Cutting balloon catheter

Abstract

The utility model provides a cutting balloon catheter. The cutting balloon catheter comprises a catheter body and a cutting balloon arranged at the far end of the catheter body in a sleeving mode. The cutting balloon comprises a balloon body and a strip-shaped blade arranged on the outer surface of the balloon body. The balloon body has a folded state, in the folded state, the balloon body comprises a plurality of lobes, and part of the lobes abut against the side wall of the strip-shaped blade; the maximum height of the part, abutting against the side wall of the blade, of the leaf is larger than or equal to the radial height of the blade. The leaflets formed by the cutting balloon in the compressed state are wound and folded, so that at least part of the leaflets abut against the side wall of the blade, the height of the leaflets abutting against the side wall of the blade is not lower than the highest point of the blade, the risk that the blade is obviously higher than the leaflets and is exposed outside, and consequently blood vessels are accidentally injured is reduced, and the cutting efficiency is improved. The overall uniformity of the balloon is high, and the excellent passing performance of the product in the blood vessel is guaranteed.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a cutting balloon catheter. Background Art

[0002] In the existing minimally invasive interventional treatment technology for vascular calcification, special balloons such as cutting balloons or scoring balloons are used to destroy plaques and dilate blood vessels to achieve the therapeutic effect of keeping blood vessels open. The cutting balloon is to install a micro blade on the balloon, and use the balloon expansion to prompt the blade to complete the plaque cutting action. The scoring balloon is to install a deformable metal mesh on the surface of the balloon, and then use the balloon expansion to expand the metal mesh, thereby forcing the metal mesh to squeeze and destroy the vascular plaque.

[0003] like Figure 1 and Figure 2 As shown, the cutting balloon 20' adopts the traditional "Z-shaped" folding method, which will result in no direct contact between the balloon leaflets 211' and the blade 22', that is, the leaflets 211' are pressed below the blade 22' during the winding process, and finally the blade 22' will be significantly higher than the leaflets 211' and exposed to the outside, posing a risk of accidentally damaging healthy blood vessels. Utility Model Content

[0004] In response to the problems in the prior art, the purpose of the utility model is to provide a cutting balloon catheter, in which part of the leaflets of the folded balloon body rest against the side wall of the blade and are not lower than the highest point of the blade, thereby reducing the risk of accidental damage to the blood vessel due to the blade being significantly higher than the leaflets and exposed to the outside.

[0005] An embodiment of the utility model provides a cutting balloon catheter, comprising a tube body and a cutting balloon sleeved on the distal end of the tube body, the cutting balloon comprising a balloon body and a strip-shaped blade arranged on the outer surface of the balloon body; the balloon body has a folded state, in which the balloon body comprises a plurality of lobes, some of the lobes abut against the side walls of the strip-shaped blade, and the maximum height of the part of the lobes abutting against the side walls of the blade is greater than or equal to the radial height of the blade.

[0006] In some embodiments, each of the leaflets has an "L" shape or a quasi-"L" shape in a cross section perpendicular to the central axis of the balloon body.

[0007] In some embodiments, each of the lobe has a "Z" shape in a cross-section perpendicular to the central axis of the balloon body, the middle of the "Z"-shaped lobe extends along the circumference of the balloon body, and the two ends of the "Z"-shaped lobe respectively abut against the side walls of two adjacent strip-shaped blades.

[0008] In some embodiments, the strip blade includes a cutting portion and a contact portion in contact with the balloon body, the cutting portion is located on a side of the contact portion facing away from the balloon body, and the contact portion is fixed to the outer surface of the balloon body.

[0009] In some embodiments, the edge of the strip blade is serrated or continuous line-shaped.

[0010] In some embodiments, the strip-shaped blades extend along the axial direction of the balloon body, and the plurality of leaflets are arranged along the circumferential direction of the balloon body.

[0011] In some embodiments, the outer surface of the balloon body is provided with a groove, and the strip-shaped blade is placed in the groove.

[0012] In some embodiments, the difference between the width of the groove and the width of the strip blade is 0.1 mm to 0.3 mm.

[0013] In some embodiments, the difference between the length of the groove and the length of the strip blade is 0.1 mm to 0.3 mm.

[0014] In some embodiments, the balloon body in the folded state has 3 to 6 leaflets.

[0015] The cutting balloon catheter provided by the utility model has the following advantages: the overall radial height of the balloon body in the folded state is small, which facilitates the cutting balloon catheter to pass through thinner blood vessels smoothly; at the same time, the multiple leaflets included in the balloon body in the folded state abut against the side walls of the strip-shaped blade, which can also stabilize the blade, and the maximum height of the leaflets abutting against the side walls of the blade is greater than or equal to the highest point of the strip-shaped blade, which can also significantly reduce the damage to the blood vessel when passing through the blood vessel and improve the passing performance of the cutting balloon catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Other features, objectives and advantages of the present invention will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings.

[0017] Figure 1 is a stereoscopic view of a cutting balloon folded using prior art techniques;

[0018] Figure 2 yes Figure 1 A cross-sectional view of the cutting balloon after folding;

[0019] Figure 3 is a cross-sectional view of the balloon body in a folded state;

[0020] Figure 4 is a stereoscopic view of a folded cutting balloon using an embodiment of the utility model;

[0021] Figure 5It is a schematic diagram of a cutting balloon catheter provided by an embodiment of the utility model;

[0022] Figure 6 yes Figure 5 Schematic diagram of the saccule in;

[0023] Figure 7 yes Figure 5 A three-dimensional view of a blade;

[0024] Figure 8 yes Figure 5 A cross-sectional view of a blade;

[0025] Fig. 9 It is a schematic diagram of a petal splitting tool used when folding a cutting balloon in an embodiment of the utility model;

[0026] Fig.10 It is a schematic diagram of a winding tool used when cutting and folding a balloon in one embodiment of the utility model.

[0027] Reference numerals:

[0028] 100 cutting balloon catheter 222 contact portion

[0029] 10 pipe body 30 pipe seat

[0030] 11 outer tube 31 opening

[0031] 111 opening 200 split tooling

[0032] 12 Inner tube 210 First through hole

[0033] 20 Cutting balloon 220 Supporting protrusion

[0034] 21 Balloon body 230 Leaflet forming part

[0035] 211 leaf petal 240 receiving groove

[0036] 212 groove 300 winding tool

[0037] 22 blade 310 second through hole

[0038] 221 blade 320 winding groove

[0039] 330 Blocking DETAILED DESCRIPTION

[0040] Example embodiments will now be described more fully with reference to the accompanying drawings. However, example embodiments can be implemented in a variety of forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present invention will be comprehensive and complete and fully convey the concepts of the example embodiments to those skilled in the art. In the figures, the same reference numerals represent the same or similar structures, and thus their repeated description will be omitted. "or" and "or" in the specification may both mean "and" or "or".

[0041] In the representations of the present application, the representations with reference to the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" etc. mean that the specific features, structures, materials or characteristics represented in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. Moreover, the represented specific features, structures, materials or characteristics may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples represented in the present application and the features of the different embodiments or examples, unless they contradict each other.

[0042] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the representation of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0043] In this specification, the proximal end and the distal end are relative to the operator. The end closer to the operator is called the proximal end, and the end farther from the operator is called the distal end.

[0044] In order to solve the problems of cutting balloon catheters in the prior art, the present utility model provides a cutting balloon catheter. Figure 3 , Figure 4 and Figure 5 As shown, the cutting balloon catheter 100 comprises a tube body 10, a cutting balloon 20 sleeved on the distal end of the tube body 10, and the cutting balloon 20 comprises a balloon body 21 and a strip-shaped blade 22 arranged on the outer surface of the balloon body 21; Figure 3 A cross-sectional view of a balloon body in a folded state is shown, wherein the circle is a catheter; Figure 4 A three-dimensional view of a balloon in a folded state is shown, which also includes a catheter, with the balloon being sleeved on the catheter.

[0045] like Figure 3 and Figure 4As shown, the balloon body 21 has a folded state, in which the balloon body 21 includes a plurality of lobes 211, part of the lobes 211 abut against the side wall of the strip blade 22, and the maximum height of the part of the lobes abutting against the side wall of the blade 22 is greater than or equal to the radial height of the blade 22. Unless otherwise specified, the maximum height D(max) of the lobes 211 in the present application refers to the distance from the outer surface of the lobes 211 to the aforementioned base point along the direction perpendicular to the central axis of the cutting balloon catheter 100 or the balloon body 21, with the central axis of the cutting balloon catheter 100 or the balloon body 21 as the base point. The radial height of the blade 22 is defined similarly to the maximum height D(max) of the lobes 211, that is, the maximum distance from the outer surface of the blade 22 to the aforementioned base point along the direction perpendicular to the central axis of the cutting balloon catheter 100 or the balloon body 21, with the central axis of the cutting balloon catheter 100 or the balloon body 21 as the base point, is generally the vertical distance between the blade portion of the blade 22 and the central axis. It can be understood that abutting or abutting means that the leaflets 211 touch or bump against the blade 22 but are not fixed, and can also be expressed as being attached or close. The overall radial height of the balloon body 21 in the folded state is small, which facilitates the cutting balloon catheter 100 to pass through thinner blood vessels smoothly; at the same time, the multiple leaflets 211 included in the balloon body 21 in the folded state abut against the side wall of the strip blade 22, which can also play a role in stabilizing the blade, and the maximum height of the leaflets 211 abutting against the side wall of the blade 22 is greater than or equal to the highest point of the strip blade 22, which can also significantly reduce the damage to the blood vessel when passing through the blood vessel and improve the passing performance of the cutting balloon catheter. Preferably, the maximum height of the partial leaflets 211 abutting against the side wall of the blade 22 is equal to the radial height of the blade 22, that is, the highest point of the partial leaflets 211 abutting against the side wall of the blade 22 is flush with the highest point of the blade 22. Preferably, the balloon body 21 in the folded state has 3 to 6 leaflets 211 , and may also be 3, 4, 5, 6 or a combination thereof, and more preferably 3.

[0046] In some embodiments, each leaflet has an "L" shape or a quasi-"L" shape in a cross section perpendicular to the central axis of the balloon body. "L" shape or a quasi-"L" shape means that each leaflet has a fold in a cross section perpendicular to the central axis, and also has a complete long side ("L" shape) or an incomplete long side ("L" shape), wherein the incomplete long side means that one end of the long side in a direction away from the aforementioned fold has a bent shape. Figure 3 In some embodiments, each leaflet has a "Z" shape in a cross section perpendicular to the central axis of the balloon body, the middle portion of the "Z"-shaped leaflet 211 extends along the circumference of the balloon body 21, and the two ends of the "Z"-shaped leaflet respectively abut against the side walls of two adjacent strip blades. Figure 3 It can also be considered as the aforementioned "Z" shaped embodiment.

[0047] See also Figure 5 The tube body 10 includes an outer tube 11 and an inner tube 12. The proximal end of the inner tube 12 is received in the hollow portion of the outer tube 11, and the distal end of the inner tube 12 protrudes from the distal end of the outer tube 11, that is, the distal end of the tube body 10 is a double-layer tube structure. An opening 111 is provided on the proximal side wall of the outer tube 11, and the hollow interior of the inner tube 12 is connected to the opening 111. The hollow interior of the inner tube 12 is a guidewire cavity for inserting a guidewire.

[0048] like Figure 6 As shown, in this embodiment, the surface of the balloon body 21 is provided with a plurality of grooves 212 which are regularly distributed, and are used to install one or more blades 22. The grooves 212 can enable the blades to be accurately installed on the balloon body 21, and can also ensure the firmness of the combination of the blades 22 and the balloon body 21. In some embodiments, the blades 22 can also be directly fixed to the outer surface of the balloon body 21 by bonding. The proximal end of the balloon body 21 is fixed to the distal end of the outer tube 11, and the distal end of the balloon body 21 is fixed to the distal end of the inner tube 12. The interior of the balloon body 21 is connected to the hollow interior of the outer tube 11, so that the hollow interior of the outer tube 11 can form an expansion cavity for the balloon body 21 to be expanded with a fluid. By injecting an expansion fluid into the interior of the balloon body 21 through the expansion cavity, the balloon body 21 can be expanded. The expansion fluid can be a gas, such as nitrogen, carbon dioxide, oxygen, and the like; the expansion fluid can also be a liquid, such as a liquid such as physiological saline and a contrast agent.

[0049] The cutting balloon catheter 100 further comprises a tube seat 30 fixed to the proximal end of the tube body 10. The tube seat 30 is provided with an opening 31 which is connected to the hollow interior of the outer tube 11, and the opening 31 provides a port for the expansion fluid used for the expansion of the balloon body 21 to flow in and out.

[0050] See also Figure 7 and Figure 8 The strip blade 22 includes a blade portion 221 and a contact portion 222 in contact with the balloon body 21, and the blade portion 221 is located on the side of the contact portion 222 away from the balloon body 21. The blade portion 221 of the blade 22 on the cutting balloon 20 can be serrated. In other embodiments, the blade portion of the blade 22 can also be continuous linear. The contact portion 222 is fixed to the outer surface of the balloon body 21. The fixing method is not limited in the present application, and can be achieved by groove installation, pasting or other methods. The blade 22 is preferably made of a metal material with memory function and superelasticity, and can also be made of other metal or non-metal materials. In some embodiments, the blade portion of the strip blade is serrated or continuous linear. In some embodiments, the strip blade 22 extends along the axial direction of the balloon body 21, and a plurality of leaflets 211 are arranged along the circumference of the balloon body 21.

[0051] Next, the folding tool used when folding the cutting balloon 20 will be described.

[0052] like Fig. 9 As shown, the petal splitting tool 200 provided in the embodiment of the utility model is used to split the cutting balloon 20. The petal splitting tool 200 includes a first cylinder, the first cylinder includes a first through hole 210, the inner surface of the first cylinder includes a plurality of support protrusions 220 arranged circumferentially around the first through hole 210, and a lobe forming portion 230 is provided between two adjacent support protrusions 220, and the lobe forming portion 230 is connected to the first through hole 210; each support protrusion 220 is provided with a receiving groove 240 on a side close to the first through hole 210, and the width and height of the receiving groove 240 are about 0.1mm to 0.3mm larger than the width and height of the blade 22. The petal splitting tool 200 in this embodiment is used to split the balloon body 21 into three lobe 211, but the petal splitting tool 200 can also be set to split the balloon body 21 into more than 3 or less than 3 lobe, which is not specifically limited here.

[0053] When the cutting balloon 20 is to be split, the filled cutting balloon 20 is first placed into the first through hole 210 of the splitting tool 200, and the blade 22 is placed in the corresponding receiving groove 240. The receiving groove 240 is used to confine the cutting balloon 20 inside the splitting tool 200, so that the cutting balloon 20 shakes inside the splitting tool 200 to avoid affecting the splitting of the balloon body 21. When the balloon body 21 confined inside the splitting tool 200 is depressurized, the balloon body 21 can form a corresponding shape of the leaflet 211 along the leaflet forming part 230. The leaflet forming part 230 is used to ensure that the splitting range and length of each leaflet 211 are uniform.

[0054] like Fig.10 As shown, the winding tool 300 provided in the embodiment of the utility model is used to wind and fold the balloon body 21 divided into a plurality of lobes 211, and bend the portion of the lobes 211 that is higher than the blade 22. The winding tool 300 includes a second cylinder, and the second cylinder includes a second through hole 310 and a winding groove 320 that is uniformly radiated outward around the second through hole 310, and a blocking portion 330 is provided between two adjacent winding grooves 320. When the winding tool 300 is used to wind and fold the lobes 211, the filled cutting balloon 20 is first placed into the second through hole 310, and then the lobes 211 are placed in the winding groove 320 accordingly, and the winding tool 300 is rotated alternately in the first direction and the second direction to bend the lobes 211 that exceed the radial height of the blade 22. Here, the first direction and the second direction are clockwise or counterclockwise directions as viewed from the paper.

[0055] In some embodiments, the winding tool is rotated alternately in the first direction and the second direction, and the blocking portion 330 is used to further press the folded lobe 211 against the side wall of the blade 22, and the maximum height of the lobe 211 pressed against the side wall of the blade 22 is not less than the height of the blade 22.

[0056] The device for folding and cutting the balloon also includes a pressure-increasing and pressure-reducing device (not shown in the figure), which is connected to the opening 31 of the tube seat 30. Through the pressure-increasing and pressure-reducing device, the corresponding expansion fluid passes through the expansion cavity to achieve expansion and pressure relief and compression of the balloon body 21, even if the balloon body 21 is in a filled state or a compressed state. The pressure-increasing and pressure-reducing device can be a pump, a syringe, a pressurizer, etc. For example, when the pressure-increasing and pressure-reducing device is a syringe, physiological saline is filled into the balloon body 21 through the syringe. As the volume of the physiological saline in the balloon body 21 increases, the balloon body 21 can be pressurized and expanded; when the physiological saline in the balloon body 21 is extracted through the syringe, as the volume of the physiological saline in the balloon body 21 decreases, the balloon body 21 can be pressure-relieved and compressed. The specific pressure-increasing and pressure-reducing device can be set according to actual needs, and no specific restrictions are made here.

[0057] Next, combine Fig. 9 and Fig.10 A folding method of the cutting balloon is described.

[0058] S100: Provide a cutting balloon catheter 100, which includes a tube body 10 and a cutting balloon 20 sleeved on the distal end of the tube body 10, and the cutting balloon 20 includes a balloon body 21 and a strip blade 22 arranged on the outer surface of the balloon body 21; the balloon body 21 is in a filled state.

[0059] S200 : The inflated balloon body 21 is evenly divided into a plurality of leaflets 211 by the leaflet dividing tool 200 , and each leaflet 211 extends in an axial direction away from the balloon body 21 .

[0060] In the specific petal separation step, the filled balloon 21 is first placed into the first through hole 210 of the petal separation tool 200, and the strip blade 22 is placed in the corresponding receiving groove 240. The receiving groove 240 can fix the balloon 21 and the petal separation tool 200 to limit the shaking of the balloon 21 in the petal separation tool 200.

[0061] Then, the pressure of the balloon body 21 is relieved by the pressure increasing and decompression device, so that the balloon body 21 is formed into a plurality of lobes 211 through the lobule forming part 230. In a preferred embodiment, in order to make the lobule range and length uniformity of each lobule 211 formed by the balloon body 21 consistent, the lobule separation tool 200 can be rotated around the axial direction of the balloon body 21 during lobule separation (even if the lobule separation tool rotates with the central axis of the balloon body 21 as the rotation axis). Since the balloon body 21 is completely limited during the pressure relief process, the balloon body 21 stops the diameter by compression and accurately controls the length of the lobes 211, and the length of the formed lobes 211 is approximately equal to 1 / 2 to 1 / 5 of the circumference of the balloon body 21 in the folded state.

[0062] Preferably, in order to make the length of the lobe 211 formed after pressure relief along the radial direction of the balloon body 21 and the distance between two adjacent blades 22 as consistent as possible, the lobe tool 200 can be rotated during pressure relief, thereby driving the balloon body 21 to rotate (that is, the cutting balloon catheter 100 rotates with the central axis of the balloon body 21 as the rotation axis), so that the pressure relief speed in all directions of the balloon body 21 is consistent, ensuring that the height of the lobe 211 formed after pressure relief and the position distributed on the two adjacent blades 22 are basically consistent, so as to facilitate the simultaneous winding and folding of the lobe 211 during the subsequent folding.

[0063] In one embodiment, in order to well maintain the shape of the evenly formed lobes 211 of the balloon body 21 , the formed lobes may be heated.

[0064] S300: Winding each lobe 211 by a winding tool, so that at least part of the folded lobe 211 abuts against the side wall of the blade 22 , and the maximum height of the lobe 211 abutting against the side wall of the blade 22 is greater than or equal to the radial height of the blade 22 .

[0065] Specifically, after the balloon body 21 is petaled, the balloon body 21 is first taken out from the petaling tool 200 , and then the petaled balloon body 21 is inserted into the winding tool 300 .

[0066] The petaled balloon body 21 is first inserted into the second through hole 310 of the winding tool 300, and each leaf 211 is correspondingly inserted into the winding groove 320 in the winding tool 300. Then the winding tool 300 is slowly rotated, and the balloon body 21 is fixed relative to the winding tool 300. When the winding tool 300 rotates, the leaf 211 is driven to rotate, so that the leaf 211 is folded. In the process of slowly rotating the winding tool 300 in the first direction and the second direction alternately, the leaf 211 is controlled to be folded at the radial length of the blade 22.

[0067] Furthermore, after the leaflets 211 that extend beyond the blade 22 are folded in half using the winding tool 300, part of the leaflets 211 are attached to the side wall of the blade 22 using the winding tool 400. During the rotation process, the blocking portion 330 of the winding tool 300 causes part of the leaflets 211 to fall toward the side wall of the blade 22 until the leaflets 211 are completely against the side wall of the blade 22. Figure 3 and Figure 4 shown.

[0068] It should be noted that during the winding process, the leaf petals 211 also need to be heated so that the leaf petals 211 can be shaped after winding.

[0069] Using the above-mentioned folding method, part of the leaflets 211 can be attached to the side wall of the blade 22 and rolled up, so that the cutting edge of the blade 22 can be wrapped between the rolled leaflets 211, avoiding the cutting edge of the blade 22 from being exposed, thereby reducing the risk of accidental damage to the blood vessel by the blade 22 during transportation.

[0070] In summary, the cutting balloon catheter provided by the utility model has the following advantages:

[0071] By rolling and folding the lobes formed by the cutting balloon in a compressed state, the process is simple and the reliability is high; at least part of the multiple lobes rest against the side wall of the blade, and the height of the lobes attached to the side wall of the blade is not lower than the highest point of the blade, thereby reducing the risk of accidental damage to the blood vessel caused by the blade being significantly higher than the lobes and exposed to the outside. The overall height and strength distribution of the balloon are highly consistent, ensuring the excellent passing performance of the product in the blood vessel.

[0072] The above contents are further detailed descriptions of the present invention in combination with specific preferred implementations, and the specific implementation of the present invention cannot be considered to be limited to these descriptions. For ordinary technicians in the technical field to which the present invention belongs, several simple deductions or substitutions can be made without departing from the concept of the present invention, which should be regarded as falling within the protection scope of the present invention.

Claims

1. A cutting balloon catheter, characterized in that: The invention comprises a tube body and a cutting balloon sleeved on the distal end of the tube body, wherein the cutting balloon comprises a balloon body and a strip-shaped blade arranged on the outer surface of the balloon body; the balloon body has a folded state, in which the balloon body comprises a plurality of lobes, and some of the lobes abut against the side wall of the strip-shaped blade; The maximum height of the portion of the lobe that abuts against the side wall of the blade is greater than or equal to the radial height of the blade.

2. The cutting balloon catheter according to claim 1, characterized in that: Each of the leaflets has an "L" shape or a quasi-"L" shape in a cross section perpendicular to the central axis of the balloon body.

3. The cutting balloon catheter according to claim 1, characterized in that: Each of the lobe has a "Z" shape in a cross section perpendicular to the central axis of the balloon body, the middle portion of the "Z"-shaped lobe extends along the circumference of the balloon body, and the two ends of the "Z"-shaped lobe respectively abut against the side walls of two adjacent strip-shaped blades.

4. The cutting balloon catheter according to claim 1, characterized in that: The strip blade comprises a cutting edge and a contact portion in contact with the balloon body, the cutting edge is located at a side of the contact portion away from the balloon body, and the contact portion is fixed to the outer surface of the balloon body.

5. The cutting balloon catheter according to claim 4, characterized in that: The edge of the strip-shaped blade is in a sawtooth shape or a continuous line shape.

6. The cutting balloon catheter according to claim 1, characterized in that: The strip-shaped blades extend along the axial direction of the balloon body, and the plurality of leaflets are arranged along the circumferential direction of the balloon body.

7. The cutting balloon catheter according to claim 1, characterized in that: The outer surface of the balloon body is provided with a groove, and the strip-shaped blade is placed in the groove.

8. The cutting balloon catheter according to claim 7, characterized in that: The difference between the width of the groove and the width of the strip blade is 0.1 mm to 0.3 mm.

9. The cutting balloon catheter according to claim 7, characterized in that: The difference between the length of the groove and the length of the strip blade is 0.1 mm to 0.3 mm.

10. The cutting balloon catheter according to claim 1, characterized in that: The balloon body in the folded state has 3 to 6 lobes.

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