Balloon catheter cutting jig and drug coating uniformity testing device

Abstract

This utility model belongs to the technical field of medical devices, specifically relating to a balloon dilatation catheter cutting clamp and a drug coating uniformity testing device. The balloon dilatation catheter cutting clamp of this utility model utilizes the clamping surfaces of a first arc-shaped jaw and a second arc-shaped jaw to achieve precise clamping of drug-eluting balloons of different sizes. It also provides radial and axial cutting gaps for radial and axial cutting of the balloon dilatation catheter, cutting out regularly shaped sample fragments for testing, facilitating the calculation of the area or length of each sample fragment. Because the clamping surfaces are all concave, it ensures that even after axial cutting, the balloon dilatation catheter remains between the two clamping surfaces, preventing sample drop and drug detachment.

Description

Technical Field

[0001] This utility model belongs to the technical field of medical devices, specifically relating to a balloon dilation catheter cutting clamp and a drug coating uniformity testing device. Background Technology

[0002] Drug-coated balloon dilatation catheters are balloon dilatation catheters with a drug coating such as paclitaxel on their surface. After the balloon reaches the lesion site, it dilates to restore blood flow. The drug is released into the local tissue to inhibit excessive proliferation of smooth muscle cells and reduce the inflammatory response, thereby inhibiting excessive intimal hyperplasia and reducing restenosis. With its "intervention without implantation" treatment concept and increasingly abundant clinical evidence, drug-coated balloons have shown extremely broad application prospects in areas such as in-stent restenosis, small vessel disease, and branch ostial disease.

[0003] The uniformity of the drug coating is a prerequisite for ensuring that the drug can evenly cover the blood vessel wall at the lesion site, and it is also a necessary indicator of product process stability. Current technical documents such as the "Guiding Principles for Registration Review of Drug-Coated Balloon Dilatation Catheters" and ASTM F 3320-18: Standard Guide for Coating Characterization of Drug-Coated Balloons both stipulate that the longitudinal and circumferential uniformity of the coating should be evaluated, but specific test equipment and measurement methods are not provided.

[0004] 1. Due to the light weight of the balloon, the mass method has a large error.

[0005] 2. Because the balloon is made of flexible material and is mostly supplied in a folded state, direct cutting or cutting after inflation cannot detect regular patterns, making it difficult to obtain the area of ​​each part and resulting in large errors.

[0006] 3. The area obtained by using 3D scanning technology after cutting is more accurate, but the cost is too high.

[0007] 4. The size range of balloons is quite large, ranging from 1.0mm to 12mm in diameter and 5mm to 300mm in length. The ability to cut balloons of different sizes onto a single device requires a high degree of adaptability from the device itself. Utility Model Content

[0008] To address the aforementioned technical problems, this utility model provides a balloon dilation catheter cutting clamp and a balloon dilation catheter drug coating uniformity testing device. The device utilizes vertically arranged concave clamping surfaces of a first arc-shaped clamp and a second arc-shaped clamp to hold balloons of different diameters after filling and shaping. It provides axial and radial cutting gaps for both axial and radial cutting, resulting in regularly shaped sample fragments for testing. This facilitates the calculation of the area or length of each sample fragment, thus providing technical support for subsequent balloon dilation catheter drug coating uniformity testing.

[0009] The technical problem to be solved by this utility model is achieved by the following technical solution: a balloon dilation catheter cutting clamp, comprising a linear drive module, a first arc-shaped clamp, and a second arc-shaped clamp; The first arc-shaped gripper and the second arc-shaped gripper are slidably mounted on the linear drive module. The upper ends of the first arc-shaped gripper and the second arc-shaped gripper are vertically provided with concave clamping surfaces. The clamping surfaces of the first arc-shaped gripper and the second arc-shaped gripper are arranged opposite to each other to form an axial cutting gap. The upper ends of the first arc-shaped gripper and the second arc-shaped gripper are provided with a plurality of radially spaced cutting gaps along the axial direction. The radial cutting gaps are arranged to penetrate the clamping surface radially along the first arc-shaped gripper and the second arc-shaped gripper. The linear drive module is used to drive the relative movement of the first arc-shaped gripper and the second arc-shaped gripper. Since the first and second arc-shaped grippers are arched, they can hold the balloon dilation catheter in mid-air, facilitating the cutting of the balloon dilation catheter along the axial and radial directions.

[0010] Preferably, the upper front side of the first arc-shaped gripper and the second arc-shaped gripper is provided with an arc-shaped support groove with an upward opening, and the arc-shaped support groove intersects with the clamping surface; The inner diameter of the arc-shaped support groove is larger than the outer diameter of the balloon dilation catheter after filling and shaping. The end of the balloon dilation catheter has a tapered structure, so it will not contain any medication or be clamped. To prevent the end of the balloon dilation catheter from falling off during the cutting process and making it inconvenient to retrieve, an upward-opening arc-shaped support groove is provided on the upper front side of the first and second arc-shaped grippers. The arc-shaped support groove is used to catch the tip of the balloon dilation catheter that has been cut off radially. In addition, the arc-shaped support groove structure provides the necessary space for placement, making it convenient for the operator to hold the balloon dilation catheter between the first and second arc-shaped grippers.

[0011] In a preferred embodiment of this invention, the linear drive module includes a support base, a guide rod, a bidirectional drive screw, and a knob. The stud threads on both sides of the bidirectional drive screw have opposite directions; The guide rod and the bidirectional drive screw are arranged in parallel on the support base. The bidirectional drive screw is rotatably arranged on the support base. The first arc-shaped gripper and the second arc-shaped gripper are threadedly connected to the studs on both sides of the bidirectional drive screw. The knob is located at the end of the bidirectional drive screw. The bidirectional drive screw drives the first and second arc-shaped grippers to move relative to each other, thereby clamping balloon dilation catheters of different sizes. The knob structure allows the operator to control the clamping force on the balloon dilation catheter, avoiding excessive clamping force that could cause the drug to fall off.

[0012] In a preferred embodiment of this invention, a guide rod is provided on each side of the bidirectional drive screw; The lower ends of the first and second arc-shaped grippers are provided with sliding support blocks; The sliding support block is suspended on two guide rods and is slidably connected to the guide rods. The first and second arc-shaped grippers are suspended on the guide rods, reducing the sliding resistance of the first and second arc-shaped grippers and facilitating manual adjustment of their distance.

[0013] Preferably, in this invention, the clamping surface comprises two clamping planes intersecting at an obtuse angle. Using these two intersecting clamping planes at an obtuse angle to clamp the balloon dilation catheter is suitable for fixing balloon dilation catheters of different diameters.

[0014] This utility model also discloses a balloon dilation catheter drug coating uniformity testing device, which utilizes the above-mentioned balloon dilation catheter cutting fixture, including a support, an axial cutting module and a radial cutting module; The balloon dilation catheter cutting clamp is fixedly mounted on the support; The axial cutting module is slidably mounted on the bracket along the axial cutting gap. The axial cutting module includes a vertically arranged axial cutting tool located between the clamping surfaces of the first arc-shaped gripper and the second arc-shaped gripper. The radial cutting module includes a radial cutting support frame and radial cutting blades. One end of the radial cutting support frame is hinged to a bracket, and a plurality of radial cutting blades are arranged on the lower end face of the radial cutting support frame. The position of the radial cutting blade corresponds to the radial cutting gap.

[0015] In a preferred embodiment of this invention, the axial cutting module includes an axial cutting guide rod and an axial cutting support frame; The axial cutting guide rod is horizontally mounted on the bracket, and the axial cutting support frame is slidably mounted on the axial cutting guide rod. The axial cutting support frame has a U-shaped structure and includes two support arms. The axial cutting tool is disposed between the two support arms and located at the U-shaped opening of the axial cutting support frame. Positioning the axial cutter on the support arms of the U-shaped axial cutting support frame facilitates control of the axial cutter passing through the axial cutting gap between the first and second arc-shaped grippers.

[0016] In a preferred embodiment of this invention, the axial cutting device includes two axial cutting blades with pointed tops, each mounted on one of two support arms and spaced apart from the other. The two spaced-apart axial cutting blades are used to axially cut the balloon dilation catheter, ensuring only the cylindrical sidewall of the catheter is cut open. The tip of the catheter does not need to be completely cut, reducing cutting resistance and allowing the tip sidewall to act as a guide, making it easier to cut the outer wall of the balloon dilation catheter.

[0017] Preferably, this utility model further includes a positioning mechanism, which includes a first clamping plate and a second clamping plate. The first clamping plate is fixedly mounted on the support arm, and the first clamping plate and the second clamping plate are connected by bolts. The axial cutting blade is located between the first clamping plate and the second clamping plate. The second clamping plate has bolt through holes, the first clamping plate has bolt holes and limiting posts, and the axial cutting blade has through holes that match the bolt holes and limiting posts. While the axial cutting blade is clamped and fixed using the first and second clamping plates, the bolt holes and limiting posts on the first clamping plate further limit and fix the axial cutting blade, ensuring its stability during the cutting process.

[0018] In a preferred embodiment of this invention, the radial cutting support frame includes a rectangular frame and multiple tool fixing rods; The tool fixing rod is detachably mounted on the inner side of the rectangular frame by bolts, and the tool fixing rods are spaced apart from each other; The radial cutting blade is detachably mounted on the side of the blade fixing rod via bolts. By detachably mounting the radial cutting blade on the side of the blade fixing rod, and then detachably mounting the blade fixing rod on the inside of the rectangular frame via bolts, the installation and replacement of the radial cutting blade are facilitated.

[0019] Compared with the prior art, the beneficial effects of this utility model are: The balloon dilation catheter cutting fixture of this invention utilizes the clamping surfaces of the first arc-shaped clamp and the second arc-shaped clamp to achieve precise clamping of drug-filled and shaped balloons of different specifications. It also provides radial and axial cutting gaps for radial and axial cutting of the balloon dilation catheter to cut out regularly shaped sample fragments to be tested, facilitating the calculation of the area or length of each sample fragment to be tested.

[0020] Because the clamping surfaces are all concave, the balloon dilation catheter remains between the two clamping surfaces even after being axially cut, preventing the sample from falling out and causing the drug to detach.

[0021] This invention relates to a balloon dilation catheter drug coating uniformity testing device. Based on the effective clamping of the balloon dilation catheter using a balloon dilation catheter cutting clamp, the device utilizes an axial cutting module to accurately segment the balloon dilation catheter along the axial direction. By rotating the angle of the balloon dilation catheter, multiple cuts can be made along the circumference of the balloon dilation catheter. The device also utilizes a radial cutting module to quickly cut the balloon dilation catheter into multiple segments along the radial direction, thereby obtaining regularly shaped sample fragments to be tested, while ensuring the efficiency and quality of the cutting. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the balloon dilation catheter cutting clamp of the present invention; Figure 2 This is a schematic diagram of the structure of the balloon dilation catheter drug coating uniformity testing device of this utility model. Figure 1 ; Figure 3 This is a schematic diagram of the structure of the balloon dilation catheter drug coating uniformity testing device of this utility model. Figure 2 ; Figure 4 This is a schematic diagram of the positioning mechanism described in this utility model; Figure 5 This is a schematic diagram showing the usage status of the balloon dilation catheter drug coating uniformity testing device of this utility model; Figure 6 This is a schematic diagram of an axial cut of the balloon dilation catheter drug coating uniformity testing device of this utility model; Figure 7 This is a longitudinal cut diagram of the balloon dilation catheter drug coating uniformity testing device of this utility model; In the figure, 1 is the linear drive module, 2 is the first arc-shaped gripper, and 3 is the second arc-shaped gripper; 100 clamping surface, 200 axial cutting gap, 300 radial cutting gap; 4. Arc-shaped support grooves; 5. Sliding support blocks; 11 Support base, 12 Guide rod, 13 Bidirectional drive screw, 14 Knob; 101 Clamping plane; 6 brackets, 7 axial cutting modules, 8 radial cutting modules; 71-axis cutting tool, 711-axis cutting blade, 7111 through hole; 72 Axial cutting guide rod, 73 Axial cutting support frame, 731 Support arm; 81 Radial cutting support frame, 82 Radial cutting blade; 811 Rectangular frame, 812 Tool fixing rod; 9 Positioning mechanism, 91 First clamping plate, 92 Second clamping plate, 921 Bolt through hole, 911 Bolt hole, 912 Limiting post. Detailed Implementation

[0023] The technical solutions in the embodiments of this utility model will now be clearly and completely described in conjunction with the accompanying drawings.

[0024] For ease of description, balloon dilation catheters can also be simply referred to as balloons.

[0025] like Figure 1 As shown, a balloon dilation catheter cutting clamp includes a linear drive module 1, a first arc-shaped gripper 2, and a second arc-shaped gripper 3.

[0026] The first arc-shaped gripper 2 and the second arc-shaped gripper 3 are horizontally slidable on the linear drive module 1.

[0027] The upper ends of the first arc-shaped gripper 2 and the second arc-shaped gripper 3 are vertically provided with concave clamping surfaces 100. The clamping surfaces 100 of the first arc-shaped gripper 2 and the second arc-shaped gripper 3 are arranged opposite to each other to form an axial cutting gap 200.

[0028] The upper ends of the first arc-shaped gripper 2 and the second arc-shaped gripper 3 are provided with a plurality of radially spaced cutting gaps 300 along the axial direction. The radially cutting gaps 300 are arranged to penetrate the clamping surface 100 radially along the first arc-shaped gripper 2 and the second arc-shaped gripper 3.

[0029] The linear drive module 1 is used to drive the first arc-shaped gripper 2 and the second arc-shaped gripper 3 to move relative to each other.

[0030] The upper front side of the first arc-shaped gripper 2 and the second arc-shaped gripper 3 is provided with an arc-shaped support groove 4 with an upward opening, and the arc-shaped support groove 4 intersects with the clamping surface 100.

[0031] The inner diameter of the arc-shaped support groove 4 is larger than the outer diameter of the balloon dilation catheter after filling and shaping.

[0032] The linear drive module 1 includes a support base 11, a guide rod 12, a bidirectional drive screw 13, and a knob 14.

[0033] The stud threads on both sides of the bidirectional drive screw 13 are in opposite directions.

[0034] The guide rod 12 and the bidirectional drive screw 13 are arranged in parallel on the support base 11, and the first arc-shaped gripper 2 and the second arc-shaped gripper 3 are threadedly connected to the studs on both sides of the bidirectional drive screw 13.

[0035] The bidirectional drive screw 13 is rotatably mounted on the support base 11 via a bearing, and the knob 14 is located at the end of the bidirectional drive screw 13.

[0036] A guide rod 12 is provided on each side of the bidirectional drive screw 13.

[0037] The lower ends of the first arc-shaped gripper 2 and the second arc-shaped gripper 3 are provided with sliding support blocks 5.

[0038] The sliding support block 5 is suspended on two guide rods 12, and the sliding support block 5 is slidably connected to the guide rods 12.

[0039] The clamping surface 100 includes two clamping planes 101 that intersect at an obtuse angle.

[0040] like Figures 2-7 As shown, a balloon dilation catheter drug coating uniformity testing device utilizes the aforementioned balloon dilation catheter cutting fixture, including a support 6, an axial cutting module 7, and a radial cutting module 8.

[0041] The balloon dilation catheter cutting clamp is fixedly mounted on the support 6.

[0042] The axial cutting module 7 is slidably mounted on the bracket 6 along the axial cutting gap 200. The axial cutting module 7 includes a vertically arranged axial cutting tool 71, which is located between the clamping surfaces 100 of the first arc-shaped clamp 2 and the second arc-shaped clamp 3.

[0043] The radial cutting module 8 includes a radial cutting support frame 81 and radial cutting blades 82. One end of the radial cutting support frame 81 is hinged to the bracket 6, and a plurality of radial cutting blades 82 are arranged on the lower end face of the radial cutting support frame 81.

[0044] The position of the radial cutting blade 82 corresponds to the radial cutting gap 300.

[0045] The axial cutting module 7 includes an axial cutting guide rod 72 and an axial cutting support frame 73.

[0046] The axial cutting guide rod 72 is horizontally mounted on the bracket 6, and the axial cutting support frame 73 is slidably mounted on the axial cutting guide rod 72.

[0047] The axial cutting support frame 73 has a U-shaped structure and includes two support arms 731. The axial cutting tool 71 is disposed between the two support arms 731 and located at the U-shaped opening of the axial cutting support frame 73.

[0048] The axial cutting tool 71 includes two axial cutting blades 711 with pointed tops. The two axial cutting blades 711 are respectively mounted on two support arms 731 and are arranged at a distance from each other. Both sides of the pointed top of the axial cutting blades 711 are provided with cutting edges.

[0049] The balloon dilation catheter drug coating uniformity testing device further includes a positioning mechanism 9, which includes a first clamping plate 91 and a second clamping plate 92. The first clamping plate 91 is fixedly mounted on the support arm 731, and the first clamping plate 91 and the second clamping plate 92 are bolted together. The axial cutting blade 711 is located between the first clamping plate 91 and the second clamping plate 92.

[0050] The second clamping plate 92 is provided with a bolt through hole 921, the first clamping plate 91 is provided with a bolt hole 911 and a limiting post 912, and the axial cutting blade 711 is provided with a through hole 7111 that matches the bolt hole 911 and the limiting post 912.

[0051] The radial cutting support frame 81 includes a rectangular frame 811 and multiple tool fixing rods 812.

[0052] The tool fixing rod 812 is detachably mounted on the inner side of the rectangular frame 811 by bolts, and the tool fixing rods 812 are spaced apart from each other.

[0053] The radial cutting blade 82 is detachably mounted on the side of the blade fixing rod 812 by bolts.

[0054] Working principle or working process: 1. Clamping the balloon: Under the preset temperature environment, fill the balloon expansion catheter with liquid phase change molding filler, and then lower the ambient temperature to the test temperature to allow the phase change molding filler to solidify and shape inside the balloon expansion catheter. Rotate the knob to drive the balloon clamp, namely the first arc-shaped clamp 2 and the second arc-shaped clamp 3, through the bidirectional screw rotation to firmly clamp the experimental balloon.

[0055] Specifically, the phase change stabilized filler is first placed in a water bath slightly above the phase transition temperature in a container to make it liquid. The liquid is then drawn up with a syringe and injected into the balloon. At room temperature, the phase change stabilized filler gradually solidifies inside the balloon, providing stable support and facilitating cutting. (Without support, air would leak when cut, and it would be impossible to cut into uniform pieces.)

[0056] The phase change shaping filler is a eutectic mixture.

[0057] In this embodiment, the eutectic mixture is a quaternary eutectic mixture of quinic acid, lauric acid, myristic acid, and palmitic acid (QA-LA-MA-PA). The formulation has been optimized and is currently determined to be 8%-15% decanoic acid (C10) + 35%-45% lauric acid (C12) + 25%-35% myristic acid (C14) + 10%-15% palmitic acid (C16), with a melting point of 39℃-41℃. In practice, researchers can adjust and select appropriate phase change fillers as needed.

[0058] 2. Axial Cutting: Sliding the axial cutting blade 711 along the axial cutting guide rod 72 allows for precise axial division of the experimental balloon. Rotating the balloon enables multi-segment cutting. The resulting sample fragments are used to evaluate the circumferential homogeneity of the drug.

[0059] 3. Radial Cutting: Rotating the radial cutting support 81 around its axis, the radial cutting blade 82 cuts the balloon into several small segments of equal length. Expanding the outer surface of the balloon at this point yields rectangles of equal area. The resulting sample fragments are used to evaluate the longitudinal uniformity of the drug coating.

[0060] Sample determination was performed using the method described in this embodiment (taking paclitaxel as an example): (1) Preparation of test solution: Place the cut balloon samples of equal area into different stoppered test tubes. Add an appropriate volume of acetonitrile. This volume needs to be calculated based on the balloon specifications and the labeled drug content (the above method is a conventional method. For example, if the linear range is 1-100 μg / mL and the labeled drug content of the sample is 1 mg, the added volume can be set to 20 mL, so that the concentration of the target substance in the test solution is 50 μg / mL, which is in the middle of the standard curve). Ensure that the drug concentration of the final prepared test solution is within the range of the standard curve. Immerse the balloon in acetonitrile, sonicate to completely dissolve the drug, and then vortex mix to obtain the test solution.

[0061] (2) Preparation of reference solution: Weigh an appropriate amount of reference standard into a brown volumetric flask, dissolve it in acetonitrile and dilute to the mark to obtain the standard stock solution. Accurately transfer an appropriate amount of the above solution and dilute it with acetonitrile to prepare a series of standard solutions.

[0062] Current drug capsules typically contain paclitaxel or rapamycin. Brown bottles protect the drug from light, further ensuring its stability, which is especially important for photosensitive drugs. Light exposure can cause paclitaxel to polymerize or break down, and rapamycin is easily oxidized when exposed to light for extended periods. In short, light protection is a crucial protective measure.

[0063] (3) Chromatographic conditions Chromatographic column: octadecylsilane-bonded silica column; mobile phase: methanol-water-acetonitrile (23:41:36); column temperature: 35℃; flow rate: 1.0 mL / min; detection wavelength: 227 nm; injection volume: 10 μL.

[0064] (4) Calculation of results Example 1: Example of longitudinal uniformity of drug coating A drug-eluting balloon is divided into three nearly equal parts, A, B, and C, with each segment having a length of L. A L B L C The drug content of each segment was analyzed separately, and the results are as follows: Measured content of segment A: m A ; Measured content in section B: m B Content determined in section C: m C .

[0065] The expected drug content of segment A of the balloon is calculated using the following formula: m A '=L A / (L) A +L B +L C )*(m A +m B +m C ).

[0066] The drug concentration on segment A of the balloon is compared to the expected drug concentration, calculated as a percentage; for example, for segment A (QA), the % concentration is as follows: (m A / m A ')×100%.

[0067] Example 2: Example of drug circumferential uniformity A drug-eluting balloon is cut circumferentially into two parts that are as even as possible. Measure the area: a surface: S a b side: S b .

[0068] Then, the drug content of each side was analyzed separately, and the results are as follows: Drug content measured on side a: m A Content measured on side b: m b The expected drug content on side a is calculated using the following formula: m a '=S a / (S) a +S b )*(m A +m B +m C ).

[0069] The drug content on side A is compared to the expected drug content, calculated as a percentage; for example, for side A (QA), the % content is as follows: (ma / m a ')×100%.

[0070] Example 3: Simultaneous determination of longitudinal and circumferential uniformity of drug coating A single drug-eluting balloon is divided into approximately three equal parts along its longitudinal direction and two equal parts along its circumference, resulting in a total of six parts: Aa, Ab, Ba, Bb, Ca, and Cb.

[0071] Calculate the area of ​​each part, S. Aa S Ab S Ba S Bb S Ca S Cb The drug content of each part was analyzed separately, and the results were m. Aa m Ab m Ba m Bb m Ca m Cb Then, along the longitudinal direction, m are respectively A =(m Aa +m Ab ), m B =(m Ba +m Bb ), m C =(m Ca +m Cb ), along the circumferential direction, are m respectively a =(m Aa +m Ba +m Ca ), m b =(m Ab +m Bb +m Cb S A =S Aa +S Ab S B =S Ba +S Bb ,S C =S Ca +S Cb .

[0072] The expected drug content of part A is calculated using the following formula: m A '=S A / (S) A +S B +S C )*(m A +m B +m C ).

[0073] The drug content in Part A is compared to the expected drug content, calculated as a percentage; for example, for Part A (QA), the % content is as follows: (m A / m A ')×100%, and the calculation of the remaining part is the same as the example above.

[0074] Application prospects of this embodiment: 1. Quality control of drug-coated balloon dilation catheters By performing both axial and radial cutting, the balloon is expanded into rectangular segments of equal area. Combined with chromatographic analysis, the uniformity of the drug coating distribution is quantified. This technology resolves the efficacy differences caused by uneven coating in the production of drug-coated balloon dilatation catheters.

[0075] 2. Support for the research and development of new balloon products By revealing coating process defects through multi-segment cutting, companies can be guided to improve their coating technologies. This also provides technical support for the development of complex novel balloons.

[0076] The balloon dilation catheter drug coating uniformity testing device in this embodiment has the following advantages: 1. Improved ease of operation and controllability: The drug-eluting balloon is securely clamped by driving the bidirectional drive screw 13 with a knob. The operation is simple and the clamping force is controllable.

[0077] Both axial and radial cutting are accomplished through a dedicated guide structure (the hinge shaft of the axial cutting guide rod 72 and the radial cutting support frame 81), which significantly reduces the difficulty and error of manual operation and improves the accuracy and repeatability of the operation.

[0078] 2. Cutting precision and uniformity are significantly improved: The axial cutting structure slides along the axial cutting guide 72, while the balloon dilation catheter can rotate between the two clamping surfaces 100, ensuring that the axial cutting blade 7111 can accurately achieve axial equidistant cutting and accurate cut position.

[0079] The radial cutting structure's axial rotation design, combined with its radial cutting blade 82, can cut the balloon into small segments of identical length at equal intervals.

[0080] The synergistic effect of the dual precision cutting ensures that the outer surface of the expanded balloon becomes a rectangle with strictly equal area, providing a highly uniform sample with consistent geometry for subsequent experiments.

[0081] 3. Standardized sample preparation: This solution provides a highly standardized and repeatable balloon cutting method that overcomes the problems of inconsistent size and shape caused by manual cutting.

[0082] The resulting rectangular samples of equal area are suitable for studying the coating uniformity of drug-eluting balloons.

[0083] 4. Improve experimental efficiency and reliability: The systematic cutting process, which first uses the first arc-shaped clamp 2 and the second arc-shaped clamp 3 to hold the sample, and then performs axial and radial cutting, reduces human intervention and shortens the sample preparation time.

Claims

1. A balloon dilatation catheter cutting jig, characterized by: It includes a linear drive module (1), a first arc-shaped gripper (2), and a second arc-shaped gripper (3); The first arc-shaped gripper (2) and the second arc-shaped gripper (3) are horizontally slidable on the linear drive module (1); The upper ends of the first arc-shaped gripper (2) and the second arc-shaped gripper (3) are vertically provided with concave clamping surfaces (100). The clamping surfaces (100) of the first arc-shaped gripper (2) and the second arc-shaped gripper (3) are arranged opposite to each other to form an axial cutting gap (200). The upper ends of the first arc-shaped gripper (2) and the second arc-shaped gripper (3) are provided with a plurality of radially spaced cutting gaps (300) along the axial direction. The radial cutting gaps (300) are provided to penetrate the clamping surface (100) radially along the first arc-shaped gripper (2) and the second arc-shaped gripper (3). The linear drive module (1) is used to drive the relative movement of the first arc-shaped gripper (2) and the second arc-shaped gripper (3).

2. The balloon catheter cutting clamp of claim 1, wherein: The upper front side of the first arc-shaped gripper (2) and the second arc-shaped gripper (3) is provided with an arc-shaped support groove (4) with an upward opening, and the arc-shaped support groove (4) intersects with the clamping surface (100); The inner diameter of the arc-shaped support groove (4) is larger than the outer diameter of the balloon dilation catheter after filling and shaping.

3. The balloon catheter cutting clamp of claim 1, wherein: The linear drive module (1) includes a support base (11), a guide rod (12), a bidirectional drive screw (13), and a knob (14). The stud threads on both sides of the bidirectional drive screw (13) are in opposite directions; The guide rod (12) and the bidirectional drive screw (13) are arranged in parallel on the support base (11). The bidirectional drive screw (13) is rotatably arranged on the support base (11). The first arc-shaped gripper (2) and the second arc-shaped gripper (3) are threadedly connected to the studs on both sides of the bidirectional drive screw (13). The knob (14) is located at the end of the bidirectional drive screw (13).

4. The balloon catheter cutting clamp of claim 3, wherein: A guide rod (12) is provided on each side of the bidirectional drive screw (13); The lower ends of the first arc-shaped gripper (2) and the second arc-shaped gripper (3) are provided with sliding support blocks (5); The sliding support block (5) is suspended on two guide rods (12), and the sliding support block (5) is slidably connected to the guide rods (12).

5. The balloon catheter cutting clamp of claim 1, wherein: The clamping surface (100) includes two clamping planes (101) that intersect at an obtuse angle.

6. A device for testing the uniformity of drug coating on a balloon dilation catheter, utilizing the balloon dilation catheter cutting clamp according to any one of claims 1 to 5, characterized in that: It includes a bracket (6), an axial cutting module (7), and a radial cutting module (8); The balloon dilation catheter cutting clamp is fixedly mounted on the support (6); The axial cutting module (7) is axially and reciprocally slidable on the bracket (6) along the axial cutting gap (200). The axial cutting module (7) includes a vertically arranged axial cutting tool (71), which is located between the clamping surfaces (100) of the first arc-shaped clamp (2) and the second arc-shaped clamp (3). The radial cutting module (8) includes a radial cutting support frame (81) and a radial cutting blade (82). One end of the radial cutting support frame (81) is hinged to the bracket (6), and a plurality of the radial cutting blades (82) are arranged on the lower end face of the radial cutting support frame (81). The position of the radial cutting blade (82) corresponds to the radial cutting gap (300).

7. The balloon dilatation catheter drug coating uniformity test device of claim 6, wherein: The axial cutting module (7) includes an axial cutting guide rod (72) and an axial cutting support frame (73). The axial cutting guide rod (72) is horizontally mounted on the bracket (6), and the axial cutting support frame (73) is slidably mounted on the axial cutting guide rod (72); The axial cutting support frame (73) has a U-shaped structure and includes two support arms (731). The axial cutting tool (71) is arranged between the two support arms (731) and located at the U-shaped opening of the axial cutting support frame (73).

8. The balloon dilatation catheter drug coating uniformity test device of claim 7, wherein: The axial cutting tool (71) includes two axial cutting blades (711) with pointed tops. The two axial cutting blades (711) are respectively mounted on two support arms (731) and are arranged at a distance from each other.

9. The balloon dilatation catheter drug coating uniformity test device of claim 8, wherein: It also includes a positioning mechanism (9), which includes a first clamping plate (91) and a second clamping plate (92); The first clamping plate (91) is fixedly mounted on the support arm (731), and the first clamping plate (91) and the second clamping plate (92) are bolted together. The axial cutting blade (711) is located between the first clamping plate (91) and the second clamping plate (92). The second clamping plate (92) is provided with a bolt through hole (921), the first clamping plate (91) is provided with a bolt hole (911) and a limiting post (912), and the axial cutting blade (711) is provided with a through hole (7111) that matches the bolt hole (911) and the limiting post (912).

10. The balloon dilatation catheter drug coating uniformity test device of claim 6, wherein: The radial cutting support frame (81) includes a rectangular frame (811) and multiple tool fixing rods (812). The tool fixing rod (812) is detachably mounted on the inside of the rectangular frame (811) by bolts, and the tool fixing rods (812) are spaced apart from each other; The radial cutting blade (82) is detachably mounted on the side of the blade fixing rod (812) by bolts.

Images