Catheter

Abstract

To provide a catheter capable of reducing a risk of closing an unintended blood vessel such as a peripheral blood vessel by leak or dispersion of a high polymer material such as an embolic agent.SOLUTION: A catheter 2 includes: a shaft 3 which is the shaft 3 having one or more expanded lumens 11 for balloon expansion, and a delivery lumen 12 of a high polymer material, and has an opening 4 for communicating the delivery lumen 12 and the outside of the shaft 3; a first balloon 21 which is the first balloon 21 disposed at a distal side from the opening 4, and in which the inside is communicated with one of the one or more expanded lumens 11; and a second balloon 22 which is the second balloon 22 disposed at a proximal side from the opening 4, and in which the inside of the second balloon 22 is communicated with the expanded lumen 11 different from the expanded lumen 11 communicated with the inside of the first balloon 21 of the one or more expanded lumens 11, or the expanded lumen 11 communicated with the inside of the first balloon 21.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to a catheter for performing intravascular treatment. [Background technology]

[0002] Intravascular treatment using a catheter is one of the treatment methods for vascular lesions such as head aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, abdominal aneurysms, etc. As an example of intravascular treatment, embolization is known, which prevents the rupture of an aneurysm by modifying the blood flow by placing an embolizing device or an embolic agent in the vascular lesion, or prevents a stroke caused by a blood clot breaking off and traveling to a cerebral blood vessel.

[0003] For example, Patent Document 1 discloses an intracranial stent having a tubular side wall and a patch covering at least a portion of the side wall, the side wall having a loosely woven metal material with a first density and the patch having a tightly woven metal material with a second density greater than the first density, the patch being made of an expandable photon-activated gel material.

[0004] Patent document 2 also discloses that a thrombus-formed left atrial appendage is treated using an occlusion device in which a balloon is configured to receive tissue adhesive, and tissue adhesive flows into the balloon from the proximal end of the conduit and flows out through multiple openings. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Special Publication No. 2017-515567 [Patent Document 2] Special Publication No. 2020-521561 Summary of the Invention [Problem to be solved by the invention]

[0006] In the intracranial stent disclosed in Patent Document 1, it was difficult to intentionally orient a patch made of a photon-activated gel material toward the aneurysm side, and if the gel material adhered to both the aneurysm side and the parent blood vessel side, there was a possibility that the gel material would adversely affect the parent blood vessel side.

[0007] The tissue adhesive disclosed in Patent Document 2 can be applied to the left atrial appendage when delivered as a liquid, but when applied to a cranial aneurysm, there is a risk that the tissue adhesive will leak or splash into peripheral blood vessels, resulting in the occlusion of unintended blood vessels (such as lacunar infarction).

[0008] In view of the above circumstances, an object of the present invention is to provide a catheter that can reduce the risk of blocking unintended blood vessels, such as peripheral blood vessels, due to leakage or scattering of a polymeric material, such as an embolic agent. [Means for solving the problem]

[0009] A catheter according to an embodiment of the present invention that can solve the above problems is as follows. [1] A shaft having a longitudinal direction and at least one expansion lumen through which a fluid for expanding a balloon passes and a delivery lumen for delivering a polymeric material to a distal side, the shaft having an opening in a side wall of a distal portion of the shaft that communicates the delivery lumen with the outside of the shaft; a first balloon disposed distal to the opening in the distal portion of the shaft, the interior of the first balloon being in communication with one of the at least one expansion lumen; a second balloon disposed proximal to the opening in the distal portion of the shaft, the interior of the second balloon communicating with one of the at least one expansion lumen that is different from the expansion lumen communicating with the interior of the first balloon or the expansion lumen communicating with the interior of the first balloon; A catheter having

[0010] The catheter according to the embodiment of the present invention is preferably any one of the following items [2] to

[10] . [2] A catheter as described in [1], wherein, in a cross section perpendicular to the longitudinal direction, the central axis of the shaft is offset from the central axis of the first balloon, and the central axis of the shaft is offset from the central axis of the second balloon. [3] A catheter as described in [2], wherein in a cross section perpendicular to the longitudinal direction, the central axis of the shaft is located radially outward from the central axis of the first balloon, and in a cross section perpendicular to the longitudinal direction, the central axis of the shaft is located radially outward from the central axis of the second balloon. [4] The catheter described in [1], wherein the shaft has a curved portion between the first balloon and the second balloon in the longitudinal direction, and the opening is disposed at the curved portion. [5] The catheter described in [4], wherein the curved portion has an arc-shaped curved shape. [6] A catheter as described in [4] or [5], wherein the curved portion protrudes radially outward, is arranged on at least one of the shaft, the first balloon, and the second balloon, and further has a first marker for identifying the protruding direction of the curved portion in the circumferential direction of the shaft. [7] A catheter described in any one of [1] to [6], further comprising a light-guiding member disposed within the shaft and movable longitudinally relative to the shaft, the shaft having a light-transmitting portion at a distal portion, the light-guiding member having a light-irradiating portion at a distal portion, the light-irradiating portion being arranged to overlap the light-transmitting portion when the light-guiding member is moved to the most distal side relative to the shaft, and the polymer material being a photoactivatable polymer material. [8] The catheter described in [7], wherein the light-transmitting portion is arranged between the first balloon and the second balloon in the longitudinal direction. [9] A catheter as described in [7] or [8], wherein when the light-guiding member is moved to the distal end relative to the shaft, the light irradiation section is arranged to overlap with the opening in the longitudinal direction.

[10] The catheter described in any one of [1] to [9], further comprising a second marker arranged on the shaft for identifying the orientation of the opening in the circumferential direction of the shaft. Effect of the Invention

[0011] According to the catheter, the distal part of the catheter can be fixed to the lesion by two balloons, the first balloon and the second balloon. In addition, the lesion can be positioned between the first balloon and the second balloon to confine the lesion, which prevents the embolic agent from leaking or scattering outside the lesion. This reduces the risk of unintended vascular occlusion due to leakage or scattering of the embolic agent. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a side view of a catheter according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a longitudinal cross-sectional view of the distal portion of the catheter shown in FIG. 1. [Diagram 3] FIG. 3 is an explanatory diagram of the distal portion of the catheter shown in FIG. 2 placed in a blood vessel lumen where an aneurysm has developed. [Figure 4] 4 is a cross-sectional end view of the catheter shown in FIG. 2 taken along line IV-IV. [Diagram 5] 3 is a cross-sectional end view of the catheter shown in FIG. 2 taken along line VV. [Figure 6] FIG. 3 is a cross-sectional view showing a modification of the catheter shown in FIG. [Figure 7] FIG. 7 is a cross-sectional end view of the catheter shown in FIG. 6 taken along line VII-VII. [Figure 8] 5 is a cross-sectional view showing a modified example of the shaft shown in FIG. [Figure 9] FIG. 6 is a cross-sectional view showing a modification of the catheter shown in FIG. [Figure 10] FIG. 3 is a cross-sectional view showing another modified example of the catheter shown in FIG. [Figure 11]FIG. 11 is a cross-sectional end view of the catheter shown in FIG. 10 taken along line XI-XI. [Figure 12] FIG. 2 is a side view showing a modified example of the catheter shown in FIG. [Figure 13] FIG. 2 is a side view showing another modified example of the catheter shown in FIG. [Figure 14] FIG. 14 is a longitudinal cross-sectional view of the distal portion of the catheter shown in FIG. 13. [Figure 15] 15 is a cross-sectional end view of the catheter shown in FIG. 14 taken along line XV-XV. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The present invention will be described below based on the embodiments, but the present invention is not limited to the following embodiments, and can be modified as appropriate within the scope of the above and below, and all of these are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, the specification and other drawings should be referred to. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, since priority is given to helping understand the features of the present invention.

[0014] A catheter according to an embodiment of the present invention has a shaft having a longitudinal direction and at least one expansion lumen through which a fluid for expanding the balloon passes and a delivery lumen for delivering a polymeric material to the distal side, the shaft having an opening in a side wall of the distal portion of the shaft that connects the delivery lumen to the outside of the shaft, a first balloon arranged distal to the opening in the distal portion of the shaft, the interior of the first balloon communicating with one of the at least one expansion lumens, and a second balloon arranged proximal to the opening in the distal portion of the shaft, the interior of the second balloon communicating with an expansion lumen different from the expansion lumen communicating with the interior of the first balloon or an expansion lumen communicating with the interior of the first balloon, among the at least one expansion lumen.

[0015] According to the catheter, the distal part of the catheter can be fixed to the lesion by two balloons, the first balloon and the second balloon. In addition, the lesion is positioned between the first balloon and the second balloon, and then a polymeric material such as an embolic agent can be discharged from the opening, so that leakage or scattering of the polymeric material outside the lesion can be prevented. Therefore, the risk of unintended occlusion of the blood vessel due to leakage or scattering of the polymeric material can be reduced.

[0016] In this specification, the catheter according to the embodiment of the present invention will be described as being applied to an aneurysm as an example; however, the catheter according to the embodiment of the present invention can be applied not only to an aneurysm but also to arteriovenous malformations, dural arteriovenous fistulas, abdominal aortic aneurysms, varicose veins of the lower limbs, and vascular occlusion in the hepatic artery of patients with hepatocellular carcinoma and other lesions.

[0017] Hereinafter, a catheter according to an embodiment of the present invention will be described with reference to Figs. 1 to 15. Fig. 1 is a side view of a catheter according to an embodiment of the present invention. Fig. 2 is a longitudinal cross-sectional view of the distal part of the catheter shown in Fig. 1. Fig. 3 is a longitudinal cross-sectional view of the distal part of the catheter shown in Fig. 2 when it is placed in a blood vessel lumen where an aneurysm has occurred. Fig. 4 is a cross-sectional end view of the catheter shown in Fig. 2, taken along line IV-IV. Fig. 5 is a cross-sectional end view of the catheter shown in Fig. 2, taken along line VV. Fig. 6 is a cross-sectional view showing a modified example of the catheter shown in Fig. 2. Fig. 7 is a cross-sectional end view of the catheter shown in Fig. 6, taken along line VII-VII. Fig. 8 is a cross-sectional view showing a modified example of the shaft shown in Fig. 4. Fig. 9 is a cross-sectional view showing a modified example of the catheter shown in Fig. 5. Fig. 10 is a cross-sectional view showing another modified example of the catheter shown in Fig. 2. Fig. 11 is a cross-sectional end view of the catheter shown in Fig. 10, taken along line XI-XI. Fig. 12 is a side view showing a modified example of the catheter shown in Fig. 1. Fig. 13 is a side view showing a modified example of the catheter shown in Fig. 1. Fig. 14 is a longitudinal cross-sectional view of the distal part of the catheter shown in Fig. 13. Fig. 15 is a cross-sectional end view taken along line XV-XV of the catheter shown in Fig. 14. As shown in Figs. 1 and 2, the catheter 2 has a shaft 3, a first balloon 21, and a second balloon 22, and the shaft 3 has an opening 4.

[0018] In this specification, the configuration and effects of catheter 2 will be described using an example in which catheter 2 is used to treat aneurysm 61, but catheter 2 can of course be used for similar purposes in lesions other than aneurysm 61. Aneurysm 61 is sometimes simply called aneurysm 61.

[0019] In FIG. 1, the shaft 3 preferably has a longitudinal direction x, a radial direction y that is perpendicular to the longitudinal direction x, and a circumferential direction z that is along the outer circumference. The catheter 2 preferably has a longitudinal direction x, a radial direction y, and a circumferential direction z, similar to the shaft 3. The shaft 3 preferably has a distal end and a proximal end in the longitudinal direction x. In this specification, the direction toward the user's hand in the longitudinal direction x is referred to as the proximal side, and the opposite side to the proximal side, i.e., the direction toward the treatment target, is referred to as the distal side. The longitudinal direction x can also be referred to as the near-far direction or the extension direction of the shaft 3. The radial direction y refers to the radial direction of the shaft 3, and in the radial direction y of the shaft 3, the inward direction refers to the direction toward the longitudinal central axis of the shaft 3, and in the radial direction y, the outward direction refers to the direction extending radially from the longitudinal central axis opposite to the inward direction. 1 to 3, 6, 10 and 12 to 14, the right side of the figure is the proximal side, and the left side of the figure is the distal side.

[0020] Each member and portion constituting the catheter 2 has a longitudinal direction x, a radial direction y, and a circumferential direction z, which may be the same as or different from the longitudinal direction x, radial direction y, and circumferential direction z of the shaft 3.

[0021] As shown in Figure 2, the shaft 3 has at least one expansion lumen 11 through which fluid for expanding the balloon passes and a delivery lumen 12 for delivering polymeric material 50 to the distal side. One or more expansion lumens 11 may be provided. Multiple delivery lumens 12 may be provided, but it is preferable that only one is provided. The at least one expansion lumen 11 and the delivery lumen 12 each preferably extend in the longitudinal direction x of the shaft 3. Hereinafter, the at least one expansion lumen 11 may be simply referred to as the expansion lumen 11.

[0022] 1 and 2, the shaft 3 has an opening 4 on the side wall of the distal portion, which connects the delivery lumen 12 to the outside of the shaft 3. By providing the opening 4, the polymer material 50 is delivered from the proximal side to the distal side through the delivery lumen 12, as shown in Fig. 3. As a result, the polymer material 50 can be discharged from the opening 4 to the outside of the shaft 3.

[0023] As shown in Figs. 1 and 2, the catheter 2 has a first balloon 21 disposed distal to the opening 4 at the distal part of the shaft 3. The inside of the first balloon 21 communicates with one of at least one expansion lumen 11. The catheter 2 also has a second balloon 22 disposed proximal to the opening 4 at the distal part of the shaft 3. The inside of the second balloon 22 communicates with an expansion lumen 11 different from the expansion lumen 11 communicating with the inside of the first balloon 21, or with an expansion lumen 11 communicating with the inside of the first balloon 21, among at least one expansion lumen 11. A fluid for balloon expansion is supplied to the inside of the first balloon 21 and the second balloon 22 through the expansion lumen 11 of the shaft 3. Hereinafter, the first balloon 21 and the second balloon 22 may be collectively referred to simply as balloons.

[0024] An example of use of the catheter 2 will be described. As can be seen from FIG. 3, the distal part of the shaft 3 is delivered to a lesion such as an aneurysm 61 in the blood vessel lumen. During delivery of the catheter 2, the first balloon 21 and the second balloon 22 are preferably in a contracted state, and are preferably in an expanded state when the catheter 2 is delivered to a position where the polymeric material 50 is to be discharged to the lesion. When the first balloon 21 and the second balloon 22 are in an expanded state, the balloons come into contact with the blood vessel wall 60 and are fixed. As a result, the distal part of the catheter 2 can be reliably fixed to the lesion by the two balloons, the first balloon 21 and the second balloon 22. At this time, the blood vessel lumen may be in a state in which the distal side and the proximal side are blocked by the first balloon 21 and the second balloon 22. According to the catheter 2, the lesion is positioned between the first balloon 21 and the second balloon 22, and the polymeric material 50 such as an embolic agent can be discharged from the opening 4 after the lesion is trapped. This makes it possible to prevent the polymer material 50 from leaking or scattering outside the affected area, thereby reducing the risk of unintended blood vessel blockage due to leakage or scattering of the polymer material 50.

[0025] The shaft 3 may have one or more openings 4 that communicate between the delivery lumen 12 and the outside of the shaft 3, but it is preferable to have only one opening. This makes it easier to eject the polymer material 50 toward the lesion, making it easier to place the polymer material 50 in the lesion.

[0026] The shape of the opening 4 when viewed from the outside in the radial direction y of the shaft 3 is not particularly limited, and may be, for example, a circle, an oval, a polygon, or a combination of these, or may be an irregular shape. The oval shape includes an ellipse, an egg, and a rounded rectangle. The same applies in the following description.

[0027] In the circumferential direction z, the range in which the openings 4 are arranged is preferably 180° or less, more preferably 90° or less, and even more preferably 60° or less. By setting the range in which the openings 4 are arranged to be 180° or less, it becomes easier to eject the polymer material 50 toward the lesion, and therefore it becomes easier to place the polymer material 50 in the lesion. In addition, the range in which the openings 4 are arranged in the circumferential direction z may be, for example, 10° or more, 30° or more, or 45° or more.

[0028] The distal end of the shaft 3 is preferably blocked. This can prevent the fluid passing through the expansion lumen 11 and the polymeric material 50 passing through the delivery lumen 12 from being discharged from the distal end of the shaft 3. In addition, the distal end of the delivery lumen 12 may be located at the same position as the distal end of the opening 6 in the longitudinal direction x. The distal end of the expansion lumen 11 may be located at the same position as the distal end of the fluid communication port 15A in the longitudinal direction x.

[0029] Although not shown, the shaft 3 may have a distal opening at the distal end of the expansion lumen 11 that communicates with the expansion lumen 11. The shaft 3 may have a distal opening at the distal end of the delivery lumen 12 that communicates with the delivery lumen 12. These distal openings are preferably openings whose normal vector of the opening surface faces the distal side. The shaft 3 may have a proximal opening at the proximal end of the expansion lumen 11 that communicates with the expansion lumen 11. The shaft 3 may have a proximal opening at the proximal end of the delivery lumen 12 that communicates with the delivery lumen 12. These proximal openings are preferably openings whose normal vector of the opening surface faces the proximal side.

[0030] At least one of the extension lumen 11 and the delivery lumen 12 extends along a longitudinal direction x. As can be seen from Figure 2, the central axis of the extension lumen 11 and the central axis of the delivery lumen 12 of the shaft 3 may be arranged parallel to each other in the longitudinal direction x.

[0031] Shaft 3 may be composed of one or more members. Expansion lumen 11 and delivery lumen 12 may be disposed in one member constituting shaft 3, or each may be disposed in a different member. In Figs. 1 to 3, shaft 3 has expansion lumen 11 and delivery lumen 12, and shaft 3 further has a partition wall 5 that separates expansion lumen 11 and delivery lumen 12. Thus, shaft 3 may have one or more partition walls 5.

[0032] 2, 4, and 5, the inside of the first balloon 21 and the inside of the second balloon 22 may be connected to the same expansion lumen 11. In FIG. 2, the shaft 3 has a first overlapping portion 3L overlapping with the first balloon 21 and a second overlapping portion 3M overlapping with the second balloon 22 in the longitudinal direction x, and has a fluid communication port 15A on the side wall of the first overlapping portion 3L and a fluid communication port 15B on the side wall of the second overlapping portion 3M. In detail, the first balloon 21 has an expansion portion 21E that is not joined to the shaft 3, and the second balloon 22 has an expansion portion 22E that is not joined to the shaft 3, and the fluid communication port 15A may be arranged in a portion of the side wall of the shaft 3 that overlaps with the expansion portion 21E, and the fluid communication port 15B may be arranged in a portion of the side wall of the shaft 3 that overlaps with the expansion portion 22E.

[0033] Another embodiment of the shaft 3 will be described. Although not shown, the shaft 3 may have a first tube defining the expansion lumen 11 and a second tube arranged in parallel with the first tube defining the delivery lumen 12, and the outer circumferential surfaces of the first tube and the second tube may be fixed to each other. In this case, the first balloon 21 and the second balloon 22 may be connected to the first tube and the second tube, respectively, so that the inside of the first balloon 21 and the inside of the second balloon 22 communicate with the same expansion lumen 11. An opening 4 through which the polymer material 50 is discharged may be arranged in the side wall of the second tube.

[0034] Still another embodiment of the shaft 3 will be described. As shown in Figs. 6 to 7, the shaft 3 may have an outer tube 3A that defines the expansion lumen 11, and an inner tube 3B that is disposed in the expansion lumen 11 and defines the delivery lumen 12. A part of the outer peripheral surface of the inner tube 3B may be fixed to a part of the inner peripheral surface 3A of the outer tube. The first balloon 21 and the second balloon 22 may be connected to the outer tube 3A so that the inside of the first balloon 21 and the inside of the second balloon 22 communicate with the same expansion lumen 11. The opening 4 from which the polymer material 50 is discharged may be disposed in a portion where the outer tube 3A and the inner tube 3B are fixed to each other. The opening 4 is preferably disposed so as to penetrate the side walls of the outer tube 3A and the inner tube 3B.

[0035] Still another embodiment of the shaft 3 will be described. As shown in Fig. 8, the shaft 3 may have two expansion lumens 11A and 11B and a delivery lumen 12. In Fig. 8, the shaft 3 has a partition wall 5A separating the expansion lumen 11A from the delivery lumen 12, a partition wall 5B separating the expansion lumen 11A from the delivery lumen 12, and a partition wall 5C separating the two expansion lumens 11A and 11B. A first balloon 21 may be connected to the shaft 3 such that the inside of the first balloon 21 communicates with the expansion lumen 11A, and a second balloon 22 may be connected to the shaft 3 such that the inside of the second balloon 22 communicates with the other expansion lumen 11B.

[0036] The shaft 3 may have one or more lumens in addition to the expansion lumen 11 and the delivery lumen 12. For example, they may function as a guidewire lumen, an insertion path for the light-guiding member 40 described below, or a blood passage lumen.

[0037] The fluid passing through the at least one expansion lumen 11 may include air, nitrogen, water, etc. The fluid may be a pressurized fluid, such as a fluid pressurized by a pump.

[0038] The polymeric material 50 passing through the delivery lumen 12 is preferably a medical adhesive that is biocompatible and is also known as an embolic agent. The polymeric material 50 may be in a liquid, sol, or gel state, so long as it can be introduced into the delivery lumen 12 and expelled from the opening 4 of the shaft 3. It is more preferable that the polymeric material 50 is composed of a polymeric material 50 that undergoes a sol-gel transition in response to a combination of at least one initiator selected from temperature, solvent, pH, and ultraviolet light, such as a hydrogel.

[0039] From the viewpoint of preventing leakage or scattering from the target site, the polymer material 50 preferably has a viscosity of at least a predetermined value, and the viscosity at 25°C is preferably 0.1 Pa·s or more, more preferably 0.5 Pa·s or more, even more preferably 1.0 Pa·s or more, and preferably 200 Pa·s or less, more preferably 150 Pa·s or less, and even more preferably 100 Pa·s or less. Even if the polymer material 50 has a viscosity of at least a predetermined value, the maximum pressure applied to the delivery lumen 12 can be increased, so that the polymer material 50 introduced from the proximal side of the delivery lumen 12 can be discharged from the opening 4. Alternatively, in the case of an embodiment in which the polymer material 50 is cured after being discharged from the opening 4 as described below, the polymer material 50 before curing may have a low viscosity (about 1 mPa·s) similar to that of water.

[0040] Examples of the polymer material 50 include a cyanoacrylate adhesive, a polyvinyl alcohol adhesive, a polyurethane adhesive, a fibrin adhesive, and a gelatin adhesive. The polymer material 50 may contain a metal such as tantalum powder to provide visibility. The polymer material 50 may be dissolved in a solvent such as dimethyl sulfoxide (DMSO) before use.

[0041] As the polymer material 50, poly(N-isopropylacrylamide) (PNIPAM) gel is suitable. NIPAM has hydrophilic amide groups and hydrophobic isopropyl groups, and hydrogen bonds are formed around the amide groups at temperatures below 32°C. At temperatures above 32°C, molecular motion becomes active, hydrogen bonds are broken, and hydrophobic isopropyl groups gather, pushing water out of the gel and causing the gel to shrink. Preferably, the functional groups are replaced with carboxylic acid, hydroxyl, ketone, and ether groups to provide functionality so that the gel will gel at 37°C, which is the temperature in the body. Also, pH responsiveness can be provided to the gel by copolymerizing N-isopropylacrylamide (NIPAM) and methacrylic acid. More preferably, both pH and temperature responsiveness can be provided by using NIPAM, acrylic acid, and a diacrylamide crosslinker. More preferably, the molecular weight of the polymer to be polymerized is controlled according to the application by changing the concentration of the chain transfer agent to adjust the gel to the desired one. Alternatively, the polymer material 50 may be composed of a gel containing a reaction product of an ethylenically unsaturated monomer, a crosslinker, and, if necessary, a bifunctional macromer, and a visualization agent. The visualization agent mainly refers to a positive contrast agent that absorbs X-rays when X-rays are taken in intravascular treatment, and includes a water-soluble iodine contrast agent. Alternatively, the material may be a material that gels by chemical reaction with a component of the visualization agent.

[0042] The diameter of delivery lumen 12 is preferably 0.2 mm or more, more preferably 0.5 mm or more, even more preferably 0.7 mm or more, and is preferably 2.2 mm or less, more preferably 2.0 mm or less, and even more preferably 1.8 mm or less. If delivery lumen 12 has a diameter within the above range, polymer material 50 can be introduced into delivery lumen 12 and discharged from opening 4 into aneurysm 61 without impairing the insertability of shaft 3 through the blood vessel lumen.

[0043] As shown in FIG. 1, the catheter 2 may have a handle 10 at its proximal portion. The handle 10 may be connected to the proximal portion of the shaft 3. A user can easily operate the catheter 2 by gripping the handle 10. The handle 10 may extend in the longitudinal direction x, for example, or a part or the entirety of the handle 10 may be inclined with respect to the longitudinal direction x. The handle 10 may be composed of one or more members.

[0044] The material of which the handle 10 is made is not particularly limited, but examples of the material that can be used include synthetic resins such as polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resins, ABS resins, and polyurethane resins.

[0045] 1, the catheter system 1 may include a catheter 2 and at least one fluid supply unit 31 connected to the catheter 2 for introducing a fluid for expanding a balloon into the expansion lumen 11. The fluid supply unit 31 may be connected to the handle 10. As the fluid supply unit 31, for example, a syringe or a balloon pressurizer can be used.

[0046] 1, the catheter system 1 may include a catheter 2 and a polymer material supply unit 32 connected to the catheter 2 for introducing a polymer material 50 into the delivery lumen 12. The polymer material supply unit 32 may be connected to the handle 10. The polymer material supply unit 32 may be, for example, a syringe or a pressurizer.

[0047] Although not shown, the catheter system 1 includes a catheter 2, a fluid supply unit 31, and a polymer material supply unit 32, and may further include a supply pressure control unit connected to the fluid supply unit 31 and the polymer material supply unit 32, which controls the supply pressure of the fluid and the supply pressure of the polymer material 50 so that the maximum pressure applied to the delivery lumen 12 when the polymer material 50 is introduced into the delivery lumen 12 is greater than the maximum pressure applied to at least one expansion lumen 11 when the first balloon 21 and the second balloon 22 are in an expanded state by introducing a fluid. The supply pressure control unit may control the maximum pressure applied to the delivery lumen 12 when the polymer material 50 is introduced into the delivery lumen 12 to be greater than the maximum pressure applied to all of the expansion lumens 11 when the first balloon 21 and the second balloon 22 are in an expanded state by introducing a fluid. The high maximum pressure applied to the delivery lumen 12 makes it possible to supply a polymer material 50 with a high viscosity to the delivery lumen 12. As a result, while a low-viscosity polymer material 50 is prone to leakage and scattering from within the aneurysm 61, the use of a high-viscosity polymer material 50 improves the effect of preventing leakage and scattering, thereby reducing the risk of unintended blocking of blood vessels.

[0048] The maximum pressure applied to expansion lumen 11 when the balloon is expanded by introducing a fluid therein is preferably 0.01 MPa or more and 0.06 MPa or less in terms of gauge pressure for cerebral blood vessels, and 2.0 MPa or more and 4.0 MPa or less in terms of calcified lesions of varicose veins of the lower limbs, and when the balloon is made of a flexible styrene-based plastic elastomer, is preferably 0.01 MPa or more, and is preferably 0.04 MPa or less, more preferably 0.03 MPa or less, and even more preferably 0.02 MPa or less. Since the maximum pressure is within the above range and the maximum pressure applied to delivery lumen 12 when polymer material 50 is introduced into delivery lumen 12 is greater than the maximum pressure, the expanded balloon placed at the lesion can easily block parent blood vessel lumen 62.

[0049] The shaft 3 and the balloon can be connected by bonding with an adhesive, welding, or by attaching a ring-shaped member to the overlapping portion of the shaft 3 and the balloon and crimping the same. Of these, it is preferable that the shaft 3 and the balloon are joined by welding. This makes it difficult for the connection between the shaft 3 and the balloon to come apart even when the balloon is repeatedly expanded or contracted, thereby improving the strength of the catheter 2.

[0050] The material constituting the shaft 3 is preferably a resin, a metal, or a combination of a resin and a metal. By using a resin as the material constituting the shaft 3, it becomes easier to impart flexibility and elasticity to the shaft 3. In addition, by using a metal as the material constituting the shaft 3, it becomes possible to improve the insertability of the catheter 2 into the blood vessel lumen.

[0051] Examples of resins constituting the shaft 3 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, polystyrene resins, fluorine resins, vinyl chloride resins, silicone resins, natural rubber, synthetic rubber, polyimide, and the like. These may be used alone or in combination of two or more. When DMSO is used as the solvent for the polymer material 50, the resin constituting the shaft 3 is preferably polyethylene, polypropylene, polystyrene, fluorine resin, or a mixture thereof. This can reduce damage to the catheter 2 caused by DMSO.

[0052] Examples of metals constituting the shaft 3 include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, nickel-titanium alloys, cobalt-chromium alloys, or combinations thereof. The shaft 3 may be formed by combining a metal with a resin, or may be configured by combining a reinforcing material such as a wire made of the above metal with a cylindrical body made of resin.

[0053] The shaft 3 may have different configurations in the proximal and distal parts in the longitudinal direction x. For example, the proximal part may be made of metal and the distal part may be made of resin. Furthermore, the shaft 3 may have a laminated structure made of different materials or the same material. As an example, the shaft 3 is made of SUS304, and is more preferably covered with polyimide over a 5 cm range from the proximal end toward the distal side, is not covered over a 5 cm range from the distal end toward the proximal side, and is covered with fluororesin over the entire circumference of the other range. By covering with polyimide, the surgeon can grip and push the shaft 3 without slipping even when wearing latex or nitrile gloves, improving the distal blood vessel reachability. In addition, by covering with fluororesin, friction with the blood vessel wall 60 in saline or blood can be reduced, improving the slipperiness of the shaft 3 and improving the passage through tortuous blood vessels.

[0054] When the shaft 3 is made up of a plurality of members, for example when it has an inner tube and an outer tube, the members may be made up of the same material or different materials.

[0055] The outer diameter of the shaft 3 is preferably 0.7 mm or more, more preferably 1.0 mm or more, even more preferably 1.5 mm or more, and is preferably 3.5 mm or less, more preferably 3.0 mm or less, and even more preferably 2.5 mm or less. By having the outer diameter of the shaft 3 within the above range, it is possible to obtain a shaft 3 having appropriate rigidity and improved insertability through the blood vessel lumen.

[0056] 2, the first balloon 21 preferably has a non-expanding proximal sleeve portion 21P and a distal sleeve portion 21D, and an expansion portion 21E. Similarly, the second balloon 22 preferably has a non-expanding proximal sleeve portion 22P and a distal sleeve portion 22D, and an expansion portion 22E. By having the non-expanding proximal sleeve portion and distal sleeve portion, the balloon can be stably connected to the proximal sleeve portion and the distal sleeve portion.

[0057] The expansion section may have a cylindrical shape with both ends tapered. Although not shown, the expansion section may have a shape having a straight tube section having a substantially constant diameter and tapered sections having a tapered diameter on the proximal and distal sides of the straight tube section. An expansion section having a cylindrical shape or a straight tube section is easily applied to a lesion where an aneurysm 61 is formed on the side surface of the vascular wall 60. The shapes of the first balloon 21 and the second balloon 22 may be the same or different from each other.

[0058] Suitable materials for forming the balloon include polyamide resins such as nylon 11 and nylon 12, polyester resins such as polyethylene terephthalate and polybutylene terephthalate, polyurethane resins, and styrene-based plastic elastomers. From the viewpoint of flexibility, the balloon may be made of polyamide elastomers such as polyether block amide copolymers. The first balloon 21 and the second balloon 22 may be made of the same material or different materials.

[0059] The maximum diameter of the balloon in the expanded state is preferably 1.5 mm or more, more preferably 2.0 mm or more, even more preferably 2.5 mm or more, and is preferably 10.0 mm or less, more preferably 8.0 mm or less, and even more preferably 7.0 mm or less. If the maximum diameter of the balloon in the expanded state is within the above range, it is easy to fix the shaft 3 with the balloon and prevent the polymeric material 50 discharged from the opening 4 from leaking into the parent blood vessel lumen 62 by expanding the balloon according to the diameter of the parent blood vessel lumen 62 to be indwelled. The maximum diameters of the first balloon 21 and the second balloon 22 may be the same, or the maximum diameter of the first balloon 21 may be smaller than the maximum diameter of the second balloon 22, or the maximum diameter of the first balloon 21 may be larger than the maximum diameter of the second balloon 22.

[0060] The thickness of the balloon is preferably 12 μm or more, more preferably 15 μm or more, and even more preferably 20 μm or more, and is preferably 60 μm or less, more preferably 50 μm or less, and even more preferably 40 μm or less. By having the thickness of the balloon within the above range, the balloon can have improved durability and flexibility. The thicknesses of the first balloon 21 and the second balloon 22 may be the same or different.

[0061] In a cross section perpendicular to the longitudinal direction x, the balloon may have a shape such as a circle, a polygon, an ellipse, a spindle shape, or a combination of these. The following description will be given taking the first balloon 21 as an example, but the second balloon 22 can be configured in the same manner. In FIG. 5, the first balloon 21 has a circular shape in a cross section perpendicular to the longitudinal direction x. On the other hand, as shown in FIG. 9, in a cross section perpendicular to the longitudinal direction x of the shaft 3, the outer edge of the first balloon 21 may have a non-contact portion 21F that does not contact the circumscribing circle 21C of the first balloon 21. Since the outer edge of the first balloon 21 has the non-contact portion 21F, even if the first balloon 21 expands and blocks a blood vessel, blood can perfuse the space formed by the non-contact portion 21F, so that it is possible to prevent the surrounding tissue from becoming ischemic due to the blood flow being stopped during the time it takes for the polymer material 50 to block the aneurysm 61. In addition, the contact portion 21T other than the non-contact portion 21F can block the blood vessel or fix the catheter 2.

[0062] When the first balloon 21 has the non-contact portion 21F, the range in which the non-contact portion 21F is arranged in the circumferential direction z is preferably 30° or more. To achieve such a configuration, the balloon may be an irregular balloon in which the outer edge of the balloon in a cross section perpendicular to the longitudinal direction x is not circular. FIG. 9 shows an example of a configuration in which a part of the outer edge of the balloon has a part recessed inward in the radial direction y, but other configurations include a part of the outer edge of the balloon having a part protruding outward in the radial direction y, or a shape such as a polygon, an ellipse, a spindle shape, or a combination of these. When a plurality of non-contact portions 21F are provided on the circumference of the circumscribed circle 21C, the range in which the non-contact portions 21F are arranged is preferably 30° or more in total. In the circumferential direction z, the range in which the non-contact portions 21F are arranged may be 300° or less, 240° or less, or 180° or less in total.

[0063] As can be seen from FIG. 5, in a cross section perpendicular to the longitudinal direction x, the central axis CS of the shaft 3 may be arranged to overlap with the central axis C1 of the first balloon 21 and the central axis (not shown) of the second balloon 22. On the other hand, as can be seen from FIG. 10 to FIG. 11, in a cross section perpendicular to the longitudinal direction x, the central axis CS of the shaft 3 is preferably offset from the central axis C1 of the first balloon 21, and the central axis CS of the shaft 3 is preferably offset from the central axis of the second balloon 22. In detail, in a cross section perpendicular to the longitudinal direction x, the central axis CS of the shaft 3 is preferably positioned radially outward from the central axis C1 of the first balloon 21, and the central axis CS of the shaft 3 is preferably positioned radially outward from the central axis of the second balloon 22. By arranging the shaft 3 and the balloons in this way, the opening 4 arranged between the first balloon 21 and the second balloon 22 can be easily brought close to the lesion. It is preferable that the central axis C1 of the first balloon 21 and the central axis of the second balloon 22 overlap with each other in a cross section perpendicular to the longitudinal direction x. In this way, an offset balloon in which the central axis of the balloon is positioned off from the central axis CS of the shaft 3 can also be suitably used.

[0064] 11, in the radial direction y, the distance D1 from the central axis CS of the shaft 3 to an arbitrary first position P1 on the outer surface of the first balloon 21 is longer than the distance D2 from the central axis CS of the shaft 3 to a second position P2 that is on the opposite side in the radial direction y to the first position P1 on the outer surface of the first balloon 21. As can be seen from FIG. 10, the second balloon 22 may have a similar configuration.

[0065] Although FIG. 1 shows an example in which the shaft 3 has a linear shape (straight line), the shaft 3 may be curved in part or in whole. For example, as shown in FIG. 12, the shaft 3 may have a curved portion 6 between the first balloon 21 and the second balloon 22 in the longitudinal direction x, and an opening 4 may be arranged in the curved portion 6. By providing the curved portion 6, the opening 4 arranged between the first balloon 21 and the second balloon 22 can be easily brought close to the lesion. As a result, the polymer material 50 discharged from the opening 4 can be easily retained in the lump 61. The curved portion 6 can be formed by forming a shape in the portion of the shaft 3 between the first balloon 21 and the second balloon 22.

[0066] It is preferable that the curved portion 6 protrudes outward in the radial direction y. It is more preferable that the curved portion 6 protrudes outward in the radial direction y beyond the central axis of the first balloon 21 and the central axis of the second balloon 22. This configuration makes it easier to deposit the polymer material 50 discharged from the opening 4 within the lump 61.

[0067] 12, it is preferable that the curved portion 6 has an arc-shaped curved shape. This makes it easier to protrude the curved portion 6 outward in the radial direction y, and makes it easier to deposit the polymeric material 50 discharged from the opening 4 within the lump 61. It is preferable that the opening 4 is disposed so as to overlap with the portion of the arc-shaped curved portion 6 that is located furthest outward in the radial direction y.

[0068] When the first balloon 21 and the second balloon 22 are fully expanded, the portion of the curved portion 6 that protrudes most outward in the radial direction y is preferably located inward in the radial direction y from the maximum diameter portion of the first balloon 21. Similarly, when the first balloon 21 and the second balloon 22 are fully expanded, the portion of the curved portion 6 that protrudes most outward in the radial direction y is preferably located inward in the radial direction y from the maximum diameter portion of the second balloon 22. By adjusting the sizes of the balloon and the curved portion 6 in the radial direction y in this manner, it is possible to easily bring the opening 4 close to the lesion while ensuring the insertability of the catheter 2 in the blood vessel lumen.

[0069] The catheter 2 having the shaft 3 with the curved portion 6 may be operated in the following manner. First, the catheter 2 is delivered into the body so that the maximum diameter portion of the first balloon 21 is located distal to the lesion. In order to put the first balloon 21 into an expanded state, a fluid is introduced into the expansion lumen 11 communicating with the inside of the first balloon 21. Then, the shaft 3 is moved distally to bring the opening 4 arranged in the curved portion 6 close to the lesion. At this time, the degree of curvature of the curved portion 6 may be adjusted by adjusting the amount of pushing of the shaft 3 toward the distal side. For example, when the amount of pushing of the shaft 3 toward the distal side is small, the curved portion 6 is curved gently, and when the amount of pushing of the shaft 3 toward the distal side is large, the curved portion 6 is curved more. Next, in order to put the second balloon 22 into an expanded state, a fluid is introduced into the expansion lumen 11 communicating with the inside of the second balloon 22. After the lesion is positioned between the first balloon 21 and the second balloon 22 and the lesion is confined, the polymer material 50 is discharged from the opening 4.

[0070] As can be seen from FIG. 12, when the curved portion 6 protrudes outward in the radial direction y, it is preferable to further include a first marker 45 that is arranged on at least one of the shaft 3, the first balloon 21, and the second balloon 22 and is used to identify the protruding direction of the curved portion 6 in the circumferential direction z of the shaft 3. By providing such a first marker 45, the protruding direction of the curved portion 6 is visualized, so that when the first balloon 21 is fixed to the vascular wall 60, it becomes easier to orient the part of the curved portion 6 that protrudes most outward in the radial direction y toward the lesion. In FIG. 12, the first marker 45 is arranged in the proximal portion of the first balloon 21. Although not shown, the first marker 45 may be arranged on the curved portion 6 of the shaft 3.

[0071] The catheter 2 may have one or more first markers 45. The shape of the first marker 45 is not particularly limited, and may be an L-shape, a T-shape, a ring shape, a ring with a slit in cross section that has a C-shape, a coil shape formed by winding a wire, etc. Examples of the first marker 45 include a radiopaque marker containing a radiopaque substance, a magnetic marker using magnetic particles, etc., an optical marker such as a fluorescent material, etc.

[0072] The catheter 2 may further include a light-guiding member 40. In Figs. 14 and 15, the catheter 2 further includes a light-guiding member 40 that is disposed in the shaft 3 and is movable in the longitudinal direction x relative to the shaft 3. The shaft 3 includes a light-transmitting portion 7 at a distal portion. The light-guiding member 40 includes a light-irradiating portion 41 at a distal portion, and when the light-guiding member 40 is moved to the most distal side relative to the shaft 3, the light-irradiating portion 41 is arranged to overlap with the light-transmitting portion 7. Here, the polymer material 50 is preferably a photoactivated polymer material. Since the photoactivated polymer material is solidified by exposure to light, the polymer material 50 discharged from the delivery lumen 12 into the lumen 61 is irradiated from the light-irradiating portion 41 and solidified by the light passing through the light-transmitting portion 7, and can remain in the lumen 61. This can prevent the polymer material 50 from moving from within the lumen 61 or leaking into the parent blood vessel lumen 62, making efficient occlusion easier. Furthermore, since leakage or scattering of the polymer material 50 can be more easily prevented, the effect of reducing the risk of unintended blocking of blood vessels is improved.

[0073] Examples of photoactivatable polymer materials include acrylic resins that generate radicals when irradiated with ultraviolet light and initiate a reaction, epoxy resins that generate cations when irradiated with ultraviolet light and initiate a reaction, and methacryloyl-based resins that are cured when irradiated with electron beams. In particular, it is preferable to dissolve photoreactive gelatin and macromonomers, which have benzophenone groups bonded to their side chains and which generate radicals when irradiated with ultraviolet light and initiate a reaction, in physiological saline and irradiate them with ultraviolet light.

[0074] The light-guiding member 40 includes an optical fiber, and the optical fiber may have a core and a cladding that covers the outside of the core in the radial direction y, and the part where the cladding is absent may be the light irradiation section 41. There are no particular limitations on the material that constitutes the core and the cladding, and plastic, quartz glass, fluoride glass, or other glass may be used. A connector 42 is provided at the proximal end of the light-guiding member 40, and the connector 42 is preferably connected to a light source such as a semiconductor laser.

[0075] Since the light guiding member 40 is movable in the longitudinal direction x with respect to the shaft 3, the light transmission portion 7 can be overlapped with the light irradiation portion 41 in the longitudinal direction x. Furthermore, since the light guiding member 40 is movable in the longitudinal direction x with respect to the shaft 3, the light irradiation portion 41 can be kept on standby on the proximal side until the polymer material 50 is placed in the lump 61, and after the polymer material 50 is placed in the target site, the light irradiation portion 41 can be moved to the distal side to be arranged so as to overlap with the light transmission portion 7 in the longitudinal direction x, and light can be irradiated from the light irradiation portion 41 toward the polymer material 50. As a result, the polymer material 50 does not solidify until the polymer material 50 is placed in the target site, making it easy to place the polymer material 50 in the lump 61.

[0076] The shaft 3 preferably has a light guiding lumen 13 into which a light guiding member 40 is inserted, in addition to the extension lumen 11 and the delivery lumen 12. Fig. 15 shows an example in which the light guiding lumen 13 is disposed inward in the radial direction y from the delivery lumen 12.

[0077] The distal end of the light-guiding lumen 13 may be located proximal to the distal end of the shaft 3. By adjusting the position of the distal end of the light-guiding lumen 13, it is possible to configure the light irradiation section 41 to overlap with the light transmission section 7 when the light-guiding member 40 is moved to the most distal side with respect to the shaft 3. The distal end of the light-guiding lumen 13 may be located distal to the distal end of the shaft 3, or may be at the same position as the distal end of the shaft 3.

[0078] It is preferable that the light-transmitting portion 7 of the shaft 3 is made of a light-transmitting material. The entire shaft 3 in the longitudinal direction x may be made of a light-transmitting material. Note that the portion of the shaft 3 other than the light-transmitting portion 7 may be made of a light-opaque material.

[0079] Examples of light-transmitting materials include synthetic resins such as (meth)acrylic resins (e.g., polymethyl methacrylate (PMMA)), polycarbonate resins (e.g., polydiethylene glycol bisallyl carbonate (PC)), polystyrene-based resins (e.g., methyl methacrylate-styrene copolymer resin (MS), acrylonitrile styrene resin (SAN)), polyamide resins (e.g., nylon), and polyolefin resins. These may be used alone or in combination of two or more.

[0080] The light transmitting portion 7 may contain a light diffusing material. This allows the light emitted from the light emitting portion 41 to be appropriately diffused as it passes through the light transmitting portion 7, so that the light can be irradiated evenly onto the polymer material 50. Examples of light diffusing materials include inorganic particles such as titanium oxide, barium sulfate, calcium carbonate, and zinc oxide, and organic particles such as cross-linked acrylic resin and cross-linked styrene resin.

[0081] The light transmitting portion 7 is preferably disposed on the side wall of the shaft 3, and more preferably on the side wall and the partition wall. The light transmitting portion 7 may be composed of one or more light transmitting windows.

[0082] In the longitudinal direction x, the light-transmitting portion 7 may be arranged throughout the entire space between the balloons from the proximal end of the first balloon 21 to the distal end of the second balloon 22, or may be arranged only partially between the balloons.

[0083] In the longitudinal direction x, the distal end of the light transmitting portion 7 may be disposed distal to the proximal end of the first balloon 21. In addition, the proximal end of the light transmitting portion 7 may be disposed proximal to the distal end of the second balloon 22.

[0084] The light transmitting portion 7 may be disposed over the entire circumferential direction z of the shaft 3, but is preferably disposed over only a portion of the circumferential direction z. Since the shaft 3 is preferably disposed inside the body so that the opening 4 faces the direction of the lump 61, even if the light transmitting portion 7 is provided over only a portion of the circumferential direction z, a necessary amount of light can be irradiated to the polymer material 50.

[0085] 14, in the longitudinal direction x, the light transmitting section 7 is preferably disposed between the first balloon 21 and the second balloon 22. By disposing the light irradiating section 41 in this manner, the light from the light irradiating section 41 can easily strike the polymer material 50 discharged from the opening 4, making it easier to solidify the polymer material 50.

[0086] 14, when the light-guiding member 40 is moved to the distalmost side relative to the shaft 3, the light irradiation unit 41 is preferably disposed so as to overlap with the opening 4 in the longitudinal direction x. By disposing the light irradiation unit 41 in this manner, the polymer material 50 discharged from the opening 4 is more easily hit by light from the light irradiation unit 41, and therefore the polymer material 50 is more easily solidified.

[0087] When the light-guiding member 40 is moved to the most distal side with respect to the shaft 3, the distal end of the light irradiation unit 41 is preferably located distal to the distal end of the opening 4 in the longitudinal direction x. Also, when the light-guiding member 40 is moved to the most distal side with respect to the shaft 3, the proximal end of the light irradiation unit 41 is preferably located proximal to the proximal end of the opening 4 in the longitudinal direction x. By providing the light irradiation unit 41 over a wide range, it becomes easier for the polymer material 50 to be exposed to light from the light irradiation unit 41.

[0088] It is more preferable that the length of the light irradiation section 41 in the longitudinal direction x is longer than the length of the opening 4. By providing the light irradiation section 41 longer than the opening 4, the polymer material 50 can be easily solidified even if the polymer material 50 discharged from the opening 4 spreads.

[0089] When the light-guiding member 40 is moved to the most distal side with respect to the shaft 3, the light irradiation unit 41 may be arranged to overlap at least one of the first balloon 21 and the second balloon 22 in the longitudinal direction x. In this case, it is preferable that the part of the balloon overlapping with the light irradiation unit 41 is made of a light-transmitting material. The light emitted from the light irradiation unit 41 may be transmitted through the light transmitting unit 7 and at least one of the first balloon 21 and the second balloon 22, thereby irradiating the polymer material 50 with light.

[0090] The distal end of the light transmitting portion 7 may be located distal to the proximal end of the first balloon 21. The proximal end of the light transmitting portion 7 may be located proximal to the distal end of the second balloon 22. By providing the light transmitting portion 7 over a wide range in this manner, more light from the light irradiating portion 41 passes through the light transmitting portion 7, making it easier for the light to hit the polymer material 50. In addition, in order to increase the directionality of the light that hits the polymer material 50, the distal end of the light transmitting portion 7 may be located proximal to the proximal end of the first balloon 21. Similarly, the proximal end of the light transmitting portion 7 may be located distal to the distal end of the second balloon 22.

[0091] 1, the catheter 2 is preferably disposed on the shaft 3 and further includes a marker (second marker 46) for identifying the orientation of the opening 4 in the circumferential direction z of the shaft 3. By providing such a second marker 46, the orientation of the opening 4 is visualized, making it easier to eject the polymer material 50 from the opening 4 toward the lump 61 and preventing leakage or scattering outside the lump 61. The configuration of the second marker 46 can be seen from the configuration of the first marker 45.

[0092] The second markers 46 may be arranged around the opening 4. The second markers 46 may also be arranged around the entire circumferential direction of the opening 4, that is, so as to completely surround the opening 4. By providing the second markers 46 in this manner, the orientation of the opening 4 can be easily visually confirmed. [Explanation of symbols]

[0093] 1: Catheter system 2: Catheter 3: Shaft 4:Aperture 6: Curved section 7: Light transmission part 11, 11A, 11B: Extended lumen 12: Delivery lumen 13: Light guide lumen 15A:Fluid communication port 15B:Fluid communication port 21: First balloon 22: Second balloon 31: Fluid introduction section 32: Polymer material introduction section 40: Light guide member 41: Light irradiation unit 42: Connector 45: First marker 46: Second marker 50: Polymer material 60: Blood vessel wall 61:Aneurysm 62: Parent vessel lumen x: Longitudinal direction y: radial direction z: Circumferential direction

Claims

1. a shaft having a longitudinal direction and at least one expansion lumen through which a fluid for expanding the balloon passes and a delivery lumen for delivering a polymeric material to a distal side, the shaft having an opening in a side wall of a distal portion of the shaft that communicates the delivery lumen with the outside of the shaft; a first balloon disposed distal to the opening in the distal portion of the shaft, the interior of the first balloon being in communication with one of the at least one expansion lumen; a second balloon disposed proximal to the opening in the distal portion of the shaft, the interior of the second balloon communicating with an expansion lumen different from the expansion lumen communicating with the interior of the first balloon among the at least one expansion lumen or the expansion lumen communicating with the interior of the first balloon; A catheter having

2. The catheter according to claim 1, wherein in a cross section perpendicular to the longitudinal direction, a central axis of the shaft is offset from a central axis of the first balloon, and a central axis of the shaft is offset from a central axis of the second balloon.

3. In a cross section perpendicular to the longitudinal direction, a central axis of the shaft is located radially outward from a central axis of the first balloon, The catheter according to claim 2 , wherein in a cross section perpendicular to the longitudinal direction, a central axis of the shaft is located radially outward from a central axis of the second balloon.

4. The catheter according to claim 1 , wherein the shaft has a curved portion between the first balloon and the second balloon in the longitudinal direction, and the opening is disposed in the curved portion.

5. The catheter according to claim 4, wherein the curved portion has an arcuate curved shape.

6. The curved portion protrudes radially outward, The catheter according to claim 4 or 5, further comprising a first marker arranged on at least one of the shaft, the first balloon, and the second balloon for identifying the protruding direction of the curved portion in the circumferential direction of the shaft.

7. a light guide member disposed within the shaft and movable longitudinally relative to the shaft; The shaft has a light transmitting portion at a distal portion, the light guiding member has a light irradiation portion at a distal portion, and the light irradiation portion is arranged to overlap the light transmission portion when the light guiding member is moved to the most distal side with respect to the shaft, The catheter according to claim 1 , 2 or 4 , wherein the polymeric material is a photoactivated polymeric material.

8. The catheter according to claim 7 , wherein the light transmitting portion is disposed between the first balloon and the second balloon in the longitudinal direction.

9. The catheter according to claim 7 , wherein when the light-guiding member is moved to the most distal side relative to the shaft, the light irradiation section is arranged to overlap with the opening in the longitudinal direction.

10. The catheter according to claim 1 , further comprising a second marker arranged on the shaft for identifying the orientation of the opening in the circumferential direction of the shaft.

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