JP7328864B2 - Balloon catheter for bronchodilation - Google Patents

Description

The present invention relates to a balloon catheter for bronchial dilation.

Balloon catheters have hitherto been used to dilate and treat stenosed regions in gastrointestinal tracts such as esophagus and bile ducts, trachea, blood vessels, and the like. For example, U.S. Pat. No. 5,400,000 discloses a balloon catheter comprising a shaft having at least one lumen extending longitudinally therethrough and a balloon disposed at the distal end of the shaft, the balloon comprising a braided layer on its outer surface. ing.

JP-A-2008-36391

Known pulmonary diseases include those causing constriction, lung cancer, and the like. Some lung cancers develop in the periphery of the bronchi, but because the periphery of the bronchi is extremely narrow, it is difficult to observe with an endoscope by inserting a bronchoscope into the periphery of the bronchi using conventional techniques. Ta. Therefore, a method of inserting a balloon catheter into the bronchial periphery to expand the bronchial periphery with a balloon and then observing the bronchial periphery may be considered. However, the end of the peripheral bronchi is adjacent to the visceral pleura, and if the visceral pleura is damaged, the lung may perforate and cause pneumothorax. , safety is required.

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a balloon catheter for bronchial peripheral dilation which is excellent in safety.

The balloon catheter according to the present invention, which has solved the above problems, has the following configuration.
[1] A balloon catheter having a shaft having a distal direction and a balloon provided on the distal side of the shaft,
The balloon has a fixed portion that is fixed to the shaft and a non-fixed portion that is not fixed,
The balloon catheter has a rod-shaped portion extending distally from the distal end of the non-fixed portion, and the bending load A when the rod-shaped portion is pushed 1.0 mm, which is obtained by the bending load measuring method described below. A balloon catheter for bronchial dilation, wherein ₁ is 0.17N or less.
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter is placed between the lower block and the upper block such that the axial direction of the shaft is parallel to the longitudinal direction of the lower block and the upper block. Next, the distal end of the lower block, the distal end of the upper block, and the distal end of the non-fixed portion of the balloon are aligned in the axial direction of the shaft, and the balloon catheter is aligned. is sandwiched and fixed between the lower block and the upper block. Next, a portion from the distal end of the rod-shaped portion to a position 1.0 mm apart in the axial direction of the shaft is pushed in by 1.0 mm in a direction perpendicular to the axial direction of the shaft using a pressurizer having a rectangular pressurizing surface. Measure the load (N) at that time.

When the bending load A ₁ of the rod-like portion when pushed in by 1.0 mm is 0.17 N or less, damage to the visceral pleura can be easily avoided.

Furthermore, the balloon catheter according to the present invention preferably includes the following configurations [2] to [4].
[2] The bending load A ₁ (N) when the rod-shaped portion is pushed by 1.0 mm and the bending load A _1.5 (N) when the rod-shaped portion is pushed by 1.5 mm, which is obtained by the bending load measuring method described below. A balloon catheter for bronchial peripheral dilation according to [1], which satisfies the following formula (1).
A _1.5 ≧1.15 A ₁ (1)
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter is placed between the lower block and the upper block such that the axial direction of the shaft is parallel to the longitudinal direction of the lower block and the upper block. Next, the distal end of the lower block, the distal end of the upper block, and the distal end of the non-fixed portion of the balloon are aligned in the axial direction of the shaft, and the balloon catheter is aligned. is sandwiched and fixed between the lower block and the upper block. Next, a portion from the distal end of the rod-shaped portion to a position 1.0 mm apart in the axial direction of the shaft is pushed in by 1.5 mm in a direction perpendicular to the axial direction of the shaft using a pressurizer having a rectangular pressurizing surface. Measure the load (N) at that time.
[3] Bending load A ₁ (N) when the rod-shaped portion is pushed 1.0 mm, and bending load when the rod-shaped portion is pushed 1.0 mm again after being unloaded after being pushed 1.0 mm. A balloon catheter for bronchial peripheral dilation according to [1] or [2], wherein A _1-2 (N) satisfies the following formula (2).
A _1-2 ≧0.90 A ₁ (2)
[4] The bending load _A1 when the rod portion is pushed in by 1.0 mm and the bending load _B1 of the shaft obtained by the following bending load measuring method satisfy the following formula (3) [1] A balloon catheter for bronchial peripheral dilation according to any one of to [3].
A ₁ ≧0.1 B ₁ (3)
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the proximal end of the balloon is cut radially to separate the distal side from the proximal end of the balloon, and the axial direction of the shaft after the cutting is aligned with the length direction of the lower block and the upper block. The cut shaft is placed between the lower block and the upper block so as to be parallel. Next, the distal end of the lower block, the distal end of the upper block, and a point 5.0 mm apart in the axial direction from the distal end of the cut shaft are aligned in the axial direction. After alignment, the cut shaft is sandwiched and fixed between the lower block and the upper block. Next, when the portion from the distal end of the cut shaft to the position 1.0 mm away in the axial direction is pushed by 1.0 mm in a direction perpendicular to the axial direction with a presser having a rectangular pressing surface. Measure the load (N) of

ADVANTAGE OF THE INVENTION According to this invention, the said structure can provide the balloon catheter for bronchial peripheral expansion excellent in safety|security.

1 is a side view of an example of a balloon catheter according to an embodiment of the present invention; FIG. FIG. 2 is a side view showing a method of measuring the bending load of the rod-shaped portion of the balloon catheter according to the embodiment of the present invention. Figure 3 is an axial cross-sectional view at region A of the balloon catheter of Figure 1 in a pressurized state; 4 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. 5 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. 6 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. 7 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. 8 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. 9 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. 10 is a cross-sectional view showing another example of the cross section of FIG. 3. FIG. FIG. 11 is a perspective view of a bronchoscope into which a balloon catheter according to an embodiment of the invention has been inserted; FIG. 12 is a side view (partial cross-sectional view) showing how to use the balloon catheter and bronchoscope according to the embodiment of the present invention. FIG. 13 is a side view showing how to use the balloon catheter and bronchoscope according to the embodiment of the present invention. 14 is a plan view of the distal end of the sheath of the bronchoscope of FIG. 11; FIG.

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope of the above and later descriptions. Of course, it is also possible to implement by adding and all of them are included in the technical scope of the present invention. Note that in each drawing, for the sake of convenience, reference numerals for members and the like may be omitted. In such cases, the specification and other drawings should be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

A balloon catheter for bronchial peripheral dilation of the present invention is a balloon catheter having a shaft having a distal direction and a balloon provided on the distal side of the shaft, the balloon being fixed to the shaft. The balloon catheter has a fixed portion and a non-fixed portion that is not fixed, and has a bar-shaped portion extending distally from the distal end of the non-fixed portion. The bending load A ₁ when the rod-like portion is pushed in by 1.0 mm is 0.17 N or less. This makes it easier to avoid damage to the visceral pleura.
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter is placed between the lower block and the upper block such that the axial direction of the shaft is parallel to the longitudinal direction of the lower block and the upper block. Next, the distal end of the lower block, the distal end of the upper block, and the distal end of the non-fixed portion of the balloon are aligned in the axial direction of the shaft, and the balloon catheter is aligned. is sandwiched and fixed between the lower block and the upper block. Next, a portion from the distal end of the rod-shaped portion to a position 1.0 mm apart in the axial direction of the shaft is pushed in by 1.0 mm in a direction perpendicular to the axial direction of the shaft using a pressurizer having a rectangular pressurizing surface. Measure the load (N) at that time.

A balloon catheter according to an embodiment of the present invention will be described below with reference to FIGS. 1 to 10. FIG. 1 is a side view of an example of a balloon catheter according to an embodiment of the present invention; FIG. FIG. 2 is a side view showing a method of measuring the bending load of the rod-shaped portion of the balloon catheter according to the embodiment of the present invention. Figure 3 is an axial cross-sectional view at region A of the balloon catheter of Figure 1 in a pressurized state; 4 to 10 are cross-sectional views showing other examples of the cross section of FIG.

As shown in FIGS. 1-3, the balloon catheter 20 has a shaft 21 having a distal direction X and a balloon 22 provided on the distal side of the shaft 21 . The balloon 22 has a fixed portion 27 that is fixed to the shaft 21 and a non-fixed portion 28 that is not fixed. The balloon 22 includes a pressurization lumen 26 through which positive pressure is applied by infusing fluid into a non-fixed portion 28, and pressurization of the pressurization lumen 26 within the distal bronchi as shown in FIG. By dilating 22, the bronchial extremities can be dilated. Further, the balloon catheter 20 includes a bar-shaped portion 25 extending distally from the distal end 28B of the non-fixed portion 28 .

The balloon catheter 20 has a bending load A ₁ of 0.17 N or less when the rod-shaped portion 25 is pushed in by 1.0 mm, which is obtained by the bending load measuring method described below. A method for measuring the bending load will be described below with reference to FIG.

As shown in FIG. 2, a rectangular parallelepiped lower block 90 made of stainless steel having a length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more; A rectangular parallelepiped upper block 91 having a length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter 20 is arranged between the lower block 90 and the upper block 91 so that the axial direction of the shaft 21 is parallel to the longitudinal direction of the lower block 90 and the upper block 91 . Next, the distal end 90B of the lower block 90, the distal end 91B of the upper block 91, and the distal end 28B of the non-fixed portion 28 of the balloon 22 are aligned in the axial direction of the shaft 21, and The balloon catheter 20 is sandwiched between the lower block 90 and the upper block 91 and fixed. Next, a portion from the distal end 25C of the rod-shaped portion 25 to a position 1.0 mm apart in the axial direction of the shaft 21 is pressed by a pressing member 92 having a rectangular pressing surface 92a in a direction perpendicular to the axial direction of the shaft 21. Measure the load (N) when pushed in by 0 mm.

When the bending load A ₁ when the rod-shaped portion 25 of the balloon catheter 20 is pushed by 1.0 mm is 0.17 N or less, damage to the visceral pleura can be easily avoided. The bending load A ₁ when the rod-shaped portion is pushed in by 1.0 mm is preferably 0.16 N or less, more preferably 0.15 N or less, and still more preferably 0.08 N or less. Although the lower limit is not particularly limited, it may be, for example, 0.001 N or more.

The bending load A ₁ (N) when the rod-shaped portion 25 is pushed 1.0 mm, and the bending load A _1.5 (N) when pushed 1.5 mm by the measuring method of the bending load of the rod-shaped portion 25 obtained by the bending load measurement method below. ) preferably satisfies the following formula (1).
A _1.5 ≧1.15 A ₁ (1)

A method for measuring the bending load will be described below with reference to FIG. First, a rectangular parallelepiped lower block 90 made of stainless steel having a length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more as shown in FIG. A rectangular parallelepiped upper block 91 having a length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter 20 is arranged between the lower block 90 and the upper block 91 so that the axial direction of the shaft 21 is parallel to the longitudinal direction of the lower block 90 and the upper block 91 . Next, the distal end 90B of the lower block 90, the distal end 91B of the upper block 91, and the distal end 28B of the non-fixed portion 28 of the balloon 22 are aligned in the axial direction of the shaft 21, and The balloon catheter 20 is sandwiched between the lower block 90 and the upper block 91 and fixed. Next, a portion from the distal end 25C of the rod-shaped portion 25 to a position 1.0 mm apart in the axial direction of the shaft 21 is pressed by a pressing member 92 having a rectangular pressing surface 92a in a direction perpendicular to the axial direction of the shaft 21. Measure the load (N) when pushed in by 5 mm.

When the rod-shaped portion 25 satisfies the formula (1), the occurrence of kinking and buckling of the rod-shaped portion 25 can be easily reduced. You can easily perceive what you have done. The bending load A _1.5 (N) is preferably 1.20 times or more the bending load A ₁ (N), more preferably 1.25 times or more, and more preferably 1.28 times or more. More preferred. On the other hand, the upper limit is not particularly limited, but may be, for example, 2.0 times or less, or 1.5 times or less.

The bending load A ₁ (N) when the rod-shaped portion 25 is pushed in by 1.0 mm, and the bending load A 1 (N) when the rod-shaped portion 25 is pushed in again by 1.0 mm after being unloaded after being pushed in by _1.0 mm. ₂ (N) preferably satisfies the following formula (2).
A _1-2 ≧0.90 A ₁ (2)

By satisfying the formula (2), it is possible to prevent the rod-shaped portion 25 from deforming even if a load is repeatedly applied to the rod-shaped portion 25 when it is inserted into the bronchial periphery. can be easily communicated to The bending load A _1-2 (N) is more preferably 0.93 times or more the bending load A ₁ (N), still more preferably 0.95 times or more, and 0.98 times or more. is even more preferred, and most preferably 1.0 times.

It is preferable that the bending load A ₁ when the rod-like portion 25 is pushed in by 1.0 mm and the bending load B ₁ of the shaft 21 obtained by the bending load measuring method described below satisfy the following formula (3).
A ₁ ≧0.1 B ₁ (3)

A method of measuring the bending load B ₁ of the shaft 21 will be described below with reference to FIG. First, a rectangular parallelepiped lower block 90 made of stainless steel having a length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more as shown in FIG. A rectangular parallelepiped upper block 91 having a length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the proximal end 22A of the balloon 22 is cut radially to separate the distal side from the proximal end 22A of the balloon 22, and the axial direction of the shaft 21 after cutting is the length of the lower block 90 and the upper block 91. The cut shaft 21 is arranged between the lower block 90 and the upper block 91 so as to be parallel to the direction. Next, the distal end 90B of the lower block 90, the distal end 91B of the upper block 91, and a point 5.0 mm axially away from the distal end of the cut shaft 21 are axially aligned. After alignment, the cut shaft 21 is sandwiched between the lower block 90 and the upper block 91 and fixed. Next, when the portion of the cut shaft 21 from the distal end to the position 1.0 mm away in the axial direction is pushed in by 1.0 mm in the direction perpendicular to the axial direction by the pressing member 92 having a rectangular pressing surface 92a. Measure the load (N) of

When the balloon catheter 20 satisfies the expression (3), the difference in rigidity between the rod-shaped portion 25 and the shaft 21 can be easily reduced, and the occurrence of kink and buckling due to the difference in rigidity can be easily reduced. It is possible to make it easier to sense that the rod-shaped part 25 has reached the visceral pleura located at the end of the bronchus periphery. The bending load A ₁ (N) is preferably 0.1 times or more the bending load B ₁ (N), more preferably 0.2 times or more, and further preferably 0.3 times or more. preferable. On the other hand, the upper limit is not particularly limited, but may be, for example, 0.98 times or less, or 0.95 times or less.

The shaft 21 may have an inner tube 21a and an outer tube 21b, as shown in FIGS. 1-3. The inner tube 21a can be used as an insertion passage for a guide wire or the like. 1 to 3, the distal end side of the balloon 22 is fixed to the inner tube 21a by the distal fixing portion 27, and the proximal end side of the balloon 22 is fixed to the outer side by the proximal fixing portion 27. It is fixed to the tube 21b. With such a configuration, the space between the inner tube 21a and the outer tube 21b can be used as a flow path for injecting fluid, and the space between the inner tube 21a and the balloon 22 can be used as a pressure lumen 26. can be 3 to 5, the distal end 21B of the inner tube 21a may be located on the distal side of the distal end 27B of the fixed portion 27 on the distal side of the balloon 22, or as shown in FIG. may be positioned axially aligned with distal end 27B. The outer diameter of the inner tube 21a is preferably 0.3 mm or more and 0.7 mm or less. The inner diameter of the inner tube 21a is preferably 0.2 mm or more and 0.5 mm or less. The outer tube 21b preferably has an outer diameter of 0.5 mm or more and 1.2 mm or less. The inner diameter of the outer tube 21b is preferably 0.4 mm or more and 0.9 mm or less.

The outer diameter of the distal end 27B of the fixing portion 27 is preferably 1.0 mm or less. Thereby, the bending load of the rod-shaped portion 25 can be easily reduced. It is more preferably 0.90 mm or less, still more preferably 0.65 mm or less. On the other hand, the outer diameter of the distal end 27B of the fixing portion 27 may be, for example, 0.2 mm or more, or 0.3 mm or more.

As shown in FIGS. 3-6, when the balloon catheter 20 includes a rod-shaped body 25a, the distal end 21B of the inner tube 21a is distal to the distal end 25B of the rod-shaped body 25a as shown in FIG. 4, and may be axially aligned with the distal end 25B of rod 25a, as in FIG. 4, and proximal to distal end 25B of rod 25a, as in FIG. and may be positioned distally of the distal end 27B of the distal fixation portion 27 of the balloon 22, and positioned axially aligned with the distal end 27B as shown in FIG. good too. That is, the distal end of the inner tube 21a may pass through the rod-shaped body 25a in the axial direction as shown in FIGS. 3 and 4, or may be built in the rod-shaped body 25a as shown in FIG. It may be joined so as to be adjacent to the rod-shaped body 25a as shown in FIG.

As shown in FIG. 7, the shaft 21 may include an outer tube 21b and a linear body 21c arranged inside the outer tube 21b. As a result, the distal end side of the balloon 22 is fixed to the linear body 21c by the distal side fixing portion 27, and the proximal end side of the balloon 22 is fixed to the outer tube 21b by the proximal side fixing portion 27. can do. With such a configuration, the space between the linear body 21c and the outer tube 21b can be used as a flow path for injecting fluid, and the space between the linear body 21c and the balloon 22 can be a pressurized lumen. 26. 7 and 8, the distal end 21C of the filamentous body 21c may be positioned further distal than the distal end 27B of the fixing portion 27 on the distal side of the balloon 22. may be positioned axially aligned with distal end 27B such as.

As shown in FIGS. 7 to 9, when the balloon catheter 20 includes a rod-shaped body 25a, the distal end 21C of the linear body 21c is axially aligned with the distal end 25B of the rod-shaped body 25a as shown in FIG. As shown in FIG. 8, it is proximal to the distal end 25B of the rod-shaped body 25a and distal to the distal end 27B of the fixing portion 27 on the distal side of the balloon 22. It may be positioned, and may be positioned axially aligned with distal end 27B as in FIG. That is, the distal end portion of the linear body 21c may pass through the rod-shaped body 25a in the axial direction as shown in FIG. 7, or may be incorporated in the rod-shaped body 25a as shown in FIG. Like 9, it may be joined so as to be adjacent to the rod-shaped body 25a.

Although not shown, the shaft 21 may be composed of the linear body 21c without the inner tube 21a and the outer tube 21b.

The inner pipe 21a contains at least one selected from the group consisting of, for example, polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. It may contain at least one selected from the group consisting of polyamide-based elastomers, polyester-based elastomers, polyurethane-based elastomers, polyolefin-based elastomers, vinyl chloride-based elastomers, and silicone-based elastomers. These may use only 1 type and may use 2 or more types together. Among these, at least one selected from the group consisting of polyamide resins, polyolefin resins, and fluorine resins is preferably included, and at least one selected from the group consisting of polyolefin resins and fluorine resins is included. is more preferable.

The outer tube 21b contains at least one selected from the group consisting of polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. It may contain at least one selected from the group consisting of polyamide-based elastomers, polyester-based elastomers, polyurethane-based elastomers, polyolefin-based elastomers, vinyl chloride-based elastomers, and silicone-based elastomers. These may use only 1 type and may use 2 or more types together. Among these, at least one selected from the group consisting of polyamide resins, polyolefin resins, and polyurethane resins is preferable.

The inner tube 21a and the outer tube 21b may have reinforcing members. Examples of the reinforcing member include a braided body in which a wire is braided, or a coiled body in which a wire is helically wound. This makes it easier to improve the strength.

A metal wire, a fiber, etc. are mentioned as a wire which comprises a reinforcement member. As a material for forming the metal wire, for example, stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, tungsten alloy, and the like are preferable. Of these, stainless steel is more preferred. The metal wire may be a single wire or a twisted wire. Examples of fibers include polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, PBO fibers, and carbon fibers. The fibers may be monofilaments or multifilaments.

A metal wire, a resin wire, etc. are mentioned as the linear body 21c. As metal wires, those whose distal ends are covered with resin (so-called polymer jacket type) and those whose distal ends are covered with metal coils (so-called coil jacket type) have flexibility at the distal end. It is preferable because it is easy to improve. Examples of the outer shape of the metal wire or resin wire in the cross section in the thickness direction include a circular shape, an elliptical shape, and a rectangular shape.

Examples of materials for the metal wires and metal coils include shape memory alloys such as nickel-titanium alloys, stainless steel, titanium, cobalt-chromium alloys, and tungsten alloys. Of these, stainless steel is preferred.

Examples of resins used for covering resin wires and metal wires include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, fluorine-based resins, vinyl chloride-based resins, silicone-based resins, and natural rubber. Among these, at least one selected from the group consisting of polyamide elastomers, polyester elastomers, polyurethane elastomers, polyolefin elastomers, vinyl chloride elastomers, and silicone elastomers is preferred.

The shaft 21 is not limited to the so-called over-the-wire type (OTW type) in which the proximal end 21A of the inner tube 21a is positioned inside a handle portion 29 described later as shown in FIG. A so-called rapid exchange type (RX type) in which the proximal end 21A of 21a is located on the distal side of the handle portion 29 may be used. In the RX type, the inner tube 21a can be used as an insertion passage for a guide wire or the like. 10, the distal end of the outer tube 21d is coupled to the proximal ends of the inner tube 21a and the outer tube 21b, and the lumen of the outer tube 21d and the space between the inner tube 21a and the outer tube 21b A passage is formed so as to communicate with the , and the passage can be used as a flow path for injecting fluid. For the material of the outer tube 21d, the description of the outer tube 21b can be referred to.

The rod-shaped portion 25 may be configured to include the distal end portion of the inner tube 21a, the distal side fixing portion 27 of the balloon 22, and the rod-shaped body 25a as shown in FIGS. As shown in FIGS. 7 to 9, it may be configured to include the distal end portion of the linear body 21c, the fixed portion 27 on the distal side of the balloon 22, and the rod-shaped body 25a. Moreover, the rod-shaped portion 25 may include the linear body 21c but not the rod-shaped body 25a. In this case, the filamentous body 21c can detect the bronchus periphery.

By forming the rod-shaped body 25a from, for example, flexible resin, metal wire, or the like, it is possible to easily avoid damage to the bronchus periphery. Examples of the resin forming the rod-shaped body 25a include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, vinyl chloride-based resins, silicone-based resins, natural rubber, and the like. These may use only 1 type and may use 2 or more types together. Among these resins, elastomer resins are preferable because they are excellent in flexibility. That is, at least one selected from the group consisting of polyamide-based elastomers, polyester-based elastomers, polyurethane-based elastomers, polyolefin-based elastomers, vinyl chloride-based elastomers, and silicone-based elastomers is preferred.

Examples of materials for the metal wire forming the rod-shaped body 25a include shape memory alloys such as nickel-titanium alloys, stainless steel, titanium, nickel-titanium alloys, cobalt-chromium alloys, and tungsten alloys.

As shown in FIG. 3, the outer diameter at the distal end 25C of the rod-shaped portion 25 is preferably smaller than the outer diameter of the inner tube 21a at the distal end 27B of the fixing portion 27 on the distal side. This facilitates insertion into the peripheral bronchi. On the other hand, the outer diameter at the distal end 25C of the rod-shaped portion 25 may be 0.7 times or more the outer diameter of the inner tube 21a at the distal end 27B of the fixing portion 27 on the distal side. or more.

The axial length (mm) of the rod-shaped portion 25 is preferably 6.0 times or more the outer diameter (mm) of the distal end 27B of the fixed portion 27 on the distal side. This makes it easier to reduce the bending load when the rod-shaped portion 25 is pushed. Furthermore, it is also possible for the bar-shaped portion 25 to easily satisfy the formula (1). Therefore, the axial length (mm) of the rod-shaped portion 25 is preferably at least 6.2 times the outer diameter (mm) of the distal end 27B of the fixing portion 27 on the distal side. It is preferable that it is above. On the other hand, the axial length (mm) of the rod-shaped portion 25 is preferably 10.0 times or less the outer diameter (mm) of the distal end 27B of the fixed portion 27 on the distal side. This makes it easier for the bar-shaped portion 25 to satisfy the formula (2). More preferably, it is 9.0 times or less.

The axial length (mm) of the rod-shaped portion 25 is equal to the outer diameter (mm) of the distal end 27B of the distal fixing portion 27 and the outer diameter (mm) of the outer tube 21b at the proximal end 22A of the balloon 22. ) is preferably 10.0 times or less of the product. This makes it easier for the balloon catheter 20 to satisfy the formula (3). More preferably, it is 8.0 times or less. On the other hand, the lower limit is not particularly limited, but may be 3.0 times or more, or may be 5.0 times or more.

As shown in FIG. 3, the axial length (mm) of the rod-shaped portion 25 is the outer diameter (mm ) is preferably 0.5 times or more. The closer to the end of the bronchus periphery, the more easily the bronchus periphery is damaged when the balloon 22 is expanded. Concomitant damage can be easier to avoid. Therefore, the axial length (mm) of the rod-shaped portion 25 is more preferably 0.7 times or more, more preferably 0.9 times or more, the outer diameter (mm) at the axial center 22C of the balloon 22. It is more preferably 1.0 times or more, and particularly preferably 1.4 times or more. On the other hand, by setting the axial length (mm) of the rod-shaped portion 25 to 5 times or less the outer diameter (mm) at the axial center 22C of the balloon 22, it is possible to easily expand the vicinity of the end of the bronchus periphery. can. Therefore, the axial length (mm) of the rod-shaped portion 25 is preferably 5 times or less, more preferably 4.5 times or less, the outer diameter (mm) at the axial center 22C of the balloon 22. It is more preferably 3.5 times or less.

As shown in FIGS. 4 to 9, the distal end of rod-shaped portion 25 preferably has a curved portion with a radius of curvature of 0.1 mm or more and 10 mm or less in an axial cross-sectional view. When the radius of curvature is 0.1 mm or more, damage to the bronchus periphery can be easily avoided. Therefore, the radius of curvature is more preferably 0.2 mm or more, and still more preferably 0.4 mm or more. On the other hand, when the length is 10 mm or less, the rod-shaped portion 25 can be easily inserted into the bronchial periphery. Therefore, the radius of curvature is preferably 10 mm or less, more preferably 8 mm or less, even more preferably 6 mm or less, and even more preferably 2 mm or less.

The shape of the distal end portion of the rod-shaped portion 25 is not particularly limited, but may be cylindrical, hemispherical, spherical, tapered, or the like. Of these, a hemispherical shape or a spherical shape is preferable because damage to the peripheral bronchi 101 can be easily avoided. Examples of the spherical distal end include the configurations shown in FIGS. 4 to 9, and examples of the tapered distal end include the configuration shown in FIG. The shape of the portion other than the distal end portion of the rod-shaped portion 25 may be a columnar shape, a polygonal columnar shape, or a shape in which these diameters decrease toward the distal side. Among these, the columnar shape is preferable because it tends to exhibit flexibility.

The rod-like body 25a may be formed of a hollow material having an axially penetrating bore as shown in FIGS. 3, 4 and 7, or a solid material as shown in FIGS. may be formed by

The lumen of the hollow member can be used as an insertion passage for a guide wire or the like, and the guide wire may be used to detect the terminal end of the bronchi. Additionally, drugs such as bronchodilators may be administered through the lumen. The hollow member is preferably joined so as to cover the inner tube 21a of the shaft 21 or the outer surface of the linear body 21c as shown in FIGS.

A solid material can facilitate the transmission of the feel of the end of the bronchi to the shaft 21 . As the solid material, as shown in FIGS. 5 and 8, a concave portion is provided at the proximal end for joining with the distal end of the inner tube 21a or the linear body 21c of the shaft 21, or a convex portion is provided. provided (not shown). That is, in the case of a solid material, the inner tube 21a of the shaft 21 or the outer surface of the linear body 21c may be covered by the concave portion, or the convex portion may be inserted into the inner tube 21a of the shaft 21 for joining. may Also, the solid material may be joined to the fixing portion 27 of the balloon 22 without having the concave portion and the convex portion as shown in FIGS.

As shown in FIG. 1, the balloon catheter 20 preferably has a handle portion 29 on the proximal side. The handle portion 29 preferably has a distally extending lumen communicating with the inner tube 21a. The lumen can be used as an insertion passage for a guide wire or the like. The handle portion 29 also preferably includes a fluid injection portion 29a and has a lumen communicating with a fluid passageway for injecting fluid into the pressurization lumen 26 of the balloon 22 .

Balloon catheter 20 can be used with a bronchoscope. A description of a bronchoscope and how to use the bronchoscope and balloon catheter 20 will now be described with reference to Figures 11-14. FIG. 11 is a perspective view of a bronchoscope into which a balloon catheter according to an embodiment of the invention has been inserted; FIG. 12 is a side view (partial cross-sectional view) showing how to use the balloon catheter and bronchoscope according to the embodiment of the present invention. FIG. 13 is a side view showing how to use the balloon catheter and bronchoscope according to the embodiment of the present invention. 14 is a plan view of the distal end of the sheath of the bronchoscope of FIG. 11; FIG.

The bronchoscope 50 preferably comprises a sheath 5 having a first lumen 1 and a second lumen 2 having a perspective direction X as shown in FIGS. The sheath 5 preferably has an outer diameter of 6 mm or less, more preferably 3 mm or less. As a result, the sheath 5 can be easily inserted into the bronchus periphery 101 having an inner diameter of 2 mm or less located distal to the bronchus 100 as shown in FIG. On the other hand, the lower limit of the outer diameter of the sheath 5 is preferably 1 mm or more, more preferably 2 mm or more, in consideration of the dimensions of the endoscope camera 10 to be described later. Materials for the sheath 5 include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, vinyl chloride-based resins, silicone-based resins, fluorine-based resins, epoxy-based resins, and natural rubber. These may use only 1 type and may use 2 or more types together.

As shown in FIG. 12, an endoscope camera 10 is preferably inserted into the first lumen 1 . The endoscopic camera 10 is preferably fixed in the first lumen 1 so as not to move in the perspective X direction. The endoscope camera 10 is not particularly limited, and includes, for example, an objective lens 11 and image transmission means 12 . Examples of the image transmission means 12 include an image guide fiber composed of an optical fiber, a relay lens composed of a large number of lenses, and the like. The image information obtained by the endoscope camera 10 is transmitted to the display device via the connector portion 53 of the bronchoscope 50 shown in FIG. 11, for example, and displayed on the display device.

A balloon catheter 20 can be inserted into the second lumen 2 of the sheath 5 so as to be movable in the far-near direction X. As shown in FIG. Specifically, the balloon catheter 20 is inserted into the second lumen 2 of the sheath 5 through the insertion hole 52 of the bronchoscope 50 shown in FIG. It has become. As a result, the balloon 22 inserted into the second lumen 2 is pushed out from the second lumen 2 to the distal side as shown in FIG. 13 to expand the balloon 22 as shown in FIG. can be pulled back into the second lumen 2 after contracting. Furthermore, this allows the sheath 5 to be inserted into the dilated bronchial extremity 101 with the balloon 22 housed in the second lumen 2 .

By applying a negative pressure to the second lumen 2, the distal end 5B of the sheath 5 can be adhered to the inner wall of the bronchi 100. As shown in FIG. Further, by pressing the distal end 5B of the sheath 5 against the inner wall of the bronchial tube 100 and sliding it in a state of being adsorbed to the inner wall of the bronchial tube 100, contaminants in the bronchial tube 100 adhering to the objective lens 11 of the endoscope camera 10 are removed. can be wiped. This makes it easier to observe the bronchus periphery 101 .

As shown in FIG. 12, the outer diameter (mm) at the axial center 22C of the shaft 21 of the balloon 22 in the pressurized state in which the fluid is injected into the pressurization lumen 26 is equal to the outer diameter (mm) of the sheath 5 at the distal end 5B of the sheath 5. is preferably larger than the outer diameter (mm) of the As a result, the inner diameter of the bronchial periphery 101 can be easily made larger than the outer diameter of the sheath 5 , so that the sheath 5 can be easily inserted into the bronchial periphery 101 . The outer diameter (mm) at the axial center 22C of the balloon 22 is more preferably 1.2 times or more, more preferably 1.5 times or more, the outer diameter (mm) of the sheath 5 at the distal end 5B of the sheath 5. It is more preferably 2.0 times or more, and particularly preferably 2.5 times or more. On the other hand, by setting the outer diameter (mm) of the balloon 22 at the center 22C in the axial direction to be 5.0 times or less the outer diameter (mm) of the sheath 5 at the distal end 5B of the sheath 5, damage to the bronchial periphery 101 is avoided. can be made easier. Therefore, it is preferably 5.0 times or less, more preferably 4.5 times or less, still more preferably 4.0 times or less, and even more preferably 3.5 times or less.

The shape of the balloon 22 is not particularly limited. For example, the balloon 22 may have a straight tube portion 23 and a tapered portion 24 as shown in FIG. 12, or may have a spherical portion or an elongated spherical portion. The larger the contact area with the inner wall of the peripheral bronchus 101, the more easily the balloon 22 expands the peripheral bronchus 101. Therefore, it is preferable that the balloon 22 has a straight tube portion or a spheroidal portion, and has a straight tube portion. is more preferable. On the other hand, when it is necessary to increase the negative pressure when the distal end 5B of the sheath 5 is adhered to the inner wall of the bronchi 100, the shorter the axial length of the balloon 22, the more the expansion of the balloon 22 by the negative pressure. Since it is easy to prevent this, it is preferable to have a spherical portion.

If the balloon 22 includes a straight tube portion 23, the axial length of the shaft 21 from the proximal end 23A to the distal end 23B of the straight tube portion 23 in the pressurized state in which the pressurization lumen 26 is filled with fluid. The length (mm) is preferably equal to or greater than the outer diameter (mm) of the balloon 22 at the axial center 22C of the shaft 21 . As a result, the peripheral bronchi 101 can be easily expanded in a wide range, and the sheath 5 can be easily inserted into the peripheral bronchi 101 . Therefore, the length (mm) from the proximal end 23A to the distal end 23B is preferably 1.1 times or more, more preferably 1.2 times or more, the outer diameter (mm) at the axial center 22C of the balloon 22. is more preferable. On the other hand, the upper limit of the length (mm) from the proximal end 23A to the distal end 23B is not particularly limited. .

When the balloon 22 comprises a bulbous portion or a prolate portion, the axial length (mm) of the shaft 21 from the proximal end to the distal end of the bulbous portion or prolate portion is the axial length of the shaft 21 of the balloon 22 It is preferable that the length is equal to or longer than the outer diameter (mm) at the center 22C. As a result, the peripheral bronchi 101 can be easily expanded in a wide range, and the sheath 5 can be easily inserted into the peripheral bronchi 101 . Therefore, the length (mm) from the proximal end to the distal end is more preferably 1.1 times or more, more preferably 1.2 times or more, the outer diameter (mm) at the axial center 22C of the balloon 22. is more preferred. On the other hand, the upper limit of the length (mm) from the proximal end to the distal end is not particularly limited.

Balloon 22 is preferably a non-compliant balloon or a semi-compliant balloon. Since these are difficult to expand when the pressure for injecting fluid exceeds a certain level, damage to the bronchus periphery 101 due to excessive expansion of the balloon 22 can be easily avoided. Among these, the semi-compliant balloon is more preferable because it is easy to achieve both safety and dilation of the bronchus periphery 101 . A non-compliant balloon has an outer diameter change rate of 4% or less at the center 22C in the axial direction of the balloon 22 when pressurized from 50% of the specified pressure of the balloon (nominal pressure = nominal pressure) to the specified pressure. is. On the other hand, the semi-compliant balloon has an outer diameter change rate of more than 4% at the axial center 22C of the balloon 22 when pressurized from 50% of the specified pressure of the balloon (nominal pressure = nominal pressure) to the specified pressure. 15% or less. The specified pressure is preferably 2 atm or more and 20 atm or less, more preferably 3 atm or more and 10 atm or less.

Examples of the resin forming the balloon 22 include polyamide-based resins, polyester-based resins, polyurethane-based resins, polyolefin-based resins, vinyl chloride-based resins, silicone-based resins, natural rubber, and the like. These may use only 1 type and may use 2 or more types together. Of these, polyamide-based resins are preferred.

The balloon 22 may be configured by providing a reinforcing material on the outer surface of the resin layer formed of the above resin in order to increase the dimensional stability against expansion pressure. For example, a fiber material can be used as the reinforcing material. The reinforcing material may be provided on the entire outer surface of the resin layer without gaps, or may be provided only on a part of the outer surface of the resin layer. Fiber materials used as reinforcing materials include polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, PBO fibers, carbon fibers, and the like. These fibrous materials may be monofilaments or multifilaments.

The fluid injected into pressurized lumen 26 of balloon 22 is not particularly limited and may be either liquid or gas. The fluid may be pressurized by, for example, a syringe, indeflator, pump, or the like and injected into the pressurized lumen 26 .

The number of balloons 22 is not limited to one, and may be two or more. The smaller the number of balloons 22, the easier it is to put in and take out from the second lumen 2, so the number of balloons 22 is preferably one.

In a cross section perpendicular to the axial direction of the sheath 5, the area (mm ² ) of the second lumen 2 is 1.2 times the area (mm ² ) of the region surrounded by the outer circumference of the balloon 22 in the deflated state. It is preferably more than double. As a result, even when the balloon 22 is placed inside the second lumen 2, negative pressure can be applied to make it easier for the distal end 5B of the sheath 5 to adhere to the inner wall of the bronchi 100. FIG. Therefore, the area (mm ² ) of the second lumen 2 is more preferably 1.3 times or more the area (mm ² ) of the region surrounded by the outer circumference of the balloon 22 in the deflated state. Four times or more is more preferable. On the other hand, by setting the area (mm ² ) of the second lumen 2 to 8 times or less the area (mm ² ) of the region surrounded by the outer circumference of the balloon 22 in the contracted state, the distal end of the sheath 5 Damage associated with too much adherence of 5B to the inner wall of the bronchi 100 can be easily avoided. More preferably 6.5 times or less, still more preferably 5 times or less.

As shown in FIG. 14, at the distal end 5B of the sheath 5, the distance between the center of the second lumen 2 and the center of the objective lens 11 is preferably less than twice the diameter of the second lumen 2. . This makes it easier to remove contaminants adhering to the objective lens 11 when the distal end 5B of the sheath 5 is adsorbed and slid on the inner wall of the bronchi 100 . It is more preferably 1.5 times or less, still more preferably 1.2 times or less. On the other hand, the lower limit may be, for example, 0.6 times or more.

Preferably, at the distal end 5B of the sheath 5, the second lumen 2 is not centered in the sheath 5, as shown in FIG. Accordingly, by rotating the sheath 5 in the axial direction, the distal end of the second lumen 2 can be easily attracted to a desired position.

In the axial direction of the sheath 5, the distal end of the objective lens 11 is at the same position as the distal end 5B of the sheath 5 as shown in FIG. preferably. This makes it easier to wipe off contaminants in the bronchi 100 adhering to the objective lens 11 . The distance between the distal end of the objective lens 11 and the distal end 5B of the sheath 5 in the axial direction of the sheath 5 is preferably 5 mm or less, more preferably 3 mm or less, and even more preferably 1 mm or less. . As a result, the distal end 5B of the sheath 5 can be easily adsorbed to the inner wall of the bronchi 100 .

As shown in FIG. 14, the sheath 5 may comprise a third lumen 3 having a perspective direction X and may further comprise a fourth lumen 4 having a perspective direction X. As shown in FIG. Furthermore, a first illumination lens 30 may be inserted in the third lumen 3 and a second illumination lens 40 may be inserted in the fourth lumen 4 . This makes it easier to observe the bronchus periphery 101 . The first illumination lens 30 and the second illumination lens 40 are preferably fixed in the third lumen 3 and the fourth lumen 4 so as not to move in the perspective direction X, respectively.

At the distal end 5B of the sheath 5, lumens other than the second lumen 2 are preferably sealed. This makes it easier to improve the adsorption force in the second lumen 2 .

It is preferable that the proximal side of the sheath 5 is provided with an operation part 55 so as to incorporate the proximal side of the sheath 5 as shown in FIG. 11 . By having the operating portion 55 , the operator can adjust the insertion angle of the sheath 5 and the like while gripping the operating portion 55 . As the operation unit 55, a housing made of resin can be used.

The sheath 5 may be branched into two or more on the proximal side. For example, when branched into two, the proximal end of the second lumen 2 of one branch is connected to the negative pressure generator mounting port 51 of the operation part 55, and the second lumen 2 of the other branch is connected. is connected to the insertion hole 52 of the operation part 55 . Also, the sheath 5 may not be branched on the proximal side. In that case, for example, while the proximal end of the second lumen 2 is connected to the negative pressure generator mounting port 51, a through hole is provided from the second lumen 2 toward the outer surface, and the through hole is operated. The passage leading to the insertion hole 52 in the portion 55 may be made to communicate. Alternatively, for example, while the proximal end of the second lumen 2 is connected to the insertion hole 52 , a through hole is provided from the second lumen 2 toward the outer surface so that the through hole and the operation portion 55 are negatively pressurized. A passage leading to the generator mounting port 51 may be made to communicate.

A negative pressure generator having a pump can be used as the negative pressure generator. A negative pressure can be applied to the second lumen 2 by the negative pressure generator. A negative pressure generator (not shown) may be connected to a negative pressure generator attachment port 51 that communicates directly or indirectly with the proximal end of the second lumen 2 of the sheath 5, for example as shown in FIG. Just install it.

The insertion hole 52 is preferably provided with a sealing member that seals the insertion hole 52 when negative pressure is applied to the second lumen 2 . This makes it easier to improve the adsorption force of the second lumen 2 . Examples of the sealing member include a forceps plug provided with a notch, and more specifically, a silicone rod having a Y connector notch.

Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to the following examples, and it is possible to implement it by adding changes within the scope that can conform to the gist of the above and later descriptions. All of them are included in the technical scope of the present invention.

Using the guide wire of Reference Example 1 and the balloon catheters of Examples 1 to 3 and Comparative Examples 1 to 3, a bending load test, evaluation of touch, and evaluation of safety were performed.

Reference example 1
Guide wire: PTCA guide wire "ASAHI SION Blue" manufactured by Asahi Intecc Co., Ltd.

Example 1
Balloon catheter: rapid exchange type (RX type)
Balloon catheter length: 1460mm
Material of rod: Polyamide block amide copolymer Length of rod in axial direction: 4.0 mm
Outer diameter of distal end of rod: 0.386mm
Balloon material: Polyamide block amide copolymer Balloon outer diameter, axial length: 1.00 mm, 6.0 mm
Outer diameter of the distal end of the fixation part: 0.58 mm
Inner tube: 3-layer structure (high-density polyethylene/adhesive low-density polyethylene/polyether block amide copolymer)
Inner tube outer diameter, inner diameter: 0.47 mm, 0.39 mm
Material of the outer tube of the distal end: polyamide block amide copolymer Outer diameter and inner diameter of the outer tube of the distal end: 0.84 mm, 0.70 mm
Material of the outer tube of the intermediate part: Polyamide Outer diameter and inner diameter of the outer tube of the intermediate part: 0.84 mm, 0.68 mm
Material of the proximal end outer tube: stainless steel (SUS304)
Outer diameter, inner diameter of the proximal end outer tube: 0.65 mm, 0.50 mm
Axial length ratio of the outer tube at the distal end, the outer tube at the intermediate section, and the outer tube at the proximal end: 3:3:8

Example 2
Balloon catheter: rapid exchange type (RX type)
Balloon catheter length: 1450mm
Material of rod: Polyamide block amide copolymer Length of rod in axial direction: 4.0 mm
Outer diameter of distal end of rod: 0.460 mm
Balloon material: Polyamide block amide copolymer Balloon outer diameter, axial length: 1.20 mm, 6.0 mm
Outer diameter of the distal end of the fixation part: 0.64 mm
Inner tube: 3-layer structure (high-density polyethylene/adhesive low-density polyethylene/polyether block amide copolymer)
Inner tube outer diameter, inner diameter: 0.55 mm, 0.42 mm
Material of the outer tube of the distal end: polyamide block amide copolymer Outer diameter and inner diameter of the outer tube of the distal end: 0.84 mm, 0.72 mm
Material of the outer tube of the intermediate part: Polyamide Outer diameter and inner diameter of the outer tube of the intermediate part: 0.84 mm, 0.68 mm
Material of the proximal end outer tube: stainless steel (SUS304)
Outer diameter, inner diameter of the proximal end outer tube: 0.60 mm, 0.45 mm
Axial length ratio of the outer tube at the distal end, the outer tube at the intermediate section, and the outer tube at the proximal end: 3:3:8

Example 3
Balloon catheter: over-the-wire type (OTW type)
Balloon catheter length: 1450mm
Material of rod: Polyamide block amide copolymer Length of rod in axial direction: 7.0 mm
Outer diameter of distal end of rod: 0.565 mm
Balloon material: Polyamide block amide copolymer Balloon outer diameter, axial length: 5.00 mm, 6.0 mm
Outer diameter of the distal end of the fixing part: 0.85 mm
Inner tube: 3-layer structure (high-density polyethylene/adhesive low-density polyethylene/polyether block amide copolymer)
Inner tube outer diameter, inner diameter: 0.57 mm, 0.43 mm
Material of the outer tube of the distal end: polyamide block amide copolymer Outer diameter and inner diameter of the outer tube of the distal end: 0.95 mm, 0.78 mm
Material of the outer tube of the intermediate part: Polyamide Outer diameter and inner diameter of the outer tube of the intermediate part: 1.11 mm, 0.87 mm
Proximal end outer tube material: Polyamide block amide copolymer Proximal outer tube outer and inner diameters: 1.28 mm, 0.94 mm
Axial length ratio of the outer tube at the distal end, the outer tube at the intermediate section, and the outer tube at the proximal end: 1:2:3

Comparative example 1
Balloon catheter: rapid exchange type (RX type)
Balloon catheter length: 1460mm
Material of rod: Polyamide block amide copolymer Length of rod in axial direction: 4.0 mm
Outer diameter of distal end of rod: 0.444 mm
Balloon material: Polyamide block amide copolymer Balloon outer diameter, axial length: 3.00 mm, 15.0 mm
Outer diameter of the distal end of the fixation part: 0.69 mm
Inner tube: 3-layer structure (high-density polyethylene/adhesive low-density polyethylene/polyether block amide copolymer)
Inner tube outer diameter, inner diameter: 0.56 mm, 0.42 mm
Material of the outer tube of the distal end: polyamide block amide copolymer Outer diameter and inner diameter of the outer tube of the distal end: 0.84 mm, 0.72 mm
Material of the outer tube of the intermediate part: Polyamide Outer diameter and inner diameter of the outer tube of the intermediate part: 0.84 mm, 0.68 mm
Material of the proximal end outer tube: stainless steel (SUS304)
Outer diameter, inner diameter of the proximal end outer tube: 0.65 mm, 0.50 mm
Axial length ratio of the outer tube at the distal end, the outer tube at the intermediate section, and the outer tube at the proximal end: 3:3:8

Comparative example 2
Balloon catheter: over-the-wire type (OTW type)
Balloon catheter length: 1450mm
Material of rod: Polyamide block amide copolymer Length of rod in axial direction: 4.0 mm
Outer diameter of distal end of rod: 0.460 mm
Balloon material: Polyamide block amide copolymer Balloon outer diameter, axial length: 5.00 mm, 6.0 mm
Outer diameter of the distal end of the fixation part: 0.90 mm
Inner tube: 3-layer structure (high-density polyethylene/adhesive low-density polyethylene/polyether block amide copolymer)
Inner tube outer diameter, inner diameter: 0.57 mm, 0.43 mm
Material of the outer tube of the distal end: polyamide block amide copolymer Outer diameter and inner diameter of the outer tube of the distal end: 0.95 mm, 0.78 mm
Material of the outer tube of the intermediate part: Polyamide Outer diameter and inner diameter of the outer tube of the intermediate part: 1.11 mm, 0.87 mm
Proximal end outer tube material: Polyamide block amide copolymer Proximal outer tube outer and inner diameters: 1.28 mm, 0.94 mm
Axial length ratio of the outer tube at the distal end, the outer tube at the intermediate section, and the outer tube at the proximal end: 1:2:3

Comparative example 3
Balloon catheter: over-the-wire type (OTW type)
Balloon catheter length: 1450mm
Material of rod: Polyamide block amide copolymer Length of rod in axial direction: 4.0 mm
Outer diameter of distal end of rod: 0.489 mm
Balloon material: Polyamide block amide copolymer Balloon outer diameter, axial length: 5.00 mm, 6.0 mm
Outer diameter of the distal end of the fixing part: 0.85 mm
Inner tube: 3-layer structure (high-density polyethylene/adhesive low-density polyethylene/polyether block amide copolymer)
Inner tube outer diameter, inner diameter: 0.57 mm, 0.43 mm
Material of the outer tube of the distal end: polyamide block amide copolymer Outer diameter and inner diameter of the outer tube of the distal end: 0.95 mm, 0.78 mm
Material of the outer tube of the intermediate part: Polyamide Outer diameter and inner diameter of the outer tube of the intermediate part: 1.11 mm, 0.87 mm
Proximal end outer tube material: Polyamide block amide copolymer Proximal outer tube outer and inner diameters: 1.28 mm, 0.94 mm
Axial length ratio of the outer tube at the distal end, the outer tube at the intermediate section, and the outer tube at the proximal end: 1:2:3

<Bending load test>
For each of the balloon catheters of Examples 1 to 3 and Comparative Examples 1 to 3, the bending load A ₁ when the rod portion was pushed in by 1.0 mm and the bending load A 1.5 (N) when the rod portion was pushed in by _1.5 mm. Then, the bending load A _1-2 (N) and the bending load B ₁ (N) of the shaft when the rod-shaped portion was pushed 1.0 mm and then unloaded and pushed again by 1.0 mm were measured. . Details are as follows. As for the guide wire of Reference Example 1, the bending load was measured with the region up to a position 4 mm away from the distal end as a rod-shaped portion. The details of the measurement method are as follows.

<Bending load A ₁ of rod-shaped part>
A rectangular parallelepiped lower block made of stainless steel with a longitudinal length of 6 cm, a width perpendicular to the longitudinal direction of 4 cm, and a thickness of 2 cm; A rectangular parallelepiped upper block having a width of 4 cm in a direction perpendicular to the height direction and a thickness of 2 cm was prepared. The balloon catheter was then placed between the lower and upper blocks so that the axial direction of the shaft was parallel to the lengthwise direction of the lower and upper blocks. Next, the distal end of the lower block, the distal end of the upper block, and the distal end of the free portion of the balloon are aligned in the axial direction of the shaft, and the balloon catheter is placed between the lower block and the upper portion. It was fixed by sandwiching it with a block. Next, using a tension/compression tester manufactured by Shimadzu Corporation, a portion from the distal end of the rod-shaped portion to a position 1.0 mm away in the axial direction of the shaft is pressed by a pressurizer having a rectangular pressurizing surface. The load (N) when pushed 1.0 mm in the direction perpendicular to the axial direction of the shaft was measured. This value was defined as bending load A ₁ (N).

<Bending load of bar A _1-2 >
After measuring the bending load A ₁ (N) when the rod portion was pushed in by 1.0 mm, the load was removed and the bending load A _1-2 (N) when the rod portion was pushed in by 1.0 mm was measured again.

<Bending load A _1.5 of rod-shaped part>
Bending load A 1.5 (N) when pushed 1.5 mm was measured in the same manner as measurement of bending load A ₁ (N) when pushed 1.0 mm of the rod-shaped portion except that the amount of pushing was _1.5 mm. did.

<Shaft bending load B ₁ >
The same lower block and upper block as those used in the measurement of the bending load A ₁ (N) when the rod-like portion is pushed in by 1.0 mm are prepared, and the proximal end of the balloon is cut radially. The distal end was cut away from the proximal end, and the cut shaft was placed between the lower and upper blocks such that the axial direction of the cut shaft was parallel to the length of the lower and upper blocks. . Next, the distal end of the lower block, the distal end of the upper block, and a point axially 5.0 mm away from the distal end of the cut shaft are aligned in the axial direction, and cut. The rear shaft was fixed by sandwiching it between the lower block and the upper block. Next, using a tension/compression tester manufactured by Shimadzu Corporation, a portion from the distal end of the cut shaft to a position 1.0 mm away in the axial direction is axially compressed by a pressurizer having a rectangular pressurizing surface. The load (N) when pushed 1.0 mm in the direction perpendicular to the shaft was measured and defined as the bending load B ₁ (N) of the shaft. After cutting, the inner tube of the shaft and the outer tube at the distal end were present in the portion from the distal end of the shaft to the position 1.0 mm apart in the axial direction.

<Safety evaluation>
After inserting a bronchoscope sheath as shown in FIG. 11 into the periphery of the lung field of a pig under general anesthesia, the guide wire of Reference Example 1 and the balloon catheter of Example 1 in which the guide wire was inserted into the inner tube was inserted into the insertion port of the bronchoscope. After that, the guide wire and the balloon catheter were pushed together from the distal end of the sheath of the bronchoscope to the visceral pleura, and the distal ends of the guide wire and the balloon catheter were pressed against the visceral pleura. After that, the presence or absence of pneumothorax was confirmed by CT images. This operation was performed on the balloon catheters of Examples 2 to 3 and Comparative Examples 1 to 3, and the guidewire of Reference Example 1 alone was also subjected to the same operation to evaluate the safety.

<Evaluation of feeling>
Regarding the feeling when the distal end of the balloon catheter reaches the visceral pleura, it is easy to tell that it has reached the visceral pleura, and it is "good". evaluated as excellent. These results are shown in Table 1.

As shown in Table 1, the balloon catheters of Examples 1 to 3 had a bending load A ₁ of 0.17 N or less when the rod portion was pushed in by 1.0 mm. Ta.

1 First Lumen 2 Second Lumen 3 Third Lumen 4 Fourth Lumen 5 Sheath 5B Distal End of Sheath 10 Endoscopic Camera 11 Objective Lens 12 Image Transmission Means 20 Balloon Catheter 21 Shaft 21a Inside Tube 21A proximal end of inner tube 21B distal end of inner tube 21b outer tube 21c linear body 21C distal end of linear body 21d outer tube 22 balloon 22A proximal end of balloon 22C axial center of shaft of balloon 23 Straight Tube Part 23A Proximal End of Straight Tube Part 23B Distal End of Straight Tube Part 24 Tapered Part 25 Rod 25B Distal End of Rod 25a Rod 25C Distal End of Rod 26 Pressure Lumen 27 Fixing Part 27B distal end of fixed part 28 non-fixed part 28A proximal end of non-fixed part 28B distal end of non-fixed part 29 handle part 29a injection part 30 first illumination lens 40 second illumination lens 50 bronchoscope 51 shade Pressure generator attachment port 52 Insertion hole 53 Connector part 55 Operation part 90 Lower block 91 Upper block 90B Distal end of lower block 91B Distal end of upper block 92 Pressurizer 92a Pressure surface 100 Bronchi 101 Peribronchus

Claims (4)

A balloon catheter having a shaft having a distal direction and a balloon provided distally of the shaft,
The shaft has an outer tube and an inner tube partially disposed within the lumen of the outer tube, the distal end of the inner tube being distal to the distal end of the outer tube. Position to,
The balloon has a proximal fixed portion fixed to the outer tube, a distal fixed portion fixed to the inner tube, and a non-fixed portion not fixed to the shaft,
The balloon catheter comprises a rod-shaped portion extending distally from the distal end of the non-fixed portion, and the bending load A when the rod-shaped portion is pushed by 1.0 mm, which is obtained by the bending load measuring method described below. A balloon catheter for bronchial dilation, wherein ₁ is 0.17N or less.
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the longitudinal direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter is placed between the lower block and the upper block such that the axial direction of the shaft is parallel to the longitudinal direction of the lower block and the upper block. Next, the distal end of the lower block, the distal end of the upper block, and the distal end of the non-fixed portion of the balloon are aligned in the axial direction of the shaft, and the balloon catheter is aligned. is sandwiched and fixed between the lower block and the upper block. Next, the portion from the distal end of the rod-shaped portion to a position 1.0 mm apart in the axial direction of the shaft is pushed in by 1.0 mm in a direction perpendicular to the axial direction of the shaft using a pressurizer having a rectangular pressing surface. Measure the load (N) at that time. The bending load A ₁ (N) when the rod-shaped portion is pushed 1.0 mm, and the bending load A _1.5 (N) when the rod-shaped portion is pushed 1.5 mm, which is obtained by the bending load measurement method described below, are obtained by the following formula ( The balloon catheter for bronchial peripheral dilation according to claim 1, which satisfies 1).
A _1.5 ≧1.15 A ₁ (1)
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the longitudinal direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the balloon catheter is placed between the lower block and the upper block such that the axial direction of the shaft is parallel to the longitudinal direction of the lower block and the upper block. Next, the distal end of the lower block, the distal end of the upper block, and the distal end of the non-fixed portion of the balloon are aligned in the axial direction of the shaft, and the balloon catheter is aligned. is sandwiched and fixed between the lower block and the upper block. Next, the portion from the distal end of the rod-shaped portion to a position 1.0 mm apart in the axial direction of the shaft is pushed in by 1.5 mm in a direction perpendicular to the axial direction of the shaft using a pressurizer having a rectangular pressurizing surface. Measure the load (N) at that time. The bending load A ₁ (N) when the rod-shaped portion is pushed 1.0 mm, and the bending load A 1 when the rod-shaped portion is pushed 1.0 mm again after being unloaded after being pushed 1.0 mm _{. 3.} The balloon catheter for bronchial peripheral dilation according to claim 1 or 2, wherein (N) satisfies the following formula (2).
A _1-2 ≧0.90 A ₁ (2) The bending load A ₁ when the rod-like portion is pushed in by 1.0 mm and the bending load B ₁ of the shaft obtained by the bending load measuring method described below satisfy the following formula (3): A balloon catheter for bronchial dilation according to any one of the preceding claims.
A ₁ ≧0.1B ₁ (3)
[Measurement method of bending load]
A rectangular parallelepiped lower block made of stainless steel having a longitudinal length of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the longitudinal direction, and a thickness of 2 cm or more, and a stainless steel longitudinal length A rectangular parallelepiped upper block having a width of 5 cm or more, a width of 2 cm or more in a direction perpendicular to the length direction, and a thickness of 2 cm or more is prepared. Next, the proximal end of the balloon is cut radially to separate the distal side from the proximal end of the balloon, and the axial direction of the cut shaft is aligned with the length direction of the lower block and the upper block. The cut shaft is placed between the lower block and the upper block so as to be parallel. Next, the distal end of the lower block, the distal end of the upper block, and a point 5.0 mm apart in the axial direction from the distal end of the cut shaft are aligned in the axial direction. After alignment, the cut shaft is sandwiched and fixed between the lower block and the upper block. Next, when the portion of the cut shaft from the distal end to the position 1.0 mm away in the axial direction is pushed in by 1.0 mm in a direction perpendicular to the axial direction with a pressurizer having a rectangular pressurizing surface. Measure the load (N) of

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