A fixture for measuring the outer diameter of a balloon expandable stent

Abstract

The utility model relates to the field of fixture tool, more specifically, relate to a kind of fixture tool for measuring balloon dilatation stent outer diameter, including base, displacement adjusting device and clamping device, the displacement adjusting device has multiple, respectively set in the both ends of base, still include angle adjusting device, the angle adjusting device is set on displacement adjusting device, the clamping device is set on angle adjusting device, and there is inflation port on the clamping device, angle adjusting device and displacement adjusting device of at least one end. By setting angle adjusting device, the clamping device is set on angle adjusting device, so that the ballon catheter being clamped can be rotated, and its angle is adjusted, so as to measure the outer diameter of the same axial part of balloon dilatation stent on different directions preassembled on ballon catheter, without needing to disassemble and clamp ballon catheter again, simple operation, and measurement efficiency is high.

Description

Technical Field

[0001] This utility model relates to the field of fixtures and tooling, and more specifically, to a fixture and tooling for measuring the outer diameter of a balloon dilation stent. Background Technology

[0002] Balloon-expandable stents are key devices in interventional medicine, widely used to treat stenosis or occlusion of coronary arteries, peripheral blood vessels, biliary tract, and esophagus. Their core function is to maintain patency of the lumen through mechanical support and to deliver drugs locally within the drug-eluting stent (DES) to inhibit restenosis. Balloon-expandable stents are typically made of metals (such as cobalt-chromium alloys or nickel-titanium alloys) or absorbable materials and are pre-loaded onto a balloon catheter. During the procedure, after the balloon-expandable stent is delivered to the target location, the balloon is inflated to expand it and embed it into the vessel wall. The balloon is then withdrawn, and the balloon-expandable stent remains inflated to maintain blood flow.

[0003] The outer diameter of a balloon-expandable stent is one of its key performance parameters, directly affecting treatment efficacy and long-term prognosis. If the outer diameter after stent expansion exceeds the design value (e.g., over-expansion), it may lead to intimal tearing, dissection, or even perforation. If the outer diameter is insufficient, the stent cannot adequately conform to the vessel wall, increasing the risk of thrombosis and stent migration. The outer diameter is directly related to the mechanical properties of the stent, ensuring it can resist elastic recoil or external pressure within the body. The consistency of the outer diameter affects the distribution of the drug coating; uneven expansion may lead to abnormal local drug concentrations, affecting efficacy. Measuring the outer diameter of a balloon-expandable stent is a crucial step in ensuring its safety, effectiveness, and compliance. High-precision measurement technology not only optimizes the manufacturing process but also reduces clinical risks, providing patients with more reliable interventional treatment solutions. The YY / T 0694-2020 standard, "Standard Test Method for Elastic Recoil of Balloon-Expandable Stents," clearly specifies the requirements for measuring the outer diameter of balloon-expandable stents: measurements must be taken at multiple axial locations, including the middle section along one length and the sections near both ends of the stent. Furthermore, when measuring the outer diameter of the stent at each axial measurement point, rotational measurements should be performed in two approximately perpendicular directions. Measurements at multiple axial locations are used to assess the stent's length consistency or longitudinal variations in local diameter (e.g., tapered stents). The measurement method involves uniformly selecting multiple cross-sections (e.g., proximal, mid-section, distal) along the stent's length and performing circumferential measurements on each cross-section. At each axial measurement point, circumferential measurements should also be performed in two approximately perpendicular directions to assess the stent's roundness (ellipticity) or radial symmetry, and to determine if local collapse or deformation exists. Therefore, it is necessary to measure the outer diameter of balloon-expandable stents at multiple axial locations, as well as in multiple directions within the same axial location. Existing fixtures can only measure the outer diameter of one axial location or one direction at a time. To measure the outer diameter of multiple axial locations or in multiple directions within the same axial location, multiple disassembly and clamping of the balloon catheter are required, which is inconvenient and inefficient. Utility Model Content

[0004] The present invention aims to overcome at least one defect (deficiency) of the prior art and provide a fixture for measuring the outer diameter of a balloon dilatation stent. This solves the problem that existing fixtures can only measure the outer diameter of one axial part or one direction at a time, and that it is necessary to disassemble and clamp the balloon catheter multiple times if multiple axial parts or multiple directions of the same axial part are to be measured.

[0005] The technical solution adopted by this utility model is a fixture for measuring the outer diameter of a balloon dilatation stent, including a base, a displacement adjustment device and a clamping device. There are multiple displacement adjustment devices, which are respectively arranged at both ends of the base. It also includes an angle adjustment device, which is arranged on the displacement adjustment device. The clamping device is arranged on the angle adjustment device. An inflation port is provided on at least one end of the clamping device, the angle adjustment device and the displacement adjustment device.

[0006] The base provides stable support, ensuring the fixture does not wobble during use. An inflation port at at least one end facilitates inflation of the balloon catheter, allowing the pre-installed balloon dilatation support to expand and thus enabling measurement of its outer diameter. Two displacement adjustment devices, two angle adjustment devices, and two clamping devices are located at each end of the base. The clamping devices hold and fix the balloon catheter, and are mounted on the angle adjustment devices. These devices allow for rotation of the clamping devices and the balloon catheter, adjusting the angle to measure the outer diameter of the balloon dilatation support in multiple directions along the same axial direction without requiring repeated disassembly and reassembly of the balloon catheter. This simplifies operation and improves measurement efficiency. The displacement adjustment devices adjust the displacement of the clamping devices at both ends.

[0007] Furthermore, the displacement adjustment device includes a horizontal displacement adjustment device and a vertical displacement adjustment device. The horizontal displacement adjustment device is adjusted on the base, the vertical displacement adjustment device is set on the horizontal displacement adjustment device, and the angle adjustment device is set on the vertical displacement adjustment device.

[0008] The horizontal displacement adjustment device is used to adjust the horizontal displacement between the clamping devices, making it suitable for measuring balloon dilatation stents of different lengths. The vertical displacement adjustment device is used to adjust the vertical height of the clamping devices and the balloon dilatation stent, ensuring that the part of the balloon dilatation stent to be measured is on the measurement path of the micrometer.

[0009] Furthermore, the horizontal displacement device includes a first linear guide rail and a first connecting block, the first connecting block being movably connected to the first linear guide rail, and the vertical displacement adjustment device being disposed on the first connecting block.

[0010] The first connecting block is movably connected to the first linear guide rail. The first connecting block can move along the first linear guide rail, thereby moving the vertical displacement adjustment device, angle adjustment device, and clamping device mounted on the first connecting block. This adjusts the horizontal distance between the clamping devices at both ends, making it suitable for balloon catheters of different lengths. There are several ways to connect the first connecting block to the first linear guide rail. For example, a slider can be provided on the first linear guide rail, and a groove can be provided on the first connecting block. The slider and groove cooperate to allow the first connecting block to slide along the first linear guide rail. Alternatively, rollers or balls can be used to allow the first connecting block to roll along the first linear guide rail, enabling the first connecting block to move along the first linear guide rail.

[0011] Furthermore, the vertical displacement adjustment device includes a second linear guide rail and a second connecting block. The second linear guide rail is vertically mounted on the first connecting block, and the second connecting block is movably connected to the second linear guide rail. The angle adjustment device is mounted on the second connecting block.

[0012] The second connecting block is movably connected to the second linear guide rail. The second connecting block can move along the second linear guide rail. The angle adjustment device is set on the second connecting block. When the second connecting block moves along the second linear guide rail, it can drive the angle adjustment device and the clamping device set on the angle adjustment device to move up and down, thereby adjusting the up and down displacement of the balloon catheter held by the clamping device, so that the part of the balloon dilation stent that needs to be measured is on the measurement path of the micrometer.

[0013] Furthermore, the angle adjustment device includes a first turntable and a second turntable, the first turntable and the second turntable are rotatably connected, the first turntable is disposed on the second connecting block, and the clamping device is disposed on the second turntable.

[0014] The first turntable is rotatably connected to the second turntable. The second turntable can rotate relative to the first turntable, thereby driving the clamping device and the balloon catheter clamped by the clamping device to rotate relative to the first turntable, so that the micrometer can measure the outer diameter of the balloon dilation stent in different directions at the same axial part without having to disassemble and re-clamp the balloon catheter.

[0015] Furthermore, the first turntable has a first scale line, and the second turntable has a first indicator line.

[0016] A first scale is set on the first turntable, and a first mark line is set on the second turntable. The first scale and the first mark line work together to precisely control the rotation angle and make it easier to ensure that the rotation angles of the angle adjustment devices at both ends are consistent, thereby making the measurement results more accurate.

[0017] Furthermore, an angle locking device is provided on the first turntable.

[0018] An angle locking device is used to fix the second turntable and prevent it from rotating during the measurement process, which would affect the measurement results.

[0019] Furthermore, the clamping device is detachably mounted on the second turntable.

[0020] The clamping device can be configured in various sizes to clamp balloon catheters of different diameters. The clamping device is detachably connected to the second turntable for easy replacement. The clamping device can be mounted on the second turntable via threaded connection, plug-in connection, or other connection methods.

[0021] Furthermore, the clamping device includes a clamping component and a locking component. One end of the clamping component is connected to the second turntable, and the other end is provided with a plurality of arc-shaped claws. The outer surface of the arc-shaped claws is provided with external threads. The locking component is sleeved on the arc-shaped claws and is matched with internal threads.

[0022] The curved grippers are designed to hold and secure the balloon catheter without deforming it. By rotating the locking mechanism, multiple curved grippers can simultaneously contract or open radially, thus achieving the clamping and release of the balloon catheter.

[0023] Furthermore, a flexible layer is provided on the inner surface of the arc-shaped gripper.

[0024] A flexible layer is incorporated into the inner surface of the curved gripper to prevent direct contact between the metal gripper and the balloon catheter, thus protecting the catheter from damage. The flexible layer also increases the static friction coefficient with the balloon catheter, eliminating relative displacement during rotational measurement and improving accuracy. When the clamping force exceeds a threshold, the flexible layer preferentially undergoes compressive deformation, preventing plastic deformation of the balloon catheter and providing overload protection, thereby enhancing operational safety. The flexible layer can be made of medical-grade silicone, polyurethane, or other similar materials.

[0025] Compared with the prior art, the beneficial effects of this utility model are as follows: By setting an angle adjustment device, the clamping device is mounted on the angle adjustment device, allowing the clamped balloon catheter to be rotated and its angle adjusted for measuring the outer diameter of different directions at the same axial position without having to disassemble and reassemble the balloon catheter. This simplifies operation and increases measurement efficiency. The angle adjustment device is mounted on the vertical displacement adjustment device, allowing adjustment of the vertical displacement of the clamping device and the balloon catheter, ensuring that the part of the balloon dilatation stent on the balloon catheter to be measured is on the measurement path of the micrometer. The vertical displacement adjustment device is mounted on the horizontal displacement adjustment device, allowing adjustment of the horizontal displacement of the clamping device to accommodate balloon dilatation stents of different lengths. The clamping device includes a clamping component and a locking component. One end of the clamping component is detachably connected to the angle adjustment device, facilitating the replacement of clamping devices of different specifications to clamp balloon catheters of different diameters, thus enabling measurement of balloon dilatation stents of different specifications. The other end of the clamping component is equipped with multiple arc-shaped grippers. The outer surface of each arc-shaped gripper has external threads. A locking element, fitted onto the arc-shaped grippers and matching internal threads, allows the multiple arc-shaped grippers to synchronously contract or open radially by rotating the locking element, achieving clamping and release of the balloon catheter. The arc-shaped grippers effectively clamp and fix the balloon catheter without deforming it. The inner surface of the arc-shaped grippers also has a flexible layer, preventing direct contact between the metal grippers and the balloon catheter surface, thus avoiding damage. This also increases the static friction coefficient with the balloon catheter, eliminating relative displacement during rotational measurement and improving measurement accuracy. Furthermore, it provides overload protection, enhancing operational safety. All adjustment mechanisms are manually adjustable, making operation simple and convenient. Operators can quickly master the operation, and the simple, stable structure is not easily damaged. Attached Figure Description

[0026] Figure 1 This is a structural diagram of the present invention.

[0027] Figure 2 This is a structural diagram of the vertical displacement adjustment device.

[0028] Figure 3 This is a structural diagram of the angle adjustment device.

[0029] Figure 4 This is a structural diagram of the angle adjustment device at another angle.

[0030] Figure 5 This is a structural diagram of the clamping device.

[0031] Figure 6 This is the left view of the present invention.

[0032] Figure 7This is a schematic diagram of the present invention in use.

[0033] 1. Base; 11. Elongated hole; 12. Support leg; 13. Positioning block; 14. Bolt; 2. Displacement adjustment device; 21. Horizontal displacement adjustment device; 211. First linear guide rail; 2111. Second scale line; 212. First connecting block; 2121. Second marking line; 213. First locking bolt; 22. Vertical displacement adjustment device; 221. Second linear guide rail; 2211. Third scale line; 2212. Elongated hole; 222. Second connecting block; 2221. Third marking line. 2222, through hole, 223, second locking bolt, 3, angle adjustment device, 31, first turntable, 311, through hole, 312, first scale line, 32, second turntable, 321, threaded hole, 322, first marking line, 33, angle locking bolt, 34, handle, 4, clamping device, 41, clamping part, 411, hollow bolt, 412, arc-shaped gripper, 42, fastener, 43, flexible layer, 5, balloon catheter, 51, balloon dilation support, 6, micrometer. Detailed Implementation

[0034] The accompanying drawings are for illustrative purposes only and should not be construed as limiting the scope of this invention. To better illustrate the following embodiments, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0035] like Figure 1 As shown, a fixture for measuring the outer diameter of a balloon dilatation stent includes a base 1, a displacement adjustment device 2, and a clamping device 4. Multiple displacement adjustment devices 2 are respectively disposed at both ends of the base 1. The fixture also includes an angle adjustment device 3 disposed on the displacement adjustment device 2, and the clamping device 4 disposed on the angle adjustment device 3. An inflation port is provided on at least one end of the clamping device 4, the angle adjustment device 3, and the displacement adjustment device 2. The displacement adjustment device 2 includes a horizontal displacement adjustment device 21 and a vertical displacement adjustment device 22.

[0036] like Figure 1As shown, the horizontal displacement adjustment device 21 includes a first linear guide rail 211 and two first connecting blocks 212. The first connecting blocks 212 are respectively disposed at both ends of the first linear guide rail 211 and are movably connected to it. Both first connecting blocks 212 can move along the first linear guide rail 211, thereby adjusting the horizontal distance between them. The first linear guide rail 211 is provided with a second scale line 2111, and the first connecting blocks 212 are provided with a second marking line 2121, used to determine the horizontal distance between the two first connecting blocks 212. A first locking bolt 213 is also provided on the first connecting block 212. When the first connecting block 212 moves to a preset position, it can be fixed by the first locking bolt 213 to prevent it from moving during measurement and affecting the measurement results.

[0037] like Figure 1 As shown, there are two of each of the vertical displacement adjustment device 22, angle adjustment device 3 and clamping device 4. The clamping device 4 is mounted on the angle adjustment device 3, the angle adjustment device 3 is mounted on the vertical displacement adjustment device 22, and the displacement adjustment device 22 is mounted on the first connecting block 212.

[0038] like Figure 1 , Figure 2 As shown, the vertical displacement adjustment device 22 includes a second linear guide rail 221 and a second connecting block 222. The second linear guide rail 221 is vertically mounted on the first connecting block 212, and the second connecting block 222 is slidably connected to the second linear guide rail 221, allowing the second connecting block 222 to move along the second linear guide rail 221. By adjusting the vertical displacement of the second connecting block 222, the vertical height of the clamping device 4 and the balloon catheter 5 can be adjusted, ensuring that the balloon dilation support 51 on the balloon catheter 5 is positioned on the measurement path of the micrometer 6. A third scale line 2211 is provided on the second linear guide rail 221, and a third marking line 2221 is provided on the second connecting block 222, ensuring that the heights of the two ends of the second connecting block 222 are consistent. A second locking bolt 223 is also provided on the second connecting block 222. When the second connecting block 222 moves to a preset position, it can be fixed by the second locking bolt 223 to prevent it from moving during the measurement process and affecting the measurement results. The second linear guide 221 has a strip hole 2212, which is arranged along the length of the second linear guide 221. The center of the second connecting block 222 has a through hole 2222.

[0039] like Figure 3 , Figure 4As shown, the angle adjustment device 3 includes a first turntable 31 and a second turntable 32. The first turntable 31 is mounted on the second connecting block 222, and the second turntable 32 is coaxially connected to the first turntable 31 and can rotate relative to the first turntable 31. A through threaded hole 321 is provided at the center of the second turntable 32, and a through hole 311 is provided at the center of the first turntable 31. A first scale line 312 and a first marking line 322 are respectively provided on the first turntable 31 and the second turntable 32 to determine the rotation angle of the second turntable 32 and to ensure that the rotation angles of the two second turntables 32 are the same. An angle locking bolt 33 is also provided on the first turntable 31. When the second turntable 32 rotates to a preset position, it can be fixed by the angle locking bolt 33 to prevent rotation during measurement, which would affect the measurement results. A handle 34 is also provided on the second turntable 32 for easy rotation.

[0040] like Figure 5 As shown, the clamping device 4 includes a clamping member 41 and a fastener 42. The clamping member 41 is a hollow cylindrical structure. One end of the clamping member 41 is provided with a hollow bolt 411 for connection with the threaded hole 321 in the second turntable 32. The other end is provided with multiple arc-shaped jaws 412. In their natural state, the multiple arc-shaped jaws 412 are open. When tightened, the multiple arc-shaped jaws 412 synchronously retract radially, forming a hollow cylindrical structure. The outer surface of the arc-shaped jaws 412 is provided with external threads, and the inner surface is provided with a flexible layer 43, which can prevent damage to the balloon catheter 5 and increase the friction coefficient with the balloon catheter 5. There is no relative displacement during rotation measurement, thus improving measurement accuracy. The fastener 42 is sleeved on the arc-shaped jaws 412, and the fastener 42 is matched with internal threads. By rotating the fastener 42, the multiple arc-shaped jaws 412 can synchronously retract or open radially, realizing the clamping and release of the balloon catheter 5.

[0041] like Figures 2-6 As shown, the through hole 2222 on the second connecting block 222, the through hole 311 on the first turntable 31, the threaded hole 321 on the second turntable 32, the hollow part of the hollow bolt 411, the hollow part of the clamping member 41, and the hollow part formed when the multiple arc-shaped grippers 412 contract are all on the same straight line. The hollow structure of the clamping member 41 and the hollow bolt 411, the through hole 2222 on the second connecting block 222, the through hole 311 on the first turntable 31, the through threaded hole 321 on the second turntable 32, and the strip hole 2212 on the second linear guide rail 221 together form an inflation port to facilitate inflation of the balloon catheter 5. Of course, an inflation port can also be provided only on the vertical displacement adjustment device 22, the angle adjustment device 3, and the clamping device 4 at one end.

[0042] like Figure 1As shown, the base 1 has multiple elongated holes 11 located on both sides of the first linear guide rail 211. These holes are parallel to and along the length of the first linear guide rail 211. Two positioning blocks 13 are also provided on the lower side of the base 1. These positioning blocks 13 are cuboid in shape, perpendicular to the first linear guide rail 211, and fixed to the base 1 by bolts 14 and the elongated holes 11. By adjusting the position of the bolts 14 within the elongated holes 11, the positions of the two positioning blocks 13 can be adjusted to regulate the horizontal displacement of the micrometer 6, enabling it to measure different axial positions of the balloon dilation support 51. The positioning blocks 13 facilitate the positioning of the micrometer 6 and ensure its perpendicularity to the first linear guide rail 211, thereby reducing measurement errors and improving measurement accuracy. Support legs 12 are also provided below the base 1.

[0043] like Figure 7 As shown, when using this fixture, the micrometer 6 is positioned below the base 1, with its sides tightly against the sides of the two positioning blocks 13 to ensure that the micrometer 6 is perpendicular to the first linear guide rail 211. Based on the length of the balloon catheter 5, the horizontal displacement of the first connecting block 212 is adjusted so that the clamping devices 4 at both ends can clamp the balloon catheter 5. Then, by adjusting the horizontal displacement of the micrometer 6 and the vertical displacement of the second connecting block 222, the part of the balloon dilation support 51 to be measured is positioned on the measurement path of the micrometer 6. After adjustment, the balloon catheter 5 is inflated to dilate the balloon dilation support 51 for outer diameter measurement. After measuring the outer diameter in one direction of the same axial portion, the balloon dilation support 51 is rotated by the angle adjustment device 3 to measure the outer diameter in another direction of the same axial portion. After measuring the outer diameter in different directions of the same axial portion, the horizontal displacements of the positioning blocks 13 and the micrometer 6 are adjusted to measure different axial portions.

[0044] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the technical solution of this utility model, and are not intended to limit the specific implementation of this utility model. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the claims of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A fixture for measuring the outer diameter of a balloon dilatation stent, comprising a base, a displacement adjustment device, and a clamping device, wherein multiple displacement adjustment devices are respectively disposed at both ends of the base, characterized in that... It also includes an angle adjustment device, which is disposed on the displacement adjustment device, and a clamping device is disposed on the angle adjustment device. An air inlet is provided on at least one end of the clamping device, the angle adjustment device, and the displacement adjustment device.

2. The fixture for measuring the outer diameter of a balloon dilatation stent according to claim 1, characterized in that, The displacement adjustment device includes a horizontal displacement adjustment device and a vertical displacement adjustment device. The horizontal displacement adjustment device is mounted on the base, the vertical displacement adjustment device is mounted on the horizontal displacement adjustment device, and the angle adjustment device is mounted on the vertical displacement adjustment device.

3. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 2, characterized in that, The horizontal displacement device includes a first linear guide rail and a first connecting block, the first connecting block being movably connected to the first linear guide rail, and the vertical displacement adjustment device being disposed on the first connecting block.

4. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 3, characterized in that, The vertical displacement adjustment device includes a second linear guide rail and a second connecting block. The second linear guide rail is vertically mounted on the first connecting block, and the second connecting block is movably connected to the second linear guide rail. The angle adjustment device is mounted on the second connecting block.

5. A fixture for measuring the outer diameter of a balloon dilatation stent according to any one of claims 1-4, characterized in that, The angle adjustment device includes a first turntable and a second turntable, the first turntable and the second turntable are rotatably connected, the first turntable is disposed on a second connecting block, and the clamping device is disposed on the second turntable.

6. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 5, characterized in that, The first turntable has a first scale line, and the second turntable has a first indicator line.

7. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 5, characterized in that, An angle locking device is installed on the first turntable.

8. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 5, characterized in that, The clamping device is detachably mounted on the second turntable.

9. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 5, characterized in that, The clamping device includes a clamping component and a locking component. One end of the clamping component is connected to the second turntable, and the other end is provided with multiple arc-shaped claws. The outer surface of the arc-shaped claws is provided with external threads. The locking component is sleeved on the arc-shaped claws and is matched with internal threads.

10. A fixture for measuring the outer diameter of a balloon dilatation stent according to claim 9, characterized in that, The inner surface of the arc-shaped gripper is provided with a flexible layer.

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