CN116963799A - Balloon catheter - Google Patents
Balloon catheter Download PDFInfo
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- CN116963799A CN116963799A CN202280017486.2A CN202280017486A CN116963799A CN 116963799 A CN116963799 A CN 116963799A CN 202280017486 A CN202280017486 A CN 202280017486A CN 116963799 A CN116963799 A CN 116963799A
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- balloon
- balloon catheter
- straight tube
- distal
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- 238000001069 Raman spectroscopy Methods 0.000 claims abstract description 17
- 230000003247 decreasing effect Effects 0.000 claims description 2
- 210000004204 blood vessel Anatomy 0.000 abstract description 6
- 239000011505 plaster Substances 0.000 description 18
- 229920005989 resin Polymers 0.000 description 16
- 239000011347 resin Substances 0.000 description 16
- 239000012530 fluid Substances 0.000 description 11
- 229920001971 elastomer Polymers 0.000 description 9
- 238000003780 insertion Methods 0.000 description 8
- 230000037431 insertion Effects 0.000 description 8
- 208000031481 Pathologic Constriction Diseases 0.000 description 7
- 238000000071 blow moulding Methods 0.000 description 7
- 230000003902 lesion Effects 0.000 description 7
- -1 e.g. Polymers 0.000 description 5
- 239000000806 elastomer Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 229920006122 polyamide resin Polymers 0.000 description 5
- 239000004952 Polyamide Substances 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 229920002647 polyamide Polymers 0.000 description 4
- 229920002614 Polyether block amide Polymers 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 229920001225 polyester resin Polymers 0.000 description 3
- 239000004645 polyester resin Substances 0.000 description 3
- 229920005672 polyolefin resin Polymers 0.000 description 3
- 229920005749 polyurethane resin Polymers 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 244000043261 Hevea brasiliensis Species 0.000 description 2
- 229910000831 Steel Inorganic materials 0.000 description 2
- 238000002399 angioplasty Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 229920003052 natural elastomer Polymers 0.000 description 2
- 229920001194 natural rubber Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 229920002050 silicone resin Polymers 0.000 description 2
- 239000010959 steel Substances 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004734 Polyphenylene sulfide Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004960 Rilsamid Substances 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003570 air Substances 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
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- 230000001186 cumulative effect Effects 0.000 description 1
- 239000011737 fluorine Substances 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 230000009477 glass transition Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 229920000126 latex Polymers 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
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- 229920001155 polypropylene Polymers 0.000 description 1
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- 229920003225 polyurethane elastomer Polymers 0.000 description 1
- 239000004065 semiconductor Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
-
- 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
Abstract
Provided is a balloon catheter which is easy to introduce an incision into a hardened stenosed portion in a blood vessel. The balloon catheter has: a shaft having a distal portion and a proximal portion; and a balloon located at a distal portion of the shaft and having a straight tube portion, the balloon having a blade-shaped portion in a contracted state and having a protruding portion on an outer surface, wherein, in a cross section of the straight tube portion in a direction perpendicular to the axial direction, when a direction from a top of the protruding portion toward a center of the shaft is a Y direction and a direction perpendicular to the Y direction is an X direction, scattering intensity of each portion of the cross section measured by a laser raman spectroscopy satisfies the following formula (1). I 2 >I 1 … (1) [ formula I 1 Is the value of Ia/Ib at the top of the protrusion, I 2 Is the value of Ia/Ib of the central part of the base end part of the protruding part in the circumferential direction. Wherein Ia is the wave number 1640.+ -.10 cm in the X direction ‑1 Peak intensity is 1640.+ -.10 cm with respect to wave number in Y direction ‑1 Ib is the wave number 1440.+ -.10 cm in the X direction ‑1 Peak intensity of 1440.+ -.10 cm relative to wave number in Y direction ‑1 Is the ratio of the peak intensities of (a).]。
Description
Technical Field
The present application relates to balloon catheters.
Background
There are cases where a stenosed portion hardened by calcification or the like is formed on the inner wall of a blood vessel, and diseases such as angina pectoris and myocardial infarction are caused. As one of treatments for such diseases, there is an angioplasty in which a balloon catheter is used to dilate a stricture. Balloon catheters used in such angioplasty have a protrusion, braid, etc. for introducing an incision by biting into a hardened stricture.
For example, patent document 1 discloses a balloon catheter including a protruding portion protruding from an outer surface of a balloon and extending linearly along the outer surface, the protruding portion including a first protruding portion disposed in a straight tube portion and a second protruding portion disposed in a tapered portion on a distal end side, at least a part of the second protruding portion in a longitudinal direction being a high protruding portion having a larger protruding amount from the outer surface than the first protruding portion.
Patent document 2 discloses a balloon catheter including a bulge portion disposed along an outer surface of a balloon, the bulge portion being fixed to the outer surface of the balloon in a joint portion region, the balloon catheter including an expansion element extending in a direction away from the outer surface of the balloon and characterized by a second effective width, and a connector connecting the expansion element to the outer surface of the balloon at the joint portion and characterized by a first effective width smaller than the second effective width of the expansion element.
Patent document 1: international publication No. 2020/0126850
Patent document 2: japanese patent application publication No. 2011-513031
Disclosure of Invention
In the conventional balloon catheter, since the protruding portion having a high rigidity derived from the shape, the woven layer of metal having a higher hardness than the balloon main body as the expansion element, the resin, or the like is used, when the balloon is pressurized and expanded, the protruding portion pushed back by the hardness of the lesion or the expansion element may be buried in the balloon and may not be sufficiently bitten into the stricture portion. The present application has been made in view of the above-described problems, and an object thereof is to provide a balloon catheter in which an incision is easily made in a hardened stenosed portion in a blood vessel.
The balloon catheter according to the embodiment of the present application capable of solving the above-described problems is as follows.
[1] A balloon catheter, comprising:
a shaft having a distal portion and a proximal portion; and
a balloon positioned at the distal portion of the shaft and having a straight tube portion,
the balloon has a blade-shaped portion in the shape of a blade in a contracted state, and has a protruding portion on an outer side surface,
in a cross section of the straight tube portion in a direction perpendicular to the axial direction, when a direction from the top of the protruding portion toward the center of the axis is a Y direction and a direction perpendicular to the Y direction is an X direction, scattering intensity of each portion of the cross section measured by a laser raman spectroscopy method satisfies the following formula (1).
I 2 >I 1 …(1)
[ formula I 1 Is the value of Ia/Ib at the top of the above-mentioned protrusion, I 2 The value of Ia/Ib is the value of the central part of the base end part of the protruding part in the circumferential direction.
Wherein Ia is the wave number 1640.+ -.10 cm in the X direction -1 Peak intensity of 1640.+ -.10 cm with respect to the wave number in the Y direction -1 Ib is the ratio of the peak intensities in the X-direction wave number 1440.+ -.10 cm -1 Peak intensity of (2) is 1440.+ -.10 cm with respect to the wave number in the Y direction -1 Is the ratio of the peak intensities of (a).]
As described above, when the straight tube portion of the balloon satisfies the formula (1), the central portion in the circumferential direction of the base end portion of the protruding portion is a portion excellent in rigidity due to the large orientation of the higher-order structure, and as a result, the protruding portion is less likely to be buried in the balloon. When the straight tube portion of the balloon satisfies the expression (1), the top portion of the protruding portion is a portion having a relatively small orientation and moderate flexibility, and as a result, the portion is likely to enter a narrowed portion having a complicated shape. By utilizing the functions of the circumferential center portion of the proximal end portion of the protruding portion and the top portion of the protruding portion, it is possible to easily introduce an incision into a hardened narrow portion in a blood vessel. The balloon catheter according to the embodiment of the present application is preferably the following [2] or [3].
[2] The balloon catheter according to [1], wherein,
the scattering intensity of each part of the cross section measured by the laser raman spectroscopy satisfies the magnitude relation of the following formula (2).
I 3 >I 1 …(2)
[ formula I 1 I is the same as above 3 Is the value of Ia/Ib at one end of the base end of the protruding portion in the circumferential direction. Wherein Ia and Ib are the same as above.]
[3] The balloon catheter according to [1] or [2], wherein,
in the cross section, X is a direction from the top of the blade-shaped portion toward the center of the shaft 4 Direction, to be in line with the above X 4 The direction perpendicular to the direction is Y 4 In the direction, the scattering intensity of each part of the cross section measured by the laser raman spectroscopy satisfies the magnitude relation of the following formula (3).
I 2 >I 4 …(3)
[ formula I 2 I is the same as above 4 Is the value of Ic/Id at the top of the blade shape described above.
Wherein Ic is X as described above 4 Wave number 1640.+ -.10 cm in direction -1 The peak intensity of the polymer is relative to the above Y 4 Wave number 1640.+ -.10 cm in direction -1 Id is the ratio of the peak intensities of X 4 Wave number of 1440.+ -.10 cm in direction -1 The peak intensity of the polymer is relative to the above Y 4 Wave number of 1440.+ -.10 cm in direction -1 Is the ratio of the peak intensities of (a).]
[4] The balloon catheter according to any one of [1] to [3], wherein,
the balloon has: a proximal tapered portion located closer to the straight tube portion than the straight tube portion, and having a diameter decreasing with distance from the straight tube portion; and a distal taper portion which is located on a distal side from the straight tube portion and which reduces in diameter as it is separated from the straight tube portion.
[5] The balloon catheter according to [4], wherein,
the balloon has: a proximal fixing portion which is located closer to the proximal taper portion than the proximal taper portion, and is fixed to the shaft; and a distal fixing portion which is located on a distal side of the distal taper portion and is fixed to the shaft.
[6] The balloon catheter according to any one of [1] to [5], wherein,
the protruding portion is disposed at least in the straight tube portion.
[7] The balloon catheter according to [4] or [5], wherein,
the protruding portion is disposed at least in the proximal tapered portion, the straight tube portion, and the distal tapered portion.
[8] The balloon catheter according to [5], wherein,
the protruding portion is disposed in the proximal fixing portion, the proximal tapered portion, the straight tube portion, the distal tapered portion, and the distal fixing portion.
[9] The balloon catheter according to any one of [1] to [8], wherein,
the protruding portion is disposed at a portion of the balloon other than the blade-shaped portion.
According to the present application, with the above-described structure, a balloon catheter in which an incision is easily made in a hardened stenosed portion in a blood vessel can be provided.
Drawings
Fig. 1 is a side view of a balloon catheter according to an embodiment.
Fig. 2 is a cross-sectional view A-A of the balloon catheter of fig. 1 in a contracted state.
Fig. 3 is a B-B cross-sectional view of the balloon catheter of fig. 1 in an expanded state.
Fig. 4 is a perspective view of a parison before inflation according to the embodiment.
Fig. 5 is a radial cross-sectional view of the parison of fig. 4.
Fig. 6 is a photograph showing a drawing of a plaster model in which the balloon of example 1 was inflated and pulled out in the plaster model.
Fig. 7 is a photograph showing another alternative drawing of the plaster model in which the balloon of example 1 was inflated and pulled out in the plaster model.
Fig. 8 is a photograph showing a drawing of a plaster model in which the balloon of example 2 was inflated and pulled out in the plaster model.
Fig. 9 is a photograph showing another alternative drawing of the plaster model in which the balloon of example 2 was inflated and pulled out in the plaster model.
Detailed Description
The present application will be described more specifically below based on the following embodiments, but the present application is not limited to the following embodiments, and can be implemented by adding and changing the components appropriately within the scope of the gist described above, and they are included in the technical scope of the present application. In each drawing, for convenience, reference numerals and the like may be omitted, but in this case, reference is made to the specification and other drawings. In addition, the dimensions of the various components in the drawings are preferred to facilitate an understanding of the features of the present application, and thus there are cases where they are different from the actual dimensions.
The balloon catheter according to the embodiment of the present application includes: a shaft having a distal portion and a proximal portion; and a balloon located at a distal portion of the shaft and having a straight tube portion, the balloon having a blade-shaped portion in a contracted state and having a protruding portion on an outer surface, wherein, in a cross section of the straight tube portion in a direction perpendicular to the axial direction, when a direction from a top of the protruding portion toward a center of the shaft is a Y direction and a direction perpendicular to the Y direction is an X direction, scattering intensity of each portion of the cross section measured by a laser raman spectroscopy satisfies the following formula (1).
I 2 >I 1 …(1)
[ formula I 1 Is the value of Ia/Ib at the top of the protrusion, I 2 Is the value of Ia/Ib of the central part of the base end part of the protruding part in the circumferential direction.
Wherein Ia isWave number 1640+ -10 cm in X direction -1 Peak intensity is 1640.+ -.10 cm with respect to wave number in Y direction -1 Ib is the wave number 1440.+ -.10 cm in the X direction -1 Peak intensity of 1440.+ -.10 cm relative to wave number in Y direction -1 Is the ratio of the peak intensities of (a).]
As described above, when the straight tube portion of the balloon satisfies the formula (1), the central portion in the circumferential direction of the base end portion of the protruding portion is a portion excellent in rigidity due to the large orientation of the higher-order structure, and as a result, the protruding portion is less likely to be buried in the balloon. When the straight tube portion of the balloon satisfies the expression (1), the top portion of the protruding portion is a portion having a relatively small orientation and moderate flexibility, and as a result, the portion is likely to enter a narrowed portion having a complicated shape. By utilizing the functions of the circumferential center portion of the proximal end portion of the protruding portion and the top portion of the protruding portion, it is possible to easily introduce an incision into a hardened narrow portion in a blood vessel.
The balloon catheter according to the embodiment will be described below with reference to fig. 1 to 3. Fig. 1 is a side view of a balloon catheter according to an embodiment after balloon inflation. Fig. 2 is a cross-sectional view A-A of the balloon catheter of fig. 1 in a contracted state prior to balloon inflation. Fig. 3 is a B-B cross-sectional view of the balloon catheter of fig. 1 after balloon inflation.
As shown in fig. 1, the balloon catheter 1 has: a shaft 3 having a distal portion 1B and a proximal portion 1A; and a balloon 2 located at the distal portion 1B of the shaft 3 and having a straight tube portion 23. The balloon catheter 1 is preferably configured to be supplied with fluid to the interior of the balloon 2 via the shaft 3. For example, the inflation and deflation of the balloon 2 can be controlled using a balloon pressurizer. The fluid may be a pressurized fluid pressurized by a pump or the like.
The shaft 3 preferably has a fluid flow path inside. The shaft 3 preferably further has an insertion passage for a wire-like body such as a guide wire. Specifically, the shaft 3 preferably includes an outer tube 31 and an inner tube 32 in which at least a proximal portion is disposed in the outer tube 31. This allows the inner tube 32 to function as an insertion passage of the linear body, and allows the space between the inner tube 32 and the outer tube 31 to function as a fluid flow path. In this case, the inner tube 32 preferably extends and protrudes from the distal end of the outer tube 31. It is further preferable that 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 tube portion 23 preferably has substantially the same diameter in the axial direction a. Further, the straight tube portion 23 preferably has the largest diameter in the balloon 2 when inflated. By having the straight tube portion 23 with the maximum diameter, when the balloon 2 is expanded in a lesion such as a stricture, the straight tube portion 23 is sufficiently brought into contact with the lesion, and the expansion of the lesion can be facilitated.
The balloon 2 preferably has: a straight pipe portion 23; a proximal-side tapered portion 22 located on the proximal side of the straight tube portion 23; and a distal taper portion 24 located on a distal side from the straight tube portion 23. The proximal tapered portion 22 and the distal tapered portion 24 are preferably tapered as they are away from the straight tube portion 23. The proximal tapered portion 22 and the distal tapered portion 24 facilitate movement of the balloon 2 in the body cavity.
The balloon 2 preferably has a proximal fixing portion 21 fixed to the shaft 3 on the proximal side of the proximal tapered portion 22, and a distal fixing portion 25 fixed to the shaft 3 on the distal side of the distal tapered portion 24. For example, in the case where the shaft 3 has the outer tube 31 and the inner tube 32, at least a part of the proximal fixing portion 21 is preferably fixed to the outer tube 31, and at least a part of the distal fixing portion 25 is preferably fixed to the inner tube 32.
As shown in fig. 2, the balloon 2 has a blade-shaped portion 70 in the shape of a blade in a contracted state, and has a protruding portion 60 on the outer side surface. It is preferable that the blade-shaped portion 70 has portions overlapping each other in the inner surface of the balloon 2 in the state where the balloon 2 is contracted. In addition, it is preferable that the blade shape portion 70 is formed to be folded with the top portion 71 as a crease, for example.
The protruding portion 60 is provided on the outer side surface of the balloon 2. By expanding the balloon 2 in a calcified lesion or the like, the protruding portion 60 can introduce a crack into a calcified and hardened lesion, for example, to expand a stricture.
As shown in fig. 1 and 2, the protruding portion 60 is preferably located at a portion other than the blade-shaped portion 70. Since the protruding portion 60 is located at a portion other than the blade-shaped portion 70, the blade-shaped portion 70 and the protruding portion 60 are disposed at different positions in the circumferential direction of the balloon 2 in the contracted state, and when the blade-shaped portion 70 of the balloon 2 is folded, the outer diameter of the balloon 2 can be reduced.
The maximum length of the protruding portion 60 in the radial direction is preferably 1.2 times or more, more preferably 1.5 times or more, and even more preferably 2 times or more the film thickness of the balloon main body 20. Thus, an incision having a proper depth is easily introduced into the narrowed portion. On the other hand, the maximum length of the protruding portion 60 in the radial direction may be 100 times or less, 50 times or less, 30 times or less, or 10 times or less. The radial length of the protruding portion 60 may be different or the same in the axial direction a.
The shape of the A-A section and the B-B section of the protruding portion 60 is preferably triangular, trapezoidal, semicircular, or semi-elliptical. Further, it is more preferable that the sectional shape is a 1-step taper shape having only one taper portion tapering in a direction from the center 3a of the shaft 3 toward the top 61 of the protruding portion 60.
As shown in fig. 1, the protruding portion 60 is preferably provided in the straight tube portion 23, more preferably in the proximal tapered portion 22, the straight tube portion 23, and the distal tapered portion 24, and further preferably in the proximal fixed portion 21, the proximal tapered portion 22, the straight tube portion 23, the distal tapered portion 24, and the distal fixed portion 25. The number of the protruding portions 60 may be one or a plurality. In the case where a plurality of the protruding portions 60 are provided in the circumferential direction, the plurality of protruding portions 60 are preferably separated in the circumferential direction, and more preferably arranged at equal intervals in the circumferential direction.
As shown in fig. 1, the protruding portion 60 preferably extends in the axial direction a on the outer side surface of the balloon main body 20. This makes it possible to cut the narrow portion straight. Although not shown, the protruding portion 60 may be disposed at different positions in the circumferential direction in the axial direction a, for example, in a spiral shape so as to circumferentially surround the outer surface of the balloon main body 20. Thereby enabling the narrow portion to be cut obliquely.
In a cross section of the straight tube portion 23 in a direction perpendicular to the axial direction a as shown in fig. 2, when the direction from the top 61 of the protruding portion 60 toward the center 3a of the shaft 3 is the Y direction and the direction perpendicular to the Y direction is the X direction, the scattering intensity of each portion of the cross section measured by the laser raman spectroscopy satisfies the following expression (1).
I 2 >I 1 …(1)
[ formula I 1 Is the value of Ia/Ib at the top 61 of the projection 60, I 2 Is the value of Ia/Ib of the circumferential center 62 of the base end of the protruding portion 60.
Wherein Ia is the wave number 1640.+ -.10 cm in the X direction -1 Peak intensity is 1640.+ -.10 cm with respect to wave number in Y direction -1 Ib is the wave number 1440.+ -.10 cm in the X direction -1 Peak intensity of 1440.+ -.10 cm relative to wave number in Y direction -1 Is the ratio of the peak intensities of (a).]
Wave number 1640.+ -.10 cm in spectrum obtained by laser Raman spectroscopy -1 The peak of (2) is a peak derived from C=O structure, and the wave number is 1440.+ -.10 cm -1 Is a peak derived from the C-H structure. The larger the value of Ia/Ib calculated based on this laser raman spectroscopy, the larger the orientation of the higher order structure within the balloon 2. Thus, as in the above formula (1), the formula I 2 Greater than I 1 As a result, the circumferential center portion 62 of the base end portion of the protruding portion 60 becomes a portion having high-order structure with greater orientation and excellent rigidity, and as a result, the protruding portion 60 is less likely to be buried in the balloon 2. Thus, I 2 Preferably I 1 More preferably not less than 1.5 times, still more preferably not less than 2.5 times, still more preferably not less than 3.5 times, still more preferably not less than 4.0 times. On the other hand, preference is given to I 2 Is I 1 Is less than 10 times of the total weight of the steel sheet. This can facilitate manufacturing of the balloon 2. I 2 More preferably I 1 More preferably not more than 8 times, still more preferably not more than 6 times, still more preferably not more than 5 times. In fig. 2, the broken line is a virtual line segment showing the base end edge of the protruding portion 60, and the center portion 62 of the protruding portion 60 is preferably located in a region on the virtual line segment separated from both ends of the virtual line segment by more than 1/4 of the length of the virtual line segment, and more preferably located at the center point of the virtual line segment.
Preferably, the scattered intensity of each part of the cross section of the balloon catheter 1 measured by the laser raman spectroscopy satisfies the magnitude relation of the following formula (2).
I 3 >I 1 …(2)
[ formula I 1 I is the same as above 3 Is the base end of the projection 60The value of Ia/Ib of the circumferential end 63 of the portion. Wherein Ia and Ib are the same as above.]
Through I 3 Greater than I 1 As a result, the protruding portion 60 is less likely to be embedded in the balloon 2 because the rigidity of the one end 63 in the circumferential direction of the base end of the protruding portion 60 is increased due to the higher-order structure. I 3 Preferably I 1 More preferably not less than 1.5 times, still more preferably not less than 2.0 times, still more preferably not less than 2.5 times. On the other hand, I 3 Preferably I 1 Is less than 6 times of the total weight of the steel sheet. This can facilitate manufacturing of the balloon 2. I 3 More preferably I 1 And more preferably not more than 5 times, and still more preferably not more than 4 times. Further, it is more preferable that the above formula (2) is satisfied at both ends in the circumferential direction of the base end portion of the protruding portion 60. In fig. 2, the broken line is a virtual line segment showing the base end edge of the protruding portion 60, and the one end 63 of the protruding portion 60 is preferably located in a region of the virtual line segment within 1/4 of the length of the virtual line segment from the one end of the virtual line segment, and more preferably located at the one end of the virtual line segment.
In the cross section, X is a direction from the top 71 of the blade-shaped portion 70 toward the center 3a of the shaft 3 4 Direction, to be with X 4 The direction perpendicular to the direction is Y 4 In the direction, the scattering intensity of each part of the cross section measured by the laser raman spectroscopy preferably satisfies the magnitude relation of the following formula (3).
I 2 >I 4 …(3)
[ formula I 2 I is the same as above 4 Is the value of Ic/Id for the top 71 of the blade shape 70.
Wherein Ic is X 4 Wave number 1640.+ -.10 cm in direction -1 Peak intensity relative to Y 4 Wave number 1640.+ -.10 cm in direction -1 Id is X 4 Wave number of 1440.+ -.10 cm in direction -1 Peak intensity relative to Y 4 Wave number of 1440.+ -.10 cm in direction -1 Is the ratio of the peak intensities of (a).]
The larger the values of Ia/Ib, ic/Id calculated based on this laser raman spectroscopy, the larger the orientation of the higher order structures within the balloon 2. Thus, through I 2 Greater than I 4 As a result, the circumferential center portion 62 of the base end portion of the protruding portion 60 becomes a portion having high-order structure with greater orientation and excellent rigidity, and as a result, the protruding portion 60 is less likely to be buried in the balloon 2. I 2 Preferably I 4 More preferably 1.01 times or more, still more preferably 1.02 times or more, and still more preferably 1.03 times or more. On the other hand, I 2 Preferably I 4 Is 3.0 times or less of the total number of the components. This can improve the rigidity in the vicinity of the top 71 of the blade-shaped portion 70. I 2 More preferably I 4 More preferably not more than 2.0 times, still more preferably not more than 1.5 times, still more preferably not more than 1.2 times.
Preferably, the scattered intensity of each part of the cross section of the balloon catheter 1 measured by the laser raman spectroscopy satisfies the magnitude relation of the following expression (4).
I 2 >I 3 …(4)
[ formula I 2 、I 3 The same as described above.]
Through I 2 Greater than I 3 Thus, the protruding portion 60 can be easily bitten into the lesion when the balloon is inflated. Thus, I 2 Preferably I 3 More preferably 1.1 times or more, still more preferably 1.2 times or more, and still more preferably 1.4 times or more. On the other hand, I 2 Preferably I 3 Is less than 2.5 times of the total number of the components. This makes it possible to easily support the protruding portion 60 at the one end 63 in the circumferential direction of the base end portion of the protruding portion 60.I 3 More preferably I 2 And more preferably 2.0 times or less, and still more preferably 1.8 times or less. Further, it is more preferable that the above formula (4) is satisfied at both ends in the circumferential direction of the base end portion of the protruding portion 60.
The entire region of the straight tube portion 23 in the axial direction a does not need to satisfy the above-described formulas (1) to (4), and a portion having excellent rigidity may be provided appropriately. For example, the above formulas (1) to (4) are preferably satisfied in a region including the midpoint of the straight tube portion 23 in the axial direction a, a point at a distance of 1/3 of the length of the straight tube portion 23 from one end of the straight tube portion 23 in the axial direction a, a point at a distance of 1/4 of the length of the straight tube portion 23 from one end of the straight tube portion 23 in the axial direction a, and the like. Thus, a portion having excellent rigidity can be provided at a desired position such as the center, front end, rear end, etc. of the straight tube portion 23. The length of the region satisfying the above formulas (1) to (4) is not particularly limited, but is preferably 1/18 or more, more preferably 1/15 or more, and still more preferably 1/12 or more of the length of the straight tube portion 23 in the axial direction a. Formulas (1) to (4) mean formula (1); formulas (1) and (2); formulas (1) and (3); formulas (1) and (4); formula (1), formula (2) and formula (3); formula (1), formula (2) and formula (4); formula (1), formula (3) and formula (4); any one of the formulas (1), (2), (3) and (4). In the above region, the formula (1) is preferably satisfied; formulas (1) and (2); formulas (1) and (3); or formula (1), formula (2) and formula (3).
The balloon 2 preferably comprises, more preferably consists of, a resin, a rubber or a mixture thereof. As the resin, polyamide resins such as polyamide elastomers, e.g., polyamide and polyether block amide copolymers, are preferable; polyester resins such as polyethylene terephthalate and polyester elastomers; polyurethane resins such as polyurethane and polyurethane elastomers; and resins containing C-H units and c=o units. In addition, an elastomer in these resins is more preferable. The balloon 2 may contain other resins, for example, resins such as polyphenylene sulfide resin, fluorine resin, silicone resin, polyethylene, polypropylene, and polyolefin resin such as ethylene-propylene copolymer. Examples of the rubber include natural rubber such as latex rubber. Only 1 kind of them may be used, or 2 or more kinds may be used in combination. More preferably a polyamide resin, a polyester resin, a polyurethane resin, or a mixture thereof, still more preferably a polyamide resin, and particularly preferably a polyether block amide copolymer. This can facilitate formation of a portion of the higher order structure having a large orientation.
Preferably, the projection 60 is composed of the same material as the balloon body 20. This can maintain the flexibility of the balloon 2, and the protruding portion 60 is less likely to damage the outer surface of the balloon main body 20. Preferably, the balloon body 20 and the projection 60 are integrally formed. This can prevent the protrusion 60 from falling off the balloon main body 20.
The balloon 2 can be manufactured using, for example, a parison 200 made of resin and having a thick wall portion 220 extending in the axial direction a as shown in fig. 4. For example, the parison 200 can be produced by disposing it in an inner cavity of a mold and blow molding it. Specifically, the balloon 2 can be formed by, for example, disposing the parison 200 in the cavity of a mold, inserting the thick portion 220 of the parison 200 into a groove of a predetermined shape of the mold, introducing a fluid into the cavity 210 of the parison 200, and heating while expanding the parison 200. The width and height of the protruding portion 60 can be adjusted by the thickness of the thick-wall portion 220 of the parison 200, and the depth and shape of the groove of the mold. The fluid may be air, nitrogen, water, or the like. In blow molding, the parison 200 is preferably heated at a temperature equal to or higher than the glass transition temperature of the resin. In addition, the parison 200 may be extended in the axial direction a before this expansion. The step of expanding the parison 200 may be performed only 1 time or may be performed a plurality of times. In the case of performing the expansion step a plurality of times, a different mold may be used for each expansion.
As shown in fig. 5, the thick portion 220 of the parison 200 preferably includes: a first tapered portion 221 that tapers in a direction from the inner cavity 210 toward the top of the thick-walled portion 220; and a second tapered portion 222, which is located closer to the top of the thick portion 220 than the first tapered portion 221, and which tapers in a direction from the inner cavity 210 toward the top of the thick portion 220. Since the parison 200 has the 2-step tapered portion in this way, tension is easily applied to the first tapered portion 221 during blow molding, and thus the orientation in the vicinity of the center portion 62 of the base end portion of the protruding portion 60 obtained by blow molding can be increased. In fig. 5, a parison having a 2-step taper portion over the entire length is shown, but a parison having a 2-step taper portion in a part of the parison may be used. Thus, a portion having excellent rigidity can be provided at a desired position of the straight tube portion 23.
In the blow molding, the protrusion 60 having a 1-stage tapered shape is preferably formed by eliminating the 2-stage tapered shape of the parison 200. This can further increase the orientation in the vicinity of the center portion 62 of the base end portion of the protruding portion 60. As a method of eliminating the 2-step tapered shape of the parison 200, the parison 200 may be blow molded after only the second tapered portion 222 is inserted into the groove without inserting the first tapered portion 221 into the groove in the cavity of the mold. Further, the groove is preferably a V-shaped groove.
The width W1 of the base end portion of the first tapered portion 221 is preferably 1.5 times or more, more preferably 2.0 times or more the width W2 of the base end portion 222 of the second tapered portion. This makes it possible to easily apply tension to the first tapered portion 221 during blow molding. On the other hand, the magnification may be 10 times or less, or 5 times or less.
The height h1 of the first tapered portion 221 is preferably 0.9 times or less, more preferably 0.8 times or less the height h2 of the second tapered portion 222. This makes it possible to easily apply tension to the first tapered portion 221 during blow molding. On the other hand, the magnification may be 0.1 times or more, or 0.2 times or more.
Preferably, the shaft 33 comprises a resin, rubber or a mixture thereof. Examples of the resin and the rubber include polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluororesin, vinyl chloride resin, silicone resin, natural rubber, and the like. Only 1 kind of them may be used, or 2 or more kinds may be used in combination. It is preferable that the laminate contains a polyamide resin, a polyolefin resin, a fluororesin, a mixture thereof, or a laminate obtained by laminating resin layers thereof. This can improve the sliding property of the surface of the shaft 3 and the insertion property of the balloon catheter 1 into the body cavity. As a method of fixing the balloon 2 to the shaft 3, a method of joining and welding with an adhesive, and a method of caulking and fixing the annular member are mentioned. The shaft 3 may include a metal pipe, a single or a plurality of wires, a twisted wire, or the like.
As shown in fig. 1, the balloon catheter 1 may have a pivot (hub) 4 on the proximal side of the shaft 3. The pivot 4 may also have: a fluid injection unit 7 that communicates with a flow path of a fluid to be supplied to the interior of the balloon 2; and a guide wire insertion portion 5 communicating with the insertion passage of the guide wire. This makes it possible to easily perform an operation of supplying a fluid into the balloon 2 to expand the balloon 2 and an operation of delivering the balloon 2 to a treatment site along a guide wire. The balloon catheter 1 is preferably of The so-called Over-The-Wire type as shown in fig. 1, in which a guide Wire is inserted from The distal side to The proximal side of The shaft 3, but may be of The so-called Rapid Exchange type in which a guide Wire is inserted from The distal side to The halfway of The proximal side of The shaft 3.
The present application claims the benefit of priority based on japanese patent application No. 2021-182760, filed on day 2021, 11 and 9. For reference, the entire contents of the specifications of japanese patent application nos. 2021-182760, filed on 11/9 of 2021, are incorporated herein by reference.
Examples
The present application will be described more specifically with reference to the following examples, but the present application is not limited to the following examples, and may be modified and implemented within the scope of the gist described above, and all of them are included in the technical scope of the present application.
Example 1
An extrusion molding using a polyamide elastomer (PEBAX (registered trademark) 7233 manufactured by ARKEMA corporation) was performed to produce a molded article having an inner diameter as shown in fig. 4 and 5: 0.50mm, outside diameter: 1.00mm, axial length: 300mm tubular portion, and a thick wall portion 220, i.e., parison 200. The thick portion 220 has the following dimensions.
Width (W1) of the base end portion of the first tapered portion: 1.0mm
Width (W2) of the base end portion of the second tapered portion: 0.5mm
Height (h 1) of the first taper: 0.2mm
Height of the second taper (h 2): 0.5mm
Length of axial direction a: 35mm
Next, the parison 200 is disposed in the cavity of the mold. The mold includes a cavity and a V-groove having the following dimensions in the portions corresponding to the respective portions of the balloon 2.
A lumen forming part of the proximal fixing portion 21
Diameter: 1.0mm
Length in axial direction: 5mm of
Lumen of portion forming proximal cone 22
Diameter of proximal end: 1.0mm
Diameter of distal end: 2.75mm
Length in axial direction: 5mm of
Inner cavity of the portion forming the straight tube portion 23
Diameter: 2.75mm
Length in axial direction: 15mm of
Inner cavity of the portion forming the distal-side tapered portion 24
Straight tube at the proximal end: 2.75mm
Diameter of distal end: 1.0mm
Length in axial direction: 5mm of
An inner cavity forming part of the distal-side fixing portion 25
Diameter: 1.0mm
Length in axial direction: 5mm of
V-groove forming part of the projection 60
Depth: 0.8mm
Maximum width: 0.5mm
Length in axial direction: 35mm
Using this mold, the parison 200 was biaxially stretch blow molded at 100 ℃ to produce the balloon 2. Next, the straight tube portion 23 of the balloon 2 was cut, and the obtained sample was embedded in a resin, and then a frozen microtome (UC 6) for the measurement was used to prepare a section for observation. Next, wave numbers 1630 to 1650cm in the X-direction and Y-direction in each of the top 61 of the protruding portion 60, the circumferential center portion 62 of the base end portion, the circumferential one end portion 63 of the base end portion, and the top 71 of the blade-shaped portion 70 were obtained by using a Raman spectrometer 1 Peak intensity of peaks in the range of (1), and the presence of the same at wave numbers 1430-1450 cm- 1 Peak intensities of peaks in the range of (2). The details of this measurement are as follows.
The device comprises: raman spectrometer (Ranshao in Via) TM Qontor)
And (3) a microscope: leika microsystem DM2700 system
An objective lens: x 100
Beam diameter: 1 μm
Laser power: 100 percent of
Exposure time: 30 seconds
Cumulative number of times: 1 time
Light source: semiconductor laser 532nm
Based on the peak intensities obtained by the above measurement, I as described in the above (1) to (4) was calculated 1 ~I 4 Is a value of (2). The results are shown in table 1.
TABLE 1
As shown in table 1, balloon 2 satisfies formula (1). When the balloon 2 is fixed to the shaft and the balloon 2 is expanded in the plaster model, the protruding portion 60 of the straight tube portion 23 bites into the plaster model. After the balloon is contracted and pulled out from the plaster model, the shape in which the protruding portion 60 bites can be confirmed as shown in fig. 6 and 7. As described above, the protruding portion 60 of the straight tube portion 23 of the balloon 2 is not easily buried in the balloon 2, and is easily bitten into the plaster model. When the balloon 2 is moved in the plaster model simulating the stricture before the expansion, the insertion and extraction operations can be smoothly performed without being caught by the proper flexibility of the top 61 of the protruding portion 60.
Example 2
A balloon was produced in the same manner as in example 1 except that the base end portion of the first tapered portion of the parison 200 was formed to have a width (W1) of 0.7mm by extrusion molding using a polyamide elastomer (Rilsamid (registered trademark) PA 12) manufactured by ARKEMA, and the peak intensities of the respective portions were obtained to calculate I as described in the above (1) to (4) 1 ~I 4 Is a value of (2). The results are shown in table 2.
TABLE 2
As shown in table 2, the balloon of example 2 satisfies the formula (1). When the balloon is fixed to the shaft and the balloon is expanded in the plaster model, the protruding portion of the straight tube portion bites into the plaster model. After the balloon is contracted and pulled out from the plaster model, the shape in which the protruding portion bites can be confirmed as shown in fig. 8 and 9. In this way, the protruding portion of the straight tube portion of the balloon is not easily buried in the balloon, and is easily bitten into the plaster model. In addition, when the balloon is moved in the plaster model simulating the stricture before the expansion, the balloon is not hooked due to the proper flexibility of the top of the protruding portion, and the insertion and extraction operations can be smoothly performed.
Description of the reference numerals
1 … balloon catheter; 1a … proximal portion; 1B … distal; 2 … balloon; 3 … axis; the center of the 3a … axis; 4 … pivot; 5 … guidewire insertion; 7 … fluid injection; 20 … balloon body; 21 … proximal fixing portion; 22 … proximal taper; 23 … straight tube portions; a … axial direction; 24 … distal taper; 25 … distal fixing portion; 31 … outer tube; 32 … inner tube; 60 … projections; 61 … projection; a circumferential center portion of the base end portion of the 62 … projection; a circumferential one end portion of the base end portion of the 63 … projection; 70 … blade shape; the top of the 71 … vane shape; 200 … parison; 210 … parison cavity; 220 … thick wall portion of the parison; 221 … first taper; 222 … second taper; width of the base end portion of the W1 … first tapered portion; width of the base end portion of the W2 … second taper; h1 … height of the first taper; h2 … height of the second taper.
Claims (9)
1. A balloon catheter, comprising:
a shaft having a distal portion and a proximal portion; and
a balloon positioned at the distal portion of the shaft and having a straight tube portion,
the balloon has a blade-shaped portion in the shape of a blade in a contracted state, and has a protruding portion on an outer side surface,
in a cross section of the straight tube portion in a direction perpendicular to the axial direction, when a direction from the top of the protruding portion toward the center of the axis is defined as a Y direction and a direction perpendicular to the Y direction is defined as an X direction, scattering intensity of each portion of the cross section measured by laser raman spectroscopy satisfies the following formula (1),
I 2 >I 1 …(1)
wherein I is 1 Is the value of Ia/Ib at the top of the protrusion, I 2 Is the value of Ia/Ib of the central part of the base end part of the protruding part in the circumferential direction,
wherein Ia is the wave number 1640.+ -.10 cm in the X direction -1 Peak intensity of 1640±10cm with respect to wave number in the Y direction -1 Ib is the ratio of the peak intensities in the X-direction wave number 1440.+ -.10 cm -1 Peak intensity of 1440.+ -.10 cm with respect to the wave number in the Y direction -1 Is the ratio of the peak intensities of (a).
2. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
the scattering intensity of each part of the cross section measured by the laser raman spectroscopy satisfies the magnitude relation of the following formula (2),
I 3 >I 1 …(2)
wherein I is 1 I is the same as above 3 The value of Ia/Ib is the same as that of one end of the base end of the protrusion in the circumferential direction.
3. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
in the cross section, X is a direction from the top of the blade-shaped part toward the center of the shaft 4 Direction, to be in contact with the X 4 The direction perpendicular to the direction is Y 4 In the direction, the scattering intensity of each part of the cross section measured by the laser Raman spectroscopy satisfies the magnitude relation of the following formula (3),
I 2 >I 4 …(3)
wherein I is 2 I is the same as above 4 Is the value of Ic/Id at the top of the blade shape,
wherein Ic is the X 4 Wave number 1640.+ -.10 cm in direction -1 Peak intensity of (c) relative to the Y 4 Wave number 1640.+ -.10 cm in direction -1 Id is the ratio of the peak intensities of said X 4 Wave number of 1440.+ -.10 cm in direction -1 Peak intensity of (2)Degree relative to the Y 4 Wave number of 1440.+ -.10 cm in direction -1 Is the ratio of the peak intensities of (a).
4. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
the balloon has: a proximal tapered portion located closer to the straight tube portion than the straight tube portion, and having a diameter decreasing with distance from the straight tube portion; and a distal-side tapered portion located on a distal side from the straight tube portion, the tapered portion being tapered as it is separated from the straight tube portion.
5. The balloon catheter of claim 4, wherein the balloon catheter is configured to move,
the balloon has: a proximal fixing portion which is located closer to a proximal side than the proximal taper portion and is fixed to the shaft; and a distal-side fixing portion which is located on a distal side from the distal-side tapered portion and is fixed to the shaft.
6. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
the protruding portion is disposed at least in the straight tube portion.
7. The balloon catheter of claim 4, wherein the balloon catheter is configured to move,
the protruding portion is disposed at least in the proximal tapered portion, the straight tube portion, and the distal tapered portion.
8. The balloon catheter of claim 5, wherein the balloon catheter is configured to move,
the protruding portion is disposed at the proximal fixing portion, the proximal tapered portion, the straight tube portion, the distal tapered portion, and the distal fixing portion.
9. The balloon catheter of claim 1, wherein the balloon catheter is configured to be positioned over the patient,
the protruding portion is disposed at a portion of the balloon other than the blade-shaped portion.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2021182760 | 2021-11-09 | ||
JP2021-182760 | 2021-11-09 | ||
PCT/JP2022/040651 WO2023085149A1 (en) | 2021-11-09 | 2022-10-31 | Balloon catheter |
Publications (2)
Publication Number | Publication Date |
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CN116963799A true CN116963799A (en) | 2023-10-27 |
CN116963799B CN116963799B (en) | 2024-04-05 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN202280017486.2A Active CN116963799B (en) | 2021-11-09 | 2022-10-31 | Balloon catheter |
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JP (1) | JP7304504B1 (en) |
CN (1) | CN116963799B (en) |
WO (1) | WO2023085149A1 (en) |
Citations (8)
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JP2006340914A (en) * | 2005-06-09 | 2006-12-21 | Sekisui Chem Co Ltd | Balloon catheter |
JP2014057793A (en) * | 2012-09-19 | 2014-04-03 | Kaneka Corp | Balloon for balloon catheter |
JP2014057792A (en) * | 2012-09-19 | 2014-04-03 | Kaneka Corp | Method of manufacturing balloon for balloon catheter |
CN107073247A (en) * | 2014-11-18 | 2017-08-18 | 日本来富恩株式会社 | Foley's tube |
CN110339456A (en) * | 2019-08-22 | 2019-10-18 | 贝克顿·迪金森公司 | Sacculus dilating catheter and its sacculus |
WO2020195170A1 (en) * | 2019-03-28 | 2020-10-01 | 株式会社カネカ | Balloon catheter |
WO2020195697A1 (en) * | 2019-03-28 | 2020-10-01 | 株式会社カネカ | Balloon catheter |
WO2020250611A1 (en) * | 2019-06-11 | 2020-12-17 | 株式会社カネカ | Balloon for balloon catheter and method of manufacturing balloon catheter |
-
2022
- 2022-10-31 JP JP2023521800A patent/JP7304504B1/en active Active
- 2022-10-31 CN CN202280017486.2A patent/CN116963799B/en active Active
- 2022-10-31 WO PCT/JP2022/040651 patent/WO2023085149A1/en active Application Filing
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2006340914A (en) * | 2005-06-09 | 2006-12-21 | Sekisui Chem Co Ltd | Balloon catheter |
JP2014057793A (en) * | 2012-09-19 | 2014-04-03 | Kaneka Corp | Balloon for balloon catheter |
JP2014057792A (en) * | 2012-09-19 | 2014-04-03 | Kaneka Corp | Method of manufacturing balloon for balloon catheter |
CN107073247A (en) * | 2014-11-18 | 2017-08-18 | 日本来富恩株式会社 | Foley's tube |
WO2020195170A1 (en) * | 2019-03-28 | 2020-10-01 | 株式会社カネカ | Balloon catheter |
WO2020195697A1 (en) * | 2019-03-28 | 2020-10-01 | 株式会社カネカ | Balloon catheter |
WO2020250611A1 (en) * | 2019-06-11 | 2020-12-17 | 株式会社カネカ | Balloon for balloon catheter and method of manufacturing balloon catheter |
CN110339456A (en) * | 2019-08-22 | 2019-10-18 | 贝克顿·迪金森公司 | Sacculus dilating catheter and its sacculus |
Also Published As
Publication number | Publication date |
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CN116963799B (en) | 2024-04-05 |
JP7304504B1 (en) | 2023-07-06 |
JPWO2023085149A1 (en) | 2023-05-19 |
WO2023085149A1 (en) | 2023-05-19 |
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