INSULIN INFUSION SETS TECHNICAL FIELD

The invention relates to a new "air bubble detection device" that detects air bubbles present in insulin passing through infusion sets used in the treatment of diabetes mellitus. BACKGROUND

Insulin pumps are widely used in the treatment of diabetes, especially for patients with type 1 diabetes mellitus. In this treatment, an insulin pump passes the insulin in the reservoir through an infusion set consisting of a flexible tube with a millimeter diameter and delivers it to the subcutaneous fat tissue through the needle cannula. The amount of insulin used is applied in micro-liter doses since insulin is a very effective hormone. Air bubbles can occur in insulin in the reservoir for various reasons. When the very small amount of air bubble replaces insulin, the amount of insulin given to the patient decreases, and the patient's blood glucose value becomes excessively high. This air bubble is difficult to see visually as the infusion set is too narrow. Insulin pumps used in the market determine the amount of delivered insulin volumetrically, and there is no measurement of the actual insulin value entering the body. Patients can perceive this problem after blood glucose levels increase. This process causes organ damage in patients. Various measurement techniques have been developed to detect air bubbles that occur. However, these devices have neither technology nor ergonomics suitable for the practical use of patients. These devices are also not compatible with the wide variety of sizes available infusion sets. In addition, the structure of the device is very large as a body compared to infusion sets. For this reason, it is not useful and could not find a usage area. There is no air bubble detection device that is compatible with all kinds of infusion sets, can be easily adapted to infusion sets, not needed any adjustment and extra technical knowledge, not damaged the infusion set, not imposed an additional burden to patients and devices. l LIST OF FIGURES

Figure 1. Air Bubble Detection Device For Insulin Infusion Sets

Description of the Numbers Given in Figure

1. Thin film sensor

2. Film strip

3. Non-stick top surface

4. Sticky bottom surface

5. Thin film capacitor

6. Electronic circuit

7. Connection socket

8. ADC (Analog to digital converter) chip

9. Microcontroller

10. Wireless communication module

11. Display

12. Keypad

13. Battery

14. Smartphone BRIEF DESCRIPTION OF THE INVENTION

The invention is a measuring device that has been developed to detect air bubbles in insulin infusion sets, can be easily connected to all types of infusion sets, not obstruct the flow of the fluid passing through the set, not contact into the liquid, installed easily.

DETAILED DESCRIPTION OF THE INVENTION

The invention is a measuring device developed to detect air bubbles in insulin infusion sets and can be easily mounted on infusion sets of all types and sizes. The device is very small in size and does not cause difficulties in transportation and assembly. It can easily adhere to the outside of infusion sets. It does not block the flow of liquid and does not come into contact with the liquid. The invention is consisting of a film sensor, an electronic circuit, a smartphone, and interface software that works on this smartphone and provides the coordination of all this equipment. The device detects the presence and amount of air bubbles passing through the infusion set during insulin delivery and sends a warning to the user. The device also detects air bubbles in all liquid fluids that are transmitted through a pipe made of non-conductive material. It also practically detects the level of liquid in a container made of non-conductive material. Level measurement is taken by connecting the device immediately without the need for electrical installation at the place where the measurement will be made.

This device has;

- A thin film sensor (1) to be used by adhering to the surface of the object to be measured, composed of flexible film layers and whose features are listed below,

- A thin and flat film strip (2), which is the main structure of the film sensor (1), made of flexible, insulating material, wrapped in rolls,

- The adhesive-free top surface (3) of the film strip (2),

- The adhesive bottom surface (4) formed in order to ensure that this film strip (2) adheres easily to the surfaces,

- A film capacitor (5) formed by coating a flexible and conductive material on the upper surface of the film strip (2) as two parallel rows of thin films,

- An electronic circuit (6) whose features are listed below to analyze the information coming from the thin-film sensor (1),

- A clip-shaped connection socket (7) to easily connect the film sensor (1) to the electronic circuit (6),

- An ADC (analog to digital converter) chip (8) that converts the capacitance information to a digital value,

- A microcontroller (9) used to process the information coming from the ADC chip

(8),

- A wireless communication module (10) that sends the measurement values obtained by the microcontroller (9) to other devices using a wireless communication protocol such as Bluetooth,

- A display (11 ) for displaying the measured information,

- A keypad (12) to enter set values on the device,

- A battery (13) that meets the power requirement of the electronic circuit (6),

- A smartphone (14) in which the measured capacity information is transmitted and the user interface software is run. The device mainly consists of three main equipment given below. These:

A. Thin film sensor

B. Electronic circuit

C. Smartphone

It was described below the new method offered by the device and the run of the device.

A. Thin film sensor (1)

- The thin-film sensor (1) has a flexible structure and is adhered throughout the area where the air bubble is desired to be detected in the infusion set.

- The thin-film sensor (1) adheres to the outside of the surface to be measured and does not have any contact with the liquid. It does not prevent the flow of liquid.

- The remaining part of the thin film sensor (1 ) is left on a roll without being glued. If desired, the excess part is cut with scissors.

- The area of use of the thin film sensor (1 ) is not limited to infusion sets. It is used to measure the level of any liquid in any tank made of non-conductive material and to detect air bubbles in the liquid passing through a pipe made of non- conductive material.

B. Electronic circuit (6)

- The electronic circuit (6) is used to measure the capacitance detected by the thin film sensor (1).

- The thin-film sensor (1 ) is easily connected to the clip-shaped connection socket (7) and the capacitance value is transmitted to the electronic circuit (6).

- The capacitance value is read by the ADC chip (8) and this value is converted to digital capacitance information.

- This numerical value is transmitted to the microcontroller (9) by using a serial communication protocol on the electronic circuit (6). - The microcontroller (9) processes the measured capacity information and sends it to the wireless communication module (10) to be transmitted. - The wireless communication module (10) transmits the measurement information to other field devices over a wireless communication protocol such as Bluetooth.

- The display screen (11) allows the measured information to be seen on the device.

- Keys (12) allows the set values to be entered on the device.

- The battery (13) meets the power requirement of the electronic circuit (6).

C. Smartphone (14) ve interface sotfware - The capacitance information transmitted wirelessly to other field devices via a wireless communication module (10) is received by a smartphone (14).

- There is an interface software on the smartphone (14) that transmits this information to the users.

- On the screen of the smartphone (14), information on the presence of liquid and air in the area where the measurement is made is displayed as a percentage.

- The volume information of the infusion pipe is entering as parameters by the user, then the mass and the volume values that belong to liquid and air quantities are calculated by the interface software of the smartphone (14).

- A standard calibration protocol is applied when the device starts up for the first time.

- The calibration process is done by filling the area to be measured first completely with air and then completely with liquid. The capacitance values measured in both stages are stored in the memory for reference. All subsequent measurements are calculated with reference to these values. - If the presence of air in the measured liquid is detected and the detected air ratio exceeds a threshold value entered, a warning is output via the smartphone (14).