The present invention relates to a digital insulin pen, which provides ability to use the insulin pen to be self-administering insulin in healthy manner for vision impaired, illiterate, older people or type 1 or type 2 diabetics.

Known State of Technology:

Diabetes; It is a chronic disease that persists for the lifetime and treatment due to the lack or absence of insulin hormone released from the pancreas. Type 1 and Type 2 diabetes are divided into two. Insulin therapy, which is of vital importance for patients with type 1 diabetes, and which provides adequate metabolic control, is also important for patients with Type 2 diabetes. Diabetic retinopathy (DR), the most important cause of blindness worldwide, is one of the most important complications of diabetes. According to the general population, the risk of blindness is 25 times higher in diabetic patients. Also, Type 2 diabetes usually occurs after 40 years of age and these patients are usually elderly patients with decreased vision.

In recent years, patients prefer ready-to-use insulin pens because they are easier to use and more reliable in dosage than doing insulin injection on their own. However, during the use of the insulin pen, the dose cannot be adjusted correctly by the visually impaired, elderly and vision-impaired elderly patients as removing the pen before the subsequent amount of insulin is not transmitted subcutaneous and it creates problems.

In the published guidelines, the importance of the correct dosage to be adjusted, the right angle is entered and how the needle is removed from the skin correctly and timely after the injection process is being explained. Complications such as hypoglycemia, hyperglycemia, bleeding at the injection site, bruising, insulin lipoatrophy and hypertrophy may occur if these steps are not observed. In order to prevent these complications and benefit for the patient's treatment, patients should have sufficient sensation, knowledge and skills, or existing insulin pens should have preventive properties.

In the commonly used insulin pens, the dose setting is manually adjusted by twisting the head of the pen. In each turn, the dose increases and decreases with the“snap” sound. The dose increasing and decreasing could be read by following the little eye at the top of the pen. The needle is usually attached by twisting to the tip of the pen. After starting the treatment with a insulin pen, practical training is usually given by a doctor, diabetes nurse or a health care professional who is in charge of the subject and the patient is provided with self-injection by the insulin pen. This makes it difficult for the elderly to have self-injection both in patients with low vision and illiteracy, and to learn these methods. Nowadays, it is generally seen that this responsibility is assumed by the patient’s relatives or caregivers. In order to provide a more effective drug application with insulin pen, auxiliary techniques that can be mounted on insulin pen have been developed.

In the European patent application EP3188061 A3, the "additional device for injector system for monitoring injected quantity" is described. The present invention is commercially available under the brand name“Insulog”. The device is a part that is attached to the insulin pen, compatible with every insulin pen in the market. Intelligent sensors are used to automatically detect the dosing and show how much insulin has been taken and the final time of exposure with a small screen image. It aims to automatically transmit data to a smart phone application for easy viewing and data sharing with physicians using the built-in Bluetooth connection. However, in the present invention, although there is a digital display, an effective drug delivery and notification method has been planned, there is no audible warning system for elderly, visually impaired, visually impaired, illiterate patients. Chinese patent application CN201375731Y is described in“Insulin syringe with voice punctuality function. The invention includes an insulin syringe with sound function. A useful feature has been added to the medical device by adding voice recording to the commonly used mechanical insulin pen. In the present invention, the dose is adjusted by rotating the mechanical insulin dosing knob and the dose corresponding to the dose is reported by the sound.

During injection, the injection push button is fully depressed when the syringe needle enters the body. After 10 seconds, the loudspeaker sounds a“tick” sound to remind the removal of the needle and the injection is completed.

In the above invention, there is an audible warning system for elderly, visually impaired, illiterate patients, but there is no digital display and no warning system to prevent repeated use of the needle.

In patent application no. TR201803977, "Timed, audible and light warning system for increasing the efficiency of application in insulin products" is described. The invention consists of a terminal that provides insertion into the insulin pen, the time indicator for measuring the time of treatment, and the signals that provide audible, illuminated signals.

In the present invention, insulin therapy starts after the injection button is pressed and when the light signal is activated, the patient can terminate the application. The present invention allows only the patient to deliver the entire dose to the subcutaneous tissue during injection. The patient does not have an audible voice warning especially for visually impaired elderly patients and to remind the removal of the needle from the insulin pen.

In addition, many insulin pens in the market are used and discarded. The insufficiency of existing systems makes it difficult for the patients to take the insulin pen at different times during the application, and thus complicates the follow-up of the patient's treatment and hence adversely affects the sugar system. As a result, there is a need for a new technology that can overcome all the above mentioned disadvantages, which is a domestic production, which will contribute to the national economy, reduce costs and create jobs. Definition of Invention:

The present invention relates to a digital insulin pen, which is characterized by to aim to enable elderly diabetic patients, visually impaired or illiterate patient to easily adjust the correct dose by self-injection with insulin pen, to terminate the application at the right time, and to remove the disposable needle from the pen injector after the application.

The invention enables the visually impairment, elderly with vision difficulties, or illiterate patients with diabetes perform their own insulin application effectively, reducing the risk of complications, facilitating application, and increasing patient comfort.

The invention is a new technology, which is entirely domestic production and contributes to the country's economy, reducing costs and creating jobs. The present invention provides an improved insulin injector with superior properties that makes the administration more accurate and effective for patients with visually impairment, elderly with vision difficulties, or illiterate patients with diabetes.

The patient begins to use the invention by inserting the standard administration needle into the tip of the insulin pen. The digital display from the on-off button easily adjusts the dose to be applied by pressing the plus and minus buttons on the insulin pen. The numbers on the screen are easily visible and the numbers could be heard audibly when the dose is increased or decreased. When the patient presses the plus (+) key, the display shows 1 the words“one” could be heard from the insulin pen. The dose is increased one by one and the number on the screen is heard from the insulin pen at each time.

When the dose required in the invention is adjusted, the plunger of the pen is so constructed that it injects the set dose (prescribed quantity of insulin). The patient selects the area of application and injects the drug by pressing the large button next to the digital display of the insulin pen. Normally, after injection, the patient is asked to count the slowly up to 10. In the invention, the countdown starts from 10 to the back after the injection and when the time is up, the words of“the injection is complete you may remove the needle” is heard from the insulin pen. A few seconds after the needle is removed from the skin, the words of“please remove the needle from the pen” is heard from the insulin pen.

The needle is removed and the lid of the insulin pen is closed and the device is switched off by the switch. The invention operates with a rechargeable battery. Unlike disposable pens that are discarded ones it’s used and finished the only thing needs to be change is the cartridge when it is needed.

Because of this invention, visually impairment, elderly with vision difficulties or illiterate patients with diabetes can easily make insulin injections. Because of the reduction of complications, the patient leads to better quality and more comfortable life.

The invention reduces health and maintenance costs. It provides a better treatment for hypoglycemia, hyperglycemia, bleeding at the injection site, bruising, insulin lipotrophy and hypertrophy by reducing complications for health care providers who does the care and the follow-ups.

The invention can be easily produced and marketed by companies engaged in the manufacture of medical products in the industry.

Description of Figures:

The invention will now be described with reference to the accompanying drawings, whereby the features of the invention will become more apparent and appreciated, but this is not intended to limit the invention to these particular embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents which may be included in the scope of the invention as defined by the appended claims. It should be understood that the details shown are presented solely for the purposes of illustrating preferred embodiments of the present invention, and are provided to provide both the shaping of the methods and the most useful and easy-to-understand description of the rules and conceptual features of the invention. In these drawings;

Figure 1 is a front view of the invention.

Figure 2 is a rear view of the invention.

Fig. 3 is an insulin pen cap view of the invention.

Fig. 4 is a front detailed view of the invention. Figures to assist in the understanding of the present invention are numbered as indicated in the accompanying drawing and are given below with their names.

Description of References:

I . Digital display

2. Injection button

3. Dose adjustment keys (+ and -)

4. On-off button

5. Audible warning system

6. Battery

7. Loudspeaker

8. Insulin pen cap

9. Engine

10. Drive piston

I I . Insulin cartridge

12. Needle

13. Body

Description of the Invention: The invention comprises a body 13, a digital display (1) positioned on the housing (13) with the on-off switch (4) positioned on the body (13), on the side of the on-off switch (4), the bottom of the digital display (1). the dose adjustment keys (+ and -) (3) positioned on the body (13), the injection button (2) associated with the right side surface of the body (13), the audible warning system (5) positioned on the rear surface of the body (13), at least one battery (6) positioned on the rear surface of the body (13) so that the loudspeaker (7) located on the rear surface of the body (13), on the left side of the audible warning system (5), is on the upper side of the audible warning system (5), at least one motor (9) associated to the right side of the drive piston (10), which detects and adjusts the digitally written dose, and is connected to the left side of the drive piston (10). The hypodermic insulin cartridge (11) consists of the needle (12) and the insulin pen cap (8) associated with the left side of the insulin cartridge (11) (Figure- 1, Figure-2, Figure-4).

The invention has dose adjustment keys (+ and -) (3) which allow the dose to be applied to be increased or decreased. Invention; includes an audible warning system (5) for thr dose, which reminds the termination time of the application and removal of the needle at the end of the application (Figure- 1, Figure-2).

The invention has a drive piston (10) which detects and regulates the dose written digitally by the dose setting keys (+ and -) (3). The invention includes a rechargeable battery (6) that enables the digital display (1) and the audible warning system (5) to operate. In addition, the invention has a motor (9) which injects a digitally entered dose (Figure- 1, Figure-2, Figure-4).

Detailed Description of the Invention:

The inventive components; body (13), digital display (1), injection button (2), dose adjustment keys (+ and -) (3), on-off button (4), audible warning system (5), battery (6), speaker (7), insulin pen cap (8), motor (9), drive piston (10), insulin cartridge (11), needle (12) (Figure- 1, Figure-2, Figure-4).

The operation of the invention is as follows. The invention is opened from the on-off switch (4). While pressing the dose setting buttons (+ and -) (3) the dose should be applied to the insulin pen, the acoustic warning system (5) speaks the numbers shown on the digital display (1) (Figure-l, Figure-2). By means of the invention, the audible warning system (5), which pushes the injection button (2) and tells the removal of the needle (12) from the skin when the application is completed, which is activated after 10 seconds. Thus, the entire dose is injected (Figure- 1, Figure-2).

By means of the invention, the audible warning system (5) is activated to prevent the removal of the disposable needle (12) after the application and warns the patient to separate the needle (12) from the insulin pen. The sounds are announced from the loudspeaker (7) behind the head of the device. After the needle (12) is removed, the insulin pen cap (8) is closed and finally the device closes from the opening switch (4) (Figure-2, Figure-4).