Medical device and treatment method

Abstract

A medical device according to the present disclosure comprises a first shaft, a second shaft, a volume-reducing balloon, a first vaso-occlusive balloon, a second vaso-occlusive balloon, and a third vaso-occlusive balloon, wherein: the first shaft defines a first communication lumen and at least one first communication port; the second shaft defines a second communication lumen and at least one second communication port; and the maximum expanded outer diameter of the volume-reducing balloon is greater than the maximum expanded outer diameter of any of the first vaso-occlusive balloon, the second vaso-occlusive balloon, and the third vaso-occlusive balloon.

Description

Medical Device and Treatment Method

[0001] The present disclosure relates to a medical device and a treatment method.

[0002] Conventionally, medical devices used to apply a chemical solution to the blood vessel wall of an aortic aneurysm have been known. Patent Document 1 describes this type of medical device.

[0003] The medical device described in Patent Document 1 includes a sealing catheter including a first sealing element and an introducer sheath including a second sealing element.

[0004] U.S. Patent No. 9,889,279

[0005] However, the medical device described in Patent Document 1 still has room for improvement in terms of efficiency when applying a chemical solution to the blood vessel wall of an aortic aneurysm, specifically, from the viewpoints of the amount of chemical solution used and the procedure time.

[0006] An object of the present disclosure is to provide a medical device and a treatment method capable of improving the efficiency when applying a chemical solution to the blood vessel wall of an aortic aneurysm.

[0007] A medical device as a first aspect of the present disclosure comprises: (1) an elongated first shaft; an elongated second shaft; a volume-reducing balloon that can be placed in the internal space of an aortic aneurysm formed in the aorta; a first vascular occlusion balloon capable of occluding a first vessel connected to one side of the aortic aneurysm in the direction of extension of the aorta; a second vascular occlusion balloon capable of occluding a second vessel, which is one of two vessels connected to the other side of the aortic aneurysm in the direction of extension and branching from each other; and a third vascular occlusion balloon capable of occluding a third vessel, which is the other of the two vessels, wherein the first shaft comprises a first communication lumen and at least one first communication port capable of connecting the internal space of the aortic aneurysm to the first communication lumen; and the second shaft comprises a second communication lumen and at least one second communication port capable of connecting the internal space of the aortic aneurysm to the second communication lumen. The maximum expanded outer diameter of the volume-reducing balloon is greater than the maximum expanded outer diameter of any of the first vascular occlusion balloon, the second vascular occlusion balloon, and the third vascular occlusion balloon, and the at least one first communication port and the at least one second communication port are configured to be positioned in the internal space of the aortic aneurysm when the volume-reducing balloon is positioned in the internal space of the aortic aneurysm, the first vascular occlusion balloon occludes the first vessel, the second vascular occlusion balloon occludes the second vessel, and the third vascular occlusion balloon occludes the third vessel, (A) the volume-reducing balloon and the first vascular occlusion balloon are provided on the first shaft, and the second vascular occlusion balloon and the third vascular occlusion balloon are provided on the second shaft, (B) the volume-reducing balloon, the first vascular occlusion balloon, and the second vascular occlusion balloon are provided on the first shaft, and the third vascular occlusion balloon is provided on the second shaft, (C) The volume-reducing balloon and the second vascular occlusion balloon are provided on the first shaft, and the first vascular occlusion balloon and the third vascular occlusion balloon are provided on the second shaft, or(D) A medical device wherein the volume-reducing balloon, the second vascular occlusion balloon, and the third vascular occlusion balloon are provided on the first shaft, and the first vascular occlusion balloon is provided on the second shaft.

[0008] One embodiment of the present disclosure is a medical device as described in (1) above, wherein the volume-reducing balloon is positioned in the internal space of the aortic aneurysm, the first vascular occlusion balloon occludes the first blood vessel, the second vascular occlusion balloon occludes the second blood vessel, and the third vascular occlusion balloon occludes the third blood vessel, and one of the at least one first communication port and the at least one second communication port is positioned on one side in the extending direction relative to the volume-reducing balloon, and the other of the at least one first communication port and the at least one second communication port is positioned on the other side in the extending direction relative to the volume-reducing balloon.

[0009] A medical device as one embodiment of the present disclosure is the medical device according to (1) or (2) above, wherein the total area of ​​the at least one first communication port is equal to or greater than the cross-sectional area of ​​the first communication lumen.

[0010] A medical device as one embodiment of the present disclosure is the medical device according to any one of (1) to (3) above, wherein the total area of ​​the at least one second communication port is greater than or equal to the cross-sectional area of ​​the second communication lumen.

[0011] One embodiment of the present disclosure is a medical device according to any one of (1) to (4) above, wherein (5) when the volume-reducing balloon is in an expanded state, at least one recess is provided on the surface of the volume-reducing balloon.

[0012] One embodiment of the present disclosure is a medical device as described in (6) (B) the medical device described in any one of (1) to (5) above, wherein the volume-reducing balloon, the first vascular occlusion balloon and the second vascular occlusion balloon are provided on the first shaft and the third vascular occlusion balloon is provided on the second shaft.

[0013] A medical device as one embodiment of the present disclosure is the medical device as described in (6) above, wherein the at least one first communication port is located on the first shaft between the volume-reducing balloon and the first vascular occlusion balloon or between the volume-reducing balloon and the second vascular occlusion balloon, and the at least one second communication port is located on the second shaft where the third vascular occlusion balloon is not present.

[0014] One embodiment of the present disclosure is a medical device according to any one of (1) to (5) above, wherein (8) (C) the volume-reducing balloon and the second vascular occlusion balloon are provided on the first shaft, and the first vascular occlusion balloon and the third vascular occlusion balloon are provided on the second shaft.

[0015] A medical device as one embodiment of the present disclosure is the medical device described in (8) above, wherein the at least one first communication port is located in the first shaft where the volume reduction balloon and the second vascular occlusion balloon are not present, and the at least one second communication port is located in the second shaft between the first vascular occlusion balloon and the third vascular occlusion balloon.

[0016] A second aspect of the present disclosure is a treatment method for an aortic aneurysm formed in the aorta, comprising: (10) a volume-reducing balloon and at least two vascular occlusion balloons, and defining two communicating lumens, wherein the volume-reducing balloon is placed in the internal space of the aortic aneurysm, at least one of the at least two vascular occlusion balloons is placed in at least one blood vessel connected to one side of the aortic aneurysm in the direction of extension of the aorta, and the remaining at least one of the at least two vascular occlusion balloons is placed in at least one blood vessel connected to the other side of the aortic aneurysm in the direction of extension, the volume-reducing balloon placed in the internal space of the aortic aneurysm is expanded to a size that does not occlude the aortic aneurysm, the at least two vascular occlusion balloons are expanded to occlude the at least one blood vessel connected to one side of the aortic aneurysm in the direction of extension and the at least one blood vessel connected to the other side of the aortic aneurysm in the direction of extension, The treatment method is characterized by removing blood from the internal space through one of the two communicating lumens that communicate with the internal space, injecting a drug solution into the internal space through the other of the two communicating lumens to allow the drug solution to act on the blood vessel wall of the aortic aneurysm, removing the drug solution from the internal space through one of the two communicating lumens while injecting a biocompatible liquid into the internal space through the other of the two communicating lumens, and deflating the at least two vascular occlusion balloons and the volume reduction balloon.

[0017] One embodiment of the present disclosure is the treatment method described in (10) above, wherein when the drug solution acts on the blood vessel wall, a pumping operation is performed in which the volume-reducing balloon is repeatedly expanded and contracted while the drug solution is contained in the internal space.

[0018] One embodiment of the present disclosure is the treatment method described in (11) above, wherein the outer diameter of the volume-reducing balloon in the pumping operation is limited to the outer diameter of the volume-reducing balloon immediately before the drug solution is injected into the internal space.

[0019] One embodiment of the present disclosure is a treatment method according to any one of (10) to (12) above, wherein when injecting the drug solution into the internal space, the injection of the drug solution into the internal space and the aspiration of the liquid from the internal space are performed in parallel.

[0020] This disclosure provides a medical device and treatment method that can improve the efficiency of applying a drug solution to the blood vessel wall of an aortic aneurysm.

[0021] This figure shows a medical device according to one embodiment of the present disclosure. This is a cross-sectional view taken along line I-I in Figure 1. This figure shows a modified example of the cross-sectional shape of the first shaft shown in Figure 2A. This is a cross-sectional view taken along line II-II in Figure 1. This figure shows a modified example of the cross-sectional shape of the second shaft shown in Figure 3A. This figure shows a state in which the volume-reducing balloon, the first vascular occlusion balloon, the second vascular occlusion balloon, and the third vascular occlusion balloon have been expanded to their maximum outer diameter from the state shown in Figure 1. This is a cross-sectional view taken along line III-III in Figure 4. This is a flowchart showing an example of a treatment method performed using the medical device shown in Figure 1. This figure shows an overview of step S1 shown in Figure 6. This figure shows an overview of step S2 shown in Figure 6. This figure shows an overview of step S3 shown in Figure 6. This figure shows an overview of step S4 shown in Figure 6. This figure shows an overview of step S5 shown in Figure 6. This figure shows an overview of step S6 shown in Figure 6. This figure shows an overview of step S7 shown in Figure 6. This figure shows an overview of step S8 shown in Figure 6. This figure shows a modified example of the medical device shown in Figure 1. This figure shows a modified example of the medical device shown in Figure 1. This figure shows a modified example of the medical device shown in Figure 1. This figure shows an example of the medical device shown in Figure 11 being placed inside a blood vessel in a different arrangement than in Figure 11. This figure shows a modified example of the medical device shown in Figure 1. This figure shows another example of a medical device used in the treatment method shown in Figure 6.

[0022] The embodiments of the medical device and treatment method relating to this disclosure will be described below with reference to the drawings. In each drawing, identical components are denoted by the same reference numerals.

[0023] Figure 1 shows a medical device 1 as one embodiment of the medical device according to the present disclosure. Figure 2A is a cross-sectional view taken along line I-I of Figure 1. Figure 3A is a cross-sectional view taken along line II-II of Figure 1. The medical device 1 is used in treatment to apply a drug solution to the vascular wall of an aortic aneurysm X formed in the aorta. In this embodiment, an example in which the medical device 1 is used in treatment to apply a drug solution to the vascular wall of an abdominal aortic aneurysm X is illustrated and explained (see Figures 7A to 7H), but the medical device 1 may also be used in treatment to apply a drug solution to the vascular wall of other aortic aneurysms X, such as a thoracic aortic aneurysm.

[0024] For the sake of explanation, the direction of extension of the aorta in which the aortic aneurysm X treated using medical device 1 is formed will be simply referred to as "extension direction L". Also, in this embodiment, for the sake of explanation, the proximal side of the extension direction L of the aorta will be described as one side of the extension direction L, and the distal side of the extension direction L of the aorta will be described as the other side of the extension direction L (see Figures 7A to 7H).

[0025] As shown in Figure 1, the medical device 1 comprises a long first shaft 11, a long second shaft 21, a volume-reducing balloon 50, a first vascular occlusion balloon 51, a second vascular occlusion balloon 52, and a third vascular occlusion balloon 53. In the medical device 1 of this embodiment, the volume-reducing balloon 50 and the first vascular occlusion balloon 51 are provided on the first shaft 11, and the second vascular occlusion balloon 52 and the third vascular occlusion balloon 53 are provided on the second shaft 21.

[0026] As will be described in detail later, as shown in Figures 7A to 7H, the volume-reducing balloon 50 can be placed in the internal space of the aortic aneurysm X formed in the aorta. The first vascular occlusion balloon 51 can occlude the first vessel Y1 which is connected to one side of the aortic aneurysm X in the direction of extension L. The second vascular occlusion balloon 52 can occlude the second vessel Y2 which is one of two vessels that are connected to the other side of the aortic aneurysm X in the direction of extension L and branch off from each other. The third vascular occlusion balloon 53 can occlude the third vessel Y3 which is the other of the two vessels that branch off from each other. The first shaft 11 comprises a first communication lumen 11d (see Figure 2A) and at least one first communication port 13 (see Figure 1) which can connect the internal space of the aortic aneurysm X to the first communication lumen 11d. The second shaft 21 comprises a second communication lumen 21c (see Figure 3A) and at least one second communication port 23 (see Figure 1) that can connect the internal space of the aortic aneurysm X to the second communication lumen 21c. The at least one first communication port 13 and the at least one second communication port 23 are configured to be positioned in the internal space of the aortic aneurysm X with the volume-reducing balloon 50 positioned therein, the first vascular occlusion balloon 51 occluding the first vessel Y1, the second vascular occlusion balloon 52 occluding the second vessel Y2, and the third vascular occlusion balloon 53 occluding the third vessel Y3. The blood vessels connected to the aortic aneurysm X are not limited to blood vessels directly connected to the aortic aneurysm X, but also include blood vessels indirectly connected to the aortic aneurysm X via other blood vessels. In other words, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 are not limited to configurations that occlude a blood vessel at a location adjacent to the aortic aneurysm X.

[0027] With the medical device 1 configured as described above, a closed space S (see Figure 7C, etc.) including the internal space of the aortic aneurysm X can be formed by occluding the first vessel Y1, the second vessel Y2, and the third vessel Y3 with the first vessel occlusion balloon 51, the second vessel occlusion balloon 52, and the third vessel occlusion balloon 53. Here, the closed space S refers to a state in which one side and the other side in the direction of extension L of the aortic aneurysm X, that is, the proximal and distal sides of the aortic aneurysm X, are occluded, and also includes a state in which the collateral vessels extending from the aortic aneurysm X are not occluded. This is because by occluding the proximal and distal sides of the aortic aneurysm X, most of the blood flow in the aortic aneurysm X is blocked. By injecting the drug solution into the internal space of the aortic aneurysm X while the closed space S is formed, it is possible to suppress the drug solution from spreading to the normal parts of the patient's blood vessels. Furthermore, with the medical device 1 configured as described above, it is possible to inject liquid (e.g., drug solution) into the internal space of the aortic aneurysm X through at least one first communication port 13 and at least one second communication port 23, while simultaneously aspirating liquid (e.g., blood) from the internal space of the aortic aneurysm X through the other of the at least one first communication port 13 and at least one second communication port 23 (see Figures 7D and 7G). By performing liquid injection and aspiration in parallel in this way, it is possible to replace the liquid in the internal space of the aortic aneurysm X while suppressing an excessive increase in pressure in the internal space of the aortic aneurysm X and preventing excessive stress on the aortic aneurysm X. Before injecting the drug solution, it is also possible to inject another liquid, such as physiological saline, while aspirating blood, and then inject the drug solution while aspirating the previously injected liquid. Furthermore, with the medical device 1 configured as described above, by expanding the volume-reducing balloon 50 in the internal space of the aortic aneurysm X, the amount of fluid required to fill the internal space of the aortic aneurysm X (hereinafter sometimes simply referred to as "the volume of the internal space of the aortic aneurysm X") can be reduced by the volume of the expanded volume-reducing balloon 50. As a result, compared to the case without the volume-reducing balloon 50, the internal space of the aortic aneurysm X can be filled with the drug solution, and the drug solution can be applied to the blood vessel wall of the aortic aneurysm X. In other words, the efficiency of applying the drug solution to the blood vessel wall of the aortic aneurysm X can be improved.

[0028] Next, we will describe further details of medical device 1.

[0029] As shown in Figure 1, the medical device 1 of this embodiment comprises two balloon catheters: a first balloon catheter 10 and a second balloon catheter 20.

[0030] <First balloon catheter 10> As shown in Figure 1, the first balloon catheter 10 comprises a first shaft 11, a volume-reducing balloon 50, a first vascular occlusion balloon 51, and a first hub 19. The volume-reducing balloon 50, the first vascular occlusion balloon 51, and the first hub 19 are provided on the first shaft 11.

[0031] For the sake of explanation, the longitudinal direction of the first shaft 11 will be referred to as "longitudinal direction A1". Furthermore, within longitudinal direction A1, the direction from the tip side of the first shaft 11 that is inserted into the body to the proximal end side that is manipulated outside the body by a physician or other operator will be referred to as "proximal side of longitudinal direction A1", and the opposite direction will be referred to as "distal side of longitudinal direction A1". In addition, the direction around the axis with the first shaft 11 as the central axis will be referred to as "circumferential direction B1". Furthermore, the radial direction of a virtual circle with the first shaft 11 as the central axis in a cross section perpendicular to longitudinal direction A1 will be referred to as "radial direction C1".

[0032] The volume-reducing balloon 50 covers the outside of the first shaft 11 in the radial direction C1. The volume-reducing balloon 50 defines a containment space capable of accommodating the expansion fluid. The volume-reducing balloon 50 expands outward in the radial direction C1 when the expansion fluid is supplied to its containment space. Conversely, the volume-reducing balloon 50 contracts inward in the radial direction C1 when the expansion fluid contained in its containment space is sucked out.

[0033] The first vascular occlusion balloon 51 covers the outside of the first shaft 11 in the radial direction C1. The first vascular occlusion balloon 51 defines a containment space capable of accommodating expansion fluid. The first vascular occlusion balloon 51 expands outward in the radial direction C1 when expansion fluid is supplied to its containment space. Conversely, the first vascular occlusion balloon 51 contracts inward in the radial direction C1 when the expansion fluid contained in its containment space is sucked out.

[0034] The expanding fluid can be a gas or a liquid. Examples of expanding fluids include gases such as helium gas, CO2 gas, and O2 gas, and liquids such as physiological saline and contrast agents.

[0035] As shown in Figure 2A, the first shaft 11 defines four lumens internally: a guidewire lumen 11a, a volume-reducing balloon lumen 11b, a vascular occlusion balloon lumen 11c, and a first communication lumen 11d. A guidewire can be inserted through the guidewire lumen 11a. The volume-reducing balloon lumen 11b communicates with the space containing the volume-reducing balloon 50. The vascular occlusion balloon lumen 11c communicates with the space containing the first vascular occlusion balloon 51. The first communication lumen 11d communicates with the outside of the first balloon catheter 10 through at least one (two in this embodiment) first communication port 13 defined in the first shaft 11.

[0036] As shown in Figure 2A, the first shaft 11 comprises a first circumferential wall 15a1, a second circumferential wall 15a2, and a third circumferential wall 15a3, which are arranged concentrically from the inside to the outside in the radial direction C1 in a cross-sectional view perpendicular to the longitudinal direction A1. The first shaft 11 also comprises two connecting walls 16a that connect the first circumferential wall 15a1 and the second circumferential wall 15a2 in the radial direction C1 at different positions in the circumferential direction B1 in a cross-sectional view perpendicular to the longitudinal direction A1. The guidewire lumen 11a is defined inside the first circumferential wall 15a1. The volume-reducing balloon lumen 11b and the vascular occlusion balloon lumen 11c are defined by the first circumferential wall 15a1, the second circumferential wall 15a2, and the two connecting walls 16a, outside the radial direction C1 of the guidewire lumen 11a, aligned in the circumferential direction B1. The first connected lumen 11d is defined between the second peripheral wall 15a2 and the third peripheral wall 15a3.

[0037] The cross-sectional shape of the first shaft 11 is not limited to the cross-sectional shape shown in Figure 2A. Figure 2B shows one modified example of the cross-sectional shape of the first shaft 11. As shown in Figure 2B, the first shaft 11 has a first circumferential wall 15b1 and a second circumferential wall 15b2 arranged concentrically from the inside to the outside in the radial direction C1 in a cross-sectional view perpendicular to the longitudinal direction A1. The first shaft 11 also has three connecting walls 16b that connect the first circumferential wall 15b1 and the second circumferential wall 15b2 in the radial direction C1 at different positions in the circumferential direction B1 in a cross-sectional view perpendicular to the longitudinal direction A1. The guide wire lumen 11a is defined inside the first circumferential wall 15b1. The volume-reducing balloon lumen 11b, the vascular occlusion balloon lumen 11c, and the first communication lumen 11d are defined by a first circumferential wall 15b1, a second circumferential wall 15b2, and three connecting walls 16b, so as to be aligned in the circumferential direction B1 outside the radial direction C1 of the guidewire lumen 11a.

[0038] Preferably, the total area of ​​at least one first communication port 13 is greater than or equal to the cross-sectional area of ​​the first communication lumen 11d. This prevents the fluid from becoming difficult to flow at the location of the first communication port 13 when injecting fluid into the internal space of the aortic aneurysm X or aspirating fluid from the internal space of the aortic aneurysm X through the first communication port 13 and the first communication lumen 11d. "Total area of ​​at least one first communication port 13" means the sum of the minimum cross-sectional areas of each of the at least one first communication port 13 in a direction perpendicular to the direction of fluid flow passing through the first communication port 13. Also, "cross-sectional area of ​​the first communication lumen 11d" means the minimum cross-sectional area of ​​the first communication lumen 11d in a direction perpendicular to the direction of fluid flow passing through the first communication lumen 11d.

[0039] As shown in Figure 1, the first hub 19 is connected to the proximal end of the first shaft 11. The first hub 19 divides into a connection port 19a connected to the volume-reducing balloon lumen 11b, a connection port 19b connected to the vascular occlusion balloon lumen 11c, and a connection port 19c connected to the first communication lumen 11d. The connection port connected to the guidewire lumen 11a may be divided in the third circumferential wall 15a3 of the first shaft 11, or it may be divided in the first hub 19. In other words, the first balloon catheter 10 may be a rapid exchange type or an over-the-wire type.

[0040] <Second balloon catheter 20> As shown in Figure 1, the second balloon catheter 20 comprises a second shaft 21, a second vascular occlusion balloon 52, a third vascular occlusion balloon 53, and a second hub 29. The second vascular occlusion balloon 52, the third vascular occlusion balloon 53, and the second hub 29 are provided on the second shaft 21.

[0041] For the sake of explanation, the longitudinal direction of the second shaft 21 will be referred to as "longitudinal direction A2". Furthermore, within longitudinal direction A2, the direction from the tip side of the second shaft 21, which is inserted into the body, to the proximal end side, which is manipulated outside the body by a physician or other operator, will be referred to as "proximal side of longitudinal direction A2", and the opposite direction will be referred to as "distal side of longitudinal direction A2". In addition, the direction around the axis with the second shaft 21 as the central axis will be referred to as "circumferential direction B2". Furthermore, the radial direction of a virtual circle with the second shaft 21 as the central axis in a cross section perpendicular to longitudinal direction A2 will be referred to as "radial direction C2".

[0042] The second vascular occlusion balloon 52 covers the outside of the second shaft 21 in the radial direction C2. The second vascular occlusion balloon 52 defines a containment space capable of accommodating expansion fluid. The second vascular occlusion balloon 52 expands outward in the radial direction C2 when expansion fluid is supplied to its containment space. Conversely, the second vascular occlusion balloon 52 deflates inward in the radial direction C1 when the expansion fluid contained in its containment space is sucked out.

[0043] The third blood vessel occlusion balloon 53 covers the outside in the radial direction C2 of the second shaft 21. The third blood vessel occlusion balloon 53 defines an accommodation space capable of accommodating an expansion fluid. The third blood vessel occlusion balloon 53 expands to the outside in the radial direction C2 when the expansion fluid is supplied to its accommodation space. Further, the third blood vessel occlusion balloon 53 contracts to the inside in the radial direction C1 when the expansion fluid accommodated in its accommodation space is sucked.

[0044] As shown in FIG. 3A, the second shaft 21 defines three lumens inside, namely a guide wire lumen 21a, a blood vessel occlusion balloon lumen 21b, and a second communication lumen 21c. A guide wire can be inserted into the guide wire lumen 21a. The blood vessel occlusion balloon lumen 21b communicates with the accommodation spaces of both the second blood vessel occlusion balloon 52 and the third blood vessel occlusion balloon 53. The second communication lumen 21c communicates with the outside of the second balloon catheter 20 through at least one (two in this embodiment) second communication port 23 defined in the second shaft 21.

[0045] As shown in FIG. 3A, in a cross-sectional view orthogonal to the longitudinal direction A2, the second shaft 21 includes a first peripheral wall 25a1, a second peripheral wall 25a2, and a third peripheral wall 25a3 that are arranged concentrically from the inside to the outside in the radial direction C2. The guide wire lumen 21a is defined inside the first peripheral wall 25a1. The blood vessel occlusion balloon lumen 21b is defined between the first peripheral wall 25a1 and the second peripheral wall 25a2. The second communication lumen 21c is defined between the second peripheral wall 25a2 and the third peripheral wall 25a3.

[0046] The cross-sectional shape of the second shaft 21 is not limited to the cross-sectional shape shown in FIG. 3A. FIG. 3B is a diagram showing a modified example of the cross-sectional shape of the second shaft 21. As shown in FIG. 3B, the second shaft 21 includes a first peripheral wall 25b1 and a second peripheral wall 25b2 that are concentrically arranged from the inside to the outside in the radial direction C2 in a cross-sectional view perpendicular to the longitudinal direction A2. Further, the second shaft 21 includes two connecting walls 26 that connect the first peripheral wall 25b1 and the second peripheral wall 25b2 in the radial direction C2 at different positions in the circumferential direction B2 in a cross-sectional view perpendicular to the longitudinal direction A2. The guide wire lumen 21a is defined inside the first peripheral wall 25b1. The vascular occlusion balloon lumen 21b and the second communication lumen 21c are defined outside the guide wire lumen 21a in the radial direction C2 and arranged side by side in the circumferential direction B2 by the first peripheral wall 25b1, the second peripheral wall 25b2, and the two connecting walls 26.

[0047] The second shaft 21 of the present embodiment defines one vascular occlusion balloon lumen 21b that communicates with the accommodation spaces of both the second vascular occlusion balloon 52 and the third vascular occlusion balloon 53. However, the second shaft 21 may be configured to define a vascular occlusion balloon lumen that communicates with the accommodation space of the third vascular occlusion balloon 53 separately from the vascular occlusion balloon lumen that communicates with the accommodation space of the second vascular occlusion balloon 52.

[0048] Preferably, the total area of at least one second communication port 23 is not less than the cross-sectional area of the second communication lumen 21c. By doing so, when injecting or sucking liquid into the internal space of the aortic aneurysm X through the second communication port 23 and the second communication lumen 21c, it is possible to suppress the liquid from flowing less easily at the position of the second communication port 13. The "total area of at least one second communication port 23" means the sum of the minimum values of the cross-sectional areas of the at least one second communication port 23 in the direction perpendicular to the flow direction of the liquid passing through the second communication port 23. Further, the "cross-sectional area of the second communication lumen 21c" means the minimum value of the cross-sectional area of the second communication lumen 21c in the direction perpendicular to the flow direction of the liquid passing through the second communication lumen 21c.

[0049] As shown in Figure 1, the second hub 29 is connected to the proximal end of the second shaft 21. The second hub 29 divides a connection port 29a connected to the vascular occlusion balloon lumen and a connection port 29b connected to the second communication lumen 21c. The connection port connected to the guidewire lumen 21a may be partitioned in the third circumferential wall 25a3 of the second shaft 21 or in the second hub 29. In other words, the second balloon catheter 20 may be a rapid exchange type or an over-the-wire type.

[0050] Figure 4 shows the volume-reducing balloon 50, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 shown in Figure 1, expanded to their maximum expanded outer diameter. As shown in Figure 4, the maximum expanded outer diameter of the volume-reducing balloon 50 is larger than the maximum expanded outer diameter of any of the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53. In this way, the volume of the internal space of the aortic aneurysm X, which has a larger inner diameter than a normal blood vessel, can be efficiently reduced. "Maximum expanded outer diameter" refers to the predetermined maximum outer diameter of each balloon in the case of non-compliance balloons, where the maximum expanded outer diameter of the volume-reducing balloon 50, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 is predetermined. Furthermore, if the volume-reducing balloon 50, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 are semi-compliance balloons or compliance balloons with variable maximum outer diameters, then this refers to the maximum outer diameter of each balloon when these four balloons are expanded at the same predetermined pressure.

[0051] Figure 5 is a cross-sectional view taken along line III-III of Figure 4. For the sake of clarity, only the volume-reducing balloon 50 is shown in Figure 5. As shown in Figure 5, when the volume-reducing balloon 50 is expanded, at least one recess 50a is provided on the surface of the volume-reducing balloon 50, which is recessed radially in the direction C1. Specifically, in this embodiment, when the volume-reducing balloon 50 is expanded, a number of recesses 50a are provided on the surface of the volume-reducing balloon 50. By doing so, when the fluid replacement of the internal space of the aortic aneurysm X is performed while the volume-reducing balloon 50 is expanded in the internal space of the aortic aneurysm X (specifically S4 and S7 described later), backflow of fluid due to boundary layer separation at the surface of the volume-reducing balloon 50 can be suppressed. As a result, the fluid replacement of the internal space of the aortic aneurysm X can be performed efficiently.

[0052] Preferably, the recesses 50a are arranged continuously in the circumferential direction B1 or intermittently at predetermined intervals in the circumferential direction B1 over the entire circumferential direction B1 of the surface of the volume-reducing balloon 50. Specifically, in the example shown in Figure 5, the recesses 50a are arranged continuously in the circumferential direction B1 over the entire circumferential direction B1 of the surface of the volume-reducing balloon 50. By doing so, the suppression of backflow can be achieved over the entire circumferential direction B1 of the surface of the volume-reducing balloon 50. This makes it possible to replace the fluid in the internal space of the aortic aneurysm X more efficiently. In this embodiment, the recesses 50a are dimple-shaped, but the shape of the recesses 50a may be changed as appropriate.

[0053] <Treatment Method> Next, an overview of the treatment method according to this disclosure will be described. The treatment method according to this disclosure is a method for treating an aortic aneurysm X formed in the aorta, which is performed using a medical device that comprises a volume-reducing balloon and at least two vascular occlusion balloons and defines two communicating lumens. Below, an overview of a treatment method performed using the medical device 1 of this embodiment will be described as an example of the treatment method according to this disclosure. Figure 6 is a flowchart of an example of a treatment method performed using the medical device 1 of this embodiment. The treatment method shown in Figure 6 includes steps S1 to S8. Figures 7A to 7H are diagrams showing an overview of steps S1 to S8.

[0054] In step S1, the volume-reducing balloon is placed in the internal space of the aortic aneurysm X, and at least one of the at least two vascular occlusion balloons is placed in at least one blood vessel connected to one side in the extending direction L of the aortic aneurysm X, and the remaining at least one of the at least two vascular occlusion balloons is placed in at least one blood vessel connected to the other side in the extending direction L of the aortic aneurysm X. Specifically, as shown in Figure 7A, in step S1, two balloon catheters, the first balloon catheter 10 and the second balloon catheter 20, are inserted into the blood vessel. As a result, the volume-reducing balloon 50 is placed in the internal space of the aortic aneurysm X, the first vascular occlusion balloon 51 is placed in the first vessel Y1 which is connected to one side of the aortic aneurysm X in the extending direction L, the second vascular occlusion balloon 52 is placed in the second vessel Y2 which is one of two vessels that branch off from each other and is connected to the other side of the aortic aneurysm X in the extending direction L, and the third vascular occlusion balloon 53 is placed in the third vessel Y3 which is the other of the two vessels that branch off from each other. In step S1, the first balloon catheter 10 is inserted such that the distal end in the longitudinal direction A is on one side of the extending direction L (the side on which the first vessel Y1 is located relative to the aortic aneurysm X). Also, when the first balloon catheter 10 and the second balloon catheter 20 are inserted into the aorta, the volume-reducing balloon 50, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon are in a deflated state.

[0055] As shown in Figure 1, in the first shaft 11, the first vascular occlusion balloon 51 is positioned distal to the volume-reducing balloon 50 in the longitudinal direction A1. In the second shaft 21, the third vascular occlusion balloon 53 is positioned distal to the second vascular occlusion balloon 52 in the longitudinal direction A2. However, as long as it is possible to achieve a positional relationship in which the volume-reducing balloon 50 is positioned within the aortic aneurysm X, the first vascular occlusion balloon 51 is positioned within the first vessel Y1, the second vascular occlusion balloon 52 is positioned within the second vessel Y2, and the third vascular occlusion balloon 53 is positioned within the third vessel Y3, the positional relationship in which each balloon is positioned within the first shaft 11 and the second shaft 21 is not limited to the configuration of this embodiment, as will be described later (see Figure 13).

[0056] As shown in Figure 7B, in step S2, the volume-reducing balloon (volume-reducing balloon 50 in the example shown in Figure 7B) placed in the internal space of the aortic aneurysm X is expanded to a size that does not occlude the aortic aneurysm X.

[0057] As shown in Figure 7C, in step S3, at least two vascular occlusion balloons are inflated to occlude at least one blood vessel connected to one side of the aortic aneurysm X in the direction of extension L, and at least one blood vessel connected to the other side of the aortic aneurysm X in the direction of extension L. Specifically, as shown in Figure 7C, in step S3, with the volume-reducing balloon 50 inflated in the internal space of the aortic aneurysm X, the first vascular occlusion balloon 51 placed in the first blood vessel Y1, the second vascular occlusion balloon 52 placed in the second blood vessel Y2, and the third vascular occlusion balloon 53 placed in the third blood vessel Y3 are inflated. As a result, in the example shown in Figure 7C, the first blood vessel Y1, the second blood vessel Y2, and the third blood vessel Y3 are occluded, forming a closed space S including the internal space of the aortic aneurysm X. As mentioned above, the closed space S refers to a state in which the central and peripheral sides of the aortic aneurysm X are occluded, and also includes a state in which the side branch blood vessels extending from the aortic aneurysm are not occluded.

[0058] As shown in Figure 7C, in this embodiment, when step S3 is performed, the first shaft 11 of the first balloon catheter 10 is positioned within the second blood vessel Y2, the internal space of the aortic aneurysm X, and the first blood vessel Y1, but not within the third blood vessel Y3. Also, when step S3 is performed as described above, the second shaft 21 of the second balloon catheter 20 is positioned within the second blood vessel Y2, the internal space of the aortic aneurysm X, and the third blood vessel Y3, but not within the first blood vessel Y1.

[0059] As shown in Figure 7C, when step S3 is completed, at least one first communication port 13 and at least one second communication port 23 are positioned in the internal space of the aortic aneurysm X. In other words, at least one first communication port 13 and at least one second communication port 23 are positioned in the internal space of the aortic aneurysm X with the volume-reducing balloon 50 positioned in the internal space of the aortic aneurysm X, the first vascular occlusion balloon 51 occluding the first vessel Y1, the second vascular occlusion balloon 52 occluding the second vessel Y2, and the third vascular occlusion balloon 53 occluding the third vessel Y3. Therefore, when step S3 is completed, the first communication lumen 11d defined by the first shaft 11 is in communication with the internal space of the aortic aneurysm X through at least one first communication port 13. Furthermore, the second communication lumen 21c defined by the second shaft 21 is in communication with the internal space of the aortic aneurysm X through at least one second communication opening 23 when step S3 is completed.

[0060] As shown in Figure 7D, in step S4, blood is removed from the internal space of the aortic aneurysm X through one of the two communicating lumens that communicate with the internal space of the aortic aneurysm X, while the drug solution is injected into the internal space of the aortic aneurysm X through the other of the two communicating lumens to allow the drug solution to act on the blood vessel wall of the aortic aneurysm X. Specifically, as shown in Figure 7D, in step S4, with the volume-reducing balloon 50 expanded in the internal space of the aortic aneurysm X, blood is aspirated and removed from the internal space of the aortic aneurysm X through at least one second communicating port 23 and second communicating lumen 21c defined by the second shaft 21 of the second balloon catheter 20, while the drug solution is injected into the internal space of the aortic aneurysm X through at least one first communicating port 13 and first communicating lumen 11d defined by the first shaft 11 of the first balloon catheter 10. This replaces the blood in the internal space of the aortic aneurysm X with the drug solution, allowing the drug solution to act on the blood vessel wall of the aortic aneurysm X. In this case, the presence of an expanded volume-reducing balloon 50 in the internal space of the aortic aneurysm X reduces the volume of the internal space of the aortic aneurysm X by the volume of the expanded volume-reducing balloon 50. This allows the drug solution to act on the blood vessel wall of the aortic aneurysm X with a smaller amount of drug solution compared to when the volume-reducing balloon 50 is not present. In other words, the efficiency of acting the drug solution on the blood vessel wall of the aortic aneurysm X can be improved. Examples of drug solutions include, but are not limited to, those containing PGG (Pentagalloyl Gulucose), which reduces the rate of aneurysm diameter expansion by binding to elastin or collagen in the blood vessel wall.The drug solution contains, for example, tannic acid, galloylic acid, galloylic acid esters, ellagic acid, proanthocyanidins, anthocyanidins, anthocyanidin glucoside compounds (pelargonidin-3-glucoside, cyanidin-3-glucoside, malvidin-3-glucoside), quercetin, xanthocyanidins, catechins and their derivatives (epicatechin, epigallocatechin, catechin gallate, epicatechin gallate), and flavonoids (soy isoflavones, geniste). (Diazein, glycitein, biocanin), chlorogenic acid, curcumin, resveratrol, polygalloyl compounds (polygalloyl mannose, polygalloyl galactose, polygalloyl xylose, polygalloyl ribose, polygalloyl arabinose, polygalloyl fructose, polygalloyl uinositol, polygalloyl allose, polygalloyl talose, polygalloyl uilludose, polygalloyl lucrose, polygalloyl elutrose, polygalloyl Lutreose, Polygalloyl sucrose, Polygalloyl lactose, Polygalloyl maltose, Polygalloyl isomaltose, Polygalloyl kojibiose, Polygalloyl nigerose, Polygalloyl laminaribiose, Polygalloyl mannobiose, Polygalloyl chitobiose, Polygalloyl fucosyl lactose, Polygalloyl galactobiose, Polygalloyl rutinose, Polygalloyl neotrehalose, Polygalloyl leucose, Polygalloyl The drug solution may contain rehalose, polygalloyl cellobiose, polygalloyl sorbitol, polygalloyl mannitol, polygalloyl maltitol, polygalloyl galactitol, polygalloyl fusitol, polygalloyl isomalt, polygalloyl xylitol, polygalloyl ribitol, polygalloyl arabitol, polygalloyl erythritol, polygalloyl threitol, polygalloyl ruiditol, or a combination thereof. After injecting saline solution into the internal space of the aortic aneurysm X through the other of the two connecting lumens to flush the inside of the aortic aneurysm X, the drug solution may be injected into the internal space of the aortic aneurysm X while removing the saline solution to allow the drug solution to act on the blood vessel wall of the aortic aneurysm X. This allows the drug solution to act on the blood vessel wall more efficiently by removing blood cell components and thrombi from the closed space S before the drug solution is injected.

[0061] As shown in Figure 7D, in step S4, one of the at least one first communication port 13 and the at least one second communication port 23 is positioned on one side of the volume-decreasing balloon 50 in the extending direction L (the side where the first vessel Y1 is located relative to the aortic aneurysm X), and the other of the at least one first communication port 13 and the at least one second communication port 23 is positioned on the other side of the volume-decreasing balloon 50 in the extending direction L (the side where the second vessel Y2 and the third vessel Y3 are located relative to the aortic aneurysm X). Specifically, in the example shown in Figure 7D, the at least one first communication port 13 is positioned on one side of the volume-decreasing balloon 50 in the extending direction L, and the at least one second communication port 23 is positioned on the other side of the volume-decreasing balloon 50 in the extending direction L. In this way, the at least one first communication port 13 and the at least one second communication port 23 can be positioned on both sides of the volume-decreasing balloon 50 in the extending direction L. By arranging the first communication port 13 and the second communication port 23 in this manner, the fluid in the internal space of the aortic aneurysm X can be efficiently replaced.

[0062] As described above, in step S4, one of the at least one first communication port 13 and the at least one second communication port 23 is positioned on one side of the extension direction L relative to the volume-reducing balloon 50, and the other of the at least one first communication port 13 and the at least one second communication port 23 is positioned on the other side of the extension direction L relative to the volume-reducing balloon 50. In other words, with the volume-reducing balloon 50 positioned in the internal space of the aortic aneurysm X, the first vascular occlusion balloon 51 occluding the first vessel Y1, the second vascular occlusion balloon 52 occluding the second vessel Y2, and the third vascular occlusion balloon 53 occluding the third vessel Y3, the at least one of the at least one first communication port 13 and the at least one second communication port 23 is positioned on one side of the extension direction L relative to the volume-reducing balloon 50, and the other of the at least one first communication port 13 and the at least one second communication port 23 is positioned on the other side of the extension direction L relative to the volume-reducing balloon 50. To realize this configuration, as shown in Figure 1, in this embodiment, at least one first communication port 13 is located in the first shaft between the volume reduction balloon 50 and the first vascular occlusion balloon 51 in the longitudinal direction A1, and at least one second communication port 23 is located in the second shaft between the second vascular occlusion balloon 52 and the third vascular occlusion balloon 53 in the longitudinal direction A.

[0063] As shown in Figure 7E, in step S5, when the drug solution is applied to the blood vessel wall of the aortic aneurysm X, a pumping operation is performed by repeatedly expanding and contracting the volume-reducing balloon while the drug solution is contained within the internal space of the aortic aneurysm X. This allows the drug solution to be applied efficiently to the blood vessel wall of the aortic aneurysm X.

[0064] The outer diameter of the volume-reducing balloon used in the pumping procedure is limited to the outer diameter of the balloon immediately before the drug solution is injected into the internal space of the aortic aneurysm X. This prevents the pressure inside the aortic aneurysm X from rising excessively and placing excessive stress on the aneurysm X during the pumping procedure.

[0065] As shown in Figure 7F, in step S6, the drug solution is contained within the internal space of the aortic aneurysm X and left for a certain period of time. This ensures that the drug solution acts reliably on the blood vessel wall of the aortic aneurysm X. The waiting time may be adjusted as appropriate depending on the condition of the aortic aneurysm X.

[0066] As shown in Figure 7G, in step S7, the drug solution is removed from the internal space of the aortic aneurysm X through one of the two communicating lumens, while a biocompatible fluid is injected into the internal space of the aortic aneurysm X through the other of the two communicating lumens. At this time, because there is an expanded volume-reducing balloon 50 in the internal space of the aortic aneurysm X, the volume of the internal space of the aortic aneurysm X can be reduced by the volume of the expanded volume-reducing balloon 50. As a result, the drug solution in the aortic aneurysm X can be replaced with a smaller amount of biocompatible fluid compared to when there is no volume-reducing balloon 50. Specifically, as shown in Figure 7G, in step S7, the drug solution is aspirated and removed from the internal space of the aortic aneurysm X through at least one second communicating port 23 and second communicating lumen 21c, while a biocompatible fluid is injected into the internal space of the aortic aneurysm X through at least one first communicating port 13 and first communicating lumen 11d. As a result, the drug solution in the internal space of the aortic aneurysm X can be replaced with a biocompatible fluid. Examples of biocompatible liquids include, but are not limited to, physiological saline.

[0067] As shown in Figure 7H, in step S8, at least two vascular occlusion balloons and volume-reducing balloons that are in an expanded state are deflated. Specifically, as shown in Figure 7H, in step S8, the volume-reducing balloon 50, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53, which are in an expanded state, are deflated. In this state, the procedure can be completed by removing the first balloon catheter 10 and the second balloon catheter 20 from the body.

[0068] The medical devices and treatment methods relating to this disclosure are not limited to the specific configurations and processes shown in the embodiments and modifications described above, and various modifications, changes, and combinations are possible as long as they do not deviate from the scope of the claims.

[0069] In the following section, modifications of the medical device 1 of the above-described embodiment will be explained with reference to Figures 8 to 13. Figures 8 to 13 show modifications of the medical device of the above-described embodiment. Even when using the medical devices shown in Figures 8 to 13, the same treatment method as described above using medical device 1 (see Figure 1, etc.) (see Figures 7A to 7H) can be performed. Figures 8 to 13 also show the state of the medical device in each modification immediately after performing step S3 described above.

[0070] In the modified example shown in Figure 8, the volume-reducing balloon 50, the first vascular occlusion balloon 51, and the second vascular occlusion balloon 52 are provided on the first shaft 11, and the third vascular occlusion balloon 53 is provided on the second shaft 21. Specifically, the medical device 101 shown in Figure 8 comprises a first balloon catheter 110 and a second balloon catheter 120. The first balloon catheter 110 comprises a first shaft 11, a volume-reducing balloon 50, a first vascular occlusion balloon 51, and a second vascular occlusion balloon 52. The second balloon catheter 120 comprises a second shaft 21 and a third vascular occlusion balloon 53. In this case, at least one first communication port 13 may be located on the first shaft 11, in the longitudinal direction A1 of the first shaft 11, at a position between the volume-reducing balloon 50 and the first vascular occlusion balloon 51, or at a position between the volume-reducing balloon 50 and the second vascular occlusion balloon 52. Furthermore, at least one second communication port 23 may be positioned on the second shaft 21 in a location where the third vascular occlusion balloon 53 is not present in the longitudinal direction A2 of the second shaft 21. Specifically, in the modified example shown in Figure 8, at least one first communication port 13 is positioned on the first shaft 11 in a location between the volume-reducing balloon 50 and the first vascular occlusion balloon 51 in the longitudinal direction A1 of the first shaft 11. Also, at least one second communication port 23 is positioned on the second shaft 21 in a location distal to the third vascular occlusion balloon 53 in the longitudinal direction A2 of the second shaft 21. In addition, in this modified example, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 110 is positioned within the second vessel Y2, the internal space of the aortic aneurysm X, and the first vessel Y1, but not within the third vessel Y3. On the other hand, when step S3 described above is performed, the second shaft 21 of the second balloon catheter 120 is positioned within the third blood vessel Y3 and the internal space of the aortic aneurysm X, but not within the first blood vessel Y1 and the second blood vessel Y2.Therefore, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 110 does not overlap with the third vascular occlusion balloon 53 of the second balloon catheter 120, and the second shaft 21 of the second balloon catheter 120 does not overlap with the first vascular occlusion balloon 51 and the second vascular occlusion balloon 52 of the first balloon catheter 110. As a result, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 can reliably occlude the first vessel Y1, the second vessel Y2, and the third vessel Y3.

[0071] In the modified example shown in Figure 9, the volume-reducing balloon 50 and the second vascular occlusion balloon 52 are provided on the first shaft 11, and the first vascular occlusion balloon 51 and the third vascular occlusion balloon 53 are provided on the second shaft 21. Specifically, the medical device 201 shown in Figure 9 comprises a first balloon catheter 210 and a second balloon catheter 220. The first balloon catheter 210 comprises a first shaft 11, a volume-reducing balloon 50, and a second vascular occlusion balloon 52. The second balloon catheter 220 comprises a second shaft 21, a first vascular occlusion balloon 51, and a third vascular occlusion balloon 53. In this case, at least one first communication port 13 may be positioned on the first shaft 11 in a location where the volume-reducing balloon 50 and the second vascular occlusion balloon 52 are not present in the longitudinal direction A1 of the first shaft 11. Furthermore, at least one second communication port 23 may be positioned on the second shaft 21 between the first vascular occlusion balloon 51 and the third vascular occlusion balloon 53 in the longitudinal direction A2 of the second shaft 21. Specifically, in the modified example shown in Figure 9, at least one first communication port 13 is positioned on the first shaft 11 between the volume reduction balloon 50 and the second vascular occlusion balloon 52 in the longitudinal direction A1 of the first shaft 11. Also, at least one second communication port 23 is positioned on the second shaft 21 between the first vascular occlusion balloon 51 and the third vascular occlusion balloon 53 in the longitudinal direction A2 of the second shaft 21. In addition, in this modified example, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 210 is positioned within the second vessel Y2 and the internal space of the aortic aneurysm X, but not within the first vessel Y1 and the third vessel Y3. On the other hand, when performing step S3 described above, the second shaft 21 of the second balloon catheter 220 is positioned within the third blood vessel Y3, the internal space of the aortic aneurysm X, and the first blood vessel Y1, but not within the second blood vessel Y2.Therefore, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 210 does not overlap with the first vascular occlusion balloon 51 and the third vascular occlusion balloon 53 of the second balloon catheter 220, and the second shaft 21 of the second balloon catheter 220 does not overlap with the second vascular occlusion balloon 52 of the first balloon catheter 210. As a result, the first vascular occlusion balloon 51, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 can reliably occlude the first vessel Y1, the second vessel Y2, and the third vessel Y3.

[0072] In the modified example shown in Figure 10, the volume-reducing balloon 50, the second vascular occlusion balloon 52, and the third vascular occlusion balloon 53 are provided on the first shaft 11, and the first vascular occlusion balloon 51 is provided on the second shaft 21. Specifically, the medical device 301 shown in Figure 10 comprises a first balloon catheter 310 and a second balloon catheter 320. The first balloon catheter 310 comprises a first shaft 11, a volume-reducing balloon 50, a second vascular occlusion balloon 52, and a third vascular occlusion balloon 53. The second balloon catheter 320 comprises a second shaft 21 and a first vascular occlusion balloon 51. In this case, at least one first communication port 13 may be located on the first shaft 11, in the longitudinal direction A1 of the first shaft 11, at a position between the volume-reducing balloon 50 and the second vascular occlusion balloon 52, or at a position between the volume-reducing balloon 50 and the third vascular occlusion balloon 53. Furthermore, at least one second communication port 23 may be positioned on the second shaft 21 in a location where the first vascular occlusion balloon 51 is not present in the longitudinal direction A2 of the second shaft 21. Specifically, in the modified example shown in Figure 10, at least one first communication port 13 is positioned on the first shaft 11 in a location between the volume-reducing balloon 50 and the second vascular occlusion balloon 52 in the longitudinal direction A1 of the first shaft 11. Also, at least one second communication port 23 is positioned on the second shaft 21 in a location distal to the first vascular occlusion balloon 51 in the longitudinal direction A2 of the second shaft 21. In addition, in this modified example, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 310 is positioned within the second vessel Y2, the internal space of the aortic aneurysm X, and the third vessel Y3, but not within the first vessel Y1. Furthermore, the second shaft 21 of the second balloon catheter 320 is positioned within the first blood vessel Y1 and the internal space of the aortic aneurysm X, but not within the second blood vessel Y2 or the third blood vessel Y3. Therefore, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 310 does not overlap with the first blood vessel occlusion balloon 51 of the second balloon catheter 320, and the second shaft 21 of the second balloon catheter 320 does not overlap with the second blood vessel occlusion balloon 52 and the third blood vessel occlusion balloon 53 of the first balloon catheter 310.This ensures that the first vessel Y1, the second vessel Y2, and the third vessel Y3 are reliably occluded by the first vessel occlusion balloon 51, the second vessel occlusion balloon 52, and the third vessel occlusion balloon 53.

[0073] In the modified example shown in Figure 11, similar to the modified example shown in Figure 8, the volume-reducing balloon 50, the first vascular occlusion balloon 51, and the second vascular occlusion balloon 52 are provided on the first shaft 11, and the third vascular occlusion balloon 53 is provided on the second shaft 21. That is, the medical device 401 shown in Figure 11 comprises a first balloon catheter 110 and a second balloon catheter 420. The first balloon catheter 110 comprises a first shaft 11, a volume-reducing balloon 50, a first vascular occlusion balloon 51, and a second vascular occlusion balloon 52. The second balloon catheter 420 comprises a second shaft 21 and a third vascular occlusion balloon 53. However, the modified example shown in Figure 11 differs from the modified example shown in Figure 8 in that at least one second communication port 23 is located on the second shaft 21, proximal to the third vascular occlusion balloon 53 in the longitudinal direction A2 of the second shaft 21. Therefore, in this modified example, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 110 is positioned in the same way as the first shaft 11 of the first balloon catheter 110 shown in Figure 8. On the other hand, when step S3 described above is performed, the second shaft 21 of the second balloon catheter 420 is positioned within the second blood vessel Y2, the internal space of the aortic aneurysm X, and the third blood vessel Y3, but not within the first blood vessel Y1.

[0074] Figure 12 shows an example in which the medical device 401 shown in Figure 11 is placed inside a blood vessel in a different configuration than in Figure 11. Specifically, in the example shown in Figure 12, when step S3 described above is performed, the first shaft 11 of the first balloon catheter 110 is placed in the same configuration as the first shaft 11 of the first balloon catheter 110 shown in Figure 11. On the other hand, the second shaft 21 of the second balloon catheter 420 is placed inside the first blood vessel Y1, the internal space of the aortic aneurysm X, and the third blood vessel Y3, but not inside the second blood vessel Y2.

[0075] In the modified example shown in Figure 13, similar to the embodiments shown in Figures 1 to 7H, the volume-reducing balloon 50 and the first vascular occlusion balloon 51 are provided on the first shaft 11, and the second vascular occlusion balloon 52 and the third vascular occlusion balloon 53 are provided on the second shaft 21. That is, the medical device 501 shown in Figure 13 comprises a first balloon catheter 510 and a second balloon catheter 20. The first balloon catheter 510 comprises a first shaft 11, a volume-reducing balloon 50, and a first vascular occlusion balloon 51. The second balloon catheter 20 comprises a second shaft 21, a second vascular occlusion balloon 52, and a third vascular occlusion balloon 53. However, in the modified example shown in Figure 13, the first vascular occlusion balloon 51 is positioned proximal to the volume-reducing balloon 50 in the longitudinal direction A1, which differs from the embodiments shown in Figures 1 to 7H. Therefore, in this modified example, when step S3 is performed, the first shaft 11 of the first balloon catheter 510 is positioned within the first blood vessel Y1 and the internal space of the aortic aneurysm X, but not within the second blood vessel Y2 and the third blood vessel Y3. On the other hand, when step S3 is performed, the second shaft 21 of the second balloon catheter 20 is positioned within the second blood vessel Y2, the internal space of the aortic aneurysm X, and the third blood vessel Y3, but not within the first blood vessel Y1. By positioning them in this way, when step S3 is performed, the first shaft 11 of the first balloon catheter 510 does not overlap with the second blood vessel occlusion balloon 52 and the third blood vessel occlusion balloon 53 of the second balloon catheter 20, and the second shaft 21 of the second balloon catheter 20 does not overlap with the first blood vessel occlusion balloon 51 of the first balloon catheter. As a result, the first blood vessel Y1, the second blood vessel Y2, and the third blood vessel Y3 can be reliably occluded by the first blood vessel occlusion balloon 51, the second blood vessel occlusion balloon 52, and the third blood vessel occlusion balloon 53.

[0076] Furthermore, the treatment method for aortic aneurysm X described above (see Figures 6-7H) is performed using four balloons in two balloon catheters, a first balloon catheter and a second balloon catheter, but is not limited to this. The treatment method for aortic aneurysm X may also be performed using a medical device equipped with three balloons, for example, as shown in Figure 14. Specifically, the medical device 601 shown in Figure 14 includes a balloon catheter 610. The balloon catheter 610 includes a long shaft 611, a volume-reducing balloon 50 that can be placed in the aortic aneurysm X, a first vascular occlusion balloon 51 that can occlude a first blood vessel Y1 connected to one side in the extending direction L of the aortic aneurysm X, and a second vascular occlusion balloon 52 that can occlude a second blood vessel Y4 connected to the other side in the extending direction L of the aortic aneurysm X. The volume-reducing balloon 50, the first vascular occlusion balloon 51, and the second vascular occlusion balloon 52 are provided on the shaft 611. The shaft 611 shown in Figure 11 defines two communication lumens: a first communication lumen and a second communication lumen. The shaft 611 shown in Figure 14 defines at least one first communication port 613 that can connect the first communication lumen to the internal space of the aortic aneurysm X, and at least one second communication port 623 that can connect the second communication lumen to the internal space of the aortic aneurysm X. The configuration of the first and second communication lumens defined by the shaft 611 is the same as the configuration in the medical device of the embodiment and the modified example described above. In the example shown in Figure 14, at least one first communication port 613 is located between the first vascular occlusion balloon 51 and the volume reduction balloon 50 in the longitudinal direction of the shaft 611. In the example shown in Figure 14, at least one second communication port 623 is located between the second vascular occlusion balloon 52 and the volume reduction balloon 50 in the longitudinal direction of the shaft 611. Furthermore, the treatment method for an aortic aneurysm X using the medical device 601 shown in Figure 14 is the same as the flowchart shown in Figure 6. In step S3 described above, with the volume-reducing balloon 50 expanding in the internal space of the aortic aneurysm X, the first vascular occlusion balloon 51 placed in the first blood vessel Y1 and the second vascular occlusion balloon 52 placed in the second blood vessel Y4 are expanded. As a result, in the example shown in Figure 14, the first blood vessel Y1 and the second blood vessel Y4 are occluded, forming a closed space S including the internal space of the aortic aneurysm X.As mentioned above, the closed space S refers to a state in which the proximal and distal ends of the aortic aneurysm are occluded, and also includes a state in which the collateral vessels extending from the aortic aneurysm (not shown in Figure 14) are not occluded. In the above embodiment, three balloons were provided on a single shaft, but it is also possible to have three long shafts, with the volume-reducing balloon 50, the first vessel occlusion balloon 51, and the second vessel occlusion balloon 52 provided on each shaft.

[0077] This disclosure relates to medical devices and treatment methods.

[0078] 1, 101, 201, 301, 401, 501, 601: Medical devices 10, 110, 210, 310, 510: First balloon catheter 11: First shaft 11a: Guidewire lumen of the first shaft 11b: Volume-reducing balloon lumen of the first shaft 11c: Vascular occlusion balloon lumen of the first shaft 11d: First communication lumen 13: First communication port 15a1, 15b1: First circumferential wall of the first shaft 15a2, 15b2: Second circumferential wall of the first shaft 15a3: Third circumferential wall of the first shaft 16a, 16b: Connecting wall of the first shaft 19: First hub 19a: Connection port of the first hub connected to the volume-reducing balloon lumen 19b: Connection port of the first hub connected to the vascular occlusion balloon lumen 19c: Connection port connected to the first communication lumen of the first hub 20, 120, 220, 320, 420: Second balloon catheter 21: Second shaft 21a: Guidewire lumen of the second shaft 21b: Vascular occlusion balloon lumen of the second shaft 21c: Second communication lumen 23: Second communication port 25a1: First circumferential wall of the second shaft 25a2: Second circumferential wall of the second shaft 25a3: Third circumferential wall of the second shaft 26: Connecting wall of the second shaft 29: Second hub 29a: Connection port connected to the vascular occlusion balloon lumen of the second hub 29b: Connection port connected to the second communication lumen of the second hub 50: Volume reduction balloon 50a: Recess 51: First vascular occlusion balloon 52: Second vascular occlusion balloon 53: Third vascular occlusion balloon 610: Balloon catheter 611: Shaft 613: First communication port 623: Second communication port A1: Longitudinal direction of the first shaft A2: Longitudinal direction of the second shaft B1: Circumferential direction of the first shaft B2: Circumferential direction of the second shaft C1: Longitudinal direction of the first shaft C2: Longitudinal direction of the second shaft L: Direction of extension S: Closed space X: Aortic aneurysm Y1: First vessel Y2, Y4: Second vessel Y3: Third vessel

Claims

1. The device comprises a long first shaft, a long second shaft, a volume-reducing balloon that can be placed in the internal space of an aortic aneurysm formed in the aorta, a first vessel occlusion balloon capable of occluding a first vessel connected to one side of the aortic aneurysm in the direction of extension of the aorta, a second vessel occlusion balloon capable of occluding a second vessel, which is one of two vessels that are connected to the other side of the aortic aneurysm in the direction of extension and branch off from each other, and a third vessel occlusion balloon capable of occluding a third vessel, which is the other of the two vessels, wherein the first shaft comprises a first communication lumen and at least one first communication opening capable of connecting the internal space of the aortic aneurysm to the first communication lumen, and the second shaft comprises a second communication lumen and at least one second communication opening capable of connecting the internal space of the aortic aneurysm to the second communication lumen. The maximum expanded outer diameter of the volume-reducing balloon is greater than the maximum expanded outer diameter of any of the first vascular occlusion balloon, the second vascular occlusion balloon, and the third vascular occlusion balloon, and the at least one first communication port and the at least one second communication port are configured to be positioned in the internal space of the aortic aneurysm when the volume-reducing balloon is positioned in the internal space of the aortic aneurysm, the first vascular occlusion balloon occludes the first vessel, the second vascular occlusion balloon occludes the second vessel, and the third vascular occlusion balloon occludes the third vessel, (A) the volume-reducing balloon and the first vascular occlusion balloon are provided on the first shaft, and the second vascular occlusion balloon and the third vascular occlusion balloon are provided on the second shaft, (B) the volume-reducing balloon, the first vascular occlusion balloon, and the second vascular occlusion balloon are provided on the first shaft, and the third vascular occlusion balloon is provided on the second shaft, (C) The volume-reducing balloon and the second vascular occlusion balloon are provided on the first shaft, and the first vascular occlusion balloon and the third vascular occlusion balloon are provided on the second shaft, or (D) The volume-reducing balloon, the second vascular occlusion balloon and the third vascular occlusion balloon are provided on the first shaft, and the first vascular occlusion balloon is provided on the second shaft, a medical device.

2. The medical device according to claim 1, wherein the volume-reducing balloon is positioned in the internal space of the aortic aneurysm, the first vascular occlusion balloon occludes the first blood vessel, the second vascular occlusion balloon occludes the second blood vessel, and the third vascular occlusion balloon occludes the third blood vessel, and one of the at least one first communication port and the at least one second communication port is positioned on one side in the extending direction relative to the volume-reducing balloon, and the other of the at least one first communication port and the at least one second communication port is positioned on the other side in the extending direction relative to the volume-reducing balloon.

3. The medical device according to claim 1 or 2, wherein the total area of ​​at least one first communication port is equal to or greater than the cross-sectional area of ​​the first communication lumen.

4. The medical device according to claim 1 or 2, wherein the total area of ​​at least one second communication port is equal to or greater than the cross-sectional area of ​​the second communication lumen.

5. The medical device according to claim 1 or 2, wherein, in the expanded state of the volume-reducing balloon, at least one recess is provided on the surface of the volume-reducing balloon.

6. (B) The medical device according to claim 1 or 2, wherein the volume-reducing balloon, the first vascular occlusion balloon and the second vascular occlusion balloon are provided on the first shaft, and the third vascular occlusion balloon is provided on the second shaft.

7. The medical device according to claim 6, wherein the at least one first communication port is located on the first shaft between the volume-reducing balloon and the first vascular occlusion balloon or between the volume-reducing balloon and the second vascular occlusion balloon, and the at least one second communication port is located on the second shaft where the third vascular occlusion balloon is not present.

8. (C) The medical device according to claim 1 or 2, wherein the volume-reducing balloon and the second vascular occlusion balloon are provided on the first shaft, and the first vascular occlusion balloon and the third vascular occlusion balloon are provided on the second shaft.

9. The medical device according to claim 8, wherein the at least one first communication port is located on the first shaft in a position where the volume-reducing balloon and the second vascular occlusion balloon are not present, and the at least one second communication port is located on the second shaft in a position between the first vascular occlusion balloon and the third vascular occlusion balloon.

10. A method for treating an aortic aneurysm formed in the aorta, comprising a volume-reducing balloon and at least two vascular occlusion balloons, and comprising a medical device comprising defining two communicating lumens, wherein the volume-reducing balloon is placed in the internal space of the aortic aneurysm, at least one of the at least two vascular occlusion balloons is placed in at least one blood vessel connected to one side of the aortic aneurysm in the direction of extension of the aorta, the remaining at least one of the at least two vascular occlusion balloons is placed in at least one blood vessel connected to the other side of the aortic aneurysm in the direction of extension, the volume-reducing balloon placed in the internal space of the aortic aneurysm is expanded to a size that does not occlude the aortic aneurysm, the at least two vascular occlusion balloons are expanded to occlude the at least one blood vessel connected to one side of the aortic aneurysm in the direction of extension of the aortic aneurysm, and the at least one blood vessel connected to the other side of the aortic aneurysm in the direction of extension, A treatment method characterized by removing blood from the internal space through one of the two communicating lumens that communicate with the internal space, injecting a drug solution into the internal space through the other of the two communicating lumens to allow the drug solution to act on the blood vessel wall of the aortic aneurysm, injecting a biocompatible liquid into the internal space through the other of the two communicating lumens while removing the drug solution from the internal space through one of the two communicating lumens, and deflating the at least two vascular occlusion balloons and the volume reduction balloon.

11. The treatment method according to claim 10, wherein, when the drug solution is applied to the blood vessel wall, a pumping operation is performed in which the volume-reducing balloon is repeatedly expanded and contracted while the drug solution is contained in the internal space.

12. The treatment method according to claim 11, wherein the outer diameter of the volume-reducing balloon in the pumping operation is limited to the outer diameter of the volume-reducing balloon immediately before the drug solution is injected into the internal space.

13. The treatment method according to any one of claims 10 to 12, wherein when injecting the drug solution into the internal space, the injection of the drug solution into the internal space and the aspiration of liquid from the internal space are performed in parallel.

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