Stent device including expandable crown

Abstract

A stent device is provided. The stent device includes at least one radially expandable body portion extending along a longitudinal axis of the stent device, defining a lumen, and at least one outwardly flaring portion connected to the body portion. The outwardly flaring portion includes at least one radially expandable ring connected to the body portion and at least one flaring link connected to the at least one ring and configured to automatically flare a crown of the at least one ring radially outwardly relative to other portions of the ring upon radial expansion of the body portion, thereby forming a flared crown. The outwardly flaring portion can be held in place after radial expansion by support struts that weaken its ability to collapse. A method of deploying the stent device is also provided.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 866,414, filed June 25, 2019, and U.S. Provisional Patent Application No. 62 / 965,373, filed January 24, 2020, the disclosures of which are hereby incorporated herein by reference in their entirety. Background Technology Technical Field

[0004] This disclosure relates to expandable intraluminal devices for use within body passages or tubes, and more particularly to stent devices comprising one or more portions configured to flare radially outward relative to other portions of the stent device for positioning, improving subsequent access to the stent device, and / or securing the stent device within the body passage or tube.

[0005] Description of related technologies

[0006] A common approach to treating vascular stenosis, aneurysms, or other channel blockages is the use of expandable prosthetic or stent devices. These devices are expandable structures configured to deploy in an expanded state within the vessel or channel to maintain its patency or continuity. Conventional stents are typically formed from interconnected member frames or toothed frames. Many stent designs are known, and they can include combinations of different types of frame structures, such as helical coils, meshes, grids, or interconnected rings. Such frame structures can be made of, for example, stainless steel and / or cobalt-chromium alloys. Some stents are formed from shape memory materials, such as nickel-titanium alloys (e.g., NITINOL), which can be biased into a deployed position or configured to be deployed when heated above a selected temperature (such as body temperature). Conventional stents can be covered or uncovered. Coverage can be made of biocompatible materials such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). In a common design, the stent may comprise a series of cylindrical rings aligned in series along a central longitudinal axis. These rings can be securely fastened to each other using multiple interconnecting components, such as longitudinally extending struts.

[0007] In many surgical procedures, stent devices are configured to be delivered to a target site, expanded, and secured in place. For example, in fenestrated endovascular aneurysm repair (FEVAR) surgery, several stents can be placed in pre-formed openings or fenestrations within the main implant or prosthesis to establish a connection between the main implant and the target branch vessel or catheter. In vascular applications, covered stents can extend several millimeters into the aortic main implant or prosthesis. Once deployed and secured in place, one or more stents create a closed lumen space for blood to flow from the main implant or prosthesis to the target vessel. One or more stents can also provide enhanced reinforcement to the vessel wall to maintain patency of the lumen or access.

[0008] Stent devices can include an area that can be selectively expanded laterally to a larger diameter to secure the stent at a desired or target location within the blood vessel. For example, during a FEVAR procedure or stent implantation for visceral artery occlusive disease, the portion of the stent inserted into the aorta can be expanded laterally to help maintain the stent device's positioning within the aorta and arteries and to create a patent pathway for future catheterization into the stent-bearing vessel. To provide such an expandable portion, surgeons typically introduce a second balloon catheter into the stent after deploying it intracavitarily. The second balloon catheter can be expanded to open the stent tip. Therefore, the deployment of a conventionally expanded stent is a two-step process. First, the stent is deployed along with the first balloon catheter. Second, a portion of the stent is opened using the second balloon catheter.

[0009] In some cases, the outwardly opening portion of the stent may also include protruding structures to enhance the engagement between the stent device and the vessel wall. For example, conventional protruding structures may include deployable hooks, fasteners, or barbs configured to protrude from the stent body when the stent is deployed. As the stent opens radially outward, the protruding structures can contact the vessel wall to secure the stent device in place.

[0010] For stents formed of shape memory materials, the stent body can be biased to adopt or conform to an outwardly flaring orientation when the stent deploys in the body cavity or after the temperature of the stent body rises above a preselected temperature. In some cases, the outwardly flaring portion of the device may also include protruding, pointed, or sharp structures to enhance the engagement between the device and the vessel wall. For example, conventional protruding structures may include deployable hooks, fasteners, or barbs configured to protrude from the body of the device when it deploys. As the device deploys radially outward, the internal bias of the shape memory material allows the protruding structures to contact the vessel wall to secure the stent device in place. In some cases, these outwardly flaring portions may be supported by support struts that restrict the flared portions from retracting or collapsing from the desired position. Summary of the Invention

[0011] There is a need for new stent designs that facilitate insertion and deployment, and provide unobstructed post-deployment access. For example, the stent devices disclosed herein may include portions configured to open radially outward without requiring additional manipulation of the stent device after deployment. Such stent devices may be referred to as “self-opening” or “auto-expanding” stent devices. In contrast, current stent devices typically require the use of auxiliary devices, such as a second balloon catheter, to open portions of the stent, which significantly increases the cost and time required for various procedures. There is also a constant need for stent designs with lower complexity that reduce manufacturing costs. The stent devices disclosed herein are designed to provide such benefits.

[0012] According to one aspect of this disclosure, a support device includes: at least one radially expandable body portion extending along a longitudinal axis of the support device and defining a lumen; and at least one outwardly opening portion connected to the body portion. The outwardly opening portion includes: at least one radially expandable ring connected to the body portion; and at least one opening connector connected to the at least one ring and configured to automatically open the crown of the at least one ring radially outward relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown. Once the open crown is in the unfolded configuration, the opening connector acts as a support post that holds the open crown in the open position and prevents it from collapsing or retracting.

[0013] According to another aspect of this disclosure, a method of deploying a stent device includes the step of preparing the stent device for surgical procedures. The stent device includes: at least one radially expandable body portion extending along a longitudinal axis of the stent device and defining a lumen; and at least one outwardly expandable portion connected to the body portion, the outwardly expandable portion including: at least one radially expandable ring connected to the body portion; and at least one opening connector connected to the at least one ring, configured to automatically radially open the crown of the at least one ring relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown and a support strut, the support strut preventing the open crown from retracting. The method further includes the steps of: advancing the stent device through a body cavity to a deployed position with the opening connector in a retracted position; and once in the deployed position, deploying the stent device, thereby allowing the body portion of the stent device and the at least one ring to radially expand outward.

[0014] Examples of this disclosure will now be described in the following numbered clauses:

[0015] Clause 1: A support device comprising: at least one radially expandable body portion extending along a longitudinal axis of the support device and defining a lumen; and at least one outwardly opening portion connected to the body portion, including: at least one radially expandable ring connected to the body portion; and at least one opening connector connected to the at least one ring and configured to automatically open the crown of the at least one ring radially outward relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown.

[0016] Clause 2: The support device according to Clause 1, wherein at least one opening connector is not biased to the expanded position.

[0017] Clause 3: The support device according to Clause 1, wherein at least one opening connector is biased to the expanded position.

[0018] Clause 4: A support device according to any one of Clauses 1 to 3, wherein the at least one ring comprises a plurality of substantially repeating curved segments and at least one longitudinally extending strut connecting at least one of the plurality of curved segments to the body portion of the support device, and wherein each curved segment comprises a peak, a valley, and a transition region disposed between the peak and the valley.

[0019] Clause 5: A support device according to any one of Clauses 1 to 4, wherein, when the main body portion expands radially, the opening connector is configured to transition from a retracted position to an expanded position, in the retracted position, the crown of the at least one ring being substantially longitudinally aligned with a portion of the main body portion of the support device, and in the expanded position, the opening crown of the at least one ring opening radially outward relative to other portions of the expandable main body portion of the support device.

[0020] Clause 6: The support device according to Clause 5, wherein, when the opening connector is in the retracted position, the crown of the at least one ring and the other portions of the at least one ring are equidistant from the longitudinal axis, and wherein, when the opening connector is in the expanded position, the opening crown of the ring is farther from the central longitudinal axis than the other portions of the at least one ring.

[0021] Clause 7: A support device according to any one of Clauses 1 to 6, wherein the outwardly opening portion is located at an end of the support device.

[0022] Clause 8: A support device according to any one of Clauses 1 to 7, wherein the radially expandable body portion includes a first longitudinal section and a second longitudinal section, and wherein the outwardly expandable portion is disposed between the first longitudinal section and the second longitudinal section of the body portion.

[0023] Clause 9: A support assembly according to any one of Clauses 1 to 8, wherein the at least one radially expandable ring and the at least one opening connector of the outwardly opening portion comprise: at least one first ring; at least one first opening connector configured to open a portion of the first ring; at least one second ring; and at least one second opening connector configured to open a portion of the second ring, wherein the at least one first ring and the at least one second ring are arranged in series along the longitudinal axis of the support.

[0024] Clause 10: A stent assembly according to any one of Clauses 1 to 8, wherein the at least one radially expandable body portion comprises: a plurality of radially expandable rings arranged in series along the longitudinal axis of the stent assembly; and at least one interconnecting member extending between and connecting the plurality of radially expandable rings, wherein radial outward expansion of the plurality of radially expandable rings of the body portion causes the at least one opening connector to automatically open the crown to form the open crown.

[0025] Clause 11: A support device according to any one of Clauses 1 to 10, wherein the at least one radially expandable body portion comprises: a plurality of radially expandable rings arranged in series along the longitudinal axis of the support device; and at least one interconnecting member extending between and connecting the plurality of radially expandable rings, wherein, after radial outward expansion, the at least one opening connector prevents the opening crown from collapsing.

[0026] Clause 12: A support device according to any one of Clauses 1 to 11, wherein the main body portion, the outwardly opening portion, or both portions are at least partially covered by at least one of a sheet, tube, or film, said sheet, tube, or film being formed of a material configured to reduce protein adsorption.

[0027] Clause 13: The scaffold device according to Clause 12, wherein the material configured to reduce protein adsorption includes a PTFE membrane.

[0028] Clause 14: A support device according to any one of Clauses 1 to 13, wherein the at least one opening connector comprises a first leg, a second leg, and a third leg fixedly connected together at a common point.

[0029] Clause 15: The support device according to Clause 14, wherein the first leg includes a first end opposite to the common point, the second leg includes a second end opposite to the common point, and the third leg includes a third end opposite to the common point, and wherein, as the expandable ring expands radially outward, the distance between the first end and the second end increases, and the third leg rotates about the common point, thereby causing the crown of the at least one ring to automatically open radially outward to form the open crown.

[0030] Clause 16: A support device according to any one of Clauses 1 to 15, wherein the crown of the at least one ring includes at least one barb, the at least one barb being configured to secure the support device in the unfolded position when the opening connector is in the expanded position.

[0031] Clause 17: A support device according to any one of Clauses 1 to 16, wherein the outwardly opening portion is formed of a material that does not have shape memory properties.

[0032] Clause 18: A support device according to any one of Clauses 1 to 16, wherein the outwardly opening portion is formed of a material having shape memory properties.

[0033] Clause 19: A support device according to any one of Clauses 1 to 16, wherein the support device is configured to expand radially outward in response to the expansion of an expandable member positioned in the lumen defined by the body portion of the support device.

[0034] Clause 20: A support device according to any one of Clauses 1 to 16, wherein the outwardly opening portion is formed of one or more materials selected from the group consisting of stainless steel, cobalt-chromium, nickel-titanium alloys and biocompatible plastics.

[0035] Clause 21: A support device according to any one of Clauses 1 to 16, wherein the outwardly expandable portion comprises a shape memory alloy that has been heat-set to the expanded position, such that the device is self-expanding.

[0036] Clause 22: A support device according to any one of Clauses 1 to 21, wherein the outwardly opening portion is supported by a support strut that reduces the collapse capacity of the opening element or barb.

[0037] Clause 23: A support device according to any one of Clauses 1 to 13, wherein the at least one opening connector comprises: a first leg connected to the crown portion of the at least one ring; and a plurality of pairs of second legs extending from the first leg to other portions of the at least one ring, wherein each pair of second legs is connected to the first leg at a unique common point on the first leg.

[0038] Clause 24: A support device according to any one of Clauses 1 to 13, wherein the at least one opening connector comprises: a first leg connected to the crown portion of the at least one ring; and at least a pair of second legs extending from the first leg to portions of the at least one ring at a common point, and at least one of the second legs includes an expandable portion that allows further extension of the at least one second leg when the at least one opening connector is in a nominal unfolded configuration.

[0039] Clause 25: A support device according to any one of Clauses 1 to 13, wherein the outwardly expandable portion comprises: at least one first radially expandable ring connected to the body portion; at least one first opening connector connected to the at least one first ring and configured to automatically radially open the crown of the at least one first ring relative to other portions of the first ring in a first direction when the body portion is radially expanded, thereby forming a first open crown; at least one second radially expandable ring connected to the first at least one radially expandable ring; and at least one second opening connector connected to the at least one second ring and configured to automatically radially open the crown of the at least one second ring in a second direction different from the first direction and relative to other portions of the second ring when the body portion is radially expanded, thereby forming a second open crown.

[0040] Clause 26: A support device according to any one of Clauses 1 to 13, wherein, prior to radial expansion of the main body portion, the end of the support device formed by the crown portion of the at least one ring is angled relative to the longitudinal axis of the at least one radially expandable body.

[0041] Clause 27: A method of deploying a stent device, comprising the steps of: preparing the stent device for surgical use, the stent device comprising: at least one radially expandable body portion extending along a longitudinal axis of the stent device and defining a lumen; and at least one outwardly expandable portion connected to the body portion, the outwardly expandable portion comprising: at least one radially expandable ring connected to the body portion; and at least one opening connector connected to the at least one ring and configured to automatically open the crown of the at least one ring radially outward relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown; advancing the stent device through a body cavity to a deployed position while the opening connector is in a retracted position; and deploying the stent device once in the deployed position, thereby allowing the body portion and at least one ring of the stent device to expand radially outward.

[0042] Clause 28: The method according to Clause 27, wherein advancing the stent device to the deployed position includes advancing the stent device on the guidewire.

[0043] Clause 29: The method according to Clause 27 or Clause 28, wherein the stent device is deployed by intravascular technique or by the sidewall of the body cavity.

[0044] Clause 30: The method according to any one of Clauses 27 to 29, wherein deploying the stent device further comprises dilating an expandable balloon positioned within the lumen of the stent device, thereby causing the main body portion of the stent device and the at least one expandable ring to expand radially outward.

[0045] Clause 31: The method according to any one of Clauses 27 to 29, wherein the support device comprises a shape memory alloy and is internally biased to self-expand, and unfolding the support device further comprises releasing the internally biased support device from the sheath, thereby causing the body portion of the internally biased support device and the at least one expandable ring to expand radially outward.

[0046] Clause 32: The method according to any one of Clauses 27 to 29, wherein the at least one opening connector is not biased to the expanded position.

[0047] Clause 33: The method according to any one of Clauses 27 to 29, wherein the at least one opening connector is biased to the expanded position.

[0048] Clause 34: The method according to any one of Clauses 27 to 29, wherein deploying the stent device comprises causing the crown of the at least one ring to automatically radially open outward relative to the expandable body portion of the stent device, without directly expanding the expandable portion via any expandable balloon.

[0049] Clause 35: The method according to any one of Clauses 27 to 34, wherein the at least one opening connector comprises: a first leg connected to the crown portion of the at least one ring; and a plurality of pairs of second legs extending from the first leg to other portions of the at least one ring, wherein each pair of second legs is connected to the first leg at a unique common point on the first leg.

[0050] Clause 36: The method according to any one of Clauses 27 to 35, wherein the stent device is initially deployed to a nominal deployment configuration, the method further comprising: with the stent device in the nominal deployment configuration, advancing an expandable catheter into the stent device and expanding the expandable catheter within the lumen of the stent device for post-expansion of the stent device.

[0051] Clause 37: The method according to Clause 36, wherein the rear expansion of the support device increases the diameter of the support device by 0.5 mm to 5 mm compared to the diameter of the support device when it is in the nominal unfolded configuration.

[0052] Clause 38: The method according to any one of Clauses 27 to 35, wherein the at least one opening connector comprises: a first leg connected to the crown of the at least one ring; and at least a pair of second legs extending from the first leg to a portion of the at least one ring at a common point, and wherein at least one of the second legs includes an expandable portion that allows for further extension of the at least one second leg when the at least one opening connector is in a nominal unfolded configuration.

[0053] Clause 39: The method according to Clause 38, wherein the stent device is initially deployed to the nominal deployment configuration, the method further comprising: with the stent device in the nominal deployment configuration, advancing an expandable catheter into the stent device and expanding the expandable catheter within the lumen of the stent device for post-expansion of the stent device, thereby extending the expandable portion of the second leg of the opening connector in length and increasing the diameter of the stent device.

[0054] Clause 40: The method according to Clause 39, wherein, during the subsequent expansion of the support device, the diameter of the support device increases from about 0.5 mm to about 5 mm from the diameter of the support device in the nominal unfolded configuration.

[0055] Clause 41: The method according to any one of Clauses 27 to 40, wherein the outwardly expandable portion of the support device comprises: at least one first radially expandable ring connected to the body portion; at least one first opening connector connected to the at least one first ring, configured to automatically radially open the crown of the at least one first ring relative to other portions of the first ring in a first direction when the body portion is radially expanded, thereby forming a first open crown; at least one second radially expandable ring connected to the first at least one radially expandable ring; and at least one second opening connector connected to the at least one second ring, configured to automatically radially open the crown of the at least one second ring in a second direction different from the first direction and relative to other portions of the second ring when the body portion is radially expanded, thereby forming a second open crown.

[0056] Clause 42: The method according to Clause 41, wherein the unfolding position is selected such that when the support device is unfolded, the annular structure is held within a groove defined by the first opening crown and the second opening crown, for automatically aligning the annular structure relative to the support device in the unfolded position.

[0057] Clause 43: The method according to Clause 42, wherein the annular structure held within the groove includes a fenestrated ring of the implant.

[0058] Clause 44: The method according to any one of Clauses 27 to 43, wherein, prior to radial expansion of the main body portion of the stent device, the end of the stent device formed by the portion of the coronal portion of the at least one ring is angled relative to the longitudinal axis of the at least one radially expandable body, and wherein the stent device is adjacent to the branch vessel or artery expansion.

[0059] Clause 45: The method according to Clause 44, wherein, when deployed, a shorter portion of the angled end of the stent device is positioned adjacent to an opening in the branch vessel or artery, and a longer portion of the angled end of the stent device is positioned on a sidewall of the vessel or artery opposite to the opening.

[0060] Clause 46: A support device comprising: at least one radially expandable body portion extending along a longitudinal axis of the support device and defining a lumen; and at least one outwardly opening portion connected to the body portion, including: at least one radially expandable ring connected to the body portion; and at least one opening connector connected to the at least one ring, configured to automatically open the crown of the at least one ring radially outward relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown, wherein the at least one opening connector includes: a first leg connected to the crown of the at least one ring; and a plurality of pairs of second legs extending from the first leg to other portions of the at least one ring, and wherein each pair of second legs is connected to the first leg at a unique common point on the first leg.

[0061] Clause 47: The support device according to Clause 46, wherein at least a portion of the open crown automatically bends radially inward and toward the main body portion of the support device.

[0062] Clause 48: The support device according to Clause 46, wherein at least a portion of the open crown automatically bends radially inward and toward the main body portion of the support device at an angle greater than 90° relative to the longitudinal axis of the support device.

[0063] Clause 49: A support device according to any one of Clauses 46 to 48, wherein the opening connector comprises two pairs of second legs and two common points.

[0064] Clause 50: A support device according to any one of Clauses 46 to 48, wherein the opening connector comprises three or more pairs of second legs and three or more common points.

[0065] Clause 51: A support device according to any one of Clauses 46 to 50, wherein each of the second legs includes an end connected to the at least one ring, and wherein, as the expandable ring expands radially outward, the distance between the ends of the second legs in each pair of second legs increases, thereby causing the portion of the first leg located distal to each common point to rotate about the respective common point, thereby causing the crown of the at least one ring to automatically open to form the open crown.

[0066] Clause 52: A support device according to any one of Clauses 46 to 51, wherein, prior to radial expansion of the main body portion, the first leg extends in an axial direction substantially parallel to the longitudinal axis of the support body.

[0067] Clause 53: A support device comprising: at least one radially expandable body portion extending along a longitudinal axis of the support device and defining a lumen; and at least one outwardly opening portion connected to the body portion, including: at least one radially expandable ring connected to the body portion; and at least one opening connector connected to the at least one ring, configured to automatically open the crown of the at least one ring radially outward relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown, wherein the at least one opening connector includes: a first leg connected to the crown of the at least one ring; and at least a pair of second legs extending at a common point from the first leg to portions of the at least one ring, and wherein at least one of the second legs includes an expandable portion.

[0068] Clause 54: The support device according to Clause 53, wherein the outwardly expandable portion is configured in a nominally expandable configuration in which the angle formed between the first leg and each of the pair of second legs is less than about 120°, and wherein, in the nominally expandable configuration, the expandable portion of the at least one second leg is capable of further extension.

[0069] Clause 55: The support device according to Clause 54, wherein the outwardly expandable portion is configured to transition from the nominal unfolding configuration to the rear-expanding configuration, and wherein the transition from the nominal unfolding configuration to the rear-expanding configuration causes the expandable portion of the at least one second leg to extend.

[0070] Clause 56: The support device according to any one of Clauses 53 to 55, wherein the expandable portion of the at least one second leg includes at least one of a U-shaped bend, a W-shaped bend, an S-shaped bend, and a J-shaped bend.

[0071] Clause 57: A support device according to any one of Clauses 53 to 55, wherein the expandable portion comprises at least one curved segment of the at least one second leg having a curvature greater than 90° and less than or equal to 180°.

[0072] Clause 58: A support device according to any one of Clauses 53 to 57, wherein the at least one opening connector comprises at least two pairs of second legs extending from the first leg to other portions of the at least one ring, and wherein each pair of second legs is connected to the first leg at a unique common point on the first leg.

[0073] Clause 59: A support device comprising: at least one radially expandable body portion extending along a longitudinal axis of the support device and defining a lumen; and at least one outwardly opening portion connected to the body portion, comprising: at least one first radially expandable ring connected to the body portion; at least one first opening connector connected to the at least one first ring and configured to automatically open radially outward in a first direction relative to other portions of the first ring when the body portion is radially expanded, thereby forming a first open crown; at least one second radially expandable ring connected to the first at least one radially expandable ring; and at least one second opening connector connected to the at least one second ring and configured to automatically open radially outward in a second direction different from the first direction and relative to other portions of the second ring when the body portion is radially expanded, thereby forming a second open crown.

[0074] Clause 60: The support device according to Clause 59, wherein the first direction is toward a first end of the support device and the second direction is toward a second end of the support device.

[0075] Clause 61: A support device according to Clause 59 or Clause 60, wherein, when the main body portion expands radially, the first opening crown and the second opening crown extend radially outward and toward each other.

[0076] Clause 62: The support device according to any one of Clauses 59 to 61, wherein the at least one outwardly opening portion comprises: a plurality of first opening connectors connected to the at least one first ring; and a plurality of second opening connectors connected to the at least one second ring.

[0077] Clause 63: The support assembly according to Clause 62, wherein each of the plurality of first opening connectors is axially aligned with one of the plurality of second opening connectors.

[0078] Clause 64: The support device according to Clause 62 or Clause 63, wherein each of the plurality of first opening connectors and the plurality of second opening connectors is of equal length.

[0079] Clause 65: The support device according to Clause 62 or Clause 63, wherein each of the plurality of first opening connectors and the plurality of second opening connectors comprises at least one short opening connector and at least one long opening connector with an axial length longer than the short opening connector.

[0080] Clause 66: The support device according to Clause 65, wherein each of the plurality of first opening connectors and the plurality of second opening connectors comprises a plurality of short opening connectors and a plurality of long opening connectors, the plurality of short opening connectors and the plurality of long opening connectors being connected to the ring at alternating positions around a corresponding ring.

[0081] Clause 67: The support device according to Clause 65 or Clause 66, wherein the short opening connector of the plurality of first opening connectors is axially aligned with the long opening connector of the plurality of second opening connectors, and / or wherein the long opening connector of the plurality of first opening connectors is axially aligned with the short opening connector of the plurality of second opening connectors.

[0082] Clause 68: A support device according to any one of Clauses 59 to 67, wherein the at least one first opening connector and / or the at least one second opening connector comprises: a first leg connected to the crown portion of the at least one ring; and at least a pair of second legs extending from the first leg to other portions of the at least one ring at a common point on the first leg.

[0083] Clause 69: A support device according to any one of Clauses 59 to 67, wherein the at least one first opening connector and / or the at least one second opening connector comprises: a first leg connected to the crown portion of the at least one ring; and a plurality of pairs of second legs extending from the first leg to other portions of the at least one ring, wherein each pair of second legs is connected to the first leg at a unique common point on the first leg.

[0084] Clause 70: A support device comprising: at least one radially expandable body portion extending along a longitudinal axis of the support device and defining a lumen; and at least one outwardly opening portion connected to the body portion, including: at least one radially expandable ring connected to the body portion; and a plurality of opening connectors connected to the at least one ring and configured to automatically open the crown of the at least one ring radially outward relative to other portions of the ring when the body portion is radially expanded, thereby forming an open crown, wherein, prior to the radial expansion of the body portion, the end of the support device formed by the portion of the crown of the at least one ring is angled relative to the longitudinal axis of the at least one radially expandable body portion.

[0085] Clause 71: The support device according to Clause 70, wherein, prior to radial expansion of the main body portion, the end of the support device formed by the portion of the crown forms an angle of about 1° to about 89° relative to the longitudinal axis of the radially expandable body.

[0086] Clause 72: A stent device according to Clause 70 or Clause 71, wherein the stent device is configured to deploy in a branch vessel or artery, wherein a side of the stent device having a shorter axial length is located near a branch portion of the branch vessel, and a longer side of the stent device is positioned against the side of the vessel opposite the branch portion.

[0087] Clause 73: A support device according to any one of Clauses 70 to 72, wherein the end of the at least one radially expandable body portion of the support device is angled relative to the longitudinal axis of the expandable body portion, thereby forming an angled end of the support device.

[0088] Clause 74: A support device according to any one of Clauses 70 to 73, wherein the axial lengths of the plurality of opening connectors are different, thereby forming the angled ends of the support device.

[0089] Clause 75: A support device according to any one of Clauses 70 to 74, wherein one or more of the plurality of opening connectors comprises: a first leg connected to the crown portion of the at least one ring; and a plurality of pairs of second legs extending from the first leg to other portions of the at least one ring, wherein each pair of second legs is connected to the first leg at a unique common point on the first leg.

[0090] These and other features, operational methods and functions of structurally related elements, and combinations of components and manufacturing economies of the apparatus and other embodiments described herein will become more apparent upon consideration of the following description and appended claims with reference to the accompanying drawings, all of which form part of this specification; wherein the same reference numerals denote corresponding components in the various figures. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to limit the scope of the invention. Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “described” as used in this specification and claims include plural references. Attached Figure Description

[0091] Figure 1 This is a perspective view of the support assembly in the retracted position according to one aspect of this disclosure;

[0092] Figure 2A This is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0093] Figure 2B yes Figure 2A A plan view of the support assembly in the retracted position;

[0094] Figure 2C yes Figure 2AA front perspective view of the support assembly in a partially expanded position;

[0095] Figure 2D yes Figure 2A A front perspective view of the support assembly in its expanded position;

[0096] Figure 3A This is a front perspective view of the film-covered support device in the retracted position according to one aspect of this disclosure;

[0097] Figure 3B yes Figure 3A A front perspective view of the covered support device in the expanded position;

[0098] Figure 4A This is a front perspective view of another example of a support device in a retracted position according to one aspect of this disclosure;

[0099] Figure 4B yes Figure 4A A plan view of the support assembly in the retracted position;

[0100] Figure 4C yes Figure 4A A front perspective view of the support assembly in a partially expanded position;

[0101] Figure 4D yes Figure 4A A front perspective view of the support assembly in its expanded position;

[0102] Figure 5A This is a front perspective view of another example of a support device in a retracted position according to one aspect of this disclosure;

[0103] Figure 5B yes Figure 5A A plan view of the support assembly in the retracted position;

[0104] Figure 5C yes Figure 5A A front perspective view of the support assembly in its expanded position;

[0105] Figure 6A This is a front view of another example of a support device in the retracted position according to one aspect of this disclosure;

[0106] Figure 6B yes Figure 6A A plan view of the support assembly in the retracted position;

[0107] Figure 6C yes Figure 6A A front perspective view of the support assembly in a partially expanded position;

[0108] Figure 6D yes Figure 6A A front perspective view of the support assembly in its expanded position;

[0109] Figure 6E yes Figure 6A End view of the expansion support device;

[0110] Figure 7 This is a plan view of another example of a support device in a retracted position according to one aspect of this disclosure;

[0111] Figure 8 This is a plan view of another example of a support device in a retracted position according to one aspect of this disclosure;

[0112] Figure 9A This is a front perspective view of another example of a support device in a retracted position according to one aspect of this disclosure;

[0113] Figure 9B yes Figure 9A A plan view of the support assembly in the retracted position;

[0114] Figure 9C yes Figure 9A A front perspective view of the support assembly in a partially expanded position;

[0115] Figure 9D yes Figure 9A A front perspective view of the support assembly in its expanded position;

[0116] Figure 10A This is a front perspective view of another example of a support device in a retracted position according to one aspect of this disclosure;

[0117] Figure 10B yes Figure 10A A plan view of the support assembly in the retracted position;

[0118] Figure 10C yes Figure 10A A front perspective view of the support assembly in a partially expanded position;

[0119] Figure 10D yes Figure 10A A front perspective view of the support assembly in its expanded position;

[0120] Figure 11 This is a flowchart illustrating a method for deploying a support device according to one aspect of this disclosure;

[0121] Figure 12A This is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0122] Figure 12B yes Figure 12A A plan view of the support assembly in the retracted position;

[0123] Figure 13A This is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0124] Figure 13B yes Figure 13A A plan view of the support assembly in the retracted position;

[0125] Figure 14A It is a perspective view including the opening crown of the opening connector, wherein a pair of side legs or a second leg are connected to the first leg or the main leg at a common point;

[0126] Figure 14B It is a perspective view including the opening crown of the opening connector, wherein two pairs of side legs or second legs are connected to the first leg or main leg at two different common points;

[0127] Figure 14C It is a perspective view including the opening crown of the opening connector, wherein three pairs of side legs or second legs are connected to the first leg or main leg at three different common points;

[0128] Figure 15A , Figure 15B and Figure 15C They are respectively shown as near Figure 14A , Figure 14B and Figure 14C A schematic diagram representing the partially transparent circular area of ​​the open crown;

[0129] Figure 16A This is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0130] Figure 16B yes Figure 16A A plan view of the support assembly in the retracted position;

[0131] Figure 16C yes Figure 16A A front perspective view of the outwardly opening portion of the support device in its nominal unfolding configuration;

[0132] Figure 16D yes Figure 16A A front perspective view of the outwardly opening portion of the support device in a rear-expanding configuration;

[0133] Figures 17A to 17C An example of an expandable portion of a leg of a folding connector according to one aspect of this disclosure is shown;

[0134] Figure 18AThis is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0135] Figure 18B yes Figure 18A A plan view of the support assembly in the retracted position;

[0136] Figure 18C yes Figure 18A A front perspective view of the outwardly opening portion of the support device in a partially expanded position;

[0137] Figure 18D yes Figure 18A A front perspective view of the outwardly opening portion of the support assembly in its fully expanded position;

[0138] Figure 18E This illustrates a representation of a windowed ring according to one aspect of this disclosure. Figure 18A A schematic diagram of the support device;

[0139] Figure 18F This illustrates a configuration according to one aspect of the present disclosure, in which the window ring is engaged with the open structure. Figure 18A A schematic diagram of the support device;

[0140] Figure 19 This is a schematic diagram illustrating a stent device deployed in a patient's vascular system according to one aspect of this disclosure;

[0141] Figure 20A This is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0142] Figure 20B yes Figure 20A A plan view of the support assembly in the retracted position;

[0143] Figure 20C yes Figure 20A A front perspective view of the outwardly opening portion of a support device in an open structure;

[0144] Figure 21A This is a front perspective view of another support device in the retracted position according to one aspect of this disclosure;

[0145] Figure 21B yes Figure 20A A plan view of the support assembly in the retracted position;

[0146] Figure 21C yes Figure 21A A front perspective view of the outwardly opening portion of a support device in an open structure;

[0147] Figure 22The image is a computer-generated image of an exemplary model support designed in the initial or “native” position according to this disclosure;

[0148] Figure 23 yes Figure 22 Computer-generated image of the model support design in a curled position;

[0149] Figure 24 yes Figure 22 Computer-generated image of the modular support design in the expanded position;

[0150] Figure 25 This is a screenshot of a computer modeling program, which shows... Figure 22 The distribution of plastic strain on the expansion portion of the support design;

[0151] Figure 26 yes Figure 25 The screenshot shown illustrates the computer modeling program. Figure 22 The radial displacement profile on the end view of the bracket design;

[0152] Figures 27 to 29 The image shows a photograph of a prototype support manufactured according to the principles of this disclosure.

[0153] Figure 30A This is a computer-generated image showing an end view of an exemplary support device according to the present disclosure;

[0154] Figure 30B It is used with Figure 30A End view of the prototype support device compared with computer-generated images;

[0155] Figure 31A and Figure 31B This is an end view of an exemplary film-coated prototype support device based on the principles of this disclosure; and

[0156] Figure 32 This is a schematic diagram of an intravascular abdominal aortic aneurysm (AAA) device with a window according to one aspect of this disclosure, showing the location where an automatically deployable stent device can be arranged. Detailed Implementation

[0157] The illustrations as a whole show preferred and non-limiting aspects of the apparatus, components, and methods of this disclosure. While the description presents various aspects of the apparatus and components, it should not be construed as limiting this disclosure in any way. Furthermore, modifications, concepts, and applications of aspects of this disclosure should be understood by those skilled in the art to be included, but not limited to, the illustrations and descriptions herein.

[0158] Furthermore, for the purposes described below, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” “radial,” and their derivatives, and as oriented as they are in the accompanying drawings, shall be used in connection with this disclosure. The term “proximal” refers to a direction toward the center or central region of the device. The term “farward” refers to a direction extending outward from the central region of the device. However, it should be understood that, unless explicitly stated otherwise, this disclosure may assume various alternative variations and sequences of steps. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be considered limiting. To facilitate understanding of this disclosure, the accompanying drawings and description illustrate preferred aspects of this disclosure, from which the disclosure, various aspects of its structure, methods of construction and operation, and numerous advantages can be understood and appreciated.

[0159] This disclosure relates in general to support devices, such as Figure 1 The stent device 2 shown is configured to be implanted in a patient’s body channel or tube (referred to herein as a body cavity). Figure 1 The entire support device 2 extending L between the first end 4 and the second end 6 is shown. Other figures show partial views of the support device as a whole, emphasizing the radially outwardly opening portion of the support device during deployment. This disclosure also relates to a method of deploying such a support device 2 within a body cavity.

[0160] According to one aspect of this disclosure, the stent device 2 may be an automatically opening or self-opening stent device, including a portion configured to open radially outward relative to other portions of the stent device 2, such as an outwardly opening portion 14. As used herein, “automatically opening” or “self-opening” means that the outwardly opening portion 14 of the stent device 2 moves to or adopts an opening configuration in response to radial expansion of other portions of the device 2, such as the body portion 12 of the device 2. The body portion 12 may be radially expanded using, for example, an expandable catheter (such as an expandable catheter or a balloon catheter). In response to the radial expansion of the body portion 12, the outwardly opening portion 14 moves to an open position, wherein the outwardly opening portion 14 has a wider diameter and encloses a larger cross-sectional area than other portions of the expandable stent device 2.

[0161] Alternatively, according to another aspect of this disclosure, the stent device 2 may be made of a shape memory alloy that has been heat-set to bias the device into an expanded position without the use of expandable catheters, such as dilatation catheters or balloon catheters. In this case, for example, the body portion 12 can be radially expanded by removing a sheath used to compressively restrain the device. Once the sheath is removed, the stent device 2 automatically expands to a preset configuration. Expansion is not required via dilatation catheters or balloon catheters. In response to the radial expansion of the body portion 12, the outwardly expandable portion 14 moves to an open position, wherein the outwardly expandable portion 14 has a wider diameter and surrounds a larger cross-sectional area than other portions of the expandable stent device 2. In the open position, the open crown of the stent device 2 is prevented from collapsing by a support strut provided by the open connector 18. In the context of the shape memory alloy embodiment, the open connector 18 acts as a support strut when in the expanded position because the shape memory properties of such alloys (such as NITINOL) enable the open connector 18 to support and maintain the expanded configuration of the stent device 2.

[0162] In some examples, the stent device 2 disclosed herein is configured to expand in a non-uniform manner, meaning that the outwardly expandable portion 14 of the stent device 2 expands differently from other portions of the stent device 2 (e.g., expands to encompass a larger cross-sectional area or twists or rotates in a different manner). Non-uniform expansion is generally avoided in conventional stent designs. For example, because the stent device is sized to fit a single lumen diameter, non-uniform radial expansion of the stent device is generally not expected. Since non-uniform expansion is generally avoided, any expansion is provided by a separate second balloon dilation performed after the conventional stent has been deployed into the body cavity. For example, dilation using a separate second balloon is used in procedures such as FEVAR or in procedures where the stent end conforms to an opening (e.g., an inlet) in a body passage or tube.

[0163] The stent device 2, with its self-opening or automatically opening design, eliminates the need for introducing a second dilation or opening catheter to radially open portions of the implanted stent device, a common practice in conventional stent designs. The non-uniform expansion of the stent device 2 also provides enhanced migration resistance and fixation along the device length and / or at selected locations in a prescribed direction. Furthermore, it is believed that eliminating the need to introduce a second catheter into the body cavity to manipulate the stent device 2 reduces the time required for stent deployment procedures, lowers the cost of such procedures, reduces the likelihood of complications, reduces the need for radiation exposure during deployment, improves technical and clinical success rates, and enhances patient safety.

[0164] Furthermore, it should be understood that the arrangement of the stent device 2 disclosed herein is not limited to its use as a fenestrated covered stent in surgical procedures such as fenestrated endovascular aneurysm repair (FEVAR). The stent device design disclosed herein can be used in any number of medical applications and procedures, wherein the self-opening structure can be used to maintain the positioning of the medical device within a body cavity. For example, all medical devices, including implantable grafts, fixation devices, drug delivery devices, filters, shunts, and similar medical devices, can be modified to include the self-opening design of this disclosure.

[0165] In some examples, the outwardly opening portion 14 disclosed herein may also be adapted to radially outwardly deploy barbs, hooks, fasteners, pins, or anchors to contact and engage the inner surface of the body cavity wall, thereby enhancing fixation between the implanted device and the wall. Such improved fixation can help prevent the implanted device from migrating across the body cavity over time. Once the outwardly opening portion 14 is deployed, the opening connector 18, which assists in the deployment of the opening coronal, is tensioned, preventing the opening coronal from collapsing.

[0166] While it is not necessary for any part of the support device 2 to be "self-expanding" or formed of a "self-expanding material" for the function of the support device 2 disclosed herein, in some examples, the body portion 12 or other portions of the support device 2 may be self-expanding. As used herein, a portion of the support device 2 may be "self-expanding," "biased to," or "internal biased to" an orientation or position when, for example, internal forces of the body portion 12 of the support device 2 cause the body portion 12 to adopt a particular orientation or position when deployed or in response to activation conditions (such as temperature changes).

[0167] In some examples, stents formed of shape memory materials can be biased to an deployed or expanded state. Such biased stents are configured to automatically move from a retracted state to an deployed or expanded state immediately after the stent is ejected from the catheter, without requiring, for example, inflation of a balloon or similar expandable structure to expand the stent. In response to radial expansion of the body portion 12, the outwardly expandable portion 14 can “automatically” expand to the expanded configuration as described above. However, in such cases, the outwardly expandable portion 14 may not be formed of a self-expanding material or may not be biased to the expanded configuration. Instead, the outwardly expandable portion 14 expands “automatically” in response to radial outward expansion of the body portion 12. In other words, according to some embodiments of this disclosure, the stent device 2 is made of a self-expanding material (such as a heat-set shape memory nickel-titanium alloy) to allow for self-expansion, thereby causing one or more expandable portions 14 to automatically expand together with the self-expansion of one or more body portions 12. According to other embodiments of this disclosure, one or more body portions 12 and one or more expandable portions 14 are made of a heat-set shape memory nickel-titanium alloy, thus promoting self-expansion.

[0168] As those skilled in the art will understand, manufacturing the support device 2 to be biased to the expansion position increases manufacturing costs because shape memory materials can be more expensive than support materials without shape memory properties. Manufacturing the support to be biased to the expansion position also increases the complexity of the manufacturing process, which further increases manufacturing costs. Therefore, support devices (such as...) Figure 1 The stent device 2 shown, which does not self-expand and is not biased from the inside to the expanded position (as provided by the various stent devices disclosed herein), offers certain advantages over other types of conventional or self-expanding stents known in the art.

[0169] The support device 2 need not be made of a superelastic material, such as NITINOL (a nickel-titanium alloy that differs from other materials due to its shape memory and superelastic properties); however, using such a material can provide benefits useful for various applications. Therefore, according to some embodiments of this disclosure, the support device 2 is made of a shape memory alloy. According to other embodiments of this disclosure, the support device 2 is made of a material other than a shape memory alloy. As described herein, the opening connector 18 and other portions of the device 2 can be “self-expanding” or “internal biased” to an expanded position. In the application described, when the support device 2 is in the expanded position, the opening crown 20b of the opening portion 14 is supported by one or more opening connectors 18. When made of NITINOL and heat-set to the expanded position, one or more opening connectors 18 act as support pillars. Therefore, the construction of the support device 2 disclosed herein can be made self-expanding or internally biased by making the device 2 with NITINOL and heat-setting the device 2 to the expanded state to impart self-expanding, internal biasing characteristics to the device 2. When constructed in the manner described, the opening crown 20b is held in place by one or more opening connectors 18 as long as the diameter of the device 10 remains in the expanded position, thus forming a supported opening.

[0170] As used herein, a component or connector is “biased” or “internal biased” to an orientation or position when internal forces cause it to adopt a particular orientation or position. For example, as described above, a device formed of shape memory material can be thermoset biased to an expanded or extended position. Such devices are configured to automatically move from a retracted position to an expanded or extended position immediately after the device is ejected from the catheter, without requiring, for example, inflation of the dilating catheter device or balloon catheter device to expand the device 10. Therefore, such devices are referred to as “self-expanding.” Some devices formed of shape memory materials can also adopt new orientations or positions in response to temperature changes. For example, a device formed of shape memory material can be configured to expand as the temperature increases, as occurs when the device is implanted in the body. Thus, a device 2 including an expanded coronal portion 20b in the expanded position (which is internally biased and supported to prevent collapse along with the expanded connector 18, as provided by the various stent devices 2 disclosed herein) offers certain advantages over currently available self-expanding devices.

[0171] For details, please refer to the following: Figure 1The stent device 2 is a substantially tubular structure extending between a first end 4 and a second end 6. For example, the tubular structure or main body portion 12 of the stent 2 may be formed from several expandable rings 8 connected together by longitudinally extending members, teeth, and / or struts. The rings 8 and members, teeth, and / or struts of the stent device 2 may be formed from suitable metallic materials such as stainless steel, cobalt-chromium, or nickel-titanium alloys. The stent device 2 may also be formed from, for example, biocompatible polymers, absorbable polymers, and other biomaterials. The stent device 2 may be coated, filmed, partially filmed, fully encapsulated, partially encapsulated, or unfilmed. In some cases, stent devices 2, including those of the elongated members and ring types disclosed herein, may be cut from a continuous tube using automated cutting processes such as laser cutting. In some cases, portions of the stent device 2 may also be formed by joining individual elongated members together to form a tubular structure. For example, elongated members may be joined together by ultrasonic welding, laser welding, or other suitable joining processes. Moreover, multiple teeth or elongated members may be woven together to form portions of the stent device 2.

[0172] In some examples, the stent assembly 2 includes: a radially expandable body portion 12 extending along the longitudinal axis L1 of the stent assembly 2; and an outwardly flaring portion 14 connected to or extending from the body portion 12. The outwardly flaring portion 14 includes several outwardly flaring or protruding structures, referred herein as flaring crown portions or flaring crowns 20a, for maintaining the stent assembly 2 in the body cavity. The outwardly flaring portion 14 can allow unobstructed access after deployment and allows the stent assembly 2 to conform to openings in body passages or tubes. The flaring crowns 20a can include different types of rounded peaks, spikes, protrusions, hooks, barbs, anchors, pins, or similar structures configured to flare radially outward when the flaring crown 14 radially expands. As described in detail herein, the arrangement, size, and shape of these protruding structures, crown portions, or flaring crowns 20a can be selected based on the intended application, the deployment location of the stent assembly, and / or the size and shape of the stent assembly 2.

[0173] In some examples, such as Figure 3A and Figure 3B As shown, the stent device 10 can be covered. It is believed that when used as a bridging stent in a FEVAR, in combination with the expandable portion to include a covering (e.g., PTFE or ePTFE covering) enhances the fixation and seal of the aortic graft. Advantageously, an additional opening step using a second catheter device is not required.

[0174] In some examples, the outwardly opening portion 14 is connected to one end of the main body portion 12, such that the outwardly opening portion 14 forms the first end 4 of the support device 2, as shown below. Figure 1As shown. In other examples, such as... Figures 6A to 6E As shown, one or more outwardly flaring portions 214 can be positioned at any point along the length of the support assembly 2, such as at the middle of the support assembly 2, or between the middle and one of the ends 4, 6 of the support assembly 2. In other configurations, the support assembly 2 may include outwardly flaring portions positioned, for example: at both ends 4, 6 of the support assembly 2; at the middle of the support assembly 2 and one end 4, 6; or at the middle of the support assembly 2 and both ends 4, 6.

[0175] Support with opening at the end

[0176] Figures 2A to 2D An exemplary support device 10 including an openable end portion is shown. The support device 10 includes an outwardly openable portion 14 as in the previous example. Figures 2A to 2D The illustrated outwardly flaring portion 14 may include: a radially expandable ring 16 connected to the body portion 12; and one or more flaring connectors 18 connected to the ring 16 at one or more locations on the ring 16. In other examples, one or more flaring connectors 18 may be connected to a strut 30 extending between the ring 16 and the body portion 12 (e.g., Figure 2B (As shown) or other portions of the circumferential expansion connected to the body 12 to cause one or more opening connectors 18 to move. Figures 2A to 2D As shown, the support assembly 10 includes eight opening connectors 18 extending around the ring 16. However, the number of opening connectors 18 is not intended to limit the scope of this disclosure. For example, some support assemblies 10 may include fewer than eight opening connectors 18. Some support assemblies 10 may include only a single opening connector 18 positioned on the ring 16. Some support assemblies 10 may include more than eight opening connectors 18. In any case, when the ring 16 and the body portion 12 are expanded, one or more opening connectors 18 are configured to allow a portion or segment of the ring 16 (referred herein to as the opening crown 20a) to be expanded. Figure 2A and Figure 2B As shown, the openable crown 20a opens radially outward relative to the other parts of the ring 16. Therefore, when the main body 12 and the ring 16 expand, the openable crown 20a opens radially outward relative to the other parts of the support assembly 10, thereby forming the openable crown 20b (as shown). Figure 2C and Figure 2D(As shown). The dimensions of the outwardly flaring portion 14, such as its longitudinal length, can be selected based on the size of the support assembly 10 and its intended use. For example, a support assembly 10 with a longer outwardly flaring portion 14 can extend radially outward from the body portion 12 more than a shorter outwardly flaring portion 14. Similarly, the opening angle, length, and geometry of the opening crown 20b can be selected or customized for a specific application. For example, the opening crown 20b can have an opening angle relative to the longitudinal axis L1 ranging from greater than 0° to greater than 90°. In some preferred examples, the opening crown 20b can be configured to open at approximately 45° relative to the longitudinal axis L1. In other examples, the opening crown 20b can open outward from the body portion 12 by only 10° or less (within this range, the lower limit of the outward opening of the opening crown 20b is substantially greater than zero degrees, as will be understood by those skilled in the art).

[0177] To allow the openable crown 20a to open radially outward, the opening connector 18 is configured in the retracted position ( Figure 2A and Figure 2B (as shown), partial expansion location ( Figure 2C (as shown) and fully expanded position ( Figure 2D Transition between (as shown in the image). In the retracted position ( Figure 2A and Figure 2B As shown in the diagram, the expandable crown 20a is recessed or substantially aligned longitudinally with the corresponding areas of the body portion 12 and the ring 16 of the stent assembly 10. In this position, the expandable crown 20a does not protrude or substantially does not protrude beyond the outer circumference defined by the body portion 12 and the ring 16 of the stent assembly 10, thus giving the stent assembly 10 a substantially cylindrical appearance. In the retracted position, the stent assembly 10 can be easily advanced through the catheter to the expanded position within the body cavity. In the partially and fully expanded positions (… Figure 2C and Figure 2D As shown in the diagram, the openable crown 20a of the ring 16 opens radially outward relative to the main body portion 12 and is not longitudinally aligned with the corresponding area of ​​the main body portion 12, as shown in the diagram. Figure 2C and Figure 2D As shown.

[0178] As previously described, the stent assembly 10 opens automatically or self-opens. Therefore, unlike conventional stent assemblies where the second conduit expands after deployment to open a specific area of ​​the stent assembly 10, one or more opening connectors 18 of this disclosure are configured to automatically transition from a retracted position to an expanded position in response to radially outward expansion of other portions or regions of the stent assembly 10, such as the body portion 12. As previously stated, the one or more opening connectors 18 need not be self-expanding and / or internally biased to the expanded position to induce such a transition, as occurs with the stent assembly 10 formed of a shape memory material.

[0179] In some examples, at least one ring 16 of the outwardly opening portion 14 is a circular or cylindrical structure, at least in the retracted position. When the opening connector 18 is in the retracted position, the distance D1 between the opening crown 20a and the main body portion 12 of the ring 16 and the longitudinal axis L1 of the support assembly 10 is... Figure 2A (As shown) are all the same. When one or more opening connectors 18 are in the expanded position ( Figure 2D As shown in the diagram, the distance from the open crown 20b of ring 16 to the central longitudinal axis L1 is D2, while the distance from the main body 12 to the central longitudinal axis L1 is D3. Both distances D2 and D3 are longer than distance D1. Figure 2D As shown, because the open crown 20b opens outward relative to the main body 12, the distance D2 is greater than the distance D3.

[0180] For details, please refer to the following: Figure 2B The expandable ring 16 may be formed from a plurality of flexible, folded, or curved segments or regions configured to expand radially outward as the ring 16 expands. For example, the expandable ring 16 may include repeating or substantially repeating curved segments 22 connected end-to-end around the circumference of the ring 16. As used herein, “substantially repeating” may refer to a unit (e.g., a curved segment 22) that repeats around the circumference of the ring 16, but may be adapted to minor interruptions in the repeating pattern. Therefore, the arrangement of the curved segments 22 of the ring 16 is not intended to limit it to a strict and precise repeating pattern of the curved segments 22. For example, a ring 16 that includes repeating curved segments 22 but has one or more minor interruptions in the repeating pattern is considered to be within the scope of this disclosure. “Minor interruptions” may be deletions, replacements, or alterations to the repeating pattern, for example, that do not affect the overall expansion of the ring 16. For example, some curved segments 22 of the ring 16 may be of different lengths or may contain a greater degree of curvature compared to other segments 22, as long as the ring 16 is able to expand in response to the expansion of an expandable member (such as a balloon catheter), as described herein.

[0181] In some examples, each bend 22 includes a peak 24, a valley 26, and a transition region 28 between the peak 24 and the valley 26. The segments 22 are arranged such that the transition regions 28 of adjacent bends 22 connect to the peak 24 or valley 26 of each bend 22. The ring 16 may also include longitudinally extending struts 30 that connect some or all of the bends 22 to corresponding points on the body portion 12 of the support assembly 10. For example, the strut 30 may extend between the valley 26 of the bend 22 of the ring 16 and the corresponding peak 34 of the ring 32 of the body portion 12.

[0182] Continue to refer to Figure 2BThe main body portion 12 of the support device 10 is typically a cylindrical structure configured to be positioned within a body cavity and maintain its patency. The main body portion 12 may include several different structural elements, including continuous tubular members, porous or non-porous membranes or sheets, woven mesh members, or frames of interconnecting members or teeth formed in various forms. Because any suitable main body portion 12 capable of radially expanding from a retracted state to an expanded state can be used with the expandable portion 14 of this disclosure, the construction of the main body portion 12 is not generally intended to be construed as limiting the scope of this disclosure. Typically, the main body portion 12 is capable of radially expanding between a retracted state for facilitating insertion into the body cavity and an expanded state for maintaining the patency of the body cavity. The type, design, or arrangement of the interconnecting members or teeth can vary and may include, for example, interconnecting spiral coils, rings, and struts. In one example, the main body portion 12 includes: radially expandable rings 32 arranged in series along the longitudinal axis L1 of the support device 10; and at least one interconnecting member 36 extending between the rings 32 and connecting them. As previously described, for example, radial expansion of the main body portion 12 including the ring 32, achieved by the expansion of the balloon catheter positioned in the stent device 10, causes the opening connector 18 of the outwardly opening portion 14 to be turned to the expanded position.

[0183] Similar to the expandable ring 16 of the outwardly opening portion 14, the ring 32 of the main body portion 12 may include substantially repeating curved segments 38 connected end-to-end around the circumference of the ring 32. Each curved segment 38 may include a peak 34, a valley 40, and a transition region 42 extending between the peak 34 and the valley 40. The rings 32 may be arranged in series along the longitudinal axis L1 of the support assembly 10 in various orientations. For example, adjacent rings 32 may be aligned such that the peak 34 of one ring 32 is positioned near the valley 40 of the adjacent ring 32, as... Figure 2B As shown. In other examples, ring 32 can be arranged such that the peak 34 of one ring 32 is longitudinally aligned with the peak 34 of the adjacent ring 32. In other examples, the peak 34 and valley 40 can be offset from the peak 34 and valley 40 of the adjacent ring 32.

[0184] Continue to refer to Figure 2B The interconnecting member 36 is a longitudinally extending structure, such as a strut or tooth, that connects a portion of one ring 32 to a corresponding portion of an adjacent ring 32. For example, the interconnecting member 36 can connect the midpoint 44 of a transition region 42 of one ring 32 to the midpoint 44 of a transition region 42 of an adjacent ring 32. In some cases, the interconnecting member 36 includes a first connecting end 46 connected to the ring 32, a second connecting end 48 connected to the adjacent ring 32 opposite to the first connecting end 46, and an elongated portion 50 extending between the connecting ends 46, 48. The interconnecting member 36 can be a flexible structure configured to bend, flex, or buckle to accommodate expansion of the body portion 12 of the support assembly 10. For example, as Figure 2C and Figure 2D As shown, the interconnecting member 36 is depicted as slightly bent due to the expansion of the ring 32. In some examples, the interconnecting member 36 may also be bent or twisted to accommodate the torsion of different parts of the support assembly 10 during expansion.

[0185] The structure of the opening connector 18 and its movement between the retracted and expanded positions will now be described in detail. As previously mentioned, the opening connector 18 is configured to allow the opening crown 20a of the ring 16 (such as...) Figure 2B (As shown) responds to the radial expansion of the main body 12 and the expandable ring 16, opening radially outward to form an open crown 20b (such as... Figure 2C and Figure 2D (As shown). Therefore, in practice, the opening connector 18 is designed and arranged to convert the radial expansion of the ring 16 into a pivoting or rotational movement sufficient to cause the openable crown 20a of the ring 16 to open radially outward relative to the other parts of the ring 16 to form the openable crown portion 20b. As previously mentioned, the opening connector 18 can be customized and designed to provide different degrees or angles of opening depending on the intended use or size of the support assembly 10. For internally biased support assemblies made of shape memory alloys, these support assemblies are constructed with the following characteristic: the opening connector 18 is configured to allow the openable crown 20a to open radially outward together with the radial expansion of the ring 16 of the outwardly opening portion 14. Support assemblies without internal bias also have the aforementioned characteristic. However, internally biased support assemblies have the additional characteristic that their opening connector 18 (which has been heat-set to the expanded position) provides at least some internal bias force that causes the self-opening device to self-expand.

[0186] In some examples, the flared connector 18 is a frame, column, or connector that includes an inclined first portion or leg 52, an inclined second portion or leg 54, and a longitudinally extending third portion or leg 56. Legs 52, 54, and 56 are fixedly connected together at a common point 58. In some embodiments, the common point 58 is a center point defining the geometric center or centroid of the flared connector 18; however, in other embodiments, the common point 58 is not a center point. Figure 2B As shown, the first portion or leg 52 includes an end connected to the strut 30 at a first position 60, the second portion or leg 54 includes an end connected to the strut 30 at a second position 62, and the third portion or leg 56 includes an end connected to the ring 16 at a third position 64. In other examples, legs 52, 54 may be connected to the ring 16 instead of the strut 30. For example, legs 52, 54 may be connected near the valley 26 of the ring 16 or to other portions of the curved section 22, such as at a location along the transition region 28.

[0187] The open connector 18 or legs 52, 54, 56 are configured such that the distance between the first position 60 and the second position 62 increases as the expandable ring 16 expands radially outward, as compared to distance D4 (in Figure 2C (in the middle) and distance D5 (in Figure 2D As shown in the diagram, distance D5 is greater than distance D4. Increasing the distance between the ends of the first leg 52 and the second leg 54 will cause the opening connector 18 to change from the retracted position to the expanded position, for example, by making the common point 58 in the proximal direction (by... Figure 2C and Figure 2D (As shown by arrow A1) Move upwards and cause the third part of the open connector 18 or the leg 56 to move along arrow A2 ( Figure 2C and Figure 2D (As shown) pivot or rotate about the common point 58 in the direction of the ring 16, thereby causing the openable crown 20a of the ring 16 to open radially outward to the expanded position, as shown. Figure 2D As shown, to form an open crown portion 20b.

[0188] In some examples, the legs 52, 54, and 56 may be positioned symmetrically relative to the openable crown 20a. However, because those skilled in the art can determine that one or more of the legs 52, 54, and 56 are of different lengths and / or asymmetrical embodiments, the described configuration of the legs 52, 54, and 56 is not intended to limit the scope of this disclosure. For example, the length of one or more of the legs 52, 54, and 56 may be adjusted or tuned to exert a degree of torsion about the axis of the openable crown 20a as it transforms into the openable crown 20b.

[0189] In some examples, outriggers 52, 54 may be connected to circumferentially periodic locations on the support assembly 10, such as along the curved section 22 or the longitudinally extending strut 30. Figure 2B(As shown in the diagram). As previously described, the radial expansion of the device 10 increases the circumferential spacing of the legs 52, 54, resulting in an increased angle formed by the legs 52, 54. Furthermore, tensile loads exist in the legs 52, 54, 56 of the opening connector 18. The tensile load within the leg 56 acts in both radial and axial directions at the third position 64, with a net effect of bending the openable crown 20a relative to the longitudinal axis L1, causing the openable crown 20a to displace radially away from the expanding body portion 12 as the body portion 12 of the device 10 expands radially. Kinematically, it is believed that the degree of opening can be determined by the rate of increase of the angle between the legs 52, 54 compared to the unfolding of one or more segments of the ring 16. In some examples, the degree of opening can be controlled by the overall amplitude of the openable crown 20a (i.e., the linear dimension along the longitudinal axis L1 of the support device 10). The degree of opening can also be influenced by the relative amplitude or height of different portions of the opening connector 18 and / or the position of the common point 58. For example, the degree of opening can be based on the difference in amplitude or height between the legs 52, 54 of the opening connector 18 and the third leg 56.

[0190] As previously described, the outwardly expandable portion 14 of the stent device 10 is configured to facilitate holding the deployed stent device 10 in a desired position within the body cavity, due to the expansionable coronary 20a forming an expansionable coronary 20b. The stent device 10 can also be configured to provide unobstructed access to the stented vessel for future cannulation. In some examples, to secure the stent device 10 in the desired deployed position, the ring 16 of the outwardly expandable portion 14 includes structures for engaging the walls of the body cavity to hold or secure the stent device 10 in place. For example, as discussed herein, the expansionable coronary 20a may include, for example, teeth, barbs, or pins for engaging the walls of the body cavity. In some examples, such as when the stent device 10 is made of a shape memory alloy, the outwardly expandable portion 14 forms the expansionable coronary 20b after radial expansion and is prevented from collapsing by an expansion connector 18, which also serves as a support strut in the expanded configuration.

[0191] The stent device 10 may be a covered stent or a partially covered stent. Exemplary covered stent devices 10 incorporating the features of this disclosure are... Figure 3A It is shown in a retracted state and in Figure 3B It is shown in an expanded state. For example... Figure 3A and Figure 3BAs shown, the main body portion 12 and / or the outwardly expandable portion 14 of the stent device 10 includes a membrane 66 surrounding at least a portion of the main body portion 12 and / or the outwardly expandable portion 14 of the stent device 10. The membrane 66 can be formed of a sheet, tube, or film, such as a biocompatible material. The sheet, tube, or film can be configured to protect the walls of the body cavity from the edges of the rings or interconnecting portions of the stent device 10, for example, to prevent endoleak and restenosis. In some cases, the membrane 66 can be formed of a low-friction material configured to protect the stent device 10 and reduce or prevent biomaterial adhesion to portions of the stent device 10. For example, the low-friction material can be PTFE or ePTFE. When the stent device 10 is in the retracted position ( Figure 3A ) to expand position ( Figure 3B When the film 66 is stretched, the material of the film 66 has appropriate elasticity to withstand the stretch without breaking; however, the elasticity of the material of the film 66 is not too strong, so the material will not cause the support device 10 to collapse from the expanded position back to the retracted position.

[0192] refer to Figures 4A to 4D Another exemplary support device 10b is shown, which includes an outwardly opening portion 14b positioned near an end of the support device 10b. Device 10b includes elements similar to those in the previous example, including, for example, an expandable ring 16b, an opening connector 18b, and a body portion 12b. However, Figures 4A to 4D The support device 10b differs from the previous example in the positioning of the legs 52b, 54b of the opening connector 18b. Specifically, the legs 52b, 54b of the opening connector 18b are connected to the transition region 28b of the curved section 22b. Figure 4B (as shown), instead of being connected to pillar 30b, with Figures 2A to 2D The same applies to the support assembly 10 shown. Due to the positioning of the legs 52b, 54b, the amplitude or height (i.e., linear dimension) of the opening connector 18b can be smaller than that in the previous example, where the legs are connected to the support column 30b. Furthermore, the degree of opening can be influenced by the relative amplitudes of different portions of the opening connector 18b and / or the position of the common point 58b. For example, by connecting the legs 52b, 54b to the ring 16b instead of the support column 30b, the outwardly opening portion 14b can expand in a unique orientation. In a similar manner, the outwardly opening portion 14b can have greater flexibility for twisting or rotating when deployed compared to when the legs 52b, 54b of the opening connector are directly connected to the support column 30b.

[0193] refer to Figures 5A to 5CThis illustration shows another example of a support device 110 incorporating the features of this disclosure. The support device 110 includes a body portion 112 and an outwardly expandable portion 114, the outwardly expandable portion including expandable rings 116 formed by repeating curved segments 122 of the aforementioned example. Furthermore, as in the preceding example, the body portion 112 includes a plurality of radially extending rings 132. Each ring 132 includes repeating curved segments 138, the curved segments including peaks 134, valleys 140, and transition regions 142.

[0194] However, as Figures 5A to 5C As shown and unlike the previous examples, the expandable ring 116 of the outwardly flaring portion 114 includes fewer bends 122 than the ring 132 of the main body portion 112. For example, the ring 116 of the outwardly flaring portion 114 may have twelve bends 122, while the ring 132 of the main body portion 112 may have twenty-four bends 138, as... Figure 5B As shown. As used herein, "curved segment" refers to a single segment of rings 116, 132. Therefore, the openable or opening crown of ring 116 includes upwardly oriented curved segments and downwardly oriented curved segments. In other words, ring 116 having twelve curved segments 122 includes six openable or opening crowns, each crown formed by upwardly oriented curved segments and downwardly oriented curved segments. Furthermore, rings 116, 132 having twelve curved segments 122, 138 will have six peaks 134 and / or six opening connectors 118.

[0195] like Figures 5A to 5C As shown, the curved segment 122 is positioned as two corresponding curved segments 138 spanning the ring 132 of the main body portion 112. Since the outwardly expandable portion 114 includes fewer curved segments 122 than in the previous example, it also includes fewer opening connectors 118 and longitudinally extending struts 130 than in the previous example. Increasing the length of the curved segments 122 of the outwardly expandable portion 114 compared to the previous example allows for greater design flexibility for the outwardly expandable portion 114. For example, because the curved segments 122 are longer (e.g., spanning a longer portion of the ring 116), the ring 116 can be made thicker or wider than in the previous example, which can improve the strength of the outwardly expandable portion 114 to better resist migration through the body cavity when expanded. Moreover, increasing the length of the curved segments 122 or changing the geometry of the opening connectors when in the expanded state increases the diameter difference between the main body portion 112 and the outwardly expandable portion 114 of the support assembly 110. An increased diameter difference can be useful for stents designed to extend between body cavities of different sizes and increase resistance to migration through the cavity or to create an unobstructed pathway into a stented vessel for future cannulation.

[0196] In addition, although Figures 5A to 5CThe curved segment 122 is shown as two corresponding curved segments 138 spanning the ring 132 of the main body portion 112, but this arrangement does not limit the scope of this disclosure. For example, the curved segment 122 of the outwardly opening portion 114 may span multiple corresponding curved segments 138 of the ring 132 of the main body portion 112. Moreover, in some examples, different curved segments 122 of the outwardly opening portion 114 may span different numbers of curved segments 138 of the main body portion 112. For example, some curved segments 122 of the outwardly opening portion 122 may be longer, thus spanning multiple corresponding curved segments 138 of the main body portion 112, while other curved segments 122 may be shorter, thus spanning only one or two curved segments 138 of the main body portion.

[0197] Figures 6A to 6E An exemplary support device 210 is shown, including one or more expandable portions positioned between the ends of the support device 210. For example, the support device 210 may expand at or near the middle of the device 210, or at one end closer to the ends of the device 210. The support 210 may expand in a first direction (e.g., toward a first end of the device) or a second direction (e.g., toward a second end of the device). As in the previous examples, the support device 210 includes a body portion 212 and an outwardly expandable portion 214 connected together along the longitudinal axis of the support device 210. As in the previous examples, the body portion 212 is an example of a support body that can be used with the support device 210 of this disclosure. However, since a variety of suitable body portions capable of radially expanding from a retracted state to an expanded state can be used with the outwardly expandable portion 214 disclosed herein, the structure of the support body 210 should not be construed as limiting the disclosure. Furthermore, unlike the previous example, the outwardly opening portion 214 is located in the middle of the support assembly 210, for example, between the first main body portion and the second main body portion 212. Moreover, the openable crown 220a of the outwardly opening portion 214 ( Figure 6A and Figure 6B The orientation (as shown) can vary. For example, some openable crowns 220a may be configured to open toward or towards the first end 270 of the support device 210, while other openable crowns 220a may be configured to open outward toward the second end 272 of the support device 210. Figures 6A to 6E In a non-limiting example, multiple openable crowns 220a point directly toward or open toward the second end 272.

[0198] As in the previous example, the outwardly opening portion 214 includes an expandable ring 216, which includes repeating bending segments 222. Figure 6B(As shown in the diagram). The outwardly opening portion 214 also includes opening connectors 218 connected to some of the curved sections in the curved section 222, which, when the ring 216 and the body portion 212 expand, cause the opening crown 220a of the ring 216 to open radially outward to form the opening crown 220b. Figure 6C and Figure 6E (As shown in the diagram). Only those curved sections 222 with the opening connector 218 form the openable crown 220a, which opens to form the openable crown 220b when the ring 216 expands.

[0199] The outwardly opening portion 214 may also include a support column 230. Figures 6B to 6D As shown in the diagram, the support 230 is used to connect the curved segment 222 of the expandable ring 216 to the corresponding curved segment 238 on the ring 232 of the body portion 212 of the support assembly 210. The support 230 typically extends from the peak 234 of the ring 232 of the body portion 212 to the valley 226 of the ring 216 of the outwardly expandable portion 212. The support assembly 210 may also include a plurality of interconnecting members 236, whose shape and size are similar to the interconnecting member 36 described in conjunction with the preceding examples. The interconnecting member 236 may extend between the midpoint 244 of the transition region 242 of the curved segment 238 of the ring 232 on the body portion 212 and the midpoint 245 of the transition region 228 of the curved segment 222 on the ring 216. In other examples, the interconnecting member 236 may be connected to any convenient portion of the curved segment 238. As in the previous example, the interconnecting member 236 includes a first coupling end 246 connected to one of the rings 232, a second coupling end 248 connected to the ring 216, and an elongated region 250 extending between the coupling end portions 246, 248.

[0200] exist Figures 6A to 6EIn the example shown, the support assembly 210 includes two opening connectors 218 circumferentially connected along a ring 216 of an outwardly opening portion 214. The opening connectors 218 are arranged in the same orientation, meaning that when the opening connectors 218 are in the expanded position, each opening crown 220b points towards the second end 272 of the support assembly 210. However, other arrangements are possible within the scope of this disclosure. For example, the direction in which the opening crowns 220b point or open can alternate around the ring 216, such that when the opening connectors 218 and the rings 216, 232 are in the expanded position, the support assembly 210 includes some opening crowns 220b pointing towards the first end 270 and some opening crowns 220b pointing in the opposite direction (e.g., towards the second end 272). Furthermore, in some examples, the opening connectors 218 may be positioned at multiple locations along the longitudinal length of the support assembly 210. For example, the support device 210 may include a plurality of outwardly flared portions 214 spaced longitudinally from each other along the longitudinal length of the support device 210. In some examples, the support device 210 may include outwardly flared portions 214 at one or both ends of the device 210 and outwardly flared portions 214 spaced longitudinally from each other along the longitudinal length of the support device 210.

[0201] In some examples, the openable crown 220a and openable crown 220b of ring 216 may include protrusions 268, such as barbs, tips, pins, or hooks, which radially open outward and press into the wall of the body cavity as the opening connector 218 moves toward the expanded position and as the openable crown 220a opens to form the openable crown 220b. Like the opening connector 218 and the corresponding openable crown 220a, the protrusions 268 may be configured to remain in the retracted position when the support assembly 210 is advanced into the expanded position within the body cavity. Once the support assembly 210 is in place within the body cavity, the protrusions 268 are configured to move together with the opening connector 218 and the openable crown 220b to adopt an expanded or outwardly projecting configuration and engage the wall of the body cavity due to the formation of the openable crown 220b.

[0202] Support with multiple outwardly opening rings

[0203] Figure 7 and Figure 8 Exemplary support devices 310, 410 are shown, including outwardly opening portions 314, 414 having multiple rings 316a, 316b, 416a, 416b and multiple rows of opening connectors 318, 418. For example, as... Figure 7As shown, the outwardly opening portion 314 of the support assembly 310 includes: a first ring 316a positioned at an end of the support assembly 310; and a second ring 316b positioned between the first ring 316a and the main body portion 312. The first ring 316a and the second ring 316b can be connected together by longitudinal struts 330. Furthermore, the second ring 316b can be connected to the main body portion 312 by another row of longitudinally extending struts 330. For example, as... Figure 7 As shown, rings 316a and 316b are arranged such that the valley 326 of the first ring 316a is adjacent to and connected to the peak 324 of the second ring 316b via a support post 330.

[0204] As in the previous example, the body portion 312 includes an expandable ring 332 connected by interconnecting members 336. The body portion 312 is configured to expand radially outward when: for example, when an expandable catheter (such as a balloon catheter) positioned in the body portion 312 expands by inflating a balloon; or, in the case of an embodiment made of a shape memory alloy, when an internal biasing force provided by the shape memory alloy causes automatic self-expansion to proceed to the expansion configuration. The expansion of the body portion 312 causes the outwardly expandable portion 314 to move from a retracted position to an expanded position, wherein the expandable crown 320a ( Figure 7 (As shown) it expands radially outward to form an open crown.

[0205] The outwardly flaring portion 314 also includes flaring connectors 318 connected to the rings 316a, 316b at different locations around the circumference of each ring 316a, 316b. For example, each ring 316a, 316b may include eight flaring connectors 318 spaced apart around the circumference of the rings 316a, 316b. In some examples, the flaring connectors 318 may be equidistantly spaced around the circumference of the rings 316a, 316b. In other examples, the flaring connectors 318 may be spaced at any distance. The flaring connectors 318 connected to the rings 316a, 316b may be substantially identical to each other and structurally similar. Figures 4A to 4D The example shown is the opening connector 18b. In other examples, the opening connector 318 may have a different shape than the opening connector described above. For example, the lengths of the legs 352, 354, and 356 may be determined to achieve the desired opening amplitude. Figure 7 As shown, the legs 352, 354 of each of the opening connectors 318 are connected to portions of the rings 316a, 316b. However, the connection points of the legs 352, 354, 356 are not intended to be restrictive, and for example, some or all of the opening connectors 318 may include legs 352, 354 connected to the strut 330.

[0206] Typically, compared to exemplary support devices of this disclosure where the outwardly opening portion comprises only a single ring, the outwardly opening portion 314, including multiple rings 316a, 316b, provides increased opening movement or degree of opening. Specifically, as the main body portion 312 of the support device 310 expands radially, the opening crown 320a of the second ring 316b opens radially outward, which also effectively causes a portion of the first ring 316a to move radially outward, thus forming a double-opening configuration. As the first ring 316a expands, the opening crown 320a of the first ring 316a also opens outward, resulting in the outwardly opening portion 314 encompassing a larger cross-sectional area compared to the case where only a single ring exists.

[0207] Figure 8 Another exemplary support device 410 is shown, which includes an outwardly opening portion 414 comprising two rings 416a and 416b and two rows of opening connectors 418. Similar to the previous example, the first ring 416a is positioned at an end of the support device 410 and connected to the second ring 416b via, for example, a longitudinally extending strut 430. In other examples, the first ring 416a may be directly connected to the second ring 416b or connected via a variety of other longitudinally and / or circumferentially extending members. The second ring 416b is connected to a ring 432 of the body portion 412 via another row of longitudinally extending struts 430. The support 410 differs from the previous example in that the first ring 416a includes fewer opening connectors 418 than the second ring 416b. Specifically, as... Figure 8 As shown, the first ring 416a includes four opening connectors 418 connected to the opening crown 420a, while the second ring 416b includes eight opening connectors 418. Therefore, each opening crown 420a of the first ring 416a spans two opening crowns 420a of the second ring 416b. Furthermore, the opening connectors 418 of the first ring 416a are shorter than those of the second ring 416b. As previously mentioned, shorter opening connectors open outwards by a smaller amount than longer connectors. Of course, as the main body 412 of the support assembly 410 expands radially, the opening crowns 420a of the second ring 416b open radially outwards, which also effectively causes a portion of the first ring 416a to move radially outwards, thus forming another double-opening configuration, which is similar to... Figure 7 The double-opening structure of the support device 310 is fundamentally different. As the first ring 416a expands, the openable crown 420a of the first ring 416a also opens outward, resulting in the outwardly opening portion 414 enclosing a larger cross-sectional area compared to the case where only a single ring exists.

[0208] Bracket with connectors of varying lengths

[0209] Figures 9A to 9DAnother exemplary support device 510 is shown. Similar to the previous example, the support device 510 includes an outwardly flaring portion 514 connected to the main body portion 512 via a longitudinal strut 530. Specifically, for example, as... Figure 9B As shown, the support column 530 extends between the valley 526 of the ring 516 of the outwardly opening portion 514 and the peak 534 of the ring 532 of the main body portion 512.

[0210] As in the previous example, the outwardly opening portion 514 includes an expandable ring 516 and an openable crown 520a. Figure 9A and Figure 9B As shown in the diagram, when the main body portion 512 of the device 510 expands radially outward, these openable crowns open radially outward to form openable crowns 520b. Figure 9C and Figure 9D (As shown in the diagram). The outwardly opening portion 514 also includes opening connectors 518a, 518b, which are connected to the ring 516 to open the openable crown 520a outward in response to the radial expansion of the device 510.

[0211] The support assembly 510 differs from the previous examples in that it includes opening connectors 518a and 518b of different sizes. For example, the outwardly opening portion 514 may include a combination of long opening connectors 518a and short opening connectors 518b. The support assembly 510 may include four long opening connectors 518a and four short opening connectors 518b. The opening connectors 518a and 518b may be positioned alternately around the circumference of the ring 516. In other examples, the opening connectors 518a and 518b may be arranged in any convenient manner.

[0212] like Figure 9B The first leg 552a and the second leg 554a of the elongated opening connector 518a are connected to the ring 516 near the valley 526 of the ring 516. Therefore, the elongated opening connector has a total amplitude or height H1 in the retracted position, as... Figure 9B As shown. The legs 552b and 554b of the short opening connector 518b are connected to the ring 516 at a midpoint between the peak 524 and the valley 526. Therefore, the short opening connector 518b in the retracted position ( Figure 9B(As shown) has a total amplitude or height H2, which is shorter than the height H1 of the long opening connector 518a. Changing the height or amplitude of a portion of the opening connectors 518a and 518b will affect the degree of opening of the opening crown 520b. For example, the degree of opening of the opening crown 520b can be a function of one or more of the following: the total height of the connectors 518a and 518b; the lengths of the legs 552a, 552b, 554a, and 554b; and / or the ratio between the lengths of the legs 552a, 552b, 554a, and 554b and the total heights H1 and H2 of the opening crown 520a.

[0213] In some examples, due to differences in height or amplitude, the outwardly opening portion 514 of the support device 510, including the opening connectors 518a, 518b, may have a partially folded appearance or a grooved structure when unfolded and expanded. Some of the opening crowns 520b open further away from the longitudinal axis L1 of the device 510 than other opening crowns 520b due to differences in the height and position of the opening connectors 518a, 518b.

[0214] Bracket with bendable connector

[0215] Figures 10A to 10D Another exemplary support device 610 is shown. Similar to the previous example, the support device 610 includes an outwardly opening portion 614 connected to the main body portion 612. The outwardly opening portion 614 is structurally similar to... Figures 4A to 4D The outwardly opening portion 14b shown includes, for example, an expandable ring 616 and opening connectors 618. Specifically, the support assembly 610 includes eight opening connectors 618 configured to allow the opening crown 620a ( Figure 10A and Figure 10B (As shown) it opens radially outward to form an open crown 620b ( Figure 10C and Figure 10D (As shown in the diagram). Legs 652, 654 of the opening connector 618 are connected to the portion of ring 618 near the valley 626 of ring 616. Of course, in other embodiments, the opening connector 618 may be connected to a portion of ring 618 located at or near the midpoint between the peak 624 and valley 626 of ring 616. Indeed, in any of the foregoing embodiments employing the opening connector, the opening connector may be connected to portions of the expandable ring that are outwardly expandable, located near the valley of the expandable ring, or near the midpoint between the peak and valley of the expandable portion of the ring, or anywhere within the aforementioned range.

[0216] The support assembly 610 differs from the previous example in that the substantially straight, longitudinally extending strut of the previous example is replaced by a flexible or curved connector 630. The curved connector 630 includes: a first end 660 connected to the valley 626 of the ring 616 of the outwardly flaring portion 614; and a second end 662 connected to the ring 632 of the body portion 612. For example, the second end 662 may be connected to a transition region 642 of the ring 632 that is close to but slightly away from the peak 634 of the ring 632 (i.e., offset from the peak 634 of the ring 632).

[0217] When the support device 610 expands and the crown 620a can be opened ( Figure 10A and Figure 10B When (as shown) it opens radially outward to form an open crown 620b ( Figure 10C and Figure 10D As shown in the diagram, the bending connector 630 allows the outwardly flaring portion 614 to have greater freedom of movement relative to the main body portion 612. For example, due to the flexibility of the bending connector 630, the outwardly flaring portion 614 can be slightly twisted or rotated relative to the main body portion 612 of the support assembly 610, as can be seen by comparing the outwardly flaring portion 614 in a partially expanded position (as shown in the diagram). Figure 10C (as shown) and in the fully expanded position ( Figure 10D The position is shown in the diagram. Specifically, at the fully expanded position (as shown in the diagram). Figure 10D As shown in the diagram, the outwardly flaring portion 614 rotates slightly such that the valley 626 of the ring 616 is not longitudinally aligned with the peak 634 of the ring 632 of the main body portion 612. In contrast, in the previously described exemplary support device, where the rings of the outwardly flaring portion are connected to the main body portion by longitudinally extending, substantially linear struts, the alignment of the valleys and peaks of the rings of the outwardly flaring portion with the main body portion does not change significantly or substantially when the support device expands and the flaring crown opens radially outward to form the open crown. Therefore, the support device 610 has the characteristic that the longitudinal alignment of the peak 634 of the ring 632 with the valley 626 of the ring 616 is not maintained when the rings 616 and 632 expand and the flaring crown 620a transforms into the open crown 620b.

[0218] A bracket with an open connector having two or more common points.

[0219] Figures 12A to 13B An additional exemplary support assembly 810 is shown. Similar to the previous examples, the support assembly 810 includes a longitudinal strut 830 connected to an outwardly flaring portion 814 of the body portion 812 via an expandable ring 816. In other examples, the strut 830 may be composed of a curved connector (such as from 10A to...). Figure 10DThe curved connector 630 shown is used instead to allow the outwardly opening portion 814 to have greater freedom of movement relative to the main body portion 812. Figures 12A to 13B As shown, the strut 830 extends between the valley 826 of the ring 816 of the outwardly flaring portion 814 and the peak 834 of the ring 832 of the main body portion 812. The main body portion 812 may include any of the features of the aforementioned main body portions, including a plurality of rings, helices, and combinations thereof arranged in series. The main body portion 812 may be coated or uncoated. The main body portion 812 and the outwardly flaring portion 814 may be formed of a shape memory alloy heat-set to an expanded structure, or of any other of the aforementioned biocompatible materials, with or without shape memory properties.

[0220] The outwardly opening portion 814 includes an expandable ring 816 and an openable crown 820a. Figure 12A , Figure 12B , Figure 13A and Figure 13B As shown in the diagram, when the main body portion 812 of the support assembly 810 expands radially outward, these openable crowns open radially outward to form openable crowns 820b. Figure 14B and Figure 14C (As shown). The outwardly opening portion 814 also includes an opening connector 818a (as shown). Figure 12A and 12B (as shown) or open connector 818b ( Figure 13A and 13B (As shown in the diagram), these connectors are attached to the ring 816 to allow the openable crown 820a of the ring 816 to open radially outward in response to the radial expansion of the device 810.

[0221] The support assembly 810 differs from the previous examples in the construction of the opening connectors 818a and 818b. The opening connectors include a center point or common point (such as...). Figure 2B The commonality shown in point 58) differs from the preceding examples. Figures 12A to 13B The opening connectors 818a and 818b in the middle have several common features. For example, the opening connector 818a ( Figure 12A and Figure 12B (As shown) includes two common features. The opening connector 818b ( Figure 13A and Figure 13B (As shown) there are three common points. However, Figures 12A to 13B The number of common features shown is not intended to limit the scope of this disclosure. In some examples, the opening connectors 818a, 818b may include more than three common features.

[0222] In some examples, the opening connectors 818a, 818b include an axially oriented leg or first leg 852 connected to the opening crown 820a of the ring 816. For example, the axially oriented leg or first leg 852 may be connected at or near the peak 824 of the ring 816. The axially oriented leg or first leg 852 extends axially in a proximal direction from the peak 824 of the ring 816 toward the body portion 812 of the support assembly 810. The opening connectors 818a, 818b also include multiple pairs of side legs or second legs 854 extending from the first leg 852 to other portions of the ring 816. As used herein, "a pair of side legs or second legs" means at the same common point, such as at the first common point 858 (…). Figures 12A to 13B (as shown), second common point 860 ( Figures 12A to 13B (as shown) and / or the third common point 862 ( Figure 13A and Figure 13B As shown (if present), two side legs or a second leg 854 extend from the first leg 852. The side legs or the second leg 854 can extend from the first leg 852 to any convenient location on the ring 816. For example, as... Figures 12A to 13B As shown, a pair of side legs or second legs 854 extend from a first common point 858 to a pillar 830. Other pairs of second legs 854 extend from common points 860, 862 to a transition region 828 of the ring 816, which extends between a valley 826 and a peak 824 of the ring 816. In other examples, the side legs or second legs 854 may be connected to the peak 824, valley 826, or any other convenient location on the ring 816.

[0223] like Figure 12A and Figure 12B As shown, the opening connector 818a includes two pairs of side legs or second legs 854 extending from the axially oriented leg or first leg 852 at two distinct common points (i.e., first common point 858 and second common point 860). Figure 13A and Figure 13B As shown, the opening connector 818b includes three pairs of side legs or second legs 854 extending from the axially oriented leg or first leg 852 at three distinct common points (i.e., first common point 858, second common point 860, and third common point 862). As used herein, a "distinctive common point" refers to a location on the axially oriented leg or first leg 852 from which each of a pair of side legs or second legs 854 extends. The other pairs of second legs extend from other common points located elsewhere along the first leg 852. The common points 858, 860, and 862 are spaced apart from each other by a selected distance (e.g., distance D10). Figure 12B and Figure 13B (as shown) and / or distance D12 ( Figure 13B As shown in the diagram). The farthest common point is spaced apart from the peak 824 of ring 816 by a distance D14. Figure 12B and Figure 13B As shown in the diagram). As discussed in further detail herein, the distances D10, D12, D14 between the corresponding common points 858, 860, 862 and between the common points 860, 862 and the peak 824, as well as the length of the second leg 854, can be selected to obtain an open crown 820b with a specific curvature and / or a specific backward bend. Figure 14B and Figure 14C As shown). Figure 12B and Figure 13B As shown, the distance D10 between the common points 858 and 860 is... Figure 12B and Figure 13B (as shown) and distance D12 (only in) Figure 13B (As shown) is significantly greater than the distance D14 between the farthest common points 860, 862 and the peak 824 of ring 816. Figure 12B and Figure 13B (as shown in the diagram). However, the construction described is not intended to be limiting, and in other examples, the lengths of D10 to D14 may be equal, or the length of D14 may be greater than the lengths of D10 and D12. Typically, when distance D14 is small compared to distances D10 and / or D12, the radially outermost tip or portion of the opening crown 820b is only slightly curved, which has a limited effect on the overall opening of the opening crown 820b. In contrast, when distances D10, D12, and D14 are similar in length, the opening crown 820b has a more uniform curvature along its entire length (including at the radially outermost tip or portion of the opening crown 820b).

[0224] As in the previous example, the opening connectors 818a, 818b are configured to open the openable crown 820a radially outward relative to the rest of the ring 816 to form the openable crown 820b when the main body portion 812 expands radially. Figure 14B and Figure 14C As shown in the diagram. More specifically, as the main body 812 expands radially, the distance D16 between the side legs of the ring 816 connected to each pair of second legs 854 or between the ends of the second legs 854 (as shown in the diagram). Figure 12B and Figure 13B(As shown) This increases the number of legs, causing the portions of the first leg 852 located distal to common points 858, 860, 862 to rotate about the respective common points 858, 860, 862, thereby causing the openable crown 820a to automatically open radially outward to form the openable crown 820b. Including multiple pairs of side legs or second legs 854 and multiple common points 858, 860, 862 in the opening connectors 818a, 818b will cause the radially outermost tip or portion of the openable crown 820b to bend rearward (i.e., radially inward and towards the body portion 812 in the direction of arrow A10, as shown). Figure 14B and Figure 14C (As shown). For example, the outermost radial tip or portion may be relative to the longitudinal axis L1 of the support assembly 10 (as shown). Figure 12A and Figure 13A (As shown in the figure) it bends at an angle α10 greater than 90° (i.e., the range is from greater than 90° to less than 180°).

[0225] As those skilled in the art will understand, the number of pairs of side legs or second legs 854, the number of common points 858, 860, 862, the distances D10, D12, D14 between common points in opening connectors 818a, 818b, and the length of the side legs or second legs 854 affect the curvature and angle α10 of the opening connector 820b. Typically, including multiple pairs of second legs 854 and common points 858, 860, 862 allows for additional control over the curvature of the opening crown 820b. Furthermore, the contribution of each pair of second legs 854 and common points 858, 860, 862 to the overall opening of the opening crown 820b is influenced by the distances D10, D12, D14 between common points 858, 860, 862 and the peak 824, as well as the length of the second legs 854.

[0226] Figures 14A to 14C The diagram shows open crown portions 20b and 820b, which include open connectors 18, 818a, and 818b with varying numbers of common features. (See diagram for reference.) Figure 14A As shown, the open connector 18 has only one thing in common (similar to) Figure 2A and Figure 2B The opening connector 18 shown has an angle α10 of approximately 90°, meaning that the opening connector 20b will not bend backward. The opening crown 820b has an opening connector 818a with two common points 858 and 860. Figure 14B (As shown) It bends slightly backward at an angle α10 of slightly more than 90°. The opening crown 820b has an opening connector 818b with three common points 858, 860, and 862. Figure 14C As shown in the diagram, the opening is more pronounced backward, with the opening angle α10 being generally greater than 90°.

[0227] In some examples, the curvature of the dilated coronary 820b is selected and controlled for specific surgical procedures, such as fenestrated endovascular aneurysm repair (FEVAR) surgery. For FEVAR surgery, increasing the opening of the dilated coronary 820b may be important for better sealing of the fenestration. For example, Figures 15A to 15C A partially transparent circular region 802 is shown, which is the same size and shape and is placed relative to the open crowns 20b and 820b. Figures 15A to 15C The circular region 802 illustrates how the curvature of the opening coronals 20b and 820b affects their interaction with annular structures, such as other intravascular components or aspects of the target vascular system. Specifically, Figures 15A to 15C This shows an increase in the opening of the crown portion by 20b ( Figure 15A ), 820b Figure 15B and Figure 15C The curvature of the circular region 802 allows for improved interaction between the open crown portions 20b and 820b. As the number of the second leg pairs and common points increases from one ( Figure 15A Increased to three ( Figure 15C The curvature of the open crown 820b better matches the shape of the circular region 802.

[0228] Support with opening connector for post-expansion repositioning

[0229] Figures 16A to 16D Another exemplary support device 910 is shown. Similar to the previous example, the support device 910 has a longitudinal axis L1. Figure 16A (As shown) includes an outwardly flaring portion 914 connected to the body portion 912 via a longitudinal strut 930 of a ring 916. The strut 930 extends between the valley 926 of the ring 916 of the outwardly flaring portion 914 and the peak 934 of the ring 932 of the body portion 912. The body portion 912 and the outwardly flaring portion 914 may be formed of any of the aforementioned materials (including, for example, shape memory materials biased or heat-set to an expanded position), or of a biocompatible material without shape memory properties. The outwardly flaring portion 914 includes an expandable ring 916 and a flaring connector 918 connected to the ring 916. When the body portion 912 expands radially outward, the flaring connector 918 is configured such that the flaring crown 920a of the ring 916 ( Figure 16A and Figure 16B (As shown) it opens radially outward relative to the other parts of ring 916 to form an open crown 920b ( Figure 16C and Figure 16D (as shown in the image).

[0230] The opening connector 918 includes an axially oriented leg or first leg 952 connected to the opening crown 920a of the ring 916. For example, one end of the first leg 952 may be connected to the ring 916 near the peak 924, and the first leg may extend axially in a proximal direction from the peak 924 of the ring 916 toward the body portion 912 of the support assembly 910. The opening connector 918 also includes one or more pairs of lateral legs or second legs 954 extending from the first leg 952 to portions of the ring 916. For example, as... Figures 16A to 16D As shown, the opening connector 918 includes a pair of side legs or second legs 954 extending from a common point 958 on the axially oriented leg or first leg 952 to the strut 930 of the ring 916; however, this configuration is not intended to limit the scope of this disclosure. In other examples, the opening connector 918 may include multiple pairs of side legs or second legs 954 and multiple common points, such as Figures 12A to 13B An exemplary support device 810 is shown in the diagram. Furthermore, a side leg or second leg 954 can be connected to the ring 916 at any location on the ring 916. For example, the side leg or second leg 954 can be connected to the strut 930, valley 926, peak 924, or transition portion 928 of the ring 916 (e.g., between the peak 924 and valley 926).

[0231] The opening connector 918 differs from the previous example because the second leg 954 includes an expandable portion 964 capable of increasing length after the support assembly 910 has initially deployed to the nominal deployment configuration. As used herein, "nominal deployment configuration" Figure 16C (As shown in the diagram) refers to a position in which the open coronary portion 920b extends radially outward, for example, by a sufficient amount relative to the other portions of the stent device 910, thereby maintaining the positioning of the stent device 910 within the body's blood vessels. However, for some procedures, it may be desirable to perform post-dilation of the stent device 910 after initial deployment.

[0232] In the “nominal deployment configuration”, the deploying connector 918 can be arranged such that the angle α12 between the axial directional leg or the first leg 952 and either the side leg or the second leg 954 is ( Figure 16C As shown, the angle α12 is reduced to approximately 90°. For example, in the nominal unfolded configuration, the angle α12 can be less than 120°, less than 105°, or approximately 90°. Significantly, in the nominal unfolded configuration (… Figure 16C As shown, the expandable portion 964 of the side leg or second leg 954 remains extendable, meaning that the distance D16 between the ends of the side leg or second leg 954 connected to the ring 916 can be increased. Increasing the distance D16 between the ends of the second leg 954 (as shown) Figure 16B , Figure 16C and Figure 16DThe capability shown allows for post-expansion adjustment of the stent device 910 after initial deployment. As used herein, "post-expansion adjustment" may refer to increasing the expansion diameter of the rings 916, 932 of the stent device 910, and adjusting or repositioning the opening of the coronal portion 920b after nominal deployment of the expandable stent device 910. To post-expansion of the stent device 910, after nominal deployment, the user may use a second deployment device, such as a second expandable balloon catheter, to post-expansion the stent device 910. In some examples, post-expansion is performed to aid in sealing around the opening or to conform the stent device 910 to the opening. In some examples, during post-expansion, the diameter of the rings 916, 932 of the stent device 910 may increase by approximately 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm compared to the diameter of the rings 916, 932 during nominal deployment. In a specific example, the diameter of rings 916 and 932 can be increased by 4 mm, from 6 mm (in the nominal unfolded configuration) to 10 mm in the post-expanded or fully unfolded configuration.

[0233] To allow for such post-expansion adjustment and repositioning, the expandable portion 964 has the desired sufficient rigidity and / or an appropriate geometry to accommodate the support assembly 910 from its constrained position. Figure 16A and Figure 16B (as shown) to the nominal expansion construction ( Figure 16C (as shown) resists elongation and / or straightening during the initial unfolding. This is achieved during post-expansion adjustment or from the nominal unfolding construction (as shown). Figure 16C Repositioned to post-extensional structures Figure 16D During this period, the expandable portion 964 is stretched or straightened to increase the distance D16 between the ends of the side leg or the second leg 954. Without these expandable portions 964, the side leg or the second leg 954 of the opening connector 918 would be fully extended (e.g., unfolded and straightened) during the initial deployment of the support assembly 910, which would mean that it would be difficult to perform post-expansion of the support assembly 910 after the initial deployment.

[0234] The expandable portion 964 can refer to any part or segment of the second leg 954 when the outwardly opening portion 914 is in the nominally deployed configuration. Figure 16C The expandable portion 964 may include segments and portions of the second leg 954, having specific material properties, geometry, thickness, width, curvature, and / or amplitude to substantially or partially resist movement (e.g., stretching or unfolding) during the nominal deployment of the support assembly 910, and retaining the ability to extend further when the opening connector 918 is in the nominally deployed configuration. Thus, the expandable portion 964 allows the opening connector 918 to extend from the nominally deployed configuration ( Figure 16C ) transforms into a post-expanding or fully unfolded structure ( Figure 16D).

[0235] In some examples, the expandable portion 964 may be a part or segment of a side leg or a second leg 954, comprising a stretchable or elastic material that allows for the basic extension of the second leg 954. In other examples, the expandable portion 964 may include mechanical structures such as springs, telescopic arrangements, and other mechanisms for extending the length of the member. Continue to refer to Figures 16A to 16D In some examples, the expandable portion 964 includes one or more bends, ridges, or curves 966 configured to allow rearward expansion of the second leg 954. The curves 966 of the expandable portion 964 are configured to remain folded during the initial deployment of the support assembly 910. During rearward expansion repositioning or adjustment of the support assembly 910, the curves 966 of the expandable portion 964 unfold as the opening connector 918 moves from the nominal open configuration to the rearward expansion configuration. In the rearward expansion configuration ( Figure 16D In the expansion portion 964, the curved portion 966 is fully or partially expanded, such that the second leg 954 is substantially straight. In some examples, the expansion portion 964 may include various configurations of bends and curves 966 selected to allow for different degrees of post-expansion adjustment or repositioning. For example, the expansion portion 964 may include bends or curves 966 with a curvature greater than 90° and less than or equal to 180°. In some examples, the expansion portion includes a U-shaped bend (…). Figure 17A ), J-shaped bend ( Figure 17B ) or S-shaped bend ( Figure 17C The length of the expandable portion 964, the number of curved portions, the curvature, and / or the shape of the curved portion 966 are selected based on the amount of post-expansion extension or repositioning that may be required for different uses, surgical procedures, and techniques.

[0236] Bracket with opposing opening connectors for automatic alignment

[0237] Figures 18A to 18F Another example of a support device 1010 is shown. The support device 1010 includes an outwardly flaring portion 1014 connected to the main body portion 1012 via an elongated longitudinal strut or member 1030. For example, as... Figure 18BAs shown, the ring 1016 of the outwardly flaring portion 1014 includes a valley 1026 and a peak 1024. An elongated member 1030 extends between the valley 1026 of the ring 1016 and a portion of the ring 1032 of the body portion 1012. For example, the elongated member 1030 may be connected to a transition region 1038 of the ring 1032 between the peak 1034 and the valley 1036. In other examples, the elongated member 1030 may be connected to the valley 1036, the peak 1034, or any other convenient location on the ring 1032. The body portion 1012 and the outwardly flaring portion 1014 may be formed of any of the aforementioned materials, including biocompatible shape memory materials and biocompatible materials without shape memory properties. The portion of the support device 1010 including the body 1012 and / or the outwardly flaring portion 1014 may be coated. The membrane can be made of PTFE, ePTFE or other biocompatible hydrophobic materials. The outwardly opening portion 1014 of the support device 1010 can be positioned at one end of the support device 1010, at both ends of the support device 1010 or in the middle portion of the support device 1010.

[0238] The stent assembly 1010 differs from the previous example in that the outwardly expandable portion 1014 includes two expandable rings, such as an inner or first expandable ring 1016 and an outer or second expandable ring 1070. The first ring 1016 includes an expandable crown 1020a oriented in a first direction (e.g., pointing towards a first end of the stent assembly 1010), and the second ring 1070 includes an expandable crown 1074a oriented in a second direction (e.g., pointing towards a second end of the stent assembly 1010). Figure 18B and Figure 18C As shown, when the main body 1012 and the rings 1016 and 1070 expand radially, the openable crowns 1020a and 1074a are configured to open radially outward and toward each other.

[0239] The first ring 1016 and the second ring 1070 are along the longitudinal axis L1 of the support assembly 1010. Figure 18A The rings 1016 and 1070 are arranged in series and connected together by longitudinal struts 1040. As shown, struts 1040 extend between the valley 1026 of the inner ring or first ring 1016 and the valley 1076 of the outer ring or second ring 1070. In other examples, struts 1040 may be connected between transition portions of the rings 1016 and 1070 (such as the transition portion between the valley 1076 and the peak 1078 of ring 1070), or to any other convenient location on the rings 1016 and 1070.

[0240] The outwardly opening portion 1014 further includes: an opening connector 1018 connected to the opening crown 1020a; and an opening connector 1072 connected to the opening crown 1074a. As in the previous example, the opening connectors 1018 and 1072 include a first leg 1052 and a side leg or second leg 1054 connected together and at a common point 1058 to the first leg 1052. The opening connector 1018 is connected to the inner ring or the first ring 1016 and is oriented in a first direction (e.g., towards the first end of the support assembly 1010). The opening connector 1072 is connected to the outer ring or the second ring 1070 and is oriented in the opposite direction (e.g., towards the second end of the support assembly 1010). The opening connectors 1018 and 1072 are configured to open the openable crowns 1020a and 1074a radially outward in response to the radial expansion of the main body portion 1012 and the rings 1016 and 1070, thereby opening the openable crowns 1020a and 1074a ( Figure 18A and Figure 18B (as shown) becomes the open crown 1020b, 1074b ( Figure 18C and Figure 18D As shown in the diagram). As previously described, the expandable crowns 1020a and 1074a are configured to open toward each other, such that the expandable crowns 1020b and 1074b form or define annular grooves or recesses, sized to engage, grasp, capture, and / or align with certain annular structures, such as the fenestration ring 1002 of an endoplasm. Figure 18E and Figure 18F (as shown in the image).

[0241] A fenestration ring 1002 is typically included in the endgraft to allow access to branch vessels. Since the vessels leading to the fenestration may not be square (e.g., forming a 90° angle with each other), it is useful to have an auto-alignment feature on the self-opening stent. Therefore, the stent assembly 1010 includes an outwardly opening portion 1014 that captures the fenestration ring 1002 and serves as an auto-alignment structure. Specifically, the outwardly opening portion 1014 of the stent assembly 1010, comprising rings 1016, 1070 with opposite orientations, can be configured to capture and align with the fenestration ring 1002 during the deployment of the openable coronals 1020a, 1074a to ensure proper alignment of the stent assembly 1010 relative to the graft. By capturing and properly aligning with the fenestration ring 1002, the openable coronals 1020b, 1074b are ensured to be adequately secured to the fenestration ring 1002, which, as desired, forms a seal sufficient to prevent leakage (e.g., type IIIa endoleak).

[0242] Continue to refer to Figures 18A to 18DRings 1016 and 1070 may include any number of openable crowns 1020a and 1074a and openable connectors 1018 and 1072, selected, for example, based on the size and shape of the blood vessel, the implant, and the fenestration ring 1002. For example, Figures 18A to 18D The rings 1016 and 1070 each include six opening connectors 1018 and 1072 and openable crowns 1020a and 1074a or openable crowns 1020b and 1074b. However, within the scope of this disclosure, the number of openable connectors and crowns is variable and may be more or less than six. In some cases, and although not shown in the figures, the rings 1016 and 1070 may include non-openable crowns circumferentially distributed between the openable crowns 1020a and 1074a around the rings 1016 and 1070. Moreover, the extent of the openable crowns 1020a and 1074a (and the non-openable crowns, if present) is adjustable to any desired length and / or can be configured to open to any desired extent depending on the intended use of the support assembly 1010. Figures 18A to 18D As shown, in some examples, the opening connector 1018 of the first ring 1016 can be axially aligned with the corresponding opening connector 1072 of the second ring 1070. In other examples, some or all of the opening connectors of the inner ring or the opening connectors 1018 of the first ring 1016 can be deflected or offset from the opening connectors 1072 of the outer ring or the second ring 1070, such that the opening crown 1074b of the outer ring or the second ring 1070 can be twisted, pivoted or rotated relative to the opening crown 1020b of the inner ring or the first ring 1016.

[0243] In some examples, the outwardly opening portion 1014 includes opening connectors 1018 and 1072 of different lengths. For example, as... Figure 18B As shown, the opening connectors 1018 and 1072 may include a short opening connector with an axial length L10 and a long opening connector with a longer axial length L12. For Figures 18A to 18DIn the exemplary support device 1010 shown, the ratio (L12 / L10) between the length L12 of the longer opening connectors 1018, 1072 and the length L10 of the shorter opening connectors 1018, 1072 is 1.6 (4:2.5). However, this exemplary ratio between lengths L12 and L10 is not intended to be limiting. In other examples, the ratio of length L12 to length L10 may be selected based on the dimensions (e.g., diameter or thickness) of the ring or annular structure intended to be grasped by the opening crowns 1020b, 1074b. For example, the length L10 of the shorter opening connectors 1018, 1072 may be from about 99% to about 1% of the length L12 of the longer opening connectors 1018, 1072. In other examples, the length L10 may be approximately 90%, approximately 80%, approximately 75%, approximately 50%, or approximately 25% of the length L12 of the longer open connectors 1018 and 1072.

[0244] In some examples, short flare connectors (shown by length L10) and long flare connectors (shown by length L12) can alternate around the circumference of each ring 1016, 1070, as... Figures 18A to 18D As shown. However, the described configuration of the long and short opening connectors 1018, 1072 and the openable crowns 1020a, 1074a is not intended to be limiting, and in other examples, the long crowns 1020a, 1074a may be separated from other long crowns by two or more short crowns surrounding the circumference of the rings 1016, 1070. Alternatively, the short crowns 1020a, 1074a may be separated from other short crowns by two or more long crowns surrounding the circumference of the rings 1016, 1070. In some examples, the short opening connectors and openable crowns 1020a, 1074a of one ring 1016, 1070 may be axially aligned with the long opening connectors 1018, 1072 and the corresponding openable crowns 1020a, 1074a of another ring 1016, 1070.

[0245] Short and long opening connectors 1018 and 1072 can be provided to facilitate the unfolding of the scaffold assembly 1010 relative to the endoplasty at the desired location. In particular, when the scaffold assembly 1010 is implanted under fluorescence examination, precise alignment of the scaffold assembly 1010 and the fenestration ring 1002 of the endoplasty may be difficult. Such alignment can be facilitated by increasing the size of the target placement area (i.e., the portion of the outwardly opening portion 1014 that must contact the fenestration ring 1002 to successfully receive or capture the ring 1002) without substantially increasing the overall length of the scaffold assembly 1010 or the outwardly opening portion 1014. Figure 18E and Figure 18F A schematic diagram showing the bracket assembly 1010 and the window ring 1002 is provided. (See attached diagram.) Figure 18E As shown, the window ring 1002 of the cover bracket device 1010 is relative to the longitudinal axis L1 of the bracket device 1010. Figure 18A (As shown) it is tilted at an angle α14. However, since the window ring 1002 is located in the area defined by the longer opening connectors 1018, 1072 and the opening crowns 1020a, 1074a of length L12 in the "target parking area", the window ring 1002 can be captured or received therein by the grooves defined by the opening crowns 1020b, 1074b. In particular, as the opening crowns 1020a, 1074a open radially outward, the longer opening crowns 1020a, 1074a can contact and align the window ring 1002 and the support device 1010, such that when fully extended, the window ring 1002 is captured and correctly aligned with the opening crowns 1020b, 1074b, as... Figure 18F As shown.

[0246] Stents with angled ends or openings for branch vessels

[0247] Figures 19 to 21C Other exemplary support devices 1110 are shown in the figure. Support device 1110 includes an outwardly opening portion 1114, wherein an opening crown 1120a is provided at an end of device 1110, the end being relative to the longitudinal axis L1 of support device 1110. Figure 20A and Figure 21A (as shown in the diagram) at an angle. For example, before the support device 1110 expands radially, the end of the support device 1110 formed by the portion of the openable crown 1120a can be at an angle α16 relative to the longitudinal axis L1 of the support device 1110. Figure 20A (As shown in the diagram). Angle α16 can be selected based on the intended use of the support device 1110 and can vary relative to the longitudinal axis L1 of the support device 1110 in, for example, a range of about 1 degree to about 89 degrees.

[0248] For a stent device 1110 with an angled end, the degree of opening of the expandable coronary 1120a can vary around the circumference of the stent device 1110, such that the geometry of the expandable coronary 1120b is a function of circumferential position. It is believed that, compared to the aforementioned uniformly opening stent device (e.g., a stent device with a flat end), the stent device 1110 (which has an angled end with a variable degree of opening around the circumference of the device 1110) better adapts to the shape of the opening at a bifurcation-associated location in the vascular system. Bifurcation-associated regions in the vascular system include, for example, the bifurcation of the common iliac artery / internal iliac artery and upwardly oriented visceral vessels. When deployed at such bifurcations, a uniformly opening stent device would protrude into the main vessel. In contrast, the stent device 1110 with an angled, outwardly expandable portion 1114 better conforms to the shape of the opening.

[0249] Figure 19 A stent device 1110 with an angled end extending into the internal iliac artery is depicted. For example... Figure 19 As shown, due to the angled, outwardly opening portion 1114, the portion of the stent device 1110 extending into the main blood vessel is minimized. Conversely, in the expansion configuration, the opening coronary portion 1120b at the angled end of the stent device 1110 conforms to the opening and does not protrude significantly into the main blood vessel (e.g., the iliac artery).

[0250] Similar to the previous example, the support assembly 1110 includes a longitudinal strut 1130 connected to an outwardly flaring portion 1114 of the body portion 1112 via an expandable ring 1116. For example, the strut 1130 may extend between the valley 1126 of the ring 1116 of the outwardly flaring portion 1114 and the peak 1134 of the ring 1132 of the body portion 1112, or between any other convenient location on the rings 1116, 1132. The outwardly flaring portion 1114 includes an expandable ring 1116 and a flaring crown 1120a, which flares radially outward to form a flaring crown 1120b when the body portion 1112 of the support assembly 1110 expands radially outward. Figure 20C and Figure 21C(As shown in the diagram). The outwardly opening portion 1114 also includes an opening connector 1118 connected to the ring 1116 to allow the opening crown 1120a to open radially outward in response to radial expansion of the support assembly 1110. As in the previous examples, the opening connector 1118 may include an axially oriented leg or a first leg 1152 extending proximally from the peak 1124 of the ring 1116 toward the body portion 1112 of the support assembly 1110. The opening connector 1118 may also include one or more pairs of lateral legs or second legs 1154 extending from the first leg 1152 from a common point 1158 toward other portions of the ring 1116. In some examples, the opening connector 1118 may include multiple pairs of second legs 1118 and multiple common points. The body portion 1112 and the outwardly opening portion 1114 may be formed of any of the aforementioned biocompatible materials, including materials with shape memory properties and materials without shape memory properties. For a stent device 1110 formed of a shape memory material, when the device 1110 is released from, for example, the distal end of a delivery catheter, the outwardly expandable portion 1114 can automatically expand radially outward. For a stent device formed of a material that does not have shape memory properties, when the main body 1112 is expanded using, for example, an expandable balloon catheter, the outwardly expandable portion 1114 can expand.

[0251] The support assembly 1110 may include various structural features and configurations for providing an angled end of an outwardly flaring portion 1114. In some examples, such as Figures 20A to 20C As shown, the end of the radially expandable main body portion 1112 of the support device 1120 is relative to the longitudinal axis L1 of the expandable main body portion 1112. Figure 20A (As shown in the diagram) Angled. The outwardly opening portion 1114 extends from the angled end of the main body portion 1112 and is thus angled at an angle similar to that of the end of the main body portion 1112. To provide the angled end of the main body portion 1112, the farthest ring 1132 of the main body portion 1112 may include curved sections of varying lengths (e.g., peaks 1134, valleys 1136, and transition regions 1138 between peaks 1134 and valleys 1136) to form the angled end. Due to the orientation of the angled ring 1132, some or all of the opening connectors 1118 and the opening crown 1120a extending from the ring 1132 are angled relative to the longitudinal axis L1 of the support assembly 1110. For example, one of the opening connectors 1118 is angled α18 relative to the longitudinal axis L1 of the support assembly 1110, as shown in the diagram. Figure 20AAs shown. Angle α18 can be between approximately 1 degree and approximately 89 degrees. The angles of the opening connector 1118 and the opening crown 1120b can be selected or modified to provide further control over the steepness of the angle of the end of the outwardly opening portion 1114 and the degree of opening of the opening crown 1120b, to ensure that the support assembly 1110 can be securely installed in the opening when deployed.

[0252] In other examples, such as Figures 21A to 21C As shown, the end of the main body 1112 is not angled (e.g., it is flat and transverse to the longitudinal axis L1 of the support assembly 1110), and conversely, the axial length L16 of the opening connector 1118 and the opening crown 1120a is ( Figure 21B The difference is as shown in the diagram. Specifically, the axial length L16 of the opening connector 1118 and the opening crown 1120a is different. Figure 21B As shown, the angled ends of the support device 1110 are formed by the circumference of the device 1110 increasing in a circular manner.

[0253] Expanding method

[0254] refer to Figure 11 This document illustrates a method for deploying a stent device including the features described herein. The deployment method can be applied to any embodiment of the stent device embodiments of this disclosure. As shown in step 710 of the method, the stent device is prepared for surgery by removing it from its packaging and removing the protective sheath covering the stent during storage. The stent device is initially positioned in a retracted position, such as coiled on a balloon catheter. In the retracted position, for example, as... Figure 2A As shown, the main body and the outwardly opening portion are aligned longitudinally. Furthermore, both the main body and the outwardly opening portion of the support assembly are equidistant from the central longitudinal axis of the support assembly.

[0255] In step 712 of the method, a delivery assembly including a catheter or sheath and a guidewire is provided for advancing the stent device through the patient's vascular system to a deployment location. The deployment location can be any desired location within the patient's vascular system. For example, the stent device can be deployed in a blood vessel or artery. In some examples, the stent device is deployed in an internal graft. For a stent device (which has an outwardly flaring portion with an angled end), such as... Figures 19 to 21C As shown, the deployment position can be located within a branch vessel or artery adjacent to the opening. As previously described, the stent device is coiled into the balloon catheter and can be inserted into the delivery catheter. To deploy the stent device, in step 714 of the method, a guidewire is introduced through the vascular system to the desired deployment position. Once the guidewire is in place, in step 716 of the method, the delivery catheter, balloon catheter, and stent device mounted thereon are advanced through the guidewire to the deployment position.

[0256] In step 718 of the method, once the stent device is in the desired deployment position, the balloon catheter is dilated. As previously described, the radial outward expansion of the expandable portion of the balloon catheter causes the expandable ring and outwardly expandable portion of the stent device to expand outward. In the case of a self-expanding stent device (such as a stent device made of shape memory alloy), step 718 can be modified to release the stent device only from the delivery system, allowing the self-expanding stent device to self-expand to the previously heat-set internal bias configuration. In this case, releasing the self-expanding stent device involves releasing the stent device from the delivery system such that the self-expanding stent device is no longer constrained by the stent delivery system and remains in the retracted configuration. Because it is released from the stent delivery system, the self-expanding stent device can freely self-expand to the expansion position without dilating the balloon.

[0257] In step 720 of the method, in response to the expansion of the ring, the opening connector changes from a retracted position to an expanded position, thereby partially opening the expandable ring of the outwardly opening portion. For example, during the expansion of the main body and the ring, the first portion or leg and the second portion or leg of each opening connector can move away from each other, thereby causing the third portion or leg of the opening connector to rotate forward in the direction of arrow A2 (e.g., Figure 2C and 2D (As shown), this causes the coronal portion of the ring to project radially outward relative to the other parts of the ring and the main body of the stent assembly, thereby forming an open coronal portion. When in the expanded position, the outwardly expandable portion of the stent assembly helps maintain the positioning of the stent assembly in the expanded position within the body cavity. According to the method, when the ring of the outwardly expandable portion and / or the main body is manufactured to expand via self-expansion or via balloon expansion, the self-expansion process that occurs as the expandable coronal portion transforms into an open coronal portion relative to the expandable coronal portion can occur automatically. Because the expandable coronal portion automatically transforms into an open coronal portion when the expandable ring of the outwardly expandable portion is expanded, a second balloon catheter is not required to achieve the opening of the coronal portion of the outwardly expandable portion when the stent assembly is expanded.

[0258] Continue to refer to Figure 11 For support devices including expandable connectors (such as...) Figures 16A to 16D The support device 910 shown has an expandable portion 964. The support device is initially deployed to a nominal deployed configuration, such as... Figure 16C As shown. In this case, in step 722, a post-expansion can be performed to change the support device from a nominally deployed configuration to a post-expansion or fully deployed configuration. Figure 16D(As shown in the diagram). In some cases, the stent device can be post-expanded while in its nominally deployed configuration by introducing a second expandable catheter (such as a second balloon catheter) into the lumen of the stent device. The expandable catheter is then expanded, increasing the diameter of the stent device to a post-expanded or fully deployed configuration. For example, as previously described, the diameter of the stent device may be increased by approximately 0.5 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, or approximately 5 mm compared to the diameter of the stent device when nominally deployed.

[0259] Example

[0260] The following embodiments are provided to illustrate the general principles of the embodiments of this disclosure. This disclosure and any claimed embodiments should not be considered as limited to the specific embodiments presented.

[0261] Example 1

[0262] The design of the automatically opening or self-opening support was modeled using commercial computer-aided design (CAD) and computer-aided engineering (CAE) software. Specifically, SolidWorks 2016 was used to create the CAD model of the support design. Abaqus / CAE 2016 was used for finite element model preprocessing and post-processing. Abaqus / Standard 2016 was used as the finite element solver. The modeling design included the opening portion of the support, which was configured to be controlled by the expansion of the support's diameter. For illustrative purposes, in Figures 22 to 26 Only the last three ring elements of the support are shown. Specifically, Figure 22 The image shows the initial "native" computer image of the model. The diameter of the generated model is then virtually reduced to represent its behavior during the curling process. Figure 23 The image shows a curled model support.

[0263] The model support is then virtually expanded to an inner diameter of 8mm to visualize the behavior of the opening feature. As the inner diameter increases, the diameter of the opening also increases, such as... Figure 24 , Figure 25 and Figure 26 shown. Specifically, Figure 24 This is a front perspective view of the model support design after simulating expansion to 8mm. Figure 25 An isometric view of the model support design after simulation expansion to 8mm is shown. Figure 26 An end view of the design of the support structure that automatically opens after being simulated to expand to 8mm is shown.

[0264] A prototype was then fabricated using stainless steel based on the model support design. One prototype support sample was loosely placed on an 8mm diameter balloon catheter. The balloon was inflated to 8 ATM, then to 10 ATM. The balloon was then deflated and the prototype support removed. Figure 27 , Figure 28 and Figure 29 The image shows a photograph of the expanded prototype support. Specifically, Figure 27 This is a front perspective view of the prototype bracket after it has been expanded to 8mm. Figure 28 This is an isometric view of the prototype bracket after it has been expanded to 8mm. Figure 29 This is an end view of the prototype bracket after it has been expanded to 8mm.

[0265] Then, a comparison was made between a predictive computer-generated model of the stent and a prototype stent expanded to 8 mm. Figure 30A and Figure 30B End views of the model and prototype are shown for comparison purposes. The inventors conclude that the comparison between the model support and the prototype shows that the support can be deployed in a self-opening or automatically opening manner, wherein the degree of opening is controlled by the design of the support and the expansion diameter.

[0266] Example 2

[0267] Using proprietary stent coating technology, four prototypes of the automatically opening stent (as described in Example 1 and as...) were applied. Figures 22 to 24 The prototype stent (as depicted in the image) was encapsulated in an ePTFE membrane. The stent was then placed on an 8 mm diameter balloon, with the inflated section aligned with the proximal radiopaque (RO) marking strip of the catheter. The stent was then rolled onto the balloon using a roll-up machine manufactured by MSI Machine Solutions in Flagstaff, Arizona. The rolled stent was then immersed in 37°C water for 30 seconds, deployed to a first nominal pressure of 8 ATM for 30 seconds, and then deployed to a rated burst pressure (RBP) of 10 ATM for 30 seconds. The stent was then removed from the balloon catheter and placed in 37°C water for 10 minutes to relax it before analysis.

[0268] Visual inspection concluded that all open-end struts were completely encapsulated within the ePTFE membrane. The standard inner diameter ID of the membrane-covered stent was measured using a digital microscope. Figure 31A (as shown) and maximum opening diameter FD ( Figure 31B (As shown in the table below). Then the maximum opening diameter FD is compared with the measured ID, and the average opening percentage is calculated to be 23%, as shown in the table below.

[0269] Sample batch number Straight inner diameter(mm) Maximum opening diameter (FD) (mm) Opening percentage EG00880-51-1 7.69 9.65 25％ EG00880-51-2 7.65 9.55 25％ EG00880-51-3 7.77 9.63 24％ EG00880-51-4 7.69 9.11 18％

[0270] The inventors concluded that the degree of opening measured in these embodiments indicates that significant opening of the ePTFE-coated stent can be achieved using a standard straight balloon catheter, depending on the stent design and expansion diameter.

[0271] Example 3

[0272] Model 1200 of an intravascular abdominal aortic aneurysm (AAA device 1210) device with fenestrations 1212 and 1214 is created. Figure 32 A schematic representation of the AAA model 1200 is shown. The open covered stents 1216 and 1218 are modeled and then placed in the AAA device 1210 to depict two different locations. In location A, the open covered stent 1216 is positioned such that the open portion 1220 extends approximately one to three ring elements within the AAA device 1210.

[0273] At position B, the opening portion 1222 of the covered stent 1218 is positioned through the fenestration 1214 and adjacent to the wall of the AAA device 1210. While not wishing to be bound by theory, it is believed that the opening portion or opening portion 1220, 1222 has multiple uses, including maintaining the stent's position within the AAA device 1210, preventing endoleak, and facilitating guidewire placement for future procedures that may be required.

[0274] Although embodiments of this disclosure have been described in detail for illustrative purposes based on what is now considered to be the most practical and preferred aspects, it should be understood that such details are only for this purpose, and the applicant's invention is not limited to the disclosed aspects, but rather intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any aspect may be combined with one or more features of any other aspect.

Claims

1. A support device comprising: A radially expandable main body portion that extends along the longitudinal axis of the support assembly and defines a lumen; as well as An outwardly opening portion, which is connected to the main body portion and includes: A first radially expandable ring is connected to the main body portion; A first opening connector extends longitudinally in a first direction away from a first end connected to the crown of the first radially expandable ring. The first opening connector is configured to cause the crown of the first radially expandable ring to automatically open radially outward relative to other parts of the first radially expandable ring when the main body portion expands radially, thereby forming a first opening crown. A second radially expandable ring is connected to a first radially expandable ring, wherein the first direction extends from the crown of the first radially expandable ring toward the second radially expandable ring; and The second opening connector extends longitudinally along a second direction from a first end connected to the second radially expandable ring. The second opening connector is configured to cause the crown of the second radially expandable ring to automatically open radially outward relative to other parts of the second radially expandable ring when the main body portion expands radially, thereby forming a second opening crown, wherein the second direction is opposite to the first direction. Wherein, the first radially expandable ring is connected to the first side of the second radially expandable ring and is positioned adjacent to the first side of the second radially expandable ring; Wherein, the second radially expandable ring is connected to the main body portion on the opposite second side of the second radially expandable ring and is positioned adjacent to the main body portion; The first radially expandable ring and the second radially expandable ring are arranged in series along the longitudinal axis of the support device; In the open position, the first and second opening crowns open towards each other, thereby creating an annular groove, the size and shape of which are configured to capture and align with the opening ring; and The main body expands radially but does not open outward.

2. The support device according to claim 1, wherein the first opening connector is not biased to the expanded position.

3. The support device according to claim 1, wherein the first opening connector is biased to the expanded position.

4. The support device of claim 1, wherein the first radially expandable ring comprises a plurality of substantially repeating curved segments and a longitudinally extending strut, the strut connecting the first curved segment of the plurality of curved segments to the body portion of the support device, and wherein the first curved segment comprises a peak, a valley, and a transition region disposed between the peak and the valley.

5. The support device according to claim 1, wherein, When the main body portion expands radially, the first opening connector is configured to transition from a retracted position to an expanded position, in which the crown of the first radially expandable ring is substantially longitudinally aligned with a portion of the main body portion of the support device, and in the expanded position, the first opening crown of the first radially expandable ring opens radially outward relative to the other portions of the radially expandable main body portion of the support device.

6. The support device according to claim 5, wherein, When the first opening connector is in the retracted position, the crown portion of the first radially expandable ring and the other portions of the first radially expandable ring are equidistant from the longitudinal axis, and wherein, when the first opening connector is in the expanded position, the first opening crown portion is farther from the longitudinal axis than the other portions of the first radially expandable ring.

7. The support device according to claim 1, wherein the outwardly opening portion is positioned at an end of the support device.

8. The support device according to claim 1, wherein the main body portion includes a first longitudinal section and a second longitudinal section, and wherein the outwardly opening portion is disposed between the first longitudinal section and the second longitudinal section of the main body portion.

9. The support device of claim 1, wherein the main body portion includes an interconnecting member extending between and connecting the first radially expandable ring and the second radially expandable ring, and wherein the radial outward expansion of the first radially expandable ring and the second radially expandable ring causes the first opening connector to automatically open the crown of the first radially expandable ring to form the first open crown.

10. The stent device of claim 1, wherein the first radially expandable ring and the second radially expandable ring are arranged in series along the longitudinal axis of the stent device; and an interconnecting member extends between and connects the first radially expandable ring and the second radially expandable ring, wherein after radial outward expansion, the first opening connector prevents the first opening crown from collapsing.

11. The support device of claim 1, wherein at least one of the main body portion and the outwardly expandable portion is at least partially covered by at least one of a sheet, tube, or film, said sheet, tube, or film being formed of a material configured to reduce protein adsorption.

12. The scaffold device of claim 11, wherein the material configured to reduce protein adsorption comprises a PTFE membrane.

13. The support device according to claim 1, wherein the first opening connector includes a first leg, a second leg, and a third leg fixedly connected together at a common point.

14. The support device of claim 13, wherein the first leg includes a first end opposite to the common point, the second leg includes a second end opposite to the common point, and the third leg includes a third end opposite to the common point, and in, As the first radially expandable ring expands radially outward, the distance between the first end and the second end increases, and the third leg rotates about the common point, thereby causing the first crown of the first radially expandable ring to automatically open radially outward to form the first open crown.

15. The support device of claim 1, wherein the first crown of the first radially expandable ring includes at least one barb, the at least one barb being configured to anchor the support device in the unfolded position when the first opening connector is in the expanded position.

16. The support device according to claim 1, wherein the outwardly opening portion is formed of a material that does not have shape memory properties.

17. The support device according to claim 1, wherein the outwardly opening portion is formed of a material having shape memory properties.

18. The support device of claim 1, wherein the support device is configured to expand radially outward in response to the expansion of an expandable member positioned in the lumen defined by the body portion of the support device.

19. The support device of claim 1, wherein the outwardly opening portion comprises one or more materials selected from the group consisting of stainless steel, cobalt-chromium alloy, nickel-titanium alloy and biocompatible plastics.

20. The support device of claim 1, wherein the outwardly expandable portion comprises a shape memory alloy that has been heat-set to the expansion position, such that the support device is self-expanding.

21. The support device according to claim 1, wherein the outwardly opening portion is supported by a support strut that reduces the collapse capability of the opening member or barb.

22. The support device according to claim 1, wherein the first opening connector comprises: The first leg is connected to the crown portion of the first radially expandable ring; And multiple pairs of second legs extending from the first leg to other portions of the first radially expandable ring, wherein each pair of second legs connects to the first leg at a unique common point on the first leg.

23. The support device according to claim 1, wherein the first opening connector comprises: The first leg is connected to the crown portion of the first radially expandable ring; And a pair of second legs that extend from the first leg to a portion of the first radially expandable ring at a common point, and the first of the second legs includes an expandable portion that allows for further extension of the first second leg when the first opening connector is in a nominal unfolded configuration.

24. The support device according to claim 1, wherein, Before the main body portion expands radially, the end of the support device formed by the crown portion of the first radially expandable ring is angled relative to the longitudinal axis of the main body portion.

Images