A Novel Approach to Successful Enteroatmospheric Fistula Isolation

Materials Science and Engineering Senior Project

Kenza Coubrough

Peer collaborators: Brennan Enright2, Brianna Goodwin3, Nhu Nguyen4

Biochemistry2, Mechanical Engineering3, Chemical Engineering4

Clinical Mentors
Nancy Unger N.P , JoAnn D Whitney PhD2, Sam Arbabi MD3
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1
Unger@uw.edu, 2joiewhit@uw.edu,3 sarbabi@uw.edu

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Contents

1. Need Analysis
1.1 The Need
1.2 Existing Solutions
1.3 Current Materials
1.4 Need Statement
2. Engineering Design Constraints
2.1 Stakeholders
2.2 Core Functions
2.3 Additional Materials Considerations
2.4 Testing to Fulfill Core Functions
3. Design and Prototyping
3.1 Design Process
3.2 Prototype Evolution
3.3 Final Design
3.4 Materials: Prototype vs. Finished Product
3.5 Construction Process
3.6 Engineering Drawings
4. Engineering Analyses and Prototype Testing
4.1 Modeling Enteroatmospheric Fistula
4.2 Testing
4.2.1 Leak Test
4.2.2 Instron Pull-out Test
4.2.3 Bead Size Analysis
4.3 Results
4.4 Next Steps
5. Intellectual Property
5.1 Related Existing Patents
5.2 Intellectual Property
6. Market
6.1 Market Analyses and Business Opportunity
6.2 Value Proposition
6.3 Lean Canvas
7. Regulatory and reimbursement
7.1 Regulation and FDA Approval
7.2 Reimbursement and Related Financial Regulation
8. References

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1. Need Analysis
1.1 The need
An enteroatmospheric fistula (EAF) is a communication between the gastrointestinal tract
that and an unhealed wound and thus the open air. This is a surgical nightmare in abdominal
surgery and occurs most often in damage control laparotomy. They almost never close
spontaneously and have a mortality rate of over 40% [1]. EAF formation is a dreaded
complication of damage control surgery, with its incidence ranging from 5-19% of damage
control surgery patients who survive long enough to develop complications. It is estimated that
between 1,0000 and 4,000 occur each year within the United States [2]. EAFs typically develop
as a result from a cut made too close to the GI tract during surgery, exposure of a dehydrated GI
tract to abrasive bowel closure materials, adhesion of the bowel to the intestinal wall, severe
trauma, and numerous other surgical complications [3]. Most cases involve large abdominal
wounds that require the surrounding skin to heal to a point at which it could support sutures or
staples to completely close the wound. Because EAFs leak interstitial fluid into the wound, the
healing process can be halted without appropriately isolating the fistula from the wound, making
it a critical need that our solution effectively isolates all fistula leakage from the surrounding
wound bed.
The abdominal wounds surrounding EAFs are typically aided in their healing by negative
pressure wound therapy devices (NWPTs). These mechanically draw fluid from the wound and
increases blood flow, facilitating a more rapid healing process [4]. In order to not interfere with
the healing of surrounding tissue, it is critical that our device is compatible with NWPT and does
not adhere to the wound bed in a damaging way.
Proteasespresent, in extremely high concentrations in the gutbreak down tissue undergoing
healing and break down most things put in place to isolate the EAF. Not only does this fluid
break down tissue and wound dressings, it leads to infection since the GI tract is non-sterile,
hosting a plethora of bacteria that normally aid in digestion. This environment makes it critical
that our device is resistant to breakdown, biocompatible, and allows drainage of the pathogenic
fluids.
The effect EAFs have on patients is enormous. EAFs need to be resolved before abdominal
closure can occur, and since the presence of an EAF will typically halt or delay healing, patients
can be left for extended amounts of time with an unclosed abdominal wound. Due to the
discomfort of having an EAF, it is a secondary need that our device is comfortable and allows
patient maneuverability. An open abdomen requires indefinite hospitalization, halting the
patients life and incurring immense financial burden on the patient, his or her family, and the
involved insurance company. A patient spends on average 88.9 days in the hospital and with an
average cost of about $3,000 per day the medical costs can reach over a quarter of a million
dollars [2]. This immense cost has led our team to design our device with cost effectiveness as a
secondary need.
Fistula leakage, while problematic when in contact with the wound, needs to be given a route
to exit the fistula. Patients presenting fistulas typically have numerous other problems in their

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gastrointestinal tract such as blockage, other fistulas, or severe damage. Trying to plug a fistula
instead of facilitating its drainage can exacerbate many of the other problems in addition to
potentially creating another fistula. Maintaining efficient drainage while isolating the drainage
from the surrounding wound is a necessary trait of an effective solution making effective
drainage a critical need.
Small hospitals do not have the personnel or technology to treat enteroatmospheric fistulas.
Patients are typically sent to large regional hospitals (far from their homes) for fistula
management. Even with this the regional hospitals still struggle to treat these patients. Nurses
can spend up to 5 hours a day creating a custom solution for patients which are expected to fail
within a matter of hours. This places a tremendous burden on the clinical care team, taking away
from time which could be spent tending to other patients. Creating a device to isolate and treat
EAFs would not only benefit many patients, but also nurses and the clinical teams treating these
patients.

1.2 Existing Solutions

There are numerous methods of EAF isolation that have been tried with limited to no
success. Two methods of isolation have been attempted: external, and internal. External solutions
are placed over the fistula opening to isolate the leakage from the outside providing a path for the
leakage to flow. Internal solutions are placed through the fistula opening and deploy inside of the
intestine. These connect to a tube that allows drainage of the leakage as well.
The current method employed most often by hospitals is external and based on
improvisation. The nurse builds up rings of pectin surrounding the outside of the fistula and then
caulks the rings to the wound with ostomy paste. This solution typically takes 1-2 hours to install
requiring a large amount of improvisation. In addition, this method typically does not isolate the
fistula for more than one day, at which point it needs to be replaced. Another attempt to isolate
fistulas is sewing surgical gloves over the opening. This solution is rarely successful because
sutures dont stay in the severely damaged tissue. Some surgeons have attempted solutions that
are placed to isolate the fistula from the inside. A gel lamellar was sutured to a drainage tube, the
lamellar was folded and placed through the fistula at which point it unfolded against the inside of
the intestine. This solution, in addition to being extremely hard to perform and replicate, would
fall out easily due to the lack of rigidity of the gel lamellar. In addition to improvised solutions,
there have been attempts at systematic solutions. Fistula Solution is a company that has
patented multiple inventions regarding isolation of enteroatmospheric fistula, and their
technologies are currently on the market. The company carries the Wound Crown and Fistula
Funnel (U.S. Patent No. 9,078,990, Appendix B), two different silicon-based devices designed
to solve the complex fistula isolation problem. They can be cut to fit fistulas ranging in size from
one to three centimeters [8]. However, according to Nancy Unger NP, both of these devices have
many shortcomings including cost, lack of customizability, rigidity, and failing to create a
successful seal. These patented devices do a poor job of managing complex fistulae geometry,
leaving nurses at major trauma centers looking for a better solution.

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 External solutions fail to isolate fluid entirely from the fistula, preventing it from healing.
Since they are placed over the fistula, leakage inevitably comes in contact with the fistula
opening on its way out. In our solution, we have chosen to isolate the fistula with a device that is
placed through the fistula into the intestine to isolate it from the source.

1.3 Current Materials

1.4 Needs Statement

After all stakeholders were identified, the patient, nurses, and insurance companies were
identified as ones with the largest needs. A needs statement was created for each group and a
combination of the three yielded a primary needs statement. These are listed below.

Patient: A solution to address intestinal fluid wound interference in EAF patients so fistulas can
be isolated from a surrounding wound bed, abdominal wounds can heal in a timely manner, and
patients are more comfortable and mobile.
Nurses: A way to address the time and skill-intensive issue of fistula isolation for medical staff
so that they can allocate their time in more effective ways by seeing more patients.
Insurance companies: A way to address the high cost of EIF patient treatment due to extended
hospital stays and inefficient use of materials for insurance companies (and patients) to conserve
money and resources.
Primary Need Statement: A cost effective, simple, conformable and corrosion resistant device to
address intestinal fluid wound interference in Enteroatmospheric Fistula (EAF) patients, to
isolate fistulas from a surrounding wound bed, with the goal of healing abdominal wounds in a
more timely manner.
This unmet need requires a solution to isolate enteric fluids exuding from EAF in patients for
their speedy recovery. There are multiple stakeholders which are involved and all want various
specified outcomes.

2. Engineering Design Constraints

2.1 Stakeholders
Below is a list of the main stakeholders for the treatment and isolation of EAF.
1. Patients: EAF causes major health issues for patients as the intestinal fluids interfere with
the wound healing process. Typically patients need to be under constant clinician care and do
not leave the hospital until the wound heals. The patient benefits from a new device as it will
expedite their recovery time and comfort.
2. Surgeons: EAF is a very challenging complication for surgeons as there is currently no
good way to treat it. Surgeons will be placing the new FistUSeal device.
3. Nurses: Nurses can spend large amounts of time and labor to treat one EAF patient.
Currently none of the products on the market meet the major requirements of effectively

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treating fistulas (this will be discussed in future sections). Nurses therefore can spend up to 5
hours a day creating custom solutions that typically fail very quickly. Creating a better way
to isolate fistulas will decrease the time needed for nurses to spend with patients and thus
allow them to spend time doing other tasks.
4. Family Members and Caregivers: This condition is mentally and financially exhausting
for family members and caregivers, as it requires physical and emotional support for patients.
As current products are costly and require clinical skill, the patients need to spend extended
amounts of time in the hospital, making it difficult both for patients and family members.
5. Insurance Companies: This medical condition is very costly for insurance companies as
patients need to be kept under medical care until the wound heals, which could take months.
6. Device Manufacturers: As we are striving for an effective and inexpensive solution to this
problem, current device manufacturers might have a conflict as their sales would drop.
Future device manufactures would be interested in the ease of manufacturing this new
technology as it will generate income.

2.2 Core Functions

After understanding our main stakeholders, a list of primary and secondary core functions
were developed.
Primary List of Core Functions
1. Device must completely isolate intestinal fluid from wound bed.
2. Device must be able to withstand the acidity of intestinal fluid and must be able to
resist enzyme breakdown for 48 hours.
3. Device cannot adhere to the wound bed.
4. Device must be compatible with negative pressure wound healing therapy.
5. Device should not require lengthy attention/adjustments for at least two days.
6. Device should expedite wound healing, allowing patients to spend less time in the
hospital.
7. Device must be customized for various individuals.

Secondary List of Core Functions

1. Device should not cause other health related concerns.
2. Ease of installation to prevent trial and error (one and done).
3. Installation of the device should take no longer than 20 minutes.
4. Device must allow patient to move and be comfortable while installed.
Throughout the design process we changed from an externally placed device to an internal
device. Although our main core functions stayed similar throughout this process, some of the
secondary functions were reevaluated and reworded.
2.3 Additional Materials Specifications

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 2.4 Testing to Fulfill Core Functions
Each core function will be tested to ensure the FistUSeal device meets the functions
necessary to be an effective device. Below is a list of tests which will be executed to ensure
all core functions are met.
1. An internal fistula model will be created using an eggplant due to early carving ability
and similar surface wetness characteristics. This model is often employed when
teaching nurses to dress fistualas .The FistUSeal device will be deployed in this and
tested to ensure it creates an effective seal.
2. Device will be made of medical grade material to ensure it does not breakdown by
enzyme degredation for the specified amount of time.
3. The FistUSeal device is an internal solution, completely avoiding the wound bed.
Therefore, no specific test needs to be done of this function.
4. Device will be tested on our model to ensure compatibility with negative pressure
wound therapy components.
5. Pull-out tests using our tissue model and an Instron will be carried out to compare
effects of various bead sizes and stability of placement.
6. The amount of time patients are in the hospital, along with rates of wound healing,
will be monitored to ensure our device is expediting this process.*
7. Various internal geometries will be employed with the fistula model. This will allow
our group to ensure the FistUSeal will work for multiple people.
8. Device immobilization will be taken into account throughout the design process, but
there is not an effective way to test this without actually putting the device in a
moving subject.

3. Design and Prototyping

3.1 Design Process

Our design process began with starting to develop a solution that was external, like the
current improvisations that nurses use, but improved and streamlined. By external we mean
that the solution remains outside of the fistula opening and covers the hole that connects the
fistula to the wound. Our top ideas in this category were a 3D printed custom solution and a
hardening, sprayable foam.
The 3D printed solution would consist of three steps: 1) take a 3D scan off the fistula and
the surrounding wound geometry, 2) use a CAD program to develop a device that exactly fits
the wound geometry and 3D print it, 3) attach a drainage tube and place onto the wound with
ostomy paste as adhesive. This solution, while meeting the customizable and wound sealing
needs failed to be cost-effective or easy for nurses to perform. In addition, healing wounds
are very dynamic and a device designed for a wound geometry at one given time may not fit

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for very long as the wound heals and changes. In addition, the time required to process the
3D scan and manufacture a device would be too lengthy of a process for it to be feasible.
The sprayable foam was thus our more promising external solution in that it would be
customizable, cheap, and instantly available for application. When we began attempting to
prototype for this solution we realized that our work space was not equipped for the materials
engineering required to develop a biocompatible, sprayable, hardening foam. This was more
the task for a biomaterials research lab. In addition, we had been talking more and more with
surgeons who had dealt with surgeons and with their different perspective came the idea of
an internal solution. An internal solution would be placed through the fistula opening and be
deployed within the intestine creating a seal from the inside while
also connecting to a tube that exits the fistula opening to allow
drainage.
Our first idea for an internal solution was a plastic sheet sutured
orthogonally to the end of a drainage tube. The drainage tube would
fit within an outer application tube in which the plastic sheet would
also fold into (figure 1). The end of the applicator tube would be
placed through the fistula and the inner drainage tube would be
pushed forward to deploy the plastic sheet thus creating a seal with

the inside of the intestine. When we proposed this solution to Dr. Figure 1: First internal
Arbabi, he said that it wouldnt work for two reasons: 1) the prototype in partially deployed
inside of the intestine is constantly secreting mucous so it would state. Plastic sheet sewn to a
be impossible to get something to adhere to it, and 2) the plastic drainage tube.
sheet isnt rigid enough to prevent it from simply being pulled
out. We then discussed with him the possibility of using a
balloon catheter placed and deployed within the fistula and he said
that he has tried this and it does not work because even a balloon
isnt rigid enough to prevent getting pulled out. This conversation
led to discussion of a percutaneous endoscopic gastrostomy (PEG)
device (figure 2). These devices are used to place semi-permanent
feeding tubes in patients. The process, which is rather invasive,
involves endoscopic placement of the internal bumper from the
mouth down through the stomach and into the intestinal tract. Here
the internal bumper is met by a needle that is inserted through the
abdominal skin. This needle attaches to the internal bumper and
is pulled up against the side of the intestine. The desirable Figure 2: PEG diagram.
characteristics about this device are the rigidity of the internal
bumper and the drainage potential; however, endoscopic delivery of a rigid internal bumper
is not possible in EAF patients due to the complicated and often severely damaged nature of
their bowels. We need to develop something that can entirely fit through a fistula opening
and then expand into something that is as rigid as a PEG device bumper. Accomplishing this

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 would not only efficiently and successfully isolate EAFs, but would also provide a less
invasive alternative to PEG devices.

3.2 Prototype Evolution

Our prototyping for this specific idea started by brainstorming
what types of materials can undergo a transformation from
moldable and low-profile (for application) to wide, disc shaped,
and rigid. This led us to a technology used in surgical cushions.
These cushions are designed to hold patients in a very specific
position during surgical procedures so the patients body does not
move during surgery. When being used, the cushions start out the
consistency of a beanbag so the clinical staff can position it around
the patient in the desired shape. Once in the desired shape and
orientation, a negative pressure pump is attached to a valve that
connects to the inside of the beanbag. The negative pressure
Figure 3: Bead prototype.
draws out air from the beanbag, causing all the individual spheres
to align into a close packed structure, decreasing the spaces between each bean. This causes
the cushion to harden into a rigid structure until the negative pressure is released. This
technology is currently used only in external positioning devices, so the beads and outer
materials are not necessarily safe for use within the
human body. We did some research and found that there
is a company that makes a product called LC Beads
which are small hydrogel-based beads used to cause
intentional embolisms in blood vessels that supply
tumors. Since the only necessary trait of the beads used
for negative pressure hardening is that they are
spherical, these beads would provide a safe alternative
to the Styrofoam beads used in positioning cushions.
Developing a design with these beads has been our
Figure 4A: Early prototype of
focus for the past few months. Our first prototype using
current design.
these beads can be seen in figure 3. The prototype
consisted to sandwiched plastic sheets with beads in-
between them cut into a circle. A negative pressure tube (red tube in the figure) connected to
a syringe that allows the user to draw out negative pressure causing it to harden. The issues
with this prototype are that the disc doesnt fold up adequately to be placed through a narrow
fistula opening and and the negative pressure tube doesnt hold pressure without physically
holding the syringe plunger out. In addition, the negative pressure syringe would draw in not
only air, but several of the beads when drawing in negative pressure.
Further prototyping lead to a device that had a sliding tube over the base drainage tube
that causes the bead pouch to expand when slid forward (figure 4). The sliding tube (black in the

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figure) would be pulled back during application to give the device a low profile (not shown),
then once through the fistula opening the sliding tube would be slid forward giving the device the
larger profile that will seal off the fistula from the inside. The disc-shaped bead pouch is attached
to a tube with that provides the negative pressure that hardens the disc when it is deployed. This
pressure is supplied by a syringe (pictured) that attaches to a valve that will maintain the negative
pressure when it has been applied. For removal, the negative pressure will be released by
opening the valve, the sliding tube will be slid back, and the device can be pulled out through the
fistula opening. This isolation allows the fistula opening itself to heal which will speed up the
process of getting the surrounding tissue to be healthy enough to hold sutures and thus be able to
be closed.

3.3 Final Design

This prototype would be composed of a balloon catheter
that is filled with beads instead of with air. Once filled, the
filling tube will be sealed and a negative pressure tube which
blocks bead entry via a small mesh will be used to harden the
beads into position.

3.4 Materials Used

3.5 Construction Process

Figure 4B: Insertion position and

3.6 Engineering Drawings deployed position

4. Engineering Analyses & Prototype Testing

4.1 Modeling Enteroatmospheric Fistula

4.2 Testing
4.2.1 Leak Test

4.2.2 Instron Pull-out Test

4.2.3 Bead Size Analysis

4.3 Results

4.4 Next Steps

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5. Intellectual Property
5.1 Related Existing Patents
a) Surgical positioning device
Patent number: US 5906205 A
Filing date: July 28, 1998.
Major claims of interest: A medical device that supports
patients to stay in selected positions. The device
consists of a bag made of airtight material filled with
deformable polystyrene beads that stay loose at normal
condition and get rigid when air is evacuated from the
bag. Due to this designs flexibility, the device increases
ease of performance when adjusting patients position
and provides perfect, customized support to keep
Figure 8: Surgical positioning device [7]
patients in desired position [7].
Relation to FistUSeal design: We will be using the
patented technology of filling a container with small beads that allow the container to changes its
rigidity under pressure stimulus. However, because the patent term for patents filed between
1995 and 2015 is 20 years from their file dates [6], we expect patent US 5906205 A will have
expired by the time our patent is filed and we will not need license from the inventors.

b) Percutaneous endoscopic gastrostomy (PEG) apparatus and method

Patent number: US 5112310 A
Filing date: Feb 6, 1991
Major claims of interest: An apparatus and method for PEG
that employs a sleeve with a tapered end and a gastrostomy
tube with expandable retention device at one end. This
retention device can be either an inflatable balloon or an
expandable basket. The insertion procedure is similar to
conventional pull and push method. The inventor
claimed that (1) the tapered end sleeve provides focused use
of force while creating a tract from the inner of the stomach
out through the abdominal walls, (2) expandable retention
device allows ease of removal without use of endoscopy, (3) insertion of gastrostomy tube
through the abdomen (and not through the mouth) enables use of device for patients with
difficult or narrow esophagus-to-stomach tract [8].
Relation to FistUSeal design: Based on current knowledge, claim (2) mentioned above is quite
similar to our intended advantage of FistUSeal in PEG procedure, namely ease of removal.
However, provided this patent was filed in 1991 with enough time to become widespread and our

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clinical mentor believes that there is room for improvement, we are hopeful that we can do
additional research in the near future to learn more about this products weaknesses as well as
PEG market.

c) Other EAF solutions

Most of the current EAF products on the market are very different from our present design.
Table 1 below summarizes some of the designs that we have encountered so far.

Patent ID Major Claims Supported drawings Discussions

- Patent An internal device that
number: includes a tubular body device inside bowel
WO that is inserted along the
2013119879 length of the bowel.
A1 Intestinal fluid is directed
- Filing date: to flow through the tube
Feb 7, 2013 and blocked from
flowing by with the
fistula opening by two
inflatable cuffs at either
ends of the tube [9]
- Patent An implantable fistula
number: management device. The
WO device comprises a distal
2014113461 anchor with multiple
A2 foldable members
- Filing date: attached to the tissue
Jan 15, 2014
using suture [10]
- Patent An implantable device
number: that plugs the fistula
US opening. The device
20140379025 consists of a cap and an
A1 anchor that seal the
- Filing date: fistula from both sides
Jun 19, 2014
[11]
Figure 10: Fistula Although this is an
internal device, it is a
[9] totally different idea from
what we aim to do.
Insertion technique seems
challenging and is
unclear from the
description.
Figure 11: Implantable Similar to our design, this
fistula anchor [10] device is placed in
surgery and can stay in
for multiple days.
However it requires
suture uses and probably
does not work well on
wet wounded tissue.
Figure 12: Cap and This patent is similar to
anchor plug [11] Wound Crown and other
common design on the
current market where a
plug of various shapes
typically made of plastic
is inserted into the fistula.
These designs are
external solutions and
thus basically different
from ours.

Table 1: Summary of current EAF solutions

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 5.2 Intellectual Property
1. Our device employs an external technology to create an internal seal without use of invasive
attachment means like adhesion or suture.
2. By exploiting the flexibility of the beads, our seal can change from a straight and thin shape to
an expanded disc shape, allowing it to easily enter and exit through multiple sizes of fistula
without pressing on the wound or requiring extensive adjustment.
3. Once the seal is inside the intestine, air evacuation allows the seal to conform to the intestinal
inner geography, generating a perfect customized seal that current solutions fail to achieve.
4. Fill-in material will be inert and biocompatible. This has the potential that the seal container
can be popped open and the material is flushed through the digestive tract so the device is
removed with minimal pressure on the wound bed, shortening healing time.

6. Market Analysis and Business Opportunity

6.1 Market Analysis and Business Opportunity
There are three main contributors to the EAF market; device sales, decreased hospitalization
time, and the potential to leverage the solution in the Endoscopic Percutaneous Gastrostomy
market.
1. Device sales: The FistUSeal device will be used to allow the patients wound to heal, but it is
not a long term solution. Eventually the patient will receive surgery. This device is an interim
solution with the goal of increasing the persons quality of life prior to surgery. The chart below
shows the $6 million market associated specifically with device sales.

Number of Number of devices per Cost of

Patients patient Device Total Market

2500 6 $400 $6,000,000

Table 2: Market based only on device sales.

Currently only large trauma hospitals treat these patients. Some small hospitals will attempt
to treat EAFs, however due to the complexity and uniqueness of each fistula, small hospitals
typically lack the personnel and technology to appropriately treat these patients. We investigated
the advantages and disadvantages with continuing to only target large hospitals with our market
or to also target small hospitals. The advantages associated with targeting large hospitals include
the staff already understands the complexity of the condition and is knowledgeable about the
procedures. Disadvantages associated with only targeting large hospitals include the patient
needing to continue traveling far from their home and not having a community support system.
Targeting either small or large hospitals will not change the number of devices sold, because the

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number of patients with EAF will remain constant. For these reasons we decided to target
hospitals which are already treating EAF patients.

2. Decrease Hospitalization: Although compared to other diseases there are not a great number
of people who suffer from EAF, the people who do have immense challenges associated with it.
Because of these challenges people are hospitalized on average 88.9 days a year [1]. By
decreasing that amount by 10 days we can save health insurance companies $75 million.

Number of Reduced Number of Days in Daily ICU

Patients Hospital Cost Total Market

2500 10 $3,000 $75,000,000

Table 3: Total health care impact.

3. Percutaneous Endoscopic Gastrostomy (PEG): This is a procedure used to place a plug in a

patients intestine. The current procedure will not work for EAF patients because of the
condition of the diseased bowel. The FistUSeal solution would be an effective solution to this
procedure as it is less invasive and would accomplish the same goal of plugging/allowing
drainage when necessary. This would also improve the current (PEG) procedure as the device is
currently roughly pulled out to be removed with no concern for the intestines. Our device will be
removed with no negative effect on the intestine. This is a $30 million market expansion
opportunity [12].
Including PEG, the EAF market is $36 million with the opportunity to save insurance
companies $75 million per year. The hospitals will be our specific customers, however the nurses
and surgeons are key stakeholders in the market as we need their help to implement this solution.
This is shown in figure 13.

Figure 13: Total EAF market incorporating all three segments.

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6.2 Value Proposition
The customers identified in the value proposition canvas are the patient, nurses, and
hospitals/insurance companies (people spending money). To effectively treat EAF, the fistula
must be completely isolated from the wound bed. Each stakeholder has specific jobs to
accomplish this. First, the patient needs to follow the instructions given by the clinical team.
The nurses jobs include installing an isolation device and reconfiguring the device when it is
not completely isolating the wound.
Currently there is not a device which effectively addresses this surgical nightmare
leaving a patient with an unclosed abdomen for an extended amount of time. Because of this
lack of effective treatment patients feel pains of prolonged healing times/extended hospital
stays. They are also hindered by autonomy and movement. Maintenance of isolation of a
fistula involves up to 5 hours per day of intensive, often improvised, labor by the nurses and
surgeons on staff. At most hospitals, staff are not qualified to manage fistula due to the
complex attention the wound requires and uniqueness of each wound. In addition to this, the
current solution deteriorates quickly due to the caustic intestinal fluid passing through it. This
causes the device to be replaced at least every 24 hours, causing pain to the patient and taking
time away from nurses that could otherwise be used tending to other patients. Furthermore,
being bound in a hospital bed is not only an enormous burden on the patient, but the hospital
suffers from this as well.
An effective solution to this problem would alleviate numerous pains. A successful seal
would eliminate the problems associated with intestinal fluid entering an open wound bed,
which would facilitate rapid wound healing. If rapid wound healing is achieved, the nursing
staff would no longer have the burden of constantly attending to the wound and the patient
would be bound to a hospital bed for far less time. Reduction in hospital time, resources used
in device turnover and deterioration, and time spent hospital staff will all ultimately lead to
money being saved by the patient, insurance companies, and the hospital overall.
The FistuSeal isolation and drainage tube will allow for the pains of the stakeholders to
be eliminated.

6.3 Lean Canvas:

The goal of this project is to allow drainage from a fistula, without leakage into the
wound bed. Other problems with EAF treatment include lengthy installation time and the
need for customization as no patient is the same. Our solution will completely isolate the
fistula from the wound bed. It will also be easy to customize and therefore easy for a nurse to
install. It will withstand the acidity of intestinal fluids and last multiple days without
replacement. This is beneficial for both the patient and care providing team. To test the
strength of our device we would measure the frequency at which each device needs to be
changed, the length of time the patient is in the hospital, and the quality of the seal.
Measuring this will tell us if the fistula is completely isolated. We will also measure our
profit margins to determine how we are doing as a company.

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 Ideally our product will streamline the process to effectively treat enteroatmospheric
fistulas, with an internal device. Our group has an unfair advantage in that enteroatmospheric
fistulas are very complex to treat. The Harborview medical center is a regional center which
treats patients from over 5 states. This is an advantage because we are at close proximity and
have access to both patients and the people who work to treat EAFs. There are two methods
for which we could commercialize our product. First, we could target large hospitals and
eventually decide if we want to educate the smaller hospitals on the procedures associated
with using our device. Right now it does not make sense to target all hospitals because
instead of treating patients, the smaller hospitals are sending their patients to regional
hospitals for treatment. The other option for commercialization is to license our device and
technology to a medical device company.
We believe the way to successful adoption would be to target nurses. Nurses are going to
be the people who want to use this product and will have the leveraging power to prove the
advantages associated with this technology and therefore get the hospitals on board to
purchase our product. We believe the main things we will need to spend money on are:
licensing, distribution, manufacturing, training, and the team. Our product streams are
product sales and investors.

7. Regulatory & reimbursement

7.1 Regulation and FDA approval
Device class: Preliminary risk assessment shows that FistUSeal is a Class II device. It
cannot be Class III because it does not either sustain life or stay inside the body permanently.
Our device is also not Class I device because an internal solution involves high risks of
infection and other complications like bowel obstruction

Predicate device: Some of the early considerations for a predicate device include
products such as Wound Crown. However this choice is no longer appropriate because our
current design is an internal solution that must be placed in surgery, potentially introduces
foreign fill-in material into the digestion tract, and stays in contact with the wound for a
significantly longer period. Other considerations that have more equivalent aspects consists
of drainage devices such as chest tube, wound drain catheter system, and internal fistula
products that are used on other fistula types. Unfortunately professionals with expertise in
medical device approval by FDA gave the same advice that these devices most quite likely
will not qualify as our predicate because our device is used in a substantially different
environment.

Approval challenges and pathway: If we identify a suitable predicate device, the

regulatory pathway will be 510(k). Unfortunately the biggest current regulatory challenge is
that there is not a predicate device that closely aligns with our proposed solution. The
designs innovative features have differentiated us from current products and inadvertently

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raised new risks. Some specific concerns include proving that our pressure stimulus does not
cause ischemia, fill-in material does not lead to immune reaction or bowel obstruction if it
comes in contact with the intestinal wall and fluid, and the device in general does not
promote infection at any time during time of use. In the event that we will not submit our
device through the regular 510(k) pathway due to lack of a predicate device or we submit and
receive a not substantially equivalent status that will automatically place our device in
Class III, we have an alternative to submit for a de novo request for a low to moderate device
to be classified into Class I or Class II without submitting a 510(k) [13]. This will allow us to
avoid going through the lengthy and expensive process of pre-market approval (PMA).
Furthermore, in order to successfully be granted De Novo approval, we still need thorough
and sufficient data to prove that our device functions well and safely [14]. This data consists
of human and potentially animal tests, both of which require extensive financial and time
investment. We have not yet looked into the approval process to be able to test on living
subjects since it is at least several months ahead, but our clinical mentor mentioned that he
has connections with an animal lab that we can use once that milestone approaches. We plan
to build our device using FDA-approved materials that are biocompatible and inert to
minimize the amount of testing. Another problem we anticipate is that animal tests may not
be relevant enough to predict results from human tests since animal digestive tract could be
very different from human tract. Large animal digestive tract like that of dog or pig has been
proved to have a closer resemblance; however, tests with large animals are much more
expensive. We have received inputs from professionals at the Health Innovation Challenge
that it may be beneficial to skip animal tests and apply directly to test on humans. This is an
interesting insight and we plan to research further in this direction.

7.2 Reimbursement and related financial regulation

ICD and CPT codes: As our clinical need to devise an instrument for isolating
enteroatmospheric fistula, the relevant codes for ICD-10 in specific manner is K63.2 - fistula
of intestine, K31.1- fistula of stomach and duodenum, K82.3- fistula of gall bladder, K 83.3-
fistul of biliary duct.
CPT codes for our clinical need in a broader sense are:
(a) 43500-43999: surgical procedures on stomach,
(b) 44005-44799: surgical procedures on intestines,
(c) 45000-45999: surgical procedures on rectum,
(d) 46020-46999: surgical procedures on anus,
(e) 47000-47399: surgical procedures on liver,
(f) 47400-47999: surgical procedures on biliary tract,
(g) 48000-48999: surgical procedures on the pancreas,
(h) 49000-49999: surgical procedures on the abdomen.

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 Discussion: Reimbursement process includes coverage, coding, and payment [15]. While
FDA approval requires safety and efficacy, the Centers for Medicare and Medicaid Services
(CMS) who regulates reimbursement decisions care about medical effectiveness compared to
other products. In order to for our device to be covered via National Coverage Decision or Local
Coverage Decision, it must be different from all other currently regulated medical technologies
and methods, which requires innovations that delivers results [15]. Given that our device works
consistently and properly, coverage may not be our biggest concern thanks to some novel
features of our design. Next step in the reimbursement process is to either identify an area of
codes that our device fits in or creating a new code. Codes can be generated based on factors like
whom the procedure is performed by, where it is performed, and what equipment is used in the
procedure [15]. We believe that this will be the focus of our reimbursement plan as our
procedure will be performed by physicians instead of nurses and equipment involved may be
different from that used for current product as well. Moving forward, examining a
reimbursement pathway will be our next step should we decide to pursue development of
FistUSeal into a real product.

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References
[1] Di Saverio, Salomone et al. Open Abdomen with Concomitant Enteroatmospheric Fistula:
Attempt to Rationalize the Approach to a Surgical Nightmare and Proposal of a Clinical
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[2] Dasta JF. Daily cost of an intensive care unit day: the contribution of mechanical ventilation.
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[13] Evaluation of Automatic Class III Designation (De Novo) Summaries. Retrieved from
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[14] De Novo Classification Process (Evaluation of Automatic Class III Designation) Draft
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[15] Diage, Tiffini. Planning for Successful Medical Device Reimbursement. NAMSA.

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