Balloon catheter

Abstract

To provide a balloon catheter which can suppress kinking of a long part.SOLUTION: A balloon catheter 10 includes a balloon 22 which can expand in a radial direction, a long, solid core metal 20 having the balloon 22 on a distal end part, and a long expansion tube 24 for supplying an expansion fluid to the balloon 22, and the solid core metal 20 and the expansion tube 24 are arranged coaxially or in parallel at least in one part in a long axis direction. The balloon 22 is hermetically sealed with a distal end part fixed on the solid core metal 20 and is hermetically sealed with a proximal end part fixed on the solid core metal 20 and the expansion tube 24.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a balloon catheter having an expandable balloon inserted into a living body lumen.

Background Art

[0002] For improving a lesion (stenosis) occurring in a living body lumen, a balloon catheter having a balloon at its tip is widely used. The balloon catheter includes a long shaft portion and a balloon provided at the tip side of the shaft portion and expandable in the radial direction. The balloon catheter can expand the contracted balloon after reaching the target location in the body via a thin living body lumen, thereby expanding the lesion.

[0003] Also, as a balloon catheter, a trapping balloon catheter that expands the balloon inside a guiding catheter for use is also known. As such a trapping balloon catheter, for example, there is one described in Patent Document 1.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] A balloon catheter has a tubular shaft with an expansion lumen through which an expansion fluid flows, and a balloon is provided at the tip of the shaft. By forming the shaft of the balloon catheter with a rigid tube, it achieves both catheter maneuverability and the provision of an expansion lumen. However, when the balloon catheter is advanced to a highly curved section, the shaft may kink. Thus, with conventional balloon catheters, kinking in the long section can prevent the force from being transmitted from the proximal end to the tip.

[0006] This invention was made to solve the above-mentioned problems and aims to provide a balloon catheter that can suppress kinking in the long portion. [Means for solving the problem]

[0007] The balloon catheter according to the present invention, which achieves the above objective, comprises a balloon expandable in the radial direction, a long solid core having the balloon at its tip, and a long expansion tube for supplying expansion fluid to the balloon, wherein the solid core and the expansion tube are arranged coaxially or parallel in at least a portion of the longitudinal direction. The balloon is sealed with its tip fixed to the solid core and its base fixed to the solid core and the expansion tube. ru. [Effects of the Invention]

[0008] In the balloon catheter constructed as described above, the solid core metal that ensures the rigidity of the long portion does not kink, thus suppressing kinking of the long portion.

[0009] before The balloon is sealed with its tip fixed to the solid core and its base fixed to the solid core and the expansion tube. ru This allows the balloon catheter to seal the balloon by removing the lumen of the expansion tube, enabling the balloon to be expanded and deflated radially using the expansion tube.

[0010] (2) Another embodiment of the balloon catheter according to the present invention that achieves the above objective comprises a radially expandable balloon, a long solid core having the balloon at its tip, and a long expansion tube for supplying expansion fluid to the balloon, wherein the solid core and the expansion tube are arranged coaxially or parallel in at least a portion of the longitudinal direction, The expansion tube has a smaller outer diameter than the solid core metal. Sai This allows the balloon catheter to have a smaller cross-sectional area when cut in a plane perpendicular to the long axis of the solid core and expansion tube, making it easier to insert other devices within the guiding catheter.

[0011] ( 3 ) (1) or (2) In the balloon catheter described above, the expansion tube may have a portion of its longitudinal axis wrapped around the solid core. This allows the balloon catheter to be inserted integrally with the solid core and the expansion tube, thereby preventing it from getting caught on other devices.

[0012] ( 4 ) (1) or (2) In the balloon catheter described above, at least a portion of the expansion tube in the longitudinal direction may be tightly fixed to the solid core. This allows the balloon catheter, with the solid core and the expansion tube, to be inserted integrally, thereby preventing it from getting caught on other devices. [Brief explanation of the drawing]

[0014] [Figure 1] This is a front view showing the overall structure of a balloon catheter. [Figure 2] This is a magnified cross-sectional view of the tip of a balloon catheter. [Figure 3] This is a front view showing the overall configuration of the balloon catheter according to the first modified example. [Figure 4] This is an enlarged cross-sectional view of the long portion of the balloon catheter according to the first modified example. [Figure 5] This is an enlarged cross-sectional view of the hub area of ​​the balloon catheter according to the first modified example. [Figure 6] This is an enlarged cross-sectional view of the tip area of ​​the balloon catheter according to the first modified example. [Figure 7] This is a front view showing the overall configuration of the balloon catheter according to the second modified example. [Figure 8]It is a front view showing the overall configuration of the balloon catheter according to the third modification example.

Mode for Carrying Out the Invention

[0015] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may be different from the actual ratios. In this specification, the side inserted into the living body lumen of the balloon catheter 10 will be referred to as the "tip" or "tip side", and the hand side for operation will be referred to as the "base end" or "base end side".

[0016] First, the configuration of the balloon catheter 10 will be described. As shown in FIG. 1, the balloon catheter 10 has a long solid core wire 20, a balloon 22 provided at the tip of the solid core wire 20, and a long expansion tube 24 connected to the balloon 22. A first hub 26 is provided at the base end of the solid core wire 20, and a second hub 28 is provided at the base end of the expansion tube 24. The solid core wire 20 and the expansion tube 24 are arranged in parallel at least in part in the long axis direction.

[0017] The balloon catheter 10 of the present embodiment is a trapping balloon catheter in which a long solid core wire 20 and an expansion tube 24 are inserted into a guiding catheter inserted into a living organ, and a balloon 22 provided at the tip of the solid core wire 20 is radially expanded within the guiding catheter.

[0018] The solid core wire 20 is formed of a solid long body having no lumen. Among the solid core wire 20, the portion on the base end side of the balloon 22 is a long portion 30 having a constant diameter. As shown in FIG. 2, in the solid core wire 20, the vicinity of the balloon 22 is a tapered portion 32 whose diameter gradually decreases toward the tip side. Among the solid core wire 20, the portion on the tip side of the balloon 22 is a tip portion 33 exposed from the balloon 22. Note that the tip portion of the balloon catheter 10 may be provided with a tip chip without exposing the tip portion 33 of the solid core wire 20.

[0019] The expansion tube 24 has a smaller outer diameter than the solid core metal 20 and has an expansion lumen 25 along its long axis. The tip of the expansion tube 24 is positioned inside the balloon 22, and the expansion lumen 25 communicates with the inside of the balloon 22.

[0020] The balloon 22 has an expandable / contractable section 40 that can expand and contract radially, a balloon tip 42, and a balloon base 44. The balloon tip 42 is fixed to and sealed by a solid core 20. The balloon base 44 is fixed to and sealed by the solid core 20 and the expansion tube 24. As a result, the balloon 22 is sealed except for its communication with the expansion lumen 25 of the expansion tube 24.

[0021] By injecting an expansion fluid into the balloon 22 through the expansion lumen 25, the balloon 22 can be expanded radially. The expansion fluid can be a gas or a liquid; for example, gases such as helium, CO2, or O2, or liquids such as saline solution or contrast agents can be used.

[0022] The solid core 20 is preferably made of a material with a certain degree of flexibility. Examples of materials for the solid core 20 include stainless steel, NiTi alloy, and PEEK resin. However, the solid core 20 may be made of materials other than these. The outer diameter of the solid core 20 is approximately 0.1 mm to 0.6 mm. However, the outer diameter of the solid core 20 is not limited to this range.

[0023] The expansion tube 24 is preferably made of a material with a certain degree of flexibility. Examples of such materials include polyamide, polypropylene, PEEK resin, and polyimide. However, the expansion tube 24 may be made of materials other than these. The inner diameter of the expansion tube 24 is approximately 0.2 mm to 0.3 mm, and the outer diameter is approximately 0.4 mm to 0.6 mm. However, the inner and outer diameters of the expansion tube 24 are not limited to these ranges.

[0024] The balloon 12 is formed from a thin balloon membrane and, like the expansion tube 24, is made from a flexible material. The material of the balloon 22 can be one of those listed above for the expansion tube 24, or it may be a different material.

[0025] In this embodiment, the balloon catheter 10 can prevent kinking because the solid core metal 20 is solid. Furthermore, because the rigidity of the long portion of the balloon catheter 10 can be ensured by the solid core metal 20, the expansion tube 24 can be formed to be small in diameter and flexible. As a result, the area occupied by the cross-section of the balloon catheter 10 when cut with a plane perpendicular to the long axis direction of the long portion can be reduced. Since multiple devices such as guide wires and other catheters are inserted into the guiding catheter into which the balloon catheter 10 is inserted, reducing the area occupied by the balloon catheter 10 makes it easier to insert other devices into the guiding catheter.

[0026] Next, a balloon catheter 50 according to the first modified example will be described. As shown in Figure 3, the balloon catheter 50 has a balloon 52 at the tip of a solid core 51 and a hub 55 at the base. The expansion tube 53 is arranged coaxially, covering the outer circumference of the long portion 60 of the solid core 51.

[0027] As shown in Figure 4, the solid core metal 51 has grooves 61 on the outer circumferential surface of the elongated portion 60. The grooves 61 are formed in a continuous helical shape along the long axis of the solid core metal 51. When the expansion tube 53 covers the outer circumference of the solid core metal 51, an expansion lumen 54 is formed by the gap between the inner circumferential surface of the expansion tube 53 and the grooves 61 of the solid core metal 51. Note that the grooves 61 do not have to be helical as long as they are continuous along the long axis of the solid core metal 51; for example, they may be linear along the long axis of the solid core metal 51. In this case, multiple grooves 61 may be formed in the circumferential direction.

[0028] As shown in Figure 5, the solid core metal 51 is fixed to the inner circumferential surface of the hub 55 at the base end fixing portion 64. The expansion tube 53 extends into the interior of the hub 55, and its outer circumferential surface is fixed to the inner circumferential surface of the hub 55. The groove 61 is continuous into the interior of the hub 55. Inside the hub 55, the groove 61 is exposed on the base end side of the expansion tube 53. Therefore, the expansion fluid injected into the hub 55 from a syringe or the like can flow from the groove 61 towards the expansion lumen 54.

[0029] As shown in Figure 6, the solid core 51 has a tapered end 62 that narrows in diameter towards the tip near the balloon 52. The gap formed between the tapered end 62 and the expansion tube 53 forms the expansion lumen 54. The expansion lumen 54 formed between the tapered end 62 and the expansion tube 53 communicates with the expansion lumen 54 formed between the groove 61 and the expansion tube 53. The balloon 52 is sealed by fixing the balloon tip 52a and balloon base end 52b to the solid core 51. This allows the balloon 52 to be expanded by the expansion fluid injected from the expansion lumen 54.

[0030] Next, a balloon catheter 70 relating to a second modified example will be described. As shown in Figure 7, the balloon catheter 70 has a balloon 72 at the tip of a solid core 71 and a first hub 74 at the base of the solid core 71. The balloon catheter 70 also has an expansion tube 73 connected to the balloon 72 and a second hub 75 provided at the base of the expansion tube 73. The expansion tube 73 is wrapped around the solid core 71.

[0031] In this example, the outer diameter of the solid core 71 is set to 0.1 mm to 0.6 mm, and the inner diameter of the expansion tube 73 is set to 0.2 mm to 0.3 mm and the outer diameter to 0.4 mm to 0.6 mm. However, the dimensions are not limited to these.

[0032] This balloon catheter 70 allows the solid core metal 71 and the expansion tube 73 to be inserted integrally by wrapping a portion of the expansion tube 73 along its long axis around the solid core metal 71, thereby preventing it from getting caught on other devices.

[0033] Next, a balloon catheter 80 relating to a third modified example will be described. As shown in Figure 8, the balloon catheter 80 has a balloon 82 at the tip of a solid core 81 made of a guide wire, and an expansion tube 83 is tightly fixed to the solid core 81. A hub 84 is provided at the base end of the expansion tube 83. The base end of the solid core 81 is located on the tip side of the hub 84, but it may extend into the interior of the hub 84.

[0034] In this example, the outer diameter of the guide wire, which forms the solid core 81, is set to 0.36 mm to 0.90 mm, and the inner diameter of the expansion tube 83 is set to 0.2 mm to 0.3 mm and the outer diameter to 0.4 mm to 0.6 mm. However, the dimensions are not limited to these.

[0035] In this balloon catheter 80, a portion of the expansion tube 83 along its long axis is tightly fixed to the solid core wire 81, allowing the solid core wire 81 to be inserted integrally with the expansion tube 83, thus preventing it from getting caught on other devices. Furthermore, since the solid core wire 81 of this balloon catheter 80 is a guidewire, it can also be inserted into narrowed areas of blood vessels such as coronary arteries and peripheral blood vessels for treatment.

[0036] As described above, the balloon catheter 10 in embodiment (1) of this embodiment includes a radially expandable balloon 22, a long solid core 20 having the balloon 22 at its tip, and a long expansion tube 24 for supplying expansion fluid to the balloon 22, wherein the solid core 20 and the expansion tube 24 are arranged coaxially or parallel in at least a portion of the longitudinal direction. With the balloon catheter 10 configured in this way, the solid core 20 that ensures the rigidity of the long portion does not kink, thus suppressing kinking of the long portion.

[0037] In embodiment (2), the balloon catheter 10 is configured such that, in the balloon catheter 10 of embodiment (1), the tip of the balloon 22 is fixed and sealed to the solid core metal 20, and the base of the balloon 22 is fixed and sealed to the solid core metal 20 and the expansion tube 24. As a result, the balloon catheter 10 can seal the balloon 22 except for the lumen of the expansion tube 24, so that the balloon 22 can be expanded and contracted radially using the expansion tube 24.

[0038] In embodiment (3), the balloon catheter 10 is such that, in embodiment (1) or embodiment (2), the expansion tube 24 has a smaller outer diameter than the solid core 20. As a result, the balloon catheter 10 can reduce the area occupied by the cross-section when cut in a plane perpendicular to the long axis of the solid core 20 and the expansion tube 24, making it easier to insert other devices within the guiding catheter.

[0039] The balloon catheter 70 of embodiment (4) is an embodiment of the balloon catheters of embodiments (1) to (3) in which the expansion tube is wrapped around a solid core in the longitudinal direction. As a result, the balloon catheter 70 can be inserted integrally with the solid core 71 and the expansion tube 73, thereby preventing it from getting caught on other devices.

[0040] In embodiment (5), the balloon catheter 80 is such that, compared to the balloon catheters of embodiments (1) to (3), at least a portion of the expansion tube 83 in the longitudinal direction is tightly fixed to the solid core metal 81. As a result, the balloon catheter 80 can be inserted integrally with the solid core metal 81 and the expansion tube 83, thus preventing it from getting caught on other devices.

[0041] The balloon catheter 50 of embodiment (6) is the same as the balloon catheter of embodiment (1), but the solid core metal 51 has a groove 61 on its outer circumference that is continuous along the long axis, and the expansion tube 53 is arranged coaxially to cover the outer circumference of the solid core metal 51 and forms an expansion lumen 54 between itself and the groove 61 through which expansion fluid flows. As a result, the outer diameter of the elongated portion having the expansion lumen 54 of the balloon catheter 50 can be reduced, making it easier to insert other devices inside the guiding catheter.

[0042] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. [Explanation of symbols]

[0043] 10 Balloon catheter 20 Solid core metal 22 Balloons 24 Expansion tubes 25 Extended Lumens 26 First Hub 28. Second Hub 30 Long section 32. Details 33 Tip 40 Expand / contract section 42 Balloon tip 44 Balloon base

Claims

1. A balloon that can expand radially, A long solid core metal having the aforementioned balloon at its tip, The balloon has a long expansion tube that supplies expansion fluid to the balloon, The solid core and the expansion tube are arranged coaxially or parallel to each other in at least a portion of the longitudinal direction. The balloon catheter is characterized in that the tip of the balloon is fixed to the solid core and sealed, and the base of the balloon is fixed to the solid core and the expansion tube and sealed.

2. A balloon that can expand radially, A long solid core metal having the aforementioned balloon at its tip, The balloon has a long expansion tube that supplies expansion fluid to the balloon, The solid core and the expansion tube are arranged coaxially or parallel to each other in at least a portion of the longitudinal direction. The aforementioned expansion tube is a balloon catheter with an outer diameter smaller than that of the solid core metal.

3. The balloon catheter according to claim 1 or 2, wherein a portion of the expansion tube in the longitudinal direction is wrapped around the solid core metal.

4. The balloon catheter according to claim 1 or 2, wherein at least a portion of the expansion tube in the longitudinal direction is tightly fixed to the solid core metal.

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