Vascular occlusion coil and obturator formed therefrom

Abstract

A vascular obturator may include a container defining a container space. The container space may receive a vascular occlusion coil. The vascular occlusion coil may have an elastically relaxed configuration comprising a series of arcuate segments arranged in two or more different orientations. A vascular occlusion coil may include a cylindrical helical body having a core member disposed therein. The vascular occlusion coil may transition from a secondary structure to a tertiary structure as the vascular occlusion coil is dispensed into the container space.

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 Occlusive Device in a Blood Vessel.” 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 a different type of mechanical embolic device 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. Some vascular plugs are considered superior to coils in this regard; however, they are significantly more expensive than metal coils and are less suitable for implantation in target implant sites that vary in size and shape.

[0006] In view of these and other shortcomings, there is a need for improved vaso-occlusive coils, and improved systems and methods for deploying and implanting vaso-occlusive coils in body lumens, for achieving improved results in one or more of: reducing the time and / or skill required to deliver, deploy, manipulate, and / or compact the coil into a self-anchoring structure configured to occlude an open body lumen; reducing the total volume and / or total surface area of implanted metal in the patient's body; and a predetermined or adaptive coil-based solution that is independent of local conditions and the shape and size of the landing zone of the target implantation site.

[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 one embodiment, a vaso-occlusive coil has an elastically relaxed configuration comprising a series of arcuate segments arranged in two or more different orientations. The vaso-occlusive coil is configured to elastically deform into a linear configuration for placement in a coil dispensing catheter, and the vaso-occlusive coil is configured to sequentially form the series of arcuate segments in the elastically relaxed configuration as it is ejected from the distal end of the coil dispensing catheter. The vaso-occlusive coil can be used in a variety of procedures and is particularly advantageous for occluding the lumen of a target vessel by dispensing into a container positioned within the target vessel to be occluded.

[0010] In one embodiment, a vaso-occlusive device includes a container including a sidewall, wherein the sidewall defines a container space. A vaso-occlusive coil is located in the container space. Arc segments of the vaso-occlusive coil are positioned and urged against different portions of the sidewall, wherein at least some different arc segments extend along distinct planes having different spatial orientations relative to planes along which other arc segments extend, thereby collectively forming a structure in the container space that is configured to resist compressive forces extending along multiple spatial directions.

[0011] In certain embodiments, a vaso-occlusive device forming system is provided, which may include: (a) a vaso-occlusive coil; (b) a container comprising a fluid-permeable sidewall surrounding a container space, the fluid-permeable sidewall being configured for implantation within a luminal segment of a target vessel; and (c) a coil dispenser configured to release the vaso-occlusive coil into the container space. When the vaso-occlusive coil is released into the container, arcuate segments of the vaso-occlusive coil are sequentially positioned and urged against different portions of the sidewall. In some embodiments, the vaso-occlusive coil may include a cylindrical helical body surrounding an elongated coil channel; and a core member disposed within the cylindrical helical body and configured to force the vaso-occlusive coil into a secondary configuration in which the cylindrical helical body is bent, rotated, and / or twisted into a three-dimensional form.

[0012] In some embodiments, the container is configured to receive the vaso-occlusive coil in the secondary structure into the container space and, when the cylindrical helical body is axially compressed and / or radially expanded from the secondary structure, force the vaso-occlusive coil into a tertiary structure that can be guided out of the sidewall.

[0013] In some embodiments, the vaso-occlusive coil in the tertiary configuration is configured to anchor the vessel to the target vessel within the lumen segment.

[0014] In some embodiments, a flexible sidewall extends between the proximal end and the distal end, enclosing the container space, and the container is capable of radially and / or axially expanding and / or compressing and is configured to engage the inner wall surface of the target blood vessel with the outer surface of the sidewall to prevent blood flow through the sidewall and / or accumulation of clotted blood in the container space.

[0015] In some embodiments, the outer surface of the sidewall is configured with a variable average roughness that can change based on relative radial and / or axial compression of the vessel when implanted in a target vessel.

[0016] In some embodiments, when the container contains a vaso-occlusive coil in a tertiary configuration, the variable average roughness is greater than when the container is empty, for anchoring the container to the target vessel.

[0017] In some embodiments, the sidewall comprises a first material configured with a first roughness and a second material configured with a second roughness greater than the first roughness, wherein, when the container is axially extended and / or radially compressed relative to its elastically relaxed form, the ratio between the cumulative surface areas of the first material and the second material included in the outer surface is greater than when the container is axially compressed and / or radially extended relative to its elastically relaxed form.

[0018] In some embodiments, the sidewalls are mesh, braided, woven, or perforated.

[0019] In some embodiments, the sidewalls are formed of a metallic material, such as a Ni-Ti alloy, optionally in the form of a braided wire.

[0020] In some embodiments, the core member is extendable along the elongate coil channel when in an elastically stretched form, and when released from the elastically stretched form to a more elastically relaxed configuration, the core member is configured to force the vaso-occlusive coil into the secondary structure.

[0021] In some embodiments, the vaso-occlusive coil in the secondary configuration is elastically extendable to a substantially linear stretched form configured for fitting and advancement via pushing within a microcatheter lumen.

[0022] In some embodiments, the core member comprises an elastic wire or cord, optionally of metallic material.

[0023] In some embodiments, the vaso-occlusive coil in the secondary structure forms a plurality of helical segments interconnected with corresponding curved connecting portions.

[0024] In some embodiments, the helical segments are substantially coincident and spaced apart from one another such that they form a tubular framework configured with a substantially constant helical diameter and / or pitch.

[0025] In some embodiments, each of the helical segments is configured to form one of the arcuate segments when fully released in the container space.

[0026] In some embodiments, at least one of the helical segments comprises a single winding or partial winding of the core member between each consecutive pair of corresponding curved link portions.

[0027] In some embodiments, at least one of the curved connecting portions is formed as an arc, optionally having an arc center angle in the range of about 45° to about 225°, optionally particularly greater than about 90°, optionally particularly about 180°.

[0028] In some embodiments, the helical segments of at least one consecutive pair of helical segments are counter-wound relative to each other.

[0029] In some embodiments, at least a portion of the core member is axially slidable within the elongated coil channel.

[0030] In some embodiments, the distal portion of the vaso-occlusive coil extends distally relative to the distal end of the core member.

[0031] In some embodiments, the coil dispenser is configured to allow for gradual, continuous release of the vaso-occlusive coil in the container space while constraining portions of the vaso-occlusive coil in the stretched form before the vaso-occlusive coil is fully released in the container space.

[0032] In some embodiments, a vaso-occlusive device forming system is configured to form a vaso-occlusive device in a target vessel such that when the vaso-occlusive coil is released from a coil dispenser into the container space, the arcuate segments of the vaso-occlusive coil in the secondary configuration are sequentially positioned and urged against different portions of the vessel wall, wherein each of the arcuate segments extends along a distinct plane having a different spatial orientation relative to the planes along which the other arcuate segments extend, thereby collectively forming a cocoon-like internal structure configured to resist compressive forces extending along multiple spatial directions.

[0033] In some embodiments, the coil dispenser is a microcatheter or a distal portion of a microcatheter, or is connected to a microcatheter.

[0034] In some embodiments, the coil dispenser is removably connected or connectable to the container.

[0035] In certain embodiments, a method for forming a vaso-occlusive device in a blood vessel is provided, the method comprising: providing a coil dispenser coupled to a container, the container comprising a flexible tubular wall extending between a proximal end and a distal end and surrounding a container space, the container being capable of radially expanding and / or axially compressing and configured to impede blood flow therethrough and accumulate clotted blood in the container space; positioning the container in a target blood vessel such that the container engages an inner wall surface of the target blood vessel; and gradually releasing a vaso-occlusive coil into the container space, thereby allowing the vaso-occlusive coil to elastically reshape from a substantially linearly stretched form in the filler dispenser to a three-dimensional framework structure in the container.

[0036] In some embodiments, releasing comprises sequentially positioning and urging arcuate segments of the vaso-occlusive coil against different portions of the vessel wall, wherein each of the arcuate segments extends along a distinct plane having a different spatial orientation relative to a plane along which the other arcuate segments extend, until collectively forming an internal structure configured to resist compressive forces extending along multiple spatial directions.

[0037] 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

[0038] 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.

[0039] 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;

[0040] Figures 2A-2E schematically illustrates an exemplary scenario showing steps in an exemplary procedure for forming a vascular occluder in a blood vessel, according to some embodiments;

[0041] Figures 3A-3C schematically illustrates a vaso-occlusive coil, a core member insertable into the vaso-occlusive coil, and the vaso-occlusive coil in a secondary configuration after the core member has been inserted therein, respectively, according to some embodiments;

[0042] Figures 4A-4B A diagram illustrating an exemplary vaso-occlusive coil arranged in an exemplary secondary configuration, in accordance with some embodiments. DETAILED DESCRIPTION

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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. In some embodiments, the container 12 is configured such that it is not effectively inflatable by gases and / or liquids, and / or it is configured to self-expand while allowing fluid to flow therein.

[0048] 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.

[0049] Figures 2A-2EAn exemplary scenario is schematically illustrated representing steps in an exemplary procedure for forming a vaso-occlusive device 100b in a target vessel (TBV) using a vaso-occlusive device forming system 200, which includes a vaso-occlusive coil 10 and a container 16. As described above, the container 16 includes a fluid-permeable, shaped covering 19 surrounding a container space or receiving space 25, which is configured for implantation within a lumen segment of the target vessel (TBV). The container 16 is configured to receive the vaso-occlusive coil 10 in a secondary configuration S2 into the container space 25 and force the vaso-occlusive coil into a tertiary configuration S3, which is configured to anchor the container 16 within the lumen segment to the target vessel. The tertiary configuration S3 can be derived from the shape of the sidewalls when the container 12 is axially compressed and / or radially expanded by the coil 10. The system 200 may further include a coil dispenser 14 configured to allow for gradual and continuous release of the vaso-occlusive coil 10 within the container space 18 while constraining portions of the vaso-occlusive coil 10 in a stretched and / or linear form before the vaso-occlusive coil 10 is fully released within the container space 18. The coil dispenser 14 may be an element or portion of the container 16, or it may be a separate component fixedly or removably connected to the container 16. In some other embodiments, the coil dispenser 14 may be part of a catheter or microcatheter, or may be disposed within a lumen thereof, and / or the coil dispenser 14 may be fixedly or removably connected to the catheter or microcatheter.

[0050] The shaped cover 19 comprises a flexible tubular wall extending between a proximal end 21 and a distal end 22 and enclosing a containment space 25. The container 12 is radially and / or axially expandable and / or compressible and is configured to engage the inner wall surface of the target vessel (TBV) with the outer surface of the sidewall 19 to prevent blood flow through the wall and / or accumulate clotted blood in the containment space 25. In some embodiments, at least the outer surface of the sidewall 19 is configured with a variable average roughness that varies based on relative radial and / or axial compression of the container when implanted in the target vessel (TBV). In some embodiments, when the container 12 contains the vaso-occlusive coil 10 in the tertiary configuration S3 within the containment space 25, the variable average roughness is greater than when the containment space 25 of the container 12 is empty, thereby improving anchoring of the container 12 to the target vessel (TBV).

[0051] For example, sidewall 19 may include a first material (e.g., a metal) configured with a first roughness and a second material (e.g., a polymer) configured with a second roughness greater than the first roughness. In some such embodiments, when container 12 is axially extended and / or radially compressed relative to its elastically relaxed form, the ratio between the cumulative surface area of the first material and the second material included on the outer surface of sidewall 19 is greater than when container 12 is axially compressed and / or radially extended relative to its elastically relaxed form. In some embodiments, sidewall 19 is formed from one or more braided or woven metal wires or filaments covered with an at least partially fluid-permeable polymer film.

[0052] Figure 2A Container 12 is shown after being positioned within a target blood vessel (TBV), with sidewall 19 engaging the inner surface of the vessel (TBV). Container 12 can be inserted into the target blood vessel (TBV) in a compressed configuration and then actively (e.g., selectively by a user) or passively (e.g., elastically) expanded to engage the vessel wall. As shown, sidewall 19 is fluid-permeable and allows blood to flow from the lumen of the vessel (TBV) surrounding container 12 through sidewall 19 into containment space 25 (as schematically illustrated by dashed arrows). Figure 2B A blood-filled container 12 is shown during advancement of a vaso-occlusive coil 10 into the container 12 through a coil dispenser 14 .

[0053] Figure 2C The system 200 is shown when the vaso-occlusive coil 10 is partially released in the container space 18, and Figure 2D System 200 is shown after the coil 10 is largely or completely released from the receiving space 25, and optionally after the coil dispenser 14 has been removed, thereby forming the vaso-occlusive device 100b. As shown, system 200 is configured such that when the vaso-occlusive coil 10 is released from the coil dispenser 14 into the receiving space 25, the arcuate segments 24 of the vaso-occlusive coil 10 in the secondary configuration S2 sequentially position and urge against different portions of the sidewall 19 of the container 12, wherein each of the arcuate segments 24 extends along a distinct plane having a different spatial orientation relative to the plane along which the other arcuate segments extend. In this regard, the arcuate segments 24 collectively form a tertiary configuration S3, which serves as an internal structure (which may be cocoon-like) configured to resist compressive forces extending along multiple spatial directions. The vaso-occlusive coil 10 in the tertiary configuration S3 can radially expand and axially compress the container 12, thereby promoting anchoring within the target vessel TBV. Figure 2EThe vaso-occlusive device 100 is shown after blood captured in the containment space 25 has substantially coagulated, solidified, and / or adhered to the vaso-occlusive coil 10 and the sidewalls 19, thereby substantially (e.g., in some embodiments, desirably completely or substantially completely) blocking the lumen of the target vessel TBV.

[0054] Figures 3A-3C The vascular occlusive coil 50 that can be used in the above-described vascular occlusive device embodiment is schematically shown. In this embodiment, the vascular occlusive coil 50 has a primary structure S1 ( Figure 3A Shown in), core component 51 ( Figure 3B ) and the secondary structure after the core member 51 is inserted therein ( Figure 3C ). The vaso-occlusive coil 50 in its primary structure S1 comprises a cylindrical helical body 52 surrounding an elongated coil channel 53. The coil 50 is optionally flexible and / or stretchable; additionally, or alternatively, the coil 50 may be elastic, tending to form a substantially straight shape when in an elastic, relaxed configuration.

[0055] The core member 51 is readily disposed or insertable within the cylindrical helical body 52 and (when disposed therein) is configured to force the vaso-occlusive coil 50 into the secondary structure S2, wherein the cylindrical helical body 52 is shaped into a three-dimensional form, optionally, in particular, a curved, rotated, and / or twisted form. When in an elastically stretched form, the core member 51 is capable of extending along the elongated coil channel 53. When in the secondary structure S2, the vaso-occlusive coil 50 is elastically extendable to a substantially linear stretched form configured for engagement and advancement via propulsion within a microcatheter lumen (such as catheter 13 above). When released from the elastically stretched form to a more elastically relaxed form, the core member 51 is configured to force the vaso-occlusive coil 50 into the secondary structure S2. The core member 51 may be unattached and / or capable of sliding axially within the elongated coil channel 53. Alternatively, the core member 51 may be attached or attachable to the vaso-occlusive coil 50 in at least one portion. In some embodiments, the proximal portion of the core member 51 is connected to the proximal portion of the vaso-occlusive coil 50, while the distal end of the core member is free to move axially relative to the distal portion 54 of the vaso-occlusive coil 50. Figure 3C As shown in FIG, the distal portion 54 can extend distally relative to the distal end of the core member 51.

[0056] Figures 4A-4B A view of an exemplary vaso-occlusive coil 60 is shown, optionally after being internally formed using a core member (e.g., core member 51) and arranged into an exemplary secondary structure S2. FIG10A shows the vaso-occlusive coil 50 in an elastically relaxed configuration, with an enlarged or "zoomed-in" portion thereof illustrating its primary coil structure. Figure 4BA portion of a segment of coil 60 is shown with a few of its helical segments.

[0057] As shown, the vaso-occlusive coil 60 includes a cylindrical helical body 61 and forms a secondary structure S2 in an elastically relaxed state, in which the cylindrical helical body 61 is bent, rotated, and / or twisted into a three-dimensional form. The vaso-occlusive coil 60 in the secondary structure S2 is elastically extendable to a substantially linear stretched form configured for engagement and advancement via pushing within a microcatheter lumen and / or a coil dispenser.

[0058] The vaso-occlusive coil 60 in the secondary configuration is formed into a plurality of helical segments 62 interconnected with corresponding curved connecting portions 63. The helical segments 62 are substantially coincident and spaced apart from one another such that they form a tubular framework configured with a substantially constant helical diameter and / or pitch. Each helical segment 62 is configured to form an arcuate segment (e.g., similar to arcuate segment 24) when fully released within a container space (e.g., container space 25). At least one helical segment 62 includes a single or partial winding 64 between each consecutive pair of corresponding curved connecting portions 63. At least one curved connecting portion 63 is formed as an arc, optionally having an arc center angle in the range of approximately 45° to approximately 225°, optionally, particularly greater than approximately 90°, and optionally, particularly approximately 180°. The helical segments in at least one consecutive pair of helical segments 62 are optionally wound in opposite directions relative to one another. General principles of interpretation for this disclosure

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.).

[0065] 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).

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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."

[0072] 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.

[0073] 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.

[0074] 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.

[0075] As used herein, the term "about" when applied to numerical values means ± 10% of the stated numerical value.

[0076] 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.

[0077] 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 forming system, comprising: vascular occlusion coils; a container comprising a fluid-permeable sidewall surrounding a container space, the fluid-permeable sidewall being configured for implantation within a luminal segment of a target blood vessel, wherein the container space is configured to accommodate the vaso-occlusive coil; a coil dispenser configured to release the vaso-occlusive coil into the container space; wherein the coil dispenser, the container, and the vaso-occlusive coil are configured such that when the vaso-occlusive coil is released from the coil dispenser into the container, arcuate segments of the vaso-occlusive coil are sequentially positioned and urged against different portions of the sidewall.

2. The vascular occluder forming system according to claim 1, wherein: At least some of the different arcuate segments extend along distinct planes having different spatial orientations relative to the planes along which other arcuate segments extend, thereby collectively forming a structure in the container space configured to resist compressive forces extending along multiple spatial directions.

3. The vascular occluder forming system according to any one of claims 1 or 2, wherein: The vaso-occlusive coil includes a cylindrical helical body surrounding an elongated coil channel.

4. The vascular occluder forming system according to claim 3, wherein: The vaso-occlusive coil includes a core member within the cylindrical helical body.

5. The vascular occluder forming system according to claim 4, wherein: The core component includes an elastic wire.

6. The vascular occluder forming system according to claim 5, wherein: The core member is formed of metal.

7. The vascular occluder forming system according to claim 4, wherein: The core member is configured to force the vaso-occlusive coil into a secondary configuration in which the cylindrical helical body bends, rotates, and / or twists into a three-dimensional form.

8. The vascular occluder forming system according to claim 7, wherein: The container is configured to receive the vaso-occlusive coil in the secondary structure into the container space and, when the cylindrical helical body is axially compressed and / or radially expanded from the secondary structure upon release from the coil dispenser into the container space, force the vaso-occlusive coil into a tertiary structure derivable from the shape of the sidewall.

9. The vascular occluder forming system according to claim 1, wherein: The vaso-occlusive coil has a resiliently relaxed configuration comprising a series of arcuate segments arranged in two or more different orientations, wherein the vaso-occlusive coil is configured to resiliently deform into a linear configuration for placement in the coil dispenser, and wherein the vaso-occlusive coil is configured to sequentially form the series of arcuate segments in the resiliently relaxed configuration as the vaso-occlusive coil is ejected from a distal end of the coil dispenser.

10. A vascular occlusive device comprising: a container comprising a sidewall, wherein the sidewall defines a container space; A vaso-occlusive coil in the container space, wherein arcuate segments of the vaso-occlusive coil are positioned and urged against different portions of the sidewall, wherein at least some different arcuate segments extend along distinct planes having different spatial orientations relative to planes along which other arcuate segments extend, thereby collectively forming a structure in the container space configured to resist compressive forces extending along multiple spatial directions.

11. The vascular occlusive device according to claim 10, wherein: The arcuate segments are preformed portions of the elastically relaxed configuration of the vaso-occlusive coil.

12. The vascular occlusive device according to any one of claims 10 or 11, wherein: The vaso-occlusive coil includes a cylindrical helical body surrounding an elongated coil channel.

13. The vascular occlusive device according to claim 12, wherein: The vaso-occlusive coil includes a core member within the cylindrical helical body.

14. The vascular occlusive device according to claim 13, wherein: The core component includes an elastic wire.

15. The vascular occlusive device according to claim 13, wherein: The core member is formed of metal.

16. The vascular occlusive device according to claim 12, wherein: The core member is configured to force the vaso-occlusive coil into a secondary configuration in which the cylindrical helical body bends, rotates, and / or twists into a three-dimensional form.

17. A method of forming a vascular occlusive device, the method comprising: providing a coil dispenser connected to a container, the container including a flexible wall extending between a proximal end and a distal end and surrounding a container space, wherein the container is radially expandable and / or axially compressible and is configured to accumulate clotted blood in the container space; positioning the container in a target blood vessel such that the container engages an inner wall surface of the target blood vessel; gradually releasing a vaso-occlusive coil into the container space, thereby allowing the vaso-occlusive coil to elastically reshape from a substantially linear stretched form in the coil dispenser to a three-dimensional framework structure in the container; wherein the releasing comprises positioning and urging arcuate segments of the vaso-occlusive coil against different portions of the flexible wall, wherein each of the arcuate segments extends along a distinct plane having a different spatial orientation relative to a plane along which the other arcuate segments extend, until collectively forming a structure configured to resist compressive forces extending along a plurality of spatial directions.

18. The method according to claim 17, wherein The vaso-occlusive coil includes a cylindrical helical body surrounding an elongated coil channel.

19. The method according to claim 18, wherein The vaso-occlusive coil includes a core member within the cylindrical helical body.

20. The method according to claim 19, wherein The core component includes an elastic wire.

21. The method according to claim 19, wherein The core member is formed of metal.

22. The method according to any one of claims 19, 20 or 21, wherein The core member is configured to force the vaso-occlusive coil into a secondary configuration in which the cylindrical helical body bends, rotates, and / or twists into a three-dimensional form.

23. A vascular occlusive coil comprising: a cylindrical helical body surrounding an elongated coil channel; as well as A core member is positioned within the elongated coil channel.

24. The vaso-occlusive coil of claim 23, wherein: The core member is configured to force the vaso-occlusive coil into a secondary configuration in which the cylindrical helical body bends, rotates, and / or twists into a three-dimensional form.

25. The vaso-occlusive coil of claim 24, wherein: The secondary structure comprises a series of arcuate segments arranged in two or more different orientations.

26. A vaso-occlusive coil having an elastically relaxed configuration, comprising a series of arcuate segments arranged in two or more different orientations, wherein the vaso-occlusive coil is configured to elastically deform into a linear configuration for placement in a coil dispensing catheter, and wherein the vaso-occlusive coil is configured to sequentially form the series of arcuate segments into the elastically relaxed configuration as the vaso-occlusive coil is ejected from a distal end of the coil dispensing catheter.

27. The vaso-occlusive coil of claim 26, wherein: The vascular occlusive coil comprises: a cylindrical helical body surrounding the elongated coil channel; and A core member is positioned within the elongated coil channel.

28. The vaso-occlusive coil of claim 26, wherein: The vaso-occlusive coil forms a plurality of helical segments interconnected with corresponding curved connecting portions.

29. The vaso-occlusive coil of claim 28, wherein The helical segments are substantially coincident and spaced apart from one another such that they form a tubular frame configured with a substantially constant helical diameter and / or pitch.

30. The vaso-occlusive coil of claim 28, wherein: Each of the helical segments is configured to form one of the arcuate segments.

31. The vaso-occlusive coil of claim 28, wherein At least one of the helical segments includes a single winding or partial winding between each consecutive pair of corresponding curved link portions.

32. The vaso-occlusive coil of claim 28, wherein: At least one of the curved connecting portions is formed as an arc having an arc center angle in the range of about 45° to about 225°, optionally in particular greater than about 90°, optionally in particular about 180°.

33. The vaso-occlusive coil of claim 28, wherein: At least one of the curved linking portions is formed as an arc having an arc center angle greater than 90°.

34. The vaso-occlusive coil of claim 28, wherein: At least one of the curved linking portions is formed as an arc having an arc center angle of approximately 180°.

35. The vaso-occlusive coil of claim 28, wherein The helical segments of at least one consecutive pair of the helical segments are counter-wound relative to each other.

36. A vascular occluder forming system comprising: a vaso-occlusive coil comprising a cylindrical helical body surrounding an elongated coil channel; a core member disposed within the cylindrical helical body and configured to force the vaso-occlusive coil into a secondary configuration in which the cylindrical helical body bends, rotates, and / or twists into a three-dimensional form; and a container comprising a fluid-permeable shaped cover surrounding a container space, the fluid-permeable shaped cover configured for implantation within a luminal segment of a target blood vessel, the container configured to receive the vaso-occlusive coil in the secondary structure into the container space and to force the vaso-occlusive coil into a tertiary structure derivable from the shaped cover, wherein the cylindrical helical body is axially compressed and / or radially expanded from the secondary structure; The vaso-occlusive coil in the tertiary configuration is configured to anchor the vessel to the target vessel within the lumen segment.

37. The vascular occluder forming system according to claim 36, wherein: The shaped covering includes a flexible tubular wall extending between a proximal end and a distal end and surrounding the container space, the container being capable of radially and / or axially expanding and / or compressing and being configured to engage an inner wall surface of the target blood vessel with an outer surface of the tubular wall to prevent blood flow through the tubular wall and / or accumulation of clotted blood in the container space.

38. The vascular occluder forming system according to claim 37, wherein: The outer surface of the tube wall is configured with a variable average roughness that is variable based on relative radial and / or axial compression of the vessel when implanted in the target blood vessel.

39. The vascular occluder forming system according to claim 38, wherein: When the container contains the vaso-occlusive coil in the tertiary configuration, the variable average roughness is greater than when the container is empty, for anchoring the container to the target vessel.

40. The vascular occluder forming system according to claim 38, wherein: The tube wall includes a first material configured with a first roughness and a second material configured with a second roughness greater than the first roughness, wherein when the container is axially extended and / or radially compressed relative to its elastically relaxed form, the ratio between the cumulative surface areas of the first material and the second material contained in the outer surface is greater than when the container is axially compressed and / or radially extended relative to its elastically relaxed form.

41. The vascular occluder forming system according to claim 37, wherein: The flexible tube wall is meshed, braided, woven or perforated.

42. The vascular occluder forming system according to claim 37, wherein: The flexible tube wall is formed of a metallic material, such as a Ni-Ti alloy, optionally in the form of a braided wire.

43. The vascular occluder forming system according to claim 36, wherein: The core member is extendable along the elongated coil channel when in an elastically stretched form and is configured to force the vaso-occlusive coil into the secondary structure when released from the elastically stretched form to a more elastically relaxed configuration.

44. The vascular occluder forming system according to claim 36, wherein: The vaso-occlusive coil in the secondary structure is elastically extendable to a substantially linear stretched form configured for engagement and advancement via pushing within a microcatheter lumen.

45. The vascular occluder forming system according to claim 36, wherein: The core member comprises a resilient wire or cord, optionally of metallic material.

46. The vascular occluder forming system according to claim 36, wherein: The vaso-occlusive coil in the secondary structure forms a plurality of helical segments interconnected with corresponding curved connecting portions.

47. The vascular occluder forming system according to claim 46, wherein: The helical segments are substantially coincident and spaced apart from one another such that they form a tubular frame configured with a substantially constant helical diameter and / or pitch.

48. The vascular occluder forming system according to claim 46, wherein: Each of the helical segments is configured to form one of the arcuate segments when fully released in the container space.

49. The vascular occluder forming system according to claim 46, wherein: At least one of the helical segments comprises a single winding or partial winding of the core member between each consecutive pair of corresponding curved link portions.

50. The vascular occluder forming system according to claim 46, wherein: At least one of the curved connecting portions is formed as an arc, optionally having an arc center angle in the range of about 45° to about 225°, optionally particularly greater than about 90°, optionally particularly about 180°.

51. The vascular occluder forming system according to claim 46, wherein: The helical segments of at least one consecutive pair of the helical segments are counter-wound relative to each other.

52. The vascular occluder forming system according to claim 36, wherein: At least a portion of the core member is axially slidable within the elongated coil channel.

53. The vascular occluder forming system according to claim 36, wherein: A distal portion of the vaso-occlusive coil extends distally relative to the distal end of the core member.

54. The vaso-occlusive device forming system of claim 36, further comprising a coil dispenser configured to allow for gradual, continuous release of the vaso-occlusive coil within the container space while constraining portions of the vaso-occlusive coil in the stretched form prior to complete release of the vaso-occlusive coil within the container space.

55. The vaso-occlusive device forming system of claim 54, configured to form a vaso-occlusive device in a target vessel such that when a vaso-occlusive coil is released from the coil dispenser into the container space, arcuate segments of the vaso-occlusive coil in the secondary structure are sequentially positioned and urged against different portions of the vessel wall, wherein Each of the arcuate segments extends along a distinct plane having a different spatial orientation relative to the plane along which the other arcuate segments extend, thereby collectively forming a cocoon-like internal structure configured to resist compressive forces extending along multiple spatial directions.

56. The vascular occluder forming system according to claim 54, wherein: The coil dispenser is a microcatheter or a distal portion of a microcatheter, or is connected to a microcatheter.

57. The vascular occluder forming system according to claim 54, wherein: The coil dispenser is detachably connected or connectable to the container.

58. A method for forming a vascular occluder in a blood vessel, the method comprising: providing a coil dispenser connected to a container, the container including a flexible tubular wall extending between a proximal end and a distal end and surrounding a container space, the container being radially expandable and / or axially compressible and configured to impede blood flow therethrough and accumulate clotted blood in the container space; positioning the container in a target blood vessel such that the container engages an inner wall surface of the target blood vessel; gradually and continuously releasing a vaso-occlusive coil into the container space, thereby allowing the vaso-occlusive coil to elastically reshape from a substantially linear stretched form in the filler dispenser to a three-dimensional framework structure in the container; wherein the releasing comprises sequentially positioning and urging arcuate segments of the vaso-occlusive coil against different portions of the vessel wall, wherein each of the arcuate segments extends along a distinct plane having a different spatial orientation relative to a plane along which the other arcuate segments extend, until collectively forming a cocoon-like internal structure configured to resist compressive forces extending along multiple spatial directions.

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