Claims:WE CLAIM:

An AI Based Insulin Pen Integrated with Smart Patch for Visually Impaired Person Comprising:

1. A pen filled with insulin with three components: a base which contains the mechanism for measuring the correct dose; a holder for the cartridge of insulin; and a cap, which is removed and replaced by the needle prior to the injection.
2. An adhesive patch which consists of Glucose sensor, Raspberry Pi, Buzzer.
3. According to claim 1 & 2 Wi-Fi enabled module for communication between pen and patch.

4. According to claim 2, glucose sensor measures a blood glucose level.
5. According to claim 2, Raspberry Pi which stores the dosage information.
6. According to claim 2, Buzzer with loud alarm sound can indicate that there is no dosage in pen, Buzzer sound with single beep can indicate that half of the dosage left in the pen and Buzzer with two beep sound can indicate to blind people about their increase/decrease in blood glucose level.
, Description:FIELD OF THE INVENTION

The present invention AN AI BASED INSULIN PEN INTEGRATED WITH SMART PATCH FOR VISUALLY IMPAIRED PERSON relates to insulin pen integrated with adhesive patch for diabetes patient to measure blood glucose and gives sound alert to visually impaired persons about availability of insulin dosage in pen.

BACKGROUND OF THE INVENTION

US20120072236A1 An insulin pen data recording and transmitting system was proposed in the invention. An electromechanical device is combined with an insulin delivery device, resulting in the recording of insulin delivery date, time, and number, according to a system and process.
US20190298920A1-Invention proposed a continuous glucose monitoring injection device. A glucose monitor sends data to an automated insulin delivery system, which calculates the bolus dose. The system could resemble an insulin pen, with a motor connected to an encoder providing automatic priming and precise dosing. A smart phone system can communicate with and monitor the device. The smart phone system has a user interface that allows users to submit instructions to the device, such as dose number, and receive data such as patient weight, insulin to carbohydrate ratio, and exercise factor. The dosage is calculated based on the glucose level and trend, as well as other factors. The glucose monitor and smart phone can be in constant contact with the delivery system, allowing for near real-time changes in glucose treatment. Data on blood sugar levels, insulin injections, and other related information can be preserved and made available to interested parties.
US20180228979A1patent applies to an assembly for administering a specific dose of insulin or other medications from a cartridge by moving a plug led in said cartridge, which includes an adapter assembly for adapting cartridges of various sizes or contents. The adapter assembly includes a first threaded element threaded with a thread lead and movable in a moving direction to pass the plug, as well as a second threaded element pivotably screwed to said first threaded element and restricting the movement of said first threaded element for setting a selected dose. and where said first element's thread lead and said second threaded element's thread lead are tailored to the dimensions and/or contents of said cartridge
DE10146454B4- An insulin syringe system was proposed in the patent. The innovation is a compact, automated insulin syringe system with an automatic insulin injection feature that can calculate and display the amount of insulin administered to the patient as well as the user's blood glucose level. More specifically, the present invention offers a compact, automatic insulin syringe system, which includes a blood glucose measurement machine disposed in a syringe device housing and capable of measuring the user's blood glucose levelA control unit modified to obtain the value determined by the blood glucose measurement unit, whereby the measured value is shown along with the amount of insulin administered to the user so that the syringe system can monitor the user's blood sugar level.
US9358334B2An integrated glucose metre and insulin injection pen with automatic emergency warning is described in a patent. A single unit combines an insulin injection pen and a blood glucose monitoring system that fits in a user's clothing pocket or handbag. A blood glucose monitoring system detects the user's blood glucose level, an insulin injection mechanism, and a microprocessor calculates an insulin dosage suitable for the detected blood glucose level of a

specific user and sets the insulin injection mechanism to administer the calculated insulin dosage. If the microprocessor decides that the detected blood glucose level poses a risk to the patient, the system automatically alerts a remote emergency care provider. The microprocessor also measures and shows treatment regimens based on the detected blood glucose levels on an LCD monitor. The device may include a GPS receiver that detects the device's location and transmits that information to the remote emergency service.
InPen is an FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI). This system now provides real-time glucose readings as well as information on insulin doses. Instead of switching between apps, users can see all of their information in one place, in real time. The addition of Companion Medical's InPen to the Medtronic portfolio in September 2020 resulted in the integration of real-time CGM data into the smart insulin pen app.
WO1993000948A1- Patent proposed a Syringe system. A pen-shaped syringe with an insulin cartridge and an injection needle makes up an insulin injection system. The insulin is a type that can freely flow through a G 30 needle, and the needle is a G 30 needle. The maximum dimension of any crystal in insulin that contains suspended crystals is 15 vm.
US5226895A- A multiple dose injection pen was proposed in the patent. A housing for holding a container of liquid similar to that known in the prior art is included in a syringe constructed in accordance with the present invention. A plunger rod is inserted into the housing to exert force on a piston that closes the container's second end. The plunger rod has a non-cylindrical cross-section with a first surface with threads and a second surface with a line of ratchet teeth as an option. For permanent retention of the liquid container within the housing, a collar is received within the housing adjacent to the container second end. The collar has a non-cylindrical opening that roughly corresponds to the plunger rod's cross-section. The collar prevents the plunger rod from rotating with respect to the housing as it passes through the non-cylindrical opening. The collar has a mechanism that engages the second surface of the plunger rod, preventing the plunger rod from moving away from the liquid container.

PRIOR ART SEARCH

US20120072236A1- Insulin pen data recording and transmission device: 2012-03-22.
US20190298920A1-Continuous glucose monitoring injection device: 2019-10-03.
US20180228979A1-Assembly to administer insulin from a cartridge: 2018-08-16.
US5226895A-Multiple dose injection pen: 1993-07-13.
DE29918149U1-Insulin delivery device: 1999-12-30.
DE10330984B4-Injection device with position sensor: 2009-12-10.
US6663602B2-Injection device: 2003-12-16.
JP4278382B2 -Electronically controlled syringe or injection device: 2009-06-10.
NL2005017C2-Replaceable cap for a dosing device: 2012-01-03.
CN107750174B-Data collection device for attachment to an injection device: 2020-10-27.
JP2018516151A-Monitoring device for drug application with a drug pen type injector with log recording function, communication function and alarm: 2018-06-21.
PCT/EP2010/054383-Arrangement for administering insulin from a cartridge: 2010-03-31.
US15/954,833- Assembly to administer insulin from a cartridge: 2018-04-17.
US9717852B2-Cartridge holder and pen-type injector: 2017-08-01.
US10058655B2-Pen-type drug injection device with controller and time lock-out mechanism for its drive: 2018-08-28
US10543321B2-Pen cap: 2020-01-28.
DE10146454B4-Insulin syringe device: 2018-03-01.
GB2379978B- Portable automatic insulin syringe device with blood sugar measuring function: 2005-03-23.
KR20180118368A-Nleedle Unit with Glucose Sensor and Simultaneous Infusion-Glucose Detecting System: 2018-10-31.
US9358334B2- Integrated glucose monitor and insulin injection pen with automatic emergency notification: 2016-06-07.

REFERENCES:

1. Ann S. Williams et.al “A Comparison of Dosing Accuracy: Visually Impaired and Sighted People Using Insulin Pens”, J Diabetes Sci Technol. 2010 May; 4(3): 514–521. Published online 2010 May 1.
2. Bernbaum M, et.al, “Effectiveness of glucose monitoring systems modified for the visually impaired. Diabetes Care” 1993;16(10):1363–1366.
3. Sokol-McKay D, et.al, “Adaptive low-vision and blindness techniques for blood glucose monitoring”, Diabetes Educ. 2003;29(4):614–618. 620, 622 passim.
4. Rubin RR and Peyrot M, “Factors affecting use of insulin pens by patients with type 2 diabetes”, Diabetes Care. 2008;31(3):430–432.
5. Klonoff DC, ”The pen is mightier than the needle (and syringe) Diabetes”, Technol Ther. 2001;3(4):631–633.
6. Spollett G,” Addressing barriers to insulin therapy with the ideal pen”, Diabetes Educ. 2008;34(6):957–967. 963, 967.
7. Clarke A and Dain MP, “Dose accuracy of a reusable insulin pen using a cartridge system with an integrated plunger mechanism”, Expert Opin Drug Deliv. 2006;3(5):677–683.
8. Hermanns N et.al,” Dosing accuracy with a novel pen device (SoloSTAR) as performed by patients with diabetes in a clinical setting”, Diabetes Technol Ther. 2008;10(4):322–327.
9. Schwartz S and Vlajnic A,” Validation of the SoloSTAR insulin pen”, Diabetes Technol Ther. 2008;10(5):351–357.
10. Pfutzner A et.al, “ Insulin delivery with FlexPen: dose accuracy, patient preference and adherence”, Expert Opin Drug Deliv. 2008;5(8):915–925.
11. Asakura T et.al,” Dosing accuracy of two insulin pre-filled pens”, Curr Med Res Opin. 2008;24(5):1429–1434.
12. Gnanalingham MG et.al, “Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes”, Arch Dis Child. 1998;79(1):59–62.
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15. Fox C et.al,” Ability to handle, and patient preference for, insulin delivery devices in visually impaired patients with type 2 diabetes”, Practical Diabetes Int. 2002;19(4):104–107.

OBJECTIVES OF THE INVENTION
• To make diabetes patient safe and convenient.
• To give less injection pain by using insulin pen.
• To give awareness about dosage left in the insulin pen to blind people by using different buzzer sounds.
• To measure blood glucose level on every second for taking correct dosage of insulin.
• To provide adhesive patch with sensors for measuring glucose level and giving alarm awareness for visually impaired people

SUMMARY OF THE INVENTION

Managing diabetes often necessitates the administration of insulin shots during the day. Insulin pens and other insulin delivery devices can make administering insulin shots much easier. Insulin pens do not remove the need to use a needle to inject insulin. They actually make it easier to measure and administer our insulin. Insulin pens can deliver between.5 and 80 units of insulin at a time. They can produce insulin in half-unit, one-unit, or two-unit increments. Each pen has a different maximum dose and incremental number. The total number of insulin units in the cartridges also varies.
There are two types of pens: disposable and reusable. If the prefilled cartridge in a disposable insulin pen runs out, the whole pen is thrown away. When the insulin cartridge in your reusable pen runs out, you should refill it. For visually impaired people, injecting insulin may be difficult because they are unaware of the dosage options in an insulin pen. This innovation will enable blind people to receive a warning when a dose is available. Insulin pens and adhesive patches are the subject of the present invention. A patch with a blood glucose monitor, a buzzer, and a Raspberry Pi can be stuck to our wrist. The adhesive patch tests the distance travelled by the plunger inside the pen from its original position of "zero" to the position where the plunger lies immediately prior to injection as the patient rotates the top of the pen to pick the prescribed dose of insulin to be injected into the body. The plunger's displacement is transformed into a unit of insulin measurement.
The amount of insulin injected, along with the time and date, is registered by the adhesive patch and retained in the patch memory when the plunger is depressed and returns to the "zero" spot, signalling an insulin injection. Based on the storage availability in the insulin pen, an AI algorithm on the Raspberry Pi analyses the availability of dosage. Buzzer will indicate alarm to alert visually impaired persons about dose left in the pen. Buzzer sound with single beep can indicate that half of the dosage left in the pen. Buzzer with loud alarm sound can indicate that there is no dosage in pen. So blind person can get awareness about dosage without help of others. Also, patch measuring a blood glucose level of visually impaired persons (VIP’s) on every second by using sensor attached with patch. Buzzer with two beep sound can indicate to blind people about their increase/decrease in blood glucose level. Blind people can increase/decrease their dose in insulin pen based on glucose level in their body.

BRIEF DESCRIPTION OF THE INVENTION

Diabetes and high blood sugar can lead to severe or life-threatening complications such as heart disease, stroke, kidney problems, nerve damage, and vision problems. Taking medication(s), making lifestyle improvements (e.g., diet, exercise, and stopping smoking), and monitoring our blood sugar on a regular basis will all help us control our diabetes and improve our health and a suspension. Human insulin is usually injected subcutaneously several times a day, and more than one type of insulin may be needed. An insulin pen is the subject of this invention. An insulin pen is a needle-based injection system that injects insulin into the subcutaneous tissue. A reusable or disposable pen-like device with a disposable needle for injecting a desired dose of insulin into people with diabetes to regulate blood sugar levels.
Insulin Pen
It consists of a chamber or cartridge of medication, a tip to attach a needle, and a piston or plunger to inject the dose. The following components are embedded in insulin pen. 1. Needle 2. Needle Cap 3. Barrel 4. Plunger 5. Syringe. Needles are available in a variety of lengths to suit different depths of subcutaneous tissue under the surface of the skin. Pen needles are intended for single-use subcutaneous injection of medication and are not intended to be reused. The needles usually have an outer protective plastic shell that is used to bind the needle to the pen and an inner protective plastic shell that protects the needle itself. To avoid injury from accidental contact after use, pen needles should be properly disposed of after each use, preferably in a purpose-made sharps jar. Injector pens eliminate some of the drawbacks of syringes by allowing the pen to be "pushed" against the skin at a 90-degree angle and by eliminating the need for a long, thin needle. A syringe with a thin plunger and a simple button that is depressed and held to administer the dose.

Adhesive Patch

A transdermal patch is a medicated adhesive patch that is applied to the skin and used to inject a particular dose of medicine into the bloodstream through the skin. This also aids in the healing of an injured body part. This invention uses an adhesive patch for measuring glucose level of diabetes patient. It consists of glucose sensor, Buzzer, Raspberry Pi.

A glucose sensor is a device that measures a patient's blood glucose level and is a vital part of treating diabetes mellitus. Implantable glucose monitors with interface circuits have a lot of potential for continuous blood glucose measurement and tracking. persons who are inebriated about the dose left in the pen. Buzzer sound with single beep can indicate that half of the dosage left in the pen. Buzzer with loud alarm sound can indicate that there is no dosage in pen. So blind person can get awareness about dosage without help of others. Also, patch measuring a blood glucose level of visually impaired persons (VIP’s) on every second by using sensor attached with patch. Buzzer with two beep sound can indicate to blind people about their increase/decrease in blood glucose level. Blind people can increase/decrease their dose in insulin pen based on glucose level in their body. Insulin pen and patch are interconnected by Wi-Fi module of Raspberry Pi. It analyses the data which is collected from glucose sensor. Artificial intelligence algorithm will analyses the data and giving alert about dosage through buzzer connected with patch.