WO2023189387A1

WO2023189387A1 - Medical device

Info

Publication number: WO2023189387A1
Application number: PCT/JP2023/009151
Authority: WO
Inventors: 篤志小川; 雅之高寺
Original assignee: 株式会社カネカ
Priority date: 2022-03-29
Filing date: 2023-03-09
Publication date: 2023-10-05

Abstract

A medical device (1) is provided with a basket (30) having a plurality of wires (20), a connecting member (80) positioned more to the proximal side than the basket (30), and a basket pusher (40) positioned more to the proximal side than the connecting member (80), in which the connecting member (80) includes a distal-side member (81) and a proximal-side member (82), and the distal-side member (81) is formed rotatably with respect to the proximal-side member (82).

Description

medical device

The present invention relates to a medical device used in a lumen in a living body such as a blood vessel.

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 arteries, and abdominal aneurysms. An example of endovascular treatment is embolization, which prevents the aneurysm from rupturing by placing an embolization device with a coil for embolization at the target site, such as inside the aneurysm or other aneurysm, to promote thrombosis. used.

If the opening of an aneurysm or the like in the blood vessel wall is large, the embolization coil placed inside the aneurysm may come out from within the aneurysm. In order to prevent the coil placed in the aneurysm from deviating from the aneurysm, an indwelling device may be used that is placed within the aneurysm or in a blood vessel near the opening of the aneurysm. Also known is an embolization technique in which a basket is placed within the aneurysm and a coil is stuffed into the basket, thereby retaining the coil within the aneurysm to fill the aneurysm and prevent the aneurysm from rupturing.

For example, Patent Document 1 discloses a device for treating an aneurysm that is located within a parent blood vessel that defines a lumen and has a neck and an inner wall that define a lumen that communicates with the lumen, The device is configured to be deployed within the lumen and further comprises a collapsible member adapted to span the neck of the aneurysm and contact the inner wall of the aneurysm when the device is deployed. There is. US Pat. No. 5,001,000 describes a plurality of elongated elastic filaments with a woven structure secured to each other at the proximal and distal ends of the filaments and for delivery within a microcatheter. a radially constrained elongated condition configured such that the thin woven filaments are radially adjacent to each other along the length of the filaments longitudinally from the proximal end to the distal end; an expanded relaxed state having a spherical longitudinally foreshortened configuration relative to the radially constrained state, whereby the textile filaments are the self-expanding elasticity within a smooth path extending radially from the longitudinal axis between the proximal and distal ends, including a plurality of openings in the shell formed therebetween; a self-expanding elastic body forming a permeable shell, the largest of the openings having a relaxed state configured to allow blood flow through the opening at a velocity below the thrombus critical velocity; A device is described that includes a transmissive shell. Patent Document 3 has a proximal end region and a distal end region, has a first expanded state and a second collapsed state, and has a patient's blood vessel in the second collapsed state. a substantially tubular structure having dimensions suitable for insertion through the system and through the neck of the aneurysm, having an outer surface capable of abutting the aneurysm in an expanded state, and further having an inner surface; is disposed in the proximal end region of the structure to prevent radial expansion of the proximal end region and to provide an engagement feature during operation of the closure device. A control ring having an at least substantially surrounding substantially annular body is described. Patent Document 4 discloses a holding part formed from a plurality of wires braided into a cylindrical shape with a closed proximal end, the closed proximal end having a first opening, and a holding part that can be attached to and detached from the holding part. a catheter having a tip operably connected thereto, the catheter having a passageway extending to a distal end of the catheter and aligned with the first opening of the retaining portion, the embolic material within the passageway of the catheter; A closure device is described that is advanceable through the passageway, through the first opening, and into the cylindrical shape of the retaining portion. US Pat. No. 5,001,201 includes a self-expanding permeable shell having a proximal end, a distal end, and a longitudinal axis, the shell including a plurality of elongated resilient filaments having a braided structure, A filament is secured to at least one of a proximal end or a distal end of the permeable shell, and the permeable shell is configured and radially constrained for delivery within a microcatheter. in an extended state and in an expanded state having an axially shortened configuration relative to the radially constrained state, the permeable shell having a plurality of A device is described having an opening; the permeable shell in its expanded state includes a plurality of circumferentially aligned lobes. U.S. Pat. No. 6,002,200 discloses an implant movable from a collapsed state to a deployed state, the implant having a proximal end, a distal end, and a substantially continuous portion between the proximal end and the distal end. a braided section forming a braided structure; and an outer occluding pouch, wherein in the deployed state, the implant extends from the proximal end of the implant and is capable of occluding an aneurysm neck. an inner occlusion pouch forming and extending the distal end of the implant and forming a groove within the outer occlusion pouch; and the braid positioned between the outer occlusion pouch and the inner occlusion pouch. A folding portion within a section is described.

Special Publication No. 2001-518320 Special Publication No. 2011-519632 Japanese Patent Application Publication No. 2015-196092 Special table 2019-506230 publication Special Publication No. 2020-509922 JP2020-58808A

In devices such as Patent Documents 1 to 6, the opening through which a long medical object such as a coil can be inserted into the device is limited. Therefore, depending on the condition of the lesion or the procedure, it may be difficult to insert a long medical object into the device. In order to make it easier to insert long medical objects into devices such as those disclosed in Patent Documents 1 to 6, there is a problem in that the size of the device itself becomes large, and there is room for improvement.

The present invention has been made in view of the above circumstances, and its purpose is to provide a medical device that allows long medical objects to be easily inserted into the basket.

Medical devices that have been able to solve the above problems are as follows.
[1] A basket having multiple wires,
a connecting member disposed on a proximal side of the basket;
a basket pusher disposed on the proximal side of the connecting member;
The connecting member includes a distal member and a proximal member,
The medical device, wherein the distal member is rotatably formed relative to the proximal member.
[2] It has an outer cylinder having a distal end and a proximal end,
The medical device according to [1], wherein the basket is disposed in the inner lumen of the outer cylinder and is expandable when exiting the outer cylinder.
[3] The connecting member can be separated,
The medical device according to [1] or [2], wherein the basket is removable from the basket pusher.
[4] One of the distal side member and the proximal side member has a spherical portion,
The medical device according to any one of [1] to [3], wherein the other of the distal member and the proximal member has a covering portion that covers the spherical portion.
[5] The connecting member has a shaft member on the proximal side of the distal side member and distal side of the proximal side member,
The medical device according to any one of [1] to [3], wherein the shaft member is inserted through the distal member and the proximal member.
[6] The medical device according to any one of [1] to [5], wherein at least one of the material constituting the distal side member and the material constituting the proximal side member is metal.
[7] In a state in which the distal side member is rotated relative to the proximal side member, a straight line passing through the extending direction of the basket pusher, the distal end of the basket, and the proximal end of the basket; The medical device according to any one of [1] to [6], wherein the angle formed by the proximal side is 45 degrees or more and 150 degrees or less.
[8] The basket includes a first binding part that bundles and fixes the plurality of wires at its distal part, and a second binding part that bundles and fixes the plurality of wires at its proximal part. , comprising:
The medical device according to any one of [1] to [7], wherein the first binding part and the second binding part contain an X-ray opaque material.

According to the medical device of the present invention, the connecting member includes a distal side member and a proximal side member, and the distal side member is formed to be rotatable with respect to the proximal side member. The distal side member and the proximal side member are rotated, the connecting member is bent, and the basket connected to the basket pusher via the connecting member is tilted with respect to the basket pusher. be able to. Therefore, for example, when the basket is placed inside the aneurysm by passing through the aperture of the aneurysm, the side surface of the basket can be directed toward the aneurysm opening. The sides of the basket tend to have larger gaps between the wires than the proximal and distal ends of the basket, so the coils can be inserted into the basket through the gaps between the wires. It is possible to easily insert long medical objects such as the like.

FIG. 3 depicts a cross-sectional view of the distal end of the medical device in an embodiment of the present invention, parallel to the direction of extension of the basket pusher. 2 shows an enlarged view of a portion of the medical device shown in FIG. 1 with a connecting member; FIG. FIG. 2 shows a cross-sectional view of the medical device shown in FIG. 1 in a state where the basket is housed in the outer cylinder, parallel to the extending direction of the basket pusher. FIG. 6 shows an enlarged view of a portion of a medical device in accordance with another embodiment of the present invention with a connecting member.

Hereinafter, the present invention will be explained in more detail based on the following embodiments. However, the present invention is not limited by the following embodiments, and modifications may be made as appropriate within the scope that fits the spirit of the above and below. Of course, additional implementations are also possible, and all of these are included within the technical scope of the present invention. In addition, in each drawing, hatching, member codes, etc. may be omitted for convenience, but in such cases, the specification and other drawings shall be referred to. Further, the dimensions of various members in the drawings are given priority to help understanding the features of the present invention, and therefore may differ from actual dimensions.

FIG. 1 is a sectional view parallel to the extending direction of the basket pusher 40 at the distal end of the medical device 1 according to the embodiment of the present invention, and FIG. 2 is a sectional view of the portion of the medical device 1 where the connecting member 80 is located. This is an enlarged view. In the present invention, the proximal side refers to the side near the user's hand with respect to the extending direction of the basket pusher 40, and the distal side refers to the side opposite to the proximal side, that is, the side on which treatment is performed with the medical device 1 ( This refers to the lesion side). Moreover, the extending direction of the basket pusher 40 may be referred to as the longitudinal axis direction. The longitudinal axis direction of the basket pusher 40 can be referred to as the perspective direction of the basket pusher 40. In addition, in FIG. 1 and FIG. 2, the right side of the figure is the proximal side, and the left side of the figure is the distal side. In addition, in FIGS. 1 and 2, only some of the plurality of wires 20 included in the basket 30 are shown, and other wires are not shown, in order to make it easier to understand the positional relationship of each member and region. It is omitted.

As shown in FIGS. 1 and 2, the medical device 1 of the present invention includes a basket 30 having a plurality of wires 20, a connecting member 80 disposed on the proximal side of the basket 30, and a connecting member 80 disposed closer than the connecting member 80. The connecting member 80 includes a distal side member 81 and a proximal side member 82, and the distal side member 81 has a basket pusher 40 disposed on the proximal side. It is formed to be rotatable relative to the side member 82.

The medical device 1 can be used for embolization, etc., in which the basket 30 is placed in a vascular lesion such as an aneurysm to promote thrombosis and prevent the aneurysm from rupturing. In embolization, for example, the basket 30 is placed within the aneurysm at the end of the in-vivo lumen, within the aneurysm at the side wall of the in-vivo lumen, at the distal end of the main body of the in-vivo lumen, and A long medical object is placed inside a basket 30 placed at the distal end of the main tube to promote thrombosis of the aneurysm. Examples of medical long objects include coils, wires, string-like objects, and the like. Furthermore, the medical long object may be a tube for conveying a long object such as a coil. In addition, the tubular long medical object may be for transporting semi-solid fluids, gels, semi-solids, liquids, or even bag-like objects into the aneurysm. The liquid for the tubular long medical object may be, for example, a liquid that hardens or a liquid that precipitates.

As shown in FIGS. 1 and 2, the basket 30 has a plurality of wires 20. Basket 30 is expandable and deflated. Specifically, when the basket 30 is receiving an external force, the basket 30 is deflated and has a reduced diameter, and when it is not receiving an external force, the basket 30 is expanded and has an enlarged diameter. Note that when the basket 30 is placed inside the aneurysm, the basket 30 comes into contact with the aneurysm wall and receives external force from the aneurysm, causing it to deform.

The material constituting the wire 20 is preferably elastic, and includes, for example, stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, aluminum, gold, silver, and Ni-Ti alloy. , a single wire, a flat wire, a double wire, a composite material wire, or a stranded metal wire made of a Co--Cr alloy or the like. Among these, the material constituting the wire 20 is preferably a superelastic material, and more preferably a metal wire of Ni--Ti alloy. Since the material constituting the wire 20 is a Ni-Ti alloy metal wire, the elasticity of the wire 20 is increased, and even if the deformation amount of the basket 30 ejected from the outer cylinder 10 is large, the amount of return is large, and the basket 30 is The shape can be made less likely to collapse.

The number of wires 20 that the basket 30 has may be plural, and the number of wires 20 can be selected depending on the inner diameter of the in-vivo lumen, etc. Note that in the drawings, the number of wires 20 in the basket 30 is limited. However, in embodiments of the present invention, the basket 30 may be comprised of, for example, 8 to 64 wires 20. The wire diameter of the wire 20 can be set depending on the size of the basket 30, the number of wires 20, the material, etc. The number of wires 20 that the basket 30 has is preferably 16 or more and 32 or less.

As shown in FIGS. 1 and 2, the connecting member 80 is placed closer to the basket 30. The connecting member 80 is a member that connects the basket 30 and the basket pusher 40. In other words, the basket 30 and the basket pusher 40 are directly or indirectly connected via the connecting member 80. Since the medical device 1 has the connecting member 80 on the proximal side of the basket 30 and on the distal side of the basket pusher 40, the basket 30 and the basket pusher 40 can be easily connected.

As shown in FIGS. 1 and 2, the basket pusher 40 is disposed on the proximal side of the connecting member 80. The basket pusher 40 is connected to the basket 30 via a connecting member 80 and moves the basket 30 in the longitudinal axis direction of the outer cylinder 10 to eject the basket 30 from the outer cylinder 10 or move the basket 30 into the outer cylinder 10. can be accommodated. Although not shown, the basket pusher 40 may include a handle at the proximal end of the outer cylinder 10 for controlling the position and rotation in the longitudinal axis direction.

The material constituting the basket pusher 40 is preferably metal, and examples thereof include metals such as stainless steel, carbon steel, and nickel-titanium alloy. Among these, it is preferable that the material forming the basket pusher 40 is stainless steel. By making the material of the basket pusher 40 stainless steel, the rigidity of the basket pusher 40 can be increased. As a result, the force applied to the basket pusher 40 can be efficiently transmitted to the basket 30, making it easier to move the basket 30 in the longitudinal direction.

As shown in FIGS. 1 and 2, the connecting member 80 includes a distal member 81 and a proximal member 82, and the distal member 81 is rotatable with respect to the proximal member 82. possible. Since the distal member 81 of the connecting member 80 is rotatable with respect to the proximal member 82, the connecting member 80 can be bent, and the basket 30 is tilted with respect to the basket pusher 40. be able to. Therefore, for example, when the basket 30 is placed inside the aneurysm by passing through the opening of the aneurysm, the connecting member 80 is bent by pushing the basket pusher 40, and the distal end of the basket 30 is moved proximally. Rotate towards. As a result, the sides of the basket 30 can be directed toward the opening of the aneurysm. Since the gaps between the plurality of wires 20 of the basket 30 tend to be larger than those of the proximal and distal ends of the basket 30, the side portions of the basket 30 can pass through the gaps between the plurality of wires 20. A long medical object such as a coil can be easily inserted into the basket 30.

FIG. 3 is a sectional view parallel to the extending direction of the basket pusher 40 in a state where the basket 30 is housed in the outer cylinder 10. In addition, in FIG. 3, the right side of the figure is the proximal side, and the left side of the figure is the distal side.

As shown in FIG. 3, the medical device 1 has an outer tube 10 having a distal end 10d and a proximal end 10p. Preferably, it is expandable upon exiting the tube 10. That is, it is preferable that the basket 30 is disposed in a lumen of the outer cylinder 10, and that the basket 30 can be expanded when released from the outer cylinder 10. When the basket 30 is disposed in the inner cavity of the outer cylinder 10, it is in contact with the inner wall of the outer cylinder 10, receives external force from the outer cylinder 10, and is deflated and reduced in diameter. When the basket 30 is released from the outer cylinder 10, it is no longer subjected to the external force, and when there is no other external force, the basket 30 is expanded and expanded in diameter. By disposing the basket 30 in the inner cavity of the outer cylinder 10, it becomes easy to transport the basket 30 to the target site, and it becomes easy to perform a procedure such as embolization using the medical device 1.

The outer cylinder 10 is a cylindrical member extending in the longitudinal direction, and has at least one lumen extending in the longitudinal direction. Although the number of lumens that the outer cylinder 10 has may be plural, it is preferable that the number of lumens is one. Since the outer tube 10 has one lumen, the outer diameter of the outer tube 10 can be made small. As a result, it becomes possible to improve the minimally invasive nature of the medical device 1.

The material constituting the outer cylinder 10 is preferably resin or metal. Examples of the resin constituting the outer cylinder 10 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine resins, vinyl chloride resins, silicone resins, and natural rubber. These may be used alone or in combination of two or more. Among these, the resin constituting the outer cylinder 10 is preferably at least one of a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, and a fluororesin. Since the material constituting the outer cylinder 10 is at least one of a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, and a fluorine resin, the surface of the outer cylinder 10 has increased slipperiness, and can be used for blood vessels, etc. The insertion into the lumen can be improved. The tube made of resin, which becomes the outer cylinder 10, can be manufactured using a conventional method such as extrusion molding or injection molding.

Examples of the metal constituting the outer cylinder 10 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or a combination thereof. It will be done. The tube made of metal, which becomes the outer cylinder 10, may be a tube made by spirally winding a metal wire, a tube made by knitting a metal wire, or the like. Further, the outer cylinder 10 may be a tube made of a combination of metal and resin. The outer cylinder 10 may be a cylindrical body made of resin and provided with a reinforcing material such as a metal wire. When using a resin tubular member with a wire arranged thereon as the outer cylinder 10, a wire made of a Ni--Ti alloy is preferable because it has excellent shape memory and high elasticity. Further, the wire may be a fibrous material such as the above-mentioned metal, polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, or carbon fiber. The fibrous material may be monofilament or multifilament.

The outer cylinder 10 may be composed of a single layer or a plurality of layers. Moreover, in the longitudinal axis direction, a part of the outer cylinder 10 may be composed of a single layer, and other parts may be composed of a plurality of layers.

It is preferable that the outer surface of the outer cylinder 10 is coated with a hydrophilic resin. That is, it is preferable that the outer cylinder 10 has a hydrophilic resin layer on the outside of the outer cylinder 10. Since the outer surface of the outer tube 10 is coated with a hydrophilic resin, the slipperiness of the outer tube 10 is increased, and the insertability within the lumen of the living body can be improved.

Furthermore, it is preferable that the inner surface of the outer cylinder 10 is coated with a fluororesin. In other words, the outer cylinder 10 preferably has a fluororesin layer inside the outer cylinder 10. By having the fluororesin layer inside the outer cylinder, the slipperiness of the inner surface of the outer cylinder 10 is improved. Therefore, the basket 30 can be easily moved in the longitudinal axis direction in the inner cavity of the outer cylinder 10.

The cross-sectional shape of the outer shape of the outer cylinder 10 in a cross section perpendicular to the longitudinal axis direction may be circular, elliptical, polygonal, or a combination thereof. Further, the cross-sectional shape of the inner cavity of the outer cylinder 10 in a cross section perpendicular to the longitudinal axis direction may also be circular, elliptical, polygonal, or a combination thereof.

It is preferable that the basket 30 is capable of sliding inside a cylinder having an inner diameter of 0.021 inch (0.5334 mm) or less. When the outer cylinder 10 has one lumen, it is preferable that the inner diameter of the outer cylinder 10 is 0.021 inches or less, and that the basket 30 is disposed in the inner cavity of the outer cylinder 10. . Moreover, when the outer cylinder 10 has a plurality of lumens, it is preferable that the inner diameter of the lumen in which the basket 30 is placed is 0.021 inch or less. Since the basket 30 can slide inside a cylinder with an inner diameter of 0.021 inch or less, the outer diameter of the outer cylinder 10 can be reduced, and the medical device 1 can be easily inserted and minimally invasive. can.

It is preferable that the connecting member 80 is separable and that the basket 30 is removable from the basket pusher 40. That is, it is preferable that the basket 30 can be detached from the basket pusher 40 by separating the connecting member 80. Since the connecting member 80 can be separated, the basket 30 can be detached from the basket pusher 40 by separating the connecting member 80 after transporting the basket 30 to the target site, making it easier to leave the basket 30 in the target site.

Various methods can be used to separate the connection member 80, such as a mechanical separation mechanism, fusing, thermal, electrical, and chemical separation.

As shown in FIG. 2, one of the distal member 81 and the proximal member 82 has a spherical portion 83, and the other of the distal member 81 and the proximal member 82 has a spherical portion 83. It is preferable to have a cover part 84 that covers 83. That is, the connecting member 80 has a spherical part 83 and a covering part 84, and when the distal member 81 has the spherical part 83, the proximal member 82 has the covering part 84. However, when the distal side member 81 has the cover part 84, it is preferable that the proximal side member 82 has the spherical part 83. One of the distal side member 81 and the proximal side member 82 has a spherical part 83, and the other of the distal side member 81 and the proximal side member 82 has a cover part 84, so that the spherical part The connection member 80 is bent by sliding the cover portion 84 on the cover portion 83 . Therefore, the connecting member 80 can be bent smoothly, and the degree of bending of the connecting member 80 can be easily controlled.

When the connecting member 80 has the spherical portion 83 and the cover portion 84, the proximal member 82 has a longitudinally extending lumen, as shown in FIG. It is preferable that it has an elongated member 86 that is inserted through it, and that the distal end of this elongated member 86 contacts the spherical portion 83 or the cover portion 84 . Specifically, when the proximal member 82 has the cover part 84 and the distal member 81 has the spherical part 83, the distal end of the elongated member 86 has the spherical part. If the proximal member 82 has a spherical portion 83 and the distal member 81 has a cover portion 84, the distal end of the elongate member 86 preferably contacts the spherical portion 83. It is preferable to contact the cover part 84. Since the connecting member 80 has the spherical part 83 and the covering part 84 and the medical device 1 has the elongated member 86, the distal end of the elongated member 86 is connected to the spherical part 83 or the covering part 84. By contacting the spherical part 83 and the cover part 84, either one of the spherical part 83 and the cover part 84 is pushed out from the other, and the connection between the spherical part 83 and the cover part 84 can be easily released.

FIG. 4 is an enlarged view of a portion of the medical device 1 in which the connecting member 80 is located in another embodiment of the present invention. In addition, in FIG. 4, the right side of the figure is the proximal side, and the left side of the figure is the distal side. In addition, in FIG. 4, only some of the plurality of wires 20 included in the basket 30 are shown, and illustrations of other wires are omitted to make it easier to understand the positional relationship of each member and region. There is.

As shown in FIG. 4, the connecting member 80 has a shaft member 85 on the proximal side of the distal side member 81 and on the distal side of the proximal side member 82. is preferably inserted through the distal side member 81 and the proximal side member 82. That is, the connecting member 80 has a distal side member 81, a proximal side member 82, and a shaft member 85, and by inserting the shaft member 85 through the distal side member 81 and the proximal side member 82, It is also preferable that the side member 81 and the proximal side member 82 be connected. The connecting member 80 has a shaft member 85 on the proximal side of the distal side member 81 and on the distal side of the proximal side member 82, and the shaft member 85 connects the distal side member 81 and the proximal side. By being inserted through the side member 82, the distal side member 81 can rotate relative to the proximal side member 82 using the shaft member 85 as an axis of rotation. Therefore, the bending of the connecting member 80 tends to be smooth, and the bending of the connecting member 80 can be easily controlled.

As shown in FIG. 4, it is preferable that the basket pusher 40 has a lumen extending in the longitudinal direction, and that an elongated member 86 that contacts the connecting member 80 is disposed in this lumen. Specifically, the medical device 1 has an elongated member 86, the elongated member 86 is disposed in the lumen of the basket pusher 40, and the distal end of the elongated member 86 is Preferably, the proximal end of the connecting member 80 is contacted. Since the medical device 1 includes the elongated member 86, the elongated member 86 comes into contact with the connecting member 80, and the connecting member 80 is pushed out from the basket pusher 40. As a result, the connecting member 80 is separated from the basket pusher 40, and the basket 30 can be removed from the basket pusher 40.

Although not shown, the connection member 80 may further include another member on the proximal side of the proximal member 82, and the member and the proximal member 82 may be connected. . Further, the connecting member 80 may further include another member distal to the distal member 81, and the member and the distal member 81 may be connected. Furthermore, the connecting member 80 may include a spherical portion 83, a cover portion 84, and a shaft member 85. Since the connecting member 80 includes the spherical portion 83, the cover portion 84, and the shaft member 85, the connecting member 80 can be bent in various directions.

Examples of the material constituting the connecting member 80 include metal, resin, or a combination thereof. Examples of the metal constituting the connecting member 80 include stainless steel, carbon steel, nickel titanium alloy, and the like. Examples of the resin constituting the connecting member 80 include polyamide resin, polyolefin resin, fluorine resin, polycarbonate resin, and PVA (polyvinyl alcohol).

In the connection member 80, the distal side member 81 and the proximal side member 82 may be made of metal, or the distal side member 81 and the proximal side member 82 may be made of resin. Alternatively, the distal member 81 may be made of metal and the proximal member 82 may be made of resin, or the distal member 81 may be made of resin and the proximal member 82 may be made of metal. may have been done.

It is preferable that at least one of the material constituting the distal side member 81 and the material constituting the proximal side member 82 is metal. Since at least one of the material constituting the distal side member 81 and the material constituting the proximal side member 82 is metal, the strength of the connecting member 80 is increased, and even if the connecting member 80 is repeatedly bent, the connecting member 80 remains stable. Less likely to be damaged.

A part of the connecting member 80 includes a heat-melting member having a property of being melted by heat, and the medical device 1 may include a heating mechanism 90 that heats the heat-melting member. Since the connecting member 80 includes a heat-melting member having a property of being melted by heat, the connecting member 80 melts and breaks when the heat-melting member is heated by the heating mechanism 90. Therefore, it becomes easy to separate the connecting member 80 and separate the basket 30 from the basket pusher 40.

The material that forms the heat-melting member included in the connecting member 80 and has the property of being melted by heat is preferably a thermoplastic resin, and more preferably PVA (polyvinyl alcohol). Since the material constituting the heat-melting member included in the connecting member 80 is PVA, the connecting member 80 can be easily separated, and the medical device 1 can be easily handled.

Preferably, the heating mechanism 90 is connected to the basket pusher 40. Since the heating mechanism 90 is connected to the basket pusher 40, the heat-melting member included in the connecting member 80 can be heated via the basket pusher 40, so that the heat of the heating mechanism 90 is transmitted to the heat-melting member. There is no need to separately provide a member for this purpose, and the medical device 1 can be made smaller.

As shown in FIG. 3, the length of the connecting member 80 in the extending direction of the basket pusher 40 is preferably shorter than the length of the basket pusher 40 and the length of the basket 30. Since the length of the connecting member 80 in the extending direction of the basket pusher 40 is shorter than the length of the basket pusher 40 and the length of the basket 30, the basket pusher 40 has a long distance from the hand side in order to convey the basket 30 to the target site. The force applied toward the rear side is easily transmitted to the basket 30, making it easier to transport the basket 30 smoothly.

The length of the connecting member 80 in the extending direction of the basket pusher 40 is preferably 70% or less, more preferably 60% or less, and even more preferably 50% or less of the length of the basket 30. . By setting the upper limit of the ratio of the length of the connecting member 80 to the length of the basket 30 in the above range, the strength of the connecting member 80 is increased, and the force that pushes the basket pusher 40 to move it distally is applied to the basket 30. It becomes easier to convey. Further, the length of the connecting member 80 in the extending direction of the basket pusher 40 is preferably 5% or more, more preferably 7% or more, and preferably 10% or more of the length of the basket 30. More preferred. By setting the lower limit of the ratio of the length of the connecting member 80 to the length of the basket 30 within the above range, the connecting member 80 can be easily bent, and the basket 30 can be easily rotated with respect to the basket pusher 40.

As shown in FIG. 1, when the distal side member 81 is rotated relative to the proximal side member 82, the extending direction L1 of the basket pusher 40, the distal end 30d of the basket 30, and the proximal side of the basket 30 are The angle θ1 formed by the straight line L2 passing through the end 30p on the proximal side is preferably 45 degrees or more and 150 degrees or less. The angle θ1 formed by the extending direction L1 of the basket pusher 40 and the straight line L2 passing through the distal end 30d of the basket 30 and the proximal end 30p of the basket 30 on the proximal side is 45 degrees or more and 150 degrees or less. This makes it easier for the connecting member 80 to be in a bent state and for the basket 30 to be in a sufficiently inclined state with respect to the basket pusher 40. As a result, for example, when the basket 30 is placed inside the aneurysm by passing through the aneurysm opening, the basket 30 is rotated by pushing the basket pusher 40, and the side surface of the basket 30 is directed toward the aneurysm opening. be able to. Since the gaps between the plurality of wires 20 of the basket 30 tend to be larger than those of the proximal and distal ends of the basket 30, the side portions of the basket 30 can pass through the gaps between the plurality of wires 20. A long medical object such as a coil can be easily inserted into the basket 30.

As shown in FIG. 1, when the distal end of the basket 30 is concave, an imaginary straight line connecting the most distal portions of at least two wires 20 of the basket 30 (see FIG. 1) is defined as the distal end 30d of the basket 30.

The angle θ1 formed on the proximal side by the extending direction L1 of the basket pusher 40 and the straight line L2 passing through the distal end 30d of the basket 30 and the proximal end 30p of the basket 30 is preferably 45 degrees or more. , more preferably 50 degrees or more, even more preferably 55 degrees or more, even more preferably 60 degrees or more, particularly preferably 65 degrees or more. By setting the lower limit value of the angle θ1 within the above range, the basket 30 can more easily rotate toward the side surface than the distal end 30d of the basket 30, thereby reducing the gap between the plurality of wires 20 that the basket 30 has. It is possible to easily insert a long medical object such as a coil through the tube. Further, the angle θ1 formed by the extending direction L1 of the basket pusher 40 and the straight line L2 passing through the distal end 30d and the proximal end 30p of the basket 30 on the proximal side is 150 degrees or less. is preferably 145 degrees or less, more preferably 140 degrees or less, even more preferably 135 degrees or less, particularly preferably 130 degrees or less, and 125 degrees or less. is more particularly preferred, and most preferably 120 degrees or less. By setting the upper limit value of the angle θ1 within the above range, the basket 30 can more easily rotate toward the side surface than the proximal end 30p of the basket 30, and the basket 30 can easily rotate a plurality of long medical objects that the basket 30 has. It becomes easier to insert the wires 20 through between them.

As shown in FIGS. 1 and 3, the basket 30 includes a first binding part 51 that bundles and fixes a plurality of wires 20 at its distal part, and a first binding part 51 that bundles and fixes a plurality of wires 20 at its proximal part. It is preferable that the first binding part 51 and the second binding part 52 contain an X-ray opaque substance. Since the first binding part 51 and the second binding part 52 contain an X-ray opaque substance, the first binding part 51 at the distal part of the basket 30 and the proximal part of the basket 30 can be seen under X-ray fluoroscopy. The position of the second binding section 52 can be confirmed in the section. As a result, it becomes possible to grasp the position of the basket 30 within the body.

Examples of the X-ray opaque substance include platinum, gold, tungsten, iridium, tantalum, and alloys of combinations of at least one of these.

The basket 30 is formed into a basket shape by braiding a plurality of bent wires 20 or right-handed and left-handed helical wires 20 between the first binding part 51 and the second binding part 52. It is preferable that Above all, it is preferable that the basket 30 is constructed by braiding a right-handed helical wire 20 and a left-handed helical wire 20. Since the basket 30 is constructed by braiding the right-handed helical wire 20 and the left-handed helical wire 20, the basket 30 has a mesh-like wall surface. As a result, objects stored inside the basket 30 are less likely to come out of the basket 30, making it easier to promote thrombosis efficiently.

In order to bundle and fix the plurality of wires 20 in the first binding part 51 and the second binding part 52, for example, the plurality of wires 20 are welded, caulked together with a separate member, or bonded using an adhesive. , fixing with brazing material, and a combination of these methods. Among these, it is preferable to caulk and fix the plurality of wires 20 in the first binding part 51 and the second binding part 52 using separate members. By caulking and fixing the plurality of wires 20 with separate members in the first binding part 51 and the second binding part 52, it is easy to firmly fix the plurality of wires 20 in the first binding part 51 and the second binding part 52. , the basket 30 is less likely to be damaged.

In the first binding part 51 and the second binding part 52, the separate members for bundling and fixing the plurality of wires 20 include, for example, a ring-shaped member, a member having a C-shaped cross section with a cut in the ring, and a wire wound member. Examples include a twisted coil-shaped member, a member tied and fixed with a string-like object, and the like. Among these, the separate member for bundling and fixing the plurality of wires 20 is preferably a ring-shaped member, and more preferably the ring-shaped member is held or fixed by swaging. The separate member for bundling and fixing the plurality of wires 20 is a ring-shaped member, and by holding or fixing the plurality of wires 20 by swaging processing, the plurality of wires 20 can be firmly fixed. It becomes possible to make it difficult for the wires 20 to be untied.

For example, the same material as the wire 20 of the basket 30 or the basket pusher 40 can be used as the material constituting the separate member for bundling and fixing the plurality of wires 20. Among these, the material constituting the separate member for bundling and fixing the plurality of wires 20 is preferably stainless steel. By using stainless steel as the material constituting the separate member for bundling and fixing the plurality of wires 20, the fixing strength of the plurality of wires 20 can be increased. Durability can be improved. Furthermore, it is more preferable that the material constituting the separate member for bundling and fixing the plurality of wires 20 is an X-ray opaque substance. Examples of the X-ray opaque substance include platinum, gold, tungsten, iridium, tantalum, and alloys of combinations of at least one of these. Since the material constituting the separate member for bundling and fixing the plurality of wires 20 is an X-ray opaque material, the positions of the first binding part 51 and the second binding part 52 can be confirmed under X-ray fluoroscopy. This makes it possible to grasp the position of the basket 30 inside the body.

As shown in FIG. 3, when the basket 30 is housed in the outer cylinder 10, the first binding part 51 is preferably located on the distal side of the distal end 20d of the wire 20. The first binding portion 51 is a portion where the plurality of wires 20 of the basket 30 are bundled and fixed. When the basket 30 is housed in the outer cylinder 10, the first binding part 51 is located on the distal side of the distal end 20d of the wire 20, so that the wires 20 are bundled by the first binding part 51. This makes it difficult for the plurality of wires 20 to come apart. Therefore, the basket 30 can be easily ejected from the outer cylinder 10 while the plurality of wires 20 maintain their respective phases.

As shown in FIG. 3, the second binding portion 52 is preferably located closer to the proximal end 20p of the wire 20. Like the first binding part 51, the second binding part 52 is a part where the plurality of wires 20 included in the basket 30 are bundled and fixed, and thus the second binding part 52 tends to have higher rigidity than other parts of the basket 30. By locating the second binding portion 52 on the proximal side of the proximal end 20p of the wire 20, the rigidity of the proximal end of the basket 30 can be increased, and the basket 30 added from the proximal side can be It becomes possible to efficiently transmit the force pushing toward the distal side to the basket 30. As a result, the medical device 1 can easily release the basket 30 from the outer cylinder 10.

It is preferable that the wire 20 included in the basket 30 contains a superelastic alloy. Since the wire 20 contains a superelastic alloy, the basket 30 has excellent elasticity. Since the basket 30 has excellent elasticity, the amount of deformation of the basket 30 can be increased. Therefore, the basket 30 can be housed in the outer cylinder 10 having a small outer diameter, and when the basket 30 comes out of the outer cylinder 10, the basket 30 can be greatly expanded.

It is preferable that the wire 20 included in the basket 30 contains an X-ray opaque substance. Since the wire 20 contains an X-ray opaque substance, it becomes possible to confirm the expansion state and position of the basket 30 under X-ray fluoroscopy, making it easier to perform the procedure smoothly.

As described above, the medical device of the present invention includes a basket having a plurality of wires, a connecting member disposed on the proximal side of the basket, and a basket pusher disposed on the proximal side of the connecting member. The connecting member includes a distal side member and a proximal side member, and the distal side member is formed to be rotatable with respect to the proximal side member. With such a configuration of the medical device of the present invention, the distal side member and the proximal side member are rotated, the connecting member is in a bent state, and the connecting member is connected to the basket pusher via the connecting member. The basket being held can be tilted with respect to the basket pusher. Therefore, for example, when the basket is placed inside the aneurysm by passing through the aperture of the aneurysm, the side surface of the basket can be directed toward the aneurysm opening. The sides of the basket tend to have larger gaps between the wires than the proximal and distal ends of the basket, so the coils can be inserted into the basket through the gaps between the wires. It is possible to easily insert long medical objects such as the like.

This application claims the benefit of priority based on Japanese Patent Application No. 2022-053545 filed on March 29, 2022. The entire contents of the specification of Japanese Patent Application No. 2022-053545 filed on March 29, 2022 are incorporated by reference into this application.

1: Medical device 10: Sheath 10d: Distal end of sheath 10p: Proximal end of sheath 20: Wire 20d: Distal end of wire 20p: Proximal end of wire 30: Basket 30d: Distal of basket End 30p: Proximal end of basket 40: Basket pusher 51: First binding part 52: Second binding part 80: Connection member 81: Distal side member 82: Proximal side member 83: Spherical part 84: Cover part 85 : Shaft member 86: Long member 90: Heating mechanism L1: Extending direction of the basket pusher L2: Straight line passing through the distal end of the basket and the proximal end of the basket θ1: Extending direction of the basket pusher and the far end of the basket An angle formed on the proximal side by a straight line passing through the proximal end of the basket and the proximal end of the basket.

Claims

A basket having multiple wires;
a connecting member disposed on a proximal side of the basket;
a basket pusher disposed on the proximal side of the connecting member;
The connecting member includes a distal member and a proximal member,
The medical device, wherein the distal member is rotatably formed relative to the proximal member.
having an outer barrel having a distal end and a proximal end;
The medical device of claim 1, wherein the basket is disposed within a lumen of the sheath and is expandable upon exiting the sheath.
The medical device according to claim 1 or 2, wherein the connecting member is separable and the basket is removable from the basket pusher.
One of the distal member and the proximal member has a spherical portion,
The medical device according to claim 1 or 2, wherein the other of the distal member and the proximal member has a cover portion that covers the spherical portion.
The connecting member has a shaft member on the proximal side of the distal side member and distal side of the proximal side member,
The medical device according to claim 1 or 2, wherein the shaft member is inserted through the distal side member and the proximal side member.
The medical device according to claim 1 or 2, wherein at least one of the material constituting the distal side member and the material constituting the proximal side member is metal.
When the distal member is rotated relative to the proximal member, the extending direction of the basket pusher and a straight line passing through the distal end of the basket and the proximal end of the basket are close to each other. The medical device according to claim 1 or 2, wherein the angle formed on the side is 45 degrees or more and 150 degrees or less.
The basket includes a first binding part that bundles and fixes the plurality of wires at its distal part, and a second binding part that bundles and fixes the plurality of wires at its proximal part. ,
The medical device according to claim 1 or 2, wherein the first binding portion and the second binding portion include an X-ray opaque material.