Balloon catheter

Abstract

To provide a balloon catheter of a new structure capable of efficiently controlling a deformation volume of a balloon in a stable manner.SOLUTION: In a balloon catheter 10 in which a balloon 12 is provided on a distal end side of a shaft 14, a first control body 32 extending in a length direction of the balloon 12 and a second control body 34 composed of a braided body are mutually separate bodies, and the first and second control bodies 32 and 34 are mounted, positioned with respect to the balloon 12.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] The present invention relates to a balloon catheter having a balloon provided on the distal end side of a shaft.

Background Art

[0002] Conventionally, a balloon catheter has been known as a medical instrument for expanding a stenotic portion of a blood vessel. As proposed in, for example, Japanese Patent Application Laid-Open No. 5-84304 (Patent Document 1), the balloon catheter has a balloon provided on the distal end side of a shaft, and the stenotic portion is expanded by expanding the balloon at the stenotic portion of the blood vessel.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, in the balloon catheter as described above, it is preferable that, for example, the amount of deformation in the longitudinal direction or the radial direction of the balloon is controlled so that the shape of the balloon after inflation and the like become a preset shape and the like according to the patient's symptoms and the like. Specifically, in a patient in whom calcification of the blood vessel has progressed and the stenotic portion has become hard, it is necessary to expand the stenotic portion with a greater pressure, and even when the pressure inside the balloon is higher than normal, it is desirable that the amount of deformation in the longitudinal direction or the radial direction of the balloon is appropriately controlled so that the balloon becomes a preset shape.

[0005] The problem to be solved by the present invention is to provide a balloon catheter having a novel structure that can stably and efficiently control the amount of deformation of the balloon.

Means for Solving the Problems

[0006] Hereinafter, preferred embodiments for understanding the present invention will be described. However, each of the embodiments described below is described by way of example, and not only can they be adopted in appropriate combinations with each other, but also for the plurality of components described in each embodiment, they can be recognized and adopted independently as much as possible, and can also be adopted in combination with any of the components described in other embodiments as appropriate. Thus, in the present invention, various other embodiments can be realized without being limited to the embodiments described below.

[0007] A first aspect is a balloon catheter provided with a balloon on the distal end side of a shaft, in which a first control body extending in the longitudinal direction of the balloon and a second control body composed of a braided body are separate from each other, and these first and second control bodies are positioned and attached to the balloon.

[0008] According to the balloon catheter having the structure according to this aspect, while controlling the amount of deformation in the longitudinal direction of the balloon by the first control body, and controlling the amount of deformation in the radial direction of the balloon by the second control body, it is possible to increase the pressure inside the balloon while maintaining a predetermined shape. Further, since the first control body and the second control body are separate from each other, it is possible to efficiently control the amount of deformation in the longitudinal direction of the balloon and the amount of deformation in the radial direction separately, and for example, it becomes easy to appropriately set the amount of deformation in the longitudinal direction and the radial direction of the balloon according to the characteristics required for the balloon.

[0009] Note that examples of the braided body in the present invention include knitted fabrics, cords, woven fabrics, etc. made of a plurality of filaments. That is, the current technologies of knitting, weaving, and braiding have blurred category boundaries and each term is not interpreted restrictively, and for braiding, the techniques and configurations of knitting and weaving can be adopted alone or in combination.

[0010] A second aspect is the balloon catheter according to the first aspect, in which the first control body is integrally formed with the balloon.

[0011] According to the balloon catheter structured according to this aspect, it is possible to omit the troublesome procedure of separately forming and subsequently fixing the first control body. Further, it is possible to prevent the first control body from detaching from the balloon, and for example, it is possible to avoid fragments of the first control body flowing within the blood vessel. Furthermore, since the first control body is integrally formed with the balloon, it has biocompatibility, and for example, since there is no need to fix the first control body to the balloon using an adhesive, heat, or light, the composition of the balloon and the first control body does not denature, and it is also possible to provide a balloon catheter that is safe for the patient.

[0012] A third aspect is the balloon catheter according to the first or second aspect, in which the first control body is provided on the inner peripheral side of the balloon.

[0013] According to the balloon catheter structured according to this aspect, it is possible to greatly suppress the amount of protrusion of the first control body to the outer peripheral side of the balloon, and the insertability within the blood vessel is improved. Further, since it is also possible to avoid the first control body partially protruding in the circumferential direction to the outer peripheral side of the balloon, it is also possible to expand the stenotic portion substantially uniformly over the entire circumference in the circumferential direction when the balloon expands.

[0014] Also, it is possible to improve the rigidity of the balloon at the formation position of the first control body, and it is also possible to control the shape of the balloon after contraction. Thereby, it is also possible to avoid the balloon being caught on the blood vessel wall when the balloon catheter is removed or reinserted.

[0015] A fourth aspect is the balloon catheter according to any one of the first to third aspects, in which the first control body is provided on the outer peripheral side of the balloon.

[0016] According to the balloon catheter structured according to this aspect, for example, when the first control body is formed separately from the balloon, the first control body can be easily fixed to the balloon. Further, in this case, since the degree of freedom in selecting the material of the first control body is improved, the amount of deformation in the longitudinal direction of the balloon can be more easily controlled.

[0017] A fifth aspect is a balloon catheter according to any one of the first to fourth aspects, in which the second control body is provided on the outer peripheral side of the first control body.

[0018] According to the balloon catheter structured according to this aspect, it is also possible to make the outer peripheral surface of the balloon provided with the first and second control bodies into a smoother annular surface, improving the insertability in the blood vessel and enabling the stenosis site to be expanded substantially uniformly over the entire circumference in the circumferential direction when the balloon is inflated.

[0019] A sixth aspect is a balloon catheter according to any one of the first to fifth aspects, in which a plurality of the first control bodies are provided at intervals in the circumferential direction, and the second control body is formed in a cylindrical shape.

[0020] According to the balloon catheter structured according to this aspect, it is also possible to efficiently exert the deformation restraining force during balloon inflation by the first and second control bodies over a wide range, and it is also possible to inflate the balloon more uniformly as a whole.

[0021] A seventh aspect is a balloon catheter according to any one of the first to sixth aspects, in which the first and second control bodies are provided over the entire length of the balloon.

[0022] According to the balloon catheter structured according to this aspect, it is also possible to avoid local inflation of the balloon at locations where the first and second control bodies are not provided when the balloon is inflated.

[0023] The eighth aspect is the balloon catheter according to any one of the first to seventh aspects, wherein the second control body is woven only with filaments inclined with respect to the longitudinal direction of the balloon.

[0024] According to the balloon catheter having the structure according to this aspect, with respect to suppressing deformation in the balloon longitudinal direction, the contribution of the second control body can be suppressed and more can be borne by the first control body. Therefore, it is also possible to more efficiently control the suppression of the deformation amount in the longitudinal direction of the balloon and the suppression of the deformation amount in the radial direction.

[0025] Further, compared with the case where filaments extending parallel to the balloon longitudinal direction are employed in the second control body, it is also possible to avoid a decrease in the flexibility of the balloon due to excessive concentration of the filaments constituting the second control body at both longitudinal ends (cone portions and leg portions) where the outer diameter dimension of the balloon becomes small.

[0026] The ninth aspect is a balloon catheter having a balloon provided on the distal end side of a shaft, wherein a plurality of control bodies extending in the longitudinal direction of the balloon and separated in the circumferential direction are positioned and provided on the inner circumferential side of the balloon.

[0027] According to the balloon catheter having the structure according to this aspect, by providing a plurality of control bodies extending in the longitudinal direction of the balloon while being separated in the circumferential direction, the deformation amount of the balloon, particularly in the longitudinal direction, can be efficiently controlled with a simple structure. Further, by providing such a control body on the inner circumferential side of the balloon, it is also possible to reduce the protruding dimension to the outer circumferential side of the balloon or to expand the balloon substantially uniformly over the entire circumference in the circumferential direction.

Advantages of the Invention

[0028] According to the balloon catheter having the structure according to the present invention, the deformation amount of the balloon can be stably controlled.

Brief Description of the Drawings

[0029]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Mode for Carrying Out the Invention

[0030] Hereinafter, in order to more specifically clarify the present invention, embodiments of the present invention will be described in detail with reference to the drawings.

[0031] First, FIGS. 1 to 4 show a balloon catheter 10 as a first embodiment of the present invention in an inflated state of the balloon 12. The balloon catheter 10 includes a long shaft 14, and the balloon 12 is provided on the distal end side (left side in FIG. 1) of the shaft 14, and a hub 16 is provided on the proximal end side (right side in FIG. 1) of the shaft 14.

[0032] More specifically, as also shown in FIGS. 2 and 3, the shaft 14 has a double-tube structure in which an inner shaft 18 and an outer shaft 20, each of which is tubular, are inserted into each other.

[0033] Further, the distal end portion of the inner shaft 18 protrudes from the distal end of the outer shaft 20 by a predetermined length, and a tip tip 22 is attached to the protruding end portion of the inner shaft 18. The tip tip 22 has a substantially cylindrical shape, and a central hole communicating with the inner hole of the inner shaft 18 is formed through the central axis thereof. Note that, for example, a contrast marker having an annular or C-shaped shape may be externally fixed to the inner shaft 18 and / or the outer shaft 20.

[0034] Furthermore, the balloon 12 is disposed in an externally inserted state on the distal end portion of the inner shaft 18 protruding from the outer shaft 20. The balloon 12 is composed of, for example, a cylindrical body formed of a film made of a deformable synthetic resin material or the like, and is expandable and contractible in the length direction (left-right direction in FIG. 1) and the radial direction (up-down direction in FIG. 1).

[0035] Note that, as the material of the balloon 12, a conventionally known material can be adopted, and for example, polyethylene terephthalate, nylon, polyamide, polyether amide, polyether block amide copolymer, polyethylene, polyethylene elastomer, polypropylene, silicone rubber, latex rubber, etc. are preferably adopted.

[0036] In the inflated state, the balloon 12 of the present embodiment has a cylindrical shape in which the intermediate portion in the longitudinal direction extends substantially straight, and cone portions 12a, 12a having a tapered cylindrical shape that gradually decreases in diameter outward from both end portions in the longitudinal direction are integrally extended. Further, from the longitudinal end portions (portions where the outer diameter dimension is the smallest) of the respective cone portions 12a, cylindrical leg portions 12b that extend substantially straight outward are integrally extended. In the contracted state of the balloon 12, a predetermined folding shape may be set, for example, it may be wrapped in the circumferential direction so as to be folded at a plurality of locations on the circumference.

[0037] The inner peripheral surface of the leg portion 12b on the proximal end side of the balloon 12 is fluid-tightly fixed to the outer peripheral surface of the distal end portion of the outer shaft 20, and the inner peripheral surface of the leg portion 12b on the distal end side is fluid-tightly fixed to the outer peripheral surface of the distal end portion of the inner shaft 18 and / or the tip chip 22. Thereby, the space inside the balloon 12 communicates with the annular space between the inner shaft 18 and the outer shaft 20 in the radial direction, and the annular space communicates with the supply / discharge port 24 provided in the hub 16. As a result, it is possible to supply fluid to the inside of the balloon 12 and discharge fluid from the inside of the balloon 12 through the annular space by a syringe or the like connected to the supply / discharge port 24, and a supply / discharge lumen 26 for supplying and discharging fluid to and from the balloon 12 including the annular space between the inner shaft 18 and the outer shaft 20 in the radial direction is formed.

[0038] Further, the central hole of the tip chip 22 communicates with the inner hole of the inner shaft 18, and the inner hole of the inner shaft 18 communicates with a guide wire port 28 provided in the hub 16. Thus, in the present embodiment, a guide wire lumen 30 that communicates over substantially the entire length from the distal end to the proximal end of the balloon catheter 10 is formed including the inner hole of the inner shaft 18, and the balloon catheter 10 can be guided by a guide wire inserted into the guide wire lumen 30 when inserted into the patient. That is, in the present embodiment, the balloon catheter 10 is an over-the-wire type catheter. Note that the catheter according to the present invention may be a rapid exchange type catheter.

[0039] Here, as also shown in FIGS. 2 to 4, a first control body 32 extending in the length direction and a second control body 34 made of a braided body are positioned and attached to the balloon 12. The second control body 34 is formed by braiding a plurality of filaments 36.

[0040] In the present invention, braiding includes not only knitting but also weaving techniques, which may be employed alone or in combination. The braided body constituting the second control body 34 includes, for example, any one or a combination of knitted fabrics, braided cords, woven fabrics, etc. In the present embodiment, the second control body 34 is formed as a braided cord of a plurality of filaments 36. Note that the filament 36 is not limited to a filament in the narrow sense, i.e., a twisted combination of fibrous bodies. For example, it may be in the form of a cord having a larger cross-sectional area than a filament, or in the form of a belt having a rectangular cross-section. Further, the cross-sectional shape of the filament 36 is not limited, and may be circular (including oval, ellipse, semi-circle), or polygonal such as triangular or quadrangular.

[0041] The first and second control members 32 and 34 are separate from each other. In this embodiment, in the braided body (braided cord) constituting the second control member 34, there is no filament extending in the longitudinal direction of the balloon 12, and it is braided only with the filaments 36 inclined with respect to the longitudinal direction of the balloon 12. However, as long as the filaments 36 are braided so as to be inclined as a whole with respect to the longitudinal direction of the balloon 12, they may partially extend in the longitudinal direction of the balloon 12. In FIGS. 1 and 2, the second control member 34 (braided body) is shown in a mesh shape, but it is not limited to a mesh. Also, in FIGS. 3 and 4, although the second control member 34 is shown as a braided body of a plurality of filaments 36, the braided structure is not limited. In FIGS. 3 and 4, the second control member 34 is exaggeratedly shown for easy understanding that the second control member 34 is a braided body of a plurality of filaments 36.

[0042] The material of the first control member 32 is appropriately selected according to the required deformation characteristics of the balloon 12 and the like, and is formed from, for example, a hard or soft synthetic resin, rubber, metal, etc. For example, a material with high strength and no or small elongation (substantially inelastic) such as polyaramide, liquid crystal polymer, ultra-high molecular weight polyethylene, etc. can also be adopted. In this embodiment, on the inner peripheral surface of the balloon 12, the first control member 32 is integrally formed with the balloon 12. In particular, in this embodiment, a plurality of first control members 32 are provided at substantially equal intervals and separated in the circumferential direction, and each first control member 32 is formed over substantially the entire length in the longitudinal direction of the balloon 12.

[0043] Note that the protruding dimension of the first control body 32 toward the inner circumferential side is larger at the conical portions 12a, 12a at both ends in the length direction than at the straight portion in the middle of the length direction, and the rigidity of the portion where the first control body 32 is provided is increased. Also, in the contracted state of the balloon 12 before use, the portion where the first control body 32 is provided is formed as a peak portion, and the portion where the first control body 32 is not provided is formed as a valley portion, so that unevenness is formed in the circumferential direction. Then, after the balloon 12 is inflated and used and then contracted again, it is restored to the above-described shape in which peak portions and valley portions are provided in the circumferential direction according to the presence or absence of the first control body 32. Generally, when a balloon is inflated and then contracted again, it tends to extend laterally a little and become a flat shape, which easily causes problems such as getting caught during catheter removal or reinsertion. However, by providing the first control body 32 as in the present embodiment, the shape of the balloon 12 in the contracted state can be controlled, and the above-described problems can be solved.

[0044] The number of such first control bodies is preferably two or more. Also, it is desirable that the number of the first control bodies is such that the flexibility of the balloon is not significantly impaired. Further, the first control bodies do not need to be provided at equal intervals in the circumferential direction, and for example, it is sufficient that there is no large bias in the circumferential direction, such as when the first control bodies are only in a part of the circumferential direction.

[0045] The material of the filament 36 that constitutes the second control body 34 is also appropriately selected according to the required deformation characteristics of the balloon 12 and the like. For example, materials with high strength and little or no elongation (substantially inelastic), such as polyaramid, liquid crystal polymer, and ultra-high molecular weight polyethylene, can be preferably adopted. Also, the braided structure of the filament 36 that constitutes the second control body 34 is also appropriately selected according to the required deformation characteristics of the balloon 12 and the like. As the second control body 34, for example, woven fabrics such as plain weave, twill weave, and damask weave, knitted fabrics such as mesh knitting, rubber knitting, and pearl knitting, and braided cords with weaving methods such as overhand knotting and flat knotting can adopt conventionally known braided structures. In the present embodiment, the second control body 34 is formed as a separate body from the balloon 12 and has a substantially cylindrical shape extending over substantially the entire length of the balloon 12. In particular, in the present embodiment, after the second control body 34 is inserted into the balloon 12, it is adhered to the outer peripheral surface of the balloon 12 over substantially the entire area, whereby the second control body 34 is positioned and attached to the balloon 12.

[0046] By inflating the balloon 12 with the first and second control bodies 32 and 34 attached as described above, the amount of deformation in the longitudinal direction of the balloon 12 is controlled by the first control body 32, and the amount of deformation in the radial direction of the balloon 12 is controlled by the second control body 34. That is, in the present embodiment, at the formation position of the first control body 32, the balloon 12 is partially thickened, and the deformation rigidity in the longitudinal direction of the balloon 12 is improved. Also, by inserting the second control body 34, which is cylindrical with respect to the balloon 12, the amount of deformation in the radial direction of the balloon 12 is suppressed. As a result, it is possible to relatively increase the internal pressure of the balloon 12, and for example, even at a stenotic site of a blood vessel with advanced calcification, the blood vessel expansion effect can be stably exhibited. Note that, although the deformation rigidity in the longitudinal and radial directions of the balloon can also be improved by making the entire balloon thick, by making the balloon partially thick, it is possible to avoid significantly impairing the flexibility of the balloon and to minimize the deterioration of the insertability into the blood vessel.

[0047] In particular, by providing the first control body 32 for controlling the amount of deformation in the longitudinal direction of the balloon 12 and the second control body 34 for controlling the amount of deformation in the radial direction as separate bodies, it is possible to use different materials for the first control body 32 and the second control body 34, and it is also possible to separately set the amount of deformation in the longitudinal direction and the amount of deformation in the radial direction of the balloon 12. As a result, the shape of the balloon 12 after inflation can be set according to the patient's symptoms and the like. For example, by controlling the amount of deformation in the longitudinal direction of the balloon 12 by the first control body 32, it is possible to avoid the balloon 12 stretching too much in the longitudinal direction and damaging parts other than the stenosis site in the blood vessel. Further, as in the present embodiment, since the second control body 34 is formed as a braided cord and has appropriate elasticity, it is possible to avoid preventing the inflation of the balloon 12 or completely suppressing the inflation of the balloon 12, and the internal pressure of the balloon 12 can be stably increased.

[0048] Furthermore, in the present embodiment, the first control body 32 is integrally formed on the inner peripheral side of the balloon 12, and it is possible to avoid the first control body 32 protruding to the outer peripheral side of the balloon 12. Further, since the second control body 34 is formed in a substantially cylindrical shape and is externally inserted into the balloon 12, the outer peripheral surface of the balloon 12 with the second control body 34 attached thereto can be made into a substantially smooth annular surface. Thereby, the insertability of the balloon 12 into the blood vessel is maintained well, and when the balloon 12 is inflated, the balloon 12 can be pressed against the blood vessel wall substantially uniformly over substantially the entire circumference in the circumferential direction. Further, since the first control body 32 is integrally formed with the balloon 12, there is no risk of the first control body 32 detaching from the balloon 12, and there is no change in the composition of the first control body and the balloon due to the fixing of the first control body to the balloon, and a balloon 12 and a balloon catheter 10 that have no adverse effect on the patient or can suppress the adverse effect to a small extent can be provided.

[0049] In addition, in the present embodiment, since the second control body 34 is woven only with the filament 36 inclined with respect to the longitudinal direction of the balloon 12, for example, compared with the case where the second control body includes filaments extending parallel to the longitudinal direction of the balloon, the amount of the filament 36 can be reduced. In particular, in the cone portion 12a and the leg portion 12b of the balloon 12, since the outer diameter dimension is reduced, the filaments 36 constituting the second control body 34 are concentrated. However, by reducing the amount of the filaments 36, it is possible to avoid deterioration of the flexibility of the cone portion 12a and the leg portion 12b.

[0050] Here, the inventors actually prototyped a balloon 12 including the first control body 32 and the second control body 34 (Example 1), and confirmed that the deformation amounts in the longitudinal direction and the radial direction of the balloon 12 are controlled by the first control body 32 and the second control body 34, respectively. The results are shown in FIGS. 5 and 6. In FIG. 5, as Comparative Example 1, a balloon provided with only the second control body was manufactured to confirm the control effect of the deformation amount in the longitudinal direction by the first control body 32. In FIG. 6, as Comparative Example 2, a balloon provided with only the first control body on the inner peripheral surface was manufactured to confirm the control effect of the deformation amount in the radial direction by the second control body 34. Here, in FIG. 5, the difference in the overall length of the balloon between Example 1 and Comparative Example 1 when the balloon internal pressure is minimized is due to the variation during the manufacture of the balloon, that is, the variation when the balloon is inflated once, the second control body is attached, and then the balloon is shrunk again to minimize the balloon internal pressure. In FIG. 6, the difference in the outer diameter dimension of the balloon between Example 1 and Comparative Example 2 when the balloon internal pressure is minimized is because the outer diameter dimension increases by the amount of the second control body 34 provided in Example 1. The overall length of the balloon is the longitudinal dimension of the balloon including the cone portions on both sides in the longitudinal direction (excluding the leg portions of the balloon). In the following description, the balloons of the example and the comparative example were each warmed to about 37 degrees and used as test materials.

[0051] As shown in FIG. 5, by comparing Example 1 and Comparative Example 1, it can be understood that the first control body 32 contributes to the control of the amount of deformation in the longitudinal direction of the balloon 12. That is, in Example 1, up to about 10 atm, the deformation in the longitudinal direction is substantially suppressed, and above 10 atm, the deformation in the longitudinal direction is made gentler compared to Comparative Example 2.

[0052] Further, as shown in FIG. 6, by comparing Example 1 and Comparative Example 2, it can be understood that the second control body 34 contributes to the control of the amount of deformation in the radial direction of the balloon 12. That is, in Example 1, even when the inside of the balloon 12 is at a relatively high pressure, the amount of deformation of the outer diameter dimension of the balloon 12 is suppressed, and the outer diameter dimension of the balloon 12 is maintained at a substantially constant value.

[0053] From the results of FIGS. 5 and 6, by providing the first and second control bodies 32 and 34 for the balloon 12, the amounts of deformation in the longitudinal and radial directions of the balloon 12 are suppressed, and even when the inside of the balloon 12 is at a relatively high pressure, the balloon 12 is maintained in a substantially predetermined shape. Therefore, by providing the first and second control bodies 32 and 34, it is possible to increase the pressure inside the balloon 12, and for example, it can be expanded even at a stenotic site of a blood vessel that has become hard due to the progression of calcification.

[0054] Next, FIG. 7 shows a balloon 40 provided in the balloon catheter as the second embodiment of the present invention. In the balloon catheter in this embodiment, since the parts other than the balloon 40 can adopt the same structure as that of the first embodiment, detailed description thereof is omitted. Also, in the following description, for members and parts that are substantially the same as those in the above embodiment, the same reference numerals as those in the above embodiment are given in the drawings to omit detailed description.

[0055] Also in the balloon 40 of the present embodiment, a first control body 32 extending in the longitudinal direction of the balloon 40 and a second control body 34 made of a braided body are provided. In the present embodiment, the first control body 32 is integrally formed on the outer peripheral surface of the balloon 40. Then, from the outer peripheral side of the balloon 40 provided with the first control body 32, a second control body 34 having the same structure as that of the first embodiment is externally inserted and adhered over the entire surface to be positioned and mounted.

[0056] Regarding the balloon 40 of the present embodiment as well, a prototype was actually made (Example 2), and it was confirmed that the deformation amounts in the longitudinal direction and the radial direction of the balloon 40 were controlled by the first and second control bodies 32 and 34, respectively. The results are shown in FIGS. 8 and 9. In FIG. 8, as Comparative Example 3, a balloon provided with only the second control body was produced, and the control effect of the deformation amount in the longitudinal direction by the first control body 32 was confirmed. In FIG. 9, as Comparative Example 4, a balloon provided with only the first control body on the outer peripheral surface was produced, and the control effect of the deformation amount in the radial direction by the second control body 34 was confirmed.

[0057] From the results of FIGS. 8 and 9, even in the balloon 40 provided with the first control body 32 on the outer peripheral surface, since the deformation amounts in the longitudinal direction and the radial direction of the balloon 40 are suppressed by the first and second control bodies 32 and 34, the same effects as those of the first embodiment can be exhibited.

[0058] Next, FIG. 10 shows a balloon 50 provided in a balloon catheter as the third embodiment of the present invention. In the present embodiment, a first control body 52 separated from the balloon 50 is positioned and mounted by being adhered to the outer peripheral surface of the balloon 50 over substantially the entire length, and a second control body 34 having the same structure as that of the first embodiment is externally inserted with respect to the balloon 50 provided with the first control body 52 and adhered over substantially the entire surface to be positioned and mounted.

[0059] Also in the balloon 50 of the present embodiment having the structure as described above, the first and second control bodies 52 and 34 are provided, so that the same effects as those of the above embodiment can be exhibited. In particular, in the present embodiment, since the first control body 52 is separate from the balloon 50, the degree of freedom in selecting the material of the first control body 52 is improved, and a material suitable for the required deformation characteristics of the balloon 50 can be selected. For example, a material having a greater elongation rigidity than the balloon 50 is adopted for the first control body 52, and it is also possible to realize the required deformation suppressing effect in the longitudinal direction with a smaller cross-sectional area. Further, since the first control body 52 is provided on the outer peripheral surface of the balloon 50, even when the first control body 52 is separate from the balloon 50, the first control body 52 can be easily fixed to the balloon 50.

[0060] As described above, the embodiments of the present invention have been described. However, the present invention is not construed as being limited by the specific descriptions in such embodiments, and can be implemented in various modified, corrected, and improved forms based on the knowledge of those skilled in the art.

[0061] For example, in the above embodiment, the second control body 34 was positioned and attached by being adhered to substantially the entire surface of the balloons 12, 40, and 50. However, the second control body having a substantially cylindrical shape may be positioned by simply being inserted into the balloon or being partially fixed at appropriate locations such as both end portions in the longitudinal direction. Further, in the third embodiment, the separate first control body 52 was positioned and attached by being adhered to substantially the entire length of the balloon 50. However, it may be positioned by being fixed at partial locations including both end portions in the longitudinal direction. Note that the first control body does not necessarily have to extend straight parallel to the central axis in the longitudinal direction of the balloon, and may extend in the longitudinal direction at a constant or changing angle with respect to the central axis of the balloon, for example, in a spiral shape. And, for example, by adjusting the inclination angle of the first control body with respect to the central axis direction, the degree of deformation suppression in the longitudinal direction of the balloon can also be changed.

[0062] In the above-described embodiment, the first control members 32 and 52 are provided on either the inner peripheral side or the outer peripheral side of the balloons 12, 40, and 50, but they may be provided on both sides.

[0063] Furthermore, in the above-described embodiment, the second control member 34 having a cylindrical shape is externally inserted into the balloons 12, 40, and 50 and is located on the outer peripheral side of the balloons 12, 40, and 50. However, the second control member may be provided on the inner peripheral side of the balloon and may be fixed and positioned in whole or in part, for example, by adhesion or the like, or may be provided on both the inner peripheral side and the outer peripheral side. Also, in the above-described embodiment, the second control member 34 is located on the outer peripheral side of the first control members 32 and 52, but the second control member may be located on the inner peripheral side of the first control member.

[0064] Moreover, in the above-described embodiment, the first and second control members 32, 34, and 52 are provided over the entire length of the balloons 12, 40, and 50, but they may be provided partially in the length direction. Also, the second control member does not necessarily have to be in a cylindrical shape extending over the entire circumference and may be provided partially in the circumferential direction.

[0065] Furthermore, in the above-described embodiment, the second control body 34 was formed by braiding a plurality of filaments 36 in a stranded manner. However, the filaments constituting the second control body do not necessarily have to be ordinary yarns obtained by twisting a plurality of fibrous bodies, and may be staple yarns, monofilaments, or multifilaments made of various materials such as synthetic resins and metals in addition to natural fibers. Also, a second control body may be formed by braiding a plurality of metal wires or the like twisted together to increase the cross-sectional area to form a cord shape, or by braiding a strip-shaped metal wire or the like. Note that the filaments constituting the second control body are braided, and for example, filaments simply stacked in the radial direction are not the second control body. On the other hand, the first control body is not braided, and the first control body is not integrally incorporated into the second control body as a filament constituting the second control body. Also, as described above, the first control body may be inclined with respect to the balloon central axis. However, such an inclination angle (with the direction parallel to the central axis being 0 degrees and the direction perpendicular to the central axis being 90 degrees) is desirably smaller than the inclination angle (average inclination angle) of the filament having the largest inclination angle among the filaments constituting the second control body. This makes it possible to more efficiently suppress the amount of deformation in the balloon length direction by the first control body. For the same purpose, the inclination angle of the first control body is preferably 60 degrees or less, more preferably 30 degrees or less, and even more preferably 15 degrees or less.

[0066] However, the balloon provided in the balloon catheter according to the present invention is not limited to the mode including both the first control body and the second control body. It may be sufficient to provide only the first control body 32 as a control body on the inner peripheral side of the balloon 60 as shown in FIG. 11. That is, by appropriately setting the number, length, material, etc. of the first control body, it becomes possible to control the amount of deformation of the balloon particularly in the longitudinal direction. In the mode shown in FIG. 11, the first control body 32 is integrally formed with the balloon 60. However, like the third embodiment, a first control body 52 separated from the balloon 60 may be adopted. Thus, as long as the amount of deformation of the balloon is controlled, it may be sufficient to provide only the first control body extending in the longitudinal direction of the balloon. A mode without the second control body can also be grasped as one mode of the present invention.

Explanation of Signs

[0067] 10 Balloon catheter 12 Balloon 12a Cone portion 12b Leg portion 14 Shaft 16 Hub 18 Inner shaft 20 Outer shaft 22 Tip 24 Supply / discharge port 26 Supply / discharge lumen 28 Guide wire port 30 Guide wire lumen 32 First control body (control body) 34 Second control body 36 Filament 40 Balloon 50 Balloon 52 First control body 60 Balloon

Claims

【Claim 1】 In a balloon catheter having a balloon provided on the distal end side of a shaft, a first control body extending in the longitudinal direction of the balloon and a second control body composed of a braided body are separate from each other, and these first and second control bodies are positioned and attached to the balloon, and a balloon catheter in which the first control body is provided on the inner circumferential side of the balloon.

Images