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 the priority and benefit of U.S. Provisional Patent Application No. 63 / 299,005, filed on January 13, 2022, U.S. Provisional Patent Application No. 63 / 357,119, filed on June 30, 2022, and U.S. Provisional Patent Application No. 63 / 388,789, filed on July 13, 2022, the entire contents of each of which are incorporated herein by reference.

Background Art

[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 potential sites for therapeutic intervention. Through various readaptation methods, flow modulation stents can be reconfigured to act as tools for the prevention or disruption of pathophysiological processes in the context of blood transport. More broadly, the conversion of blood components, whether selective or non - selective, can be shown to be essential for restoring 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 stenosis conditions caused by atherosclerosis and thrombosis. However, there are opportunities to treat innumerable other diseases percutaneously using one or more flow - regulating stents, and thus methods for doing so are needed.

Summary of the Invention

[0003] This disclosure provides novel and innovative flow diverting apparatuses and methods for use in treating chronic inflammation and lymphedema. In some examples, a flow diverting apparatus is provided. The flow diverting apparatus comprises 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 through the cavity from the inlet opening to the outlet opening. The stent frame body comprises a first portion having an inlet opening and a second portion having an outlet opening. The second portion is tapered from one end to a first position of the second portion, thereby forming a recessed portion having a plurality of pores. The first position of the second portion is located between one end and the outlet opening or on the outlet opening. The pores of the recessed portion are configured to filter leukocytes based on their size and / or shape while allowing red blood cells to pass through. The cross-sectional area of ​​the inlet opening is larger than the cross-sectional area of ​​the outlet opening. The stent frame extension protrudes from at least a portion of the side of the stent frame body and protrudes away from the inlet opening. The stent frame extension is configured to be positioned between at least a portion of the recess and the blood vessel wall, thereby preventing the vascular wall cells from migrating onto the recess.

[0004] In some examples, methods are provided for treating and / or preventing chronic inflammation in a patient. The method involves implanting a flow diverting device in the patient's primary arterial vessel, the flow diverting device having an inlet opening and an outlet opening, the flow diverting device being implanted such that the inlet opening is located in the primary arterial vessel upstream of the orifice of a secondary branch vessel branching off from the primary arterial vessel, and the outlet opening is located upstream or downstream, the implanted flow diverting device being positioned and configured such that the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading away from the secondary branch vessel is greater than the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the secondary branch vessel, the secondary branch vessel leading to a part of the patient's body suffering from chronic inflammation.

[0005] Further features and advantages of the disclosed apparatus and method will be described in the following detailed description and drawings, and will become apparent therefrom. [Brief explanation of the drawing]

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

[0007] [Figure 2] Figure 2 shows an example of the flow diverting device shown in Figure 1, installed in a primary arterial vessel.

[0008] [Figure 3] Figure 3 is a diagram of a flow diverting apparatus according to an example of the present disclosure.

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

[0010] [Figure 5A]Figure 5A is a diagram of a flow diverting apparatus according to an example of the present disclosure.

[0011] [Figure 5B] Figure 5B is a diagram of the flow diverting apparatus shown in Figure 5A, where the stain frame extension of the flow diverting apparatus is shown transparently for illustrative purposes.

[0012] [Figure 5C] Figure 5C is an exemplary cross-sectional view along line CC of the flow diverting apparatus of Figure 5A, according to an example of the present disclosure.

[0013] [Figure 5D] Figure 5D shows the shape and arrangement of pores in a flow diverting apparatus, according to an example of the present disclosure. [Figure 5E] Figure 5E is a diagram of the shape and arrangement of pores in a flow diverting apparatus according to an example of the present disclosure. [Figure 5F] Figure 5F is a diagram of the shape and arrangement of pores in a flow diverting apparatus according to an example of the present disclosure. [Figure 5G] Figure 5G is a diagram of the shape and arrangement of pores in a flow diverting apparatus, according to an example of the present disclosure.

[0014] [Figure 6A] Figure 6A shows a flow diverting device, as described in this disclosure, installed in a primary arterial vessel, as shown in Figure 5A.

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

[0016] [Figure 7A] Figure 7A is a diagram of a flow diverting apparatus according to an example of the present disclosure.

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

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

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

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

[0021] [Figure 8C] FIG. 8C is another exemplary cross-sectional view along line C-C of the flow diverting device of FIG. 5A according to another example of the present disclosure.

MODE FOR CARRYING OUT THE INVENTION

[0022] The present application relates to a flow diverting device for treating chronic inflammation in various regions of the body and a method of using the flow diverting device. In various examples, the flow diverting device can be a stent, a stent graft, a balloon, or other suitable diverters. In some examples, the flow diverting device may be a stent graft described in the pamphlet of International Publication No. 2020 / 168216 titled "FLOW RESTRICTING STENT-GRAFT" filed on February 14, 2020, which pamphlet is hereby incorporated by reference in its entirety.

[0023] With respect to chronic inflammation, flow diverting devices can be used to selectively filter blood components and ultimately compartmentalize the luminal region within the body's blood vessels so that one sub-region of the lumen does not become significantly concentrated with all or some types of leukocytes compared to the rest of the luminal region. Aspects of the disclosure may provide a flow diverting device that can prevent the hematogenous passage of immune cells into the arterial vascular tree of inflammatory tissue. For example, a flow diverting device according to the disclosure can prevent leukocytes involved in persistent pathological inflammation from approaching and entering an opening(s) of a secondary branch vessel supplied from a primary vessel, where the flow diverting device is deployed and positioned.

[0024] In some examples, the flow diverting devices according to this disclosure may be configured to provide a selective barrier that can redirect or divert immune cells as blood passes through the flow diverting device. In some examples, the materials comprising the flow diverting device may be useful in providing the selective barrier. For example, the flow diverting device may be composed of a mesh material. The mesh material may allow the passage of specific blood components while preventing the passage of other blood components. In various embodiments, the mesh material may be made of or contain a suitable metal such as cobalt, nitinol (nickel titanium), or stainless steel. In some examples, the mesh material may be additionally or alternatively made of or contain a fabric material such as polyester, polytetrafluoroethylene (PTFE), stretched polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), or any other suitable biocompatible material or a combination thereof.

[0025] In various examples, the material comprising the flow diverting device may be permeable. For example, the flow diverting device of this disclosure may include pores. The pores may be small enough to allow important blood components such as red blood cells, platelets, and plasma to pass through, but to prevent a significant amount of larger leukocytes (e.g., leukocytes with a diameter of 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 μm or larger) 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, for example, 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 fabric from a biocompatibility standpoint is that, in addition to customizing the pore shape to be spherical, circular, or elliptical rather than slits or channels that can be sharp-angled, the pore size can be made uniform across the entire surface area of ​​the fabric. On the other hand, as mentioned above, other suitable fabrics or metals can also be used. In some examples, the pores in the fabric of the flow diverter stent graft may be broadly circular, elliptical, rectangular, or square (with rounded corners). In other examples, the pores in the fabric of the flow diverter stent graft may have any other suitable shape.

[0027] In some cases, a selective barrier fabric consisting of ovals may be used in flow diverting devices according to this disclosure for chronic inflammatory conditions primarily facilitated by the migration and infiltration of T lymphocytes or B lymphocytes, as seen in osteoarthritis or subacute and chronic organ transplant rejection. Filtration of lymphocytes away from arterial bifurcations supplying the affected organ may require selective filtration based primarily on shape rather than size. This is because lymphocytes and erythrocytes have approximately the same diameter size of 7-8 μm. Since lymphocytes are spherical and erythrocytes are disc-shaped, erythrocytes can more easily penetrate the oval pore passages through the selective barrier fabric. Thus, the risk of ischemic complications to downstream tissues can be minimized, while at the same time, major pro-inflammatory factors such as lymphocytes can be prevented from approaching arterial bifurcations supplying the affected tissue.

[0028] In some examples, the elliptical pores of the flow diverting device may extend across the thickness of the fabric selective barrier, and for example, to achieve therapeutic purposes, they may be about 4 to 36 μm in length and about 8 to 64 μm in width. For example, the elliptical pores of the flow diverting device may be about 4 to 9 μm in length and 8 to 16 μm in width, about 9 to 18 μm in length and 16 to 32 μm in width, about 18 to 27 μm in length and 32 to 48 μm in width, or about 27 to 36 μm in length and 48 to 64 μm in width.

[0029] In some examples, various pore shapes may be arranged in rows and / or columns along a desired / predetermined section of the stent frame body / stent graft fabric, and the longest side of the elliptical 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, for example, 45%, 50%, 55%, or 60% or more. In some examples, the pores may be aligned along the axis, with squares, ovals, circles, or rectangles positioned directly above or below others. In other examples, the pores may not be aligned along the axis, with squares, ovals, circles, or rectangles positioned diagonally above or below others.

[0031] In some cases, the shape of the flow diverting device can help provide a selective barrier. For example, a flow diverting device may have a tapered structure such that the cross-sectional area of ​​the upstream (inlet) opening of the flow diverting device into which blood enters is larger 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 internal cross-sectional area through which blood can flow, thereby allowing only a portion of the blood to flow from the upstream opening through the downstream opening, thus pushing a considerable amount of blood flow through the stent frame body of the flow diverting device. Furthermore, as mentioned above, the flow diverting device material can help prevent the passage of larger blood components, so these larger blood components can be mainly guided through the interior of the flow diverting device and out through the downstream opening.

[0032] In some examples, the orientation of the flow diverting device when implanted in a patient may help guide larger blood components out of the downstream opening, such as secondary branch vessels supplied from the primary vessel into which the flow diverting device is implanted, based on where the downstream opening is located within the primary vessel. In various embodiments, the tapered section of the flow diverting device may take the form of a spiral, conical, hourglass, lobular, or crescent shape. 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 to about 90 degrees, for example, about 10 to about 20 degrees, about 20 to about 30 degrees, about 30 to about 40 degrees, about 40 to about 50 degrees, about 50 to about 60 degrees, about 60 to about 70 degrees, about 70 to about 80 degrees, or about 80 to about 90 degrees.

[0033] In some cases, implanting flow diverting devices at specific locations in a patient may help divert blood or targeted blood components to specific areas of the body. By targeting larger immune cells such as neutrophils and monocytes, which play a crucial role in the body's innate immunity, and diverting them away from the site of inflammation, the concentration of chemomedial mediators such as cytokines may decrease within the site of inflammation. This may mitigate key pathophysiological features of inflammation, such as vascular permeability of the capillary bed within the inflamed tissue. Reduced secretion of chemomedial mediators from neutrophils can lead to a decrease in the concentration of chemoattractants, which could otherwise cause a large influx of leukocytes into the site of inflammation. Furthermore, the modulation of upstream innate immunity may also result in mirror modulation of downstream adaptive immunity. Thus, local immunosuppressive targeting of innate immune cells by intravascular means may prove even more attractive, given that downstream adaptive immunity is generally recognized as a crucial factor in the exacerbation of chronic inflammation.

[0034] Figure 1 shows a flow diverting device 100 according to an 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 so that fluid flows through the cavity from the inlet opening 110 to the outlet opening 120.

[0035] In some examples, the inlet opening 110 (e.g., its cross-section) may be circular or any other suitable shape. In some examples, the outlet opening 120 (e.g., its cross-section) may be circular, partially circular, elliptical, or crescent-shaped. 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 tapered / recessed portions. For example, a 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) position of the second portion 103, thereby forming a recessed portion 130. In some examples, the first position of the second portion 103 may be located above the exit opening 120, as shown in Figure 1. In other examples, the first position may be located at any (cross-sectional) position between one end 104 and the exit opening 120. In some examples, the second portion 103 may be defined as the portion of the stent frame body 101 extending from the point where the tapering begins to the point where the exit opening 120 is located, with the first portion 103 being the remaining portion of the stent frame body 101 other than the second portion 102 (e.g., from the entrance opening 110 to the starting point of the tapering).

[0038] In some examples, the recessed portion 130 may contain pores. In some examples, only the recessed portion 130 of the stent frame body 101 contains pores, while the rest of the stent frame body 101 does not contain pores. In other examples, the stent frame body 101 may contain pores in any other suitable portion thereof.

[0039] Pores may be provided to filter leukocytes based on their size and / or shape while allowing red blood cells to pass through. In this case, most of the leukocytes from the inlet opening 110 can 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 frame body 101 may be (substantially) cylindrical when the recessed portion 130 is fully expanded.

[0041] In some examples, the recessed portion 130 may include curved portions, concave / convex portions. In some examples, the tapered portion of the flow diverting device 100 may take the form of a spiral, conical, hourglass, lobular, or crescent shape. In some examples, the tapered / recessed portion may include cross-sectional portions having the shape of a crescent, circular, or partially circular (e.g., half-moon) shape. In other examples, the tapered / recessed portion may include cross-sectional portions 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 angle of inclination formed between the longitudinal axis X and the recessed portion 130 may be in the range of about 10 to about 90 degrees, for example, about 10 to about 20 degrees, about 20 to about 30 degrees, about 30 to about 40 degrees, about 40 to about 50 degrees, about 50 to about 60 degrees, about 60 to about 70 degrees, about 70 to about 80 degrees, or about 80 to about 90 degrees. In some examples, the angle of inclination may vary over the entire recessed portion 130. For example, the angle of inclination of the recessed portion 130 near the end 104 of the second portion 103 may be smaller or larger than the angle of inclination near the outlet opening 120. In other examples, the angle of inclination of the recessed portion may be (substantially) the same over the entire recessed portion 130.

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

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

[0045] In some examples, the flow diverting device 100 may further include a plurality of flow-limiting frame wires 154 extending around the outer circumference of the stent frame body 101 within the tapered / recessed portion. The flow-limiting 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 wire may have a zigzag shape, a straight shape, a curved shape, a concave shape, a convex shape, or a combination of these shapes. In other examples, the frame wire may have any other suitable shape.

[0047] In some examples, the frame wire may have a diameter between 0.3 and 0.6 mm. In some examples, the frame wire may be made of or contain a shape memory material such as nitinol. The shape memory material can allow the flow diverting device to expand and return to its resting shape while blood pressure changes throughout the systolic and diastolic phases of the patient's cardiac cycle. In other examples, the frame wire may be made of or contain any other suitable (biocompatible) material. Further descriptions of the frame wire and stent frame body are given in the stent graft described in International Publication No. 2020 / 168216, entitled “FLOW RESTRICTING STENT-GRAFT,” filed on 14 February 2020, which is incorporated herein by reference in its entirety.

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

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

[0050] In some examples, when the flow diverting device 100 is placed in the primary arterial vessel 10, the recessed portion 130 of the stent frame body 101 may be located in the upstream portion 12, as shown in Figure 2. In other examples, when the flow diverting device 100 is placed in the primary arterial vessel 10, at least a portion of the recessed portion 130 of the stent frame body 101 may be located in the crossing portion 14 or the 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 into the luminal region of the blood vessel along the stent surface / frame (for example, not in sections of the stent frame body 101 that face the wall of the primary arterial vessel 10).

[0052] Figure 3 shows another example of a flow diverting apparatus 200 according to the present disclosure. As shown in Figure 3, the flow diverting apparatus 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 intermediate section 230 positioned 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 apparatus 200 may have an hourglass shape.

[0053] In some examples, the stent frame body 201 may include a cavity extending from an inlet opening 212 to an outlet opening 222. The stent frame body 201 may be configured to allow fluid to flow through the cavity from the inlet opening 212 to the outlet opening 222. 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 vessel 10, the inlet section 210 of the flow diverting device 200 may be positioned proximal (upstream) to the opening of the affected secondary branch vessel 20 (e.g., the upstream portion 12 of the primary arterial vessel 10).

[0055] In some examples, when the flow diverting device 200 is positioned within the primary arterial vessel 10, the intermediate recessed section 230 of the flow diverting device 200 may be positioned 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 positioned within the primary arterial vessel 10, the intermediate recessed section 230 of the flow diverting device 200 may be positioned 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 positioned within the primary arterial vessel 10, the outlet section 220 of the flow diverting device 200 may be positioned 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 positioned within the primary arterial vessel 10, the outlet section 220 (or at least a portion of the outlet section 220) of the flow diverting device 200 may be positioned within the crossing portion 14 or the downstream portion 16 of the primary arterial vessel 10.

[0057] In some examples, the recessed section 230 may include curved portions, concave / convex portions. In some examples, the recessed section 230 of the flow diverting device 200 may take the form of a spiral, conical, hourglass, lobular, or crescent shape. In some examples, the recessed section 230 may include cross-sectional portions having a crescent, circular, or partially circular (e.g., half-moon) shape. In other examples, the tapered / recessed portion may include cross-sectional portions 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 so that the crescent-shaped tapered / recessed section 230 is fixed to the vessel wall opposite to the opening of the affected secondary branch vessel. In other words, the recessed section 230 may be on the same side as the opening of the affected secondary branch vessel 20, or not (e.g., not the crossing portion 14). In this way, the orientation of the implanted flow diverting device 100 may help to divert inflammatory blood components away from the affected secondary branch vessel 20.

[0059] In some examples, the recessed portion 230 may contain pores. In some examples, only the recessed portion 230 of the stent frame body 201 contains pores, while the rest of the stent frame body 201 does not contain pores. In other examples, the stent frame body 201 may contain pores in any other suitable portion thereof.

[0060] Pores may be provided to filter leukocytes based on their size and / or shape while allowing red blood cells to pass through. In this case, most of the leukocytes from the inlet opening 212 can 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 frame body 201 may be (substantially) cylindrical when the recessed portion 230 is fully expanded.

[0062] Other components / features / characteristics of the flow diverting apparatus 200 (e.g., the inclination angle of the recessed portion 230, the material of the stent frame body 201, the frame wires) may be the same as and / or identical to those described above for the flow diverting apparatus 100, and therefore redundant descriptions may be omitted.

[0063] Figure 4 shows another example of a flow diverting device 300 according to the present disclosure. As shown in Figure 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 an inlet opening 312 to an outlet opening 322. The stent frame body 301 may be configured to allow fluid to flow through the cavity from the inlet opening 312 to the outlet opening 322.

[0065] In some examples, the inlet / outlet openings 312, 322 may have a circular or elliptical shape. 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 positioned within the primary arterial vessel 10, the inlet section 310 of the flow diverting device 300 may be positioned within the upstream portion 12 of the primary arterial vessel 10.

[0067] In some examples, when the flow diverting device 300 is positioned within the primary arterial vessel 10, the outlet section 320 / recess section 330 of the flow diverting device 300 may be positioned 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 positioned within the primary arterial vessel 10, the outlet section 320 / recess section 330 of the flow diverting device 300 may be positioned within the crossing portion 14 or the 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., polygon, regular / irregular shape).

[0069] In some examples, the recessed portion 330 may contain pores. In some examples, only the recessed portion 330 of the stent frame body 301 contains pores, while the rest of the stent frame body 301 does not contain pores. In other examples, the stent frame body 301 may contain pores in any other suitable portion thereof.

[0070] Pores may be provided to filter leukocytes based on their size and / or shape while allowing red blood cells to pass through. In this case, most of the leukocytes from the inlet opening 312 can 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 frame body 301 may be (substantially) cylindrical when the recessed portion 330 is fully expanded.

[0072] Other components / features / characteristics of the flow diverting apparatus 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 the same as and / or identical to those described above for the flow diverting apparatus 100 and / or the flow diverting apparatus 200, and therefore redundant descriptions may be omitted.

[0073] In some cases, methods can be provided to treat and / or prevent chronic inflammation affecting areas of the body above the pelvis (e.g., suprapelvic) by using an implantable flow diverting device (e.g., a flow diverting device described herein). Examples of suprapelvic chronic inflammation that can be treated using the methods and devices of this disclosure may 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 diseases, 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 the cylindrical inlet section / first portion of the flow diverting device is positioned above or proximal to the opening of the abdominal trunk. A tapering / recessed portion, which may be crescent-shaped, hourglass-shaped, vortex-shaped, or lobular in shape, may extend to be positioned adjacent to the opening of the abdominal trunk. If the distal segment of the tapering is crescent-shaped, the convex surface of the flow diverting device frame may be oriented (e.g., using guidance from 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 subsequently be deployed internally during the same catheter delivery procedure. After the first flow diverting device has been 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 tapering / recessed portion may be crescent-shaped, hourglass-shaped, spiral-shaped, or lobular-shaped and may extend until it is positioned adjacent to the opening of the inferior mesenteric artery. If the distal segment of the tapering is crescent-shaped, the convex surface of the flow diverting device frame may be oriented (e.g., using guidance from an embedded radiopaque marker) to be fixed against the posterior aortic wall. Furthermore, the second flow diverting device may, as an alternative option, be a non-poreless cylindrical shape and may be delivered at the level of the inferior mesenteric artery opening to block blood perfusion into the aortic branch vessels.

[0076] In some examples, a method of treating and / or preventing inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, using a flow diverting device according to the present disclosure may include implanting the 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 positioned above or proximal to the opening of the trunk of the abdominal cavity. The tapering / recessed portion, which may be crescent-shaped, hourglass-shaped, spiral-shaped, or lobular, may extend distally and may be positioned adjacent to the openings of the trunk of the abdominal cavity, the superior mesenteric artery, and the inferior mesenteric artery. If the tapering / recessed portion is crescent-shaped, the convex surface of the flow diverting device frame may be oriented to be fixed against the posterior aortic wall (e.g., using guidance from an implanted radiopaque marker). Since all affected secondary branch vessel openings leading to the site of intestinal inflammation are generally located in the anterior wall of the aorta, the convex surface may be oriented in this manner. Furthermore, the cylindrical outlet section of the flow diverting device may be positioned distal to the opening of the inferior mesenteric artery in the aorta.

[0077] Cases of gastritis and hepatitis can also be treated in the same manner as those used to treat and / or prevent inflammatory bowel disease. However, in cases of gastritis and hepatitis, the tapered / recessed portion of the implanted flow diverting device may extend distally only to the extent of the distal edge of the trunk opening, which is the first major vessel branching 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 positioned cylindrical outlet section may not be necessary. This is because the distal end, consisting of a crescent-shaped frame, is fixed to at least 50% of the aortic wall and is therefore less likely to move or detach from its fixed position.

[0078] In another example, the treatment of multiple sclerosis using a flow diverting device according to this disclosure may involve implanting a flow diverting device along the length of the aortic arch such that the cylindrical inlet of the implanted flow diverting device is positioned proximal to the opening of the brachiocephalic artery. The tapered / recessed portion of the implanted flow diverting device extends over the entire length of the aortic arch and is positioned 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., using guidance from an implanted radiopaque marker) so that it is fixed against the inferior aortic wall. The convex surface may be oriented in this manner, since all affected secondary branch vessel openings leading to the site of encephalitis are located in the superior aortic arch wall. Finally, the flow diverting device may or may not include a cylindrical outlet section positioned distal to the opening of the left subclavian artery. For example, the deployment of a flow diverting device with a cylindrical outlet distal to the left subclavian artery opening may help ensure the prevention of potential retrograde diastolic flow of leukocytes into the aortic arch opening after they exit the tapered / recessed portion of the device. In some cases, a non-cylindrical outlet design may increase the risk of posterior leukocyte flow during diastole after immune cells first exit the tapered / recessed section during pre-plastic systolic flow.

[0079] In another example of a flow diverting device for the treatment / prevention of suprapelvic chronic inflammation, the treatment / prevention of bilateral upper limb osteoarthritis or left unilateral upper limb osteoarthritis may involve implanting a flow diverting device according to this disclosure along the length of the aortic arch such that the cylindrical inlet section of the implanted flow diverting device needs to be positioned proximal (upstream) to the opening of the brachiocephalic artery. The tapered / recessed portion of the implanted flow diverting device extends over the entire length of the aortic arch and is positioned 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., using guidance from an implanted radiopaque marker) so that it is fixed against the inferior aortic wall. The convex surface may be oriented in this manner, since all affected secondary branch vessel 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 outlet section located distal to the left subclavian artery opening. For example, the deployment of a flow diverting device with a cylindrical outlet section distal to the left subclavian artery opening may help ensure the prevention of potential retrograde diastolic flow of leukocytes into the aortic arch opening after exiting the tapered / recessed portion of the device. In some examples, a non-cylindrical outlet design may increase the risk of retrograde leukocyte flow during diastole after immune cells first exit the tapered section during pre-systolic flow.

[0080] In another example, the treatment / prevention of right unilateral upper limb osteoarthritis may involve implanting the inlet section of a flow diverting device such that the inlet section of the flow diverting device is positioned proximal (e.g., upstream portion) of the brachiocephalic opening. The tapered central section of the implanted flow diverting device extends distally as well as distal to the distal edge of the brachiocephalic artery 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 positioned 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 and is therefore less likely to move or dislodge from its fixed position.

[0081] As described above, regarding the placement of the flow diverting device within the primary arterial vessel 10, in some examples, the tapered / recessed segment of the flow diverting device (whether or not the entire length of the flow diverting device includes a cylindrical outlet segment) may be at the same level as the opening of the affected 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 affected secondary branch vessel. This alternative configuration may be applied to any vascular setting and therefore to any of the aforementioned treatment methods associated with upper limb osteoarthritis, gastritis, hepatitis, inflammatory bowel disease, or multiple sclerosis.

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

[0083] If the entire flow diverting device is positioned proximal to the opening of the affected secondary branch vessel, the flow diverting device can be expanded with a tapered / recessed segment without causing subsequent occlusion of any portion of the target branch vessel lumen when the patient no longer requires further treatment for chronic inflammation. Since the total volume of leukocytes passing through the primary arterial vessel is no longer partially or completely occluded and diverted by the flow diverting device, treatment for chronic inflammation can be terminated by expanding the flow diverting device to a fully cylindrical shape (e.g., without a tapered / recessed segment) that conforms to the cylindrical shape of the primary arterial vessel wall.

[0084] In some cases, expansion of the tapered / recessed segment of a flow diverting device can be achieved by deploying a cylindrical balloon-expandable or self-expanding stent within an already-placed flow diverting device and forcibly opening it. Another method for expanding the tapered / recessed segment of a flow diverting device during the end of treatment for chronic inflammation may involve the use of a balloon catheter containing a fluid at a sufficiently high temperature to induce an austenitic structural change in the (flow-restricting) stent frame wire (which may be made from or may contain nitinol) near the recessed portion of the flow diverting device, for example, so that the frame wire (and the recessed portion of the stent frame body associated with the frame wire) expands to, for example, have a circular shape.

[0085] While flow diverting devices can filter blood components to reduce the progression and amplification of inflammatory processes, it is important to consider potential long-term adaptability challenges related to the porous membrane, which may be essential for the device's functionality. Specifically, one of the biggest challenges to the long-term use of flow diverting devices is the risk of endothelialization spreading to the porous portion of the flow diverting device (e.g., on the surface of a concave stent graft). Endothelialization can involve the migration or movement of vascular wall cells, such as endothelial cells or smooth muscle cells, onto some external implant device, including the stent. This process may continue until a large portion or all of the device is taken up and surrounded by the vascular wall in contact with the device, especially if the device has open gaps or pores.

[0086] Therefore, in the long term, endothelialization can be a major cause of concern for flow diverting devices with pores. This is because the gradual migration of various endothelial wall cells from the proximal surface of the stent frame body aligned with the vessel wall progresses toward the more distal concave surfaces (e.g., recessed areas) of the flow diverting device, ultimately leading to occlusion and closure of pores located in the recessed areas. Pores in flow diverting devices can be closed by endothelialization within less than one month.

[0087] Aspects of the present disclosure can provide a flow diverting device 500 that can address the endothelialization problem described above. Referring to Figures 5A to 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 so that fluid flows through the cavity from the inlet opening 510 to the outlet opening 520.

[0088] In some examples, the inlet opening 510 (e.g., its cross-section) may be circular 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 tapered / recessed portions. For example, a 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) position of the second portion 503, thereby forming a recessed portion 530. In some examples, the first position of the second portion 503 may be located on the exit opening 520, as shown in Figure 5A. In other examples, the first position may be located at any point between the one end 504 and the exit opening 520. In some examples, the second portion 503 may be defined as the portion of the stent frame body 501 extending from the point where the tapering begins to the point where the exit opening 520 is located, with the first portion 502 being the remainder 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, while the rest of the stent frame body 501 does not include pores. In other examples, the stent frame body 501 may include pores 535 in any other suitable portion thereof.

[0092] Pores may be provided to filter leukocytes based on their size and / or shape while allowing red blood cells to pass through. In this case, the majority of leukocytes from the inlet opening 510 (e.g., more than 90%, 95%, 98%, or 99%) 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 frame body 501 may be (substantially) cylindrical when the recessed portion 530 is fully expanded.

[0094] In some examples, the recessed portion 530 may include curved portions, concave / convex portions. In some examples, the tapered portion of the flow diverting device 500 may take the form of a spiral, conical, hourglass, lobular, or crescent shape. In some examples, the tapered / recessed portion may include a cross-sectional portion having a crescent, circular, or partially 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 components / 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, and the frame wires 552 and 554) may be the same as and / or identical to those described above for the flow diverting device 100, and therefore redundant descriptions may be omitted.

[0096] In some examples, as shown in Figure 5A, the stent frame extension 540 may protrude from at least a portion of the 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 the 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 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 (for example, between the inlet opening 510 and the edge 532 of the recessed portion 530).

[0097] In some examples, the stent frame extension 540 may be U-shaped, as shown in Figure 5A. In this case, in some examples, the stent frame extension 540 may have the same width W1 from the first side end 541 to the second side end 542 (for example, the distance between the edge 532 of the recessed portion 530 and the free end 545 of the stent frame extension 540). 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 the vessel wall (for example, the vessel wall of the primary arterial vessel 10), thereby preventing the vessel wall cells from migrating onto the recessed portion.

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

[0100] As shown in Figures 5F and 5G, in some examples the pores 535 may have a circular shape. In this case the pores 535 may have diameters in the range of about 8 μm to about 70 μm, for example, 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, rectangle, square, hexagon, any other polygon (with or without rounded corners), or a regular / irregular shape. In this case, the pores 535 may have lengths in the range of about 8 μm to about 70 μm, for example, 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 (for example, any longest straight-line distance between any two points on the edge of the pores 535).

[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 equally apart from one another. In this case, four adjacent pores 535 (for example, two adjacent pores 535 from a first column and two adjacent pores 535 from a second column located immediately next to the two adjacent pores 535 from the first column) may form a square or rectangle.

[0103] In some examples, as shown in Figures 5E and 5G, the pores 535 are arranged to form multiple rows in the vertical direction. In each row, the pores 535 are spaced equal to one another. 2N-1 rows (where N is a non-negative integer) of pores 535 are arranged to form a first group of rows in the horizontal direction, and 2N rows of pores 535 are arranged to form a second group of rows in the horizontal direction. In this case, four adjacent pores 535 (for example, two adjacent pores 535 from the first row and two adjacent pores 535 from the second row located immediately next to the two adjacent pores 535 from the first row) may form a parallelogram. In some examples, four adjacent pores 535 in 2N-1 rows (e.g., two adjacent pores 535 from a first row and two adjacent pores 535 from a third row located immediately next to the two adjacent pores 535 from the first row) may form a virtual square / rectangle 537, and the pores 535 in 2N rows may be located at the center of the virtual square / rectangle 537.

[0104] In other examples, the pores 535 may be arranged in any other suitable manner (e.g., forming hexagons, pentagons or any other polygons, or being randomly arranged). In some examples, the pores 535 may have a uniform 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 Figure 6A, the flow diverting device 500 may be positioned within the primary arterial vessel 10 such that the inlet opening 510 (and the first portion 502) of the flow diverting device 100 is located proximal (upstream) to the opening of the affected secondary branch vessel 20 (for example, in the upstream portion 12).

[0106] In some examples, when the flow diverting device 500 is positioned within the primary arterial vessel 10, the recessed portion 530 and / or the outlet opening 520 of the stent frame body 501 may be positioned within the upstream portion 12 of the primary arterial vessel 10. In other examples, when the flow diverting device 500 is positioned within the primary arterial vessel 10, the recessed portion 530 (at least a portion thereof) and / or the outlet opening 520 of the stent frame body 501 may be positioned 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, for example, 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 move through walls having a thickness greater than 40 μm and / or walls having an internodal distance of at least 30 μm. Therefore, the movement of endothelial cell components onto the flow / lumen surface of the flow diverting device can be prevented through this pathway.

[0108] When using PET cloth, the total thickness of the PET should be at least 20 μm to penetrate the thickness of the stent frame body 501 and prevent endothelial migration onto the flow surface. Diffusion of endothelial cell components may not occur by crossing the proximal or distal end of the stent frame body from the outer wall surface of the stent frame body to the internal flow / lumen side surface of the stent frame body.

[0109] Figure 6B is an enlarged cross-sectional view of region B in Figure 6A. As described above, one of the greatest challenges to the long-term use of flow diverting devices is the risk of endothelialization spreading into the pores of the flow diverting device (e.g., in tapered / recessed portions). For example, as shown in Figure 6B, after the installation of the flow diverting device, vascular 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, occluding the pores in the recessed portions. An aspect of the present disclosure can prevent the migration of endothelial wall cells and the occlusion of pores by these endothelial wall cells by providing, for example, a stent frame extension 540 that can be positioned between the vascular wall and the recessed portion 530. Furthermore, when the stent frame body 501 and / or the stent frame extension 540 have a thickness within the above range, endothelial wall cells cannot penetrate the thickness of the stent frame body 501 and / or the stent frame extension 540, thereby preventing the vascular wall cells from occluding the pores of the recessed portion 530.

[0110] In Figures 7A and 7B, the stent frame extension 540 has a different shape from that in Figure 5A. In Figure 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 may have a cylindrical shape together with the stent frame extension 540.

[0111] In Figure 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 one end 504 of the first portion (where the tapering begins) to a point between the one end 504 and the exit opening 520. In this case, the stent frame extension 540 does not need to be in direct contact with 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 and 154 described above) extending around 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 periphery of the second portion 503 of the stent frame body 501 that is perfectly aligned with the primary arterial vessel wall, and around the stent frame extension 540. Thus, this stent wire may approximate the structure and shape of the stent wire 542 located near the inlet opening 510.

[0114] Figure 7C is a cross-sectional view of the flow diverting device 500 in Figure 7B along line DD in 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 examples, the first lumen may allow unfiltered blood (e.g., large white blood cells such as neutrophils and macrophages) to flow through it, and the second lumen may allow filtered blood through pores 535 to flow through it.

[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, partially circular, or elliptical). In some examples, the second lumen may be circular, partially circular, or elliptical in shape. In other examples, the second lumen may have any other suitable shape.

[0116] In some examples, as shown in Figure 6B, the implanted flow diverting device 500 may be oriented such that its outlet opening 520 is located on the opposite side of the vascular lumen from the location of the opening of the affected secondary branch vessel 20. In this case, the recessed portion 530 may face the direction in which the affected secondary branch vessel 20 extends from the opening.

[0117] As described above, the stent frame extension 540 can provide structural support to the stent frame body 501 in the second portion 503. For example, in the flow diverting device 100 of Figure 1, the structural support for the second portion 103 is mainly provided by the stent frame wire 154. However, in the flow diverting device 500 of Figures 5A, 7A and / or 7B, in addition to the stent wire 554 extending around the second portion 503, the structural support for the second portion 503 is further provided by the stent frame extension 540, in which case the second lumen (and / or the first and second lumen) may have a circular / elliptical ring shape similar to the shape of the stent wire near the inlet opening 510 or 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 configuration / features / characteristics of the stent frame extensions applicable to these other flow diverting device designs may be the same as and / or identical to those described above with respect to the flow diverting device 500. For example, the stent frame extension may protrude from at least a portion of the side surface of the stent frame body 201 / 301 and away from the inlet opening 210 / 310. In some examples, the stent frame extension may protrude from the edge of the recessed portion 230 / 330. In other examples, the stent frame extension 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 extension is configured to be positioned between at least a portion of the recessed portion 230 / 330 and the vessel wall (e.g., the vessel wall of the primary arterial vessel 10), thereby preventing the migration of vascular wall cells into the recessed portion.

[0119] In some examples, the flow diverting apparatus according to this disclosure may be made of a material that can consist of two or three parallel layers. For example, referring to Figure 8A, the stent frame body 501 and the stent frame extension 540 may have a two-layer structure 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 contain PET, and the inner layer 572 / 582 may be made of or contain ePTFE. In other examples, the outer and inner layers may contain any other suitable material.

[0120] Referring to Figure 8B, in some examples, the stent frame body 501 and the stent frame extension 540 may have a three-layer structure by including three parallel layers, namely an outer layer 571 / 581, an intermediate 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 intermediate layer 573 / 583 may be made of or include PET. In other examples, the outer layer, intermediate layer, and inner layer may be made of or include any other suitable material.

[0121] Referring to Figure 8C, in some examples, the flow diverting apparatus according to this disclosure may be made of materials having a hybrid configuration. For example, as shown in Figure 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 the stent frame extension 540 (e.g., for the outer / intermediate / inner layers) may include ePTFE, PET, urethane-based materials, or any combination thereof.

[0122] In some cases, the use of the flow diverting device implanted according to this disclosure (e.g., the flow diverting device described herein) may provide a method for treating and / or preventing areas of the body below the pelvis (e.g., the lower pelvis) p that are affected by chronic inflammation or lymphedema. In the case 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 so as to be positioned at the level of the subrenal aorta above the aortic bifurcation. In some cases, the tapering / recessed portion of the flow diverting device, also known as its throat, may be fixed to the aortic wall within a range of 0.5 to 7.0 cm proximal (upstream) of the aortic bifurcation. The purpose of implanting the flow diverting device in particular within the subrenal aorta may be to direct the migration of inflammatory immune cells to a slightly affected or otherwise unaffected lower extremity. By diverting inflammatory cells such as monocytes, neutrophils, macrophages, and granulocytes to the healthy contralateral limb and away from the arterial system of the diseased limb, overt inflammation causing severe pain and discomfort can be mechanically regulated. Furthermore, considering 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 resulting from leukocyte shunts into the arterial system of the healthy limb may be reduced.

[0123] In some cases, a flow diverting device with a crescent-shaped tapered section can be used to achieve a unidirectional shift in leukocyte passage. One advantage of using a crescent throat is that the orientation of the crescent-shaped tapered section is adaptable and it is not forced to take a symmetrical position along the midline of the aorta every time. Thus, in various cases, the flow diverting device can be implanted (e.g., guided by strategically placed radiopaque markers placed on the device) so that the midline of the narrowest part of the crescent-shaped tapered section rotates within a range of 10 to 90 degrees from the anterior-posterior midline of the aorta.

[0124] In at least some embodiments, to prevent the redistribution of leukocytes across the entire 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 at a near-perpendicular distance from the iliac artery supplying the healthier lower limb (when the patient is standing), which may constitute the distal end of the flow diverting device. Orienting the crescent-shaped throat, which may be designed as the distal end, in this manner may help generate a jet stream of leukocytes, ensuring their passage into the arterial system of the healthier lower limb.

[0125] Regarding the treatment of unilateral lymphedema of the lower extremities, the flow diverting device according to this disclosure may be implanted at the level of the subrenal 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 direct total blood flow to the healthy opposite lower extremity in contrast to the affected limb. By partially reducing arterial pressure in the lymphedematous limb, the collection of trapped lymphatic fluid can be slowed, thereby reducing circumferential swelling and potentially resulting in better function.

[0126] Similarly, flow diverting devices 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 surgery involves surgical anastomosis of lymphatic vessels into the venous vascular system, the diversion of lymphatic fluid into the veins 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 improve the clinical outcomes seen in patients after lymphovenous bypass surgery.

[0127] As described above, by using the implanted flow diverting device, arterial pressure can be reduced by partially diverting total blood flow from the affected lower limb in these postoperative patients, and therefore, venous return from the affected limb can also be reduced. This critical reduction in venous blood pressure will promote the drainage of excess lymph fluid through lymphatic vessels anastomosed to the venous vessels. This is because the anastomosed veins receiving the excess lymph fluid have residual volume capacity to transport more circulating fluid as needed.

[0128] In some embodiments, the use of flow diverting devices is not limited to the duration of a patient's treatment but may also be relevant to patients suffering from conditions such as chronic inflammation of one lower limb, lymphedema of one lower limb, or congestive heart failure after the completion of flow diversion therapy. When the completion of flow diversion therapy is required, full blood flow patency can be restored by expanding the tapered or narrowed segment of the flow diverting device so that the entire stent frame aligns with most or all of the inner lining of the aortic endothelium. This can be done by deploying an additional secondary balloon-expandable or self-expanding stent having a uniform conventional cylindrical shape from within the primary tapered stent device. By designing the conventional secondary stent so that its wire diameter is greater than that 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 explanation, those skilled in the art will likely find the above description useful for making the most of the claimed invention. The examples and embodiments disclosed herein should be interpreted as illustrative only and not in any way limit the scope of this disclosure. It will be apparent to those skilled in the art that modifications can be made to the details of the above examples without departing from the basic principles described. In other words, various modifications and improvements to the examples specifically disclosed above are within the scope of the appended claims. For example, any appropriate combination of features of the various examples described is conceivable.

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

[0131] Embodiment 1. The flow diverting device comprises a stent frame body and Stent frame extension, A flow diverting device that is equipped with, The stent frame body comprises an inlet opening, an outlet opening, and a cavity extending from the inlet opening to the outlet opening, wherein the stent frame body is 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 an inlet opening and a second portion having an outlet opening, the second portion being tapered from one end to a first position of the second portion, thereby forming a recessed portion having a plurality of pores, and the first position of the second portion being between the one end and the outlet opening. The stent frame extension is positioned between or over the outlet opening, and 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 through, the cross-sectional area of ​​the inlet opening is larger than the cross-sectional area of ​​the outlet opening, the stent frame extension protrudes from at least a portion of the 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 the migration of vascular wall cells onto the recessed portion.

[0132] Embodiment 2. The flow diverting apparatus according to Embodiment 1, wherein the multiple pores in the recessed portion are elliptical in shape.

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

[0134] Embodiment 4. The flow diverting apparatus according to Embodiment 1, wherein the plurality of pores in the recessed portion are circular.

[0135] Embodiment 5. The flow diverting apparatus according to Embodiment 4, wherein the diameter of the pores in the recessed portion is in the range of approximately 8 μm to approximately 70 μm.

[0136] Embodiment 6. A flow diverting apparatus according to 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 apparatus according to any one of Embodiments 1 to 6, wherein the recessed portion is expandable.

[0138] Embodiment 8. The flow diverting apparatus according to Embodiment 7, wherein the stent frame is cylindrical when the recessed portion is fully expanded.

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

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

[0141] Embodiment 11. A flow diverting apparatus according to any one of Embodiments 1 to 10, wherein the stent frame body is made of at least one of polyester, polytetrafluoroethylene, stretched polytetrafluoroethylene, and polyethylene terephthalate.

[0142] Embodiment 12. A flow diverting apparatus according to any one of Embodiments 1 to 11, wherein the stent frame body and / or stent frame extension comprises an outer layer and an inner layer.

[0143] Embodiment 13. The flow diverting apparatus according to Embodiment 12, wherein the outer layer contains polyethylene terephthalate and the inner layer contains stretched polytetrafluoroethylene.

[0144] Embodiment 14. The flow diverting apparatus according to Embodiment 12, wherein the stent frame body and / or stent frame extension further comprises an intermediate layer between the outer layer and the inner layer.

[0145] Embodiment 15. The flow diverting apparatus according to Embodiment 14, wherein the outer layer and inner layer contain stretched polytetrafluoroethylene, and the intermediate layer contains polyethylene terephthalate.

[0146] Embodiment 16. A flow diverting apparatus according to any one of Embodiments 1, further comprising one or more frame wires extending around the outer circumference of the stent frame body.

[0147] Embodiment 17. A flow diverting apparatus according to 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 so as to move away from the inlet opening.

[0148] Embodiment 18. A method for treating and / or preventing chronic inflammation in a patient, comprising the step of implanting a flow diverting device in the patient's primary arterial vessel, wherein the flow diverting device includes an inlet opening and an outlet opening, the inlet opening being located within the primary arterial vessel upstream of an opening of a secondary branch vessel branching from the primary arterial vessel, and the outlet opening being located upstream or downstream of the opening, wherein the implanted flow diverting device is positioned and configured such that the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading away from the secondary branch vessel is greater than the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the secondary branch vessel, the secondary branch vessel leading to a part of the patient's body affected by chronic inflammation.

[0149] Embodiment 19. The method according to 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 according to any one of Embodiments 18 to 19, wherein the flow diverting device is implanted along the length of the abdominal aorta such that the secondary branch vessel is the patient's abdominal trunk and the inlet opening of the flow diverting device is located upstream of the opening of the abdominal trunk.

[0151] Embodiment 21. The method according to any one of Embodiments 18 to 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 according to any one of Embodiments 18 to 21, wherein the chronic inflammation includes 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 according to any one of Embodiments 18 to 22, wherein the implanted flow divertin is positioned and configured such that the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device, which is led to the primary arterial vessel downstream of the flow diverting device, is greater than the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device, which is led to the secondary branch vessel.

[0154] Embodiment 24. The method according to any one of Embodiments 18 to 23, wherein the secondary branch vessel is a first secondary branch vessel, and the implanted flow diverting device is positioned and configured such that the proportion of pro-inflammatory 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 pro-inflammatory 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 less susceptible to chronic inflammation than the part of the body to which the first secondary branch reaches.

[0155] Embodiment 25. The method according to any one of Embodiments 18 to 24, wherein the pro-inflammatory component in the blood is a cell having a diameter of 8 μm or more.

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

[0157] Embodiment 27. The method according to any one of Embodiments 18 to 25, wherein the flow diverting apparatus is composed of 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. The method according to any one of Embodiments 18 to 27, wherein a portion of the flow diverting apparatus tapers from a first cross section to a second cross section at an angle in the range of 10 to 90 degrees, and the angle is measured from an axis extending along the length of the flow diverting apparatus.

[0159] Embodiment 29. A method for treating and / or preventing lymphedema or chronic inflammation in a patient is a method comprising the step of implanting a flow diverting device in the patient's subrenal aorta such that the flow diverting device is positioned at the upstream openings of the left and right common iliac arteries, the implanted flow diverting device being positioned and configured such that a larger proportion of blood or a larger proportion of pro-inflammatory components in the patient's blood is directed from the subrenal aorta to the other opening of the right or left common iliac artery compared to one opening of the right or left common iliac artery, the other of which leads to the lower limb of the patient suffering from lymphedema or chronic inflammation.

[0160] Embodiment 30. The method according to Embodiment 29, wherein the flow diverting device is implanted after lymphovenous bypass surgery in a lower limb affected by lymphedema.

[0161] Embodiment 31. The method according to any one of Embodiments 29 to 30, wherein the implanted flow diverting device is positioned in the subrenal aorta such that the tapered portion of the flow diverting device is located upstream of the patient's aortic bifurcation by a distance of approximately 0.5 cm to approximately 7.0 cm.

[0162] Embodiment 32. The 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 such that the midline of the crescent-shaped tapered portion is rotated 10 to 90 degrees with respect to the anterior-posterior midline of the inferior renal aorta.

[0163] As used herein, “about,” “approximately,” and “substantially” should be understood to mean a number within a range, for example, -10% to +10% of the referenced number, preferably -5% to +5%, more preferably -1% to +1%, and most preferably -0.1% to +0.1%. Furthermore, these numerical ranges should be interpreted as providing support for claims that cover any number or subset of a number within that range. For example, a disclosure of 1 to 10 should be interpreted as supporting ranges such as 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, etc.

[0164] Throughout this specification, any reference to “various embodiments,” “several embodiments,” “several examples,” “other examples,” “several cases,” or “one embodiment” means that the particular features, structures, or characteristics described in relation to that embodiment are included in at least one example. Therefore, the appearance of the phrases “in various embodiments,” “in some embodiments,” “in certain embodiments,” “in some examples,” “in other examples,” “in certain other embodiments,” “in some cases,” or “one embodiment” in several places throughout this specification does not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic illustrated or described in relation to an example may, in whole or in part, be combined with, but is not limited to, features, structures, or characteristics of one or more other embodiments.

[0165] When describing the positional relationship between two parts using terms such as “on,” “above,” “below,” “under,” and “next,” one or more parts may be positioned between the two parts unless the term is used with “immediately” or “directly.” Similarly, as used herein, the terms “mountable,” “attached,” “connectable,” “connected,” or any similar terms may include being directly or indirectly mountable, directly or indirectly attached, directly or indirectly connectable, and directly or indirectly connected.

[0166] At least some of the figures and descriptions in this specification have been simplified to illustrate elements relevant to a clear understanding of this disclosure, and other elements may have been omitted for clarity. However, those skilled in the art will recognize that these and other elements may be desirable. However, since such elements are well known in the art and would not facilitate a better understanding of this disclosure, no description of such elements is provided herein.

[0167] The terms used herein are intended to describe only specific embodiments and are not intended to limit the disclosure. Where used herein, singular forms ("a," "an," and "the") are intended to include plural forms unless otherwise specified. Where used herein, the terms "comprises" and / or "comprising" specify the presence of the described features, integers, steps, actions, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, actions, elements, components, and / or groups thereof. Where 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 obvious to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of this subject matter and without impairing its intended merits. Accordingly, such changes and modifications are intended to be covered by the appended claims.

Claims

1. The stent frame body, Stent frame extension, A flow diverting apparatus comprising, The stent frame body is The entrance opening, The exit opening and A cavity extending from the inlet opening to the outlet opening, wherein the stent frame body is configured to allow fluid to flow through the cavity from the inlet opening to the outlet opening, It is equipped with, The stent frame body includes 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 the first position of the second portion, thereby forming a recessed portion having a plurality of pores. The first position of the second portion is located between the one end and the outlet opening or on the outlet opening. The pores in the recessed portion are configured to filter out white blood cells based on their size and / or shape while allowing red blood cells to pass through. The cross-sectional area of ​​the inlet opening is larger than the cross-sectional area of ​​the outlet opening. The stent frame extension protrudes from at least a portion of the side surface of the stent frame body and protrudes away from the entrance opening. A flow diverting device in which the stent frame extension is configured to be positioned between at least a portion of the recessed area and the blood vessel wall, thereby preventing the migration of blood vessel wall cells onto the recessed area.

2. The flow diverting apparatus according to 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 in the range of approximately 4 μm to approximately 36 μm. The flow diverting apparatus according to claim 2, wherein the width of the pores in the recessed portion is in the range of approximately 8 μm to approximately 64 μm.

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

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

6. The flow diverting apparatus according to 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 apparatus according to claim 1, wherein the recessed portion is expandable.

8. The flow diverting apparatus according to claim 7, wherein the stent frame body is cylindrical when the recessed portion is fully expanded.

9. The flow diverting apparatus according to claim 1, wherein the recessed portion is curved.

10. The stent frame body has a longitudinal axis that extends from the inlet opening to the outlet opening, The flow diverting apparatus according to claim 1, wherein the angle formed between the longitudinal axis and the recessed portion is in the range of about 10 degrees to about 90 degrees.

11. The flow diverting apparatus according to claim 1, wherein the stent frame body is made of at least one of polyester, polytetrafluoroethylene, stretched polytetrafluoroethylene, and polyethylene terephthalate.

12. The flow diverting apparatus according to 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, The flow diverting apparatus according to claim 12, wherein the inner layer contains stretched polytetrafluoroethylene.

14. The flow diverting apparatus according to 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 contain stretched polytetrafluoroethylene, The flow diverting apparatus according to claim 14, wherein the intermediate layer contains polyethylene terephthalate.

16. The flow diverting apparatus according to claim 1, further comprising one or more frame wires extending around the outer circumference of the stent frame body.

17. The flow diverting apparatus according to claim 1, wherein at least a portion of the stent frame extension protrudes from one end of the second portion away from the inlet opening.

18. The stent frame body, Stent frame extension, A flow diverting apparatus comprising, The stent frame body is The entrance opening, The exit opening and A cavity extending from the inlet opening to the outlet opening, wherein the stent frame body is configured to allow fluid to flow through the cavity from the inlet opening to the outlet opening, It is equipped with, The stent frame body includes 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 the first position of the second portion, thereby forming a recessed portion having a plurality of pores. The first position of the second portion is located between the one end and the outlet opening or on the outlet opening. The pores in the recessed portion are configured to filter out white blood cells based on their size and / or shape while allowing red blood cells to pass through. The cross-sectional area of ​​the inlet opening is larger than the cross-sectional area of ​​the outlet opening. The stent frame extension protrudes from at least a portion of the side surface of the stent frame body and protrudes away from the entrance opening. In a flow diverting device, the stent frame extension is configured to be positioned between at least a portion of the recessed area and the blood vessel wall, thereby preventing the migration of blood vessel wall cells onto the recessed area. The flow diverting device is A method for treating and / or preventing chronic inflammation in patients, A step of implanting a flow diverting device in a patient's primary arterial vessel, wherein the flow diverting device includes an inlet opening and an outlet opening, and the inlet opening is positioned within the primary arterial vessel upstream of the opening of a secondary branch vessel branching from the primary arterial vessel, and the outlet opening is positioned upstream or downstream of the opening, The implanted flow diverting device is positioned and configured such that the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device, which is guided away from the secondary branch vessel, is greater than the proportion of pro-inflammatory components in the patient's blood in the primary arterial vessel upstream of the flow diverting device, which is guided to the secondary branch vessel. A method wherein the secondary branched blood vessel reaches a part of the body of the patient suffering from chronic inflammation. A flow diverting device used in this purpose.

19. The flow diverting apparatus according to claim 18, wherein the inflammatory components in the blood include neutrophils, monocytes, granulocytes, macrophages, lymphocytes, dendritic cells, mast cells, and plasma cells.

20. The flow diverting device according to claim 18, wherein the secondary branching vessel is the abdominal trunk of the patient, 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 abdominal trunk.

21. The flow diverting device according to claim 18, wherein the secondary branching vessel is the brachiocephalic artery of the patient, 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 the opening of the brachiocephalic artery.

22. The flow diverting apparatus according to claim 18, wherein the chronic inflammation includes 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. The flow diverting device according to claim 18, wherein the implanted flow diverting device is arranged and configured such that the proportion of the pro-inflammatory component in the patient's blood in the primary arterial vessel upstream of the flow diverting device, which is led to the primary arterial vessel downstream of the flow diverting device, is greater than the proportion of the pro-inflammatory component in the patient's blood in the primary arterial vessel upstream of the flow diverting device, which is led to the secondary branched vessel.

24. The flow diverting device according to claim 18, wherein the secondary branching vessel is a first secondary branching vessel, and the implanted flow diverting device is arranged and configured such that the proportion of the pro-inflammatory component in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to a second secondary branching vessel is greater than the proportion of the pro-inflammatory component in the patient's blood in the primary arterial vessel upstream of the flow diverting device leading to the first secondary branching vessel, and the second secondary branching 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 to which the first secondary branching vessel reaches.

25. The flow diverting apparatus according to claim 18, wherein the inflammation-inducing component in the blood is a cell having a diameter of 8 μm or more.

26. The flow diverting apparatus according to claim 18, wherein the flow diverting apparatus is composed of a mesh material having a pore size in the range of 8 to 70 μm.

27. The flow diverting apparatus according to claim 18, wherein the flow diverting apparatus is composed of 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. The flow diverting apparatus according to claim 18, wherein a portion of the flow diverting apparatus tapers from a first cross section to a second cross section at an angle in the range of 10 to 90 degrees, and the angle is measured from an axis extending along the length of the flow diverting apparatus.

29. A stent frame body, Stent frame extension, A flow diverting apparatus comprising, The stent frame body is The entrance opening, The exit opening and A cavity extending from the inlet opening to the outlet opening, wherein the stent frame body is configured to allow fluid to flow through the cavity from the inlet opening to the outlet opening, It is equipped with, The stent frame body includes 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 the first position of the second portion, thereby forming a recessed portion having a plurality of pores. The first position of the second portion is located between the one end and the outlet opening or on the outlet opening. The pores in the recessed portion are configured to filter out white blood cells based on their size and / or shape while allowing red blood cells to pass through. The cross-sectional area of ​​the inlet opening is larger than the cross-sectional area of ​​the outlet opening. The stent frame extension protrudes from at least a portion of the side surface of the stent frame body and protrudes away from the entrance opening. In a flow diverting device, the stent frame extension is configured to be positioned between at least a portion of the recessed area and the blood vessel wall, thereby preventing the migration of blood vessel wall cells onto the recessed area. The flow diverting device is A method for treating and / or preventing lymphedema or chronic inflammation in a patient, The procedure includes the step of implanting the flow diverting device in the patient's subrenal aorta so that the flow diverting device is positioned at the upstream openings of the left and right common iliac arteries, The implanted flow diverting device is positioned and configured such that a larger proportion of blood or a larger proportion of pro-inflammatory components in the patient's blood is directed from the subrenal aorta to the other opening of the right or left common iliac artery, compared to the opening of one of the right or left common iliac arteries. The method of having one of the right common iliac artery or the left common iliac artery reach the lower limb of the patient suffering from lymphedema or chronic inflammation. A flow diverting device used for this purpose.

30. The flow diverting device according to claim 29, wherein the flow diverting device is implanted after lymphovenous bypass surgery of the lower limb affected by lymphedema.

31. The flow diverting device to be implanted is positioned in the subrenal aorta such that the tapered portion of the flow diverting device is located upstream of the patient's aortic bifurcation by a distance of approximately 0.5 cm to approximately 7.0 cm, according to claim 29.

32. The flow diverting device according to 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 by 10 to 90 degrees with respect to the anterior-posterior midline of the inferior renal aorta.

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