In the production of indwelling needles, there are many tedious steps. Moreover, because the materials and parts of each part of the indwelling needle products are relatively small, this also brings a certain degree of difficulty to manual production. Here are some comparisons. Steps that are important but cannot be completed quickly and efficiently.
1. Organize the conduit, because the conduit is placed in a coil. After a certain period of storage, the conduit will deform in the direction of curling. At the same time, because the conduit is made of plastic and is very small after being cut, unavoidable static electricity will also cause a lot of trouble during processing.
2. Rivets are generally used to fix the catheter and the needle seat. Before inserting the rivet, the fixed end of the tube needs to be expanded to a certain angle to facilitate the insertion of the rivet. Due to the material of the catheter Because, this process will be very difficult. Some manufacturers directly insert fixing rivets without expanding the holes to improve work efficiency, but even so, inserting small rivets will still cause a lot of trouble.
3. The catheter requires a specially shaped tool to push into the bottom end of the needle seat, and there are precise
positioning requirements.
4. Due to the special needs of the indwelling needle, the catheter tip needs to be processed into a certain shape. Manual
A catheter tip forming machine is used to gradually shape the catheter tip. Currently, domestically produced tips There is still much room for improvement in the productivity and molding quality of the molding machine.
5. Manually inserting the needle into the needle blade cannot be completed efficiently
due to the precise strength and length requirements
6. Between the needle and infusion In terms of tube dispensing, some domestic manufacturers will use some homemade simple tools to complete the dispensing process, because dispensing is a work that cannot be digitized in manual processes and is very demanding for operators. Generally speaking, it takes 1-2 years to train a skilled dispensing worker. However, the proportion of dispensing in the product quality of indwelling needles is self-evident. Secondly, due to the particularity of indwelling needle products, there are many tedious but necessary quality tests that cannot be avoided in the manual production process, such as
1. Testing the binding force between the needle tube and the needle blade, which is A very important test, if the bonding force between the needle tube and the needle blade is not enough, the result will be that when the needle tube is removed after the insertion is completed, the needle tube will fall off due to insufficient bonding force, which will further damage the needle tube. leading to various possible medical accidents.
2. The shape of the catheter tip is a factor that ensures that the catheter can be inserted into the patient's vein smoothly. Without this detection process, various quality problems with the catheter tip will cause pain or pain to the patient. Insertion failed.
3. As with the previous one, the integrity test of the catheter and needle tip is the key to ensuring that the indwelling needle can
pass through the human body smoothly. In addition, such as catheter tension test, air tightness test, needle tube and needle seat overall length test all belong to this category. On the other hand, even if the manufacturer can successfully carry out the above work, it is still unable to mass produce, because these are based on the ownership of On the basis of numerous human resources, there is another important problem that cannot be avoided, that is, the inability to guarantee stable product quality, mainly due to the particularity of quality testing. First of all, effective detection cannot be carried out manually, for example:
1. All types of length detection basically rely on ruler measurement, which has very low accuracy and efficiency and will cause problems
A certain probability of misreading.
2. Catheter tip detection relies solely on the naked eye and a magnifying glass. There is no quantitative data for reference. It can only
detect major deformations such as flash edges
3 . The tip detection of the compatibility of needle tubes and catheters relies entirely on the naked eye and a magnifying glass. There is no quantitative data for reference. It can only detect flash edges and major deformations. Secondly, some tests are destructive and cannot be used. Completed under artificial conditions, such as needle pull test and catheter pull test, are generally done as sampling tests, and it is impossible to 100% monitor the quality of all finished products. In addition, there are some tests that are difficult to complete under manual conditions, such as air tightness testing.
Let us take a look at how these problems are reasonably and effectively solved on KAHLE's fully automatic assembly line.
First, let’s take a look at the process flow. Some important workstation units will be enumerated below.
1. On KAHLE’s machine, before the catheter is cut into fixed lengths, it first passes through a heating straightening unit
. This unit can quickly soften the catheter, and then With the assistance of the tensioning mechanism, cooling unit and anti-static unit, the conduit will enter the slitting unit in an optimal state. After precisely controlled length slitting, sections of conduit in optimal state enter the machine operation process. These are reflected on the machine, and all these actions have been completed in the tube feeding unit.
2. Hole expansion is realized on the assembly line by using a high-frequency heating head in conjunction with the mold, which is more efficient and accurate than traditional manual hole expansion.
3. The robot inserts the rivet quickly and efficiently
4. The fastening of the catheter and the needle seat is achieved by a pushing tool combined with a thrust gauge,
< p>This tedious work in the manual process is solved here with just one station, and it has the unsurpassed advantages of manual operation. The strength and depth can be adjusted according to different products, and the thrust gauge data is fed back in real time. .5. Almost the most important step in manual production is simplified to several workstations in KAHLE’s fully automatic assembly line, and the temperature can be set arbitrarily according to different products. With the cooperation of the high-frequency heating unit and the mold, the assembly line can easily process the catheter tip shape required by the product. In order to ensure the molding quality, the high-frequency machine is also equipped with a water-cooling cooling unit to effectively prevent various catheter quality problems caused by thermal adhesion. And tip forming inspection can be completed on the assembly line.
6. Silicone oil is an indispensable lubricating material in the production of indwelling needles. In manual production,
Applying silicone oil is a tedious task, but in the assembly line, special The designed silicone oil steel and silicone oil application unit can effectively infiltrate silicone oil at high speed, and there are corresponding excess silicone oil removal devices for links that may cause pollution.
7. Shape detection all uses video detection and is included in the workflow, which will be introduced in detail in the next chapter
section.
8. Compared with the manual method, the needle can be inserted into the needle blade more accurately, and the joint between the needle tube and the needle blade
is glued. This step can be seen on the fully automatic assembly line. This is a redundant step, and the reason will be explained in detail below
9. Glue dispensing, a very cumbersome problem in manual methods, is simplified on the fully automatic assembly line
It becomes a glue sprayer position, the glue can be sprayed quantitatively and the amount of glue can be adjusted at any time.
10. In the operation process of the assembly line, all waste materials or substandard products generated by processing are
automatically rejected by devices or workstations and have corresponding recycling devices.
Let’s take a look at the working conditions of the inspection unit of the fully automatic assembly line compared with the manual method
1. All length inspections are done on the assembly line using limited stations or detection methods Confirm
Definitely.
2. The detection of the catheter tip and the detection of the compatibility between the needle and the catheter tip all rely on a high-precision imaging system
The photography system automatically locates and scans the catheter tip, and the detection system automatically analyzes The scanning results are determined based on the pre-entered product data to determine whether the product is good or not. Then, the system displays the scanning results on the display screen in the form of images and data to facilitate operator monitoring, and at the same time feeds back the detection results to the assembly line processor to complete the rejection Waste process, the system is an independently operating subsystem, equipped with a dedicated processor and integrated into the entire assembly line work program.
3. The needle adopts thrust detection when inserting into the needle holder. The insertion thrust is used to determine whether the needle holder and
the needle tube are firmly combined, so there is no need for manual dispensing. The premise is that the quality of the indwelling needle parts passes the standard. In actual application, the yield rate of this station is almost 100%.
4. The conduit pull force test uses a counterweight method at a station where the test standard can be changed
to test the binding force between the conduit and the Y-seat. After the test is completed, the The remaining part of the catheter will be automatically removed PPT
5. At the air tightness testing station, the catheter and infusion tube will be sealed by the robot, and after stamping, the data will be tested using
Determining whether it is airtight is a test that is difficult to complete manually and can be monitored at just one station on the assembly line.
6. gQuality inspection is all included in the operation process of the assembly line, and all inspection stations can
feed back the inspection results to the assembly line and remove waste products at the scrap station. , the products come out from the discharge port as all tested finished products.
In addition to the above, KAHLE's fully automatic assembly line is also quite advanced in the following aspects.
The control panel (HMI) has a simple and efficient menu, which can be set in multiple languages ??
according to customer requirements, and various specifications of indwelling needles can be built into the machine according to customer requirements. Production data, it is very simple to select the product specifications to adjust the production parameters of the entire machine to the data required to change the specifications. The yield rate of the machine production can be queried at any time, and the quality status of each type can be queried separately by tooling and workstation. The components can work in both manual and automatic modes for easy care and maintenance. Switching them only requires a light touch on the LCD panel.
It has a complete alarm and safety system, such as a safety door alarm. When it is open, the machine will not be able to enter the working state. If various action components are not placed in the correct position, the machine will alarm and turn the machine over. Enter the protection state. In addition, each work station and production process are under the monitoring of the system. The system will adopt various warning methods according to the alarm situation, including sound and light warnings. The machine is equipped with emergency alarms on various working surfaces. Stop button ensures that if an abnormal situation occurs, the operator can stop the machine as soon as possible. And the system can detect all sensors in the system to ensure that they are working normally.
KAHLE's assembly line has special insurance and safety electrical components for each individual subsystem in the electrical system. Each cable has its own wire trough and is concealed. The wiring greatly ensures the simplicity of the machine. All electrical connectors adopt industrial standard connectors to ensure the compatibility of the machine. All cable connectors are marked to facilitate detection and maintenance.
The PLC and HMI units in the KAHLE assembly line can be connected and adjusted software parameters through various connection methods through ordinary PCs, and even the operation of the action components can be manually adjusted, and various functions in the machine can be adjusted through PCl. Software parameters to adapt to new product production or specification changes, KAHLE engineers can even remotely detect, maintain and upgrade the customer's assembly line through the INTERNET network. Customers only need a computer with Internet access and the corresponding software (provided by KAHLE). This ensures the timeliness of the work to the greatest extent.
In addition to the fully automatic assembly line for indwelling needles, KAHLE is at the forefront of disposable medical assembly equipment suppliers in more aspects. In some cutting-edge technologies, they have even become industry standards. ——This article comes from the medical community