Medical catheter haze measuring device and measuring method

Abstract

The invention belongs to the technical field of catheter production and processing, and relates to a medical catheter haze measuring device and a measuring method.The medical catheter haze measuring device comprises a base, an opening is formed in the upper end face of the base, a light source located on the same vertical line with the opening is arranged in the base, a detector is arranged above the opening through a support, and the detector is connected with the light source through the support. A catheter clamping assembly is arranged between the detector and the open hole, a display screen is arranged on the front face of the base, and the display screen and the detector are both connected with a controller arranged in the base. The haze measuring device is simple in structure, convenient to use and suitable for measuring conduits of multiple specifications and sizes. Parameters such as surface haze and material characteristic coefficients related to atomization can be measured, the raw material formula and proportion of the catheter can be adjusted according to the test result, and the catheter meeting the haze requirement is produced.

Description

Technical Field

[0001] The present invention relates to the technical field of catheter production and processing, and in particular to a device and method for measuring the haze of a medical catheter. Background Art

[0002] Medical catheters need to have a certain degree of haze to improve their appearance, while also being able to observe the flow of liquid therein and meet requirements such as automated assembly. The industry currently uses a method of preparing reference samples to distinguish between low, medium, and high haze levels, and then using production samples for comparison. Therefore, it is difficult to accurately quantify haze and conduct quality control. Patent No. CN202310533311.3 discloses a haze evaluation device and a haze evaluation method. The haze evaluation device includes: a test platform, having a first opening; an integrating sphere, located on one side of the test platform, having a window; a transmittance detector, located within the integrating sphere; a removable elevated fixture, removably disposed on a surface of the test platform away from the integrating sphere, having a second opening; a light source, located on a side of the elevated fixture away from the test platform, spaced apart from the elevated fixture; the center of the light source is aligned with the center of the first opening, the center of the window, and the center of the second opening. The haze evaluation device of this invention utilizes a test platform with a first opening, an integrating sphere with a window, a raised fixture with a second opening, and a light source. This allows haze evaluation of small, translucent sample areas, and offers advantages such as a simple structure and low cost. While the haze evaluation device and method can quantify haze, the haze of the catheter during extrusion depends on factors such as the atomization method, the proportion of atomizing agent in the formulation, and the molar absorptivity of the material. When the haze of a produced catheter does not meet requirements, multiple analyses are required to identify the root cause and make adjustments. This process is time-consuming and impacts production schedules. Therefore, the present invention proposes a novel haze measurement device and method for medical catheters. Summary of the Invention

[0003] The primary objective of this invention is to provide a device and method for measuring the haze of medical catheters. These devices are adaptable to various medical catheter specifications and can measure parameters related to haze, such as surface haze and material property coefficients. Based on these test results, the raw material formulation and ratio of the catheter can be adjusted, guiding process improvements and ultimately producing catheters that meet haze requirements.

[0004] The present invention provides a medical catheter haze measurement device, comprising a base, an opening provided on an upper end surface of the base, a light source provided within the base and aligned vertically with the opening, a detector provided above the opening via a bracket, a catheter clamping assembly provided between the detector and the opening, a display provided on the front surface of the base, and both the display and the detector connected to a controller provided within the base.

[0005] Preferably, the catheter clamping assembly includes a column arranged on the upper end surface of the base, the column is slidably connected to a movable block through a vertical slide rail, the column is provided with a vertical rack, the movable block is provided with an avoidance groove, the avoidance groove is provided with a gear meshing with the rack, the movable block is provided with a knob for driving the gear to rotate, a sample axis is horizontally provided on one side of the movable block, and the sample axis is provided with a slit along its length.

[0006] Preferably, the catheter clamping assembly includes an L-shaped sample test rack, the vertical part of the sample test rack is fixed to the side of the base, the horizontal part of the sample test rack extends above the opening, and a slit is provided on the horizontal part of the sample test rack, and the two sides of the slit are wedge-shaped.

[0007] Preferably, the light source is a broad wavelength light source with a wavelength of 380-760 nm.

[0008] The present invention also provides a method for measuring the haze of a medical catheter, comprising:

[0009] Material preparation: providing the medical catheter haze measuring device as described in any one of claims 1 to 4 and a batch of catheter samples;

[0010] To measure the haze F, the sample to be tested is mounted on the measuring device, the device is started, the light source is turned on, and the detector detects the transmittance T of the sample, where haze F = 100% - T;

[0011] Measure the surface haze f. The haze of the tubes with the same size but different surface conditions in the same batch of samples is measured. The haze of the tubes with smooth surfaces is recorded as F0, and the haze of the tubes with atomized effects is recorded as F1. The surface haze f of the tubes is F1-F0.

[0012] Determine the molar absorption coefficient K. For a smooth catheter with a known material formula ratio c1, its single-layer wall thickness is l1. Measure the haze and based on the test result F2, we have The molar absorptivity can be obtained

[0013] Determine the material characteristic coefficient P. For a smooth conduit with unknown material characteristic parameters, its single-layer wall thickness is l2. Measure the haze and according to the test result F3, there is The material characteristic coefficient can be obtained

[0014] Preferably, the determination of the surface haze f, the determination of the molar absorption coefficient K and the determination of the material characteristic coefficient P are performed in no particular order.

[0015] The beneficial effects of the technical solution of the present invention are:

[0016] The haze measuring device has a simple structure and is easy to use. It is suitable for measuring catheters of various sizes and specifications. It can measure parameters such as surface haze and material property coefficients related to atomization. Based on the test results, the process parameters, the formulation and proportion of the raw materials of the catheter can be adjusted to produce catheters that meet the haze requirements.

[0017] For materials of a given thickness, haze F is related to surface haze and material properties, the latter of which is related to the molar absorptivity and the concentration of the absorbing substance. Therefore, by adjusting the process to increase surface haze, adding a substance with a high molar absorptivity as an atomizer, or increasing the proportion of the atomizer, catheters with high haze can be produced. This avoids the time-consuming analysis of haze discrepancies encountered in existing techniques, thereby ensuring production schedules. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 FIG. 1 is a layout diagram of the medical catheter haze measurement device and measurement method in operation according to an embodiment.

[0019] Figure 2 It is a schematic diagram of the test stand structure.

[0020] The numbers in the figure represent:

[0021] 1. Base; 2. Opening; 3. Detector; 4. Column; 5. Movable block; 6. Knob; 7. Rack; 8. Sample axis; 9. Display; 10. Test stand. DETAILED DESCRIPTION

[0022] The present invention is further described in detail below with reference to specific embodiments.

[0023] Example 1:

[0024] like Figure 1As shown, a medical catheter haze measuring device of the present invention includes a base 1, an opening 2 is provided on the upper end surface of the base 1, a light source is provided in the base 1 and is located in the same vertical line as the opening 2, a detector 3 is provided above the opening 2 through a bracket, and a catheter clamping assembly is provided between the detector 3 and the opening 2, and the catheter clamping assembly includes a column 4 provided on the upper end surface of the base 1, a movable block 5 is slidably connected to the column 4 through a vertical slide rail, a vertical rack 7 is provided on the column 4, an avoidance groove is provided on the movable block 5, a gear meshing with the rack 7 is provided in the avoidance groove, and a knob 6 for driving the gear to rotate is provided on the movable block 5, a sample shaft 8 is horizontally provided on one side of the movable block 5, the sample shaft 8 is provided with a slit along its length, and the sample shaft 8 is replaceable, a display screen 9 is provided on the front of the base 1, and the display screen 9 and the detector 3 are both connected to a controller provided in the base 1.

[0025] The method for measuring the haze of the duct is as follows:

[0026] Material preparation: the above-mentioned medical catheter haze measurement device and a batch of catheter samples;

[0027] To measure the haze F, place the sample to be tested on the sample shaft 8, start the device, light the light source, and transmit light through the sample and the slit to be received by the detector 3. The detector 3 detects the transmittance T of the sample. The haze F = 100% - T.

[0028] Measure the surface haze f. The haze of the tubes with the same size but different surface conditions in the same batch of samples is measured. The haze of the tubes with smooth surfaces is recorded as F0, and the haze of the tubes with atomized effects is recorded as F1. The surface haze f of the tubes is F1-F0.

[0029] Determine the molar absorption coefficient K. For a smooth catheter with a known material formula ratio c1, its single-layer wall thickness is l1. Measure the haze and based on the test result F2, we have The molar absorptivity can be obtained Once K is known, the haze of a smooth tube can be directly calculated given the formulation ratio and tube design thickness;

[0030] Determine the material characteristic coefficient P. For a smooth conduit with unknown material characteristic parameters, its single-layer wall thickness is l2. Measure the haze and according to the test result F3, there is The material characteristic coefficient can be obtained

[0031] Wherein, both K and c are related to material properties or material formulations, and the material property coefficient P=Kc can be defined.

[0032] When the surface of the catheter is smooth, that is, when there is no surface atomization, f = 0. Thus, F = 100% - 10 -Pl For a material of a given thickness, the haze F is solely dependent on the material's properties, namely, the molar absorptivity and the concentration of the absorbing substance. Therefore, adding a substance with a high molar absorptivity as an atomizer or increasing the atomizer ratio in the formulation can produce a catheter with a higher haze. This principle can be used to measure the effectiveness of atomizers.

[0033] In the case of a tube with a fogged surface, f>0, F=100%-T1+f. Where T1 is the transmittance of the tube with a smooth surface, which follows the Lambert-Beer law. It can be seen that the final haze of the catheter is the result of the combined effect of T1 and f. Under ideal conditions, for materials with T1 = 0, the final haze of the catheter depends solely on the surface atomization state. This principle can be used to measure the atomization effect of different surface conditions.

[0034] Example 2

[0035] like Figure 2 The medical catheter haze measuring device of the present invention includes a base 1, an opening 2 is provided on the upper end surface of the base 1, a light source is provided in the base 1 and is located on the same vertical line as the opening 2, a detector 3 is provided above the opening 2 through a bracket, a catheter clamping assembly is provided between the detector 3 and the opening 2, and the catheter clamping assembly includes an L-shaped sample test rack 10, the vertical portion of the sample test rack 10 is fixed to the side of the base 1, and the horizontal portion of the sample test rack 10 extends above the opening 2. A slit is provided on the horizontal portion of the sample test rack 10, and the two sides of the slit are wedge-shaped. The test rack 10 is replaceable, and a display screen 9 is provided on the front of the base 1. The display screen 9 and the detector 3 are both connected to a controller provided in the base 1.

[0036] The method for measuring the haze of the duct is as follows:

[0037] Material preparation: the above-mentioned medical catheter haze measurement device and a batch of catheter samples;

[0038] To measure the haze F, a sample to be tested is placed in the slit on the test stand 10, the device is started, the light source is turned on, and light passes through the slit and the sample and is received by the detector 3. The detector 3 detects the transmittance T of the sample, where haze F = 100% - T.

[0039] Measure the surface haze f. The haze of the tubes with the same size but different surface conditions in the same batch of samples is measured. The haze of the tubes with smooth surfaces is recorded as F0, and the haze of the tubes with atomized effects is recorded as F1. The surface haze f of the tubes is F1-F0.

[0040] Determine the molar absorption coefficient K. For a smooth catheter with a known material formula ratio c1, its single-layer wall thickness is l1. Measure the haze and based on the test result F2, we have The molar absorptivity can be obtained Once K is known, the haze of a smooth tube can be directly calculated given the formulation ratio and tube design thickness;

[0041] Determine the material characteristic coefficient P. For a smooth conduit with unknown material characteristic parameters, its single-layer wall thickness is l2. Measure the haze and according to the test result F3, there is The material characteristic coefficient can be obtained

[0042] The above are only some embodiments of the present invention. For those skilled in the art, several modifications and improvements can be made without departing from the inventive concept of the present invention, which all fall within the scope of protection of the present invention.

Claims

1. A medical catheter haze measurement device, characterized by: The device comprises a base, an opening is provided on the upper end surface of the base, a light source is provided in the base and is located on the same vertical line as the opening, a detector is provided above the opening through a bracket, a catheter clamping assembly is provided between the detector and the opening, a display screen is provided on the front side of the base, and both the display screen and the detector are connected to a controller provided in the base.

2. The medical catheter haze measuring device according to claim 1, characterized in that: The catheter clamping assembly includes a column arranged on the upper end surface of the base, a movable block is slidably connected to the column through a vertical slide rail, a vertical rack is provided on the column, an avoidance groove is provided on the movable block, a gear meshing with the rack is provided in the avoidance groove, a knob for driving the gear to rotate is provided on the movable block, a sample shaft is horizontally provided on one side of the movable block, and a slit is provided on the sample shaft along its length.

3. The medical catheter haze measuring device according to claim 1, characterized in that: The catheter clamping assembly includes an L-shaped sample test frame, the vertical part of the sample test frame is fixed to the side of the base, the horizontal part of the sample test frame extends above the opening, and a slit is provided on the horizontal part of the sample test frame, and the two sides of the slit are wedge-shaped.

4. The medical catheter haze measuring device according to claim 1, characterized in that: The light source adopts a broad wavelength light source with a wavelength of 380-760 nm.

5. A method for measuring the haze of a medical catheter, characterized in that: include: Material preparation: providing the medical catheter haze measuring device as described in any one of claims 1 to 4 and a batch of catheter samples; To measure the haze F, the sample to be tested is mounted on the measuring device, the device is started, the light source is turned on, and the detector detects the transmittance T of the sample, where haze F = 100% - T; Measure the surface haze f. The haze of the tubes with the same size but different surface conditions in the same batch of samples is measured. The haze of the tubes with smooth surfaces is recorded as F0, and the haze of the tubes with atomized effects is recorded as F1. The surface haze f of the tubes is F1-F0. Determine the molar absorption coefficient K. For a smooth catheter with a known material formula ratio c1, its single-layer wall thickness is l1. Measure the haze and based on the test result F2, we have The molar absorptivity can be obtained Determine the material characteristic coefficient P. For a smooth conduit with unknown material characteristic parameters, its single-layer wall thickness is l2. Measure the haze and according to the test result F3, there is The material characteristic coefficient can be obtained 6. The method for measuring haze of a medical catheter according to claim 5, wherein: The determination of surface haze f, the determination of molar absorption coefficient K and the determination of material characteristic coefficient P are carried out in no particular order.

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