WO2022158100A1 - Balloon for balloon catheter - Google Patents

Abstract

Provided is a balloon that can improve trackability and protect the expansion part of the balloon while the balloon is being transported in a contracted state within a body cavity.　A balloon (2) for a balloon catheter has a balloon main body (27) and an outside protruding part (60) and satisfies (1) and/or (2) below when the balloon (2) is in a contracted state.　(1) The radius r₁ of a first imaginary cylinder C₁ circumscribed by a proximal sleeve part (21) is larger than the radius r₀ of an imaginary circle C₀ circumscribed by an expansion part (20) at the center (20c) of the expansion part (20).　(2) The radius r₂ of a second imaginary cylinder C₂ circumscribed by a distal sleeve part (22) is larger than the radius r₀ of the imaginary circle C₀ circumscribed by the expansion part (20) at the center (20c) of the expansion part (20).

Description

balloon for balloon catheter

The present invention relates to balloons for balloon catheters.

Diseases such as angina pectoris and myocardial infarction are caused by the formation of a hardened narrowed part due to calcification etc. on the inner wall of the blood vessel. One of these treatments is angioplasty, which uses a balloon catheter to dilate the stenosis. Angioplasty is a widely practiced minimally invasive therapy that does not require an open chest like bypass surgery.

In angioplasty, it may be difficult to dilate a narrowed area that has hardened due to calcification or the like with a general balloon catheter. In addition, a method of dilating the stenosis by placing an indwelling dilation device called a stent in the stenosis is also used, but after this treatment, the neointima of the blood vessel proliferates excessively, resulting in re-stenosis of the blood vessel. In some cases, ISR (In-Stent-Restenosis) lesions and the like occur. In an ISR lesion, the neointima is soft and has a slippery surface. Therefore, when using a general balloon catheter, the position of the balloon may deviate from the lesion when the balloon is inflated, which may damage the blood vessel.

As a balloon catheter that can dilate the stenosis even in such calcified lesions and ISR lesions, a balloon catheter has been developed in which the balloon is provided with protrusions, blades, and scoring elements for making it bite into the stenosis. there is For example, Patent Document 1 discloses scoring elements made of a polymeric material having higher rigidity than the polymeric material forming the balloon body, and the scoring elements are formed at one end and the other end of the balloon. A flattened balloon catheter is disclosed. Patent document 2 discloses a scoring balloon structure in which the height of the scoring element decreases along the tapered shape of the balloon. discloses a balloon catheter having an inner projection. In Patent Documents 1 to 3, the height of the scoring element is reduced at both ends of the balloon, or an inner projection is provided instead of an outer projection. On the other hand, there is also a balloon catheter having a high protruding portion in which the protruding portion arranged in the distal tapered portion has a larger protruding amount than the protruding portion arranged in the straight tube portion of the balloon (Patent Document 4). .

U.S. Patent Application Publication No. 2016/0128718 Japanese Patent Publication No. 2014-506140 WO2020/012851 pamphlet WO 2020/012850 Pamphlet

The balloon catheter is inserted into the body cavity in a contracted and folded state and delivered to the treatment site. Therefore, in the balloon catheters disclosed in Patent Documents 1 to 3, the height of the scoring element at the distal end of the balloon is suppressed so that it can be easily inserted into the body cavity, thereby suppressing an increase in the outer diameter of the balloon. We are trying to improve the passability of However, in such a balloon catheter, since the height of the scoring element is suppressed at both ends of the balloon, the expanded portion of the balloon abuts against the wall of the body cavity during delivery of the balloon. The contact area with the wall increases. As a result, there is a risk that the trackability of the balloon in the curved part of the body cavity (the ease with which the balloon can follow the curve of the body cavity when the balloon is transported within the body cavity) is degraded. In addition, since the expanded part of the balloon is brought into contact with the wall of the body cavity while the balloon is delivered to the lesion, the expanded part of the balloon, which is expanded during treatment and acts on the lesion, may be damaged during delivery and interfere with treatment. There was also In the balloon catheter disclosed in Patent Document 4, the height of the protruding portion arranged in the distal tapered portion is increased for the purpose of making it easier to cut into the lesion in the expanded state, but in the contracted state. There is room for improvement in terms of improving the trackability when transporting the balloon to the lesion site and protecting the expanded portion of the balloon during transport.

SUMMARY OF THE INVENTION In view of the above circumstances, an object of the present invention is to provide a balloon for a balloon catheter that can improve the trackability and protect the expanded portion of the balloon when the deflated balloon is transported within the body cavity. .

One embodiment of the balloon for a balloon catheter of the present invention, which has solved the above problems, comprises an expansion section, a proximal sleeve section positioned proximal to the expansion section, and a sleeve section positioned distal to the expansion section. a balloon body having an outer surface and an inner surface; and a balloon projecting radially outward from the outer surface of the balloon body. and an outward protrusion extending in the longitudinal direction of the body, and satisfying at least one of the following (1) and (2) in the deflated state of the balloon.
(1) A _first imaginary cylinder C1 having a central axis parallel to the longitudinal axis direction, the bottom surface being located at the distal end and the proximal end of the proximal side sleeve portion, and being proximal to at least a part of the side surface The radius of the first imaginary cylinder C1 circumscribed by the side sleeve portion is larger than the radius of the imaginary circle _C0 circumscribed by the extension in _a radial cross section perpendicular to the longitudinal direction at the midpoint of the extension in the longitudinal direction. big.
(2) A _second imaginary cylinder C2 having a central axis parallel to the longitudinal direction, the bottom surfaces of which are located at the distal and proximal ends of the distal sleeve portion and which are distal to at least a portion of the side surface. The radius of the _second imaginary cylinder C2 circumscribed by the side sleeve portion is larger than the radius of the imaginary circle _C0 circumscribed by the extension in a radial cross section perpendicular to the longitudinal direction at the midpoint of the extension in the longitudinal direction. big.

The expanded portion has main sections excluding 10% of each in the longitudinal direction from the distal end and the proximal end, and satisfies at least one of the following (1) and (2) when the balloon is deflated. preferably.
(1) The radius of the _first imaginary cylinder C1 is the _third imaginary cylinder C3 having a central axis parallel to the longitudinal direction, and the bottom faces are located at the distal end and the proximal end of the main section. larger than the radius of the _third imaginary cylinder C3 whose main section circumscribes at least part of
(2) The radius of the _second imaginary cylinder C2 is the _third imaginary cylinder C3 having a central axis parallel to the longitudinal direction, and the bottom faces are located at the distal end and the proximal end of the main section. larger than the radius of the _third imaginary cylinder C3 whose main section circumscribes at least part of

It is preferable that the balloon is folded in the contracted state of the balloon.

It is preferable that the outer projecting portion has a tip portion in a radial cross section and satisfies at least one of the following (1) and (2) in the contracted state of the balloon.
(1) In the proximal side sleeve portion, the distal end portion circumscribes at least a portion of the side surface of the _first imaginary column C1.
(2) In the distal sleeve portion, the tip portion circumscribes at least a portion of the side surface of the _second virtual cylinder C2.

It is preferable that the outer projecting portion has a tip portion in a radial cross section and satisfies at least one of the following (1) and (2) in the contracted state of the balloon.
(1) In the proximal side sleeve portion, only the tip portion circumscribes at least a portion of the side surface of the _first imaginary column C1.
(2) In the distal sleeve portion, only the tip portion circumscribes at least a portion of the side surface of the _second imaginary cylinder C2.

Preferably, in the deflated state of the balloon, the extension has wings and the wings circumscribe the imaginary circle C ₀ .

In the contracted state of the balloon, it is preferable that the expansion part has wings and the outward projection part is arranged other than the wings.

At least one of the following (1) and (2) is preferably satisfied.
(1) The outer protrusion of the proximal sleeve portion and the outer protrusion of the extension extend continuously in the longitudinal direction.
(2) The outer protrusion of the distal sleeve portion and the outer protrusion of the extension extend continuously in the longitudinal direction.

In the deflated state of the balloon, the radius of the first imaginary cylinder C1 in the proximal sleeve portion is greater than the radius of the imaginary circle _C0 in the expanded portion, and the radius of the _second imaginary cylinder _C2 in the distal sleeve portion is It is preferably smaller than the radius of the virtual circle _C0 . In this case, the expanded portion has main sections excluding 10% each in the longitudinal direction from the distal end and the proximal end. The radius of ₁ is a _third imaginary cylinder C3 having a central axis parallel to the longitudinal direction, the bottom surface being located at the distal end and the proximal end of the main section, and the main section being at least part of the side surface Preferably, the radius of the _second imaginary cylinder C2 at the distal sleeve portion is larger than the radius of the circumscribing _third imaginary cylinder C3, and smaller than the radius of the _third imaginary cylinder C3. Furthermore, in this case, it is preferable that the distal sleeve portion has an inner protrusion projecting radially inwardly from the inner surface of the balloon body and extending in the longitudinal direction.

It is preferable that the outer protruding portion is made of the same material as the balloon body.

According to the above-mentioned balloon for a balloon catheter, in the contracted state of the balloon, the radius of the virtual cylinder circumscribing at least one of the proximal sleeve portion and the distal sleeve portion is equal to the radius of the virtual circle circumscribing the central portion of the expanded portion. , it is possible to improve the trackability of the balloon and protect the expanded portion of the balloon when the deflated balloon is transported within the body cavity.

1 depicts a side view of a balloon catheter according to one embodiment of the present invention; FIG. Figure 2 shows a longitudinal cross-sectional view of the balloon of the balloon catheter shown in Figure 1 in its expanded state; Figure 3 shows a plan view of the balloon shown in Figure 2 as seen from the side of the outer projection; FIG. 2 shows a cross-sectional view taken along IV-IV in FIG. 1; FIG. 2 shows a side view of the balloon catheter shown in FIG. 1 in a deflated state; FIG. 6 represents a side view showing another example of the side view shown in FIG. 5 ; Represents a VII-VII cross-sectional view of FIG. FIG. 8 shows a cross-sectional view showing another example of the cross-sectional view shown in FIG. 7 ; FIG. 8 is a cross-sectional view showing still another example of the cross-sectional view shown in FIG. 7 ; FIG. 8 is a cross-sectional view showing still another example of the cross-sectional view shown in FIG. 7 ; Represents a cross-sectional view taken along line XI-XI of FIG. FIG. 12 is a cross-sectional view showing another example of the cross-sectional view shown in FIG. 11; Fig. 10 is a side view of a balloon for a balloon catheter according to another embodiment of the present invention in a contracted state; FIG. 4 shows a radial cross-sectional view at the longitudinal midpoint of the expanded portion in the folded state of the balloon for a balloon catheter according to one embodiment of the present invention; FIG. 15 is a cross-sectional view showing another example of the cross-sectional view shown in FIG. 14; FIG. 10 is a side view of a balloon for a balloon catheter according to still another embodiment of the present invention in a contracted state; 17 shows a cross-sectional view taken along line XVII-XVII of FIG. 16; FIG. FIG. 18 is a cross-sectional view showing another example of the cross-sectional view shown in FIG. 17; FIG. 1B depicts a perspective view of a parison prior to inflation, according to an embodiment of the present invention;

Hereinafter, the present invention will be described in detail based on embodiments, but the present invention is not limited by the following embodiments, and can be modified appropriately within the scope that can conform to the spirit of the preceding and following descriptions. It is of course possible to implement them, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall 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 for a balloon catheter according to an embodiment of the present invention includes an expansion section, a proximal sleeve section positioned proximal to the expansion section, and a distal sleeve section positioned distal to the expansion section. a balloon body having an outer surface and an inner surface; and a balloon body projecting radially outward from the outer surface of the balloon body and extending in the longitudinal direction of the balloon body. and an outwardly protruding portion that is present and satisfies at least one of the following (1) and (2) in the deflated state of the balloon.
(1) A _first imaginary cylinder C1 having a central axis parallel to the longitudinal axis direction, the bottom surfaces of which are located at the distal and proximal ends of the proximal sleeve portion and are close to at least a part of the side surfaces. The radius of the first imaginary cylinder C1 circumscribed by the postural side sleeve portion is greater than the radius of the imaginary circle _C0 circumscribed by the extension in _a radial cross section perpendicular to the longitudinal axis direction at the midpoint of the extension in the longitudinal direction. is also big.
(2) A _second imaginary cylinder C2 having a central axis parallel to the longitudinal axis direction, the bottom surfaces of which are located at the distal and proximal ends of the distal sleeve portion and are distal to at least a portion of the side surface. The radius of the _second imaginary cylinder C2 circumscribed by the postural sleeve portion is greater than the radius of the imaginary circle _C0 circumscribed by the extension in a radial cross section perpendicular to the longitudinal axis direction at the midpoint of the extension in the longitudinal direction. is also big.
Thus, in the contracted state of the balloon, at least one of the radius of the first virtual cylinder C1 circumscribed by the proximal sleeve portion and the radius of the _second virtual cylinder _C2 circumscribed by the distal sleeve portion is larger than the radius of the imaginary circle C ₀ circumscribed by the expanded portion in a radial cross-section at the midpoint of the longitudinal axis, the proximal sleeve portion or the distal By bringing the side sleeve portion into contact with the body cavity wall, it is possible to make it difficult for the expansion section to contact the body cavity wall. As a result, the contact area of the balloon with the wall of the body cavity can be reduced, and the trackability of the balloon (the ease with which the balloon can follow the curvature of the body cavity when the balloon is transported within the body cavity) can be improved. . In addition, since the balloon can be conveyed to the lesion while the central portion of the expansion portion is made less likely to abut against the body cavity wall, the expansion portion that is expanded during treatment and acts on the lesion can be effectively protected from damage. treatment becomes possible. Furthermore, loss of the drug can be prevented, for example, if the extension is loaded with the drug. In this specification, the balloon for balloon catheter may be simply referred to as "balloon".

A balloon for a balloon catheter will be described with reference to FIGS. 1 to 15. FIG. FIG. 1 shows a side view of a balloon catheter according to one embodiment of the invention. 2 shows a longitudinal sectional view of the balloon of the balloon catheter shown in FIG. 1 in an expanded state, and FIG. 3 shows a plan view of the balloon shown in FIG. FIG. 4 represents a cross-sectional view taken along line IV-IV of FIG. 5 is a side view of the balloon catheter shown in FIG. 1 in a deflated state, and FIG. 6 is a side view showing another example of the side view shown in FIG. FIG. 7 represents a section VII-VII of FIG. 5, ie a radial section at the longitudinal midpoint of the extension. 8 to 10 are cross-sectional views showing different examples of the cross-sectional view shown in FIG. 7, that is, cross-sectional views showing examples in which the length of the blades and the number of outward protrusions are different. 11 is a cross-sectional view taken along line XI-XI in FIG. 5, that is, a cross-sectional view in the radial direction of the proximal side sleeve portion, and FIG. 12 is a cross-sectional view showing another example of the cross-sectional view shown in FIG. FIG. 13 shows a side view of a deflated balloon for a balloon catheter according to another embodiment of the present invention. 14 represents a radial cross-sectional view at the midpoint of the longitudinal axis direction of the expanded portion in the folded state of the balloon of the balloon catheter according to one embodiment of the present invention, and FIG. 15 represents another cross-sectional view of the cross-sectional view shown in FIG. Fig. 3 shows a cross-sectional view showing an example, i.

In the present invention, the term "proximal side" refers to the direction toward the hand side of the user or the operator with respect to the extending direction of the balloon catheter 1 or the longitudinal axis direction x of the shaft 3, and the term "distal side" refers to the direction opposite to the proximal side. It refers to the direction, that is, the direction of the treatment target side. Even members other than elongated members such as the shaft 3 have the same longitudinal axis direction x as the shaft 3 . The radial direction y is a direction perpendicular to the longitudinal axis direction x and connects the center of the balloon body 27 and a point on the circumscribed circle of the expanded balloon body 27 in a cross section perpendicular to the longitudinal axis direction x. The circumferential direction z is the direction along the circumference of the circumscribed circle of the expanded balloon body 27 in the cross section in the radial direction y.

As shown in FIGS. 1 and 2, the balloon catheter 1 has a shaft 3 and a balloon 2 provided outside the shaft 3. As shown in FIG. The balloon catheter 1 has a distal side and a proximal side, and a shaft 3 is provided with a balloon 2 on the distal side. The balloon catheter 1 is configured such that a fluid is supplied to the interior of the balloon 2 through the shaft 3, and the expansion and contraction of the balloon 2 can be controlled using an indeflator (balloon pressurizer). The fluid may be a pressurized fluid pressurized by a pump or the like.

It is preferable that the shaft 3 has a fluid flow path inside, and further has an insertion passage for a guide wire. In order for the shaft 3 to have a fluid flow path and a guide wire insertion path inside, for example, the shaft 3 has an outer tube 31 and an inner tube 32, and the inner tube 32 is used for inserting the guide wire. For example, the space between the inner tube 32 and the outer tube 31 functions as a passage, and the space between the inner tube 32 and the outer tube 31 functions as a fluid flow path. When the shaft 3 thus has the outer tube 31 and the inner tube 32, the inner tube 32 extends from the distal end of the outer tube 31 and passes through the balloon 2 to the distal side, thereby Preferably, the distal side of 2 is joined to inner tube 32 and the proximal side of balloon 2 is joined to outer tube 31 .

As shown in FIGS. 1 to 12, the balloon 2 for a balloon catheter includes an expanded portion 20, a proximal sleeve portion 21 located proximal to the expanded portion 20, and a sleeve portion distal to the expanded portion 20. a balloon body 27 having an outer surface and an inner surface; and a balloon body 27 projecting outwardly in the radial direction y beyond the outer surface of the balloon body 27. and an outer projecting portion 60 extending in the longitudinal direction x of the balloon 2, and satisfies at least one of the following (1) and (2) when the balloon 2 is deflated.
(1) A _first imaginary cylinder C1 having a central axis parallel to the longitudinal direction x, the bottom surface of which is located at the distal end and the proximal end of the proximal sleeve portion 21, and at least a part of the side surface The radius r 1 of the first imaginary cylinder C ₁ circumscribed by the proximal sleeve portion 21 is the same as the radius r ₁ of the extension portion 20 in the cross section in the radial direction y perpendicular to the longitudinal axis direction x at the midpoint 20c of the extension portion 20 in the longitudinal axis direction x. is greater than the radius r ₀ of the circumscribed virtual circle C ₀ .
(2) A _second imaginary cylinder C2 having a central axis parallel to the longitudinal direction x, with bottom surfaces located at the distal and proximal ends of the distal sleeve portion 22 and The radius r 2 of the second imaginary cylinder C ₂ circumscribed by the distal sleeve portion 22 is equal to the radius r ₂ of the extension portion 20 in the cross section in the radial direction y perpendicular to the longitudinal axis direction x at the midpoint 20c of the extension portion 20 in the longitudinal direction x. is greater than the radius r ₀ of the circumscribed virtual circle C ₀ .
In the contracted state of the balloon ₂ , at least _one of the radius r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 and the radius r2 of the _second imaginary cylinder C2 circumscribed by the distal sleeve portion 22 is , the radius r ₀ of the virtual circle C ₀ circumscribing the expansion part 20 in the cross section in the radial direction y at the midpoint 20 c of the longitudinal axis direction x of the expansion part 20 , so that the deflated balloon 2 is conveyed in the body cavity. In this case, by bringing the proximal sleeve portion 21 or the distal sleeve portion 22 into contact with the body cavity wall, it is possible to make it difficult for the expansion section 20 to come into contact with the body cavity wall. As a result, the contact area of the balloon 2 with the wall of the body cavity can be reduced, and the trackability of the balloon 2 (the ease with which the balloon 2 can follow the curvature of the body cavity when the balloon 2 is transported within the body cavity) can be improved. can be improved. In addition, since the balloon 2 can be conveyed to the lesion while the central portion of the expansion section 20 is made less likely to come into contact with the body cavity wall, the expansion section 20, which is expanded during treatment and acts on the lesion, can be protected from damage. effective treatment becomes possible. Furthermore, for example, if the extension 20 is loaded with a drug, loss of the drug can be prevented.

As shown in FIGS. 1 and 2, the balloon 2 has a proximal sleeve portion 21 and a distal sleeve portion 22 on the proximal and distal sides of the expansion portion 20, respectively. At least a portion of the proximal sleeve portion 21 and the distal sleeve portion 22 can be configured to be fixed to the shaft 3, and in the case of a configuration in which the shaft 3 has an outer tube 31 and an inner tube 32, At least a portion of the distal sleeve portion 21 may be fixed to the outer tube 31 and at least a portion of the distal sleeve portion 22 may be fixed to the inner tube 32 .

The expanded portion 20 is a portion that is expanded by supplying fluid to the inside of the balloon 2 through the shaft 3, and is a proximal side sleeve portion that is located on the proximal side or distal side of the expanded portion 20, respectively. 21 and distal sleeve portion 22 preferably do not expand when fluid is supplied to the interior of balloon 2 . As a result, the fixation between the balloon 2 and the shaft 3 can be stabilized even when the balloon 2 is expanded. Further, as will be described later, when the balloon 2 is contracted from the inflated state, wings 29 are formed in the expanded portion 20. However, if the proximal sleeve portion 21 and the distal sleeve portion 22 are not expanded, the balloon 2 is not expanded. The wings 29 are not formed on the proximal sleeve portion 21 and the distal sleeve portion 22 even when contracted from the expanded state. As a result, when the balloon 2 is transported in the body cavity in the deflated state, the blades 29 of the proximal sleeve portion 21 and the distal sleeve portion 22 do not come into contact with the body cavity wall.

Although not shown, the expansion portion 20 includes a straight tube portion, a proximal tapered portion located proximal to the straight tube portion, and a distal tapered portion located distal to the straight tube portion. and Preferably, the straight pipe portion has the same diameter in the longitudinal direction x, and the proximal and distal taper portions are formed so as to decrease in diameter with increasing distance from the straight pipe portion. Since the expansion part 20 has a straight pipe part having a maximum diameter, when the balloon 2 is expanded in a lesion such as a stenotic part, the straight pipe part is in sufficient contact with the lesion to dilate the lesion. or the incision can be easily performed. In addition, since the proximal and distal tapered portions are reduced in diameter, the outer diameters of the proximal and distal ends of the balloon 2 are reduced when the balloon 2 is deflated. As a result, the difference in level between the shaft 3 and the balloon 2 can be reduced, making it easier to insert the balloon 2 into the body cavity.

As shown in FIGS. 1 to 4, the balloon 2 includes a balloon body 27 having an outer surface and an inner surface, and a balloon body 27 protruding outward in the radial direction y from the outer surface of the balloon body 27 and extending in the longitudinal axis direction x of the balloon body 27. and an extending outer projection 60 . The maximum length by which the outer protruding portion 60 protrudes outward in the radial direction y from the outer surface of the balloon main body 27 in the cross section in the radial direction y is preferably 1.2 times or more the film thickness of the balloon main body 27. , more preferably 1.5 times or more, and still more preferably 2 times or more. Also, the maximum length may be different in the longitudinal direction x. The outer protruding portion 60 having the maximum length within the above range makes it easier to make an incision with an appropriate depth in the narrowed portion, thereby facilitating the incision. Furthermore, since the balloon 2 has the outer protruding portion 60, it is possible to improve the strength of the balloon 2 and suppress the excessive expansion of the balloon 2 during pressurization.

The number of outer protrusions 60 in the circumferential direction z of the balloon 2 may be plural as shown in FIGS. can be one. When the balloon 2 has a plurality of outer protrusions 60 in the circumferential direction z, the plurality of outer protrusions 60 are preferably spaced apart in the circumferential direction z, and are arranged at regular intervals in the circumferential direction z. is more preferable. The separation distance is preferably longer than the maximum perimeter of the outer protrusion 60 . By arranging the outer protruding portions 60 at intervals in the circumferential direction z, preferably at equal intervals, fixation of the balloon 2 and incision of the stenotic portion are facilitated.

The outer projections 60 extending in the longitudinal direction x on the outer surface of the balloon body 27 are arranged at the same position in the longitudinal direction x in the circumferential direction z, i.e. straight in the longitudinal direction x as shown in FIG. may be If the outer protruding portion 60 is arranged straight, the stenotic portion can be incised straight. Alternatively, although not shown, the outer protruding portions 60 may be arranged at different positions in the longitudinal direction x in the circumferential direction z, for example, spirally around the outer surface of the balloon body 27 in the circumferential direction z. With such an outward projecting portion, it is possible to obliquely incise the constricted portion.

The balloon 2 preferably satisfies at least one of the following (1) and (2).
(1) The outer protruding portion 60 of the proximal sleeve portion 21 and the outer protruding portion 60 of the extended portion 20 extend continuously in the longitudinal direction x.
(2) The outer protruding portion 60 of the distal sleeve portion 22 and the outer protruding portion 60 of the extension portion 20 extend continuously in the longitudinal direction x.
FIG. 3 shows an embodiment that satisfies both (1) and (2) above, that is, the outer protrusion 60 of the proximal sleeve portion 21, the outer protrusion 60 of the expansion portion 20, and the outer protrusion of the distal sleeve portion 22. Although the portion 60 continuously extends in the longitudinal direction x, it is sufficient that at least one of the above (1) and (2) is satisfied. As a result, it becomes possible to further improve the strength of the balloon 2 and to further suppress the overexpansion of the balloon 2 during pressurization.

Alternatively, although not shown, in the deflated state of the balloon 2, the radius r ₁ of the first imaginary cylinder C ₁ circumscribed by the proximal sleeve portion 21 and the second imaginary cylinder C ₂ circumscribed by the distal sleeve portion 22 At least one of the radii r ₂ of is larger than the radius r ₀ of the virtual circle C ₀ circumscribed by the extension 20 in the cross section in the radial direction y at the midpoint 20 c in the longitudinal direction x of the extension 20 , the proximal sleeve portion 21, the expansion portion 20, and the outer protrusions 60 of the distal sleeve portion 22 may not extend continuously in the longitudinal direction x, and the portion where the outer protrusions 60 are not disposed There may be This makes it possible to provide a portion of the balloon 2 having a small outer diameter in the deflated state, thereby reducing the contact area of the balloon 2 with the body cavity wall and improving trackability.

As shown in FIG. 4, the outer projecting portion 60 has a tip portion 61 in a cross section in the radial direction y. Since the distal end portion 61 makes it easier to cut into the stenotic portion, the stenotic portion can be incised while preventing dissection of the intima of the blood vessel. The distal end portion 61 is the portion where the outer protruding portion 60 protrudes most outward in the radial direction y from the outer surface of the balloon body 27, and may have a shape with an acute angle as shown in FIG. but may have an obtuse angle, curvilinear shape, or flat shape. From the viewpoint of ease of cutting, it is preferable that the tip portion 61 has a shape having an acute angle. The shape of the cross section of the outer protruding portion 60 in the radial direction y may be arbitrary, and may be substantially triangular as shown in FIG. may

As shown in FIGS. 5 and 7, the contracted state of the balloon 2 is the state before the fluid is supplied to the inside of the balloon 2 or after the fluid is discharged from the inside of the balloon 2. In the contracted state of the balloon 2, the expanded portion 20 has a portion where the inner surface of the balloon body 27 is close to the shaft 3 and wings 29 . 5 and 7, the shaft 3 has an outer tube 31 and an inner tube 32, and the expanded portion 20 is a portion where the inner surface of the balloon body 27 is close to the inner tube 32 when the balloon 2 is deflated. and blades 29 . It is preferable that the blades 29 are formed so as to encircle the shaft 3 in the circumferential direction z in the contracted state of the balloon 2 . Before supplying fluid to the inside of the balloon 2, particularly in the contracted state of the balloon 2 before use, as shown in FIGS. It is preferable that the balloon membranes are shrunk so that the balloon membranes are in close contact with each other in the portions where the outer protrusions 60 are not formed, and the wings 29 are shrunk so as to be in close contact with the outer protrusions 60 in the portions where the outer protrusions 60 are arranged. Further, even in a deflated state in which the fluid is discharged from the balloon 2 that has been expanded once after use, etc., it is preferable that the deflated state of the configuration as described above is maintained. As a result, the radius r ₀ of the virtual circle C ₀ circumscribed by the extended portion 20 in the cross section in the radial direction y perpendicular to the longitudinal axis direction x at the midpoint 20c of the extended portion 20 in the longitudinal direction x can be easily reduced.

As shown in FIG. 5, the balloon 2 satisfies at least one of the following (1) and (2) in the deflated state.
(1) A _first imaginary cylinder C1 having a central axis parallel to the longitudinal direction x, the bottom surface of which is located at the distal end and the proximal end of the proximal sleeve portion 21, and at least a part of the side surface The radius r ₁ of the first virtual cylinder C ₁ circumscribed by the proximal sleeve portion 21 is the virtual circle C ₀ is greater than the radius r ₀ of
(2) A _second imaginary cylinder C2 having a central axis parallel to the longitudinal direction x, with bottom surfaces located at the distal and proximal ends of the distal sleeve portion 22 and The radius r ₂ of the second virtual cylinder C ₂ circumscribed by the distal sleeve portion 22 is the virtual circle C ₀ is greater than the radius r ₀ of
Although FIG. 5 shows a mode that satisfies both the above (1) and (2), it is sufficient if at least one of the above (1) and (2) is satisfied. When both the above (1) and (2) are satisfied, the radius r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 and the radius r1 of the _second imaginary cylinder _C2 circumscribed by the distal sleeve portion 22 r ₂ may be the same or one may be greater. With the above configuration, when the deflated balloon 2 is conveyed inside the body cavity, the proximal sleeve part 21 or the distal sleeve part 22 is brought into contact with the body cavity wall so that the expansion part 20 is pushed into the body cavity wall. It can be made difficult to abut. This makes it difficult for the expanded portion 20, which has a relatively large area, to contact the body cavity wall, so that the contact area of the balloon 2 with the body cavity wall can be reduced during transportation, and the trackability of the balloon 2 can be improved. In addition, since the expansion part 20 is less likely to come into contact with the body cavity wall, the expansion part 20, which is expanded during treatment and acts on the lesion, can be protected from damage, enabling effective treatment. Furthermore, for example, if the extension 20 is loaded with a drug, loss of the drug can be prevented.

Here, the condition (1) above is the first imaginary cylinder C ₁ having a central axis parallel to the longitudinal axis direction x and having bottom surfaces at the distal and proximal ends of the proximal sleeve portion 21. At least a part of the side surface is circumscribed by the proximal side sleeve portion 21 . In other words, when the proximal sleeve portion 21 is accommodated inside the first imaginary cylinder C ₁ so that the longitudinal axis direction x coincides, at least a part of the side surface of the first imaginary cylinder C ₁ has a proximal side When the sleeve portion 21 is in contact with the proximal side sleeve portion 21 and has different diameters in the longitudinal axis direction x, the portion having the maximum diameter is in contact with the side surface of the _first imaginary column C1. It means that The above condition (2) for the distal sleeve portion 22 can also be understood in the same manner as above.

When the proximal end of the extended portion 20 is at the 0% position and the distal end is at the 100% position in the longitudinal direction x, the midpoint 20c of the extended portion 20 in the longitudinal direction x corresponds to the 50% position. is larger than the radius of each virtual circle circumscribed by the extension 20 in the cross section in the radial direction y at the 40% and 60% positions, the radius of the first virtual cylinder C ₁ circumscribed by the proximal sleeve portion At least one of r ₁ and the radius r ₂ of the second imaginary cylinder C ₂ circumscribed by the distal sleeve portion 22 is preferably large. In addition, it is more preferable that at least one of the radius r ₁ and the radius r ₂ is larger than the radius of each imaginary circle circumscribed by the expanded portion 20 in the cross section in the radial direction y at the 30% position and the 70% position. It is more preferable that at least one of the radius r ₁ and the radius r ₂ is larger than the radius of each imaginary circle circumscribed by the expanded portion 20 in the cross section in the radial direction y at the % position and the 80% position. As a result, when the contracted balloon 2 is transported inside the body cavity, the expanded portion 20 can be made more difficult to abut against the wall of the body cavity, thereby improving the trackability of the balloon 2 and further protecting the expanded portion 20. easier.

In the case where the expansion portion 20 has a proximal side taper portion, a straight pipe portion, and a distal side taper portion, the diameter of the first imaginary column C ₁ circumscribed by the proximal side sleeve portion 21 is larger than the radius of the straight pipe portion. At least one of the radius r ₁ and the radius r ₂ of the second imaginary cylinder C ₂ circumscribed by the distal sleeve portion 22 is preferably large. As a result, when the deflated balloon 2 is conveyed within the body cavity, the straight tube portion having a relatively large area is less likely to come into contact with the body cavity wall, thereby improving the trackability of the balloon 2 and protecting the straight tube portion. It becomes possible.

Each virtual cylinder need not be circumscribed by the entire sleeve portion. For example, as shown in FIG. 6, the distal end of the distal sleeve portion 22 may have a portion that does not circumscribe the _second virtual cylinder C2. With such a configuration, when the contracted balloon 2 is inserted into the body cavity, the diameter of the distal end portion in the advancing direction can be reduced, so that the insertability can be improved. Alternatively, although not shown, the proximal end of the proximal sleeve portion 21 may have a portion that does not circumscribe the _first imaginary column C1. With such a configuration, when retracting the deflated balloon 2 from the affected area, the diameter of the distal end portion in the advancing direction can be reduced, so that the insertability can be improved.

7 to 10, an imaginary circle C ₀ circumscribed by the expanded portion 20 in the cross section in the radial direction y at the midpoint 20c of the longitudinal axis direction x of the expanded portion 20 in the deflated state of the balloon 2 will be described. FIGS. 7 and 8 show an example of a virtual circle C ₀ for a balloon 2 having three outer protrusions 60. FIG. As shown in FIG. 7, in the example of the balloon ₂ in which the diameter of the expanded portion 20 is relatively large, the length of the wing 29 that circulates in the circumferential direction z is relatively long. may be circumscribed. As shown in FIG. 8, in the example of the balloon 2 in which the diameter of the expanded portion 20 is relatively small, the length of the blades 29 that circulate in the circumferential direction z is relatively short. It may circumscribe C ₀ . 9 and 10 show an example of a virtual circle C ₀ for a balloon 2 having one outer protrusion 60. FIG. As shown in FIG. 10, in the example of the balloon ₂ in which the diameter of the expanded portion 20 is relatively large, the length of the blades 29 that circulate in the circumferential direction z is relatively long. may be circumscribed. As shown in FIG. 9, in the example of the balloon 2 in which the diameter of the expanded portion 20 is relatively small, the length of the wing 29 that circulates in the circumferential direction z is relatively short. may circumscribe the virtual circle C ₀ . When the outer projecting portion 60 circumscribes the imaginary circle C ₀ , the tip portion 61 may circumscribe the imaginary circle C ₀ . In either case, the radius r ₁ of the first virtual cylinder C ₁ circumscribed by the proximal sleeve portion 21 and the second virtual circle circumscribed by the distal sleeve portion 22 are less than the radius r ₀ of the virtual circle C ₀ . Since at least one of the radius r ₂ of the cylinder C ₂ is large, it is possible to make it difficult for the outer projecting portion 60 of the straight tube portion 20 and the vanes 29 to come into contact with the body cavity wall.

11 and 12, in the contracted state of the balloon 2, the radius r ₀ of the virtual circle C ₀ circumscribed by the expansion portion 20 in the cross section in the radial direction y at the midpoint 20c in the longitudinal axis direction x of the expansion portion 20 The _first imaginary cylinder C1 in the case where the radius r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 is larger than that of the _first imaginary cylinder C1 will be described. 11 shows an example of the first imaginary cylinder C ₁ in the case of the balloon 2 having three outer protrusions 60, and FIG. FIG. 11 is a cross-sectional view taken along the line XI-XI in FIG. 5. FIG. 5 shows a mode in which the proximal sleeve portion 21 is in contact with the first imaginary column C ₁ over the entire longitudinal axis direction x. The balloon 2 according to the embodiment of the invention is not limited to that shown in FIG. 5, and may have the cross section shown in FIG. Similarly, in the embodiment shown in FIG. 12, the balloon 2 only needs to have the cross section shown in FIG. 12 at a portion of the proximal sleeve portion 21 . As shown in FIGS. 11 and 12, in the unexpanded proximal sleeve portion 21, no vanes 29 are formed even in the deflated state of the balloon 2, and in the embodiment shown in FIG. A virtual cylinder C ₁ can be circumscribed. In other embodiments, including the embodiment shown in FIG. 12, the outer protruding portion 60 and the balloon body 27 may circumscribe the first imaginary cylinder C ₁ . The _first imaginary column C1 can also be regarded as the body cavity wall when the balloon 2 is transported inside the body cavity, and as shown in FIGS. 11 and 12, the proximal side sleeve portion 21 contacts the body cavity wall with a small contact area. By doing so, it is possible to secure the transport path for the balloon 2 and improve the trackability of the balloon 2 .

As shown in FIG. 12, for example, even if the proximal sleeve portion 21 is provided with one outer protrusion 60 and the extension portion 20 is provided with a plurality of outer protrusions 60, The vanes 29 of the expanded portion 20 contract the balloon 2 so that the balloon membranes are in close contact with each other, and the portion where the outer protrusion 60 is arranged is in close contact with the outer protrusion 60, so that the radius r At least one of ₁ and r ₂ can be greater than radius r ₀ .

In the deflated state of the balloon 2, the distal sleeve portion 22 circumscribes the radius _r0 of the virtual circle _C0 circumscribed by the expanded portion 20 in the cross section in the radial direction y at the midpoint 20c of the longitudinal axis direction x of the expanded portion 20. Although the _second imaginary cylinder C2 when the radius r2 of the _second imaginary cylinder _C2 is large is not shown, please refer to FIGS. can be understood.

From the viewpoint of protection of the expanded portion 20, as shown in FIGS. The radius r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 and the radius r of the _second imaginary cylinder _C2 circumscribed by the distal sleeve portion 22 are larger than the radius _r0 of the circumscribed imaginary circle _C0 . It is preferable that both of ₂ are large. From the viewpoint of easiness of insertion of the balloon 2 during transportation, in the cross section in the radial direction y at the midpoint 20c in the longitudinal axis direction x of the expansion portion 20, the radius r ₀ of the virtual circle C ₀ circumscribing the expansion portion 20 Preferably, either the radius _r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 or the radius r2 of the _second imaginary cylinder _C2 circumscribed by the distal sleeve portion 22 is larger. In particular, when only the radius r ₁ of the first imaginary cylinder C ₁ circumscribed by the proximal sleeve portion 21 is larger than the radius r ₀ , the distal sleeve portion 22 which is the distal end side when inserted into the body cavity The outer diameter can be suppressed, and the balloon 2 can be easily transported within the body cavity. In addition, since the radius r ₁ is larger than the radius r ₀ , the proximal side sleeve portion 21 is brought into contact with the body cavity wall when the balloon 2 is transported inside the body cavity, thereby supporting the body cavity wall on the proximal side of the balloon 2 . As a result, it is possible to make it difficult for the expansion part 20 to come into contact with the wall of the body cavity while securing the transport path for the balloon 2, and to improve the trackability of the balloon 2 and protect the expansion part 20. When the radius r ₂ of the distal sleeve portion 22 is larger than the radius r ₀ , the distal sleeve portion 22 abuts against the body cavity wall when the balloon 2 is transported, and the transport path for the balloon 2 can be secured. There is an advantage that deterioration of the insertability of the balloon 2 due to disturbance of the deflated state of the balloon 2 due to the tip of the balloon membrane curling up due to the portion 20 contacting the wall of the body cavity can be prevented.

Radius r ₀ , radius r ₁ , and radius r ₂ are the radial y lengths of the outer projection 60 in the radial y cross section of the extension 20 , the proximal sleeve portion 21 , and the distal sleeve portion 22 . However, depending on how the expanding portion 20 is contracted, the radius r ₀ can be adjusted regardless of the length of the outer projection 60 in the radial direction y, and as a result, the radius r ₀ , with radius r ₁ and radius r ₂ can be adjusted. That is, when the balloon 2 is contracted, the balloon membranes are brought into close contact with each other in the portions where the outer protrusions 60 are not provided, and the vanes 29 are attached to the outer protrusions 60 in the portions where the outer protrusions 60 are provided. By deflating the balloon 2 in a tight fit, the radius r ₀ can be made smaller than at least one of the radius r ₁ and radius r ₂ . With this method, the radius r ₀ can be adjusted without depending on the radial y length of the outer protrusion 60 in the cross section in the radial direction y in the extension portion 20, the proximal sleeve portion 21, and the distal sleeve portion 22. so that the relationship between radius r ₀ and radius r ₁ and radius r ₂ can be adjusted.

As shown in FIG. 13, the expanded portion 20 has a main section 20m, which is 10% each in the longitudinal axis direction x removed from the distal end and the proximal end. ) and (2) are preferably satisfied.
(1) The radius r ₁ of the first imaginary cylinder C ₁ is the third imaginary cylinder C ₃ having a central axis parallel to the longitudinal axis direction x, and the bottom surfaces are located at the distal and proximal ends of the main section 20m. and is larger than the radius r3 of the _third imaginary cylinder C3 circumscribed by the main section 20m _on at least a part of the side surface.
(2) The radius r ₂ of the second virtual cylinder C ₂ is the third virtual cylinder C ₃ having a central axis parallel to the longitudinal direction x, and the bottom surfaces are located at the distal and proximal ends of the main section 20m. and is larger than the radius r3 of the _third imaginary cylinder C3 circumscribed by the main section 20m _on at least a part of the side surface.
In the contracted state of the balloon ₂ , at least _one of the radius r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 and the radius r2 of the _second imaginary cylinder C2 circumscribed by the distal sleeve portion 22 is , the main section 20m of the expansion section ₂₀ is larger than the radius r3 of the circumscribed _third virtual cylinder C3, so that when the deflated balloon 2 is conveyed in the body cavity, the main section 20m of the expansion section 20 is entirely within the body cavity. It can be made difficult to contact the wall. As a result, the contact area of the balloon 2 with the body cavity wall can be further reduced, and the trackability of the balloon 2 can be further improved. In addition, since the entire main section 20m of the expansion part 20 is made difficult to abut against the body cavity wall, the balloon 2 can be conveyed to the lesion, so that the main section 20m, which is expanded during treatment and acts on the lesion, is protected from damage. Or, for example, when the medicine is loaded in the main section 20m, loss of the medicine can be prevented.

The main section 20m is 10% each in the longitudinal direction x from the distal end and the proximal end of the expanded section 20, that is, the section excluding the portion of the expanded section 20 that is most reduced in diameter in the expanded state. In other words, the main section 20m is a section having a certain diameter or more in the expanded state. As a result, in the deflated state of the balloon 2 , the main section 20 m forms a vane 29 having a certain length or more that circulates in the circumferential direction z. , the radius r ₀ can be made smaller than at least one of the radius r ₁ and the radius r ₂ .

In the above aspect, the radius r ₃ of the third imaginary cylinder C ₃ circumscribed by the main section 20 m of the extension 20 is defined as It may be larger than, equal to, or smaller than the radius r ₀ of the imaginary circle C ₀ circumscribed by the extension 20 in cross section. _At least _one of the radius r1 of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion 21 and the radius r2 of the _second imaginary cylinder C2 circumscribed by the distal sleeve portion 22 is greater than the radius _{r0 In} view of this, it is preferable that the radius r3 of the _third virtual cylinder C3 circumscribed by the main section 20m is larger than the radius _r0 . As a result, the diameter of the central portion of the expansion portion 20 can be further suppressed with respect to the proximal end portion or the distal end portion of the balloon 2 in the contracted state, and from the viewpoint of improving trackability and protecting the expansion portion 20. preferable.

In the contracted state of the balloon 2, the balloon 2 is preferably folded. The deflated balloon 2 before the fluid is supplied to the inside of the balloon 2 or after the fluid is discharged from the inside of the balloon 2 is folded by hand or using various folding machines to form the folded balloon 2. be able to. In the folded state, the blades 29 are firmly folded around the shaft 3 and do not float from the shaft 3, so that the blades 29 can be prevented from coming into contact with the body cavity wall during transportation. As a result, the radius r ₀ can be easily reduced, so that the expanded portion 20 can be made less likely to come into contact with the body cavity wall, and the trackability of the balloon 2 can be further improved. In addition, since the expansion part 20 is less likely to come into contact with the body cavity wall, it is possible to further protect the expansion part 20, which is expanded during treatment and acts on the lesion, from being damaged.

For example, as shown in FIGS. 14 and 15, in the folded state of the balloon 2, the blades 29 may be firmly folded, and the outward protrusions 60 may be deformed in the circumferential direction z of the blades 20. By folding in this way, the radius r ₀ can be made smaller more easily. As a method for folding the balloon 2 in this manner, the balloon 2 may be shaped by hand or by using various folding machines. By folding the balloon ₂ in this way, the radius _{r 0} can be _adjusted regardless of the length y of the outer protrusion 60 in the radial direction. can be adjusted. That is, the outer protruding portion 60 deforms in the circumferential direction of the blade 29 in the circumferential direction z, so that the radius r ₀ can be reduced, and the radius r ₀ can be made smaller than at least one of the radius r ₁ and the radius r ₂ . can.

In addition, since the main section 20m is a section having the blades 29 having a certain length or more that rotates in the circumferential direction z, the outer protruding portion 60 extends around the blades 29 over the entire main section 20m of the expanded portion 20. By folding so as to deform in the circumferential direction of the direction z _, it is possible to easily reduce the radius _r3 of the _third imaginary cylinder C3 circumscribed by the _main section _20m . It can be smaller than at least one. As a result, the entire main section 20m can be made less likely to come into contact with the body cavity wall, and the contact area of the balloon 2 with the body cavity wall can be further reduced.

The outer projecting portion 60 has a tip portion 61 in a cross section in the radial direction y, and preferably satisfies at least one of the following (1) and (2) when the balloon 2 is deflated.
(1) In the proximal sleeve portion 21, the distal end portion 61 circumscribes at least a portion of the side surface of the _first imaginary column C1.
(2) In the distal sleeve portion 22, the tip portion 61 circumscribes at least a portion of the side surface of the _second imaginary column C2.
Since the distal end portion 61 circumscribes the imaginary cylinder, it is possible to reduce the area of the sleeve portion that circumscribes the imaginary cylinder. The virtual cylinder can also be regarded as the body cavity wall when the balloon 2 is transported within the body cavity, and the sleeve part abuts against the body cavity wall with a small contact area to secure the delivery path of the balloon 2 and improve the trackability of the balloon 2. can be improved. In this case, only the tip portion 61 may circumscribe the virtual cylinder as shown in FIG. 11, or the tip portion 61 and the balloon body 27 may circumscribe the virtual cylinder as shown in FIG. Alternatively, although not shown, the distal end portion 61 may be in contact with a portion other than the distal end portion 61, for example, a portion other than the distal end portion 61 of the outer protruding portion 60. 11 and 12 show the proximal sleeve portion 21 circumscribing the _first imaginary cylinder C1, but the distal sleeve portion 22 circumscribing the _second imaginary cylinder C2 is also shown in FIGS. can be referenced and understood as well.

The outer projecting portion 60 has a tip portion 61 in a cross section in the radial direction y, and preferably satisfies at least one of the following (1) and (2) when the balloon 2 is deflated.
(1) In the proximal side sleeve portion 21, only the tip portion 61 circumscribes at least part of the side surface of the _first imaginary column C1.
(2) In the distal sleeve portion 22, only the tip portion 61 circumscribes at least part of the side surface of the _second imaginary column C2.
By circumscribing only the tip portion 61 to the virtual cylinder, the area of the sleeve portion that circumscribes the virtual cylinder can be further reduced. The virtual cylinder can also be regarded as the body cavity wall when the balloon 2 is transported within the body cavity, and the sleeve part abuts against the body cavity wall with a smaller contact area to secure the delivery path of the balloon 2 and improve the trackability of the balloon 2. can be further improved. In this case, as shown in FIG. 11, for example, the sleeve portion may have a configuration in which a plurality of outer projecting portions 60 are spaced apart in the circumferential direction z. Although FIG. 11 shows the proximal sleeve portion 21 circumscribing the first imaginary cylinder C ₁ , the distal sleeve portion 22 circumscribing the second imaginary cylinder C ₂ will be similarly understood with reference to FIG. 11 . be able to.

Preferably, in the deflated state of the balloon 2, the expansion portion 20 has wings 29, and the wings 29 circumscribe the virtual circle _C0 . 7 and 8 or 9 and 10, the diameter of the balloon body 27 can be adjusted to adjust the length of the blades 29 that circulate in the circumferential direction z. By using the vane 29, the vane 29 can be configured to circumscribe the virtual circle C ₀ . For example, if the blades 29 are configured to circumscribe the virtual circle C ₀ as shown in FIGS. 7 and 10, it is easy to protect the outer projecting portion 60 from damage, and the balloon 2 can be transported within the body cavity. Even if the expansion part 20 abuts against the body cavity wall, the outer projection part 60 acting on the lesion is less likely to abut against the body cavity wall. can be prevented.

7 to 10 show an embodiment with three blades 29, but the number of blades 29 is not particularly limited as long as the balloon 2 can be deflated. The number may be 4 or more, or 5 or more. Further, the number of blades 29 is preferably 10 or less, more preferably 8 or less, and even more preferably 6 or less. If the number of vanes 29 is within the above range, the balloon 2 can be easily deflated.

Preferably, in the deflated state of the balloon 2 , the dilation portion 20 has wings 29 and the outer protrusions 60 are located outside the wings 29 . If the outer protruding portion 60 is arranged other than the blades 29, the outer protruding portion 60 does not hinder the rotation of the blades 29, so that the balloon 2 can be easily deflated. In addition, since the outer projecting portion 60 is arranged outside the blades 29 , the outer projecting portion 60 can be easily covered with the blades 29 when the balloon 2 is deflated. This makes it easy to configure the blades 29 to circumscribe the virtual circle C ₀ when the balloon 2 is deflated.

Next, a balloon for a balloon catheter according to another embodiment of the present invention will be described with reference to FIGS. 16 to 18. FIG. FIG. 16 shows a side view of a deflated balloon for a balloon catheter according to still another embodiment of the present invention. 17 represents a cross-sectional view taken along line XVII-XVII of FIG. 16, that is, a cross-sectional view in the radial direction of the distal sleeve portion, and FIG. 18 represents a cross-sectional view showing another example of the cross-sectional view shown in FIG.

As shown in FIG. 16, in the deflated state of the balloon 2, the radius r ₁ of the first imaginary cylinder C ₁ in the proximal sleeve portion 21 is larger than the radius r ₀ of the imaginary circle C ₀ in the expanded portion 20, It is preferable that the radius r ₂ of the second imaginary cylinder C ₂ in the postural side sleeve portion 22 is smaller than the radius r ₀ of the imaginary circle C ₀ . By adopting such a configuration, the outer diameter of the distal sleeve portion 22, which is the tip side when inserted into the body cavity, can be reduced, and the balloon 2 can be easily transported within the body cavity. . In addition, since the radius r ₁ is larger than the radius r ₀ , the proximal side sleeve portion 21 is brought into contact with the body cavity wall when the balloon 2 is transported inside the body cavity, thereby supporting the body cavity wall on the proximal side of the balloon 2 . As a result, it is possible to make it difficult for the expansion part 20 to come into contact with the wall of the body cavity while securing the transport path for the balloon 2, and to improve the trackability of the balloon 2 and protect the expansion part 20. Thus, by adopting the above configuration, it is possible to obtain a balloon 2 that can be easily inserted, yet has improved trackability, and the expanded portion 20 can be easily protected.

The above configuration may be formed by shortening the radial y length of the outer protrusion 60 in the radial y cross-section of the distal sleeve portion 22, as shown in FIG. It may be formed by not providing the outer protrusion 60 on the side sleeve portion 22 . By shortening the length of the outer protrusion 60 in the radial direction y or by not providing the outer protrusion 60, the radius r2 of the _second imaginary cylinder _C2 circumscribed by the distal sleeve portion 22 is decreased. can be done.

Alternatively, in order to reduce the radius r ₂ , as shown in FIG. 18, the distal sleeve portion 22 protrudes inward in the radial direction y from the inner surface of the balloon body 27 and extends in the longitudinal direction x. It is preferred to have an inner protrusion 70 that is flat. At this time, as shown in FIG. 18, an outer protruding portion 60 having a short length in the radial direction y in the cross section in the radial direction y may be provided, or the outer protruding portion 60 is not provided although not shown. It doesn't have to be. By providing the inner protruding portion 70, even if the length of the outer protruding portion 60 in the radial direction y is short or the outer protruding portion 60 is not provided, the strength of the balloon 2 can be improved and the pressure during pressurization can be improved. overexpansion of the balloon 2 can be suppressed. When the outer protrusion 60 is provided together with the inner protrusion 70, the inner protrusion 70 and the outer protrusion 60 are preferably provided at the same position in the circumferential direction z. This makes it easier to improve the strength of the balloon 2 and to suppress excessive expansion of the balloon 2 during pressurization.

As shown in FIG. 16, the expanded portion 20 has a main section 20m obtained by excluding 10% of each of the longitudinal axis direction x from the distal end and the proximal end. The radius r ₁ of the first imaginary cylinder C ₁ in the sleeve portion 21 is the third imaginary cylinder C ₃ having a central axis parallel to the longitudinal axis direction x, and has bottom surfaces at the distal and proximal ends of the main section 20 m. The radius r ₂ of the second virtual cylinder C ₂ in the distal sleeve portion 22 is larger than the radius r ₃ of the third virtual cylinder C ₃ located and circumscribed by the main section 20 m on at least part of the side surface. It is preferably smaller than the radius r ₃ of the three virtual cylinders C ₃ . With such a configuration, when the deflated balloon 2 is transported inside the body cavity, the entire main section 20m of the expanded portion 20 can be made less likely to come into contact with the body cavity wall. In addition, the outer diameter of the distal sleeve portion 22, which is the distal end side when inserted into the body cavity, can be reduced, and the balloon 2 can be easily transported within the body cavity. Since the radius r ₁ is larger than the radius r ₃ , when the balloon 2 is transported inside the body cavity, the proximal sleeve portion 21 is brought into contact with the body cavity wall to support the body cavity wall on the proximal side of the balloon 2 . The entire 20m of the main section of the expansion part 20 can be made difficult to abut on the body cavity wall while securing the transport path of the balloon 2, and the balloon 2 can be easily inserted, but the trackability is further improved and the expansion part 20 is protected. The balloon 2 can be made easier.

Examples of the material forming the balloon body 27 include polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymer; polyester resins such as polyethylene terephthalate and polyester elastomer; and polyurethane resins such as polyurethane and polyurethane elastomer. , polyphenylene sulfide-based resins, polyamide-based resins such as polyamide and polyamide elastomers, fluorine-based resins, silicone-based resins, and natural rubbers such as latex rubbers. These may use only 1 type and may use 2 or more types together. Among them, polyamide-based resins, polyester-based resins, and polyurethane-based resins are preferably used. In particular, it is preferable to use an elastomer resin from the viewpoint of thinning and flexibility of the balloon body 27 . For example, among polyamide-based resins, nylon 12, nylon 11, and the like are suitable as the resin constituting the balloon body 27, and nylon 12 is more suitable because it can be molded relatively easily in blow molding. be. Polyamide elastomers such as polyether ester amide elastomers and polyamide ether elastomers are preferably used from the viewpoint of thinning and flexibility of the balloon main body 27 . Among them, a polyether ester amide elastomer is preferably used because it has a high yield strength and improves the dimensional stability of the balloon body 27 .

The outer projecting portion 60 is preferably made of the same material as the balloon body 27 . If the outer protrusion 60 is made of the same material as the balloon main body 27 , the outer surface of the balloon main body 27 can be prevented from being damaged by the outer protrusion 60 while maintaining the flexibility of the balloon 2 . The balloon main body 27 and the outer projecting portion 60 are preferably integrally molded. This can prevent the outer projecting portion 60 from falling off from the balloon body 27 . In the embodiment in which the inner projecting portion 70 is formed, the inner projecting portion 70 is preferably made of the same material as the balloon body 27 for the same reason as described above.

The balloon 2 can be manufactured by, for example, placing a cylindrical parison 200 made of resin in a mold having a groove in the inner cavity, and biaxially stretching blow molding, as shown in FIG. For example, the outer protrusion 60 is formed by inserting the parison 200 into the mold cavity, causing the thick portion 220 of the parison 200 to enter the groove of the mold, and introducing a fluid into the cavity 210 of the parison 200 so that the parison 200 can be formed by expanding the The length in the radial direction y of the outer protruding portion 60 in the cross section in the radial direction y can be adjusted by the thickness of the thick portion 220 of the parison 200 and the depth of the mold groove. In addition, the inner projecting portion 70 is formed, for example, by pressing the thick portion 220 of the parison 200 against a portion of the mold having no groove, and introducing a fluid into the lumen 210 of the parison 200 to expand the parison 200. be able to. Furthermore, in order to form the outer protruding portion 60 and the inner protruding portion 70 having a short length in the radial direction y in the cross section in the radial direction y, for example, the thick portion 220 of the parison 200 is pressed against the shallow groove portion of the mold. , can be formed by introducing a fluid into the lumen 210 of the parison 200 to expand the parison 200 . As for the material forming the parison 200, the description of the material forming the balloon main body 27 can be referred to.

Materials constituting the shaft 3 include, for example, 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. These may use only 1 type and may use 2 or more types together. Among them, the material constituting the shaft 3 is preferably at least one of polyamide resin, polyolefin resin, and fluorine resin. As a result, the slipperiness of the surface of the shaft 3 can be enhanced, and the insertability of the balloon catheter 1 within the body cavity can be improved.

The balloon 2 and the shaft 3 can be joined by bonding with an adhesive, welding, or by attaching a ring-shaped member to the portion where the end of the balloon 2 and the shaft 3 overlap and crimping. Above all, it is preferable that the balloon 2 and the shaft 3 are joined by welding. Since the balloon 2 and the shaft 3 are welded together, even if the balloon 2 is repeatedly expanded and contracted, the joint between the balloon 2 and the shaft 3 is hardly released, and the joint strength between the balloon 2 and the shaft 3 is easily increased. can be done.

As shown in FIG. 1 , in the balloon catheter 1 , a hub 4 may be provided on the proximal side of the shaft 3 , and the hub 4 communicates with the fluid flow path supplied to the inside of the balloon 2 . A fluid injection part 7 may be provided. In addition, the hub 4 preferably has a guide wire insertion portion 5 that communicates with the insertion passage of the guide wire. Since the balloon catheter 1 has the hub 4 having the fluid injection part 7 and the guide wire insertion part 5, the fluid can be supplied to the inside of the balloon 2 to expand and contract the balloon 2, and the operation can be performed along the guide wire. The operation of delivering the balloon catheter 1 to the treatment site can be easily performed. As shown in FIG. 1, the balloon 2 according to the embodiment of the present invention is not only a so-called over-the-wire type balloon catheter in which a guide wire is inserted from the distal side to the proximal side of the shaft 3, but also the distal side of the shaft. It can also be applied to a so-called rapid exchange type balloon catheter in which a guide wire is inserted halfway from the side to the proximal side.

The joint between the shaft 3 and the hub 4 can be, for example, bonding with an adhesive, welding, or the like. Above all, it is preferable that the shaft 3 and the hub 4 are joined by adhesion. By bonding the shaft 3 and the hub 4, for example, the shaft 3 is made of a highly flexible material and the hub 4 is made of a highly rigid material. 4, the durability of the balloon catheter 1 can be enhanced by increasing the bonding strength between the shaft 3 and the hub 4.

This application claims the benefit of priority based on Japanese Patent Application No. 2021-8307 filed on January 21, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-8307 filed on January 21, 2021 are incorporated herein by reference.

1: Balloon Catheter 2: Balloon 3: Shaft 4: Hub 5: Guidewire Insertion Portion 7: Fluid Injection Portion 20: Expansion Portion 20c: Midpoint 20m in the Longitudinal Axial Direction of the Expansion Portion: Main Section 21 of the Expansion Portion: Proximal Side sleeve portion 22: Distal sleeve portion 27: Balloon body 29: Wings 31: Outer tube 32: Inner tube 60: Outer projection 61: Tip 70: Inner projection 200: Parison 210: Parison lumen 220: Thick part C ₀ of the parison: virtual circle C ₁ circumscribed by the extended part at the longitudinal midpoint: first virtual cylinder C ₂ circumscribed by the proximal sleeve part: second virtual cylinder circumscribed by the distal sleeve part Virtual cylinder C ₃ : Third virtual cylinder circumscribed by the main section of the extension r ₀ : Radius r ₁ of virtual circle C ₀ : Radius r ₂ of first virtual cylinder C ₁ : Radius r ₃ of second virtual cylinder C ₂ : Radius x of the _third virtual cylinder C3: Longitudinal axis direction y: Radial direction z: Circumferential direction

Claims (12)

1. A balloon having an expansion section, a proximal sleeve section positioned proximal to the expansion section, and a distal sleeve section positioned distal to the expansion section. A balloon for a catheter,
   a balloon body having an outer surface and an inner surface; and an outer protrusion projecting radially outward from the outer surface of the balloon body and extending in the longitudinal direction of the balloon body,
   A balloon for a balloon catheter, which satisfies at least one of the following (1) and (2) in the contracted state of the balloon.
   (1) A _first imaginary cylinder C1 having a central axis parallel to the longitudinal axis direction, the bottom surface of which is located at the distal end and the proximal end of the proximal sleeve portion, and at least a part of the side surface The radius of the _first imaginary cylinder C1 circumscribed by the proximal sleeve portion is a virtual cylinder C1 circumscribed by the extension in a radial cross section perpendicular to the longitudinal axis at the midpoint of the extension in the longitudinal direction. greater than the radius of the circle _C0 .
   (2) A _second imaginary column C2 having a central axis parallel to the longitudinal direction, with bottom surfaces located at the distal and proximal ends of the distal sleeve portion and The radius of the _second imaginary cylinder C2 circumscribed by the distal sleeve portion is the virtual diameter circumscribed by the extension in a radial cross section perpendicular to the longitudinal axis at the midpoint of the longitudinal axis of the extension. greater than the radius of the circle _C0 .
2. The expanded portion has main sections excluding 10% each in the longitudinal direction from the distal end and the proximal end, and at least one of the following (1) and (2) The balloon for a balloon catheter according to claim 1, which satisfies
   (1) The radius of the _first imaginary cylinder C1 is a _third imaginary cylinder C3 having a central axis parallel to the longitudinal direction, and the bottom surfaces are located at the distal and proximal ends of the main section. and larger than the radius of the _third imaginary cylinder C3 circumscribed by the main section on at least part of the side surface.
   (2) The radius of the _second virtual cylinder C2 is a _third virtual cylinder C3 having a central axis parallel to the longitudinal direction, and the bottom surfaces are located at the distal and proximal ends of the main section. and larger than the radius of the _third imaginary cylinder C3 circumscribed by the main section on at least part of the side surface.
3. The balloon for a balloon catheter according to claim 1 or 2, wherein the balloon is folded in the contracted state of the balloon.
4. 4. Any one of claims 1 to 3, wherein the outer projecting portion has a tip portion in the cross section in the radial direction, and satisfies at least one of the following (1) and (2) when the balloon is deflated. A balloon for a balloon catheter according to .
   (1) In the proximal sleeve portion, the distal end portion circumscribes at least a portion of the side surface of the _first imaginary column C1.
   (2) In the distal sleeve portion, the tip portion circumscribes at least a portion of the side surface of the _second imaginary column C2.
5. 5. Any one of claims 1 to 4, wherein the outer protruding portion has a tip portion in the cross section in the radial direction, and satisfies at least one of the following (1) and (2) when the balloon is deflated. A balloon for a balloon catheter according to .
   (1) In the proximal side sleeve portion, only the tip portion circumscribes at least a portion of the side surface of the _first imaginary column C1.
   (2) In the distal sleeve portion, only the tip portion circumscribes at least a portion of the side surface of the _second virtual cylinder C2.
6. The balloon for a balloon catheter according to any one of claims 1 to 5, wherein in the deflated state of the balloon, the expanded portion has wings, and the wings circumscribe the virtual circle C ₀ .
7. The balloon for a balloon catheter according to any one of claims 1 to 6, wherein, in the contracted state of the balloon, the expanded portion has wings, and the outer projecting portion is arranged outside the wings.
8. The balloon for a balloon catheter according to any one of claims 1 to 7, which satisfies at least one of the following (1) and (2).
   (1) The outwardly projecting portion of the proximal sleeve portion and the outwardly projecting portion of the extension portion extend continuously in the longitudinal direction.
   (2) The outer projection of the distal sleeve portion and the outer projection of the extension extend continuously in the longitudinal direction.
9. In the contracted state of the balloon, the radius of the first imaginary cylinder C1 in the proximal sleeve portion is greater than the radius of the imaginary circle _C0 in the expanded portion, and the _second imaginary cylinder C0 in the distal sleeve portion. The balloon for a balloon catheter according to any one of claims 1 to 8, wherein the radius of the virtual cylinder _C2 is smaller than the radius of the virtual circle _C0 .
10. The expanded portion has main sections excluding 10% each in the longitudinal direction from a distal end and a proximal end. _The radius of the cylinder C1 is a _third imaginary cylinder C3 having a central axis parallel to the longitudinal axis direction, the bottom surface being located at the distal end and the proximal end of the main section, and at least part of the side surface and the radius of the _second virtual cylinder _C2 at the distal sleeve portion is smaller than the radius of the _third virtual cylinder C3 Item 9. The balloon for balloon catheter according to item 9.
11. 11. The distal sleeve portion according to claim 9 or 10, comprising an inner protrusion projecting radially inwardly beyond the inner surface of the balloon body and extending in the longitudinal direction. Balloon for balloon catheter.
12. The balloon for a balloon catheter according to any one of claims 1 to 11, wherein the outward protrusion is made of the same material as the balloon main body.

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