Cutting balloon catheter and using method thereof

Abstract

The invention discloses a cutting balloon catheter and a using method thereof, and relates to the technical field of medical instruments.The cutting balloon catheter comprises an outer tube, a conveying tube is slidably connected to the interior of the outer tube in a penetrating mode, one end of the outer tube is fixedly connected with a first channel, a second channel and a third channel, and the side, away from the first channel, of the conveying tube is fixedly connected with a balloon body; blade bodies are annularly arranged on the outer surface of the balloon body at equal intervals, the blood vessel protection mechanism comprises an inflation tube and a protection layer, the protection layer is arranged on the outer surface of the balloon body in a sleeving mode, the blade bodies are located in the protection layer, and the protection layer can be arranged on the outer surfaces of the blade bodies in a sleeving mode; the vascular endothelium is prevented from being damaged in the conveying process of the blade body, and the blade body can be effectively prevented from being in direct contact with the vascular endothelium in the conveying process, so that the damage risk of vascular endothelial cells is remarkably reduced, the integrity of the vascular endothelium is maintained, and inflammatory reactions are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a cutting balloon catheter and a use method thereof. BACKGROUND

[0002] In the field of vascular intervention, with the continuous development of medical technology, the treatment means for vascular stenosis and other diseases are increasingly rich. Vascular stenosis is usually caused by pathological processes such as atherosclerosis, resulting in thickening of the blood vessel wall, narrowing of the lumen, and further affecting blood flow, causing a series of clinical symptoms. In order to improve vascular stenosis and restore blood vessel patency, a variety of interventional treatment instruments have emerged, among which the cutting balloon catheter as an important treatment tool has gradually attracted attention. During the delivery of the cutting balloon catheter into the blood vessel, when there is severe stenosis, tortuosity or calcification in the blood vessel, the cutting balloon catheter has a large outer diameter and the blades protrude, which can easily scratch the blood vessel wall when passing through these complex lesions. The blades on the surface of the balloon can damage the blood vessel wall, not only causing damage to the endothelial cells of the blood vessel wall and causing an inflammatory response of the blood vessel wall, but also causing micro-tears in the blood vessel wall, increasing the risk of bleeding. Moreover, after the endothelial injury, platelets will gather at the injury site, activate the coagulation system, and thus induce thrombus formation. The thrombus can further block the blood vessel, causing blood flow obstruction, and even causing serious complications such as acute myocardial infarction or stroke. In addition, the blade scratching the blood vessel wall can cause the intima of the blood vessel to tear, forming a blood vessel dissection, which can further damage the integrity of the blood vessel wall, causing the blood vessel wall to delaminate, affecting blood flow, and even causing the blood vessel to rupture.

[0003] Therefore, the present application provides a cutting balloon catheter and a use method thereof to solve the above problems. SUMMARY

[0004] (I) Technical problems to be solved In view of the deficiencies of the prior art, the present application provides a cutting balloon catheter and a use method thereof, which can effectively solve the problems in the prior art.

[0005] (II) Technical solutions To achieve the above-mentioned purposes, the purposes of the present application can be realized by the following technical solutions: The utility model provides a cutting balloon catheter, including outer tube, the inside sliding joint has the delivery pipe, the outer tube one end is fixedly connected with first channel, second channel and third channel respectively, the delivery pipe is fixedly connected with balloon body away from first channel side, the balloon body outer surface annular equidistance is provided with blade body, still include blood vessel protection mechanism and balloon expansion protection mechanism, blood vessel protection mechanism includes inflation pipe and protection layer, the protection layer is set up on the balloon body outer surface, and the blade body is located in the protection layer inside, blood vessel protection mechanism is used for separating the blade body with blood vessel in the process of delivering the blade body, balloon expansion protection mechanism is used for avoiding the situation that the balloon body breaks down because of the excessive pressure in the balloon body.

[0006] As a further scheme of the utility model: the balloon body outer surface annular equidistance fixedly connected with adhesion layer, the protection layer all through adhesion layer and balloon body are connected.

[0007] As a further scheme of the utility model: the protection layer outer surface annular equidistance is provided with pre-fold, the pre-fold number and the blade body number are same, and the pre-fold and the blade body are all in the same horizontal line.

[0008] As a further scheme of the utility model: the inflation pipe is fixedly connected in the delivery pipe, and the inflation pipe outer surface is annular equidistance and is provided with inflation port close to the balloon body.

[0009] As a further scheme of the utility model: the inflation pipe inside is close to the inflation port and is slidably connected with the moving column, the moving column outer surface annular equidistance is rotatably connected with connecting rod, the connecting rod away from the moving column one end is rotatably connected on the blade body, the blade body outer surface is all set with the limit block, the limit block all is fixedly connected on the balloon body, and the blade body all is slidably connected on the limit block.

[0010] As a further scheme of the utility model: the balloon expansion protection mechanism includes the limit disc, the limit disc is slidably connected in the inflation pipe, the limit disc is located on the moving column side away from the inflation port, the limit disc away from the moving column one end is fixedly connected with pressure spring, and the pressure spring away from the limit disc one end is fixedly connected on the inflation pipe inner wall.

[0011] As a further scheme of the utility model: the moving column away from the limit disc one side is provided with the gas delivery channel, the moving column outer surface is annular equidistance and is provided with the gas delivery hole close to the gas delivery channel one side, and the gas delivery hole all is connected with the gas delivery channel.

[0012] A cutting balloon catheter uses method, comprising the following steps: Step 1: A comprehensive assessment is performed on the patient, including medical history, physical examination, angiography or other imaging examinations, to determine the location, length, degree of stenosis and calcification of the lesion; Step 2: Select the appropriate cutting balloon catheter according to the diameter and length of the diseased vessel; Step 3: Under the guidance of angiography, insert the guide wire into the blood vessel, pass through the stenosis or lesion site, and slowly advance the cutting balloon catheter along the guide wire to the lesion site; Step 4: After reaching the lesion site, slowly inflate the balloon, so that the blades gradually protrude and begin to cut the plaque; Step 5: After completing the cutting, slowly deflate the balloon, so that the blades retract inside the catheter, and then slowly retrieve the catheter along the guide wire and exit the blood vessel.

[0013] As a further scheme of the present application: after selecting the appropriate cutting balloon catheter in step 2, a protective sleeve is sleeved on the blades of the cutting balloon catheter.

[0014] As a further scheme of the present application: when the blades begin to cut the plaque in step 4, multiple cutting operations can be performed according to the severity of the lesion, and the balloon is appropriately deflated after each cutting to observe the cutting effect.

[0015] (Three) beneficial effects Compared with the prior art, the present application provides a cutting balloon catheter and a method for using the same, which has the following beneficial effects: 1. By setting the vascular protection mechanism, a protective layer can be sleeved on the outer surface of the blade body, avoiding damage to the vascular endothelium during the transportation of the blade body. Not only can the blade body be effectively prevented from directly contacting the vascular endothelium during transportation, thereby significantly reducing the risk of damage to the vascular endothelial cells and maintaining the integrity of the vascular endothelium, but also reducing the occurrence of inflammatory reactions. Moreover, due to the reduction of endothelial cell damage, the degree of vascular wall inflammatory reaction is correspondingly reduced, facilitating the recovery and long-term stability of the patient's blood vessels after surgery. In addition, the protective layer can effectively prevent the blade body from scratching the vascular wall and causing intimal tear, thereby reducing the formation of vascular dissection, maintaining the integrity of the vascular wall, avoiding the delamination of the vascular wall, and thus reducing the impact on blood flow and the risk of vascular rupture.

[0016] 2、By setting the pre-fold mark and the adhesive layer, the protective layer can be automatically destroyed during the cutting process of the balloon body expansion driving the blade body to cut the plaque, and the protective layer is left on the adhesive layer. The setting of the pre-fold mark not only ensures that the protective layer is accurately destroyed when the balloon body expands, avoids accidental residues of the protective layer, thereby ensuring that the blade body can be completely exposed during the cutting process, effectively playing its cutting role. Moreover, since the protective layer is only destroyed when cutting is needed, this reduces the potential risk of scratches on the blood vessel wall during the delivery process of the blade body, further ensuring the safety of the operation, and automatically destroying the protective layer and leaving it on the adhesive layer reduces the free movement of the protective layer fragments in the blood vessel, avoiding thrombosis or other complications caused by these fragments.

[0017] 3、By setting the moving column and the connecting rod, the blade body can be driven to slide out of the limiting block before the balloon body is inflated, to destroy the protective layer. This not only ensures that the protective layer does not interfere with the normal operation of the blade body during balloon expansion, improving the safety of the operation, but also avoids accidental damage to the blood vessel wall caused by the protective layer during balloon expansion, further protecting the blood vessel endothelium.

[0018] 4、By setting the balloon expansion protection mechanism, when the balloon body is subjected to excessive inflation pressure during the inflation of the balloon body by the inflation tube through the inflation hole, the moving column will automatically move, so that the gas inlet hole on the moving column is blocked by the inflation tube. Automatically closing the gas inlet hole not only prevents the balloon body from overexpanding due to excessive inflation pressure, avoiding unnecessary damage to the blood vessel wall and reducing the risk of blood vessel wall tearing, dissection or rupture caused by excessive expansion of the balloon body, but also accurately controls the inflation pressure of the balloon body, ensuring that the balloon body works within a safe pressure range, improving the accuracy of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to facilitate the understanding of those skilled in the art, the present application will be further described below with reference to the accompanying drawings.

[0020] Figure 1 is a schematic diagram of the overall structure of the present application; Figure 2 is a schematic diagram of the overall structure of the present application Figure 1 is an enlarged structure schematic diagram of the balloon body connection in the present application; Figure 3 is a schematic diagram of the initial state structure of the protective layer and the balloon body in the present application; Figure 4 is a schematic diagram of the balloon body and protective layer connection structure in the present application; Figure 5 is a schematic diagram of the internal structure of the delivery tube in the present application; Figure 6 For the present application Figure 5 A region amplification structure schematic diagram; Figure 7 For the present application inflatable tube internal structure schematic diagram.

[0021] Figure: 1, the outer tube; 2, the first channel; 3, the second channel; 4, the third channel; 5, the delivery tube; 6, the balloon body; 701, protective layer; 702, limit block; 703, pre-fold mark; 704, adhesive layer; 705, connecting rod; 706, inflatable tube; 707, inflation port; 708, moving column; 8, the blade body; 901, gas delivery hole; 902, gas delivery channel; 903, limit disc; 904, pressure spring. DETAILED DESCRIPTION

[0022] The technical solutions of the present application will be described below in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of the present application.

[0023] A cutting balloon catheter and its use method of the present embodiment, as shown in Figure 1 - Figure 7 The outer tube 1 is internally connected with the delivery tube 5 through sliding, one end of the outer tube 1 is fixedly connected with the first channel 2, the second channel 3 and the third channel 4 respectively, the delivery tube 5 is fixedly connected with the balloon body 6 away from the first channel 2 side, the balloon body 6 outer surface is annularly and equidistantly provided with the blade body 8, and the balloon body 6 outer surface is annularly and equidistantly provided with the blade body 8. It also includes a blood vessel protection mechanism and a balloon expansion protection mechanism. The blood vessel protection mechanism includes an inflatable tube 706 and a protective layer 701, the protective layer 701 is sleeved on the outer surface of the balloon body 6, and the blade body 8 is located inside the protective layer 701, the blood vessel protection mechanism is used to separate the blade body 8 from the blood vessel during the delivery of the blade body 8.

[0024] In the present embodiment, as shown in Figure 4 The balloon body 6 outer surface is annularly and equidistantly fixedly connected with the adhesive layer 704, and the protective layer 701 is connected with the balloon body 6 through the adhesive layer 704. By setting the adhesive layer 704, the protective layer 701 can remain on the surface of the balloon body 6 after being divided.

[0025] In the present embodiment, as shown in Figure 4As shown, the outer surface of the protective layer 701 is annularly and equidistantly provided with pre-folds 703, the number of the pre-folds 703 is same as the number of the blade bodies 8, and the pre-folds 703 and the blade bodies 8 are on the same horizontal line. The pre-folds 703 can facilitate the blade bodies 8 to divide the protective layer 701.

[0026] In the embodiment, as shown in Figure 5 and Figure 6 The inflation pipe 706 is fixedly connected in the conveying pipe 5, and the outer surface of the inflation pipe 706 is annularly and equidistantly provided with inflation openings 707 near the balloon body 6. When the balloon body 6 is inflated by the inflation pipe 706 and the inflation openings 707, the balloon body 6 will be inflated.

[0027] In the embodiment, as shown in Figure 6 The outer surface of the moving column 708 is annularly and equidistantly rotatably connected with connecting rods 705, one end of the connecting rods 705 away from the moving column 708 is rotatably connected with the blade bodies 8, the outer surface of the blade bodies 8 is sleeved with limiting blocks 702, the limiting blocks 702 are fixedly connected with the balloon body 6, and the blade bodies 8 are slidably connected with the limiting blocks 702. When the moving column 708 slides horizontally in the inflation pipe 706, the blade bodies 8 can be pushed out of the limiting blocks 702 by the connecting rods 705.

[0028] In existing technologies, during the delivery of a cutting balloon catheter into a blood vessel, when the vessel is severely narrowed, tortuous, or calcified, the cutting balloon catheter has a large outer diameter and a protruding blade, which can easily scrape the vessel wall when passing through these complex lesions. The blade on the balloon surface can damage the vessel wall, causing damage to the vascular endothelial cells and triggering an inflammatory response in the vessel wall. This damage can lead to micro-tears in the vessel wall, increasing the risk of bleeding. Furthermore, after endothelial damage, platelets can aggregate at the site of injury, activating the coagulation system and causing thrombus formation. The thrombus can further obstruct the blood vessel, leading to blood flow obstruction and even serious complications such as acute myocardial infarction or stroke. Moreover, the blade scraping the vessel wall can cause intimal tearing, forming a vascular dissection, which further damages the integrity of the vessel wall, leading to... Delamination of the blood vessel wall affects blood flow and can even cause vascular rupture. Compared with existing technologies, a protective layer can be applied to the outer surface of the blade body 8 to avoid damage to the vascular endothelium during the delivery of the blade body 8. This not only effectively prevents the blade body 8 from directly contacting the vascular endothelium during delivery, thus significantly reducing the risk of endothelial cell damage, maintaining the integrity of the vascular endothelium, and reducing the occurrence of inflammatory responses, but also reduces the degree of vascular wall inflammation due to reduced endothelial cell damage, facilitating postoperative vascular recovery and long-term stability. Furthermore, the protective layer can effectively prevent the blade body 8 from scratching the blood vessel wall, causing intimal tearing, thereby reducing the formation of vascular dissection, maintaining the integrity of the blood vessel wall, avoiding vascular wall delamination, reducing the impact on blood flow, and lowering the risk of vascular rupture.

[0029] At other levels, this embodiment also provides a balloon inflation protection mechanism to prevent the balloon body 6 from rupturing due to excessive internal pressure, such as... Figure 5 - Figure 7 As shown, the balloon inflation protection mechanism includes a limiting plate 903, which is slidably connected inside the inflation tube 706. The limiting plate 903 is located on the side of the moving column 708 away from the inflation port 707. A pressure spring 904 is fixedly connected to the end of the limiting plate 903 away from the moving column 708. The end of the pressure spring 904 away from the limiting plate 903 is fixedly connected to the inner wall of the inflation tube 706.

[0030] In this embodiment, as Figure 7 As shown, a gas delivery channel 902 is provided on the side of the moving column 708 away from the limiting plate 903. Gas delivery holes 901 are provided in a ring at equal intervals on the outer surface of the moving column 708 near the gas delivery channel 902. All gas delivery holes 901 are connected to the gas delivery channel 902. When gas enters the gas delivery channel 902, if the gas delivery hole 901 is blocked, the gas will push the moving column 708 to move. When the gas delivery hole 901 moves into the inflation port 707, the gas in the gas delivery channel 902 will enter the interior of the balloon body 6 through the gas delivery hole 901 and the inflation port 707.

[0031] Compared with the prior art, when the inflation pressure of the balloon body 6 is too large during the inflation and expansion of the balloon body 6 through the inflation hole of the inflation tube 706, the moving column 708 can be automatically driven to move, so that the gas inlet hole 901 formed in the moving column 708 is blocked by the inflation tube 706, and the automatic closing of the gas inlet hole 901 not only prevents the balloon body 1 from being excessively expanded due to excessive inflation pressure, avoids unnecessary damage to the blood vessel wall, and reduces the risk of blood vessel wall tearing, dissection or rupture caused by excessive expansion of the balloon body 1, but also accurately controls the inflation pressure of the balloon body 6, ensures that the balloon body 6 works within a safe pressure range, and improves the accuracy of the operation.

[0032] In other aspects, the embodiment also provides a use method of the cutting balloon catheter, as shown in Figure 1 Figure 7 The method comprises the following steps: Step 1: A comprehensive evaluation is performed on the patient, including medical history, physical examination, angiography or other imaging examination, to determine the location, length, stenosis degree and calcification of the lesion; Step 2: Select a suitable cutting balloon catheter according to the diameter and length of the lesion vessel; Step 3: Under the guidance of angiography, insert a guide wire into the blood vessel, pass through the stenosis or lesion site, and slowly push the cutting balloon catheter along the guide wire to the lesion site; Step 4: After reaching the lesion site, slowly inflate the balloon, so that the blade gradually protrudes and starts to cut the plaque; Step 5: After the cutting is completed, slowly deflate the balloon, so that the blade is withdrawn into the catheter, and then slowly recover the catheter to exit the blood vessel along the guide wire.

[0033] In the embodiment, after selecting a suitable cutting balloon catheter in step 2, a protective sleeve is sleeved on the blade of the cutting balloon catheter.

[0034] In the embodiment, when the blade starts to cut the plaque in step 4, multiple cutting operations can be performed according to the severity of the lesion, and the balloon is appropriately deflated after each cutting to observe the cutting effect.

[0035] The working process and principle involved in the overall content of the above embodiment are as follows: It should be noted that the protective layer 701 is made of a dissolvable material, which has good biocompatibility and does not cause inflammatory reactions or other adverse reactions of the blood vessel wall. Even if the protective layer 701 accidentally falls into the blood vessel during the operation, it will not cause physical damage or obstruction to the blood vessel. ​When the medical staff needs to cut the plaque inside the patient's blood vessel, first deliver the outer tube 1 into the blood vessel, then pass the delivery tube 5 through one of the channels to the outer tube 1, pass the balloon body 6 connected to the delivery tube 5 to the plaque through the outer tube 1, then when the balloon body 6 moves to the designated position, because the balloon body 6 is sleeved with a protective layer 701 on the outer surface, and the blade body 8 is located inside the protective layer 701, therefore, when the balloon body 6 moves inside the blood vessel, due to the influence of the protective layer 701, the blade on the balloon body 6 will not scratch and damage the inner wall of the blood vessel, not only can effectively avoid the direct contact of the blade body 8 with the blood vessel endothelium during the delivery process, thereby significantly reducing the risk of damage to the endothelial cells, maintaining the integrity of the endothelium, reducing the occurrence of inflammatory reaction, but also because the damage to the endothelial cells is reduced, the degree of inflammatory reaction of the blood vessel wall is correspondingly reduced, facilitating the recovery and long-term stability of the blood vessel after operation, and the protective layer can effectively prevent the intimal tear caused by the scratch of the blade body 8 on the blood vessel wall, thereby reducing the formation of blood vessel dissection, maintaining the integrity of the blood vessel wall, avoiding the delamination of the blood vessel wall, thereby reducing the influence on the blood flow and reducing the risk of blood vessel rupture; When the balloon body 6 moves to the designated position and needs to cut the plaque, the medical staff can deliver gas into the inflation pipe 706, when the gas enters the inflation pipe 706, the gas will enter the gas delivery channel 902 first, and because the gas delivery hole 901 connected to the gas delivery channel 902 is blocked by the inner wall of the inflation pipe 706, it cannot be discharged, at this time the moving column 708 will slide in the inflation pipe 706 towards the limiting disc 903, because the moving column 708 is rotatably connected with the connecting rod 705 at equal intervals on the outer surface, and the connecting rod 705 is rotatably connected to the blade body 8 away from the outer surface of the moving column 708, therefore, with the movement of the moving column 708, the connecting rod 705 will be pushed from the inclined state to the vertical state, at this time the gas hole 901 on the outer surface of the moving column 708 has not moved to the inflation port 707, therefore the gas will not enter the balloon body 6, with the change of the state of the connecting rod 705, the connecting rod 705 will push the blade body 8 out of the limiting block 702, and damage the protective layer 701 sleeved on the outer surface of the balloon body 6, not only to ensure that the protective layer 701 will not interfere with the normal work of the blade body 8 during the inflation process, improve the safety of the operation, but also the blade body 8 starts to work after the protective layer 701 is damaged, avoiding accidental damage to the blood vessel wall during the inflation process of the protective layer 701, further protecting the endothelium of the blood vessel; And in the process of destroying the protective layer 701, due to the annular equidistant arrangement of the pre-folding marks 703 on the outer surface of the protective layer 701, and the connection of the protective layer 701 with the balloon body 6 through the adhesive layer 704, the arrangement of the pre-folding marks 703 can facilitate the easy destruction of the protective layer 701 by the blade body 8 during the destruction of the protective layer 701, and the destroyed protective layer 701 will be adsorbed on the outer surface of the balloon body 6 through the adhesive layer 704. The arrangement of the pre-folding marks 703 not only ensures that the protective layer 701 is accurately destroyed when the balloon body 1 is inflated, avoiding accidental residues of the protective layer 701, thereby ensuring that the blade body 8 can be completely exposed during cutting, effectively exerting its cutting effect, and since the protective layer 701 is only destroyed when cutting is needed, this reduces the potential risk of scratches on the inner wall of the blood vessel by the blade body 8 during transportation, further ensuring the safety of the operation, and automatically destroying the protective layer 701 and leaving it on the adhesive layer 704, reducing the free movement of the protective layer 701 fragments in the blood vessel, avoiding thrombosis or other complications caused by these fragments; After the mobile column 708 moves through the connecting rod 705 to destroy the protective layer 701 by the blade body 8, the mobile column 708 will move to be in contact with the limiting disc 903, at this time the gas inlet hole 901 opened on the outer surface of the mobile column 708 will be opened, and as the gas in the inflation pipe 706 continues to be injected, the gas will enter the balloon body 6 through the gas inlet channel 902, the gas inlet hole 901 and the inflation port 707, causing the balloon body 6 to expand. After the balloon body 6 expands to a specified position and cannot continue to expand, the gas in the inflation pipe 706 will continue to push the mobile column 708 to move, so that the mobile column 708 exerts a pressure on the limiting disc 903, extruding the pressure spring 904 connected between the limiting disc 903 and the inflation pipe 706, and causing the mobile column 708 to push the blade body 8 out of the limiting block 702 through the connecting rod 705, so as to control the protruding length of the blade body 8, so that the blade body 8 can accurately cut the plaque. When the pressure in the inflation pipe 706 is too large, the gas inlet hole 901 on the outer surface of the mobile column 708 will be misaligned with the inflation port 707 again during the movement of the mobile column 708, which will block and close the gas inlet hole 901. The automatic closing of the gas inlet hole 901 not only prevents the balloon body 1 from overexpanding due to excessive inflation pressure, avoiding unnecessary damage to the blood vessel wall, reducing the risk of blood vessel wall tearing, dissection or rupture caused by overexpansion of the balloon body 1, but also accurately controls the inflation pressure of the balloon body 6, ensuring that the balloon body 6 works within a safe pressure range, improving the accuracy of the operation.

[0036] The preferred embodiments of the application disclosed above are only to facilitate the elucidation of the application. The preferred embodiments do not describe all the details of the application and limit the application to the specific embodiments described. Obviously, many modifications and variations can be made in light of the teachings above. The description is chosen and described in order to best explain the principles of the application and its practical application to thereby enable others skilled in the art to best utilize the application and get the best results from the application. The application is only limited by the claims and their full scope and equivalents.

Claims

1. A cutting balloon catheter, comprising an outer tube (1), a delivery tube (5) is connected through sliding inside the outer tube (1), the outer tube (1) is respectively fixedly connected with a first channel (2), a second channel (3) and a third channel (4) at one end, the delivery tube (5) is fixedly connected with a balloon body (6) away from one side of the first channel (2), the balloon body (6) is annularly and equidistantly provided with blade bodies (8) on the outer surface, characterized in that, Also include a blood vessel protection mechanism and a balloon expansion protection mechanism; The blood vessel protection mechanism includes an inflation tube (706) and a protective layer (701), the protective layer (701) is sleeved on the outer surface of the balloon body (6), and the blade body (8) is located inside the protective layer (701), the blood vessel protection mechanism is used for separating the blade body (8) from the blood vessel during the transportation of the blade body (8); The balloon expansion protection mechanism is used for avoiding the rupture of the balloon body (6) caused by excessive internal pressure of the balloon body (6).

2. The cutting balloon catheter of claim 1, wherein, The outer surface of the balloon body (6) is annularly and equidistantly fixedly connected with an adhesive layer (704), and the protective layer (701) is connected with the balloon body (6) through the adhesive layer (704).

3. The cutting balloon catheter of claim 2, wherein, The outer surface of the protective layer (701) is annularly and equidistantly provided with pre-folds (703), the number of the pre-folds (703) is the same as that of the blade bodies (8), and the pre-folds (703) and the blade bodies (8) are located on the same horizontal line.

4. The cutting balloon catheter of claim 3, wherein, The inflation tube (706) is fixedly connected in the delivery tube (5), and the inflation tube (706) is annularly and equidistantly provided with inflation openings (707) on the outer surface close to the balloon body (6).

5. The cutting balloon catheter of claim 4, wherein, The outer surface of the inflation tube (706) is annularly and equidistantly rotatably connected with connecting rods (705) close to the inflation openings (707), one end of the connecting rod (705) away from the inflation tube (706) is rotatably connected with the blade body (8), the outer surface of the blade body (8) is sleeved with a limiting block (702), the limiting block (702) is fixedly connected with the balloon body (6), and the blade body (8) is slidably connected with the limiting block (702).

6. The cutting balloon catheter of claim 5, wherein, The balloon expansion protection mechanism includes a limiting disc (903) slidably connected in the inflation tube (706), the limiting disc (903) is located on the side of the moving column (708) away from the inflation opening (707), one end of the limiting disc (903) away from the moving column (708) is fixedly connected with a pressure spring (904), and the other end of the pressure spring (904) away from the limiting disc (903) is fixedly connected with the inner wall of the inflation tube (706).

7. The cutting balloon catheter of claim 6, wherein, The side of the moving column (708) away from the limiting disc (903) is provided with a gas delivery channel (902), and the outer surface of the moving column (708) is annularly and equidistantly provided with gas delivery holes (901) close to the gas delivery channel (902).

8. A method of using a cutting balloon catheter according to any one of claims 1-7, wherein, The steps include: Step 1: Comprehensive evaluation of the patient, including medical history, physical examination, angiography or other imaging examination, to determine the location, length, stenosis degree and calcification of the lesion; Step 2: Select the appropriate cutting balloon catheter according to the diameter and length of the diseased vessel; Step 3: Under the guidance of angiography, insert the guide wire into the blood vessel, pass through the stenosis or lesion site, and slowly push the cutting balloon catheter along the guide wire to the lesion site; Step 4: After reaching the lesion site, slowly inflate the balloon, so that the blade gradually protrudes and begins to cut the plaque; Step 5: After completing the cutting, slowly deflate the balloon, so that the blade is retracted inside the catheter, and then slowly retrieve the catheter and exit the blood vessel along the guide wire.

9. The method of using a cutting balloon catheter of claim 8, wherein, After selecting the appropriate cutting balloon catheter in step 2, a protective sleeve is fitted over the blade of the cutting balloon catheter.

10. The method of using a cutting balloon catheter of claim 8, wherein, When the blade begins to cut the plaque in step 4, multiple cutting operations can be performed according to the severity of the lesion, and after each cutting, the balloon is appropriately deflated to observe the cutting effect.

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