M.I.F.A.R

The MIFAR is a surgical tool designed to assist surgeons in accessing the fascia of the abdominal cavity for post procedure suturing. MIFAR stands for Minimally Invasive Fascia Access Retractor.

Talking to Surgeons

Communicating directly with surgeons was critical for the validity of this project. Through interviews, conversations, and first hand observation I was able to gain valuable insights and apply them towards the solution.

Identifying the Issues

The first doctor I spoke with on this project was Dr. Barbara Frazier, an OBGYN from Florence, Alabama, and also my mother. The main topic she wanted to discuss was laparoscopic surgery and the procedures surrounding it. The main issue she expressed was the need for adequate visibility of the inner fascia during post-procedure abdominal closure.

“Laparoscopic suturing is a tedious and time consuming process. This process is becoming increasingly difficult as more and more of the patients I work with are obese. Inadequate visualization increases the risk of sub-optimal fascial closure, therefore increasing the risk of wound complications and reoperation."

Laparoscopic Surgery

Laparoscopic surgery is a type of minimally invasive procedure where, instead of making a single large incision into the abdomen, multiple 1-3 cm incisions are made. Long thin tools and cameras are fed through these incisions to work in the abdomen. The goal of this type of procedure is to minimize trauma and reduce recovery time compared to traditional incisions.

The abdominal wall is made of four distinct layers that must each be sutured individually after an incision is made.

For a normal sized patient the fascia is easily accessible.

For obese patients accessing and visualizing the fascia is much more difficult.

Safety is Essential

The reason that adequate visualization of the fascia is so important is that if the surgeon can't repair the sight correctly the patient is at risk for a number of issues.

Hernia - If the fascia isn't able to heal fully the patient is at risk for hernia. A hernia is when the fascia breaks down and the internal organs of the abdomen press into the subcutaneous fat layer.
Organ Trauma - Having to work in an area with poor visibility close to vulnerable organs is a recipe for disaster.
Wound Complications -Things like infection and extra scarring can occur if the sight is not able to fully heal.
Reoperation - If the sight isn't properly sutured and healed a second operation is often necessary.

Seeing is Believing

I observed Dr. Joseph Walker performing an incisional hernia repair on an elderly woman. As he worked he talked about his ideas and he pointed out the shortcomings with current tools and processes. It was an excellent experience to be able to observe and ask questions during a surgery.

One of the main takeaways from this experience was the constant back and forth between the surgeon and the assistants to keep the fat pulled away to maintain visualization.

Broadening The Scope

After my experiences with Dr. Frazier and Dr. Walker I began thinking about how a surgical tool fits into the greater context of a hospital. In order to justify the designing and manufacture of a new tool it needed to not only make work easier for the surgeons, but to give the hospital a reason to buy it.

Time is Money

In hospitals the phrase time is money is quite literal. On average it costs $62 a minute to run an operating room. The process of post-procedure suturing can add a large and unpredictable amount of time to a surgery.

I decided to focus on lessening the amount of time that a surgeon must spend having a complex speaking back and forth with their assistants by creating a more self contained soluiton.

Existing Solutions

In broad terms most of the current solutions are too expensive, not reusable, too narrow in their application, or not practical and reliable.

A Familiar Face

I knew that designing a new tool medical meant overcoming stringent user testing and came with serious semantic challenges. I looked to the design of the Gelpi retractor, a timeless tool known to surgeons all over the world. I took direct inspiration from its ratcheting system and form language.

Solution

Goals

Cost Effective

Many single-use tools can cost hundreds of dollars. If the solution is reusable then the higher cost can be justified.

Cleanable & Reusable

To be reusable a surgical tool must be fully autoclavable, meaning it must withstand high pressure and heat to be cleaned.

Simple & Familiar

The main point is to make access to the fascia easier for the surgeon, and in turn reduce the time taken for suturing. The form and function should be familiar and intuitive to the surgeon using it.

Form and Mechanical Exploration

When ideating on the appearance and function of the tool I looked into many possible ways to grab and spread the incision while not being obtrusive to the surgeon. All the while I tried to keep in mind simplicity of motion and ease of use by adding touch points and large mechanical features.

Communicating and Refining

Futher meetings with Dr. Frazier allowed me to further refine my concept. This was done by changing to a fully stainless steel construction with two main components and making the hooks more rigid. The stainless steel allows for the tool to be cleaned dozens of times without degrading.

Physical Prototyping

Iterative physical prototyping let me get feedback on the form and feel of the tool when I met with Dr. Frazier. During the meeting she and I worked together on how the ratchet would function and be constructed.