SUBCUTANEOUS INJECTION HYBRID MODEL

Abstract

The invention describes the production method of a wearable Subcutaneous Injection Hybrid Model, designed and developed by the researcher considering the subcutaneous injection pads currently used in subcutaneous drug administration, for use in training based on Hybrid Simulation, also defined as "learner-centered simulation". The model includes the application area for subcutaneous injection (right and left upper arms, abdominal area, right and left upper thighs) and incorporates an electronic mechanism that signals the correct and incorrect injection site during the procedure.

Description

1 TARIFF 5 SUBCUTANEOUS INJECTION HYBRID MODEL TECHNICAL FIELD The invention was based on a real-world application setting of patients self-administering medication subcutaneously. to gain experience, acquire the necessary skills and competence without taking any risks Development of a wearable hybrid simulation tool and patient-based hybrid simulation. It is related to education. Hybrid Simulation is also known as "learner-centered simulation". It is defined as such. Wearable simulation tools are used in this type of simulation. STATE OF THE ART 15 Subcutaneous drug administration is a method of parenteral drug delivery where the drug enters the dermis and muscles. Subcutaneous drug administration involves injecting the drug into the loose connective tissue (adipose tissue) between the layers of tissue. In its application, it is used for small volumes of water-soluble drugs, in quantities ranging from 0.5 to 1 ml. This method of drug administration is applied both by nurses when administering medication to the patient. It is also used by patients for self-medication. Vaccine, heparin, 20 insulin, growth hormone, interferons, monoclonal antibodies, and in the gastrointestinal system Like other drug groups containing proteins that can be destroyed, it is suitable to administer orally. For drugs that are not easily absorbed and require slow absorption, subcutaneous administration is preferred. Subcutaneous drug administration sites include the outer lateral surface of the upper arm (deltoid), and the iliac joint below the costal line. abdominal region extending to the cristae, front and side of the thigh (upper leg) 25 (laterofemoral), under the shoulder blade (under the scapula) on the back and the back of the hip (dorsogluteal) It is ranked as the upper part of the region. Due to its ease of access, the deltoid, Laterofemoral and abdominal regions are the most frequently used sites. Self-administered subcutaneous medication. Patients who have to perform this procedure often prefer these areas. On the other hand, cachectic Because the subcutaneous tissue is very thin in patients, the most suitable subcutaneous drug administration site is 30°. It is stated that it is in the abdominal region. Most medications administered subcutaneously are developed in either pre-filled syringe or pen form. and contains a standard amount of medication. After receiving training, patients can administer the subcutaneous medication. They are able to perform the procedure independently, without assistance. This situation, reducing dependence on nurses; enabling the patient to receive care without needing to visit healthcare facilities, 35 This allows him to administer his medication where and when he needs it. the patient's control over their own health within the scope of their roles and responsibilities in daily life. Self-efficacy and autonomy are increasing; these developments reduce the psychological burden of the disease. It contributes to the reduction of illness and the improvement of quality of life. On the other hand, subcutaneous medication The fact that the procedure is performed by the patient himself brings with it some difficulties. 40 This includes incorrect medication administration, difficulty adhering to the treatment protocol, and injection problems. Fear, difficulties for patients with arthritis pain in using the injection device, these difficulties This can be given as an example. Skin conditions developing in association with faulty subcutaneous drug administration. 2 Complications include: ecchymosis, localized pain, bleeding, redness, inflammation, or hematoma. It is stated that, in addition, drug-related complications can occur as a result of incorrect subcutaneous drug administration. In addition to the occurrence of unwanted side effects, the effectiveness of the treatment may decrease and the patient's condition may deteriorate. The prognosis may worsen. Repeated and ineffective tests regarding subcutaneous drug administration skills are necessary. Patients who have not received training have limited application skills and cannot self-administer subcutaneous medication. This causes them to experience intense anxiety during the application. Therefore, the medication is 10 It is observed that they mostly resort to healthcare services to be able to get this done. Or due to application errors, post-application pain, and uncertainties regarding the treatment process They are able to discontinue treatment on their own. This allows patients to continue their daily lives. negatively impacting their activities and self-efficacy perceptions, thus reducing their quality of life. In addition to disrupting healthcare, it can also increase workload and costs in healthcare services. 15 In preventing or reducing the incidence of the complications mentioned above taking into account the patient's health status, individual and developmental characteristics, and needs Ensuring patient safety by providing training in accordance with the criteria is very important. Patient education “19 Within the scope of the "April Nursing Regulations," the duties, authorities, and responsibilities of a nurse include: It has been stated. Planning of patient and family education, patient care and treatment methods 20 informed about possible side effects and current and reliable health information Ensuring access is the nurse's responsibility. Self-administration of subcutaneous medication results in improved cognitive, affective, and psychomotor skills. It is an important process that requires its use. Therefore, these three areas should be included in patient education. A comprehensive training plan, prepared with this focus in mind, forms the basis of a successful implementation. This is achieved through properly administered subcutaneous drug administration. facilitating patients' daily living activities while strengthening their self-efficacy perceptions and improves their quality of life. At the same time, it reduces the workload in healthcare services and By reducing costs, it provides a significant advantage for both patients and healthcare professionals. Therefore, this practice, supported by effective training, increases patients' independence and 30 This is a valuable step that contributes to the sustainability of healthcare services. In the literature, teaching patients the skill of self-administering subcutaneous medication is discussed. Various educational methods are seen to be used. Among these are audiovisual methods. Oral training sessions, supported by materials and brochures, are conducted with supervised patient participation. Follow-up visits are organized to correct practices and errors. However, 35 The effectiveness of these methods is still debated. Currently, these patients... Existing subcutaneous drug administration training pads / models / tools used in training (http: / / merkim.com.tr / index.php?route=product / product&product_id=84;http: / / kekliko glu.com / simmod / hemsirelik-becerileri-egitim-modelleri / insulin-enjeksiyon-egitim pedi?lan=tr&sId=2; https: / / simulaids.co.uk / product / subcutaneous-injection-pad-with-strap / ; 40 (https: / / www.galaxymed.de / en / diabetic-injection-pad). ) usually with a single anatomical region It remains limited to certain areas (such as the abdomen or arms) and provides immediate feedback in case of incorrect applications. It is unable to provide this. However, the use of visual stimuli in acquiring psychomotor skills... And avoiding lengthy theoretical explanations is critically important. This situation affects the current education system. This appears to be a significant shortcoming of their tools. Furthermore, the simulation 45 on the market... Since most of their vehicles are imported products, they are expensive, which also affects healthcare. 3 This restricts the access of their institutions. Therefore, it should be more accessible, versatile, and provide feedback. 5 Educational models incorporating appropriate mechanisms are needed. To close this gap, domestically developed models are necessary. And developing economical solutions will both improve the quality of patient education and healthcare. This will strengthen the effectiveness of their services. On the market, there is a single wearable device that covers all subcutaneous drug delivery sites (abdomen, arms, and legs). Thanks to its modular design that combines these areas into one unit, these zones can be used separately when needed. allowing it to be used and adapting to the body shape when attached to the body. It offers a realistic experience with its conductive fabric layers and LED warning lights. through its mechanism, it provides users with instant visual feedback, thus identifying users' mistakes. No training tool has been found that enables them to instantly recognize the problem and learn the correct technique. As a result, the developed subcutaneous injection hybrid model surpasses 15 existing training tools. It is a cost-effective and innovative solution that addresses shortcomings, both in patient education and... It will play an important role in training healthcare professionals. THE PURPOSE OF THE INVENTION The aim of this invention is to address the limitations of existing pads used in subcutaneous drug administration training. By eliminating disadvantages such as lack of space and feedback, multiple injections 20 a wearable simulation model covering the region and equipped with a feedback mechanism to present. The specific purposes of the invention are listed below: 1. Multiple injection sites offered in a single unit: such as abdomen, upper arm, and upper thigh. By integrating different anatomical regions into a single wearable model, the user is given access to all 25 To provide the possibility of simultaneously observing and applying injections to the injection sites. 2. To provide an experience similar to real-life situations: The model's anatomical structure is accurate. Thanks to its wearable form, it gives the user the feeling of receiving real subcutaneous medication. by enabling psychomotor skills to be acquired more effectively. 3. Providing immediate feedback against incorrect applications: Correct and incorrect injection 30 conductive fabric layers located in these areas and true and false signals integrated into these layers through LED lights of different colors that will show the area to the user To enable the user to see and learn the results of the application instantly. 4. Enables repeated application: Risk-free, multiple and controlled applications. Thanks to this system, which can be implemented, especially for patients who self-inject, 35 to allow them to hone their techniques. 5. Reducing anxiety and user errors: Instant feedback received during application. Thanks to these notifications, subcutaneous transmission is observed in both patients and prospective healthcare professionals. Reducing anxiety about medication administration, increasing trust, and preventing incorrect medication Preventing these practices. 40 6. Improving the quality of health education: Clinical aspects for medical and nursing students. Supporting them in acquiring technical skills before entering the environment, providing feedback. through this mechanism, it increases the retention of learning and thus professional competence. to help them win. 4 7. Improving safety and compliance in healthcare services: Patients receiving subcutaneous medication 5 their acquisition of technical knowledge, skills and confidence regarding the application and their compliance with treatment and Supporting patient safety. In these respects, the meeting is important for both patient education and healthcare professional training. By providing advantages, it activates learning processes and improves the quality of education. EXPLANATION OF THE FIGURES The applications of the invention, briefly introduced above and detailed below, are presented in the appendix. This can be understood more clearly through the examples in the drawings. Figure 1: Front view of the Subcutaneous Injection Hybrid Model. Figure 2: Rear view of the Subcutaneous Injection Hybrid Model 15 Figure 3: Front view of the LED lights that signal when a subcutaneous injection is administered. Figure 4: Layers of the application sheet containing conductive fabric (for the abdomen) Figure 5: Detailed description of the application layer containing conductive fabric (for upper arm and upper leg) (The mechanism to be designed according to the measurements is the same) Explanation of references in figures 20 1: Silicone fabric 2: Adjustable belt at the back 3: Application layer containing conductive fabric 4: LED lamp that signals when subcutaneous injection is administered to the correct area. 5: Red LED light that signals when subcutaneous injection is given in the wrong area. 25 6: Conductive fabric for the wrong area 7: Conductive fabric for the correct area 8: Battery compartment that supplies the electrical current. 9: Silicone sheet with short hardness of 14-16A 10: Copper wires coated with plastic 30 11: Zipper 35 DESCRIPTION OF THE INVENTION 5 The Subcutaneous Injection Hybrid Model is designed for those receiving training in self-administering subcutaneous drugs. enabling patients to gain practice in multi-site application before administering medication to themselves It is a wearable training simulator that provides the following: The invention includes a physical structure (silicone body), three components: warning mechanism (conductive fabric and LED lamps) and application algorithm. It consists of 10 components. 1. Physical Structure (Body Structure) The invention is an adjustable belt designed to wrap around the front of the individual's upper body, with an adjustable strap at the back. It is a unit fixed to the body with (2). Body structure (1), RTV2 mold with 14–16 A Shore hardness. It is made of silicone material and is 1 mm thick. This structure neither harms the skin nor... It is also capable of being disinfected. 15 The trunk (1) will anatomically include injection sites such as the upper arm, abdomen and upper forelimb. It is designed in such a way that during training, specific areas such as the chest, upper arm, or upper front thigh are targeted. These areas can be separated from the body structure by a zipper (11) in cases where they should not be used. It is structurally sound and can be removed according to user preference. 2. Warning System (Electrical Feedback Layers) 20 Beneath the outer surface of the invention, there are subcutaneous injection sites for use in training (upper arm, The application layer (3) has a multi-layered structure located on the abdomen and upper thigh. The layer consists of the following components, in order: • Copper nickel plated conductive woven fabric layers (6,7): less than 1 ohm It is resistant. 25 • 0.5 mm thick silicone insulation layer (9): Two conductive fabric layers It allows for control of the circuit by isolating the components. • Needle-proof PVC outer surface: This is the outermost layer, the part that comes into contact with the patient's body. It prevents the needle from pricking the patient at the injection site. These layers, arranged separately for correct and incorrect injection sites, provide signaling 30 It is connected by a simple electrical circuit that has a specific feature. Placed in each region. It is powered by a small battery holder (8). The circuit is conductive via plastic insulated copper wires (10). They are attached to the fabrics. If the user inserts the needle into the selected area, conductive layers are formed. The circuit is completed between them and: • When applied to the correct area, a green (color given as an example) LED lamp (35) will be used. (4), • If applied to the wrong area, a red LED (color is given as an example) will be used. The lamp (5) lights up, giving the user instant visual feedback. LED indicators are visible to the user through a silicone structure and application layer. They are placed between them. Thus, each application can be directly verified by the user. 40 6 3. Usage Algorithm (Training Process) 5 A typical application of using the model involves the following steps: 1. The user secures the model to their body with the adjustable straps (2) at the back. If necessary, nursing assistance can be obtained for this procedure. 2. All anatomical areas suitable for injection can be observed simultaneously in the model. 3. The area to be treated is disinfected with an alcohol swab. 10 4. The area is grasped or stretched using the appropriate injection technique. 5. The pre-filled syringe or insulin pen is inserted into the designated area at the correct angle. 6. The needle passes through the silicone sheet (3) and joins the conductive fabric layers (6,7) and It completes the circuit. In this case: • Green (color is given as an example) LED 15 after injection to the correct area. The lamp (4) lights up. • The color will turn red (color is given as an example) after an injection in the wrong area. The LED lamp (5) lights up. This system both accelerates the learning process and permanently identifies erroneous practices. It ensures that learning is reinforced by enabling this process. 20 HOW THE INVENTION WAS APPLIED TO INDUSTRY This invention has implications for the healthcare field, particularly in patient education and medical and nursing training. wearable devices developed to provide skills for subcutaneous drug administration. It is a hybrid simulation model. The invention is industrially applicable with the following characteristics: 25 The model covers all essential areas where subcutaneous injections can be administered: upper right and upper left. A total of five different injections: in the arms, abdominal area, and the upper right and left thighs. It presents a structure that includes the region. Body-fitting feature: The model can be secured to the individual via adjustable straps at the back. It can be attached to the body, thus providing a realistic application environment experience. 30 Regional segregation: Undesirable areas can be excluded from use during training. Zipper systems that allow for easy release provide practicality and flexibility. Feedback mechanism: Copper nickel plated, present in all application areas. Conductive fabrics, thanks to the silicone insulation layers between them, form a simple electrical circuit. LED lighting system 35 that provides visual feedback during injection application. includes. The fact that the invention can be produced domestically at low cost and can be replicated on an industrial scale. This makes it possible and facilitates its widespread adoption. Due to its high costs... It is observed that many healthcare institutions shy away from simulation-based active learning methods. When considered in this context, the cost-effectiveness of this model overcomes this significant obstacle encountered in the field of education. 40 It has the potential to eliminate it. 7 The invention will be used in patient education as well as in universities, health vocational schools, and nursing schools. widespread in education and service fields such as faculties, medical schools and health institutions It is possible to use it. In these respects, the meeting both improves the quality of health education and enhances patient safety and It directly contributes to areas such as treatment adherence. Suitable for industrial production. Its ease of use and the fact that it is user-friendly makes it highly applicable to industry. This can be considered an innovation.

Claims

8 REQUIREMENTS 5 1. Invention; related to patients who self-administer medication subcutaneously and to medicine and nursing. Students who receive subcutaneous injection training in their education will apply it in real-world practice. to gain experience as if in the environment, the necessary skills and competence without any risk 10 It is a subcutaneous injection hybrid model that allows for the acquisition of nutrients without needing to take it; its characteristic feature is: ▪ All 5 injection sites (upper right and upper left) where subcutaneous injection will be administered (including arms, abdominal area, right and left upper thighs) ▪ Adjustable back for secure fitting to conform to body shape having belts, ▪ when necessary, areas such as the upper arm, upper body, and upper front thigh can be excluded from training. It has a zipper system that allows it to be released, 20 ▪ In each application area, sequentially from the outer surface towards the individual's body embedded; copper nickel plated conductive woven fabric, 0.5 mm thick. silicone layer, copper nickel plated conductive woven fabric and needle-proof It contains an application layer consisting of PVC layers, 25 ▪ Simple problems arise if the needle is inserted into the correct or incorrect area during the procedure. an electrical circuit that completes the circuit and has LEDs of different colors It has a visual feedback system that activates the lights. It is characterized by 30