JP6283221B2 - Contrast marker and catheter - Google Patents

Description

  The present invention relates to a contrast marker and a catheter to which the contrast marker is attached.

  A catheter is a hollow medical instrument that is inserted into a body cavity, tube, blood vessel, or the like, and is used for, for example, suctioning a thrombus, securing a passage of a blood vessel in a closed or stenotic state, injecting an angiographic contrast agent, and the like. Generally, a catheter is provided with a ring-shaped contrast marker as a contrast marker at the tip or the like (see, for example, Patent Document 1). The contrast marker is formed of a metal material having radiopacity and is attached to the outer peripheral surface of the catheter tube. With this contrast marker, the position of the catheter inserted into the body under X-ray projection can be confirmed from outside the body.

  This type of contrast marker is often attached to the outer peripheral surface of the catheter tube by swaging. In this case, with the contrast marker placed on the outer peripheral side of the catheter tube, the contrast marker is placed on the catheter tube by compressing and deforming the marker from the outer peripheral side using a dedicated jig or the like. Will be attached.

JP 2013-022347 A

  However, in the above configuration in which the contrast marker is attached to the catheter tube by caulking, when the contrast marker is not sufficiently compressed and deformed inward by caulking, the inner peripheral surface of the contrast marker and the outer peripheral surface of the catheter tube Is assumed to be insufficiently contacted (pressure contact). In that case, there is a concern that the contrast marker is displaced along the axial direction of the catheter tube.

  The present invention has been made in view of the above circumstances, and a main object of the present invention is to provide a contrast marker and a catheter that can suitably prevent displacement in the axial direction.

  In order to solve the above-described problem, the contrast marker of the first invention is a contrast marker attached to the outer peripheral side of the catheter tube, and has a cylindrical main body portion and an inner peripheral side from the main body portion. And the projecting portion is formed along the circumferential direction of the main body portion in a direction orthogonal to the axial direction of the main body portion.

  According to the present invention, the protrusion is provided on the inner peripheral surface of the main body formed in a cylindrical shape. Therefore, when the main body portion is arranged on the outer peripheral side of the catheter tube and the contrast marker is attached to the tube, the protruding portion bites into the catheter tube. Moreover, the protrusion part is formed along the circumferential direction of the main body part in a direction orthogonal to the axial direction of the main body part. Therefore, when the contrast marker is attached to the catheter tube, the projecting portion is in a state of being bitten along the circumferential direction of the tube in a direction orthogonal to the axial direction of the catheter tube. Thereby, it is possible to suitably prevent the contrast marker from being displaced in the axial direction.

  The contrast marker according to a second aspect of the present invention is characterized in that, in the first aspect, the protrusion is formed over the entire circumferential direction of the main body.

  According to the present invention, since the protruding portion is formed over the entire circumferential direction of the main body portion, the protruding portion can be bitten over the entire circumferential direction of the catheter tube. Thereby, it is possible to reliably prevent the positional deviation of the contrast marker in the axial direction.

  The contrast marker according to a third aspect of the present invention is characterized in that, in the first or second aspect, the protrusion is provided at an end of the main body in the axial direction.

  According to the present invention, since the protrusion is provided at the end of the main body in the axial direction, the end of the contrast marker can be bitten into the catheter tube. In this case, it is possible to prevent the contrast marker from being attached to the catheter tube in a state where the end of the contrast marker is separated from the outer peripheral surface of the catheter tube. Therefore, for example, when a catheter tube attached with a contrast marker is inserted into another tube during manufacture of the catheter, the end of the marker that is separated from the catheter tube is caught by the end surface of the other tube, and the contrast marker is positioned. It can prevent shifting.

  The contrast marker according to a fourth aspect is characterized in that, in the third aspect, the protrusions are provided at both ends of the main body in the axial direction.

  According to the present invention, since the projecting portions are provided at both end portions in the axial direction of the main body portion, both end portions of the contrast marker can be bitten into the catheter tube, respectively. In this case, it is possible to prevent the both end portions of the contrast marker from being separated from the catheter tube. Therefore, when a catheter tube to which a contrast marker is attached is inserted into another tube, the catheter tube can be inserted from either the distal end side or the proximal end side with respect to another tube. It is possible to avoid the inconvenience that the marker end portion separated from the tube is caught by the other tube. Therefore, when inserting the catheter tube into another tube, there is an advantage that the user does not have to consider whether the catheter tube is inserted from the distal end side or the proximal end side.

  A catheter of a fifth invention is a catheter comprising the catheter tube and the contrast marker of any one of the first to fourth inventions attached to the catheter tube, wherein the main body portion is the catheter tube. It is arrange | positioned in the outer peripheral side of this, The said protrusion part is provided in the state which bite into the said catheter tube.

  According to the present invention, the same effects as those of the first to fourth inventions can be achieved as a catheter.

  According to a sixth aspect of the present invention, in the fifth aspect, the protruding height of the protruding portion from the inner peripheral surface of the main body is set to ¼ or less of the wall thickness of the catheter tube. Features.

  When the protruding height of the protruding portion is larger than the thickness of the catheter tube, when the contrast marker is attached to the catheter tube, the protruding portion bites into the catheter tube so that the catheter tube is greatly deformed inward. There is a risk of damage. In that respect, according to the present invention, since the protrusion height (protrusion amount) of the protrusion is set to ¼ or less of the thickness of the catheter tube, the contrast marker without causing the protrusion to bite into the catheter tube. Can be attached to the catheter tube. Thereby, it is possible to prevent the contrast marker from being displaced in the axial direction while reducing the deformation amount of the catheter tube.

The whole side view which shows the structure of a balloon catheter. The side view of the balloon which shows a balloon and an outer tube in the state of a longitudinal cross-section, and its periphery. The structure of the contrast ring is shown, (a) is a front view showing the structure, (b) is a longitudinal sectional view, and (c) is a view seen from one side in the axial direction. The longitudinal cross-sectional view which shows the attachment state of the contrast ring with respect to an inner side tube. Explanatory drawing for demonstrating the manufacturing procedure of a contrast ring.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the present embodiment, a balloon catheter including a balloon that can be inflated and deflated is embodied. FIG. 1 is an overall side view showing the configuration of a balloon catheter.

  As shown in FIG. 1, a balloon catheter 10 includes a catheter body 11, a hub 12 attached to a proximal end (base end) of the catheter body 11, and a distal end side (tip side) of the catheter body 11. ) Attached to the balloon 13.

  The catheter main body 11 is composed of a plurality of tubes, and has an inner and outer multi-tube structure from at least an intermediate position in the axial direction (longitudinal direction) to the position of the balloon 13. Specifically, the catheter body 11 includes an outer tube 15 and an inner tube 16 having an inner diameter and an outer diameter smaller than those of the outer tube 15. Since the inner tube 16 is inserted into the outer tube 15, the catheter body 11 has an inner / outer double tube structure. The inner tube 16 corresponds to a catheter tube.

  The outer tube 15 is formed in a tubular shape having outer tube holes 21 (see FIG. 2) that are continuous over the entire axial direction and open at both ends. The outer tube 15 includes an outer proximal tube 22 that forms a predetermined range from a position continuous with the hub 12 toward the distal side, and an outer distal tube 23 that forms a distal side relative to the outer proximal tube 22. Is provided. The outer proximal tube 22 is made of a metal such as a Ni—Ti alloy or stainless steel. The outer distal tube 23 is made of thermoplastic polyamide so as to be less rigid than the outer proximal tube 22. The outer proximal tube 22 may be made of a synthetic resin. Further, the material for forming the outer distal tube 23 is not limited to thermoplastic polyamide, and may be other thermoplastic resin.

  The inner tube 16 is formed in a tubular shape having inner tube holes 29 (see FIG. 2) that are continuous over the entire axial direction and open at both ends. The inner tube 16 has a proximal end joined to an intermediate position in the axial direction of the outer tube 15, specifically, a boundary between the outer proximal tube 22 and the outer distal tube 23. Further, a part of the inner tube 16 is provided in a state extending to the distal side with respect to the outer tube 15. Hereinafter, a region of the inner tube 16 that extends to the distal side of the outer tube 15 is referred to as an extended region 24. The balloon 13 is provided so as to cover the extension region 24.

  The outer tube hole 21 of the outer tube 15 functions as a fluid lumen through which the compressed fluid flows when the balloon 13 is inflated or deflated. The inner tube hole 29 of the inner tube 16 functions as a guide wire lumen through which the guide wire G is inserted. Further, the proximal end opening 29 a of the inner tube hole 29 exists at a midway position in the axial direction of the balloon catheter 10. Therefore, the balloon catheter 10 of the present embodiment is configured as a so-called RX type catheter. However, the present invention is not limited to this, and the balloon catheter 10 is a so-called over-the-wire type catheter in which the proximal end opening 29a of the inner lumen 29 is present at the proximal end of the balloon catheter 10. Also good.

  Next, the configuration of the balloon 13 and its surroundings will be described with reference to FIG. FIG. 2 is a side view of the balloon 13 and its surroundings showing the balloon 13 and the outer tube 15 in a longitudinal cross-sectional state. In FIG. 2, the balloon 13 is shown in an inflated state.

  As described above, the balloon 13 is provided so as to cover the extended region 24 from the outside. In this state, the proximal end of the balloon 13 is joined to the distal end of the outer tube 15 (specifically, the outer distal tube 23), and the distal end of the balloon 13 is connected to the inner tube 16 (specifically, the extension). It is joined to the distal end side of the exit region 24).

  The balloon 13 is made of a thermoplastic polyamide elastomer. However, the material forming the balloon 13 is not limited to the polyamide elastomer as long as the balloon 13 can be inflated and deflated well as the fluid is supplied and discharged. The balloon 13 may be formed of other thermoplastic resins, for example, polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyamide, polyimide, polyimide elastomer, silicon rubber, or the like.

  The balloon 13 has joint portions at both ends joined to the catheter body 11 and an inflating portion between the joint portions. More specifically, the balloon 13 includes a proximal leg region 13a joined to a distal end portion of the outer tube 15 (outer distal tube 23), and a distal end portion of the proximal leg region 13a. A proximal cone region 13b that is tapered so that the inner diameter and outer diameter of the balloon 13 are continuously expanded toward the distal end side of the catheter body 11, and the distal end of the proximal cone region 13b. From the distal end of the straight tube region 13c and the straight tube region 13c extending from the distal end of the straight tube region 13c to the distal end side of the catheter main body 11 and having the same inner diameter and outer diameter of the balloon 13 throughout the length direction. A distal cone region 13d having a tapered shape so that the inner diameter and the outer diameter of the balloon 13 are continuously reduced toward the distal end side of the balloon 11, and the distal end joined to the extension region 24 of the inner tube 16. Side leg region 13e It has from the proximal side in this order. The straight tube region 13 c forms the maximum outer diameter region of the balloon 13. The joining of the outer tube 15 and the proximal leg region 13a and the joining of the inner tube 16 and the distal leg region 13e are both performed by thermal welding. However, these bondings are not necessarily performed by heat welding, and may be performed using an adhesive or the like.

  The balloon 13 is in an inflated state when the compressed fluid is supplied into the balloon 13 through the outer tube hole 21 of the outer tube 15, and a negative pressure is applied to the outer tube hole 21, so that the compressed fluid is discharged from the balloon 13. When discharged, it is in a contracted state. The balloon 13 is formed into a plurality of wings (specifically, three wings) having a plurality of wings in the circumferential direction, and the balloon 13 is inflated and expanded so that a plurality of wings are formed in the contracted state. The contraction region is folded, and the plurality of wings are wound around the inner tube 16 around the axis.

  Two contrast rings 30 are attached to the outer peripheral surface of the extension region 24 of the inner tube 16. The contrast ring 30 is for improving the visibility of the balloon 13 under X-ray projection and facilitating the alignment of the balloon 13 to the target treatment site. The contrast ring 30 corresponds to a contrast marker. Hereinafter, the configuration of the contrast ring 30 will be described with reference to FIGS. 3 and 4. FIG. 3 shows the configuration of the contrast ring 30, (a) is a front view showing the same configuration, (b) is a longitudinal sectional view, and (c) is a view seen from one side in the axial direction. FIG. 4 is a longitudinal sectional view showing a state in which the contrast ring 30 is attached to the inner tube 16.

  The two contrast rings 30 both have the same configuration. In FIG. 2, among the contrast rings 30, a sign is added to the reference contrast ring 30 on the proximal side, and the contrast ring 30 on the distal side is added. B is added to the reference numeral 30.

  As shown in FIGS. 3A to 3C, the contrast ring 30 is formed in a cylindrical shape (annular) from a metal material having radiopacity, and is made of, for example, Pt—Ir (platinum iridium). Is formed. The contrast ring 30 is formed of, for example, an alloy containing 4 to 50 mol% of Ir and 50 mol% or more of Pt. However, the contrast ring 30 is not necessarily formed of Pt—Ir, and may be formed of other metal materials such as gold, cobalt chromium alloy, and titanium. Further, the contrast ring 30 may be formed of a noble metal, for example, Pt. In addition, the contrast ring 30 is not limited to a metal and may be made of a resin as long as it performs a contrast function.

  The contrast ring 30 includes a main body 31 formed in a cylindrical shape and a pair of protrusions 32 formed on the inner peripheral surface of the main body 31. The pair of projecting portions 32 are formed at both ends in the axial direction of the main body portion 31 and project toward the inner peripheral side of the main body portion 31. Specifically, the protruding portions 32 are formed only at both end portions in the axial direction of the main body portion 31, and are not formed between both end portions in the axial direction of the main body portion 31 (that is, intermediate portions).

  Each protrusion 32 is formed along the circumferential direction of the main body 31 in a direction orthogonal to the axial direction of the main body 31. Specifically, each protrusion 32 is continuously formed over the entire circumferential direction of the main body 31. Therefore, each protrusion 32 has an annular shape.

  The protrusion height (protrusion amount) h of each protrusion 32 is the same. The protrusion height (protrusion amount) h corresponds to the length from the inner peripheral surface of the main body 31 to the tip of the protrusion 32. The protrusion height h of the protrusion 32 is the same over the entire circumferential direction of the protrusion 32. The protruding height h of the protruding portion 32 is set to be equal to or less than half the thickness t of the inner tube 16, and specifically, is set to be equal to or less than 1/4 of the thickness t of the inner tube 16. Further, the protruding height h of the protruding portion 32 is set to a height smaller than the thickness of the main body portion 31. Specifically, for example, the protrusion height h is set to a value of 10 μm or more, and the wall thickness t of the inner tube 16 is set to a value of 40 μm or more.

  In addition, the protrusion height h of each protrusion part 32 does not necessarily need to be the same, and may differ from each other. Further, the protruding height h is not necessarily required to be the same over the entire circumferential direction of the protruding portion 32 and may be changed in the circumferential direction. Furthermore, the protrusion height h does not necessarily have to be ¼ or less of the wall thickness t of the inner tube 16 and may be larger than ¼ of the wall thickness t. Therefore, for example, the protrusion height h may be set to a value less than 10 μm, and the wall thickness t of the inner tube 16 may be set to a value less than 40 μm.

  Moreover, in this embodiment, each protrusion part 32 has the same structure. Therefore, the contrast ring 30 of the present embodiment has a symmetrical shape in the axial direction.

  An R portion 33 (curved surface portion) is formed in the contrast ring 30. The R portion 33 is a portion that smoothly connects the outer peripheral surface of the main body 31 and the end surface of the main body 31 in the axial direction. The R portion 33 is formed continuously over the entire circumferential direction of the main body portion 31.

  Subsequently, a state in which the contrast ring 30 is attached to the inner tube 16 will be described.

  As shown in FIG. 4, the contrast ring 30 is attached to the outer peripheral surface of the inner tube 16. In the contrast ring 30, the main body portion 31 is disposed on the outer peripheral side of the inner tube 16, and the inner peripheral surface of the main body portion 31 is in contact (contact) with the outer peripheral surface of the inner tube 16. Specifically, the entire inner peripheral surface of the main body 31 is in close contact with the outer peripheral surface of the inner tube 16. On the other hand, each protrusion 32 is provided in a state where it bites into the inner tube 16 from the outer peripheral side. Specifically, the entire circumferential direction of each projecting portion 32 is in a state of biting into the inner tube 16. In this case, each protrusion 32 bites into the inner tube 16, so that the outer peripheral surface of the inner tube 16 is recessed. The tip of the protrusion 32 is disposed in the recessed portion.

  Next, the manufacturing procedure of the contrast ring 30 will be described with reference to FIG. FIG. 5 is an explanatory diagram for explaining a manufacturing procedure of the contrast ring 30.

  First, as shown in FIG. 5A, a pipe forming step for forming a cylindrical metal pipe 35 constituting the contrast ring 30 is performed. In this step, the metal pipe 35 is formed by cutting a Pr—Ir tube (circular tube) into a predetermined length.

  Next, as shown in FIG. 5 (b), a protruding portion forming step for forming protruding portions at both ends in the axial direction of the metal pipe 35 is performed. In this step, the protrusion is formed by polishing the metal pipe 35 (specifically, barrel polishing). Specifically, hundreds to tens of thousands of metal pipes 35 are placed in a predetermined container (barrel), and amorphous abrasive grains, abrasives, and water are placed therein. The metal pipe 35 is polished by rotating it. At the time of this polishing, both end portions of the metal pipe 35 are continuously knocked out by irregular shaped abrasive grains. As a result, both ends of the metal pipe 35 are eventually rounded into an R shape as shown in FIG. When the polishing is further continued, as shown in FIG. 5C, both end portions of the metal pipe 35 (that is, the portions rounded in an R shape) protrude to the inner peripheral side of the metal pipe 35. As a result, the projecting portions 32 are formed at both ends of the metal pipe 35 and the R portion 33 is formed, and as a result, the contrast ring 30 is formed (manufactured).

  In the above polishing, the irregular abrasive grains having a particle size larger than the inner diameter of the metal pipe 35 are used. Therefore, when polishing, the irregular shaped abrasive grains do not enter the inside of the metal pipe 35, and the end of the metal pipe 35 can be suitably knocked out toward the inner peripheral side.

  Moreover, the protrusion height of the protrusion part 32 can be set to various heights by adjusting the polishing time of barrel polishing. As the polishing time for barrel polishing is increased, the protruding height of the protruding portion 32 can be increased.

  Next, a method for manufacturing the balloon catheter 10 will be described.

  First, a contrast ring attaching step for attaching the contrast ring 30 to the outer peripheral surface of the inner tube 16 is performed. In this step, the contrast ring 30 is attached to the inner tube 16 by swaging. Specifically, first, the contrast ring 30 is arranged on the outer peripheral side of the inner tube 16. In a state where the contrast ring 30 is disposed on the outer peripheral side of the inner tube 16, the contrast ring 30 is driven from the outer peripheral side by a dedicated jig or the like. As a result, the contrast ring 30 is deformed inward. Thereby, the contrast ring 30 is attached to the inner tube 16 in a state where the main body portion 31 is in close contact with the outer peripheral surface of the inner tube 16 and the protruding portion 32 is bitten into the inner tube 16.

  Next, a balloon proximal side joining step for joining the proximal leg region 13a of the balloon 13 to the distal end portion of the outer distal tube 23 is performed. Thereby, the outer distal tube 23 and the balloon 13 are integrated.

  Next, a balloon distal side joining step for joining the distal end side of the inner tube 16 to the distal leg region 13e of the balloon 13 is performed. In this step, the inner tube 16 to which the contrast ring 30 is attached is inserted into the outer lumen 21 of the outer distal tube 23 and the inner side of the balloon 13, and the distal end of the inner tube 16 is inserted in the inserted state. It is joined to the distal leg region 13e of the balloon 13.

  Here, as described above, the contrast ring 30 is provided in a state where the protrusions 32 provided at both ends in the axial direction bite into the inner tube 16. Therefore, the contrast ring 30 is prevented from being separated from the outer peripheral surface of the inner tube 16 at both ends of the contrast ring 30 in the axial direction. Therefore, when the inner tube 16 is inserted into the outer tube hole 21, the end of the contrast ring 30 that is separated from the inner tube 16 is caught by the end surface of the outer distal tube 23, and the contrast ring 30 is displaced in the axial direction. It is possible to avoid inconvenience.

  Further, the contrast ring 30 is prevented from being separated from the inner tube 16 at both ends of the contrast ring 30 in the axial direction. Therefore, even if the inner tube 16 is inserted from the proximal end side into the outer tube hole 21 (and the balloon 13 inside) of the outer distal tube 23 from the proximal end side or the distal end side, the contrast ring spaced from the inner tube 16 is provided. There is no occurrence of catching by the end of 30 and consequently no displacement of the contrast ring 30 caused by catching. Therefore, when inserting the inner tube 16 into the outer distal tube 23, the user does not have to consider whether the inner tube 16 is inserted from the distal end side or the proximal end side. is there.

  Thereafter, as a post-process, a joining process for joining the outer distal tube 23 and the outer proximal tube 22, a joining process for joining the outer tube 15 to the inner tube 16, and the like are performed.

  Next, a method for using the balloon catheter 10 will be briefly described.

  A user first inserts a guiding catheter through a sheath introducer inserted into a blood vessel, and pushes and pulls the guiding catheter into the coronary artery entrance. Next, the user inserts the guide wire G into the inner lumen 29 of the inner tube 16 of the balloon catheter 10 and the guiding catheter, and inserts it from the coronary artery entrance to the treatment site (for example, the stenosis site) to the peripheral site. To do. Subsequently, the user inserts the balloon catheter 10 along the guide wire G to the treatment target site while performing a push-pull or twist operation. In this case, the user inserts while confirming the position of the balloon 13 with the contrast ring 30. In a state where the balloon 13 has reached the treatment target site, the user expands the balloon 13 with a pressurizer and performs treatment.

  The balloon catheter 10 is mainly passed through a blood vessel as described above and used to expand a stenosis site or an occlusion site in the blood vessel. It is also applicable to “tubes” and body cavities.

  As mentioned above, according to the structure of this embodiment explained in full detail, the following outstanding effects are acquired.

  The contrast ring 30 includes a main body 31 formed in a cylindrical shape, and a protrusion 32 that protrudes from the main body 31 toward the inner peripheral side. The main body 31 is disposed on the outer peripheral side of the inner tube 16. The contrast ring 30 is attached to the inner tube 16 in a state where the protruding portion 32 is bitten into the inner tube 16. Further, the protrusion 32 is formed along the circumferential direction of the main body 31 in a direction orthogonal to the axial direction of the main body 31. Therefore, the protruding portion 32 can be bitten along the circumferential direction of the inner tube 16 in a direction orthogonal to the axial direction of the inner tube 16. Thereby, the position shift to the axial direction of the contrast ring 30 can be prevented suitably.

  Specifically, since the protruding portion 32 is formed over the entire circumferential direction of the main body portion 31, the protruding portion 32 can be bitten into the entire circumferential direction of the inner tube 16. Thereby, the position shift to the axial direction of the contrast ring 30 can be prevented reliably.

  Further, in the configuration for preventing the position shift of the contrast ring 30 by causing the protrusion 32 to bite into the inner tube 16, when the contrast ring 30 is caulked, compression deformation inside the contrast ring 30 is not sufficiently performed, Even when the contact (adhesion) between the inner peripheral surface of the main body portion 31 and the outer peripheral surface of the inner tube 16 becomes insufficient, there is an advantage that the position shift of the contrast ring 30 can be suitably prevented.

  Since the contrast ring 30 is attached to the region covered with the balloon 13 (in other words, the extension region 24) in the inner tube 16, when the balloon 13 passes through the constricted region of the blood vessel when the balloon catheter 10 is inserted into the body. For example, a load in the axial direction is easily applied to the contrast ring 30. In this regard, by providing the projection ring 32 on the contrast ring 30, it is possible to suitably prevent the position shift in the contrast ring 30 even when the contrast ring 30 is loaded in the axial direction. .

  The protrusion height h of the protrusion 32 from the inner peripheral surface of the main body 31 is set to ¼ or less of the wall thickness t of the inner tube 16. Therefore, the contrast ring 30 can be attached to the inner tube 16 without the protrusion 32 greatly biting into the inner tube 16. Thereby, the position shift to the axial direction of the contrast ring 30 can be prevented, avoiding that the inner tube 16 is greatly deformed or damaged inside.

  A metal pipe 35 is formed by cutting a Pr-Ir tube (long metal tube) made of a material having radiopacity to a predetermined length, and the metal pipe 35 is barrel-polished to form a metal pipe 35. Protrusions 32 were formed at both ends in the axial direction. Specifically, during barrel polishing, the protruding portion 32 was formed by knocking both ends of the metal pipe 35 to the inner peripheral side with irregular shaped abrasive grains (abrasive grains). Since the protrusion 32 has a small protrusion height, it is difficult to form the protrusion 32 by bending or the like. In that respect, according to the above method for forming the protrusion 32 by barrel polishing, even the protrusion 32 having a small protrusion height can be formed relatively easily.

  The present invention is not limited to the above embodiment, and may be implemented as follows, for example.

  (1) In the above embodiment, the protrusions 32 are formed at both ends of the main body 31 in the axial direction. However, the protrusion 32 may be formed only at one end of the main body 31 in the axial direction. Even in this case, the contrast ring 30 can be prevented from separating from the outer peripheral surface of the inner tube 16 at the one end portion in the axial direction of the contrast ring 30. As a result, when the inner tube 16 to which the contrast ring 30 is attached is inserted into the outer distal tube 23 during the manufacture of the catheter, the side on the contrast ring 30 where the protrusion 32 is provided is inserted as the insertion tip side. Thus, it is possible to avoid the inconvenience that the end of the contrast ring 30 is caught on the end surface of the outer distal tube 23 and the contrast ring 30 is displaced.

  Further, instead of or in addition to providing the protruding portion 32 at the end portion of the main body portion 31 in the axial direction, the protruding portion 32 may be provided at an intermediate portion of the main body portion 31 in the axial direction. Even in this case, if the projecting portion 32 is formed along the circumferential direction of the main body 31 in a direction orthogonal to the axial direction of the main body 31, it is possible to suitably prevent the misalignment of the contrast ring 30 in the axial direction. can do.

  (2) In the above embodiment, the protrusion 32 is formed over the entire circumferential direction of the main body 31. However, the protrusion 32 may be formed only in a part of the main body 31 in the circumferential direction. Even in such a case, the protrusion 32 is formed along the circumferential direction in a direction orthogonal to the axial direction of the main body 31, so that the positional deviation of the contrast ring 30 in the axial direction can be suitably prevented. In addition, when the protrusions 32 are formed only in a part of the main body 31 in the circumferential direction, a plurality of the protrusions 32 may be formed at predetermined intervals along the circumferential direction of the main body 31. May be formed only.

  (3) In the above embodiment, the protruding portion 32 is formed by barrel polishing the metal pipe 35. However, by changing this, the protruding portion 32 is formed by cutting or bending the metal pipe 35. May be. In the above embodiment, the R portion 33 is formed in the contrast ring 30. However, the R portion 33 may not be formed on the contrast ring 30. In this case, for example, in the longitudinal sectional view of the contrast ring 30, the protrusion 32 may be connected so as to form a right angle with the main body 31.

  (4) In the above embodiment, the two contrast rings 30 are attached to the inner tube 16. However, the number of contrast rings 30 attached to the inner tube 16 is not limited to two. The number of contrast rings 30 attached to the inner tube 16 may be only one, or may be three or more. Moreover, the attachment position of the contrast ring 30 with respect to the inner tube 16 is arbitrary. For example, the contrast ring 30 may be attached to the central position of the balloon 13 in the axial direction.

  (5) Although the case where the contrast ring 30 is attached to the balloon catheter 10 (specifically, the inner tube 16) has been described in the above embodiment, the contrast ring 30 may be attached to another catheter such as a suction catheter or a contrast catheter. Good.

  DESCRIPTION OF SYMBOLS 10 ... Balloon catheter as a catheter, 16 ... Inner tube as a catheter tube, 30 ... Contrast ring as a contrast marker, 31 ... Main-body part, 32 ... Protrusion part.

Claims (5)

A marker for imaging formed by a metal material attached to the outer peripheral side of a catheter tube and having radiopacity ,
A main body formed in a cylindrical shape;
A projecting portion projecting inward from the main body portion,
The projecting portion is formed along the circumferential direction of the main body portion in a direction orthogonal to the axial direction of the main body portion, and is provided only at an end portion of the main body portion in the axial direction. Contrast marker.   The contrast marker according to claim 1, wherein the projecting portion is formed over the entire circumferential direction of the main body portion. The protrusion imaging marker according to claim 1 or 2, characterized in that only are provided at both ends in the axial direction of the main body portion. The catheter tube;
A catheter comprising the contrast marker according to any one of claims 1 to 3 attached to the catheter tube,
The main body is disposed on the outer peripheral side of the catheter tube,
The catheter, wherein the protruding portion is provided in a state of biting into the catheter tube. The catheter according to claim 4 , wherein a protruding height of the protruding portion from the inner peripheral surface of the main body portion is set to ¼ or less of a thickness of the catheter tube.

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