JPWO2019065280A1 - Balloon catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter capable of more accurately positioning an end portion of a stent with respect to a lesion portion and preventing an increase in the profile of a balloon in a contracted state.
SOLUTION: A first contrast marker portion 161 of a balloon catheter 100 is arranged at a position of an inner tube shaft 110 corresponding to a boundary portion b1 between an intermediate region 133 of the balloon 130 and an inclined region 135 on the proximal end side of the balloon. , The second contrast marker portion 162 is arranged between the proximal end portion 142 of the stent and the first contrast marker portion in a state where the stent 140 is arranged in the intermediate region of the balloon, and the contrast marker 150 is a stent. It is not located at the position of the inner tube shaft corresponding to the middle part of.
[Selection diagram] Fig. 4

Description

The present invention relates to a balloon catheter comprising a balloon on which a stent is placed.

Conventionally, stent placement is known as a method for treating a lesion such as a stenosis formed in a blood vessel or the like. For delivery and placement of the stent to the lesion, for example, a balloon catheter as described in Patent Document 1 below is used.

In a procedure using a stent, a surgeon such as a doctor operates a balloon catheter in which the stent is placed on the outer surface of the balloon in a contracted state, and delivers the balloon and the stent to the lesion site. The surgeon delivers the balloon and stent to the lesion and then dilates the stent with the balloon. The stent is placed in the lesion in an expanded state.

When placing the stent in the lesion as described above, the operator positions the stent with respect to the lesion with reference to the position of the contrast marker placed on the shaft of the balloon catheter. Specifically, the operator confirms the position of the contrast marker on an X-ray image, and places the stent at a desired position in the biological lumen based on the relative positional relationship between the contrast marker and the stent end.

Japanese Unexamined Patent Publication No. 2014-11117

Since the contrast marker of the balloon catheter has high contrast on the X-ray image, a metal such as gold or platinum is used. For example, when the contrast marker is made of a relatively hard material such as metal, when the balloon is sandwiched between the contrast marker and the end of the stent, the balloon and the end of the stent are abraded and the balloon is generated. It may be damaged. Therefore, there is a certain distance between the contrast marker and the end of the stent. However, when a certain distance is provided between the contrast marker and the end of the stent, the following problems arise.

When placing a stent in a lesion formed around a bifurcation of a blood vessel, the operator refers to the stent on the lesion with reference to a contrast marker placed on the end side (for example, the proximal end side) of the stent. Perform positioning. At that time, if there is a certain distance between the contrast marker and the end portion of the stent, the indwelling position of the end portion of the stent is displaced by the distance. Therefore, it is difficult for the operator to accurately position the end of the stent with respect to the lesion formed around the bifurcation of the blood vessel.

Further, in view of the above problems, for example, it is conceivable to place a contrast marker indicating the total length (total length in the axial direction) of the stent on the shaft of the balloon catheter. When the contrast marker is arranged in this way, the operator can easily confirm the position of the end portion of the stent on the X-ray image. Therefore, the operator can position the stent with respect to the lesion relatively accurately. However, when the contrast marker is placed as described above, the contrast marker is also placed in the intermediate region (expansion portion) of the balloon, so that the profiling (outer diameter) of the balloon at the time of delivery of the stent becomes large. The problem arises.

An object of the present invention is to provide a balloon catheter capable of more accurately positioning the end of a stent with respect to a lesion and preventing the profile of a balloon in a contracted state from becoming large.

The balloon catheter according to the present invention includes an inner tube shaft, an outer tube shaft that covers a part of the inner tube shaft, a balloon fixed to the inner tube shaft and the outer tube shaft, and a stent placed on the balloon. And a contrast marker arranged on the inner tube shaft, the balloon has an intermediate region forming the maximum outer diameter portion of the balloon and a tip to the tip of the intermediate region in a state where the balloon is expanded. It has an distal end-side tilted region extending to the side and a proximal end-side tilted region extending from the proximal end of the intermediate region to the proximal end side, and the stent is located at a position corresponding to the distal end side of the intermediate region of the balloon. It has a tip portion to be arranged, a proximal end portion arranged at a position corresponding to the proximal end side of the intermediate region of the balloon, and an intermediate portion extending between the distal end portion and the proximal end portion. The contrast marker has a first contrast marker portion made of a metal material having contrast and a second contrast marker portion made of a resin material having contrast, and the first contrast marker portion is in the middle. The second contrast marker portion is arranged at the position of the inner tube shaft corresponding to the boundary portion between the region and the proximal end side inclined region and / or the boundary portion between the intermediate region and the distal end side inclined region. With the stent placed in the intermediate region, the stent is placed between the end of the stent and the first contrast marker portion, and the contrast is provided at the position of the inner tube shaft corresponding to the intermediate portion of the stent. No marker is placed.

In the above balloon catheter, a second contrast marker portion containing a resin material is arranged between the end portion of the stent and the first contrast marker portion made of a metal material. Therefore, the second contrast marker portion prevents the end portion of the stent from coming into contact with the first contrast marker portion, and prevents the balloon arranged between the end portion of the stent and the first contrast marker portion from being damaged. Can be prevented. Thereby, the balloon catheter can place the end of the stent in close proximity to the contrast marker. Therefore, when the stent is placed, the operator such as a doctor confirms that the stent is placed at the position of the maximum outer shape (intermediate region) of the balloon by using the contrast marker as a reference, and the living lumen. The end of the stent can be more accurately positioned at the desired position. In addition, since the balloon catheter does not have a contrast marker placed at the position of the inner tube shaft corresponding to the middle part of the stent (the position of the inner tube shaft corresponding to the middle region of the balloon), the profile of the balloon in the contracted state can be obtained. It can be prevented from becoming large.

It is a figure which shows the balloon catheter which concerns on embodiment of this invention. It is sectional drawing in the axial direction of the broken line part 2A part of FIG. It is sectional drawing which shows the expanded state of the balloon shown in FIG. FIG. 4A is an enlarged cross-sectional view of the broken line portion 4A portion of FIG. 2, and FIG. 4B is an enlarged cross-sectional view of the broken line portion 4B portion of FIG. It is a schematic cross-sectional view for demonstrating the operation of the balloon catheter which concerns on embodiment. It is sectional drawing which shows the part of FIG. 5 enlarged. It is sectional drawing of the balloon catheter which concerns on the modification. It is an enlarged cross-sectional view of the broken line part 8A part of FIG. It is sectional drawing which shows the contrast marker which concerns on modification 1. FIG. It is sectional drawing which shows the contrast marker which concerns on modification 2. FIG. It is sectional drawing which shows the contrast marker which concerns on modification 3. It is sectional drawing which shows the contrast marker which concerns on modification 4. It is sectional drawing which shows the contrast marker which concerns on modification 5. It is sectional drawing which shows the contrast marker which concerns on modification 6.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

FIG. 1 shows a simplified version of the balloon catheter 10, FIG. 2 shows an enlarged cross-sectional view (axial cross-sectional view) of the broken line portion 2A shown in FIG. 1, and FIG. 3 shows the balloon 130 and FIG. 2 shown in FIG. A cross-sectional view of the expanded state of the stent 140 is shown, FIG. 4 (A) shows an enlarged cross-sectional view of the broken line portion 4A shown in FIG. 2, and FIG. 4 (B) shows the broken line portion 4B portion shown in FIG. 5 and 6 show a schematic cross-sectional view for explaining the operation of the balloon catheter 10.

As shown in FIG. 1, the balloon catheter 10 according to the present embodiment is configured as a balloon catheter for stent delivery including a stent 140 arranged (crimped) on the balloon 130.

As shown in FIGS. 1 to 3, the balloon catheter 10 includes a long shaft 100, a balloon 130 arranged on the distal end side of the shaft 100, a stent 140 arranged on the balloon 130, and a base of the shaft 100. It has a hub 190 arranged on the end side.

In the description of the embodiment, the side on which the balloon 130 is arranged is the distal end side of the balloon catheter 10, the side on which the hub 190 is arranged is the proximal end side of the balloon catheter 10, and the direction in which the shaft 100 extends is the axial direction. Further, in the description of the embodiment, the tip portion means a certain range including the tip (leading edge) and its periphery, and the proximal end portion means a certain range including the proximal end (most proximal end) and its periphery. Means a range.

As shown in FIG. 1, the balloon catheter 10 is configured as a so-called rapid exchange type catheter in which a proximal opening (guide wire port) 105 through which the guide wire 200 can enter and exit is formed near the tip end side of the shaft 100. ing.

As shown in FIG. 2, the shaft 100 includes an inner pipe shaft 110 and an outer pipe shaft 120 that covers a part of the inner pipe shaft 110.

The inner tube shaft 110 includes a lumen (guide wire lumen) 115 through which the guide wire 200 is inserted. The outer tube shaft 120 includes a lumen (expansion lumen) 125 through which a pressurizing medium for expanding the balloon 130 can flow.

The outer pipe shaft 120 is, for example, a tip side shaft and a base end side shaft that are integrally connected (fused) with the inner pipe shaft 110 in the vicinity of the base end opening 105 of the shaft 100 (the illustration of each shaft is omitted). Can be formed by

As shown in FIG. 2, the tip end side of the inner tube shaft 110 is arranged in the lumen 125 of the outer tube shaft 120. A certain range on the tip end side of the inner tube shaft 110 is arranged so as to project toward the tip end side of the outer tube shaft 120.

The inner pipe shaft 110 has a tip member 180 arranged on the tip side. The tip member 180 has a lumen 181 through which the guide wire 200 can be inserted.

By providing the tip member 180 on the tip side of the inner tube shaft 110, it is possible to prevent damage to the living organ when the tip of the balloon catheter 10 comes into contact with the living lumen (inner wall of a blood vessel or the like). The tip member 180 can be formed of, for example, a flexible resin material. However, the material of the tip member 180 is not particularly limited as long as it can be fixed to the inner pipe shaft 110.

As shown in FIG. 3, the balloon 130 includes an intermediate region 133 forming the maximum outer diameter portion of the balloon 130 and a tip-side inclined region 134 extending from the tip of the intermediate region 133 to the tip side when the balloon 130 is expanded. It has a proximal end-side inclined region 135 extending from the proximal end of the intermediate region 133 to the proximal end side. Further, the balloon 130 has a tip end side fixing portion 131 fixed to the tip end portion 111 of the inner pipe shaft 110 and a base end side fixing portion 132 fixed to the tip end portion 121 of the outer pipe shaft 120. ..

The distal end-side inclined region 134 of the balloon 130 includes a first inclined region 134a formed on the distal end side of the distal end-side inclined region 134 and a second inclined region 134b formed on the proximal end side of the distal end-side inclined region 134. Have. Further, the base end side inclined region 135 of the balloon 130 has a first inclined region 135a formed on the proximal end side of the proximal end side inclined region 135 and a second inclined region 135 formed on the distal end side of the proximal end side inclined region 135. It has a region 135b and.

The balloon 130 forms an expansion space 136 that communicates with the inner cavity 125 of the outer tube shaft 120 between the balloon 130 and the outer peripheral surface of the inner tube shaft 110. When the fluid flows into the expansion space 136, the intermediate region 133 of the balloon 130 expands in the radial direction intersecting the axial direction. The intermediate region 133 expands the stent 140 placed on the balloon 130 as the balloon 130 expands.

As shown in FIGS. 2 and 3, the stent 140 has a tip portion 141 arranged at a position corresponding to the tip end side of the intermediate region 133 of the balloon 130 and a position corresponding to the proximal end side of the intermediate region 133 of the balloon 130. It has a base end portion 142 arranged in, and an intermediate portion 143 extending between the tip end portion 141 and the base end portion 142.

The stent 140 can be configured, for example, with a known balloon-expandable stent having expandable struts (skeleton). The specific structure of the stent 140 (strut design, expansion diameter, axial length, etc.) is not particularly limited. Further, for example, a drug coat layer or the like can be provided on the outer surface of the stent 140.

As shown in FIGS. 2 and 3, the balloon catheter 10 has a contrast marker 150 placed on the inner tube shaft 110. The contrast marker 150 is not located at the position of the inner tube shaft 110 corresponding to the intermediate portion 143 of the stent 140. Details of the contrast marker 150 will be described later.

As shown in FIG. 1, the hub 190 has a port 191 that can be connected to a supply device (not shown) such as an indeflator for supplying a fluid (for example, a contrast medium or physiological saline) in a liquid-tight or airtight manner. are doing. The port 191 of the hub 190 can be configured by, for example, a known luer taper or the like so that a tube or the like can be connected and separated.

Next, the contrast marker 150 will be described.

As shown in FIGS. 2 and 3, the contrast marker 150 includes a proximal side contrast marker 160 arranged at a corresponding position on the inner tube shaft 110 on the proximal side of the balloon 130 and an inner tube on the distal end side of the balloon 130. It has an distal side imaging marker 170, which is located at a corresponding position on the shaft 110.

The balloon 130 is provided with the stent 140 placed on the inner tube shaft 110 and contracted and wound around the inner tube shaft 110, the contrast marker 150, and the outer tube shaft 120. 2, FIG. 4 (A), FIG. 4 (B), and FIG. 6 schematically show a balloon 130 in a state of being contracted and wound around an outer tube shaft 120.

As shown in FIG. 4A, the proximal side contrast marker 160 includes a first contrast marker portion 161 made of a metal material having contrast, and a second contrast marker portion 162 made of a resin material having contrast. have. The above-mentioned "consisting of a resin material" means that the resin material is used as a main material (main raw material), and is not limited to being strictly composed of only the resin material.

The first contrast marker portion 161 is arranged at the position of the inner tube shaft 110 corresponding to the boundary portion b1 (see FIG. 3) between the intermediate region 133 of the balloon 130 and the proximal end side inclined region 135 of the balloon 130. In the present embodiment, the first contrast marker portion 161 is arranged so that the tip portion 161a of the first contrast marker portion 161 overlaps the boundary portion b1 in the circumferential direction. Specifically, the first contrast marker portion 161 is arranged so that the tip portion 161a and the boundary portion b1 of the first contrast marker portion 161 overlap in the circumferential direction at substantially the same position in the axial direction of the inner tube shaft 110. ing. The first contrast marker unit 161 is the tip of the first contrast marker unit 161 as long as the position of the intermediate region 133 forming the maximum outer diameter portion of the balloon 130 can be grasped by the first contrast marker unit 161. The portion 161a may be arranged at a position corresponding to the proximal end side of the inner pipe shaft 110 with respect to the boundary portion b1.

The first contrast marker portion 161 can be formed of, for example, a ring-shaped member extending along the outer circumference of the inner tube shaft 110.

The second contrast marker portion 162 is arranged between the proximal end portion 142 of the stent 140 and the first contrast marker portion 161 in a state where the stent 140 is arranged in the intermediate region 133 of the balloon 130. Specifically, the second contrast marker portion 162 has an inner tube shaft such that the tip portion 162a of the second contrast marker portion 162 is interposed between the proximal end portion 142 of the stent 140 and the first contrast marker portion 161. It is arranged at 110.

As shown in FIG. 4A, the second contrast marker portion 162 is the position of the inner tube shaft 110 corresponding to the proximal end portion 142 of the stent 140 in a state where the stent 400 is arranged in the intermediate region 133 of the balloon 130. It is placed in. In the present embodiment, the second contrast marker portion 162 is arranged so that the tip portion 162a of the second contrast marker portion 162 overlaps the proximal end portion 142 of the stent in the circumferential direction. More specifically, in the second contrast marker portion 162, the tip portion 162a of the second contrast marker portion 162 and the proximal end portion 142 of the stent 140 are circumferentially at substantially the same positions in the axial direction of the inner tube shaft 110. They are arranged so that they overlap. In the second contrast marker portion 162, for example, as long as the position of the proximal end portion 142 of the stent 140 can be grasped by the second contrast marker portion 162, the tip portion 162a of the second contrast marker portion 162 is the stent 140. It may be arranged at a position corresponding to the proximal end side of the inner tube shaft 110 with respect to the proximal end portion 142.

As shown in FIG. 4A, with the stent 140 placed in the intermediate region 133 of the balloon 130, a part of the balloon 130 is the tip of the second contrast marker portion 162 in the circumferential direction of the inner tube shaft 110. It is located between the portion 162a and the proximal end 142 of the stent 140. In the state where the stent 140 is arranged in the intermediate region 133 of the balloon 130, a part of the balloon 130 is the tip portion 162a of the second contrast marker portion 162 and the proximal end of the stent 140 in the axial direction of the inner tube shaft 110. It may be arranged between the portion 142 and the portion 142. Further, the second contrast marker portion 162 is formed more flexibly than the first contrast marker portion 161 made of a metal material. Therefore, even when a part of the balloon 130 is sandwiched between the stent 140 and the second contrast marker portion 162, damage due to scratching is unlikely to occur during delivery to the living lumen. Therefore, in the balloon catheter 10, the proximal end portion 142 of the stent 140 and the proximal end side contrast marker 160 can be arranged in close proximity to each other. The distance between the proximal end portion 142 of the stent 140 and the proximal end side contrast marker 160 (the tip end portion 162a of the second contrast marker portion 162) can be formed to be, for example, 0 mm to 0.2 mm.

As shown in FIG. 4A, with the stent 140 placed on the balloon 130, at least a part of the balloon 130 is in the axial direction of the inner tube shaft 110 (arrows along the axial direction of the inner tube shaft 110). It is a visual view, and is arranged at a position overlapping the proximal side contrast marker 160 in the arrow view indicated by the arrow a).

The second contrast marker portion 162 has higher X-ray contrast property than the stent 140. The magnitude of the contrastability of the second contrast marker portion 162 is, for example, the type of the resin material forming the second contrast marker portion 162, the type of the particles having the contrast property contained in the resin material, and the particles having the contrast property. It can be adjusted according to the content of. The first contrast marker portion 161 can be formed so that the X-ray contrast property is larger than that of the second contrast marker portion 162, for example.

As shown in FIG. 4A, the second contrast marker portion 162 has a recess 162c. The recess 162c is formed at a substantially central position in the axial direction (left-right direction in FIG. 4A) of the second contrast marker portion 162. The first contrast marker portion 161 is arranged in the recess 162c of the second contrast marker portion 162. Further, in the first contrast marker portion 161, each end face in the axial direction (end face on the tip portion 161a side, end face on the proximal end portion 161b side) is covered with the second contrast marker portion 162. Further, in the first contrast marker portion 161, the outer peripheral surface of the first contrast marker portion 161 arranged on the inner surface side of the balloon 130 is exposed from the second contrast marker portion 162.

The cross-sectional shape and size of the recess 162c can be formed, for example, according to the cross-sectional shape of the first contrast marker portion 161. For example, as shown in FIG. 4A, the cross-sectional shape of the recess 162c can be formed so that the first contrast marker portion 161 is arranged in the recess 162c and the first contrast marker portion 161 does not protrude from the recess 162c. ..

The thickness of the first contrast marker portion 161 (maximum vertical dimension of the upper and lower one side portions shown in FIG. 4A) can be formed, for example, to be 5 to 30 μm. Further, the thickness of the second contrast marker portion 162 (maximum dimension of the upper and lower one side portions shown in FIG. 4A in the vertical direction) can be formed to, for example, 15 to 90 μm.

As shown in FIG. 4A, the tip portion 162a of the second contrast marker portion 162 forms a flat portion extending perpendicularly to a straight line passing through the axial center of the inner tube shaft 110. Further, the proximal end portion 162b of the second contrast marker portion 162 forms an inclined portion that is inclined toward the proximal end side of the inner tube shaft 110.

As shown in FIG. 4A, the inner tube shaft 110 has a recess 116 formed at a position corresponding to the proximal end side contrast marker 160 of the inner tube shaft 110. The proximal side contrast marker 160 is arranged in the recess 116 of the inner tube shaft 110. The recess 116 can be formed, for example, on the entire outer circumference of the inner pipe shaft 110. As shown in FIG. 4A, the recess 116 can be formed with a cross-sectional shape into which a part of the second contrast marker portion 162 can be inserted. However, the specific cross-sectional shape and size (length in the axial direction) of the recess 116 are not particularly limited.

As shown in FIG. 4B, the tip-side contrast marker 170 includes a first contrast marker portion 171 made of a metal material having contrast and a second contrast marker portion 172 containing a resin material having contrast. Have.

The distal side contrast marker 170 has a structure symmetrical in the axial direction with the proximal end side contrast marker 160 (a structure inverted in the left-right direction in FIGS. 2 and 3). Therefore, in the description of the distal side contrast marker 170, the point that the configuration can be substantially the same as that of the proximal side contrast marker 160 will be omitted as appropriate.

The first contrast marker portion 171 is arranged at the position of the inner tube shaft 110 corresponding to the boundary portion b2 (see FIG. 3) between the intermediate region 133 of the balloon 130 and the distal end side inclined region 134 of the balloon 130. In the present embodiment, the first contrast marker portion 171 is arranged so that the base end portion 171b of the first contrast marker portion 171 overlaps the boundary portion b2 in the circumferential direction. Specifically, the first contrast marker portion 171 is arranged so that the base end portion 171b and the boundary portion b2 of the first contrast marker portion 171 overlap in the circumferential direction at substantially the same position in the axial direction of the inner tube shaft 110. are doing. The first contrast marker unit 171 is a base of the first contrast marker unit 171 as long as the position of the intermediate region 133 forming the maximum outer diameter portion of the balloon 130 can be grasped by the first contrast marker unit 171. The end portion 171b may be arranged at a position corresponding to the tip end side of the inner pipe shaft 110 with respect to the boundary portion b2.

Since the first contrast marker portion 171 is arranged as described above, the operator has an intermediate region 133 that forms the maximum outer diameter portion of the balloon 130 in a state where the balloon 130 is expanded by the first contrast marker portion 171. You can grasp the position of. Therefore, the operator can confirm that the stent 140 is arranged in the intermediate region 133 of the balloon 130 after the balloon 130 is delivered to the lesion or the like.

The first contrast marker portion 171 can be formed of, for example, a ring-shaped member extending along the outer circumference of the inner tube shaft 110.

The second contrast marker portion 172 is arranged between the tip portion 141 of the stent 140 and the first contrast marker portion 171 in a state where the stent 140 is arranged in the intermediate region 133 of the balloon 130. Specifically, the second contrast marker portion 172 has an inner tube shaft such that the proximal end portion 172b of the second contrast marker portion 172 is interposed between the tip portion 141 of the stent 140 and the first contrast marker portion 171. It is arranged at 110.

As shown in FIG. 4B, the second contrast marker portion 172 is located at the position of the inner tube shaft 110 corresponding to the tip portion 141 of the stent 140 in a state where the stent 400 is arranged in the intermediate region 133 of the balloon 130. It is arranged. In the present embodiment, the second contrast marker portion 172 is arranged so that the base end portion 172b of the second contrast marker portion 172 overlaps the tip portion 141 of the stent 140 in the circumferential direction. More specifically, in the second contrast marker portion 172, the proximal end portion 172b of the second contrast marker portion 172 and the tip end portion 141 of the stent 140 are circumferentially at substantially the same positions in the axial direction of the inner tube shaft 110. They are arranged so that they overlap. In the second contrast marker portion 172, for example, as long as the position of the tip portion 141 of the stent 140 can be grasped by the second contrast marker portion 172, the proximal end portion 172b of the second contrast marker portion 172 is the stent 140. It may be arranged at a position corresponding to the tip end side of the inner tube shaft 110 with respect to the tip end portion 141.

Similar to the proximal end side contrast marker 160 described above, with the stent 140 placed on the balloon 130, a part of the balloon 130 is located at the proximal end of the second contrast marker portion 172 in the circumferential direction of the inner tube shaft 110. It is located between 172b and the tip 141 of the stent 140. In the state where the stent 140 is arranged in the intermediate region 133 of the balloon 130, a part of the balloon 130 is the proximal end portion 172b of the second contrast marker portion 172 and the tip of the stent 140 in the axial direction of the inner tube shaft 110. It may be arranged between the portion 141 and the portion 141. Further, the second contrast marker portion 172 is formed more flexibly than the first contrast marker portion 171 formed of the metal material. Therefore, even when a part of the balloon 130 is sandwiched between the stent 140 and the second contrast marker portion 172, damage due to scratching is unlikely to occur during delivery to the living lumen. Therefore, in the balloon catheter 10, the distal end portion 141 of the stent 140 and the distal end side contrast marker 170 can be arranged in close proximity to each other. The distance between the distal end portion 141 of the stent 140 and the distal end side contrast marker 170 (base end portion 172b of the second contrast marker portion 172) can be formed to be, for example, 0 mm to 0.2 mm.

As shown in FIG. 4B, with the stent 140 placed on the balloon 130, at least a part of the balloon 130 is in the axial direction of the inner tube shaft 110 (arrows along the axial direction of the inner tube shaft 110). It is a visual view, and is arranged at a position overlapping the distal side contrast marker 170 in the arrow view indicated by the arrow a).

The second contrast marker portion 172 has higher X-ray contrast property than the stent 140. The magnitude of the contrastability of the second contrast marker portion 172 is determined by, for example, the type of resin material forming the second contrast marker portion 172, the type of particles having contrastability contained in the resin material, and the particles having contrastability. It can be adjusted according to the content of. The first contrast marker portion 171 can be formed so that the X-ray contrast property is larger than that of the second contrast marker portion 172, for example.

As shown in FIG. 4B, the second contrast marker portion 172 has a recess 172c. The recess 172c is formed at a substantially central position in the axial direction (horizontal direction in FIG. 4B) of the second contrast marker portion 172. The first contrast marker portion 171 is arranged in the recess 172c of the second contrast marker portion 172. Further, in the first contrast marker portion 171, each end face in the axial direction (end face on the tip end portion 171a side, end face on the proximal end portion 171b side) is covered with the second contrast marker portion 172. Further, in the first contrast marker portion 171, the outer peripheral surface of the first contrast marker portion 171 arranged on the inner surface side of the balloon 130 is exposed from the second contrast marker portion 172.

The thickness of the first contrast marker portion 171 (maximum vertical dimension of the upper and lower one side portions shown in FIG. 4B) can be formed, for example, from 5 to 30 μm. Further, the thickness of the second contrast marker portion 172 (maximum dimension of the upper and lower one side portions shown in FIG. 4B) in the vertical direction can be formed, for example, 15 to 90 μm.

The tip portion 172a of the second contrast marker portion 172 forms an inclined portion that is inclined toward the tip side of the inner tube shaft 110. Further, the base end portion 172b of the second contrast marker portion 172 forms a flat portion extending perpendicularly to a straight line passing through the axial center of the inner tube shaft 110.

As shown in FIG. 4B, the inner tube shaft 110 has a recess 116 formed at a position corresponding to the distal end side contrast marker 170 of the inner tube shaft 110. The distal side contrast marker 170 is arranged in the recess 116 of the inner tube shaft 110.

Next, the action of the contrast marker 150 (base end side contrast marker 160, tip side contrast marker 170) will be described with reference to FIGS. 5 and 6.

FIG. 5 schematically shows a state when the stent 140 is placed in the narrowed portion S formed around the bifurcation portion B of the blood vessel.

When the stent 140 is placed in the stenosis portion S, a surgeon such as a doctor uses the proximal side contrast marker 160 and the distal side contrast marker 170 to make the stent 140 the maximum outer diameter of the balloon 130 in order to smoothly expand the stent 140. It is confirmed that the portion is located in the intermediate region 133 forming the portion. Further, when the stent 140 is placed in the narrowed portion S, an operator such as a doctor positions the proximal end portion 142 of the stent 140 in the vicinity of the proximal end portion Sb of the narrowed portion S, as shown in FIG. At this time, the operator positions the proximal end portion 142 of the stent 140 with reference to the position of the proximal end side contrast marker 160. Specifically, the operator confirms the position A1 of the tip portion 162a (tip portion of the proximal side contrast marker 160) of the second contrast marker portion 162 on the X-ray image, and the periphery of the branch portion B of the blood vessel. The tip portion 162a of the second contrast marker portion 162 is arranged in the second contrast marker portion 162. As described above, in the balloon catheter 10 according to the present embodiment, since the proximal end portion 142 of the stent 140 and the distal end portion of the proximal end side contrast marker 160 can be arranged close to each other, the distance between them ( The gap) is small. Therefore, the operator positions the stent 140 based on the proximal side contrast marker 160, so that the proximal end of the stent 140 is near the proximal end Sb of the stenosis S formed around the bifurcation B of the blood vessel. The portion 142 can be easily arranged. As a result, the balloon catheter 10 can improve the therapeutic effect of the stenosis portion S formed around the bifurcation portion B of the blood vessel.

Since the balloon catheter 10 has the distal side contrast marker 170, for example, when the distal end portion 141 of the stent 140 is positioned at the stenosis portion or the like by using the distal side contrast marker 170, the proximal end side contrast marker 160 is used. The tip 141 of the stent 140 can be easily placed at the desired position, as in the case of

Next, the constituent materials of the balloon catheter 10 will be described. The materials described below are merely examples. Therefore, the constituent material of the balloon catheter 10 according to the present embodiment is not particularly limited.

The inner tube shaft 110 is made of, for example, polyethylene, polypropylene, ethylene-propylene copolymer, polyolefin such as ethylene-vinyl acetate copolymer, thermoplastic resin such as soft polyvinyl chloride, polyurethane elastomer, polyamide elastomer, polyester elastomer and the like. It can be formed of various elastomers, polyamides, crystalline polyethylenes, crystalline plastics such as crystalline polypropylene, and the like.

The outer pipe shaft 120 can be formed of, for example, the same material as the above as the constituent material of the inner pipe shaft 110.

The balloon 130 includes, for example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, crosslinked ethylene-vinyl acetate copolymer, polyurethane and the like. It can be formed of a thermoplastic resin, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber, or the like.

The stent 140 can be formed of, for example, an iron-based alloy such as stainless steel, a cobalt-based alloy such as tantalum (tantal alloy), platinum (platinum alloy), gold (gold alloy), cobalt-chromium alloy, titanium alloy, niobium alloy, or the like. .. However, the stent 140 may be a part containing a polymer or the like, or may be a biodegradable stent composed of a polymer as a main material.

The first contrast marker portions 161 and 171 can be formed of, for example, a metal such as platinum, gold, silver, iridium, titanium, or tungsten, or an alloy thereof.

For the second contrast marker portions 162 and 172, for example, polyurethane, polyamide, polyamide elastomer, epoxy resin, acrylic resin and the like can be used as the resin material as the main material. Further, the resin material may contain tungsten, a halogen compound or the like having contrasting properties.

Next, the operation of the balloon catheter 10 according to the present embodiment will be described.

The balloon catheter 10 includes an inner tube shaft 110, an outer tube shaft 120 that covers a part of the inner tube shaft 110, a balloon 130 fixed to the inner tube shaft 110 and the outer tube shaft 120, and a stent arranged on the balloon 130. It includes a 140 and a contrast marker 150 arranged on the inner tube shaft 110. In the expanded state of the balloon 130, the intermediate region 133 forming the maximum outer diameter portion of the balloon 130, the distal end side inclined region 134 extending from the distal end of the intermediate region 133 to the distal end side, and the proximal end of the intermediate region 133 It has a proximal end side inclined region 135 extending from the proximal end side. The stent 140 includes a tip portion 141 arranged at a position corresponding to the distal end side of the intermediate region 133 of the balloon 130, and a proximal end portion 142 arranged at a position corresponding to the proximal end side of the intermediate region 133 of the balloon 130. It has an intermediate portion 143 extending between the tip end portion 141 and the base end portion 142. The contrast marker 150 includes first contrast marker portions 161 and 171 made of a metal material having contrast, and second contrast marker portions 162 and 172 containing a resin material having contrast. The first contrast marker portions 161 and 171 include the boundary portion b1 between the intermediate region 133 of the balloon 130 and the proximal region inclined region 135 of the balloon 130 and / or the intermediate region 133 of the balloon 130 and the distal region inclined region 134 of the balloon 130. It is arranged at the position of the inner pipe shaft 110 corresponding to the boundary portion b2 of the above. Then, the second contrast marker portions 162 and 172 are placed between the respective end portions 141 and 142 of the stent 140 and the first contrast marker portions 161 and 171 in a state where the stent 140 is arranged in the intermediate region 133 of the balloon 130. The contrast marker 150 is not placed at the position of the inner tube shaft 110 that is placed and corresponds to the intermediate portion 143 of the stent 140.

In the balloon catheter 10 configured as described above, the second contrast marker portions 162 and 172 containing the resin material are arranged between the ends 141 and 142 of the stent 140 and the first contrast marker portions 161 and 171 made of the metal material. Has been done. Therefore, the second contrast marker portions 162 and 172 prevent the ends 141 and 142 of the stent 140 from coming into contact with the first contrast marker portions 161, 171 and the ends 141 and 142 of the stent 140 and the second contrast marker. It is possible to prevent the balloon 130 arranged between the portion 172 and the portion 172 from being damaged. Thereby, the balloon catheter 10 can arrange the ends 141 and 142 of the stent 140 in close proximity to the first contrast marker portions 161 and 171. Therefore, when the stent 140 is placed, the surgeon such as a doctor uses the contrast markers (first contrast marker portions 161 and 171 and the second contrast marker portions 162 and 172) as a reference, so that the stent 140 is the maximum balloon. The ends 141, 142 of the stent 140 can be more accurately positioned with respect to the desired position of the biological lumen, while confirming that they are located at the position of the outer shape. Further, in the balloon catheter 10, the contrast marker 150 is not arranged at the position of the inner tube shaft 110 corresponding to the intermediate region 133 of the stent 140 (the position of the inner tube shaft 110 corresponding to the intermediate region 133 of the balloon 130). It is possible to prevent the profile of the balloon 130 in the contracted state from becoming large.

In addition, the second contrast marker portions 162 and 172 have higher X-ray contrast properties than the stent 140. Therefore, when the stent 140 is placed at a desired position in the living lumen, an operator such as a doctor can refer to the second contrast marker portions 162 and 172 to cover the stent 140 for a lesion portion such as a stenosis portion. The ends 141, 142 of the can be easily positioned.

Further, the contrast marker 150 has a proximal side contrast marker 160 including a first contrast marker portion 161 and a second contrast marker portion 162. The first contrast marker portion 161 of the proximal end side contrast marker 160 is an inner tube shaft 110 corresponding to the proximal end side of the boundary portion b1 or the boundary portion b1 between the intermediate region 133 of the balloon 130 and the proximal end side inclined region 135. It is placed in position. Further, the second contrast marker portion 162 of the proximal end side contrast marker 160 is located on the proximal end side of the proximal end portion 142 of the stent 140 or the proximal end portion 142 of the stent 140 in a state where the stent 140 is arranged in the intermediate region 133. It is arranged at the position of the inner tube shaft 110 corresponding to. Thereby, an operator such as a doctor can confirm from the first contrast marker portion 161 that the proximal end portion 142 of the stent 140 is located in the intermediate region 133 forming the maximum outer diameter portion of the balloon 130. Further, a surgeon such as a doctor can grasp the position of the proximal end portion 142 of the stent 140 located on the hand side of the balloon catheter 10 in the living lumen by the second contrast marker portion 162. Since the proximal end 142 of the stent 140 is located on the hand side of the balloon catheter 10, a surgeon such as a doctor can easily position the proximal end 142 of the stent 140 from the viewpoint of operability of the balloon catheter 10. .. Therefore, in a procedure using the balloon catheter 10, a surgeon such as a doctor may use the proximal end portion 142 of the stent 140 as the maximum outer diameter of the balloon 130 based on the contrast enhancement marker portions 161 and 162 of the proximal end side contrast marker 160. The proximal end 142 of the stent 140 can be positioned at a desired position in the biological lumen and the stent 140 can be appropriately placed, confirming that it is located in the intermediate region 133 forming the portion.

Further, the second contrast marker portions 162 and 172 have recesses 162c and 172c. The first contrast marker portions 161 and 171 are arranged in the recesses 162c and 172c of the second contrast marker portions 162 and 172. Therefore, the balloon catheter 10 can suitably prevent the first contrast marker portions 161 and 171 from being displaced from the second contrast marker portions 162 and 172.

Further, the inner pipe shaft 110 has a recess 116. The contrast marker 150 is arranged in the recess 116 of the inner tube shaft 110. Therefore, the balloon catheter 10 can suitably prevent the contrast marker 150 from being displaced from the inner tube shaft 110. Further, the balloon catheter 10 can prevent the profile of the balloon 130 at the portion where the contrast marker 150 of the inner tube shaft 110 is arranged from becoming large.

Further, the contrast marker 150 has a tip-side contrast marker 170 including a first contrast marker portion 171 and a second contrast marker portion 172. The first contrast marker portion 171 of the distal side contrast marker 170 is arranged at the position of the inner tube shaft 110 corresponding to the distal end side of the boundary portion b2 or the boundary portion b2 between the intermediate region 133 of the balloon 130 and the distal side inclined region 134. Has been done. Further, the second contrast marker portion 172 of the distal side contrast marker 170 corresponds to the distal end side of the stent 140 or the distal end portion 141 of the stent 140 in a state where the stent 140 is arranged in the intermediate region 133. It is arranged at the position of the tube shaft 110. Thereby, an operator such as a doctor can confirm by the first contrast marker portion 171 that the tip portion 141 of the stent 140 is located in the intermediate region 133 forming the maximum outer diameter portion of the balloon 130. In addition, an operator such as a doctor can grasp the position of the tip portion 141 of the stent 140 in the living lumen by the second contrast marker portion 172. Therefore, in a procedure using the balloon catheter 10, a surgeon such as a doctor uses the tip portion 141 of the stent 140 to perform the maximum outer diameter portion of the balloon 130 based on the contrast marker portions 171 and 172 of the tip side contrast marker 170. The tip 141 of the stent 140 can be positioned at a desired position in the biological lumen and the stent 140 can be placed, confirming that it is located in the intermediate region 133 to be formed.

<Modification example>
Next, the balloon catheter according to the modified example will be described. In the description of the modified example, the description of the same content as that already described will be omitted as appropriate. The points not particularly mentioned in the description of the modified example can be configured in the same manner as in the above-described embodiment.

FIG. 7 shows a cross-sectional view of the tip of the balloon catheter according to the modified example, and FIG. 8 shows an enlarged view of the broken line portion 8A of FIG.

As shown in FIG. 8, the second contrast marker portion 162 of the proximal side contrast marker 160 included in the balloon catheter according to the modified example is inclined from the first contrast marker portion 161 toward the proximal end 142 side of the stent 140. It has an inclined portion (tip portion) 162a.

The balloon catheter according to the modified example is arranged so that the inclined portion 162a of the second contrast marker portion 162 and a part of the proximal end portion 142 of the stent 140 overlap in the circumferential direction of the inner tube shaft 110. Therefore, an axial gap is not formed between the proximal end portion 142 of the stent 140 and the proximal end side contrast marker 160 (second contrast marker portion 162). Therefore, an operator such as a doctor can more accurately position the proximal end 142 of the stent 140 with respect to a lesion such as a stenosis. The position where the second contrast marker portion 162 and the stent 140 overlap in the circumferential direction depends on the contrast between the second contrast marker portion 162 and the stent 140, and the contrast between the second contrast marker portion 162 and the stent 140 alone. Therefore, the operator can properly position the stent.

Further, the proximal end portion 142 of the stent 140 is arranged on the inclined portion 162a of the second contrast marker portion 162. Therefore, the balloon catheter 10 can prevent the profiling of the balloon 130 at the portion where the proximal end portion 142 of the stent 140 and the proximal end side contrast marker 160 overlap in the circumferential direction from becoming large.

The distal end side contrast marker 170 has a structure symmetrical in the axial direction with the proximal end side contrast marker 160 (a structure inverted in the left-right direction in FIGS. 7 and 8). Therefore, the distal side contrast marker 170 can exert substantially the same action and effect as the proximal side contrast marker 160.

Next, each modification of the contrast marker 150 (base end side contrast marker 160) will be described.

In the proximal end side contrast marker 160 according to the modification shown in FIG. 9, the second contrast marker portion 162 is arranged so as to cover the distal end side (tip surface side) of the distal end portion 161a of the first contrast marker portion 161. .. Similar to the above-described embodiment, the second contrast marker unit 162 prevents the first contrast marker unit 161 and the balloon 130 from rubbing against each other and damaging the balloon 130 or the like. Further, since the second contrast marker portion 162 is not arranged so as to overlap the first contrast marker portion 161 in the circumferential direction, the outer diameter (vertical dimension in the drawing) of the proximal end side contrast marker 160 becomes large. Can be prevented.

The proximal end side contrast marker 160 according to the modification 2 shown in FIG. 10 is the distal end side (tip surface side) of the distal end portion 161a of the first contrast marker portion 161 and the proximal end side (base end end surface) of the second contrast marker portion 162. The second contrast marker portion 162 is arranged so as to cover the side). Similar to the above-described embodiment, the second contrast marker unit 162 prevents the first contrast marker unit 161 and the balloon 130 from rubbing against each other and damaging the balloon 130 or the like. Further, since the second contrast marker portion 162 is not arranged so as to overlap the first contrast marker portion 161 in the circumferential direction, the outer diameter (vertical dimension in the drawing) of the proximal end side contrast marker 160 becomes large. Can be prevented.

In the proximal end side contrast marker 160 according to the modification shown in FIG. 11, the second contrast marker portion 162 is arranged so as to cover the distal end side (tip surface side) and the outer peripheral surface of the distal end portion 161a of the first contrast marker portion 161. Has been done. Similar to the above-described embodiment, the second contrast marker unit 162 prevents the first contrast marker unit 161 and the balloon 130 from rubbing against each other and damaging the balloon 130 or the like. Further, the second contrast marker portion 162 projects to the tip end side of the first contrast marker portion 161 with a constant length. Therefore, the proximal end portion 142 of the stent 140 can be arranged so as to overlap in the circumferential direction on the protruding portion of the first contrast marker portion 161 (see FIG. 8). Further, since the second contrast marker portion 162 is arranged so as to cover the outer peripheral surface of the first contrast marker portion 161 of the proximal end side contrast marker 160, even when the thickness of the first contrast marker portion 161 is reduced, It is possible to prevent the contrastability of the proximal side contrast marker 160 from deteriorating.

In the proximal side contrast marker 160 according to the modified example 4 shown in FIG. 12, the first contrast marker portion 161 is embedded in the second contrast marker portion 162. Therefore, the outer surface of the first contrast marker portion 161 is covered with the second contrast marker portion 162. Similar to the above-described embodiment, the second contrast marker unit 162 prevents the first contrast marker unit 161 and the balloon 130 from rubbing against each other and damaging the balloon 130 or the like. Further, the second contrast marker portion 162 projects to the tip end side of the first contrast marker portion 161 with a constant length. Therefore, the proximal end portion 142 of the stent 140 can be arranged so as to overlap in the circumferential direction on the protruding portion of the first contrast marker portion 161 (see FIG. 8). Further, since the second contrast marker portion 162 is arranged so as to cover the outer surface of the first contrast marker portion 161 of the proximal end side contrast marker 160, even when the thickness of the first contrast marker portion 161 is reduced, It is possible to prevent the contrastability of the proximal side contrast marker 160 from deteriorating.

The proximal end side contrast marker 160 according to the modified example 5 shown in FIG. 13 is the distal end side (tip surface side) of the distal end portion 161a of the first contrast marker portion 161 and the proximal end portion 161b of the first contrast marker portion 161. The second contrast marker portion 162 is arranged so as to cover the proximal end side (base end end surface side) and the inner peripheral surface of the first contrast marker portion 161. Similar to the above-described embodiment, the second contrast marker unit 162 prevents the first contrast marker unit 161 and the balloon 130 from rubbing against each other and damaging the balloon 130 or the like. Further, the second contrast marker portion 162 projects to the tip end side of the first contrast marker portion 161 with a constant length. Therefore, the proximal end portion 142 of the stent 140 can be arranged so as to overlap in the circumferential direction on the protruding portion of the first contrast marker portion 161 (see FIG. 8). Further, the proximal end side contrast marker 160 is relatively easy to arrange and fix the first contrast marker portion 161 on the outer peripheral surface of the base material (for example, a ring-shaped member) of the resin material forming the second contrast marker portion 162. It can be manufactured by various operations.

The proximal end side contrast marker 160 according to the modification 6 shown in FIG. 14 covers the distal end side (tip surface side) of the distal end portion 161a of the first contrast marker portion 161 and the inner peripheral surface of the first contrast marker portion 161. The second contrast marker unit 162 is arranged as described above. Similar to the above-described embodiment, the second contrast marker unit 162 prevents the first contrast marker unit 161 and the balloon 130 from rubbing against each other and damaging the balloon 130 or the like. Further, the second contrast marker portion 162 projects to the tip end side of the first contrast marker portion 161 with a constant length. Therefore, the proximal end portion 142 of the stent 140 can be arranged so as to overlap in the circumferential direction on the protruding portion of the first contrast marker portion 161 (see FIG. 8). Further, the proximal end side contrast marker 160 is relatively easy to arrange and fix the first contrast marker portion 161 on the outer peripheral surface of the base material (for example, a ring-shaped member) of the resin material forming the second contrast marker portion 162. It can be manufactured by various operations.

The proximal end side contrast marker 160 described in each modification may, for example, add a tapered shape to the distal end portion 162a or the proximal end portion 162b of the second contrast marker portion 162, or add a curved shape (R shape) or the like. It is also possible to do.

As described in each modification, the contrast marker 150 has a specific shape, structure, etc. as long as the second contrast marker portion 162 is arranged between the end portion of the stent 140 and the first contrast marker portion 161. There is no limitation.

Further, in the description of the modified example, the proximal side contrast marker 160 has been described and the description of the distal end side contrast marker 170 has been omitted, but the distal end side contrast marker 170 has, for example, the proximal end side contrast as in the above-described embodiment. It can be formed with a structure symmetrical in the axial direction with the marker 160.

Although the balloon catheter according to the present invention has been described above through the embodiments, the present invention is not limited to the configuration described in the embodiments, and can be appropriately modified based on the description of the claims. is there.

For example, in the description of the embodiment, an example in which the balloon catheter is provided with two contrast markers, an apical contrast marker and a proximal contrast marker, has been described, but the contrast marker is a contrast marker indicating the distal end of the stent and a base of the stent. It suffices to have at least one of the contrast markers indicating the edges. When the balloon catheter is used for placing a stent at a bifurcation of a blood vessel as described in the embodiment, it is preferable that the balloon catheter is configured to include at least a proximal side contrast marker. Further, even when the balloon catheter includes two contrast markers, the distal contrast marker and the proximal contrast marker, the distal contrast marker and the proximal contrast marker may have different structures (for example,). It does not have to be an axially symmetric structure).

For example, the balloon catheter can also be configured as an over-the-wire balloon catheter.

Further, for example, the intended use of the balloon catheter (living lumen to be used) is not limited to blood vessels, and can be applied to various parts of living organs.

Further, for example, the structure of the balloon catheter described in the embodiment, the arrangement of the members, and the like can be appropriately changed, the use of the additional members described above is omitted, and other additional members not particularly described. The use of members and the like can also be performed as appropriate.

This application is based on Japanese Patent Application No. 2017-186924 filed on September 27, 2017, the disclosure of which is cited in its entirety by reference.

10 Balloon catheter,
100 shafts,
110 inner pipe shaft,
116 Inner pipe shaft recess,
120 outer pipe shaft,
130 balloon,
131 Tip side fixing part,
132 Base end side fixing part,
133 Intermediate region,
134 Tip side tilt area,
135 Base end side tilt area,
136 expansion space,
140 stent,
141 Stent tip,
142 Stent base,
143 The middle part of the stent,
150 contrast marker,
160 proximal side contrast marker,
161 First contrast marker section,
161a The tip of the first contrast marker,
161b The tip of the first contrast marker,
162 Second contrast marker part,
162a The tip of the second contrast marker, the inclined part,
162b Base end of the second contrast marker
162c Recessed part of the second contrast marker
170 Tip-side contrast marker,
171 First contrast marker section,
171a Tip of the first contrast marker
171b Base end of the second contrast marker
172 Second contrast marker section,
172a The tip of the second contrast marker,
172b Base end of the second contrast marker,
172c Recessed part of the second contrast marker
200 guide wire,
B Blood vessel bifurcation,
S stenosis,
Sb base end of stenosis,
b1 Boundary between the intermediate region and the base end side inclined region,
b2 The boundary between the intermediate region and the tip side inclined region.

Claims (7)

Inner pipe shaft and
An outer pipe shaft that covers a part of the inner pipe shaft and
The inner tube shaft, the balloon fixed to the outer tube shaft, and
The stent placed on the balloon and
With a contrast marker placed on the inner tube shaft,
In the expanded state of the balloon, the balloon is based on an intermediate region forming the maximum outer diameter portion of the balloon, a tip-side inclined region extending from the tip of the intermediate region to the tip side, and a base end of the intermediate region. It has an proximal end-side tilted region that extends to the end side,
The stent has a tip portion arranged at a position corresponding to the distal end side of the intermediate region of the balloon, a proximal end portion arranged at a position corresponding to the proximal end side of the intermediate region of the balloon, and the distal end portion. It has an intermediate portion extending between the portion and the proximal end portion,
The contrast marker has a first contrast marker portion made of a metal material having contrast properties and a second contrast marker portion made of a resin material having contrast properties.
The first contrast marker portion is arranged at the position of the inner tube shaft corresponding to the boundary portion between the intermediate region and the proximal end side inclined region and / or the boundary portion between the intermediate region and the distal end side inclined region. ,
The second contrast marker portion is arranged between the end portion of the stent and the first contrast marker portion in a state where the stent is arranged in the intermediate region.
A balloon catheter in which the contrast marker is not arranged at the position of the inner tube shaft corresponding to the intermediate portion of the stent. The balloon catheter according to claim 1, wherein the second contrast marker portion has higher X-ray contrast than the stent. The contrast marker has a proximal side contrast marker including the first contrast marker portion and the second contrast marker portion.
The first contrast marker portion of the proximal end side contrast marker is arranged at the position of the inner tube shaft corresponding to the boundary portion between the intermediate region and the proximal end side inclined region or the proximal end side of the boundary portion. Being done
The second contrast marker portion of the proximal end side contrast marker corresponds to the proximal end portion of the stent or the proximal end side of the stent with the stent arranged in the intermediate region. The balloon catheter according to claim 1 or 2, which is arranged at the position of the inner tube shaft. The second contrast marker portion has a recess and has a recess.
The balloon catheter according to any one of claims 1 to 3, wherein the first contrast marker portion is arranged in a recess of the second contrast marker portion. The inner tube shaft has a recess and has a recess.
The balloon catheter according to any one of claims 1 to 4, wherein the contrast marker is arranged in a recess of the inner tube shaft. The balloon catheter according to any one of claims 1 to 5, wherein the second contrast marker portion has an inclined portion that is inclined from the first contrast marker portion toward the end side of the stent. The contrast marker has a tip-side contrast marker including the first contrast marker portion and the second contrast marker portion.
The first contrast marker portion of the tip side contrast marker is arranged at least at the position of the inner tube shaft corresponding to the boundary portion between the intermediate region and the tip end side inclined region or the tip end side of the boundary portion.
The second contrast marker portion of the distal end side contrast marker is an inner tube corresponding to the distal end portion of the stent or the distal end side of the stent with the stent arranged in the intermediate region. The balloon catheter according to any one of claims 1 to 6, which is at least arranged at the position of the shaft.