JP2021146086A - Medical device - Google Patents

Abstract

To improve the passage property to a living lumen in a medical device with a lumen through which a guide wire can be inserted.SOLUTION: A medical device 100 according to the present invention has an inner tube shaft 60 and a distal end tip 65, intermediate surfaces 63, 64, 66, 67, 68, 69, and insertion members 70, 80. The inner tube shaft and the distal end tip comprise an outer wall surface 61 and an inner wall surface 62 forming a guide wire lumen L through which a guide wire G can be inserted. The intermediate surfaces 63, 64, 66, 67, 68, 69 are provided at a distal end in a longitudinal direction X and form a second lumen between the inner wall surface and the outer wall surface in a radial direction r intersecting the longitudinal direction X. The insertion members can be inserted into the second lumen and have a long configuration. The intermediate surfaces 63, 64, 67, 68 extend in the longitudinal direction of the inner tube shaft, and the intermediate surfaces 66, 69 are connected to the intermediate surfaces 63, 64, 67, 68 and are provided so as to surround the guide wire lumen.SELECTED DRAWING: Figure 4

Description

The present invention relates to medical devices.

A balloon catheter is known as a medical device used for a procedure for dilating a lesion (stenosis or the like) formed in a biological lumen such as a blood vessel or for placing a stent or the like in the lesion (see Patent Document 1). The balloon catheter has an outer tube having a lumen, an inner tube arranged in the lumen of the outer tube, and a balloon arranged on the distal end side of the inner tube and the outer tube. In a balloon catheter, a tip tip is often provided at the tip of the balloon.

In addition, a guide wire or the like is often inserted into the lumen of the inner tube.

Japanese Unexamined Patent Publication No. 2001-238953

The present inventors have diligently studied the passability of a medical device provided with a lumen through which a guide wire such as a balloon catheter is inserted when the balloon catheter or the like is delivered to a biological lumen with the guide wire inserted through the lumen. ing.

Therefore, an object of the present invention is to improve the passability through a biological lumen in a medical device provided with a lumen through which a guide wire can be inserted.

A medical device according to an aspect of the present invention that achieves the above object has a shaft member, an intermediate surface, and an insertion member. The shaft member has an outer wall surface and an inner wall surface forming a first lumen through which a guide wire can be inserted, and is formed in a long shape. The intermediate surface is provided at the tip end portion in the longitudinal direction of the shaft member, and forms a second lumen between the inner wall surface and the outer wall surface in the radial direction intersecting the longitudinal direction. The insertion member can be inserted into the second lumen and has a long shape. The intermediate surface includes a first portion extending in the longitudinal direction of the shaft member and a second portion connected to the first portion and provided so as to surround the first lumen.

Since the medical device according to the present invention is configured as described above, it is possible to improve the passability to the biological lumen in a medical device having a lumen through which a guide wire can be inserted.

It is a figure which shows the medical device which concerns on one Embodiment of this invention. It is sectional drawing which shows the tip part (2 part of FIG. 1) of a medical device. It is a figure which shows 3 parts (square broken line part) of FIG. It is a perspective view which shows the tip part of the inner pipe shaft. It is a top view of FIG. It is a figure which shows the state which cut the inner tube shaft and the tip of the tip in the medical instrument, and is the figure which shows the state before the tip, etc. are deformed, in which the insertion member is arranged in one insertion lumen. It is a figure which shows the state which cut | cut the inner tube shaft and the tip | tip in the medical instrument, and is the figure which shows the state before the tip | tip, etc. are deformed, in which the insertion member is arranged in another insertion lumen. It is a perspective view which shows the state which the tip tip and the like were deformed by the tension (traction) of an insertion member. It is a figure which shows the state which the tip tip and the like were deformed by the tension (traction) of the insertion member, without showing the insertion member. It is sectional drawing which shows the 2nd part of the insertion lumen. It is a figure which shows the relationship between the tip | tip of the inner tube shaft, and a guide wire. It is sectional drawing which shows the deformation example of the inner wall surface. It is a perspective view which shows the inner pipe shaft which concerns on 2nd Embodiment. FIG. 13 is a plan view of FIG. It is sectional drawing which shows the 1st passage which concerns on 2nd Embodiment. It is sectional drawing which shows the 2nd passage which concerns on 2nd Embodiment. It is a perspective view which shows the shaft member which concerns on the modification of 1st Embodiment. FIG. 17 is a plan view of FIG. It is a perspective view which shows the shaft member which concerns on the modification of 2nd Embodiment. FIG. 19 is a plan view of FIG. It is a top view which concerns on the modification of FIG. It is a top view which concerns on the modification of FIG.

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. The following description does not limit the technical scope and meaning of terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios. In addition, the following will be described using a coordinate system. The X in the Cartesian coordinate system is referred to as the longitudinal direction X along the longitudinal direction of the inner tube shaft 60 or the like described later. YZ in the Cartesian coordinate system is a plane that intersects the longitudinal direction X, and is referred to as a plane direction YZ. The r of the cylindrical coordinate system is a direction along the radial direction or the radial direction from the center Cn of the inner tube shaft 60 or the like in the plane direction YZ, and is referred to as a radial direction r. The θ of the cylindrical coordinate system is along the circumferential direction or the angular direction in the cross-sectional shape of the inner tube shaft 60 or the like in the plane direction YZ, and is referred to as the circumferential direction θ.

1 to 10 are views provided for explaining the medical device 100 according to the embodiment of the present invention. The medical device 100 according to the present embodiment pushes the narrowed portion by inserting the shaft 10 into the living lumen and expanding the balloon 20 arranged at the tip of the shaft 10 in the narrowed portion (lesion portion) as an example. It is configured as a medical device that can be spread and treated.

The medical device 100 can be configured as, for example, a PTCA dilation balloon used to widen a stenosis of a coronary artery. However, the medical device 100 is used for the purpose of treating and improving a stenosis formed in a living organ such as another blood vessel, bile duct, trachea, esophagus, other digestive tract, urethra, ear nose lumen, and other organs. You can also do it.

The medical device 100 includes a shaft 10 and a balloon 20 fixed to the tip end side of the shaft 10 as shown in FIGS. 1, 2 and the like. The shaft 10 has an outer tube shaft 50 having a lumen 50u and an inner tube shaft 60 arranged in the lumen 50u of the outer tube shaft 50. The balloon 20 is fixed to the tip end side of the inner tube shaft 60 and the tip end side of the outer tube shaft 50.

As shown in FIGS. 1, 2, and 3, the shaft 10 includes an outer tube shaft 50, an inner tube shaft 60, and a guide wire port P (corresponding to an opening).

The outer tube shaft 50 includes a tip shaft 51, an intermediate shaft 52 connected to the proximal end side of the distal shaft 51, and a proximal shaft 53 connected to the proximal end side of the intermediate shaft 52.

The tip shaft 51 and the intermediate shaft 52 are integrally fused (joined) with the inner pipe shaft 60 in the vicinity of the guide wire port P of the shaft 10. The base end shaft 53 is fused to the base end side of the intermediate shaft 52 in a state where the tip end side of the base end shaft 53 is arranged in the lumen 52u of the intermediate shaft 52.

The lumen 51u of the tip shaft 51, the lumen 52u of the intermediate shaft 52, and the lumen 53u of the proximal shaft 53 are connected to the expansion space 21 of the balloon 20 with the distal shaft 51, the intermediate shaft 52, and the proximal shaft 53 connected. The lumen 50u of the outer tube shaft 50 that communicates is formed.

The constituent materials of the tip shaft 51 and the intermediate shaft 52 are polyethylene, polypropylene, ethylene-propylene copolymer, polyolefin such as ethylene-vinyl acetate copolymer, thermoplastic resin such as soft polyvinyl chloride, polyurethane elastomer, polyamide elastomer, and the like. Various elastomers such as polyester elastomer, and crystalline plastics such as polyamide, crystalline polyethylene, and crystalline polypropylene can be used.

The constituent material of the base shaft 53 is a metal material having relatively high rigidity, for example, stainless steel, stainless stretchable alloy, Ni—Ti alloy, brass, and aluminum. As the material of the base end shaft 53, a resin material having a relatively large rigidity, for example, polyimide, vinyl chloride, or polycarbonate can be applied, if necessary.

The inner tube shaft 60 is arranged in the lumen 50u of the outer tube shaft 50. The inner pipe shaft 60 forms a guide wire lumen L1 (corresponding to the first lumen) through which the guide wire G can be inserted. The base end side of the guide wire lumen L1 communicates with the guide wire port P.

The guide wire port P communicates with the guide wire lumen L1 of the inner pipe shaft 60. The guide wire port P is formed on the proximal end side of the inner pipe shaft 60.

The medical device 100 is configured as a so-called rapid exchange type catheter in which a guide wire port P through which the guide wire G can enter and exit is formed near the tip end side of the shaft 10. That is, the guide wire G is configured to be insertable into the guide wire lumen L1 from the outside at the guide wire port P.

As the constituent material of the inner pipe shaft 60, for example, the same materials as those of the tip shaft 51 and the intermediate shaft 52 of the outer pipe shaft 50 can be used.

The balloon 20 is fixed to the outer tube shaft 50 and the inner tube shaft 60. The tip of the balloon 20 is connected to the tip of the inner tube shaft 60. The base end portion of the balloon 20 is connected to the tip end portion of the outer tube shaft 50.

The balloon 20 expands in the radial direction (diameter direction r) of the shaft 10 by injecting a working fluid through the lumen 50u of the outer tube shaft 50. The working fluid consists of, for example, a mixture of a contrast medium and a saline solution.

The constituent materials of the balloon 20 include, for example, polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene-terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, crosslinked ethylene-vinyl acetate copolymer, and the like. Thermoplastic resins such as polyurethane, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber and the like can be used.

The inner pipe shaft 60 includes a tip tip 65 on the tip side. The tip tip 65 has a tapered shape in which the outer diameter decreases toward the tip side. A through hole Ap that penetrates the tip 65 in the longitudinal direction X (axial direction) is formed inside the tip 65. Therefore, the through hole Ap forms a part of the guide wire lumen L1.

The tip tip 65 can be made of, for example, a flexible resin member having heat shrinkage. However, the material of the tip tip 65 is not particularly limited as long as it can be fixed to the inner tube shaft 60.

By providing the tip 65 on the tip side of the inner tube shaft 60, it is possible to preferably prevent the tip of the medical device 100 from being damaged when it comes into contact with a living organ (inner wall of a blood vessel or the like).

The inner tube shaft 60 is provided with a contrast marker portion C indicating the position of the balloon 20.

The contrast marker portion C can be made of, for example, a metal such as platinum, gold, silver, iridium, titanium, or tungsten, or an alloy thereof.

The contrast marker portion C is arranged at a position corresponding to the balloon 20 on the inner tube shaft 60.

The hub 30 has a supply device (not shown) such as an indeflator for supplying a fluid (working fluid), and a port 31 that can be connected to be liquid-tight and airtight. The port 31 of the hub 30 can be configured by, for example, a known luer taper or the like so that a fluid tube or the like can be connected and separated.

The shaft 10 is connected to the hub 30 in a state where the lumen 50u of the outer tube shaft 50 communicates with the flow path in the hub 30. The working fluid that expands and contracts the balloon 20 is supplied to the lumen 50u of the outer tube shaft 50 via the port 31 of the hub 30.

(Inner tube shaft and tip)
Next, the details of the inner tube shaft 60 and the tip tip 65 will be further described. Inserting members 70 and 80 are inserted into the inner tube shaft 60 and the tip tip 65 of the medical device 100 as shown in FIGS. 6 and 7. The insertion member 70 corresponds to the first insertion member in the present specification, and the insertion member 80 corresponds to the second insertion member. Further, the inner tube shaft 60 and the tip tip 65 correspond to shaft members.

As shown in FIGS. 8 and 9, the inner pipe shaft 60 includes an outer wall surface 61, an inner wall surface 62, and intermediate surfaces 63, 64, 67, 68. As shown in FIGS. 8 to 10, the tip tip 65 includes an outer wall surface 61, an inner wall surface 62 through which the guide wire G is inserted, and intermediate surfaces 63, 64, 66, 67, 68, 69.

The outer wall surface 61 is configured as a portion of the inner pipe shaft 60 and the tip tip 65 that is exposed to the outside.

The inner wall surface 62 is configured to form a guide wire lumen L1 through which a guide wire can be inserted. The inner wall surface 62 has a substantially circular shape when viewed from the longitudinal direction X in the present embodiment.

The intermediate surfaces 63, 64, 66, 67, 68, 69 are provided at least at the tip in the longitudinal direction X. The intermediate surfaces 63, 64, 66, 67, 68, 69 form insertion lumens L2 and L3 between the outer wall surface 61 and the inner wall surface 62 as shown in FIG.

The intermediate surfaces 63, 64, and 66 are configured as insertion lumens L2 (corresponding to the second lumen) on which the insertion member 70 is arranged (see FIG. 8). The intermediate surfaces 67, 68, and 69 are configured as insertion lumens L3 (corresponding to the second lumen) on which the insertion member 80 is arranged (see FIG. 8). The intermediate surfaces 63, 64, 67, and 68 are configured to be provided from the side of the tip tip 65 in the longitudinal direction X to the guide wire port P.

In the inner pipe shaft 60, the intermediate surfaces 63, 64, 67, 68 are configured as a first portion extending along the longitudinal direction X of the inner pipe shaft 60 as shown in FIGS. 4, 8 and the like. As shown in FIGS. 6 and 7, the intermediate surfaces 63 and 67 are arranged with the ends 71 and 81 which are one of the ends on the proximal end side of the insertion member 70, and the intermediate surfaces 64 and 68 are arranged on the proximal end side. The other ends 72, 82 of the can be arranged.

As shown in FIG. 10, the intermediate surfaces 63 and 64 on which the insertion member 70 is arranged are opposite to the intermediate surfaces 67 and 68 on which the insertion member 80 is arranged so as to sandwich the center Cn in the circumferential direction θ intersecting the longitudinal direction X. It is configured to be located on the side. That is, the intermediate surfaces 63 and 64 are configured to be arranged so as to be separated from the intermediate surfaces 67 and 68 by about 180 degrees in the circumferential direction θ.

The angle formed by the intermediate surfaces 63 and 64 and the intermediate surfaces 67 and 68 is not limited to about 180 degrees as long as the peripheral length of the inner wall surface 62 can be shortened when the insertion members 70 and 80 are towed, and is 90 degrees. The angle may be from to 180 degrees.

The intermediate surfaces 63 and 64 of the tip tip 65 and the intermediate surfaces 63 and 64 of the inner tube shaft 60 communicate with each other, and the intermediate surfaces 67 and 68 of the tip tip and the intermediate surfaces 67 and 68 of the inner tube shaft 60 communicate with each other. ing.

The intermediate surface 66 of the tip tip 65 constitutes a second portion connected to the intermediate surface 63 and the intermediate surface 64, and the intermediate surface 69 of the tip tip 65 constitutes a second portion connected to the intermediate surfaces 67 and 68. doing. The intermediate surfaces 63, 64, 67, 68 extend along the longitudinal direction X, while the intermediate surfaces 66, 69 are formed in a direction intersecting the longitudinal direction X. The intermediate surfaces 66 and 69 are provided so as to be substantially orthogonal to the intermediate surfaces 63, 64, 67 and 68 when the tip tip 65 is viewed in a plan view.

The intermediate surfaces 66 and 69 are formed in the present embodiment so as to surround the inner wall surface 62 as shown in FIG. 10 and the like, that is, to draw an arc. Here, "surrounding" means an intermediate surface 66 intersecting the longitudinal direction X to such an extent that the direction of the tip of the shaft member is changed when at least one of the insertion members 70 and 80 is pulled toward the proximal end side. It means that 69 is formed.

The intermediate surfaces 66 and 69 are configured to have an angle (central angle) of about 330 degrees in the present embodiment. However, if the orientation of the shaft member can be changed when at least one of the insertion members 70 and 80 is towed, the angle of the intermediate surfaces 66 and 69 is not limited to about 330 degrees, for example, 180 degrees or more and less than 360 degrees. There may be.

The thickness from the intermediate surfaces 66, 69 to the inner wall surface 62 (thickness in the radial direction r) is formed to be thinner than the thickness from the intermediate surfaces 66, 69 to the outer wall surface 61 (see FIG. 10). The tip portion of the tip tip 65 in the longitudinal direction X is configured as an R-shaped curved surface portion d as shown in FIG. The intermediate surfaces 66 and 69 are formed on the tip end side of the tip tip 65 in the longitudinal direction X and on the proximal end side with respect to the curved surface portion d.

In the present embodiment, the intermediate surface 66 is configured such that the intermediate surfaces 63 and 64 and the insertion lumen overlap, that is, communicate with each other. However, the intermediate surface 66 may be configured so that the insertion lumens do not overlap with the intermediate surfaces 63 and 64.

The insertion members 70 and 80 are configured as long members, and are arranged so as to be insertable on the intermediate surfaces 63, 64, 66, 67, 68 and 69 of the inner pipe shaft 60. The insertion members 70, 80 are arranged on the intermediate surfaces 63, 64, 66, 67, 68, 69, and the inner wall surface 62 of the tip tip 65 is pulled by pulling the end portions 71, 72, 81, 82 on the proximal end side. At least a part of is displaced inward in the radial direction r. By performing the above tension operation using the insertion members 70 and 80, the inner wall surface 62 is displaced so that the peripheral length becomes smaller (see FIGS. 8 and 9). The constituent materials of the insertion members 70 and 80 are not particularly limited, but for example, the constituent materials of the tip shaft 51 or the base end shaft 53 described above can be used. Further, when the hardness of the insertion members 70 and 80 is harder than that of the inner tube shaft 60 or the tip tip 65, the inner wall surface 62 of the tip tip 65 can be easily displaced. On the other hand, when the insertion members 70 and 80 are softer than the inner tube shaft 60 or the tip tip 65, the passability of the entire catheter (shaft 10) can be improved or improved.

As described above, the medical device 100 according to the present embodiment includes an inner tube shaft 60, a tip tip 65, intermediate surfaces 63, 64, 66, 67, 68, 69, and insertion members 70, 80. The inner tube shaft 60 and the tip 65 include an outer wall surface 61 and an inner wall surface 62. The inner wall surface 62 forms a guide wire lumen L1 through which the guide wire G can be inserted. The intermediate surfaces 63, 64, 66, 67, 68, 69 are provided at least at the tip end portion of the inner pipe shaft 60 in the longitudinal direction X, and the inner wall surface 62 and the outer wall surface 61 are provided in the radial direction r intersecting the longitudinal direction X. Insert lumens L2 and L3 are formed between them. The insertion members 70 and 80 can be inserted into the insertion lumens L2 and L3 and have a long shape. The intermediate surfaces 63, 64, 66, 67, 68, 69 are classified into intermediate surfaces 63, 64, 67, 68 and intermediate surfaces 66, 69. Intermediate surfaces 63, 64, 67, 68 extend in the longitudinal direction X. The intermediate surfaces 66 and 69 are connected to the intermediate surfaces 63, 64, 67 and 68 and are provided so as to surround the guide wire lumen L1.

FIG. 11 is a diagram showing a tip portion of a medical device in which a guide wire G is inserted into a guide wire lumen of the medical device. When a medical device such as a balloon catheter is caught by the clearance between the tip Po of the inner tube shaft 60 and the guide wire G on which the tip tip or the like can be placed when it is inserted into a flexion lesion or passed through a stainless steel. There is.

On the other hand, the inner wall surface of the tip tip 65 is pulled by pulling the base end side of the insertion members 70, 80 with the insertion members 70, 80 arranged on the intermediate surfaces 63, 64, 66, 67, 68, 69. 62 is deformed so as to be displaced inward in the radial direction r (see the arrow in FIG. 11). With this configuration, the distance between the guide wire G when the guide wire G is inserted into the guide wire lumen L1 and the inner wall surface 62 of the tip tip 65 located at the tip of the inner tube shaft 60 can be shortened. .. Thereby, the passability of the medical device 100 provided with the guide wire lumen L1 in the biological lumen can be improved.

Further, the medical device 100 includes insertion members 70 and 80. The intermediate surfaces 63, 64, 66, 67, 68, 69 are configured to form a plurality of lumens on which the insertion members 70 and 80 are arranged, such as the insertion lumens L2 and L3. With this configuration, the tip shape of the inner pipe shaft 60 can be deformed more according to the intention of the user by pulling the insertion members 70 and 80 by the user.

Further, the intermediate surfaces 63 and 64 on which the insertion member 70 is arranged and the intermediate surfaces 67 and 68 on which the insertion member 80 is arranged are configured to be arranged on opposite sides of the central Cn in the circumferential direction θ intersecting the longitudinal direction X. ing. With this configuration, when the insertion members 70 and 80 are towed, the distance between the inner wall surface 62 of the inner tube shaft 60 and the tip of the guide wire G can be shortened.

Further, the thickness from the inner wall surface 62 to the intermediate surfaces 66 and 69 is formed thinner than the thickness from the outer wall surface 61 to the intermediate surfaces 66 and 69. With this configuration, when the insertion members 70 and 80 are inserted into the intermediate surfaces 66 and 69, the inner wall surface 62 can be easily deformed inward in the radial direction r, and the inner tube shaft 60, the tip tip 65 and the guide The distance from the wire G can be easily shortened.

Further, the intermediate surfaces 66 and 69 are formed so as to intersect in the longitudinal direction X when the tip tip 65 is viewed in a plan view. With this configuration, when the insertion members 70 and 80 are inserted into the intermediate surfaces 66 and 69, the inner wall surface 62 is easily displaced inward in the radial direction r, and the inner wall surface 62 is brought closer to the guide wire G. It can be made easier.

Further, the tip tip 65 includes a curved surface portion d in which the leading edge in the longitudinal direction X is formed in a curved surface shape. The intermediate surfaces 66 and 69 are configured to be formed on the tip end side of the tip tip 65 and on the proximal end side with respect to the curved surface portion d. With such a configuration, it is possible to prevent or suppress the cross-sectional shape of the intermediate surfaces 66 and 69 from becoming small.

Further, the inner tube shaft 60 includes a guide wire port P capable of inserting the guide wire G into the guide wire lumen L1 from the outside on the proximal end side in the longitudinal direction X. The intermediate surfaces 63, 64, 67, and 68 are configured to be provided from the tip end side in the longitudinal direction X to the guide wire port P. With such a configuration, it is not necessary to expose the insertion members 70 and 80 to the outside of the medical device 100, and it is possible to prevent the insertion members 70 and 80 from interfering with the delivery of other medical devices during the procedure. It can be suppressed.

(Modified example of the first embodiment)
FIG. 12 is a cross section intersecting the longitudinal direction X of the tip tip 65 according to the modified example of the first embodiment. Although the tip 65 and the inner wall surface 62 of the inner tube shaft 60 have been described above as having a circular shape, they can also be configured as follows. In this modification, the shapes of the inner wall surface of the inner tube shaft and the tip tip are different from those of the first embodiment, and other configurations are the same. Therefore, detailed description thereof will be omitted. Further, although the insertion member is not shown in FIG. 12, it can be arranged (followed) along the shape of the intermediate surface or the insertion lumen.

The inner wall surface 62a of the tip tip 65a increases or decreases in the radial direction r as it is displaced in the circumferential direction θ when viewed from the longitudinal direction X as shown in FIG. 12 in this modification. It is structured like a wavy shape. The inner wall surface 62a of the inner pipe shaft is also configured in the same manner as the tip tip 65a.

As described above, in the present modification, the inner wall surface 62a is formed in a wavy shape along the circumferential direction θ that intersects the longitudinal direction X when the medical device is viewed from the longitudinal direction X. Therefore, when the inner wall surface 62a is deformed by the insertion members 70 and 80, the inner wall surface 62a can be easily brought close to the guide wire G, and the distance between the inner wall surface 62a and the guide wire G can be easily shortened.

(Second Embodiment)
Next, the medical device according to the second embodiment will be described. 13 to 16 are views showing an inner tube shaft 60 and a tip tip 65b of the medical device according to the second embodiment. In this embodiment, the configurations other than the tip tip 65b are the same as those in the first embodiment, and thus the description thereof will be omitted. Further, although the insertion member is not shown in FIGS. 13 to 16, it can be arranged (followed) along the shape of the intermediate surface or the insertion lumen as in the case of FIG.

As shown in FIGS. 15 and 16, the tip tip 65b includes an outer wall surface 61, an inner wall surface 62, and intermediate surfaces 63, 64, 66b, 67, 68, 69b. The intermediate surfaces 63, 64, 66b are configured to form an insertion lumen L4 on which the insertion member 70 is arranged. The intermediate surfaces 67, 68, 69b are configured to form an insertion lumen L5 on which the insertion member 80 is arranged.

Further, the intermediate surfaces 63, 64, 66b, 67, 68, 69b are classified into intermediate surfaces 63, 64, 67, 68 and intermediate surfaces 66b, 69b.

The intermediate surfaces 63, 64, 67, and 68 are configured to extend in the longitudinal direction X as in the first embodiment. The intermediate surfaces 66b and 69b are configured to intersect the longitudinal direction X. As shown in FIG. 14, the intermediate surfaces 66b and 69b are longer than the intermediate surfaces 66 and 69 of the first embodiment when viewed in a plan view so that the intermediate surfaces 63 and 67 and the intermediate surfaces 64 and 68 overlap each other. It is formed at an angle so that the angle of formation is small. As shown in FIGS. 15 and 16, the intermediate surfaces 66b and 69b are formed so as to surround the inner wall surface 62 forming the guide wire lumen L1 at an angle of half a circumference or more.

As described above, in the present embodiment, the intermediate surfaces 66b and 69b of the tip tip 65 are configured so that the angle formed with the longitudinal direction X is smaller than that of the intermediate surfaces 66 and 69 according to the first embodiment. With this configuration, the insertion members 70 and 80 can be easily inserted into the intermediate surface.

The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. 17 to 20 are perspective views and plan views showing deformation examples of the tip tip and the inner tube shaft.

In the first embodiment and the second embodiment, the embodiments in which the insertion lumens L2 and L3 are provided so that the insertion members 70 and 80 can be inserted into the intermediate surface have been described, but the present invention is not limited thereto. As shown in FIGS. 17 and 18 with respect to the first embodiment, the inner tube shaft 60c and the tip tip 65c are provided with intermediate surfaces 63 and 64 extending in the longitudinal direction X, and the tip tip 65c is provided with the intermediate surface 66. It is not necessary to form the insertion lumen L2 and not to form the insertion lumen L3.

Further, as shown in FIGS. 19 and 20, intermediate surfaces 67 and 68 extending in the longitudinal direction X are provided on the inner tube shaft 60d and the tip tip 65d with respect to the second embodiment, and the intermediate surface 69b is provided on the tip tip 65d. It is not necessary to provide the insertion lumen L5 to form the insertion lumen L4. When either one of the insertion members 70 and 80 is inserted by configuring as shown in FIGS. 17 and 19, the orientation of the tip portions of the tip tips 65c and 65d arranged at the tips of the inner tube shafts 60c and 60d can be changed. Can be changed. As a result, the passage of the medical device through the living lumen can be improved. When the insertion member is arranged in the insertion lumen L4 inclined with respect to the longitudinal direction X and the tension (traction) operation is performed on the base end side of the insertion member, the outer wall surface of the tip tip intersects the longitudinal direction X. It can be easily deformed so as to swing its head in a direction such as or Z.

21 and 22 are plan views showing a modified example of the intermediate surface of the first embodiment and the second embodiment. It is described that intermediate surfaces 63, 64, 66, 67, 68, 69 are formed between the outer wall surface 61 and the inner wall surface 62, but the cross-sectional area (outer shape) of the passage is partially smaller than the surrounding area on the intermediate surface. It may be configured to provide a portion.

In FIG. 21, in the tip tip 65e corresponding to the modified example of the first embodiment, the reduction portion 63f is formed on the proximal end side of the intermediate surface 63e extending in the longitudinal direction X with respect to the intermediate surface 69e. Further, a reduction portion 69f is provided at a portion of the intermediate surface 69e separated from the intermediate surface 67.

In FIG. 22, in the tip tip 65g which is a modification of the second embodiment, a reduction portion 66h is provided on the proximal end side of the intersection of the intermediate surface 66g with the intermediate surface 69g when viewed in a plan view as shown in FIG. .. Further, when the tip 65g is viewed in a plan view as shown in FIG. 22, a reduction portion 69h is provided on the proximal end side of the intersection of the intermediate surface 69g with the intermediate surface 66g.

As described above, the intermediate surfaces 63e, 69e, 66g, and 69g are configured to be provided with reduction portions 63f, 69f, 66h, 69h, which are at least partially smaller in outer shape than other portions (periphery). With this configuration, the insertion members 70 and 80 can be easily inserted into the insertion lumens L2, L3, L4 and L5 formed by the intermediate surface.

Further, although it has been described above that the medical device 100 includes the balloon 20, the present invention is not limited to this. An embodiment of the present invention also includes a medical device that does not include a balloon and forms a guide wire lumen by an inner wall surface.

Further, in the above description, an embodiment in which the intermediate surfaces 63, 64, 67 and 68 are provided up to the guide wire port P of the inner pipe shaft 60 constituting the shaft member has been described. However, if an intermediate surface on which the insertion members 70 and 80 are arranged can be provided, a medical device in which the intermediate surface is not formed up to the guide wire port is also included in one embodiment of the present invention.

60 Inner pipe shaft (shaft member),
61 outer wall surface,
62, 62a Inner wall surface,
63, 64, 67, 68 intermediate surfaces (first site, surface forming the second lumen),
63f, 69f, 66h, 69h reduction part,
65, 65a, 65b, 65c, 65d, 65e, 65g Tip (shaft member),
66, 66b, 66g, 69, 69b, 69e, 69g Intermediate surface (second site, surface forming the second lumen),
70 Insertion member (first insertion member),
80 Insertion member (second insertion member),
Cn center,
d Curved surface part,
L1 guide wire lumen (1st lumen),
L2, L3, L4, L5 Insert lumen (second lumen),
P guide wire port (opening),
r radial direction,
X longitudinal direction,
θ Circumferential direction.

Claims (9)

A long shaft member including an outer wall surface and an inner wall surface forming a first lumen through which a guide wire can be inserted.
An intermediate surface provided at least at the tip of the shaft member in the longitudinal direction and forming a second lumen between the inner wall surface and the outer wall surface in the radial direction intersecting the longitudinal direction.
It has a long insertion member that can be inserted into the second lumen.
The intermediate surface is a medical device including a first portion extending in the longitudinal direction of the shaft member and a second portion connected to the first portion and provided so as to surround the first lumen. The insertion member includes a first insertion member and a second insertion member.
The medical device according to claim 1, wherein the intermediate surface forms a plurality of the second lumens on which the first insertion member and the second insertion member are arranged. According to claim 2, the first portion for arranging the first insertion member and the first portion for arranging the second insertion member are located on opposite sides of the center in the circumferential direction intersecting the longitudinal direction. The medical device described. The medical device according to any one of claims 1 to 3, wherein the second portion is formed thinner from the intermediate surface to the inner wall surface than from the outer wall surface to the intermediate surface. The inner wall surface is formed in a corrugated shape along a circumferential direction intersecting the longitudinal direction when the tip portion is viewed from the longitudinal direction of the shaft member according to any one of claims 1 to 4. The medical device described. The medical device according to any one of claims 1 to 5, wherein the second portion is formed so as to intersect in the longitudinal direction when the tip portion is viewed in a plan view. The tip portion includes a curved surface portion whose tip end in the longitudinal direction is formed in a curved surface shape.
The medical device according to any one of claims 1 to 6, wherein the intermediate surface is provided on the distal end side in the longitudinal direction and on the proximal end side with respect to the curved surface portion. The shaft member has an opening on the proximal end side in the longitudinal direction into which the guide wire can be inserted into the first lumen from the outside.
The medical device according to any one of claims 1 to 7, wherein the intermediate surface is provided from the tip portion to the opening portion in the longitudinal direction. The medical device according to any one of claims 1 to 6, wherein the intermediate surface includes a reduction portion whose outer shape is smaller than the periphery of the intermediate surface at least in part.

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