Embolization device
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Filing Date
- 2023-06-19
- Publication Date
- 2026-06-10
AI Technical Summary
Existing embolic devices face difficulties in filling the interior with embolic material due to 'Dog Ear' formation and risk of material protrusion, leading to thrombus formation and damage to blood vessel walls.
An embolic device with a basket design featuring a distal binding part, a proximal binding part, and an accommodating part, where the distal end of the proximal binding part is distal to the proximal end of the accommodating part, facilitating easy filling and preventing material protrusion.
The device allows for efficient filling of the basket with embolic material, reducing the risk of thrombus formation and vascular damage by directing the embolus correctly and preventing the binding part from protruding into the parent artery.
Abstract
Description
Embolization Devices
[0001] The present invention relates to an embolization device for forming an embolization at a lesion in a blood vessel.
[0002] Endovascular treatment is one of the treatments for vascular lesions such as head and neck aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal artery and abdominal aneurysms, etc. As an example of endovascular treatment, embolization is known, in which a basket-shaped device is placed in the site of a vascular lesion such as an aneurysm to modify blood flow and prevent the aneurysm from rupturing.
[0003] For example, U.S. Patent No. 6,277,663 describes a device including a self-expanding, elastic, permeable shell having a proximal end, a distal end, and a longitudinal axis, the plurality of elongated, elastic filaments having a woven structure, the elongated filaments having a radially constrained elongated state configured for delivery within a microcatheter, and an expanded, relaxed state configured to allow blood flow through the opening at a rate below the critical thrombosis rate. U.S. Patent No. 6,277,663 describes a filament device including a self-expanding, elastic, permeable shell having a proximal end, a distal end, and a longitudinal axis, the permeable shell also including a plurality of elongated, elastic filaments having a woven structure secured relative to each other at their proximal and distal ends. Patent document 3 describes a medical device for left atrial appendage closure, which includes a delivery catheter having a lumen extending therethrough, a proximal collar, a distal collar, and a monolithic support frame extending between the proximal collar and the distal collar, wherein the monolithic support frame includes a first bend extending from the proximal collar toward a second bend, a first segment extending from the second bend toward a third bend, a second segment extending from the third bend toward a fourth bend, and a third segment extending from the fourth bend toward the distal collar, and the monolithic support frame is operable from a first constrained position to a second open position, a third half-open position, and a fourth unconstrained position. Patent Literature 4 describes an implant comprising a woven braided mesh, the implant having a proximal end with a hub, a distal end, a longitudinal axis extending from the proximal end to the distal end, a distal region, a proximal region, and a transition region positioned substantially perpendicular to the longitudinal axis of the implant and extending between the distal and proximal regions, the implant having an expanded configuration when deployed, the expanded implant having a region of greatest diameter extending from a proximal portion of the distal region through the transition region to a distal portion of the proximal region, and the diameter of the pores in the proximal portion of the distal region is larger than that of all the pores in the distal portion of the proximal region. Patent Literature 5 describes a device consisting of a foldable member adjusted to span the neck of an aneurysm and contact the inner wall when the device is deployed.Patent document 6 describes a device having a wire, a selectively detachable joint, and an expandable cage, wherein the joint connects the cage to the wire, the expandable cage can assume a collapsed configuration and an expanded configuration, the expanded configuration being self-assumed by the cage when the cage is released from confinement, and the cage expands to deploy within a body lumen.
[0004] Japanese Patent Publication No. 2011-519632 Japanese Patent Application Laid-Open No. 2015-198957 Japanese Patent Publication No. 2015-534881 Japanese Patent Publication No. 2017-511203 Japanese Patent Publication No. 2001-518320 U.S. Patent No. 5,916,235
[0005] In addition to embolization, which involves placing a basket-shaped device in the affected area of a blood vessel, there is also embolization in which an embolic material for embolization, such as a coil, is placed inside the aneurysm to fill the aneurysm and promote thrombosis, thereby preventing the aneurysm from rupturing. In embolization, which places an embolic material inside the aneurysm, if the opening of an aneurysm or the like in the blood vessel wall is large, the embolic material placed inside the aneurysm may escape from the aneurysm. To prevent the embolic material placed inside the aneurysm from falling out, a placement device may be used that is placed inside the aneurysm or in the blood vessel near the opening of the aneurysm. In the present invention, a basket-shaped device is placed inside the aneurysm, and an embolic material, such as a coil, is placed inside this device to prevent the placed embolic material from falling out into the parent artery.
[0006] Although the use of the devices described in Patent Documents 1 to 4 differs, if an embolic material is to be placed inside a device having a shape similar to those described in Patent Documents 1 to 4, it is difficult to place the embolic material inside the device. In particular, when the proximal portion of the device is placed at the neck of an aneurysm, the embolic material is difficult to penetrate at both ends of the proximal portion, leaving what are known as "dog ears," preventing the entire device from being sufficiently filled with embolic material. Furthermore, if the embolic material is overfilled inside the device, the bundling portions that bind the filaments constituting the device at the bottom of the device tend to protrude outward from the device, which can lead to the bundling portions protruding toward the parent artery, potentially inducing thrombus formation in the parent artery or causing the protruding bundling portions to damage the vascular wall, etc. Furthermore, devices such as those described in Patent Documents 5 and 6 are not sufficiently effective in preventing the embolic material placed inside the aneurysm from falling off, and the embolic material may escape from the aneurysm depending on the shape of the aneurysm, etc.
[0007] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an embolization device that can easily fill the entire interior with an embolization agent and that is less likely to damage the blood vessel wall, etc.
[0008] The embolization device according to the embodiment of the present invention that can solve the above-mentioned problems is as follows: [1] An embolization device for an intraluminal aneurysm, comprising: a basket for accommodating an embolic object, the basket having a plurality of wires, the basket having a distal bundling section that bundles and secures the plurality of wires on the distal side of the basket, a proximal bundling section that bundles and secures the plurality of wires on the proximal side of the basket, and a storage section that is a portion of the plurality of wires between the distal bundling section and the proximal bundling section, and the distal end of the proximal bundling section is distal to the proximal end of the storage section. [2] An embolization device according to [1], wherein the proximal portion of the basket including the proximal bundling section has a recess that is recessed distally. [3] The embolic device according to [1] or [2], which has a basket pusher disposed proximally of the proximal end of the proximal bundling part, and the distance between the distal end of the proximal bundling part and a line passing through the proximal end of the storage part and perpendicular to the extending direction of the basket pusher is 1 / 10 or more of the maximum diameter of the basket. [4] The embolic device according to any of [1] to [3], which has a basket pusher disposed proximally of the proximal end of the proximal bundling part, and the angle between the line passing through the proximal end of the storage part and perpendicular to the extending direction of the basket pusher and a line connecting the proximal end of the storage part and the distal end of the proximal bundling part is 5 degrees or more and 60 degrees or less. [5] The embolic device according to any one of [1] to [4], comprising an outer cylinder having a distal end and a proximal end, wherein the basket is disposable in an inner lumen of the outer cylinder, and wherein the distal end of the proximal binding part is more proximal than the proximal end of the container when the basket is contained in the outer cylinder. [6] The embolic device according to any one of [1] to [5], wherein the proximal end of the distal binding part is more proximal than the distal end of the container. [7] The embolic device according to any one of [1] to [6], wherein at least one of the wires of the basket contains a nickel-titanium alloy, and wherein the basket is extensible in the longitudinal axis direction and the radial direction of the basket.[8] The embolic device according to any one of [1] to [7], wherein at least one of the distal binding part and the proximal binding part has a radiopaque part containing a radiopaque material. [9] The embolic device according to any one of [1] to [8], further comprising a basket pusher arranged proximal to the proximal end of the proximal binding part, and a connecting member arranged proximal to the proximal end of the proximal binding part and distal to the distal end of the basket pusher, the connecting member connecting the basket and the basket pusher.
[10] The embolic device according to [9], wherein the connecting member is detachable.
[11] An embolic device described in any of [1] to
[10] , comprising an outer tube having a distal end and a proximal end, the basket being positionable in the inner cavity of the outer tube, and when the basket is housed within the outer tube, the distal binding portion has a first end which is the end farther from the proximal binding portion and a second end which is the end closer to the proximal binding portion, and when the entire basket is outside the outer tube and no external force is applied to the basket, the second end is located distal to the first end.
[0009] According to the embolization device of the present invention, the distal end of the proximal bundling part of the basket is located distal to the proximal end of the storage part, so that when filling the basket with emboli, the emboli sent into the basket are more likely to come into contact with the proximal bundling part and the wires located distal to the distal end of the proximal bundling part. When the emboli come into contact with the proximal bundling part and the wires located distal to the distal end of the proximal bundling part, the emboli sent into the basket are deflected and are more likely to move toward both ends of the proximal part of the basket. As a result, the emboli are more likely to enter both ends of the proximal part of the basket, making it easier to fill the entire interior of the basket with emboli. Furthermore, because the distal end of the proximal bundling part of the basket is located distal to the proximal end of the storage part, emboli fed into the basket come into contact with the proximal bundling part and the wire located distal to the distal end of the proximal bundling part, and even if the basket is overfilled with emboli, the proximal bundling part is less likely to protrude outward from the basket. As a result, the proximal bundling part of the basket is less likely to protrude toward the parent artery, making it less likely for thrombus formation to occur in the parent artery and less likely to damage other objects such as the blood vessel wall.
[0010]
[0023] Figure 1 shows a cross-sectional view parallel to the longitudinal axis of an embolic device according to one embodiment of the present invention. Figure 2 shows a cross-sectional view parallel to the longitudinal axis of the embolic device shown in Figure 1, in a state in which the basket is housed within the outer tube. Figure 3 shows a cross-sectional view parallel to the longitudinal axis of the embolic device shown in Figure 1, in a state in which the basket has protruded outside the outer tube and no external force is being applied to the basket. Figure 4 shows a cross-sectional view parallel to the longitudinal axis of an embolic device according to another embodiment of the present invention, in a state in which the basket has protruded outside the outer tube and no external force is being applied to the basket. Figure 5 shows a schematic view of a conventional basket placed within an aneurysm with an embolic material contained therein. Figure 6 shows a schematic view of a conventional basket placed within an aneurysm with an excessive amount of embolic material contained therein. Figure 7 shows a schematic view of the embolic device shown in Figure 1, in a state in which the embolic material is contained within the basket.
[0011] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification and other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.
[0012] 1 is a cross-sectional view parallel to the longitudinal axis of an embolization device 1 according to an embodiment of the present invention. In order to facilitate understanding of the relative positions of the distal binding section 30, the proximal binding section 40, and the storage section 50, only some of the wires 20 of the basket 10 are shown, and the remaining wires are not shown.
[0013] In the present invention, the proximal side refers to the side closer to the user in the extension direction of the embolic device 1, and the distal side refers to the side opposite the proximal side, i.e., the side where treatment is performed by the embolic device 1 (the side of the lesion). The extension direction of the embolic device 1 is also referred to as the longitudinal axis direction. The longitudinal axis direction can also be referred to as the near-to-far direction of the embolic device 1. The radial direction of the basket 10 refers to the radial direction of the basket 10, with the radially inward direction referring to the direction toward the axial center of the basket 10 and the radially outward direction referring to the direction opposite the inward direction. Note that in Figure 1, the right side of the figure is the proximal side and the left side of the figure is the distal side.
[0014] As shown in Figure 1, the embolic device 1 of the present invention is an embolization device 1 for an intraluminal aneurysm, and has a basket 10 for accommodating an embolic object, the basket 10 having a plurality of wires 20, a distal bundling section 30 that bundles and secures the plurality of wires 20 on the distal side of the basket 10, a proximal bundling section 40 that bundles and secures the plurality of wires 20 on the proximal side of the basket 10, and a storage section 50 that is the portion of the plurality of wires 20 between the distal bundling section 30 and the proximal bundling section 40, and the distal end 40d of the proximal bundling section 40 is located distal to the proximal end 50p of the storage section 50.
[0015] The embolization device 1 is a device for embolizing an aneurysm within a lumen. The embolization device 1 can be used in embolization procedures, such as placing a basket 10 for containing an embolic material in a vascular lesion such as an aneurysm to promote thrombosis and prevent the aneurysm from rupturing. The embolization device 1 is configured by introducing the basket 10 into a blood vessel and placing it at a target site. Specifically, the basket 10 is placed in an aneurysm at the terminal end or side wall of a blood vessel, or in the peripheral portion of a main vessel of the blood vessel, and an embolization material is placed inside the basket 10 placed in the aneurysm or the peripheral portion of the main vessel to promote thrombosis of the aneurysm.
[0016] 1, the embolization device 1 has a basket 10. The basket 10 contains an embolic object therein.
[0017] Examples of the embolic material include long objects such as coils, wires, and strings, as well as granular and bag-like objects. The embolic material may also be solid, semi-solid, fluid, gel-like, or liquid. Examples of liquid embolic materials include hardening liquids and precipitating liquids. Of these, it is preferable that the embolic material be a long, solid object such as a coil. Because the embolic material is a long object, it is easy to fill the basket 10 with the embolic material, and embolization using the embolization device 1 can be performed efficiently.
[0018] As shown in FIG. 1 , the basket 10 has a plurality of wires 20. The basket 10 is preferably expandable and contractible. Specifically, the basket 10 preferably contracts to a reduced diameter when subjected to an external force, and expands to a larger diameter when not subjected to an external force. Note that when the basket 10 is placed inside the aneurysm, the basket 10 may come into contact with the wall of the aneurysm and be subjected to an external force, which may cause deformation.
[0019] The material constituting the wire 20 is preferably elastic, and examples thereof include metal wires such as single wires, flat wires, double wires, composite material wires, or stranded wires made of stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, aluminum, gold, silver, nickel-titanium alloys, and cobalt-chromium alloys. Among these, it is more preferable that the material constituting the wire 20 be a metal wire having superelasticity such as a nickel-titanium alloy. Using a metal wire as the material constituting the wire 20 increases the elasticity of the wire 20, and increases the return rate of the basket 10 to its original shape even if the basket 10 is significantly deformed. As a result, the basket 10 is less likely to lose its shape.
[0020] The basket 10 may have any number of wires 20 as long as it is plural, and the number of wires 20 can be selected depending on the inner diameter of the biological lumen, such as an aneurysm. In the drawings, the number of wires 20 in the basket 10 is limited. However, in an embodiment of the present invention, the basket 10 may be configured with, for example, 8 to 64 wires 20. The wire diameter of the wires 20 can be set depending on the size of the basket 10, the number of wires 20, the material, etc. The number of wires 20 in the basket 10 is preferably 16 to 32.
[0021] 1 , the basket 10 has a distal bundling section 30 that bundles and secures the plurality of wires 20 on the distal side of the basket 10, a proximal bundling section 40 that bundles and secures the plurality of wires 20 on the proximal side of the basket 10, and a storage section 50 that is a portion of the plurality of wires 20 between the distal bundling section 30 and the proximal bundling section 40. The distal side of the basket 10 refers to the distal portion of the basket 10, and the proximal side of the basket 10 refers to the proximal portion of the basket 10. In other words, the basket 10 has the distal bundling section 30 that bundles and secures the plurality of wires 20, the proximal bundling section 40 that bundles and secures the plurality of wires 20 on the proximal side of the distal bundling section 30, and the storage section 50 that is a portion between the distal bundling section 30 and the proximal bundling section 40 in the portion where the wires 20 extend.
[0022] Methods for bundling and securing the plurality of wires 20 in the distal binding section 30 and the proximal binding section 40 include, for example, welding the plurality of wires 20, crimping the plurality of wires 20 together with a separate member, bonding with an adhesive, or securing with a brazing material. Among these, it is preferable to crimp and secure the plurality of wires 20 in the distal binding section 30 and the proximal binding section 40 with a separate member. By crimping and securing the plurality of wires 20 with a separate member in the distal binding section 30 and the proximal binding section 40, the securing strength of the plurality of wires 20 can be easily increased. As a result, the wires 20 secured together in the distal binding section 30 and the proximal binding section 40 are less likely to come loose, making it possible to lessen the risk of damage to the basket 10.
[0023] In the distal bundling section 30 and the proximal bundling section 40, examples of the separate member that bundles and secures the multiple wires 20 include a ring-shaped member, a member with a C-shaped cross section with a notch in the ring, a coil-shaped member with a wound wire, and a member that ties and secures the multiple wires 20 with a string-like material. Among these, the separate member that bundles and secures the multiple wires 20 is preferably a ring-shaped member, and more preferably a swaged ring-shaped member. By using a ring-shaped member that bundles and secures the multiple wires 20 and is swaged, the multiple wires 20 can be firmly secured and the bundle of the multiple wires 20 is less likely to come undone.
[0024] The material constituting the separate member that bundles and secures the plurality of wires 20 can be, for example, a material that is less elastic than the material constituting the wires 20 of the basket 10. In particular, the material constituting the separate member that bundles and secures the plurality of wires 20 is preferably a platinum alloy such as Pt-W, Pt-Ir, or Pt-Pd. By using a platinum alloy as the material constituting the separate member that bundles and secures the plurality of wires 20, the strength of the fixation of the plurality of wires 20 can be increased, and the durability of the separate member that bundles and secures the plurality of wires 20 can be improved.
[0025] The basket 10 is preferably configured in a cage-like shape in the storage section 50 by braiding a plurality of bent wires 20 or right-handed and left-handed spiral wires 20. In particular, the storage section 50 of the basket 10 is preferably configured by braiding a right-handed spiral wire 20 and a left-handed spiral wire 20. By configuring the storage section 50 of the basket 10 by braiding a right-handed spiral wire 20 and a left-handed spiral wire 20, the basket 10 can be configured as a cage-like basket having a mesh-like wall surface formed by the intersection of a plurality of wires 20. As a result, it is easy to send emboli into the basket 10 through openings in the mesh-like wall surface of the basket 10, and it is difficult for emboli contained inside the basket 10 to escape to the outside of the basket 10, which makes it easier to efficiently promote thrombosis in a lumen aneurysm.
[0026] 1 , the distal end 40d of the proximal binding portion 40 is located distally of the proximal end 50p of the storage portion 50. Because the distal end 40d of the proximal binding portion 40 is located distally of the proximal end 50p of the storage portion 50, the proximal binding portion 40 protrudes distally and is located inside the basket 10.
[0027] Fig. 5 is a schematic diagram of a conventional basket 10 placed within an aneurysm with an embolic material contained therein, Fig. 6 is a schematic diagram of a conventional basket 10 placed within an aneurysm with an excessive amount of embolic material contained therein, and Fig. 7 is a schematic diagram of an embolization device 1 of the present invention placed within an aneurysm with an embolic material contained therein. In Figs. 5 to 7, the diagrams to the left of the hollow arrows show the basket 10 placed within the aneurysm with an embolic material contained therein, and the diagrams to the right of the hollow arrows show the basket 10 placed within the aneurysm with an embolic material contained therein. In Figs. 5 to 7, the lower side of the diagram is the proximal side, and the upper side of the diagram is the distal side.
[0028] 5, when an embolic material is delivered into the interior of a conventional basket 10, the embolic material tends to remain in the center of the proximal portion of the basket 10. Therefore, when the proximal portion of the basket 10 is placed at the neck portion of an aneurysm, the embolic material does not easily enter both ends of the proximal portion of the basket 10 (portions indicated by black arrows in the figure), making it difficult to fill the entire interior of the basket 10 with the embolic material, and a portion known as a "dog ear" is likely to be formed, making it difficult to fill the entire interior of the aneurysm with the embolic material. Furthermore, when the bundling portion that bundles and secures the multiple wires 20 that make up the basket 10 is located in the center of the proximal portion of the basket 10, as shown in Figure 6, emboli tend to remain in the center of the proximal portion of the basket 10 inside the basket 10, and when the basket 10 is excessively filled with emboli, the bundling portion is likely to be pushed out from the inside to the outside of the basket 10 and protrude toward the parent artery, which can induce thrombus formation in the parent artery and can easily cause damage to other objects such as the blood vessel wall when the bundling portion comes into contact with them.
[0029] 7 , in the embolization device 1 of the present invention, the proximal bundling part of the basket 10 protrudes distally inside the basket 10, which makes it easier for embolic matter sent into the basket 10 to come into contact with the proximal bundling part and the wire 20 located distal to the distal end of the proximal bundling part. When embolic matter sent into the basket 10 comes into contact with the proximal bundling part and the wire 20 located distal to the distal end of the proximal bundling part, the direction of travel of the embolic matter is deflected and it is more likely to move toward both ends of the proximal part of the basket 10. As a result, the embolic matter is more likely to enter both ends of the proximal part of the basket 10 inside the basket 10, filling the entire interior of the basket 10 with embolic matter, making it easier to embolize the aneurysm.
[0030] Furthermore, because the distal end 40d of the proximal bundling part 40 is located distal to the proximal end 50p of the storage part 50, emboli fed into the basket 10 are more likely to come into contact with the proximal bundling part 40 and the wire 20 located distal to the distal end 40d of the proximal bundling part 40, and even if an excessive amount of emboli is loaded, the proximal bundling part 40 is less likely to protrude outward from the basket 10. Therefore, the proximal bundling part 40 of the basket 10 is less likely to protrude toward the parent artery, making it less likely that a thrombus will form in the parent artery, and also making it less likely that the proximal bundling part 40 will come into contact with other objects such as the blood vessel wall, thereby making it less likely that other objects will be damaged.
[0031] 3 and 4, when the embolization device 1 has an outer tube 80 capable of placing the basket 10 in its lumen, the embolization device 1 of the present invention has a configuration in which the distal end 40d of the proximal binding part 40 is located distal to the proximal end 50p of the storage part 50 when the basket 10 is outside the outer tube 80 and is not subjected to any external force other than gravity. Details of the outer tube 80 will be described later.
[0032] Regarding the configuration in which the distal end 40d of the proximal binding part 40 is located distal to the proximal end 50p of the storage part 50, as shown in Fig. 1, the configuration may be such that the wire 20 is located distal to the distal end 40d of the proximal binding part 40 and the proximal part of the basket 10 is concave, or as shown in Fig. 4, the configuration may be such that the wire 20 is located proximal to the proximal end 40p of the proximal binding part 40 and at least a part of the proximal binding part 40 is located inside the basket 10. In other words, the proximal binding part 40 may be located outside the basket 10 or inside the basket 10.
[0033] As shown in FIG. 1 , the basket 10 preferably has a recess 60 in which the proximal portion of the basket 10, including the proximal bundling part 40, is recessed distally. The recess 60 in the basket 10 makes it easier for emboli fed into the basket 10 to come into contact with the proximal bundling part 40 and the wire 20 located distal to the distal end 40d of the proximal bundling part 40, thereby directing the direction of travel of the emboli toward both ends of the proximal portion of the basket 10 and making it easier for the emboli to enter both ends of the proximal portion of the basket 10. Furthermore, the recess 60 in the basket 10 makes it less likely for the proximal bundling part 40 to protrude outward from the basket 10 even when excessive emboli are loaded. This reduces the likelihood of the proximal bundling part 40 protruding toward the parent artery, reducing the likelihood of thrombus formation in the parent artery and reducing the likelihood of the proximal bundling part 40 coming into contact with and damaging other objects.
[0034] The maximum depth of the recess 60 of the basket 10 is preferably greater than the length from the distal end 40d to the proximal end 40p of the proximal binding part 40. The maximum depth of the recess 60 of the basket 10 refers to the maximum depth of the depression of the recess 60 in the direction from the proximal side to the distal side of the basket 10. Since the maximum depth of the recess 60 is greater than the length from the distal end 40d to the proximal end 40p of the proximal binding part 40, the proximal binding part 40 protrudes inside the basket 10, and therefore emboli sent into the inside of the basket 10 are more likely to come into contact with the proximal binding part 40 and the wire 20 located distal to the distal end 40d of the proximal binding part 40. Furthermore, because the maximum depth of the recess 60 is greater than the length from the distal end 40d to the proximal end 40p of the proximal binding part 40, the proximal binding part 40 is less likely to protrude outward from the basket 10 even when an embolus is excessively filled inside the basket 10. Therefore, the proximal binding part 40 of the basket 10 is less likely to protrude toward the parent artery, making it less likely that a thrombus will form in the parent artery, and also making it less likely that the proximal binding part 40 will come into contact with other objects.
[0035] The maximum depth of the recess 60 of the basket 10 is preferably 1.1 times or more, more preferably 1.2 times or more, and even more preferably 1.3 times or more, the length from the distal end 40d to the proximal end 40p of the proximal binding part 40. By setting the lower limit of the ratio of the maximum depth of the recess 60 to the length from the distal end 40d to the proximal end 40p of the proximal binding part 40 within the above range, the proximal binding part 40 can be made to easily protrude from the proximal side to the distal side of the basket 10 inside the basket 10, and can be made to be less likely to protrude from the distal side to the proximal side of the basket 10 outside the basket 10. Furthermore, the maximum depth of the recess 60 of the basket 10 is preferably 10 times or less, more preferably 5 times or less, and even more preferably 3 times or less, the length from the distal end 40d to the proximal end 40p of the proximal binding part 40. By setting the upper limit of the ratio between the maximum depth of the recess 60 and the length from the distal end 40d to the proximal end 40p of the proximal binding portion 40 within the above range, the length from the distal end 10d to the proximal end 10p of the basket 10 is less likely to be longer than necessary, making it possible to make the embolization device 1 less invasive.
[0036] 1 , the embolization device 1 preferably includes a basket pusher 70 that is disposed proximally of the proximal end 40p of the proximal binding portion 40. The basket pusher 70 is directly or indirectly connected to the basket 10, and the basket 10 can be moved by pushing or pulling the basket pusher 70 from the hand side.
[0037] The material constituting the basket pusher 70 is preferably a metal, such as stainless steel, carbon steel, or a nickel-titanium alloy. Among these, the material constituting the basket pusher 70 is preferably stainless steel. Using stainless steel as the material constituting the basket pusher 70 can increase the rigidity of the basket pusher 70. As a result, the force applied to the basket pusher 70 can be efficiently transmitted to the basket 10, making it easier to move the basket 10 in the longitudinal direction.
[0038] Although not shown, basket pusher 70 may be provided with a handle at the proximal end for controlling the position and rotation in the longitudinal axis direction. Basket pusher 70 having a handle makes it easier to push and pull basket pusher 70.
[0039] 1 , the distance D1 between a line L1 that passes through the proximal end 50p of the storage section 50 and is perpendicular to the extension direction of the basket pusher 70 and the distal end 40d of the proximal bundling section 40 is preferably equal to or greater than 1 / 10 of the maximum outer diameter d1 of the basket 10. By making the distance D1 between the line L1 and the distal end 40d of the proximal bundling section 40 equal to or greater than 1 / 10 of the maximum outer diameter d1 of the basket 10, the length by which the proximal bundling section 40 protrudes from the proximal side toward the distal side within the basket 10 can be increased. As a result, within the basket 10, emboli that have been fed into the basket 10 are more likely to come into contact with the proximal bundling section 40 and the wire 20 that is located distal to the distal end 40d of the proximal bundling section 40, and the direction of travel of the emboli is more likely to be toward both ends of the proximal section of the basket 10, making it easier to fill the entire interior of the basket 10 with the emboli.
[0040] The distance D1 between a straight line L1 that passes through the proximal end 50p of the storage section 50 and is perpendicular to the extension direction of the basket pusher 70 and the distal end 40d of the proximal binding part 40 is preferably 1 / 10 or more, more preferably 1 / 8 or more, and even more preferably 1 / 5 or more of the maximum outer diameter d1 of the basket 10. By setting the lower limit of the ratio of the distance D1 between the straight line L1 and the distal end 40d of the proximal binding part 40 to the maximum outer diameter d1 of the basket 10 within the above range, the length by which the proximal binding part 40 protrudes from the proximal side toward the distal side inside the basket 10 tends to increase, and emboli sent into the basket 10 are more likely to come into contact with the proximal binding part 40 and the wire 20 that is located distal to the distal end 40d of the proximal binding part 40. Furthermore, the distance D1 between a straight line L1 that passes through the proximal end 50p of the storage section 50 and is perpendicular to the extension direction of the basket pusher 70 and the distal end 40d of the proximal binding part 40 is preferably equal to or less than ½, and more preferably equal to or less than ⅓, of the maximum outer diameter d1 of the basket 10. By setting the upper limit of the ratio of the distance D1 between the straight line L1 and the distal end 40d of the proximal binding part 40 and the maximum outer diameter d1 of the basket 10 within the above range, it is possible to prevent the length by which the proximal binding part 40 protrudes from the proximal side to the distal side inside the basket 10 from becoming excessively long, making it easier for the embolus to be distributed throughout the entire interior of the basket 10 and for the embolus to be filled into the basket 10.
[0041] 1 , the angle θ1 formed by a line L1 that passes through the proximal end 50p of the storage unit 50 and is perpendicular to the extension direction of the basket pusher 70 and a line L2 that connects the proximal end 50p of the storage unit 50 and the distal end 40d of the proximal bundling unit 40 is preferably 5 degrees or greater and 60 degrees or less. When the angle θ1 formed by the lines L1 and L2 is 5 degrees or greater and 60 degrees or less, a mountain-shaped protrusion can be formed in the proximal portion of the basket 10, including the proximal bundling unit 40, inside the basket 10. As a result, emboli being fed into the basket 10 are more likely to come into contact with the proximal bundling unit 40 and the wire 20 located distal to the distal end 40d of the proximal bundling unit 40, and the direction of travel of the emboli is more likely to be toward both ends of the proximal portion of the basket 10, making it easier for the emboli to enter both ends of the proximal portion of the basket 10.
[0042] The angle θ1 formed by a line L1 that passes through the proximal end 50p of the storage unit 50 and is perpendicular to the extension direction of the basket pusher 70, and a line L2 that connects the proximal end 50p of the storage unit 50 and the distal end 40d of the proximal binding unit 40, is preferably 5 degrees or greater, more preferably 15 degrees or greater, even more preferably 25 degrees or greater, and even more preferably 30 degrees or greater. By setting the lower limit of the angle θ1 formed by the lines L1 and L2 within the above range, a mountain-shaped protrusion is more likely to be formed inside the basket 10 in the proximal portion of the basket 10 including the proximal binding unit 40, making it easier to place an embolus on both ends of the proximal portion of the basket 10. Furthermore, the angle θ1 formed between a line L1 that passes through the proximal end 50p of the storage section 50 and is perpendicular to the extension direction of the basket pusher 70 and a line L2 that connects the proximal end 50p of the storage section 50 and the distal end 40d of the proximal binding section 40 is preferably 60 degrees or less, more preferably 50 degrees or less, and even more preferably 40 degrees or less. By setting the upper limit of the angle θ1 formed by the lines L1 and L2 within the above range, the protrusion formed inside the basket 10 at the proximal portion of the basket 10, including the proximal binding section 40, is less likely to become excessively large, and the internal volume of the basket 10 is less likely to decrease. As a result, a large amount of embolic material can be accommodated inside the basket 10, resulting in an embolization device 1 that easily fills the inside of an aneurysm.
[0043] Fig. 2 is a cross-sectional view parallel to the longitudinal axis direction of the embolization device 1 in a state in which the basket 10 is housed in the outer tube 80, Fig. 3 is a cross-sectional view parallel to the longitudinal axis direction of the embolization device 1 in a state in which the basket 10 has protruded outside the outer tube 80 and no external force is being applied to the basket 10, and Fig. 4 is a cross-sectional view parallel to the longitudinal axis direction of the embolization device 1 in another embodiment in a state in which the basket 10 has protruded outside the outer tube 80 and no external force is being applied to the basket 10. Note that Figs. 2 to 4 also illustrate only some of the multiple wires 20 of the basket 10, with the remaining wires being omitted. In Figs. 2 to 4, the right side of the figures corresponds to the proximal side, and the left side of the figures corresponds to the distal side.
[0044] As shown in Figures 2 to 4, the device has an outer cylinder 80 having a distal end 80d and a proximal end, and the basket 10 is preferably capable of being placed in the inner cavity of the outer cylinder 80. In other words, the basket 10 is preferably placed in a lumen of the outer cylinder 80. Because the basket 10 is capable of being placed in the inner cavity of the outer cylinder 80, the basket 10 can be transported to the target site while housed in the inner cavity of the outer cylinder 80. Therefore, the basket 10 is less likely to get caught on other objects such as a blood vessel wall, and the basket 10 can be smoothly transported to the target site.
[0045] The basket 10 is preferably expandable when it is released from the outer tube 80. That is, the basket 10 is preferably disposed in the lumen of the outer tube 80 and is expandable when released from the outer tube 80. When disposed in the lumen of the outer tube 80, the basket 10 is in contact with the inner wall of the outer tube 80 and is preferably subjected to an external force from the outer tube 80, resulting in a contracted outer shape and a reduced diameter. Furthermore, when released from the outer tube 80, the basket 10 is no longer subjected to the external force and is preferably expanded in the absence of any other external force. Because the basket 10 is expandable when it is released from the outer tube 80, the outer diameter of the basket 10 can be reduced when it is disposed in the lumen of the outer tube 80. As a result, the basket 10 can be easily transported to a target site, facilitating a procedure such as embolization using the embolization device 1.
[0046] The outer cylinder 80 is a tubular member extending in the longitudinal direction and has at least one lumen extending in the longitudinal direction. The outer cylinder 80 may have multiple lumens, but preferably has one. By having the outer cylinder 80 have only one lumen, the outer diameter of the outer cylinder 80 can be reduced, thereby improving the minimally invasive nature of the embolization device 1.
[0047] The material constituting the outer tube 80 is preferably a resin or metal. Examples of resins constituting the outer tube 80 include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, fluorine-based resins, vinyl chloride-based resins, silicone-based resins, and natural rubber. These may be used alone or in combination. Among these, the resin constituting the outer tube 80 is preferably at least one of polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, and fluorine-based resins. By using at least one of polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, and fluorine-based resins as the material constituting the outer tube 80, the surface slipperiness of the outer tube 80 can be improved, thereby improving insertion into a lumen such as a blood vessel. The resin tube constituting the outer tube 80 can be manufactured using conventional methods such as extrusion molding or injection molding.
[0048] Examples of metals that can be used for the outer tube 80 include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, nickel-titanium alloys, cobalt-chromium alloys, and combinations thereof. The metal tube that forms the outer tube 80 may be a tube made by spirally winding metal wire or a tube made by braiding metal wire. The outer tube 80 may also be a tube made by combining metal and resin. A resin tubular member with a reinforcing material such as a metal wire may also be used as the outer tube 80. When a resin tubular member with a wire disposed therein is used as the outer tube 80, a nickel-titanium alloy wire is preferred due to its excellent shape memory and high elasticity. The wire disposed in the resin tubular member may be the above-mentioned metal, or a fiber material such as polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, or carbon fiber. The fiber material constituting the wire may be a monofilament or a multifilament.
[0049] The outer cylinder 80 may be made of a single layer or multiple layers. Also, in the longitudinal axis direction, a portion of the outer cylinder 80 may be made of a single layer, and another portion may be made of multiple layers.
[0050] The outer surface of the sheath 80 is preferably coated with a hydrophilic resin. That is, the sheath 80 preferably has a hydrophilic resin layer on the outside of the sheath 80. Coating the outer surface of the sheath 80 with a hydrophilic resin increases the slipperiness of the sheath 80, thereby improving the insertability within a lumen in a living body.
[0051] Furthermore, the outer cylinder 80 preferably has an inner surface coated with a fluororesin. That is, the outer cylinder 80 preferably has a fluororesin layer on the inside of the outer cylinder 80. By having a fluororesin layer on the inner surface of the outer cylinder 80, the slipperiness of the inner surface of the outer cylinder 80 is improved, making it easier to move the basket 10 in the longitudinal direction within the inner cavity of the outer cylinder 80.
[0052] The cross-sectional shape of the outer cylinder 80 in a cross section perpendicular to the longitudinal axis direction may be circular, elliptical, polygonal, or a combination thereof. The cross-sectional shape of the lumen of the outer cylinder 80 in a cross section perpendicular to the longitudinal axis direction may also be circular, elliptical, polygonal, or a combination thereof.
[0053] The basket 10 is deformable and preferably slidable within a cylinder having an inner diameter of 0.021 inches (0.5334 mm) or less, and more preferably slidable within a cylinder having an inner diameter of 0.017 inches (0.4318 mm) or less. When the outer cylinder 80 has one lumen, it is preferable that the inner diameter of the outer cylinder 80 is 0.017 inches or less, and the basket 10 is disposed within the lumen of this outer cylinder 80. Furthermore, when the outer cylinder 80 has multiple lumens, it is preferable that the inner diameter of the lumen in which the basket 10 is disposed is 0.017 inches or less. Since the basket 10 is deformable and slidable within a cylinder having an inner diameter of 0.017 inches or less, the outer diameter of the outer cylinder 80 can be reduced, resulting in an embolization device 1 that is easy to insert and minimally invasive.
[0054] The basket 10 preferably has a mesh-like wall surface formed by the intersection of a plurality of wires 20. Because the basket 10 has a mesh-like wall surface formed by the intersection of a plurality of wires 20, it is possible to easily accommodate an embolic substance inside the basket 10 through a mesh-like opening where the plurality of wires 20 intersect. Furthermore, because the basket 10 has a mesh-like wall surface, the opening of the wall surface of the basket 10 is in the shape of a mesh where the plurality of wires 20 intersect, making it difficult for the embolic substance accommodated inside the basket 10 to escape from the basket 10. As a result, it is easier to embolize an aneurysm using the embolization device 1.
[0055] As shown in FIG. 2 , when the basket 10 is housed in the outer tube 80, the distal end 40d of the proximal binding part 40 is preferably located more proximal than the proximal end 50p of the housing part 50. Furthermore, as shown in FIG. 3 , when the entire basket 10 is outside the outer tube 80 and no external force is applied to the basket 10, the distal end 40d of the proximal binding part 40 is preferably located more distal than the proximal end 50p of the housing part 50. When the basket 10 is housed in the outer tube 80, the distal end 40d of the proximal binding part 40 is located more proximal than the proximal end 50p of the housing part 50, making it difficult for the wire 20 to be positioned radially outward of the proximal binding part 40 within the outer tube 80. Therefore, the outer diameter of the basket 10 placed in the lumen of the outer tube 80 can be reduced, and accordingly, the outer diameter of the outer tube 80 can also be reduced, resulting in a minimally invasive embolization device 1.
[0056] As shown in FIGS. 1 , 3 , and 4 , the proximal end 30p of the distal binding part 30 is preferably located proximal to the distal end 50d of the storage part 50. By having the proximal end 30p of the distal binding part 30 located proximal to the distal end 50d of the storage part 50, the distal binding part 30 is less likely to protrude from the distal end 10d of the basket 10. Therefore, even if the distal end 10d of the basket 10 comes into contact with an object such as a blood vessel wall when the basket 10 is placed at a target site and the storage part 50 is excessively filled with embolic material, the distal binding part 30 is less likely to come into contact with the object, making it less likely to injure the object. Note that the configuration in which the proximal end 30p of the distal binding part 30 is located proximal to the distal end 50d of the storage part 50 is preferably a configuration in which the basket 10 is not subjected to external force, such as when the entire basket 10 is outside the outer tube 80.
[0057] 2 , when the basket 10 is housed in the outer tube 80, the distal end 30d of the distal binding part 30 is preferably located distal to the distal end 50d of the housing part 50. When the basket 10 is housed in the outer tube 80, the distal end 30d of the distal binding part 30 is located distal to the distal end 50d of the housing part 50, which makes it difficult for the wire 20 to be disposed radially outward of the distal binding part 30 within the outer tube 80. This allows the outer diameter of the basket 10 placed in the lumen of the outer tube 80 to be reduced, which in turn allows the outer diameter of the outer tube 80 to be reduced, resulting in a minimally invasive embolization device 1.
[0058] Preferably, at least one wire 20 of the basket 10 comprises a nickel-titanium alloy, and the basket 10 is stretchable in the longitudinal and radial directions of the basket 10. Because at least one wire 20 of the basket 10 comprises a nickel-titanium alloy, the wire 20 has high elasticity, allowing the basket 10 to deform significantly. Furthermore, because the basket 10 is stretchable in the longitudinal and radial directions of the basket 10, the volume of the basket 10 can be expanded. In other words, because at least one wire 20 of the basket 10 comprises a nickel-titanium alloy and the basket 10 is stretchable in the longitudinal and radial directions, the basket 10 can be expanded to fit the size of the aneurysm in the lumen, allowing the basket 10 to be in close contact with the wall of the aneurysm. As a result, embolization of the aneurysm can be facilitated.
[0059] It is preferable that a radiopaque portion containing a radiopaque material is provided in at least one of the distal binding portion 30 and the proximal binding portion 40. By providing a radiopaque portion in at least one of the distal binding portion 30 and the proximal binding portion 40, the position of at least one of the distal binding portion 30 and the proximal binding portion 40 in which the radiopaque portion is provided can be confirmed under X-ray fluoroscopy, and the position of the basket 10 within the body can be determined.
[0060] Examples of radiopaque materials include platinum, gold, tungsten, iridium, palladium, tantalum, and alloys of at least one of these.
[0061] The radiopaque portion disposed in at least one of the distal binding portion 30 and the proximal binding portion 40 may be formed by incorporating a radiopaque material into the material constituting the separate member that bundles and secures the plurality of wires 20, so that the separate member that bundles and secures the plurality of wires 20 also serves as the radiopaque portion. By having the separate member that bundles and secures the plurality of wires 20 also serve as the radiopaque portion, an increase in the number of components constituting the basket 10 can be prevented, and the manufacturing efficiency of the embolization device 1 can be improved.
[0062] At least one wire 20 of the basket 10 may include a radiopaque material. By including at least one wire 20 of a radiopaque material, it becomes possible to check the expansion state and position of the basket 10 under X-ray fluoroscopy, which makes it easier to smoothly perform a procedure using the embolization device 1.
[0063] At least one wire 20 included in the basket 10 may have a core and an outer layer covering the core. By having at least one wire 20 having a core and an outer layer, the core and the outer layer can be made of different materials, and various properties can be imparted to the wire 20.
[0064] When at least one wire 20 of the basket 10 has a core and an outer layer, examples of materials for the core and outer layer include metals such as stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, aluminum, gold, silver, lead, barium, iodine, iridium, stainless steel, titanium, nickel-titanium alloy, and cobalt-chromium alloy. Among these, at least one wire 20 preferably has a core containing a radiopaque material and an outer layer containing a nickel-titanium alloy. By having at least one wire 20 having a core containing a radiopaque material and an outer layer containing a nickel-titanium alloy, the radiopaque material of the core improves the visibility of the basket 10 under X-ray fluoroscopy, while the nickel-titanium alloy of the outer layer increases elasticity, making it easier to expand the basket 10.
[0065] 2 to 4 , the embolization device 1 is disposed proximal to the proximal end 40p of the proximal binding portion 40 and distal to the distal end 70d of the basket pusher 70, and preferably further includes a connecting member 90 that connects the basket 10 to the basket pusher 70. Because the embolization device 1 includes the connecting member 90 that connects the basket 10 to the basket pusher 70, the basket 10 and the basket pusher 70 can be easily connected to each other.
[0066] The connecting member 90 is preferably detachable. In other words, it is preferable that the basket 10 can be detached from the basket pusher 70 by detaching the connecting member 90. Because the connecting member 90 is detachable, the basket 10 can be detached from the basket pusher 70 by detaching the connecting member 90 after the basket 10 has been transported to the target site. Therefore, the basket 10 can be easily placed at the target site.
[0067] The connecting member 90 can be separated by various methods, such as a mechanical separation mechanism, fusing, thermal, electrical, or chemical separation. Examples of the connecting member 90 include a rod-shaped object, a string-shaped object, a clip, or a member integrated by fitting together such as a protrusion or recess. The connecting member 90 can be made of a material such as a synthetic resin or metal. The connecting member 90 may be a separate member from the basket 10 or the basket pusher 70, or may be a part of either of them.
[0068] The material constituting the connecting member 90 preferably has a heat-melting property, and the embolization device 1 preferably has a heating mechanism for heating the connecting member 90. Because the material constituting the connecting member 90 has a heat-melting property and the embolization device 1 has a heating mechanism, the connecting member 90 can be heated by the heating mechanism to melt and break, allowing the basket 10 to be separated from the basket pusher 70. Therefore, the basket 10 and the basket pusher 70 can be firmly connected by the connecting member 90 until the heating mechanism is activated, and the connecting member 90 can be easily separated by activating the heating mechanism. As a result, the basket 10 can be placed at the target site reliably and easily.
[0069] The material that melts when heated and that constitutes the connecting member 90 is preferably a thermoplastic resin, and more preferably PVA (polyvinyl alcohol). Using PVA as the material for the connecting member 90 makes it easy to detach the connecting member 90, making the embolization device 1 easy to handle.
[0070] Although not shown, the heating mechanism is preferably connected to the basket pusher 70. By connecting the heating mechanism to the basket pusher 70, the connecting member 90 can be heated via the basket pusher 70. This eliminates the need to provide a separate member for transferring heat from the heating mechanism to the connecting member 90, thereby enabling the embolization device 1 to be made more compact. The heating mechanism may be directly connected to the basket pusher 70, or may be indirectly connected to the basket pusher 70 via another member.
[0071] As shown in Fig. 2, when the basket 10 is housed in the outer tube 80, the distal binding part 30 has a first end 31 that is the end farther from the proximal binding part 40 and a second end 32 that is the end closer to the proximal binding part 40, and as shown in Fig. 3, when the entire basket 10 is outside the outer tube 80 and no external force is being applied to the basket 10, it is preferable that the second end 32 is located distal to the first end 31. In other words, it is preferable that the positional relationship between the first end 31 and the second end 32 of the distal binding part 30 in the near / far direction be reversed between when the basket 10 is housed in the outer tube 80 and when the entire basket 10 is outside the outer tube 80 and no external force is being applied to the basket 10. In other words, it is preferable that the positional relationship between the first end 31 and the second end 32 of the distal binding portion 30 in the near and far directions be reversed between a state in which the basket 10 is housed within the outer tube 80 and a state in which the entire basket 10 is outside the outer tube 80 and no external force is applied to the basket 10.
[0072] When the basket 10 is housed in the outer tube 80, the first end 31 is located distal to the second end 32, so that the wires 20 constituting the basket 10 and the distal binding portion 30 do not overlap inside the outer tube 80. This prevents the diameter of the basket 10 from becoming large, allowing the use of an outer tube 80 with a smaller diameter, resulting in a minimally invasive embolization device 1. Furthermore, when the entire basket 10 is outside the outer tube 80 and no external force is being applied to the basket 10, the second end 32 is located distal to the first end 31, so that the wires 20 located at the distal end of the housing portion 50 are bent. As a result, even if the distal end 10d of the basket 10 comes into contact with an object such as a blood vessel wall, it is possible to prevent damage to the object.
[0073] An embolization system may also be provided that includes the embolization device 1 of the present invention and an embolic object. The embolic object is a coil body, the coil body having a primary shape formed by winding a wire and a secondary shape formed by winding a coil portion of the primary shape. The basket 10 includes a curved portion 100, which is a portion including the proximal end 50p of the storage section 50 and in which the outer shape of the basket 10 is curved. The minimum radius of curvature of the curved portion 100 is preferably larger than the radius of curvature of the secondary shape of the coil body. Since the minimum radius of curvature of the curved portion 100 of the basket 10 is larger than the radius of curvature of the secondary shape of the coil body, the coil body can easily enter the curved portion 100 of the basket 10. As a result, the coil body can easily be loaded onto both ends of the proximal portion of the basket 10.
[0074] As described above, the embolization device of the present invention is an embolization device for an intraluminal aneurysm, and includes a basket for accommodating embolic material, the basket including a plurality of wires, a distal bundling section bundling and securing the plurality of wires on the distal side of the basket, a proximal bundling section bundling and securing the plurality of wires on the proximal side of the basket, and a storage section that is a portion of the plurality of wires between the distal bundling section and the proximal bundling section, and the distal end of the proximal bundling section is located distal to the proximal end of the storage section. This configuration of the embolization device of the present invention makes it possible for embolic material to be loaded into the basket and for the embolic material to easily come into contact with the proximal bundling section and the wires located distal to the distal end of the proximal bundling section. Contact of the embolic material with the proximal bundling section and the wires located distal to the distal end of the proximal bundling section facilitates the embolic material being loaded into the basket to travel toward both ends of the proximal section of the basket. As a result, the embolic material can easily enter both ends of the proximal part of the basket, making it easier to fill the entire interior with the embolic material. Also, because the distal end of the proximal binding part is located distal to the proximal end of the storage part, even if the storage part is overfilled with the embolic material being fed into the inside of the basket, the proximal binding part is less likely to protrude toward the parent artery, making it less likely that a thrombus will form in the parent artery and that other objects, such as the blood vessel wall, will be damaged.
[0075] This application claims the benefit of priority based on Japanese Patent Application No. 2022-100662, filed on June 22, 2022. The entire contents of the specification of Japanese Patent Application No. 2022-100662, filed on June 22, 2022, are incorporated herein by reference.
[0076] 1: Embolization device 10: Basket 10d: Distal end of basket 10p: Proximal end of basket 20: Wire 30: Distal binding portion 30d: Distal end of distal binding portion 30p: Proximal end of distal binding portion 31: First end 32: Second end 40: Proximal binding portion 40d: Distal end of proximal binding portion 40p: Proximal end of proximal binding portion 50: Storage portion 50d: Distal end of storage portion 50p: Proximal end of storage portion 60: Recess 70: Basket pusher 70d: Distal end of basket pusher 80: Sheath 80d: Distal end of sheath 90: Connecting member 100: Curved portion L1: Straight line passing through the proximal end of the storage portion and perpendicular to the extension direction of the basket pusher L2: A straight line connecting the proximal end of the storage section and the distal end of the proximal binding section. D1: The distance between the line L1 and the distal end of the proximal binding section. d1: The maximum outer diameter of the basket. θ1: The angle between the line L1 and the line L2.
Claims
1. An embolization device for aneurysms within a tubular lumen, An outer cylinder having a distal end and a proximal end, It has a basket that can be placed inside the lumen of the outer cylinder and for containing the embolus, The aforementioned basket has multiple wires, The basket has a distal binding portion that bundles and secures a plurality of wires at the distal end of the basket, a proximal binding portion that bundles and secures a plurality of wires at the proximal end of the basket, and a housing portion which is the portion of the plurality of wires between the distal binding portion and the proximal binding portion. The distal end of the proximal binding portion is distal to the proximal end of the housing portion. In a state in which the basket is housed within the outer cylinder, the distal end of the proximal binding portion is located proximal to the proximal end of the housing portion of the embolic device.
2. The embolic device according to claim 1, wherein the basket has a recess in which the proximal portion of the basket, including the proximal binding portion, is recessed toward the distal side.
3. It has a basket pusher positioned proximal to the proximal end of the aforementioned proximal binding portion, The embolic device according to claim 1, wherein the distance between a straight line passing through the proximal end of the housing portion and perpendicular to the extending direction of the basket pusher and the distal end of the proximal binding portion is 1 / 10 or more of the maximum diameter of the basket.
4. It has a basket pusher positioned proximal to the proximal end of the aforementioned proximal binding portion, The embolic device according to claim 1, wherein the angle between a straight line passing through the proximal end of the housing portion and perpendicular to the extending direction of the basket pusher, and a straight line connecting the proximal end of the housing portion and the distal end of the proximal binding portion, is 5 degrees or more and 60 degrees or less.
5. The embolic device according to claim 1, wherein the proximal end of the distal binding portion is located more proximal to the distal end of the housing portion.
6. At least one of the wires in the basket contains a nickel-titanium alloy. The embolic device according to claim 1, wherein the basket is extendable in the longitudinal axis direction and radial direction of the basket.
7. The embolic device according to claim 1, wherein at least one of the distal binding portion and the proximal binding portion is provided with an X-ray opaque portion containing an X-ray opaque material.
8. It has a basket pusher positioned proximal to the proximal end of the aforementioned proximal binding portion, The embolic device according to claim 1, further comprising a connecting member that is positioned proximal to the proximal end of the proximal binding portion and distal to the distal end of the basket pusher, and connects the basket and the basket pusher.
9. The embolic device according to claim 8, wherein the connecting member is detachable.
10. In a state in which the basket is housed in the outer cylinder, the distal binding portion has a first end which is the end furthest from the proximal binding portion and a second end which is the end closest to the proximal binding portion, The embolic device according to claim 1, wherein, when the entire basket is outside the outer cylinder and no external force is applied to the basket, the second end is located distal to the first end.