WO2022158100A1 - Ballonnet pour cathéter à ballonnet - Google Patents

Ballonnet pour cathéter à ballonnet Download PDF

Info

Publication number
WO2022158100A1
WO2022158100A1 PCT/JP2021/042156 JP2021042156W WO2022158100A1 WO 2022158100 A1 WO2022158100 A1 WO 2022158100A1 JP 2021042156 W JP2021042156 W JP 2021042156W WO 2022158100 A1 WO2022158100 A1 WO 2022158100A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
radius
distal
proximal
sleeve portion
Prior art date
Application number
PCT/JP2021/042156
Other languages
English (en)
Japanese (ja)
Inventor
昌人 杖田
真弘 小嶋
良紀 中野
崇亘 ▲濱▼淵
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Priority to CN202180088986.0A priority Critical patent/CN116782844A/zh
Priority to JP2022576998A priority patent/JPWO2022158100A1/ja
Publication of WO2022158100A1 publication Critical patent/WO2022158100A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to balloons for balloon catheters.
  • 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.
  • 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.
  • ISR In-Stent-Restenosis
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • the balloon is folded in the contracted state of the balloon.
  • 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.
  • the distal end portion circumscribes at least a portion of the side surface of the first imaginary column C1.
  • the tip portion circumscribes at least a portion of the side surface of the second virtual cylinder C2.
  • 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.
  • the extension in the deflated state of the balloon, has wings and the wings circumscribe the imaginary circle C 0 .
  • 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.
  • 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 .
  • 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
  • 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.
  • 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.
  • the outer protruding portion is made of the same material as the balloon body.
  • 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.
  • FIG. 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
  • 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 ;
  • 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. 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;
  • a balloon for a balloon catheter 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • the balloon for balloon catheter may be simply referred to as "balloon".
  • 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
  • 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
  • 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.
  • FIG. 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
  • 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.
  • FIG. 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
  • 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.
  • 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.
  • 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.
  • the shaft 3 has a fluid flow path inside, and further has an insertion passage for a guide wire.
  • 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.
  • the space between the inner tube 32 and the outer tube 31 functions as a passage
  • the space between the inner tube 32 and the outer tube 31 functions as a fluid flow path.
  • 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 .
  • 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.
  • 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 .
  • 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 .
  • 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.
  • the expansion section 20 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.
  • 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.
  • 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.
  • 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 .
  • the fixation between the balloon 2 and the shaft 3 can be stabilized even when the balloon 2 is expanded.
  • wings 29 are formed in the expanded portion 20.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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 .
  • the shaft 3 has an outer tube 31 and an inner tube 32
  • 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.
  • blades 29 are formed so as to encircle the shaft 3 in the circumferential direction z in the contracted state of the balloon 2 .
  • 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.
  • 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.
  • the balloon 2 satisfies at least one of the following (1) and (2) in the deflated state.
  • 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
  • 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
  • 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.
  • the expansion part 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.
  • the expansion part 20 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.
  • 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 .
  • the proximal sleeve portion 21 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
  • the portion having the maximum diameter is in contact with the side surface of the first imaginary column C1.
  • 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.
  • 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.
  • 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.
  • Each virtual cylinder need not be circumscribed by the entire sleeve portion.
  • the distal end of the distal sleeve portion 22 may have a portion that does not circumscribe the second virtual cylinder C2.
  • the proximal end of the proximal sleeve portion 21 may have a portion that does not circumscribe the first imaginary column C1.
  • FIGS. 7 and 8 show an example of a virtual circle C 0 for a balloon 2 having three outer protrusions 60.
  • 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. 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.
  • the tip portion 61 may circumscribe the imaginary circle C 0 .
  • 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.
  • FIG. 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. 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 .
  • 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.
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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 .
  • 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.
  • the radius r 0 can be made smaller than at least one of the radius r 1 and radius r 2 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the main section 20m is a section having a certain diameter or more in the expanded state.
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • the expansion part 20 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.
  • the blades 29 may be firmly folded, and the outward protrusions 60 may be deformed in the circumferential direction z of the blades 20.
  • the radius r 0 can be made smaller more easily.
  • 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.
  • 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.
  • the outer protruding portion 60 extends around the blades 29 over the entire main section 20m of the expanded portion 20.
  • the radius r3 of the third imaginary cylinder C3 circumscribed by the main section 20m It can be smaller than at least one.
  • 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.
  • the distal end portion 61 circumscribes at least a portion of the side surface of the first imaginary column C1.
  • 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.
  • 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.
  • 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.
  • FIGS. 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.
  • 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.
  • the sleeve portion may have a configuration in which a plurality of outer projecting portions 60 are spaced apart in the circumferential direction z.
  • 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.
  • 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.
  • the vane 29 can be configured to circumscribe the virtual circle C 0 .
  • 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.
  • 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.
  • 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.
  • the dilation portion 20 has wings 29 and the outer protrusions 60 are located outside the wings 29 .
  • 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.
  • 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.
  • 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
  • FIG. 18 represents a cross-sectional view showing another example of the cross-sectional view shown in FIG.
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the radius r 3 of the three virtual cylinders C 3 is preferably smaller than the radius r 3 of the three virtual cylinders C 3 .
  • the entire main section 20m of the expanded portion 20 can be made less likely to come into contact with the body cavity wall.
  • 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.
  • an elastomer resin from the viewpoint of thinning and flexibility of the balloon body 27 .
  • 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.
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • the shaft 3 and the hub 4 are 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.
  • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un ballonnet qui peut améliorer la traçabilité et protéger la partie d'expansion du ballonnet pendant le transport du ballonnet dans un état contracté à l'intérieur d'une cavité corporelle.　Un ballonnet (2) pour cathéter à ballonnet présente un corps principal de ballonnet (27) et une partie saillante extérieure (60) et satisfait les points (1) et/ou (2) ci-dessous lorsque le ballonnet (2) se trouve dans un état contracté.　(1) Le rayon r1d'un premier cylindre imaginaire C1 circonscrit par une partie manchon proximale (21) est supérieur au rayon r0 d'un cercle imaginaire C0 circonscrit par une partie d'expansion (20) au centre (20c) de la partie d'expansion (20).　(2) Le rayon r2 d'un second cylindre imaginaire C2 circonscrit par une partie manchon distale (22) est plus grand que le rayon r0 du cercle imaginaire C0 circonscrit par la partie d'expansion (20) au centre (20c) de la partie d'expansion (20).
PCT/JP2021/042156 2021-01-21 2021-11-17 Ballonnet pour cathéter à ballonnet WO2022158100A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202180088986.0A CN116782844A (zh) 2021-01-21 2021-11-17 球囊导管用球囊
JP2022576998A JPWO2022158100A1 (fr) 2021-01-21 2021-11-17

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021-008307 2021-01-21
JP2021008307 2021-01-21

Publications (1)

Publication Number Publication Date
WO2022158100A1 true WO2022158100A1 (fr) 2022-07-28

Family

ID=82548690

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2021/042156 WO2022158100A1 (fr) 2021-01-21 2021-11-17 Ballonnet pour cathéter à ballonnet

Country Status (3)

Country Link
JP (1) JPWO2022158100A1 (fr)
CN (1) CN116782844A (fr)
WO (1) WO2022158100A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024106082A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet
WO2024106081A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et méthode de fabrication de cathéter à ballonnet
WO2024106084A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet et cathéter à ballonnet
WO2024106080A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet
WO2024106078A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet
WO2024106083A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, et cathéter à ballonnet
WO2024106079A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014147585A (ja) * 2013-02-01 2014-08-21 Asahi Intecc Co Ltd バルーンカテーテル
WO2020012850A1 (fr) * 2018-07-09 2020-01-16 株式会社グッドマン Cathéter à ballonnet
WO2020012851A1 (fr) * 2018-07-09 2020-01-16 株式会社グッドマン Cathéter à ballonnet

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014147585A (ja) * 2013-02-01 2014-08-21 Asahi Intecc Co Ltd バルーンカテーテル
WO2020012850A1 (fr) * 2018-07-09 2020-01-16 株式会社グッドマン Cathéter à ballonnet
WO2020012851A1 (fr) * 2018-07-09 2020-01-16 株式会社グッドマン Cathéter à ballonnet

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024106082A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet
WO2024106081A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et méthode de fabrication de cathéter à ballonnet
WO2024106084A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet et cathéter à ballonnet
WO2024106080A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet
WO2024106078A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet
WO2024106083A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, et cathéter à ballonnet
WO2024106079A1 (fr) * 2022-11-16 2024-05-23 株式会社カネカ Ballonnet pour cathéter à ballonnet, cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet

Also Published As

Publication number Publication date
JPWO2022158100A1 (fr) 2022-07-28
CN116782844A (zh) 2023-09-19

Similar Documents

Publication Publication Date Title
WO2022158100A1 (fr) Ballonnet pour cathéter à ballonnet
WO2022102766A1 (fr) Ballonnet pour cathéter à ballonnet
US20060135980A1 (en) Balloon with stepped sections and implements
US20220304718A1 (en) Balloon catheter
US10632291B2 (en) Medical elongated body
WO2018008514A1 (fr) Sonde à ballonnet.
CN115317766A (zh) 刀片隐藏式切割球囊导管
US10391283B2 (en) Balloon catheter and stent delivery system
WO2020195170A1 (fr) Cathéter à ballonnet
WO2020255923A1 (fr) Cathéter à ballonnet
WO2022196166A1 (fr) Ballonnet pour cathéter à ballonnet
WO2022137763A1 (fr) Ballonnet pour cathéter à ballonnet
US20240050712A1 (en) Balloon for balloon catheter
WO2023079906A1 (fr) Ballonnet pour cathéter à ballonnet
WO2023080063A1 (fr) Ballonnet pour cathéter à ballonnet
JP2023069922A (ja) バルーンカテーテル用バルーン
WO2024106402A1 (fr) Ballonnet de cathéter à ballonnet, cathéter à ballonnet équipé de celui-ci, et procédé de fabrication de cathéter à ballonnet
JP7234462B2 (ja) バルーンカテーテル用バルーン
JP2023070376A (ja) バルーンカテーテル
WO2024106176A1 (fr) Ballonnet pour cathéter à ballonnet, cathéter à ballonnet équipé de celui-ci et procédé de fabrication de cathéter à ballonnet
WO2023085112A1 (fr) Cathéter à ballonnet
JP7465696B2 (ja) バルーンカテーテル
WO2022264744A1 (fr) Cathéter à ballonnet
CN118176041A (zh) 球囊导管用球囊
JP2024140204A (ja) バルーンカテーテル用バルーン及びそれを備えるバルーンカテーテル、並びにバルーンカテーテルの製造方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21921203

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2022576998

Country of ref document: JP

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 202180088986.0

Country of ref document: CN

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21921203

Country of ref document: EP

Kind code of ref document: A1