WO2024042978A1 - Ballonnet pour cathéter à ballonnet et cathéter à ballonnet pourvu de celui-ci - Google Patents

Ballonnet pour cathéter à ballonnet et cathéter à ballonnet pourvu de celui-ci Download PDF

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Publication number
WO2024042978A1
WO2024042978A1 PCT/JP2023/027371 JP2023027371W WO2024042978A1 WO 2024042978 A1 WO2024042978 A1 WO 2024042978A1 JP 2023027371 W JP2023027371 W JP 2023027371W WO 2024042978 A1 WO2024042978 A1 WO 2024042978A1
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WIPO (PCT)
Prior art keywords
balloon
surface roughness
region
protrusion
longitudinal axis
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PCT/JP2023/027371
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English (en)
Japanese (ja)
Inventor
真弘 小嶋
崇亘 ▲濱▼淵
良紀 中野
昌人 杖田
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株式会社カネカ
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Publication of WO2024042978A1 publication Critical patent/WO2024042978A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a balloon for a balloon catheter and a balloon catheter equipped with the same.
  • Angioplasty which uses a balloon catheter to dilate the narrowed area.
  • Angioplasty is a minimally invasive therapy that does not require open heart surgery like bypass surgery, and is widely practiced.
  • ISR In-Stent-Restenosis
  • Patent Document 1 describes a balloon having a convex portion, and a method in which the convex portion is formed by welding at least part of the adjacent inner surfaces to each other in a portion where the inner surfaces of the balloon are arranged facing each other.
  • Patent Document 2 discloses a balloon in which pleats, which are protrusions, are formed, and forming the pleats on the balloon using a mold.
  • the protruding part may not penetrate sufficiently into hardened calcified lesions, and the balloon may not be able to penetrate into lesions such as ISR lesions where the surface is slippery. It is difficult to fix the balloon, which causes the balloon to shift, resulting in incisions not being made at the desired location or damage to blood vessels in areas other than the target area.
  • an object of the present invention is to provide a balloon for a balloon catheter, which allows the protruding part to easily penetrate into the stenotic part, and improves the non-slip performance in which the balloon is less likely to shift from the lesioned part, and a balloon catheter equipped with the same. shall be.
  • a balloon for a balloon catheter that can solve the above problems is as follows.
  • a balloon for a balloon catheter having a longitudinal axis direction, a radial direction, and a circumferential direction, the balloon body having an outer surface and an inner surface, and protruding outward in the radial direction from the outer surface of the balloon body.
  • a protrusion extending in the longitudinal axis direction, the balloon main body and the protrusion are made of the same material, and the surface of the protrusion is similar to the protrusion in the radial direction.
  • the base end region corresponds to the position P 0 at the height 0 to the position P 40 at the height 40
  • the base end region corresponds to the position P 40 at the height 70
  • a tip region corresponding from the position P 70 to a position P 90 with a height of 90 and when measured by the measurement method described below, the surface roughness of the tip region is equal to that of the intermediate region.
  • the surface roughness of the proximal region is smaller than the surface roughness of the intermediate region.
  • the reference length is 50 ⁇ m, and the arithmetic mean roughness of the reference length is measured at 10 different positions in the circumferential direction, and the average of the 10 obtained arithmetic mean roughnesses is defined as the surface roughness of each region.
  • the balloon for a balloon catheter according to the embodiment of the present invention is preferably one of the following [2] to [7].
  • the surface of the protrusion has a cutting edge region corresponding to the position P 90 to a position P 100 with a height of 100 , when the maximum height of the protrusion in the radial direction is 100.
  • the reference length is 50 ⁇ m
  • the arithmetic mean roughness is measured at 10 different positions in the longitudinal axis direction for the reference length in the direction perpendicular to the longitudinal axis direction, and the obtained 10 arithmetic mean roughnesses are
  • the reference length is 50 ⁇ m
  • the arithmetic mean roughness is measured at 10 different positions in the circumferential direction for the reference length in the direction parallel to the longitudinal axis direction, and the obtained 10 arithmetic mean roughness
  • the invention also provides: [8] A balloon catheter comprising the balloon for a balloon catheter according to any one of [1] to [7] above.
  • the balloon for a balloon catheter and the balloon catheter described above it is possible to easily make the protrusion provided on the outer surface of the balloon bite into the stenotic part, and improve the non-slip performance in which the protrusion is difficult to shift from the lesioned part. This makes it possible to efficiently dilate the stenotic region and to perform safe treatment by avoiding the risk of damaging blood vessels other than the treatment target site.
  • FIG. 1 depicts a side view of a balloon catheter according to an embodiment of the present invention.
  • 1 shows a perspective view of a balloon for a balloon catheter according to an embodiment of the present invention.
  • FIG. 2 shows a cross-sectional view taken along line III-III in FIG. 1.
  • 4 is a sectional view showing a modification of FIG. 3.
  • FIG. 4 represents a partially enlarged view of FIG. 3.
  • FIG. 3 shows an example of an image obtained when measuring the surface roughness of a protrusion of a balloon for a balloon catheter according to an embodiment of the present invention.
  • 1 depicts a perspective view of a parison before inflation according to an embodiment of the invention.
  • FIG. 1 is a cross-sectional view of a mold in the longitudinal axis direction according to an embodiment of the present invention.
  • 8 is a sectional view taken along line IX-IX in FIG. 8.
  • a balloon for a balloon catheter according to an embodiment of the present invention is a balloon for a balloon catheter having a longitudinal axis direction, a radial direction, and a circumferential direction, and includes a balloon body portion having an outer surface and an inner surface, and a balloon body portion having an outer surface and an inner surface.
  • the balloon has a protruding part that protrudes radially outward from the outer surface of the balloon and extends in the longitudinal axis direction, and the balloon body and the protruding part are made of the same material, and the surface of the protruding part is , when the maximum height of the protrusion in the radial direction is 100, the base end region corresponds to the position P 0 at height 0 to the position P 40 at height 40 , and the position P from position P 40 to height 70.
  • the surface roughness of the tip region is intermediate when measured using the measurement method described below.
  • the surface roughness of the proximal region is smaller than the surface roughness of the intermediate region.
  • the reference length is 50 ⁇ m, and the arithmetic mean roughness of the reference length is measured at 10 different positions in the circumferential direction, and the average of the 10 obtained arithmetic mean roughnesses is taken as the surface roughness of each region.
  • Dilation of a stenotic area using a balloon catheter involves delivering a balloon provided at the distal end of the balloon catheter to the stenotic area, then expanding the balloon, and causing a protrusion provided on the outer surface of the balloon body to bite into the stenotic area. This is done by incising the narrowed area. At this time, since the surface roughness of the tip region that initially contacts the narrowed portion is small, the resistance when the protruding portion starts to bite into the narrowed portion is reduced, so that the protruding portion easily penetrates into the narrowed portion. In addition, in the proximal region that bites into the final stage, the resistance to indentation becomes large, making it difficult for the entire protrusion to penetrate into the constriction.
  • the diameter can be made small, the entire protrusion can be inserted into the stenosis to perform efficient incision. Furthermore, since the surface roughness of the intermediate region located between the distal end region and the proximal end region is large, the protrusion can be made difficult to shift from the intended position, and the non-slip performance can be improved. In this way, by reducing the surface roughness in the proximal and distal regions and increasing the surface roughness in the intermediate region, we have created a balloon with improved non-slip performance without compromising the scoring performance of the protrusion biting into the stenosis. It can be done.
  • the balloon for a balloon catheter may be simply referred to as a "balloon.”
  • FIG. 1 is a side view of a balloon catheter according to an embodiment of the present invention.
  • FIG. 2 depicts a perspective view of a balloon for a balloon catheter according to an embodiment of the invention, showing the distal side of the balloon.
  • FIG. 3 shows a sectional view taken along line III-III in FIG. 1, and is a sectional view perpendicular to the longitudinal axis direction of a balloon for a balloon catheter according to an embodiment of the present invention.
  • FIG. 4 shows a sectional view showing a modification of FIG. 3
  • FIG. 5 shows a partially enlarged view of FIG.
  • FIG. 6 shows an example of an image obtained when the surface roughness of a protrusion of a balloon for a balloon catheter according to an embodiment of the present invention is measured using a laser microscope.
  • a balloon 2 is used in a balloon catheter 1.
  • the balloon 2 is connected to the distal end of the distal shaft 31, and the balloon 2 is expanded by introducing fluid through the lumen of the distal shaft 31, and the balloon 2 is deflated by discharging the fluid. I can do it.
  • an indeflator can be used to introduce or expel fluid.
  • the fluid may be a pressurized fluid pressurized by a pump or the like.
  • the balloon 2 is arranged in a longitudinal axis direction x1, a circumferential direction z1 along the outer edge of the balloon 2 in a cross section perpendicular to the longitudinal axis direction x1, and a centroid of the outer edge of the balloon 2 in a cross section perpendicular to the longitudinal axis direction x1. It has a radial direction y1 connecting the points.
  • the direction toward the user's hand with respect to the longitudinal axis direction x1 is referred to as the proximal side
  • the direction opposite to the proximal side, that is, the direction toward the treatment target is referred to as the distal side.
  • Members and parts other than the balloon 2 have respective longitudinal axis directions, radial directions, and circumferential directions, and these may be the same as the longitudinal axis direction x1, radial direction y1, and circumferential direction z1 of the balloon 2. Although there may be differences, in this specification, for ease of understanding, all members and portions are shown in the same longitudinal axis direction and radial direction as the longitudinal axis direction x1, radial direction y1, and circumferential direction z1 of the balloon 2. , and a circumferential direction.
  • the balloon 2 has a proximal end and a distal end in the longitudinal axis direction x1, and as shown in FIG. A proximal tapered portion 22, a proximal sleeve portion 21 located more proximally than the proximal tapered portion 22, and a distal taper located more distally than the straight pipe portion 23. 24 and a distal sleeve portion 25 located more distally than the distal tapered portion 24.
  • the straight pipe portion 23 has a substantially cylindrical shape having approximately the same diameter in the longitudinal axis direction x1, it may have a different diameter in the longitudinal axis direction x1.
  • the proximal tapered portion 22 and the distal tapered portion 24 have diameters that decrease as they move away from the straight pipe portion 23 and are formed into a substantially conical or truncated conical shape. Since the straight tube portion 23 has the maximum diameter, when the balloon 2 is expanded in a lesion such as a stenosis, the straight tube portion 23 comes into sufficient contact with the lesion, making it easy to perform treatments such as expansion of the lesion. can. In addition, since the proximal tapered part 22 and the distal tapered part 24 are reduced in diameter, when the balloon 2 is deflated, the outer diameter of the proximal end and the distal end of the balloon 2 is reduced. Since the height difference between the distal shaft 31 and the balloon 2 can be reduced, the balloon 2 can be easily inserted into the body cavity.
  • the proximal tapered part 22, the straight pipe part 23, and the distal tapered part 24 are the parts that expand when fluid is introduced into the balloon 2, whereas the proximal sleeve part 21 and the distal sleeve part 25 is preferably not expanded. At least a portion of the unexpanded proximal sleeve portion 21 may be fixed to the distal shaft 31, and at least a portion of the distal sleeve portion 25 may be fixed to an inner shaft 60, which will be described later.
  • the balloon 2 has a balloon main body 20 having an outer surface and an inner surface, and a protrusion 28 that protrudes outward in the radial direction y1 from the outer surface of the balloon main body 20 and extends in the longitudinal axis direction x1. .
  • the balloon body 20 defines the basic shape of the balloon 2, and the protrusions 28 are preferably provided on the outer surface of the balloon body 20 in any pattern such as linear, dotted, netted, or spiral.
  • the protrusion 28 can be provided with a scoring function to crack and dilate a calcified stenosis during angioplasty.
  • the protrusion 28 can contribute to improving the strength of the balloon 2 and suppressing over-expansion during pressurization.
  • the protruding portion 28 is provided on the straight pipe portion 23.
  • the protruding portion 28 may be provided in the straight pipe portion 23, the tapered portion, and the sleeve portion, that is, the entire region of the balloon 2 in the longitudinal axis direction x1.
  • the protrusions 28 may be provided in the straight pipe part 23 and not provided in the tapered part and the sleeve part, or may be provided lower than the straight pipe part 23, It may be provided on at least a portion of the tapered portion and the sleeve portion. In the tapered part and the sleeve part, there are parts where the protruding part 28 is not provided and parts which are provided lower than the straight pipe part 23, so that the passage performance of the balloon 2 can be improved.
  • the protrusion 28 is preferably made of the same material as the balloon body 20, and the balloon body 20 and the protrusion 28 are preferably integrally molded. Since the balloon body 20 and the protrusion 28 are made of the same material, the protrusion 28 can be prevented from damaging the outer surface of the balloon body 20 while maintaining the flexibility of the balloon 2. Since the balloon body 20 and the protrusion 28 are integrally formed, the protrusion 28 can be prevented from falling off from the balloon body 20. Alternatively, the material forming the protrusion 28 may be different from the material forming the balloon body 20 as long as there is some degree of compatibility with the material forming the balloon body 20. Such a balloon 2 can be manufactured, for example, by placing a parison obtained by extrusion molding in a mold having grooves and blow molding the parison. A preferred balloon manufacturing method will be described later.
  • the balloon 2 may have an inner protrusion that protrudes inward in the radial direction y1 from the inner surface of the balloon body 20. It is preferable that the protrusion 28 and the inner protrusion are arranged at the same position in the circumferential direction z1.
  • the inner protrusion is preferably integrally molded with the balloon body 20 and the protrusion 28, and the inner protrusion is preferably formed from the same material as the balloon body 20.
  • the material forming the inner protrusion may be different from the material forming the balloon body 20, provided there is some degree of compatibility with the material forming the balloon body 20.
  • one protrusion 28 may be provided in the circumferential direction z1, or as shown in FIG. 4, a plurality of protrusions 28 may be provided in the circumferential direction z1.
  • the plurality of protrusions 28 are preferably spaced apart in the circumferential direction z1, and are arranged at equal intervals in the circumferential direction z1. is more preferable.
  • the separation distance is longer than the maximum circumference of the protrusion 28.
  • the protruding portion 28 is a portion that is formed to be thicker on the outside in the radial direction y1 than the film thickness at a predetermined position of the balloon body portion 20.
  • the predetermined position is a position A facing the outer end 28T of the protrusion 28 in the radial direction y1 in the circumferential direction z1, as shown in FIG.
  • the position B corresponds to the midpoint in the circumferential direction z1 of the outer ends 28T of the protrusions 28 adjacent in the circumferential direction z1.
  • the maximum height of the protrusion 28 in the radial direction y1 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 at the predetermined position of the balloon body 20. Preferably, it is also permissible that it is 100 times or less, 50 times or less, 30 times or less, or 10 times or less. If the maximum height of the protruding portion 28 in the radial direction y1 is within the above range, it will be easier to make a cut to an appropriate depth in the narrowed portion, making it easier to form a crack.
  • the cross-sectional shape of the protrusion 28 in a cross section perpendicular to the longitudinal axis direction x1 may be arbitrary, for example, triangular, quadrilateral, polygonal, semicircular, part of a circle, approximately circular, fan-shaped, wedge-shaped, convex shape, etc. It may be spindle-shaped, a combination thereof, or the like.
  • triangles, quadrilaterals, and polygons include not only those with clear corner vertices and straight sides, but also so-called rounded polygons with rounded corners, and those with at least one side. This shall also include those whose portions are curved.
  • the cross-sectional shape of the protruding portion 28 may be an irregular shape having unevenness, notches, or the like.
  • the protrusion 28 is formed in a linear or dot shape, it is preferable that the protrusion 28 is arranged so as to extend along the longitudinal axis direction x1. Alternatively, the protrusion 28 may be arranged to extend spirally around the longitudinal axis.
  • the surface of the protrusion 28 corresponds from a position P 0 at a height of 0 to a position P 40 at a height of 40, when the maximum height of the protrusion 28 in the radial direction y1 is 100 . It has a proximal region 28b, an intermediate region 28m corresponding to a position P 40 to a position P 70 at a height of 70 , and a distal region 28t corresponding to a region from a position P 70 to a position P 90 at a height 90.
  • the surface roughness of the tip region 28t is smaller than the surface roughness of the intermediate region 28m
  • the surface roughness of the proximal region 28b is smaller than the surface roughness of the intermediate region 28m.
  • the reference length is 50 ⁇ m
  • the arithmetic mean roughness of the reference length is measured at 10 different positions in the circumferential direction z1, and the average of the 10 obtained arithmetic mean roughnesses is defined as the surface roughness of each region.
  • the surface roughness is the arithmetic mean roughness Ra of the roughness curve at the reference length, and the reference length is 50 ⁇ m.
  • the above arithmetic mean roughness Ra corresponds to the arithmetic mean roughness Ra defined in JIS B 0601 (2001).
  • a laser microscope VK-X3000 equipped with a white interferometer manufactured by Keyence Corporation can be used.
  • FIG. 6 shows an example of an image obtained when the surface roughness of region R in FIG. 2 is measured using a VK-X3000.
  • the direction of the reference length at each position is not particularly limited, and may be parallel to or perpendicular to the longitudinal axis direction x1, or may be at any angle with respect to the longitudinal axis direction x1. good.
  • the maximum height of the protrusion 28 is defined as the distance from the line connecting the proximal ends 28B on both sides of the protrusion 28 to the outer end 28T in the vertical direction in a cross section perpendicular to the longitudinal axis direction x1,
  • a position P 0 with a height of 0 is a position where the proximal end 28B of the protrusion 28 is arranged in the radial direction y1
  • a position P 100 with a height of 100 is the outer end 28T of the protrusion 28 in the radial direction y1. This is the position where is placed.
  • the proximal end 28B of the protruding portion 28 is a portion of the protruding portion 28 where the film thickness starts to become thicker on the outside in the radial direction y1 than the film thickness at the above-mentioned predetermined position of the balloon main body portion 20.
  • the protrusion 28 bites into the stenosis and forms a crack, thereby expanding the stenosis.
  • the resistance when the protruding portion 28 starts to bite into the narrowed portion is reduced, so that the protruding portion 28 easily penetrates into the narrowed portion.
  • the resistance to pushing increases, making it difficult for the entire protrusion 28 to enter the constriction.
  • the entire protruding portion 28 can be inserted into the stenosis to perform efficient incision. Furthermore, since the surface roughness of the intermediate region 28m located between the distal end region 28t and the proximal end region 28b is large, non-slip performance in which the protruding portion 28 is difficult to shift from the intended position can be improved. In this way, by reducing the surface roughness of the proximal region 28b and the distal region 28t and increasing the surface roughness of the intermediate region 28m, non-slip performance can be achieved without impairing the scoring performance of the protrusion 28 biting into the narrowed region.
  • the balloon 2 can have improved properties.
  • the surface roughness of each region is determined by measuring the arithmetic mean roughness for a reference length of 50 ⁇ m that has an arbitrary angle with the longitudinal axis direction
  • the arithmetic mean roughness of nine line segments having a length can be measured, and the average of the ten obtained arithmetic mean roughnesses can be taken as the surface roughness of each region.
  • the arbitrary angle may be, for example, 0° or 90°.
  • the predetermined interval may be, for example, 0.5 ⁇ m, 1 ⁇ m, 1.5 ⁇ m, 2 ⁇ m, 2.5 ⁇ m, 3 ⁇ m, 4 ⁇ m, 5 ⁇ m, or the like. For example, if the predetermined interval is 1 ⁇ m, it can be said that the surface roughness was measured for a region having an area of 9 ⁇ m ⁇ 50 ⁇ m.
  • the surface roughness of the proximal region 28b, the intermediate region 28m, and the distal region 28t may be compared at the same position in the longitudinal axis direction x1 or at different positions in the longitudinal axis direction x1. It is preferable that the comparison be made at the same position in the axial direction x1.
  • the same position may be the exact same position in the longitudinal axis direction x1, or the position of the measurement area in the proximal region 28b, the intermediate region 28m, and the distal region 28t may be at least partially in the longitudinal axis direction x1. It may also mean that they overlap.
  • the surface roughness of the tip region 28t is smaller than the surface roughness of the intermediate region 28m
  • the surface roughness of the proximal region 28b is smaller than the surface roughness of the intermediate region 28m.
  • the balloon 2 can have improved scoring performance and non-slip performance of the protrusion 28.
  • the surface roughness of each region may be compared in the straight pipe section 23, and when the surface roughness of each region in the straight pipe section 23 satisfies the above relationship, the protrusion 28 disposed on the straight pipe section 23 This allows the balloon 2 to have improved scoring performance and non-slip performance, making it possible to dilate the stenotic region more efficiently. Note that when a plurality of protrusions 28 are provided, the surface roughness of any one protrusion 28 may be measured.
  • the surface roughness of the proximal region 28b is preferably 0.9 times or less than the surface roughness of the intermediate region 28m, more preferably 0.8 times or less, even more preferably 0.6 times or less, 0.5 times or less, 0. It may be .4 times or less, preferably 0.01 times or more, more preferably 0.05 times or more, and even more preferably 0.1 times or more.
  • the balloon 2 can have the entire protrusion 28 easily bite into the stenosis.
  • the surface roughness of the tip region 28t is preferably 0.98 times or less than the surface roughness of the intermediate region 28m, more preferably 0.95 times or less, even more preferably 0.9 times or less, 0.85 times or less, and 0.9 times or less. It may be 8 times or less, or 0.5 times or less, preferably 0.01 times or more, more preferably 0.05 times or more, and even more preferably 0.1 times or more. Within the above range, the balloon 2 can have a protrusion 28 that easily begins to enter the stenosis.
  • each region of all the protrusions 28 satisfy the above relationship. This makes effective dilation of the stenosis easier.
  • the surface roughness of the proximal region 28b is preferably smaller than the surface roughness of the distal region 28t.
  • the distal end region 28t which penetrates into the stenotic region at an early stage, can penetrate with relatively low resistance to pushing, whereas the proximal region 28b, which penetrates into the final stage, has a large resistance to pushing, and the entire protrusion 28 penetrates into the stenotic region.
  • the surface roughness of the proximal region 28b is smaller than the surface roughness of the distal region 28t, the frictional resistance of the proximal region 28b can be reduced, allowing the entire protrusion 28 to enter the constriction and score. Ring performance can be further improved.
  • the surface roughness of the distal end region 28t and the proximal end region 28b may be compared at the same position in the longitudinal axis direction x1 or at different positions in the longitudinal axis direction x1; Preferably, they are compared by position. Since the surface roughness of the proximal end region 28b disposed at the same position in the longitudinal axis direction x1 is smaller than the surface roughness of the distal end region 28t, the protrusion 28 at that position can produce the above effect. For example, it is preferable that the surface roughness of each region is compared in the straight pipe portion 23.
  • the surface roughness of the proximal region 28b is preferably 0.9 times or less, more preferably 0.8 times or less, even more preferably 0.6 times or less, and even more preferably 0.5 times the surface roughness of the distal region 28t. It may be 0.4 times or less, preferably 0.01 times or more, more preferably 0.05 times or more, even more preferably 0.1 times or more. Within the above range, the balloon 2 can have the entire protrusion 28 easily bite into the stenosis.
  • the distal end region 28t and base end region 28b of all the protrusions 28 satisfy the above relationship. This makes effective dilation of the stenosis easier.
  • the surface of the protrusion 28 has a most extreme region 28p corresponding to a position P 90 to a position P 100 with a height of 100. It is preferable that the surface roughness of the leading edge region 28p is larger than the surface roughness of the leading edge region 28t when measured by the above measuring method. Since the surface roughness of the most extreme region 28p that first contacts the stenotic region is relatively large, the most extreme region 28p does not easily shift from the blood vessel wall at the stenotic region when starting to make an incision into the stenotic region, and the protruding portion 28 It becomes easier to bite into the desired position.
  • the surface roughness of the leading edge region 28p is preferably 1.1 times or more, more preferably 1.2 times or more, even more preferably 1.5 times or more, particularly preferably 2 times or more, as much as the surface roughness of the leading edge region 28t. Moreover, it is preferably 8 times or less, more preferably 7 times or less, and even more preferably 6 times or less.
  • the surface roughness of the leading edge region 28p is preferably smaller than the surface roughness of the intermediate region 28m.
  • the surface roughness of the leading edge region 28p is preferably 0.9 times or less than the surface roughness of the intermediate region 28m, more preferably 0.8 times or less, even more preferably 0.6 times or less, 0.5 times or less, It may be 0.4 times or less, preferably 0.05 times or more, more preferably 0.1 times or more, and even more preferably 0.2 times or more. Within the above range, it is possible to prevent the most extreme region 28p from being excessively caught on the blood vessel wall.
  • the surface roughness of the leading edge region 28p may be greater than the surface roughness of the intermediate region 28m. This makes it easier to prevent the distal end region 28p of the protrusion 28 from getting caught on the blood vessel wall and displacing the protrusion 28 from the intended position when starting to make an incision into the stenosis.
  • the balloon 2 can be made incisable.
  • the surface roughness of the leading edge region 28p may be 1.05 times or more, 1.1 times or more, 1.2 times or more, 1.5 times or more, etc., than the surface roughness of the intermediate region 28m. Moreover, it is preferable that it is 5 times or less, 4 times or less, and 3 times or less.
  • the surface roughness of the leading edge region 28p can be obtained, for example, by measuring the arithmetic mean roughness over a reference length in a direction parallel to the longitudinal axis direction x1. If a reference length of 50 ⁇ m is taken in a direction parallel to the longitudinal axis direction x1, the surface roughness of the most extreme region 28p is determined even if the length in the direction perpendicular to the longitudinal axis direction x1 of the surface of the most extreme region 28p is less than 50 ⁇ m. It is possible to measure In addition, by adjusting the predetermined intervals of the reference lengths at ten different positions, the surface of the most advanced region 28p can be Roughness can be measured.
  • the reference length is 50 ⁇ m
  • the arithmetic mean roughness is measured at 10 different positions in the longitudinal axis direction x1 for the reference length in the direction perpendicular to the longitudinal axis direction x1, and the average of the 10 arithmetic mean roughnesses obtained is
  • the surface roughness of the balloon body 20 is preferably larger than the surface roughness of the proximal end region 28b, where is the surface roughness of each region.
  • the direction perpendicular to the longitudinal axis direction x1 is the direction indicated by arrow b.
  • the surface roughness in the direction perpendicular to the longitudinal axis direction x1 affects the resistance to invasion into the stenosis, and the balloon 2 according to the embodiment of the present invention has a surface roughness in the direction perpendicular to the longitudinal axis direction x1 of the proximal end region 28b. Due to the small surface roughness, the entire protrusion 28 can easily enter the constriction, but since the surface roughness in the direction perpendicular to the longitudinal axis direction x1 of the balloon main body 20 is larger than the proximal region 28b, the balloon Even the main body portion 20 can be prevented from entering the narrowed portion. This can prevent the crack from becoming too wide than necessary.
  • the surface roughness of the balloon body 20 in the direction perpendicular to the longitudinal axis x1 is preferably 1.2 times or more, and 1.5 times or more, the surface roughness of the proximal region 28b in the direction perpendicular to the longitudinal axis x1. is more preferable, 2 times or more is even more preferable, 3 times or more is especially preferable, 10 times or less is preferable, 9 times or less is more preferable, and even more preferably 8 times or less.
  • the reference length is 50 ⁇ m
  • the arithmetic mean roughness is measured at 10 different positions in the circumferential direction z1 for the reference length in the direction parallel to the longitudinal axis direction x1, and the average of the 10 obtained arithmetic mean roughnesses is Regarding the surface roughness of each region, it is preferable that the surface roughness of the balloon main body portion 20 is smaller than the surface roughness of the proximal end region 28b.
  • the direction parallel to the longitudinal axis direction x1 is the direction indicated by arrow a.
  • the surface roughness of the balloon body 20 in the direction parallel to the longitudinal axis direction x1 is preferably 0.99 times or less, and preferably 0.8 times or less, of the surface roughness of the proximal region 28b in the direction parallel to the longitudinal axis direction x1. is more preferable, 0.7 times or less is even more preferable, 0.3 times or more is preferable, 0.4 times or more is more preferable, and even more preferably 0.5 times or more.
  • Examples of materials constituting the balloon body 20 and the protrusion 28 include polyolefin resins such as polyethylene, polypropylene, and ethylene-propylene copolymers; polyester resins such as polyethylene terephthalate and polyester elastomers; polyurethane, polyurethane elastomers, etc.
  • Examples include polyurethane resin; polyphenylene sulfide resin; polyamide resin such as polyamide and polyamide elastomer; fluorine resin; silicone resin; natural rubber such as latex rubber. These may be used alone or in combination of two or more.
  • polyamide resins, polyester resins, and polyurethane resins are preferred, polyamide resins such as nylon 12 and nylon 11 are more preferred, and nylon 12 is particularly preferred. From the viewpoint of thinning and flexibility of the balloon body 20, it is preferable to use an elastomer resin, and a polyamide elastomer such as a polyamide ether elastomer is preferably used.
  • FIG. 7 depicts a perspective view of a parison before inflation according to an embodiment of the invention.
  • FIG. 8 shows a longitudinal sectional view of a mold according to an embodiment of the present invention, and
  • FIG. 9 shows a sectional view taken along line IX-IX in FIG.
  • the balloon 2 can be manufactured by placing the parison 200 in a mold 300 and blow molding the parison 200.
  • the parison 200 is a cylindrical member that is made of resin and has an inner cavity 205. Parison 200 is produced, for example, by extrusion molding.
  • the parison 200 has a first end 201 and a second end 202, and extends in the longitudinal axis direction x2 from the first end 201 to the second end 202.
  • the parison 200 has a radial direction y2 and a circumferential direction z2.
  • the cross-sectional shape of the parison 200 perpendicular to the longitudinal axis direction x2 may be substantially uniform in the longitudinal axis direction x2. This increases the productivity of the parison 200.
  • the cross-sectional shape of the parison 200 perpendicular to the longitudinal axis direction x2 may differ depending on the position in the longitudinal axis direction x2.
  • a part of the parison 200 in the longitudinal axis direction x2 may have a larger outer diameter than other parts, and the part with the larger outer diameter may be formed to serve as the straight tube part 23 of the balloon 2.
  • blow molding may be performed in advance using a mold.
  • the parison 200 before inflation may have a protrusion 208 whose thickness increases outward in the radial direction y2.
  • the protrusion 28 of the balloon 2 can be easily formed.
  • a plurality of protrusions 208 may be provided in the circumferential direction z2, or one protrusion 208 may be provided in the circumferential direction z2, although not shown.
  • the plurality of protrusions 208 are preferably spaced apart in the circumferential direction z2, and more preferably arranged at equal intervals in the circumferential direction z2.
  • the above description regarding the resin constituting the balloon body 20 and the protrusion 28 can be referred to.
  • the mold 300 has a longitudinal axis direction x3, a radial direction y3, and a circumferential direction z3, and has an inner cavity 305 that extends in the longitudinal axis direction x3 and into which the parison 200 is inserted. are doing. It is preferable that a portion of the parison 200 in the longitudinal axis direction x2 be disposed in the inner cavity 305 of the mold 300. It is preferable that the longitudinal axis direction x2 of the parison 200 and the longitudinal axis direction x3 of the mold 300 coincide. This makes it easier to place the parison 200 in the inner cavity 305 of the mold 300.
  • the mold 300 includes, in the longitudinal axis direction x3, a mold straight pipe part 300C that forms the straight pipe part 23 of the balloon 2, and two mold straight pipe parts that are arranged on both sides of the mold straight pipe part 300C and form the tapered part of the balloon 2. It is preferable to have a mold tapered part 300T and two mold sleeve parts 300S that are arranged on a side farther from the mold straight pipe part 300C than the mold taper part 300T and form the sleeve part of the balloon 2. .
  • the straight pipe part 23 of the balloon 2 is formed by the mold straight pipe part 300C
  • the proximal tapered part 22 and the distal taper part 24 of the balloon 2 are formed by the mold taper part 300T
  • the mold sleeve The proximal sleeve portion 21 and the distal sleeve portion 25 of the balloon 2 may be formed by the portion 300S.
  • the mold 300 may be composed of one member or may be composed of multiple members. As shown in FIG. 8, a plurality of mold members may be configured by being connected to each other in the longitudinal axis direction The parts 300S may be different mold members, and these may be connected to each other in the longitudinal axis direction x3. Furthermore, the mold 300 may be divisible in the radial direction y3.
  • the inner cavity 305 of the mold 300 is formed of a groove 310 that is recessed outward in the radial direction y3 and extends in the longitudinal axis direction x3, and a cylindrical wall portion 320 other than the groove 310. is preferred.
  • the balloon 2 having the protrusion 28 can be manufactured by inserting the parison 200 into the groove 310 of the mold 300 and blow-molding the parison 200 by introducing fluid into the inner cavity 205 of the parison 200.
  • the groove portion 310 is provided in the mold straight pipe portion 300C of the mold 300.
  • the protrusion 28 can be formed on the straight pipe portion 23 of the balloon 2, so that the efficiency of incising the stenosis by the balloon 2 can be increased.
  • the groove portion 310 may also be provided in at least one of the two first mold tapered portions 300T of the mold 300. This allows the protrusion 28 to be formed on the proximal tapered portion 22 and/or the distal tapered portion 24 of the balloon 2, thereby improving the non-slip performance of the balloon 2 in the stenotic region.
  • the depth of the groove portion 310 provided in the mold taper portion 310T is equal to or less than the depth of the groove portion 310 provided in the mold straight pipe portion 300C. It is preferable that there be.
  • the height of the protruding part 28 formed on the proximal tapered part 22 and/or the distal tapered part 24 of the balloon 2 can be made equal to or less than the height of the protruding part 28 formed on the straight tube part 23.
  • the inner protrusion may be formed in a portion where the protrusion 28 is not formed or the protrusion 28 is formed at a low height.
  • the groove portion 310 may or may not be provided in the mold sleeve portion 300S of the mold 300.
  • the depth of the groove portion 310 provided in the mold sleeve portion 300S may be shallower than the depth of the groove portion 310 provided in the mold straight pipe portion 300C. preferable.
  • the height of the protrusion 28 formed on the proximal sleeve part 21 and/or the distal sleeve part 25 can be lower than the height of the protrusion formed on the straight tube part 23, so that the balloon 2 can pass through. Performance can be improved.
  • the proximal sleeve part 21 and/or the distal sleeve part 25 of the balloon 2 can have a configuration in which the protruding part 28 is not formed. can further improve passing performance.
  • the inner protrusion may be formed in a portion where the protrusion 28 is not formed or the protrusion 28 is formed at a low height.
  • the surface roughness of the balloon body 20 is greater than the surface roughness of the proximal region 28b when measured over a reference length in the direction perpendicular to the longitudinal axis direction x1, and the surface roughness is measured per reference length in a direction parallel to the longitudinal axis direction x1.
  • a method for manufacturing the balloon 2 such that the surface roughness of the balloon body 20 is smaller than that of the proximal region 28b is to rotate the inner cylinder wall 320 forming the balloon body 20 in the longitudinal direction
  • a method of forming minute polishing marks in the longitudinal axis direction x3 by polishing to a depth of 100 degrees is exemplified.
  • the material constituting the mold 300 is preferably metal, and more preferably iron, copper, aluminum, or an alloy thereof.
  • iron alloys include stainless steel
  • copper alloys include brass
  • aluminum alloys include duralumin.
  • a balloon catheter 1 according to an embodiment of the present invention includes the balloon 2 for a balloon catheter. As described in the above section "1. Balloon for Balloon Catheter", the balloon 2 is connected to the distal end of the distal shaft 31, as shown in FIG.
  • FIG. 1 shows an inner shaft 60 that has a guidewire port 50 on the way from the distal side to the proximal side of the shaft 30 and functions as a guidewire insertion path from the guidewire port 50 to the distal side of the shaft 30.
  • a so-called rapid exchange type balloon catheter 1 is shown. It is preferable that the balloon catheter 1 has a distal shaft 31 and a proximal shaft 32, and the distal shaft 31 and the proximal shaft 32 are separate members, and the distal shaft 31 and the proximal shaft 32 are separate members.
  • the shaft 30 extending from the balloon 2 to the proximal end of the balloon catheter 1 may be configured such that its proximal end is connected to the distal end of the proximal shaft 32 .
  • one shaft 30 may extend from the balloon 2 to the proximal end of the balloon catheter 1, and the distal shaft 31 and the proximal shaft 32 may further include a plurality of tube members. good.
  • the shaft 30 has an internal fluid flow path and a guide wire insertion path.
  • the inner shaft 60 disposed inside the shaft 30 functions as a guide wire insertion path, and the shaft 30 and the inner
  • the space between the shafts 60 functions as a fluid flow path.
  • the inner shaft 60 extends from the distal end of the shaft 30 and passes through the balloon 2, the distal side of the balloon 2 is connected to the inner shaft 60, and the proximal side of the balloon 2 is connected to the shaft 30. It is preferable that
  • the shaft 30 is preferably made of resin, metal, or a combination of resin and metal.
  • resin By using resin as a constituent material of the shaft 30, flexibility and elasticity can be easily imparted to the shaft 30. Further, by using metal as the constituent material of the shaft 30, the delivery performance of the balloon catheter 1 can be improved.
  • the resin constituting the shaft 30 include polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine resin, vinyl chloride resin, silicone resin, natural rubber, and synthetic rubber. These may be used alone or in combination of two or more.
  • the metal forming the shaft 30 examples include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloy, Co-Cr alloy, or a combination thereof.
  • the shaft 30 is composed of a distal shaft 31 and a proximal shaft 32 that are separate members, for example, the distal shaft 31 is made of resin and the proximal shaft 32 is made of metal. be able to. Further, the shaft 30 may have a laminated structure made of different materials or the same material.
  • the balloon 2 and the shaft 30 may be joined together by bonding with an adhesive, by welding, or by attaching a ring-shaped member to the area where the end of the balloon 2 and the shaft 30 overlap and caulking. Above all, it is preferable that the balloon 2 and the shaft 30 are joined by welding. Since the balloon 2 and the shaft 30 are welded together, the bond between the balloon 2 and the shaft 30 is unlikely to be released even if the balloon 2 is repeatedly expanded or deflated, and the bonding strength can be improved.
  • a tip member 70 is preferably provided at the distal end of the balloon catheter 1.
  • the tip member 70 may be provided at the distal end of the balloon catheter 1 by being connected to the distal end of the balloon 2 as a separate member from the inner shaft 60, or may be provided at the distal end of the balloon catheter 1.
  • the inner shaft 60 extending to the distal side may function as the tip member 70.
  • an X-ray opaque marker 80 is arranged at a portion where the balloon 2 is located in the longitudinal axis direction x1 so that the position of the balloon 2 can be confirmed under X-ray fluoroscopy. Good too.
  • the X-ray opaque marker 80 is preferably arranged at positions corresponding to both ends of the straight tube section 23 of the balloon 2, and may be arranged at a position corresponding to the center of the straight tube section 23 in the longitudinal axis direction x1. .
  • a hub 5 may be provided on the proximal side of the shaft 30, and it is preferable that the hub 5 is provided with a fluid injection part 6 that communicates with a flow path for fluid supplied to the inside of the balloon 2.
  • the shaft 30 and the hub 5 may be joined by, for example, adhesive bonding, welding, or the like. Among these, it is preferable that the shaft 30 and the hub 5 are joined by adhesive. Since the shaft 30 and the hub 5 are bonded together, for example, the shaft 30 is made of a highly flexible material and the hub 5 is made of a highly rigid material. When the materials constituting the balloon catheter 5 are different, the strength of the joint between the shaft 30 and the hub 5 can be increased, and the durability of the balloon catheter 1 can be improved.
  • the present invention can also be applied to a so-called over-the-wire balloon catheter, which has a guide wire insertion path from the distal side to the proximal side of the shaft.
  • the inflation lumen and the guide wire lumen extend to a hub disposed on the proximal side, and the proximal opening of each lumen is provided in the bifurcated hub.
  • the outer wall of the distal shaft 31 and/or the proximal shaft 32 is appropriately coated, and both the distal shaft 31 and the proximal shaft 32 are coated. It is more preferable that In the case of over-the-wire catheters, the outer wall of the outer shaft is preferably coated appropriately.
  • the coating can be a hydrophilic coating or a hydrophobic coating depending on the purpose, and the shaft 30 may be dipped in a hydrophilic coating agent or a hydrophobic coating agent, or the outer wall of the shaft 30 may be coated with a hydrophilic coating agent or a hydrophobic coating agent. This can be done by coating the outer wall of the shaft 30 with a hydrophilic coating or a hydrophobic coating.
  • the coating agent may contain drugs and additives.
  • hydrophilic coating agent examples include hydrophilic polymers such as polyvinyl alcohol, polyethylene glycol, polyacrylamide, polyvinyl pyrrolidone, methyl vinyl ether maleic anhydride copolymer, or hydrophilic coating agents made from any combination thereof. It will be done.
  • Hydrophobic coating agents include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), silicone oil, hydrophobic urethane resin, carbon coat, diamond coat, and diamond-like carbon (DLC). ) coat, ceramic coat, and substances terminated with alkyl groups or perfluoroalkyl groups with low surface free energy.
  • PTFE polytetrafluoroethylene
  • FEP fluorinated ethylene propylene
  • PFA perfluoroalkoxyalkane
  • silicone oil silicone oil
  • hydrophobic urethane resin carbon coat
  • diamond coat diamond-like carbon
  • Balloon catheter 2 Balloon for balloon catheter 5: Hub 6: Fluid injection section 20: Balloon body section 21: Proximal sleeve section 22: Proximal tapered section 23: Straight tube section 24: Distal tapered section 25 : Distal sleeve part 28 : Protruding part 28 b : Proximal region 28 B : Proximal end 28 m : Intermediate region 28 p : Most extreme region 28 t : Tip region 28 T : Outer end 30 : Shaft 31 : Distal shaft 32 : Proximal Side shaft 50: Guidewire port 60: Inner shaft 70: Tip member 80: Radiopaque marker 200: Parison 201: Parison first end 202: Parison second end 205: Parison lumen 208: Parison protrusion Section 300: Mold 300C: Mold straight pipe section 300S: Mold sleeve section 300T: Mold tapered section 305: Mold inner cavity 310: Groove section 320: Inner cylinder wall x1

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un ballonnet pour un cathéter à ballonnet qui peut facilement permettre à une partie saillante de mordre dans une sténose et d'améliorer les propriétés de non-glissement qui empêchent le ballonnet de passer d'une lésion.　Le ballonnet pour un cathéter à ballonnet comprend un corps de ballonnet (20) et une partie saillante (28). Le corps de ballonnet (20) et la partie saillante (28) sont constitués du même matériau. La surface de la partie saillante (28) a une région d'extrémité basale (28b) correspondant de la position (P0) à la position (P40), une région centrale (28m) correspondant de la position (P40) à la position (P70) et une région de pointe (28t) correspondant de la position (P70) à la position (P90). La rugosité de surface de la région de pointe (28t) est inférieure à la rugosité de surface de la région centrale (28m), et la rugosité de surface de la région d'extrémité basale (28b) est inférieure à la rugosité de surface de la région centrale (28m).
PCT/JP2023/027371 2022-08-24 2023-07-26 Ballonnet pour cathéter à ballonnet et cathéter à ballonnet pourvu de celui-ci WO2024042978A1 (fr)

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JP2022133114 2022-08-24
JP2022-133114 2022-08-24

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020250611A1 (fr) * 2019-06-11 2020-12-17 株式会社カネカ Ballonnet pour cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020250611A1 (fr) * 2019-06-11 2020-12-17 株式会社カネカ Ballonnet pour cathéter à ballonnet et procédé de fabrication de cathéter à ballonnet

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