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BIOCREATE

Microneedle Patch

Design Report

By

Lucy Ostrowski

Gabriella Vasquez

and Sebastian Orellana

Table of Contents:

List of Individual Contributions: 3

Problem Definition: ​4

Design Requirements: ​4

Conceptual Design: ​5

- Alternative Concepts

- Evaluation of Concepts

- Selection of a Concept

Detailed Design: ​8

- Main features

- Analysis, experiments, results

- Manufacturing Details

- Energy and Waste

Performance Evaluation: ​12-13

Lessons Learned: ​13-14

Gabriella Vasquez:

- Evaluation of Concepts

- Selection of a Concept

- Analysis, Experiments, Results

- Manufacturing Details

- Energy and Waste

Sebastian Orellana:

- Alternative Concepts

- Main features

Lucy Ostrowski:

- Problem Definition

- Design Requirements

- Main Features

- Performance Evaluation

- Lessons Learned
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Problem Definition:

There are many unvaccinated people in the world. Some people, especially young

children, find vaccines painful and remotely unbearable, so they refuse to receive them. Standard

vaccines cause many people anxiety and sometimes even dangerous symptoms such as fainting.

Another reason that large populations of people are unvaccinated is that they don’t have access

to the facilities or administration for vaccinations. Our goal for this project was to increase the

population of vaccinated people in the world, and we plan to do so by lessening the pain factor

and increasing the possibility of the product being used without the need for administration or

facilities.

Design Requirements:

To solve the problem previously stated, we needed to create a solution that incorporated

both a painless injection method and self-administration. We also wanted to make our design

more environmentally friendly than current methods. In order to ensure that self-administration

was an option, we needed to focus on packaging a little more than we thought. This is because

the product would be sent abroad, where facilities aren’t available. Damage could easily be done

to the product if the packaging wasn’t secure. Another way to ensure that self-administration was

possible was to include instructions. We planned to have the instructions printed in the

packaging with images and inclusiveness to all languages that the product would be sent to. In

order to ensure painless delivery, we focused on microneedle size and shape. Using microneedles

also relieves the pain factor by a great amount. In order to make the product more

environmentally safe, we focused on using recyclable materials in the packaging, and the patch

creates less waste than a generic vaccine needle.

Conceptual Design:

Alternative Concepts:

While we knew that we wanted to create a painless way of getting a vaccine, we weren't

quite sure what concepts we would use to get to that final goal. First, we considered something

similar to a nicotine patch, where the material is absorbed directly through the skin. However,

this did not work because we would have to pair the vaccine with a solution that is absorbed

through the skin, which is overcomplicated. We also considered an oral vaccine, like a vaccine

pill or syrup, but found that it had complications getting into the bloodstream through the

stomach lining.

Conceptual Drawings of Alternative Concepts:

Evaluation of Concepts:

We created three designs and conceptual sketches through a classification scheme.

Concept 1 was a ​vaccine patch with biodegradable cone-shaped microneedles, instructional

video, and cooler-type packaging. Concept 2 was ​a ​vaccine patch with cheap materials,

biodegradable microneedles, small and fitted packaging, and instructional pictures. Lastly

Concept 3 was an oral vaccination with nonprofit sponsorships, bubble wrap/packaging peanuts,

environmentally friendly manufacturing, and instructional manuals included in packaging. ​After

designing these three different and detailed concepts, we had to evaluate them in order to

properly choose the best option. We decided to evaluate them on six main functions: their

expenses, the painless delivery method, how easy it is to mass produce, its safe packaging, how

easy it is to use, and how environmentally friendly it is. We used a decision matrix to place

numerical values on how well each concept executed these functions. To find the overall value

for each concept, we first needed to create a weight value for each concept based on its

importance that added up to 1. Once we had our weight values, we created an assigned value

from 1 to 10 on how well each concept executed the function. We then multiplied the weight
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value by the assigned value for each function. Finally, we added all the values for each function

together to land on the overall value.

Selection of a Concept:

Once these values were finalized, we landed on our second concept: ​A vaccine patch

made from cheap materials, biodegradable microneedles, small and fitted packaging, and an

instructional picture pamphlet on the patch wrapper. This concept had the highest values in

affordability, accessibility, usability, mass production, and environmentally friendliness. This

design allows for profit due to cheaper materials, has biodegradable needles that are better for the

planet, instructional pictures so that a large margin of our world can self administer safely, and

small, fitted packaging that’s recyclable and safe.

Detailed Design:

Main Features:

The design has 99 by 99 dissolvable microneedles, which are filled with a vaccine and

the vaccine enters the bloodstream through tiny holes in the skin. The patch itself is adhesive so

that it’ll stick to the skin. It comes in custom packaging which fits the patch perfectly so that

none of the microneedles are bent or wasted. It also comes with instructions on how to apply the

patch in picture form so that a vast majority of clients will understand.

The microneedles are made up of hyaluronic acid, which is allergen-free and

vaccine is released into the dermis layer and can then enter the bloodstream. The patch itself

mirrors the structure of an adhesive bandage, and application is quite similar.

Designing the packaging was a whole other project in itself. The packaging needed to be

biodegradable, to allow the product to be shipped long distances, to be relatively affordable, and

to be safe. To make it safe, we designed it to have separate compartments that specifically hold

each part of the product so that it doesn't get knocked around during shipping.

Analysis, experiments, results:

In designing our product, we had to find a solution to two key components; the

dissolvability rate and functionality as well as how to stimulate the least amount of pain. These

concepts were difficult to test due to us not having proper access to materials used in biomedical

trials. Instead, we used household items that could guide us with finding the answer to our

inquiries.
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Experiment one was conducted to find the rate at which glucose microneedles dissolve in

the body. To do this, we created mock needles with melted sugar and dissolved them in 99

degree Fahrenheit water to record how long it would take to release the vaccination. We created

four different thicknesses of needle to test: ½ inch, 1 cm, ¾ cm, and ½ cm. These measurements

are taken at the base of the needle before it’s molded into a fine tip. We found that the smaller

the needle was in width rather than length, the shorter time it took to dissolve. We were also able

to estimate that the size of our microneedles would only take a few minutes to dissolve in the

skin.

Experiment two was conducted to find what type of needle tip would create the least

amount of pain. In order to figure this out, we used mock needles and styrofoam to record what

needle created the least amount of damage. We 3-D designed and printed out three different

needle shapes including two pencil shaped needles with different dimensions and a cone shaped

tip. After sticking them into the styrofoam, we found that a cone shaped tip would create

significant less damage meaning very little pain.

Manufacturing Details:

The patch itself will be constructed through a two-step manufacturing process. The first

step consists of filling silicone molds with the polymer in order to form the dissolvable

microneedles. The silicon mold will comprise the master object (a 3D printed version of the

microneedles), a baseplate, mold wall, the prepolymer and curative, and the release agent. After

24 hours of curing, the silicone molds are ready to be used. The molds will have a cavity space

of 350 nm cones in order to encapsulate the microneedles correctly (This size allows for painless

piercing of the skin with enough space for the vaccine). These molds will then be filled with the

polymer solution and the chosen vaccination in order to create the water-soluble outer-layer of
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the needles. This form of needles ensures a safe transfer into the body. After centrifugation and

drying, a baseplate of just the polymer is added on top to trap the vaccination inside the needles.

The whole product will undergo centrifugation and drying one more time before it can be

removed from the silicon mold. This concludes step one of the manufacturing process.

Step two of this process consists of the construction of the adhesive patch. This patch is

made up of multiple layers of different materials. This can be broken down into the initial layer

of structural film, a second layer of non adherent plastic film, an adhesive coating, a cavity for

the microneedles, and a covering layer. The first two layers are made of polyethylene,

polypropylene, vinyl polychloride, foamed polyurethane, non-foamed polyester or combinations

thereof and are bonded together through a covering layer. An adhesive coating of acrylic acid

and ester resin is then applied to the layers. The cavity is then created through either a hot or cold

punching process that permanently shapes the cavity. The microneedles created in step one are

then pressed into the cavity and adhered to the surface, with the sticky side of the film attaching

to the polymer baseplate. The final step is attaching a plastic, perforated film to safely cover the

adhesive side until it is ready to be used. All of these components would be made in relatively

small sizes to match the size of the microneedles. And with that, our product is manufactured.

Energy and Waste:

The energy in the manufacturing process is mechanical and thermal energy and would

come from machines mass producing these small components and putting them together

correctly. Energy would also come from human based work to make sure there are no faulty
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products. The waste would be from any faulty components, which will hopefully be minimal.

Our product already has less waste than conventional methods, and with such small parts, faulty

components won’t quickly add up. Some potentially problematic materials could be the silicon

molds (breakage or even small chips will ruin the product), incorrect procedure of creating the

water soluble microneedles (If they do not form correctly, the whole batch would need to be

discarded), and the adhesive (If the polyethylene is cured incorrectly, the layers with it applied

would also have to be discarded).

Performance Evaluation:

Due to a limit of resources, we were not able to create a physical functioning prototype.

Instead, we created detailed blueprints for our product and followed the testing and results of a

lab funding a similar design. Hypothetically, we could have followed our manufacturing process

designed in Step 3 to create a functioning prototype. We would have needed access to a safe lab

with all equipment, pure hyaluronic acid, a vaccine strain, and a test subject.

The lab report we followed was conducted at the Center for Drug Design, Development

and Delivery and the Institute for Bioengineering and Bioscience at the Georgia Institute of

Technology and was funded by the National Institutes of Health. These scientists tested the

amount of pain caused by each needle by inserting between 1 and 50 microneedles with lengths

ranging from 480 to 1450 μm, widths from 160 to 465 μm, thicknesses from 30 to 100 μm, and

tip angles from 20° to 90° into the forearms of ten healthy, human subjects in a double-blinded,

randomized study. The results from the testing are shown below, and they prove that shorter
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needles cause less pain, and needle length has the biggest impact on the pain score.

Lessons Learned:

Overall this project taught us the importance of teamwork and cooperation while working

in a group setting. We definitely learned to work through obstacles together, because the entire

group project was done virtually. This made working together really difficult, so we needed to

learn some new skills.

The first skill that we learned was organization. We organized our thoughts on sites such

as Toggl and Padlet. Toggl was a site that we made Gantt charts on each week. This really

helped us stay on track with our assignments, and also helped us to evenly distribute the

workload. On Padlet, we were able to compile our thoughts in order to decide on topics for our

project. Having all of the team members being agreeable and accommodating was definitely

valuable to the team because we were able to easily come up with and agree upon an idea. For

example, when coming up with our team logo we compiled all of our ideas and had a good
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discussion in which everyone participated in order to choose a design. Most steps in this project

went like this, and it allowed everything to go quite smoothly.

Another skill that we learned was communication. We needed to communicate with each

other, our teacher, and our mentor during this project. We communicated with each other by

setting up group chats and Gantt charts. We used the gantt charts to split up assignments and we

used texting to communicate with each other outside of class hours. We also learned to

communicate with a mentor that has a lot of knowledge in the field of study we were working

on. Our mentor’s name is Anthony Campoy, and he is a UC Irvine Biomedical Engineer. We set

up zoom meetings with him to go over project ideas, and shared documents with him for him to

add comments to. Finally, we learned communication skills by contacting our teacher. With

online learning, getting assignments right on the first try was quite difficult because we were

mainly on our own through the process of completing them. Upon turning them in, Mr. Tronconi

often gave us notes and suggestions to push our assignments to the next level, allowing us to

have the best version of our project possible.