December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 1

BIOMECHANICS OF MECHANICAL HEART VALVE

1
Benjamn Gonzlez, Humberto Bentez, Kenneth Rufino, Merisabeth Fernndez and Waleska Echevarra
2
Abstract - Heart valves all are prone to disease and
malfunction, and can be replaced by prosthetic heart
valves. The two main types of prosthetic heart valves are
mechanical and bioprosthetic. The mechanical valve is
excellent in terms of durability, but is hindered by its
tendency to coagulate the blood. Bioprosthetic valve is
less durable and must be replaced periodically. All
valve types must be durable, because the body is an
extremely hostile environment for a foreign object,
including prosthetic heart valves. Today, engineers are
researching new designs of prosthetic heart valves. They
use the mechanical properties to make an artificial heart
valve design. An artificial mitral valve is an option for
humans with irreparable valve disease.
Key words -- Heart valve, Biocompatibility, Alumina,
Titanium, Biomaterial, Polyether urethane, Polyester,
Pyrolitic carbon.
INTRODUCTION
Heart valves prevent the backflow of blood, which ensures
the proper direction of blood flow through the circulatory
system. Without these valves, the heart would have to work
much harder to push blood into adjacent chambers. The
heart is composed of 4 valves (Figure 1). The Tricuspid
valve is between the right atrium and right ventricle. The
Pulmonary valve is between the right ventricle and the
pulmonary artery. The Aortic valve is between ventricle
and the aorta and the Mitral valve is between the left
atrium and left ventricle. It opens and closes to control
blood flowing into the left side of the heart.
Heart valves open like a trapdoor. The leaflets of the mitral
valve open when the left atrium contracts, forcing blood
through the leaflets and into the left ventricle. When the
left atrium relaxes between heart contractions, the flaps
shut to prevent blood, that has just passed into the left
ventricle, from flowing backward.
1
This review article was prepared on December 8,
2003 for the course on Mechanics of Materials - I.
Course Instructor: Dr. Megh R. Goyal. Professor in
Biomedical Engineering, General Engineering
Department, PO BOX 5984, Mayagez Puerto Rico
00687-5984. For details contact:
m_goyal@ece.uprm.edu or visit at:
http://www.ece.uprm.edu/m~goyal/home.htm
2
The authors are in the alphabetical order.


The mitral valve, which lies between the two left chambers
of the heart, consists of two triangular-shaped flaps of
tissue called leaflets. The leaflets of the mitral valve are
connected to the heart muscle through a ring called the
annulus, which acts like a hinge.
The mitral valve is anchored to the left ventricle by
tendonlike cords, resembling the strings of a parachute,
called chordae tendineae cordis.
When working properly, heart valves open and close fully.
In mitral regurgitation, the mitral valve does not open or
close properly. Some blood from the left ventricle flows
backward into the left atrium with each heartbeat.
Regurgitation refers to the leakage (backflow) of blood
through a heart valve.


Figure 1. Heart Valves [1].
Heart Valve Problems [7]
There are numerous complications and diseases of the heart
valves that can prevent the proper flow of blood. Heart
valve diseases fall into two categories: Stenosis and
Incompetence. The stenotic heart valve prevents the valve
from opening fully, due to stiffened valve tissue. Hence,
there is more work required to push blood through the
valve. Whereas, the incompetent valves cause inefficient
blood circulation and cause backflow of blood in the heart,
called as regurgitation.
Treatment Options [22]
On a large scale, medication is the best alternative, but in
some cases defective valves have to be replaced with a
prosthetic valve in order for the patient to live a normal
life. An enormous amount of research and development
has proven to be most beneficial, as prosthetic heart valve
technology has saved thousands of lives. Engineers and
The best place to find helping hand is at the end of your arm --- Swedish Proverb.




December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 2








scientists have done much work to design a valve that can
withstand millions, if not billions, of cardiac cycles. The
two main prosthetic valve designs include mechanical and
bioprosthetic (tissue) Heart Valves.
Mitral Valve Replacement [22]
Valve replacement is done when valve repair is not
possible. Artificial Heart valve is the last solution for
people with a damage heart valve caused by any disease as
regurgitation, etc In valve replacement surgery, an
artificial prosthetic valve replaces the damaged mitral
valve. The two types of artificial valves are mechanical and
tissue. Mechanical valves, which are made of biomaterials,
may last a long time. However the patient with a
mechanical valve must use an anticoagulant medication
such as warfarin (Coumadin, Panwarfin) for the rest of life
to prevent blood clots from forming on the valve. If a blood
clot forms on the valve, the valve wont work properly. If a
clot escapes the valve, it could lodge in an artery to the
brain, blocking blood flow to the brain and causing a
stroke. Tissue valves are made of biological tissue such as a
pigs valve. These kinds of valves are called bioprostheses.
These may wear out over time and may need to be replaced
in another operation. However the tissue valve can avoid
use of long-term anticoagulation medication.

Mitral valve repair or replacement involves open-heart
surgery. Through an incision in the breastbone (sternum),
the heart is exposed and connected to a heart-lung machine
that assumes the breathing and blood circulation during the
procedure. The surgeon then replaces or repairs the valve.
After the operation, which lasts several hours, the patient
spends one or more days in an intensive care unit, where
the general recovery is closely monitored.
History and Advances of Artificial Heart Valves [1]
The first mechanical prosthetic heart valve was implanted
in 1952. Over the years, 30 different mechanical designs
have originated worldwide. These valves have progressed
from simple caged ball valves, to modern bileaflet valves.
The caged ball design is one of the early mechanical heart
valves that use a small ball that is held in place by a welded
metal cage. The ball in cage design was modeled after ball
valves used in industry to avoid backflow. Natural heart
valves allow blood to flow straight through the center of
the valve. This property is known as central flow, which
keeps the amount of work done by the heart to a minimum.
With non-central flow, the heart must work harder to
compensate for the momentum lost due to the change of
direction of the fluid. Caged-ball valves completely block
central flow; therefore the blood requires more energy to
flow around the central ball. In addition, the ball may cause
damage to blood cells due to collision. Damaged blood
cells release blood-clotting ingredients; hence the patients
are required to take lifelong prescriptions of anticoagulants.
For a decade and a half, the caged ball valve was the best
artificial valve design. In the mid-1960s, new classes of
prosthetic valves were designed that used a tilting disc to
better mimic the natural patterns of blood flow. The tilting-
disc valves have a polymer disc held in place by two
welded struts. The disc floats between the two struts in
such a way, as to close when the blood begins to travel
backward and then reopens when blood begins to travel
forward again. The tilting-disc valves are vastly superior to
the ball-cage design. The titling-disc valves open at an
angle of 60 and close shut completely at a rate of 70
times/minute. This tilting pattern provides improved central
flow while still preventing backflow. The tilting-disc valves
reduce mechanical damage to blood cells. This improved
flow pattern reduced blood clotting and infection.
However, the only problem with this design was its
tendency for the outlet struts to fracture as a result of
fatigue from the repeated ramming of the struts by the disc.
Bileaflet valves were introduced in 1979. The leaflets
swing open completely, parallel to the direction of the
blood flow. The bileaflet valves were not ideal valves.
The bileaflet valve constitutes the majority of modern valve
designs. These valves are distinguished mainly for
providing the closest approximation to central flow
achieved in a natural heart valve.
Mechanical Heart Valve

Prosthetic Heart Valves are fabricated of different
biomaterials. Biomaterials are designed to fit the peculiar
requirements of blood flow through the specific chambers
of the heart, with emphasis on producing more central flow
and reducing blood clots. Some of these biomaterials are
alumina, titanium, carbon, polyester, polyurethane etc

The mechanical properties of these biomaterials involve
how a material responds to the application of a force. The
three fundamental types of forces that can be applied are
stretching (tension), bending, or twisting. Materials
respond to the forces by deforming (changing shape). An
elastic response is reversible, while an inelastic response is
irreversible. In the elastic region, an elastic modulus relates
the relative deformation a material undergoes to the stress
that is applied. The transition between elastic deformation
and failure occurs at the yield point (or stress) of the
material. In designing a component with the material, an
inelastic response is considered failure. Failure can be
plastic deformation or ductile failure. It can also be
breaking, including brittle failure or fracture. Mechanical
properties of a material in the range of elastic behavior
include its elastic modulus under tension and shear stresses,
its Poissons ratio, its resilience, and its flexural modulus.
The transition to failure is denoted by the yield stress or
breaking strength of the material.




December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 3








BIOMATERIALS

The requirements for an artificial heart valve are
staggering. The valve must be easy to insert. It must last a
long time. It must be able to open and close 35 million
times a year for 20 to 50 years. It must allow high blood
flow with minimal turbulence and must not leak. The valve
also should not cause blood clots and also:

Collapse to 5 mm when crimped.
Top of stent expands to 25 mm.
Middle of stent expands to 30 mm.
Bottom of stent expands to 25 mm.
Deployed height is 25.4 mm.
Collapse to 5 mm when crimped.
Barrel shaped.
Top stent expands to 30 mm.
No damage to leaflets.
Length is 12.7 mm - 25.4 mm.

1. Alumina (Al
2
O
3
) : aluminium oxide [17]

Alumina (Al
2
O
3
) is a bioinert material. Bioinert materials
do not chemically react with the local chemicals As a
result, cells can survive next to the material but do not
form a union with it. Often fibrous protective cells grow
near the implant surface to protect local cells from
mechanical damage. Bioinert materials were first used for
prosthetics. These materials can be very strong but have
the disadvantage of not bonding to the local cells.
Numerous problems have been encountered in anchoring
the bioinert implants to bone. In early implants, some
implants became deformed or displaced, causing serious
damage to the surrounding tissue.

Alumina is a traditional ceramics that offer many
advantages compared to other biomaterials. These are
harder and stiffer than steel; more heat and corrosion
resistant than metals or polymers; less dense than most
metals and their alloys; and their raw materials are both
plentiful and inexpensive. Design requirements for alumina
as a biomaterial are:

High fluid resistance.
Avoid hemorrhage.
Low incident of thromboembolism.
Be economic.
High performance.
Avoid stiffening of the leaflets.
Optimal designs.
Good thermal conductivity.
Ability to open and close 35 million times a year
for 20-50 years.
Biocompatibility.
Avoid blood clots.
Available easily.

Alumina as biomaterial

Alumina is the most widely and versatile ceramic. Much of
the research on this ceramic was done during the 1950s and
1960s. Alumina is chemically stable against most
environments except hydrofluoric acid and some molten
salts. These traditional ceramics set upon hydration if
produced in the special form of re-hydratable alumina
cement (more commonly in the form of calcium aluminate
cement). Also alumina is widely used for medical implants
like mechanical heart valve. This type of ceramic is also
used in several medical fields as dentistry, orthopedical and
cardiologist application.

It is a ceramic, non-metallic, and inorganic compound that
displays great strength and stresses resistance to corrosion
wear and low density. Alumina is a highly bioinert
material and resistant to most corrosive environments,
including the highly dynamic environment of the human
body.

Compatibility between Bioceramics and the Human
Environment [17 and 26]

The major problem on implants designs is the fairly limited
choice of materials, and consequently, determination of the
compatibility of the material of choice with the tissue.
There are no standard methods of compatibility testing and
the number of variables involved is usually much larger
than the typical engineering problem. For example, human
blood is 1/3 as salty as seawater, stays at a steady 37C, and
contains active enzymes (the immune system).

Human body is one of the most corrosive environments that
inorganic substances can encounter. Furthermore, as the
various metabolic processes occur in an organism the
various complex molecules that may enclose a substance
continually change in concentration and variety. Lactic acid
produced from muscle cells during anaerobic cellular
respiration is a prime example. Additionally, the time
factor of the compatibility reaction is important; the
implant - tissue interaction is a sequential chain of
reactions, characteristic for the material and the patient.

Beyond the chemical factors, the response of tissue
depends additionally on geometric characteristics of the
implant, e.g. shape, size, surface/volume ratio. These
factors will generally determine the state of stress at the
interface and thus could interfere with the interfacial
reactions. Porosity and its size distribution within an
implant have been shown to affect the interactions. It has
been generally established, that tissue will grow into pores
larger than ~120 nm.
Most polymers seem to be slowly digested by the human
body and metals are slowly corroded: high concentration of
metallic elements has been detected close to the (metallic)
implant surface. Passive oxide film can significantly slow



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 4








down the reactions with tissue, rendering titanium or
stainless steel virtually neutral. However, polymeric and
metallic implants are generally classified as temporary
implants, with very low adhesive strength of attachment to
the tissue.

Alumina is considered bioinert due to a thin layer of
titanium ions on its surface, although some studies show
that the body can absorb alumina. Various researchers have
found alarmingly low levels of Al in rats nervous systems
after the 20-week postoperative period.

The bioinert ceramics, like ZrO
2
, Al
2
O
3
, SiC, Si
3
N
4
do not
develop strong interfaces, but also do not liberate ions into
the internal environment. This is at the expense of lesser
mechanical performance and reliability of ceramics, as
compared to metals. A compromise is ceramic-coated
metal, although some additional liabilities are created (e.g.
adhesion of the coating; increased processing costs etc.).

Alumina Mitral Valve [26]

Ceramic materials are somewhat limited in applicability by
their mechanical properties, which in many respects are
inferior to those of metals. The principal disadvantage is a
disposition to catastrophic fracture in a brittle manner with
very little energy absorption.

The ceramic mitral valve is comprised of a single crystal
alumina disc and titanium valve ring. Alumina consists of
aluminum and oxygen ions. These ions combine firmly by
ionic bond and are arranged in hexagonal closed packed
structure. The single crystal alumina disk is 1.0 mm thick.
Both mechanical and chemical polishing smoothed the
surfaces. The valve ring was milled from a single piece of
titanium and was coated with Tin by reactive ion plating
(See appendix IV). Alumina has a good blood
compatibility, excellent wear resistance, largely inert and
durability. Alumina mitral valve avoids thrombus
formation and thromboembolism.

Tensile strength of single alumina is more than three times
greater that LTI carbon. Alumina has hardness eight times
greater than LTI carbon. Alumina is insoluble in water and
has high corrosion.
Properties of Alumina
a. Scratch resistance: The extreme hardness of alumina is
second only to a diamond. Metal-on-metal articulations can
be scratched causing an abrasive surface. Foreign debris in
the joint may also accelerate implant wear. Alumina is
more scratch resistant than metal or polyethylene; so it is
most durable than other valve materials.

b. Ion release: Since ceramics do not release ions, there are
no long-term unknowns pertaining to systemic effects due
to ion release with this hard bearing couple, unlike metal-
metal bearing couples.

c. Friction and wetability: A material that holds
lubrication to its surface is considered wet able. Alumina
ceramic is a more wet able material than metal. Lubrication
helps to reduce friction between components. Alumina
ceramic has improved since the 1974. Third generation
materials have nearly twice the strength as the original
material because of enhancements in purity, density and
grain size.

d. Fracture: This property continues to be the primary
concern regarding ceramic components. Improper handling
and implantation, poor implant design and material, or
mismatched components caused fractures in early ceramic
designs. When correctly implanted, the fracture rate has
been reported between one-tenth to one-twentieth of a
percent (0.001 - 0.0005) and it is projected that
contemporary materials will be even lower. Alumina
should be use, only in compression.

e. Strength: Though ceramics are brittle in nature, alumina
ceramic inserts are extremely strong and exceed FDA
Guidance Document standard for ceramic heads of 46 kN
or 10,340 pounds burst strength. This exceeds the strength
of the ceramic head as well as the neck of the femoral stem.
As with any modular interface under load, there is a
potential for micro motion and associated fretting and/or
corrosion. However, the alumina design minimizes the
amount of motion at the taper interface, which should
reduce the corrosion potential.

Alumina mechanical properties are summarized as:

Good mechanical strength (Figure 3).
Good thermal conductivity.
High electrical resistivity.
High hardness (Figure 2).
Wear resistant.
Good chemical stability.
Largely inert.
Excellent tribological characteristics.



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 5








Figure 2. Hardness of different biomaterials [26].

Valve Problems with Alumina
a. It is a hard material so that machining is difficult.
Therefore, some molding process must be developed which
can produce a finished valve with the accurate internal
shape required to achieve good homodynamic performance.
b. The tissue covering requires a porous, textured alumina
surface on which to anchor itself firmly, but the main body
of the conduit valve must be in the most dense form of
alumina, with virtually no porosity, in order to maintain
structural strength. The molding process must therefore
accommodate variable porosity in some way.
c. Alumina cannot avoid thromboembolism totally.

Alumina Future
Research is being done to combine alumina with other
materials for better heart valve implants. These
experiments try to avoid tromboembolism, which is the
major problem on heart valve implants. Today, there are no
materials to avoid totally thrombosis. Alumina is a
material with good mechanical properties, but mechanical
heart valve manufactures didnt use for this purpose.
Instead alumina is utilized in dental implants.
Lawsuits against medical device manufacturers,
restructuring of FDA approval procedures, patient
expectations, and the health care reform movement are
changing the future of the medical device community and
shaping the direction of biomaterials research. As a result,
new materials and manufacturers will be required to meet
FDA standards. Another important issue not often
discussed is that implant recipients expect an implant to
function and to last forever.
Biomaterials and implant research will continue to
concentrate on serving the needs of medical device
manufacturers and recipients, as well as medical
professionals, and on developing technologies to meet
those needs. Future biomaterials like alumina will
incorporate biological factors directly into an implants
surface to improve biocompatibility and bioactivity. New
projects will be directed at materials development for
improved mechanical integrity, corrosion resistance, and
biocompatibility. Institute engineers will also apply
statistical finite element analysis, stereo imaging strain
analysis, and composite materials to the biomaterials
program. Therefore, alumina is one of these experimental
materials for the future.
Figure 3. Tensile Strength (MPa) of biomaterials [26].

2. Polyester
What is polyester? [27]
Polyester is a synthetic resin formed by the condensation of
polyhydric alcohols with diabasic acids. Polyesters are
thermosetting plastics used in making sythentic fibres and
constructional plastics. It is an extremely resilient fibre that
is smooth, crisp and particularly springy. Its shape is
determined by heat and it is insensitive to moisture. It is
lightweight, strong and resistant to creasing, shrinking,
stretching, mildew and abrasion. It is readily washable and
is not damaged by sunlight or weather and is resistant to
moths and mildew. The following requirements must be
satisfied to use polyester as a biomaterial in heart valves
implants:
The bodys immune system must not attack the
biomaterial.
Compatible with body tissues and fluids
Must have strength, flexibility and hardness
Must be nontoxic, nonreactive or biodegradable
The replacement valve must be smooth to prevent
the destruction of blood vessels.
The valve must also be anchored to the inside of
the heart.
Must be an elastomer so it can be flexible during
the pumping cycle.
0
200
400
600
800
1000
A
l
u
m
i
n
a
S
t
a
i
n
l
e
s
s
S
t
e
e
l
T
i
t
a
n
i
u
m
L
T
I
C
a
r
b
o
n
0 5 10 15 20
Alumina
LTI Carbon
Titanium
TitaniumNitride
Series1
Series2



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 6








The material must not exhibit mechanical fatigue
over the devices lifetime.
The materials surface must have an acceptable
low propensity for thrombus formation, as well as
the best possible blood compatibility
Must not be prone to calcification.
The material must be easily formed into complex
shapes.

Structure and Physical Properties of Polyester

Polyester chains tend to be flexible and are easily
entangled or folded.
Degree of crystallinity is the amount of ordering
in a polymer.
Stretching or extruding a polymer can increase
crystallinity.
Degree of crystallinity is also determined by
average molecular mass.
Bonds formed between polyester chains make the
polyester stiffer.

Development of Polyester in Vascular Surgery

Vascular prostheses fabricated as polyester textile tubes are
most frequently used devices in peripheral vascular surgery
for the replacement of large and medium sized vessels.
Long term results representing a period of follow-up over
15 20 years have shown satisfactory results when Dacron
grafts are installed in the aortic and iliac sites. Technical
developments to improve the device over the years have
passed through different generations of concepts. The
relative merits of these different designs are still a matter of
intensive research.

Woven or Knitted Design

Weslowski was the first to recognize the importance of the
porosity within the graft wall for the healing process of the
graft. By using a more open textile structure with large
pores between the polyester fibers it was predicted that
cellular elements and fibrous tissue would be able to
penetrate the interstices of the graft wall and generate a
well-attached, more completely healed surrounding
capsule. Unfortunately, measurements of water
permeability were mistakenly assumed to measure the
porosity of the graft wall, and as a result manufacturers
produced thinner and thinner textile structures using finer
and finer polyester yarns with a view to improve the
healing performance of the prostheses. The creation of the
ultra-light-weight design provided the surgeon with a more
flexible graft that was easier to handle and suture. But too
high water permeability posed difficulties in preclothing
the graft so as to achieve hemostasis. Problems of
hemorrhage at the time of implantations and complications
associated with secondary hematomas around the grafts as
well as prosthetic dilatation and failure caused this concept
to be abandoned in the late 1970s. Surprisingly enough, the
ideal values for the porosity and water permeability of a
vascular prosthesis are defined poorly.

In spite of the success of expanded PTFE grafts that remain
patent for many years without any tissue encapsulation, it is
still believed that complete healing of the luminal surface is
a critically important requirement for long-term patency.
One approach to achieve this was proposed by DeBakey
and to improve the anchoring of fibrous tissue, increase
cellular adhesion, and hence promote the formation
neointima by the use of the velour design. This involves
weaving or knitting rather than straight fibers to give a
rougher, randomized, and more open appearance to the
external and/or internal surface of the graft. External velour
enables better incorporation of the graft within the host
tissue, whereas internal velour encourages the formation of
thicker neointima. This may be less important in clinical
practice since complete endothelialization is never
accomplished in humans. Even so, internal external and
double velour grafts are widely available.

As a result of the complications such as dilatation
associated with the light-weight weft-knitted design,
manufacturers have taken steps to increase the strength of
grafts by using thicker polyester yarns and tighter, more
compact woven constructions. The more open woven
velour constructions should be anastomosed with a larger
than normal bite or cut with a hot cautery in order to reduce
the risk of fraying at the suture line. The regular woven and
low porosity woven design are used widely for the
replacement of the thoracic aorta and for interventions
involving a cardiopulmonary bypass with heparinization.
For those surgeons who prefer the ease of handling and
suturing of the knitted construction, most major models
with the more dimensionally stable warp knitted prosthesis
have now replaced former weft knitted models, thus
ensuring the same good anchorage of the neointima but
avoiding the complications associated with dilatation and
raveling of the textile structure in vivo. The importance of
maintaining the initial strength of vascular prostheses at an
acceptable level is now widely accepted.

Externally Supported Design

The problem of flattening and occlusion of a vascular graft
at the point where it crosses a knee or hip joint is well
known. External reinforcement of the graft by means of a
rigid spiral support has proven to be effective in alleviating
this problem and has found merit in the axillofemoral
position as well. The performance observed during animal
trials as well as clinical observations of explanted devices
suggest that high levels of friction and fatigue can occur to
the textile structure underneath the rigid external support.
This is particularly problematic with those models where
the external support is not well attached to the outer surface



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 7








of the prosthesis. As a result, perhaps the most valuable
application for this type of design is in the axillofemoral
bypass where compression of the graft may occur, when the
patient is lying on the relevant side.

Composite Design

In order to improve the biocompatibility of porous
synthetic grafts, it has been proposed that the polyester
textile structure be impregnated or coated with a
crosslinked protein. A number of different proteins have
been studied, including albumin, collagen, gelatin, elastin,
and chitosan. Observations from comparative in vivo
studies as well as from our explant retrieval program
indicate that the healing process is virtually identical with
the coated and uncoated grafts. The only difference, if any,
resides in the rate of the healing process, wich is slowed by
the addition of the protein coating. Because the prosthesis
is already nonpermeable to blood and ready to implant the
moment it is removed from is sterile packaging, the need
for blood transfusion and preoperative manipulation is
reduced. In addition, since the coating is resorbed slowly, it
has been proposed that antibiotics and growth promoting
factors be added to the protein in order to reduce the risk of
infection and enhance the healing of the neointima.

The cellular seeding of vascular prostheses with endothelial
cells appears to be a very promising technique. The
experimental research to date has improved our
understanding of the different functions of the endothelial
cell and its interactions with blood. However, the efficiency
of the cell seeding procedure leaves much to be desired,
and, while the technique has proven useful in a few human
trials, it is not yet ready for routine clinical use. In the long
term, there it do appear to be beneficial in using this
technology, particulary in femoropopliteal and distal sites
where the rate of flow is limited and in reducing the
incidence of infection.

Another type of surface coating proposed for vascular
grafts involves the use of the plasma graft polymerization
process. This technique can modify the surface chemistry
and hence the biocompatibility of a synthetic material.
Typically, plasma of fluorethylene gas is generated in a
evacuated chamber containing the prosthesis by means of a
high-frequency magnetic field. The free radicals so
produced react rapidly with each other and with any surface
they encounter, depositing a thin layer of a fluorocarbon
polymer on the polyester fibers of the vascular graft. The
flow surface is thus likely to be more hydrophobic and
biocompatible. Preliminary results in animals have so far
been promising, but they have not been confirmed in
humans.

Biocompatibility
Although saphenous vein remains the material of choice
for vascular reconstruction, fem-popliteal grafts composed
of polyester have gained in popularity due to the similar
rates of occlusion and ease of use. Despite these
advantages, there is continuing concern over the
nevertheless high rates of occlusion, for both native and
synthetic grafts which significantly contributes to the
greater than 30% failure rate experienced within one year.
As these failures often lead to limb loss and other serious
complications, the availability of a non-thrombogenic graft
or one with reduced thrombo-genicity would have
significant clinical impact and could serve to reduce the
incidence of thrombosis related complications. Polymeric
biomaterial surfaces such as polyester and PTFE are
intrinsically thrombogenic. Grafts composed of these
materials can be surface modified in order to reduce this
inherent thrombogenicity. Heparin treatment of the surfaces
of a number of medical devices such as catheters, heart
valves, stents and bypass circuitry has successfully been
used as a means of reducing surface thrombogenicity.

In 1991, InterVascular developed the concept of adding
unfractionated high molecular weight heparin to the inner
lumen of a graft through a stable bonding process. It was
believed that this modification of the graft surface could
significantly reduce its thrombogenicity and potentially
improve graft performance and clinical outcome. Heparin is
coupled to the InterGard Heparin surface using tri-
dodecylammonium chloride (TDMAC) which forms an
insoluble complex with heparin and in turn binds with high
affinity to the polyester flow surface through its long
hydrophobic tails. The heparinized graft is then coated with
collagen which acts as a barrier to prevent rapid release of
the heparin from the graft surface. A series of studies was
performed to evaluate the safety and efficacy of the
InterGard heparin coated graft. Animal studies were
performed to confirm that no bleeding complications and
good healing characteristics were associated with the use of
the heparin bonded graft.

In addition, complete ISO 10993 biocompatibility tests
were performed to assure that safety and biocompatibility
requirements were met. Bench studies were conducted to
evaluate the retention of heparin on the InterGard heparin
graft in a simulated model of circulation using
physiological flow rates and pressures. In these studies,
heparin levels remained constant for 7 days in the
InterGard heparin collagen coated graft but declined
dramatically in the non-collagen coated graft demonstrating
that the stable bonding process of ionic coupling to
TDMAC followed by hydrophobic interaction with
polyester immobilizes the heparin to the graft. Furthermore,
the collagen coating helps retain the heparin complex
preventing its premature release. Additional studies were
performed which demonstrated that the heparin-collagen
coating dramatically reduces the deposition of fibrin (a
measure of thrombogenicity) relative to uncoated polyester
grafts. These studies coupled with on going promising
clinical data continue to support the safety, utility and



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 8








clinical benefits associated with the InterGard Heparin
graft.

Polyesters Chemical Properties [20]

Polyesters are formed either by a reaction between a dibasic
acid and a dihydroxy alcohol or by the polymerization of a
hydroxy carboxylic acid. The chemical structure of a
polyester is shown in figure 4. Polyesters are naturally clear
and colorless; however they can be colored and made
according to specifications. Polyesters do not show wear
with exposure to poor weather conditions. They are highly
resistant to chemical deterioration, withstanding most
solvents, acids, and salts. They are also resistant to heat
damage and can be made to be self-extinguishing.
Not to be outdone, DuPont was also at the forefront of
polyurethane technology in the U.S., receiving patents in
1942 covering the reactions of diisocyanates with glycols,
diamines, polyesters and certain other active
hydrogencontaining chemicals. From these humble
beginnings emerged the polyurethanes, the most versatile
polymers in the biomaterials armamentarium.

Figure 4. Chemical Structure of polyester [20].

3. Polyurethanes [25 and 27]

Polymers are considered some of the most promising class
of biomaterial. They can be selected according to certain
characteristics such as mechanical resistance, degradability,
permeability, solubility, as well as transparency.
Polyurethanes are the polymers most widely used in the
construction of blood-contacting products and devices.

History of polyurethane

Nineteen eighty-seven marked the 50
th
anniversary of the
introduction of polyurethanes. Professor Otto Bayer was
synthesizing polymer fibers to complete with nylon when
he developed the first fiber-forming polyurethane in 1937.

Polyurethanes technology

Current activities of suppliers, designers, manufacturers
and physicians clearly indicate that devices manufactured
from synthetic polymers have become an integral part of
health-care technology. Initially focused on life-threatening
situations, their clinical uses now include permanent
implantation (e. g. artificial hearts, hip prostheses,
intraocular lenses), intermediate applications (e. g. contact
lenses, removable dental prostheses, renal dialyzers), and
transient applications (e. g. cardiopulmonary bypass, over-
the-needle catheters, diagnostic and therapeutic catheters).
The polymers used most often in these applications are the
silicone elastomers, the acrylics, polyvinyl chloride,
fluorinated ethylene propylene and polycarbonates.

In the past ten years, research work on the artificial heart
has stimulated interest in this new family of polymers, the
segmented polyurethane elastomers. Originally developed
for commercial applications, these polymers exhibit high
flexure endurance, high strength, and inherent
nonthrombogenic characteristics, and are expected to have
a positive effect on future medical applications. Segmented
polyurethane polymers are widely used as artificial heart,
vascular grafts, catheter, diaphragm of blood pump,
pacemakers wire insulation, heart valves, cardiac-assist
devices, components of hemodialysis units, skin grafts and
blood filters. Since the segmented polyurethane exhibit
high strength, nonthrombogenic characteristics, the most
important applications appear to be in the cardiovascular
area. Because of higher hydrolytic resistance and better
properties at low temperatures, the structures of
polyurethanes prepared from lactones can be used as
medical, solvent-activated, pressure-sensitive adhesives.

Future scope of polyurethane

A material used in the leaflet heart valves, mechanical heart
valve coatings and total artificial heart is polyether-based
polyurethane. However, one drawback of this material is
the absorption of the proteins and thus, the onset of
thrombosis and bacterial infection. The right materials have
the good mechanical properties of polyurethane while
eliminating the risk of thrombosis and bacterial infection.
Unfortunately, scientists have been unable to find a suitable
substitute with such mechanical properties as well as
relative biocompatibility. Therefore, scientists have begun
searching for possible improvements to polyurethane in an
attempt to increase its biocompatibility.

One possible solution to the compatibility problem is to
synthesize a polymer alloy consisting of polyurethane along
with a phospholipid polymer. A current polymer alloy that
has shown promise in combating the onset of thrombosis as
well as bacterial infection is 2-methacryloyloxethyl
phosphorylcholine (PMEH) with segmented polyurethane.
Research on this alloy has shown a significant decrease in
the amount of proteins absorbed at the blood-suface
interface. In fact, when protein adsorption data was
recorded, the amount of the protein adsorbed on the 2-
methacryloyloxethyl phosphorycholine segmented
polyurethane tubing was only 17% of that adsorbed by
segmented polyurethane tubing alone. In similar attempt,
scientists synthesized an alloy of polyurethane with the
addition of poly (tetramethylammonium) oxide and
methylene diphenylene diisocyanate along with chain



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 9








extenders of 3-trinethylammonium-1,2-propanedioliodide
(TMPI) and 3-dimethylamino-1,2-propanedioliodide
(DMP). This alloy had been previously found to restrict the
onset of thrombosis. In an experiment conducted to
determine the protein attachment rate constant of three
polyurethane alloys as well as pure polyurethane. This
polyurethane, labeled PEU-N, was found to have a higher
attachment constant (.00059 cm/min) than either of the
other polyurethane alloys including a phospholipids
polymer alloy (PEU-G). However, PEU-N did have a lower
adhesion constant than pure polyurethane (PEU-B).

Not all polyurethanes are equally effective in their
biocompatibility properties. Polyurethanes comprise a large
family of materials, with urethane linkage being the only
common characteristic. They have been found to vary in
clinical applications. When implanted in the human body,
polyester-based polyurethanes tend to undergo a rapid
hydrolysis and should be avoided in medical applications.
Due to their quick crystallization, polycaprolactone-based
polyurethanes can be used as medical applications, but only
as pressure-sensitive adhesives. Polybutadiene-based
polyurethanes have been investigated, yet no medical
application has been found to date. Castor oil-based
polyurethanes can be used, but due to their poor tear
resistance, have a very limited use in medical applications
since they are virtually insensitive to hydrolysis, and
therefore are very stable in the physiological environment.


4. Polyether urethane

In the preparation of this type of polymers, polyether-based
glycols are used. If they are cured with aromatic diamines
then their structure-property relationships will be very
similar to those of polyester urethanes. At high NCO/NH2
ratios the excess isocyanate forms biuret branch points.
Thus, an increase in cross-linking causes a reduction in
modulus, elongation, compression set, and tears strength.

The secondary reactions occur to a much less extent than
the primary reactions but their importance must not be
underestimated. Formation of allophanates or biurets is
responsible for some of the cross-linking and branching
and therefore has an important influence on the properties
of the polyurethane product.

Elasthane polyether urethane [19]

Elasthane polyether urethane is a high-strength, aromatic
thermoplastic with a chemical structure and properties very
similar to Pellethane

2363 polyetherurethane series, which

has been used to fabricate a large number of implantable
devices, including pacemaker leads and cardiac prosthesis
devices such as artificial hearts, heart valves, intraaortic
balloons, and ventricular assist devices. PTG's Elasthane is
designed for chronically-implanted medical devices and
demonstrates an impressive combination of mechanical
properties and biological compatibility. The Polymer
Technology Group developed Elasthane in response to
Dow's decision to limit Pellethane's use in chronically
implanted medical devices. In developing Elasthane, PTG
invested in the same continuous reactor technology to offer
the only Pellethane substitute with the same high molecular
weight and reduced thermal history as Pellethane. PTG has
rigorous quality control and documentation of the
manufacturing procedures, formula optimization, and
precision feed pumps. Formal validation of Elasthane was
accomplished through rigorous short- and long-term testing
in conjunction with a major academic institution and a
medical device company that has since received approval to
implant the material. A comprehensive FDA Masterfile also
backs Elasthane.

Elasthane polyether urethane is a thermoplastic
elastomer formed as the reaction product of a polyol, an
aromatic diisocyanate and a low molecular weight glycol
used as a chain extender. Polytetramethylene oxide
(PTMO) is reacted in the bulk with aromatic isocyanate,
4,4'-methylene bisphenyl diisocyanate (MDI), and chain
extended with 1,4-butanediol.

Application of Elasthane polyether urethane
Numerous medical devices and technologies have benefited
from the combination of exceptionally smooth surfaces,
excellent mechanical properties, stability, and good
biocompatibility of Elasthane polyether urethane.
Pellethane is currently the polyurethane used for the
tricuspid semilunar valves. Due to its high molecular
weight, valves fabricated from Elasthane have shown to
reduce the degree of calcification. Furthermore, Elasthane
that has been chemically modified with polyethylene oxide
(P) and sulfonate (SO) SMEs showed lower surface platelet
adhesion and thrombus formation, suggesting improved
blood compatibility.
Hydrodynamic evaluation of Pellethane valves showed
minimum pressure drop and very low energy losses
compared with other commercially available valves. It was
also found that in durability tests, prototypes have lasted
for 17 years.
Mechanical Properties of Polyether urethane [10]

At lower hardness levels, practically all elastomeric
materials, including polyurethane elastomers, merely bend
under impact. As conventional elastomers are compounded
up to higher hardness they tend to lose elasticity and crack
under impact. On the other hand, polyurethane elastomers
when at their highest hardness levels have significantly
better impact resistance than almost all plastics.




December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 10








Such great toughness, combined with the many other
outstanding properties associated with the high hardness
polyurethane leads to many applications in engineering.
(Appendix I gives properties of different kinds of
Polyurethanes).

Biocompatibility of Polyether Urethane
The blood contacting surface of some leaflets hearts valves
are made of polyether urethane (PEU, n = 22). This
polyurethane can be resistant to thrombus formation when
processed into an ultra smooth contacting surface.
Elastomeric polyurethanes are inherently thromboresistant.
Although blood compatibility and nonthrombogenicity are
subject to many complex factors, such as polymer surface
composition, device configuration, and blood-flow
characteristics, they tend to perform well in numerous
device configurations. Their apparent thromboresistance is
thought to reside in polyurethanes ability to preferentially
absorb serum albumin.
When the biomaterial surface comes into contact with
blood, a protein layer of fibrin results from the
polymerization of fibrinogen. When bacteria interacts with
the surface of a blood-contacting biomaterials it does so
through this adsorbed protein layer. Therefore, bacteria can
easily attach itself to the material surface and cause
infection.
When choosing a material to combat bacterial adhesion, it
is essential that the material limits protein adsorption.
Proteins tend to be negatively polarized and thus
hydrophobic in nature. With this in mind, it is beneficial to
select a material that is similarly polarized, thus likely to
repel the proteins from the biomaterials surface, hindering
the protein-surface interaction and protein adsorption by
the surface. By disrupting this adsorption of proteins, the
material is less likely to develop a protein layer and less
likely to promote the development of bacterial growth and
infection.
Surface modification of polyurethane heart valves:
effects on fatigue life and calcification
Polyurethane heart valves can be functionally durable with
minimal calcification, in vitro. In vivo, these characteristics
will depend on the resistance of the polyurethane to
thrombogenesis and biodegradation. Surface modification
may improve the polyurethane in these respects, but may
adversely affect calcification and durability. This study
investigates the effects of surface modifications of two
polyurethane heart valves (PEU and PEUE) on vitro fatigue
and calcification behavior. Modifications included heparin,
taurine or aminosilane. Aminosilane modification of PEUE
valves increased durability compared with PEO
modification. Appropiate surface modification may be
useful to improve blood compatibility of implantable
polyurethanes, and may also be advantageous as regards
fatigue durability of flexing materials in long term
applications.
Polyurethane heart valves: Fatigue failure, Calcification
and Polyurethane Structure
Six flexible-leaflet prosthetic heart valves, fabricated from
a polyether urethane urea (PEUE), underwent long-term
fatigue and calcification testing by Dernacca GM,
Guldransen NJ; Wikinson R; and Wheatley DJ. They
discovered that three valves exceeded 800 million cycles
without failure. Three valves failed at 775, 460, and 544
million cycles, respectively. Calcification was observed
with and without associated failure in regions of high
strain. Comparison with similar valves fabricated from a
polyether urethane (PEU) suggested that the PUE is likely
to fail sooner as a valve leaflet. Localized calcification was
developed in PEUE leaflets at the primary failure site of
PEU leaflets, close to the coaptation region of three
leaflets. The failure mode in PEU valves had the
appearance of abrasion wear associated with calcification.
High strains in the same area may render the PEUE leaflets
vulnerable to calcification. Intrinsic calcification of this
tape, however, is a long-term phenomenon unlikely to
cause early valve failure. Both polymers performed
similarly during static in vitro and in vivo calcification
testing and demonstrated a much lesser degree of
calcification than bioprosthetic types of valve materials.
Polyurethane valves can achieve the durabilities required of
an implantable prosthetic valve, equaling the fatigue life of
currently available bioprosthetic valves.
Polyurethane heart valve durability: Effects of leaflets
thickness and material
The durability of a flexible trileaflet polyurethane valve is
determined by the thickness of its leaflets. Leaflet thickness
is also a major determinant of hydrodynamic function. The
study was conducted by Dernacca GM; Guldransen NJ;
Wikinson R; and Wheatley DJ examined valves (n = 31)
with leaflets made of polyether urethane (PEU, n = 22) or a
polyether urethane urea (PEUE, n = 9), of varying
thickness distributions. The valves were subjected to
accelerated fatigue test at 37C and failure was monitored.
Leaflet thickness ranged from 60 to 200m. PEU leaflet
thickness bore no relationship to durability, which was less
than 400 million cycles. PEUE valves, in contrast,
exceeded 800 million cycles. Durability in PEUE valves
was directly related to leaflet thickness ( r = .93, p < 0.001),
with good durability achieve with median leaflet
thicknesses of approximately 150 m. Thus polyurethanes
valves can made with good hydrodynamic properties and
with sufficient durability to consider potential clinical use.



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 11








New polyurethane heart valve prosthesis: Design,
manufacture and evaluation
In light of the thrombogenicity of mechanical valves and
the limited durability of bioprosthetic valves, alternative
designs and materials are being considered for prosthetic
heart valves. A new tri-leaflet valve, made entirely from
polyurethane, has been developed. The valve comprises
three thin polyurethane leaflets (approximately 100m
thick suspended from the inside of a flexible polyurethane
frame. The closed leaflet geometry is elliptical in the radial
direction and hyperbolic in the circumferential direction.
Valve leaflets are formed and integrated with their support
frame I a single dip coating operation. The dipping process
consistently gives rise to tolerably uniform leaflet thickness
distributions. In hydrodynamic test, the polyurethane valve
exhibits pressure gradients similar to those for a
bioprosthetic valve (St Jude Bioimplant), and levels of
regurgitation and leakage are considerably less than those
for either a bileaflet mechanical valve (St Jude Medical) or
the bioprosthetic valve. Six out of six consecutively
manufactured polyurethane valves have exceeded the
equivalent of 10 years function without failure in
accelerated fatigue tests. The only failure to date occurred
after the equivalent of approximately 12 years cycling, and
three valves have reached 527 million cycles
(approximately 13 years equivalent).

5. Pyrolytic Carbon

Background

Dr. Jack Bokros and Dr. Vincent Gott [11] discovered
pyrolytic carbon, the premier material for artificial heart
valves at General Atomics (GA). In 1966, Dr. Bokros was
working on pyrolytic carbon coatings for nuclear fuel
particles for the GA gas-cooled nuclear power reactors. He
stumbled upon its potential for medical uses through what
has been called a lesson in serendipity. He read an article
by Dr. Vincent Gott, who has been testing carbon-based
paint as a blood compatible coating for artificial heart
components. Bokros contacted Gott who initiated the
collaboration.

Dr. Gott was searching for a material to use in artificial
heart valves that did not provoke blood clots and had the
mechanical durability to endure for a recipients lifetime.
Pyrolytic carbon, from GA, met both of his need. GA
initiated a development project headed by Dr. Brokros to
add the needed durability to the material. This endeavor
was successful and the biomedical grade of pyrolytic
carbon was rapidly incorporated into the existing heart
valve designs.

Today, pyrolytic carbon (Figures 5 and 6) remains a
popular material available for mechanical heart valves,
being used in more than 4 million implants in more than 25
different valve designs for a clinical experience on the
order of 18 million patient-years.

Pyrolytic carbon (PyC) belongs to the family of turbostratic
carbons, which have a similar structure of graphite, but
subtly different. In graphite, the carbon atoms are
covalently bonded in planar hexagonal arrays that are
stacked and held together by weak interlayer bonding. For
turbostratic carbons, the stacking sequence is disordered,
resulting in wrinkles or distortions within layers. This
structural distortion provides the superior ductility and
durability of pyrolytic carbon, compared to other carbon
structures such as graphite.





Figure 5. Crystal structure of graphite [23].


Mechanical properties [23]

The Pyrolytic carbon, with its inherently dense, glassy
structure and its ability to be highly polished, has become a
popular choice. Furthermore its electrical conductivity is
useful in allowing it to become electrostatically charged so
that it can repel the blood cells. This unique material is one
of the most blood-compatible of all man-made materials, as
opposed to metals. The human body recognizes implanted
metal as a foreign material, and protects itself from the
object by coating it with layers of blood. But, pyrolytic
carbon and other so-called blood-compatible coatings are
unrecognized by the body and are accepted.



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 12









Figure 6. Acoustic emission amplitude versus frequency
for crack extensionsg. This plot shows an emission peak at
90kHz, indicating a normal mode crack extension in a
pyrolytic carbon test sample [23].

In its processed form, pyrolytic carbon is a microscopically
smooth, hard, black ceramic-like material. Like ceramic, it
is subjected to brittleness.
Fortunately, pyrolytic carbon possesses a mechanical
property that mitigates this fragility in the presence of
flaws, making it inherently difficult to accidentally
introduce cracks of significant size into the material. In
particular, unlike true ceramics, pyrolytic carbon is highly
ductile. Thus, if a sharp, hard object is pressed into
pyrolytic carbon, it can respond by deforming locally to
accommodate the object elastically. When the object is
withdrawn, there may be no residual depression, and little
or no microcracking surrounding the site. It is this intrinsic,
atomic microstructure-derived resistance to externally
imposed crack nucleation that permits such an otherwise
brittle material to be used in the human body.
The mechanical properties of pyrolytic carbon are largely
dependent on the density as shown in Figures 8 and 9. The
increased mechanical properties are directly related to the
increased density, which indicates that the properties
depend mainly on the aggregate structure of the material.

Graphite and glassy carbon have lower mechanical strength
than pyrolytic carbon as given in table 1. However, the
average modulus of elasticity is almost the same for all
carbons. The strength and toughness of pyrolytic carbon are
quite high compared to graphite and glassy carbon. This is
due to the smaller number of flaws and unassociated
carbons in the aggregate.

Figure 7. Fracture stress versus density for unalloyed LTI
pyrolytic carbons [26].


Figure 8. Elastic modulus versus density for unalloyed LTI
pyrolytic carbons [25].

Deposition of pyrolytic carbon coatings for heart valves
For heart valves, a silicon-alloyed pyrolytic carbon is used
in the form of a thick coating on a polycrystalline graphite
substrate. Silicon is added to improve mechanical
properties such as stiffness, hardness, and wear resistance,
without significant loss in biocompatibility. Components
are made by co-depositing carbon and silicon carbide on
the graphite substrate by a chemical vapor-deposition,
fluidized bed process that uses a gaseous mixture of
silicon-containing carrier gas with a hydrocarbon.




December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 13








Table 1. Properties of various types of carbon [25].

Type
Graphite Glassy Pyrolytic
carbon
Density, g/ml 1.5 -1.9

1.5

1.5 -2.0

Elastic
modulus,
MPa
24


24


28


Toughness,
m-N/ cm
3

138

172

517
(525
a
)

Compressive
strength

6.3

0.6

4.8
a
1.0 w /o Si alloyed pyrolytic carbon, Pyrolite
(Carbomedics, Austin, Tex).

Pyrolytic Carbon Mechanical Valves in the Market

a. Omnicarbon
TM


The Omnicarbon mechanical heart valve is manufactured,
marketed and sold, by Medical CV. Blair Mowery,
president and chief executive officer of Medical CV, noted
that the results from at least 10 clinical studies, including
over 10,000 patient years of use, have consistently
demonstrated one-third to one-half fewer complications
with the Omnicarbon valve, such as blood clots and stroke,
compared to other mechanical valves. The Omnicarbon
heart valve is a monoleaflet valve; a valve with a single
hingeless pivoting disc to employ pyrolytic carbon in both
its housing and disc for improved blood compatibility. Also
Omnicarbon valve does not have fixed pivot recesses that
are characteristic of bileaflet designs and that are
demonstrated to be the primary location for blood clot
formation.

The disc is slightly curved and retained within the housing
ring, located 180
0
from each other on the other side of the
housing ring. The disc closes on the housing ring at a 12
0

angle relative to the plane of the housing ring, and can
open to a maximum angle of 80
0
. The disc rotates freely
within the housing ring because there are no fixed hinges
within the housing ring. Because there are no struts
protruding across the flow orifice, the open disc separates
the flow channel into two orifices.

Indications for Use:

The Omnicarbon
TM
is indicated for the replacement of
dysfunction, native or prosthetic, aortic or mitral valves.

Contra indications:
The Omnicarbon
TM
is contraindicated for patients unable to
tolerate anticoagulation therapy.


Figure 8. Omnicarbon
TH
mechanical heart valve [17].


Adverse Events potentially associated with the use of
mechanical cardiac valves include:

Angina.
Cardiac arrhythmia.
Clinically significant transvalvular regurgitation.
Disc impingement/ entrapment.
Endocarditis .
Heart failure.
Hemolysis or hemolytic anemia.
Hemorrhage.
Myocardial infarction.
Nonstructural dysfunction.
Perivalvular leak.
Stroke.
Structural dysfunction.
Thromboembolism.
Tissue interference with valve function.
Valve thrombosis.

Precautions and Warnings: In order to avoid harmful
damages to the health of the patient, the following
precautions and warnings must be taken into account:

Do not use the valve if the use-before-date on the
package has expired.
If the disc disengages undetected handling
damage or extreme pressure on the disc may
cause this. Should disengagement occur, do not
attempt to re-engage the disc into the valve
housing; the valve should not be implanted.
If the valve came in contact with blood, do nor
attempt to clean and resterilize such a valve for
use in another person. Foreign protein transfer
and/ or residue from cleaning agents may cause a
tissue reaction.



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 14








Passing a catheter, surgical instrument, or
pacemaker lead through the Omnicarbon
TM
valve
may cause serious valvular insufficiency, damage
the valve, and/ or cause catheter entrapment.

Over sizing occurs when too large a valve is
forced into the tissue annulus. This may cause
adjacent tissue to inhibit the free movement and
full travel of the valve disc.

No hard, sharp instruments should come in
contact with the disc or valve housing ring may
cause scratches or other surface imperfections
which may result in blood injury, thrombus
formation and/ or structural damage.

A valve soiled by fingerprints or foreign
materials may cause clotting or blood damage.



b. ON-X Carbon [17]

Dr. Vincent Gott compared the clotting tendencies of
silicon carbide, pyrolytic carbon alloyed with silicon
carbide and pure pyrolytic carbon. Pure carbon was shown
to be least thrombogenic. MCRI overcame the need for
silicon carbide by applying new technologies to the
pyrolytic carbon manufacturing processes. Without silicon
carbide, the pure carbons surface finish is unmatched in
purity and smoothness. There was an additional reward in
purifying carbon. ON-X carbon is 50% stronger than
previous carbons. Its added flexural strength is essential to
the manufacturability of the ON-X valves sophisticated
design.


How does ON-X work?

Like natural valves, mechanical heart valves are one-way
valves that are opened and closed by the action of the blood
pushing on flaps known as leaflets. The ON-X valves
leaflets (Figure 9) are somewhat like double doors that
open and close but never latch. In the case of doors, if the
wind blows from one direction, the doors will be blown
open. If blown from the other direction, the doors will be
close. This analogy is an over simplification as the
demands of the body can be both rigorous and subtle.


Safety and efficiency of ON-X

Two measures of a good mechanical heart valve are safety
and efficiency. To be safe, a valve must not wear out, break
or malfunction. It must not be ejected by the bodys
immune system. It must minimize blood clotting and
damage to the blood with minimum amount of effort.


ON-X and common safety problems

Thrombosis is a problem that causes blood clots on the
working surface of a valve, which impairs valve function.
As a thrombus gets bigger, it will eventually block the
moving parts so that the valve can no longer open and / or
close fully. By using extremely smooth ON-X carbon and
by designing the valve to induce smooth flow and thorough
self-cleaning, ON-X reduces the risk of thrombosis.

In the case of tissue encroachment, the bodys healing
process can also impair valve function. As the body heals
around the mechanical heart valve, tissue builds up around
the valve. This becomes a problem if the tissue grows over
the valve and begins to block it or restrict the moving parts.
The ON-X valve was designed with leaflet guards and
optimized length to ensure that tissue doesnt interfere with
valve function.

In the blood damage problem, turbulence and rapid
changes in pressure can affect the blood flow. The longer
flared body of the ON-X smoothes flow. The leaflets are
free to open completely to align with the flow and only
move a short distance to close, which reduces turbulence
and buffers. The ON-X valve minimizes damage to blood
cells.

Typical mechanical properties of ON-X Carbon are given
in table 2.




Figure 9. ON-X mechanical heart valve [17].



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 15








Table 2. Typical surface and mechanical properties of On-
X Carbon [9].




6 6. . T Ti it ta an ni iu um m ( (T Ti i) ) [ [2 24 4 a an nd d 2 27 7] ]

T Th he e h hi ig gh h s st tr re en ng gt th h, , l lo ow w w we ei ig gh ht t, , o ou ut ts st ta an nd di in ng g c co or rr ro os si io on n
r re es si is st ta an nc ce e p po os ss se es ss se ed d b by y t ti it ta an ni iu um m a an nd d t ti it ta an ni iu um m a al ll lo oy ys s h ha av ve e
l le ed d t to o a a w wi id de e a an nd d d di iv ve er rs si if fi ie ed d r ra an ng ge e o of f s su uc cc ce es ss sf fu ul l
a ap pp pl li ic ca at ti io on ns s w wh hi ic ch h d de em ma an nd d h hi ig gh h l le ev ve el ls s o of f r re el li ia ab bl le e
p pe er rf fo or rm ma an nc ce e i in n s su ur rg ge er ry y a an nd d m me ed di ic ci in ne e. . M Mo or re e t th ha an n 1 10 00 00 0
t to on ne es s ( (2 2. .2 2 m mi il ll li io on n p po ou un nd ds s) ) o of f t ti it ta an ni iu um m d de ev vi ic ce es s o of f e ev ve er ry y
d de es sc cr ri ip pt ti io on n a an nd d f fu un nc ct ti io on n a ar re e i im mp pl la an nt te ed d i in n p pa at ti ie en nt ts s
w wo or rl ld dw wi id de e e ev ve er ry y y ye ea ar r. .


Table 3. Biocompatibility Tests & Results [9].

T Th he e t ti it ta an ni iu um m a al ll lo oy y T Ti i- -6 6A Al l- -4 4V V i is s u us se ed d a as s t th he e c ca ar rr ri ie er r
s st tr ru uc ct tu ur re e f fo or r r re ep pl la ac ce em me en nt t h he ea ar rt t v va al lv ve es s. . T Th he e t ti it ta an ni iu um m i is s r ri in ng g
s sh ha ap pe ed d a an nd d s su up pp po or rt ts s t th he e m mo ov vi in ng g m me ec ch ha an ni is sm ms s o of f t th he e
r re ep pl la ac ce em me en nt t v va al lv ve e. . I It t a al ls so o c ca ar rr ri ie es s t th he e p po ol ly ye es st te er r s st tr ru uc ct tu ur re e
t th ha at t b bi in nd ds s t th he e v va al lv ve e t to o t th he e t ti is ss su ue e. .

M Me ed di ic ca al l g gr ra ad de e t ti it ta an ni iu um m a al ll lo oy ys s h ha av ve e a a s si ig gn ni if fi ic ca an nt tl ly y h hi ig gh he er r
s st tr re en ng gt th h t to o w we ei ig gh ht t r ra at ti io o t th ha an n c co om mp pe et ti in ng g s st ta ai in nl le es ss s s st te ee el ls s. .
T Th he e r ra an ng ge e o of f a av va ai il la ab bl le e t ti it ta an ni iu um m a al ll lo oy ys s e en na ab bl le es s m me ed di ic ca al l
s sp pe ec ci ia al li is st ts s d de es si ig gn ne er rs s t to o s se el le ec ct t m ma at te er ri ia al ls s a an nd d f fo or rm ms s c cl lo os se el ly y
t ta ai il lo or re ed d t to o t th he e n ne ee ed ds s o of f t th he e a ap pp pl li ic ca at ti io on n. . T Th he e f fu ul ll l r ra an ng ge e o of f
a al ll lo oy ys s r re ea ac ch he es s f fr ro om m h hi ig gh h d du uc ct ti il li it ty y c co om mm me er rc ci ia al ll ly y p pu ur re e
t ti it ta an ni iu um m u us se ed d w wh he er re e e ex xt tr re em me e f fo or rm ma ab bi il li it ty y i is s e es ss se en nt ti ia al l, , t to o
f fu ul ll ly y h he ea at t t tr re ea at ta ab bl le e a al ll lo oy ys s w wi it th h s st tr re en ng gt th h a ab bo ov ve e 1 13 30 00 0 M MP Pa a
( (1 19 90 0 k ks si i) ). . S Sh ha ap pe e m me em mo or ry y a al ll lo oy ys s b ba as se ed d o on n t ti it ta an ni iu um m f fu ur rt th he er r
e ex xt te en nd d t th he e r ra an ng ge e o of f u us se ef fu ul l p pr ro op pe er rt ti ie es s a an nd d a ap pp pl li ic ca at ti io on ns s. . A A
c co om mb bi in na at ti io on n o of f f fo or rg gi in ng g o or r c ca as st ti in ng g, , m ma ac ch hi in ni in ng g a an nd d
f fa ab br ri ic ca at ti io on n a ar re e t th he e p pr ro oc ce es ss s r ro ou ut te es s u us se ed d f fo or r m me ed di ic ca al l
p pr ro od du uc ct ts s. .

Functional Requirements

The following requirements must be satisfy to use titanium
as a biomaterial in heart valves implants:
The bodys immune system must not attack the
biomaterial.
Compatible with body tissues and fluids
Must has strength, flexibility and hardness
Must be nontoxic, nonreactive or biodegradable
The valve must also be anchored to the inside of
the heart.
The material must not exhibit mechanical fatigue
over the devices lifetime.
The materials surface must have an acceptable
low propensity for thrombus formation, as well as
the best possible blood compatibility
Must not be prone to calcification.
Tests Results
Cytotoxicity L-929
Membrane Elution
non-cytotoxic
Sensitization ISO
Kligman
0% sensitization:
Grade I
sensitization
rate, not significant
Irritation Saline CSO negligible irritant
Acute Systemic
Toxicity Saline CSO
negative
Rabbit Pyrogen non-pyrogenic
USP Physical / Chemical
Screening Tests
passes USP
standards
Mutagenicity Ames non-mutagenic
Hemolysis Direct Contact
Rabbit Blood
non-hemolytic
Complement Activation non-activating
Property Units On-X
Wear Resistance

mm
3
/km, 10
-6
<1.23
Coefficient of Friction

------ 0.15
Young's Modulus

GPa 26
Flexural Strength

MPa 490
Density

gm/cm
3
1.9
Strain to Failure

% 1.6
Strain Energy

MPa-mm/mm 7.7
Residual Stress

MPa 18.2
Fracture Toughness

MPa m
1/2
1.67
Fatigue Threshold

m/cycle
(DK
70.3
)
1.11
Fatigue Crack Velocity m/cycle, 10
-15

3.98

Critical Surface Tension

dynes(cm) 42
Surface Roughness

Ra(nm) 33.9
Surface Chemistry
Carbon

Atomic % ~85
Surface Chemistry
Silicon

Atomic % 0
Surface Chemistry
Oxygen

Atomic % ~15



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 16








Titanium Performance in Medical Applications

The titanium alloy Ti-6Al-4V is classified as biologically
inert biomaterial or bioinert. T Ti it ta an ni iu um m i is s j ju ud dg ge ed d t to o b be e
c co om mp pl le et te el ly y i in ne er rt t a an nd d i im mm mu un ne e t to o c co or rr ro os si io on n b by y a al ll l b bo od dy y
f fl lu ui id ds s a an nd d t ti is ss su ue e, , a an nd d i is s t th hu us s w wh ho ol ll ly y b bi io oc co om mp pa at ti ib bl le e. . As
such, it remains essentially unchanged when implanted into
human bodies because of its excellent corrosion resistance.
The human body is able to recognize bioinert materials as
foreign, and tries to isolate them by encasing them in
fibrous tissues. However, they do not illicit any adverse
reactions and are tolerated well by the human body.
Furthermore, they do not induce allergic reactions such as
has been observed on occasion with some stainless steels,
which have induced nickel hypersensitivity in surrounding
tissues.

T Th he e f fa av vo or ra ab bl le e c ch ha ar ra ac ct te er ri is st ti ic cs s o of f t ti it ta an ni iu um m i in nc cl lu ud di in ng g
i im mm mu un ni it ty y t to o c co or rr ro os si io on n, , b bi io oc co om mp pa at ti ib bi il li it ty y, , s st tr re en ng gt th h, , l lo ow w
m mo od du ul lu us s a an nd d d de en ns si it ty y. . T Th he e l lo ow we er r m mo od du ul lu us s o of f t ti it ta an ni iu um m a al ll lo oy ys s
c co om mp pa ar re ed d t to o s st te ee el l i is s a a p po os si it ti iv ve e f fa ac ct to or r. . T Tw wo o u us se ef fu ul ln ne es ss s
p pa ar ra am me et te er rs s o of f t th he e i im mp pl la an nt ta ab bl le e a al ll lo oy y a ar re e t th he e n no ot tc ch h
s se en ns si it ti iv vi it ty y. . T Th he e r ra at ti io o o of f t te en ns si il le e s st tr re en ng gt th h i in n t th he e n no ot tc ch he ed d
v ve er rs su us s u un n- -n no ot tc ch he ed d c co on nd di it ti io on n a an nd d t th he e r re es si is st ta an nc ce e t to o c cr ra ac ck k
p pr ro op pa ag ga at ti io on n, , o or r f fr ra ac ct tu ur re e t to ou ug gh hn ne es ss s. . T Ti it ta an ni iu um m s sc co or re es s w we el ll l i in n
b bo ot th h c ca as se es s. . T Ty yp pi ic ca al l N NS S/ /T TS S r ra at ti io os s f fo or r t ti it ta an ni iu um m a an nd d i it ts s a al ll lo oy ys s
a ar re e 1 1. .4 4 - - 1 1. .7 7 ( (1 1. .1 1 i is s a a m mi in ni im mu um m f fo or r a an n a ac cc ce ep pt ta ab bl le e i im mp pl la an nt t
m ma at te er ri ia al l) ). . F Fr ra ac ct tu ur re e t to ou ug gh hn ne es ss s o of f a al ll l h hi ig gh h s st tr re en ng gt th h
i im mp pl la an nt ta ab bl le e a al ll lo oy ys s i is s a ab bo ov ve e 5 50 0 M MP Pa am m
- -1 1/ /2 2
w wi it th h c cr ri it ti ic ca al l c cr ra ac ck k
l le en ng gt th hs s w we el ll l a ab bo ov ve e t th he e m mi in ni im mu um m f fo or r d de et te ec ct ti io on n b by y s st ta an nd da ar rd d
m me et th ho od ds s o of f n no on n- -d de es st tr ru uc ct ti iv ve e t te es st ti in ng g. . The two most common
types of Ti-6Al-4V used for the implants are Ti-6Al-4V
Grade 5 and Grade 23.
Ti-6Al-4V (Grade 5)
This alpha-beta alloy is the workhorse alloy of the titanium
industry. The alloy is fully heat treatable in section sizes up
to 15 mm and is used up to approximately 400C (750F).
Since it is the most commonly used alloy over 70% of all
alloy grades melted are a sub-grade of Ti6Al4V.
The addition of 0.05% palladium (grade 24), 0.1%
ruthenium (grade 29) and 0.5% nickel (grade 25)
significantly increases corrosion resistance in reducing
acid, chloride and sour environments, raising the threshold
temperature for attack to well over 200C (392F).
Ti-6Al-4V (Grade 23)
The essential difference between Ti6Al4V ELI (grade 23)
and Ti6Al4V (grade 5) is the reduction of oxygen content
to 0.13% (maximum) in grade 23. This offers improved
ductility and fracture toughness, with some reduction in
strength. Grade 29 also having lowered level of oxygen will
deliver similar levels of mechanical properties to grade 23
according to processing.
Advancements: Titanium

Material selection for implantable medical devices has
improved with the availability of nitinol, or NiTi, a
nickel-titanium alloy that has proved to be biocompatible,
durable and non-thrombogenic.

Researchers at University of California, Los Angeles
(UCLA) have designed thin-film NiTi semi-lunar heart
valve for use in both surgical and non-surgical
(transcatheter) human heart valve replacements:

Surgically implantable thin-film NiTi valves are
undergoing in vitro testing to determine their
functionality, durability and corrosive properties;
Designs and prototypes of percutaneously
inserted catheter-based thin-film NiTi valves are
under continuing development.
Use of thin-film nitinol as a novel material for the
development of improved human prosthetic heart
valves for surgical implantation and for
percutaneous insertion.


7. Biomaterials versus stainless steel (Table 4)


Alumina is a versatile material with applications in
medicine, because it has good compatibility with human
environment. Compared to stainless steel, mechanical
properties of Alumina are worst in modulus of elasticity,
shear modulus, thermal expansion coefficient. Alumina is
better in stress, strain and safety factor. Stainless steel is
more resistant but it is not utilized on heart valve implants,
because it doen not have good biocompatibility with human
blood. Alumina is a bioceramic while stainless steel is a
biometal with different density.

Stainless steel is stiffer than the titanium alloy Ti6Al4V.
This is explained by the steels higher modulus of elasticity
(196 GPa vs. 120 GPa). Steel is more rigid than titanium
(steels higher shear modulus: 80 GPa vs. 44 GPa).
Stainless steel is more fracture resistant than titanium (steel
has more tensile strength: 875 MPa vs. 616 MPa). Titanium
is more resistant to yielding that stainless steel (Ti has a
higher yield stress: 950 MPa vs. 700 MPa). See appendix
VI.

Pyrolytic carbon is less stiffer than stainless steel. This is
explained by the steels higher modulus of elasticity (196
GPa vs. 17-28 GPa). Stainless steel is more resistant than
pyrolytic carbon because of its tensile strength is biggest
compared to pyrolytic carbon (875 MPa vs. 200 MPa) .






December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 17












Stainless steel is stiffer than the polyetherurethane. This is
explained by the steels higher modulus of elasticity (196
GPa vs. 0.016 GPa). Stainless steel is more fracture
resistant than polyetherurethane (steel has more tensile
strength: 875 MPa vs.49.7 MPa).

Stainless steel is stiffer than Polyester. This is explained by
the steels higher modulus of elasticity (196 GPa vs. 1.84
GPa). Polyester is less fracture resistant than Stainless steel
(stainless steel has more tensile strength: 875MPa vs.
48.3MPa). Stainless steel is more resistant to yielding that
polyester (Stainless steel has a higher yield stress: 700 MPa
vs. 59.3MPa).

SUMMARY
When designing prosthetic heart valves, there are several
characteristics of natural heart valves one aims to mimic.
These include minimal transvalvular pressure gradients,
minimal regurgitation fractions, central flow characteristics
and complete biocompatibility. The materials for the
prosthesis should be durable, non-toxic and
nonthrombogenic; ideally, the materials should not require




the long-term use of anticoagulant therapy. The prosthetic
heart valve should be surgically implanted with ease and
not interfere with normal cardiac function and anatomy.
The normal function of the prosthetic valve should be
quiet, should not damage cellular blood elements or cause
denaturing of proteins. Finally, prosthetic valves should be
readily available, manufactured with ease and relatively
inexpensive.

Cardiovascular surgeons must weigh the advantage of the
durability of mechanical type prostheses without the need
for long-term anticoagulant therapy. Therefore, physicians,
biomedical engineers and other inventors have yet to
design the ideal prosthetic valve substitute.

One approach to meet the characteristics of the ideal
prosthetic valve includes new fixing processes for
bioprosthetic valves that greatly improve durability,
decrease the incidence of dystrophic calcification and do
not change the relatively nonthrombogenic nature of
existing bioprostheses. Another approach would be the
introduction of a new durable, nonthrombogenic material
Property Units Alumina Titanium Polyetheruretane Pyrolitic
Carbon
Stainless
Steel
Polyester
Poissons
Ratio
N/A 0.33 0.33 0.40 0.3-0.4 0.27-0.30 0.33-0.49
Hardness GPa 20.6 2.24 50 10 5-8.5 90
Youngs
Modulus
GPa 392 120 0.16 17-28 196 1.84
Shear
Modulus
GPa 163 44 1-2 N/A 75-80 0.744-1.586
Tensile
Strength
MPa 637 616 49.7 200 875 48.3
Compressive
Stress
GPa 4900 N/A 50-70 900 N/A 59.6
Yield Stress MPa 15.4*10
3
950 11.9 100 700 59.3
Ultimate
Stress
MPa 119 930 50 N/A 59.3 46.5
Coefficient
of Thermal
Expansion
(Linear)

10
-6

per C
6.2 11.9 25 10 N/A 70
Table 4. Mechanical Properties of biomaterials



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 18








from which mechanical type prosthesis could be fashioned.
Some think a synthetic valve which could be constructed
to copy the durability and higher than acceptable
transvalvular pressure gradients.

Currently available prostheses are markedly improved over
some earlier valve substitutes, but the search for the ideal
prosthetic valve continues. To advance towards this goal, a
major breakthrough in either materials science or collagen
biochemistry must occur.


ACKNOWLEDGEMENTS

We would like to thank Dr. Megh R. Goyal, University of
Puerto Rico, for his advice. The authors also to thank Yi-
Ren Woo (St. Jude Medical Principal engineer) and Carlos
Rosario, M.D. (Mayaguez Cardiology), Prof. Pablo
Cceres, at University of Puerto Rico for providing
technical information.


REFERENCES

1. http://cape.uwaterloo.ca/che100projects/heart/files/test
ing.htm
2. http://titaniuminfogroup.co.uk
3. http://www.azom.com
4. http://www.azom.com/details.asp?ArticleID=105
5. http://www.azom.com/details.asp?ArticleID=2103
6. http://www.ceramics.nist.gov/srd/summary/scdaos.htm
7. http://www.cnn.com/HEALTH/library/DS/00421.html
8. http://www.domme.ntu.ac.uk/research/biomec/pap...ri
alchoice.html
9. http://www.fda.com
10. http://www.gla.ac.uk/departments/cardiacsurgery/biog
_Berraca.htm
11. http://www.icr-heart.com/journal/unalloyed_pyrolytic
_carbon_for_i.htm
12. http://www.lib.umich.edu/dentlib/Dental_tables/toc.html
13. http://www.library.drexel.edu/research/guides/pdfs/ma
terialproperties.html
14. http://www.library.drexel.edu/research/guides/pdfs/ma
terialproperties.html#bio
15. http://www.mcritx.com/carbon_properties.htm
16. http://www.medhelp.org/forums/cardio/archive/848.html
17. http://www.medtronics.com
18. http://www.mkt-intl.com/ceramics/aluminaphotos.htm
19. http://www.mst.dk/udgiv/Publications/1999/87-7909-
416-3/html/bil03_eng.htm
20. http://www.polymertech.com/materials/elasthane.html
21. http://www.pyrocarbon.com
22. http://www.sts.org
23. http://www.swri.org/3pubs/ttoday/summer99/valve.htm
24. http://www.titanium.org
25. Park, J.B. 1984. Biomaterials Science and
Engineering. pp.212-216, 252-256 New York: Plenum
Press, New York.
26. Mitamura Y, Hosooka K, Matsomoto T, Otaki K and
Sakai K. Development of a fine ceramic Heart valves.
Journal of Biomaterials Application. Publisher Sage
Publication, London.
27. Sharma, Szycher. 1991. Blood Compatible Materials
and Devices. Technomic Publishing Company. Inc.
pp.33, 156-163.

GLOSSARY

Alloy: a material that consisting of two or more metals or a
metal and non-metal.
Anesthesiologists: a physician specializing in
anesthesiology (anesthesia is used during some procedures
and surgery).
Anticoagulant: a drug used to thin the blood, keeps blood
from clotting.
Aorta: the largest artery in the human body, it carries
blood from the heart to every part of the body.
Aortic valve: the valve between the left ventricle and the
aorta.
Atria (Atrium): upper-receiving chambers of the heart
Calcification: formation of calcium deposits on the surface
of the material.
Cardiac catheterization: a highly specialized non-surgical
technique that allows cardiologists to examine coronary
arteries for blockage using thin catheters inserted into the
heart.



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 19








Cardiologists: a physician specializing in the heart.
Cardio thoracic Surgeons: heart surgeons.
Creep: additional strains develop, when loaded for long
period of time is applied.
Diastole: during the cardiac cycle, when the heart relaxes
& allows blood to flow in.
Ductile: capable of being drawn out into a thin wire or
thread.

Hingeless : do not have a movable joint by means of which
it can turn on the frame.
Infarct: dead tissue as a result of obstructed blood flow to
the area.
Minimally invasive surgery: techniques that use small
incisions to gain access to the surgical site.

Mitral valve: the valve that separates the left atrium from
the left ventricle.
Modulus of Elasticity: slope of the straight line from the
stress- strain diagram.
Pericardial valve: tissue valve made from bovine tissue.
Poissons Ratio: ratio of the lateral and axial strain,
property of materials.
Polish: to make or become smooth and glossy by rubbing.
Porcine valve: tissue valve made from a pigs aortic heart
valve.
Pulmonary valve: the valve between the right ventricle
and the pulmonary artery.
Regurgitation: backward flow of blood due to inability of
valve to work properly.
Restenosis: recurrence of the blockage or narrowing of the
artery or valve.
Stenosis: narrowing of artery or heart valves.
Strain: elongation per unit of length.
Stress: intensity of force per unit of area.
Systole: in the cardiac cycle, when the heart contracts
(pumps).
Thrombus: a blood clot.
Valves: flap-like structures, which control the flow of
blood through the heart.
Valve surgery: there are a total of 4 valves in the human
heart, valve surgery repairs or replaces damaged or scarred
valves.
Ventricle: the large lower pumping chamber of the heart.




















































December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez 20








APPENDIX I: FDA POLICIES OF MECHANICAL
MITRAL VALVE REPLACEMENT. [9]



1. ATS Open Pivot Bileaflet Heart Valve
This is a brief overview of information related to FDA's
approval to market this product. See the links below to the
Summary of Safety and Effectiveness and product labeling
for more complete information on this product, its
indications for use, and the basis for FDA's approval.
Product Name: ATS Open Pivot Bileaflet Heart Valve
Manufacturer: ATS Medical, Inc.
Address: 3905 Annapolis Lane, Suite 105, Minneapolis,
Minnesota 55447
Approval Date: October 13, 2000
Approval Letter:
http://www.fda.gov/cdrh/pdf/p990046a.pdf
What is it? The ATS Open Pivot Bileaflet Heart Valve is
a mechanical heart valve with two leaflets (flap like
structures) in the shape of a circle, each leaflet a half the
circle, surrounded by a ring made of polyester fabric. The
leaflets are made of carbon. The valve is used to replace a
patients own aortic or mitral valve, or another prosthetic
aortic or mitral valve.
How does it work? The ATS Open Pivot Bileaflet Heart
Valve uses two half discs (bileaflets) that open and close as
blood flows through the valve to operate like the patients
natural heart valve. (Heart valves control the blood flow
through the chambers of the heart.)
When is it used? The ATS Open Pivot Bileaflet Heart
Valve is intended to replace diseased, damaged, or
malfunctioning natural or prosthetic aortic or mitral valves.
Heart valves may not always work as well as they should.
Disease or other heart valve malfunction may cause the
heart valve tissue to thicken, harden, weaken, or stretch. If
the valve fails to open and close properly, it can block or
interfere with blood flow causing a decrease in the efficient
flow of blood through the heart. This can reduce a patients
quality of life.
What will it accomplish? A patient who has a diseased,
damaged, or malfunctioning heart valve may feel weak,
tired, or otherwise handicapped. Surgical replacement of
the affected heart valve may be an effective option to
improve the patients quality of life.
When should it not be used? The valve should not be used
in patients who are unable to tolerate anticoagulant therapy
or the use of blood-thinning drugs.




2. Subpart D--Cardiovascular Prosthetic Devices

Sec. 870.3925 Replacement heart valve.

(a) Identification. A replacement heart valve is a device
intended
to perform the function of any of the heart`s natural valves.
This device includes valves constructed of prosthetic
materials, biologic valves (e.g., porcine valves), or valves
constructed of a combination of prosthetic and biologic
materials.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval application (PMA) or notice of
completion of a product development protocol (PDP) is
required. A PMA or
a notice of completion of a PDP is required to be filed with
the Food and Drug Administration on or before December
9, 1987 for any replacement heart valve that was in
commercial distribution before May
28, 1976, or that has on or before December 9, 1987 been
found to be substantially equivalent to a replacement heart
valve that was in commercial distribution before May 28,
1976. Any other replacement heart valve shall have an
approved PMA or a declared completed PDP in effect
before being placed in commercial distribution.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR
18163, May 13, 1987; 52 FR 23137, June 17, 1987]

3. Subpart D--Cardiovascular Prosthetic Devices
Sec. 870.3945 Prosthetic heart valve sizer.

(a) Identification. A prosthetic heart valve sizer is a device
used to measure the size of the natural valve
opening todetermine the size of the appropriate
replacement heart valve.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in
subpart E of part 807
















December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 21









APPENDIX II: OTHER PATENTS FOR COMPANY'S PRODUCTION.

APPLICATION
NUMBER / DATE of
APPROVAL
DEVICE TRADE NAME
COMPANY NAME
CITY, STATE, &
ZIP
DEVICE DESCRIPTION /
INDICATIONS
P810002/S056
5/3/01
Real-Time
St. Jude Medical Mechanical
Heart Valve Mater Series
Coated Aortic Valved Graft,
Model CAVGJ-514 00
St. Jude Medical, Inc.
St. Paul, MN
55117
Approval for the changes to the country
of origin of the bovine collagen used
for the Hemashield graft, which is a
component of the device. The device,
as modified, will be marketed under the
trade name St. Jude Medical
Mechanical Heart Valve Master Series
Coated Aortic Valved Graft, Model
CAVGJ-514 00 in sizes 19, 21, 23, 25,
27, 29, 31, 33 mm, and is indicated for
the replacement of the aortic valve and
the ascending aorta.
P000037
5/30/01
On-X Prosthetic Heart
Valve, Model ONXA
Medical Carbon Research
Institute, LLC
Austin, TX
78754
Approval for the On-X Prosthetic
Heart Valve, Model ONXA in the aortic
position including sizes 19, 21, 23, 25,
and 27/29 mm. This device is indicated
for replacement of diseased, damaged,
or malfunctioning native or prosthetic
heart valves in the aortic position.
P790018/S031
11/24/97
Medtronic Hall Prosthetic
Heart Valve (Models A7700
and M7700)
Medtronic Heart Valves,
Inc.
Irvine, CA
92714
Approval for a modification to the
controlled environment area for certain
manufacturing steps.






















December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 22








APPENDIX III: POLYURETHANE PROPERTIES.


Trade name

CARDIOMAT
610

MITRATHANE
2007

PAMPUL-3-
AMEO

Pur 1025/1

Producer
KONTRON
Cardiovascular
Inc.
MITRAL
MEDICAL
Internacional Inc.
BEIERSDORF
AG
ENKA AG

Pur - type

Polyetherurethane
Segm.
Polyetherurethane
urea

Polyetherurethane

Polyesterurethane

CONCENTRATION
(%)

15


25

10

15

SOLVENTS

THF/ DIOXAN:
2/1

DMAC

DMAC

DMAC

VISCOSITY
( m Pa s) at C

2010 at 30C

77500 at 23C

4200 at 23C

48500 at 23C

DENSITY ( g/cm^3 )

1.11 + 0.03

?

?

1.12

HARDNESS
( Shore A)

80

65 + 5

75 + 5

87

TENSILE
STRENGTH
( N/mm^2)

28.0

39.2 + 5.0

49.0 + 7.0

50.6

ELONGATION at
BREAK ( %)

500

775 + 50

605 + 30

649
























December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 23








APPENDIX IV: ALUMINA MITRAL VALVE AND THROMBUS FORMATION COMPARED WITH OTHER
MATERIALS.


ALUMINA MITRAL VALVE


THROMBUS FORMATION












December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 24








APPENDIX V: ADVERSE EVENTS OF DIFFERENT HEART VALVE IMPLANTATION.


Early Postoperative Adverse Events
n (% or cases)

Event

AVR (125)

MVR (70)

DVR (37)

Death, all causes
Thromboembolism, AII
Thromboembolism, TIA
Thromboembolism, Nontransient
Valve Thrombosis
Anticoagulant Related Hemorrhage, major
Endocarditis
Perivalvular Leak, major
Pannus Tissue Interference
Hemolytic Anemia
Structural Failure
Unacceptable Hemodynamics
Other Nonstructural Dysfuction
Reoperation
Explantation


4 (3.2)
5 (4.0)
2 (1.6)
3 (2.4)
0
0
1 (0.8)
1 (0.8)
0
0
0
0
0
2 (1.6)
2 (1.6)


6 (8.6)
0
0
0
1 (1.4)
1 (1.4)
0
0
0
0
0
0
0
1 (1.4)
1 (1.4)


2 (5.4)
0
0
0
0
0
0
1( 2.7)
0
0
0
0
0
1 (2.7)
0


Abbreviations; n= number of patients
AVR = aortic valve replacement, MVR = mitral valve replacement, DVR = double valve replacement
TIA = transient ischemic attack

















December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 25








APPENDIX VI: MECHANICAL PROPERTIES COMPARISON WITH OTHER BIOMATERIALS.




APPENDIX VII: TABLE OF TITANIUM YIELD STRENGTH VERSUS DENSITY.

Yield Strength vs Density
0 20 40 60 80 100 120 140 160 180 200
Y
i
e
l
d

S
t
r
e
n
g
t
h

(
M
P
a
)
Density (g/cm^3)
Ti6Al4V
Ta
316L SS
CoNiCrMo
F 562
Annealed
Annealed
Annealed
Cold-worked
Cold-worked
As-cast
Wrought annealed
Cold-worked
Unalloyed Grade 4
Heat treated









December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 26








APPENDIX VIII: EXERCISES

1. AXIALLY LOADED MEMBERS: A polyester graft supports a tensile load of 48 lb when the heart beats. The inner
and outer diameter of graft are d1 = 0.143 in. and d2 = 0.169 in. respectively, his length is 0.5 in. The elongation due
to the load is 0.018 in. Find the stress and strain.

Solution:

Given:

d1 = 0.143 in

d2 = 0.619 in

L = 0.5 in

P = 48 lb

Calculate the cross-sectional area:

A = ( / 4 ) ( d2 - d1 ) = ( / 4 ) ( 0.169 - 0.143 ) = 0.00637 in.

Calculate the stress:

= P / A = 48.0 lb / 0.00637 in. = 7,535 psi

Calculate the strain :

= / L = 0.018 in. / 0.5 in. = 0.036









December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 27








2. AXIALLY LOADED MEMBERS: A stainless steel implant of 2.0 in is put inside a wrist bone. Its temperature rises of 27C
to 45C. Calculate the thermal strain and temperature-displacement relation of the metal. Assume the thermal expansion
coefficient () of the implant is 0.000007/C.








Bone








Solution:

Given:

T1 = 27C

T2 = 45C

L = 2.0 in

= 0.000007/C

T = (T2 - T1)

= (0.000007/C)(45C - 27C)

= (0.000007/C)(18C)

= 1.26 x 10
-4


T = L T

= (2.0in)(1.26 x 10^-4) = 2.52 x 10
-4
inch











metal
implant



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 28








3. TORSION: A metallic bar made of stainless steel is implanted in the human vertebral column. The bar has a
diameter d=0.025 m, length L=0.3075m and shear modulus of elasticity. The bar is subjected to torque T, acting at
the ends.
a. If it has a load of 1,000N at .15375 m, calculate the magnitude of the torque.
b. Using the results of the part a, what is the maximum shear stress in the bar?
c. What is the angle of twist between the ends?
d. If the allowable shear stress is 2.037 MPa and the allowable angle of twist is 2.5
o
rad, what is the maximum
permissible torque?






L= 0.3075m

Solution:

Given:

d = 0.025 m
L = 0.3075 m
G = 196*10
6
Pa
P = 1000 N

allow
= 2.037 MPa

allow
= 2.5
o
rad

a. T= Pd
= ( 1000N)(0.025m) = 25 Nm

b.
max
= 16T/ d
3

= (16)(25N.m)/ (0.025m)
3
= 8.1487 MPa

c. I
p
= d
4
/32
= (0.025m)
4
/32 = 38.3 nm
4


= TL/ GI
p
= (25Nm)(0.3075m)/(196x10^6 Pa)(38.3x10^-9m
4
) = 1.2

rad

d. T
1
= d
3

allow
/16


allow
= P/A =1,000N /[(/4) (0.025m)
2
] = 2.037 MPa
T
1
= (0.025m)
3
(2.037x10^6 Pa)/16 = 6.25 Nm

T
2
= GI
P

allow
/L
= [(196x10^9N/m
2
)(38.4x10^-9m
4
(2.5)( rad/180)] / 0.3075m = 1068 Nm

The maximum permissible torque is smaller of T
1
and T
2
.

T
1
=6.25 Nm
d = 0.025m



December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 29








4. COMPRESSION: An open alumina mitral valve has an inner radius of 0.0508 m and outer radius of 0.0635 m. It is loaded by
a compression blood flow equal to 1,750 mm Hg. A) Determine the force to the valve sectional area. B) Find the maximum shear
stress on this mitral valve prosthesis. ***Hint: Use correct units.













P = 1,750mmHg




Free Body Diagram

Solution:

Presion = Force/Area Force = Area x Presion

Force = (1,750 mmHg) (.0635+. 0508)
2

Force =22.86 mm Hg-m
2
22.86 mm Hg (101.325KPa/ 760 mmHg) = 3.048 KPa

Maximum Shear Stress = (V*Q)/(I*b) = (4*P)/(3*) =
[4 (3.048 KPa)/ 3] * [(R2
2
+R2R1+R1
2
)/(R2
4
-R1
4
)]
12.192 [(0.0635
2
+ 0.1143 + 0.0508
2
)/ (0.0635
4
- 0.0508
4
)] =

Maximum stress = 1.47/9.6x10
-6
= 153.135 KPa




















December 2003 Applications of Engineering Mechanics in Medicine, GED at University of Puerto Rico, Mayagez. 30









5. TENSION, COMPRESSION AND SHEAR: An artificial mitral valve has a carrier structure made of a titanium Ti6Al4V ring.
The ring has a diameter of 30 mm. This ring is formed into a round bar to be used in the lab for experiments with a tensile test
machine. The bar is stretched to a final length of 190 mm. Find the tensile load applied to the specimen and the dilatation.
Ti6Al4V Poissons Ratio = 0.33
Ti6Al4V Young Modulus = 120 GPa
Ti6Al4V Yield Stress = 950 MPa

Titanium ring:








1.5 mm




Solution:

a. Initial Length of Bar:
Circumference =2*pi*(30)
= 188.50 mm

b. Strain:
(L
f
L
i
) / L
i
= (190-188.5)/188.5
= 0.0079

c. Normal Stress= E*Strain
= (120*10^9)*(0.0079)
= 948*10^6 Pa

d. Hooks valid?
948*10^6 Pa is less than Yield Stress (950*10^6 Pa)

e. Tensile Load (P) = normal stress*Area
P = 948*10^6 Pa*(pi/4)*(0.0015)^2 = 1675.25 N (Tension)
f. Dilatation (e) = Strain/(1-2V)
= 0.0079*(1-2(0.33))
= 0.002686*100
= 0.2686 %