Embolization coil implantation system

Abstract

An embolic coil implantation system is provided, including a microcoil having a portion comprising one or more sets of loops. The loops of each of the one or more sets continuously intersect one another in a cycle, collectively forming a three-dimensional shape. A shape setting device includes a three-dimensional (3D) body having a curved surface and a plurality of winding members extending from the curved surface of the 3D body and arranged in a plurality of sets. The winding members of each of the plurality of sets are configured to allow the microcoil to be wound to form loops, and adjacent sets of winding members share winding members to allow loops formed by the adjacent sets to cross one another. A method of manufacturing an embolic device is also provided.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 295337, filed December 30, 2021, and U.S. Patent Application No. 18 / 072767, filed December 1, 2022, entitled "Embolitic Coil Implant System," the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0003] This application generally relates to medical devices and methods of manufacturing and using medical devices. In particular, different embodiments of embolization devices or coil systems for deployment within the human vascular system and methods of manufacturing and / or using coil systems are described. Background Technology

[0004] Implants such as embolic devices are known for treating vascular diseases such as aneurysms. An aneurysm is a bulge or swelling that forms on the wall of an artery in the brain or other parts of the body. Cerebral aneurysms can cause severe pain and, if ruptured, can lead to a stroke in the fetus. In non-invasive or minimally invasive treatment of aneurysms, an embolic device can be placed in or at the site of the aneurysm to isolate it from blood flow and / or promote thrombosis at that site. Placement of the embolic device is typically accomplished using a delivery system that guides the device through the patient's vascular system to the location of the aneurysm. Once located at or within the aneurysm, the embolic device is detached from the delivery system by applying thermal or electrolytic energy or by activating a mechanical dissociation mechanism.

[0005] A widely used embolization device is a coil system comprising a flexible, helically wound coil. Three-dimensional microcoils have been developed for treating wide-necked aneurysms. For example, when stretched in a delivery system, a three-dimensional microcoil has a primary or linear configuration, and, for example, when deployed at the target site, it presents a secondary or three-dimensional configuration. The three-dimensional microcoil can provide adequate coverage over the wide neck of the aneurysm. The three-dimensional microcoil can also provide a framework within the aneurysm in which subsequent coils can be placed.

[0006] 3D microcoils are manufactured using shape setting tools. One type of conventional shape setting tool has a construction that can produce microcoils with simple "spiral" shapes. The end result is that once the microcoil is deployed within the aneurysm, it reconfigures itself to conform to the aneurysm's 3D dome shape. However, there is no guarantee that the microcoil will reconfigure itself to the intended 3D shape. Another type of conventional shape setting tool has a construction that can produce microcoils with true 3D shapes, but is traditionally limited in increasing the overall length of the coil by the number of parts in the shape setting tool. That is, to produce a longer length in the final microcoil product, more parts of the shape setting tool are needed.

[0007] Therefore, improved coil systems and methods for manufacturing such coil systems remain needed. It is desirable to provide a shape setting device or coil winding fixture that allows the manufacture of 3D-shaped microcoil systems with extended coil lengths having the same coil dimensions. It is also desirable to provide a 3D coil system that possesses structural stability and allows for tighter aneurysm packing. Summary of the Invention

[0008] In one aspect, embodiments of this disclosure are characterized by an embolization device. Typically, embodiments of the embolization device include a microcoil having a primary configuration. The microcoil includes a first portion having a secondary configuration. The first portion in the secondary configuration includes one or more sets of loops. The loops in each of the one or more sets intersect each other continuously in a loop, collectively forming a three-dimensional shape.

[0009] In different embodiments of this aspect, the loops of each of the one or more groups intersect at the middle portion of the loops of each of the one or more groups.

[0010] In different embodiments of this aspect, one or more sets of rings include a first set of rings and a second set of rings covering the first set of rings, wherein the rings of the first set and the rings of the second set are generally concentric. The diameter of the second set of rings may be larger than the diameter of the first set of rings.

[0011] In different embodiments of this aspect, the embolization device includes two to fourteen sets of rings, wherein the two to fourteen sets of rings are typically concentric. The two to fourteen sets of rings can extend the length of the microcoil, ranging from 20 to 400 mm.

[0012] In various embodiments of this aspect, at least one of a set or more sets of rings includes a first ring, a second ring, and one or more intermediate rings between the first ring and the second ring, wherein the first ring, the second ring, and the one or more intermediate rings intersect each other continuously in the loop, collectively forming a generally spherical or ellipsoidal shape. The first ring, the second ring, and the one or more intermediate rings may include at least one complete ring and at least one ring composed of two partial rings. In one embodiment, the first ring, the second ring, and the one or more intermediate rings include two complete rings and one or more rings composed of two partial rings.

[0013] In various embodiments of this aspect, the microcoil may further include a second portion remote from the first portion, wherein the second portion of the microcoil has a secondary configuration comprising a generally circular ring with a diameter smaller than the diameter of a complete ring or a ring composed of two partial rings of the first portion. In one embodiment, the ring of the second portion of the microcoil is adjacent to a first ring of the first portion of the microcoil, wherein the first ring is a complete ring. In an alternative embodiment, the ring of the second portion of the microcoil is adjacent to a first ring of the first portion of the microcoil, wherein the first ring is a ring composed of two partial rings.

[0014] In another aspect, embodiments of this disclosure are characterized by a shape-setting device. Typically, embodiments of the shape-setting device include a three-dimensional (3D) body having a curved surface, and a plurality of winding members extending from the curved surface of the 3D body and arranged in multiple groups in multiple portions of the curved surface. Each group of winding members is configured to allow micro-coils to be wound to form loops. Adjacent groups of winding members share a single winding member to allow loops formed by adjacent groups to intersect each other.

[0015] In various embodiments of this aspect, the 3D body is typically spherical or ellipsoidal. The winding members in each of the plurality of groups may be arranged at intervals and have an outer periphery configured to allow microcoils to wind to form generally circular or elliptical loops. Each of the plurality of groups of winding members may include a first group of winding members arranged opposite each other and a second group of winding members arranged opposite each other, wherein the extension of the outer periphery of the first group of winding members forms a generally circular or elliptical shape. In one embodiment, one of the second group of winding members is shared with an adjacent group of winding members. In another embodiment, the second group of winding members of the plurality of groups may be located at a hypothetical loop. In one embodiment, the plurality of winding members may be arranged in 2 to 24 groups, allowing microcoils to wind to form 2 to 24 loops around the 3D body in one loop.

[0016] In different embodiments of this aspect, multiple winding members are arranged in four groups, allowing the microcoil to form four loops around the 3D body in one cycle, wherein the first group of winding members in each of the four groups includes a circular segment-shaped outer periphery. In one embodiment, the radius of the outer periphery of the circular segment of the first group of winding members ranges from 1.5 mm to 10 mm.

[0017] In different embodiments of this aspect, at least one of the plurality of winding members further includes a cylindrical winding member extending from the curved surface of the 3D body and surrounded by first and second sets of winding members of at least one of the plurality of winding members, wherein the cylindrical winding member includes a periphery that allows the micro coil to be wound to form a generally circular loop with a diameter smaller than the diameter of the loop formed by the winding members of at least one of the plurality of groups.

[0018] In another aspect, embodiments of the present invention are characterized by a method for manufacturing an embolization device. Typically, one embodiment of the method includes obtaining a microcoil and a shape-setting device comprising a three-dimensional (3D) body having a curved surface and a plurality of winding members extending from the curved surface and arranged in multiple groups; winding the microcoil in a first loop around the plurality of winding members on the 3D body to form a first set of loops that continuously intersect each other; and heating the microcoil on the shape-setting device to obtain an embolization device comprising the first set of loops having a three-dimensional shape configuration.

[0019] In different embodiments of this aspect, during the first loop of winding, the micro-coil winds a single loop on each of multiple sets of winding members. A single loop can be a complete loop or a loop consisting of two partial loops. In one embodiment, the first set of loops comprises two complete loops.

[0020] In various embodiments of this aspect, the method further includes, in a second loop, winding microcoils on multiple sets of winding members around a 3D body to form a second set of loops that continuously intersect each other, wherein the second set of loops covers and is substantially concentric with the first set of loops, and heating the microcoils on the shape-setting device to obtain a plugging device comprising the first set of loops and the second set of loops. In one embodiment, in the second winding loop, the microcoils wind a single loop on each of the multiple sets of winding members. A single loop in the second winding may be a complete loop or a loop composed of two partial loops.

[0021] In different embodiments of this aspect, each of the first set of rings and the second set of rings includes at least two complete rings.

[0022] In different embodiments of this aspect, the winding step may be repeated one to fourteen times.

[0023] The content of this invention is provided to present selected aspects and embodiments of this disclosure in a simplified form, and is not intended to identify key features or essential characteristics of the claimed subject matter, nor to serve as an aid in determining the scope of the claimed subject matter. The presented aspects and embodiments are merely intended to provide the reader with a brief overview of certain forms the invention may take, and are not intended to limit the scope of the invention. Other aspects and embodiments of this disclosure are described in the Detailed Description section.

[0024] These and various other aspects, embodiments, features, and advantages of this disclosure will be better understood by reading the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0025] Figure 1A A coil system according to an embodiment of the present disclosure is described.

[0026] Figure 1B Embodiments according to this disclosure are depicted in different perspective views. Figure 1A The coil system.

[0027] Figure 2A A coil winding fixture according to an embodiment of the present disclosure is described.

[0028] Figure 2B Embodiments according to this disclosure are depicted in different perspective views. Figure 2A Coil winding fixture.

[0029] Figure 2C An embodiment according to this disclosure is shown in a different perspective view. Figure 2A Coil winding fixture.

[0030] Figure 3 This is a two-dimensional planar view of the coil winding fixture in Figure 1.

[0031] Figure 4A-4G An example winding operation according to an embodiment of this disclosure is shown.

[0032] Figure 5 An example winding operation according to an embodiment of the present disclosure is shown.

[0033] Figure 6 An example winding operation according to an alternative embodiment of this disclosure is shown.

[0034] Figure 7 An exemplary coil winding fixture according to an alternative embodiment of the present disclosure is shown. Detailed Implementation

[0035] Overview

[0036] Embodiments of this disclosure provide an embolization device or coil system. The coil system can be fabricated using a shape-setting device or a coil winding jig and has a true three-dimensional (3D) shape with varying lengths. The coil system has a unique winding pattern with concentrically unfolding cross loops that can be repeated multiple times to achieve the desired length. The winding pattern of the coil system can be designed not to overlap itself until a complete loop is wound around the winding tool. For additional lengths of the same primary microcoil diameter, the winding loops can be repeated. For example, for a given coil size, such as 10 mm, coil systems of different lengths can be fabricated, such as 10 mm × 30 mm, 10 mm × 40 mm, 10 mm × 50 mm, etc. For the same coil size, the increased length allows for the delivery of more aneurysm filling with a single coil system. This reduces the number of coils required to achieve the target filling density of the aneurysm, thereby reducing overall cost and operative time.

[0037] The cross-loops in the coil system provide structural stability and allow for tighter packaging. Structural stability is achieved by applying an outward force from the unfolded loops to a portion of the circumference of the existing coil. Tighter packaging can be provided by minimizing the straight runs between consecutive loops, as the more frequently the coil changes direction, the easier it is to fold and package. This contrasts with traditional shape-setting tools, which have gaps between each set of repeating features, resulting in longer straight sections of the coil.

[0038] Because the coil system of this disclosure is concentrically wound around itself, it naturally aims to form a 3D shape, such as the shape of a sphere or ellipsoid around which it is wound. This contrasts with conventional tools, which require additional length or features to achieve greater length. The concentric winding design has the additional feature of increasing radial force during the unfolding of a single coil. For example, by placing it on top of the preceding coil, successive windings around the same winding tool can have a slightly larger diameter, such as twice the diameter of the primary coil. When finally unfolded within the aneurysm, the subsequent larger coil loops will unfold within the smaller first loop, applying a greater force than a loop of the same size. Increasing the radial force along the length of the coil system will result in the coil system being better juxtaposed with the inner wall of the aneurysm, thereby effectively locking the coil in place or alleviating concerns about migration.

[0039] Referring to the accompanying drawings, different embodiments of the embolization device, the shape setting device, and the method of manufacturing the embolization device will now be described. It should be noted that the drawings are intended to illustrate the embodiments and are not exhaustive descriptions or to limit the scope of this disclosure. Alternative structures and components will readily be considered feasible without departing from the principles of the claimed invention.

[0040] Coil system

[0041] Figure 1A-1B An exemplary coil system or embolization device 100 according to an embodiment of the present disclosure is depicted. In general, the exemplary coil system 100 includes a primary microcoil 102 having a first portion 110 having a three-dimensional shape. The first portion 110 may include one or more sets of intersecting loops 112a-d continuously forming, for example, a generally spherical or ellipsoidal shape. For clarity, in Figure 1A-1B Only one set of rings 112a-d of the first portion 110 is shown. The coil system 100 may also include a second portion 120 distal to the first portion 110. The second portion 120 may include a damage-prevention ring 122. The size of the rings 122 of the second portion 120 may be smaller than the size of the rings 112a-d of the first portion 110. When using the coil system 100, the first portion 110 and the second portion 120 may be arranged in a linear or primary configuration in a microcatheter for delivering the coil system 100 to a target site. The second portion 120 may be positioned distal to the first portion 110 to allow the damage-prevention ring 122 to be released first, thereby minimizing tissue damage during insertion and deployment of the coil system 100. When deployed at a target site, the first portion 110 of the coil system 100 has a secondary configuration of its three-dimensional shape, such as... Figure 1A-1B As shown. For example, in treating aneurysms, the coil system 100 can present a three-dimensional shape juxtaposed with the inner wall of the aneurysm.

[0042] Reference Figure 1A-1B A set of rings 112a-d intersect each other continuously in a cycle, as shown in 114. Figure 1A-1BA group of rings is shown, including a first ring 112a, a second ring 112b, and intermediate rings 112c and 112d between the first ring 112a and the second ring 112d. As shown, the first ring 112a intersects with the intermediate ring 112c, the intermediate ring 112c intersects with another intermediate ring 112d, and the intermediate ring 112d intersects with the second ring 112b. Then, the second ring 112b intersects with the first ring 112a, completing the loop shown in 114. The individual rings, such as rings 112a-d, can intersect or be adjacent to each other continuously around axis 116, forming a three-dimensional shape. The individual rings 112a-d, which can be circular, elliptical, or other regular or irregular shapes, can be generally planar or curved. As shown, the intersection of generally circular or elliptical rings can occur in the middle portion of the ring. According to embodiments of this disclosure, in a single complete loop, a set of rings intersects each other but does not overlap. As used herein, if a large portion or area of ​​a loop, for example, more than 50%, lies on another loop, then that loop “overlaps” with the other loop. A loop “intersects” with another loop if it intersects yet another loop, but less than 50% of the area of ​​that loop lies on that yet another loop. Loops that intersect but do not overlap help ensure that the coil system is properly distributed within, for example, an aneurysm, so that the unfolded coil system does not deviate towards a specific area of ​​the aneurysm.

[0043] Figure 1A-1B Four individual loops 112a-d in a set or loop are shown for clarity. It should be noted that a set of loops may include fewer or more than four loops. According to embodiments of this disclosure, depending on the medical application, there may be 2 to 24 (2-24) individual loops in a set or loop.

[0044] Figure 1A-1BOnly one set of coils 112a-d in the first portion 110 of the coil system 100 is shown for clarity. According to embodiments of this disclosure, the first portion 110 of the coil system 100 may include two or more sets of loops. As described above, each of the two or more sets may include multiple loops that intersect each other continuously in a loop. In the two or more sets, the coils of one set may overlap the coils of another set, forming a “layer” or “loop” of the first portion of the coil system. According to embodiments of this disclosure, the two or more sets of loops are concentric, for example, around axis 116. Depending on the medical application, the first portion 110 of the coil system 100 may include two to fourteen (2-14) sets or layers of loops. According to embodiments of the invention, the loops of the outer set or layer may be slightly larger than the loops of the inner set or layer. For example, the diameter of the generally circular loop of the outer set may be twice the cross-sectional diameter of the primary coil than the diameter of the generally circular loop of the inner set. The larger loop can be unfolded within the smaller loop, applying a greater force than a loop of the same size. Adding radial force along the length of the coil system allows for better alignment of the coil system with the inner wall of the aneurysm, effectively locking the coil in place and reducing concerns about migration. According to an alternative embodiment of the invention, the outer ring may be approximately the same size as the inner ring.

[0045] A set of rings 112a-d can be a complete ring or a full ring. A set of rings 112a-d can also be a ring composed of two parts or half rings. As will be discussed further below, a complete or full ring consists of a continuous portion of a micro-coil, compared to a ring composed of two parts or half rings. Figure 1A-1B In the diagram, rings 112a-b are complete or fully ringed, while rings 112c-d are rings composed of two partial rings.

[0046] The primary microcoil 102 forming the coil system 100 of this disclosure can be made of helically wound wire. This wire can be made of metal, metal alloy, or any other material suitable for forming an embolization device, including but not limited to platinum, platinum-tungsten alloy, and platinum-iridium alloy. For neurovascular applications, the diameter of the wire can be in the range of approximately 0.001” to 0.005”, preferably in the range of 0.001” to 0.003”. For neurovascular applications, the primary microcoil 102 made of helically wound wire can have a cross-sectional diameter of approximately 0.008” to 0.04”, preferably 0.008” to 0.024”. The coil system 100, or the first portion 110 of the coil system 100 having the primary microcoil 102 formed thereon, can have a size defined by the diameter of the loop. According to embodiments of this disclosure, for neurovascular applications, the coil system 100 can have a size or diameter ranging from 3 mm to 20 mm, or from 3 mm to 15 mm.

[0047] Coil winding clamp

[0048] refer to Figure 2A-2C Figure 3 shows a coil winding clamp or shape setting device 200 according to one aspect of this disclosure. Figure 2A-2C This is a perspective view of an exemplary coil winding fixture 200. Figure 3 yes Figure 2A-2C A flattened two-dimensional illustration of the coil winding fixture 200. As shown, the coil winding fixture 200 includes a three-dimensional (3D) body 202 having a curved surface 204 and a plurality of winding members 210a-d, 220a-d, 230a-d, 240a-d (…) extending from the curved surface 204 of the 3D body 202. Figure 3 The winding members 210a-d, 220a-d, 230a-d, and 240a-d are arranged in multiple groups 210, 220, 230, and 240 in multiple portions of the curved surface 204 of the 3D body 202. The winding members 210, 220, 230, and 240a-d in each of the multiple groups are configured and / or arranged to allow micro-coils to wind to form loops. The winding members of adjacent groups can share a single winding member, such as the winding members 210d / 220c of adjacent groups 210 and 220, the winding members 220dd / 230c of adjacent groups 220 and 230, the winding members 230d / 240c of adjacent groups 230 and 240, and the winding members 240d / 210c of adjacent groups 240 and 210, to allow the coils formed on adjacent groups of the winding members to cross or be adjacent to each other, which will be discussed further below.

[0049] The 3D body 202 provides support for the coil winding and, in conjunction with the winding members 210a-d, 220a-d, 230a-d, and 240a-d, can provide a specific shape for the coil formed on the 3D body 202. The 3D body 202 can typically be spherical or ellipsoidal, or any other regular or irregular shape with curved surfaces. The 3D body 202 can be constructed from materials capable of withstanding high thermal set temperatures (e.g., from 400°C to 1000°C). Example materials suitable for the 3D body 202 include high heat-resistant alloys such as tungsten carbide, stainless steel, and other metals or metal alloys. The winding components 210a-d, 220a-d, 230a-d, and 240a-d can be made of a heat-resistant material, which may be the same as or different from the material of the 3D body 202. The winding components 210a-d, 220a-e, 230a-d, and 240a-e can be disposed on the 3D body 202 by any suitable method. Alternatively, the winding components 210a-d, 220a-d, 230a-d, 240a-d, and the 3D body 202 can be constituted by a single integral body.

[0050] The winding members 210a-d, 220a-d, 230a-d, and 240a-d can be constructed and / or arranged to allow micro-coil winding. The winding members 210a-d, 220a-d, 230a-d, and 240a-d can be arranged in multiple groups around the curved surface 204 of the 3D body 202. For illustrative purposes, Figure 2A-2C and Figure 3 The winding members 210a-d, 220a-d, 230a-d, and 240a-d shown are arranged as four groups 210, 220, 230, and 240 in four portions of the surface 204 of the spherical or ellipsoidal 3D body 202. Typically, depending on the specific application, the winding members can be arranged in 2 to 24 groups. Figure 7 An alternative embodiment of a coil winding fixture 700 is shown, which includes three sets of winding members arranged around a curved surface of a spherical or ellipsoidal body.

[0051] Reference Figure 2A-2C And 3, the winding members 210a-d, 220a-d, 230a-d, or 240a-d of a group may be constructed and / or arranged to allow micro-coils to be wound to form regular or irregular shapes. The construction and / or arrangement of the winding members 210a-d, 220a-d, 230a-d, or 240a-d of each group may be identical, such as Figure 2A-2C As shown in Figure 3. Alternatively, the construction and / or arrangement of one set of winding members may differ from the construction and / or arrangement of another set of winding members. For example, one set of winding members may be configured and / or arranged to allow microcoils to wind to form generally circular or elliptical loops, and another set of winding members may be configured and / or arranged to allow microcoils to wind to form non-circular loops or other regular or irregular shapes. In some embodiments, one set of winding members may be configured and / or arranged to allow the formation of loops having the same or different dimensions as the loops formed by the other set of winding members.

[0052] Reference Figure 2A-2C and Figure 3 According to embodiments of this disclosure, a group of winding members can be arranged in groups at intervals. As an example, group 210 may include a first group of winding members 210a, 210b arranged opposite each other and a second group of winding members 210c, 210d arranged opposite each other. For illustration, Figure 2A-2C and Figure 3A first group or pair of winding members 210a, 210b is shown, which are in the form of circular segments arranged opposite each other. Circular segments 210a, 210b may include an outer periphery having a radius. Extensions of the outer periphery of circular segments 210a, 210b may form circles having a radius. A second group or pair of winding members 210c, 210d may be arranged opposite each other. The second group or pair of winding members 210c, 210d may serve as “islands” separating the first group or pair of winding members 210a, 210b. Groups 220, 230, and 240 of winding members may have the same or similar construction and / or arrangement as group 210. The construction and / or arrangement of paired or grouped winding members allows adjacent groups of winding members to share common winding members, thereby allowing loops formed by adjacent groups to intersect each other, which will be discussed further below. The construction and / or arrangement of paired or grouped winding members also allows for the winding of micro-coils to form complete / full loops or partial / half loops, which will be discussed further below.

[0053] Reference Figure 2A-2C According to embodiments of the present disclosure, each group of winding members 210, 220, 230, 240 may include a first group of winding members 210a-b, 220a-b, 230a-b, 240a-b and a second group of winding members 210c-d, 220c-d, 230c-d and 240c-d, wherein the second group of winding members 210c-d, 220c-d, 230c-d and 240c-d of all groups 210, 220, 230, 240 are positioned such that, if connected, they will form as shown in Figure 3. Figure 3 The circle or loop shown in 250. The first set of winding members 210a-b, 220a-b, 230a-b, and 240a-b, and the second set of winding members 210c-d, 220c-d, 230c-d, and 240c-d can be arranged such that the circle or loop 250 formed by connecting the second set of winding members 210c-d, 220c-d, 230c-d, and 240c-d passes through the middle portion of a plurality of circles, which are formed by connecting the respective winding member sets 210, 220, 230, and 240. Thus, the loops formed by the micro-coils on the winding jig can intersect each other continuously at the middle portion of the loops, as will be discussed further below.

[0054] Reference Figure 2A-2C and Figure 3According to embodiments of this disclosure, the coil winding fixture 200 may further include a cylindrical winding member 212 extending from the curved surface 204 of the 3D body 202. For example, the cylindrical winding member 212 may be located within or surrounded by a group (e.g., group 210) of winding members 210a-d. The cylindrical winding member 212 may have a periphery that allows microcoils to be wound to form a generally circular loop with a diameter smaller than the diameter of the loop formed by, for example, the group 210 of winding members 210a-d. The cylindrical winding member 212 allows microcoils to be wound to form a non-invasive distal loop.

[0055] Refer to Figure 2A-2C The coil winding fixture 200 may also include an elongated post 206 for fixing the coil winding fixture 200. The elongated post 206 may be made of the same or different material as the 3D body 202 and / or the winding members 210a-d, 220a-d, 230a-d, 240a-d.

[0056] Methods for manufacturing coil systems

[0057] Reference Figure 4A-4G Embodiments of a method for manufacturing a coil system or embolization device according to one aspect of the invention are described. Typically, the method includes obtaining a primary microcoil and a coil winding jig or shaping device. The coil winding jig may include a three-dimensional (3D) body having a curved surface and multiple sets of winding members extending from the curved surface and arranged in multiple groups. The method includes: cyclically winding the primary microcoil on the multiple sets of winding members onto the 3D body to form a set of loops that continuously intersect each other; and heating the microcoil wound on the fixing device to obtain a coil system comprising a set of loops having a three-dimensional shape configuration.

[0058] Primary microcoils are available from various manufacturers on the market. Coil winding fixtures can be combined as described above. Figure 2A-2C The clamp described in section 3. Other coil winding clamps may also be used. As an example, a coil winding clamp may include a spherical or ellipsoidal body and multiple sets of winding members arranged in multiple sections of the curved surface of the spherical or ellipsoidal body.

[0059] According to embodiments of this disclosure, a winding operation may include cyclically winding microcoils on multiple sets of winding members around a 3D body of a winding fixture to form a set of loops that intersect each other continuously. According to embodiments of this disclosure, in the winding operation, a single loop of the microcoil is formed on each of the multiple sets of winding members in one loop. In alternative embodiments, more than one loop may be formed on each of the multiple sets of winding members in one loop, such as one half-loop, two or more loops. As used herein, the term "single loop" refers to a loop formed by winding one turn of a microcoil on a set of winding members. A single loop may be a complete loop or a full loop. A complete loop consists of a continuous portion of a microcoil. A single loop may also be a loop consisting of two partial loops (e.g., two half-loops). (See figures...) Figure 1A-1B In the diagram, rings 112a and 112b are complete rings, while rings 112c and 112d are rings of two partial rings. See also Figure 5 A complete or full loop 510 can be formed by continuously winding one turn of a micro coil onto a single winding member (e.g., part B). See also Figure 6 The loop of two partial loops 610 can be formed by first winding a micro coil on some winding members of one group (e.g., part B), then winding a micro coil on winding members of another group (e.g., part C), and then wrapping the micro coil on the remaining winding members of that group (e.g., part B) to complete the loop 610.

[0060] According to embodiments of this disclosure, the winding operation may include winding a microcoil around a winding jig in two or more loops onto multiple sets of winding members to form two or more sets of loops. As an example, the winding operation may include winding a microcoil around a 3D body onto multiple sets of winding members in a first loop to form a first set of loops that continuously intersect each other, and winding a microcoil around a 3D body onto multiple sets of winding members in a second loop to form a second set of loops that continuously intersect each other. The second set of loops may overlap the first set of loops and is generally concentric with the first set of loops. The winding operation may be performed in multiple loops around the 3D body to obtain an embolic device of desired length.

[0061] Reference Figure 4A-4G An example winding operation according to an embodiment of the present disclosure will now be described. The example winding operation will be illustrated using a winding jig comprising four sets of winding members arranged on the curved surface of an ellipsoid. Figure 4A-4GThe winding fixture is shown in a flattened two-dimensional view. For clarity and simplicity, the terms "part A," "part B," "part C," and "part D" are used to refer to a group of winding members arranged in one of the different parts of the curved surface of the ellipsoid. The terms "upper member" and "lower member" are used to refer to the first group of winding members arranged opposite each other. The term "island" is used to refer to the second group of winding members arranged opposite each other and located between the upper and lower members. The term "island AB" refers to the island shared by the winding members of parts A and B. The term "far-end coil element" is used to refer to the winding member used to form the far-end portion of the coil system. Figure 4A-4G In the example, numbers (1)-(9) represent the sequential steps of the winding operation.

[0062] Reference Figure 4A The winding operation can begin as follows:

[0063] (1). The primary micro coil is wound around the post of the winding fixture to fix it.

[0064] (2). Then, the micro coil is wound around the distal coil component to form a non-invasive distal loop.

[0065] (3) Then wrap the micro coil inside island AB.

[0066] Reference Figure 4B The winding operation can continue as follows:

[0067] (4). Then, starting from the inside of island AB, the micro coil is wound around the lower component B, the outside of island BC, and the upper component B to form the first complete loop.

[0068] Refer to Figure 4C The winding operation can continue as follows:

[0069] (5) The micro coil is wound around the lower component A into the interior of island AD to form the first semi-loop.

[0070] Reference Figure 4D The winding operation can continue as follows:

[0071] (6). The micro coil is wound from the outside of the island DA to the periphery of the upper component D to form a second half-ring.

[0072] Reference Figure 4E The winding operation can continue as follows:

[0073] (7) A micro-coil is wound around the lower component C until the outside of island CB, and around the upper component C until the inside of island CD, forming a second complete loop. The second complete loop intersects with the first complete loop.

[0074] Reference Figure 4F The winding operation can continue as follows:

[0075] (8) The micro coil is wound around the lower component D until it reaches the inside of the island DA, forming a third semi-loop.

[0076] Reference Figure 4G The winding operation can then continue as follows:

[0077] (9). The micro coil originates from the outside of island AD and surrounds the upper component A, forming a fourth semi-loop, completing a cycle around the ellipsoid of the winding fixture.

[0078] The winding operation can be continued by winding the micro coil around the ellipse of the winding fixture two or more times to obtain the desired length of the coil system.

[0079] It should be noted that the above is combined Figure 4A-4G The winding operation discussed is provided for illustrative purposes. Various variations of the winding sequence are possible, and this claim is not limited to the provided example. For example, in conjunction with the above... Figure 4A-4G In the discussed example, the winding operation begins with an untraumatized distal loop and then immediately follows the complete loop to complete the winding cycle, as shown in Figures 4-5. In an alternative embodiment, the winding operation may begin with an untraumatized distal loop and then immediately follow a partial loop during the completion of the winding cycle, as shown in Figures 4-5. Figure 6 As shown.

[0080] Different embodiments of coil systems, coil winding fixtures, and methods for manufacturing coil systems have been described. Advantageously, the coil winding fixture allows for the manufacture of coil systems with true 3D shapes. For the same coil dimensions, extended coil lengths can be obtained. The “straight-line” length between coils is reduced because groups or layers of coils can be wound or overlapped concentrically. By minimizing the number of tooling parts required by conventional methods, the coil winding fixture and method can significantly reduce manufacturing costs. Loops that intersect each other continuously in a cycle provide structural stability and allow for tighter filling. Concentrically layered coils increase radial force to provide improved aneurysm wall juxtaposition.

[0081] In use, the embolic device of the present invention can be delivered and deployed at the target site using any suitable delivery device to treat diseases within a patient's vascular system, such as aneurysms. The delivery device may include a dissociation mechanism, such as a mechanical, thermal, or electrolytically powered dissociation mechanism, to release the embolic device upon delivery to the target site. The microcatheter may initially be introduced to the target site via a pathway, for example, in the patient's femoral artery or groin region, using a guide sheath or guiding catheter. The microcatheter can be guided to the target site using a guidewire. The guidewire is visible via fluoroscopy, allowing the microcatheter to reliably advance along the guidewire to the target site.

[0082] Once the microcatheter tip reaches the target site, the guidewire can be withdrawn, and the lumen of the microcatheter cleared. A system comprising a delivery device and an embolic device of this disclosure within the delivery configuration can be placed in the proximal opening of the microcatheter and advanced through it. When the embolic device reaches the distal end of the microcatheter, it can be detached from the delivery device by applying thermal or electrolytic energy or by activating a mechanical dissociation mechanism. Upon release, the embolic device presents a three-dimensional shape at the target site. The delivery device can then be removed from the microcatheter, and additional embolic devices can be delivered and deployed in the same manner if appropriate treatment is required. After the implantable device has been deployed, the microcatheter can be removed from the patient's vascular system.

[0083] Different embodiments of an embolization device for deployment within the human vascular system and methods of manufacturing and / or using the embolization device are described with reference to the accompanying drawings. It should be noted that the drawings are intended for illustrative purposes, and some drawings are not necessarily drawn to scale. Furthermore, specific details may be set forth in the drawings and description to provide a thorough understanding of the present disclosure. It will be apparent to those skilled in the art that some of these specific details may not be used in practicing the embodiments of the present disclosure. In other instances, well-known components or processing steps may not be shown or described in detail to avoid unnecessarily obscuring the embodiments of the present disclosure.

[0084] Unless otherwise expressly defined, all technical and scientific terms used herein have the meanings commonly understood by one of ordinary skill in the art. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. The term “or” means “or” in a non-exclusive sense unless the context clearly specifies otherwise. Relative terms such as above, below, top, bottom, upper, lower, under, above, upper part, lower part, horizontal, vertical, etc., are used for ease of explanation and discussion, not for limitation. The term “proximal” and its grammatical equivalents refer to a position, direction, or orientation toward the operator or physician. The term “distal” and its grammatical equivalents refer to a position, direction, or orientation away from the operator or physician. The terms “first” or “second,” etc., are used. When describing various similar elements, the term “element” may be used to distinguish one element from another. It should be noted that the terms “first” and “second” as used herein include references to two or more. Furthermore, the use of the terms “first” or “second” should not be interpreted as any particular order unless the context clearly indicates otherwise.

[0085] Those skilled in the art will understand that various other modifications can be made. All such and other changes and modifications are contemplated by the inventors and are within the scope of this invention.

Claims

1. A shape setting device characterized by comprising: Comprising: a 3D body having a curved surface; and a plurality of winding members extending from the curved surface of the 3D body and arranged in a plurality of groups in a plurality of portions of the curved surface, wherein: each of the plurality of groups of winding members is configured to allow winding of the microcoil to form a loop; and winding members of adjacent groups share winding members to allow loops formed by adjacent groups to intersect each other; the winding members of each of the plurality of groups comprise a first set of winding members arranged opposite each other and a second set of winding members arranged opposite each other, wherein an extension of an outer periphery of the first set of winding members forms a substantially circular shape; one of the second set of winding members shares with a set of winding members of an adjacent group.

2. The shape setting apparatus according to claim 1, characterized by the 3D body is spherical.

3. The shape setting device of claim 2, wherein the winding members of each of the plurality of groups are arranged at intervals and have an outer periphery configured to allow winding of the microcoil to form a substantially circular loop.

4. The shape setting apparatus of claim 3, wherein the winding members of a second group of the plurality of groups are positioned in a hypothetical cycle.

5. The shape setting apparatus according to claim 3, wherein the plurality of winding members are arranged in 2 to 24 groups to allow winding of the microcoil to form 2 to 24 loops in a cycle around the 3D body.

6. The shape setting apparatus of claim 5, wherein the plurality of winding members are arranged in four groups to allow winding of the microcoil to form four loops in a cycle around the 3D body, wherein the first set of winding members of each of the four groups comprises a circular segment shaped outer periphery.

7. The shape setting apparatus of claim 6, wherein a radius of an outer periphery of the circular segment of the first set of winding members ranges from 1.5 mm to 10 mm accordingly.

8. The shape setting apparatus of claim 7, wherein at least one of the plurality of groups of winding members further comprises a cylindrical winding member extending from the curved surface of the 3D body and surrounded by the first and second set of winding members of at least one of the plurality of groups of winding members, wherein the cylindrical winding member comprises a periphery allowing winding of the microcoil to form a substantially circular loop having a diameter smaller than a diameter of a loop formed by the winding members of at least one of the plurality of groups.

9. An embolisation device manufactured on the basis of a shaping device according to any one of claims 1 to 8, characterised in that Comprising a microcoil having a primary configuration, wherein: the microcoil comprises a first portion having a secondary configuration, the first portion in the secondary configuration comprising one or more groups of loops, each of the one or more groups of loops intersecting each other consecutively in a cycle to collectively form a three-dimensional shape.

10. The embolisation device of claim 9, wherein, the loops of each of the one or more groups of loops intersect each other at a middle portion of the loops of each of the one or more groups of loops along the cycle.

11. The embolisation device of claim 10, wherein, the one or more groups of loops comprise a first group of loops and a second group of loops covering the first group of loops, wherein the first group of loops and the second group of loops are substantially concentric.

12. The embolisation device of claim 11, wherein, a diameter of the second group of loops is greater than a diameter of the first group of loops.

13. The embolisation device of claim 9, wherein, the one or more groups of loops comprise two to fourteen groups, wherein the two to fourteen groups of loops are substantially concentric.

14. The embolisation device of claim 13, wherein, the two to fourteen groups of loops extend a length of the microcoil, the length ranging from 20 mm to 400 mm.

15. The embolisation device of claim 9, wherein, at least one of the one or more groups of loops comprises a first loop, a second loop, and one or more intermediate loops between the first loop and the second loop, wherein the first loop, the second loop, and the one or more intermediate loops consecutively intersect each other in a cycle to collectively form a substantially spherical shape.

16. The embolisation device of claim 15, wherein, The first ring, the second ring, and the one or more intermediate rings comprise at least one complete ring and at least one ring composed of two partial rings.

17. The embolisation device of claim 16, wherein, The first ring, the second ring, and the one or more intermediate rings comprise two complete rings and one or more rings composed of two partial rings.

18. The embolisation device of claim 16, wherein, The microcoil further comprises a second portion distal from the first portion, wherein the second portion of the microcoil has a secondary configuration comprising a substantially circular ring having a diameter that is less than a diameter of at least a complete ring or a diameter of a ring composed of two partial rings.

19. The embolisation device of claim 18, wherein, The ring of the second portion of the microcoil is adjacent to the first ring of the first portion of the microcoil, wherein the first ring is a complete ring.

20. The embolisation device of claim 18, wherein, The ring of the second portion of the microcoil is adjacent to the first ring of the first portion of the microcoil, wherein the first ring is a ring composed of two partial rings.

21. A method of manufacturing an embolic device, comprising: obtaining a microcoil and a shape setting device as claimed in any of claims 1-8, the shape setting device comprising a 3D body having a curved surface, and a plurality of winding members extending from the curved surface and arranged in a plurality of groups; wrapping the microcoil around the 3D body in a first pass over the plurality of groups of winding members to form a first set of rings that continuously cross one another; and heating the microcoil on the shape setting device to obtain an embolic device comprising the first set of rings having a three-dimensional shape configuration.

22. The method of claim 21, wherein in the first pass, the microcoil is wrapped over each of the plurality of groups of winding members in a single ring.

23. The method of claim 22, wherein, The single ring comprises one complete ring.

24. The method of claim 22, wherein the first set of rings comprises two complete rings.

25. The method of claim 22, wherein the single ring comprises a ring composed of two partial rings.

26. The method of claim 21, further comprising: wrapping the microcoil around the 3D body in a second pass over the plurality of groups of winding members to form a second set of rings that continuously cross one another, wherein the second set of rings covers and is substantially concentric with the first set of rings, and wherein the heating comprises heating the microcoil on the shape setting device to obtain the embolic device comprising the first set of rings and the second set of rings.

27. The method of claim 26, wherein in the second pass, the microcoil is wrapped over each of the plurality of groups of winding members in a single ring.

28. The method of claim 26, wherein the single ring in the second pass comprises a complete ring.

29. The method of claim 26, wherein, The single ring in the second pass comprises a ring composed of two partial rings.

30. The method of claim 26, wherein each of the first set of rings and the second set of rings comprises at least two complete rings.

31. The method of claim 25, further comprising repeating the wrapping steps in one to fourteen passes.

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