What it does
EpiSHOT is a single hand-operated autoinjector to deliver emergency medicine intramuscularly or subcutaneously to treat life-threatening situations like anaphylaxis with the provision for reloading and sterilization for reuse within 2 minutes of first use.
Your inspiration
The problem statement of developing an autoinjector was given to us by a pediatric pulmonologist who had spent decades trying to popularize the use of epinephrine as an emergency response. Without the immediate administration of epinephrine, those with a severe allergic reaction can go into anaphylactic shock, which can be fatal. The significant gaps have been the high price tag of single-time use injectors, safety concerns for self-use, and ease of operation. We started addressing these challenges to develop EpiSHOT, a product that can be translated into market as a safe, reusable, affordable, and easy-to-use lifesaver.
How it works
EpiSHOT is a single hand-operated autoinjector that can deliver epinephrine intramuscularly or subcutaneously to treat anaphylaxis. The device consists of a pre-filled syringe cartridge with the drug and an injection mechanism. The EpiSHOT is operated by opening the safety cap on top of the device and injecting the drug by triggering the injection button. The safety cap prevents accidental injection and can be easily opened using the holding hand's thumb finger. The button is triggered after pressing the injection end of the device on the thigh. After the injection, the pressure applied on the thigh is reduced, causing a needle retraction mechanism to pull the needle out. A rigid sheath covers the needle until reloaded again, allowing safe storage of the used device. A new syringe cartridge can be placed into the device for subsequent reuse. The discardable syringe cartridge design ensures the device's sterility during reuse within a short period.
Design process
The design of EpiSHOT has undergone several design iterations, with a few iterations made as prototypes. We identified the end-user needs before the start of the design process and prioritized different features to have on the final product. We then started with a simple reusable single hand-operated autoinjector. We went on to add a safety cap in the next iteration to prevent accidental injection. Consulting with multiple clinicians experienced in using autoinjectors, we found the necessity to incorporate an automatic needle retraction mechanism after injection. This step was challenging as the injection, once triggered, should activate different mechanisms in sequence. However, solving this challenge made the device complex to reload, especially during an emergency. The next iteration enhanced reusability while maintaining all other features. Finally, to ensure sterility of the device after first use for subsequent reuse within minutes, the syringe cartridge was redesigned to prevent exposure to bodily fluids. These use and throw cartridges can also be stored safely without contamination. The device's ergonomics were tested more than a hundred times in tissue phantoms. After fine-tuning the design, the device exhibited a reliable, safe, ergonomic, and intuitive operation.
How it is different
To the best of our knowledge, there are no reusable epinephrine autoinjectors on the market. Reusability is vital as: (i) a second dose may be required if symptoms continue or recur, and (ii) autoinjectors can remain unused for long periods and expire before use. EpiSHOT can be reused by changing the syringe cartridge within two minutes in either of the two conditions. This also means that the device is more affordable than the existing autoinjectors enabling widespread use. Safe storage of the current products involves a separate casing from which the device has to be removed and used, which adds to the complexity of use in an emergency. EpiSHOT implements three levels of safety within the device that prevent accidental injections and enhance storage without additional storage units. Sterilization and storage of the device after first use is also included in the design. Additionally, the device can be operated single-handedly, making it more ergonomic.
Future plans
The next step is to modify the design for injection molding. This step will enhance the manufacturability, reliability, and portability of EpiSHOT while reducing the cost of the device. We have already filed patents for the device. We are currently discussing with pharmaceutical companies regarding the commercialization of the product. We are also making versions for EpiSHOT, compatible with intramuscular, subcutaneous, and intradermal injections for other drug applications. We are also in process of obtaining the necessary certifications for clinical trials to enable faster commercialization.
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