Stent and stent delivery

Abstract

To provide a vascular prosthesis (e.g., stent), and a packaging and delivery system to selectively deliver a vascular prosthesis.SOLUTION: A vascular prosthesis uses a low porosity section and a high porosity section, and a packaging and delivery system allows the prosthesis to be delivered such that the positions of the low porosity section and the high porosity section of the prosthesis can be varied.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 62 / 817,988, entitled "STENTS AND STENT DELIVERY," filed March 13, 2019, the entirety of which is incorporated herein by reference. [Background technology]

[0002] Vascular prostheses such as stents are used in the vascular system for a variety of purposes. These purposes include, but are not limited to, supporting blood vessels open to restore patency or treat sclerotic buildup, delivering drugs, acting as a scaffold to hold embolic material, and diverting blood flow away from an area of ​​interest such as an aneurysm. This last type of stent is known as a flow diverter. Flow diverters are placed in blood vessels adjacent to an aneurysm, spanning the neck of the aneurysm, to reduce blood flow to the aneurysm, thereby reducing the risk of aneurysm rupture. Over time, endothelial growth occurs over and around the stent, isolating the aneurysm and restoring normal blood flow in the area of ​​interest.

[0003] One problem with using these shunt stents is the difficulty of preparing a single stent that effectively treats an entire vascular region. Typical shunt stents utilize a consistent low porosity profile throughout the entire length of the stent. This can be problematic when only a portion of the stent serves for shunting. For example, a portion of the stent may be located adjacent to the aneurysmal region where low porosity / high resistance to blood flow is beneficial for restricting blood flow to the aneurysm. However, other portions of the stent may overlap a nearby branch artery where low porosity restricts blood flow to the branch artery, thereby adversely affecting natural blood flow. A typical shunt stent has a consistent porosity profile, reducing blood flow not only to the location of the aneurysm, but also to the branch artery. The reduction in blood flow to the normal branch artery over time can cause complications due to reduced oxygenation within this arterial region. Thus, the shunt interface can effectively treat the aneurysm but can cause complications in adjacent regions that do not require shunting.

[0004] There is a need for stents / stent delivery platforms that have the ability to treat a variety of areas and conditions and address these issues. Summary of the Invention [Means for solving the problem]

[0005] Vascular prosthetic devices, packaging or packing 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 constructed 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 profile along the length of the stent, with one portion of the stent having a first porosity profile and another portion of the stent having a second porosity profile. In one embodiment, the stent is constructed of metallic braided wire. In one embodiment, a bi-layer braided stent with a variable longitudinal profile is described. In one embodiment, one length of the stent utilizes a first porosity while the other length of the stent utilizes a different second porosity. In one embodiment, the stent is configured as a flow diverter stent to divert blood flow away from an aneurysm, the stent having a first portion having a porosity profile that functions as a flow diverter and a second portion having a higher porosity profile that does not function as a flow diverter.

[0006] In one embodiment, the vascular prosthetic device can be delivered in either a first configuration or a second configuration to customize which portion of the stent utilizes the low-porosity flow diversion. In the first configuration, the low-porosity flow diversion layer is located in one portion of the stent (e.g., the proximal portion) and the high-porosity layer is located in another portion of the stent (e.g., the distal portion). In the second configuration, the low-porosity flow diversion layer is located in one portion of the stent (e.g., the distal portion) and the high-porosity layer is located in another portion of the stent (e.g., the proximal portion). The stent can be selectively delivered in either the first configuration where flow diversion is useful in a particular portion of the stent (e.g., the proximal portion) or the second configuration where flow diversion is useful in another particular portion of the stent (e.g., the distal portion).

[0007] A vascular prosthesis (e.g., stent) system is described. In one embodiment, the system includes packaging utilizing a housing that contains a stent, at least one first tube connected to a first end of the packaging or housing, and at least one second tube connected to a second end of the housing. Each of the first tube and the second tube includes an introducer sleeve that is used to selectively introduce the stent into a delivery catheter. The stent utilizes a variable porosity profile, where a length of the stent utilizes a first porosity and another portion of the stent utilizes a different second porosity. As the stent advances along a first direction through the first tube, the porosity profile is such that a low porosity interface (e.g., configured for flow division) is located at one portion of the stent (e.g., a proximal portion) and a high porosity interface is located at another portion of the stent (e.g., a distal portion). As the stent advances along the second direction through the second tube, the porosity profile is switched so that a low porosity interface useful for flow diversion is located in one portion of the stent (e.g., the distal portion) and a high porosity interface is located in another portion of the stent (e.g., the proximal portion), allowing the user to customize which portion of the stent is used for flow diversion by pushing the stent through either the first or second introducer tube.

[0008] In one embodiment, the vascular prosthesis system utilizes a mechanical push system. In one embodiment, the vascular prosthesis system utilizes mechanical delivery pushers connected to each end of a stent used to deliver the stent through a tube region such 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 driven in a first direction through the first tube, the pusher on one side of the stent remains engaged with the stent and guides the stent through the first tube while the pusher on the other side of the stent disengages. When the stent is driven in a second direction through the second tube, the pusher on one side of the stent remains engaged with the stent and guides the stent through the second tube while the pusher on the other side of the stent disengages.

[0009] In one embodiment, a method of delivering a vascular prosthetic device (e.g., a stent) is described. The stent has a variable porosity profile, with a portion of the stent utilizing a low porosity interface (e.g., configured for flow shunting). The stent is contained in a housing, with tubes on either side of the housing and mechanical pusher elements on both ends of the stent. Selectively pushing the stent in a first direction guides the stent through the first tube, which places a flow shunting layer at a particular portion of the stent (e.g., the proximal portion). Alternatively, selectively pushing the stent in a second direction guides the stent through the second tube, which places a flow shunting layer at another portion of the stent (e.g., the distal portion). Each tube includes an introduction sleeve into which the stent is introduced as the stent is delivered from the housing into the tube. The stent and the overlying introduction sleeve are delivered out of the tube. The introducer sleeve is then placed near the proximal end of the catheter and the stent is advanced inside the catheter and through the catheter to the treatment site within the patient's vasculature.

[0010] In one embodiment, a method of treating a patient with a prosthetic device (e.g., a stent) is described. The stent utilizes a variable porosity interface, with a low porosity layer at certain portions of the stent. In one embodiment, the low porosity layer is configured for flow diversion. The stent is contained within a housing and is delivered by a user into an introducer sleeve and delivered through a specific tube section to position the low porosity flow diversion layer either proximally or distally of the stent depending on the condition of the vasculature and where flow diversion is desired. The introducer sleeve (containing an indwelling stent) is placed near the proximal end of a catheter, and the stent is advanced through the introducer sleeve and then advanced into the catheter and through the catheter to a treatment site within the patient's vasculature.

[0011] In some embodiments, a vascular prosthesis system is described that includes a vascular prosthesis having a low porosity region and a high porosity region, a housing that contains the vascular prosthesis, a first tube connected to a first end of the housing, and a second tube connected to a second end of the housing, wherein the vascular prosthesis is deliverable through the first tube or the second tube.

[0012] In some embodiments, the first tube and the second tube each include a lead-in sleeve. The first tube and the second tube may both be spirally wound. In other embodiments, a distal end of the vascular prosthesis is preloaded into each lead-in sleeve. The lead-in sleeve may span a portion of the housing.

[0013] In some embodiments, the system may further include a pin that engages the lead-in sleeve.

[0014] In some embodiments, delivery through a first tube results in a low porosity region being located in a proximal region of the vascular prosthesis, and delivery through a second tube results in a low porosity region being located in a distal region of the vascular prosthesis.

[0015] Also described herein is a vascular prosthesis system including a vascular prosthesis having a first porosity region and a second porosity region, a housing containing the vascular prosthesis, a first tube coupled to a first end of the housing, and a second tube coupled to a second end of the housing, where the vascular prosthesis is deliverable through the first tube or the second tube. In some embodiments, when the vascular prosthesis is delivered through the first tube, the first porosity region is located at a first longitudinal portion of the vascular prosthesis, and when the vascular prosthesis is delivered through the second tube, the first porosity region is located at a second longitudinal portion of the vascular prosthesis.

[0016] In other embodiments, the system further comprises a first pusher connected to a first portion of the vascular prosthesis and a second pusher connected to a second portion of the vascular prosthesis. The first pusher may 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 disengaged from the first portion of the vascular prosthesis. The second pusher can be disengaged from the second portion of the vascular prosthesis. The vascular prosthesis may include a flared end, and the first pusher and the second pusher engage the flared end of the vascular prosthesis. In some embodiments, the first pusher disengages from the vascular prosthesis when the vascular prosthesis is delivered through the second tube. In other embodiments, the second pusher disengages from the vascular prosthesis when the vascular prosthesis is delivered through the first tube.

[0017] Also described herein is a shunt prosthesis system including a vascular prosthesis having a shunt region with low porosity and a non-shunt region with high porosity, a housing containing the vascular prosthesis, a first tube coupled to a first end of the housing, and a second tube coupled to a second end of the housing, where the vascular prosthesis is deliverable through the first tube or the second tube. In some embodiments, when the vascular prosthesis is delivered through the first tube, the shunt region is located at a first longitudinal portion of the vascular prosthesis, and when the vascular prosthesis is delivered through the second tube, the shunt region is located at a second longitudinal portion of the vascular prosthesis.

[0018] In some embodiments, the housing has a first housing portion, a second housing portion, and a gap therebetween. 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.

[0019] Delivery through the first tube results in a shunt region located at a proximal region of the vascular prosthesis, and delivery through the second tube results in a shunt region located at a distal region of the vascular prosthesis. [Brief description of the drawings]

[0020] These and other aspects, features and advantages of the present invention will become apparent from and elucidated in the following detailed description of the embodiments of the present invention, which proceeds with reference to the accompanying drawings.

[0021] [Figure 1] FIG. 1 shows a typical flow diverter stent used to treat aneurysms. [Diagram 2] FIG. 1 illustrates a stenting technique utilizing two diverting stents used to treat a bifurcation aneurysm. [Diagram 3] FIG. 1 illustrates a variable porosity flow shunt stent according to one embodiment. [Figure 4] FIG. 13 shows a variable porosity flow shunt stent according to another embodiment. [Diagram 5] 1A-1D show a variable porosity flow diverter stent according to one embodiment used to treat an aneurysm. [Figure 6] FIG. 1 illustrates a stent packaging and delivery system according to one embodiment. [Figure 7] FIG. 1 illustrates a housing and delivery system used in stent packaging according to one embodiment. [Figure 8] FIG. 2 is a close-up view of a stent packaging and delivery system according to one embodiment. [Figure 9] FIG. 1 illustrates a pusher-stent connection interface according to one embodiment. [Figure 10] FIG. 1 illustrates a pusher-stent connection interface according to one embodiment. [Figure 11A] FIG. 1 illustrates a tubing section used in a stent packaging and delivery system according to one embodiment. [Figure 11B] 13A-13C show other tubing sections for use in a stent packaging and delivery system according to one embodiment. [Figure 12] FIG. 11B shows the exit port of the tube section of FIG. 11A. [Figure 13] FIG. 13 shows a stent passing through the exit port of FIG. 12. [Figure 14] FIG. 13 shows a stent with a distally facing shunt being introduced into a catheter according to one embodiment. [Figure 15] FIG. 13 shows a stent and delivery system passing through an exit port of a tube portion of the stent packaging according to one embodiment. [Figure 16] FIG. 13 illustrates a stent having a proximal flow shunt installed on a catheter according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Vascular prostheses such as stents may be used to treat a variety of conditions for a variety of reasons, as discussed above. A flow diverter stent is one particular type of vascular prosthesis that utilizes a relatively low porosity interface to divert flow away from a particular vascular region. Flow diverter stents are one potential treatment option for aneurysms. When a flow diverter stent is placed against the neck or opening of an aneurysm, the low porosity interface restricts blood flow to the aneurysm, reducing the risk of rupture. Over time, endothelial tissue grows over the stent, blocking blood flow to the aneurysm.

[0023] US Pat. Nos. 9,867,725 and 9,439,791 disclose information relating to stents, bilayer stents, and flow shunt stents, and are both incorporated herein by reference in their entirety.

[0024] Although shunt stenting is an effective method for treating aneurysms, there are potential problems with the procedure. Shunt stents utilize consistent porosity throughout the entire length of the stent. This can cause problems if the aneurysm is located very close to a branch vessel and the shunt stent covers both the aneurysm and the nearby branch vessel. While the shunt interface is useful for the portion adjacent to the aneurysm, it is not useful for the portion of the stent adjacent to the branch vessel, as reduced blood flow to the vessel can adversely affect normal blood circulation in the body and cause further problems. This scenario is illustrated in FIG. 1, where a shunt stent 100 is used to treat a sidewall aneurysm 104 along a vessel 102, but also overlaps a nearby branch vessel 106, thereby affecting blood flow through the branch vessel.

[0025] Diverting stents may also be used to treat bifurcation aneurysms. Aneurysms may typically be located along vessel bifurcations, due to the high blood pressure experienced by the vessel walls at these bifurcations. Because there are multiple vessels at these junctions, two stents are placed across the aneurysm, often with one low-porosity diverting stent placed through the other high-porosity stent (commonly referred to as a Y-stenting procedure, since a Y-shape is formed). Another technique, shown in Figure 2, is known as the kissing technique, in which two low-porosity stents may be placed next to each other to reduce blood flow to the aneurysm. Because diverting stents utilize a consistent low-porosity profile and only a portion of the stent is required for diversion, the stent may adversely affect blood flow through this area. This may occur, for example, if the stent is not placed flush with the vessel wall and the large amount of metal surface coating used to create the low-porosity profile impedes blood flow. This can also occur in the scenario shown in Figure 2, where stents are positioned across a blood vessel and in contact with each other, thereby creating an obstruction to blood flow.

[0026] One solution to these problems is to provide a variable profile to the stent, so that only a portion of the stent utilizes the flow shunt interface, as shown in FIG. 3. In one embodiment, the stent is a mesh of braided metal wires. Preferably, strong shape memory materials such as Nitinol, stainless steel, cobalt-chromium alloy, or pultruded filled tube (e.g., platinum core covered with Nitinol jacket) wires are used. The stent 120 utilizes a first region 122 with high porosity, which has a relatively low metal surface coverage as shown in FIG. 3. This means that the pores formed by the various wire intersections are larger compared to the less porosity regions of the stent. The stent 120 also utilizes a second region 124 with low porosity, which has a relatively high metal surface coverage. This means that the pores formed by the various wire intersections are smaller compared to the more porosity regions of the stent.

[0027] A low porosity region, such as the second region 124, can be configured in a variety of ways. In one embodiment, the entire stent is configured with a common high porosity layer disposed along the entire longitudinal length of the stent, and the low porosity region of the stent is configured with an additional low porosity layer disposed either above or below the common high porosity layer, the low porosity region of the stent utilizing a layer having a denser or finer braid pattern. In this way, a defined high porosity portion, such as the first region 122 (consisting only of the more porously wound wire portions / layers) and a low porosity portion, such as the second region 124 (consisting of both the layer directly above or below and the more porous layer, which is the denser layer) are provided. In one embodiment, a low porosity layer or portion is disposed radially inward of the high porosity layer along the low porosity portion of the stent. In one embodiment, a low porosity layer is positioned radially outward of a high porosity layer along a portion of the stent that utilizes a low porosity interface, such that one portion of the stent has a higher porosity and another portion of the stent has a lower porosity. This low porosity portion of the stent is considered the branch portion of the stent, and is in fact the region of the stent that is positioned along the neck of the aneurysm and is thereby used to treat the aneurysm.

[0028] As an example, if a first layer runs the length of the device and is taken to be the outer layer, and an inner / second layer acts as a flow divider and is located radially inward of the length of the outer layer, the outer layer wire diameter may range from 0.002" to 0.003" and the inner layer wire diameter may range from 0.00075" to 0.001". Depending on the size of the device, the outer layer may have 1-36, 6-24, or 12-18 wires and the inner layer may have 36-64 wires.

[0029] In other embodiments, the first layer extends the length of the device and is taken to be the inner layer, and the outer / second layer acts as a flow divider and is located radially outside a portion of the inner layer.

[0030] In one embodiment, the first high porosity metal section that defines the entire length of the stent is comprised of only one wire that is wound back and forth on a mandrel to define a generally tubular shape, and the low porosity section is formed of multiple metal wires (e.g., 12-24 or more) that are separately wound / braided and then placed under the high porosity section along certain portions of the stent to define separate high porosity and defined low porosity sections.

[0031] In other embodiments, the stent is constructed from only one braided layer, but the low porosity portion of the stent utilizes a tighter or denser winding pattern to create a branching section. In one example, the stent is wound on a common mandrel, but the low porosity branching section of the stent utilizes a denser winding pattern along that particular portion of the mandrel to create a denser braided profile.

[0032] In other embodiments, the stent is not constructed of braided wires. Instead, laser cut metal or polymer sheets are used, with the high porosity portion of the stent utilizing a more open profile (i.e., more cuts or openings are used along this portion) while the low porosity portion of the stent utilizing a less open profile (i.e., fewer cuts or openings are used along this portion).

[0033] In one embodiment, the stent includes multiple outwardly projecting flares 126, e.g., 2-10 flares, on both ends of the stent. The flares help stabilize the stent within the vessel and can provide a mechanism for connecting the stent to a pusher element that helps guide and deliver the stent, as described below. The flares 126 may further include a radiopaque marker band or coil 128 wrapped around a portion of the flare. The coil 128 can help visualize the end of the stent during the stent delivery process and further facilitate connection to a delivery pusher, as described below. In one embodiment, all of the flares 126 are similarly sized. In one embodiment, the flares 126 are different sizes, such that some flares are larger and some are smaller. In one embodiment, the flares 126 are staggered such that one large flare is located next to a small flare, and this pattern continues around the circumference of the end of the stent.

[0034] Although the stent shown in Figure 3 has only two interface portions, i.e., a first region 122 as a first high porosity portion and a second region 124 as a low porosity portion adjacent to the high porosity portion, various interfaces may be provided in different embodiments. For example, the stent may have three longitudinal portions, i.e., a middle low porosity portion and two high porosity portions on either side. Alternatively, as shown in Figure 4, the stent may have a middle high porosity portion 132 and two low porosity portions 134a, 134b on either side.

[0035] Alternatively, four or more sections may be used, utilizing various combinations of high and low porosity sections. Furthermore, when multiple high porosity sections and multiple low porosity sections are used, each section may utilize a different porosity profile. That is, multiple high porosity sections may each utilize a different high porosity interface (e.g., different braid profiles resulting in different pore sizes), while multiple low porosity sections may each utilize a distinct low porosity interface.

[0036] Alternatively, the low porosity region and / or the high porosity region may utilize 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 particular 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 particular high porosity range.

[0037] 5, a variable porosity stent design utilizing low porosity / flow diverging sections 144 and high porosity sections 142 can compress the low porosity regions of the stent against the aneurysm neck to treat the aneurysm 104. However, blood flow to the branch vessels adjacent to the stent is not necessarily compromised because the remainder of the stent utilizes a high porosity interface, which covers the branch vessel regions, which are covered by a high porosity interface that does not impede blood flow as much as the low porosity interface.

[0038] Diverting stents often utilize a percentage to define the level of diversion. 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 contains actual material. In the context of braided metal stents, this refers to the portion of the complete stent area that comprises 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 that the wires take up) 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 percentage of the stent that is composed only of pores. In other words, this is the ratio of the open space or pores of the stent to the total surface area of ​​the stent. The porosity percentage and the material surface coverage add up to 100%, and thus these two percentages are related.

[0039] In some embodiments, a stent can be classified as a flow diverter if the percent porosity is between about 50 and about 75%. Thus, if a variable porosity stent as described herein is capable of utilizing a portion for flow diverting, the percent porosity of that particular portion may be between about 50 and about 75%, while the portion of the stent that is not for flow diverting has a higher percent porosity. In some embodiments, that higher porosity may be a percent porosity of between about 80 and about 95%.

[0040] In other embodiments, a variable porosity stent may include a shunting portion having a percent porosity of between about 40 and about 80%, between about 30 and about 80%, between about 20 and about 80%, between about 10 and about 80%, between about 40 and about 70%, between about 30 and about 70%, between about 20 and about 70%, between about 10 and about 70%, between about 40 and about 60%, between about 30 and about 60%, between about 20 and about 60%, between about 10 and about 60%, between about 40 and about 50%, less than about 80%, less than about 70%, less than about 60%, or less than about 50%.

[0041] In other embodiments, a variable porosity stent can include a non-diverting portion having a porosity percentage of between about 80 and about 95%, between about 80 and about 90%, or between about 90 and about 95%.

[0042] Similarly, if a stent utilizes multiple diverting sections and / or multiple non-diverting sections, the respective ranges of each section will utilize the ranges set forth above.

[0043] One problem with stents is that they can usually only be configured and delivered in one direction because a fixed pusher element is connected to a portion of the stent (e.g., the proximal end) and is used to guide the stent out of the packaging (typically configured as a dispenser hoop) and into and through the delivery catheter. The pusher mechanism then detaches from the stent via pyrolytic, mechanical, or electrolytic means once the stent is expanded in the vasculature. In the context of the above-described embodiments including various configurations of variable porosity stents (e.g., where only one longitudinal portion of the stent utilizes a low porosity or flow splitter layer), typical or existing state-of-the-art pusher delivery mechanisms are connected to only one end of the stent. This means that the stent can only be delivered with the low porosity flow splitter positioned fixedly at either the proximal or distal portion of the stent. In practice, this means that a manufacturer would have to separately design and sell both a) a stent with a low-porosity interface in the proximal region and b) a stent with a low-porosity interface in the distal region of the stent to cover each scenario.

[0044] The following embodiments address this issue by utilizing 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 either 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 such that the low porosity section of the stent can be located in either the proximal or distal region of the stent. This can allow the physician to customize the delivery method to the needs of the patient and can save procedural and manufacturer costs and expenses by having a single stent that can be delivered and oriented in either direction to address a particular treatment need (e.g., either a proximally facing or a distally facing flow shunt stent section).

[0045] FIG. 6 illustrates an embodiment of a vascular prosthesis packaging and delivery system. In one embodiment, the system reflects the way an end user (e.g., a physician) picks up a vascular prosthesis. A vascular prosthesis device (e.g., a stent) is located within a housing 151 having a first end 153a and a second end 153b. The first housing portion 152a may include a first tube 154a at the first end 153a, and the second housing portion 152b may include a second tube 154b at the second end 153b. As shown in FIG. 6, each of the first tube 154a and the second tube 154b may extend in a spiral shape with concentric tube portions. Each of the first housing portion 152a and the second housing portion 152b and the tubes connected thereto respectively include a continuous lumen therein that facilitates the passage of a stent through the first tube 154a or the second tube 154b.

[0046] In other embodiments, each of the first tube 154a and the second tube 154b may be in a form other than a spiral. In some embodiments, the first tube 154a can be configured to spiral over or under the second tube 154b, thereby saving additional packing space.

[0047] Housing 151 is shown in more detail in Figure 7 and includes two housing portions, a first housing portion 152a and a second housing portion 152b separated by a gap 156. A first tube 154a extends from a first end 153a of first housing portion 152a and a second tube 154b extends from a second end 153b of second housing portion 152b.

[0048] As shown in Figures 6 and 7, the housing 151 (comprised of first housing portion 152a and second housing portion 152b) has a thickness or outer diameter that is greater than the outer diameters 160a and 160b of the first tube 154a and second tube 154b.

[0049] Additionally, the housing 151 has an interior lumen that initially houses the stent, the interior lumen having its own associated size or diameter that represents the interior passage space. The interior diameter of the housing 151 is larger or wider than the interior diameter 162a of the first tube 154a and the interior diameter 162b of the second tube 154b.

[0050] In one embodiment, the first end 153a and the second end 153b of the housing 151 (including the housing portions 152a and 152b) may include a tapered 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 the more abrupt transition shown in FIG.

[0051] An embodiment may utilize a housing having a closer diameter such that the outer diameter of the housing is substantially similar to the outer diameter of the tubes 154a, 154b. An embodiment may utilize a housing configuration in which the internal lumen of the first and second housing portions 152a, 152b may be substantially similar to the internal lumen of the first and second tubes 154a, 154b.

[0052] The stent 150 may be initially housed within both the first housing portion 152a and the second housing portion 152b such that a first portion 161a of the stent 150 is within the first housing portion 152a, a second portion 161b of the stent 150 is within the second housing portion 152b, and an intermediate region 161c of the stent 150 spans the gap 156 between the first and second housing portions 152a, 152b (see FIG. 8). This initial housing refers to how the stent is packaged for shipment and how the end user / physician receives the device / system.

[0053] Housing 151 (comprised of first housing portion 152a and second housing portion 152b) may have an internal cavity or lumen that is smaller than the fully expanded stent, such that the stent is compressed or constrained within housing 151. In some embodiments, this internal lumen has a diameter that substantially mirrors the outer diameter of the compressed or constrained stent. The stent is preferably formed of a shape memory metallic material, as described above, such that the stent has a heat-set expanded shape that it assumes when unconstrained.

[0054] A mechanical pusher is connected to each end of the stent 150, with a first pusher 158a connected to the first stent end 165a and a second pusher 158b connected to the second stent end 165b. Each pusher may span the entire associated spiral tube section. In this manner, the first pusher 158a spans the entire tube section 154a (meaning the entire spiral structure) so as to be exposed from the other open or terminal end of the tube section 154a. Similarly, the second pusher 158b spans the entire tube section 154b so as to be exposed from the other open or terminal end of the tube section 154b. Because each pusher extends beyond the terminal or terminal end of each tube section, a user can grasp and manipulate each pusher (either 158a or 158b) to move the stent 150.

[0055] The connection of the pusher to the stent is shown in more detail in FIG. 9. This is shown with respect to pusher 158b for illustrative purposes, although a similar configuration is used for pusher 158a. In one embodiment, pusher 158b includes a pair of enlarged bands 170a, 170b. In one embodiment, bands 170a, 170b include a radiopaque material such as platinum, palladium, or tantalum to aid in visualization of the connection joint. Flare 126 also utilizes a marker coil or band, as described above and shown in FIG. 3. The end of flare 126 is positioned within this marker band area, and coil 128 helps to constrain the stent flare within this area, such that coil 128 is constrained between enlarged bands 170a, 170b of pusher 158b. In this manner, the pusher is mechanically connected to the stent.

[0056] The above description has described how all of the flares 126 may be of similar length, or how some may be larger or smaller. In one embodiment, only one or some of the stent flares are sandwiched between the expansion bands 170a, 170b of the pusher. In one embodiment, all of the stent flares are sandwiched between the expansion 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 sandwiched between the expansion bands 170a, 170b of the pusher.

[0057] In some embodiments, greater than about 5% of the stent flare is sandwiched between the expansion bands of the pusher, while 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 sandwiched between the expansion bands of the pusher.

[0058] In some embodiments, the intermediate region 161c of the stent 150 is exposed through the gap 156 between the first and second housing portions 152a, 152b. However, because most of the length of the stent is contained within the smaller diameter housing portions 152a, 152b, the gap 156 is not large enough to allow the entire stent to physically expand itself to its heat-set, expanded shape. In some embodiments, less than about 5% of the intermediate region of the stent is exposed to 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 intermediate region of the stent is exposed to the gap 156.

[0059] To propel the stent through the first tube 154a, the user simply pulls on the pusher 158a (e.g., toward the left in the context of FIG. 8). The pusher 158a is connected to the first stent end 165a. As the stent is initially pulled toward the first tube 154a (e.g., toward the left in the front view of FIG. 8), the second stent end 165b passes through the gap 156 and into the housing portion 152a. Once the end of the stent (the right end, i.e., the second stent end 165b in the context of FIG. 8) passes through the gap 156, the stent is slightly exposed and allowed to expand slightly; that is, the flare begins to protrude from the second housing portion 152b. As this occurs, the pusher 158b disengages from the second stent end 165b because the stent flare is no longer constrained within the expansion bands 170a, 170b of the pusher 158b. At this point, the stent is connected only to pusher 158a, and by moving the pusher (in this case, in the context of FIG. 8, by pulling pusher 158a to the left), the stent is guided through the first housing portion 152a and connected to the first tube 154a.

[0060] The gap 156 described above is simply configured to allow the ends of the stent to expand as each end passes therethrough, thereby dislodging the opposing pusher. In one embodiment, the gap is completed by forming a circumferential space or gap between the first housing portion 152a and the second housing portion 152b, which forms the gap 156. In another embodiment, there are one or more small slits of material connecting the first housing portion 152a and the second housing portion 152b, such that the majority of the gap is still defined, but there is also a small connection point between the first housing portion 152a and the second housing portion 152b. Because the majority of the space between the first housing portion 152a and the second housing portion 152b is still defined by an open space or "gap", the stent ends can still expand to some extent as the stent passes therethrough, thereby dislodging the other opposing pusher.

[0061] To pass the stent through the second tube 154b, the user simply uses the pusher 158b (in the context of FIG. 8, pull the pusher 158b to the right) so that the first stent end 165a (in the context of FIG. 8) passes through the gap 156, which causes the stent to flare out and disengage the stent from the pusher 158a.

[0062] The configuration of the connection of stent 150 to pusher 158a is shown in Figure 10 and is essentially the same as in Figure 9, except that opposite ends of the stent / stent flare are engaged. As explained above, pulling on pusher 158b (towards the right in the context of Figure 8) causes pusher 158a to disengage from the opposite side of the stent as stent 150 passes through gap 156.

[0063] Each of the first tube 154a and the second tube 154b includes a smaller introducer tube or sleeve along a portion of the tube section, as shown in FIG. 8. The first tube 154a includes a first introducer tube / sleeve 164a, and the second tube 154b includes a second introducer tube / sleeve 164b. When the stent 150 is pulled into the first tube 154a or the second tube 154b, it is actually pulled into either the first introducer tube / sleeve 164a or the second introducer tube / sleeve 164b located inside the first tube 154a or the second tube 154b. The introducer tubes for the spiral tube section are shown in more detail in FIGS. 11A-11B, where the first tube 154a includes the first introducer tube / sleeve 164a inside a portion of the tube, and the second tube 154b includes the second introducer tube / sleeve 164b inside a portion of the tube. When the user manipulates the pusher, for example, in the context of Figure 8, by retracting the pusher 158a to the left into the first introducer tube / sleeve 164a within the first tube 154a, the stent advances into the introducer tube until it is fully received within the introducer tube. Once the stent is received within the first introducer tube / sleeve 164a, continued manipulation of the pusher 158a can pull the stent through the remainder of the first tube 154a.

[0064] Similarly, when the user manipulates the pusher, for example, in the context of Figure 8, by pulling the pusher 158b to the right into the second introducer tube / sleeve 164b within the second tube 154b, the stent advances into the introducer tube until it is fully received within the introducer tube. Once the stent is received within the second introducer tube / sleeve 164b, continued manipulation of the pusher 158b pulls the stent through the remainder of the second tube 154b.

[0065] In other embodiments, the ends of the stent (including the loop or flared regions) may be preloaded into the first and second introducer tubes / sleeves 164a and 164b. In one embodiment, each end of the stent 150 is preloaded into the first and second introducer tubes / sleeves 164a and 164b, respectively, to facilitate easier entry of the stent into the introducer tubes. In this manner, one end of the stent 150 is disposed within the first introducer tube / sleeve 164a (the first introducer tube / sleeve 164a is disposed within the first tube 154a) and the other end of the stent 150 is disposed within the second introducer tube / sleeve 164b (the second introducer tube / sleeve 164b is disposed within the second tube 154b). This configuration may have the additional advantage, for example, of allowing the size of housing 151 (including first housing portion 152a and second housing portion 152b) to be increased because pushers 158a, 158b are connected to collapsed stent ends housed in first introducer tube / sleeve 164a and second introducer tube / sleeve 164b, respectively.

[0066] In other embodiments utilizing the pre-loaded stent end approach described above, the first and second introducer tubes / sleeves 164a, 164b are positioned beyond the ends of the first and second housing portions 152a, 152b such that they are within the lumens of both the first and second tubes 154a, 154b. This allows the ends of the stent to be pre-loaded into the first and second introducer tubes / sleeves 164a, 164b, as well as allowing the entire stent to be physically located initially within both the first and second housing portions 152a, 152b, which may make it easier for the stent to enter each introducer tube (e.g., the first introducer tube / sleeve 164a or the second introducer tube / sleeve 164b).

[0067] In one embodiment, the first and second tubes 154a and 154b overlapping the first and second introducer tubes / sleeves 164a and 164b can utilize mechanical fittings to help ensure that the introducer tubes are selectively secured in place while the entire stent 150 is loaded into each introducer tube. For example, a portion of the first and / or second tubes 154a and 154b near the first and / or second ends 153a and 153b of the housing 151 can utilize a slot or cutout area, where the first and / or second introducer tubes / sleeves 164a and 164b utilize a corresponding slot or cutout area. A user can use a pin that passes through the cutout area to engage the first and / or second introducer tubes / sleeves 164a and / or 164b, thereby securing the introducer tubes in place when the stent is placed into the introducer tubes. Once the stent 150 is properly loaded into the first introducer tube / sleeve 164a and the second introducer tube / sleeve 164b, the user can then remove the pin to release the introducer tube, allowing the introducer tube to then be translated through the overlying first tube 154a or second tube 154b.

[0068] The fitting interface can be fine-tuned based on the stent packaging configuration. For example, if the first and second introducer tubes / sleeves 164a and 164b are partially loaded into the first and second housing portions 152a and 152b (as described in one embodiment above) such that the respective ends of the stent 150 are preloaded into the first and second introducer tubes / sleeves 164a and 164b, the fittings can be placed on the housings such that the pins overlap the housings and the underlying ends of the corresponding introducer sleeves. In this way, the introducer sleeves are engaged and prevented from moving as the stent advances into each introducer sleeve.

[0069] In one embodiment, each fitting is positioned proximate the first and second housing portions 152a, 152b such that the fitting is located proximate the location of the stent 150 when the stent enters the respective introducer sleeve 164a or 164b, except that the slots or cutouts in the tube 154a / 154b and the underlying introducer sleeve 164a, 164b do not extend all the way through (and therefore are only along one side of) the tube 154a / 154b and the introducer sleeve 164a / 164b, such that the pins do not necessarily contact the stent 150 as it enters the respective introducer sleeve 164a or 164b. In another embodiment, the fittings are positioned further along the tube 154a / 154b such that the stent does not enter the associated portion of the underlying introducer sleeve 164a / 164b when it enters the tube. In this embodiment, the slots or cutout areas may have a configuration that passes through the tube and underlying introducer sleeve and does not impede passage of the stent. Once the stent 150 has entered its respective introducer sleeve 164a or 164b, the pins are unpinned or removed to allow the introducer sleeve 164a / 164b to pass through the overlying tube 154a / 154b.

[0070] Each of the first introducer tube / sleeve 164a or second introducer tube / sleeve 164b preferably has dimensions similar to the respective first tube 154a or second tube 154b within which it resides, to facilitate passage of the stent 150 through the introducer tube when a user is using the appropriate pusher element 158a or 158b. Thus, in some embodiments, it is preferred that the outer diameter of the first introducer tube / sleeve 164a and / or second introducer tube / sleeve 164b closely matches the inner diameter of the first tube 154a and / or second tube 154b.

[0071] As described above, when the user uses each pusher (e.g., pusher 158a), the stent 150 can exit the housing 151 and be positioned in an introducer tube (e.g., first introducer tube / sleeve 164a within first tube 154a) that is internal to each tube. The first introducer tube / sleeve 164a spans only a portion of the first tube 154a, as shown in FIG. 11. Although the first introducer tube / sleeve 164a is not illustratively shown as spanning into the spiral of the first tube 154a, it can have a shorter or longer dimension as needed, for example, a dimension that extends into the spiral. However, the first introducer tube / sleeve 164a is shorter than the first tube 154a such that it does not extend along the entire tube.

[0072] The introducer tube / sleeve has a longer dimension than the stent to accommodate the stent as it passes entirely through the first tube 154a or the second tube 154b. Once the stent is fully within the introducer tube, further translation of the pusher causes the introducer tube (e.g., the first introducer tube / sleeve 164a) to translate through each tube (e.g., the first tube 154a) until it exits the tube section. Once the first introducer tube / sleeve 164a or the second introducer tube / sleeve 164b exits the tube or tubular housing, the introducer tube is introduced into the catheter (either through the catheter hub or the catheter's hemostasis valve). Because the introducer tube has a slightly larger size than the catheter, when the user uses the pusher by pushing the pusher distally relative to the stationary catheter, the stent passes through the lumen of the larger introducer tube and into the lumen of the smaller catheter.

[0073] The above description refers to the nature of a variable porosity stent, where at least one portion has a lower porosity and at least one portion has a higher porosity. This is illustrated with respect to the housing and delivery system of FIG. 8, where the stent 150 includes high porosity regions 150a and low porosity regions 150b. The above description further refers to the stent housing and delivery system allowing the stent to be customized such that the low porosity or flow diversion regions 150b are located either at the proximal or distal portion of the stent. This will be described in more detail with respect to the housing and delivery system.

[0074] When stent 150 is pulled in one direction (e.g., to the left in the context of FIG. 8), high porosity region 150a is the first to enter introducer tube 164a (on spiral first tube 154a) and low porosity region 150b is the last to enter the introducer tube. As shown in FIG. 11A, end 166 of spiral first tube 154a (inside spiral first tube 154a) has an opening as shown in FIG. 12 through which pusher 158a passes, allowing a user to manipulate a connected stent (e.g., stent 150) into first introducer tube / sleeve 164a. As can be understood in the context of Figures 8, 11A and 11B, the high porosity section 150a is the portion of the stent that enters the first introducer tube / sleeve 164a first, and therefore is also the portion of the stent that exits the first end 153a of the overlying tube section 154a first, as shown in Figure 13. Because the first introducer tube / sleeve 164a is generally large compared to the stent 150, the portion of the stent 150 that is introduced last into the first introducer tube / sleeve 164a (low porosity section 150b, in the context of Figure 13) will be generally flush with one end of the first introducer tube / sleeve 164a, while there may be a gap between the other end of the stent (high porosity section 150a, in the context of Figure 13) and the corresponding end of the first introducer tube / sleeve 164a. When the first introducer tube / sleeve 164a is completely removed from the first tube 154a, the low porosity section 150b is located at one end of the first introducer tube / sleeve 164a.

[0075] To place the stent inside the catheter, the configuration is simply reversed from the way the first introducer tube / sleeve 164a is withdrawn from the first tube 154a. As shown in FIG. 14, the user places the other end of the introducer tube (the part far from the pusher 158a) inside the catheter hub or catheter hemostasis valve. Logically, this makes sense, since the only way the user can deliver the stent is if they are able to grasp the pusher and manipulate the stent. In the context of FIG. 14, the first introducer tube / sleeve 164a can be considered to already be placed inside the catheter hub or hemostasis valve, where the stent is now ready to be introduced into the catheter tube 168, while the first introducer tube / sleeve 164a (having a larger diameter) remains inside the catheter hub or hemostasis valve and is withdrawn once the stent 150 has been delivered into the catheter tube. The user pushes the pusher 158a distally to move the stent 150 from the introducer sleeve into the catheter tube 168. The first introducer tube / sleeve 164a has a diameter larger than the diameter of the catheter tube. Thus, by using a pusher, the stent 150 can be guided into the catheter tube 168 while the first introducer tube / sleeve 164a remains in place. In this configuration, as shown in Figure 14, the low porosity region 150b of the stent is located at the distal portion of the stent because this was how the low porosity region 150b of the stent was delivered from the housing 151 (see Figures 8 and 13), and the high porosity region 150a of the stent is located at the proximal portion of the stent.

[0076] In connection with the above description, it should be noted that the term distal is used with reference to the direction of the patient's vasculature, while the term proximal refers to the direction outside the patient's body where access to the vasculature occurs. Thus, the user pushes the pusher distally to move the stent into the vasculature such that the low porosity portion 150b is positioned distally while the high porosity portion 150a is positioned proximally.

[0077] If the user desires to have the low porosity region 150b of the stent proximally located (e.g., in a scenario where a branch artery is located distally near the aneurysm and it is desirable to have a proximal low porosity portion and a distal high porosity portion), the user simply reverses the configuration (see FIG. 8) by using pusher 158b instead of pusher 158a to pull the stent into a second introducer tube / sleeve 164b (e.g., see FIG. 11B) on the second tube 154b. When the stent is used in this manner, it emerges from the end 166 of the second tube 154b in the configuration shown in FIG. 15, with the low porosity region 150b emerging first and the high porosity region 150a emerging last. The user can then orient the introduction tube 164b in the manner shown in FIG. 16 so that the high porosity region 150a faces the distal portion of the second introduction tube / sleeve 164b and the low porosity region 150b faces the proximal portion of the second introduction tube / sleeve 164b.

[0078] Further variations are possible. For example, Figure 8 illustratively shows the high porosity region 150a of the stent adjacent to the first tube 154a / first introducer tube / sleeve 164a. However, this could be reversed so that the high porosity region 150a is instead adjacent to the opposing second tube 154b / second introducer tube / sleeve 164b. The delivery configuration would then be reversed to orient the stent such that the low porosity flow split region is located at a particular preferred portion of the stent.

[0079] In other embodiments, the location of the first housing portion 152a and the second housing portion 152b may be changed. In the context of FIG. 6, the housing portions are shown as being located outside the outer circumference of the concentric spirals forming the first tube 154a and the second tube 154b, with the outlet port or end 166 being located along the innermost concentric spiral, respectively (as shown in FIG. 11). This may be changed in other embodiments such that the housing is directly connected to the innermost spiral forming the first tube 154a and the second tube 154b, while the end 166 is along the outermost concentric spiral. In other embodiments, the swirl dispenser housing shape may be ignored and other shapes (e.g., linear, rectangular, or other shapes) may be used.

[0080] Additionally, while the housing and delivery discussion specifically describes how the delivery configuration works with a stent utilizing only two porosity sections, other stent embodiments considered above discuss three or more porosity sections having various combinations of low and high porosity sections.

[0081] Although the term stent is often used herein, the embodiments described herein may be used in a variety of vascular prosthetic devices, such as stents, stent grafts, vascular scaffolds, etc.

[0082] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weights, reaction conditions, and the like used in the specification and claims should be understood in all instances to be modified by the term "about". Accordingly, unless otherwise indicated, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed by applying ordinary rounding techniques, at least in light of the number of reported significant digits. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical values ​​inherently contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0083] The terms "a," "an," "the," and similar referents used in the context of describing the present invention (particularly in the claims that follow) should be construed to include both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The recitation of ranges of values ​​herein is merely intended to serve as a shorthand notation for referring individually to each individual value falling within the range. Unless otherwise indicated herein, each individual value is incorporated herein as if it were individually recited herein. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended merely to further clarify the invention and does not limit the scope of the invention as otherwise described in the claims. No language in the specification should be construed as indicating any element essential to the practice of the invention not recited in the claims.

[0084] Groupings of alternative elements or embodiments of the invention disclosed herein should not be construed as limitations. Each group member may be referenced and claimed individually or in any combination with other members of the group or other elements found herein. It is contemplated that one or more members of a group may be included in or deleted from a group for reasons of convenience and / or patentability. When such inclusion or deletion occurs, the specification is deemed to include the modified group, and a written description of all Markush groups used in the appended claims is provided accordingly.

[0085] Several embodiments of the present invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations of these described embodiments will become apparent to those skilled in the art upon reading the above description. The inventors of the present invention anticipate that such variations will be employed by those skilled in the art as appropriate, and the inventors of the present invention intend that the invention be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the present invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[0086] Additionally, throughout this specification, various references are made to patents and printed publications. Each of the above cited references and printed publications is herein individually incorporated by reference in its entirety.

[0087] Finally, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the invention may be utilized in accordance with the teachings herein. Thus, the invention is not limited to that precisely as shown and described.

[0088] (Additional Note) (Appendix 1) a vascular prosthesis having low porosity regions and high porosity regions; a housing for containing the vascular prosthesis; a first tube coupled to a first end of the housing; a second tube coupled to a second end of the housing; and Equipped with the vascular prosthesis is deliverable through the first tube or the second tube; Vascular prosthesis system.

[0089] (Appendix 2) the first tube and the second tube each house an introduction sleeve; 2. A vascular prosthesis system as described in claim 1.

[0090] (Appendix 3) a plurality of distal ends of the vascular prosthesis are preloaded into each of the introducer sleeves; 3. A vascular prosthesis system as described in claim 2.

[0091] (Appendix 4) The lead-in sleeve spans a portion of the housing. 3. A vascular prosthesis system as described in claim 2.

[0092] (Appendix 5) further comprising a pin engaging the lead-in sleeve. 3. A vascular prosthesis system as described in claim 2.

[0093] (Appendix 6) The first tube and the second tube are both spirally wound. 2. A vascular prosthesis system as described in claim 1.

[0094] (Appendix 7) delivering the first tube so that the low porosity region is located at a proximal region of the vascular prosthesis; and delivering the second tube such that the low porosity region is located at a distal region of the vascular prosthesis. 2. A vascular prosthesis system as described in claim 1.

[0095] (Appendix 8) a vascular prosthesis having a first porosity region and a second porosity region; a housing for containing the vascular prosthesis; a first tube coupled to a first end of the housing; a second tube coupled to a second end of the housing; and Equipped with the vascular prosthesis is deliverable through the first tube or the second tube; the first porosity region is located on a first longitudinal portion of the vascular prosthesis when the vascular prosthesis is delivered through the first tube; the first porosity region is located on a second longitudinal portion of the vascular prosthesis when the vascular prosthesis is delivered through the second tube. Vascular prosthesis system.

[0096] (Appendix 9) a first pusher connected to a first portion of the vascular prosthesis; a second pusher connected to a second portion of the vascular prosthesis; Further comprising: 9. The vascular prosthesis system of claim 8.

[0097] (Appendix 10) the first pusher is used to guide the stent through the first tube; The second pusher is used to guide the vascular prosthesis through the second tube. 10. The vascular prosthesis system of claim 9.

[0098] (Appendix 11) The first pusher is disengageable from the first portion of the vascular prosthesis. 9. The vascular prosthesis system of claim 8.

[0099] (Appendix 12) The second pusher is disengageable from the second portion of the vascular prosthesis. 9. The vascular prosthesis system of claim 8.

[0100] (Appendix 13) the first pusher disengages from the vascular prosthesis when the vascular prosthesis is delivered through the second tube. 9. The vascular prosthesis system of claim 8.

[0101] (Appendix 14) the second pusher disengages from the vascular prosthesis when the vascular prosthesis is delivered through the first tube. 9. The vascular prosthesis system of claim 8.

[0102] (Appendix 15) the vascular prosthesis includes a plurality of flared ends; the first pusher and the second pusher engage the flared ends of the vascular prosthesis. 9. The vascular prosthesis of claim 8.

[0103] (Appendix 16) a vascular prosthesis having a shunt region having a low porosity and a non-shunt region having a high porosity; a housing for containing the vascular prosthesis; a first tube coupled to a first end of the housing; a second tube coupled to a second end of the housing; and Equipped with the vascular prosthesis is deliverable through the first tube or the second tube; the shunt region is located at a first longitudinal portion of the vascular prosthesis when the vascular prosthesis is delivered through the first tube; the shunt region is located on a second longitudinal portion of the vascular prosthesis when the vascular prosthesis is delivered through the second tube. Diverting prosthesis system.

[0104] (Appendix 17) The housing has a first housing portion, a second housing portion, and a gap therebetween. 17. The vascular prosthesis system of claim 16.

[0105] (Appendix 18) the housing lumen is larger than the first tube lumen and the second tube lumen; 17. The vascular prosthesis system of claim 16.

[0106] (Appendix 19) The outer diameter of the housing is larger than the outer diameter of the first tube and the outer diameter of the second tube. 17. The vascular prosthesis system of claim 16.

[0107] (Appendix 20) delivering the first tube such that the shunt region is located at a proximal region of the vascular prosthesis; and delivering the second tube such that the shunt region is located at a distal region of the vascular prosthesis. 17. The vascular prosthesis system of claim 16.

Claims

[Claim 1] a vascular prosthesis having low porosity regions and high porosity regions; a housing for containing the vascular prosthesis; a first tube coupled to a first end of the housing; a second tube coupled to a second end of the housing; and Equipped with the vascular prosthesis is deliverable through the first tube or the second tube; Vascular prosthesis system.

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