CN-116744998-B - Balloon for balloon catheter

Abstract

Provided is a balloon for a balloon catheter which is easy to insert into a body cavity, has excellent pushability, and can easily cut a stricture. A balloon (1) for a balloon catheter has a balloon body (20), wherein the balloon body (20) has a protruding portion (60), the protruding portion (60) protrudes outward in the radial direction y from the outer surface of the straight tube portion (23) and the proximal cone portion (22), extends in the long axis direction x, and the ratio W 1 /H 1 of the height H 1 of the protruding portion (60) to the width W 1 of the protruding portion (60) at the straight tube portion (23) is larger than the ratio W 2 /H 2 of the height H 2 of the protruding portion (60) to the width W 2 of the protruding portion (60) at the proximal cone portion (22).

Inventors

• Shinhiro Koizumi
• ZhangTian Changren
• NAKANISHI RYO
• Bin Yuan Chong Gen

Assignees

• 株式会社钟化

Dates

Publication Date

20260505

Application Date

20220204

Priority Date

20210315

Claims (12)

1. 1. A balloon for a balloon catheter is characterized in that, Comprising a balloon body having an outer surface and an inner surface, And has a longitudinal axis direction, a radial direction, and a circumferential direction, wherein the radial direction is a direction connecting a centroid of a figure having an outline of the balloon body in an expanded state and a point on the outer surface in a cross section perpendicular to the longitudinal axis direction, the circumferential direction is a direction along an outer periphery of the balloon body in an expanded state in the cross section in the radial direction, The balloon body has a straight tube portion, a proximal cone portion located on the side of the straight tube portion, and a distal cone portion located on the side of the straight tube portion, The balloon body has protruding portions at the straight tube portion and the proximal cone portion, the protruding portions protruding from an outer surface of the balloon body to the outside in the radial direction and extending in the long axis direction, The ratio W 1 /H 1 of the height H 1 of the protruding portion at the straight tube portion to the width W 1 of the protruding portion is larger than the ratio W 2 /H 2 of the height H 2 of the protruding portion at the proximal cone portion to the width W 2 of the protruding portion, The distal-side tapered portion has the protruding portion, the height H 3 of the protruding portion of the distal-side tapered portion is lower than the height H 1 of the protruding portion of the straight tube portion, Here, the height and width of the protruding portion are defined as follows: taking the difference between the radius of the circumscribing circle C b of the balloon main body and the radius of the circumscribing circle C p of the protruding part sharing the center with the circumscribing circle C b as the height of the protruding part, The maximum value of the lengths of the arcs inside the outline of the protruding portion in the circumference of the concentric circle sharing the center with the circumscribing circle C b in the radial cross section is taken as the width of the protruding portion.
2. 2. The balloon for a balloon catheter according to claim 1, wherein, The width W 1 of the protruding portion at the straight tube portion is wider than the width W 2 of the protruding portion at the proximal cone portion.
3. 3. The balloon for a balloon catheter according to claim 1 or 2, wherein, The ratio W 1 /H 1 at the straight pipe portion is 0.2 or more and 5 or less.
4. 4. The balloon for a balloon catheter according to claim 1 or 2, wherein, The ratio W 2 /H 2 at the proximal cone is 0.2 or more and 5 or less.
5. 5. The balloon for a balloon catheter according to claim 1 or 2, wherein, In the radial cross section, the protruding portion of the straight tube portion has a tip portion, a ratio W T /W 1 of a width W T of the tip portion of the protruding portion to a width W 1 of the protruding portion is 0.5 or less, Here, the width of the tip portion of the protruding portion is defined as follows: The width of the tip portion is defined by the length of an arc located inside the outline of the protruding portion, out of the circumferences of circles having a radius of 95% of the radius of the circumscribed circle C p and concentric circles sharing the center with the circumscribed circle C p in the radial cross section.
6. 6. The balloon for a balloon catheter according to claim 1 or 2, wherein, The height H 1 of the protruding part of the straight pipe part is at least 0.1 mm.
7. 7. The balloon for a balloon catheter according to claim 1 or 2, wherein, In the radial cross section, the protruding portion of the straight tube portion has a tip portion having an angle of 135 ° or less.
8. 8. The balloon for a balloon catheter according to claim 1 or 2, wherein, The protruding portion of the straight tube portion and the protruding portion of the proximal cone portion extend continuously in the long axis direction.
9. 9. The balloon for a balloon catheter according to claim 1 or 2, wherein, The protruding portion of the straight tube portion and the protruding portion of the distal-side tapered portion extend continuously in the long axis direction.
10. 10. The balloon for a balloon catheter according to claim 1 or 2, wherein, The distal cone portion has an inner protruding portion protruding from an inner surface of the balloon body toward the radial inner side and extending in the long axis direction.
11. 11. The balloon for a balloon catheter according to claim 10, wherein, The protruding portion and the inner protruding portion of the distal-side tapered portion are arranged at the same position in the circumferential direction.
12. 12. The balloon for a balloon catheter according to claim 1 or 2, wherein, The protrusion is composed of the same material as the balloon body.

Description

Balloon for balloon catheter Technical Field The present invention relates to a balloon for a balloon catheter. Background Diseases such as angina pectoris and myocardial infarction are caused by the formation of a hardened stenosed portion such as calcification on the inner wall of a blood vessel. As one of their treatments, there is an angiogenesis operation for dilating a stricture using a balloon catheter. The angiogenesis operation is a low invasive therapy that does not require an open chest operation such as bypass operation, and is widely performed. In the vascular surgery, it is sometimes difficult to dilate a stricture portion hardened by calcification or the like in a general balloon catheter. In addition, a method of dilating a stenosed portion by indwelling an indwelling Stent called Stent In the stenosed portion has been used, but there are cases such as an ISR (In-Stent-Restenosis) lesion In which a neointima of a blood vessel is excessively proliferated and a stenosis of the blood vessel is reproduced after the treatment. In ISR lesions, since the neointima is soft and the surface thereof easily slides, there is a case where a balloon is displaced from a lesion to damage a blood vessel when the balloon is expanded in a general balloon catheter. As a balloon catheter capable of dilating a stricture even with such calcified lesions or ISR lesions, a balloon catheter provided with a projection, a braid, or a scoring element for biting into the stricture in the balloon has been developed. For example, patent document 1 discloses a balloon catheter in which the protruding amount of a protruding portion disposed on the tip side taper portion is larger than the protruding amount of a protruding portion disposed on the straight tube portion. Patent document 2 discloses a balloon catheter in which an expansion element connected to the outer surface of a balloon by a connector has a first effective width and a second effective width, and the first effective width is smaller than the second effective width. Patent document 1 International publication No. 2020/0126850 pamphlet Patent document 2 Japanese patent application laid-open No. 2011-513031 The balloon catheter is inserted into the body cavity in a contracted state and delivered to the treatment site through the body cavity. At the time of delivery, the delivery of the balloon is controlled by transmitting an operation from the hand side to the tip side where the balloon is disposed. In this case, the insertion into the body cavity is easy, and the operation from the hand side is easy to transfer to the distal end side (high pushability), so that the treatment safety can be improved, the treatment time can be shortened, and the patient can be treated with a small burden. In addition, it is required to perform a narrow incision efficiently and easily after the balloon is delivered to the treatment site. However, the conventional balloon catheter has room for improvement in terms of ease of insertion into a body cavity, pushability, and ease of incision in a stricture. Disclosure of Invention In view of the above, an object of the present invention is to provide a balloon for a balloon catheter which is easy to insert into a body cavity, has excellent pushability, and can easily cut a stricture. One embodiment of a balloon for a balloon catheter according to the present invention, which can solve the above-described problems, includes a balloon body having an outer surface and an inner surface, the balloon body having a longitudinal axis direction, a radial direction in which a centroid of a figure having an outline of the balloon body in an expanded state and a point on the outer surface are connected in a cross section perpendicular to the longitudinal axis direction, and a circumferential direction in which the balloon body in the radial direction is along the outer periphery of the balloon body in the expanded state, the balloon body having a straight tube portion, a proximal cone portion located on a position side of the straight tube portion, and a distal cone portion located on a position on a distal side of the straight tube portion, the balloon body having a protrusion protruding outward in the radial direction from the outer surface of the balloon body and extending in the longitudinal axis direction, the ratio W 1/H1 of the height H 1 of the protrusion at the straight tube portion to the width W 1 of the protrusion being larger than the ratio W 2/H2 of the height H 2 of the protrusion at the proximal cone portion to the width W3525 of the protrusion at the proximal cone portion. (Here, the height and width of the protruding portion are defined as follows. The difference between the radius of the circumscribing circle C b of the balloon body and the radius of the circumscribing circle C p of the projection sharing the center with the circumscribing circle C b in the radial cross section is taken as the projection height. The maximum value