A device for testing the wet thickness of hydrophilic coating on a catheter

Abstract

The utility model provides a catheter hydrophilic coating wet thickness test device, comprising a substrate and a fixing system. The fixing system comprises a straightening shaft and a clamping device, the catheter to be tested can be sleeved on the straightening shaft and obtain the straightening force of the straightening shaft, the first end of the straightening shaft is fixed to the substrate, the second end extends parallel to the gravity direction, the catheter to be tested can be sleeved into the straightening shaft from the second end, the clamping device is located around the straightening shaft, and is used to clamp the catheter to be tested sleeved on the straightening shaft, and the coordination of the straightening shaft and the clamping device can realize the fixation and stable standing of catheters of different diameters, which is convenient for subsequent observation and measurement.

Description

Technical Field

[0001] The utility model relates to the field of medical equipment, in particular to a device for testing the wet thickness of a hydrophilic coating of a catheter. Background Art

[0002] Medical catheter devices have been widely used in interventional surgery, nursing and other processes. Such devices are usually made of polymer materials (polyvinyl chloride, polyurethane, silicone rubber, Pebax, etc.), and their surfaces are often relatively hydrophobic. When entering and withdrawing from the human body, they are very likely to generate large friction between the tissues, causing damage to human blood vessels or other cavity tissues, and also increasing the difficulty of clinical operations for medical staff. At present, a hydrophilic coating is usually applied to the surface of the device product. The application of the hydrophilic coating on the surface of the device can well solve the problem of large friction resistance between the device surface and human tissue. Through a specific coating process (such as dipping, spraying) and a curing process (such as UV curing, thermal curing), hydrophilic polymers with good biocompatibility are combined with the surface of the medical device product to form a polymer cross-linked network membrane, which is a hydrophilic coating. The hydrophilic coating on the surface of the medical device is mostly composed of hydrophilic polymers. Common hydrophilic polymers include polyethylene glycol (PEG), polyvinyl pyrrolidone (PVP), polyacrylamide (PAM) and natural polysaccharide polymers such as chitosan (CS) and hyaluronic acid (HA). Their hydrophilicity comes from the abundant amino, hydroxyl, amide and other functional groups on the polymer chain, which can form hydrogen bonds with water to promote the dissolution of the polymer. At present, the components of the hydrophilic lubricating coating on the surface of commercially available medical devices are mostly PVP or PAM. This coating quickly combines with water when it comes into contact with it to form a hydration layer, making the surface very lubricated, greatly reducing the friction between the device and human tissue, while greatly improving the convenience of doctor's operation and the comfort of patients, avoiding possible complications such as friction damage and infection.

[0003] However, when the coating thickness is small, its lubrication effect is often poor. When it is too thick, it will increase the friction between it and the supporting equipment. Especially for interventional devices, after the coating absorbs water and activates, its thickness tends to increase, resulting in increased friction during use, thereby increasing the risk of coating shedding. Therefore, there is an urgent need for a method to measure the thickness of the hydrophilic coating to evaluate its risk of shedding during use.

[0004] The thickness of the hydrophilic coating applied to the surface of medical catheters is generally at the level of several microns. For its dry thickness, a section of the coated catheter is usually cut first, and then subjected to gold spraying and placed under a scanning electron microscope for measurement. This is costly, complicated to operate, and has low work efficiency. For the test of the wet thickness of the coating, the catheter needs to be immersed in water for observation, which is not possible with current technology.

[0005] Therefore, in view of the above-mentioned existing technical problems, it is necessary to propose a new technical solution. Utility Model Content

[0006] The present application provides a catheter hydrophilic coating wet thickness testing device, which can solve the problem of accurate and efficient testing of the catheter hydrophilic coating wet thickness.

[0007] In order to solve the above technical problems, the present application provides a catheter hydrophilic coating wet thickness testing device, comprising: a substrate;

[0008] Fixing system, including straightening shaft and clamping device;

[0009] The catheter to be tested can be sleeved on the straightening shaft and obtain the straightening force of the straightening shaft;

[0010] The first end of the straightening shaft is fixed to the base, and the second end extends in the extension direction, and the measured catheter can be inserted into the straightening shaft from the second end;

[0011] The clamping device is located around the straightening shaft and is used for clamping the measured catheter sleeved on the straightening shaft.

[0012] The housing is provided with the base formed or assembled on the bottom surface or the side surface of the housing.

[0013] In one embodiment, the housing is a box.

[0014] In one embodiment, the housing is a water bath, and the base is formed or assembled on the bottom surface of the water bath.

[0015] In one embodiment, the clamping device is adjustable between a clamping position and a loosening position to be adapted to tested catheters of different sizes.

[0016] In one embodiment, the clamping device has a chuck that is treated to increase friction, including one or more of pickling, sandblasting, frosting, engraving, and adding texture.

[0017] In one of the embodiments, the clamping device and the straightening shaft cooperate to make the measured catheter stand stably and vertically.

[0018] In one embodiment, the water bath further comprises a temperature regulating device for regulating the temperature of the liquid in the water bath.

[0019] In one embodiment, the temperature regulating device is a heating device.

[0020] In one embodiment, the housing has an observation area at a position opposite to the second end of the straightening shaft.

[0021] In one embodiment, the observation area is an observation hole.

[0022] In one embodiment, the catheter hydrophilic coating wet thickness testing device further comprises an observation device, which is located above the straightening shaft and faces the second end of the straightening shaft to observe the catheter cross section.

[0023] In one embodiment, the observation device is an ultra-depth-of-field digital microscope.

[0024] In summary, the present application has the following advantages compared with the prior art:

[0025] 1. The catheter hydrophilic coating wet thickness testing device of the present application can achieve the fixation and stable standing of catheters of different diameters through the cooperation of the clamping device and the straightening shaft, avoiding the influence of other external factors and facilitating observation.

[0026] 2. The catheter hydrophilic coating wet thickness testing device of the present application has a heating device that can adjust the temperature to simulate the human body environment.

[0027] 3. The catheter hydrophilic coating thickness testing device of the present application effectively solves the problem of measuring the catheter wet thickness, and has the advantages of simple structure, easy use and good applicability.

[0028] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to better and clearly conform to the embodiments of the present application, the drawings required for use in the embodiments of the present application or the background technology are described, which does not constitute an improper limitation on the present application.

[0030] Figure 1 It is a schematic structural diagram of a catheter hydrophilic coating wet thickness testing device provided by an embodiment of the utility model.

[0031] Figure 2 It is a schematic structural diagram of a clamping device of a catheter hydrophilic coating wet thickness testing device provided by an embodiment of the utility model.

[0032] Reference numerals in the figures:

[0033] 1-test device; 2-base; 3-straightening shaft; 4-clamping device; 5-box; 6-conduit to be tested; 7-power cord; 8-purified water; 9-heating device; 301-first end of the straightening shaft; 302-second end of the straightening shaft; 401-chuck; 402-tension adjustment device; 10-observation hole. DETAILED DESCRIPTION

[0034] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below with reference to the accompanying drawings.

[0035] refer to Figure 1 , introduces the application of the utility model in the wet thickness test of the hydrophilic coating of the catheter.

[0036] like Figure 1 As shown, the test device 1 includes a base 2, a straightening shaft 3, a clamping device 4, a box 5, and a small hole 10. The base 2 is formed on the inner wall of the bottom of the box 5, and the box 5 is a water bath. The first end 301 of the straightening shaft is fixed on the base 2, and extends upward in a direction parallel to the gravity to the second end 302 of the straightening shaft. An observation hole 10 is opened at the top of the box 5 opposite to the second end 302 of the straightening shaft, so that the straightening shaft 3 and the catheter 6 to be tested can extend from the top of the box 5. The utility model also includes an observation device, and the observation device is preferably a digital microscope, and more preferably, the observation device is an ultra-depth digital microscope.

[0037] In a feasible embodiment, the clamping device 4 is as follows Figure 2 As shown, it includes a clamp 401 for clamping the catheter 6 to be tested and a tension adjustment device 402. The tension adjustment device 402 can be a knurled hand screw, which adjusts the tightness of the clamp 401 through thread matching. In practical applications, the form of the clamping device is not limited to Figure 2 As shown, it can be any clamping fixture with adjustable tightness, such as magnetic clamping, wedge clamping, etc. The clamping head 401 of the clamping device is treated to increase friction, such as pickling, sandblasting, grinding, carving, and adding texture.

[0038] In actual use, first place the test device horizontally on a flat surface, connect the power cord, inject room temperature purified water 8 into the box 5, and heat the temperature of the purified water 8 to human body temperature (37°C) through the heating device 9. Cut a section of the coated catheter from the far end, insert the catheter 6 to be tested into the adapted straightening shaft 3, adjust the tightness of the clamping device 4, make the catheter 6 to be tested stable and stand vertically, and the catheter test surface is slightly higher than the top of the box 5 to ensure that the coating that is not immersed in the purified water 8 is also wet, and the observation of the coating thickness is not affected by the refraction of light in the purified water 8. Purified water has surface tension, and the hydrophilic group can form hydrogen bonds with water molecules, enhance the mutual attraction between water molecules, and thus enhance the surface tension. Therefore, it is not only the catheter coating under the water surface that is wet, but the observation part is only slightly above the water surface. Although it is not immersed in water, it is also in a swollen state after absorbing water, that is, the wet coating thickness. The ultra-depth digital microscope is used to observe and measure the small hole 10 to obtain the coating thickness data. Then cut a section from the middle and proximal ends of the coated catheter, repeat the above process, and measure the coating thickness. In the fixation of the support shaft 3 and the base 2, the fixing method can be threaded connection, concave-convex fit, snap connection, welding, etc., and of course it can also be an integrally formed temperature control device, which can be a heating device or a cooling device. The position of the clamping device is not limited to the lower end of the catheter shown in the figure, and the position of the clamping device can be adjusted according to the test requirements.

[0039] The above are only specific application examples of the utility model, and do not constitute any limitation on the protection scope of the utility model. Any technical solution formed by equivalent transformation or equivalent replacement falls within the protection scope of the utility model.

[0040] The description of this application is concise and does not describe all possible combinations of the various technical features in the above embodiments. However, as long as there is no contradiction in the combination of these technical features, they all fall within the scope of the description of the present utility model.

Claims

1. A catheter hydrophilic coating wet thickness testing device, characterized in that: include: substrate; Fixing system, including straightening shaft and clamping device; The catheter to be tested can be sleeved on the straightening shaft and obtain the straightening force of the straightening shaft; The first end of the straightening shaft is fixed to the base, and the second end extends parallel to the direction of gravity, and the measured catheter can be inserted into the straightening shaft from the second end; The clamping device is located around the straightening shaft and has a clamp and a tension adjustment device. The clamp can be adjusted between a clamping position and a loose position. When the clamp is in the clamping position, it is used to clamp the measured catheter sleeved on the straightening shaft; The housing is provided with the base formed or assembled on the bottom surface or the side surface of the housing.

2. The catheter hydrophilic coating wet thickness testing device according to claim 1, characterized in that: The shell is a box.

3. The catheter hydrophilic coating wet thickness testing device according to claim 2, characterized in that: The box body is a water bath box, and the base is formed or assembled on the bottom surface of the water bath box.

4. The catheter hydrophilic coating wet thickness testing device according to claim 1, characterized in that: The clamping device can be adjusted between a plurality of clamping positions and loosening positions, and is suitable for tested catheters of different sizes.

5. The catheter hydrophilic coating wet thickness testing device according to claim 1, characterized in that: The clamping head of the clamping device is treated to increase friction, including one or more of pickling, sandblasting, grinding, carving, and adding texture.

6. The catheter hydrophilic coating wet thickness testing device according to any one of claims 1 to 5, characterized in that: The clamping device cooperates with the straightening shaft to make the measured catheter stand stably and vertically.

7. The catheter hydrophilic coating wet thickness testing device according to claim 3, characterized in that: The water bath also includes a temperature regulating device for regulating the temperature of the liquid in the water bath.

8. The catheter hydrophilic coating wet thickness testing device according to claim 7, characterized in that: The temperature regulating device is a heating device.

9. The catheter hydrophilic coating wet thickness testing device according to claim 1, characterized in that: The housing has an observation area at a position facing the second end of the straightening shaft.

10. The catheter hydrophilic coating wet thickness testing device according to claim 9, characterized in that: The observation area is an opened observation hole.

11. The catheter hydrophilic coating wet thickness testing device according to claim 1, characterized in that: The catheter hydrophilic coating thickness testing device also includes an observation device, which is located above the straightening shaft and directly facing the second end of the straightening shaft and is used to observe the cross section of the catheter.

12. The catheter hydrophilic coating wet thickness testing device according to claim 11, characterized in that: The observation device is a super-depth-of-field digital microscope.

Images