top of an existing skirt (e.g., outward). The skirt 1804 includes a first end 1812 and a second end 1814, which are fastened to the inflow end 1810 by sutures or other fasteners. The suture can be formed of any filamentous or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 1804 can be formed from a cylindrical body (eg, a tube). In at least one embodiment, in a compressed state, the skirt first end 1812 can extend beyond the inflow end 1810 of the frame.

[0190] The collapse sutures 1808 may include individual sutures spaced apart from one another around the circumference of the skirt 1804 and the frame 1806. In one or more embodiments, these individual sutures may be equally spaced apart from adjacent sutures. Fig.18A and Fig.18BAs shown, the collapse sutures 1808 include a first suture 1808A, a second suture 1808B, and a third suture 1808C. The first suture 1808A is fastened to the first end 1812 of the skirt 1804 at an anchor point 1816A and is fastened to the frame 1802 of the cardiac implant device 1800 at an anchor point 1818A. The second suture 1808B is fastened to the first end 1812 of the skirt 1804 at an anchor point 1816B and is fastened to the frame 1802 of the cardiac implant device 1800 at an anchor point 1818B. The third suture 1808C is fastened to the first end 1812 of the skirt 1804 at an anchor point 1816C and is fastened to the frame 1802 at an anchor point 1818C.

[0191] Each of these individual sutures may have a complementary or congruent shape. The shapes may be set using a shape-setting material for sutures (e.g., Nitinol). Fig.18A As shown, the first suture 1808A, the second suture 1808B, and the third suture 1808C have congruent curved shapes. Anchor points 1816A, 1816B, and 1816C can fasten the ends of the first suture 1808A, the second suture 1808B, and the third suture 1808C to the outer surface of the skirt 1804. Anchor points 1818A, 1818B, and 1818C can fasten the other ends of the first suture 1808A, the second suture 1808B, and the third suture 1808C to a frame node or a straight support of the frame 1802. Anchor points 1816A, 1816B, and 1816C can be circumferentially positioned around the circumference (e.g., the entire circumference) of the skirt 1804 to form a circle 1818 including those anchor points. The circle 1818 can coincide with the first end 1812 of the skirt 1804. The anchor points 1818A, 1818B, and 1818C can be circumferentially positioned around the circumference (eg, the entire circumference) of the frame 1802 to form a circle 1820 that includes those anchor points.

[0192] like Fig.18A and Fig.18B As shown, anchor points 1816A, 1816B, and 1816C are circumferentially offset from anchor points 1818A, 1818B, and 1818C. In the delivery state, the collapsed suture 1808 can have a compressed offset. In the compressed state, the skirt 1804 and the frame 1802 can extend together to reduce the profile of the delivered cardiac implant device 1800.

[0193] exist Fig.18B, the inflow segment 1802 has been deployed to increase the nominal diameter of the inflow segment 1802 and reduce the length of the inflow segment 1802 from the delivery state. The increased nominal diameter and reduced length of the inflow segment 1802 between the compressed state and the deployed state increases the offset to the deployment offset, thereby causing the collapsed suture 1808 to pull the skirt 1804 inwardly in the axial direction (see arrow 1822) and outwardly in the radial direction (see arrow 1824). In one or more embodiments, the individual sutures have the same length so that they move in unison by the inward axial force and the outward radial force. The individual sutures can have a measure of elasticity or stretchability sufficient to facilitate movement of the individual sutures between the delivery state and the deployed state, while still having sufficient stability to provide sufficient force to pull the skirt 1804 upward. In the deployed state, the gathered skirt 1804 forms an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 1800 and / or reduce PVL while maintaining a lower profile in the delivery state. The gathered skirt 1804 may be disposed at an inflow portion of the frame, such that the skirt end 1812 is aligned or substantially aligned with the inflow end 1810 of the frame.

[0194] Fig.19A A schematic side view of a cardiac implant device 1900 is depicted in a compressed state (eg, a delivery state). Fig.19B A schematic side view of a cardiac implant device 1900 in an expanded state (e.g., a delivery state) is depicted. The cardiac implant device 1900 includes an inflow segment 1902. The cardiac implant device 1900 includes: a frame 1906 (e.g., an expandable frame of a TAVR device) including an inflow segment 1902 terminating at an inflow end 1910, and a collapse suture 1908 anchored to the frame 1906 and the skirt 1904 as described herein. The collapse suture 1908 can be formed of any filamentary or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 1904 can replace Fig. 10A 1016, or may be an additional skirt on top of (e.g., outwardly) skirt 1016. Skirt 1904 includes a first end 1912 and a second end 1914, which is fastened to inflow end 1910 by a suture or other fastener. Sutures can be formed of any filamentous or linear material, such as polymers, metals, or natural materials, and are not limited to surgical sutures. Skirt 1904 can be formed of a cylindrical body (e.g., a tube). In at least one embodiment, in a compressed state, skirt end 1912 can extend beyond inflow end 1910 of the frame.

[0195] The collapse sutures 1908 may include separate sutures spaced apart from each other around the circumference of the skirt 1904 and the frame 1906. These separate spaced sutures may have a spiral shape. In one or more embodiments, these separate sutures may be equally spaced apart from adjacent sutures. These separate sutures may extend from the first end 1912 of the skirt 1904 through the inflow section 1902, the contraction section 1916, and the outflow section 1918 of the frame 1906.

[0196] like Fig.19A and Fig.19B As shown, the collapse suture 1908 includes a first suture 1908A and a second suture 1908B, but additional sutures may also be included. The first suture 1908A is fastened to the first end 1912 of the skirt 1904 at an anchor point 1920A and is fastened to the outflow end 1922 of the outflow section 1918 at an anchor point 1924A. The second suture 1908B is fastened to the first end 1912 of the skirt 1904 at an anchor point 1920B and is fastened to the outflow end 1922 of the outflow section 1918 at an anchor point 1924B. The anchor points 1920A and 1920B can be circumferentially positioned around the circumference (e.g., the entire circumference) of the skirt 1904 to form a circle 1926 that includes those anchor points. The circle 1926 can coincide with the first end 1912 of the skirt 1904. The anchor points 1924A and 1924B can be positioned circumferentially around the circumference (eg, the entire circumference) of the frame 1906 to form a circle 1928 that includes those anchor points. The circle 1928 can coincide with the outflow end 1922 of the outflow segment 1918.

[0197] Between their anchor points, the first suture 1908A and the second suture 1908B can be loosely connected to one or more nodes or straight struts of the frame 1906 such that the loose connection does not interfere with the transition of the first suture 1908A and the second suture 1908B from a compressed state to an expanded state.

[0198] Each of these individual sutures may have a complementary or congruent shape. The shapes may be set using a shape-setting material for sutures (e.g., Nitinol). Fig.19A As shown, the first suture 1908A and the second suture 1908B have congruent spiral shapes.

[0199] like Fig.19A As shown, anchor points 1920A and 1920B are circumferentially offset from each other by a first distance, and anchor points 1924A and 1924B are circumferentially offset from each other by a first distance. In other embodiments, the first offset distance may be different. Fig.19BAs shown, anchor points 1920A and 1920B are circumferentially offset from each other by a second distance, and anchor points 1924A and 1924B are circumferentially offset from each other by a second distance. In other embodiments, the second offset distance may be different.

[0200] exist Fig.19B , the cardiac implant device 1900 has been expanded to increase the nominal diameter of the frame 1906 and decrease the length of the frame 1906 from the delivery state. The increased nominal diameter and decreased length of the frame 1906 between the compressed state and the expanded state increase the first offset and the second offset to the expanded first offset and the second offset, thereby causing the collapsing suture 1908 to pull the skirt 1904 inward in the axial direction (see arrow 1930) and outward in the radial direction (see arrow 1932). In one or more embodiments, the individual sutures have the same length so that they move in unison via inward axial forces and outward radial forces. The individual sutures can have a measure of elasticity or stretchability sufficient to facilitate movement of the individual sutures between the delivery state and the expanded state, while still having sufficient stability to provide sufficient force to pull the skirt 1904 upward. As Fig.19B As shown, the skirt 1904 is gathered. In the deployed state, the gathered skirt 1904 forms an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 1900 and / or reduce PVL while maintaining a low profile in the delivery state. The gathered skirt 1904 can be arranged at the inflow portion of the frame, for example, the skirt end 1912 is aligned or substantially aligned with the inflow end 1910 of the frame.

[0201] Fig. 20A A schematic side view of an inflow section 2002 of a cardiac implant device 2000 is depicted in a fully deployed state. Fig. 20B Depicted is a schematic side view of an inflow section 2002 of a cardiac implant device 2000 in a partially deployed state. Fig. 20C A schematic side view of an inflow section 2002 of a cardiac implant device 2000 in a compressed state (eg, a delivery state) is depicted. The cardiac implant device 2000 includes a skirt 2004 and a frame 2006. The inflow section 2002 terminates in an inflow end 2010.

[0202] The cardiac implant device 2000 includes a stretchable suture 2008. The stretchable suture 2008 can extend in an axial direction along the frame 2006. The stretchable suture 2008 can be formed of any filamentary or thread-like material having stretchable, extensible or stretchable properties, such as polymers, metals, or natural materials, and is not limited to surgical sutures. Fig.20DA schematic diagram of the stretchable sutures 2008 axially cross-woven relative to the frame nodes 2012 of the frame 2006 is depicted. Fig.20D As shown, the stretchable suture 2008 is woven over the framework node 2012A and woven under the framework node 2012B. This weaving pattern (i.e., one above and one below) can be repeated when the stretchable suture 2008 extends to, for example, the connection unit 2014 of the frame 2006. Other weaving patterns (e.g., two above and two below) can be used. The second end of the stretchable suture 2008 is anchored to the connection unit 2014 via an anchor point 2020. The first end can be a free end that is not fixed to the frame but attached to the skirt. The stretchable suture 2008 can be positioned to separate several units from each other (e.g., separate 2, 3, 4, or 5 units). If each stretchable suture 2008 is positioned to separate 3 units, each stretchable suture 2008 is connected to the second unit, where the skirt terminates at a third node (e.g., at Fig.20D ) at skirt edge 2022 shown in .

[0203] The stretchable suture 2008 can be passed through the pleated section 2024 (e.g., Fig. 20A In one or more embodiments, the stretchable suture 2008 can be passed through the pleated section 1424 any number of times or within a range of any two of the following numbers: 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, and 20. When the frame 2006 is loaded in a restricted position within the delivery system (e.g., as Fig. 20C ), the frame 2006 is held compressed within the capsule (e.g., capsule 1056), which may be referred to as a compressed state. As the frame 2006 transitions from a fully expanded state to a partially expanded state (e.g., Fig. 20B ) to a compressed state (e.g., Fig. 20A When radially compressed during operation (as shown), the pleated section 2024 can be unfolded and laid flat or substantially flat so as not to increase the packing density of the cardiac implant device 2000.

[0204] The stretchable suture 2008 can be configured to maintain alignment of the skirt 2004 when it is pleated with the pleated section 2024 in the fully expanded state and when it is flat in the compressed state. The stretchable suture 2008 is configured to extend from a fully deployed length in the fully deployed state to a delivery length in the compressed state while remaining secured to the anchor points 2020 and loosely connected to the framework nodes (e.g., framework nodes 2012A and 2012B) (e.g., no tension is observed in the stretchable suture 2008) such that the fully deployed length is less than the compressed length. The stretchable suture 2008 is configured to contract from the delivery length to the fully expanded extension when the cardiac implant device 2000 is deployed, thereby forming an outwardly expanded pleated section 2024, as shown. Fig. 20A As shown. The stretchable sutures 2008 can be configured so that in the fully expanded state they are under tension (but do not undergo plastic deformation when stretched) through the outflow segment (not shown). In the fully expanded state, the pleated segment 2024 forms an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 2000 and / or reduce paravalvular leakage (PVL).

[0205] Fig.21A A side view of a cardiac implant device 2100 is depicted in a compressed state (eg, a delivery state). Fig.21A As shown, the cardiac implant device 2100 is compressed within the capsule 2102. The cardiac implant device 2100 includes a frame 2104 (e.g., an expandable frame of a TAVR device), a skirt 2106 anchored to the frame 2104, and a collapse suture 2108 anchored to the frame 2104 and the skirt 2106. The collapse suture 2108 can be formed of any filamentary or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 2106 can replace Fig. 10A The existing skirt shown in , or it may be an additional skirt on top of the existing skirt (eg, outward).

[0206] The frame 2104 includes an outflow end 2110, an inflow end 2112, and a frame body 2114 extending therebetween. The frame 2104 also includes a contraction section 2115, which may include a commissure. The skirt 2106 includes a first end 2116, a second end 2118, and a skirt body 2120 extending therebetween. The skirt body 2120 may be formed by a cylindrical body (e.g., a tube).

[0207] The first end 2116 of the skirt 2106 is secured to the collapse suture 2108 in a repeating pattern via anchor points 2122. The anchor points 2122 may include sutures that secure the skirt 2106 and the collapse suture 2108 together. The anchor points 2122 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the skirt 2106 to form a circle 2123 including the anchor points 2122 at the first end 2116 of the skirt 2106. The anchor points 2122 may be evenly spaced from one another around the circumference (e.g., the entire circumference) of the skirt 2106 to strengthen the connection between the frame 2104 and the skirt 2106.

[0208] like Fig.21A As shown, the skirt body 2120 extends away from the circle 2123 to axially coincide with the contracted portion 2115 of the frame 2104, thereby occupying the portion of the frame body 2114 with reduced diameter, so that the skirt 2106 has no effect or only a negligible effect on the packing density of the cardiac implant device 2100 in a compressed state within the capsule 2102.

[0209] The collapse suture 2108 is secured to the inflow end 2112 of the frame 2104 at anchor points 2124. The anchor points 2124 can be positioned circumferentially around the circumference (eg, the entire circumference) of the inflow end 2112 of the frame 2104 to form a circle 2127 that includes the anchor points 2124.

[0210] Fig.21A The collapse suture 2108 is schematically illustrated having a first sinusoidal suture 2128 and a second sinusoidal suture 2130 (although in other embodiments, the first and second sutures may be zigzag loops forming an annular scissor arm). The alternating peaks and valleys of the first sinusoidal suture 2128 are secured to the frame 2104 via alternating anchor points 2122 and 2124, and the alternating peaks and valleys of the second sinusoidal suture 2130 are secured via alternating anchor points 2124 and 2122, such that the first and second sinusoidal sutures 2128 and 2130 are out of phase with each other (e.g., the peaks of one sinusoidal suture are aligned with the valleys of the other).

[0211] The first sinusoidal suture 2128 and the second sinusoidal suture 2130 can have a delivery amplitude and a delivery period in the delivery state (in other embodiments, the first sinusoidal suture 2128 and the second sinusoidal suture 2130 can have different amplitudes and periods). The delivery amplitude can refer to the distance between the inflow end 2112 of the frame 2104 at the anchor point 2124 and the first end 2116 of the skirt 2106 at the second anchor point 2122. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 2122) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 2124) of the first sinusoidal suture 2128 or the second sinusoidal suture 2130 of the collapsed suture 2108.

[0212] Fig.21B A side view of the inflow section 2134 of the cardiac implant device 2100 is depicted in an expanded state (e.g., partially deployed state) with the balloon 2102 partially retracted as indicated by arrow 2132 to partially deploy the cardiac implant device 2100. Fig.21B , the inflow segment 2134 has been deployed from the delivery state to increase the nominal diameter of the inflow segment 2134 and decrease the length of the inflow segment 2134. The increased nominal diameter and decreased length of the inflow segment 2134 between the compressed state and the partially deployed state reduces the amplitude and increases the period of the first sinusoidal suture 2128 and the second sinusoidal suture 2130, thereby causing the collapsing suture 2108 (e.g., via the anchor point 2122) to pull the skirt 2106 downward toward the inflow end 2112, as depicted by arrow 2136.

[0213] Fig. 21C A side view of the inflow section 2134 of the cardiac implant device 2100 is depicted in an expanded state (e.g., a fully deployed state) wherein the balloon 2102 has been released from the inflow section of the cardiac implant device 2100. Fig. 21C , the inflow segment 2134 has been fully deployed to further increase the nominal diameter of the inflow segment 2134 and reduce the length of the inflow segment 2134. The further increased nominal diameter and further reduced length of the inflow segment 2134 between the partially deployed state and the fully deployed state further reduce the amplitude of the first sinusoidal suture 2128 and the second sinusoidal suture 2130 and further increase their period, thereby causing the collapse suture 2108 to further pull the skirt 2106 downward and outward toward the inflow end 2112 to increase the circumference of the skirt 2106. The downward / outward pulling force can have a longitudinal direction component and a radial direction component. In the fully deployed state of the inflow segment 2134, a portion of the inflow segment 2134 and the skirt 2106 overlap to form an area of ​​increased radial thickness, which is configured to enhance the seal of the cardiac implant device 2100 and / or reduce PVL.

[0214] Fig.22A A side view of a cardiac implant device 2200 in a compressed state is depicted. Fig.22A As shown, cardiac implant device 2200 is compressed within capsule 2202. Cardiac implant device 2200 includes frame 2204, skirt 2206 anchored to frame 2204, collapse suture 2209 anchored to frame 2204 and skirt 2206, and collapse suture 2208 anchored to skirt 2206. Collapse sutures 2208 and 2209 can be formed of any filamentary or thread-like material, such as polymers, metals, or natural materials, and are not limited to surgical sutures. Skirt 2206 can replace Fig. 10A The existing skirt shown in , or it may be an additional skirt on top of the existing skirt (eg, outward).

[0215] The frame 2204 includes an outflow end 2210, an inflow end 2212, and a frame body 2214 extending therebetween. The frame 2204 also includes a contraction section 2215, which may include a commissure. The skirt 2206 includes a first end 2216, a second end 2218, and a skirt body 2220 extending therebetween. The skirt body 2220 may be formed by a cylindrical body (e.g., a tube).

[0216] The collapse suture 2208 is secured to the first end 2216 of the skirt 2206 in a repeating pattern via anchor points 2219 and to the second end 2218 of the skirt 2206 in a repeating pattern via anchor points 2221. The anchor points 2219 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the skirt 2206 to form a circle 2223 at the first end 2216 of the skirt 2206 that includes the anchor points 2219. The anchor points 2221 may be positioned circumferentially around the circumference (e.g., the entire circumference) of the skirt 2206 to form a circle 2227 at the second end 2218 of the skirt 2206 that includes the anchor points 2221. Fig.22A The collapsing sutures 2208 are schematically illustrated having a first sinusoidal suture and a second sinusoidal suture (although in other embodiments, the first and second sutures may be zigzag loops forming an annular scissor arm).

[0217] The first end 2216 of the skirt 2206 is secured to the collapse suture 2209 via anchor points 2222 in a repeating pattern. The anchor points 2222 may include sutures that secure the skirt 2206 and the collapse suture 2209 together. The anchor points 2222 may be circumferentially positioned around a circle 2223 at the first end 2216 of the skirt 2206 that includes the anchor points 2219 and 2222, around the circumference (e.g., the entire circumference) of the skirt 2206. The anchor points 2219 and / or 2122 may be evenly spaced from one another around the circumference (e.g., the entire circumference) of the skirt 2206 to strengthen the connection between the frame 2204 and the skirt 2206. The collapse suture 2209 is secured to the inflow end 2212 of the frame 2204 at the anchor points 2228. The anchor points 2228 can be positioned circumferentially around the circumference (eg, the entire circumference) of the inflow end 2112 of the frame 2104 to form a circle that includes the anchor points 2228 .

[0218] like Fig.22A As shown, the skirt body 2220 extends away from the circle 2223 to axially coincide with the contracted portion 2215 of the frame 2204, thereby occupying the portion of the frame body 2214 with reduced diameter, so that the skirt 2206 has no effect or only a negligible effect on the packing density of the cardiac implant device 2200 in a compressed state within the capsule 2202.

[0219] Fig.22A The collapse suture 2209 is schematically illustrated having a first sinusoidal suture and a second sinusoidal suture (although in other embodiments, the first and second sutures may be zigzag loops forming annular scissor arms). The alternating peaks and valleys of the first sinusoidal suture are secured to the frame 2204 via alternating anchor points 2222 and 2228, and the alternating peaks and valleys of the second sinusoidal suture are secured via alternating anchor points 2222 and 2226, such that the first and second sinusoidal sutures are out of phase with each other (e.g., the peaks of one sinusoidal suture are aligned with the valleys of the other).

[0220] The first and second sinusoidal sutures can have a delivery amplitude and a delivery period in a delivery state (in other embodiments, the first and second sinusoidal sutures can have different amplitudes and periods). The delivery amplitude can refer to the distance between the inflow end 2212 of the frame 2204 at the anchor point 2228 and the first end 2216 of the skirt 2206 at the second anchor point 2222. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 2222) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 2228) of the first or second sinusoidal sutures of the collapsed sutures 2209.

[0221] Fig. 22BA side view of the inflow segment 2234 of the cardiac implant device 2200 is depicted in an expanded state (e.g., a fully deployed state) in which the balloon 2202 has been released from the inflow segment 2234 of the cardiac implant device 2200. The inflow segment 2234 has been fully deployed to increase the nominal diameter of the inflow segment 2234 and to decrease the length of the inflow segment 2234. The increased nominal diameter and decreased length of the inflow segment 2234 decreases the amplitude of the first or second sinusoidal sutures of the collapse sutures 2208 and 2209 and further increases the period thereof, thereby causing the collapse sutures 2209 to pull the skirt 2206 downwardly and outwardly toward the inflow end 2212 to increase the circumference of the skirt 2206 and cause the collapse sutures 2208 to collapse to cause the skirt 2206 to wrinkle or pleat (e.g., as depicted by arrows 2238). The downward / outward pulling force (e.g., as depicted by arrow 2236) can have a longitudinal direction component and a radial direction component. In the fully deployed state of the inflow segment 2234, the inflow segment 2234 and a portion of the skirt 2206 overlap to form an area of ​​increased radial thickness that is configured to enhance the seal of the cardiac implant device 2200 and / or reduce PVL.

[0222] The stitching pattern from the frame may extend to the top of the skirt and / or there may be two separate stitching patterns, wherein an alternate pattern may be included only in the skirt to assist in pleating by increasing the density of the pattern.

[0223] Fig.23A A side view of a cardiac implant device 2300 compressed within a capsule 2302 is depicted. The cardiac implant device 2300 includes a frame 2304, a skirt 2306 anchored to the frame 2304, and a collapse suture 2308 anchored to the frame 2304 and the skirt 2306. The collapse suture 2308 can be formed of any filamentary or thread-like material, such as a polymer, metal, or natural material, and is not limited to surgical sutures. The skirt 2306 can replace Fig. 10A The skirt 1016 shown in the figure, or it can be an additional skirt on top of the skirt 1016 (e.g., outward). The frame 2304 includes an outflow end 2310, an inflow end 2312, and a frame body 2314 extending therebetween. The skirt 2306 includes a first end 2316, a second end 2318, and a skirt body 2320 extending therebetween. The skirt body 2320 can be formed by a cylindrical body (e.g., a tube).

[0224] The first end 2316 of the skirt 2306 is secured to the frame body 2314 via anchor points 2322. The anchor points 2322 may be circumferentially positioned around the circumference (e.g., the entire circumference) of the frame body 2314, thereby forming a circle 2317 that includes the anchor points 2322. The anchor points 2322 may be evenly spaced from one another around the circumference (e.g., the entire circumference) of the frame body 2314 to strengthen the connection between the frame 2304 and the skirt 2306.

[0225] The collapse suture 2308 is secured to the inflow end 2312 of the frame 2304 at anchor points 2324 and to the second end 2318 of the skirt 2306 at anchor points 2326 in a periodic, alternating, repeating pattern. Fig.23A As shown, anchor points 2324 and 2326 respectively fasten the collapse suture 2308 to the outer surface of the frame 2304 and the outer surface of the skirt 2306, so that the collapse suture 2308 is located outside the skirt 2306. Alternatively, anchor points 2324 and 2326 can fasten the collapse suture 2308 to the outer surface of the frame 2304 and the inner surface of the skirt 2306, respectively, so that the collapse suture 2308 is located inside the skirt 2306.

[0226] Fig.23A The collapse suture 2308 is schematically illustrated having a first sinusoidal suture 2328 and a second sinusoidal suture 2330 (although in other embodiments, the first and second sutures may be zigzag loops forming an annular scissor arm). The alternating peaks and valleys of the first sinusoidal suture 2328 are secured to the frame 2304 via alternating anchor points 2324 and 2326, and the alternating peaks and valleys of the second sinusoidal suture 2330 are secured via alternating anchor points 2326 and 2324, such that the first and second sinusoidal sutures 2328 and 2330 are out of phase with each other (e.g., the peaks of one sinusoidal suture are aligned with the valleys of the other).

[0227] The first sinusoidal suture 2328 and the second sinusoidal suture 2330 can have a delivery amplitude and a delivery period in the delivery state (in other embodiments, the first sinusoidal suture 2328 and the second sinusoidal suture 2330 can have different amplitudes and periods). The delivery amplitude can refer to the distance between the inflow end 2312 of the frame 2304 at the anchor point 2324 and the second end 2318 of the skirt 2306 at the second anchor point 2326. The delivery period can refer to the distance between adjacent peaks (e.g., adjacent peaks at adjacent anchor points 2324) or adjacent valleys (e.g., adjacent valleys at adjacent anchor points 2326) of the first sinusoidal suture 2328 or the second sinusoidal suture 2330 of the collapsed suture 2308.

[0228] Fig. 23B A side view of the inflow segment 2334 of the cardiac implant device 2300 is depicted in an expanded state (e.g., partially deployed state) wherein the balloon 2302 is partially retracted as indicated by arrow 2335 to partially deploy the cardiac implant device 2300. The inflow segment 2334 has been deployed from the delivery state to increase the nominal diameter of the inflow segment 2334 and decrease the length of the inflow segment 2334. The increased nominal diameter and decreased length of the inflow segment 2334 between the compressed state and the partially deployed state decreases the amplitude and increases the period of the first sinusoidal suture 2328 and the second sinusoidal suture 2330, thereby causing the collapsing suture 2308 (e.g., through the anchor point 2316) to pull the skirt 2306 downwardly and outwardly toward the inflow end 2312, as depicted by arrow 2336, thereby causing the skirt 2306 to wrinkle or pleat. The downward / outward pulling force may have a longitudinal direction component and a radial direction component. In the fully deployed state of the inflow segment 2334, the inflow segment 2334 and a portion of the skirt 2306 overlap to form a region of increased radial thickness configured to enhance the seal of the cardiac implant device 2300 and / or reduce PVL. Fig.23C A side view of cardiac implant device 2300 is depicted in an expanded state (eg, a fully deployed state) wherein balloon 2302 has been released from cardiac implant device 2300.

[0229] The embodiments shown above with one sinusoidal suture may have two or more sinusoidal sutures, and the embodiments shown with two sinusoidal sutures may have more than two sinusoidal sutures.The sutures disclosed in any embodiments herein may be elastic or inelastic sutures.

[0230] The detailed description set forth herein includes several embodiments, each of which may include several parts, features, and / or steps. For the avoidance of doubt, any parts, features, and / or steps of an embodiment may be applied, mixed, replaced, matched, and / or combined with one or more parts, features, and / or steps of other embodiments. Such resulting embodiments are clearly within the scope of this disclosure. For example, any type of collapse suture disclosed herein may be used in combination with any disclosed embodiment. As another example, any interval of the anchor point disclosed herein may be used in combination with any disclosed embodiment.

[0231] Although exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms. The words used in this specification are illustrative rather than restrictive words, and it should be understood that various changes can be made without departing from the spirit and scope of the present disclosure. As previously described, the features of each embodiment can be combined to form other embodiments of the present invention, which may not be explicitly described or illustrated. Although each embodiment may be described as providing advantages or being preferred over other embodiments or prior art embodiments in terms of one or more desired characteristics, it should be recognized by those skilled in the art that one or more features or characteristics may be compromised in order to achieve the desired overall system properties, depending on the specific application and implementation. These properties may include, but are not limited to, cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, maintainability, weight, manufacturability, ease of assembly, etc. Thus, insofar as any embodiment is described as being less desirable than other embodiments or prior art embodiments in terms of one or more characteristics, these embodiments do not exceed the scope of the present disclosure, and may be desirable for specific applications.

Claims

1. A component comprising: a graft material, the graft material comprising a margin; a stent coupled to the graft material at an anchor point, the graft material including a sealing skirt between the anchor point and the rim; as well as Collapse sutures are coupled to the sealing skirt and the graft material at periodic points in an alternating, repeating pattern.

2. The assembly of claim 1, wherein: The periodic points include first periodic points defining a first stitching trace and second periodic points defining a second stitching trace.

3. The assembly of claim 2, wherein: When the stent is expanded, a longitudinal distance between the first suture trace and the second suture trace decreases.

4. The assembly of claim 3, wherein: When the stent is expanded, the circumferential distance between the first suture points increases, and the circumferential distance between the second suture points increases.

5. The assembly of claim 1, wherein: The collapse suture collapses the sealing skirt when the stent is expanded.

6. The assembly of claim 5, wherein: The sealing skirt protrudes radially outward when collapsed.

7. The assembly of claim 6, further comprising: a sealing stent graft comprising the graft material, the stent, and the collapsing suture; and a first component, the sealing skirt being located within the first component.

8. The assembly of claim 5, wherein: The sealing skirt protrudes radially inwardly when collapsed.

9. The assembly of claim 8, further comprising: a sealing stent graft comprising the graft material, the stent, and the collapsing suture; and a first component located within the sealing skirt.

10. The assembly of claim 1, wherein: The sealing skirt lies flat on the stent prior to expansion of the stent.

11. A component comprising: A sealed stent graft, the sealed stent graft comprising: Graft material; a stent coupled to the graft material, and a collapsing suture coupled to the graft material, wherein the sealing skirt of graft material lies flat on the stent when the sealed stent graft is in the delivery configuration, and Wherein, when the sealing stent graft is in the expanded configuration, the sealing skirt is collapsed by the collapse suture and protrudes from the stent.

12. The assembly of claim 11, wherein: The graft material further includes an insulation section.

13. The assembly of claim 12, wherein: The stent includes a first crown, a second crown, and struts extending between the first crown and the second crown, the second crown being attached to the graft material at an anchor point where the sealing skirt and the shut-off section meet.

14. The assembly of claim 13, wherein: The graft material includes an edge defining an opening, the edge overlapping the struts.

15. The assembly of claim 13, wherein: The bracket extends from the second crown portion beyond the edge to the first crown portion.

16. A method comprising: providing a sealing stent graft comprising: a graft material, a stent coupled to the graft material, a sealing skirt of the graft material lying flat on the stent, and a collapsing suture coupled to the graft material; and The stent is expanded to cause the collapse suture to collapse the sealing skirt.

17. The method of claim 16, wherein: The collapsing of the sealing skirt creates wrinkles in the sealing skirt.

18. The method of claim 16, further comprising: prior to said expanding step, positioning said sealed stent graft in a vessel; as well as The sealing stent graft is deployed in the vessel.

19. The method of claim 18, wherein: The sealing skirt forms a seal with the vessel.

20. The method of claim 16, further comprising: A seal is formed between the sealing stent-graft and a first component by the sealing skirt.

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