Coronary artery cutting balloon catheter with medicine carrying function

Abstract

The invention discloses a coronary artery cutting balloon catheter with a medicine carrying function, and relates to the technical field of cutting balloon catheters.The coronary artery cutting balloon catheter comprises an outer tube, and a balloon capable of expanding in the radial direction is arranged at the far end of the outer tube in a sealed mode; the inner tube is coaxially arranged in the outer tube in a sleeved mode, the far end of the inner tube is fixedly connected with the far end of the outer tube, the inner tube and an inner cavity of the balloon form a fluid channel, and an annular cavity between the inner tube and the outer tube forms an extension section of the fluid channel; the cutting knife assemblies are attached to the outer surface of the balloon; the far end of the outer tube is further connected with a first knife protection ring and a second knife protection ring which are located at the two ends of the balloon, and a plurality of knife protection pull belts corresponding to the cutting knife assemblies are connected between the first knife protection ring and the second knife protection ring. When the sacculus is in a collapsed shape, the cutter protecting drawstring correspondingly covers the cutter assembly, when the sacculus expands in the radial direction, the cutter protecting drawstring is driven by the first cutter protecting ring and the second cutter protecting ring to deviate from the cutter assembly, and safety is higher.

Description

Technical Field

[0001] The present invention relates to the technical field of cutting balloon catheters, in particular to a coronary artery cutting balloon catheter with a drug-carrying function. Background Art

[0002] Coronary artery disease is one of the most common cardiovascular diseases, and its treatment has evolved from simple balloon angioplasty, bare-metal stents, to drug-eluting stents. However, the management of complex lesions (such as calcified and fibrotic plaques) remains challenging: traditional balloon angioplasty may cause vascular elastic recoil, dissection, or poor stent adhesion, while stent implantation may induce intimal hyperplasia and the risk of late thrombosis. To address this, the Cutting Balloon Catheter was developed. Microblades on the balloon surface cut plaque during expansion, reducing expansion pressure and improving vascular compliance.

[0003] Currently, coronary artery cutting balloon catheters focus on the mechanical cutting performance of micro-blades. Although the single-blade design can reduce vascular trauma, it is limited by the spatial layout of the single-blade structure. The drug-loading slots mostly adopt a simple linear arrangement design, resulting in insufficient drug storage capacity and poor distribution uniformity, making it difficult to form a stable drug concentration coverage in the lesion area. Furthermore, to ensure the delivery passability of coronary artery cutting balloon catheters in blood vessels, the micro-blades need to maintain an extremely low profile when not expanded. However, in this state, the interaction between the blade tip and the balloon material may cause potential damage risks. While the use of blunted blades can reduce accidental scratches on the blood vessel wall during delivery, it will significantly reduce cutting efficiency.

[0004] Therefore, it is necessary to provide a coronary artery cutting balloon catheter with drug loading function to solve the above problems. Summary of the Invention

[0005] To solve the above problems, the present invention provides the following technical solution: a coronary artery cutting balloon catheter with drug-carrying function, comprising:

[0006] an outer tube, wherein a radially expandable balloon is sealed at the distal end of the outer tube;

[0007] an inner tube, the inner tube being coaxially sleeved inside the outer tube, the distal end of the inner tube being fixedly connected to the distal end of the outer tube, the inner tube and the inner cavity of the balloon forming a fluid channel, and the annular cavity between the inner tube and the outer tube constituting an extension of the fluid channel;

[0008] a plurality of cutting blade assemblies attached to the outer surface of the balloon;

[0009] The distal end of the outer tube is further connected to a first knife guard ring and a second knife guard ring located at both ends of the balloon, and a plurality of knife guard drawstrings corresponding to the cutting knife assembly are connected between the first knife guard ring and the second knife guard ring;

[0010] When the balloon is in a collapsed state, the knife guard drawstring covers the cutting knife assembly accordingly. When the balloon expands radially, the knife guard drawstring deviates from the cutting knife assembly under the drive of the first knife guard ring and the second knife guard ring.

[0011] Furthermore, preferably, the cutting blade assembly comprises:

[0012] a knife holder attached to the outer surface of the balloon;

[0013] Two knife bodies are spaced apart along the width direction of the knife seat, and the knife bodies are connected to the knife seat by using support pads.

[0014] Furthermore, preferably, the side of the blade body has a plurality of medicine loading grooves spaced apart along the length direction of the blade body, and the medicine body is carried between the medicine loading grooves corresponding to two blade bodies.

[0015] Furthermore, preferably, both of the two blade bodies are capable of moving relative to the blade holder along the length direction of the blade holder;

[0016] One end of one of the blade bodies is connected to an axial push balloon, which passes through the blade seat and is connected to the balloon. When the axial push balloon expands axially, it can push the blade body to move slightly along its length direction.

[0017] Furthermore, preferably, a transition portion is formed between the end of the balloon and the inner tube, and the first knife guard ring and the second knife guard ring both partially cover the transition portion;

[0018] A plurality of reset pads are connected between the first knife guard ring, the second knife guard ring and the outer tube and are distributed at intervals along the circumference of the first knife guard ring or the second knife guard ring.

[0019] Furthermore, preferably, a circumferential push sac is connected between the first knife guard ring and the second knife guard ring and the balloon. The circumferential push sac is communicated with the balloon, and when the circumferential push sac expands circumferentially, it can push the first knife guard ring or the second knife guard ring to deflect circumferentially.

[0020] Further, preferably, the inner tube located inside the balloon is installed with a developing ring.

[0021] Furthermore, preferably, the outer surface of the balloon is provided with at least three groups of cutting knife assemblies spaced apart along the circumference of the outer tube, and each group comprises at least two cutting knife assemblies spaced apart along the length direction of the outer tube.

[0022] Furthermore, preferably, the knife guard strap is made of a slow-rebound material.

[0023] Furthermore, preferably, the distance between the two blades on the blade holder is 0.5-3 mm.

[0024] Compared with the prior art, the present invention provides a drug-loaded coronary artery cutting balloon catheter, which has the following beneficial effects:

[0025] In the present invention, during the delivery of the coronary artery cutting balloon catheter, the knife guard strap covers the cutting knife assembly, effectively preventing the cutting knife assembly from accidentally damaging the blood vessel wall before reaching the target position, thereby ensuring the safety of the operation.

[0026] In the present invention, when the balloon is expanded, the knife guard can smoothly deviate from the cutting knife assembly, ensuring that the cutting knife assembly can fully expose and accurately cut the diseased tissue on the blood vessel wall, thereby improving the accuracy and efficiency of the operation.

[0027] In the present invention, the double-blade design significantly improves the drug loading capacity compared to the single-blade design, so that more drugs can be released to the treatment area while cutting the diseased tissue, thereby improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a schematic diagram of the main structure of a coronary artery cutting balloon catheter with drug loading function;

[0029] Figure 2 This is a schematic diagram of the main structure of a cutting blade assembly in a coronary artery cutting balloon catheter with drug loading function;

[0030] Figure 3 Schematic diagram of the installation structure of the second blade guard ring in a coronary artery cutting balloon catheter with drug loading function Figure 1 ;

[0031] Figure 4 Schematic diagram of the installation structure of the second blade guard ring in a coronary artery cutting balloon catheter with drug loading function Figure 2 ;

[0032] In the figure: 1. Outer tube; 2. Inner tube; 3. Developing ring; 4. Balloon; 5. Cutting knife assembly; 6. Transition part; 7. First knife guard ring; 8. Second knife guard ring; 9. Knife guard pull belt; 10. Circumferential push bladder; 11. Reset pad; 51. Knife seat; 52. Support pad; 53. Knife body; 54. Medicine loading groove; 55. Axial push bladder. DETAILED DESCRIPTION

[0033] The terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned description of the drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequential order. It should be understood that the terms used in this way can be interchangeable under appropriate circumstances, and this is merely a way of distinguishing the objects of the same attributes when describing them in the embodiments of the present application. In addition, the terms "including" and "having" and any of their variations are intended to cover non-exclusive inclusions, so that the process, method, system, product or equipment comprising a series of units need not be limited to those units, but may include other units that are not clearly listed or inherent to these processes, methods, products or equipment.

[0034] Example: Please refer to Figures 1-4 In an embodiment of the present invention, a coronary artery cutting balloon catheter with drug loading function is provided, comprising:

[0035] An outer tube 1, wherein a radially expandable balloon 4 is provided at the distal end of the outer tube 1;

[0036] An inner tube 2 is coaxially sleeved inside the outer tube 1, with its distal end fixedly connected to the distal end of the outer tube 1. The inner tube 2 and the inner cavity of the balloon 4 form a fluid channel, and the annular cavity between the inner tube 2 and the outer tube 1 constitutes an extension of the fluid channel;

[0037] a plurality of cutting blade assemblies 5 attached to the outer surface of the balloon 4;

[0038] The distal end of the outer tube 1 is further connected to a first knife guard ring 7 and a second knife guard ring 8 located at both ends of the balloon 4, and a plurality of knife guard straps 9 corresponding to the cutting knife assembly 5 are connected between the first knife guard ring 7 and the second knife guard ring 8;

[0039] When the balloon 4 is in a collapsed state, the knife guard drawstring 9 covers the cutting knife assembly 5 accordingly. When the balloon 4 expands radially, the knife guard drawstring 9 deviates from the cutting knife assembly 5 under the drive of the first knife guard ring 7 and the second knife guard ring 8.

[0040] Therefore, the implementation includes the following steps:

[0041] Step 1: In the unexpanded state, the coronary artery cutting balloon catheter is delivered into the patient's vascular system through an interventional procedure, such as percutaneous coronary intervention (PCI). At this time, the balloon 4 is in a collapsed state.

[0042] Step 2: The cutting blade assembly 5 is attached to the outer surface of the balloon 4. The blade protection strap 9, under the action of the first and second blade protection rings 7 and 8, covers the cutting blade assembly 5, forming a protective layer. This ensures that the cutting blade assembly 5 does not cause accidental damage to the healthy blood vessel wall before the coronary artery cutting balloon catheter passes through the blood vessel to the target lesion.

[0043] Step 3: Once the target location is reached, fluid is injected into the balloon 4 through the extension of the fluid channel and the fluid channel to radially expand the balloon 4. This process not only expands the narrowed blood vessel area, but also prepares the conditions for the subsequent cutting operation.

[0044] Step 4: As the balloon 4 expands, the first and second knife guard rings 7 and 8 drive the knife guard pull belt 9 to deviate from the cutting knife assembly 5. At this time, the cutting knife assembly 5 is exposed and can directly contact and cut the diseased tissue on the blood vessel wall.

[0045] Step 5: After the cutting is completed, the fluid injection into the balloon 4 is stopped, and the balloon 4 gradually collapses back to its initial state. At the same time, the first blade guard ring 7, the second blade guard ring 8, and the blade guard pull strap 9 are reset to ensure that the blood vessel will not be damaged again during the withdrawal of the coronary artery cutting balloon catheter.

[0046] In other words, in this embodiment, the design of the blade guard 9 effectively prevents accidental exposure of the cutting blade assembly 5 before reaching the target location, significantly reducing the risk of damage to healthy blood vessel walls during surgery. Furthermore, by precisely controlling the expansion and collapse of the balloon 4, the exposure and concealment of the cutting blade assembly 5 can be precisely controlled, thereby achieving precise incision of diseased tissue. This coronary artery cutting balloon catheter is suitable for treating a variety of coronary artery lesions, particularly complex lesions that require precise incision, such as calcified lesions.

[0047] In this embodiment, the cutting blade assembly 5 includes:

[0048] a knife holder 51 , which is attached to the outer surface of the balloon 4 ;

[0049] Two blade bodies 53 are spaced apart along the width direction of the blade seat 51 , and the blade bodies 53 are connected to the blade seat 51 using support pads 52 .

[0050] The side of the blade body 53 has a plurality of medicine loading grooves 54 spaced apart along the length direction of the blade body 53 , and the medicine loading grooves 54 corresponding to two blade bodies 53 are used to carry medicine.

[0051] In this embodiment, the two blade bodies 53 are spaced apart along the width direction of the blade holder 51. Such a layout not only ensures the stability and accuracy of the cutting operation, but also provides a possibility for increasing the drug loading amount.

[0052] Specifically, each blade body 53 is designed with a plurality of drug loading grooves 54 spaced apart along its length on its side. These drug loading grooves 54 are not only used to accommodate drugs, but also, through their special design, allow additional drugs to be carried between the corresponding drug loading grooves 54 of the two blade bodies.

[0053] Therefore, during balloon expansion, as the blade 53 expands outward and contacts the lesion, the drug is released from the drug loading groove 54 as the blade 53 cuts, acting on the cut surface. The additional drug loading space between the two blades 53 increases the amount of drug released, thereby improving the therapeutic effect.

[0054] Furthermore, the spacing between the two blades 53 on the blade holder 51 is 0.5-3 mm, ensuring that the blades 53 remain stable during expansion and avoid mutual interference, while also ensuring the flatness and precision of the cut surface. This spacing also optimizes the use of the space between the drug loading slots 54, maximizing the additional load-bearing space between the two blades 53. This not only increases the drug-bearing capacity, but also improves the efficiency and uniformity of drug release during the cutting process.

[0055] Furthermore, the two blade bodies 53 are both capable of moving relative to the blade holder 51 along the length direction of the blade holder 51;

[0056] One end of one of the blade bodies 53 is connected to an axial push capsule 55, which passes through the blade seat 51 and is connected to the balloon 4. When the axial push capsule 55 expands axially, it can push the blade body 53 to move slightly along its length direction.

[0057] That is, in this embodiment, both blade bodies 53 are movable relative to the blade holder 51 along its length, and an axial push capsule 55 is introduced and connected to the end of one of the blade bodies 53. This design not only enhances the flexibility of the cutting blade assembly 5, but also enables the dislocation of the drug-loading groove 54 through the expansion of the axial push capsule 55, further improving the drug release efficiency.

[0058] In this embodiment, a transition portion 6 is formed between the end of the balloon 4 and the inner tube 2 , and the first knife guard ring 7 and the second knife guard ring 8 both partially cover the transition portion 6 ;

[0059] A plurality of reset pads 11 are connected between the first knife guard ring 7 and the second knife guard ring 8 and the outer tube 1 and are distributed at intervals along the circumference of the first knife guard ring 7 or the second knife guard ring 8 .

[0060] A circumferential push balloon 10 is connected between the first knife guard ring 7 and the second knife guard ring 8 and the balloon 4. The circumferential push balloon 10 is communicated with the balloon 4. When the circumferential push balloon 10 expands circumferentially, it can push the first knife guard ring 7 or the second knife guard ring 8 to deflect circumferentially.

[0061] That is, once the target location is reached, fluid is injected into the balloon 4, causing it to expand radially. As the balloon 4 expands, the circumferential push balloon 10 also expands, pushing the first and second blade guards 7 and 8 to circumferentially deflect. This deflection helps the blade guard 9 to more smoothly deflect from the cutting blade assembly 5, ensuring that the cutting blade assembly 5 can fully expose and contact the diseased tissue on the vessel wall. Simultaneously, the deflection of the blade guards (first and second blade guards 7 and 8) stretches the reset pad 11, storing potential energy for subsequent reset operations. After the cut is completed, fluid injection into the balloon 4 is stopped, and the balloon 4 and circumferential push balloon 10 gradually collapse back to their initial state. As the balloon 4 and circumferential push balloon 10 collapse, the reset pad 11 releases the stored potential energy, pushing the blade guards back into place, and the blade guard 9 re-covers the cutting blade assembly 5.

[0062] Furthermore, the knife guard strap 9 is made of a slow-rebound material.

[0063] When fluid is injected into the balloon 4, it expands radially. As the balloon 4 expands, the circumferential pusher 10 also expands, pushing the knife guard ring to circumferentially deflect. This deflection causes the knife guard pull strap 9, driven by the knife guard ring, to gradually detach from the cutting knife assembly 5.

[0064] At the same time, because the knife guard pull strap 9 is made of a slow-rebound material, during the process of the knife guard ring being reset, the knife guard pull strap 9 can gradually restore its original shape and position and re-cover the cutting knife assembly 5. This recovery ensures that the knife guard pull strap 9 will not cause secondary damage to the healthy blood vessel wall during the withdrawal of the catheter.

[0065] Furthermore, before inserting the coronary artery cutting balloon catheter, lubricant is applied to the surface of the knife guard strap 9 close to the slave cutting knife assembly 5, so as to reduce the probability of the knife guard strap 9 being stuck on the slave cutting knife assembly 5, and ensure that it can be detached from the cutting knife assembly 5 under the drive of the knife guard ring. In addition, it should be noted that the knife guard strap 9 has a tensile limit. Generally, when the balloon 4 expands radially to the limit, the knife guard strap 9 reaches the tensile limit.

[0066] In this embodiment, a developing ring 3 is installed on the inner tube 2 located inside the balloon 4 .

[0067] In this embodiment, the outer surface of the balloon 4 is provided with at least three groups of cutting blade assemblies 5 spaced circumferentially along the outer tube 1. Each group comprises at least two cutting blade assemblies spaced along the length of the outer tube 1, ensuring comprehensive and uniform cutting. This arrangement facilitates more thorough and uniform cutting of diseased tissue.

[0068] The above is only a preferred specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with this technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solutions and inventive concepts of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. A coronary artery cutting balloon catheter with drug loading function, characterized in that: include: An outer tube (1), wherein a radially expandable balloon (4) is provided at the distal end of the outer tube (1); An inner tube (2), the inner tube (2) being coaxially sleeved inside the outer tube (1), the distal end of the inner tube (2) being fixedly connected to the distal end of the outer tube (1), the inner tube (2) and the inner cavity of the balloon (4) forming a fluid channel, and the annular cavity between the inner tube (2) and the outer tube (1) constituting an extension of the fluid channel; a plurality of cutting knife assemblies (5) attached to the outer surface of the balloon (4); The distal end of the outer tube (1) is further connected to a first knife guard ring (7) and a second knife guard ring (8) located at both ends of the balloon (4); a plurality of knife guard drawstrings (9) corresponding to the cutting knife assembly (5) are connected between the first knife guard ring (7) and the second knife guard ring (8); When the balloon (4) is in a collapsed state, the knife guard drawstring (9) is correspondingly covered on the cutting knife assembly (5); when the balloon (4) is radially expanded, the knife guard drawstring (9) deviates from the cutting knife assembly (5) under the drive of the first knife guard ring (7) and the second knife guard ring (8).

2. The drug-loaded coronary artery cutting balloon catheter according to claim 1, characterized in that: The cutting blade assembly (5) comprises: a knife holder (51) attached to the outer surface of the balloon (4); Two knife bodies (53) are spaced apart along the width direction of the knife seat (51); the knife bodies (53) are connected to the knife seat (51) by using a support pad (52).

3. The drug-loaded coronary artery cutting balloon catheter according to claim 2, characterized in that: The side of the blade body (53) has a plurality of medicine loading grooves (54) spaced apart along the length direction of the blade body (53), and the medicine loading grooves (54) corresponding to two blade bodies (53) are used to carry medicine.

4. The drug-loaded coronary artery cutting balloon catheter according to claim 3, characterized in that: The two blade bodies (53) are both capable of moving relative to the blade seat (51) along the length direction of the blade seat (51); One end of one of the blade bodies (53) is connected to an axial push capsule (55), which passes through the blade seat (51) and is connected to the balloon (4). When the axial push capsule (55) expands axially, it can push the blade body (53) to move slightly along its length direction.

5. The drug-loaded coronary artery cutting balloon catheter according to claim 1, characterized in that: A transition portion (6) is formed between the end of the balloon (4) and the inner tube (2), and the first knife guard ring (7) and the second knife guard ring (8) both partially cover the transition portion (6); A plurality of reset pads (11) are connected between the first knife guard ring (7) and the second knife guard ring (8) and the outer tube (1) and are distributed at intervals along the circumference of the first knife guard ring (7) or the second knife guard ring (8).

6. The drug-loaded coronary artery cutting balloon catheter according to claim 5, characterized in that: A circumferential push sac (10) is connected between the first knife guard ring (7) and the second knife guard ring (8) and the balloon (4). The circumferential push sac (10) is in communication with the balloon (4). When the circumferential push sac (10) expands circumferentially, it can push the first knife guard ring (7) or the second knife guard ring (8) to perform circumferential deflection.

7. The drug-loaded coronary artery cutting balloon catheter according to claim 1, characterized in that: The inner tube (2) located inside the balloon (4) is equipped with a developing ring (3).

8. The drug-loaded coronary artery cutting balloon catheter according to claim 1, characterized in that: The outer surface of the balloon (4) is provided with at least three groups of cutting knife assemblies (5) spaced apart along the circumference of the outer tube (1), and each group comprises at least two cutting knife assemblies spaced apart along the length direction of the outer tube (1).

9. The drug-loaded coronary artery cutting balloon catheter according to claim 1, characterized in that: The knife guard strap (9) is made of a slow-rebound material.

10. The drug-loaded coronary artery cutting balloon catheter according to claim 2, characterized in that: The distance between the two blades (53) on the blade seat (51) is 0.5-3 mm.

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