Stents and Stent Delivery

Abstract

Vascular prostheses (e.g., stents) and packaging and delivery systems for selectively delivering vascular prostheses are described. In some embodiments, the vascular prosthesis employs low porosity and high porosity sections, and the packaging and delivery system allows the prosthesis to be delivered such that the positions of the low porosity and high porosity sections of the prosthesis can be varied.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 817,988, filed on March 13, 2019, entitled “Stents and Stent Delivery,” which is incorporated herein by reference in its entirety. Background Art

[0003] Vascular prostheses (e.g., stents) are used in the vasculature for a variety of reasons, including, but not limited to, propping up open blood vessels to restore patency or treat sclerotic buildup, delivering drugs, acting as a temporary scaffold to retain embolic material, and diverting blood flow away from an area of ​​interest such as an aneurysm—this last type of stent is called a flow diverter. A flow diverter is placed in a vessel adjacent to an aneurysm and across the neck of the aneurysm to reduce blood flow into the aneurysm, thereby reducing the risk of aneurysm rupture. Over time, endothelial growth occurs over and around the stent, which closes the aneurysm and restores normal blood flow to the target area.

[0004] One problem with using these diverting stents is that it is difficult to have a stent that effectively treats the entire vascular area. Typical diverting stents use a constant, low porosity distribution along the entire length of the stent. This can be problematic when only a portion of the stent is used for diversion purposes. For example, a portion of the stent may be adjacent to the aneurysm area, in which the low porosity / high resistance to blood flow is conducive to limiting blood flow into the aneurysm. However, another section of the stent may cover a nearby branch artery, in which the low porosity limits blood flow into the branch artery, thereby adversely affecting the natural flow of blood. Typical diverting stents have a consistent porosity distribution, reducing blood flow into the branch artery and the aneurysm location. Due to reduced oxygenation in this arterial area, the reduced blood flow into the normal branch artery can cause complications over time. Therefore, although the diversion interface can effectively treat aneurysms, it will cause complications in adjacent areas where diversion is not required.

[0005] There is a need for a stent / stent delivery platform that can treat a variety of areas and conditions and address these issues. Summary of the invention

[0006] Vascular prosthetic devices, packaging or wrappers for these devices, and methods of using these devices are described. In one embodiment, the vascular prosthetic device is a stent. In one embodiment, the stent is composed of multiple layers (e.g., two or more layers). In one embodiment, the stent has two layers. In one embodiment, the stent has a variable porosity distribution along the longitudinal section of the stent, wherein a portion of the stent has a first porosity distribution and another portion of the stent has a second porosity distribution. In one embodiment, the stent is composed of metal braided wire. In one embodiment, a double-layer braided stent with a variable longitudinal distribution is described. In one embodiment, a longitudinal portion of the stent adopts a first porosity, while another longitudinal portion of the stent adopts a different second porosity. In one embodiment, the stent is configured as a diverting stent to deflect blood flow from an aneurysm, wherein the stent has a first section and a second section, wherein the first section has a porosity distribution that acts as a diverter, and the second section has a higher porosity distribution that does not act as a diverter.

[0007] In one embodiment, a vascular prosthetic device can be delivered in a first configuration or a second configuration to customize which portion of the stent employs a low porosity flow-conducting portion. In the first configuration, the low porosity flow-conducting layer is on one portion of the stent (e.g., the proximal portion), and the high porosity layer is on another portion of the stent (e.g., the distal segment). In the second configuration, the low porosity flow-conducting layer is on one portion of the stent (e.g., the distal portion), and the high porosity layer is on another portion of the stent (e.g., the proximal portion). The stent can be selectively delivered in a first configuration, in which flow-conducting is useful on a specific segment of the stent (e.g., the proximal portion), and in a second configuration, in which flow-conducting is useful on another specific segment (e.g., the distal segment).

[0008] A vascular prosthesis (e.g., stent) system is described. In one embodiment, the system includes a package that uses a shell containing a stent and at least a first tube and at least a second tube, the at least first tube being connected to a first end of the package or shell, and the at least second tube being connected to a second end of the shell. The first tube and the second tube each contain an introducer sleeve, which is used to selectively introduce the stent into a delivery catheter. The stent uses a variable porosity distribution, wherein a certain length of the stent uses a first porosity, and another length of the stent uses a different second porosity. When the stent is advanced through the first tube in a first direction, the porosity distribution is such that a lower porosity interface (e.g., configured for diversion) is located on one portion of the stent (e.g., a proximal portion), and a higher porosity interface is located on another portion of the stent (e.g., a distal portion). When the stent is advanced through the second tube in a second direction, the porosity distribution is converted so that a lower porosity interface that can be used for diversion is located on one portion of the stent (e.g., a distal portion), and a higher porosity interface is located on another portion of the stent (e.g., a proximal portion). In this way, the user can customize which portion of the stent is used for drainage by pushing the stent through the first introducer tube or the second introducer tube.

[0009] In one embodiment, the vascular prosthesis system employs a mechanical push system. In one embodiment, the vascular prosthesis system employs a mechanical delivery pusher connected to each end of the stent to deliver the stent through the tube region so that a first pusher engages a first portion of the stent and a second pusher engages a second portion of the stent. When the stent is advanced through the first tube in a first direction, the pusher on one side of the stent remains engaged with the stent to guide it through the first tube, while the pusher on the other side of the stent disengages. When the stent is advanced through the second tube in a second direction, the pusher on one side of the stent remains engaged with the stent to guide the stent through the second tube, while the stent on the other side of the stent disengages.

[0010] In one embodiment, a method for delivering a vascular prosthetic device (e.g., a stent) is described. The stent has a variable porosity distribution, wherein a portion of the stent adopts a low porosity interface (e.g., configured for diversion). The stent is contained in a shell, with tubes on both sides of the shell, and mechanical push elements at both ends of the stent. The stent is selectively pushed in a first direction to guide the stent through the first tube-in this way, the diversion layer is located on a specific part of the stent (e.g., the proximal part). Alternatively, the stent is selectively pushed in a second direction to guide the stent through the second tube-in this way, the diversion layer is located on another part of the stent (e.g., the distal part). Each tube includes an introducer sleeve (introducersleeve), and when the stent is transported from the shell to the tube, the stent is introduced into the introducer sleeve. The stent and the overlying introducer sleeve are transported out of the tube. The guide sleeve is then placed near the proximal end of the catheter, and the stent is advanced into the catheter and passed through the catheter to reach the treatment site in the patient's vascular system.

[0011] In one embodiment, a method for treating a patient with a prosthetic device (e.g., a stent) is described. The stent employs a variable porosity interface, wherein a low porosity layer is located on a specific portion of the stent. In one embodiment, the low porosity layer is configured for diversion. The stent is contained in a housing and is delivered by a user to an introducer sleeve and through a specific tube segment, thereby obtaining a low porosity diversion layer at the proximal or distal segment of the stent, depending on the condition of the vascular system and where diversion is required. The introducer sleeve (including an indwelling stent) is placed near the proximal end of the catheter, and the stent is advanced through the introducer sleeve, into the catheter and through the catheter to reach a treatment site in the patient's vascular system.

[0012] In some embodiments, a vascular prosthesis system is described that includes: a vascular prosthesis having a lower porosity region and a higher porosity region; a housing that houses the vascular prosthesis; and a first tube connected to a first end of the housing, a second tube connected to a second end of the housing, wherein the vascular prosthesis is capable of being delivered through the first tube or the second tube.

[0013] In some embodiments, the first tube and the second tube each include an introducer sleeve. The first tube and the second tube can both be coiled. In other embodiments, the end of the vascular prosthesis is preloaded into each introducer sleeve. The introducer sleeve can span a portion of the housing.

[0014] In some embodiments, the system can further include a pin that engages the introducer sleeve.

[0015] In some embodiments, delivery through the first tube causes the region of lower porosity to be located on the proximal region of the vascular prosthesis, and delivery through the second tube causes the region of lower porosity to be located on the distal region of the vascular prosthesis.

[0016] Also described herein is a vascular prosthesis system comprising: a vascular prosthesis having a first porosity region and a second porosity region; a housing containing the vascular prosthesis; and a first tube connected to a first end of the housing, a second tube connected to a second end of the housing; the vascular prosthesis is deliverable through the first tube or the second tube. In some embodiments, if the vascular prosthesis is delivered through the first tube, the first porosity region is located on a first longitudinal segment of the vascular prosthesis; and if the vascular prosthesis is delivered through the second tube, the first porosity region is located on a second longitudinal segment of the vascular prosthesis.

[0017] In other embodiments, the system further comprises a first pusher connected to a first section of the vascular prosthesis and a second pusher connected to a second section of the vascular prosthesis. The first pusher can be used to guide the vascular prosthesis through the first tube, and the second pusher is used to guide the vascular prosthesis through the second tube. The first pusher can be detached from the first portion of the vascular prosthesis. The second pusher can be detached from the second portion of the vascular prosthesis. The vascular prosthesis may include a flared end, wherein the first pusher and the second pusher engage the flared end of the vascular prosthesis. In some embodiments, the first pusher detaches from the vascular prosthesis as the vascular prosthesis is transported through the second tube. In other embodiments, the second pusher detaches from the vascular prosthesis as the vascular prosthesis is transported through the first tube.

[0018] Also described herein is a flow-conducting prosthesis system, comprising: a vascular prosthesis having a flow-conducting region with lower porosity and a non-flow-conducting region with higher porosity; a housing that contains the vascular prosthesis; a first tube connected to a first end of the housing, a second tube connected to a second end of the housing; the vascular prosthesis is capable of being delivered through the first tube or the second tube. In some embodiments, if the vascular prosthesis is delivered through the first tube, the flow-conducting region is located on a first longitudinal segment of the vascular prosthesis; and if the vascular prosthesis is delivered through the second tube, the flow-conducting region is located on a second longitudinal segment of the vascular prosthesis.

[0019] In some embodiments, the housing has a first housing segment, a second housing segment, and a gap between the first housing segment and the second housing segment. In other embodiments, the lumen of the housing is larger than the lumen of the first tube and the lumen of the second tube. In other embodiments, the outer diameter of the housing is larger than the outer diameter of the first tube and the outer diameter of the second tube.

[0020] Delivery through the first tube may position the flow diversion region over the proximal region of the vascular prosthesis, and delivery through the second tube may position the flow diversion region over the distal region of the vascular prosthesis.

[0021] BRIEF DESCRIPTION OF THE DRAWINGS

[0022] These and other aspects, features and advantageous effects of embodiments of the present invention will be apparent and explained from the following description of embodiments of the present invention with reference to the accompanying drawings, in which:

[0023] Figure 1 A typical flow-diverting stent for treating an aneurysm is shown.

[0024] Figure 2 A stenting technique using two flow-diverting stents for treating a bifurcation aneurysm is shown.

[0025] Figure 3 A flow guiding support with variable porosity according to one embodiment is shown.

[0026] Figure 4 A flow guiding support with variable porosity according to another embodiment is shown.

[0027] Figure 5 A variable porosity flow-diverting stent for treating an aneurysm according to one embodiment is shown.

[0028] Figure 6 A stent packaging and delivery system according to one embodiment is shown.

[0029] Figure 7 A housing for use in a stent packaging and delivery system is shown according to one embodiment.

[0030] Figure 8 A close-up view of a stent packaging and delivery system is shown according to one embodiment.

[0031] Fig. 9 A pusher-support connection interface is shown according to one embodiment.

[0032] Fig.10 A pusher-support connection interface is shown according to one embodiment.

[0033] Fig.11A A tube section for use in a stent packaging and delivery system according to one embodiment is shown. Fig. 11B Another tube section for use in a stent packaging and delivery system according to one embodiment is shown.

[0034] Fig.12 Show Fig.11A The outlet of the tube section.

[0035] Fig.13 Shown through Fig.12 The export bracket.

[0036] Fig.14 A stent according to one embodiment is shown wherein the distal directional flow guide portion is introduced into a catheter.

[0037] Fig.15 A stent is shown passing through an outlet of a tube portion of a stent packaging and delivery system according to one embodiment.

[0038] Fig.16 A stent according to one embodiment is shown having a proximally directed flow-directing portion introduced into a catheter. DETAILED DESCRIPTION

[0039] As mentioned above, vascular prostheses such as stents can be used to treat a variety of conditions for a variety of reasons. Flow-diverting stents are a special class of vascular prostheses that utilize a relatively low porosity interface to deflect flow away from a specific region of the vessel. Flow-diverting stents are a potential treatment option for aneurysms. Flow-diverting stents are placed close to the neck or opening of the aneurysm, where the low porosity interface restricts blood flow into the aneurysm, reducing the risk of rupture. Over time, endothelial tissue grows over the stent to cut off blood flow into the aneurysm.

[0040] U.S. Patent Nos. 9,867,725 and 9,439,791 disclose information about stents, double-layer stents, and flow-diverting stents, and the entire contents of both patents are incorporated herein by reference.

[0041] While flow-diverting stenting is an effective method for treating aneurysms, the procedure has potential complications. Flow-diverting stents use a consistent porosity throughout the length of the stent. This can be problematic in situations where the aneurysm is located near a branching vessel and the flow-diverting stent will cover both the aneurysm and the nearby branching vessel. The flow-diverting interface is useful for the segment adjacent to the aneurysm, but not for the segment of the stent adjacent to the branching vessel because the reduced blood flow to the vessel can negatively impact normal blood circulation through the body—potentially introducing additional complications. This situation is not ideal for patients with aneurysms that are located near a branching vessel. Figure 1 , where a flow-diverting stent 100 is used to treat a sidewall aneurysm 104 along a blood vessel 102, but also covers a nearby branch vessel 106, thereby affecting blood flow through the branch vessel.

[0042] Flow-diverting stents can also be used to treat bifurcated aneurysms. Aneurysms are often located along the bifurcation of a vessel because a large amount of blood pressure is exerted on the vessel wall at the junction of the bifurcation of the vessel. Because there are multiple vessels at these junctions, two stents are placed across the aneurysm, usually a low-porosity flow-diverting stent placed through another high-porosity stent (often called a Y-stent because of the Y shape it forms). Figure 2As shown in Figure 1, another technique is called the kissing technique, where two low-porosity stents can be placed adjacent to each other to reduce blood flow into the aneurysm. Because the diverting stent uses a consistent low-porosity distribution and only a portion of the stent is needed for diversion purposes, the stent may negatively affect blood flow through that area. This can occur, for example, if the stent is not aligned flush with the vessel wall and the large amount of metal surface covering used to create the low-porosity distribution impedes blood flow. This can also occur in Figure 2 The situation shown is one in which stents are placed against each other across a blood vessel, thereby creating an obstruction to blood flow.

[0043] One solution to these problems is to make the stents have a variable distribution, e.g. Figure 3 As shown - only a portion of the stent has a flow-conducting interface. In one embodiment, the stent is a braided wire mesh. It is preferred to use a material with strong shape memory, such as nitinol, stainless steel, cobalt-chromium alloy, or a drawn filling tube (e.g., a platinum core with a nitinol sheath). The stent 120 has a first region 122 with high porosity, such as Figure 3 As shown, this section has a relatively low metal surface coverage - meaning that the pores formed by the various wire intersections are larger than in the lower porosity areas of the stent. The stent 120 also employs a second region 124 having a low porosity, which has a relatively high metal surface coverage - meaning that the pores formed by the various wire intersections are smaller than in the higher porosity areas of the stent.

[0044] The low porosity regions, such as the second region 124, can be constructed in a variety of ways. In one embodiment, the entire stent includes a conventional high porosity layer along the entire longitudinal length of the stent, and the lower porosity region of the stent is composed of an additional low porosity layer located above or below the conventional high porosity layer - wherein the lower porosity region of the stent adopts a layer with a denser or less "open" weaving pattern; in this way, there are defined high porosity segments and low porosity segments, such as the first region 122 (consisting only of more porous wound wire segments / layers), and low porosity segments such as the second region 124 (consisting of a more porous layer and a denser layer located above or below the layer). In one embodiment, the low porosity layer or segment is radially located within the high porosity layer along the low porosity portion of the stent. In one embodiment, the low porosity layer is radially located on the outside of the high porosity layer along the portion of the stent that adopts a low porosity interface. In this way, one portion of the stent has a higher porosity and another portion of the stent has a lower porosity. The lower porosity section of the stent is considered the flow conducting portion of the stent, and in practice this is the area of ​​the stent that would be placed along the neck of an aneurysm and thereby used to treat the aneurysm.

[0045] For example, the first layer extends along the length of the device and is interpreted as the outer layer, while the inner / second layer acts as a deflector and is radially located within the longitudinal portion of the outer layer. The diameter of the outer layer wires can be between 0.002"-0.003", and the diameter of the inner layer wires can be between 0.00075"-0.001". The outer layer can have 1-36, 6-24, or 12-18 wires, and the inner layer can have 36-64 wires, depending on the device size.

[0046] In other embodiments, the first layer extends along the length of the device and is interpreted as the inner layer, and the outer / second layer acts as a flow-directing portion and is located radially outward from a portion of the inner layer.

[0047] In one embodiment, the first high porosity metal section defining the entire length of the stent is composed of only 1 wire that is wound back and forth on a mandrel to define a generally tubular shape. The low porosity portion is then formed by a plurality of metal wires (e.g., 12-24 or more) that are individually wound / braided and then placed below the high porosity section along a specific portion of the stent to define a distinct high porosity section and a defined low porosity section.

[0048] In an alternative embodiment, the stent is composed of only one braided layer. However, the lower porosity portion of the stent uses a tighter or denser winding pattern to create a flow-conducting portion. In one example, the stent is wound on a common mandrel, but the lower porosity flow-conducting portion of the stent uses a denser winding pattern along that particular mandrel segment to create a denser braid distribution.

[0049] In other embodiments, the stent is not constructed of braided wires. Instead, a laser cut metal sheet or polymer sheet is used, wherein the higher porosity portion of the stent is more openly distributed (meaning more cuts or openings are used along that section), while the lower porosity portion of the stent is less openly distributed (meaning fewer cuts or openings are used along that section).

[0050] In one embodiment, the stent includes a plurality of outwardly protruding flares 126, such as 2-10 flares, at each end of the stent. Flares help to stabilize the stent in the blood vessel, and as will be explained below, a mechanism for connecting the stent to a pusher can be provided, which helps to guide and transport the stent. Flares 126 can also include radiopaque marker bands or coils 128 wrapped around the flared portion. Coils 128 help to see the end of the stent during the stent transport process, and as will be explained below, can further be realized with the connection of the transport pusher. In one embodiment, all flares 126 have similar sizes. In one embodiment, flares 126 have different sizes, so that some flares are larger and some flares are smaller. In one embodiment, flares 126 are arranged in an alternating manner so that a larger flare is adjacent to a smaller flare, wherein the pattern is continuous around the periphery of the stent end.

[0051] Despite Figure 3 The scaffold shown shows only two interface segments - a first high porosity portion (first region 122) and a low porosity portion (second region 124) adjacent to the high porosity portion, but in different embodiments, various interfaces may be used. For example, a scaffold with three longitudinal sections - a central low porosity portion and two high porosity portions on either side; or alternatively - as shown in FIG. Figure 4 As shown - a middle high porosity portion 132 and two low porosity portions 134a, 134b on both sides.

[0052] Alternatively, more than three segments may be used, with various combinations of high porosity and low porosity portions. In addition, where multiple high porosity segments and multiple low porosity segments are used, each segment may utilize a different porosity distribution—meaning that multiple high porosity segments may each utilize a different high porosity interface (e.g., different weave distributions produce different pore sizes), while multiple low porosity segments may each utilize a different low porosity interface.

[0053] Alternatively, the low porosity and / or high porosity regions may have a variable porosity within the porosity region. For example, the low porosity region may have a variable porosity configuration such that the pore size varies over the length of the low porosity region within a specific low porosity range. Similarly, the high porosity region may have a variable porosity configuration such that the pore size varies over the length of the high porosity region within a specific high porosity range.

[0054] like Figure 5As shown, with a variable porosity stent design employing a low porosity / flow conducting portion 144 and a high porosity portion 142, the lower porosity region of the stent can be placed against the neck of the aneurysm to treat the aneurysm 104. However, the remainder of the stent will employ a high porosity interface, so blood flow to any branch vessels in the vicinity of the stent will not necessarily be affected because the branch vessel region is covered by the high porosity interface, representing less obstruction to blood flow than a low porosity interface.

[0055] Flow-conducting stents typically use a percentage to define the level of flow conduction. This percentage can be reflected in one of two ways. The first percentage calculation refers to the material surface coverage, which is the percentage of the total area of ​​the stent that includes the actual material. In the context of a braided metal stent, this refers to the portion of the complete stent area that includes the metal wires. This calculation reflects the ratio of the total surface area of ​​the wires that make up the stent (meaning the total surface area occupied by the wires) to the total surface area of ​​the stent. The second percentage calculation is the porosity percentage, which reflects the amount of open space that does not include the metal wires. This can be thought of as the proportion of the stent that is just pores. In other words, the ratio of the open space or pores of the stent to the total surface area of ​​the stent. The porosity percentage plus the material surface coverage totals 100%, and in this way, the two percentages are related.

[0056] In some embodiments, a scaffold may be classified as a flow diverter if the porosity percentage is from about 50% to about 75%. In this way, where a variable porosity scaffold as described herein may employ a segment for diversion, the porosity percentage of that particular segment may be from about 50% to about 75%, while segments of the scaffold not intended for diversion have a higher porosity. In some embodiments, the higher porosity may be a porosity percentage of from about 80% to about 95%.

[0057] In other embodiments, a scaffold having a varied porosity may include a segment intended for fluid diversion, wherein the segment intended for fluid diversion has a porosity percentage of about 40% to about 80%, about 30% to about 80%, about 20% to about 80%, about 10% to about 80%, about 40% to about 70%, about 30% to about 70%, about 20% to about 70%, about 10% to about 70%, about 40% to about 60%, about 30% to about 60%, about 20% to about 60%, about 10% to about 60%, about 40% to about 50%, less than about 80%, less than about 70%, less than about 60%, or less than about 50%.

[0058] In other embodiments, a variable porosity scaffold may include sections not intended for fluid diversion having a porosity percentage of about 80% to about 95%, about 80% to about 90%, or about 90% to about 95%.

[0059] Similarly, if the stent employs multiple sections intended for fluid diversion and / or multiple sections not intended for fluid diversion, the corresponding range for each section employs the range specified above.

[0060] A problem with stents is that stents can usually only be constructed and delivered in one direction. This is because a fixed pusher element is connected to a portion (e.g., proximal end) of the stent and is used to guide the stent out of a packaging unit (e.g., typically configured as a distributor hoop) and into, through a delivery catheter. Once the stent expands in the vascular system, the pusher mechanism is separated from the stent by pyrolysis, mechanical or electrolytic means. In the context of the various configurations of the stents with variable porosity described above (e.g., wherein only one longitudinal portion of the stent adopts a low porosity or flow-conducting layer), a typical or existing pusher delivery mechanism in the art will only be connected to one end of the stent. This means that the stent can only be delivered so that the low porosity flow-conducting portion is located in a fixed manner on the proximal portion or distal portion of the stent. In practice, this means that manufacturers need to design and sell respectively: a) stents with a low porosity interface on the proximal region and b) stents with a low porosity interface on the distal region of the stent to cover each case.

[0061] The following embodiments solve this problem by using a packaging and delivery system in which a single stent having at least one low porosity section and at least one high porosity section can be delivered in a first or second direction. In some embodiments, a single stent having at least one low porosity section and at least one high porosity section is provided that can be delivered in either direction so that the low porosity section of the stent can be located in the proximal region of the stent, or can be located in the distal region of the stent. This can allow a physician to customize the delivery procedure according to the needs of the patient, and can save surgical and manufacturing costs by having a single stent that can be delivered and oriented in either direction to meet specific treatment needs (e.g., a proximal-oriented flow-diverting stent section, or a distal-oriented flow-diverting stent section).

[0062] Figure 6 One embodiment of a vascular prosthesis packaging and delivery system is shown. In one embodiment, the system reflects how an end user (e.g., a physician) receives a vascular prosthesis. A vascular prosthesis device (e.g., a stent) is located in a housing 151 having a first end 153a and a second end 153b. The first housing segment 152a may include a first tube 154a at the first end 153a and the second housing segment 152b may include a second tube 154b at the second end 153b. Each of the first tube 154 and the second tube 154b may extend into a spiral configuration having concentric tube segments - such as Figure 6Each of the first housing 152a and the second housing 152b and their respective connected tubes include a continuous lumen therein to facilitate passage of the stent through the first tube 154a or the second tube 154b.

[0063] In other embodiments, each of the first tube 154 and the second tube 154b can be a configuration other than a spiral. In some embodiments, the first tube 154 can be configured in a spiral above or below the second tube 154b, thereby saving additional packaging space.

[0064] The housing 151 is shown in more detail at Figure 7 , includes two housing segments, a first housing segment 152a and a second housing segment 152b, separated by a gap 156. A first tube segment 154a extends from a first end 153a of the first housing segment 152a, and a second tube segment 154b extends from a second end 153b of the second housing segment 152b.

[0065] like Figure 6 and 7 As shown, the housing 151 (composed of the first housing section 152a and the second housing section 152b) has a larger outer diameter or a larger thickness than the outer diameters 160a and 160b of the first tube section 154a and the second tube section 154b.

[0066] Furthermore, the housing 151 has an internal lumen that initially accommodates the stent, the internal lumen having its own associated size or diameter, representing an internal passage space. The inner diameter of the housing 151 is greater than the inner diameter 162a of the first tube 154a and the inner diameter 162b of the second tube 154b.

[0067] In one embodiment, the first end 153a and the second end 153b of the housing 151 (including the housing segments 152a and 152b) may include a sloped or funnel shape such that the outer diameter tapers to the outer diameters 160a and 160b of the first tube 154a and the second tube 154b - rather than Figure 7 A more abrupt transition is shown in .

[0068] One embodiment may employ a housing having a more closed diameter such that the outer diameter of the housing is substantially similar to the outer diameter of the tubes 154a, 154b. One embodiment may employ a housing configuration wherein the interior lumens of the first and second housing segments 152a, 152b may be substantially similar to the lumens of the first and second tubes 154a, 154b.

[0069] Bracket 150 may be initially contained within both first housing segment 152a and second housing segment 152b (see Figure 8), such that the first portion 161a of the stent 150 is located within the first housing segment 152a, the second portion 161b of the stent 150 is located within the second housing segment 152b, and the middle region 161c of the stent 150 spans the gap portion 156 between the first housing segment 152a and the second housing segment 152b. This initial inclusion refers to how the stent may be packaged for shipping and how the end user / physician receives the device / system.

[0070] The housing 151 (which is comprised of the first housing segment 152a and the second housing segment 152b) can have an interior chamber or lumen that is smaller than a fully expanded stent, such that the stent is compressed or constrained when located within the housing 151. In some embodiments, the diameter of the interior lumen substantially reflects the outer diameter of the compressed or constrained stent. As described above, the stent is preferably formed of a shape memory metal material such that the stent has a heat set expanded shape when unconstrained.

[0071] Mechanical pushers are connected to each end of the support 150, wherein the first pusher 158a is connected to the first support end 165a and the second pusher 158b is connected to the second support end 165b. Each pusher can span the entirety of the tubular section of the relevant coil. In this way, the first pusher 158a spans the entirety of the tubular portion 154a (meaning the entire coiled structure) so that it is exposed from the other open end or end of the tubular portion 154a. Similarly, the second pusher 158b spans the entirety of the tubular portion 154b so that it is exposed from the other open end or end of the tubular portion 154b. Since each pusher extends beyond the terminal end or end of each tubular portion, the user can grasp and manipulate each pusher (158a or 158b) to move the support 150.

[0072] exist Fig. 9 The pusher connection to the bracket is shown in more detail in FIG. Fig. 9 158a. In one embodiment, the pusher 158b includes a pair of expanded bands 170a, 170b. In one embodiment, the bands 170a, 170b include a radiopaque material such as platinum, palladium or tantalum to aid in visualization of the joint. The flare 126 also employs a marker coil or band, as discussed above and Figure 3 The end of the flare 126 is located within the marker band region, wherein the coil 128 helps to limit the flare of the stent within this region, so that the coil 128 is confined between the enlarged bands 170a, 170b of the pusher 158b. In this way, the pusher is mechanically connected to the stent.

[0073] The above description discusses how all of the flares 126 can be of similar length, or how some flares can be larger and some smaller. In one embodiment, only one or some of the plurality of stent flares are grasped between the enlarged bands 170a, 170b of the pusher. In one embodiment, all of the plurality of stent flares are grasped between the enlarged bands 170a, 170b of the pusher. In one embodiment, some stent flares are larger and some are smaller, with only the larger stent flares being grasped between the enlarged bands 170a, 170b of the pusher.

[0074] In some embodiments, greater than about 5% of the stent flare is captured between the expanded bands of the pusher. In other embodiments, greater than about 10%, greater than about 20%, greater than about 30%, greater than about 40%, greater than about 50%, greater than about 60%, greater than about 70%, greater than about 80%, or greater than about 90% of the stent flare is captured between the expanded bands of the pusher.

[0075] In some embodiments, the middle region 161c of the stent 150 is exposed through the gap 156 between the first shell segment 152a and the second shell segment 152b. However, the gap 156 is not large enough to allow the entire stent to physically expand itself to its heat-set expanded shape because most of the length of the stent is contained within the smaller diameter shell portions 152a, 152b. In some embodiments, less than about 5% of the middle region of the stent is exposed in the gap 156. In other embodiments, less than about 10%, less than about 20%, less than about 30%, less than about 40%, or less than about 50% of the middle region of the stent is exposed in the gap 156.

[0076] To advance the stent through the first tube 154a, the user simply pulls on the pusher 158a (e.g., Figure 8 In the context of FIG. 1 , left direction). Pusher 158a is connected to first bracket end 165a. As the bracket is first pulled toward first tube 154a (e.g., Figure 8 The second bracket end 165b passes through the gap 156 and enters the housing portion 152a. When the end of the bracket (on the left side in the context of Figure 8 When the stent (in the context of FIG. 1 , the right end, second stent end 165b) passes through gap 156, the stent is slightly exposed and allowed to expand slightly - meaning the flared end begins to extend out of second housing 152b. Once this occurs, pusher 158 disengages from second stent end 165b as the stent flare is no longer constrained within the enlarged bands 170a, 170b of pusher 158b. At this point, the stent is only connected to pusher 158a and is released by moving the pusher (in this case, at Figure 8In the context of , by pulling the pusher 158a to the left) is guided through the first housing part 152a and the connected first tube 154a.

[0077] The gap 156 is simply constructed to allow the stent ends to expand as the respective ends pass through, thereby disengaging the opposing pusher. In one embodiment, the gap is complete so that a circumferential space or gap is formed between the first shell segment 152a and the second shell segment 152b that form the gap 156. In another embodiment, there are one or more small seams of material connecting the first shell segment 152a and the second shell segment 152b, so that there is still a defined main gap segment, and there is also a small connection point between the first shell segment 152a and the second shell segment 152b. Since most of the space between the first shell segment 152a and the second shell segment 152b is still defined by open space or "gap", as the stent passes through, the stent ends can still expand to a certain extent, thereby disengaging the other opposing pusher.

[0078] To pass the stent through the second tube 154b, the user simply engages the pusher 158b (at Figure 8 In the context of FIG. 1 , pull pusher 158b to the right). Doing so will cause first bracket end 165a (at Figure 8 ) through gap 156, thereby allowing the stent to flare somewhat and disengage the stent from pusher 158a.

[0079] The structure of the support 150 connected to the pusher 158a is shown in Fig.10 and basically Fig. 9 The same, except that only the opposite end of the bracket / bracket flare is engaged. Similar to the above description, as the bracket 150 passes through the gap 156, the pusher 158b is pulled (at Figure 8 , to the right) will cause pusher 158a to disengage from the opposite side of the bracket.

[0080] Each of the first and second tubes 154a, 154b includes a smaller introducer tube or introducer sleeve along a section of the tube portion - such as Figure 8 As shown. The first tube 154a includes a first introducer tube / first introducer sleeve 164a, and the second tube 154b includes a second introducer tube / second introducer sleeve 164b. When the stent 150 is pulled into the first tube 154a or the second tube 154b, it is actually pulled into the first introducer tube / first introducer sleeve 164a or the second introducer tube / second introducer sleeve 164b located inside the first tube 154a or the second tube 154b. Figures 11A-11B, where the first tube 154a includes a first introducer tube / first introducer sleeve 164a located within a portion of the tube, and the second tube 154b includes a second introducer tube / second introducer sleeve 164b located within a portion of the tube. When the user manipulates the pusher, for example, Figure 8 In the context of the present invention, the pusher 158a is pulled leftward into the first introducer tube / first introducer sleeve 164a located in the first tube 154a, and the stent enters the introducer tube until it is completely contained in the introducer tube. Once the stent is contained in the first introducer tube / first introducer sleeve 164a, continued operation of the pusher 158a can pull the stent through the rest of the first tube 154a.

[0081] Likewise, when the user manipulates the pusher, e.g. Figure 8 In the context of the present invention, the pusher 158b is pulled to the right into the second introducer tube / second introducer sleeve 164b located in the second tube 154b, and the stent enters the introducer tube until it is completely contained in the introducer tube. Once the stent is contained in the second introducer tube / second introducer sleeve 164b, the pusher 158b is continued to be operated to pull the stent through the rest of the second tube 154b.

[0082] In other embodiments, the ends of the stent (including the annular region or the flared region) can be preloaded into the first introducer tube / first introducer sleeve 164a and the second introducer tube / second introducer sleeve 164b. In one embodiment, in order to better facilitate the stent to enter the introducer tube, each end of the stent 150 is preloaded into the first introducer tube / first introducer sleeve 164a and the second introducer tube / second introducer sleeve 164b respectively. In this way, one end of the stent 150 is located in the first introducer tube / first introducer sleeve 164a (the first introducer tube / first introducer sleeve 164a is located in the first tube 154a), and the other end of the stent 150 is located in the second introducer tube / second introducer sleeve 164b (the second introducer tube / second introducer sleeve 164b is located in the second tube 154b). This construction can have further beneficial effects, such as allowing the housing 151 (including the first housing segment 152a and the second housing segment 152b) to be larger in size because the pushers 158a, 158b are connected to the collapsed stent ends, which are respectively accommodated in the first introducer tube / first introducer sleeve 164a and the second introducer tube / second introducer sleeve 164b.

[0083] In another embodiment employing the preloaded stent end approach outlined above, the first introducer tube / first introducer sleeve 164a and the second introducer sleeve 164b extend beyond the ends of the first tube 154a and the second tube 154b so that they are located within the lumens of the first shell segment 152a and the second shell segment 152b. This can allow the ends of the stent to be preloaded into the first introducer tube / first introducer sleeve 164a and the second introducer sleeve 164b while still allowing the stent to initially be physically completely located within the first shell segment 152a and the second shell segment 152b - thereby making it easier to get the stent into the corresponding introducer tube (e.g., the first introducer tube / first introducer sleeve 164a or the second introducer tube / second introducer sleeve 164b).

[0084] In one embodiment, the first tube 154a and the second tube 154b covering the first introducer tube / first introducer sleeve 164a and the second introducer tube / second introducer sleeve 164b can use mechanical fittings to help ensure that the introducer is selectively fixed in place (in place) while ensuring that the entire stent 150 is loaded into the corresponding introducer. For example, a portion of the first tube 154a and / or the second tube 154b near the first end 153a and / or the second end 153b of the housing 151 can use a narrow groove or cut-out area, wherein the first introducer tube / first introducer sleeve 164a and / or the second introducer tube / second introducer sleeve 164b use a corresponding narrow groove or cut-out area. The user can engage a pin passing through the cut-out area to engage the first introducer tube / first introducer sleeve 164a and / or the second introducer tube / second introducer sleeve 164b, thereby fixing the introducer in place as the stent is placed into the introducer. Once the stent 150 is properly loaded into the first introducer tube / first introducer sheath 164a and the second introducer tube / second introducer sheath 164b, the user may then remove the pins to disengage the introducers, allowing them to then be delivered through the covering first tube 154a or second tube 154b.

[0085] The adapter interface can be adjusted based on the stent packaging configuration. For example, if the first introducer tube / first introducer sleeve 164a and the second introducer tube / second introducer sleeve 164b are partially loaded in the first shell segment 152a and the second shell segment 152b (as described in one embodiment above), so that each end of the stent 150 is preloaded into the first introducer tube / first introducer sleeve 164a and the second introducer tube / second introducer sleeve 164b, then the adapter can be placed on the shell so that the pin covers the lower end of the shell and the corresponding introducer sleeve. In this way, as the stent enters the corresponding introducer sleeve, the introducer sleeve is engaged and prevented from moving.

[0086] In one embodiment, each respective adapter is located adjacent to the first and second housing segments 152a, 152b so that as the stent enters the respective guide sleeve 164a or 164b, the adapter is adjacent to the location of the stent 150. However, the slots or cutouts of the tube 154a / 154b and the underlying guide sleeve 164a, 164b do not extend all the way through the tube 154a / 154b and the underlying guide sleeve 164a / 164b (thus each only along one side). In this way, as the pin enters the respective introducer sleeve 164a or 164b, the pin will not necessarily contact the stent 150. In another embodiment, the adapter is located further along the tube 154a / 154b so that the stent does not enter the associated section of the underlying guide sleeve 164a / 164b as it enters the tube. In this embodiment, the slot or cutout area may have a configuration where it extends all the way through the tube and the underlying introducer sleeve and does not interfere with the passage of the stent. Once the stent 150 enters the respective introducer sheath 164a or 164b, the pins are disengaged or removed to allow the introducer sheath 164a / 164b to pass through the covering tube 154a / 154b.

[0087] Each of the first introducer tube / first introducer sleeve 164a or the second introducer tube / second introducer sleeve 164b is preferably sized to approximate the size of the corresponding first tube 154a or second tube 154b in which the introducer tube is located, thereby facilitating the entry of the stent 150 into the introducer tube as the user engages the appropriate push element 158a or 158b. Thus, in some embodiments, it is preferred that the outer diameter of the first introducer tube / first introducer sleeve 164a and / or the second introducer tube / second introducer sleeve 164b closely matches the inner diameter of the first tube 154a and / or the second tube 154b.

[0088] As described above, as the user engages the corresponding pusher (e.g., pusher 158a), the stent 150 can leave the housing 151 and enter the introducer tube (e.g., the first introducer tube / first introducer sleeve 164a in the first tube 154a) located within the corresponding tube. As shown in Figure 11, the first introducer tube / first introducer sleeve 164a only spans a portion of the first tube 154a. Although the first introducer tube / first introducer sleeve 164a is not illustratively shown as spanning into the coiled portion of the first tube 154a, its size can be shortened or lengthened as needed, for example, the size is set to a length that will extend into the coiled portion. However, the first introducer tube / first introducer sleeve 164a is shorter than the first tube 154a, so that it does not extend along the entire tube.

[0089] The size of the introducer tube / introducer sleeve is longer than the stent and means to accommodate the stent when the stent passes through the entire first tube 154a or the second tube 154b. Once the stent is completely located in the introducer tube, the further movement of the pusher will move the introducer tube (e.g., the first introducer tube / first introducer sleeve 164a) through the corresponding tube (e.g., the first tube 154a) until the introducer tube leaves the tubular portion. Once the first introducer tube / first introducer sleeve 164a or the second introducer tube / second introducer sleeve 164b leaves the tube or tubular shell, the introducer tube is introduced into the catheter (by the hemostatic valve of the catheter hub (catheterhub) or catheter). The size of the introducer is slightly larger than the catheter, so as the user engages the pusher by pushing the pusher to the distal end relative to the static catheter, the stent passes through the larger introducer lumen and enters the smaller catheter lumen.

[0090] The above description indicates that the property of a variable porosity stent is that at least one section has a lower porosity and at least one section has a higher porosity. This is shown for the housing and delivery system in Figure 8 In which the stent 150 includes a high porosity region 150a and a low porosity region 150b. The above description further points out that the stent housing and the delivery system can allow the stent to be customized so that the low porosity region or the diversion region 150b can be located at the proximal portion or the distal portion of the stent. This will now be explained in more detail with respect to the housing and the delivery system.

[0091] If in one direction (for example, Figure 8 If the stent 150 is pulled leftward in the context of FIG. 1 , the high porosity region 150a is the first segment to enter the introducer tube 164a (located in the coiled first tube 154a), and the low porosity segment 150b will be the last segment to enter the introducer tube. Fig.11A As shown, the end 166 of the coiled first tube 154a (inside the coiled first tube 154a) has a Fig.12 The pusher 158a is inserted through the opening shown, and in this manner, the user can manipulate the attached stent (e.g., stent 150) into the first introducer tube / first introducer cannula 164a. Figure 8 , 11A As can be understood in the context of FIGS. 11B and 11B, the high porosity portion 150a is the first portion of the stent that enters the first introducer tube / first introducer sleeve 164a and is also the first section of the stent that exits from the first end 153a of the covered tubular portion 154a. Fig.13 As shown. Since the first introducer tube / first introducer sleeve 164a is generally larger than the size of the stent 150, the first introducer tube / first introducer sleeve 164a (low porosity portion 150b, Fig.13The rearmost portion of the stent 150 will be approximately flush with one end of the first introducer tube / first introducer sleeve 164a, while the other end of the stent (in the context of Fig.13 There may be a gap between the first introducer tube / first introducer sleeve 164a and the corresponding end of the first introducer tube / first introducer sleeve 164a. When the first introducer tube / first introducer sleeve 164a is completely removed from the first tube 154a, the low porosity section 150b will be located at one end of the first introducer tube / first introducer sleeve 164a.

[0092] To place the stent into the catheter, the configuration is simply flipped so that the first introducer tube / first introducer sleeve 164a is withdrawn from the first tube 154a. The user places the other end of the introducer tube (the portion away from the pusher 158a) into the catheter hub or catheter hemostasis valve - such as Fig.14 Logically, this makes sense because the only way a user can deliver a stent is by being able to grasp the pusher to maneuver the stent. Fig.14 In the context of, it can be considered that the first introducer tube / first introducer sleeve 164a has been placed within the catheter hub or hemostasis valve, wherein the stent is now ready to be introduced into the catheter tube 168, while the first introducer tube / first introducer sleeve 164a (having a larger diameter) remains in the catheter hub or hemostasis valve and once the stent 150 is delivered into the catheter tube, the first introducer tube / first introducer sleeve 164a will be withdrawn. The user pushes the pusher 158a distally to move the stent 150 from the introducer sleeve into the catheter tube 168. The diameter of the first introducer tube / first introducer sleeve 164a is larger than the diameter of the catheter tube. Therefore, the engagement pusher can guide the stent 150 into the catheter tube 168, while the first introducer tube / first introducer sleeve 164a remains. In this construction, as Fig.14 As shown, the low porosity region 150b of the stent is located at the distal portion of the stent because this is how it is delivered from the housing 151 (see Figure 8 and 13 ), and the high porosity region 150b of the stent is located at the proximal portion of the stent.

[0093] Referring to the above, note that the term distal is used with respect to the direction of the patient's vasculature, while proximal refers to the direction outside the patient's body where entry into the vasculature occurs. In this manner, the user would push the pusher distally to move the stent into the vasculature, with the low porosity portion 150b positioned distally and the high porosity portion 150a positioned proximally.

[0094] If the user wishes the low porosity region 150b of the stent to be located proximally (e.g., where a branching artery is located distally near an aneurysm, it is desirable to have a proximal low porosity section and a distal high porosity section), the user would simply invert the configuration (see Figure 8 ), by engaging pusher 158b instead of pusher 158a, the stent is pulled into the second introducer tube / second introducer sleeve 164b located in the second tube 154b (see, for example, Fig. 11B ). When the bracket is engaged in this manner, the bracket will Fig.15 In the illustrated configuration, the second tube 154b emerges from the end 166, with the low porosity region 150b appearing first and the high porosity region 150a appearing last. The user can then Fig.16 The introducer tube 164b is oriented in the manner shown in FIG. 1 , whereby the high porosity region 150a is oriented toward the distal section of the second introducer tube / sleeve 164b and the low porosity region 150b is oriented toward the proximal section of the second introducer tube / second introducer sleeve 164b.

[0095] Further variations are possible. For example, Figure 8 The high porosity region 150a of the stent is illustratively shown adjacent to the first tube 154a / first introducer tube / first introducer sleeve 164a. However, this can be flipped so that the high porosity region 150a is flipped adjacent to the opposing second tube 154b / second introducer tube / second introducer sleeve 164b. The delivery configuration that orients the stent can then be flipped so that the low porosity deflector region is located on a specific preferred section of the stent.

[0096] Other embodiments may vary the position of the first housing segment 152a and the second housing segment 152b. Figure 6 In the context of FIG. 1 , the housing segments are shown as being located outside the periphery of the concentric spirals forming the first tube 154a and the second tube 154b - and wherein the outlets or ends 166 are arranged along the innermost concentric spirals (as shown in FIG. 11 ). This can be varied in other embodiments, such that the housing is directly connected to the innermost spirals forming the first tube 154a and the second tube 154b, and the ends 166 are along the outermost concentric spirals. Other embodiments can ignore the spiral distributor housing shape and adopt other shapes (e.g., linear, rectangular, or other shapes).

[0097] Furthermore, while the housing and delivery descriptions specifically refer to how the delivery configuration will work with a stent using only two porosity segments, other stent embodiments considered above discuss three or more porosity segments, employing various combinations of low porosity and high porosity segments.

[0098] Although the term stent is often used in the specification, the embodiments described herein may be used with a variety of vascular prosthetic devices, such as stents, stent grafts, and vascular scaffolds.

[0099] Unless otherwise stated, all the numbers used in the specification and claims to represent the amount of ingredients, properties such as molecular weight, reaction conditions, etc. should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise stated, the numerical parameters set forth in the specification and the appended claims are approximate values, which can vary according to the desired characteristics sought to be obtained by the present invention. At least, rather than attempting to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be interpreted according to the number of reported significant figures and by applying ordinary rounding techniques. Although the numerical ranges and parameters setting forth the wide range of the present invention are approximate values, the numerical values ​​set forth in the specific embodiments are reported as accurately as possible. However, any numerical value inherently contains certain errors that are necessarily caused by the standard deviation found in their respective test measurements.

[0100] The terms "a / an", "the", and similar references used in the context of describing the present invention (especially in the context of the claims) and the absence of quantifiers should be interpreted as covering the singular and the plural, unless otherwise specified herein or clearly contradictory to the context. The description of the range of values ​​herein is intended only to be used as a shorthand method for individually referring to each individual value falling within the range. Unless otherwise specified herein, each individual value should be incorporated into the specification as if it were described individually herein. Unless otherwise specified herein or clearly contradictory to the context, all methods described herein can be implemented in any suitable order. The use of any and all examples or exemplary language (e.g., "such as / for example") provided herein is intended only to better illustrate the present invention and is not intended to limit the scope of the claimed invention. Any language in the specification should not be interpreted as representing any unclaimed element essential to the implementation of the present invention.

[0101] The grouping of the alternative elements of the present invention disclosed herein or embodiments should not be construed as limiting.Each group member can be mentioned or protected individually, or any combination with other members of the group or with other elements found herein is mentioned and protected.It can be expected that, for convenience and / or patentability reasons, one or more members of the group can be included in the group, or one or more constituent members can be deleted from the group.When any such inclusion or deletion occurs, this specification is deemed to include the modified group, thereby satisfying the written description of all Markush groups used in the appended claims.

[0102] Certain embodiments of the present invention are described herein, including the best mode known to the inventor for carrying out the present invention. Of course, after reading the above description, changes in the embodiments of these descriptions will become apparent to those of ordinary skill in the art. The inventor expects that the technician will appropriately adopt such changes, and the inventor intends to practice the present invention in a manner different from that specifically described herein. Therefore, the present invention includes all modifications and equivalents of the subject matter recorded in the appended claims where permitted by applicable law. In addition, unless otherwise specified herein or clearly contradictory to the context, the present invention covers any combination of all possible variations of the above elements.

[0103] In addition, numerous references are made to patents and printed publications throughout the specification. Each of the above-cited references and printed publications is individually incorporated herein by reference in its entirety.

[0104] Finally, it should be understood that the embodiments of the present invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the present invention. Therefore, by way of example and not limitation, alternative configurations of the present invention may be used in accordance with the teachings herein. Therefore, the present invention is not limited to those precisely shown and described.

Claims

1. A vascular prosthesis system, include: A vascular prosthesis having a region of lower porosity and a region of higher porosity; a housing accommodating the vascular prosthesis; as well as a first tube connected to a first end of the housing, the first tube comprising a first introducer cannula; a second tube connected to a second end of the housing, the second tube containing a second introducer cannula; The vascular prosthesis is deliverable through the first tube or the second tube.

2. The vascular prosthesis system of claim 1, wherein a distal end of the vascular prosthesis is preloaded into each introducer sheath.

3. The vascular prosthesis system of claim 1, wherein at least one of the first introducer sheath or the second introducer sheath spans a portion of the housing.

4. The vascular prosthesis system of claim 1 further comprising a pin engaging at least one of the first introducer sheath or the second introducer sheath.

5. The vascular prosthesis system of claim 1, wherein the first tube and the second tube are each coiled.

6. The vascular prosthesis system of claim 1 , wherein delivery through the first tube causes the lower porosity region to be located on a proximal region of the vascular prosthesis, and delivery through the second tube causes the lower porosity region to be located on a distal region of the vascular prosthesis.

7. A vascular prosthesis system, include: a vascular prosthesis having a first region of porosity and a second region of porosity; a housing accommodating the vascular prosthesis; a first tube connected to a first end of the housing, the first tube containing a first introducer sheath; and a second tube connected to a second end of the housing, the second tube containing a second introducer cannula; wherein the vascular prosthesis is deliverable through the first tube or the second tube; and Wherein, if the vascular prosthesis is delivered through the first tube, the first porosity region is located on a first longitudinal section of the vascular prosthesis; and if the vascular prosthesis is delivered through the second tube, the first porosity region is located on a second longitudinal section of the vascular prosthesis.

8. The vascular prosthesis system of claim 7, further comprising a first pusher and a second pusher, the first pusher being connected to the first segment of the vascular prosthesis and the second pusher being connected to the second segment of the vascular prosthesis.

9. The vascular prosthesis system according to claim 8, in, The first pusher is used to guide the vascular prosthesis through the first tube, and the second pusher is used to guide the vascular prosthesis through the second tube.

10. The vascular prosthesis system according to claim 8, in, The first pusher is detachable from the first section of the vascular prosthesis.

11. The vascular prosthesis system according to claim 8, in, The second pusher is detachable from the second section of the vascular prosthesis.

12. The vascular prosthesis system according to claim 8, in, As the vascular prosthesis is delivered through the second tube, the first pusher is disengaged from the vascular prosthesis.

13. The vascular prosthesis system of claim 8, wherein the second pusher is disengaged from the vascular prosthesis as the vascular prosthesis is delivered through the first tube.

14. The vascular prosthesis system according to claim 8, in, The vascular prosthesis includes a flared end, and wherein the first pusher and the second pusher engage the flared end of the vascular prosthesis.

15. A diversion prosthesis system, include: A vascular prosthesis, wherein the vascular prosthesis has a flow-conducting region with lower porosity and a non-flow-conducting region with higher porosity; a housing accommodating the vascular prosthesis; a first tube connected to a first end of the housing, the first tube comprising a first introducer cannula; a second tube connected to a second end of the housing, the second tube containing a second introducer cannula; The vascular prosthesis is deliverable through the first tube or the second tube; If the vascular prosthesis is transported through the first tube, the flow guide area is located on a first longitudinal section of the vascular prosthesis; and if the vascular prosthesis is transported through the second tube, the flow guide area is located on a second longitudinal section of the vascular prosthesis.

16. The flow diversion prosthesis system according to claim 15, in, The housing has a first housing section, a second housing section, and a gap between the first housing section and the second housing section.

17. The flow diversion prosthesis system according to claim 15, in, The lumen of the housing is larger than the lumens of the first tube and the second tube.

18. The flow diversion prosthesis system according to claim 15, in, The outer diameter of the housing is larger than the outer diameter of the first tube and the outer diameter of the second tube.

19. The flow diversion prosthesis system according to claim 15, in, Delivery through the first tube causes the flow diversion region to be located on a proximal region of the vascular prosthesis, and delivery through the second tube causes the flow diversion region to be located on a distal region of the vascular prosthesis.

Images