Flow Diverting Device for Chronic Inflammation and Lymphedema

Abstract

The flow diverting device includes a stent frame body and a stent frame extension. The stent frame body includes an inlet opening, an outlet opening, and a cavity extending from the inlet opening to the outlet opening. The stent frame body is configured to allow fluid to flow from the inlet opening to the outlet opening through the cavity. The stent frame body includes a first portion having an inlet opening and a second portion having an outlet opening. The second portion is tapered from an end of the second portion to a first location on the second portion, thereby forming a recessed portion having a plurality of pores. The stent frame extension is configured to be disposed between at least a portion of the recessed portion and a vessel wall, thereby preventing vessel wall cells from migrating onto the recessed portion.

Description

[Technical field]

[0001] Priority claim This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 299,005, filed January 13, 2022, U.S. Provisional Patent Application No. 63 / 357,119, filed June 30, 2022, and U.S. Provisional Patent Application No. 63 / 388,789, filed July 13, 2022, each of which is incorporated by reference in its entirety herein. [Background technology]

[0002] The concept of flow modulation stents in the treatment of various disease states involves utilizing access to the systemic vasculature throughout the human body as a potential site of therapeutic intervention. Through various re-adaptation methods, flow modulation stents can be reconfigured to serve as tools for the prevention or disruption of pathophysiological processes in the context of blood transport. More broadly, diversion of blood components, whether selective or non-selective, may prove essential to the restoration of physiological homeostasis, and thus survival and quality of life, while avoiding the complications and resistance associated with more radical methods of therapeutic intervention, such as the use of corticosteroids or invasive surgery. Stent technology is most traditionally known for its role in reversing conditions of stenosis caused by atherosclerosis and thrombosis. However, opportunities exist to percutaneously treat a myriad of other diseases with one or more flow modulation stents, and thus methods for doing so are needed. Summary of the Invention

[0003] The present disclosure provides novel and innovative flow diverting apparatus and methods for use in treating chronic inflammation and lymphedema. In some examples, a flow diverting apparatus is provided. The flow diverting apparatus includes a stent frame body and a stent frame extension. The stent frame body includes an inlet opening, an outlet opening, and a cavity extending from the inlet opening to the outlet opening. The stent frame body is configured to allow fluid to flow from the inlet opening to the outlet opening through the cavity. The stent frame body includes a first portion having an inlet opening and a second portion having an outlet opening. The second portion is tapered from an end of the second portion to a first location of the second portion, thereby forming a recessed portion having a plurality of pores. The first location of the second portion is disposed between the one end and the outlet opening or over the outlet opening. The pores of the recessed portion are configured to filter white blood cells based on the size and / or shape of the white blood cells while allowing red blood cells to pass through. A cross-sectional area of ​​the inlet opening is greater than a cross-sectional area of ​​the outlet opening. The stent frame extension projects from at least a portion of a side of the stent frame body and projects away from the inlet opening. The stent frame extension is configured to be disposed between at least a portion of the recessed portion and the vessel wall, thereby preventing migration of vessel wall cells onto the recessed portion.

[0004] In some examples, a method of treating and / or preventing chronic inflammation in a patient is provided, the method comprising implanting a flow diverting device in a primary arterial blood vessel of the patient, the flow diverting device including an inlet opening and an outlet opening, the flow diverting device being implanted such that the inlet opening is disposed in the primary arterial blood vessel upstream of an orifice of a secondary branch blood vessel branching off from the primary arterial blood vessel and the outlet opening is disposed upstream or downstream, the implanted flow diverting device being positioned and configured such that a proportion of proinflammatory components in the patient's blood in the primary arterial blood vessel upstream of the flow diverting device that is directed away from the secondary branch blood vessel is greater than a proportion of proinflammatory components in the patient's blood in the primary arterial blood vessel upstream of the flow diverting device that is directed to the secondary branch blood vessel, the secondary branch blood vessel leading to a portion of the patient's body suffering from chronic inflammation.

[0005] Additional features and advantages of the disclosed apparatus and methods are described in, or will be apparent from, the following detailed description and drawings. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 is a diagram of a flow diverting device according to an example of the present disclosure.

[0007] [Diagram 2] FIG. 2 is a diagram of the flow diverting device of FIG. 1 placed in a primary arterial vessel according to one example of the present disclosure.

[0008] [Diagram 3] FIG. 3 is a diagram of a flow diverting device according to an example of the present disclosure.

[0009] [Figure 4] FIG. 4 is a diagram of a flow diverting device according to an example of the present disclosure.

[0010] [Figure 5A]FIG. 5A is a diagram of a flow diverting device according to one example of the present disclosure.

[0011] [Figure 5B] FIG. 5B is a diagram of the flow diverting device of FIG. 5A, with the stain frame extension of the flow diverting device shown transparent for illustration purposes.

[0012] [Figure 5C] FIG. 5C is an illustrative cross-sectional view of the flow diverting device of FIG. 5A along line CC according to one example of the present disclosure.

[0013] [Figure 5D] FIG. 5D is a diagram of orifices shaped and arranged in a flow diverting device according to one example of the present disclosure. [Figure 5E] FIG. 5E is a diagram of a shape and arrangement of orifices in a flow diverting device according to one example of the present disclosure. [Figure 5F] FIG. 5F is a diagram of a shape and arrangement of orifices in a flow diverting device according to one example of the present disclosure. [Figure 5G] FIG. 5G is a diagram of the shape and arrangement of orifices in a flow diverting device according to one example of the present disclosure.

[0014] [Figure 6A] FIG. 6A is a diagram of the flow diverting device of FIG. 5A placed in a primary arterial vessel according to one example of the present disclosure.

[0015] [Figure 6B] FIG. 6B is an enlarged cross-sectional view of region B of FIG. 6A.

[0016] [Figure 7A] FIG. 7A is a diagram of a flow diverting device according to one example of the present disclosure.

[0017] [Figure 7B]FIG. 7B is a diagram of a flow diverting device according to one example of the present disclosure.

[0018] [Figure 7C] FIG. 7C is a cross-sectional view of the flow diverting device of FIG. 7B along line DD according to one example of the present disclosure.

[0019] [Figure 8A] 8A is another exemplary cross-sectional view of the flow diverting device of FIG. 5A along line CC, according to another example of the present disclosure.

[0020] [Figure 8B] 8B is another exemplary cross-sectional view of the flow diverting device of FIG. 5A along line CC, according to another example of the present disclosure.

[0021] [Figure 8C] 8C is another exemplary cross-sectional view of the flow diverting device of FIG. 5A along line CC, according to another example of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] This application relates to a flow diverting device and methods of using the flow diverting device to treat chronic inflammation in various regions of the body. In various examples, the flow diverting device may be a stent, a stent graft, a balloon, or other suitable diverter. In some examples, the flow diverting device may be a stent graft as described in International Publication No. WO 2020 / 168216, entitled "FLOW RESTRICTING STENT-GRAFT," filed February 14, 2020, which is incorporated herein by reference in its entirety.

[0023] With regard to chronic inflammation, a flow diverting device can be used to selectively filter blood components and ultimately compartmentalize luminal regions within the body's blood vessels such that one subregion of the lumen is not significantly concentrated with all or some types of leukocytes compared to the remaining luminal regions. Aspects of the disclosure may provide a flow diverting device that can prevent hematogenous passage of immune cells into the arterial vascular tree of an inflamed tissue. For example, a flow diverting device according to the present disclosure can block leukocytes involved in persistent pathological inflammation from accessing and entering the opening(s) of a secondary branch vessel fed from a primary vessel, where the flow diverting device is deployed and positioned.

[0024] In some examples, a flow diverting device according to the present disclosure may be configured to provide a selective barrier that can reroute or divert immune cells as blood passes through the flow diverting device. In some examples, the material from which the flow diverting device is constructed may be useful for providing a selective barrier. For example, the flow diverting device may be constructed of a mesh material. The mesh material may allow the passage of certain blood components while preventing the passage of other blood components. In various aspects, the mesh material may be made of or include a suitable metal, such as cobalt, nitinol (nickel titanium), stainless steel, etc. In some examples, the mesh material may additionally or alternatively be made of or include a fabric material, such as polyester, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), or any other suitable biocompatible material or combination thereof.

[0025] In various examples, the material from which the flow diverting device is constructed may be permeable. For example, the flow diverting device of the present disclosure may include pores. The pores may be small enough in diameter to allow important blood components such as red blood cells, platelets, and plasma to pass, but prevent a significant amount of larger sized white blood cells (e.g., white blood cells having a diameter of 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 μm or more), such as neutrophils, monocytes, macrophages, granulocytes, and plasma cells, from passing through. In some examples, the pore diameter of the material of the flow diverting device may be in the range of about 8 μm to about 70 μm, such as about 10 μm to about 50 μm, about 20 μm to about 40 μm, about 25 μm to about 35 μm, or about 8 μm to about 15 μm.

[0026] One advantage of using PTFE or ePTFE fabrics from a biocompatibility standpoint may include the ability to uniform pore size across the entire surface area of ​​the fabric, in addition to customizing the pore shapes to be spherical, circular or elliptical, rather than slits or channels that may have sharp angles, while other suitable fabrics or metals may be used as described above. In some examples, the pores in the flow diverter stent graft fabric may be broad, circular, elliptical, rectangular or square (with rounded corners). In other examples, the pores in the flow diverter stent graft fabric may have any other suitable shape.

[0027] In some instances, a selective barrier fabric comprised of ellipses may be used in a flow diverting device according to the present disclosure for chronic inflammatory conditions driven primarily by migration and infiltration of T or B lymphocytes as seen in cases such as osteoarthritis or subacute and chronic organ transplant rejection. Filtration of lymphocytes away from arterial bifurcations supplying diseased organs may require selective filtration based primarily on shape, not size. This is because lymphocytes and red blood cells have approximately the same diameter size of 7-8 μm. Because lymphocytes are spherical and red blood cells are discoidal, red blood cells can more easily penetrate ellipsoid pore passages through the selective barrier fabric. Thus, the risk of ischemic complications to downstream tissues may be minimized while at the same time major inflammatory promoters such as lymphocytes may be prevented from accessing arterial bifurcations supplying diseased tissues.

[0028] In some examples, the elliptical pores of the flow diverting device may span the thickness of the selected fabric barrier, e.g., may be about 4 to about 36 μm long and about 8 to about 64 μm wide to achieve a therapeutic purpose. For example, the elliptical pores of the flow diverting device may be about 4 to about 9 μm long and about 8 to about 16 μm wide, about 9 to about 18 μm long and about 16 to about 32 μm wide, about 18 to about 27 μm long and about 32 to about 48 μm wide, or about 27 to about 36 μm long and about 48 to about 64 μm wide.

[0029] In some examples, the various pore shapes may be organized in rows and / or columns along a desired / predetermined section of the stent frame body / stent graft fabric, and the longest side of the oval or rectangular pores may be oriented perpendicular or parallel to the direction of blood flow (e.g., from the inlet opening to the outlet opening). The pores may be uniform in shape throughout the flow diverter stent graft, or various pore shapes may be created within the same flow diverter stent graft.

[0030] In some examples, the pore density in a particular flow diverter stent graft may vary. The relative porosity of the fabric in the porous section of the stent frame body / graft material may be 40% or more of the total blood flow, e.g., 45% or more, 50% or more, 55% or more, or 60% or more. In some examples, the pores may be aligned along an axis, with squares, ovals, circles, or rectangles positioned directly above or below one another. In other examples, the pores may not be aligned along an axis, with squares, ovals, circles, or rectangles positioned diagonally above or below one another.

[0031] In some instances, the shape of the flow diverting device can help provide a selective barrier. For example, the flow diverting device may have a tapered configuration such that the cross-sectional area of ​​the upstream (inlet) opening of the flow diverting device where blood enters is greater than the cross-sectional area of ​​the downstream (outlet) portion of the flow diverting device. The tapering or narrowing of the flow diverting device reduces the cross-sectional area of ​​the interior of the flow diverting device through which blood can flow, thereby allowing only a portion of the blood to flow from the upstream opening through the downstream opening, thereby pushing a significant amount of blood flow to travel through the stent frame body of the flow diverting device. Additionally, the flow diverting device material can help prevent the passage of larger blood components, as discussed above, so that these larger blood components may be directed primarily through the interior of the flow diverting device and out the downstream opening.

[0032] In some examples, the orientation of the flow diverting device when implanted in a patient may serve to direct larger blood components exiting the downstream opening, such as secondary branch vessels that feed from the primary vessel in which the flow diverting device is implanted, based on where the downstream opening is located within the primary vessel. In various aspects, the tapered section of the flow diverting device may take the form of a spiral, cone, hourglass, lobule, or crescent. In some examples, the flow diverting device may include a taper angle (from an axis extending along the length of the flow diverting device) in the range of about 10 degrees to about 90 degrees, e.g., about 10 degrees to about 20 degrees, about 20 degrees to about 30 degrees, about 30 degrees to about 40 degrees, about 40 degrees to about 50 degrees, about 50 degrees to about 60 degrees, about 60 degrees to about 70 degrees, about 70 degrees to about 80 degrees, or about 80 degrees to about 90 degrees.

[0033] In some instances, implanting a flow diverting device at a specific location in a patient may help to divert blood or targeted blood components to specific regions of the body. By targeting larger sized immune cells such as neutrophils and monocytes, which play a key role in the body's innate immunity, and divert them away from the site of inflammation, the concentration of chemical mediators such as cytokines may be reduced within the site of inflammation. This may alleviate key pathophysiological features of inflammation such as vascular permeability of capillary beds within inflamed tissues. The reduction in secretion of chemical mediators from neutrophils may result in a reduction in the concentration of chemoattractants that may otherwise cause a large influx of leukocyte migration to the site of inflammation. Furthermore, modulation of upstream innate immunity may also result in a mirror modulation of downstream adaptive immunity. Thus, local immunosuppressive targeting of innate immune cells by intravascular means may prove even more attractive as downstream adaptive immunity is generally recognized as a key factor in the exacerbation of chronic inflammation.

[0034] 1 illustrates a flow diverting device 100 according to one example of the present disclosure. The flow diverting device 100 may include a stent frame body 101. The stent frame body 101 may include an inlet opening 110, an outlet opening 120, and a cavity extending from the inlet opening 110 to the outlet opening 120. The stent frame body 101 may be configured to allow fluid to flow from the inlet opening 110 to the outlet opening 120 through the cavity.

[0035] In some examples, the inlet opening 110 (e.g., its cross-section) may have a circular shape or any other suitable shape. In some examples, the outlet opening 120 (e.g., its cross-section) may have a circular, partial circular, elliptical, or crescent shape. In other examples, the outlet opening 120 may have any other suitable shape.

[0036] The stent frame body 101 may include a first portion 102 having an inlet opening 110 and a second portion 103 having an outlet opening 120. In some examples, the first portion 102 may have a cylindrical shape.

[0037] In some examples, the stent frame body 101 may include a tapered / recessed portion. For example, the second portion 103 of the stent frame body 101 may be tapered from one (cross-sectional) end 104 of the second portion 103 to a first (cross-sectional) location of the second portion 103, thereby forming a recessed portion 130. In some examples, the first location of the second portion 103 may be a location on the outlet opening 120, as shown in FIG. 1. In other examples, the first location may be located at any (cross-sectional) location between the one end 104 and the outlet opening 120. In some examples, the second portion 103 may be defined as the portion of the stent frame body 101 that extends from the (cross-sectional) point where the taper begins to the point where the outlet opening 120 is located, and the first portion 103 is the remaining portion of the stent frame body 101 that is not the second portion 102 (e.g., from the inlet opening 110 to the start of the taper).

[0038] In some examples, the recessed portion 130 may include pores. In some examples, only the recessed portion 130 of the stent frame body 101 includes pores, and other portions of the stent frame body 101 do not include pores. In other examples, the stent frame body 101 may include pores in any other suitable portion thereof.

[0039] The pores may be provided to filter white blood cells based on their size and / or shape while allowing red blood cells to pass through. In this case, a majority of the white blood cells from the inlet opening 110 may pass through the outlet opening 120. In some examples, the diameter or cross-sectional area of ​​the inlet opening 110 may be larger than the diameter or cross-sectional area of ​​the outlet opening 120.

[0040] In some examples, the recessed portion 130 may be expandable. For example, the stent framework body 101 may be (substantially) cylindrical in shape when the recessed portion 130 is fully expanded.

[0041] In some examples, the recessed portion 130 may include a curved portion, a concave / convex portion. In some examples, the tapered portion of the flow diverting device 100 may take the form of a spiral, a cone, an hourglass, a lobe, or a crescent. In some examples, the tapered / recessed portion may include a cross-sectional portion having a crescent, circular, partial circular (e.g., half-moon) shape. In other examples, the tapered / recessed portion may include a cross-sectional portion having any other suitable shape (e.g., polygonal, regular / irregular shape).

[0042] The stent frame body 101 may define a longitudinal axis X extending from the inlet opening 110 to the outlet opening 120. In some examples, the inclination angle formed between the longitudinal axis X and the recessed portion 130 may be within a range of about 10 degrees to about 90 degrees, such as about 10 degrees to about 20 degrees, about 20 degrees to about 30 degrees, about 30 degrees to about 40 degrees, about 40 degrees to about 50 degrees, about 50 degrees to about 60 degrees, about 60 degrees to about 70 degrees, about 70 degrees to about 80 degrees, or about 80 degrees to about 90 degrees. In some examples, the inclination angle may vary throughout the recessed portion 130. For example, the inclination angle of the recessed portion 130 near the end 104 of the second portion 103 may be smaller or larger than the inclination angle near the outlet opening 120. In other examples, the inclination angle of the recessed portion may be (substantially) the same throughout the recessed portion 130.

[0043] In some examples, the stent frame body 101 may be made of or include polyester, PTFE, ePTFE, PET, or any combination thereof, while in other examples, the stent frame body 101 may be made of or include any other suitable (biocompatible) material (e.g., any other suitable metallic material such as cobalt, nitinol, or stainless steel).

[0044] In some examples, the flow diverting device 100 may further include one or more stent frame wires that extend around the stent frame body 101. For example, the flow diverting device 100 may include one or more seal frame wires 152 that extend around the circumference of the stent frame body 101. The one or more seal frame wires 152 may extend around the stent frame 101 at its greatest circumference, for example, outside of the tapered / recessed portion (e.g., first portion 102).

[0045] In some examples, the flow diverting device 100 may further include a plurality of flow-restricting frame wires 154 that extend around the circumference of the stent frame body 101 within the tapered / recessed portion. The flow-restricting frame wires 154 may be used to create and maintain the shape of the tapered / recessed portion. In some examples, the flow diverting device 100 may include one or more fixed frame wires.

[0046] In some examples, the frame wires may have a zigzag shape, a straight shape, a curved shape, a concave shape, a convex shape, or a combination of these shapes, while in other examples, the frame wires may have any other suitable shape.

[0047] In some examples, the frame wire may have a diameter between 0.3-0.6 mm. In some examples, the frame wire may be made of or may include a shape memory material, such as Nitinol. The shape memory material may allow the flow diverting device to expand and return to its resting shape during changes in blood pressure through the systole and diastole of the patient's cardiac cycle. In other examples, the frame wire may be made of or may include any other suitable (biocompatible) material. Further description of the frame wire and stent frame body is provided in the stent graft described in International Publication No. WO 2020 / 168216, entitled "FLOW RESTRICTING STENT-GRAFT," filed February 14, 2020, which is incorporated herein by reference in its entirety.

[0048] 2, the flow diverting device 100 may be positioned within the primary arterial blood vessel 10 such that the inlet opening 110 and / or first portion 102 of the flow diverting device 100 is proximal (upstream) to the opening of the diseased secondary branch blood vessel 20. As used herein, a diseased secondary branch blood vessel may refer to a blood vessel that branches off from the primary arterial blood vessel to an area of ​​the body affected by chronic inflammation.

[0049] The primary arterial vessel 10 may include an upstream portion 12 disposed upstream of an opening of the diseased secondary branch vessel 20, a downstream portion 16 disposed downstream of the opening of the diseased secondary branch vessel 20, and an intersection portion 14 disposed between the upstream portion 12 and the downstream portion 16. The intersection portion 14 is where the primary arterial vessel 10 meets (the opening of) the diseased secondary branch vessel 20. In some examples, when the flow diverting device 100 is disposed within the primary arterial vessel 10, the inlet opening 110 and / or the first portion 102 of the flow diverting device 100 may be disposed within the upstream portion 12.

[0050] In some examples, when the flow diverting device 100 is disposed within the primary arterial vessel 10, the recessed portion 130 of the stent frame body 101 may be disposed within the upstream portion 12 as shown in Figure 2. In other examples, when the flow diverting device 100 is disposed within the primary arterial vessel 10, (at least a portion of) the recessed portion 130 of the stent frame body 101 may be disposed within the crossing portion 14 or downstream portion 16 of the primary arterial vessel 10.

[0051] In some examples, the pores that may form part of the flow diverting device 100 shown in Figures 1 and 2 may be concentrated in sections of the stent frame body 101 that protrude along the stent surface / frame into the luminal region of the blood vessel (e.g., not in the sections of the stent frame body 101 that face the wall of the primary arterial vessel 10).

[0052] 3 illustrates another example of a flow diverting device 200 according to an example of the present disclosure. As shown in FIG. 3, the flow diverting device 200 may include a stent frame body 201. The stent frame body 201 may include an inlet section 210 having an inlet opening 212, an outlet section 220 having an outlet opening 222, and a tapered / recessed middle section 230 disposed between the inlet section 210 and the outlet section 220. In some examples, the inlet section 210 and the outlet section 220 may have a cylindrical shape. The flow diverting device 200 may have an hourglass shape.

[0053] In some examples, the stent frame body 201 may include a cavity extending from the inlet opening 212 to the outlet opening 222. The stent frame body 201 may be configured to allow fluid communication from the inlet opening 212 to the outlet opening 222 through the cavity. In some examples, the inlet / outlet openings 212, 222 may have a circular or elliptical shape. In other examples, the inlet / outlet openings 212, 222 may have any other suitable shape.

[0054] In some examples, when the flow diverting device 200 is positioned within the primary arterial blood vessel 10, the inlet section 210 of the flow diverting device 200 may be positioned proximal (upstream) of an opening of a diseased secondary branch blood vessel 20 (e.g., the upstream portion 12 of the primary arterial blood vessel 10).

[0055] In some examples, when the flow diverting device 200 is disposed within the primary arterial vessel 10, the intermediate recessed section 230 of the flow diverting device 200 may be disposed within the upstream portion 12 of the primary arterial vessel 10, as shown in Figure 3. In other examples, when the flow diverting device 200 is disposed within the primary arterial vessel 10, the intermediate recessed section 230 of the flow diverting device 200 may be disposed within the crossing portion 14 or the downstream portion 16 of the primary arterial vessel 10.

[0056] In some examples, when the flow diverting device 200 is disposed within the primary arterial vessel 10, the outlet section 220 of the flow diverting device 200 may be disposed within the upstream portion 12 of the primary arterial vessel 10, as shown in Figure 3. In other examples, when the flow diverting device 200 is disposed within the primary arterial vessel 10, the outlet section 220 of the flow diverting device 200 (or at least a portion of the outlet section 220) may be disposed within the crossing portion 14 or downstream portion 16 of the primary arterial vessel 10.

[0057] In some examples, the recessed section 230 may include a curved portion, a concave / convex portion. In some examples, the recessed section 230 of the flow diverting device 200 may take the form of a volute, a cone, an hourglass, a lobe, or a crescent. In some examples, the recessed section 230 may include a cross-sectional portion having a crescent, circular, or partial circular (e.g., half-moon) shape. In other examples, the tapered / recessed portion may include a cross-sectional portion having any other suitable shape (e.g., polygonal, regular / irregular shape).

[0058] In some examples, when the recessed section 230 (e.g., its cross-section) has a crescent shape, the implanted flow diverting device 200 may be oriented such that the crescent-shaped tapered / recessed section 230 is secured to the opposing vessel wall relative to the opening of the diseased secondary branch vessel. In other words, the recessed section 230 may not be ipsilateral or ipsilateral to the opening of the diseased secondary branch vessel 20 (e.g., not the intersection portion 14). In this manner, the orientation of the implanted flow diverting device 100 may help to divert inflammation-inducing blood components away from the diseased secondary branch vessel 20.

[0059] In some examples, the recessed portion 230 may include pores. In some examples, only the recessed portion 230 of the stent frame body 201 includes pores, and other portions of the stent frame body 201 do not include pores. In other examples, the stent frame body 201 may include pores in any other suitable portion thereof.

[0060] The pores may be provided to filter white blood cells based on their size and / or shape while allowing red blood cells to pass through. In this case, a majority of the white blood cells from the inlet opening 212 may pass through the outlet opening 222. In some examples, the diameter or cross-sectional area of ​​the inlet opening 212 may be (substantially) the same as the diameter or cross-sectional area of ​​the outlet opening 222.

[0061] In some examples, the recessed portion 230 may be expandable. For example, the stent framework body 201 may be (substantially) cylindrical when the recessed portion 230 is fully expanded.

[0062] Other configurations / features / characteristics of the flow diverting device 200 (e.g., the inclination angle of the recessed portion 230, the material of the stent frame body 201, the frame wire) may be similar and / or identical to those described above with respect to the flow diverting device 100, and therefore duplicate descriptions may be omitted.

[0063] 4 illustrates another example of a flow diverting device 300 according to an example of the present disclosure. As shown in FIG. 4, the flow diverting device 300 may include a stent frame body 301. The stent frame body 301 may include an inlet section 310 having an inlet opening 312 and an outlet section 320 having an outlet opening 322. The outlet section 320 may include a tapered / recessed section 330. In some examples, the inlet section 310 may have a cylindrical shape. The flow diverting device 300 may have a wine bottle shape.

[0064] In some examples, the stent frame body 301 may include a cavity extending from the inlet opening 312 to the outlet opening 322. The stent frame body 301 may be configured to allow fluid communication from the inlet opening 312 to the outlet opening 322 through the cavity.

[0065] In some examples, the inlet / outlet openings 312, 322 may have a circular or elliptical shape, while in other examples, the inlet / outlet openings 312, 322 may have any other suitable shape.

[0066] In some examples, when the flow diverting device 300 is disposed within the primary arterial blood vessel 10, the inlet section 310 of the flow diverting device 300 may be disposed within the upstream portion 12 of the primary arterial blood vessel 10.

[0067] In some examples, when the flow diverting device 300 is disposed within the primary arterial vessel 10, the outlet section 320 / recess section 330 of the flow diverting device 300 may be disposed within the upstream portion 12 of the primary arterial vessel 10, as shown in Figure 4. In other examples, when the flow diverting device 300 is disposed within the primary arterial vessel 10, the outlet section 320 / recess section 330 of the flow diverting device 300 may be disposed within the intersection portion 14 or downstream portion 16 of the primary arterial vessel 10.

[0068] In some examples, the recessed section 330 may include a curved portion or a concave / convex portion. In some examples, the recessed section 230 may include a cross-sectional portion having a crescent, circular, or partially circular (e.g., half-moon) shape. In other examples, the tapered / recessed section 230 may include a cross-sectional portion having any other suitable shape (e.g., polygonal, regular / irregular shape).

[0069] In some examples, the recessed portion 330 may include pores. In some examples, only the recessed portion 330 of the stent frame body 301 includes pores, and other portions of the stent frame body 301 do not include pores. In other examples, the stent frame body 301 may include pores in any other suitable portion thereof.

[0070] The pores may be provided to filter white blood cells based on their size and / or shape while allowing red blood cells to pass through. In this case, a majority of the white blood cells from the inlet opening 312 may pass through the outlet opening 322. In some examples, the diameter or cross-sectional area of ​​the inlet opening 312 may be larger than the diameter or cross-sectional area of ​​the outlet opening 322.

[0071] In some examples, the recessed portion 330 may be expandable. For example, the stent framework body 301 may be (substantially) cylindrical when the recessed portion 330 is fully expanded.

[0072] Other configurations / features / characteristics of the flow diverting device 300 (e.g., the inclination angle of the recessed portion 330, the material of the stent frame body 301, the frame wire, etc.) may be similar and / or identical to those described above with respect to the flow diverting device 100 and / or the flow diverting device 200, and therefore duplicate descriptions may be omitted.

[0073] In some examples, the use of an implanted flow diverting device (e.g., a flow diverting device described herein) can provide a method of treating and / or preventing chronic inflammation affecting areas of the body above the pelvis (e.g., above the pelvis). Examples of chronic inflammation above the pelvis that can be treated using methods and devices according to the present disclosure can include, but are not limited to, autoimmune hepatitis, gastritis, inflammatory bowel disease, glomerulonephritis, osteoarthritis of the upper extremities, rheumatoid arthritis of the upper extremities, ankylosing spondylitis, myocarditis, thyroiditis, psoriasis, transplant rejection, and multiple sclerosis.

[0074] In some examples, a method of treating and / or preventing inflammatory bowel disease, including Crohn's disease and ulcerative colitis, using a flow diverting device according to the present disclosure may include implanting a first flow diverting device along the length of the abdominal aorta such that a cylindrical inlet section / first portion of the flow diverting device is positioned above or proximal to the opening of the celiac trunk. The tapered / recessed portion, which may be crescent, hourglass, whorl, or lobule shaped, may extend until it is positioned adjacent to the opening of the celiac trunk. If the tapered distal segment is crescent shaped, the convex surface of the flow diverting device frame may be oriented (e.g., with the guidance of an implanted radiopaque marker) to be fixed against the posterior aortic wall.

[0075] A second flow diverting device having the same shape as the first flow diverting device may be subsequently deployed internally during the same catheter delivery procedure. After the first flow diverting device is delivered to its desired / predetermined location, the catheter delivery system may be pulled distally toward the distal aorta to deliver the second flow diverting device. The second flow diverting device may be deployed along the length of the abdominal aorta such that the cylindrical inlet portion / first portion is positioned above or proximal to the opening of the inferior mesenteric artery. The tapered / concave portion may be crescent, hourglass, whorl or leaflet shaped and may extend until it is positioned adjacent to the opening of the inferior mesenteric artery. If the tapered distal segment is crescent shaped, the convex surface of the flow diverting device frame may be oriented (e.g., with the guidance of an implanted radiopaque marker) to be fixed against the posterior aortic wall. Additionally, the second flow diverting device may alternatively be cylindrical in shape without any pores and may be delivered at the level of the inferior mesenteric artery opening to seal off blood perfusion to the aortic branch vessels.

[0076] In some examples, a method of treating and / or preventing inflammatory bowel disease, including Crohn's disease and ulcerative colitis, using a flow diverting device according to the present disclosure may include implanting a flow diverting device according to the present disclosure along the length of the abdominal aorta such that the cylindrical inlet of the flow diverting device is located above or proximal to the opening of the celiac trunk. The tapered / recessed portion, which may be crescent-shaped, hourglass-shaped, whorl-shaped, or lobular-shaped, may extend distally and may be located adjacent to the celiac trunk, superior mesenteric artery, and inferior mesenteric artery openings. If the tapered / recessed portion is crescent-shaped, the convex surface of the flow diverting device frame may be oriented (e.g., with the guidance of an implanted radiopaque marker) so that it is fixed against the posterior aortic wall. The convex surface may be oriented in this manner, since all of the diseased secondary branch vascular openings leading to the site of intestinal inflammation are generally located in the anterior aortic wall. Additionally, the cylindrical outlet section of the flow diverting device may be located distal to the opening of the inferior mesenteric artery in the aorta.

[0077] Cases of gastritis and hepatitis may also be treated by methods similar to those for treating and / or preventing inflammatory bowel disease. However, in the case of gastritis and hepatitis, the tapered / recessed portion of the implanted flow diverting device may only extend as distally as the distal edge of the celiac trunk opening, which is the first major vessel branching off from the proximal abdominal aorta. Beyond that point, the implanted flow diverting device may or may not include a cylindrical outlet, depending on whether the tapered section of the flow diverting device is crescent shaped. If it is crescent shaped, a more distally located cylindrical outlet section may not be necessary. This is because the distal end of the crescent frame is fixed to at least 50% of the aortic wall circumference and is therefore unlikely to move or become dislodged from its fixed position.

[0078] In another example, treatment of multiple sclerosis using a flow diverting device according to the present disclosure may include implanting the flow diverting device along the length of the aortic arch such that the cylindrical inlet of the implanted flow diverting device is located proximal to the opening of the brachiocephalic artery. The tapered / recessed portion of the implanted flow diverting device spans the entire length of the aortic arch and is located adjacent to the openings of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery. If the tapered / recessed segment is crescent shaped, the convex surface of the flow diverting device frame is oriented (e.g., with the guidance of an implanted radiopaque marker) so that it is fixed against the inferior aortic wall. The convex surface may be oriented in this manner because all of the diseased secondary branch vascular openings leading to the brain inflammation site are located in the superior aortic arch wall. Finally, the flow diverting device may or may not include a cylindrical outlet section located distal to the opening of the left subclavian artery. For example, deployment of a flow diverting device with a cylindrical outlet distal to the left subclavian artery opening may help ensure prevention of potential retrograde diastolic flow of leukocytes into the aortic arch opening after exiting the tapered / recessed portion of the device. In some instances, non-cylindrical outlet designs may increase the risk of retrograde leukocyte flow during diastole after immune cells first exit the tapered / recessed section during preformed systolic flow.

[0079] In another example of a pelvic chronic inflammation treatment / prevention application for a flow diverting device, treatment / prevention of bilateral or left unilateral upper limb osteoarthritis may include implanting a flow diverting device according to the present disclosure along the length of the aortic arch such that the cylindrical inlet section of the implanted flow diverting device needs to be located proximal (upstream) to the opening of the brachiocephalic artery. The tapered / recessed portion of the implanted flow diverting device spans the entire length of the aortic arch and is located adjacent to the openings of the brachiocephalic artery, the left common carotid artery, and the left subclavian artery. When the tapered / recessed segment is crescent-shaped, the convex surface of the flow diverting device frame is oriented (e.g., with the guidance of an implanted radiopaque marker) so that it is fixed against the inferior aortic wall. The convex surface may be oriented in this manner because all of the diseased secondary branch vascular openings leading to the site of upper limb osteoarthritis are located in the superior aortic arch wall. Finally, the flow diverting device may or may not include a cylindrical exit section located distal to the left subclavian artery opening. For example, deployment of a flow diverting device with a cylindrical exit section distal to the left subclavian artery opening may help ensure prevention of potential retrograde diastolic flow of leukocytes into the aortic arch opening after exiting the tapered / recessed portion of the device. In some instances, a non-cylindrical exit design may increase the risk of retrograde leukocyte flow during diastole after immune cells first exit the tapered section during forward systolic flow.

[0080] In another example, treatment / prevention of right unilateral upper limb osteoarthritis may include implanting an inlet section of the flow diverting device such that the inlet section is located proximal (e.g., upstream) of the brachiocephalic opening. The tapered central section of the implanted flow diverting device extends distally as far as the distal edge of the brachiocephalic opening. Beyond that point, the flow diverting device may or may not include a cylindrical outlet depending on whether the tapered / recessed section of the flow diverting device is crescent shaped. If it is crescent shaped, a more distally located cylindrical outlet may not be incorporated. This is because the crescent shaped frame of the flow diverting device is fixed to at least 50% of the aortic wall circumference and is therefore unlikely to move or become dislodged from its fixed position.

[0081] As mentioned above, with regard to the placement of the flow diverting device within the primary arterial vessel 10, in some instances, the tapered / recessed segment of the flow diverting device (whether or not the entire length of the flow diverting device includes a cylindrical exit segment) may be at the same level as the opening of the diseased secondary branch vessel. In an alternative configuration, the flow diverting device may also be placed within the primary arterial vessel, but slightly proximal to the level of the opening of the diseased secondary branch vessel. This alternative configuration may be applied to any vascular setting, and thus may be applied to any of the aforementioned methods of treatment related to upper limb osteoarthritis, gastritis, hepatitis, inflammatory bowel disease, or multiple sclerosis.

[0082] For example, by having a tapered / depressed segment of the flow diverting device at a distance less than the diameter of the opening of the diseased secondary branch vessel and more proximal to the level of the opening of the diseased secondary branch vessel, filtered immune cells can be deflected away from the opening of the diseased secondary branch vessel and are less likely to enter that opening after exiting the distal end of the flow diverting device.

[0083] When the entire flow diverting device is placed proximal to the opening of the diseased secondary branch vessel, the flow diverting device may be expanded at the tapered / recessed segment without causing subsequent occlusion of any portion of the target branch vessel lumen when the patient does not require further treatment of the chronic inflammation. Since the total volume of leukocytes passing through the primary arterial vessel is no longer partially or fully occluded and diverted by the flow diverting device, expansion of the flow diverting device to a completely cylindrical shape (e.g., no tapered / recessed segment) that matches the cylindrical shape of the primary arterial vessel wall may be applied to terminate the treatment of the chronic inflammation.

[0084] In some examples, the expansion of the tapered / recessed segments of the flow diverting device can be accomplished by deploying a cylindrical balloon-expandable or self-expanding stent into the already placed flow diverting device to force it open. Another method of expanding the tapered / recessed segments of the flow diverting device during the termination period of chronic inflammation treatment may include the use of a balloon catheter with a fluid at a sufficiently high temperature to, for example, induce an austenitic structural change in the (flow-restricting) stent frame wire (which may be made from or include Nitinol) near the recessed portion of the flow diverting device such that the frame wire (and the recessed portion of the stent frame body associated with the frame wire) is expanded to have, for example, a circular shape.

[0085] Although flow diverting devices may be able to filter blood components to reduce the progression and amplification of inflammatory processes, it is important to consider potential long-term adaptability issues with the porous fabric membrane that may be essential to the functionality of the device. Specifically, one of the greatest challenges to long-term use of flow diverting devices is the risk of endothelialization spreading to the porous parts of the flow diverting device (e.g., at the concave stent graft surface). Endothelialization may involve the migration or movement of vessel wall cells, such as endothelial cells or smooth muscle cells, onto some externally implanted devices, including stents. This process may continue until most or all of the device is incorporated and surrounded by the vessel wall in contact with the device, especially if the device has open gaps or pores.

[0086] Therefore, in the long term, endothelialization may be a major cause of concern for flow diverting devices with pores, because the gradual migration of various endothelial wall cells from the proximal surface of the stent frame body aligned against the vessel wall may progress toward the more distal concave surface (e.g., the recessed portion) of the flow diverting device, eventually causing the obstruction and closure of the pores located in the recessed portion. The pores of the flow diverting device may be closed by endothelialization within less than one month.

[0087] Aspects of the present disclosure may provide a flow diverting device 500 that may address the endothelialization problems discussed above. With reference to FIGS. 5A-5C, in some examples, the flow diverting device 500 may include a stent frame body 501 and a stent frame extension 540. The stent frame body 501 may include an inlet opening 510, an outlet opening 520, and a cavity 525 extending from the inlet opening 510 to the outlet opening 520. The stent frame body 501 may be configured to allow fluid to flow from the inlet opening 510 to the outlet opening 520 through the cavity.

[0088] In some examples, the inlet opening 510 (e.g., its cross-section) may have a circular shape or any other suitable shape. In some examples, the outlet opening 520 (e.g., its cross-section) may be circular, partially circular, or crescent-shaped. In other examples, the outlet opening 520 may have any other suitable shape.

[0089] The stent frame body 501 may include a first portion 502 having an inlet opening 510 and a second portion 503 having an outlet opening 520. In some examples, the first portion 502 may have a cylindrical shape.

[0090] In some examples, the stent frame body 501 may include a tapered / indented portion. For example, the second portion 503 of the stent frame body 501 may be tapered from one (cross-sectional) end 504 of the second portion 503 to a first (cross-sectional) location of the second portion 503, thereby forming a indented portion 530. In some examples, the first location of the second portion 503 may be a location on the outlet opening 520, as shown in FIG. 5A. In other examples, the first location may be located at any point between the one end 504 and the outlet opening 520. In some examples, the second portion 503 may be defined as the portion of the stent frame body 501 that extends from the (cross-sectional) point where the taper begins to the point where the outlet opening 520 is located, and the first portion 502 is the remainder of the portion of the stent frame body 501 that is not the second portion 503.

[0091] In some examples, the recessed portion 530 may include pores 535. In some examples, only the recessed portion 530 of the stent frame body 501 includes pores 535, and other portions of the stent frame body 501 do not include pores. In other examples, the stent frame body 501 may include pores 535 in any other suitable portion thereof.

[0092] The pores may be provided to filter white blood cells based on their size and / or shape while allowing red blood cells to pass through. In this case, a majority (e.g., greater than 90%, 95%, 98%, or 99%) of the white blood cells from the inlet opening 510 may pass through the outlet opening 520. In some examples, the diameter or cross-sectional area of ​​the inlet opening 510 may be larger than the diameter or cross-sectional area of ​​the outlet opening 520.

[0093] In some examples, the recessed portion 530 may be expandable. For example, the stent framework body 501 may be (substantially) cylindrical when the recessed portion 530 is fully expanded.

[0094] In some examples, the recessed portion 530 may include a curved portion, a concave / convex portion. In some examples, the tapered portion of the flow diverting device 500 may take the form of a spiral, a cone, an hourglass, a lobe, or a crescent. In some examples, the tapered / recessed portion may include a cross-sectional portion having a crescent, circular, or partial circular (e.g., half-moon) shape. In other examples, the tapered / recessed portion may include a cross-sectional portion having any other suitable shape (e.g., polygonal, regular / irregular shape).

[0095] Other configurations / features / characteristics of the flow diverting device 500 (e.g., the inclination angle of the recessed portion 530, the material of the stent frame body 501, the frame wires 552, 554) may be similar and / or identical to those described above with respect to the flow diverting device 100, and therefore duplicate descriptions may be omitted.

[0096] 5A, the stent frame extension 540 may protrude from at least a portion of a side surface of the stent frame body 501 and away from the inlet opening 510. For example, in some examples, the stent frame extension 540 may protrude from an edge 532 of the recessed portion 530. In this case, at least a portion of the stent frame extension 540 may protrude from one end 504 of the second portion 503 and away from the inlet opening 510. In other examples, the stent frame extension 540 may protrude from any other suitable portion of the surface of the stent frame body 501 (e.g., between the inlet opening 510 and the edge 532 of the recessed portion 530).

[0097] 5A, the stent frame extension 540 may be U-shaped. In this case, in some examples, the stent frame extension 540 may have the same width W1 (e.g., the distance between the edge 532 of the recessed portion 530 and the free end 545 of the stent frame extension 540) from the first side end 541 to the second side end 542. In other examples, the width W1 of the stent frame extension 540 may vary between the first side end 541 and the second side end 542.

[0098] The stent frame extension 540 is configured to be positioned between at least a portion of the recessed portion 530 and a vessel wall (e.g., the vessel wall of the primary arterial vessel 10), thereby preventing vessel wall cells from migrating onto the recessed portion.

[0099] 5D-5G show, for example, exemplary shapes and arrangements of pores 535 taken from region A of flow diverting device 500. As shown in FIG. 5D and FIG. 5E, in some examples, pores 535 may have an elliptical shape. In this case, the size of pores 535 may be about 4 to about 36 μm in length and about 8 to about 64 μm in width, for example, about 4 to about 9 μm in length and about 8 to about 16 μm in width, about 9 to about 18 μm in length and about 16 to about 32 μm in width, about 18 to about 27 μm in length and about 32 to about 48 μm in width, or about 27 to about 36 μm in length and about 48 to about 64 μm in width. In some examples, elliptical pores 535 may be oriented perpendicular or parallel to the direction of blood flow (e.g., the direction of the longitudinal axis extending from inlet opening 510 to outlet opening 520).

[0100] 5F and 5G, in some examples, the pores 535 may have a circular shape, in which case the pores 535 may have a diameter in the range of about 8 μm to about 70 μm, e.g., about 10 μm to about 50 μm, about 20 μm to about 40 μm, about 25 μm to about 35 μm, or about 8 μm to about 15 μm.

[0101] In other examples, the pores 535 may have any other suitable shape, such as a triangle, a rectangle, a square, a hexagon, any other polygon (with or without rounded corners), or a regular / irregular shape, etc. In this case, the pores 535 may have a length (e.g., any longest linear distance between two points on the edge of the pores 535) in the range of about 8 μm to about 70 μm, e.g., about 10 μm to about 50 μm, about 20 μm to about 40 μm, about 25 μm to about 35 μm, or about 8 μm to about 15 μm.

[0102] In some examples, as shown in Figures 5D and 5F, the pores 535 are arranged to form multiple columns and rows in the vertical and horizontal directions, respectively. In each column and each row, the pores 535 are spaced the same distance apart from each other. In this case, four adjacent pores 535 (e.g., two adjacent pores 535 from a first column and two adjacent pores 535 from a second column disposed immediately next to the two adjacent pores 535 from the first column) may form a square or a rectangle.

[0103] In some examples, as shown in Figures 5E and 5G, the pores 535 are arranged to form multiple columns in the vertical direction. In each column, the pores 535 are spaced apart from each other by the same distance. 2N-1 columns (N is an integer equal to or greater than 0) of pores 535 are arranged to form a first group of rows in the horizontal direction, and 2N columns of pores 535 are arranged to form a second group of rows in the horizontal direction. In this case, four adjacent pores 535 (e.g., two adjacent pores 535 from a first column and two adjacent pores 535 from a second column arranged immediately next to the two adjacent pores 535 from the first column) may form a parallelogram. In some examples, four adjacent pores 535 in a 2N-1 row (e.g., two adjacent pores 535 from a first row and two adjacent pores 535 from a third row positioned immediately next to the two adjacent pores 535 from the first row) may form an imaginary square / rectangle 537, and the 2N rows of pores 535 may be positioned at the center of the imaginary square / rectangle 537.

[0104] In other examples, the pores 535 may be arranged in any other suitable manner (e.g., forming a hexagon, pentagon, or any other polygonal shape, or randomly arranged). In some examples, the pores 535 may be uniform in shape throughout the recessed portion 530 / stent frame body 501. In other examples, the pores 535 may have different pore shapes within the recessed portion 530 / stent frame body 501.

[0105] As shown in FIG. 6A, the flow diverting device 500 can be positioned within the primary arterial blood vessel 10 such that the inlet opening 510 (and first portion 502) of the flow diverting device 100 is proximal (upstream) of the opening of the diseased secondary branch blood vessel 20 (e.g., at the upstream portion 12).

[0106] In some examples, when the flow diverting device 500 is disposed within the primary arterial vessel 10, the recessed portion 530 and / or the exit opening 520 of the stent frame body 501 may be disposed within the upstream portion 12 of the primary arterial vessel 10. In other examples, when the flow diverting device 500 is disposed within the primary arterial vessel 10, the recessed portion 530 (at least a portion thereof) and / or the exit opening 520 of the stent frame body 501 may be disposed within the crossing portion 14 and / or the downstream portion 16 of the primary arterial vessel 10.

[0107] In some examples, the stent frame body 501 and / or the stent frame extension 540 may be configured to have a thickness sufficient to prevent endothelialization. In some examples, the thickness of the stent frame body 501 and / or the stent frame extension 540 may be at least 40 μm, e.g., at least 50 μm, at least 60 μm, at least 70 μm, or at least 80 μm. Endothelial cell components may not be able to migrate through walls having a thickness greater than 40 μm and / or walls having an internodal distance of at least 30 μm. Thus, migration of endothelial cell components onto the flow / luminal surface of the flow diverting device may be prevented through this pathway.

[0108] In the case of using PET fabric, the total thickness of the PET should be at least 20 μm to prevent endothelial migration onto the flow surface through the thickness of the stent frame body 501. Diffusion of endothelial cell components may not occur by crossing the proximal or distal ends of the stent frame body from the outer wall surface of the stent frame body to the inner flow / luminal surface of the stent frame body.

[0109] FIG. 6B is an enlarged cross-sectional view of region B of FIG. 6A. As mentioned above, one of the biggest challenges to long-term use of a flow diverting device is the risk of endothelialization spreading to the pores of the flow diverting device (e.g., in the tapered / recessed portion). For example, as shown in FIG. 6B, after placement of the flow diverting device, vessel wall cells 15, 17, such as endothelial cells or smooth muscle cells, may penetrate and / or migrate along the surface of the flow diverting device and occlude the pores of the recessed portion. An embodiment of the present disclosure can prevent the migration of endothelial wall cells and the occlusion of the pores by these endothelial wall cells, for example, by providing a stent frame extension 540 that can be positioned between the vessel wall and the recessed portion 530. Furthermore, when the stent frame body 501 and / or the stent frame extension portion 540 have a thickness within the above range, the endothelial wall cells cannot penetrate the thickness of the stent frame body 501 and / or the stent frame extension portion 540, thereby preventing the vascular wall cells from blocking the pores in the recess portion 530.

[0110] 7A and 7B, the stent frame extension 540 has a different shape than in FIG 5A. In FIG 7A, the stent frame extension 540 may cover the entire area of ​​the recessed portion 530. In this case, a portion of the stent frame extension 540 may be in direct contact with the exit opening 520. In some examples, the second portion 503 together with the stent frame extension 540 may have a cylindrical shape.

[0111] 7B, the stent frame extension 540 may partially cover the recessed portion 530. For example, the stent frame extension 540 may cover the recessed portion 530 from the first portion end 504 (where the taper begins) to a point between the end 504 and the exit opening 520. In this case, the stent frame extension 540 may not directly contact the exit opening 520.

[0112] In some examples, the shortest distance D1 between a point on one end 504 of the stent frame extension 540 and a point on the free end 545 of the stent frame extension 540 may be in the range of about 2 mm to about 20 mm, for example, in the range of about 2 mm to about 5 mm, about 5 mm to about 15 mm, or about 15 mm to about 20 mm.

[0113] In some examples, the stent frame extension 540 may not include a frame wire. In other examples, the stent frame extension 540 may include one or more frame wires (similar to the frame wires 152, 154 described above) that extend around the circumference of the stent frame extension 540. In some examples, when the stent frame extension 540 includes one or more frame wires, the recessed portion 530 of the stent frame body 501 may not include a stent frame wire. That is, the stent wire support may only be present around the circular circumference of the second portion 503 of the stent frame body 501 that is in full alignment with the primary arterial vessel wall and around the stent frame extension 540. This stent wire may thus approximate the structure and shape of the stent wire 542 that is disposed near the inlet opening 510.

[0114] Figure 7C is a cross-sectional view of the flow diverting device 500 of Figure 7B along line DD of Figure 7B. As shown in Figure 7C, the stent frame body 501 (second portion 503) may form a first lumen, and the stent frame extension 540 and recessed portion 530 may form a second lumen. In some instances, the first lumen may allow unfiltered blood (e.g., large white blood cells such as neutrophils and macrophages) to flow therethrough, and the second lumen may allow filtered blood to flow therethrough through pores 535.

[0115] In some examples, the first lumen may be crescent shaped. In other examples, the first lumen may have any other suitable shape (e.g., circular, partial circular, elliptical). In some examples, the second lumen may be circular, partial circular, or elliptical in shape. In other examples, the second lumen may have any other suitable shape.

[0116] 6B, the implanted flow diverting device 500 may be oriented such that the outlet opening 520 is located on the opposite side of the vessel lumen to where the opening of the diseased secondary branch vessel 20 is located. In this case, the recessed portion 530 may face the direction in which the diseased secondary branch vessel 20 extends from the opening.

[0117] As discussed above, the stent frame extensions 540 may provide structural support to the stent frame body 501 at the second portion 503. For example, in the flow diverting device 100 of FIG. 1, the structural support for the second portion 103 is provided primarily by the stent frame wires 154. However, in the flow diverting device 500 of FIGS. 5A, 7A and / or 7B, in addition to the stent wires 554 extending around the second portion 503, structural support for the second portion 503 is further provided by the stent frame extensions 540, in which case the second lumen (and / or the first and second lumens) may have a circular / elliptical ring shape similar to the shape of the stent wires at or near the inlet opening 510.

[0118] In some examples, the stent frame extension 540 may be provided in other flow diverting device designs (e.g., those shown in Figures 3 and 4). The configurations / features / characteristics of the stent frame extensions applied to these other flow diverting device designs may be similar and / or identical to those described above with respect to the flow diverting device 500. For example, the stent frame extensions may protrude from at least a portion of the side of the stent frame body 201 / 301 and protrude away from the inlet opening 210 / 310. In some examples, the stent frame extensions may protrude from an edge of the recessed portion 230 / 330. In other examples, the stent frame extensions may protrude from any other suitable portion of the surface of the stent frame body 201 / 301 (e.g., between the inlet opening 212 / 312 and the edge of the recessed portion 230 / 330). The stent frame extensions are configured to be positioned between at least a portion of the recessed portion 230 / 330 and a vessel wall (e.g., the vessel wall of the primary arterial vessel 10), thereby preventing migration of vessel wall cells into the recessed portion.

[0119] In some examples, the flow diverting device according to the present disclosure may be made of a material that may be composed of two or three parallel layers. For example, referring to FIG. 8A, the stent frame body 501 and the stent frame extension 540 may have a bi-layer construction by including two parallel layers, namely, an outer layer 571 / 581 and an inner layer 572 / 582. In some examples, the outer layer 571 / 581 may be made of or include PET, and the inner layer 572 / 582 may be made of or include ePTFE. In other examples, the outer and inner layers may include any other suitable material.

[0120] 8B, in some examples, the stent frame body 501 and the stent frame extension 540 may have a three-layer configuration by including three parallel layers: an outer layer 571 / 581, a middle layer 573 / 583, and an inner layer 572 / 582. In some examples, the outer layer 571 / 581 and the inner layer 572 / 582 may be made of or include ePTFE, and the middle layer 573 / 583 may be made of or include PET. In other examples, the outer layer, the middle layer, and the inner layer may be made of or include any other suitable material.

[0121] 8C, in some examples, a flow diverting device according to the present disclosure may be made of materials having a hybrid configuration. For example, as shown in FIG. 8C, the stent frame body 501 (and stent frame extension 540) may have a three-layer configuration, except for the recessed portion 530, which may have a single layer or two-layer configuration. Non-limiting examples of materials for the stent frame body 501 and stent frame extension 540 (e.g., for the outer / middle / inner layers) may include ePTFE, PET, urethane-based materials, or any combination thereof.

[0122] In some examples, the use of an implanted flow diverting device according to the present disclosure (e.g., a flow diverting device described herein) may provide a method of treating and / or preventing chronically inflamed or lymphedema-affected areas of the body below the pelvis (e.g., lower pelvis) p. For cases of unilateral or bilateral chronic inflammation of the lower extremities (e.g., osteoarthritis of the knee or hip), the flow diverting device may be implanted to be positioned at the level of the infrarenal aorta above the aortic bifurcation. In some examples, the most tapered / concave portion of the flow diverting device, also known as its throat, may be anchored to the aortic wall within 0.5-7.0 cm proximal (upstream) of the aortic bifurcation. The purpose of implanting a flow diverting device specifically in the infrarenal aorta may be to direct the migration of inflammatory immune cells to slightly affected or otherwise unaffected lower extremities. By directing inflammatory cells such as monocytes, neutrophils, macrophages and granulocytes into the healthy contralateral limb and away from the arterial system of the diseased limb, the overt inflammation that causes severe pain and discomfort can be mechanically regulated. Furthermore, given that the level of capillary bed permeability in the healthy contralateral limb may be lower than that of the diseased limb due to less inflammatory signaling, the probability of complications arising from shunting of leukocytes into the arterial system of the healthy limb may be reduced.

[0123] In some instances, a flow diverting device having a crescent tapered section can be used to achieve a unilateral shift in leukocyte passage. One advantage of using a crescent throat is that the orientation of the crescent tapered section is adaptive and is not forced to assume a symmetrical position along the aorta at every turn. Thus, in various instances, the flow diverting device can be implanted (e.g., with guidance from strategically placed radiopaque markers placed on the device) such that the midline of the narrowest part of the crescent tapered section is rotated within a range of 10 degrees to 90 degrees from the anterior-posterior midline of the aorta.

[0124] In at least some embodiments, to prevent redistribution of leukocytes across the cross-sectional area of ​​the aortic lumen after exiting the distal end (downstream opening) of the flow diverting device, the throat of the flow diverting device may be positioned within a near-perpendicular distance of the iliac artery supplying the healthier leg (with the patient standing), which may be the distal end of the flow diverting device. Such an orientation of the crescent-shaped throat, which may be designed as the distal end, may help generate a jet of leukocytes and ensure their passage into the arterial system of the healthier leg.

[0125] For the treatment of unilateral lymphedema of the lower limb, a flow diverting device according to the present disclosure may be implanted at the level of the infrarenal aorta above the aortic bifurcation where the aorta divides into the left and right common iliac arteries (sometimes referred to as secondary branches). This placement of the flow diverting device may help to direct all blood flow to the healthy contralateral lower limb as opposed to the diseased limb. By partially reducing arterial pressure in the lymphedematous limb, the collection of trapped lymphatic fluid may be slowed, thereby reducing circumferential swelling and potentially resulting in better function.

[0126] Similarly, the flow diverting device can also be used as a treatment method for patients with unilateral lower limb lymphedema after lymphovenous bypass surgery of the affected lower limb. Since lymphovenous bypass surgical procedures involve surgical anastomosis of lymphatic vessels to the venous vasculature, rerouting of lymph to the vein is achieved to restore drainage. However, the effectiveness of this procedure may be limited. Therefore, parallel synergistic treatment methods may be needed that can significantly enhance the clinical outcomes seen in patients after lymphovenous bypass.

[0127] By partially diverting the total blood flow away from the affected limb of these post-operative patients using a flow diverting device implanted as described above, the arterial pressure can be reduced, and therefore the venous return from the affected limb can be reduced as a result. This critical reduction in venous blood pressure will promote the drainage of excess lymph through lymphatic vessels anastomosed to the venous vessels, because the anastomosed vein receiving the excess lymph has a residual volumetric capacity to transport more circulating fluid if needed.

[0128] In some aspects, the use of the flow diverting device is not limited to the duration of a patient's treatment, but may also be relevant after the termination of flow diversion therapy, for example, for patients suffering from unilateral lower limb chronic inflammation, unilateral lower limb lymphedema, or congestive heart failure. When termination of flow diversion therapy is required, full blood flow patency can be restored by expanding the tapered or stenosed segment of the flow diverting device so that its entire stent frame circumference is aligned with most or all of the aortic endothelial lining. This can be done by deploying an additional secondary balloon-expandable or self-expandable stent having a uniform conventional cylindrical shape from within the primary tapered stent device. By designing the conventional secondary stent such that the wire diameter is larger than the wire diameter of the primary tapered stent, the radial force exerted by the conventional secondary stent on the luminal side of the primary tapered stent can overcome the resistance to expansion, ultimately restoring normal vascular patency.

[0129] Without further elaboration, it is believed that those skilled in the art can use the preceding description to make the most of the claimed invention. The examples and embodiments disclosed herein should be construed as merely illustrative and in no way limit the scope of the present disclosure. It will be apparent to those skilled in the art that changes can be made to the details of the above examples without departing from the basic principles described. In other words, various modifications and improvements of the examples specifically disclosed in the above description are within the scope of the appended claims. For example, any suitable combination of features of the various examples described is contemplated.

[0130] Embodiment Various aspects of the subject matter described herein are set forth in the following numbered embodiments.

[0131] Embodiment 1. The flow diverting device comprises a stent frame body, a stent frame extension; A flow diverting device comprising: The stent frame body includes an inlet opening, an outlet opening, and a cavity extending from the inlet opening to the outlet opening, the stent frame body configured to allow fluid to flow through the cavity from the inlet opening to the outlet opening, the stent frame body includes a first portion having the inlet opening and a second portion having the outlet opening, the second portion tapering from an end of the second portion to a first location on the second portion thereby forming a recessed portion having a plurality of pores, the first location on the second portion being between the one end and the outlet opening. the pores of the recessed portion are configured to filter white blood cells based on their size and / or shape while allowing red blood cells to pass, the cross-sectional area of ​​the inlet opening is greater than the cross-sectional area of ​​the outlet opening, the stent frame extension protrudes from at least a portion of a side of the stent frame body and protrudes away from the inlet opening, and the stent frame extension is configured to be positioned between at least a portion of the recessed portion and the blood vessel wall, thereby preventing migration of blood vessel wall cells onto the recessed portion.

[0132] Embodiment 2. A flow diverting device as described in embodiment 1, wherein the multiple pores in the recessed portion are elliptical in shape.

[0133] Embodiment 3. A flow diverting device according to any one of embodiments 2, wherein the length of the pores in the recessed portion is within the range of about 4 μm to about 36 μm, and the width of the pores in the recessed portion is within the range of about 8 μm to about 64 μm.

[0134] Embodiment 4. A flow diverting device as described in embodiment 1, wherein the multiple pores in the recessed portion are circular.

[0135] Embodiment 5. A flow diverting device as described in embodiment 4, wherein the diameter of the pores in the recessed portion is within the range of about 8 μm to about 70 μm.

[0136] Embodiment 6. A flow diverting device described in any one of embodiments 1 to 5, wherein the thickness of the stent frame body and / or the stent frame extension is at least 40 μm.

[0137] Embodiment 7. A flow diverting device according to any one of embodiments 1 to 6, wherein the recessed portion is expandable.

[0138] Embodiment 8. A flow diverting device as described in embodiment 7, wherein the stent frame is cylindrical in shape when the recessed portion is fully expanded.

[0139] Embodiment 9. A flow diverting device according to any one of embodiments 1 to 8, wherein the recessed portion is curved.

[0140] Embodiment 10. A flow diverting device described in any one of embodiments 1 to 8, wherein the stent frame body defines a longitudinal axis extending from the inlet opening to the outlet opening, and the angle formed between the longitudinal axis and the recessed portion is within the range of about 10 degrees to about 90 degrees.

[0141] Embodiment 11. A flow diverting device described in any one of embodiments 1 to 10, wherein the stent frame body is made of at least one of polyester, polytetrafluoroethylene, expanded polytetrafluoroethylene, and polyethylene terephthalate.

[0142] Embodiment 12. A flow diverting device described in any one of embodiments 1 to 11, wherein the stent frame body and / or the stent frame extension portion has an outer layer and an inner layer.

[0143] Embodiment 13. A flow diverting device as described in embodiment 12, wherein the outer layer comprises polyethylene terephthalate and the inner layer comprises expanded polytetrafluoroethylene.

[0144] Embodiment 14. A flow diverting device as described in embodiment 12, wherein the stent frame body and / or the stent frame extension further comprises an intermediate layer between the outer layer and the inner layer.

[0145] Embodiment 15. A flow diverting device as described in embodiment 14, wherein the outer and inner layers comprise expanded polytetrafluoroethylene and the middle layer comprises polyethylene terephthalate.

[0146] Embodiment 16. A flow diverting device described in any one of embodiments 1, further comprising one or more frame wires extending around the outer periphery of the stent frame body.

[0147] Embodiment 17. A flow diverting device described in any one of embodiments 1 to 16, wherein at least a portion of the stent frame extension protrudes from one end of the second portion away from the inlet opening.

[0148] Embodiment 18. A method of treating and / or preventing chronic inflammation in a patient, comprising the steps of implanting a flow diverting device in a primary arterial blood vessel of the patient, the flow diverting device including an inlet opening and an outlet opening, the flow diverting device being implanted such that the inlet opening is positioned within the primary arterial blood vessel upstream of an opening of a secondary branch blood vessel branching off from the primary arterial blood vessel and the outlet opening is positioned upstream or downstream of said opening, the implanted flow diverting device being positioned and configured such that a proportion of proinflammatory components in the patient's blood in the primary arterial blood vessel upstream of the flow diverting device leading away from the secondary branch blood vessel is greater than a proportion of proinflammatory components in the patient's blood in the primary arterial blood vessel upstream of the flow diverting device leading to the secondary branch blood vessel, the secondary branch blood vessel leading to a part of the patient's body suffering from chronic inflammation.

[0149] Embodiment 19. The method of embodiment 18, wherein the pro-inflammatory components of the blood include neutrophils, monocytes, granulocytes, macrophages, lymphocytes, dendritic cells, mast cells and plasma cells.

[0150] Embodiment 20. The method of any one of embodiments 18-19, wherein the secondary branch vessel is the patient's celiac trunk and the flow diverting device is implanted along the length of the abdominal aorta such that the inlet opening of the flow diverting device is positioned upstream of the opening of the celiac trunk.

[0151] Embodiment 21. The method of any one of embodiments 18-20, wherein the secondary branch vessel is the patient's brachiocephalic artery and the flow diverting device is implanted along the length of the aortic arch such that the inlet opening of the flow diverting device is located upstream of the opening of the brachiocephalic artery.

[0152] Embodiment 22. The method of any one of embodiments 18 to 21, wherein the chronic inflammation comprises at least one of autoimmune hepatitis, gastritis, inflammatory bowel disease, glomerulonephritis, osteoarthritis of the upper limbs, rheumatoid arthritis of the upper limbs, ankylosing spondylitis, myocarditis, psoriasis, transplant rejection, and multiple sclerosis.

[0153] Embodiment 23. The method of any one of embodiments 18 to 22, wherein the implanted flow diverter is positioned and configured such that the proportion of proinflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the primary arterial vessel downstream of the flow diverting device is greater than the proportion of proinflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the secondary branch vessel.

[0154] Embodiment 24. The method of any one of embodiments 18 to 23, wherein the secondary branch vessel is a first secondary branch vessel, the implanted flow diverting device is positioned and configured such that the proportion of proinflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the second secondary branch vessel is greater than the proportion of proinflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the first secondary branch vessel, and the second secondary branch vessel branches off from the primary arterial vessel to a part of the patient's body that is less susceptible to chronic inflammation than the part of the body reached by the first secondary branch.

[0155] Embodiment 25. The method of any one of embodiments 18 to 24, wherein the proinflammatory components in the blood are cells having a diameter of 8 μm or more.

[0156] Embodiment 26. The method of any one of embodiments 18 to 25, wherein the flow diverting device is made of a mesh material having a pore size in the range of 8 to 70 μm.

[0157] Embodiment 27. The method of any one of embodiments 18 to 25, wherein the flow diverting device is constructed from a mesh material having a pore length in the range of about 4 μm to about 36 μm and a pore width in the range of about 8 μm to about 64 μm.

[0158] Embodiment 28. A method according to any one of embodiments 18 to 27, wherein a portion of the flow diverting device tapers from the first cross section to the second cross section at an angle in the range of 10 degrees to 90 degrees, said angle being measured from an axis extending along the length of the flow diverting device.

[0159] Embodiment 29. A method of treating and / or preventing lymphedema or chronic inflammation in a patient comprising the step of implanting a flow diverting device in the patient's infrarenal aorta such that the flow diverting device is positioned at an upstream opening of the left or right common iliac artery, the implanted flow diverting device being positioned and configured such that a greater proportion of blood or a greater proportion of inflammation-inducing components in the patient's blood is directed from the infrarenal aorta to the opening of the other of the right common iliac artery or the left common iliac artery compared to the opening of one of the right common iliac artery or the left common iliac artery, one of the right common iliac artery or the left common iliac artery leading to the lower limbs of the patient suffering from lymphedema or chronic inflammation.

[0160] Embodiment 30. The method of embodiment 29, wherein the flow diverting device is implanted after lymphatic venous bypass surgery in a lower limb affected by lymphedema.

[0161] Embodiment 31. The method of any one of embodiments 29 to 30, wherein the implanted flow diverting device is positioned within the infrarenal aorta such that the most tapered portion of the flow diverting device is a distance within a range of about 0.5 cm to about 7.0 cm upstream of the patient's aortic bifurcation.

[0162] Embodiment 32. A method according to any one of embodiments 29 to 31, wherein the flow diverting device includes a crescent-shaped tapered portion and the implanted flow diverting device is positioned so that the midline of the crescent-shaped tapered portion is rotated 10 degrees to 90 degrees relative to the anterior-posterior midline of the infrarenal aorta.

[0163] As used herein, "about," "approximately," and "substantially" should be understood to refer to numbers within a numerical range, e.g., a range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1% to +1% of the referenced number, and most preferably -0.1% to +0.1% of the referenced number. Moreover, these numerical ranges should be construed to provide support for claims directed to any number or subset of numbers within that range. For example, a disclosure of 1 to 10 should be construed to support ranges of 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, etc.

[0164] Throughout this specification, reference to "various aspects," "some aspects," "some examples," "other examples," "some cases," or "one aspect" means that a particular feature, structure, or characteristic described in connection with that aspect is included in at least one example. Thus, the appearances of the phrases "in various aspects," "in some aspects," "in certain embodiments," "in some examples," "in other examples," "certain other embodiments," "in some cases," or "in one aspect" in various places throughout this specification do not necessarily all refer to the same aspect. Furthermore, a particular feature, structure, or characteristic illustrated or described in connection with one example can be combined, in whole or in part, with a feature, structure, or characteristic of one or more other aspects, without limitation.

[0165] When terms such as "on," "above," "below," "under," and "next" are used to describe a positional relationship between two parts, one or more parts may be disposed between the two parts, unless the terms are used "immediately" or "directly." Similarly, as used herein, the terms "attachable," "attached," "connectable," "connected," or any similar term may include directly or indirectly attachable, directly or indirectly attached, directly or indirectly connectable, and directly or indirectly connected.

[0166] It is to be understood that at least some of the figures and descriptions herein have been simplified to show elements relevant to a clear understanding of the present disclosure, and may exclude other elements for clarity. However, one of ordinary skill in the art will recognize that these and other elements may be desirable. However, because such elements are well known in the art and because they do not facilitate a better understanding of the present disclosure, descriptions of such elements are not presented herein.

[0167] The terms used herein are intended to describe only certain embodiments and are not intended to limit the disclosure. As used herein, the singular forms ("a", "an" and "the") are intended to include the plural forms unless otherwise specified. It will be further understood that the terms "comprises" and / or "comprising" as used herein specify the presence of stated features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. As used herein, the terms "at least one of X or Y" or "at least one of X and Y" should be interpreted as X, Y or X and Y.

[0168] It should be understood that various changes and modifications to the examples described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. Accordingly, such changes and modifications are intended to be covered by the appended claims.

Claims

1. A stent frame body; a stent frame extension; A flow diverting device comprising: The stent frame body is An entrance opening; An outlet opening; a cavity extending from the inlet opening to the outlet opening, the stent frame body configured to permit fluid to pass through the cavity from the inlet opening to the outlet opening; Equipped with the stent frame body including a first portion having the inlet opening and a second portion having the outlet opening; the second portion is tapered from one end of the second portion to a first location on the second portion, thereby forming a recessed portion having a plurality of pores; the first location of the second portion is disposed between the one end and the outlet opening or above the outlet opening; the pores in the recessed portion are configured to filter white blood cells based on their size and / or shape while allowing red blood cells to pass through; a cross-sectional area of ​​the inlet opening is greater than a cross-sectional area of ​​the outlet opening; the stent frame extension projects from at least a portion of a side surface of the stent frame body and projects away from the inlet opening; A flow diverting device, wherein the stent frame extension is configured to be disposed between at least a portion of the recessed portion and a vessel wall, thereby preventing migration of vessel wall cells onto the recessed portion.

2. The flow diverting device of claim 1 , wherein the plurality of pores in the recessed portion are elliptical in shape.

3. the length of the pores in the recessed portion is within a range of about 4 μm to about 36 μm; The flow diverting device of claim 2 , wherein the width of the pores in the recessed portion is in the range of about 8 μm to about 64 μm.

4. The flow diverting device of claim 1 , wherein the plurality of pores in the recessed portion are circular.

5. 5. The flow diverting device of claim 4, wherein the diameter of the pores in the recessed portion is in the range of about 8 μm to about 70 μm.

6. 2. The flow diverting device of claim 1, wherein the thickness of the stent frame body and / or the stent frame extension is at least 40 μm.

7. The flow diverting device of claim 1 , wherein the recessed portion is expandable.

8. 8. The flow diverting device of claim 7, wherein the stent frame is cylindrical when the recessed portion is fully expanded.

9. The flow diverting device of claim 1 , wherein the recessed portion is curved.

10. the stent frame body defines a longitudinal axis extending from the inlet opening to the outlet opening; The flow diverting device of claim 1 , wherein an angle formed between the longitudinal axis and the recessed portion is within a range of about 10 degrees to about 90 degrees.

11. 10. The flow diverting device of claim 1, wherein the stent frame body is made of at least one of polyester, polytetrafluoroethylene, expanded polytetrafluoroethylene, and polyethylene terephthalate.

12. 10. The flow diverting device of claim 1, wherein the stent frame body and / or the stent frame extension comprises an outer layer and an inner layer.

13. the outer layer comprises polyethylene terephthalate; 13. The flow diverting device of claim 12, wherein the inner layer comprises expanded polytetrafluoroethylene.

14. 13. The flow diverting device of claim 12, wherein the stent frame body and / or the stent frame extension further comprises an intermediate layer between the outer layer and the inner layer.

15. the outer layer and the inner layer comprise expanded polytetrafluoroethylene; 15. The flow diverting device of claim 14, wherein the intermediate layer comprises polyethylene terephthalate.

16. 10. The flow diverting device of claim 1, further comprising one or more frame wires extending around a circumference of the stent frame body.

17. 2. The flow diverting device of claim 1, wherein at least a portion of the stent frame extension projects away from the inlet opening from the one end of the second portion.

18. 1. A method of treating and / or preventing chronic inflammation in a patient, comprising: implanting a flow diverting device in a primary arterial blood vessel of a patient, the flow diverting device including an inlet opening and an outlet opening, the flow diverting device being implanted such that the inlet opening is disposed within the primary arterial blood vessel upstream of an opening of a secondary branch blood vessel branching off from the primary arterial blood vessel, and the outlet opening is disposed upstream or downstream of the opening; The implanted flow diverting device is positioned and configured such that a proportion of the patient's blood in the primary arterial vessel upstream of the flow diverting device leading away from the secondary branch is greater than a proportion of the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the secondary branch; The method, wherein the secondary branch vessels lead to a part of the patient's body that is afflicted with chronic inflammation.

19. 20. The method of claim 18, wherein the pro-inflammatory components in the blood include neutrophils, monocytes, granulocytes, macrophages, lymphocytes, dendritic cells, mast cells and plasma cells.

20. 20. The method of claim 18, wherein the secondary branch vessel is the patient's celiac trunk, and the flow diverting device is implanted along the length of the abdominal aorta such that the inlet opening of the flow diverting device is positioned upstream of an opening of the celiac trunk.

21. 19. The method of claim 18, wherein the secondary branch vessel is the patient's brachiocephalic artery, and the flow diverting device is implanted along the length of the aortic arch such that the inlet opening of the flow diverting device is positioned upstream of an opening of the brachiocephalic artery.

22. 20. The method of claim 18, wherein the chronic inflammation comprises at least one of autoimmune hepatitis, gastritis, inflammatory bowel disease, glomerulonephritis, osteoarthritis of the upper limbs, rheumatoid arthritis of the upper limbs, ankylosing spondylitis, myocarditis, psoriasis, transplant rejection, and multiple sclerosis.

23. 19. The method of claim 18, wherein the implanted flow diverting device is positioned and configured such that the proportion of the proinflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the primary arterial vessel downstream of the flow diverting device is greater than the proportion of the proinflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the secondary branch vessel.

24. 19. The method of claim 18, wherein the secondary branch vessel is a first secondary branch vessel, the implanted flow diverting device is positioned and configured such that a percentage of the inflammation-inducing components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to a second secondary branch vessel is greater than a percentage of the inflammation-inducing components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the first secondary branch vessel, and the second secondary branch vessel branches off from the primary arterial vessel to a part of the patient's body that is less susceptible to chronic inflammation than a part of the body reached by the first secondary branch.

25. 20. The method of claim 18, wherein the proinflammatory components in the blood are cells having a diameter of 8 μm or greater.

26. 20. The method of claim 18, wherein the flow diverting device is constructed from a mesh material having pore sizes in the range of 8 to 70 μm.

27. 20. The method of claim 18, wherein the flow diverting device is constructed from a mesh material having a pore length in the range of about 4 μm to about 36 μm and a pore width in the range of about 8 μm to about 64 μm.

28. 20. The method of claim 18, wherein a portion of the flow diverting device tapers from a first cross section to a second cross section at an angle in the range of 10 degrees to 90 degrees, the angle being measured from an axis extending through a length of the flow diverting device.

29. 1. A method of treating and / or preventing lymphedema or chronic inflammation in a patient, comprising: implanting a flow diverting device within the patient's infrarenal aorta such that the flow diverting device is positioned at an upstream opening of the right and left common iliac arteries; The implanted flow diverting device is positioned and configured to direct a greater percentage of blood or a greater percentage of proinflammatory components in the patient's blood from the infrarenal aorta to the other opening of the right common iliac artery or the left common iliac artery as compared to the other opening of the right common iliac artery or the left common iliac artery; The method, wherein the one of the right common iliac artery or the left common iliac artery leads to a lower limb of the patient suffering from lymphedema or chronic inflammation.

30. 30. The method of claim 29, wherein the flow diverting device is implanted after lymphatic venous bypass surgery in the lymphedema-affected lower limb.

31. 30. The method of claim 29, wherein the implanted flow diverting device is positioned within the infrarenal aorta such that the most tapered portion of the flow diverting device is a distance within a range of about 0.5 cm to about 7.0 cm upstream of the patient's aortic bifurcation.

32. 30. The method of claim 29, wherein the flow diverting device includes a crescent-shaped tapered portion, and the implanted flow diverting device is positioned such that the midline of the crescent-shaped tapered portion is rotated 10 degrees to 90 degrees relative to the anterior-posterior midline of the infrarenal aorta.

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