WO2023085150A1 - バルーンカテーテル - Google Patents

バルーンカテーテル Download PDF

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Publication number
WO2023085150A1
WO2023085150A1 PCT/JP2022/040652 JP2022040652W WO2023085150A1 WO 2023085150 A1 WO2023085150 A1 WO 2023085150A1 JP 2022040652 W JP2022040652 W JP 2022040652W WO 2023085150 A1 WO2023085150 A1 WO 2023085150A1
Authority
WO
WIPO (PCT)
Prior art keywords
section
balloon
proximal
tapered
peak intensity
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2022/040652
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
真弘 小嶋
崇亘 ▲濱▼淵
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kaneka Corp
Original Assignee
Kaneka Corp
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 Kaneka Corp filed Critical Kaneka Corp
Priority to CN202280017511.7A priority Critical patent/CN116916997B/zh
Priority to JP2023521801A priority patent/JP7305904B1/ja
Priority to US18/708,042 priority patent/US20250256072A1/en
Publication of WO2023085150A1 publication Critical patent/WO2023085150A1/ja
Priority to JP2023105123A priority patent/JP2023120410A/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • the present invention relates to balloon catheters.
  • angina pectoris and myocardial infarction may be caused by the formation of a hardened narrowed part due to calcification etc. on the inner wall of the blood vessel.
  • One of the treatments for such diseases is angioplasty in which a balloon catheter is used to dilate the stenosis.
  • a balloon catheter used in such angioplasty has projections, blades, etc. for cutting into the hardened stenosis.
  • a first protrusion provided on the outer surface of a balloon and extending linearly along the outer surface of the balloon is provided.
  • a balloon catheter is disclosed.
  • U.S. Pat. No. 5,400,001 also discloses a ridge disposed along the outer surface of the balloon and secured to the outer surface of the balloon in the region of the joint and comprising an expansion element and a connector, the expansion element extending away from the outer surface of the balloon. and characterized by a second effective width, the connector connecting the expansion element to the outer surface of the balloon at the junction and characterized by a first effective width less than the second effective width of the expansion element. and a balloon catheter is disclosed.
  • the present invention has been made in view of the above-mentioned problems, and its object is to provide a balloon catheter that facilitates fine adjustment of the position of a balloon in a hardened stenosis in a blood vessel and that facilitates cutting into the stenosis. is to provide
  • a balloon catheter that can solve the above problems is as follows. [1] a shaft having a distal portion and a proximal portion; a balloon located at the distal portion of the shaft and having a straight section and at least one tapered section; The balloon has a wing-shaped portion that is wing-shaped in a contracted state, and has a protrusion on the outer surface, In the cross section perpendicular to the axial direction of the straight pipe portion and the cross section perpendicular to the axial direction of the taper portion, the direction from the top of the protrusion toward the center of the shaft is the Y direction, and the direction is perpendicular to the Y direction.
  • I mc is the value of Ia/Ib at the center in the circumferential direction of the proximal end of the protrusion in the straight pipe portion, and Itc is the proximal end of the protrusion in the tapered portion. is the value of Ia/Ib at the center in the circumferential direction.
  • Ia is the ratio of the peak intensity at the wave number of 1640 ⁇ 10 cm ⁇ 1 in the X direction to the peak intensity at the wave number of 1640 ⁇ 10 cm ⁇ 1 in the Y direction
  • Ib is the wave number in the X direction of 1440 ⁇ 10 cm ⁇ 1 . It is the ratio of the peak intensity of 1 to the peak intensity of the wave number 1440 ⁇ 10 cm ⁇ 1 in the Y direction.
  • the central portion in the circumferential direction of the base end portion of the protrusion in the straight pipe portion is a portion with excellent rigidity due to the large orientation of the higher-order structure.
  • the projecting portion is less likely to be buried inside the balloon when a cut is made in the stenotic portion.
  • the central portion in the circumferential direction of the proximal end portion of the protrusion in the tapered portion becomes a portion having relatively small orientation and moderate flexibility.
  • the balloon catheter according to the embodiment of the present invention preferably has any one of the following [2] to [5]. [2] The balloon catheter according to [1], wherein the scattering intensity at each cross section measured by laser Raman spectroscopy satisfies the following formula (2).
  • Imp is the value of Ia/Ib at the top of the protrusion in the straight pipe section and Itp is the value of Ia/Ib at the top of the protrusion in the tapered section.
  • Imp is the value of Ia/Ib at the top of the protrusion in the straight pipe section
  • Itp is the value of Ia/Ib at the top of the protrusion in the tapered section.
  • Ic/Id is the value of Ic/Id at the top of the vane profile at the taper.
  • Ic is the ratio of the peak intensity at the wave number of 1640 ⁇ 10 cm ⁇ 1 in the X4 direction to the peak intensity at the wave number of 1640 ⁇ 10 cm ⁇ 1 in the Y4 direction
  • Id is the wave number of 1440 in the X4 direction. It is the ratio of the peak intensity of ⁇ 10 cm ⁇ 1 to the peak intensity of wavenumber 1440 ⁇ 10 cm ⁇ 1 in the Y4 direction.
  • Ic is the ratio of the peak intensity at the wave number of 1640 ⁇ 10 cm ⁇ 1 in the X4 direction to the peak intensity at the wave number of 1640 ⁇ 10 cm ⁇ 1 in the Y4 direction
  • Id is the wave number of 1440 in the X4 direction. It is the ratio of the peak intensity of ⁇ 10 cm ⁇ 1 to the peak intensity of wavenumber 1440 ⁇ 10 cm ⁇ 1 in the Y4 direction.
  • the at least one tapered portion is located on the proximal side of the straight pipe portion, and has a proximal tapered portion that decreases in diameter as it separates from the straight pipe portion, and
  • the balloon catheter according to any one of [1] to [5], further comprising a distal tapered portion located distally and having a diameter that decreases with increasing distance from the straight tube portion.
  • the balloon is located on the proximal side of the proximal tapered portion, and includes a proximal fixing portion fixed to the shaft and a distal side of the distal tapered portion.
  • a balloon catheter according to [6] having a distal anchor positioned and secured to the shaft.
  • FIG. 1 is a side view of a balloon catheter according to an embodiment
  • FIG. FIG. 2 is a cross-sectional view AA of the balloon catheter of FIG. 1 in a deflated state.
  • 3 is a cross-sectional view BB of the balloon catheter of FIG. 1 in an expanded state
  • FIG. FIG. 4 is a perspective view of a parison before expansion according to an embodiment
  • 5 is a radial cross-sectional view of the distal portion of the parison of FIG. 4
  • FIG. 6 is a radial cross-sectional view of the proximal portion of the parison of FIG. 4
  • FIG. FIG. 7 is a cross-sectional view of a modification of the cross-section of FIG. FIG.
  • FIG. 8 is a cross-sectional view of the parison of FIG. 7 after expansion;
  • FIG. 9 is a drawing-substituting photograph showing the state of the gypsum model after the balloon of Example 1 was expanded in the gypsum model and removed.
  • FIG. 10 is another drawing-substituting photograph showing the state of the gypsum model after the balloon of Example 1 was expanded in the gypsum model and removed.
  • FIG. 11 is a drawing-substituting photograph showing the state of the gypsum model after the balloon of Example 2 was expanded in the gypsum model and removed.
  • FIG. 12 is another drawing-substituting photograph showing the state of the gypsum model after the balloon of Example 2 was expanded in the gypsum model and removed.
  • a balloon catheter includes a shaft having a distal portion and a proximal portion, and a balloon located at the distal portion of the shaft and having a straight tube portion and at least one tapered portion.
  • the balloon has a wing-shaped portion that is wing-shaped in a contracted state, and has a protrusion on the outer surface, and has a cross section in a direction perpendicular to the axial direction of the straight pipe portion and a tapered portion.
  • Ia is the ratio of the peak intensity at the wave number of 1640 ⁇ 10 cm in the X direction to the peak intensity at the wave number of 1640 ⁇ 10 cm in the Y direction
  • Ib is the peak at the wave number of 1440 ⁇ 10 cm in the X direction. It is the ratio of the intensity to the peak intensity at wave number 1440 ⁇ 10 cm ⁇ 1 in the Y direction.
  • the center portion in the circumferential direction of the proximal end portion of the protrusion of the straight pipe portion has a high degree of orientation of the higher-order structure, and thus has excellent rigidity.
  • the projecting portion is less likely to be buried inside the balloon when a cut is made in the stenotic portion.
  • the central portion in the circumferential direction of the proximal end portion of the protruding portion of the tapered portion has a relatively small orientation and thus has moderate flexibility.
  • the protruding portion of the tapered portion is less likely to get caught in the constricted portion, making it easier to finely adjust the position of the balloon. That is, with the above configuration, it is possible to provide a balloon catheter that facilitates fine adjustment of the position of the balloon in the hardened stenotic portion of the blood vessel and facilitates making a cut in the stenotic portion.
  • FIG. 1 is a side view of an embodiment balloon catheter after balloon expansion.
  • FIG. 2 is a cross-sectional view AA of the balloon catheter of FIG. 1 in a deflated state prior to balloon expansion.
  • FIG. 3 is a cross-sectional view BB of the balloon catheter of FIG. 1 after balloon expansion.
  • the balloon catheter 1 has a shaft 3 having a distal portion 1B and a proximal portion 1A, and a straight tube portion 23 and tapered portions 22, 24 located at the distal portion 1B of the shaft 3.
  • Balloon catheter 1 is preferably configured such that fluid is supplied to the interior of balloon 2 through shaft 3 .
  • a balloon pressurizer can be used to control inflation and deflation of the balloon 2 .
  • the fluid may be a pressurized fluid pressurized by a pump or the like.
  • the shaft 3 preferably has a fluid channel inside. It is preferable that the shaft 3 further has an insertion passage for a linear body such as a guide wire.
  • the shaft 3 preferably has an outer tube 31 and an inner tube 32 at least a proximal portion of which is disposed within the outer tube 31 .
  • the inner tube 32 can function as an insertion path for the linear body, and the space between the inner tube 32 and the outer tube 31 can function as a fluid flow path.
  • inner tube 32 preferably extends from the distal end of outer tube 31 .
  • the distal side of the balloon 2 is fixed to the inner tube 32 and the proximal side of the balloon 2 is fixed to the outer tube 31 .
  • the straight pipe portion 23 preferably has approximately the same diameter in the axial direction a. Moreover, the straight tube portion 23 preferably has the maximum diameter inside the balloon 2 when inflated. Since the straight tube portion 23 has the maximum diameter, when the balloon 2 is expanded at a lesion such as a stenotic portion, the straight tube portion 23 comes into sufficient contact with the lesion and facilitates dilation of the lesion. can.
  • the balloon 2 has a proximal tapered portion 22 located proximal to the straight tube portion 23 and a distal tapered portion 24 located distal to the straight tube portion 23 . preferably. It is preferable that the proximal tapered portion 22 and the distal tapered portion 24 have a shape that decreases in diameter as it separates from the straight tube portion 23 . Proximal taper 22 and distal taper 24 facilitate movement of balloon 2 within the body cavity.
  • the balloon 2 may have either one of the proximal tapered portion 22 and the distal tapered portion 24 .
  • the balloon 2 has a proximal fixing portion 21 fixed to the shaft 3 proximally of the proximal tapered portion 22 and fixed to the shaft 3 distally of the distal tapered portion 24. It is preferred to have a distal fixation 25 that is held in place.
  • the shaft 3 has an outer tube 31 and an inner tube 32
  • at least part of the proximal fixing part 21 is fixed to the outer tube 31 and at least part of the distal fixing part 25 is fixed to the inner tube 32. It is preferably fixed.
  • the balloon 2 has wing-shaped portions 70 that are wing-shaped in a contracted state, and has projections 60 on the outer surface.
  • the vanes 70 preferably have portions of the inner surface of the balloon 2 that overlap each other when the balloon 2 is deflated. Further, it is preferable that the vane-shaped portion 70 is formed so as to be foldable, for example, using the top portion 71 as a crease.
  • the projecting portion 60 is provided on the outer surface of the balloon 2 .
  • the protrusion 60 can, for example, crack a calcified and hardened lesion to dilate the stricture.
  • the projecting portion 60 is preferably located in a portion other than the blade-shaped portion 70 as shown in FIGS. By locating the projecting portion 60 at a portion other than the vane-shaped portion 70, the vane-shaped portion 70 and the projecting portion 60 are arranged at different positions in the circumferential direction of the deflated balloon 2, and the vane-shaped portion 70 of the balloon 2 is arranged. The outer diameter of the balloon 2 can be reduced when folded.
  • the maximum radial length of the projecting portion 60 is preferably 1.2 times or more, more preferably 1.5 times or more, and still more preferably 2 times or more the film thickness of the balloon body 20 . As a result, it becomes easier to cut into the narrowed portion to an appropriate depth.
  • the maximum radial length of the protrusion 60 may be 100 times or less, 50 times or less, 30 times or less, or 10 times or less.
  • the radial length of the projecting portion 60 may be different or the same in the axial direction a.
  • the shape of the protruding portion 60 in cross section AA and cross section BB is preferably triangular, trapezoidal, semicircular, or semielliptical. More preferably, the cross-sectional shape is a single-step tapered shape having only one tapered portion that tapers in the direction from the center 3 a of the shaft 3 toward the top portion 61 of the projecting portion 60 .
  • the protruding portion 60 is preferably provided on at least one of the proximal taper portion 22 and the distal taper portion 24, and on the straight tube portion 23. 22, the distal tapered portion 24, and the straight tube portion 23, and the proximal fixing portion 21, the proximal tapered portion 22, the straight tube portion 23, the distal tapered portion 24, and the distal side fixing portion 25 is more preferably provided.
  • the number of protrusions 60 may be one or plural.
  • the plurality of projecting portions 60 are preferably spaced apart in the circumferential direction, and more preferably arranged at equal intervals in the circumferential direction.
  • the projecting portion 60 preferably extends in the axial direction a on the outer surface of the balloon body 20, as shown in FIG. This makes it easier to incise the constriction straight.
  • the projecting portion 60 may be arranged at different positions in the axial direction a in the circumferential direction, for example, spirally around the outer surface of the balloon body 20 in the circumferential direction. As a result, the constriction can be obliquely incised.
  • I mc is the value of Ia/Ib at the circumferential central portion 62 of the proximal end portion of the projecting portion 60 in the straight pipe portion 23, and Itc is the value of the projecting portion 60 in the tapered portions 22 and 24. It is the value of Ia/Ib at the center portion 62 in the circumferential direction of the proximal portion.
  • Ia is the ratio of the peak intensity at the wave number of 1640 ⁇ 10 cm in the X direction to the peak intensity at the wave number of 1640 ⁇ 10 cm in the Y direction
  • Ib is the peak at the wave number of 1440 ⁇ 10 cm in the X direction. It is the ratio of the intensity to the peak intensity at wave number 1440 ⁇ 10 cm ⁇ 1 in the Y direction.
  • the peak at a wave number of 1440 ⁇ 10 cm -1 is a peak derived from the CH structure.
  • I mc is preferably 1.1 times or more, more preferably 1.2 times or more , even more preferably 1.3 times or more, as much as Itc.
  • I mc is preferably 5 times or less of Itc , more preferably 3 times or less, and even more preferably 2 times or less. This makes it easier to manufacture the balloon 2 .
  • both the proximal side taper section 22 and the distal side taper section 24 satisfy the above formula (1), but only one of the taper sections may satisfy the above formula (1).
  • the dashed line is a virtual line segment indicating the base edge of the protrusion 60, and the central portion 62 of the protrusion 60 is on the virtual line segment and extends from both ends of the virtual line segment. It is preferably located in a region more than 1/4 of the length of , and more preferably located at the center point of the imaginary line segment.
  • the scattering intensity at each cross section measured by laser Raman spectroscopy preferably satisfies the following formula (2).
  • Ime is the value of Ia/Ib at one end 63 in the circumferential direction of the proximal end of the protrusion 60 in the straight tube portion 23, and Ite is the value of the protrusion 60 in the tapered parts 22 and 24. It is the value of Ia/Ib at one circumferential end 63 of the proximal end.
  • Ia and Ib are the same as above.
  • one end 63 in the circumferential direction of the proximal end of the projecting portion 60 in the straight tube portion 23 has a higher orientation of the higher-order structure and becomes a portion with excellent rigidity.
  • the part 60 becomes even more difficult to be buried inside the balloon.
  • one end portion 63 in the circumferential direction of the base end portion of the protruding portion 60 of the tapered portions 22 and 24 has a relatively small orientation, and as a result, it becomes a portion having moderate flexibility, and as a result, it tapers in a constricted portion having a complicated shape. Since the protruding portions 60 of the portions 22 and 24 are less likely to get caught, fine adjustment of the position of the balloon 2 can be made easier.
  • I me is preferably 1.1 times or more, more preferably 1.2 times or more, I te .
  • I me is preferably 5 times or less of I te , more preferably 3 times or less, and even more preferably 2 times or less. This makes it easier to manufacture the balloon 2 .
  • both circumferential ends of the proximal end of the projecting portion 60 satisfy the above formula (2).
  • both the proximal side taper section 22 and the distal side taper section 24 satisfy the above formula (2), but only one of the taper sections may satisfy the above formula (2).
  • the dashed line is a virtual line segment indicating the base edge of the protrusion 60, and one end 63 of the protrusion 60 is on the virtual line segment and extends from one end of the virtual line segment to the virtual line segment. It is preferably positioned within a quarter of the length of , and more preferably positioned at one end of the imaginary line segment.
  • the scattering intensity at each cross section measured by laser Raman spectroscopy preferably satisfies the following formula (3).
  • Imp is the value of Ia/Ib at the top portion 61 of the protrusion 60 in the straight pipe portion 23
  • Itp is the value of Ia/Ib at the top portion 61 of the protrusion 60 in the tapered portions 22 and 24. is.
  • Ia and Ib are the same as above.
  • Imp is larger than Itp , the orientation of the higher-order structure of the top portion 61 of the projecting portion 60 in the straight tube portion 23 is increased, resulting in a portion having excellent rigidity. As a result, it becomes easier to make a cut in the hardened narrowed portion.
  • I tp is lower than I mp , the apex 61 of the projecting portion 60 in the tapered portions 22 and 24 is less likely to get caught in the stenotic portion, thus facilitating fine adjustment of the position of the balloon 2 . Therefore, I mp is preferably 1.01 times or more, more preferably 1.02 times or more, I tp .
  • Imp is preferably 3 times or less than Itp , more preferably 2 times or less. This makes it easier to manufacture the balloon 2 . Further, it is more preferable that both the proximal side taper section 22 and the distal side taper section 24 satisfy the above formula (3), but only one of the taper sections may satisfy the above formula (3).
  • each cross section measured by laser Raman spectroscopy, where the direction from the top portion 71 of the blade-shaped portion 70 to the center 3a of the shaft 3 is the X4 direction, and the direction perpendicular to the X4 direction is the Y4 direction.
  • the scattering intensity at preferably satisfies the following formula (4).
  • I tc ⁇ I tq (4) [In the formula, Itc is the same as above. Itq is the value of Ic/Id at the top 71 of the vane 70 in the tapered portions 22,24.
  • Ic is the ratio of the peak intensity at wave number 1640 ⁇ 10 cm ⁇ 1 in X4 direction to the peak intensity at wave number 1640 ⁇ 10 cm ⁇ 1 in Y4 direction
  • Id is the wave number 1440 ⁇ 10 cm ⁇ 1 in X4 direction
  • magnification may be 0.1 times or more, or may be 0.5 times or more.
  • both the proximal side taper portion 22 and the distal side taper portion 24 satisfy the above formula (4), but only one of the taper portions may satisfy the above formula (4).
  • each cross section measured by laser Raman spectroscopy, where the direction from the top portion 71 of the blade-shaped portion 70 to the center 3a of the shaft 3 is the X4 direction, and the direction perpendicular to the X4 direction is the Y4 direction.
  • the scattering intensity at preferably satisfies the following formula (5).
  • I mc >I mq (5) [In the formula, Imc is the same as above.
  • I mq is the value of Ic/Id at the top portion 71 of the vane-shaped portion 70 in the straight pipe portion.
  • Ic is the ratio of the peak intensity at wave number 1640 ⁇ 10 cm ⁇ 1 in X4 direction to the peak intensity at wave number 1640 ⁇ 10 cm ⁇ 1 in Y4 direction
  • Id is the wave number 1440 ⁇ 10 cm ⁇ 1 in X4 direction
  • I mc is preferably at least 1.01 times I mq , more preferably at least 1.02 times, even more preferably at least 1.03 times.
  • the magnification may be 3 times or less, or may be 2 times or less.
  • the scattering intensity at each cross section measured by laser Raman spectroscopy preferably satisfies the following formula (6).
  • I mc /I tc I me /I te (6)
  • I mc , Itc , I me , and I te are the same as above.
  • I mc /I tc is preferably at least 1.01 times I me /I te , more preferably at least 1.02 times.
  • the magnification is preferably 3 times or less, more preferably 2 times or less. This makes it easier to manufacture the balloon 2 .
  • both the proximal tapered portion 22 and the distal tapered portion 24 satisfy the above formula (6), but only one of the tapered portions may satisfy the above formula (6). It is more preferable that both circumferential ends of the proximal end of the projecting portion 60 satisfy the above formula (6).
  • the length of the region satisfying the above formulas (1) to (6) in the axial direction a is not particularly limited. It is preferably 1/15 or more, more preferably 1/12 or more.
  • Formulas (1) to (6) refer to formula (1); or formula (2), formula (3), formula (4), formula (5), formula (6), or a combination thereof and formula (1) means In the above region, formula (1); or formula (2), formula (3), formula (4), formula (5), or a combination thereof and formula (1) are preferably satisfied, and formula (1); More preferably, (1) and formula (2); formula (1) and formula (3); or formula (1) and formula (2) and formula (3) are satisfied.
  • the balloon 2 preferably contains resin, rubber, or a mixture thereof, and is more preferably made of resin, rubber, or a mixture thereof.
  • resins include polyamide resins such as polyamide elastomers such as polyamides and polyether block amide copolymers; polyester resins such as polyethylene terephthalate and polyester elastomers; polyurethane resins such as polyurethanes and polyurethane elastomers; Resins containing O units are preferred. Elastomers are more preferred among these resins.
  • the balloon 2 may contain other resins such as polyphenylene sulfide resins, fluororesins, silicone resins, and polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymers.
  • resins such as polyphenylene sulfide resins, fluororesins, silicone resins, and polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymers.
  • rubber include natural rubber such as latex rubber. These may use only 1 type and may use 2 or more types together.
  • polyamide resins, polyester resins, polyurethane resins, or mixtures thereof are more preferred, polyamide resins, polyurethane resins, or mixtures thereof are more preferred, polyamide resins are even more preferred, and polyether block amide copolymers are preferred. Especially preferred. As a result, it is possible to easily form a portion having a high orientation of the higher-order structure.
  • the projecting portion 60 is preferably made of the same material as the balloon body 20 . As a result, while maintaining the flexibility of the balloon 2 , the projecting portion 60 is less likely to damage the outer surface of the balloon body 20 . It is preferable that the balloon main body 20 and the projecting portion 60 are integrally molded. This can prevent the projecting portion 60 from falling off from the balloon body 20 .
  • the balloon 2 can be manufactured, for example, using a parison 200 made of resin and having a thick portion 220 extending in the axial direction a as shown in FIG.
  • the parison 200 can be manufactured by placing it in the lumen of a mold and blow molding it. More specifically, the balloon 2 is prepared, for example, by placing the parison 200 in the lumen of a mold, allowing the thickened portion 220 of the parison 200 to enter a groove of a predetermined shape in the mold, and allowing the fluid to enter the lumen 210 of the parison 200 . can be formed by introducing and expanding the parison 200 while heating.
  • the width and height of the projecting portion 60 can be adjusted by the thickness of the thick portion 220 of the parison 200 and the depth and shape of the mold groove.
  • fluids include air, nitrogen, water, and the like.
  • the parison 200 may be stretched in the axial direction a before the expansion.
  • the step of inflating the parison 200 may be performed only once or may be performed multiple times. If the expansion step is performed multiple times, a different mold may be used for each expansion.
  • the thick portion 220 at the distal portion 200B of the parison 200 as shown in FIG.
  • a second tapered portion 222 that tapers in a direction from the lumen 210 toward the top of the thick portion 220 is preferably provided. Since the parison 200 has the two-step tapered portion, tension is easily applied to the first tapered portion 221 during blow molding. Orientation can be increased.
  • FIG. 5 shows the parison having the two-step tapered portion at the distal portion 200B of the parison 200, the portion having the two-step tapered portion is not limited to the distal portion 200B.
  • a parison 200 having a two-step tapered portion at least in part can be used corresponding to a portion in the straight pipe portion 23 where a portion having excellent rigidity is desired to be provided.
  • the two-step tapered shape of the parison 200 When performing blow molding, it is preferable to eliminate the two-step tapered shape of the parison 200 and form the one-step tapered protruding portion 60 . This makes it possible to further increase the orientation of the protruding portion 60 in the vicinity of the central portion 62 of the base end thereof.
  • the first tapered portion 221 of the parison 200 is not fitted into the groove in the inner cavity of the mold, and only the second tapered portion 222 is fitted into the groove before blow molding. should be done.
  • the groove is preferably a V-shaped groove.
  • the width W1 of the base end portion of the first taper portion 221 is preferably 1.5 times or more, more preferably 2.0 times or more, the width W2 of the base end portion of the second taper portion 222. This makes it easier to apply tension to the first tapered portion 221 during blow molding.
  • the magnification may be 10 times or less, or 5 times or less.
  • the height h1 of the first taper portion 221 is preferably 0.9 times or less, and more preferably 0.8 times or less, the height h2 of the second taper portion 222. This makes it easier to apply tension to the first tapered portion 221 during blow molding.
  • the magnification may be 0.1 times or more, or 0.2 times or more.
  • the thick portion 220 of the proximal portion 200A of the parison 200 preferably has a one-step tapered shape as shown in FIGS.
  • the proximal portion 200A of the parison 200 should form at least part of the proximal side tapered portion 22 of the balloon 2 .
  • a portion of the distal portion 200B of the parison 200 is tapered by one step to form the distal tapered portion 24. You should do it like this.
  • 8 is a cross-sectional view of the parison 200 of FIG. 7 after being expanded, and the projecting portion 60 may have an irregular shape as shown in FIG.
  • the shaft 3 preferably contains resin, rubber, or a mixture thereof.
  • resins and rubbers include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluororesins, vinyl chloride resins, silicone resins, and natural rubbers. These may use only 1 type and may use 2 or more types together. Among these, it is preferable to include a polyamide resin, a polyolefin resin, a fluororesin, a mixture thereof, or a laminate obtained by laminating these resin layers. As a result, it is possible to improve the insertability of the balloon catheter 1 in the body cavity while improving the lubricity of the surface of the shaft 3 .
  • Methods for fixing the balloon 2 to the shaft 3 include bonding with an adhesive, welding, and fixing by caulking a ring-shaped member.
  • the shaft 3 may include a metal tube, a single wire or a plurality of wires, a stranded wire, or the like.
  • the balloon catheter 1 may have a hub 4 on the proximal side of the shaft 3, as shown in FIG.
  • the hub 4 may have a fluid injection section 7 in communication with the flow path of the fluid supplied to the inside of the balloon 2, a guide wire insertion section 5 in communication with the insertion passage of the guide wire, and the like.
  • This makes it possible to easily perform an operation to expand the balloon 2 by supplying fluid to the inside of the balloon 2 and an operation to deliver the balloon 2 to the treatment site along the guide wire.
  • the balloon catheter 1 is preferably of a so-called over-the-wire type in which a guide wire as shown in FIG. It may be a so-called rapid exchange type in which the guide wire is inserted halfway to the end.
  • Example 1 By extrusion molding using a polyamide elastomer (PEBAX (registered trademark) 7233) manufactured by ARKEMA, a tubular portion having an inner diameter of 0.50 mm, an outer diameter of 1.00 mm, an axial length of 300 mm, and a thick portion A parison, which is a tube for making balloons, was produced.
  • the thick part of the parison has a first one-step tapered part, a two-step tapered part, and a second one-step tapered part in order from the proximal end to the distal end,
  • the dimensions are as follows.
  • Width of base end of taper 0.3 mm Height of tapered part: 0.5mm Length in axial direction a: 5mm ⁇ Two-stage tapered portion (straight pipe portion 23 forming portion) Width (W1) of base end of first tapered portion: 1.0 mm Width (W2) of the proximal end of the second tapered portion: 0.5 mm Height of first taper portion (h1): 0.2 mm Height of second taper portion (h2): 0.3 mm Length in axial direction a: 10mm ⁇ Second two-stage tapered portion (distal side taper portion 24, distal side fixing portion 25 forming portion) Width of base end of taper: 0.5 mm Height of tapered part: 0.5mm Length in axial direction a: 5mm
  • the parison 200 was then placed in the mold cavity.
  • the mold has lumens and V-shaped grooves having the following dimensions in the portions corresponding to the respective portions of the balloon 2 .
  • ⁇ Lume diameter of the part forming the proximal side fixing part 21 1.0 mm
  • Axial length: 5mm ⁇ Lume of the portion forming the proximal side taper portion 22 Diameter of the proximal end: 1.0 mm Distal end diameter: 2.75mm
  • the parison 200 was subjected to biaxial stretch blow molding at 100° C. to produce the balloon 2 .
  • the proximal tapered portion 22 and the straight tube portion 23 of the balloon 2 are cut, and the obtained sample is embedded in resin, and then a cross section for observation is prepared using a Leica frozen ultramicrotome (UC6), Using a Raman spectrometer, wavenumbers of 1630 to 1650 cm ⁇ 1 in the X and Y directions at each of the top portion 61 of the protrusion 60 , the center portion 62 in the circumferential direction of the base end portion, and the one end portion 63 in the circumferential direction of the base end portion were measured. and peak intensities of the peaks present in the wave number range of 1430 to 1450 cm -1 were obtained. Details of the measurement are as follows.
  • Raman spectrometer in Via TM Qontor manufactured by Renishaw
  • Microscope Model DM2700 manufactured by Leica Microsystems Objective lens: ⁇ 100 Beam diameter: 1 ⁇ m Laser power: 100% Exposure time: 30 seconds Accumulation times: 1
  • Light source Semiconductor laser 532 nm
  • balloon 2 satisfied formula (1).
  • the projecting portion 60 bit into the gypsum model.
  • FIGS. After deflating the balloon and removing it from the inside of the model, as shown in FIGS.
  • the projecting portion 60 of the straight tube portion 23 was difficult to be buried inside the balloon 2 .
  • the central portion 62 of the proximal end portion of the projecting portion 60 in the proximal side taper portion 22 and the distal side taper portion 24 was relatively flexible, the gypsum model simulating the narrowed portion before the dilation was performed. When the balloon 2 was moved inside, it could be inserted and removed smoothly without being caught.
  • Example 2 Extrusion molding was performed using a polyamide elastomer (Rilsamid (registered trademark) PA12) manufactured by ARKEMA, except that the width (W1) of the base end of the first tapered portion of parison 200 was set to 0.7 mm.
  • a balloon was produced in the same manner as in Example 1, the peak strength of each part was determined, and I mp , I mc , I me , I tp according to the above (1) to (6) according to the above (1) to (6). , Itc and I te were calculated. Table 2 shows the results.
  • the balloon of Example 2 satisfied formula (1).
  • this balloon was fixed to the shaft and expanded within the gypsum model, the projecting portion bit into the gypsum model. Furthermore, after deflating the balloon and removing it from the inside of the model, as shown in FIGS. In this way, the protruding portion of the straight tube portion was difficult to be buried inside the balloon.
  • the balloon since the central portion of the proximal end of the protrusion in the proximal and distal tapers was relatively flexible, the balloon was placed in a gypsum model simulating the stenosis prior to dilation. When I moved it, I was able to smoothly insert and remove it without getting caught.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/JP2022/040652 2021-11-09 2022-10-31 バルーンカテーテル Ceased WO2023085150A1 (ja)

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CN202280017511.7A CN116916997B (zh) 2021-11-09 2022-10-31 球囊导管
JP2023521801A JP7305904B1 (ja) 2021-11-09 2022-10-31 バルーンカテーテル
US18/708,042 US20250256072A1 (en) 2021-11-09 2022-10-31 Balloon catheter
JP2023105123A JP2023120410A (ja) 2021-11-09 2023-06-27 バルーンカテーテル

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014057793A (ja) * 2012-09-19 2014-04-03 Kaneka Corp バルーンカテーテル用バルーン
WO2020195697A1 (ja) * 2019-03-28 2020-10-01 株式会社カネカ バルーンカテーテル
WO2020250611A1 (ja) * 2019-06-11 2020-12-17 株式会社カネカ バルーンカテーテル用のバルーンおよびバルーンカテーテルの製造方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006340914A (ja) * 2005-06-09 2006-12-21 Sekisui Chem Co Ltd バルーンカテーテル
GB2494395B (en) * 2011-09-02 2014-01-08 Cook Medical Technologies Llc Ultrasonically visible scoring balloon
JP6304711B2 (ja) * 2014-11-18 2018-04-04 日本ライフライン株式会社 バルーンカテーテル
CN111542364B (zh) * 2017-12-27 2022-07-15 株式会社钟化 导管及其制造方法
US12268829B2 (en) * 2019-03-28 2025-04-08 Kaneka Corporation Balloon catheter
JPWO2024071115A1 (https=) * 2022-09-29 2024-04-04

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014057793A (ja) * 2012-09-19 2014-04-03 Kaneka Corp バルーンカテーテル用バルーン
WO2020195697A1 (ja) * 2019-03-28 2020-10-01 株式会社カネカ バルーンカテーテル
WO2020250611A1 (ja) * 2019-06-11 2020-12-17 株式会社カネカ バルーンカテーテル用のバルーンおよびバルーンカテーテルの製造方法

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CN116916997A (zh) 2023-10-20
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