JPWO2020152743A1 - Scoring device and scoring system - Google Patents

Abstract

Provided is a scoring device or the like capable of improving convenience during treatment. The scoring device (3) of the present invention includes a shaft (31) extending along the axial direction and a scoring member (32) provided on the tip end side of the shaft and into which a balloon is inserted during treatment. ) And. The scoring member can be elastically deformed according to the expansion and contraction of the balloon, and has a plurality of elements (411, 412) for causing a crack on the surface of the stenosis during treatment, and the plurality of elements. It has a connecting portion for connecting the two to each other. The connecting portion is a first connecting portion (421) that connects the elements to each other near each tip of the plurality of elements, and a second connecting portion (422) that connects the elements to each other near each base end of the plurality of elements. ) And a third connecting portion (423) that connects the elements to each other in the intermediate region between the vicinity of the tip end and the vicinity of the base end of the plurality of elements.

Description

The present invention relates to a scoring device used in the treatment of expanding a stenosis in a blood vessel, and a scoring system including such a scoring device and a balloon catheter.

In the field of clinical medicine, a catheter treatment method such as PTCA (Percutaneous Transluminal Angioplasty) is used as a treatment method for a stenosis in a blood vessel due to a plaque lesion or a calcified lesion. (See, for example, Patent Document 1). In the treatment with this PTCA, generally, the balloon on the distal end side of the balloon catheter is percutaneously (without incising the skin) placed near the stenosis and inflated to expand the stenosis and expand the blood vessel. It is designed to reshape.

Further, in such a treatment, a scoring device having a plurality of elements (scoring elements) on the distal end side is generally used together with the balloon catheter. In a state where the balloon is arranged (inserted) inside the plurality of elements, each element is pressed against the inner surface of the blood vessel when the balloon is inflated so as to cause a crack on the surface of the stenosis. It has become. This makes it possible, for example, to facilitate dilation of the narrowed portion. In addition, since the lesion can be cracked and expanded, it can be expanded at a lower pressure than in the case of a normal balloon.

Japanese Unexamined Patent Publication No. 2003-310762

By the way, in such a scoring device or the like, it is generally required to improve the convenience at the time of treatment. It is desirable to provide scoring devices and scoring systems that can improve convenience during treatment.

The scoring device according to an embodiment of the present invention is a device used in the treatment of expanding a stenosis in a blood vessel by utilizing the expansion of a balloon in a balloon catheter, and extends along the axial direction. It is provided with a shaft to be used and a scoring member provided on the tip end side of the shaft and into which a balloon is inserted during the above treatment. Each of the scoring members extends along the axial direction, is capable of elastic deformation according to the expansion and contraction of the balloon, and causes a crack on the surface of the stenosis portion during the above treatment. It has a plurality of elements of the above, and a connecting portion that connects at least two or more elements of the plurality of elements to each other along the circumferential direction. This connecting portion connects a first connecting portion that connects at least two or more elements to each other in the vicinity of each tip of the plurality of elements, and at least two or more elements in the vicinity of each base end of the plurality of elements. A second connection portion that connects to each other and a third connection that connects at least two or more elements to each other at one or a plurality of points in the intermediate region between the vicinity of the tip end and the vicinity of the base end of the plurality of elements. Includes part and. The above-mentioned "connecting portion" may be integrally formed with the "plurality of elements" or may be provided as a separate body. Further, the above-mentioned "scoring member" may be integrally formed with the above-mentioned "shaft" or may be provided as a separate body.

The scoring system according to the embodiment of the present invention is a system used in the treatment of expanding a narrowed portion in a blood vessel by utilizing the expansion of a balloon, and includes a balloon catheter having a balloon and the above-mentioned present invention. The scoring device according to the embodiment is provided.

In the scoring device and scoring system according to the embodiment of the present invention, the first and first near the tip and the base end are connected to the connecting portion of the scoring member into which the balloon is inserted during the treatment. In addition to the two connecting portions, a third connecting portion is provided in the intermediate region between them. As a result, for example, even when it is necessary to increase the axial length of each element, when such a third connecting portion is not provided (only the first and second connecting portions are provided). Compared with (if provided), it is as follows. That is, it is possible to avoid the possibility that the plurality of elements are twisted together and the balloon cannot be arranged inside the scoring member, and the operability during the above treatment is improved.

Here, in the scoring device according to the embodiment of the present invention, the first and third connecting portions may each have a spiral structure along the axial direction. In this case, the first and third connecting portions (near the tip and the intermediate region) can be expanded to some extent, so that the scoring member can be easily delivered from the tip side to the periphery of the balloon catheter. Further, when the balloon is inflated from the inside of the scoring member, the balloon can be inflated to some extent also in the vicinity of the first and third connecting portions (near the tip and in the intermediate region). It becomes easier to spread the narrowed part. From these facts, the therapeutic effect at the time of the said treatment is improved, and the convenience at the time of treatment is further improved. Further, in this case, the plurality of elements may be divided along the axial direction via the spiral structure. In this case, since the balloon can be further inflated in the vicinity of the first and third connecting portions, the therapeutic effect during the above treatment is further improved, and the convenience during the treatment is further improved. Will be done.

Further, in the scoring device according to the embodiment of the present invention, the first and third connecting portions each have a first C-shaped structure as a C-shaped structure, and the first and third connecting portions have the first C-shaped structure. In the C-shaped structure of 1, a first C-shaped ring having a first notch formed in the first angular direction and a second C-shaped ring formed in a second angular direction different from the first angular direction are formed. The second C-shaped ring having the second notch may be arranged to face each other along the axial direction. Alternatively, the first and third connecting portions may each have a second C-shaped structure as a C-shaped structure including a single C-shaped ring. Even in these cases, the first and third connecting portions can be expanded to some extent, so that the scoring member can be easily delivered from the distal end side to the periphery of the balloon catheter. In addition, since the balloon can be expanded to some extent in the vicinity of the first and third connecting portions, it becomes easy to spread the narrowed portion in these regions. From these facts, the therapeutic effect at the time of the said treatment is improved, and the convenience at the time of treatment is further improved.

In these cases, some elements of the plurality of elements are divided along the axial direction via the C-shaped structure (the first or second C-shaped structure). You may do so. In this case, since the balloon can be further inflated in the vicinity of the first and third connecting portions, the therapeutic effect during the above treatment is further improved, and the convenience during the treatment is further improved. Will be done.

Further, in the scoring device according to the embodiment of the present invention, the second connecting portion may be in the shape of a ring. In the vicinity of the second connecting portion (near the base end), the need for the balloon to inflate is lower than in the vicinity of the first and third connecting portions (near the tip and the intermediate region). By forming the connecting portion of the above into a ring shape and avoiding the possibility that the balloon will come off from the inside of the scoring member, the convenience at the time of the above treatment will be further improved.

Further, in the scoring system according to the embodiment of the present invention, the length (axial length) of the expansion region in the balloon along the axial direction is set to the length along the axial direction in the scoring member. It may be shorter than (axial length). In this case, since the entire balloon can be arranged inside the scoring member, the therapeutic effect at the time of the above treatment is improved, and the convenience at the time of treatment is further improved.

According to the scoring device and the scoring system according to the embodiment of the present invention, the connecting portion in the scoring member is provided with the third connecting portion in addition to the first and second connecting portions. Therefore, the operability during the above treatment can be improved. Therefore, it is possible to improve the convenience of the above treatment.

It is a schematic perspective view which shows the schematic structure example of the scoring system which concerns on one Embodiment of this invention. It is a schematic perspective view which shows the schematic structure of the scoring device shown in FIG. It is a schematic perspective view which shows the detailed structure of each connecting part shown in FIG. It is a schematic diagram which shows an example of the treatment method using the scoring system shown in FIG. It is a schematic perspective view which shows the schematic structure example of the scoring device which concerns on a comparative example. It is a schematic side view which shows the schematic structure example of the scoring device which concerns on modification 1. FIG. It is a schematic perspective view which shows the detailed structure of each connecting part shown in FIG. It is a schematic side view which shows the schematic structure example of the scoring device which concerns on modification 2. It is a schematic perspective view which shows the detailed structure of each connecting part shown in FIG. It is a schematic perspective view which shows the structural example of each connecting part in the scoring device which concerns on modification 3. FIG. It is a schematic perspective view which shows the schematic structure example of the scoring device which concerns on modification 4.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The explanation will be given in the following order.
1. 1. Embodiment (Example in which the first to third connecting portions are ring-shaped and the second connecting portion is a plurality)
2. Deformation example Deformation example 1 (Example where the first and third connecting parts have a spiral structure and the second connecting part has a plurality of parts)
Modification 2 (Examples in which the first and third connecting portions have a first C-shaped structure and the second connecting portion has a plurality of parts)
Modification 3 (Examples in which the first and third connecting portions have a second C-shaped structure and the second connecting portion has a plurality of parts)
Modification 4 (Example in which the first to third connecting portions are ring-shaped and the second connecting portion is one)
3. 3. Other variants

<1. Embodiment>
[Outline configuration]
FIG. 1 is a schematic perspective view showing a schematic configuration example of a scoring system (scoring system 1) according to an embodiment of the present invention. This scoring system 1 is a system used for treatment of a stenosis in a blood vessel due to a plaque lesion, a calcified lesion, or the like (treatment with PTCA). In this example, as shown in FIG. 1, a balloon catheter is used. 2 and a scoring device 3. In such a treatment, although the details will be described later, the stenosis in the blood vessel is expanded by utilizing the expansion of the balloon (balloon 22 described later) in the balloon catheter 2. Examples of the stenotic portion to be treated include a stenotic portion in a blood vessel of a relatively large lower limb portion.

(A. Balloon catheter 2)
The balloon catheter 2 includes a shaft 21 and a balloon 22 as shown in FIG.

(Shaft 21)
The shaft 21 has flexibility and extends (stretches) along the Z-axis direction, which is its own axial direction (longitudinal direction). The vicinity of the base end of the shaft 21 is a portion (grip portion) gripped by the operator of the scoring system 1, and the balloon 22 is attached near the tip of the shaft 21 (see FIG. 1).

The length (total length) of the shaft 21 along the axial direction (Z-axis direction) is, for example, about 600 to 1800 mm, preferably about 1200 to 1600 mm. The outer diameter of the shaft 21 is, for example, about 0.6 to 1.5 mm, preferably about 0.7 to 1.3 mm.

The shaft 21 is made of a synthetic resin such as nylon, polyether block amide (PEBAX), or polyurethane.

(Balloon 22)
The balloon 22 is attached near the tip of the shaft 21 as described above, and is directed toward the periphery of the shaft 21 in response to a predetermined operation by the operator, for example, as shown by the broken line arrow in FIG. It is possible to expand (expand) and contract to the original state. As such a balloon 22, for example, it is possible to deal with a semi-compliant type balloon having sufficient flexibility and excellent delivery property, a narrowed portion such as a calcified lesion, and the like, and it is relatively hard. It is possible to use a low compliant type balloon or the like having excellent expandability.

Here, the length (axial length L22) of the expansion region of the balloon 22 along the axial direction (Z-axis direction) is as follows in the example shown in FIG. That is, the axial length L22 is shorter than the length (axial length L32) of the scoring member 32 described later in the scoring device 3 along the axial direction (Z-axis direction) (L22 <L32). : See Fig. 1).

The axial length L22 is, for example, about 20 to 350 mm, preferably about 80 to 200 mm. The axial length L32 is, for example, about 30 to 360 mm, preferably about 90 to 210 mm.

(B. Scoring device 3)
As shown in FIG. 1, the scoring device 3 includes a shaft 31 and a scoring member 32.

(Shaft 31)
The shaft 31 has flexibility and extends (stretches) along the Z-axis direction, which is its own axial direction (longitudinal direction). The vicinity of the base end of the shaft 31 is also a portion (grip portion) to be gripped by the operator of the scoring system 1, and the scoring member 32 is attached near the tip of the shaft 31 (see FIG. 1). The scoring member 32, which will be described later, may be formed integrally with the shaft 31 or may be provided as a separate body.

The length (total length) of the shaft 31 along the axial direction (Z-axis direction) is, for example, about 700 to 1900 mm, preferably about 1300 to 1700 mm. The outer diameter of the shaft 31 is, for example, about 0.4 to 1.0 mm, preferably about 0.5 to 0.7 mm.

Examples of the material of such a shaft 31 include a metal material such as a Ni (nickel) -Ti (titanium) alloy, a resin material, and the like, as long as the material has predetermined shape retention characteristics and elasticity. , Not particularly limited. Specifically, examples of the material of the shaft 31 include stainless steel (SUS), titanium alloy, polyamide, polyamide elastomer, polyester, polyether blockamide copolymer, polyether ether ketone, and polytetrafluoroethylene (PTFE). , Fluorine-based materials such as tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), and the like, and it is desirable that a radiation-impermeable contrast agent is blended. Examples of such a contrast agent include barium sulfate, bismuth oxide, and bismuth subcarbonate.

(Scoring member 32)
The scoring member 32 is attached near the tip of the shaft 31 as described above, and the balloon 22 is inserted into the scoring member 32 during the above-mentioned treatment (see FIG. 1).

FIG. 2 schematically shows a schematic configuration of the scoring device 3 (mainly the scoring member 32) shown in FIG. 1 in a perspective view. Further, FIG. 3 (FIGS. 3 (A) to 3 (C)) schematically shows a detailed configuration of each connecting portion (connecting portion 421, 422, 423 described later) shown in FIG. 2 in a perspective view. It was done. Specifically, FIG. 3 (A) shows a detailed configuration of the connecting portion 421, FIG. 3 (B) shows a detailed configuration of the connecting portion 423, and FIG. 3 (C) shows a detailed configuration of the connecting portion 422. There is.

As shown in FIGS. 2 and 3, the scoring member 32 has a plurality of (two in this example) elements 411,412 (scoring elements) and three types of connecting portions 421,422,423. doing. Further, as shown in FIG. 2, the connecting portions 421 and 422 are provided one by one, and a plurality of connecting portions 422 (two in this example) are provided.

As shown in FIG. 2, the elements 411 and 412 extend so as to be parallel to each other along the axial direction (Z-axis direction), and the above-mentioned elastic deformation corresponding to the expansion and contraction of the balloon 22 is performed. It is possible. That is, each of the elements 411 and 412 is a member having elasticity (superelasticity). Further, each of these elements 411 and 412 is a member for causing a crack (crack) on the surface of the narrowed portion to be treated during the above-mentioned treatment, although the details will be described later. In the initial state of the scoring device 3, it is desirable that the elements 411 and 412 are not loosened or bent.

As shown in FIG. 2, each of such elements 411 and 412 has a quadrangular cross section (XY cross section). The length of each element 411,412 along the axial direction (Z-axis direction) is, for example, about 10 to 100 mm, preferably about 20 to 50 mm. The outer diameter of each element 411,412 is, for example, about 0.05 to 0.5 mm, preferably about 0.1 to 0.3 mm.

Each element 411,412 is made of, for example, a metal material such as a Ni—Ti alloy, a resin material, or the like.

Each of the above-mentioned connecting portions 421, 422, 423 attaches at least two or more elements (two elements 411, 412 to each other in the examples of FIGS. 2 and 3) of the plurality of elements 411, 412 to X-. It is a portion that connects (bundles) to each other along the circumferential direction in the Y plane.

As shown in FIGS. 2 and 3A, the connecting portion 421 connects the elements 411 and 412 to each other in the vicinity of the tips of the elements 411 and 412 (the tips in the example of FIGS. 2 and 3A). Are connected to each other.

As shown in FIGS. 2 and 3, the connecting portion 422 is formed in the vicinity of each base end of the elements 411 and 412 (the base end in the example of FIGS. 2 and 3 (C)) of these elements 411 and 4. The 412s are connected to each other.

As shown in FIGS. 2 and 3B, the connecting portion 423 is located in the intermediate region between the vicinity of the tip end and the vicinity of the base end of each element 411 and 412 (in the example of FIGS. 2 and 3B). , In the intermediate region excluding the tip and base), these elements 411 and 412 are connected to each other. Further, as described above, in the example of FIGS. 2 and 3B, since a plurality (two) connecting portions 423 are provided, elements are provided at a plurality (two) of the connecting portions 423 in such an intermediate region. The 411 and 412 are connected to each other. Further, these two connecting portions 423 are arranged apart from each other along the axial direction (Z-axis direction) of the elements 411 and 412. Specifically, as shown in FIG. 2, the connecting portions 421 and 422 and the two connecting portions 423 are arranged so as to be substantially equal to each other along the Z-axis direction.

Each of such connecting portions 421, 422, and 423 has a ring shape as shown in FIGS. 2 and 3 (A) to 3 (C). That is, the connecting portions 421, 422, 423 connect the two elements 411, 412 to each other so as to completely orbit in the XY plane (without including the notch portion or the like). ..

The inner diameter of each ring shape in such connecting portions 421, 422, 423 is, for example, about 0.7 to 2.0 mm, preferably about 1.0 to 1.5 mm. The outer diameter of each ring shape is, for example, about 0.9 to 2.2 mm, preferably about 1.2 to 2.7 mm.

Here, each of these connecting portions 421, 422, 423 corresponds to a specific example of the "connecting portion" in the present invention. Further, the connecting portion 421 corresponds to a specific example of the "first connecting portion" in the present invention, the connecting portion 422 corresponds to a specific example of the "second connecting portion" in the present invention, and the connecting portion 423 corresponds to a specific example of the "second connecting portion". It corresponds to a specific example of the "third connecting portion" in the present invention.

The scoring member 32 having such a shape is formed by, for example, laser processing or the like, and the same applies to the modified examples described later.

[Action / Effect]
(A. Basic operation)
This scoring system 1 (balloon catheter 2 and scoring device 3) is used in the treatment of the above-mentioned intravascular stenosis. During such treatment, the balloon 22 in the balloon catheter 2 is percutaneously inflated while being arranged near the stenosis, so that the stenosis is expanded and blood vessels are reshaped.

Further, during this treatment, in a state where the balloons 22 are arranged inside the plurality of elements 411 and 412 in the scoring device 3, each element 411 and 412 is pressed against the inner surface of the blood vessel when the balloon 22 is inflated. This causes a crack on the surface of the narrowed portion. This makes it possible, for example, to facilitate dilation of the narrowed portion. In addition, since the lesion can be cracked and expanded, it can be expanded at a lower pressure than in the case of a normal balloon.

Here, FIG. 4 (FIGS. 4 (A) to 4 (C)) is a schematic diagram showing an example of a treatment method using such a scoring system 1. In addition, in FIG. 4, the narrowed portion 90 in the blood vessel 9 to be treated is also shown.

At the time of this treatment, first, as shown in FIG. 4A, for example, the balloon 22 of the balloon catheter 2 and the scoring member 32 of the scoring device 3 are used up to the narrowed portion 90 of the blood vessel 9 to be treated. Are delivered in this order using a guide wire or the like (not shown). At this time, if the scoring member 32 cannot be delivered to the narrowed portion 90, the balloon 22 is arranged in the narrowed portion 90 and expanded, the balloon 22 is contracted, and then the scoring member 32 is placed in the narrowed portion 90. Try to deliver. In FIG. 4A, the balloon 22 is delivered to the stenosis 90 in a contracted state, and then the scoring member 32 is delivered from the tip end side to the stenosis 90 (FIG. 4A). (See the dashed arrow inside).

Subsequently, for example, as shown in FIG. 4 (B), the scoring member 32 is also delivered to the narrowed portion 90 (see the broken line arrow in FIG. 4 (B)), and the inside of the scoring member 32 is provided. In the state where the balloon 22 is inserted.

In such a state, for example, as shown in FIG. 4C, the balloon 22 in the balloon catheter 2 is inflated in response to a predetermined operation by the operator of the scoring system 1 (in FIG. 4C). See the dashed arrow). Specifically, for example, when a predetermined fluid is supplied into the balloon 22 via a predetermined lumen provided in the balloon catheter 2, the balloon 22 expands and deforms and expands. Then, with the expansion of the balloon 22, each element 411, 412 in the scoring member 32 located on the outer peripheral side of the balloon 22 is elastically deformed so as to inflate toward the outer peripheral side. Specifically, each element 411, 412 is elastically deformed so as to follow the shape of the balloon 22 in the inflated state (see FIG. 4C).

As a result, the outer peripheral surfaces of the elements 411 and 412 are pressed against the inner surface of the blood vessel 9 (stenosis 90), and cracks (cracks and cuts) are formed on the surface of the stenosis 90, thereby pushing the stenosis 90. It is unfolded (see the dashed arrow in FIG. 4C). In this way, treatment with the scoring system 1 (balloon catheter 2 and scoring device 3) reshapes the blood vessel 9 to be treated.

In particular, in this scoring system 1, since the balloon catheter 2 and the scoring device 3 are separate bodies, as compared with the case where they are integrally formed (integrated type), for example, as follows. There are advantages. That is, first, in this scoring system 1, the rigidity at the fixed portion of each element 411, 412 can be reduced as compared with the case of the integrated type. Further, in this scoring system 1, since the outer diameter dimension of the fixed portion of each element 411, 412 can be reduced as compared with the case of the integrated type, a narrow portion in the blood vessel 9 can be easily inserted, which is excellent delivery. Sex is realized.

(B. Action / effect in scoring device 3)
Subsequently, the action / effect of the scoring device 3 of the present embodiment will be described in detail in comparison with a comparative example.

(Comparison example)
FIG. 5 schematically shows a schematic configuration of a scoring device (scoring device 103) according to a comparative example in a perspective view. The scoring device 103 of this comparative example corresponds to the scoring device 3 (see FIG. 2) of the embodiment in which the scoring member 102 is provided instead of the scoring member 32, and other configurations are It is similar.

As shown in FIG. 5, the scoring member 102 corresponds to the scoring member 32 of the embodiment in which the connecting portion 423 is not provided (omitted), and the other configurations are the same. It has become. That is, the scoring member 32 is provided with the above-mentioned three types of connecting portions 421, 422 and 423, whereas the scoring member 102 is provided with the connecting portion 421 near the tip and the connecting portion 422 near the base end, respectively. Although it is provided, the connecting portion 423 in the intermediate region described above is not provided.

The scoring member 102 having such a configuration may cause the following problems, for example.

That is, first, as the stenosis portion to be treated in the above-mentioned treatment, for example, a stenosis portion in a blood vessel of a relatively large lower limb portion is assumed. In that case, since it is assumed that the size of the stenotic portion in the blood vessel also increases, it is necessary to increase the axial length (length in the Z-axis direction) of each element 411,412. Then, in such a case, like the scoring member 102 of this comparative example, only the connecting portions 421 and 422 are provided (the connecting portion is provided in the intermediate region between the vicinity of the tip end and the vicinity of the base end). (No), it becomes as follows. That is, there is a possibility that the plurality of elements 411 and 412 are twisted together, and the balloon 22 cannot be arranged inside the scoring member 102. As a result, when the scoring device 103 of this comparative example is used, the operability at the time of the above-mentioned treatment is lowered, and the convenience at the time of the treatment is impaired.

(Implementation)
On the other hand, in the scoring device 3 of the present embodiment, as shown in FIGS. 2 and 3, as the connecting portion in the scoring member 32, the connecting portion 421 near the tip and the connecting portion 422 near the base end. In addition, a connecting portion 423 is provided in their intermediate region.

As a result, in the present embodiment, for example, as described above, even when it is necessary to increase the axial length of each element 411, 412, the connecting portion 423 is not provided (connecting portion 421, Compared with the above comparative example (only 422 is provided), the result is as follows. That is, as described above, there is a possibility that the plurality of elements 411 and 412 are twisted together and the balloon 22 cannot be arranged inside the scoring member 32. As a result, in the present embodiment, the operability at the time of treating the narrowed portion 90 in the blood vessel 9 described above is improved as compared with the above comparative example. Therefore, in the present embodiment, as compared with the above comparative example, it is possible to improve the convenience at the time of such treatment and also to improve the therapeutic effect.

Further, in the present embodiment, since the connecting portion 422 near the base end is formed into a ring shape, it becomes as follows. That is, first, in the vicinity of the connecting portion 422 (near the base end), it is less necessary for the balloon 22 to inflate as compared with the vicinity of the connecting portions 421 and 423 (near the tip and the intermediate region). Therefore, by forming the connecting portion 422 into a ring shape and avoiding the possibility that the balloon 22 will come off from the inside of the scoring member 32, it is possible to further improve the convenience during the above-mentioned treatment.

Further, in the present embodiment, in addition to the above-mentioned connecting portion 422, the connecting portions 421 and 423 are also formed into a ring shape (the connecting portions 421, 422 and 423 are all formed into a ring shape), so that the following is obtained. That is, as compared with the cases of Modifications 1 to 3 described later, the scoring member 32 can have a simple structure, and the scoring device 3 can be easily manufactured.

In addition, in the present embodiment, the axial length L22 of the expansion region in the balloon 22 is shorter than the axial length L32 in the scoring member 32 (L22 <L32), so that it is as follows. That is, for example, as shown in FIG. 1, since the entire balloon 22 can be arranged inside the scoring member 32, the therapeutic effect during the above-mentioned treatment can be improved, and the convenience during the treatment can be improved. Can be further improved.

<2. Modification example>
Subsequently, modification examples (modification examples 1 to 4) of the above-described embodiment will be described.

Each of these modifications 1 to 4 corresponds to a modification in which the shape of the scoring device 3 is changed. By combining the scoring devices (scoring devices 3A to 3D described later) according to the modified examples 1 to 4 with the balloon catheter 2 described in the embodiment, the scoring system according to the modified examples 1 to 4 is also used. It is possible to configure. The same components as those in the above embodiment are designated by the same reference numerals, and the description thereof will be omitted as appropriate.

[Modification 1]
(Outline configuration)
FIG. 6 schematically shows a schematic configuration of the scoring device (scoring device 3A) according to the first modification in a side view. Further, FIGS. 7 (A) to 7 (C) schematically show a detailed configuration of each connecting portion (connecting portions 421A, 422A, 423A described later) shown in FIG. 6 in a perspective view. .. Specifically, FIG. 7A shows a detailed configuration of the connecting portion 421A, FIG. 7B shows a detailed configuration of the connecting portion 423A, and FIG. 7C shows a detailed configuration of the connecting portion 422A. There is.

As shown in FIGS. 6 and 7, the scoring device 3A of the first modification includes a shaft 31 and a scoring member 32A. Further, the scoring member 32A has a plurality of (five in this example) elements 411 to 415 and three types of connecting portions 421A, 422A, and 423A. Further, as shown in FIG. 6, one connecting portion 421A and one 422A are provided, and a plurality of connecting portions 423A (two in this example) are provided.

That is, in the scoring member 32A of the modification 1, in the scoring member 32 of the embodiment (see FIGS. 2 and 3), the number of elements is changed and the connecting portion is replaced with the connecting portion 421, 422, 423. It corresponds to the one in which 421A, 422A, and 423A are provided, and other configurations are the same.

Each of the elements 411 to 415 is basically composed of the same shape and material as the elements 411 and 412 described in the embodiment, and can be elastically deformed according to the expansion and contraction of the balloon 22. .. Further, as shown in FIG. 6, each of these elements 411 to 415 extends so as to be parallel to each other along the axial direction (Z-axis direction), and the elements 411 to 415 as a whole extend XY. They are arranged so as to form an annular shape in a plane (see FIGS. 6 and 7).

Similar to the connecting portion 421, the connecting portion 421A is provided in the vicinity of each tip of the elements 411 to 415 (the tip in the example of FIGS. 6 and 7 (A)) as shown in FIGS. 6 and 7 (A). These elements 411 to 415 are connected to each other.

Similar to the connecting portion 422, the connecting portion 422A is located near each base end of the elements 411 to 415 as shown in FIGS. 6 and 7 (C) (in the example of FIGS. 6 and 7 (C), the base end). In, these elements 411 to 415 are connected to each other.

Similar to the connecting portion 423, the connecting portion 423A is in the intermediate region between the vicinity of the tip end and the vicinity of the base end of each element 411 to 415 as shown in FIGS. 6 and 7 (B) (FIGS. 6 and 6). In the example of 7 (B), these elements 411 to 415 are connected to each other in the intermediate region excluding the tip end and the base end. Further, as described above, in the example of FIGS. 6 and 7 (B), since a plurality (two) connecting portions 423A are provided, elements are provided at a plurality (two) of the connecting portions 423A in such an intermediate region. 411 to 415 are connected to each other. Further, these two connecting portions 423A are arranged apart from each other along the axial direction (Z-axis direction) of the elements 411 to 415. Specifically, as shown in FIG. 6, the connecting portions 421A and 422A and the two connecting portions 423A are arranged so as to be substantially equal to each other along the Z-axis direction.

Here, the connecting portion 422A has a ring shape as shown in FIGS. 6 and 7 (C), similarly to the connecting portion 422. That is, the connecting portion 422A connects the five elements 411 to 415 to each other so as to completely orbit in the XY plane (without including the notch portion or the like).

On the other hand, the connecting portions 421A and 423A are different from the connecting portions 421 and 423, respectively, and as shown in FIGS. 6, 7 (A) and 7 (B), spirals along the axial direction (Z-axis direction). It has a spiral structure. Further, among these connecting portions 421A and 423A, in this example, in the connecting portion 423A, a plurality of elements 411 to 415 are divided along the axial direction (Z-axis direction) via such a spiral structure. (See FIG. 7 (B)).

Here, each of these connecting portions 421A, 422A, and 423A corresponds to a specific example of the "connecting portion" in the present invention. Further, the connecting portion 421A corresponds to a specific example of the "first connecting portion" in the present invention, the connecting portion 422A corresponds to a specific example of the "second connecting portion" in the present invention, and the connecting portion 423A corresponds to a specific example of the "second connecting portion". It corresponds to a specific example of the "third connecting portion" in the present invention.

(Action / effect)
Even in the scoring device 3A of the modified example 1 having such a configuration, it is possible to obtain the same effect by basically the same operation as that of the embodiment. That is, also in the scoring device 3A of this modification, in addition to the connecting portion 421A near the tip and the connecting portion 422A near the base end, the connecting portion 423A is provided in the intermediate region between them as the connecting portion in the scoring member 32A. So, it becomes as follows. That is, also in this modified example, as compared with the above-mentioned comparative example, the operability at the time of the above-mentioned treatment can be improved, the convenience at the time of the treatment can be improved, and the therapeutic effect can be improved. It is also possible.

Further, also in this modification 1, since the connecting portion 422A near the base end is formed into a ring shape as in the embodiment, the following is obtained. That is, as described above, it is possible to avoid the possibility that the balloon 22 will come off from the inside of the scoring member 32A, and it is possible to further improve the convenience during the above-mentioned treatment.

Further, particularly in this scoring device 3A, since the connecting portions 421A and 423A each have the above-mentioned spiral structure, the following is obtained. That is, first, since the connecting portions 421A and 423A (near the tip and the intermediate region) can be expanded to some extent, the scoring member 32A is easily delivered from the tip side to the periphery of the balloon catheter 2. Further, when the balloon 22 is inflated from the inside of the scoring member 32A, the balloon 22 can be slightly inflated in the vicinity of the connecting portions 421A and 423A (near the tip and in the intermediate region). Also makes it easier to spread the narrowed portion 90. From these facts, it is possible to improve the therapeutic effect at the time of the above-mentioned treatment and further improve the convenience at the time of treatment.

Further, in this scoring device 3A, the plurality of elements 411 to 415 are divided along the axial direction (Z-axis direction) via the spiral structure described above, so that the following is obtained. .. That is, for example, since the balloon 22 can be further inflated in the vicinity of the connecting portion 423A, the therapeutic effect during the above-mentioned treatment can be further improved, and the convenience during the treatment can be further improved. It becomes.

[Modification 2]
(Outline configuration)
FIG. 8 schematically shows a schematic configuration of the scoring device (scoring device 3B) according to the second modification in a side view. Further, FIGS. 9 (A) to 9 (C) schematically show a detailed configuration of each connecting portion (connecting portions 421B and 423B described later) shown in FIG. 7 in a perspective view. Specifically, FIG. 9A shows a detailed configuration of the connecting portion 421B, FIG. 9B shows a detailed configuration of the connecting portion 423B (connecting portion 423B1 described later), and FIG. 9C shows the connecting portion 423B ( The detailed configuration of the connecting portion 423B2) described later is shown.

As shown in FIGS. 8 and 9, the scoring device 3B of the second modification includes a shaft 31 and a scoring member 32B. Further, the scoring member 32B has a plurality of (five in this example) elements 411 to 415 and three types of connecting portions 421B, 422B, and 423B. Further, as shown in FIG. 8, one connecting portion 421B and one 422B are provided, and a plurality of connecting portions 423B (in this example, two connecting portions 423B1 and 423B2) are provided. The connecting portion 423B1 is relatively arranged on the distal end side, and the connecting portion 423B2 is relatively arranged on the proximal end side.

That is, the scoring member 32B of the modified example 2 is provided with the connecting portions 421B, 422B, 423B instead of the connecting portions 421A, 422A, 423A in the scoring member 32A of the modified example 1 (see FIGS. 6 and 7). The other configurations are the same.

Similar to the connecting portion 421A, the connecting portion 421B is provided in the vicinity of each tip of the elements 411 to 415 (the tip in the example of FIGS. 8 and 9 (A)) as shown in FIGS. 8 and 9 (A). These elements 411 to 415 are connected to each other.

Similar to the connecting portion 422B, the connecting portion 422B connects the elements 411 to 415 to each other in the vicinity of the base ends of the elements 411 to 415 (base ends in the example of FIG. 8) as shown in FIG. doing.

Similar to the connecting portion 423A, the connecting portion 423B (423B1, 423B2) includes the vicinity of the tip end and the vicinity of the base end of each element 411 to 415 as shown in FIGS. 8, 9 (B) and 9 (C). In the intermediate region between them (in this example, in the intermediate region excluding the tip end and the base end), these elements 411 to 415 are connected to each other. Further, in this example, the connecting portions 423B1 and 423B2 connect the elements 411 to 415 to each other at a plurality of (two) positions in such an intermediate region. The two connecting portions 423B1 and 423B2 are arranged apart from each other along the axial direction (Z-axis direction) of the elements 411 to 415. Specifically, as shown in FIG. 8, the connecting portions 421B and 422B and the connecting portions 423B1 and 423B2 are arranged so as to be substantially equal to each other along the Z-axis direction.

Here, the connecting portion 422B has a ring shape as shown in FIG. 8, similarly to the connecting portions 422 and 422A. That is, the connecting portion 422B connects the five elements 411 to 415 to each other so as to completely orbit in the XY plane (without including the notch portion or the like).

On the other hand, the connecting portions 421B and 423B (423B1, 423B2) are different from the connecting portions 421A and 423A, respectively, and as shown in FIGS. It has a shaped structure (first C-shaped structure). That is, in the C-shaped structure of this modification, the C-shaped rings 431a and 433a and the C-shaped rings 431b and 433b are arranged to face each other along the Z-axis direction (FIGS. 9A to 9A). 9 (B)). Further, among these connecting portions 421B and 423B, in this example, the connecting portion 423B (423B1, 423B2) is a part of the elements of the plurality of elements 411 to 415 (in addition, through such a C-shaped structure). In this example, 2 out of 5) are divided along the Z-axis direction.

Specifically, in the connecting portion 421B shown in FIG. 9A, the C-shaped ring 431a and the C-shaped ring 431b are arranged to face each other along the Z-axis direction. The C-shaped ring 431a has a notch 441a (first notch) formed in a predetermined angular direction (first angular direction). On the other hand, the C-shaped ring 431b has a notch 441b (second notch) formed in a predetermined angular direction (a second angular direction different from the first angular direction).

Further, in the connecting portions 423B1 and 423B2 shown in FIGS. 9B and 9C, the C-shaped ring 433a and the C-shaped ring 433b are respectively arranged to face each other along the Z-axis direction. .. The C-shaped ring 433a has a notch 443a (first notch) formed in a predetermined angular direction (first angular direction). On the other hand, the C-shaped ring 433b has a notch 443b (second notch) formed in a predetermined angular direction (a second angular direction different from the first angular direction).

Then, in the connecting portion 423B1, two elements 413 and 414 out of the five elements 411 to 415 are divided along the Z-axis direction via the C-shaped structure described above (FIG. 9 (B). )reference). Further, in the connecting portion 423B2, two elements 421 and 413 out of the five elements 411 to 415 are divided along the Z-axis direction via the above-mentioned C-shaped structure (FIG. 9 (C)). )reference).

Here, each of these connecting portions 421B, 422B, and 423B corresponds to a specific example of the "connecting portion" in the present invention. Further, the connecting portion 421B corresponds to a specific example of the "first connecting portion" in the present invention, the connecting portion 422B corresponds to a specific example of the "second connecting portion" in the present invention, and the connecting portion 423B corresponds to a specific example of the "second connecting portion". It corresponds to a specific example of the "third connecting portion" in the present invention.

(Action / effect)
Even in the scoring device 3B of the modified example 2 having such a configuration, it is possible to obtain the same effect by basically the same operation as that of the embodiment. That is, also in the scoring device 3B of this modification, in addition to the connecting portion 421B near the tip and the connecting portion 422B near the base end, the connecting portion 423B is provided in the intermediate region between them as the connecting portion in the scoring member 32B. So, it becomes as follows. That is, also in this modified example, as compared with the above-mentioned comparative example, the operability at the time of the above-mentioned treatment can be improved, the convenience at the time of the treatment can be improved, and the therapeutic effect can be improved. It is also possible.

Further, also in this modification 2, since the connecting portion 422B near the base end is formed into a ring shape as in the embodiment, the following is obtained. That is, as described above, it is possible to avoid the possibility that the balloon 22 will come off from the inside of the scoring member 32B, and it is possible to further improve the convenience during the above-mentioned treatment.

Further, particularly in this scoring device 3B, the connecting portions 421B and 423B each have a C-shaped structure shown in FIG. Then, in this C-shaped structure, the above-mentioned C-shaped rings 431a and 433a and the above-mentioned C-shaped rings 431b and 433b are arranged so as to face each other along the Z-axis direction. become that way. That is, as in the case of the above-described modification 1, first, since the connecting portions 421B and 423B (near the tip and the intermediate region) can be expanded to some extent, the scoring member 32B is moved from the tip side to the periphery of the balloon catheter 2. In addition, it becomes easy to be delivered. Further, when the balloon 22 is inflated from the inside of the scoring member 32B, the balloon 22 can be slightly inflated in the vicinity of the connecting portions 421B and 423B (near the tip and in the intermediate region). Also makes it easier to spread the narrowed portion 90. From these facts, it is possible to improve the therapeutic effect at the time of the above-mentioned treatment and further improve the convenience at the time of treatment.

Further, in the scoring device 3B, some elements of the plurality of elements 411 to 415 are divided along the axial direction (Z-axis direction) through the C-shaped structure shown in FIG. Since I made it so, it becomes as follows. That is, for example, since the balloon 22 can be further inflated in the vicinity of the connecting portion 423B, the therapeutic effect during the above-mentioned treatment can be further improved, and the convenience during the treatment can be further improved. It becomes.

[Modification 3]
(Outline configuration)
10 (A) to 10 (D) schematically show the configuration of each connecting portion (connecting portions 421C, 422C, 423C) in the scoring device (scoring device 3C) according to the third modification. It is shown in the figure. Specifically, FIG. 10 (A) shows the detailed configuration of the connecting portion 421C, FIGS. 10 (B) and 10 (C) show the detailed configuration of the connecting portion 423C, and FIG. 10 (D) shows the detailed configuration of the connecting portion 422C. The configuration is shown respectively.

As shown in FIGS. 10A to 10D, the scoring device 3C of the modified example 3 includes a shaft 31 and a scoring member 32C. Further, the scoring member 32C has a plurality of (four in this example) elements 411 to 414 and three types of connecting portions 421C, 422C, and 423C. Further, one connecting portion 421C and one 422C are provided, and a plurality of connecting portions 423C (two in this example) are provided.

That is, the scoring member 32C of the modified example 3 changes the number of elements in the scoring member 32A of the modified example 1 (see FIGS. 6 and 7), and instead of the connecting portions 421A, 422A, and 423A, the connecting portion It corresponds to the one in which 421C, 422C, and 423C are provided, and other configurations are the same.

Similar to the connecting portions 421A and 421B, the connecting portion 421C is provided with these elements 411 in the vicinity of the respective tips of the elements 411 to 414 (the tips in the example of FIG. 10 (A)) as shown in FIG. ~ 414 are connected to each other.

Similar to the connecting portions 422A and 422B, the connecting portion 422C is provided in the vicinity of each base end of the elements 411 to 414 (the base end in the example of FIG. 10 (D)) as shown in FIG. 10 (D). The elements 411 to 414 are connected to each other.

Similar to the connecting portions 423A and 423B, the connecting portion 423C is in the intermediate region between the vicinity of the tip end and the vicinity of the base end of each element 411 to 414 as shown in FIGS. 10 (B) and 10 (C). (In this example, in the intermediate region excluding the tip end and the base end), these elements 411 to 414 are connected to each other. Further, in this example, the connecting portion 423C connects the elements 411 to 414 to each other at a plurality of (two) positions in such an intermediate region. The two connecting portions 423C are arranged apart from each other along the axial direction (Z-axis direction) of the elements 411 to 414. Specifically, the connecting portions 421C and 422C and the two connecting portions 423C are arranged so as to be substantially equal to each other along the Z-axis direction.

Here, the connecting portion 422C has a ring shape as shown in FIG. 10C, similarly to the connecting portions 422, 422A and 422B. That is, the connecting portion 422C connects the four elements 411 to 414 to each other so as to completely orbit in the XY plane (without including the notch portion or the like).

On the other hand, the connecting portions 421C and 423C are different from the connecting portions 421A, 423A, 421B and 423B, respectively, and as shown in FIGS. 2 C-shaped structure). That is, the C-shaped structure of this modification includes a single C-shaped ring 451 and 453 (ring having a notch). Specifically, the C-shaped structure in the connecting portion 421C shown in FIG. 10 (A) includes a single C-shaped ring 451 and is shown in FIGS. 10 (B) and 10 (C). Each C-shaped structure at the connecting portion 423C includes a single C-shaped ring 453.

Further, among these connecting portions 421C and 423C, in this example, in the connecting portion 423C, some elements among a plurality of elements 411 to 414 (four in this example) are provided via such a C-shaped structure. One of them) is divided along the Z-axis direction. Specifically, in the connecting portion 423C shown in FIG. 10B, one element 414 of the four elements 411 to 414 is divided along the Z-axis direction via the above-mentioned C-shaped structure. Has been done. Further, in the connecting portion 423C shown in FIG. 10C, one element 412 of the four elements 411 to 414 is divided along the Z-axis direction via the above-mentioned C-shaped structure. ..

Here, each of these connecting portions 421C, 422C, and 423C corresponds to a specific example of the "connecting portion" in the present invention. Further, the connecting portion 421C corresponds to a specific example of the "first connecting portion" in the present invention, the connecting portion 422C corresponds to a specific example of the "second connecting portion" in the present invention, and the connecting portion 423C corresponds to a specific example of the "second connecting portion". It corresponds to a specific example of the "third connecting portion" in the present invention.

(Action / effect)
Even in the scoring device 3C of the modified example 3 having such a configuration, it is possible to obtain the same effect by basically the same operation as that of the embodiment. That is, also in the scoring device 3C of this modification, in addition to the connecting portion 421C near the tip and the connecting portion 422C near the base end, the connecting portion 423C is provided in the intermediate region between them as the connecting portion in the scoring member 32C. So, it becomes as follows. That is, also in this modified example, as compared with the above-mentioned comparative example, the operability at the time of the above-mentioned treatment can be improved, the convenience at the time of the treatment can be improved, and the therapeutic effect can be improved. It is also possible.

Further, also in this modification 3, since the connecting portion 422C near the base end is formed into a ring shape as in the embodiment, the following is obtained. That is, as described above, it is possible to avoid the possibility that the balloon 22 will come off from the inside of the scoring member 32C, and it is possible to further improve the convenience during the above-mentioned treatment.

Further, particularly in this scoring device 3B, the connecting portions 421C and 423C each have a C-shaped structure (a structure including a single C-shaped ring 451 and 453) shown in FIG. become that way. That is, as in the case of the above-described modified examples 1 and 2, first, since the connecting portions 421C and 423C (near the tip and the intermediate region) can be slightly expanded, the scoring member 32C moves from the tip side to the balloon catheter 2. It becomes easy to be delivered around. Further, when the balloon 22 is inflated from the inside of the scoring member 32C, the balloon 22 can be slightly inflated in the vicinity of the connecting portions 421C and 423C (near the tip and in the intermediate region). Also makes it easier to spread the narrowed portion 90. From these facts, it is possible to improve the therapeutic effect at the time of the above-mentioned treatment and further improve the convenience at the time of treatment.

Further, in the scoring device 3B, some elements of the plurality of elements 411 to 415 are divided along the axial direction (Z-axis direction) through the C-shaped structure shown in FIG. Since I made it so, it becomes as follows. That is, for example, since the balloon 22 can be further inflated in the vicinity of the connecting portion 423C, the therapeutic effect during the above-mentioned treatment can be further improved, and the convenience during the treatment can be further improved. It becomes.

[Modification example 4]
(Outline configuration)
FIG. 11 schematically shows a schematic configuration of the scoring device (scoring device 3D) according to the modified example 4 in a perspective view.

As shown in FIG. 11, the scoring device 3D of the modified example 4 includes a shaft 31 and a scoring member 32D. Further, the scoring member 32D has a plurality of (two in this example) elements 411 and 412, and three types of connecting portions 421, 422 and 423. Further, one connecting portion 421, 422, 423 is provided for each.

That is, the scoring member 32D of the modified example 4 corresponds to the scoring member 32 of the embodiment (see FIGS. 2 and 3) in which the number of connecting portions 423 is changed from a plurality (two) to one. The other configurations are the same. In the scoring member 32D as well, the connecting portions 421, 422, and 423 are all ring-shaped as in the scoring member 32.

(Action / effect)
Even in the scoring device 3D of the modified example 4 having such a configuration, it is possible to obtain the same effect by basically the same operation as that of the embodiment. That is, also in the scoring device 3D of this modification, in addition to the connecting portion 421 near the tip and the connecting portion 422 near the base end, the connecting portion 423 is provided in the intermediate region between them as the connecting portion in the scoring member 32D. So, it becomes as follows. That is, also in this modified example, as compared with the above-mentioned comparative example, the operability at the time of the above-mentioned treatment can be improved, the convenience at the time of the treatment can be improved, and the therapeutic effect can be improved. It is also possible.

<3. Other variants>
Although the present invention has been described above with reference to embodiments and modifications, the present invention is not limited to these embodiments and can be modified in various ways.

For example, the shape, arrangement position, size, number, material, and the like of each member described in the above-described embodiment and the like are not limited, and other shapes, arrangement positions, sizes, numbers, materials, and the like may be used. Specifically, for example, the configuration of the scoring member, the balloon catheter, and the like in the scoring device is not limited to that described in the above-described embodiment and may be other configurations.

In detail, for example, the number of a plurality of elements in the scoring member is not limited to that described in the above-described embodiment and the like, and the connecting portion in the scoring member is not all of the plurality of elements. , Only some of the elements may be connected to each other. Further, such a connecting portion is not limited to the case where it is integrally formed with a plurality of elements, and may be provided as a separate body from the plurality of elements, for example. Further, the cross-sectional shape of each element is not limited to the quadrangular shape described in the above-described embodiment or the like, and any shape such as another polygonal shape such as a triangular shape or a circular shape can be applied. ..

In addition, in the above-described embodiment and the like, the case where the narrowed portion in the blood vessel of the lower limb portion having a relatively large size is the treatment target has been mainly illustrated, but the case is not limited to this case. That is, the scoring device and scoring system of the present invention are also applied to the treatment of a stenosis in a blood vessel other than the blood vessel of the lower limbs (for example, viscera, abdomen, etc.), a stenosis in a shunt, and the like. It is possible.

Claims (9)

A device used in the treatment of expanding a stenosis in a blood vessel by utilizing the expansion of a balloon in a balloon catheter.
A shaft that extends along the axial direction,
It is provided on the tip end side of the shaft, and includes a scoring member into which the balloon is inserted during the treatment.
The scoring member
Each extends along the axial direction and is capable of elastic deformation in response to expansion and contraction of the balloon, and at the same time, a plurality of pieces for causing a crack on the surface of the constriction portion during the treatment. With the element
It has a connecting portion that connects at least two or more of the plurality of elements to each other along the circumferential direction.
The connecting portion
In the vicinity of each tip of the plurality of elements, a first connecting portion for connecting the at least two or more elements to each other, and a first connecting portion.
In the vicinity of each base end of the plurality of elements, a second connecting portion for connecting the at least two or more elements to each other, and a second connecting portion.
Scoring including a third connecting portion for connecting at least two or more elements to each other at one or a plurality of points in an intermediate region between the vicinity of the tip and the vicinity of the base end of the plurality of elements. device. The scoring device according to claim 1, wherein the first and third connecting portions each have a spiral structure along the axial direction. The scoring device according to claim 2, wherein the plurality of elements are each divided along the axial direction via the spiral structure. The first and third connecting portions each have a first C-shaped structure as a C-shaped structure.
In the first C-shaped structure,
A first C-shaped ring with a first notch formed in the first angular direction and
A second C-shaped ring having a second notch formed in a second angular direction different from the first angular direction is
The scoring device according to claim 1, wherein the scoring devices are arranged so as to face each other along the axial direction. The scoring device according to claim 1, wherein the first and third connecting portions each have a second C-shaped structure as a C-shaped structure including a single C-shaped ring. The scoring device according to claim 4 or 5, wherein a part of the plurality of elements is divided along the axial direction through the C-shaped structure. The scoring device according to any one of claims 2 to 6, wherein the second connecting portion has a ring shape. A system used in the treatment of expanding a stenosis in a blood vessel by using the expansion of a balloon.
A balloon catheter having the balloon and
A scoring device comprising a shaft extending along the axial direction and a scoring member provided on the tip end side of the shaft and into which the balloon is inserted during the treatment.
The scoring member
Each extends along the axial direction and is capable of elastic deformation in response to expansion and contraction of the balloon, and at the same time, a plurality of pieces for causing a crack on the surface of the constriction portion during the treatment. With the element
It has a connecting portion that connects at least two or more of the plurality of elements to each other along the circumferential direction.
The connecting portion
In the vicinity of each tip of the plurality of elements, a first connecting portion for connecting the at least two or more elements to each other, and a first connecting portion.
In the vicinity of each base end of the plurality of elements, a second connecting portion for connecting the at least two or more elements to each other, and a second connecting portion.
Scoring including a third connecting portion that connects at least two or more elements to each other at one or a plurality of points in an intermediate region between the vicinity of the tip and the vicinity of the base of the plurality of elements. system. The scoring system according to claim 8, wherein the length of the inflatable region of the balloon along the axial direction is shorter than the length of the scoring member along the axial direction.

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