catheter

Abstract

The present invention provides a catheter that can improve the delivery efficiency of administered substances, which are delivered to the treatment site through the vascular endothelium. [Solution] The catheter according to the present disclosure comprises a catheter body having an insertion lumen inside, and an insertion body that can be inserted into the insertion lumen, wherein the side wall of the catheter body has a side hole that connects the insertion lumen to the outside of the catheter body, and the insertion body has an expandable portion that can expand radially outward from the catheter body through the side hole.

Description

[[Technical Field]]

[0001] The present disclosure relates to a catheter. [[Background Art]]

[0002] Conventionally, there has been known a procedure of administering an administered substance such as a drug or cells to a predetermined region in a blood vessel and retaining the administered substance in the predetermined region. The administered substance is supplied, for example, through the surrounding vascular endothelium to a treatment target site such as a diseased tissue. Patent Document 1 describes a balloon catheter used for this type of procedure. [[Prior Art Literature]] [[Patent Literature]]

[0003] [[Patent Document 1]] International Publication No. 2004 / 045702 [[Summary of Invention]] [[Problems to be Solved by the Invention]]

[0004] In the balloon catheter described in Patent Document 1, the administered substance such as a drug, cells or the like is administered to the outside of the catheter body through the injection port of the catheter body. However, the balloon catheter described in Patent Document 1 still has room for improvement in terms of the supply efficiency with which the administered substance administered into the blood vessel is supplied to the treatment target site such as a diseased tissue through the vascular endothelium.

[0005] An object of the present disclosure is to provide a catheter that can improve the supply efficiency with which the administered substance is supplied to the treatment target site through the vascular endothelium. [[Means for Solving the Problems]]

[0006] A catheter according to the present disclosure comprises: (1) a catheter body defining an insertion lumen therein; and an insertion member insertable into the insertion lumen, The side wall of the catheter body comprises a side hole that connects the insertion lumen to the outside of the catheter body. The insertion body is a catheter having an expandable portion that can expand radially outward from the catheter body through the side hole.

[0007] A catheter as one embodiment of the present disclosure is (2) The catheter described in (1) above has a side hole which is a slit.

[0008] A catheter as one embodiment of the present disclosure is (3) The catheter described in (2) above, wherein, in a front view of the slit while the expansion portion is expanded through the slit, the length of the slit in the extending direction is longer than the length of the expansion portion in the extending direction.

[0009] A catheter as one embodiment of the present disclosure is (4) The catheter according to (3) above, wherein the expanded portion, when expanded through the slit, has a membrane-like portion including a stirring surface on at least one surface in the thickness direction that extends in a direction intersecting the extending direction of the slit when viewed from the front of the slit.

[0010] A catheter as one embodiment of the present disclosure is (5) The insertion body comprises an insertion body portion to which the expansion portion is attached at the tip, The aforementioned extension is The hinge part, A rotating part is rotatably attached to the insertion body via the hinge portion, A catheter according to any one of (1) to (4) above, comprising a membrane-like portion stretched between the rotating portion and the insertion body portion.

[0011] A catheter according to one embodiment of the present disclosure, (6) The catheter according to any one of the above (1) to (5), wherein the side wall of the catheter body defines a discharge hole capable of discharging an administration substance to be administered to a living body.

[0012] A catheter according to one embodiment of the present disclosure, (7) The catheter body internally defines an administration lumen separate from the insertion lumen, through which the administration substance can flow, The catheter according to the above (6), wherein the discharge hole communicates with the administration lumen.

[0013] A catheter according to one embodiment of the present disclosure, (8) The catheter according to any one of the above (1) to (7), comprising a first balloon and a second balloon which are attached to the catheter body on both longitudinal sides of the catheter body with respect to the side hole and are expandable in the radial direction. Effects of the Invention

[0014] According to the present disclosure, it is possible to provide a catheter capable of improving the supply efficiency with which an administration substance is supplied to a treatment target site through vascular endothelium. Brief Description of the Drawings

[0015] [Figure 1] FIG. 1 is a diagram showing a catheter as one embodiment of the present disclosure. [Figure 2A] FIG. 1 is a cross-sectional view taken along line I-I in FIG. 1. [Figure 2B] It is a cross-sectional view taken along line II-II in FIG. 1. [Figure 2C] It is a cross-sectional view taken along line III-III in FIG. 1. [Figure 2D] It is a cross-sectional view taken along line IV-IV in FIG. 1. [Figure 2E] It is a cross-sectional view taken along line V-V in FIG. 1. [Figure 2F] This is a cross-sectional view taken at the position of line VI-VI in Figure 1. [Figure 3] Figure 1 is a cross-sectional view showing a catheter inserted into a blood vessel, with the expandable portion of the insertion body not yet expanded. [Figure 4] This figure shows the state after the expansion portion of the insertion body has expanded from the state shown in Figure 3. [Figure 5] This is a front view of the catheter slit, with the side holes seen from the front. [Figure 6] This figure shows one modified example of the expanded section shown in Figure 5. [Figure 7] This figure shows one modified example of the expanded section shown in Figure 5. [Figure 8] This diagram shows a handle section in which multiple insertion parts are connected. [Figure 9A] Figure 1 shows an example of how to use the catheter. [Figure 9B] Figure 1 shows an example of how to use the catheter. [Figure 9C] Figure 1 shows an example of how to use the catheter. [Figure 9D] Figure 1 shows an example of how to use the catheter. [Figure 9E] Figure 1 shows an example of how to use the catheter. [Figure 10] This figure shows a modified example of the catheter shown in Figure 1. [Modes for carrying out the invention]

[0016] Hereinafter, embodiments of the catheter relating to this disclosure will be described with reference to the drawings. In each figure, identical components are denoted by the same reference numerals.

[0017] Figure 1 shows a catheter 100 as one embodiment of the catheter according to this disclosure. The catheter 100 can be inserted percutaneously into the blood vessels of a patient.

[0018] As shown in Figure 1, the catheter 100 comprises a catheter body 10 and one or more insertion bodies 30. The catheter 100 in this embodiment comprises two insertion bodies 30. However, the catheter 100 may comprise only one or three or more insertion bodies 30. The two insertion bodies 30 in this embodiment are the first insertion body 30a and the second insertion body 30b. Hereafter in this embodiment, unless the first insertion body 30a and the second insertion body 30b are specifically distinguished, they will simply be referred to as "insertion body 30".

[0019] As will be described in detail later, the catheter 100 of this embodiment is equipped with one or more balloons 50 attached to the catheter body 10. More specifically, the catheter 100 of this embodiment is equipped with two balloons 50. However, the catheter 100 does not have to be equipped with balloons 50. Also, when the catheter 100 is equipped with balloons 50, the catheter 100 may be equipped with only one balloon or three or more balloons 50. The two balloons 50 of this embodiment are the first balloon 50a and the second balloon 50b. Hereafter in this embodiment, unless the first balloon 50a and the second balloon 50b are specifically distinguished, they will simply be referred to as "balloon 50".

[0020] For the sake of explanation, in the following, the direction parallel to the central axis O of the catheter body 10 will be referred to as "longitudinal direction A of the catheter body 10" or simply "longitudinal direction A". Furthermore, within longitudinal direction A, the direction from the proximal end to the distal end of the catheter 100 will be referred to as "catheter insertion direction A1", and the direction from the distal end to the proximal end of the catheter 100 will be referred to as "catheter withdrawal direction A2". In addition, in the catheter 100, the direction around the central axis O of the catheter body 10 will be referred to as "circumferential direction B of the catheter body 10" or simply "circumferential direction B". Furthermore, in a cross-section perpendicular to the central axis O of the catheter body 10, the radial direction of a virtual circle centered on the central axis O will be referred to as "radial direction C of the catheter body 10" or simply "radial direction C".

[0021] Figure 2A is a cross-sectional view at the position of line II in Figure 1. Figure 2B is a cross-sectional view at the position of line II-II in Figure 1. Figure 2C is a cross-sectional view at the position of line III-III in Figure 1. Figure 2D is a cross-sectional view at the position of line IV-IV in Figure 1. Figure 2E is a cross-sectional view at the position of line VV in Figure 1. Figure 2F is a cross-sectional view at the position of line VI-VI in Figure 1.

[0022] As shown in Figures 2A to 2D, the catheter body 10 has an insertion lumen 11 through which the insertion body 30 can be inserted. More specifically, the catheter body 10 of this embodiment has a first insertion lumen 11a through which the first insertion body 30a can be inserted. Furthermore, the catheter body 10 of this embodiment has a second insertion lumen 11b through which the second insertion body 30b can be inserted. Hereafter in this embodiment, unless the first insertion lumen 11a and the second insertion lumen 11b are specifically distinguished, they will simply be referred to as "insertion lumen 11". Figures 1 to 2D show the state in which the insertion body 30 is not inserted into the insertion lumen 11 of the catheter body 10.

[0023] The side wall of the catheter body 10 defines a side hole 12 that connects the insertion lumen 11 to the outside of the catheter body 10. More specifically, the catheter body 10 of this embodiment defines a first side hole 12a that connects the first insertion lumen 11a to the outside of the catheter body 10. Furthermore, the catheter body 10 of this embodiment defines a second side hole 12b that connects the second insertion lumen 11b to the outside of the catheter body 10. Hereinafter, in this embodiment, unless the first side hole 12a and the second side hole 12b are specifically distinguished, they will simply be referred to as "side hole 12".

[0024] Furthermore, as shown in Figure 1, the insertion body 30 includes an expandable portion 31 that can expand radially outward from the catheter body 10 through the side hole 12. More specifically, the first insertion body 30a of this embodiment includes a first expandable portion 31a that can expand radially outward from the catheter body 10 through the first side hole 12a. The second insertion body 30b of this embodiment includes a second expandable portion 31b that can expand radially outward from the catheter body 10 through the second side hole 12b. Hereafter, in this embodiment, unless the first expandable portion 31a and the second expandable portion 31b are specifically distinguished, they will simply be referred to as "expandable portion 31".

[0025] Thus, the catheter 100 is equipped with an insertion body 30 that can be inserted through the insertion lumen 11 of the catheter body 10. The insertion body 30 is equipped with an expandable portion 31 that can expand radially C outward from the catheter body 10 through a side hole 12. By expanding and moving the expandable portion 31, the administered substance administered intravascularly can be agitated within the blood vessel. The administered substance may be, for example, a drug, cells, extracellular vesicles, etc. The administered substance administered intravascularly is supplied to the target site for treatment, such as diseased tissue, through the vascular endothelium. By agitating the administered substance within the blood vessel using the expandable portion 31, the administered substance is more easily taken up by the vascular endothelium, and the efficiency of supplying the administered substance to the target site for treatment through the vascular endothelium can be increased.

[0026] The movement of the expandable portion 31 when agitating the administered substance in the blood vessel may be, for example, movement within the side hole 12 while the expandable portion 31 is protruding radially C outward from the catheter body 10 through the side hole 12. In other words, the movement of the expandable portion 31 may be relative movement of the insertion body 30 with respect to the catheter body 10. In this case, the expandable portion 31 may be movable, for example, in the longitudinal direction A within the side hole 12. Also, the expandable portion 31 may be movable, for example, in the circumferential direction B within the side hole 12. Furthermore, the movement of the expandable portion 31 may follow the movement of the catheter body 10, for example. In other words, the movement of the expandable portion 31 may occur as a result of the catheter body 10 and the insertion body 30 moving together in the blood vessel. In this case, the movement of the expandable portion 31 may be, for example, movement in the circumferential direction B accompanying the rotation of the catheter body 10 in the circumferential direction B. However, the direction of movement of the expandable portion 31 is not particularly limited. The direction of movement of the extension 31 may be set appropriately, for example, depending on the specific configuration of the extension 31.

[0027] Thus, with the catheter 100, the administered substance can be agitated using the expandable portion 31 of the insertion body 30. This improves the efficiency of supplying the administered substance to the treatment site through the vascular endothelium.

[0028] The details of the catheter 100 of this embodiment will be described below.

[0029] [Catheter body 10] As shown in Figures 2A to 2F, the catheter body 10 of this embodiment has, in addition to the first insertion lumen 11a and the second insertion lumen 11b described above, an administration lumen 13 and a fluid supply / discharge lumen 14 partitioned inside. The administration lumen 13 is through which the substance to be administered to the body can flow. The substance may flow through the administration lumen 13 on its own, or it may flow through the administration lumen 13 in a state mixed with a liquid. The tip side of the administration lumen 13 in this embodiment is closed in the longitudinal direction A. In other words, the tip surface of the catheter body 10 of this embodiment does not have a tip opening connected to the administration lumen 13. Fluid for expanding and contracting the balloon 50 can flow through the fluid supply / discharge lumen 14.

[0030] As shown in Figures 1, 2C, and 2E, the side wall of the catheter body 10 in this embodiment partitions a side hole 15 through which administered substances can be discharged into the body. Hereinafter, in order to distinguish between the side hole 12 and the side hole 15, the side hole 15 will be referred to as "discharge hole 15". Two discharge holes 15 are partitioned in the side wall of the catheter body 10 in this embodiment. The number of discharge holes 15 partitioned in the side wall of the catheter body 10 is not particularly limited. For example, the side wall of the catheter body 10 may have only one discharge hole 15, or three or more discharge holes 15. The two discharge holes 15 in this embodiment are a first discharge hole 15a located on the proximal end side (see Figure 2C) and a second discharge hole 15b located on the tip side (see Figure 2E). Hereinafter, in this embodiment, if the first discharge hole 15a and the second discharge hole 15b are not particularly distinguished, they will simply be referred to as "discharge hole 15".

[0031] In this embodiment, the first discharge hole 15a and the second discharge hole 15b are formed at different positions in the circumferential direction B from the first side hole 12a and the second side hole 12b, but the configuration is not limited to this. The discharge hole 15 may be formed at the same position in the circumferential direction B as the side hole 12, but at different positions in the longitudinal direction A.

[0032] The discharge port 15 communicates with the administration lumen 13. More specifically, the first discharge port 15a and the second discharge port 15b of this embodiment each communicate with the administration lumen 13. Therefore, the administered substance flowing through the administration lumen 13 can be discharged into the blood vessel through the discharge port 15. In other words, the catheter body 10 of this embodiment can administer the administered substance into the patient's blood vessel by using the administration lumen 13 and the discharge port 15. The catheter 100 of this embodiment is inserted into a blood vessel such that the discharge port 15 of the catheter body 10 is located in a predetermined region within the blood vessel. The predetermined region within the blood vessel may be determined based on the location of the treatment target area, such as diseased tissue. For example, the predetermined region within the blood vessel is the region near the treatment target area. In this way, the administered substance administered in the vicinity of the treatment target area within the blood vessel is agitated within the blood vessel by the expansion and movement of the expansion portion 31 of the insertion body 30 described above. As a result, the administered substance is easily taken up by the vascular endothelium near the treatment target area, and the administered substance can be efficiently supplied to the treatment target area.

[0033] When a plurality of discharge holes 15 are partitioned in the side wall of the catheter body 10, the positional relationship of these discharge holes 15 in the longitudinal direction A and the positional relationship in the circumferential direction B are not particularly limited. As with the first discharge hole 15a and the second discharge hole 15b in this embodiment, the plurality of discharge holes 15 may be arranged at substantially equal positions in the circumferential direction B and at different positions in the longitudinal direction A. Alternatively, the plurality of discharge holes 15 may be arranged at substantially equal positions in the longitudinal direction A and at different positions in the circumferential direction B. Furthermore, the plurality of discharge holes 15 may be arranged such that both their positions in the longitudinal direction A and their positions in the circumferential direction B are different. Moreover, the catheter body 10 may partition a plurality of administration lumens 13, and the first discharge hole 15a and the second discharge hole 15b may communicate with separate administration lumens 13.

[0034] Furthermore, as shown in Figures 2B and 2F, the side wall of the catheter body 10 in this embodiment is partitioned with side holes 16 that allow fluid to be supplied to and discharged from the internal space 51 of the balloon 50. Hereinafter, in order to distinguish between side holes 12 and side holes 16, side hole 16 will be referred to as "supply / discharge hole 16". The supply / discharge hole 16 connects the fluid supply / discharge lumen 14 and the internal space 51 of the balloon 50. Two supply / discharge holes 16 are partitioned in the side wall of the catheter body 10 in this embodiment. The number of supply / discharge holes 16 partitioned in the side wall of the catheter body 10 may be appropriately changed according to the number of balloons 50. The two supply / discharge holes 16 in this embodiment are a first supply / discharge hole 16a located on the proximal end side and a second supply / discharge hole 16b located on the tip side. The first supply / discharge hole 16a connects the fluid supply / discharge lumen 14 and the internal space 51a of the first balloon 50a. The second supply / discharge port 16b connects the fluid supply / discharge lumen 14 to the internal space 51b of the second balloon 50b. Hereinafter, in this embodiment, unless otherwise specified, the first supply / discharge port 16a and the second supply / discharge port 16b will simply be referred to as "supply / discharge port 16".

[0035] As described above, the catheter body 10 of this embodiment has internally partitioned first insertion lumen 11a through which the first insertion body 30a can be inserted, second insertion lumen 11b through which the second insertion body 30b can be inserted, administration lumen 13 through which the administered substance can flow, and fluid supply / discharge lumen 14 through which fluid can be supplied to the balloon 50. In this embodiment, fluid is supplied to the first balloon 50a and the second balloon 50b from a single fluid supply / discharge lumen 14, but the configuration is not limited to this. The catheter body 10 may also have separately partitioned internally a fluid supply / discharge lumen through which fluid can be supplied to the first balloon 50a and a fluid supply / discharge lumen through which fluid can be supplied to the second balloon 50b.

[0036] Furthermore, as shown in Figures 2A to 2F, the administration lumen 13 of this embodiment is formed at the center of the radial direction C, including the central axis O of the catheter body 10. In addition, the insertion lumen 11 and the fluid supply / discharge lumen 14 of this embodiment are formed within the wall of the peripheral wall that partitions the administration lumen 13. Moreover, the first insertion lumen 11a and the second insertion lumen 11b of this embodiment are arranged at opposing positions in the radial direction C. However, the positional relationship of the insertion lumen 11, the administration lumen 13, and the fluid supply / discharge lumen 14 in a cross-section perpendicular to the central axis O is not particularly limited. For example, the first insertion lumen 11a and the second insertion lumen 11b may be arranged at positions that do not face each other in the radial direction C.

[0037] Furthermore, as shown in Figure 1, the catheter body 10 of this embodiment is provided with a first insertion port 17a at its proximal end, through which a first insertion body 30a can be inserted from the outside into the first insertion lumen 11a (see Figure 2A, etc.). Furthermore, the catheter body 10 of this embodiment is provided with a second insertion port 17b at its proximal end, through which a second insertion body 30b can be inserted from the outside into the second insertion lumen 11b (see Figure 2A, etc.). Furthermore, the catheter body 10 of this embodiment is provided with an injection port 17c at its proximal end, through which an administered substance can be injected into the administration lumen 13 (see Figure 2A, etc.). In addition, the catheter body 10 of this embodiment is provided with a fluid supply / discharge port 17d at its proximal end, through which fluid for the expansion and contraction of the first balloon 50a and the second balloon 50b can be supplied and discharged. A fluid supply / discharge device such as a syringe can be connected to the fluid supply / discharge port 17d.

[0038] More specifically, the catheter body 10 of this embodiment comprises a cylindrical tubular body 10a and a hub 10b to which the proximal end of the tubular body 10a is fixed. The first insertion lumen 11a, the second insertion lumen 11b, the administration lumen 13, and the fluid supply / discharge lumen 14 described above extend in the longitudinal direction A across the tubular body 10a and the hub 10b. The side holes 12, discharge holes 15, and supply / discharge holes 16 of this embodiment described above are partitioned in the side wall of the tubular body 10a. The hub 10b of this embodiment comprises the first insertion port 17a, the second insertion port 17b, the injection port 17c, and the supply / discharge port 17d described above. Furthermore, the hub 10b of this embodiment includes a hub body portion 17e to which the tips of the first insertion port portion 17a, the second insertion port portion 17b, the inlet portion 17c, and the supply / discharge port portion 17d described above are fixed, and to which the base end of the tubular body 10a is fixed.

[0039] The tubular body 10a of the catheter body 10 is preferably made of a flexible material, but the material is not particularly limited. Examples of constituent materials include various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based materials, and combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.) can also be used. In addition, a hydrophilic lubricating coating layer that exhibits lubricity when wet may be placed on the outer surface of the tubular body 10a.

[0040] The constituent material of the hub 10b of the catheter body 10 is not particularly limited, but examples include resin materials such as polyethylene, polypropylene, polyolefins such as ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyester, polycarbonate, polybutadiene, polyvinyl chloride, and polyacetal.

[0041] [Insertable body 30] As shown in Figure 1, the insertion body 30 of this embodiment comprises a long, rod-shaped insertion body portion 32 and an expansion portion 31 attached to the tip of the insertion body portion 32. More specifically, the first insertion body 30a of this embodiment comprises a first insertion body portion 32a and a first expansion portion 31a. The second insertion body 30b of this embodiment comprises a second insertion body portion 32b and a second expansion portion 31b. Hereafter in this embodiment, unless the first insertion body portion 32a and the second insertion body portion 32b are specifically distinguished, they will simply be referred to as "insertion body portion 32".

[0042] Figures 3 and 4 are cross-sectional views showing a cross-section of the catheter 100 along its longitudinal direction A. Figure 3 shows the expanded portion 31 of the insertion body 30 positioned in the catheter withdrawal direction A2 through the side hole 12. Figure 4 shows the expanded portion 31 of the insertion body 30 expanded radially outward through the side hole 12. Figures 3 and 4 also show the catheter 100 inserted into the blood vessel BV and the balloon 50 expanded. Furthermore, for ease of explanation, Figures 3 and 4 show the insertion body 30 in a side view. As shown in Figures 1 to 4, the side hole 12 in this embodiment is a slit. Specifically, the side hole 12 in this embodiment is a slit extending along the longitudinal direction A.

[0043] As shown in Figures 1, 3, and 4, the expansion portion 31 of this embodiment comprises a hinge portion 41, a pivot portion 42 rotatably attached to the insertion body portion 32 via the hinge portion 41, and a membrane-like portion 43 spanning between the pivot portion 42 and the insertion body portion 32. The pivot portion 42 of this embodiment is a rod-shaped body extending substantially parallel to the insertion body portion 32. The base end of the pivot portion 42 is attached to the insertion body portion 32 via the hinge portion 41. Therefore, the pivot portion 42 of this embodiment is configured to be rotatable relative to the insertion body portion 32 with its tip end as a pivot point. By rotating the pivot portion 42 from a state where it extends substantially parallel to the insertion body portion 32 (see Figure 3), the membrane-like portion 43 can be unfolded from a folded state, as shown in Figure 4. The state change of the membrane portion 43 between the folded state (see Figure 3) and the unfolded state (see Figure 4) can be achieved, for example, by pre-forming bellows-like folds in the membrane portion 43. In this way, the expandable portion 31 can be deformed like a folding fan by the hinge portion 41, the rotating portion 42, and the membrane portion 43. The expandable portion 31 of this embodiment can change its state between a contracted state (see Figure 3) in which it does not protrude radially C outward from the catheter body 10 through the side hole 12, and an expanded state (see Figure 4) in which it expands to protrude radially C outward from the catheter body 10 through the side hole 12. Preferably, the angle in which the rotating portion 42 can rotate relative to the insertion body portion 32 with respect to the hinge portion 41 is 60° to 180°. In this embodiment, moving the insertion body 32 in the catheter insertion direction A1 increases the length of the rotating part 42 in the longitudinal direction A that enters the region where the side hole 12 is located in the longitudinal direction A. Therefore, moving the insertion body 32 in the catheter insertion direction A1 increases the angle at which the rotating part 42 can rotate around the hinge part 41 without being obstructed by the catheter body 10. Thus, the rotatable angle of the rotating part 42 may gradually increase as the insertion body 32 is moved in the catheter insertion direction A1.

[0044] Figure 5 shows a front view of the slit of the catheter 100, with the slit serving as the side hole 12 viewed from the front. As shown in Figure 5, in a front view of the slit with the expansion portion 31 expanding through the slit serving as the side hole 12 (see Figure 4), the length L1 of the slit serving as the side hole 12 in the extending direction D is longer than the length L2 of the expansion portion 31 in the extending direction D. In other words, the insertion body 30 of this embodiment can move along the extending direction D of the slit serving as the side hole 12 while the expansion portion 31 is protruding outward in the radial direction C of the catheter body 10 through the slit serving as the side hole 12. In this way, the expansion portion 31 can be moved within the blood vessel by moving the insertion body 30 relative to the catheter body 10 without moving the catheter body 10 itself. As a result, the administered substance can be agitated into the blood vessel by the expansion portion 31 of the insertion body 30 without moving the catheter body 10 within the blood vessel.

[0045] The rotating part 42 may be biased to be in an unfolded state (see Figure 4) by an elastic member such as a coil spring. In other words, the expansion part 31 may be kept in a folded state (see Figure 3) against the elastic force of the elastic member by the inner surface that partitions the insertion lumen 11 within the insertion lumen 11. The expansion part 31 may be configured to expand outward in the radial direction C at the position of the side hole 12 by the restoring force of the elastic member. In this case, when contracting the expansion part 31 from the unfolded state (see Figure 4) to the folded state (see Figure 3), the insertion body 30 should be moved in the catheter removal direction A2. In this way, the rotating part 42 is pressed against the inner surface of the tubular body 10a that partitions the side hole 12, and rotates relative to the hinge part 41 from the unfolded state (see Figure 4) to the folded state (see Figure 3), and is drawn into the insertion lumen 11. In other words, the rotating part 42 begins to fold when it comes into contact with the base end of the side hole 12, and is drawn into the insertion lumen 11, which has a smaller diameter than the side hole 12, thereby becoming folded.

[0046] The configuration of the expansion portion 31 is not particularly limited, as long as it can be inserted through the insertion lumen 11 and expand radially outward from the catheter body 10 through the side hole 12. Figure 6 shows a modified example of the expansion portion 31, namely 131. Figure 6, like Figure 5, shows a front view of the slit of the catheter 100. In the front view of the slit shown in Figure 6, the membrane portion 143 of the expansion portion 131 includes a stirring surface 143a, in which at least one surface in the thickness direction extends in a direction intersecting the extending direction D of the slit, which serves as the side hole 12, when the expansion portion 131 is expanded through the slit, which serves as the side hole 12. In this way, by moving the expansion portion 131 in the extending direction D of the slit, the administered substance administered into the blood vessel can be stirred more efficiently by the stirring surface 143a. The stirring surface 143a of the film-like portion 143 can be realized, for example, by causing the expanded portion 131 to twist in the circumferential direction B as it protrudes radially outward from the slit as a side hole 12. Such twisting of the expanded portion 131 can be realized, for example, by causing the tip of the rotating portion 142 to twist in the circumferential direction B as it rotates radially outward from the base end of the rotating portion 142 as a fulcrum. The stirring surface 143a of the film-like portion 143 may also be realized by other methods.

[0047] Figure 7 shows an expansion section 231 as another modified example of the expansion section 31. The expansion section 231 shown in Figure 7 is configured to change the folded state and unfolded state (see Figure 7) of the membrane section 243 by rotating it with a plane perpendicular to the extending direction D of the slit, which serves as the side hole 12, as the rotation plane. In this way, a wide stirring surface 243a of the membrane section 243 can be secured. Therefore, by moving the insertion body 30 in the extending direction D within the slit, which serves as the side hole 12, the administered substance administered into the blood vessel can be stirred more efficiently. The bent tip 234 of the insertion body 232 and the rotating part 242 are configured to extend along the circumferential direction B when the membrane section 243 is in the folded state.

[0048] Furthermore, the expansion portion 31 is not limited to the configuration described above. The expansion portion 31 may be made of a shape memory alloy that maintains an elastically deformed state within the insertion lumen 11 and is capable of protruding radially outward C by a restoring force at the position of the side hole 12.

[0049] As described above, the catheter 100 of this embodiment is equipped with two insertion bodies 30. Specifically, the catheter 100 of this embodiment is equipped with a first insertion body 30a that can be inserted into the first insertion lumen 11a of the catheter body 10, and a second insertion body 30b that can be inserted into the second insertion lumen 11b of the catheter body 10. As shown in Figure 8, when the catheter 100 is equipped with multiple insertion bodies 30, it is preferable to be equipped with a handle portion 60 to which these multiple insertion bodies 30 are connected. The handle portion 60 is connected to the proximal end of the insertion body 30 that protrudes from the catheter body 10 in the catheter withdrawal direction A2 when the insertion body 30 is inserted into the insertion lumen 11. With such a handle portion 60 provided, medical professionals such as doctors can move multiple insertion bodies 30 simultaneously in the longitudinal direction A by operating the handle portion 60. In other words, each of the expansion portions 31 (see Figure 1, etc.) of the multiple insertion bodies 30 can be expanded simultaneously through their respective side holes 12. Furthermore, when the expansion portions 31 of multiple insertion bodies 30 are all in the expanded state, the handle portion 60 can be operated to simultaneously change all of the expansion portions 31 of the multiple insertion bodies 30 to the retracted state. In this way, the provision of the handle portion 60 makes it easier to operate the multiple insertion bodies 30.

[0050] [Balloon 50] The balloon 50 is attached to the catheter body 10. As described above, the balloon 50 can be expanded and contracted radially C by supplying and discharging fluid through the fluid supply and discharge lumen 14 of the catheter body 10. Specifically, the balloon 50 can be expanded outward radially C by supplying fluid to the internal space of the balloon 50 through the fluid supply and discharge lumen 14. Figures 1, 3, and 4 show the expanded state of the first balloon 50a and the second balloon 50b. Furthermore, when the balloon 50 is expanded, the balloon 50 contracts inward radially C by discharging fluid from the internal space 51 of the balloon 50 through the fluid supply and discharge lumen 14 of the catheter body 10. In the contracted state, the balloon 50 may be folded so as to wrap around the tubular body 10a of the catheter body 10. In this embodiment, the catheter 100 is inserted into a blood vessel BV (see Figures 3 and 4) with the balloon 50 in a contracted state and delivered to a predetermined area within the blood vessel BV.

[0051] As shown in Figure 1 and other figures, the first balloon 50a and the second balloon 50b of this embodiment are attached to the catheter body 10 on both sides in the longitudinal direction A of the catheter body 10 with respect to the side holes 12. In other words, all the side holes 12 (first side holes 12a and second side holes 12b in this embodiment) partitioned by the catheter body 10 of this embodiment are formed between the first balloon 50a and the second balloon 50b in the longitudinal direction A. Also, all the discharge holes 15 (first discharge hole 15a and second discharge hole 15b in this embodiment) partitioned by the catheter body 10 of this embodiment are formed between the first balloon 50a and the second balloon 50b in the longitudinal direction A. With this configuration, as shown in Figures 3 and 4, a region unaffected by blood flow can be formed between the first balloon 50a and the second balloon 50b, which are in an expanded state within the blood vessel BV. Furthermore, with the catheter 100, the administered substance can be administered through the discharge holes 15 to this region unaffected by blood flow. Furthermore, with the catheter 100, the administered substance can be agitated by the expandable portion 31 of the insertion body 30 in an area unaffected by blood flow. Therefore, by creating this area unaffected by blood flow near the treatment site and agitating the administered substance within this area using the expandable portion 31, the administered substance can be delivered to the treatment site more efficiently.

[0052] The balloon 50 is preferably formed from a material having a certain degree of flexibility. Examples of such materials include engineering plastics, such as polyolefins like polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these; thermoplastic resins such as flexible polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, and fluororesin; silicone rubber; and latex rubber.

[0053] <An example of how to use Catheter 100> Next, with reference to Figures 9A to 9E, an example of how to use the catheter 100 shown in Figure 1 will be explained.

[0054] Figure 9A shows the catheter 100 inserted to a predetermined area within the blood vessel BV. More specifically, it shows the catheter 100 inserted into the blood vessel BV such that the area between the first balloon 50a and the second balloon 50b is near the treatment site. As shown in Figure 9A, when inserting the catheter 100 into the blood vessel BV, the first balloon 50a and the second balloon 50b are in a deflated state. Also, when inserting the catheter 100 into the blood vessel BV, the insertion body 30 is inserted through the insertion lumen 11. In other words, both the tubular body 10a of the catheter body 10 and the insertion body 30 may be inserted into the blood vessel BV. However, when inserting the catheter 100 into the blood vessel BV, the expansion portion 31 of the insertion body 30 is positioned in the catheter withdrawal direction A2 relative to the side hole 12.

[0055] Figure 9B shows the balloon 50 expanded from the state shown in Figure 9A. In other words, Figure 9B shows a state in which a region unaffected by blood flow is formed between the first balloon 50a and the second balloon 50b. As shown in Figure 9B, in this state, the administered substance X is discharged through the discharge port 15. This allows the administered substance X to remain in a predetermined region within the blood vessel BV without being affected by blood flow.

[0056] Figure 9C shows the state in which the administered substance X is agitated by the expandable portion 31 after moving the insertion body 30 in the catheter insertion direction A1 from the state shown in Figure 9B, expanding the expandable portion 31 radially outward through the side hole 12, and then moving the insertion body 30 in the longitudinal direction A. By being agitated by the expandable portion 31, the administered substance X is less likely to accumulate near the tubular body 10a. As a result, the administered substance X is more easily taken up by the surrounding vascular endothelium.

[0057] Figure 9D shows the state in which the expansion portion 31 of the insertion body 30 is retracted and pulled back into the insertion lumen 11, compared to the state shown in Figure 9C. This state is maintained, for example, for a predetermined time. This allows a desired amount of the administered substance X to be delivered to the treatment area.

[0058] Figure 9E shows the balloon 50 deflated from the state shown in Figure 9D. This restores blood flow. Next, the catheter 100 is removed from the body. This completes the treatment.

[0059] The catheters relating to this disclosure are not limited to the specific configurations shown in the embodiments and modifications described above, and various modifications, changes, and combinations are possible as long as they do not depart from the scope of the claims. For example, the catheter 100 described above includes a balloon 50 attached to the catheter body 10, but is not limited to this configuration. As shown in Figure 10, the catheter 100 may have a configuration that includes a catheter body 10 and an insertion body 30, but does not include a balloon 50. In such a case, the catheter 100 can be used in combination with another catheter that includes a balloon to perform the treatments shown in Figures 9A to 9E described above. [Industrial applicability]

[0060] This disclosure relates to catheters. [Explanation of Symbols]

[0061] 10: Catheter body 10a: Tubular body 10b: Hub 11: Insertion lumens 11a: First insertion lumen 11b: Second insertion lumen 12: Side hole 12a: 1st side hole 12b: 2nd side hole 13: Administration Lumen 14: Fluid supply and discharge lumens 15: Discharge hole 15a: 1st discharge hole 15b: 2nd discharge hole 16: Supply / discharge hole 16a: 1st supply / discharge hole 16b: 2nd supply / discharge hole 17a: First insertion port 17b: Second insertion port 17c: Inlet part 17d: Supply / discharge port 17e: Hub body 30: Insertion body 30a: First insertion body 30b: Second insertion body 31, 131, 231: Extension section 31a: First extension 31b: Second extension 32, 232: Insertion body 32a: First insertion body 32b: Second insertion body 41: Hinge section 42, 142, 242: Rotating parts 43:143, 243: Membrane 50: Balloon 50a: First balloon 50b: Second balloon 51: Interior space 51a: Internal space of the first balloon 51b: Internal space of the second balloon 60: Handle section 100: Catheter 143a, 243a: Stirring surface 234: Tip of the insertion body A: Long direction A1: Catheter insertion direction A2: Catheter removal direction B: Circumferential direction C: Radial direction D: Direction of extension of the slit BV: Blood vessel L1: Length of the slit in the direction of extension of the slit L2: Length of the extended portion in the direction of extension of the slit O: Central axis X: administered substance

Claims

1. The catheter body, which partitions the insertion lumen inside, It comprises an insertion body that can be inserted into the insertion lumen, The side wall of the catheter body comprises a side hole that connects the insertion lumen to the outside of the catheter body. The insertion body is a catheter having an expandable portion that can expand radially outward from the catheter body through the side hole.

2. The catheter according to claim 1, wherein the side hole is a slit.

3. The catheter according to claim 2, wherein, in a front view of the slit while the expansion portion is expanded through the slit, the length of the slit in the extending direction is longer than the length of the expansion portion in the extending direction.

4. The catheter according to claim 3, wherein the expanded portion, when expanded through the slit, comprises a membrane-like portion including a stirring surface on at least one surface in the thickness direction that extends in a direction intersecting the extending direction of the slit when viewed from the front of the slit.

5. The insertion body comprises an insertion body portion to which the expansion portion is attached at the tip, The aforementioned extension is The hinge part, A rotating part is rotatably attached to the insertion body via the hinge portion, A catheter according to any one of claims 1 to 4, comprising a membrane-like portion stretched between the rotating portion and the insertion body portion.

6. The catheter according to any one of claims 1 to 4, wherein the side wall of the catheter body comprises an outlet through which an administered substance administered to a living body can be discharged.

7. The catheter body has an internally partitioned administration lumen through which the administered substance can flow, separate from the insertion lumen. The catheter according to claim 6, wherein the discharge port is in communication with the administration lumen.

8. The catheter according to any one of claims 1 to 4, comprising a first balloon and a second balloon that are attached to the catheter body on both sides in the longitudinal direction of the catheter body with respect to the side holes and are expandable in the radial direction.

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