relaxed, low pressure ventricles.
But when the
Heart Valve Design
Project
Authors: Sam Krahling, Carol Perez-
Ajax, and Mackenzie Andrews
INTRODUCTION
BACKGROUND
The heart is an organ that circulates blood
through the vascular system and allows for the
delivery of oxygen to all of the cells in the body.
In humans, the heart consists of four chambers
allowing for efficient pulmonary oxygenation
and systemic circulation of blood. When the
oxygen has been delivered to the cells in the
body, the deoxygenated blood returns to the right
atrium where it is pumped down to the right
ventricle. From the ventricle, the deoxygenated
blood is delivered to the lungs where it exchanges
carbon dioxide for oxygen. The newly
oxygenated blood then enters the left atrium
where it is pumped into the left ventricle. The left
ventricle then delivers the oxygenated blood back
into systemic circulation.
Figure 1: Simple graphic labelling the heart valves and their
positions.
The movement of blood follows a pressure
gradient where blood always flows from areas of
high pressure to low pressure. Therefore, when
the atria contract, they produce a high pressure
within the chamber which forces blood into the
ventricles contract, they don't push the blood back
into the atrium but instead deliver it into
circulation. This unidirectional flow path is
facilitated by the placement of one-way valves at
the connection between the atrium and ventricles
called atrioventricular valves (mitral and
tricuspid valve), and the exit from the ventricles
(aortic and pulmonary valve) (Figure 1).1 The
valves use leaflets or cusps, which are pushed
open to allow blood flow into the proper direction
and then close to prevent backflow in the reverse
direction.
In normal valve function, the valves fully open to
allow maximal forward flow and fully seal to
allow no backflow. However, many conditions
such as birth defects, heart disease, and heart
attacks can affect the proper function of heart
valves causing disruptions in the flow of blood
through the heart. If the valve is unable to fully
open, the heart must work harder to pump blood.
If the valve is unable to fully close, the efficiency
of the heart will decrease as some of the blood
flows in the wrong direction. In some cases,
deficiency in valve function can cause severe
health complications or death. In order to correct
these deficiencies and prevent severe health
problems, heart valve replacement surgery can be
done to replace the defective heart valve with a
mechanical or transplanted biological valve. In
this report, we will focus on the design of
mechanical heart valves for use in valve
replacement surgery.
PRIOR ART
Caged Ball
The caged ball valve was the first mechanical
heart valve designed and used clinically. It was
implanted as a mitral valve replacement in 1960.2
Many variations on the original Hufnagel design
were manufactured and implanted, however all
the designs are based on the same principle. The
valve consists of a cage that houses a ball (Figure
2). When the blood pressure gradient pushes
against the valve, the ball is pushed against the
cage and allows blood to flow. At the end of the
contraction, the ball moves back against the base
of the valve forming a seal.
Figure 2: Ball and cage heart valve labelling the key
features of a caged ball valve.
The primary problem with the ball and cage
design is in the flow profile it creates. In normal
heart valve flow, blood flows through the middle
of the valve resulting in a central flow profile.
The physics of the ball and cage valve forces the
blood to flow around the sides of the ball, close
to the wall of the artery. This causes the heart to
have to work harder to pump the blood out of the
atrium. Another concern of the ball and cage
valve is that it damages blood cells when the ball
collides with the cage. When blood cells are
damaged they initiate an inflammatory response
and the buildup of clots and scar tissue around the
valve.
Bileaflet
The bileaflet design was first introduced in 1978.2
The design consists of two semicircular leaflets
which pivot on hinges (Figure 3). Just like regular
heart valves, the half circle flaps will open when
the blood pressure gradient pushes them open,
and close when the reverse gradient occurs.
Figure 3: Bileaflet heart valve labelling the primary features
of the valve.
The bileaflet valve allows for a much more
natural central flow profile compared to the ball
and cage valve. The bileaflet valve also cases less
damage to blood cells, however this is still a
concern because any buildup of clots or scar
tissue around the hinges can cause the valve to
not work properly or fail altogether. The primary
concern of the bileaflet valve is the amount of
backflow it allows. Even in fully functioning
mechanical bileaflet valves, the leaflets close
with a small gap between them allowing for a
built in amount of allowed backflow up to 22% of
forward flow.3 In the presence of clotting or scar
tissue, the leaflets may not close all the way
allowing for three paths of backflow (through the
center and around the two sides). Since many
heart valves are replaced due to their inability to
prevent backflow, this is a design flaw that is
important to address.
CLINICAL NEED
Heart diseases are the leading cause of death in
the United States, killing more than 600,000
Americans in 2008.4 Heart disease is a very broad
term that encompasses many heart
conditions. Although coronary artery disease
(CAD) is the most common type of heart disease,
many kinds of heart disease involve valves in the
heart.5 Heart valve diseases can be divided into
three main categories: valvular insufficiency
(regurgitation), valvular stenosis, and congenital
heart diseases (example: atresia).6,7
 Regurgitation occurs when blood leaks
back into the chambers instead of
flowing forward. It occurs due to the
valve not closing tightly enough not fully
closing.
  Stenosis results when the valve flaps
stiffen or fuse together, which prevents
the valve from fully opening leading to
not enough blood flow through the valve.
 Atresia is a congenital heart valve disease
in which the heart valve lacks an
opening.
The treatment for heart valve diseases depends on
the severity and type of valve disease. Replacing
or repairing valves is a common surgical
procedure to treat heart valve diseases. In 2011,
more than 47,000 cases of valve replacement
were reported.8 Many types of replacement heart
valves are currently in use. The three main
categories are manufactured mechanical valve,
donor valve implantation, and tissue
(bioprosthetic) valves.
The focus of the report is to analyze current
mechanical heart valves and to attempt to
improve a functional aspect of the mechanical
heart valves. Minimal regurgitation, as described
above, is a primary functional aspect of heart
valves. Current heart valves are designed to have
extremely low regurgitation, yet due to various
valve-tissue interactions, such as scar tissue
preventing valve flaps to close, the valves may
acquire some regurgitation. Our goal is to design
a heart valve that reduces backflow while still
allowing for a central flow profile.
DESIGN CONSTRAINTS
SIZE
The physiologic environment where the valve
would be implemented guided the design of the
valve’s dimensions. The diameter of the aorta in
the average adult is between two and three
centimeters.9 The valve should therefore have a
diameter within this range to be appropriately
sized for use in adults.
The average thickness of the cusps in the aortic
valve in adults is about two millimeters.9
However, the fabricated heart valve replacement
does not need to match this thickness. The valve
cusps only need to be a thickness that allows it to
function correctly, allowing forward flow during
systole and preventing backflow in diastole.
The replacement heart valve must also be capable
of tolerating the conditions in the bloodstream.
The valve should be capable of withstanding
temperatures around 310 K and be all materials
must be insoluble in blood.
MATERIAL
The material used in the fabrication of the heart
valve must be biocompatible. It cannot cause
harm to the tissue in which it is implanted or
degrade in the body.10 The valve is implanted into
two tissues, the vessel wall and the circulating
blood itself. To not harm the aortic wall, the valve
cannot irritate that tissue, most likely due to valve
movement. The FDA requires that a device in
contact with circulating blood not cause
significant hemolysis or thrombogenesis.11 The
destruction of a significant number of red blood
cells by the valve would be significant harm to
the circulating blood. The formation of clots
around the device could not only disrupt the
valve’s function, but also lead to stenosis around
the valve. This would disrupt normal blood flow.
To be biocompatible, the FDA also requires that
any parts of the device be resistant to corrosion in
the physiologic environment in which it will be
implemented.12
The final constraint imposed by the FDA is for
passive devices to be safe concerning use with
Magnetic Resonance (MR). To meet this
criterion, the device must not undergo
magnetically induced torque or displacement
forces, and must not heat up due to the radio
frequency pulses used during MR imaging.13 Any
metal or other magnetic material used in the heart
valve should be MR safe, though avoiding
magnetic materials in general would be safest.
DURABILITY
The FDA requires that all parts of a rigid valve,
such as a mechanical valve, be functional for 600
million cycles “using a back pressure between
125 and 150mmHg.”14 A flexible valve should
remain functional for 200 million cycles. These
cycles should use appropriate fluid and flow rates
that the valve will be subjected to in the body.
DESIGN SPECIFICATIONS
PHYSICAL
Dimensions
The device must fit within an average adult’s
aorta. To fit the heart valve testing device, the
valve must be about one inch in diameter. One
inch in diameter is 2.54 centimeters, which is
within the required 2-3 centimeter range of
average aortic diameter.
Material
All materials used in the implant must be
biocompatible. Any metals should be MR safe
and non-corrosive. Titanium would be a good
candidate for its resistance to corrosion and its
MR compatibility.15,16
Pressure
The flap or cusps that block backflow in the aorta
must be able to withstand the normal force during
backflow without fracturing or failing. During
backflow, the pressure drop across the valve from
the aorta to the left ventricle is between 80 and
100mmHg, or 10.7 to 13.3 kPa. The materials
must therefore be able to withstand this normal
stress without deforming significantly.
The hinge used to secure the flap to the wall of
the aorta must also withstand stress. The shear
stress on the valve flap due to the fluid flowing
past it would exert a force on this hinge.
The average blood velocity in the aorta is 0.4
m/s.17 Shear stress is equal to the product of the
fluid viscosity and the velocity gradient along the
normal direction, the radial direction in this case
with the disk being vertical parallel to fluid flow.
The distance from the center of the fluid to the
disk when the valve is open is ⅜ inches, and the
velocity changes from 0.4 m/s to 0 m/s over this
distance. Average blood viscosity is 3.5 mPa *s.18
Assuming a linear velocity gradient, the shear
stress was calculated to be 0.22 Pa. Using an area
for the disk of one square inch, or 0.000645
square meters, the force parallel to fluid flow on
the hinge would be 0.142 mN. Though this force
is small, the hinge would need to be able to
withstand this force without large deformations.
Backflow
Biological porcine heart valves have a backflow
value of about 6% of flow per stroke.3 Bileaflet
valves have been shown to have a backflow 22%
of flow per stroke. To achieve the goal of creating
a replacement heart valve with a backflow
percentage lower than current heart valve
replacement, backflow must be less than 22% of
forward flow. The goal is to achieve a backflow
value as close to 6% of flow as possible to match
biological valves.
THEORETICAL
Lifespan
Under normal physiological conditions, the heart
valve should be able to retain function for more
than 600 million cycles of opening and closing,
or 600 million heart beats. The heart valve should
therefore be able to function for 14 to 19 years,
calculated using a heart rate of 60 to 80 beat per
minute. Due to time constraints and limited
access to accelerated wear testing methods, this
specification will not be assessed in this report.
PROTOTYPE
DESCRIPTION
The heart valve prototype was designed similar to
a check valve. A swing check valve consists of a
disk that swings open when forward flow is
present and fully closes when forward flow is
zero due to backflow. The closing of the valve
prevents regurgitation. Figure 4 shows a diagram
of a check valve. A disk is connected to a hinge
that allows it to open and close. The hinge is
attached with a pin to the body of the valve. The
disk sits against the disk seat, which is fixed to
the body of the valve, which prevents the disk
from prolapsing and allows the disk to fully close
the valve opening. When the valve is fully open,
the disk sits against the wall of the valve allowing
for uninterrupted central flow through the valve.
  Goop: Be careful while handling the
glue. Try to avoid touching the glue.

Equipment:

 Soldering iron

Materials:

Figure 4: Check valve diagram: The main components of a  One-inch flat metal washer
check valve are disk, hinge, disk seat, and valve body. The  Solder (filler metal)
inlet flow allows the valve to open. When the inlet flow is  Soldering flux
zero, the valve closes and prevents backflow.  Copper wire
 rubber washer (1 ¼-inch outer diameter
and ¾-inch inner diameter)
DESIGN ITERATIONS
 Needle
 Monofilament
The beginning prototype idea was to create a tri-
 Amazing Goop
leaflet heart valve with materials that have similar
 Tubing (4 ½-inch long and 1 ¼-inch
properties as tissues. The leaflets were made out
diameter)
wire structures covered with a section of latex
from gloves. The body of the valve consisted of a
wire shaped as a ring covered with a small piece
Procedure
of tubing. The design did not have a good
structural support and did not prevent backflow.
The disk for the prototype was made using a one-
After some thoughtful consideration, the
inch flat metal washer. The washer was soldered
prototype design was decided to be similar to a
to cover the hole to make a disk. A small piece of
check valve. Several disks designs were tested. A
copper wire was shaped into a spring and
plastic disk with a rubber surrounding the edges
soldered to the disk to make a hinge. The disk seat
was not effective to prevent back flow. In
consists of a rubber washer with the a 1 ¼-inch
addition, the ¾-inch flat metal washer size was
outer diameter and ¾-inch inner diameter. A
also tested, but it was finally decided to use a 1-
piece of tubing (4 ½-inch long and 1 ¼-inch
inch flat metal washer. Several disk seats made
diameter) was used as the body of the valve. The
out of rubber washers were also tested, but the
disk seat was placed inside the piece of tubing.
rubber washer with 1 ¼ -inch outer diameter and
The disk with the hinge was placed on top of the
the inner diameter of 3/4 -inch was the most
seat in a position that covered the seat opening.
effective.
Monofilament was used as a pin hinge. After
locating an adequate position, a needle was used
FABRICATION
to pierce the tubing to run the monofilament
through the hinge. After testing the location of the
Safety
disk, the disk seat and thread were glued to the
body of the valve to prevent them from moving.
 Soldering: The soldering iron needs to be
The final heart valve prototype is shown in
used carefully to prevent injuries, such as
Figures 5 and 6.
burns. Safety glasses are recommended
while soldering. Be conscious of where
Soldering procedure: Soldering flux was applied
the soldering iron is placed while it is hot.
to the desired piece to solder. The piece was
Unplug the soldering iron when not used.
heated using the soldering iron. Using the
 Needle: Be careful when using the needle
soldering iron, solder (filler) was applied in the
to avoid injury.
desired space. When the piece was soldered as
wanted, the piece was placed in water to cool
down.
Figure 5: Final Prototype - the heart valve in its close state.
The disk, hinge, and monofilament can be observed from this
view.
Figure 6: Final prototype - heart valve in its open state. The
disk seat can be observed from this view.
COMPUTATIONAL MODEL
COMSOL MODEL DESCRIPTION
The prototype was modeled computationally
using COMSOL. It was modeled both closed and
open, with the closed model using a solid
mechanics study and the open model using a
laminar fluid flow study. Both models were
created using the real dimensions of the model.
The pipe housing was created with a height of 4.5
in and a radius of ⅝ in. The seat was an annulus
of height 0.25 in, outer radius of ⅝ in and an inner
radius of ⅜ in. The seat was centered around the
center axis of the pipe housing, and located 2
inches above the inlet. The valve disk was a
cylinder with height 1/32 in and a radius of ½ in.
In the open valve model, the disk was modeled as
being vertical in flow, 2/8 inch from the center
axis of the pipe housing, with its center 3 inches
above the inlet. The hinge was also used in the
open valve model, modeled as a cylinder of
length 1.1 in and radius 1/32 in. It was positioned
11/32 in from the center axis of the housing, and
2.5 in above the inlet. The pressure drop between
the inlet and outlet was set to 400 Pa. Though the
real pressure drop would be much higher, over 10
kPa as stated before, a higher pressure made
convergence of the COMSOL study impossible.
The housing material was then set to water, and
the overlap of the housing with the hinge, disk,
and seat was removed to model the valve
apparatus as a column of water around the valve
components. The physical model used in the
open valve model can be seen in Figure 7, with
the inlet as the bottom surface.
Figure 7: Physical design of the open valve computational
model.
The closed valve model was modeled using a 2-
D axisymmetric model, instead of the three-
dimensional model used for the open valve. The
closed valve model used the same dimensions for
the pipe housing, and disk, with the exception of
the disk having the same center axis as the
housing at height 52/16 in. The sloping nature of
the seat was used in this model by modeling the
seat as a polygon as shown in Figure 8.

Figure 9: Top view of von Mises Stress for closed heart valve
Figure 8: Physical design of the closed valve computational under physiological backflow pressure conditions modeled
model. in COMSOL.

To model the force on the valve, a pressure of 11

kPa applied to the top surface of the valve disk.
The housing and seat were modeled as being
made of nylon material, and the disk was modeled
as titanium.

RESULTS

Closed Structural Model Results

When closed, the greatest stresses on the valve

occur in the center of the disk, the point at which
the seat and valve meet, and the contact between
the housing and the seat. This can be seen in
Figures 9 and 10.

Figure 10: Side view of von Mises Stress for closed heart
valve under physiological backflow pressure conditions
modeled in COMSOL.
Open Valve Fluid Flow Results
The COMSOL model of the open valve shows the
fluid flow profile in Figure 11, with the fluid
traveling faster at and after the valve than at the
inlet, due to the decrease in diameter. The fluid’s
flow is not obstructed in the center of the vessel,
and so the fluid exhibits central flow. The
increase in speed at the diameter constriction is to
be expected to maintain the same flow rate.
Figure 11: Fluid flow profile in open heart valve modeled in
COMSOL.
DISCUSSION
The main goals of the prototype are to minimize
backflow and maintain central flow that normal
blood flow exhibits. The closed valve
computational model shows where stress will be
maximized. If theses stresses exerted on the valve
do not cause large deformations that compromise
its function, the valve will block backflow
effectively. The valve was never seen to have
deformed after use in the experimental tests
shown below, leading us to believe it can function
with very minimal backflow.
The open valve computational model shows that
when flow passes through the valve, it continues
to exhibit central flow, with flow velocity being
highest in the center and decreasing along the
radial direction. The model was created assuming
laminar flow, which may not be entirely accurate
around the area directly after the constriction.
There is probably some whirlpool-like motion at
the edges of the housing after the constriction.
This turbulent flow should not affect the tendency
of the flow to be central after the valve.
EXPERIMENTAL TEST
To experimentally test the flow behavior
supported by the prototype, we worked with a
heart valve test team. The heart valve test team
made a heart valve tester that measures the
pressure difference across the valve. This
pressure difference can be used to draw
conclusions about the open flow behavior and
supported resistance to backflow.
HEART VALVE TESTER
Description
The heart valve tester (Figure 12) consists of a
pump (A) connected to a horizontal tube (B) used
to model the flow through the aorta. In the center
of the tube is an opening which the heart valve is
placed for testing (C). On either side of the heart
valve is a vertical tube used to measure fluid
Figure 12: Heart valve test device consisting of A) Pump, B)
Horizontal tube, C) Opening for heart valve, D) Inlet pressure
tube, E) Outlet pressure tube, and F) Data acquisition ruler.
height on either side of the valve during testing
(D, E). These heights measured from the ruler (F)
can be translated to pressures to measure a
pressure drop across the valve.
Theory
The tester works like a differential barometer.
The tops of both of the vertical tubes are open to
atmospheric pressure. If the pressure in the
horizontal tube is greater than atmospheric
pressure, it will force water into the vertical tube.
The height of the water column in the vertical
tube can be translated into a pressure using the
simplified Navier-Stokes equation,
P = ρ*g*h + Patm,
Where P is the fluid pressure, ρ is fluid density, g
is gravity, h is the fluid column height, and Patm is
atmospheric pressure. This simplification uses
the assumptions that the differential velocity or
flow rate between the two sides of the valve is
conserved, the fluid is incompressible, and
gravity is constant.
The pressure difference across the valve can be
calculated by subtracting the height in tube E
from the height in tube D,
ΔP = PD – PE= (ρ*g*hD + Patm) - (ρ*g*hE + Patm)
= ρ*g*(hD - hE),
Where ΔP is the pressure drop across the valve,
PD is the pressure in tube D, PE is the pressure in
tube E, hD is the fluid height in tube D, and hE is
the fluid height in tube E.
PROCEDURE
Forwards Flow
To test the open (forwards) flow pressure drop
across the valve, the valve was placed in the tester
at opening C with the valve open to flow from the
left to the right. The valve was sealed in place
using parafilm to prevent water leakage across
the valve. The pump was then used to initiate a
pressure gradient driving force for flow through
the valve. As water was pumped through the
valve, the heights in tubes D and E were
measured and recorded. These measurements
were repeated 5 times. An attempt to control the
pump pressure was made so that drag/viscous
effects due to the change in flow rate could be
neglected in our pressure calculations.
Backflow
To test the closed (backwards) flow pressure drop
across the valve, the valve was turned around so
the valve was closed to flow from the left to right.
The valve was sealed in place using parafilm to
prevent water leakage across the valve. The pump
was then used to initiate a pressure gradient
driving force for flow through the valve. As
pressure was increased with the pump, the heights
in tubes D and E were measured at both time, t =
0 seconds after pump and time, t = 1 second after
pump so test how well the valve maintains a
resistance to backflow. These measurements
were repeated 5 times.
CRITERIA FOR SUCCESS
Forward Flow
For the forward flow test, we would ideally see
no pressure drop across the valve because the
goal of the device is to make the valve entirely
open to undisturbed flow. However, we would
not expect this to be the case because our device
design has built in flow obstructions and a
decrease in tube diameter. Therefore, in order to
be considered “successful” we are looking for a
pressure drop of no more than 10 percent of the
entering differential pressure.
Backflow
For the backflow test, we would ideally see a
large pressure drop across the valve with a high
pressure pushing forward on the closed valve and
a low pressure on the other end telling us that no
flow is getting through the valve. In biological
conditions, the difference between average
systolic and diastolic blood pressures is between
5 and 7 kPa. We are unable to measure pressure
drops of this magnitude with the test device we
are working with, so to be successful, we are
looking for a pressure drop on the magnitude of 2
kPa. We would also like to see this pressure drop
be maintained for 1 second (approximate duration (Δh) was calculated and used to find the change
of a heart beat) with less than 6 percent pressure in pressure (ΔP) between the inlet and outlet flow
defined leakage (leakage percentage per stroke of of the valve. The water height in tube D was used
biological valves.3 If we can achieve a pressure to calculate the differential inlet pressure (PD).
defined leakage of 6% per stroke or less, it would The percentage pressure drop was then calculated
suggest that our mechanical device is as resistant by dividing the total pressure drop by the inlet
to backflow as biological valves. pressure. All derived values are shown in Table
2.
RESULTS
Table 2: Forward Flow, Pressure Calculations
Forward Flow Differential
Δh, Inlet
During the forward flow test, the columns of (hD- ΔP, Pressure, (PD Percentage
water in both vertical tubes moved up and down hE) (ρ*g*Δh) = ρ*g*hD) Pressure Drop,
together with only a small visual drop in height (cm) (Pa) (Pa) (ΔP/PD*100%)
from tube D to tube E. The columns of water
increased in height when pumping down and 2 196 1372 14.3%
decreased in height while pulling the pump up. 1.5 147 1176 12.5%
This makes sense because as we push the pump
1.5 147 1372 10.7%
down, we are applying a pressure to the fluid in
the horizontal tube which would cause more 2 196 1274 15.4%
water to be pushed up into the vertical tubes. 1.5 147 1372 10.7%
When we pull the pump up, the check valve in the
pump will stop fluid from entering the test system Average =
so as fluid drains out of the system (due to ρ = 1000 kg m-3, g = 9.8 m s-2 12.72%
gravitational forces) the pressure in the system
will drop causing the column heights to decrease. Backflow

The fact that the columns of water are roughly the During the backflow test, the column of water in
same height, and move together is what we would tube D was visibly higher than the column of
expect for ideal, unrestricted forwards flow. The water in tube E. The same behavior of the column
small drop in height from tube D to tube E is not heights increasing while pumping down and
ideal (as it suggests a resistance to flow within the decreasing while pumping up was observed, but
valve), but expected due to the design of our the inlet column height increased much more
valve. Table 1 shows the recorded heights of rapidly than the outlet column height.
water in tubes D and E.
This rapid increase of the inlet pressure makes
sense because as pressure is applied to the system
Table 1: Forward Flow, Raw Data by the pump, the valve will be resisting flow
Inlet height, hD (cm) Outlet height, hE (cm) causing the added pressure to be applied almost
exclusively to the inlet side of the system. A small
14 12 decrease in height in the inlet tube was observed
12 10.5 as the pressure was held by the pump, potentially
due to valve leakage. Table 3 shows the recorded
14 12.5
heights of water in tubes D and E at times 0 and
13 11 1 seconds.
14 12.5

Using the recorded water column heights in Table

1, the difference in height between the columns
Table 3: Backflow, Raw Data
Inlet Outlet Inlet Outlet DISCUSSION
height, hD height, hE height, hD height, hE
(cm), time, (cm), time, (cm), time, (cm), time, Forward Flow
t = 0 sec t = 0 sec t = 1 sec t = 1 sec
In the forward flow test, we ended up observing
34 14 33 14 an average pressure drop of 12.72% of the
35 14 34 14.5 entering differential pressure drop. This value
34 13 33 13.5 most likely indicates that the design of our heart
valve has obstructions causing a drag on the fluid
34 12 33 12 which is causing a pressure drop across the valve.
35 13 34 13.5 Our criteria for success defined a pressure drop of
“no more than 10 percent” as reasonable for the
35 12 34 12 forward flow pressure drop. The experimental
value ended up being 2.72% higher than our
Using the recorded water column heights in Table defined value. Therefore, we did not meet the
3, the difference in height between the columns criteria of success for the forwards flow test.
(Δh) was calculated and used to find the change
in pressure (ΔP) between the inlet and outlet flow The most likely cause of the pressure drop is due
of the valve at times 0 and 1 seconds. These to the rapid diameter change from the pipe to the
pressure drops were then used to calculate a disk seat. This diameter change of approximately
percentage of pressure defined leakage in the 50% would cause flow disruptions leading to
system by subtracting the pressure drop at 1 turbulent flow. Turbulent flow would be a likely
second from the initial pressure drop and dividing cause for the pressure drop observed. Other
by the initial pressure drop. This value is an factors that could have caused there to be a
estimate of the backflow percentage per greater pressure drop than intended are leakage
heartbeat. All derived values are shown in table across the valve, friction in the tubing, design
4. flaws in the test device, or measurement errors.

Table 4: Backflow, Pressure Calculations Backflow

Δh, Δh, (hD- ΔP, ΔP, Percentag In the backflow test, we ended up observing an
(hD- hE)(cm) (ρ*g*Δh (ρ*g*Δh e average pressure drop across the valve of 2116.8
hE) , time, t ) (Pa) ) (Pa) Pressure Pascals. This value means that the valve was able
(cm), = 1 sec time, t = time, t = Defined to resist a backflow pressure of 2.1 kPa. In
time, 0 sec 1 sec Leakage biological conditions, heart valves must support
t=0 ((ΔP(t = backflow pressures of 5 to 7 kPa. While we could
sec 0)-ΔP(t = not prove that our device could support biological
1))/ΔP(t = pressures (due to limitations of the test device),
0)*100%) we met our criteria for success of supporting 2
kPa of pressure. Given a different test device, we
20 19 1960 1862 5%
could test our device under biological pressures.
21 19.5 2058 1911 7.14%
22 21 2156 2058 4.5% During the backflow test, we also observed a
pressure defined leakage of 5.55% per second.
22 20.5 2156 2009 6.8% This value represents a 5.55% loss of a pressure
23 22 2254 2156 4.3% gradient across the valve over the course of 1
second (approximate length of one heart beat).
ρ = 1000 kg m-3, g Average Average =
Biological porcine valves have been shown to
= 9.8 m s-2 = 2116.8 5.55%
have a 6% leakage rate per heart stroke.3
Comparing these two values, our experimental
results suggest that our heart valve is as effective
at blocking back flow if not more efficient than
biological heart valves. Comparable mechanical
heart valves such as the bileaflet valve experience
backflow leakage of up to 22%.3 We achieved our
criteria for success for this test which was to
observe a backflow percentage of 6% or less.
FUTURE WORK
The heart valve prototype has very simple
structure and has the advantage of minimizing
backflow while maintaining an adequate central
flow profile. The structure itself is not suitable for
the heart, since the designed valve needs a greater
amount of space to allow the disk move and fully
open the valve. The designed could be applied to
be similar to a tilting disk valve, since only one
disk has movement that opens and closes the
valve. The movement could be more localized as
in the tilting disk valve. Bileaflet and tri-leaflet
valves resemble more the natural structure of
heart valve than the prototype designed or a
tilting disk valve.
The prototyped heart valve needs to be greatly
improved to make an actual heart valve. As
mentioned before, the design is not adequate for
the heart, but the principle of having one moving
disk could be useful to reduce backflow. Forward
and backward flow shear would need to be
analyzed to determine if the valve damages red
blood cells and other blood components. In
addition, the material of the valve would need to
be carefully selected to analyze the body's
reaction to the presence of a foreign material, to
improve valve-tissue interactions, and to avoid
thrombogenesis. The valve would also have to be
designed to be long-lasting, and if needed, easily
replaceable. The main focus would be to design a
mechanical heart valve that performs as closest as
possible to a natural heart valve, which would
include maintaining an adequate pressure
gradient and blood flow.
WORK TIMELINES
Before we started work on our project, we worked
out a timeline to keep us organized and on track
to finish the project. Our timeline included
estimated start dates, projected end dates, and
estimated time to be spent on each aspect of the
report. We also assigned each component of the
project to a group member so we could plan out
our work on our own schedule. These values can
be seen in Table 5. While we worked on the
project, we kept track of when we started work on
each component, when we finished that
component, and how much time was spent on that
component overall. These “actual” values can
also be seen in Appendix A.
We projected that the project would take us a total
of 50 hours overall to complete. In reality, we
spent about 74 hours on the project over the
course of approximately 3 weeks. Much of the
extra time came in a poor estimation of how much
time we would have to put into the prototype as
well as the amount of time needed for the
COMSOL model.
We used a Gantt Chart (Appendix B) to visualize
the estimated and actual intervals of completion
throughout the project. Gantt charts are helpful
tools for tracking project completion and serve
well as a visually interpreted reference for future
project planning. The estimated intervals of
completion (light blue) are displayed above the
actual completion intervals (dark blue) for each
component of the project. By looking at the Gantt
Chart, it can be observed that many components
of the project were started later than planned but
completed over a shorter interval of time. In the
case of the technical writing sections, we started
research on the project component early on, but
didn't start writing the section until closer to the
project deadline which makes it look like the
component took comparatively longer than other
aspects of the project.
TEAMWORK EVALUATION
As a design team, the three of us worked well
together. Communication was easy via modern
technology. Nobody shirked responsibilities or
missed meetings which had been agreed upon.
Hard deadlines were not missed, though many
parts did get put off by the group as a whole when
life continuously occurred. Overall, working with
the group was relatively painless.
Communication with other groups was not as
smooth. Some aspects of the project were clearly
conveyed, such as the diameter the valve should
be in order to fit in the testing device. There were
other aspects that we had thought were agreed
upon that either changed during the course of the
project, or were not originally understood. For
example, as a group we thought our valve needed
to be housed in a pipe in order to be easily tested
in the testing group’s apparatus. However, it
turned out that it would have been much easier if
the valve stood alone without a pipe housing.
Continuous communication between our group
and the testing group would have avoided this
confusion. However, it all worked out in the end
so no major problems arose.

ACKNOWLEDGMENTS
We would like credit Guy Everett, Payton
Christiano, and Wen Shi for the creation of the
heart valve testing apparatus used to obtain our
test results. We would also like to acknowledge
Dr. Neils for his COMSOL expertise used in the
creation of our computational models.
REFERENCES
1. Borgeson, D. Journal of the American Society of Echocardiography, 1996; vol 9: pp 832-837.
Enriquez-Sarano, M. New England Journal of Medicine, 2004; vol 351: pp 1539-1546.
2. Jaron, D., P. Lelkes, and R. Seliktar. "Mechanical Heart Valves - Types: Ball Valves." Mechanical
Heart Valves - Types: Ball Valves. The Body Synthetic, Winter 2008. Web.
3. Sabbah, H. N., and P. D. Stein. "Comparative Study of the Amount of Backflow Produced by Four
Types of Aortic Valve Prostheses." Journal of Biomechanical Engineering (1984): 66-71.
ASME.org. The American Society of Mechanical Engineers, 2016. Web.
4. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Division of Vital Statistics.
Deaths: Final Data for 2008. By Arialdi M. Miniño, Sherry L. Murphy, Jiaquan Xu, and Kenneth
D. Kochanek. Vol. 59. N.p.: NVSS, 2011. Ser. 10. Cdc.gov. Web.
5. "Heart Disease Facts." Centers for Disease Control and Prevention. Centers for Disease Control
and Prevention, 10 Aug. 2015. Web.
6. "What Is Heart Valve Disease?" National Institutes of Health. U.S. Department of Health and
Human Services, 22 June 2015. Web.
7. Davis, Charles P. "Heart Valve Disease: Get Facts on Symptoms and Treatment." MedicineNet.
WebMD, 06 Aug. 2016. Web.
8. Mozaffarian, Dariush, Emelia J. Benjamin, and Alan S. Go. "Heart Disease and Stroke Statistics-
2016 Update." Heart Disease and Stroke Statistics-2016. American Heart Association, 16 Dec.
2016. Web. Erbel, R. "Aortic Dimensions and the Risk of Dissection." Heart 92.1 (2006): 137-42.
Sciencedirect.com. Web. 8 Dec. 2016.
9. Erbel, R. "Aortic Dimensions and the Risk of Dissection." Heart 92.1 (2006): 137-42.
Sciencedirect.com. Web. 8 Dec. 2016.
10. Williams, David F. "On the Mechanisms of Biocompatibility." Biomaterials 29.20 (2008): 2941-
953. Sciencedirect.com. Web. 8 Dec. 2016.
11. United States of America. U.S. Department of Health and Human Services. Food and Drug
Administration. Use of International Standard ISO 10993-1, "Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing within a Risk Management Process.
12. United States of America. U.S. Department of Health and Human Services. Food and Drug
Administration. Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval
(PMA) Applications.
13. United States of America. U.S. Department of Health and Human Services. Food and Drug
Administration. Establishing Safety and Compatibility of Passive Implants in the Magnetic
Resonance (MR) Environment.
14. Mitchell, J. R., and J.-J. Wang. "Expanding Application of the Wiggers Diagram to Teach
Cardiovascular Physiology." AJP: Advances in Physiology Education 38.2 (2014): 170-75. Web.
9 Dec. 2016.
15. Brunette, D. M., P. Tengval, M. Textor, and P. Thomsen. Titanium in Medicine: Material Science,
Surface Science, Engineering. Place of Publication Not Identified: Springer, 2013. Print.
16. Rupp, Robert, Nabil A. Ebraheim, Edward R. Savolaine, and W. Thomas Jackson. "Magnetic
Resonance Imaging Evaluation of the Spine With Metal Implants|General Safety and Superior
Imaging With Titanium." Spine 18.3 (1993): 279-385. Spine. Web. 8 Dec. 2016.
17. Tortora, Gerard J., and Bryan Derrickson. Principles of Anatomy & Physiology. Hoboken, NJ:
Wiley, 2012. Print.
18. Elert, Glenn. "Viscosity." The Physics Hypertextbook.
APPENDIX A – Work Timelines
APPENDIX B – Gantt Chart