DEVICES FOR SUBCUTANEOUS INJECTION OF FLOWABLE DRUG FORMULATIONS

Abstract

ABSTRACT Devices for Subcutaneous Injection of Flowable Drug Formulations The present disclosure introduces a device for subcutaneous injection of flowable drug formulations 100 designed to enhance precision, safety, and patient comfort. The device features housing 102 for durable protection and ergonomic handling, with a drug reservoir 104 to store and maintain the sterility of formulations. It incorporates a delivery mechanism 106 for consistent injection, paired with a microneedle array or needle cartridge 108 for painless administration. The control panel 110 enables real-time customization of injection parameters, while connectivity module 112 ensures seamless data sharing and remote monitoring. Additional components are automatic locking mechanism 114 for post-injection safety, drug compatibility sensors 116 to monitor formulation stability, temperature control system 126 to preserve heat-sensitive drugs, adaptive learning algorithm 132 to optimize settings dynamically, injection site rotation mechanism 134 to prevent tissue damage, and biometric sensors 136 for user safety. These features collectively ensure efficient and user-friendly drug administration. Reference Fig 1

Specification

Description:Devices for Subcutaneous Injection of Flowable Drug Formulations
TECHNICAL FIELD
[0001] The present innovation relates to medical devices for the subcutaneous delivery of flowable drug formulations, enhancing precision, safety, and patient comfort.

BACKGROUND

[0002] The subcutaneous delivery of flowable drug formulations is a critical method for administering therapeutics such as biologics, monoclonal antibodies, and other sensitive medications. Despite its advantages in enabling gradual absorption and sustained therapeutic effects, traditional methods like syringes and autoinjectors present significant challenges. These conventional options often require manual dexterity, leading to dosing variability and potential user errors. Additionally, the discomfort and anxiety associated with needle insertion, along with the risk of needlestick injuries, deter many patients from adhering to prescribed treatments. For biologics and complex formulations, issues such as sensitivity to temperature and shear stress further complicate their administration, demanding precise handling and delivery parameters.

[0003] Existing solutions, including basic syringes and autoinjectors, often fail to address patient-centric concerns such as ease of use, safety, and compatibility with sensitive formulations. Autoinjectors provide some automation but are typically bulky, lack customization, and do not offer real-time feedback or smart connectivity. These limitations make them suboptimal for modern healthcare needs, especially for patients managing chronic conditions that require frequent and precise medication delivery.

[0004] The invention introduces a novel subcutaneous injection device designed to overcome these drawbacks through innovative features. It incorporates microneedle technology for painless delivery, a programmable control panel for customizable injection parameters, and connectivity options like Bluetooth and Wi-Fi for real-time monitoring and dosage tracking. The device ensures compatibility with sensitive drug formulations using integrated sensors and maintains sterility through advanced materials and design. Features such as automatic locking, adaptive injection systems, and emergency override capabilities enhance safety and usability.

[0005] The novelty of the invention lies in its patient-centric design and advanced technologies, which improve comfort, precision, and adherence while addressing the limitations of traditional devices. This innovation transforms subcutaneous drug delivery, making it safer, more efficient, and better suited for modern therapeutic applications.

OBJECTS OF THE INVENTION

[0006] The primary object of the invention is to provide a device for subcutaneous injection that enhances precision and safety in the delivery of flowable drug formulations.

[0007] Another object of the invention is to improve patient comfort by incorporating microneedle technology, which minimizes pain and reduces anxiety associated with traditional needles.

[0008] Another object of the invention is to enable customizable injection parameters, allowing users to adjust dosage and delivery speed for personalized treatment regimens.

[0009] Another object of the invention is to enhance medication adherence through smart connectivity features such as Bluetooth and Wi-Fi, enabling real-time monitoring and dosage tracking.

[00010] Another object of the invention is to ensure compatibility with sensitive drug formulations by integrating sensors that monitor drug stability and environmental conditions.

[00011] Another object of the invention is to reduce the risk of needlestick injuries and accidental reactivation with safety features such as an automatic locking mechanism and needle retraction system.

[00012] Another object of the invention is to promote patient independence and ease of use with an intuitive control panel and visual instructions for device operation.

[00013] Another object of the invention is to support chronic disease management by providing a reliable and user-friendly solution for frequent subcutaneous injections.

[00014] Another object of the invention is to align with sustainable practices by offering a modular design with reusable components and environmentally friendly materials.

[00015] Another object of the invention is to overcome the limitations of traditional syringes and autoinjectors by integrating advanced technologies that prioritize patient-centric care and efficiency.

SUMMARY OF THE INVENTION

[00016] In accordance with the different aspects of the present invention, devices for subcutaneous injection of flowable drug formulations is presented. The invention relates to an advanced device for subcutaneous injection of flowable drug formulations, offering precision, safety, and enhanced patient comfort. It features microneedle technology for painless delivery, smart connectivity for real-time monitoring, and customizable injection parameters for personalized treatment. The device ensures compatibility with sensitive formulations through integrated sensors and promotes ease of use with an ergonomic design and intuitive controls. Safety is enhanced with features like automatic locking and needle retraction, reducing the risk of needlestick injuries. This innovation addresses the limitations of traditional methods, improving medication adherence and therapeutic outcomes.

[00017] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiments constructed in conjunction with the appended claims that follow.

[00018] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the appended claims.

BRIEF DESCRIPTION OF DRAWINGS
[00019] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.

[00020] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:

[00021] FIG. 1 is component wise drawing for devices for subcutaneous injection of flowable drug formulations.

[00022] FIG 2 is working methodology of devices for subcutaneous injection of flowable drug formulations.

DETAILED DESCRIPTION

[00023] The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognise that other embodiments for carrying out or practising the present disclosure are also possible.

[00024] The description set forth below in connection with the appended drawings is intended as a description of certain embodiments of devices for subcutaneous injection of flowable drug formulations and is not intended to represent the only forms that may be developed or utilised. The description sets forth the various structures and/or functions in connection with the illustrated embodiments; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimised to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

[00025] While the disclosure is susceptible to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the drawings and will be described in detail below. It should be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

[00026] The terms "comprises", "comprising", "include(s)", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a setup, or system that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or system. In other words, one or more elements in a system or apparatus preceded by "comprises... a" does not, without more constraints, preclude the existence of other elements or additional elements in the system or apparatus.

[00027] In the following detailed description of the embodiments of the disclosure, reference is made to the accompanying drawings and which are shown by way of illustration-specific embodiments in which the disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure, and it is to be understood that other embodiments may be utilized and that changes may be made without departing from the scope of the present disclosure. The following description is, therefore, not to be taken in a limiting sense.

[00028] The present disclosure will be described herein below with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail since they would obscure the description with unnecessary detail.

[00029] Referring to Fig. 1, devices for subcutaneous injection of flowable drug formulations 100 is disclosed in accordance with one embodiment of the present invention. It comprises of housing 102, drug reservoir 104, delivery mechanism 106, microneedle array or needle cartridge 108, control panel 110, connectivity module 112, automatic locking mechanism 114, drug compatibility sensors 116, safety features 118, integrated feedback mechanism 120, injection depth and parameter customization system 122, power supply 124, temperature control system 126, emergency override system 128, data logging and remote sharing 130, adaptive learning algorithm 132, injection site rotation mechanism 134, biometric sensors 136, medication database integration 138, visual instruction system 140, disposable and reusable components 142, multi-drug capability 144, user authentication system 146, real-time injection history tracking 148, environmental monitoring sensors 150, emergency override and manual operation option 152, painless microneedle technology 154, integrated smart alerts and reminders 156.

[00030] Referring to Fig. 1, the present disclosure provides details of a device for subcutaneous injection of flowable drug formulations 100. It is designed to enhance the precision, safety, and comfort of delivering therapeutic agents using advanced technologies such as microneedle arrays and smart connectivity. The device ensures compatibility with sensitive formulations, minimizes pain, and improves user adherence. In one embodiment, the device for subcutaneous injection of flowable drug formulations 100 may be provided with the following key components such as drug reservoir 104, delivery mechanism 106, and control panel 110, facilitating precise and customizable injection. The system incorporates connectivity module 112 and adaptive learning algorithm 132 to enhance real-time monitoring and personalized usage. It also features biometric sensors 136 for patient safety and environmental monitoring sensors 150 to ensure drug stability. Additional components such as injection site rotation mechanism 134 and multi-drug capability 144 further improve usability and functionality.

[00031] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with housing 102, which forms the outer shell of the device, ensuring durability and safety during usage. The housing 102 is designed from biocompatible materials, offering a lightweight and ergonomic structure for comfortable handling. It securely encases other components such as drug reservoir 104 and delivery mechanism 106, protecting them from external contamination. The housing 102 incorporates provisions for easy access to the control panel 110, facilitating seamless operation. Additionally, it works in conjunction with safety features 118 to prevent accidental exposure or damage to internal components.

[00032] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with drug reservoir 104, which serves as the storage unit for flowable drug formulations. The reservoir 104 is constructed to maintain sterility and accommodate varying dosage requirements, ensuring compatibility with multiple formulations. It comprises a transparent monitoring window, allowing users to visually check the remaining volume and refill as needed. The reservoir 104 is directly connected to the delivery mechanism 106, ensuring precise drug transfer during operation. It also interacts with drug compatibility sensors 116 to monitor formulation stability.

[00033] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with delivery mechanism 106, which facilitates the controlled injection of drugs into subcutaneous tissue. This mechanism uses either a spring-loaded or electrically powered actuator for consistent drug delivery. The delivery mechanism 106 is linked to the microneedle array or needle cartridge 108 to ensure precise and painless injections. It works closely with the control panel 110 for dosage customization and injection speed adjustments. The integration of automatic locking mechanism 114 ensures safe operation and prevents accidental reuse.

[00034] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with microneedle array or needle cartridge 108, which serves as the primary interface for drug administration. The microneedle array 108 penetrates the upper skin layers, enabling painless and efficient drug delivery while avoiding deeper nerve endings. Alternatively, interchangeable needle cartridges 108 can be used for varying patient needs. This component integrates seamlessly with the delivery mechanism 106 for precise drug dispensation. The microneedle array 108 also benefits from the feedback mechanism 120, which provides real-time updates during injection.

[00035] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with control panel 110, which serves as the user interface for managing device operations. The control panel 110 displays clear instructions, dosage settings, and real-time feedback during injections. Users can customize parameters such as injection depth and speed using this panel. It communicates with connectivity module 112 to sync data with mobile applications or electronic health records. The control panel 110 also facilitates integration with adaptive learning algorithm 132, allowing dynamic adjustments based on usage patterns and patient feedback.

[00036] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with connectivity module 112, which enables the device to integrate with mobile applications, electronic health records, and other digital platforms. The connectivity module 112 facilitates Bluetooth and Wi-Fi communication, allowing real-time data sharing and remote monitoring. It interacts with the control panel 110 to provide users with reminders and alerts about injection schedules. The connectivity module 112 also synchronizes data with the adaptive learning algorithm 132, ensuring continuous improvement of the injection process based on historical usage.

[00037] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with automatic locking mechanism 114, which ensures safe usage by preventing accidental activation or reactivation after injection. The mechanism 114 engages immediately upon completion of the injection process, locking the delivery mechanism 106 and microneedle array 108 securely. It works in tandem with safety features 118 to minimize the risk of needlestick injuries. The automatic locking mechanism 114 also integrates with the emergency override system 128 to allow manual reset by authorized personnel when necessary.

[00038] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with drug compatibility sensors 116, which monitor the stability and integrity of the drug formulation within the device. These sensors detect environmental changes such as temperature or humidity that could affect the drug's efficacy. The drug compatibility sensors 116 are directly connected to the drug reservoir 104, providing real-time updates to the control panel 110. They also interact with environmental monitoring sensors 150 to ensure that storage and injection conditions remain within acceptable ranges.

[00039] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with safety features 118, which incorporates protective caps, sterility-maintaining materials, and safeguards against contamination. These features shield the microneedle array or needle cartridge 108 before and after use, ensuring hygienic operation. Safety features 118 work closely with the housing 102 and automatic locking mechanism 114 to protect both users and internal components. They also support the emergency override system 128, allowing safe device access during critical scenarios.

[00040] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with integrated feedback mechanism 120, which provides real-time visual and auditory signals during the injection process. This mechanism guides users by indicating the start, progress, and completion of injections. The feedback mechanism 120 is connected to the control panel 110, enhancing user confidence and ensuring accurate dosage delivery. It also works with the connectivity module 112 to relay feedback data to mobile applications for further analysis and tracking

[00041] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with injection depth and parameter customization system 122, which allows users to tailor injection settings according to their preferences and medical requirements. This system integrates with the control panel 110, enabling adjustments to injection depth, speed, and volume. It interacts with the delivery mechanism 106 and microneedle array 108 to ensure precise drug delivery. The system also benefits from the adaptive learning algorithm 132, which optimizes settings based on historical usage patterns.

[00042] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with power supply 124, which powers all electronic components, including the control panel 110, connectivity module 112, and delivery mechanism 106. The power supply 124 is designed to be rechargeable or replaceable, ensuring consistent device operation. It integrates with environmental monitoring sensors 150 to maintain efficiency under various conditions and supports the emergency override system 128 during manual interventions.

[00043] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with temperature control system 126, which maintains the optimal temperature for heat-sensitive drug formulations. The system ensures that biologics and other sensitive formulations remain stable throughout storage and administration. The temperature control system 126 interacts with the drug reservoir 104 and drug compatibility sensors 116 to monitor and regulate conditions. It also provides alerts via the control panel 110 if temperatures deviate from acceptable ranges.

[00044] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with emergency override system 128, which allows healthcare providers to manually control the device during critical situations. The system temporarily bypasses automated features, enabling adjustments to the delivery mechanism 106 and injection parameters. The emergency override system 128 works alongside the automatic locking mechanism 114 to ensure safety during manual operations. It is also linked to the power supply 124, ensuring functionality even in low-power scenarios.

[00045] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with data logging and remote sharing 130, which records comprehensive injection history, including dosage, time, and location. This component interacts with the connectivity module 112, enabling secure sharing of injection data with healthcare providers. Data logging and remote sharing 130 integrates with the adaptive learning algorithm 132 to analyze historical data for improving injection precision and adherence. It also supports real-time monitoring through mobile applications linked to the control panel 110.

[00046] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with adaptive learning algorithm 132, which analyzes usage patterns and patient feedback to optimize device settings over time. The algorithm dynamically adjusts parameters for the injection depth and delivery mechanism 106 based on past performance. It works closely with the control panel 110 and connectivity module 112 to deliver personalized treatment experiences. The adaptive learning algorithm 132 also facilitates predictive maintenance alerts, ensuring uninterrupted device functionality.

[00047] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with injection site rotation mechanism 134, which tracks previous injection sites and suggests or automatically rotates to new locations. This feature reduces the risk of tissue damage and enhances patient comfort over time. The injection site rotation mechanism 134 integrates with the control panel 110 and connectivity module 112 to provide visual guidance. It also utilizes data from data logging and remote sharing 130 for accurate site tracking.

[00048] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with biometric sensors 136, which monitor user physiological parameters such as heart rate and skin temperature during injections. These sensors ensure patient safety by detecting potential adverse reactions. The biometric sensors 136 work in conjunction with the feedback mechanism 120 to alert users in case of abnormalities. They also interact with the control panel 110, providing real-time updates for better user confidence.

[00049] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with medication database integration 138, which offers users access to a repository of drug information, including recommended injection techniques and side effects. This feature is accessible via the connectivity module 112 and control panel 110, aiding informed decision-making. Medication database integration 138 also supports healthcare providers by offering detailed insights into patient-specific treatment plans.

[00050] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with visual instruction system 140, which displays tutorials and step-by-step guidance for device operation. This system is especially useful for patients new to self-injection, offering instructions through the control panel 110. The visual instruction system 140 integrates with the feedback mechanism 120 to ensure smooth operation and minimize user errors. It also links to data logging and remote sharing 130 for tracking user interactions.

[00051] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with disposable and reusable components 142, promoting sustainability while maintaining safety and sterility. These modular components include replaceable microneedle arrays 108 and protective caps. The disposable and reusable components 142 work seamlessly with the housing 102 and safety features 118, ensuring ease of maintenance and operation.

[00052] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with multi-drug capability 144, which allows the device to administer multiple formulations simultaneously. The feature is especially beneficial for patients requiring combination therapies. Multi-drug capability 144 integrates with the drug reservoir 104 and delivery mechanism 106 to ensure accurate and independent delivery of each drug. It also interacts with the data logging and remote sharing 130 for tracking multiple drug administrations.

[00053] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with user authentication system 146, which restricts device access to authorized users, ensuring security and preventing misuse. The system utilizes biometric sensors 136 or passcodes to verify the user's identity. The user authentication system 146 works with the control panel 110 and connectivity module 112 to facilitate secure access. It also provides activity logs via data logging and remote sharing 130.

[00054] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with real-time injection history tracking 148, which records and displays injection details, including dosage, time, and location. This component integrates with data logging and remote sharing 130 for seamless access by healthcare providers. Real-time injection history tracking 148 also interacts with the injection site rotation mechanism 134 to optimize site selection and ensure patient safety.

[00055] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with environmental monitoring sensors 150, which measure ambient conditions such as temperature and humidity around the device. These sensors ensure drug stability and generate alerts via the control panel 110 if conditions deviate from safe ranges. Environmental monitoring sensors 150 work closely with drug compatibility sensors 116 and temperature control system 126 to maintain formulation integrity.

[00056] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with emergency override and manual operation option 152, which allows healthcare providers to bypass automated settings during emergencies. This component facilitates manual control of the delivery mechanism 106 and injection parameters. The emergency override system 152 integrates with the power supply 124 and safety features 118 to ensure secure operation.

[00057] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with painless microneedle technology 154, which targets superficial skin layers, ensuring painless drug delivery while maintaining efficiency. This component integrates with the delivery mechanism 106 and adaptive learning algorithm 132 to optimize injection settings. Painless microneedle technology 154 also benefits from feedback provided by the integrated feedback mechanism 120 during injections.

[00058] Referring to Fig. 1, device for subcutaneous injection of flowable drug formulations 100 is provided with integrated smart alerts and reminders 156, which notify users of upcoming injections and provide adherence guidance. These alerts are communicated via the control panel 110 and connectivity module 112 to mobile applications. Integrated smart alerts and reminders 156 also work with data logging and remote sharing 130 to track user compliance and injection history.

[00059] Referring to Fig 2, there is illustrated method 200 for device for subcutaneous injection of flowable drug formulations 100. The method comprises:
At step 202, method 200 includes the user preparing the injection site by cleaning the skin with an antiseptic wipe to ensure sterility;
At step 204, method 200 includes the user selecting the appropriate dosage, injection depth, and speed using the control panel 110, which displays real-time feedback and instructions;
At step 206, method 200 includes the user ensuring the device housing 102 is securely positioned against the skin, aligning the microneedle array or needle cartridge 108 with the injection site;
At step 208, method 200 includes the drug compatibility sensors 116 verifying the stability of the drug formulation stored in the drug reservoir 104 before injection to ensure it is suitable for use;
At step 210, method 200 includes the delivery mechanism 106 activating to inject the drug formulation from the drug reservoir 104 into the subcutaneous tissue with consistent pressure;
At step 212, method 200 includes the temperature control system 126 maintaining optimal conditions for heat-sensitive formulations during the injection process;
At step 214, method 200 includes the integrated feedback mechanism 120 providing visual and auditory signals to indicate the start, progress, and completion of the injection;
At step 216, method 200 includes the automatic locking mechanism 114 engaging immediately after injection to secure the microneedle array or needle cartridge 108 and prevent accidental reuse or injury;
At step 218, method 200 includes the environmental monitoring sensors 150 ensuring external conditions like humidity and temperature remain within safe limits for the drug formulation during the operation;
At step 220, method 200 includes the injection site rotation mechanism 134 tracking the current injection site and suggesting or automatically identifying the next site to reduce tissue damage;
At step 222, method 200 includes the connectivity module 112 transmitting injection data, including dosage and time, to the data logging and remote sharing system 130, which stores it securely;
At step 224, method 200 includes the adaptive learning algorithm 132 analyzing historical injection data and patient feedback to adjust future settings, such as depth, speed, and dosage, for improved user experience;
At step 226, method 200 includes the biometric sensors 136 monitoring user physiological parameters, such as heart rate and skin temperature, during the injection to ensure safety and alerting the user via the control panel 110 if abnormalities are detected;
At step 228, method 200 includes integrated smart alerts and reminders 156 notifying the user of upcoming injections, missed doses, or device maintenance requirements through the connectivity module 112 and control panel 110;
At step 230, method 200 includes the medication database integration 138 providing the user with detailed information about the drug being administered, such as its usage instructions and potential side effects, through the control panel 110 or connected applications;
At step 232, method 200 includes the visual instruction system 140 displaying step-by-step guidance for device setup and injection, ensuring proper use, especially for new users;
At step 234, method 200 includes the power supply 124 ensuring all electronic components, including the control panel 110, connectivity module 112, and delivery mechanism 106, function reliably during the entire process;
At step 236, method 200 includes the disposable and reusable components 142 being safely replaced or sterilized after injection to maintain device hygiene and sustainability;
At step 238, method 200 includes the multi-drug capability 144 enabling simultaneous administration of different formulations from the drug reservoir 104, particularly useful for combination therapies.

[00060] In the description of the present invention, it is also to be noted that, unless otherwise explicitly specified or limited, the terms "fixed" "attached" "disposed," "mounted," and "connected" are to be construed broadly, and may for example be fixedly connected, detachably connected, or integrally connected, either mechanically or electrically. They may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

[00061] Modifications to embodiments of the present disclosure described in the foregoing are possible without departing from the scope of the present disclosure as defined by the accompanying claims. Expressions such as "including", "comprising", "incorporating", "have", "is" used to describe and claim the present disclosure are intended to be construed in a non- exclusive manner, namely allowing for items, components or elements not explicitly described also to be present. Reference to the singular is also to be construed to relate to the plural where appropriate.

[00062] Although embodiments have been described with reference to a number of illustrative embodiments thereof, it should be understood that numerous other modifications and embodiments can be devised by those skilled in the art that will fall within the spirit and scope of the principles of this disclosure. More particularly, various variations and modifications are possible in the component parts and/or arrangements of the subject combination arrangement within the scope of the present disclosure, the drawings and the appended claims. In addition to variations and modifications in the component parts and/or arrangements, alternative uses will also be apparent to those skilled in the art.

, Claims:WE CLAIM:
1. A device for subcutaneous injection of flowable drug formulations 100 comprising of
housing 102 to provide the main structure for holding and protecting the internal components;
drug reservoir 104 to store the flowable drug formulation while maintaining sterility;
delivery mechanism 106 to enable precise and consistent injection of the drug;
microneedle array or needle cartridge 108 to ensure painless and efficient drug delivery;
control panel 110 to allow users to customize injection settings and view feedback;
connectivity module 112 to enable data sharing and integration with mobile applications and health records;
automatic locking mechanism 114 to prevent accidental reuse or activation after injection;
drug compatibility sensors 116 to monitor the stability and suitability of the drug formulation;
safety features 118 to ensure sterility and protect the device and user during operation;
integrated feedback mechanism 120 to provide real-time visual and auditory signals during injection;
injection depth and parameter customization system 122 to adjust depth, speed, and dosage for personalized treatment;
power supply 124 to provide reliable energy to all electronic components;
temperature control system 126 to maintain optimal conditions for heat-sensitive drug formulations;
emergency override system 128 to enable manual control during critical scenarios;
data logging and remote sharing 130 to securely store and transmit injection data to healthcare providers;
adaptive learning algorithm 132 to optimize injection settings based on past usage and patient feedback;
injection site rotation mechanism 134 to track and suggest new injection sites to prevent tissue damage;
biometric sensors 136 to monitor user physiological parameters for enhanced safety;
medication database integration 138 to provide information about the drug and its administration;
visual instruction system 140 to guide users through the setup and injection process;
disposable and reusable components 142 to promote hygiene and sustainability in device usage;
multi-drug capability 144 to allow the simultaneous administration of different formulations;
user authentication system 146 to ensure that only authorized individuals operate the device;
real-time injection history tracking 148 to log detailed records of dosage, time, and injection sites;
environmental monitoring sensors 150 to track conditions like temperature and humidity for drug safety;
painless microneedle technology 154 to deliver drugs with minimal discomfort;
integrated smart alerts and reminders 156 to notify users of upcoming injections and missed doses.

2. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein microneedle array 108 is configured to deliver drugs with minimal pain by targeting superficial skin layers, ensuring efficient absorption while avoiding deeper nerve endings.

3. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein delivery mechanism 106 is configured to provide precise and consistent injection of drug formulations, integrating automated pressure control to adapt to varying viscosities of the formulations.

4. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein control panel 110 is configured to allow real-time customization of injection parameters, including dosage, depth, and speed, while displaying feedback and alerts for enhanced user confidence and safety.
5. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein connectivity module 112 is configured to transmit injection data to mobile applications and health records, enabling real-time tracking, remote monitoring, and adherence to prescribed schedules.

6. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein drug compatibility sensors 116 are configured to monitor the stability and suitability of formulations within the reservoir, providing alerts for temperature or chemical deviations that could compromise drug efficacy.

7. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein adaptive learning algorithm 132 is configured to analyze injection history and user feedback, dynamically optimizing future injection settings to enhance precision and patient comfort.

8. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein injection site rotation mechanism 134 is configured to track and suggest new injection sites, reducing the risk of tissue damage and ensuring effective subcutaneous delivery over time.

9. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein temperature control system 126 is configured to maintain the optimal conditions for heat-sensitive drug formulations, ensuring their stability and efficacy throughout the injection process.

10. The device for subcutaneous injection of flowable drug formulations 100 as claimed in claim 1, wherein method comprises of
preparing the injection site by cleaning the skin with an antiseptic wipe to ensure sterility;
selecting the appropriate dosage, injection depth, and speed using the control panel 110, which displays real-time feedback and instructions;
ensuring the device housing 102 is securely positioned against the skin, aligning the microneedle array or needle cartridge 108 with the injection site;
drug compatibility sensors 116 verifying the stability of the drug formulation stored in the drug reservoir 104 before injection to ensure it is suitable for use;
delivery mechanism 106 activating to inject the drug formulation from the drug reservoir 104 into the subcutaneous tissue with consistent pressure;
temperature control system 126 maintaining optimal conditions for heat-sensitive formulations during the injection process;
integrated feedback mechanism 120 providing visual and auditory signals to indicate the start, progress, and completion of the injection;
automatic locking mechanism 114 engaging immediately after injection to secure the microneedle array or needle cartridge 108 and prevent accidental reuse or injury;
environmental monitoring sensors 150 ensuring external conditions like humidity and temperature remain within safe limits for the drug formulation during the operation;
injection site rotation mechanism 134 tracking the current injection site and suggesting or automatically identifying the next site to reduce tissue damage;
connectivity module 112 transmitting injection data, including dosage and time, to the data logging and remote sharing system 130, which stores it securely;
adaptive learning algorithm 132 analyzing historical injection data and patient feedback to adjust future settings, such as depth, speed, and dosage, for improved user experience;
biometric sensors 136 monitoring user physiological parameters, such as heart rate and skin temperature, during the injection to ensure safety and alerting the user via the control panel 110 if abnormalities are detected;
integrated smart alerts and reminders 156 notifying the user of upcoming injections, missed doses, or device maintenance requirements through the connectivity module 112 and control panel 110;
medication database integration 138 providing the user with detailed information about the drug being administered, such as its usage instructions and potential side effects, through the control panel 110 or connected applications;
visual instruction system 140 displaying step-by-step guidance for device setup and injection, ensuring proper use, especially for new users;
power supply 124 ensuring all electronic components, including the control panel 110, connectivity module 112, and delivery mechanism 106, function reliably during the entire process;
disposable and reusable components 142 being safely replaced or sterilized after injection to maintain device hygiene and sustainability;
multi-drug capability 144 enabling simultaneous administration of different formulations from the drug reservoir 104, particularly useful for combination therapies.

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