Porous membranes for vascular occlusion

Abstract

A vascular implant for vascular occlusion may define an enclosure or accommodation space. A vascular implant may include a porous membrane configured to adsorb and / or retain blood cells to facilitate blood clotting and / or granulation in the porous membrane during a blood filling period.

Description

Related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 421,722, filed on November 2, 2022, entitled “Forming a Vascular Occluder in a Blood Vessel,” and U.S. Provisional Application No. 63 / 532,972, filed on August 16, 2023, entitled “Blood-Retaining Vascular Occluder.” Technical Field

[0002] The present disclosure relates to vascular implants and methods for implanting vascular implants in blood vessels, and more particularly, but not exclusively, to systems, devices, and methods for forming vascular occluders in blood vessels. Background Art

[0003] Some medical procedures, such as embolization, involve occluding a blood vessel, such as to reduce pressure on an aneurysm, restrict bleeding, or reduce blood supply to a tumor or growth in the body.

[0004] Vascular occlusive coils can be used to occlude spaces in a patient's vascular system using intravascular spiral coiling and embolization techniques. These coils have a tiny spiral body, often made of soft metal, and are sized and configured for delivery and implantation using a catheter. One or more coils are delivered to a single site, then manually crimped and squeezed together at the target implantation site until a plug-like structure is formed, which is used to harvest clotted blood adhering to its outer surface, gradually causing local occlusion and embolization.

[0005] Vascular plugs are different types of mechanical embolic devices that are typically used to occlude a target portion of a vein or artery with a relatively low profile delivery and can be released in a controlled manner. One type of vascular plug comprises a balloon-like expandable device that is intended to locally block and seal the vascular lumen immediately upon expansion, for preventing blood flow through the vascular lumen. Another type of vascular plug comprises an expandable mesh (e.g., braided or woven) device that relies on natural blood clotting that can gradually develop over time on the foreign surface until a localized embolism is potentially formed. While the first plug type is more prone to problems with accidental implant displacement and gradual physical and / or functional degradation, the second plug type requires a considerable amount of time until an effective blockage is formed and is associated with a phenomenon of recanalization whereby openings are formed in the thrombus over time.

[0006] There is a need for improved vascular occlusive devices for achieving improved results, such as one or more of: reducing the time from deployment to occlusion; reducing the likelihood of inadvertent implant migration; preventing or delaying physical and / or functional degradation; and preventing or delaying recanalization.

[0007] It should be noted that this background technology is not intended to help determine the scope of the claimed subject matter, nor should it be considered to limit the claimed subject matter to any or all implementations that solve the shortcomings or problems presented above. The discussion of any technology, document, or reference in this background technology section should not be construed as an admission that the described material is prior art with respect to any of the subject matter claimed herein. Summary of the Invention

[0008] The present disclosure relates to vascular implants and methods for implanting vascular implants in blood vessels, and more particularly, but not exclusively, to systems, devices, and methods for forming vascular occluders in blood vessels.

[0009] In certain embodiments, a vascular occluder is provided that may include: (a) a vascular implant configured to define an enclosure configured to accommodate a volume of blood, the enclosure configured to radially expand for engaging an inner wall surface of a blood vessel; and (b) a porous membrane disposed at least at a proximal end and / or a distal end of the container, configured to cover most or all of the luminal cross-sectional area of the blood vessel when the container engages the inner wall surface of the blood vessel.

[0010] In some embodiments, the porous membrane is configured to allow blood to flow through the porous membrane into the container space during a predetermined blood fill period after the container radially expands and engages the inner wall surface of the blood vessel, and then prevent blood from flowing from the container space through the porous membrane, thereby retaining the volume of blood in the container space as the volume of blood coagulates and / or granulates.

[0011] In some embodiments, the vascular occluder is configured to induce granulation tissue formation by retaining the volume of blood in the vessel space.

[0012] In some embodiments, the vaso-occluder is configured to induce blood clotting in and / or on the porous membrane during a blood-filled period.

[0013] In some embodiments, the porous membrane is configured to adsorb and / or retain blood cells associated with initiating or contributing to blood coagulation and / or granulation that pass through the porous membrane during a blood fill period.

[0014] In some embodiments, the porous membrane is configured to adsorb coagulation proteins, such as fibrinogen and albumin.

[0015] In some embodiments, the porous membrane is configured to promote adhesion, activation, and aggregation of platelets.

[0016] In some embodiments, the porous membrane is constructed as a thin, fluid-permeable, three-dimensional network structure.

[0017] In some embodiments, the porous membrane comprises a porous, fluid-permeable, random or aligned three-dimensional network of polymeric microfibers and / or nanofibers.

[0018] In some embodiments, the three-dimensional network of polymeric microfibers and / or nanofibers is constructed with an average fiber diameter of less than about 5 microns, optionally less than about 2 microns, and / or an average pore size of less than about 50 microns and / or in the range of about 1 micron to about 50 microns.

[0019] In some embodiments, the porous membrane is formed via electrospinning.

[0020] In some embodiments, the porous membrane is disposed at both the proximal and distal ends of the container.

[0021] In some embodiments, most or all of the surface of the container is attached to, coated with, or impregnated with the porous membrane.

[0022] In some embodiments, the vascular occluder further comprises a vessel expansion and / or anchoring element configured to expand the vessel beyond the local inner diameter of the vessel and / or maintain the vessel radially pressed against the inner wall surface of the vessel for anchoring the vessel thereto.

[0023] In some embodiments, the vessel expansion and / or anchoring element is configured to selectively fill the vessel space for effecting radial expansion and / or anchoring of the vessel.

[0024] In some embodiments, the vessel expansion and / or anchoring element comprises a flexible member having an elastically stretchable three-dimensional framework structure.

[0025] In some embodiments, the container comprises a flexible tubular wall, which is optionally mesh, braided, woven, or perforated.

[0026] In some embodiments, the flexible tubular wall is formed of a metallic material, such as a Ni-Ti alloy, optionally in the form of a braided wire.

[0027] In some embodiments, the predetermined blood fill period is less than about 90 seconds, optionally particularly less than about 60 seconds, optionally particularly less than about 30 seconds, optionally particularly less than about 10 seconds, or optionally particularly less than about 5 seconds.

[0028] In some embodiments, the predetermined blood fill period is less than a minimum achievable result in a local activated clotting time (ACT) type clotting test.

[0029] In some embodiments, the vessel space is not partitioned so as to promote the formation of a single coagulation or granulation mass sized to fill most or all of the vessel space for occluding the vessel.

[0030] In certain embodiments, a method for occluding a blood vessel is provided. The method may include positioning a vascular occluder in the blood vessel, expanding the device so that the device engages the wall of the blood vessel, allowing blood to flow through the porous membrane to fill the vessel space until the porous membrane is at least 75% blocked by blood cells and / or clotted blood, preventing blood from flowing through the porous membrane, thereby retaining a volume of blood in the vessel space, and retaining the volume of blood in the vessel space while the volume of blood coagulates and / or granulates into a single clot or granulation mass, the single clot or granulation mass being sized to fill most or all of the vessel space to occlude the blood vessel.

[0031] In some embodiments, the porous membrane is configured to completely occlude within a predetermined blood fill period of less than about 90 seconds.

[0032] In some embodiments, the expansion is configured in size and / or magnitude sufficient to cause local inflammation, such as via stretching the vessel wall and / or preventing oxygenation thereof.

[0033] In some embodiments, expanding includes filling the container space with a three-dimensional framework structure.

[0034] It is understood that from this disclosure, various configurations of the subject technology will become apparent to those skilled in the art, wherein the various configurations of the subject technology are shown and described by way of illustration. As will be appreciated, the subject technology can have other and different configurations, and its several details can be modified in various other aspects, all without departing from the scope of the subject technology. Therefore, the summary of the invention, the drawings, and the detailed description are to be regarded as illustrative in nature, and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Various embodiments are discussed in detail in conjunction with the accompanying drawings described below, with emphasis placed on highlighting advantageous features. These embodiments are for illustrative purposes only, and any scale that may be shown therein does not limit the scope of the disclosed technology. These figures include the following figures, in which like numbers indicate like parts.

[0036] 1A-1D schematically illustrate exemplary scenarios showing steps in a method for forming a vaso-occlusive device in a blood vessel using a vaso-occlusive coil, according to some embodiments;

[0037] Figures 2A-2B schematically illustrates cross-sectional views of an exemplary vascular occluder before and after actuation, according to some embodiments;

[0038] Figures 3A-3F Schematically illustrating a representation for converting Figures 2A-2B An exemplary embodiment of the steps in a method of implanting a second exemplary vascular occlusive device in a blood vessel;

[0039] Figures 4A-4B schematically illustrates cross-sectional views of a third exemplary vaso-occlusive device before and after actuation, according to some embodiments; and

[0040] Figures 5A-5D Schematic diagram showing a method for extracting blood from a blood vessel according to some embodiments Figures 4A-4B

[0014] An exemplary scenario of the steps in a third exemplary vascular occluder method. DETAILED DESCRIPTION

[0041] The following description and examples illustrate some exemplary implementations, embodiments and arrangements of the disclosed invention in detail. Those skilled in the art will recognize that there are many variations and modifications of the present invention that are encompassed by the scope of the present invention. Therefore, the description of a certain exemplary embodiment should not be considered as limiting the scope of the present invention.

[0042] Certain embodiments relate to vascular implants and methods of implanting vascular implants in blood vessels, and more particularly, but not exclusively, to systems, devices, and methods for forming a vascular occlusive device in a blood vessel. In some embodiments, a system for forming a vascular occlusive device is provided, comprising a vascular occlusive coil and a device for deploying and shaping the coil within the lumen of a target blood vessel. In some embodiments, such a device may comprise a core member configured to shape the vascular occlusive coil from within an interior passageway or space enclosed by the helical body of the vascular occlusive coil (e.g., to impose the shape of the vascular occlusive coil) and / or a shaped or formable container configured to shape the vascular occlusive coil from within its surrounding space formed by the container (e.g., to impose the shape of the vascular occlusive coil), into which the coil is inserted.

[0043] 1A-1D schematically illustrate exemplary scenarios representing steps in a method for forming a vaso-occlusive device 100a in a target blood vessel (TBV) using a vaso-occlusive coil 10. A system 200 for forming the vaso-occlusive device 100a includes the coil 10, a container 12, a catheter 13 (e.g., a single-lumen catheter, optionally a microcatheter), and a coil dispenser 14.

[0044] FIG1A(I) shows a first scenario in which a catheter 13 is positioned about its distal portion 15 in the lumen of a target blood vessel (TBV) (for ease of description, the catheter 13 is shown in a side view, while the blood vessel TBV is shown in a side cross-sectional view). FIG1A(II) shows the catheter distal portion 15 in an enlarged side cross-sectional view. The container 12 is positioned and / or can be delivered in a lumen 16 of the catheter 13 (optionally, particularly in the distal portion 15) in a crimped or radially compressed configuration. The container 12 is pushable and optionally releasably connected to an elongated pusher 17 (such as via a threaded connection or a snap lock), which optionally extends along the lumen 16 so that its proximal end can be manipulated by a user via the proximal portion 18 of the catheter 13.

[0045] FIG1B(I) shows a second scenario, in which container 12 is pushed into the lumen of the target vessel TBV via distal portion 15 (for ease of illustration, container 12 and catheter 13 are shown in side view, while the vessel TBV is shown in a side cross-sectional view). FIG1B(II) shows, in an enlarged side cross-sectional view, container 12 connected to pusher 17, exposed via distal portion 15. Container 12 is allowed to elastically expand, creating a containment space, optionally until its sidewall 19 engages the inner wall surface of the target vessel TBV. In some embodiments, a user may select a container 12 of a specific size and / or shape based on considerations of how the container 12 fits within the target vessel TBV. Container 12 may be formed into a tubular or other shaped structure via one or more wires, optionally metal wires (e.g., Ni-Ti or Co-Cr alloy wires) (the one or more wires may be braided or otherwise arranged and connected as known in the art), but may also be made of other materials, optionally non-stretchable wires, such as nylon, polyester, cotton, polypropylene, or aramid. As will be described further below, the container 12 is advantageously fully or partially covered or impregnated with another material, optionally in the form of a coating or membrane, however, the sidewall 19 is configured to be liquid permeable for allowing or promoting blood flow from the target blood vessel TBV therethrough into the container 12. Optionally, additionally, or alternatively, one or more openings on or beside the sidewall 19 are configured to allow blood to flow into the container 12 and / or allow blood to flow out of the container 12. In some embodiments, the container 12 is configured such that it is not effectively inflatable by gas and / or liquid, and / or it is configured to self-expand while allowing fluid to flow therein.

[0046] FIG1C(I) shows a third scenario, in which the vaso-occlusive coil 10 is fully dispensed within the container 12 (for ease of illustration, the container 12 and catheter 13 are shown in side view, while the blood vessel TBV is shown in a side cross-sectional view). FIG1C(II) shows, in an enlarged side cross-sectional view, the container 12 connected to the pusher 17, exposed via the distal portion 15. The vaso-occlusive coil 10 is gradually pushed through the coil dispenser 14 to form a three-dimensional, tertiary structure (which may be cocoon-like), designated S3 in FIG1C(II). Its arcuate segments engage the shaped covering of the container 12, forcing it to deform. The coil 10 can be advanced using or by the pusher 17, optionally using other means. In some embodiments, once fully deployed within the container 12, the vaso-occlusive coil 10 forces the container 12 to expand laterally and / or compress axially, thereby increasing the anchoring force or pressure against the wall of the target blood vessel TBV. 1D (I) and (II) similarly illustrate system 200 after vaso-occluder 100a (formed in a tertiary configuration by container 12 filled with coils 10) is disconnected from pusher 17 and after catheter 13 is removed from blood vessel TBV, leaving the vaso-occluder in place.

[0047] Figures 2A-2B Another exemplary vascular occluder 100b is schematically shown in cross-sectional views before and after actuation. The vascular occluder 100b includes a container 31. The container may be substantially as described above with reference to Figures 1A-1D and may be implanted using the same or similar methods as described above, with a porous (in some embodiments, temporarily porous, as described in detail below) membrane 32 disposed over part or all of the outer surface of the container 31. In some embodiments, the membrane 32 may be disposed only over the regions of the proximal end 33 and distal end 34 of the container 31. The container 31 encloses a container space 25 configured to hold a volume of blood. The container 31 is capable of radially expanding for engaging the inner wall surface of a blood vessel. Similar to the embodiments described above, the container 31 includes a sidewall that is optionally meshed, braided, woven, or perforated and is optionally formed of a metallic material such as a Ni-Ti alloy.

[0048] The porous membrane 32 is configured to cover most or all of the luminal cross-sectional area of the vessel when the container 31 engages the inner surface of the vessel wall. The porous membrane 32 is configured to allow blood to flow through it into the container space 25 during a predetermined blood-filling period after the container has radially expanded, and then to prevent blood from flowing through it from the container space 25, thereby retaining the volume of blood in the container space 25 as it coagulates and / or granulates. As shown, the container space 25 may be undivided to promote the formation of a single coagulation or granulation mass sized to fill most or all of its volume. The predetermined blood-filling period may optionally be less than approximately 90 seconds, optionally, particularly less than approximately 60 seconds, optionally, particularly less than approximately 30 seconds, optionally, particularly less than approximately 10 seconds, or optionally, particularly less than approximately 5 seconds. Additionally or alternatively, the predetermined blood-filling period may be less than the minimum achievable result in a local activated clotting time (ACT)-type coagulation test, depending on the patient's specific response to anticoagulant use.

[0049] In some embodiments, the vascular occluder 100b is configured to induce blood coagulation in and / or on the porous membrane 32 during the blood fill period, and / or to induce granulation tissue formation by the volume of blood retained in the container space 25 after the blood fill period. In some embodiments, the porous membrane 32 is configured to adsorb and / or retain blood cells associated with causing or contributing to blood coagulation and / or granulation, including but not limited to coagulation proteins such as fibrinogen and albumin, that pass through it during the blood fill period. The porous membrane 32 is optionally configured to promote the adhesion, activation, and aggregation of platelets.

[0050] In some embodiments, the porous membrane 32 is constructed as a thin fluid-permeable three-dimensional network structure, which optionally includes a porous fluid-permeable random or aligned three-dimensional network of polymer microfibers and / or nanofibers. The three-dimensional network of polymer microfibers and / or nanofibers is constructed with an average fiber diameter of less than about 5 microns, optionally less than about 2 microns, and / or an average pore size of less than about 50 microns and / or in the range of about 1 micron to about 50 microns. In some embodiments, the porous membrane 32 is formed by electrospinning ultrafine fibers above a rotating mandrel covered with a container 31, so that most or all of the surface of the container 31 is connected to the porous membrane 32, coated with or impregnated with the porous membrane 32.

[0051] In some embodiments, the porous membrane 32 is constructed as a porous electrospun microfiber and / or nanofiber membrane, which is composed of a three-dimensional network of polymer microfibers and / or nanofibers made by electrospinning. In some such embodiments, the porous membrane 32 has a porous and fluid-permeable sponge-like structure characterized by high porosity, large specific surface area, small pore size, good channel connectivity and easy functional modification. In some embodiments, the porous membrane is constructed as a 3D electrospun fiber sponge formed by 3D reconstruction of the electrospun fiber membrane. In some such embodiments, the fiber membrane 32 is made via electrospinning, homogenization, shaping and thermal cross-linking, and exhibits high porosity, water absorption and compression resilience.

[0052] The container 31 can be configured to self-expand to a certain state under relatively low resistance (such as within the lumen of a blood vessel), yet without requiring significant strength to locally expand or radially stretch the vessel wall. The vascular occluder 100b can also include a container expansion and / or anchoring element 36 configured to expand the container 31 to exceed the local inner diameter of the host vessel and / or maintain the container radially pressed against the inner wall surface of the vessel for anchoring the container 31 to the inner wall surface. The container expansion and / or anchoring element 36 can include a flexible member having an elastically stretchable three-dimensional framework structure configured to selectively fill the container space 25 to achieve radial expansion and / or anchoring of the container 31. In some embodiments, the container expansion and / or anchoring element 36 can include an occlusive coil according to the various occlusive coil embodiments described herein.

[0053] Figures 3A to 3F Schematically showing the Figure 2A and 2B 100b in a blood vessel BV. The distal end of the delivery device 37 is first introduced into a selected position within the blood vessel BV, and the vascular occluder 100b can then be withdrawn from the delivery device 37, such as by holding the vascular occluder 100b in place (e.g., using a pusher) while pulling the delivery device 37 proximally until the vascular occluder 100b is exposed in the blood vessel BV. Once the delivery device 37 is attached to the vascular occluder 100b, further positioning can be performed as needed. Figure 3A The vaso-occluder 100c is shown partially withdrawn from the distal end of the delivery device 37. At this stage, blood may begin to permeate through the porous membrane 32 into the container space 25, however optionally in an insignificant volume. Figure 3B The vaso-occlusive device 100b is shown fully exposed and withdrawn from the delivery device 37, allowing it to self-expand within the lumen of the blood vessel BV to a certain (but not maximum) extent. At this stage, more blood has accumulated in the vessel space 25 and can flow through the porous membrane 32 into and from the vessel space 25.

[0054] like Figure 3C , the container expansion and / or anchoring element 36 is then introduced into the container space 25 via a delivery device 37 and through a dedicated opening in the porous membrane 32. The element 36 is delivered in an elastically stretched form and is then allowed to elastically return to its more expanded three-dimensional form in the container space 25, yet it is still constrained from forming a stress-free three-dimensional framework structure at its maximum expansion. Thus, the element 36 applies continuous radial or volumetric pressure to the container 31, thereby forcing it, together with the porous membrane 32, to further expand radially against the vessel wall. In some embodiments, the element 36 is configured to apply sufficient pressure to the vessel wall through the container 31 to cause the vessel wall to expand laterally, and in some particular embodiments, this causes the vessel wall to fully stretch and / or reduce its oxygenation in order to cause or induce local inflammation. In some embodiments, this additional expansion of the container 31 under stress increases the pressure differential, which causes blood to be drawn into the container space 25 via the porous membrane 32 until the container space 25 is substantially or completely filled with blood.

[0055] Figure 3D The deployed vascular occluder 100b is shown in the vessel BV after a blood fill period (optionally within a few seconds to about 90 seconds). As shown, after the blood fill period, the fiber membrane 32 may be substantially or completely blocked, so that blood is prevented from flowing therethrough into and out of the vessel space 25. This results in blocking blood flow in the vessel BV and retaining a volume of blood RBV in the vessel space 25, which undergoes a natural coagulation and / or granulation process. Figure 3E As shown in FIG, delivery device 37 may be disconnected from vaso-occlusive device 100b and removed from blood vessel BV, and this may be performed before or after fibrous membrane 32 is substantially or completely occluded.

[0056] Figure 3F The vaso-occlusive device 100b is shown after natural coagulation and / or granulation of the retained blood volume RBV, several days, weeks, or months after implantation of the vaso-occlusive device 100b in the blood vessel BV. In some embodiments, the vaso-occlusive device 100b is configured to allow, induce, or promote the natural formation of a single mass MS of granulation tissue and / or thrombus, which fills most or all of the vessel space 25, occluding the vessel BV. In some embodiments, inducing inflammation in the vessel BV (such as by stretching the vessel wall and / or preventing oxygenation using element 26) specifically induces, induces, or promotes the formation of granulation tissue throughout the volume of the vessel space 25.

[0057] Figures 4A-4BA third exemplary vascular occluder 100c is schematically shown in cross-sectional views before and after actuation. Vascular occluder 100c may be similar or identical to vascular occluder 100b in most or all structural and / or functional embodiments, except that vascular occluder 100c further includes one or more blood extraction openings 39 in porous membrane 32. Similar to vascular occluder 100b, vascular occluder 100c includes a container 31, a porous membrane 32, a proximal end 33, a distal end 34, a container space 25, and a container expansion and / or anchoring element 36, and may optionally be releasably connected to a delivery device 37. The blood extraction openings 39 are configured to allow blood to drain from the container space 25 into the host vessel when container 31 is pressurized (such as by drawing it with an external force). This embodiment may be advantageous, for example, when a user wishes to remove or reposition vascular occluder 100c after initial deployment and substantial occlusion of porous membrane 22. In some embodiments, the blood extraction opening 39 is provided at a lateral portion configured to engage the vessel wall when the container 31 is expanded using the element 36, such that when the container 31 is pressed against the vessel wall, the opening 39 is covered by the vessel wall. In some embodiments, the blood extraction opening 39 is configured as a through-hole, a cutout, a diaphragm valve, or a pressure relief valve. In some embodiments, the diameter of the blood extraction opening 39 is approximately 1 mm or less, and optionally 0.5 mm or less.

[0058] Figures 5A-5D An exemplary scenario representing steps in a method for extracting a vaso-occlusive device 100c from a blood vessel BV is schematically shown. Figure 5A 1 shows a possible exemplary situation in which the vascular occluder 100d has been deployed in the blood vessel BV, the vessel space 25 is substantially or completely filled with the retained blood volume RBV, and the fiber membrane 32 is substantially or completely blocked (e.g., blocked by more than about 75%, optionally blocked by more than 90%) with coagulated blood (e.g., covering the fiber membrane and / or accumulated across its thickness, such as included within its pores) so as to retain the already existing blood volume RBV in the vessel space 25. The retained blood volume RBV cannot escape from the vessel space 25 because the vessel 31 is pressed against the wall BVW of the blood vessel BV and the blood extraction opening 39 is blocked or obstructed by the blood vessel wall BVW.

[0059] Figure 5B Indicates Figure 5AFollowing the previous situation shown in FIG, a possible situation after deciding to remove or reposition the vascular occluder 100c is presented, in which the first step would be to remove element 36 so as not to occupy the vessel space 25. Element 36 acts to expand the vessel 31 against the vessel wall BVW. This may cause an immediate initial contraction of the vessel 31 and / or the exposure of the blood extraction opening 39. Depending on one or more variables, such as the effective opening area of the blood extraction opening 39, the internal pressure within the vessel space 25, and / or the viscosity of the retained blood volume RBV within the vessel space 25, blood may already begin to seep from the vessel space 25 through the opening 39 at this stage.

[0060] When the vascular occluder 100c is pulled back into the lumen of the delivery device 37 (or other device or instrument), a substantial amount of blood can be discharged from the container space 25 via the opening 39, as shown in FIG. Figure 5C This process causes the vaso-occlusive device 100c to be withdrawn and forces the retained blood volume RBV to be discharged from the container space 25 into the blood vessel BV through the blood withdrawal opening 39 due to the increased internal pressure in the container space 25, such as from the tensile force applied to the container 31. Once the vaso-occlusive device is fully withdrawn into the delivery device 37, substantial or complete emptying of the retained blood RBV from the container space 25 can be achieved, such as Figure 5D Suggested in. General principles of interpretation for this disclosure

[0061] The various aspects of the novel systems, devices, and methods are described more fully below with reference to the accompanying drawings. However, the disclosure of the teachings can be embodied in many different forms and should not be interpreted as being limited to any specific structure or function presented throughout the present disclosure. On the contrary, these aspects are provided so that the present disclosure will be comprehensive and complete, and the scope of the present disclosure will be fully conveyed to those skilled in the art. Based on the teachings herein, those skilled in the art should recognize that the scope of the present disclosure is intended to cover any aspect of the novel systems, devices, and methods disclosed herein, whether implemented independently or in combination with any other aspects of the present disclosure. For example, any one or more of the aspects set forth herein can be used to implement a system or device, or any one or more of the aspects set forth herein can be used to practice a method. In addition, the scope of the present disclosure is intended to cover such systems, devices, or methods that are practiced using other structures, functions, or structures and functions in addition to or in addition to the various aspects of the disclosure set forth herein. It should be understood that any aspect disclosed herein may be set forth in one or more elements of the claims. Although some benefits and advantages of preferred aspects are mentioned, the scope of the present disclosure is not intended to be limited to particular benefits, uses, or objectives. The detailed description and drawings are merely illustrative of the present disclosure rather than limiting, the scope of the present disclosure being defined by the appended claims and their equivalents.

[0062] Regarding the use of plural and singular terms herein, those skilled in the art may convert from plural to singular and / or from singular to plural as appropriate to the context and / or application. For clarity, various singular / plural permutations may be explicitly set forth herein.

[0063] When describing absolute values of characteristics or attributes of things or actions described herein, the terms "substantial," "essentially," "essentially," "approximately," and / or other terms or phrases of degree may be used without specifically reciting numerical ranges. When applied to characteristics or attributes of things or actions described herein, these terms refer to ranges of characteristics or attributes that are consistent with providing the desired function associated with the characteristic or attribute.

[0064] In those cases where a single numerical value is given for a property or attribute, that single numerical value is intended to be interpreted as encompassing at least the deviation of that value within one significant figure of the given numerical value.

[0065] If a value or range of values is provided to define a characteristic or property of a thing or behavior described herein, the specific method of measuring the characteristic or property may also be defined herein, regardless of whether the value or range is modified by a degree term. Where a specific method of measuring a characteristic or property is not defined herein, and there are different generally accepted methods of measuring the characteristic or property, the method of measurement should be interpreted as the method of measurement that a person skilled in the art would most likely use given the description and context of the characteristic or property. In another case where there are more than one method of measurement that a person skilled in the art might also use to measure the characteristic or property, the value or range of values should be interpreted as being satisfied regardless of which method of measurement is chosen.

[0066] Those skilled in the art will understand that the terms used herein, and especially in the appended claims (e.g., the bodies of the appended claims), are intended to be “open” terms unless expressly indicated otherwise (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “comprising” should be interpreted as “including but not limited to,” etc.).

[0067] Those skilled in the art will further understand that if a specific number of an introduced claim recitation is intended, such intent will be expressly recited in the claim, and in the absence of such recitation, no such intent is present. For example, as an aid to understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite article "a" or "an" limits any particular claim including such introduced claim recitation to embodiments including only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article, such as "a" or "an" (e.g., "a" and / or "an" should typically be interpreted as meaning "at least one" or "one or more"); the same applies to the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is expressly recited, those skilled in the art will recognize that such recitation should typically be interpreted as meaning at least the number of recitations (e.g., the mere recitation of "two recitations" without other modifiers typically means at least two recitations, or two or more recitations).

[0068] In those cases where a convention similar to "at least one of A, B, and C" is used, such construction will include systems having only A, only B, only C, having A and B together without C, having A and C together without B, having B and C together without A, and having A, B, and C together. Those skilled in the art will further understand that, in practice, any transitional words and / or phrases indicating two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one, either, or both of the terms. For example, the phrase "A or B" will be understood to include A without B, B without A, and A and B together.

[0069] Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the disclosure. Therefore, the disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the claims, principles, and novel features disclosed herein. The word "exemplary" is used exclusively herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or superior to other implementations.

[0070] Certain features described in this specification in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations individually or in any suitable subcombination. Furthermore, while features may be described above as functioning in certain combinations and even initially claimed as such, in some cases one or more features from a claimed combination may be deleted from the combination, and a claimed combination may involve subcombinations or variations of subcombinations.

[0071] The methods disclosed herein include one or more steps or actions for implementing the described methods. Method steps and / or actions may be interchangeable with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

[0072] As used herein, each of the following terms written in singular grammatical form: "a," "an," and "the" means "at least one" or "one or more." The use of the phrase "one or more" herein does not change the intended meaning of "a," "an," or "the." Therefore, as used herein, the terms "a," "an," and "the" may also refer to and encompass multiple stated entities or objects, unless otherwise expressly limited or stated herein, or unless the context clearly dictates otherwise. For example, as used herein, the phrases "unit," "device," "component," "mechanism," "member," "element," and "step or procedure" may also refer to and encompass multiple units, multiple devices, multiple components, multiple mechanisms, multiple members, multiple elements, and multiple steps or procedures, respectively.

[0073] As used herein, each of the following terms: "comprises," "comprising," "having," "having," "containing," and "covering," and their linguistic / grammatical variations, derivatives, and / or inflections, means "including but not limited to," and will be considered to specify the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude the addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or combinations thereof. Each of these terms is considered equivalent in meaning to the phrase "consisting essentially of."

[0074] As used herein, the term "method" refers to steps, procedures, ways, means and / or techniques for completing a given task, including but not limited to those steps, procedures, ways, means and / or techniques that are known to practitioners in the relevant(s) fields of the disclosed invention or that are readily developed by such practitioners from known steps, procedures, ways, means and / or techniques.

[0075] Throughout this disclosure, the numerical value of a parameter, feature, characteristic, object or size can be stated or described according to a numerical range format. As used herein, such numerical range format illustrates the implementation of some exemplary embodiments of the present invention, and does not so stubbornly limit the scope of exemplary embodiments of the present invention. Therefore, the numerical range stated or described also refers to and encompasses all possible subranges and single numerical values (wherein numerical values can be expressed as whole numbers, integers or fractions) within the numerical range stated or described. For example, the numerical range "1 to 6" stated or described also refers to and encompasses all possible subranges, such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc., and single numerical values within the numerical range stated or described, such as "1", "1.3", "2", "2.8", "3", "3.5", "4", "4.6", "5", "5.2" and "6". Regardless of the numerical width, scope or size of the numerical range stated or described, this applies.

[0076] In addition, for the purpose of stating or describing a numerical range, the phrase "within a range between about a first value and about a second value" is considered equivalent to the phrase "within a range from about a first value to about a second value" and has the same meaning as it, and therefore, the two equivalent phrases can be used interchangeably. For example, for the purpose of stating or describing a numerical range of room temperature, the phrase "room temperature refers to a temperature in the range between about 20°C and about 25°C" is considered equivalent to the phrase "room temperature refers to a temperature in the range from about 20°C to about 25°C" and has the same meaning as it.

[0077] As used herein, the term "about" when applied to numerical values means ± 10% of the stated numerical value.

[0078] It will be fully understood that certain aspects, features, and characteristics of the invention that, for clarity, are illustratively described and presented in the context of multiple separate embodiments or formats may also be illustratively described and presented in the context of a single embodiment or format in any suitable combination or subcombination. Conversely, various aspects, features, and characteristics of the invention that are illustratively described and presented in the context of a single embodiment or format in combination or subcombination may also be illustratively described and presented in the context of multiple separate embodiments or formats.

[0079] Although the present invention has been illustratively described and presented through specific exemplary embodiments and examples thereof, it is apparent that many alternatives, modifications and / or variations thereof will be apparent to those skilled in the art. It is therefore intended that all such alternatives, modifications and / or variations fall within the spirit of and are encompassed by the broad scope of the appended claims.

Claims

1. A vascular occluder, comprising: a vascular implant configured to create an enclosure when engaged with an inner wall surface of a blood vessel, wherein the enclosure is configured to contain a volume of blood, wherein the vascular implant is radially expandable for engaging the inner wall surface of the blood vessel; and A porous membrane is disposed on part or all of the vascular implant and is configured to cover most or all of the luminal cross-sectional area of the blood vessel when the vascular implant is engaged with the inner wall surface of the blood vessel.

2. The vascular occlusive device according to claim 1, wherein: The porous membrane is configured to allow blood to flow through the porous membrane into the enclosed space during a predetermined blood-filling period after the vascular implant radially expands and engages the inner wall surface of the blood vessel, and then prevent blood from flowing from the enclosed space through the porous membrane, thereby retaining the volume of blood in the enclosed space as the volume of blood coagulates and / or granulates.

3. The vascular occluder according to any one of claims 1 or 2, configured to induce granulation tissue formation by retaining the volume of blood in the enclosed space.

4. The vascular occluder according to any one of claims 1 or 2, configured to induce blood coagulation in and / or on the porous membrane during the blood filling period.

5. The vascular occlusive device according to any one of claims 1 or 2, wherein: The porous membrane is configured to adsorb and / or retain blood cells associated with causing or contributing to blood coagulation and / or granulation that pass through the porous membrane during the blood filling period.

6. The vascular occlusive device according to any one of claims 1 or 2, wherein: The porous membrane is configured to adsorb coagulation proteins, such as fibrinogen and albumin.

7. The vascular occlusive device according to any one of claims 1 or 2, wherein: The porous membrane is configured to promote platelet adhesion, activation, and aggregation.

8. The vascular occlusive device according to any one of claims 1 or 2, wherein: The porous membrane is constructed as a thin, fluid-permeable, three-dimensional network structure.

9. The vascular occlusive device according to any one of claims 1 or 2, wherein: The porous membrane comprises a porous, fluid-permeable, random or aligned three-dimensional network of polymeric microfibers and / or nanofibers.

10. The vascular occlusive device according to claim 9, wherein: The three-dimensional network of polymeric microfibers and / or nanofibers is constructed with an average fiber diameter of less than about 5 microns, optionally less than about 2 microns, and / or an average pore size of less than about 50 microns and / or in the range of about 1 micron to about 50 microns.

11. The vascular occlusive device according to claim 10, wherein: The porous membrane is formed via electrospinning.

12. The vascular occlusive device according to any one of claims 1 or 2, wherein: The porous membrane is disposed at both the proximal end and the distal end of the vascular implant.

13. The vascular occlusive device according to any one of claims 1 or 2, wherein: Most or all of the surface of the vascular implant is connected to, coated with, or impregnated with the porous membrane.

14. The vascular occlusive device according to any one of claims 1 or 2, wherein: The predetermined blood fill period is less than about 90 seconds, optionally particularly less than about 60 seconds, optionally particularly less than about 30 seconds, optionally particularly less than about 10 seconds, or optionally particularly less than about 5 seconds.

15. The vascular occlusive device according to any one of claims 1 or 2, wherein: The predetermined blood fill period is less than a minimum achievable result in a local activated clotting time (ACT) type coagulation test.

16. The vascular occlusive device according to any one of claims 1 or 2, wherein: The vascular occluder further comprises a container having an expansion and / or anchoring element configured to expand the container beyond the local inner diameter of the blood vessel and / or to maintain the container radially pressed against the inner wall surface of the blood vessel for anchoring the container thereto.

17. The vascular occlusive device according to claim 16, wherein: The container expansion and / or anchoring element is configured to selectively fill the container space for influencing radial expansion and / or anchoring of the container.

18. The vascular occlusive device according to claim 16, wherein: The vessel expansion and / or anchoring element comprises a flexible component having an elastically stretchable three-dimensional framework structure.

19. The vascular occlusive device according to claim 16, wherein: The vessel expansion and / or anchoring element comprises a vaso-occlusive coil.

20. The vascular occlusive device according to claim 19, wherein The arcuate segments of the vaso-occlusive coil engage the sidewall of the vessel.

21. The vascular occlusive device according to any one of claims 1 or 2, wherein: The vascular implant comprises a container having sidewalls that are optionally mesh, braided, woven, or perforated.

22. The vascular occlusive device according to claim 21, wherein The sidewalls are formed from a metallic material, such as a Ni-Ti alloy, optionally in the form of a braided wire.

23. A method for occluding a blood vessel, the method comprising: positioning the vascular occlusive device according to any one of claims 1 or 2 in a blood vessel; radially expanding the vaso-occlusive device such that the vaso-occlusive device engages a wall of the blood vessel; allowing blood to flow through the porous membrane to fill the enclosed space until the porous membrane is at least 75% blocked by blood cells and / or clotted blood, preventing blood from flowing through the porous membrane, so as to retain a volume of blood in the enclosed space; as well as The volume of blood is held in the enclosed space during coagulation and / or granulation of the volume of blood into a single coagulated or granulated mass sized to fill most or all of the enclosed space for occluding the blood vessel.

24. The method according to claim 23, wherein The porous membrane is configured to completely occlude within the predetermined blood fill period of less than about 90 seconds.

25. The method according to claim 23, wherein The expansion is configured in size and / or magnitude to cause local inflammation, such as via stretching the vessel wall and / or preventing oxygenation thereof.

26. The method according to claim 23, wherein The expanding includes filling the enclosed space with a three-dimensional frame structure.

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