WO2019022145A1

WO2019022145A1 - Embolic-substance capturing device

Info

Publication number: WO2019022145A1
Application number: PCT/JP2018/027911
Authority: WO
Inventors: 筒井　宣政; 筒井　康弘; 宏成加藤; 真悟山田
Original assignee: 株式会社東海メディカルプロダクツ
Priority date: 2017-07-26
Filing date: 2018-07-25
Publication date: 2019-01-31
Also published as: JP6749695B2; JP2019024624A

Abstract

[Problem] To provide a shaft member that is capable of easily and quickly guiding a device when guiding the device to an affected area, and that facilitates transmission of the feeling of the advancing shaft to the hand of an operator. [Solution] An embolic-substance capturing device 100 includes a shaft member 10, and an embolus capturing filter 20: that is mainly formed of a plurality of elastic or shape-memory wires; that has, on one side thereof, a mesh section formed like a mesh bag; that has, on the other side thereof, bundle sections in which wires are aggregated into two or more bundles; and in which openings are formed between the bundle sections. The embolic-substance capturing device 100 is characterized in that the shaft member 10 is formed so as to have a lower hardness on the distal-end side thereof.

Description

Embolic material capture device

The present invention relates to an embolism capture device.

Conventionally, percutaneous angioplasty surgery by stent graft placement by interventional procedure, dilation surgery by a balloon catheter, etc. are performed in vascular stenosis parts such as coronary artery, carotid artery, vein graft and the like. However, debris or thrombus or the like released during or after the operation may flow to the periphery of the blood vessel and cause the blood vessel or the like to be infarcted.

The filter device is a device which is placed on the peripheral side of the treatment site to capture the embolic material in order to prevent the outflow of the embolic material such as blood vessels to the peripheral side in such surgery. As this filter device, a device is used in which a bag-like opening is disposed on the proximal rear end side of the guide wire and a bag-like filter having a bag part disposed on the distal tip side is attached (Patent Document 1) 1).

Japanese Patent Application Publication No. 2005-537856

The present invention, in such a filter device, provides a shaft member capable of guiding the device easily and quickly when guiding the device to the affected area, and easily transmitting to the operator the feeling of the progress of the shaft at hand. The main purpose is

The present invention adopts the following means in order to achieve the above object.

The device for capturing embolic material of the present invention is
A shaft member,
Mainly composed of a plurality of elastic or shape memory wires, and having a mesh part formed in a bag shape of one side on one side and a bundle part bundled in at least two or more on the other side; An embolic capture filter, between which an embolic inlet is formed;
In an embolic material capture device having
The shaft member is characterized in that the hardness on the tip side is reduced.

Further, in the device for capturing embolic material according to the present invention, the shaft member may be characterized by having color-coded markings for each predetermined length or markings having different surface textures. .

Furthermore, in the device for capturing embolic material according to the present invention, the shaft member may be characterized by having a non-slip processed portion having a non-slip processed on at least a part thereof.

Furthermore, in the device for capturing embolic material according to the present invention, the non-slip processed portion is formed on the proximal side of the shaft member and in a region not inserted into the body. It is also good.

Furthermore, in the device for capturing embolic material according to the present invention, the non-slip processed portion may be formed by roughening the surface of the shaft member.

Furthermore, in the device for capturing embolic material according to the present invention, the shaft member may be made of different materials on the proximal side and the distal side.

Furthermore, in the device for capturing embolic material according to the present invention, the distal end guide portion formed at the distal end of the shaft member may be characterized by having a reduced slip characteristic.

Furthermore, in the device for trapping embolic material according to the present invention, the shaft member is made of a metal whose particle structure is different between the proximal side and the distal side by ultra-fine grain steel processing or the like. It may be.

According to the device for capturing embolic material according to the present invention, when guiding the device to the affected area, the device can be easily and quickly guided, and the shaft can easily transmit to the operator the feeling of the progress of the shaft. A member can be provided.

FIG. 1 is a view schematically showing the configuration of an embolic substance capturing device 100 according to the embodiment. FIG. 2 is a view schematically showing the configuration of the embolic capture filter 20 of the embolic material capture device 100 according to the embodiment. FIG. 3 is a view showing a cross section of the mesh side sleeve 41 of the embolic capture filter 20 in the embolic material capture device 100 according to the embodiment. FIG. 4 is a view showing a cross section of the bundle-side sleeve 42 in the embolic substance capturing device 100 according to the embodiment. FIG. 5 is a view showing another embodiment of the cross section of the bundle-side sleeve 42 in the embolic substance capturing device 100 according to the embodiment. FIG. 6 is a view schematically showing the configuration of a method of attaching the embolic capture filter 20 of the embolic material capture device 100 according to the embodiment. FIG. 7A is a view schematically showing the configuration of another embodiment of the method for attaching the embolic capture filter 20 of the embolic material capture device 100 according to the embodiment. FIG. 7B is a diagram schematically showing the configuration of still another embodiment of the method for attaching the embolic capture filter 20 of the embolic material capture device 100 according to the embodiment. FIG. 8 is a view schematically showing the configuration of still another embodiment of the method of attaching the embolic capture filter 20 of the embolic material capture device 100 according to the embodiment. FIG. 9 is a view schematically showing the state of use of the embolic substance capturing device 100 according to the embodiment.

Next, an embodiment of the embolic substance capturing device 100 according to the present invention will be described in detail with reference to the drawings. Note that the embodiments and the drawings described below exemplify a part of the embodiments of the present invention, and are not used for the purpose of limiting to these configurations, and do not deviate from the scope of the present invention. It can change suitably in the range.

FIG. 1 shows a schematic view of an embolic substance capturing device 100 according to the embodiment. The embolic material capture device 100 according to the embodiment mainly includes the shaft member 10 and the embolic capture filter 20, and may optionally further include a tip guide 30, a delivery catheter 60, and the like.

The shaft member 10 is used to guide the embolic capture filter 20 into a desired blood vessel and adjust the expanded state of the embolic capture filter 20 by operating the proximal side.

In the shaft member 10 according to the present embodiment, the distal end guide portion 30 is provided at the distal end, and the embolic capture filter 20 is provided adjacent to the distal end guide portion 30. As a material of the shaft member 10, stainless steel, Ni-Ti (nickel titanium) alloy, Ni-Ti-Co (nickel titanium cobalt) alloy or the like is used. Of course, the material is not limited to this, and other metal wires and resin wires can be selected.

The shaft member 10 may be formed to have a lower hardness towards the distal end. The distal end side is formed more flexibly to improve the followability of the blood vessel. As a method of changing the hardness of the shaft member 10, the shaft member 10 is formed with a taper so that the thickness becomes thinner toward the tip. Also, for example, the distal end side is made of a nickel-titanium alloy, and the proximal side is made of stainless steel so that the distal side and the proximal side are made of different materials. Furthermore, the method of changing hardness by changing the crystal grain size of a metal material according to the place of the shaft member 10 by ultra-fine grain steel technology etc. is employable. In particular, it is preferable to flexibly form a range of 30 cm to 50 cm in length from the tip. By setting such a range flexibly, the followability in the blood vessel can be effectively improved and can be more easily inserted.

In addition, the shaft member 10 has a fluorine coating or a hydrophilic property in order to improve the insertability when inserting the embolic substance capturing device 100, or to improve the passage of the treatment device, or to prevent the adhesion of the thrombus. You may give the process for improving the slipperiness | lubricacy of a metallic coating etc. The hydrophilic coating may be directly coated when the shaft member 10 is metal, but may be coated after resin coating. By improving the slidability of the shaft member 10, when moving the embolic capture filter 20 inside the delivery catheter 60, it can be moved more smoothly.

Furthermore, in order to make it easy to understand the length inserted in the delivery catheter 60, the shaft member 10 is provided with markings in which the shaft member 10 is color-coded for each predetermined length so that the insertion length can be confirmed by visual observation. It is also good. In addition, the coating on the surface of the shaft member 10 is peeled off, roughened, or coated or coated with a silicone resin or rubber, etc. to provide markings that are different in touch depending on the portion of the shaft member 10 It is also good. If the touch is different, the operator can check the insertion length with the touch of the hand without looking at the hand. At this time, the marking may be provided at a position from the embolic capture filter 20 to the same length as the length of the delivery catheter 60 or in the vicinity thereof. By providing the marking at this position, it can be easily recognized that the embolic capture filter 20 has reached the tip of the delivery catheter 60. Therefore, it is possible to reduce the possibility of inserting the shaft member 10 too much and causing the embolic capture filter 20 to pop out and expand in the wrong place.

In addition, anti-slip processing may be applied to a part on the proximal side, preferably an area not inserted into the body and operated by an operator such as a doctor by hand. For example, the surface of the shaft member 10 may be roughened, covered with a silicon resin or rubber, or coated. By giving anti-slip processing to the hand side, it can function as anti-slip when holding the torquer used when operating the shaft member 10 at the hand side. In addition, when the doctor inserts the embolic substance capturing device 100 into the blood vessel, the operator does not necessarily look at and manipulate at hand, and therefore, by giving the surface of the shaft member 10 a texture different from other parts, It is possible to know the insertion length of the shaft member 10 to some extent by the sense of the hand without visually recognizing the. In addition, when the embolic capture filter 20 is indwelled in the affected area, the operation is facilitated even when the shaft member 10 is directly operated without using a torquer or the like.

The distal end guide portion 30 is a portion having a function of a guide when the shaft member 10 travels in the blood vessel, and is flexibly formed in order to ensure the followability of the blood vessel and to prevent the blood vessel from being damaged. Preferably, a coiled coil wire or a braided wire may be used. The tip guide unit 30 may use or attach an X-ray opaque material such as platinum or tungsten so that the position of the tip guide unit 30 can be visually recognized by X-rays. A distal end tip portion 31 is provided at the distal end of the distal end guide portion 30. The distal end tip portion 31 may have a rough surface or may be coated with a non-slippery material such as silicon or rubber. By making the surface of the distal end tip portion 31 less slippery, when advancing the shaft member 10 into the blood vessel, it is possible to easily transmit the feel of the distal end to the shaft member 10 on the proximal side.

The embolic capture filter 20 is formed into a linear shape by bundling a mesh portion 22 formed in a mesh shape by weaving or knitting a thin wire 21 having elasticity or shape memory and a wire 21 forming the mesh portion 22. And the bundle portion 24. In addition, except for FIG. 2, the oblique lines in the mesh portion 22 do not reflect the embodiment, and merely indicate the location of the mesh portion 22. The end of the mesh portion 22 side (hereinafter referred to as "mesh portion side end 22a") is a shaft through the mesh portion side sleeve 41 by aggregating the end portions of the wire 21 woven or knitted into a mesh shape It is attached to the member 10, and the distal end side is closed and formed into a bag shape. The mesh hole of the mesh portion 22 is preferably formed to be about 50 μm to 1000 μm, but is not limited to this. More preferably, it is 100 μm to 500 μm. On the other hand, at the end on the bundle 24 side (hereinafter referred to as "bundle side end 24a"), the wire 21 extended from the mesh 22 is bundled into a plurality of bundles 24 and in a bundled state It is attached to the shaft member 10 via the bundle side sleeve 42. In this embodiment, although it is formed by three bundle parts, it may not be limited to three and may be formed by two or four or more bundle parts. Thus, the embolic capture filter 20 according to the present invention is formed in a bag shape having a plurality of mesh holes on one side, and the embolic inflow port 26 is formed between the bundle portions 24 on the other side.

As shown in FIG. 2, the respective wires 21 arranged in the mesh portion 22 are each curved in an S shape, and are arranged in parallel with the S-shaped wires 21 a formed in parallel. The arranged reverse S-shaped wires 21b are formed to be alternately woven. In FIG. 2, only a part of the wires 21 is illustrated. The wire 21 is shape-stored in an S-shape in the final product state. The S-shape is in a range of 1⁄5 of the total length of the embolic capture filter 20 from the mesh portion side end 22 a (a range of α in FIG. 2) in a state where the embolic capture filter 20 is expanded naturally. It is preferable to make a large curve, and to arrange the portion from the mesh part side end 22a to the mesh part side end 26a of the embolic flow inlet 26 (range of β in FIG. 2) substantially parallel without curving too much. By forming the wire 21 in the S shape in this manner, the mesh portion 22 can be effectively inflated by the shape memory of the S character as compared with the one woven or knitted by the straight line. Also, in comparison with the case where the wire 21 is woven or woven between the mesh portion side end 22a and the mesh portion side end 26a of the embolic inflow port 26 (range of β in FIG. 2), Since the angle of 21 can be made large by comparison with the longitudinal direction of the shaft member 10, a larger embolic inlet 26 can be formed. Furthermore, if it is difficult to make the mesh holes the same or approximate size when bundling a plurality of wires 21 when it is not bent in the S shape, it is difficult to use the wire 21 curved in the S shape. Thus, even in the case where a plurality of wires 21 are bundled at the bundle end portion 24a, the shape and size of the mesh holes in the circumferential direction can be made identical or approximate. This can prevent the formation of a large mesh pore, and can prevent the capture of a thrombus.

In addition, it is preferable to use the radiopaque expanded confirmation wire 21c for at least one or more of the wires 21 disposed in the mesh portion 22. In addition to the position of the embolic capture filter 20, the expanded state can also be confirmed by using the expansion confirmation wire 21c in the mesh portion 22. Although the number of the extension confirmation wires 21c is not limited, it is preferable to provide three or more. By having at least three, as described above, since the wire 21 according to the invention is formed in an S shape, the size of the entire embolic capture filter 20 can be easily recognized. In the case of using a material having low rigidity or restorability such as platinum or gold, the influence on the expansion force of the wire 21 other than the expansion confirmation wire 21c (hereinafter, also referred to as "main wire 21") is minimized. In order to limit it, it is preferable to use at most one fifth or less. In addition, the expanded confirmation wire 21 c may have a diameter larger than that of the main wire 21. By using the thick expanded confirmation wire 21c, the expanded state of the embolic capture filter 20 can be made more visible when viewed with X-rays. On the other hand, as long as the expansion confirmation wire 21c has the same degree of rigidity as the main wire 21, all the wires 21 may be used as the expansion confirmation wire 21c. For example, a nickel titanium platinum core wire, a gold-plated nickel titanium wire, etc. can be considered. In addition, the same material as the material used for the main wire 21, the same thickness as the twisted material of the radiopaque wire, or the one in which a thin radiopaque wire 21 is wound You may use Thus, by using the same material as the wire 21 used for the main wire 21, the strength of the rigidity can be made substantially the same as that of the main wire 21.

The bundle part 24 bundles the wire 21 extended from the mesh part 22, and forms the embolic inflow port 26 in the proximal end side. The wires 21 constituting the bundle portion 24 may be separated without being tied together, but preferably, they may be twisted or woven. For example, one bundle may be further formed into a plurality of bundles into a braided shape. By forming the bundle portion into a twisted yarn or knitting, it is possible to prevent the wire 21 from scattering, and it is possible to reduce the sticking of the embolism to the dispersed wire 21. Further, the rigidity of the bundle portion 24 can be improved, and the expansion force can be improved and the expanded state after expansion can be easily maintained.

Next, a method of producing the embolic substance capturing device 100 will be described. First, a method of producing the embolic capture filter 20 will be described.

First, the mesh portion 22 is manufactured using a mold formed in the expanded form of the embolic capture filter 20. At this time, the wire 21 of the mesh portion 22 is woven or knitted in advance so as to draw an S-shape. When weaving or weaving, it may be a so-called plain weave type alternately weaved alternately, or a so-called twill weave or satin weave type in which a plurality of wires are passed.

Thereafter, the bundle is restrained by twisting the wire 21 forming the bundle portion 24 or by weaving. Then, each wire is shaped. That is, the shape is stored by heating the embolic capture filter 20 in the expanded state. In this way, the embolic capture filter 20 in a state where the center is inflated is manufactured.

Next, the mesh side sleeve 41 and the bundle side sleeve 42 are attached to both ends of the embolic capture filter 20 thus manufactured.

In order to attach the mesh part side sleeve 41 to the mesh part side end 22a, as shown in FIG. 3, the tip of the wire 21 collected is inserted between the sleeves 40 having the inner sleeve 41a and the outer sleeve 41b. The inner sleeve 41a or the outer sleeve 41b to be used may use radiopaque material such as platinum. After the insertion, the adhesive or the solder is poured between the inner sleeve 41a and the outer sleeve 41b or fixed by immersion. At this time, the portion of the wire 21 inserted into the sleeve 40 may be reduced in diameter. By reducing the diameter, the outer diameter of the outer sleeve 41b can be reduced. For the reduction in diameter, electrolytic polishing, physical polishing, chemical polishing or the like can be used. Thus, the outer diameter of the sleeve 40 can be made the same as the outer diameter of the distal end guide portion 30 or the difference in level with the distal end guide portion 30 can be reduced. By eliminating the step with the distal end guide portion 30 or reducing the level difference, the distal end guide portion can be smoothly advanced when being advanced in the blood vessel. Further, the distal end side tip of the mesh section side sleeve 41 may be formed to be rounded as shown in FIG. This may be in the form of the sleeve itself, or may be made of solder or an adhesive.

Similarly, when the bundle side sleeve 42 is attached to the bundle side end 24a, as shown in FIG. 4, after the end of the bundle 24 is inserted between the inner sleeve 42a and the outer sleeve 42b, the inner sleeve An adhesive or solder is poured and fixed between 42a and the outer sleeve 42b. The inner sleeve 42a or the outer sleeve 42b used for the bundle-side sleeve 42 may use a radiopaque material such as platinum. By using radiopaque materials for both the mesh side sleeve 41 and the bundle side sleeve 42, the expanded state of the embolic capture filter 20 can also be confirmed by recognizing the respective distances. As in the case of the mesh portion side end 22a, the end portion inserted into the bundle portion side sleeve 42 may be reduced in diameter. In particular, since the plurality of wires 21 are gathered into a bundle, the bundle end portion 24 a is effective because the entire bundle becomes thinner by reducing the diameter. In addition, when inserting in the inner sleeve 42a and the outer sleeve 42b, it is not necessary to necessarily arrange equally. As shown in FIG. 5, the inner sleeve 42a and the outer sleeve 42b may be inserted in an eccentric state. With such eccentricity, the bundle side end 24a of the wire 21 can be easily formed between the inner sleeve 42a and the outer sleeve 42b, even if the bundle is woven and bundled as compared with the case of concentric circles. Can be inserted. In addition, since a large gap is more likely to be formed than when evenly disposed between the inner sleeve 42a and the outer sleeve 42b, it becomes easier for the solder or adhesive to flow or permeate, and the bundle of the wire 21 can be more reliably It can be fixed to the side end 24a. In addition, the distal end side tip of the bundle side sleeve 42 may be formed to be rounded as shown in FIG. This may be in the form of the sleeve itself, or may be made of solder or an adhesive.

The embolic capture filter 20 thus manufactured attaches the embolic capture filter 20 to the shaft member 10 so that the tip of the shaft member 10 passes through the sleeve 40. Only by inserting the shaft member 10 into the embolic capture filter 20, the embolic capture filter 20 can freely slide the shaft member 10 largely. Therefore, means are provided to control the slide of the embolic capture filter 20. There are a plurality of such means, which will be described below.

(Slide control means 1)
In the slide control means 1, as shown in FIG. 6, a stopper 51 is provided between the mesh portion side end 22a of the embolic capture filter 20 and the bundle portion side end 24a. The stopper 51 is formed to be larger than the inner diameters of the inner sleeves of the mesh portion side sleeve 41 and the bundle portion side sleeve 42. By providing the stopper 51, the embolic capture filter 20 can be slidably moved by an interval between the mesh portion side end 22a and the bundle portion side end 24a. Thus, by providing the stopper 51, the slidable embolic capture filter 20 can be attached within a predetermined range. By slidably providing the embolic capture filter 20 as it travels through the delivery catheter, even if the front end side is pushed backward, the embolic capture filter 20 moves by moving the entire embolic capture filter 20. It is possible to prevent the filter 20 from becoming wrinkled and the mesh portion side end 22a from entering the mesh. Further, also when the embolic capture filter 20 is recovered, the same effect can be exerted by sliding in the opposite direction to the direction of advancing inside the delivery catheter described above when drawing into the recovery catheter. Furthermore, by making the predetermined range slidable, the position of the embolic capture filter 20 does not shift even if the shaft member 10 moves somewhat during surgery, and the position and the expanded state can be stabilized.

(Slide control means 2)
In the slide control means 2, as shown in FIG. 7A, the thickness of the shaft member 10 is changed at the mesh part side end 22a and the bundle part side end 24a. That is, the mesh portion side end 22a side is formed thin, and the bundle portion 24 side is formed thicker than the inner diameter of the mesh portion side sleeve 41, and the step portion 15 is formed. As a result, the mesh side sleeve 41 of the embolic capture filter 20 can move between the distal end guide portion 30 and the stepped portion 15, and the embolic capture filter 20 can also slide according to the movement range of the mesh side sleeve 41.

By slidably providing the embolic capture filter 20 as it travels through the delivery catheter, even if the front end side is pushed backward, the embolic capture filter 20 moves by moving the entire embolic capture filter 20. It is possible to prevent the filter 20 from becoming wrinkled and the mesh portion side end 22a from entering the mesh. Further, by making the predetermined range slidable, the position of the embolic capture filter 20 does not shift even when the shaft member 10 is moved somewhat during surgery, and the position and the expanded state can be stabilized.

Furthermore, by adopting a slide means such as the slide control means 2, a narrow portion (the portion 18 in FIG. 6) for inserting the embolic capture filter 20 on the proximal side of the bundle side sleeve 42, The formation of a so-called neck portion 18 can be prevented. That is, the diameter of the bundle-portion-side sleeve 42 can be increased, and the diameter of the neck portion 18 can be increased. Generally, the neck portion 18 is formed thick at the proximal rear end side of the shaft member 10, and where the embolic capture filter 20 is present, the rigidity of the mesh is added, so the portion of the neck portion 18 is necessarily weakened or bent. There was a possibility that a phenomenon called so-called kink could occur. However, by adopting a configuration such as the slide control means 2, the neck portion 18 can be made thicker than in the past, or the same thickness as the proximal rear end side of the shaft member 10, so the neck portion 18 becomes strong. And the occurrence of kinks such as breakage can be reduced.

As a form having the same effect as FIG. 7A, as shown in FIG. 7B, the thickness of the shaft member 10 is entirely or partially tapered at the mesh side end 22a and the bundle side end 24a. The stopper 51 may be disposed in this taper so as to be gradually thickened from the mesh portion side end 22a toward the bundle portion side end 24a. The tapered shape formed on the stepped portion can reduce the possibility of stress concentration on the stepped portion. At this time, the stopper may be omitted and the function of the stopper may be shared depending on the thickness of the shaft member.

(Slide control means 3)
In the slide control means 3, as shown in FIG. 1, the shaft member 10 is formed thin only in the sliding portion of the embolic capture filter 20. By providing the thin portion on the shaft member 10 itself in this manner, the embolic capture filter 20 can be moved therebetween.

(Slide control means 4)
The slide control means 4 fixes the bundle side sleeve 42 of the bundle side end 24 a of the embolic capture filter 20 or the mesh side sleeve of the mesh side end 22 a to the shaft member 10. If the mesh portion 22 of the embolic capture filter 20 is not expanded, that is, the full length of the embolic capture filter 20 is the longest, the mesh portion side sleeve 41 of the mesh portion end 22a contacts the distal end guide portion 30 or It is good to fix the bundle part side sleeve 42 in the position which is arrange | positioned near. By fixing the embolic capture filter 20 at such a position, it is possible to prevent a step from being formed between the distal end guide portion 30 and the mesh portion side sleeve 41, so that smooth insertion or recovery becomes possible.

In this fixing method, since it is defined by the position of the bundle-side sleeve 42 of the embolic capture filter 20, it is suitable for adjusting the indwelling position of the embolic capture filter 20 within a narrow range.

(Slide control means 5)
In the slide control means 5, as shown in FIG. 8, the stopper 50 is attached to the outside of the bundle-side sleeve 42 of the embolic capture filter 20. The stopper 50 has a larger diameter than the inner sleeve 42 a of the bundle-side sleeve 42, and prevents the embolic capture filter 20 from moving proximal to the stopper 50. Thus, the embolic capture filter 20 is provided slidably only between the distal end guide portion 30 and the stopper 50.

As described above, after the embolic capture filter 20 is attached to the shaft member 10, the distal end guide part 30 is attached to the tip to make the embolic material capture device 100.

The embolic substance capturing device 100 thus produced is used as follows.

First, before inserting the embolic substance capturing device 100 according to the present invention, the delivery catheter 60 is inserted near the treatment site. When inserting the delivery catheter 60, a guide wire or the like may be used.

Then, the embolic capture filter 20 is inserted from the rear end of the delivery catheter 60. At this time, when the shaft member 10 is provided with a marker, the insertion length can be confirmed by the marker. Then, as shown in FIG. 9, when reaching the vicinity of the tip of the delivery catheter 60, the operator can be recognized by the marker indicating that the embolic capture filter 20 has reached the shaft member 10 near the tip. At this time, the coating of the shaft member 10 is peeled off to provide a step or rough surface, so that the embolic capture filter 20 can be recognized without feeling the shaft member 10 because it can be recognized by feeling of the hand. It can be recognized that the tip of the delivery catheter 60 has been reached. Then, when it is confirmed that the embolic capture filter 20 has been introduced to the downstream side of the treatment site such as a stenosis in a blood vessel, the delivery catheter 60 is pulled proximally to expose the embolic capture filter 20. By exposing the embolic capture filter 20, the wire 21 is shape-memory in the expanding direction, and the resilience of the wire 21 expands the embolic capture filter 20. By this expansion, the embolic capture filter 20 is formed in a state where the outer periphery is in contact with the inner wall of the blood vessel. In this way, placement of the embolic capture filter 20 is completed. At this time, in the embolic capture filter 20 according to the present invention, since the wire 21 is partially made of the expansion confirmation wire 21c, the position and the expanded state of the embolic capture filter 20 can be confirmed.

Thereafter, the target therapeutic instrument is inserted and the target treatment is performed. For example, an operation such as a dilation with a balloon catheter for dilation of a stenosis, an operation for removing an embolic material with a catheter for removing an embolism, or an operation such as a surgery in which a stent graft is placed at a branch such as an aortic arch and the head and neck or arms. Instruments used for vent surgery and the like are inserted. At this time, the shaft member 10 is used instead of a guide wire. At the time of such operation, a part of the destroyed embolism may be transported downstream by the blood flow. However, since the embolism is captured by the mesh portion 22 from the opening of the embolic capture filter 20, the embolism is prevented from flowing to the peripheral side. The embolic capture filter 20 according to the present invention has a mesh-like shape as a whole capture part, so many mesh holes are formed even when an embolic material is captured, and therefore the flow of blood flow is greatly inhibited. Is prevented.

Once treatment is complete, the treatment device, such as a balloon catheter, is withdrawn and then retrieved using the delivery catheter 60 used at insertion or a different retrieval catheter. Specifically, the delivery catheter 60 is guided to the distal end, and at least a portion of the embolic capture filter 20 is accommodated. At this time, the entire embolic capture filter 20 may be accommodated, or in the case where a large amount of embolic material is captured, the embolic inlet 26 may be accommodated. Since the wire 21 of the embolic capture filter 20 of the present invention is made of a radiopaque material, it is possible to confirm the storage condition with respect to the delivery catheter 60. With the embolic capture filter 20 of the sheath housed to the desired position, the embolic material is recovered by recovering the embolic material capture device 100.

As shown in the above-described embodiment, it can be particularly used to prevent the scattering of thrombi and debris.

DESCRIPTION OF SYMBOLS 10 ... Shaft member, 15 ... Step difference part, 18 ... Neck part, 20 ... Embolic capture filter, 21 ... Wire, 21a ... Wire, 21b ... Wire, 21c ... Expansion confirmation wire, 22 ... Mesh part, 22a ... Mesh part side end Part 24 24 bundle part 24a bundle part side end part 26 embolic inflow port 26a mesh part side end part 30 tip guide part 31 tip part tip 40 sleeve 41 mesh part side Sleeves 41a: inner sleeves 41b: outer sleeves 42: bundle side sleeves 42a: inner sleeves 42b: outer sleeves 50: stoppers 51: stoppers 60: delivery catheter 100: device for capturing embolic material

Claims

A shaft member,
Mainly composed of a plurality of elastic or shape memory wires, and having a mesh part formed in a bag shape of one side on one side and a bundle part bundled in at least two or more on the other side; An embolic capture filter, between which an embolic inlet is formed;
In an embolic material capture device having
The device for capturing embolic material, wherein the shaft member is formed to have a low hardness on the tip side.
The device for capturing an embolic material according to claim 1, wherein the shaft member has markings color-coded for each predetermined length or markings having different textures on the surface.
The device for capturing embolic material according to claim 1 or 2, wherein the shaft member has a non-slip processed portion at least a part of which is non-slip processed.
The device for capturing embolic material according to claim 3, wherein the anti-slip portion is formed on the proximal side of the shaft member and in a region not inserted into the body.
The device for capturing embolic material according to claim 3 or 4, wherein the non-slip processed portion is formed by roughening the surface of the shaft member.
The device for capturing an embolic material according to any one of claims 1 to 5, wherein the shaft member is made of different materials on the proximal side and the distal side.
The embolic material capturing device according to any one of claims 1 to 6, wherein a tip guide portion formed at a tip of the shaft member has a sliding property reduced.
The embolic material according to any one of claims 1 to 7, wherein the shaft member is made of a metal whose particle structure is different between the proximal side and the distal side by ultrafine grain steel processing or the like. Capture device.