Source: https://patents.google.com/patent/JP2016086878A/en
Timestamp: 2019-12-05 20:35:47
Document Index: 214212405

Matched Legal Cases: ['art 35', 'art 35', 'art 23', 'art 23', 'arts 23', 'art 23', 'art 39', 'art 35', 'art 35', 'art 16', 'art 35', 'art 35', 'art 35', 'art 35', 'art 16', 'art 16', 'art 35', 'arts 42', 'art 35', 'art 35', 'art 35', 'art 35', 'art 35', 'arts 35', 'art, 18', 'art, 39']

JP2016086878A - Balloon catheter - Google Patents
JP2016086878A
JP2016086878A JP2014221134A JP2014221134A JP2016086878A JP 2016086878 A JP2016086878 A JP 2016086878A JP 2014221134 A JP2014221134 A JP 2014221134A JP 2014221134 A JP2014221134 A JP 2014221134A JP 2016086878 A JP2016086878 A JP 2016086878A
JP2014221134A
JP6442229B2 (en
健志 岩野
孝政 三宅
Takamasa Miyake
智一 尾川
圭介 小川
宗一郎 藤澤
Soichiro FUJISAWA
光浩 太田
2014-10-30 Application filed by 株式会社グッドマン, Goodman Co Ltd filed Critical 株式会社グッドマン
2014-10-30 Priority to JP2014221134A priority Critical patent/JP6442229B2/en
2016-05-23 Publication of JP2016086878A publication Critical patent/JP2016086878A/en
2018-12-19 Publication of JP6442229B2 publication Critical patent/JP6442229B2/en
PROBLEM TO BE SOLVED: To provide a balloon catheter capable of suppressing warp of a balloon.SOLUTION: A balloon catheter 10 includes: a balloon 14; an outer shaft 11 joined with a base end of the balloon 14; and an inner shaft 12 inserted across the inside of the outer shaft 11 and the inside of the balloon 14 and joined with the tip end side of the balloon 14. The inner shaft 12 includes a core wire 18. The core wire 18 is formed into a coil part 35 formed by spirally winding a part thereof in the axial direction, in the same direction. The coil part 35 is configured to be extended/contracted in the axial direction.SELECTED DRAWING: Figure 2
The present invention relates to a balloon catheter.
Conventionally, balloon catheters have been used in treatments such as PTA (percutaneous angioplasty) and PTCA (percutaneous coronary angioplasty) (see, for example, Patent Document 1). The balloon catheter includes a catheter shaft and a balloon provided on the distal end side of the catheter shaft. In a balloon catheter, a balloon is introduced into a stenosis or occlusion site generated in a blood vessel, and the balloon is expanded (inflated) in the radial direction to expand the portion.
In the balloon catheter, the catheter shaft includes an outer shaft and an inner shaft that is inserted into the outer shaft. The proximal end portion of the balloon is joined to the distal end portion of the outer shaft. In this case, the balloon is inflated or deflated by allowing the compressed fluid to flow through the lumen of the outer shaft.
The inner shaft is provided so as to extend to the tip side from the outer shaft, and the extended portion is covered from the outside by a balloon. The inner shaft has its distal end joined to the distal end of the balloon, and its proximal end joined to an intermediate position of the outer shaft.
JP 2008-237844 A
By the way, it is conceivable that the balloon expands (expands) not only in the radial direction but also in the axial direction when inflated. Here, as described above, since the base end portion of the balloon is joined to the outer shaft, the balloon tends to extend toward the distal end side with respect to the outer shaft when extending in the axial direction. On the other hand, the inner shaft is joined to the distal end portion of the balloon, and the inner shaft is joined to the outer shaft or the like at the proximal end portion. Therefore, even if the balloon tries to extend toward the distal end side, the distal end portion of the balloon Is displaced by the inner shaft. Therefore, in this case, it is assumed that the balloon warps in a banana shape, and there is a concern about the occurrence of inconvenience such as blood vessel damage accompanying the warping of the balloon.
This invention is made | formed in view of the said situation, and makes it a main objective to provide the balloon catheter which can suppress the curvature of a balloon.
In order to solve the above problems, a balloon catheter of a first invention includes a balloon that is inflated or deflated using a fluid, an outer shaft that is joined to a proximal end portion of the balloon and through which the fluid flows, An inner shaft that is inserted across the inside of the outer shaft and the inside of the balloon and joined to the distal end of the balloon, the inner shaft being proximal to the joint with the balloon Further, it has an extending portion that can extend in the axial direction.
According to the present invention, the inner shaft has the extending portion that can extend in the axial direction on the proximal end side of the joint portion with the balloon. In this case, when the balloon is expanded in the axial direction when the balloon is expanded, that is, when the balloon extends toward the distal end side with respect to the outer shaft, the inner shaft joined to the distal end portion of the balloon is pulled toward the distal end side by the balloon. Thereby extending the extension of the inner shaft in the axial direction. That is, in this case, since the extension portion is extended, the joint portion between the inner shaft and the balloon is displaced toward the distal end side, so that the balloon can be prevented from warping.
The balloon catheter according to a second aspect of the present invention is characterized in that, in the first aspect, the elongated portion is an expandable portion that can be expanded and contracted in the axial direction by elastic deformation.
According to the present invention, since the extension portion is an extension / contraction portion that can be extended / contracted in the axial direction by elastic deformation, the extension / contraction portion self-extends when the balloon is deflated after the extension / contraction portion is extended in the axial direction as the balloon is inflated. It is contracted in the axial direction by the elastic force (restoring elastic force) and returns to the original length (before expansion). In this case, when the length of the expansion / contraction part returns to the original length, the length in the axial direction of the balloon also returns to the original length, and as a result, the balloon returns to the original contracted state (before inflation). As a result, when the balloon is deflated (re-deflated) and then withdrawn from the body after the balloon has been inflated, the balloon can be returned to its original (before inflated) deflated state and thus withdrawn. It can suppress that the operativity of this falls.
In the balloon catheter of a third invention, in the second invention, the expansion / contraction part is a coil part formed by winding a wire constituting the inner shaft spirally in the axial direction. Features.
According to the present invention, a coil part is formed by winding a wire (for example, a metal wire) constituting the inner shaft in a spiral shape in the axial direction, and the coil part forms an expansion / contraction part. Yes. In this case, it is possible to form the stretchable part while avoiding a significant decrease in rigidity as compared with the case where the stretchable part is formed of a highly flexible material (for example, a rubber material).
A balloon catheter according to a fourth aspect of the present invention is characterized in that, in any one of the first to third aspects of the invention, the elongated portion is disposed on a proximal end side with respect to the balloon.
It is conceivable that the extension portion of the inner shaft has a larger radial dimension like the coil portion described above. For this reason, when the elongated portion is disposed in the balloon, the balloon diameter when the balloon is deflated increases, and the passage of the balloon in the body may decrease. In that respect, in the present invention, since the elongated portion is disposed on the proximal end side with respect to the balloon, it is possible to suppress the warpage of the balloon while avoiding a decrease in the passage of the balloon.
The balloon catheter according to a fifth aspect of the present invention is the balloon catheter according to the fourth aspect, wherein the outer shaft has a diameter-expanded portion whose diameter on the proximal end side is larger than that on the distal end side. The elongated portion is disposed inside the enlarged diameter portion.
According to the present invention, the enlarged diameter portion is provided at the proximal end portion of the outer shaft, and the elongated portion is disposed inside the enlarged diameter portion. In this case, even when the radial dimension of the elongated portion is increased as in the coil portion described above, the elongated portion can be disposed inside the outer shaft (in other words, on the proximal end side than the balloon). It becomes. Moreover, since the enlarged diameter part is provided in the base end side in the outer shaft, when the outer shaft is introduced into the body, the enlarged diameter part can be prevented from being introduced into the body. Thereby, it becomes possible to arrange | position an extending | stretching part inside an outer shaft, avoiding the fall of the penetration property of an outer shaft.
The balloon catheter according to a sixth aspect of the present invention is characterized in that, in the fifth aspect, the elongated portion is disposed on the distal end side in the enlarged diameter portion.
By the way, when the extension portion is extended along with the extension of the balloon in the axial direction, the tip side portion of the inner shaft is displaced to the tip side of the extension portion. It is conceivable that the slider slides with the inner peripheral surface of the outer shaft. In that case, the case where the displacement of the said front end side part is not made smoothly by the resistance at the time of the sliding is assumed. In particular, in the configuration of the fifth invention in which the elongated portion is disposed in the enlarged diameter portion on the proximal end side of the inner shaft, the length of the distal end side portion is increased, and thus the displacement is not smoothly performed. Is likely to occur. In this case, there exists a possibility that the expansion | extension function of an expansion | extension part may not be exhibited suitably.
Therefore, in the present invention, in view of this point, the elongated portion is arranged on the distal end side in the enlarged diameter portion. In this case, since the extended portion is disposed in the enlarged diameter portion, the length of the tip side portion can be shortened as much as possible. Therefore, when the tip side portion slides with the inner peripheral surface of the outer shaft, It is possible to reduce the sliding resistance. For this reason, even if it has this structure, it becomes possible to exhibit the expansion | extension function of an expansion | extension part suitably.
A balloon catheter according to a seventh aspect of the present invention is the balloon catheter according to any one of the first to sixth aspects, wherein the balloon is provided on the outer peripheral side of the balloon so as to straddle the axial direction, and the balloon has a predetermined interval in the circumferential direction. A plurality of linear members are arranged, and each of the linear members has a base end portion attached to the outer shaft, and an end portion of the linear member that extends to the front end side of the balloon on the inner shaft. It is attached to the part.
According to the present invention, since a plurality of linear members are provided on the outer peripheral side of the balloon, when the balloon is inflated, the linear members can be pressed against the tube wall in the body by the balloon and bite into the tube wall. it can. Therefore, these linear members can function as anti-slip when the balloon is inflated. Here, in such a configuration, when the balloon is warped, each linear member is concentrated on the outer peripheral side of the balloon on the side opposite to the side on which the balloon is warped. There is a risk that it will not be arranged at intervals. In that case, there is a possibility that the function of preventing slipping by the linear member cannot be suitably performed. In that respect, in the present invention, since the first invention is applied to such a configuration, warping of the balloon is suppressed, and as a result, the anti-slip function by the linear member can be preferably exhibited. It becomes.
In the balloon catheter of the eighth invention according to the seventh invention, a guide wire lumen extending from the distal end to the proximal end side is formed in the extension portion, and the lumen is on the proximal end side. Is opened at the outer peripheral surface of the extension portion, and the portion where the circumferential position is the same position as the opening portion on the outer peripheral surface of the balloon is defined as the opening side portion, The interval between the linear members adjacent in the circumferential direction across the opening side portion is larger than the interval between the linear members adjacent in the circumferential direction without sandwiching the opening side portion. Features.
When the lumen for the guide wire is formed in the extending portion on the distal end side than the balloon, the opening on the proximal end side of the lumen is opened on the outer peripheral surface of the extending portion. In this case, the guide wire is led out from the lumen to the proximal end side through the opening, and is disposed across the balloon in the axial direction on the outer peripheral surface of the balloon. Specifically, at this time, it is considered that the guide wire is disposed on a portion (opening side portion) where the circumferential position is the same position as the opening on the outer peripheral surface of the balloon.
On the other hand, a plurality of linear members are provided on the outer peripheral side of the balloon. These linear members need to be arranged on the outer peripheral surface of the balloon so as not to interfere with the guide wire. Therefore, it is conceivable that among the linear members, two linear members adjacent in the circumferential direction across the opening side portion are arranged with a large interval. However, if it does so, since the whole linear member will be biased and arrange | positioned in the circumferential direction, there exists a possibility that the problem of the curvature of the balloon mentioned above may arise easily. In that respect, in the present invention, since the first invention is applied to such a configuration, the warping of the balloon can be suitably suppressed while avoiding the interference between each linear member and the guide wire.
The whole side view which shows the structure of a balloon catheter. (A) is a longitudinal cross-sectional view which shows the structure of a balloon catheter, (b) is the sectional view on the AA line of FIG. It is a longitudinal cross-sectional view for demonstrating the effect | action of a coil part, (a) has shown the deflated state of the balloon, (b) has shown the inflated state of the balloon. The front view which shows another form of an expansion-contraction part.
Hereinafter, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is an overall side view showing the configuration of a balloon catheter. 2A is a longitudinal sectional view showing the configuration of the balloon catheter, and FIG. 2B is a sectional view taken along line AA in FIG. 2A and 2B show the balloon inflated state.
As shown in FIGS. 1 and 2A, the balloon catheter 10 includes an outer shaft 11, an inner shaft 12 inserted into the outer shaft 11, and proximal ends (proximal) of the shafts 11 and 12. And a balloon 14 attached to the tip side (distal end side) of each shaft 11, 12.
The outer shaft 11 is made of a resin material, for example, a polyamide elastomer. The outer shaft 11 has a lumen 11a extending in the entire axial direction inside thereof. The lumen 11 a communicates with the inside of the balloon 14 and also communicates with the inside of the hub 13.
The outer shaft 11 has a diameter-enlarged portion 16 having a proximal end portion that is larger in diameter than the distal end portion in terms of both the inner diameter and the outer diameter. The enlarged diameter portion 16 is formed over a predetermined range including the base end portion of the outer shaft 11. That is, the enlarged diameter portion 16 is formed over a range from the base end portion of the outer shaft 11 to a position on the front end side by a predetermined dimension L from the base end portion. In the present embodiment, the predetermined dimension L is set to 5 mm to 300 mm.
The outer shaft 11 is not necessarily formed of the same material over the entire axial direction, and may be formed by connecting a plurality of tubes made of different materials in the axial direction, for example. In this case, of the tubes constituting the outer shaft 11, the proximal end side tube is formed of a metal material having relatively high rigidity, and the distal end side tube is formed of a resin material (polyamide elastomer) having relatively low rigidity. It is possible.
The inner shaft 12 includes a core wire 18 and a distal tip 19 joined to the distal end side of the core wire 18. The core wire 18 is formed of a metal wire, and specifically is formed of a stainless steel wire. The wire 18a constituting the core wire 18 has a circular cross section, and the outer diameter is constant over the entire axial direction (more specifically, only the tip is tapered). The outer diameter of the core wire 18 (wire 18a) is smaller than the inner diameter of the outer shaft 11 (specifically, the portion on the distal end side of the enlarged diameter portion 16 in the outer shaft 11). Therefore, a predetermined gap is formed between the outer peripheral surface of the core wire 18 and the inner peripheral surface of the outer shaft 11. The core wire 18 is fixed to the hub 13 at the base end portion.
The core wire 18 may be formed of a material other than stainless steel, for example, a super elastic alloy such as a nickel titanium alloy. Further, the core wire 18 may be formed so that the outer diameter decreases stepwise or continuously from the proximal end side toward the distal end side.
The tip 19 is made of a flexible resin material. The distal tip 19 has a hole 25 that is open toward the proximal end. The distal end portion of the core wire 18 is inserted into the hole 25, and the distal end tip 19 and the core wire 18 are joined and integrated with each other in the inserted state.
A part of the inner shaft 12 extends to the tip side from the outer shaft 11, and a balloon 14 is provided so as to cover the extended region from the outside. The balloon 14 is made of a thermoplastic polyamide elastomer. However, the balloon 14 may be formed of other thermoplastic resins such as polyethylene and polypropylene.
The balloon 14 has a proximal end side joining portion 21 in which the distal end portion of the outer shaft 11 is joined to the proximal end portion thereof, and a distal end side joining portion 22 in which the distal end side of the inner shaft 12 is joined to the distal end portion. Have. The distal end portion of the outer shaft 11 is inserted inside the proximal end side joining portion 21, and the proximal end side joining portion 21 and the outer shaft 11 are joined to each other in the inserted state. Further, the inner shaft 12 is inserted inside the distal end side joining portion 22. Specifically, a joint portion between the core wire 18 and the tip chip 19 in the inner shaft 12 is disposed inside the tip side joint portion 22. In this case, the three members of the distal end side joining portion 22, the distal tip 19 and the core wire 18 are overlapped with each other in the radial direction, and the three members 18, 19, and 22 are joined by thermal welding in the overlapped state. Further, in this joined state, the proximal end portion of the distal tip 19 is substantially at the same position as the proximal end portion of the distal end side joined portion 22.
The balloon 14 has an inflatable portion 23 that can be inflated and deflated between the joint portions 21 and 22. The inflating part 23 has a cylindrical part 23a and a pair of tapered parts 23b, 23c provided on both sides in the axial direction of the cylindrical part 23a. In the cylindrical portion 23a, the outer diameter of the inflatable portion 23 (balloon 14) is the maximum, and in each of the tapered portions 23b and 23c, the outer diameter gradually decreases as the distance from the cylindrical portion 23a increases.
The inside of the balloon 14 communicates with the hub 13 through the inner cavity 11 a of the outer shaft 11. In this case, the compressed fluid supplied through the hub 13 is supplied into the balloon 14 through the lumen 11 a of the outer shaft 11. Therefore, the lumen 11a functions as a fluid lumen through which the compressed fluid flows. When the compressed fluid is supplied into the balloon 14 through the lumen 11a of the outer shaft 11, the balloon 14 is in an inflated state. On the other hand, when a negative pressure is applied to the lumen 11a and the compressed fluid is discharged from the balloon 14, the balloon 14 is in a contracted state.
The balloon 14 is formed in a plurality of wings (specifically, three wings) having a plurality of wings in the circumferential direction. In the contracted state of the balloon 14, the inflating portion 23 of the balloon 14 is folded so that the plurality of wings are formed, and the plurality of wings are wound around the inner shaft 12 around the axis.
The inner shaft 12 extends to the tip side from the balloon 14, and a guide wire lumen 27 into which the guide wire G can be inserted is formed in the extended portion. The guide wire lumen 27 is formed on the distal tip 19. Specifically, the guide wire lumen 27 is formed on the distal tip side of the distal tip 19 relative to the core wire 18. The guide wire lumen 27 is formed so as to extend in the axial direction, the distal end opening 27a is opened at the distal end surface of the distal end tip 19, and the proximal end opening 27b (corresponding to the opening on the proximal end side) is the distal end tip. 19 is opened at the outer peripheral surface 19a. In this case, the base end opening 27b is opened toward the outside in the radial direction (direction orthogonal to the axial direction) of the distal tip 19.
The guide wire G is introduced into the guide wire lumen 27 through the distal end opening 27a and led out from the guide wire lumen 27 to the proximal end side through the proximal end opening 27b. The guide wire G led out from the guide wire lumen 27 is disposed along the axial direction on the outer peripheral surface of the balloon 14 on the same side as the opening side of the proximal end opening 27b in the circumferential direction (FIG. 2B). reference).
A pair of contrast rings 29 are attached to the inner portion of the balloon 14 in the inner shaft 12 (specifically, the core wire 18). The contrast ring 29 is for improving the visibility of the balloon 14 under X-ray projection and facilitating the positioning of the balloon 14 at a target treatment site.
A plurality (specifically three) of elements 31 (corresponding to linear members) are provided on the outer peripheral side of the balloon 14. Each of these elements 31 is formed in a linear shape from a resin material having elasticity, and specifically is formed of a polyamide resin. The element 31 has a triangular cross section. The element 31 is arranged such that one side of the triangular shape is located on the outer peripheral surface of the balloon 14 and one corner of the triangular shape protrudes outward from the outer peripheral surface of the balloon 14. Each element 31 does not necessarily have a triangular shape in the cross section, and may have another shape such as a circular shape or a quadrangular shape in the cross section.
Each element 31 is provided across the balloon 14 in the axial direction. Each element 31 has a base end portion attached to the outer shaft 11 via a base end side mounting member 32, and a tip end portion attached to the inner shaft 12 via a front end side mounting member 33. . The mounting member 32 on the proximal end side is made of a resin material and has a cylindrical shape surrounding the outer shaft 11. The mounting member 32 is provided on the proximal end side of the outer shaft 11 with respect to the balloon 14 and is disposed close to the balloon 14. The mounting member 32 is joined to the outer peripheral surface of the outer shaft 11 by thermal welding in the arrangement state. Moreover, the base end part of each element 31 is joined to the outer peripheral surface of the mounting member 32 by heat welding.
The mounting member 32 may be arranged so as to be movable with respect to the outer shaft 11 without being joined (fixed) to the outer shaft 11.
The mounting member 33 on the distal end side is formed of a resin material and has a cylindrical shape surrounding the inner shaft 12. The mounting member 33 is provided on the distal side of the inner shaft 12 with respect to the balloon 14 and is disposed close to the balloon 14. Only the distal end side of the mounting member 33 is joined to the outer peripheral surface of the inner shaft 12 (specifically, the distal tip 19), and the proximal end side thereof is arranged away from the outer peripheral surface of the inner shaft 12. Yes. And the front-end | tip part of each element 31 is joined to the inner surface of the base end side in the mounting member 33 by heat welding.
Each element 31 is arranged at a predetermined interval in the circumferential direction of the balloon 14 as shown in FIG. Specifically, the elements 31 are arranged at 90 ° intervals in the circumferential direction of the balloon 14. In this case, any two elements 31a and 31b among the elements 31 are arranged adjacent to each other at an interval of 180 ° in the circumferential direction. The two elements 31a and 31b are adjacent to each other in the circumferential direction across a portion of the balloon 14 where the circumferential position is the same as the proximal end opening 27b (hereinafter referred to as the opening side portion 39). The opening side part 39 is located in the center part between the two elements 31a and 31b adjacent in the direction. Therefore, among the elements 31a, 31b, and 31c arranged on the balloon 14, the distance between the two elements 31a and 31b that are adjacent in the circumferential direction with the opening-side portion 39 interposed therebetween does not sandwich the opening-side portion 39. The distance between the two adjacent elements 31a and 31c (31b and 31c) in the circumferential direction is larger.
On the balloon 14, a guide wire G is disposed in the opening side portion 39 so as to straddle the balloon 14 in the axial direction. In this case, the guide wire G is disposed between two adjacent elements 31a and 31b with a large interval, and more specifically, is disposed in the center between the two elements 31a and 31b. ing. Therefore, the elements 31 a to 31 c and the guide wire G are arranged on the outer peripheral surface of the balloon 14 at 90 ° intervals (equal intervals) in the circumferential direction.
As described above, the elements 31 a to 31 c are arranged on the balloon 14, thereby preventing the elements 31 a to 31 c and the guide wire G from interfering with each other on the balloon 14. In addition, the arrangement | positioning space | interval and number of each element 31 on the balloon 14 are not necessarily limited to what was mentioned above, You may be arbitrary.
By the way, in this balloon catheter 10, a stretchable portion that can be stretched and contracted in the axial direction is provided on a part of the inner shaft 12. The balloon catheter 10 is characterized in that this stretchable portion is provided, and the configuration of the stretchable portion will be described below.
As shown in FIG. 2A, the core wire 18 of the inner shaft 12 has a part of the wire 18 a constituting the wire 18 wound in a spiral shape (coil shape) along the axial direction of the inner shaft 12. The wound portion is a coil portion 35. The coil portion 35 can be expanded and contracted in the axial direction by elastic deformation, and corresponds to the expandable portion. FIG. 2A shows the extended state of the coil portion 35, and FIG. 3A, which will be described later, shows the contracted state of the coil portion 35. FIG.
The coil portion 35 is formed by tightly winding (tightly winding) the wire 18a constituting the core wire 18. Specifically, the coil portion 35 is in a tightly wound state in a natural state where no tensile force in the axial direction is applied (see FIG. 3A). In this tightly wound state, the wire rods 18a adjacent to each other in the axial direction in the coil portion 35 are in contact with each other (contacted).
In addition, the coil part 35 does not necessarily need to be a close winding state in a natural state, and may be a rough winding state. That is, a gap may exist between the wire members 18a adjacent to each other in the axial direction in the coil portion 35.
The coil part 35 is disposed inside the enlarged diameter part 16 (the inner cavity 11 a) of the outer shaft 11. Specifically, the coil portion 35 is disposed on the distal end side in the enlarged diameter portion 16, and more specifically, is disposed near the distal end portion of the enlarged diameter portion 16. The coil portion 35 has an outer diameter D1 (see FIG. 3A) that is larger than an inner diameter D2 of the region on the distal end side of the enlarged diameter portion 16 in the outer shaft 11 (D1> D2). The outer diameter D1 (coil diameter) of the coil portion 35 is smaller than the inner diameter D3 of the enlarged diameter portion 16 (D1 <D3). Therefore, in a state where the coil portion 35 is disposed inside the enlarged diameter portion 16, a predetermined gap 37 exists between the outer peripheral surface of the coil portion 35 and the inner peripheral surface of the enlarged diameter portion 16. Incidentally, the fluid flows through the gap 37 and the inside of the coil portion 35 in the portion where the coil portion 35 is disposed in the enlarged diameter portion 16.
Next, the operation of the coil unit 35 will be described with reference to FIG. 3A and 3B are longitudinal sectional views for explaining the operation of the coil portion 35, in which FIG. 3A shows the contracted state of the balloon 14 and FIG. 3B shows the inflated state of the balloon 14. FIG.
As shown in FIG. 3A, in the contracted state of the balloon 14, the coil portion 35 is in a natural state, that is, in a contracted state (a contracted state). In this case, the length of the balloon 14 in the axial direction is L1, and the length of the coil portion 35 in the axial direction is L2.
When the compressed fluid is introduced into the balloon 14, the balloon 14 is in an inflated state as shown in FIG. When the balloon 14 is inflated, the balloon 14 expands (extends) in the axial direction in addition to expanding in the radial direction. In this case, the balloon 14 extends by ΔL in the axial direction, and the length in the axial direction becomes L3 (L3−L1 = ΔL).
Specifically, the balloon 14 extends by ΔL toward the distal end side with respect to the outer shaft 11 when extending in the axial direction. As the balloon 14 expands, the inner shaft 12 (core wire 18) joined to the distal end portion of the balloon 14 is pulled toward the distal end side by the balloon 14, whereby the coil portion 35 of the core wire 18 extends in the axial direction. . Specifically, the coil portion 35 extends by the same length as the amount of extension ΔL of the balloon 14 in the axial direction, and the length of the coil portion 35 in the axial direction becomes L4 (L4−L2 = ΔL). That is, in this case, since the coil portion 35 extends in the axial direction, the joint portion of the inner shaft 12 with the balloon 14 is displaced toward the distal end by ΔL (the amount of expansion of the balloon 14). It is possible to suppress the occurrence of warpage.
Thereafter, when the compressed fluid is discharged from the inside of the balloon 14, the balloon 14 is deflated again. When the balloon 14 is in a contracted state, the tensile force in the axial direction due to the balloon 14 acting on the coil portion 35 is lost, so the coil portion 35 contracts in the axial direction based on its own elastic force (return elastic force). . Thereby, the coil part 35 returns to a natural state, and the length in the axial direction returns to the original length L2 (before balloon inflation). Further, when the length of the coil portion 35 returns to the original length L2, the length in the axial direction of the balloon 14 also returns to the original length L1. Therefore, in this case, the balloon 14 returns to the original contracted state (before inflation) (the state shown in FIG. 3A).
Next, a method for using the balloon catheter 10 will be briefly described.
First, a guiding catheter is inserted into a sheath introducer inserted into a blood vessel, and the distal end opening of the guiding catheter is introduced to the coronary artery entrance. Next, the guide wire G is inserted into the guiding catheter, and the inserted guide wire G is introduced from the coronary artery entrance to a peripheral site through a treatment site such as a stenosis site.
Subsequently, the balloon catheter 10 is introduced into the guiding catheter along the guide wire G. When the balloon catheter 10 is introduced, the outer shaft 11 is only introduced into the guiding catheter with respect to the distal end side with respect to the enlarged diameter portion 16, and the enlarged diameter portion 16 is not introduced into the guiding catheter (and thus into the body). Like that. After the balloon catheter 10 is introduced into the guiding catheter, the balloon 14 is placed at the treatment site while performing a push-pull operation.
Subsequently, the compressed fluid is supplied to the balloon 14 from the hub 13 side through the inner cavity 11a of the outer shaft 11 using a pressurizer. Thereby, the balloon 14 is inflated, and the constricted portion is expanded by the inflated balloon 14. Further, when the balloon 14 is inflated, each element 31 arranged on the outer peripheral side of the balloon 14 is pressed against the blood vessel wall by the balloon 14 and bites into the blood vessel wall, so that the balloon 14 is prevented from slipping from the narrowed portion. be able to.
Here, when the balloon 14 is inflated, warping of the balloon 14 is suppressed by the action of the coil portion 35 as described above. For this reason, when the balloon 14 is warped, the elements 31 are not arranged around the balloon 14 at a predetermined interval, such as being concentrated on the outer peripheral side of the balloon 14 on the opposite side of the balloon 14. Is avoided. Thereby, it becomes possible to suitably exhibit the anti-slip function of the balloon 14 by each element 31.
After the expansion of the constricted portion by the balloon 14 is completed, the compressed fluid is discharged from the balloon 14 to bring the balloon 14 into a deflated state. Then, the balloon 14 and thus the balloon catheter 10 are pulled out from the body in the contracted state. Since the balloon 14 returns to the original contracted state (before inflating) when it is re-contracted as described above, in this case, it is possible to suppress deterioration in operability when the balloon 14 is pulled out.
As mentioned above, according to the structure of this embodiment explained in full detail, the following outstanding effects are acquired.
The coil part 35 was formed by winding the wire 18a which comprises the core wire 18 spirally to the axial direction, and the expansion-contraction part which can be expanded-contracted to the axial direction by the coil part 35 was comprised. In this case, it is possible to form the stretchable part while avoiding a significant decrease in rigidity as compared with the case where the stretchable part is formed of a highly flexible material (for example, a rubber material).
The coil portion 35 has a larger dimension in the radial direction than other portions of the core wire 18. For this reason, when the coil portion 35 is disposed in the balloon 14, the balloon diameter when the balloon 14 is deflated increases, and the passage of the balloon 14 in the body may decrease. In that respect, since the coil part 35 is arranged on the proximal end side with respect to the balloon 14, the warpage of the balloon 14 can be suppressed while avoiding a decrease in the passing property of the balloon 14.
A diameter-expanded portion 16 having a diameter larger than that of the distal end side is provided at a proximal end side portion of the outer shaft 11, and a coil portion 35 is disposed inside the diameter-expanded portion 16. In this case, even the coil portion 35 having a large radial dimension can be disposed inside the outer shaft 11. Moreover, since the enlarged diameter part 16 is provided in the base end side of the outer side shaft 11, when the outer side shaft 11 is introduced into the body, the enlarged diameter part 16 can be prevented from being introduced into the body. Accordingly, the coil portion 35 can be disposed inside the outer shaft 11 while avoiding a decrease in the insertion property of the outer shaft 11.
Since the coil portion 35 is disposed on the distal end side in the enlarged diameter portion 16, the coil portion 35 is disposed on the enlarged diameter portion 16, and the length of the portion on the distal end side of the coil portion 35 in the core wire 18 is made as short as possible. can do. Thereby, when the tip side portion is displaced in the axial direction along with the expansion and contraction of the coil portion 35, it is possible to reduce resistance when the tip side portion slides with the inner peripheral surface of the outer shaft 11. . For this reason, even if it is this structure, it becomes possible to exhibit the expansion-contraction function of the coil part 35 suitably.
The present invention is not limited to the above embodiment, and may be implemented as follows, for example.
(1) In the said embodiment, although the coil part was formed using a part of core wire 18, you may form a coil part separately from a core wire. For example, in FIG. 4A, the core wire 41 has a plurality (specifically, two) of wire portions 42 and 43 divided in the middle of the axial direction. A coil spring 44 (corresponding to a coil portion) formed separately from the core wire 41 (wire portions 42, 43) is provided between the wire portions 42, 43. The coil spring 44 is connected to each wire. They are attached to the parts 42 and 43, respectively.
The coil spring 44 is formed by winding a metal (for example, stainless steel) wire spirally in the axial direction (of the catheter). The coil spring 44 has hook portions 44a and 44b at both ends thereof. On the other hand, hook portions 42a and 43a are provided at the end portions on the coil spring 44 side of the wire portions 42 and 43, respectively. The hook portion 42 a of the wire portion 42 is hooked on the hook portion 44 a of the coil spring 44, and the hook portion 43 a of the wire portion 43 is hooked on the hook portion 44 b of the coil spring 44. Thereby, the coil spring 44 is attached to each of the wire portions 42 and 43, respectively.
According to this configuration, since the coil spring 44 is formed separately from the core wire 41, the degree of freedom can be increased in designing the coil portion. Therefore, it is convenient to design the coil portion according to the specifications (size, shape, inflation pressure, etc.) of the balloon 14. In this case, the inner shaft including the coil spring 44 and the core wire 41 is configured.
(2) In the above-described embodiment, the coil part 35 is provided as an elastic part that can be expanded and contracted in the axial direction by elastic deformation. However, the elastic part is not necessarily the coil part 35. For example, as shown in FIG. 4B, it is conceivable to use a resin tube 46 formed of a resin material having elasticity (for example, a rubber material) as the stretchable portion. The resin tube 46 can be expanded and contracted in the axial direction by elastic deformation. In the example of FIG. 4B, the core wire 41 has a plurality of wire portions 42 and 43 divided in the axial direction, as in the case of the above-described example of FIG. A resin tube 46 is provided between 42 and 43. The proximal end portion of the wire portion 42 is inserted into the distal end side of the resin tube 46, and the resin tube 46 and the wire portion 42 are bonded to each other by bonding in the inserted state. Further, the distal end portion of the wire portion 43 is inserted on the proximal end side of the resin tube 46, and the resin tube 46 and the wire portion 43 are bonded to each other by bonding in the inserted state. That is, in this case, the wire portions 42 and 43 are connected to each other via the resin tube 46.
Even in such a configuration, since the resin tube 46 can be expanded and contracted in the axial direction by elastic deformation, the resin tube 46 can be used as the expansion and contraction portion. Further, unlike the coil portion 35 and the coil spring 44, the resin tube 46 is not so large in the radial direction. In this case, the coil portion (the resin tube 46 is not provided with the enlarged diameter portion 16 on the outer shaft 11). ) Can be arranged in the outer shaft 11. In this case, the inner shaft including the core wire 41 and the resin tube 46 is configured.
(3) In the above embodiment, the coil portion 35 that can be expanded and contracted by elastic deformation is provided as the expansion and contraction portion, but the expansion and contraction portion does not necessarily have to be expandable and contractible by elastic deformation. For example, it is conceivable to use a wavy line portion in which a part of a core wire (wire material) is formed in a wavy line shape (zigzag shape) along the axial direction as the stretchable part. The wavy line portion is configured to be foldable and unfoldable in the same direction when an external force is applied in the axial direction, shortened in the axial direction when folded, and lengthened in the axial direction when unfolded. That is, since the wavy line portion can be expanded and contracted in the axial direction, in this case, the wavy line portion can be used as the expandable portion.
(4) Instead of the coil portion 35 (extensible / contracting portion) that can be expanded and contracted in the axial direction, the core wire 18 may be provided with an extending portion that can be expanded only in the axial direction. The extending portion is formed of, for example, a plastically deformable material, and is extended in the axial direction by plastic deformation when a tensile force in the axial direction is applied. In addition, once the extension unit is in the extended state, it continues to maintain the extended state. Even in such a configuration, when the balloon 14 extends in the axial direction, the inner shaft 12 is pulled toward the distal end side by the balloon 14, and the extending portion extends in the axial direction. That is, also in this case, since the extension portion extends, the joint portion of the inner shaft 12 with the balloon 14 is displaced to the distal end side, so that the balloon 14 can be prevented from warping.
(5) In the above embodiment, the coil portion 35 is arranged on the distal end side in the enlarged diameter portion 16 of the outer shaft 11. However, by changing this, the coil portion 35 is arranged on the proximal end side in the enlarged diameter portion 16. Also good. Further, the coil portion 35 may be disposed on the distal end side with respect to the enlarged diameter portion 16 in the outer shaft 11. However, in this case, it is necessary to make the outer diameter of the coil portion 35 smaller than the inner diameter of the outer shaft 11 (the distal end portion of the shaft 11 relative to the enlarged diameter portion 16).
Furthermore, the coil part 35 may be provided in the balloon 14. However, if the coil part 35 is provided in the balloon 14, there is a concern that the outer diameter of the balloon 14 when the balloon 14 is deflated increases and the passage of the balloon 14 decreases. Therefore, in view of this point, it is desirable to provide the coil portion 35 on the proximal end side with respect to the balloon 14.
(6) In the above embodiment, only one coil part 35 is provided on the core wire 18, but a plurality of coil parts 35 may be provided on the core wire 18 at predetermined intervals in the axial direction.
(7) In the above embodiment, the solid core wire 18 is used as a part of the inner shaft 12, but a hollow tube may be used instead of the core wire 18. And you may form a coil part using the hollow tube (equivalent to a wire).
(8) In the above embodiment, the present invention is applied to the balloon catheter 10 in which the element 31 is provided on the outer peripheral side of the balloon 14. However, the present invention may be applied to a balloon catheter that does not include the element 31.
(9) In the above embodiment, the present invention is applied to the balloon catheter 10 used for the treatment of the coronary artery. However, other blood vessels such as the femoral artery and the pulmonary artery, or other in vivo “tubes” such as the ureter and the digestive tract. The present invention may also be applied to balloon catheters used for "body cavities".
DESCRIPTION OF SYMBOLS 10 ... Balloon catheter, 11 ... Outer shaft, 12 ... Inner shaft, 14 ... Balloon, 16 ... Diameter expansion part, 18 ... Core wire, 18a ... Wire rod, 27 ... Guide wire lumen, 27b ... Base end opening, 31 ... Linear member 35 as an element, 35 as a coil part as an extension part and an elastic part, 39 as an opening side part.
A balloon that is inflated or deflated using a fluid;
An outer shaft joined to the proximal end of the balloon and through which the fluid flows;
An inner shaft inserted through the inside of the outer shaft and the inside of the balloon and joined to the tip of the balloon;
The balloon catheter according to claim 1, wherein the inner shaft has an extending portion that is extendable in an axial direction on a proximal end side with respect to a joint portion with the balloon.
The balloon catheter according to claim 1, wherein the extension portion is a stretchable portion that can be stretched and contracted in the axial direction by elastic deformation.
The balloon catheter according to claim 2, wherein the expansion / contraction part is a coil part formed by winding a wire constituting the inner shaft spirally in the axial direction.
The balloon catheter according to any one of claims 1 to 3, wherein the extending portion is disposed on a proximal end side with respect to the balloon.
The outer shaft has a diameter-increased portion in which the proximal end portion has a larger diameter than the distal end portion,
The balloon catheter according to claim 4, wherein the elongated portion is disposed inside the enlarged diameter portion.
The balloon catheter according to claim 5, wherein the elongated portion is disposed on a distal end side in the enlarged diameter portion.
A linear member provided on the outer peripheral side of the balloon across the balloon in the axial direction, and a plurality of linear members arranged at predetermined intervals in the circumferential direction of the balloon;
Each of the linear members has a base end portion attached to the outer shaft, and a distal end portion attached to an extending portion that extends to the distal end side of the balloon on the inner shaft. The balloon catheter according to any one of claims 1 to 6.
The extension portion is formed with a guide wire lumen extending from the distal end to the proximal end,
The lumen has an opening on the base end side that is opened at the outer peripheral surface of the extension part,
On the outer peripheral surface of the balloon, when the portion where the circumferential position is the same position as the opening is an opening-side portion, the linear members adjacent to each other in the circumferential direction across the opening-side portion The balloon catheter according to claim 7, wherein the interval is larger than the interval between the linear members adjacent in the circumferential direction without sandwiching the opening side portion.
JP2014221134A 2014-10-30 2014-10-30 Balloon catheter Active JP6442229B2 (en)
JP2014221134A JP6442229B2 (en) 2014-10-30 2014-10-30 Balloon catheter
EP15855569.8A EP3213791A4 (en) 2014-10-30 2015-10-28 Balloon catheter
CN201580054353.2A CN106794332A (en) 2014-10-30 2015-10-28 Foley's tube
PCT/JP2015/080334 WO2016068167A1 (en) 2014-10-30 2015-10-28 Balloon catheter
US15/499,996 US20170252542A1 (en) 2014-10-30 2017-04-28 Balloon Catheter
JP2016086878A true JP2016086878A (en) 2016-05-23
JP6442229B2 JP6442229B2 (en) 2018-12-19
ID=55857502
JP2014221134A Active JP6442229B2 (en) 2014-10-30 2014-10-30 Balloon catheter
US (1) US20170252542A1 (en)
EP (1) EP3213791A4 (en)
JP (1) JP6442229B2 (en)
CN (1) CN106794332A (en)
WO (1) WO2016068167A1 (en)
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2014-10-30 JP JP2014221134A patent/JP6442229B2/en active Active
2015-10-28 EP EP15855569.8A patent/EP3213791A4/en active Pending
2015-10-28 WO PCT/JP2015/080334 patent/WO2016068167A1/en active Application Filing
2015-10-28 CN CN201580054353.2A patent/CN106794332A/en active Search and Examination
2017-04-28 US US15/499,996 patent/US20170252542A1/en active Pending
EP3213791A8 (en) 2017-10-11
EP3213791A4 (en) 2018-08-01
CN106794332A (en) 2017-05-31
EP3213791A1 (en) 2017-09-06
WO2016068167A1 (en) 2016-05-06
US20170252542A1 (en) 2017-09-07
JP6442229B2 (en) 2018-12-19
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