The History of Perfusion

1800 - 1970
. . . as told through the lives
of the pioneers that made it happen
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The progress of the development of perfusion as a clinical service throughout the world
is not just the evolution of technology and product development.
It is a progression of the human and personal evolvement of individuals,
and their dedicated efforts to make the impossible, possible.
Throughout the relatively short history of perfusion there have been many courageous and intelligent individuals that worked
diligently to make perfusion the reality that we accept as a clinical practice today.
The most enlightening method of telling the history of the development of the equipment, technology, and procedures of the
present is to examine not only how this technology developed, but to look at the lives and experiences of the individuals
that made the technology possible.
Through this developing archive of The American Academy of Cardiovascular Perfusion Internet Services, we will examine
the contributions of individuals that had a profound impact on the development of not only the perfusion equipment, but the
procedures and practices, as well as the ethos of our thinking,
that we commonly practice today.

Enjoy and learn from the past,

. . . so that you may contribute to the future.

1800

1900

La Gallois
1813

Concept of Artificial Circulation

Kay
1828

Re-perfusion

Ludwig & Schmidt

1868

External Arterial Infusion

von Schroder
1882

Bubble Oxygenation

von Frey & Gruber

1885

Pump & Film Oxygenator

Jacobj
1895

Cross Circulation Research

Alexis Carrel
1902-1935

Vascular Suture Techniques

Aortocoronary Grafts
Heart Transplantation
First U.S. Pump Oxygenator

Gibbon
1937

Concept of Pump Oxygenator

Support for Heart Surgery

1910
1920
1930

1940

Willem J. Kolff
1945-1955

Charles Hufnagel
1946-1952
1950

First Aortic Valve Prosthesis

Andreasen & Watson

1952

Azygos Flow Principle

Ross et.al
1952 - 2000

Ross Procedure

Lillehei
1957
1960

First Clinical Renal Dialysis

Clinical Membrane Oxygenator
Artificial Heart

Richard N. Sarns
1958 - 1995

Clinical Use of Azygos Flow

for Surgery

Pioneering Biomedical Engineer

1970

History of Perfusion
1958 - 1995

Richard N. Sarns:
Pioneer Biomedical Engineer
Speech preented by Richard (Dick) Sarns
on January 24, 1999 in San Antonio, Texas
for a panel presentation before The American Academy of Cardiovascular Perfusion
Reprinted with permission from
The Proceedings of the American Academy of Cardiovascular Perfusion
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Good afternoon. Thank you for the generous introduction.

I will begin with a discussion of the benchmarks in perfusion
hardware and the development of the Sarns' product line
and end with some thoughts about perfusion hardware for
the future.
Open heart surgery began in May of 1953 when a patient of
Dr. John Gibbon was home within two weeks of surgery
after having stopped breathing and pumping her own blood
for 26 minutes while Gibbon's heart-lung machine kept her
alive.
People often ask how we got into the business of building
heart lung machines. It was an exciting time to be a young
engineer in Ann Arbor looking for an opportunity to start a
business designing, building and marketing quality
electromechanical products.
One winter evening I attended a staff party hosted by the
University of Michigan Hospital school where my wife
Norma was a teacher. Most of the 15 teachers were married
to medical students and doctors. I was the lone engineer who felt a little uneasy about communicating with these men.
However, their conversation quickly moved to shoptalk discussing the challenges they were facing getting devices to support

their research in the laboratories. The evening took a course I least expected as I was bombarded with questions regarding
their needs for tools and devices in plastic surgery, orthopedic surgery, urology and cardiac surgery. They vented their
frustration about their inability to get new equipment that was necessary for their work in the laboratory. They were actually
going to hardware stores to buy connectors, tubing, vises and other items.
Over the next few years, I worked closely with surgeons to develop a number of medical devices. This work was done outside of
my day job with Argus Camera Company. It was fascinating to work alongside the surgeons in the laboratory and the doctors
were so appreciative of the quick response we provided. It was a pioneering time and I was in the right place.

In the late 50's I began to focus on cardiac surgery. There were

no regulatory hurdles to overcome at the time, just our own
sense of quality and ethics.
Cardiovascular surgery was being performed at the University
of Michigan on a limited basis.

One early project was to redesign the disc oxygenator that was
owned by the University of Michigan Hospital. Our new
design took the form of a stainless steel shell with a lexan
plastic cover material from General Electric. The oxygenator
featured less priming volume, an anti-vortex blood outlet and
easier disassembly and cleaning. Nurses spent enormous
amounts of time disassembling, cleaning and maintaining
hundreds of parts used in the early open-heart surgeries. The
materials of choice were stainless steel, pyrex glass, silicon
rubber and latex tubing that was routinely autoclaved and
used in surgery over and over again. In those days the
surgeons spent vast amounts of time in the laboratories
perfecting their skills and running the equipment. They knew
how everything worked and demanded high quality.

By 1960 we developed a number of devices used in open-heart

surgery including a stainless steel blood heat exchanger, disc We were receiving orders from local hospitals which forced the
oxygenator, an assortment of stainless steel connectors and
decision to start our own business - Sarns Inc.
venous and arterial cannulae.

We established our business in the basement of our home.

Our first medical exhibit was at the American Society of

Thoracic Surgeons in Philadelphia, Pa. Not only were
commercial exhibitors only grudgingly tolerated, in sharp
contrast to their presence today, but the meeting room itself was
filled with tobacco smoke. Prevention was much lower on the
agenda than it is now.
My stress level was at an all time high. I was really shaking in
my boots at this meeting exhibiting our products for the first
time. This was an era when surgeons made the decision to buy
instruments personally or as an advocate in their institutions.

The next major milestone for our startup company was an

order in 1961 for a complete heart lung machine custom
designed and built for Dr. Delbert Neis,
Omaha, Nebraska. He had received his thoracic training from
the University of Michigan Hospital and knew Dr. Joe D.
Morris, a local cardiovascular surgeon who recommended that
Dr. Neis contact me. A meeting was held with Dr. Neis who
had very specific ideas on how he wanted his new machine to
function.
We drew up the specifications, had a hand shake and went to
work. We had 6 months to design and build the machine
which included 5 in-line pump heads, a disc oxygenator, heat
exchangers, bubble trap, a large blood reservoir and several
other custom accessories.
Dr. Neis requested features that had not existed before and
this caused us to stretch the design envelope which resulted in
several innovations.

We developed a pump head where the occlusion could be

adjusted without any hand tools while the pump head was
rotating. We eliminated a gear head drive system and
transmitted power from a variable speed motor directly to the
pump head using a state of the art belting system.

We incorporated lighted push button controls and we spent a

great deal of time arranging the controls and components so
that the pump operator, the forerunner of the perfusionist, had
a good range of motion and a field of vision. Another
requirement was to bring in outside air from a 5 foot level and
pump it into the interior space in the machine to purge
explosive gases which might be present near the floor in the
operating room. Quality materials and components were
mandatory in the building of Dr. Neis' machine. The machine
was assembled in the basement of our home, tested and driven
to Omaha. We put the machine in Dr. Neis' lab for a couple
days of testing. He was satisfied and wrote me a check for
$12,000. It was a happy ride home.

Once again an opportunity spawned a challenge. Dr. Neis' pump order was a major event. Through word of mouth we
received more pump orders in the next few months.

At this time we had 3 full-time employees and some part time

help for the electronics and electrical wiring and had just
moved out of the basement into a leased factory space on Main
Street in Ann Arbor. As there were no grants, development
funds or prepayments, it was a challenge to scrape together the
money to build these machines.

In the early 60's, the Sarns Inc. business was in a market that
was small and undefined. There were only a few thousand
open-heart surgeries performed in a small number of hospitals
in the U.S. and abroad.

The exhibitors at the meetings were primarily from small companies. A few large companies including IBM and General
Motors had developed blood pumps and working heart lung machines in their laboratories, but their designs were spun off to

small firms which completed their development and brought them to the market place. There were several different devices to
move and pump blood as the market place hadn't yet determined which device would be the standard.
There are many ways to move blood such as a squeeze device like a milking machine, a ventricular bellows arrangement, a
piston pump, centrifugal pumps and vacuum displacement pumps. We chose the roller pump due to its lower cost, non-contact
with fluids, reliability and simplicity.
Another significant advancement in materials occurred in the early 60's The early pump systems used rubber latex tubing.
This material was not ideal for use in a roller pump head for several reasons including variable wall thickness of the tubing.
It did not have memory stability. It also had a tendency to tear when there was an abrasion. In addition, it was expensive. It
was routinely sterilized and reused. The advancement in plastics by several companies made a huge contribution to the
medical industry. Norton Company came out with clear plastic tubing called tygon. This new plastic tubing offered superior
memory qualities, uniform wall thickness, durability and lower cost to a point where tubing sets became disposable.

During the mid-sixties, Sarns began a working relationship with

Baxter Laboratories. A significant product development was the
transfer of our roller pump technology into a small blood pump
package for use in kidney dialysis. We also designed and built a
kidney machine for Baxter laboratories.

This relationship lasted for several years and provided our small
company with a steady flow of orders and cash flow which we invested
in the development of our cardiovascular products.

One of the early characteristics of the heart lung machine business

was that there were no two machines built exactly alike. The surgeons
and people with whom we worked in the OR's had very strong
opinions on how their machine was to be laid out in regard to where
the heat exhangers would be mounted, what type of oxygenator would
be used and what accessories would be needed and where they would
be placed. So what we had was a custom design business with the
roller pump and drive system being the only standard parts.

The need for some type of standardization, while providing our

customers with flexibility, drove the development of the Sarns
modular pump system. We also thought that the modular pump
system would have an appeal overseas for an emergency standby
system should service be required. History proved us wrong on the
overseas market. Overseas customers preferred the custom designed
pump console. However, customers in the U.S. drove the market for
modular pump systems. Customers could start out with a basic system
and then add more pump heads and other equipment as needed.

In 1967 our small company moved into a new 16,000 square foot
facility on 5 acres of land on Jackson Road just west of Ann Arbor.
We added to the property and expanded several times resulting in the
current campus of three buildings on 55 acres.

That same year another historical milestone occurred for Sarns Inc.
when Dr. Christian Barnard from South Africa performed the first
human heart transplant using the Sarns Model 2000 heart-lung
machine.
Clearly the U. S. was the leader in the training of cardiovascular and
thoracic surgeons. Sarns was fortunate to have its equipment in many
of the leading teaching institutions including the University of
Michigan Hospital, the Texas Heart Institute and Mayo Clinic.
Doctors from overseas came to the U.S. for their training, returned to
their countries to set up practice and in many instances ordered Sarns
equipment on which they had trained.

In 1968 we made a strategic move to aggressively market our products

overseas.
Our first exhibit through the U.S. Chamber of Commerce was in
Milan, Italy. It turned out to be a wonderful show for us because Dr.
Michael Debakey was there and our equipment was selected to be
used in his mock operating room theater.
Later that year we exhibited Sarns' products in Japan, Hongkong and
Taiwan which also turned out to be successful markets.

A very important medical benchmark occurred in 1968 with the

introduction of the coronary artery bypass graft surgery. No longer
were heart lung machines used almost exclusively on congenital heart
defects, heart valve surgery and gravely ill patients in the late stages of
cardiac disease.
The financial engine that fueled the expansion of open-heart surgery
was the creation of Medicaid and Medicare by the U.S. Government
which subsidizes the payments for the vast majority of open heart
surgeries.

In the 1970's coronary artery bypass surgery became the gold standard and expanded very rapidly in the U.S. and Europe where heart
disease was the number one cause of death in the mature male population. In Asia and surrounding countries, coronary artery disease was
remarkably low and in some areas almost non-existent, but still there was a market for perfusion hardware for cardiac valve surgery and
congenital heart defects.

In 1972 I traveled to Russia with a group of small U.S. companies to

exhibit in Moscow. An export company in N.Y. promoted the show as
a sell out opportunity to export U.S. products into Russia.

We were encouraged to bring large quantities of products to the exhibit because the potential was to sell all the products we brought.

This is an interesting Russian built heart lung machine, a vertical

configuration with roller pumps extending from a center support. The
marketing trip to Russia was a total bust for all the U.S. companies;
we had zero sales.

An important benchmark for the medical device industry occurred in

1976 when the U.S. Government enacted the medical device legislation
governed by the U.S. Food and Drug Administration.
In the late 70's, Sarns management made a strategic decision to seek a
corporate partner with financial, technical and marketing resources
which would enable Sarns to offer state of art products worldwide. In
1981, after two years of discussion and planning for the future, Sarns
Inc. became a wholly owned subsidiary of 3M. 3M's vast technical
resources and investments in R & D resulted in a new generation of
heart lung equipment.

First, the Model 7400 blood pump which I am pleased to report won the national award given by the professional Engineering Society of
America in 1983.

The Model 9000 console was a significant technical achievement with computerized touchscreen
display and backup systems. It received the national Professional Engineering Society of
America award in 1988. The centrifical pump and CDI monitoring products were major product
line additions.

Reflecting on the heart lung pump system

since our first involvement thirty-nine years
ago, the heart lung bypass system has been
used in millions of surgeries worldwide.
Over the years there has been a substantial
number of important refinements which
have greatly improved the reliability and
operation of the equipment. The addition of
onboard microprocessor driven monitoring
equipment provides online information for
the perfusionist and heart surgery team.
The projection for open-heart surgeries this year is estimated at 500,000 U.S. and 500,000 abroad. Interestingly, there are about the same
number projected for angioplasty procedures which include stints and minimally invasive heart surgery. Clearly there is increasing
competition and new procedures for treating people with heart disease. However, when we consider the growth of the aging population in the
U.S. and abroad, it is clear that the demand for perfusion hardware devices will remain well into the next century.

In the future we will see continuing refinements in devices to make a seamless transition on and off extracorporeal bypass
focusing on safety, reliability and online monitoring of fluid flows, temperatures and blood gasses during surgery. The ultimate
goal is to provide a system where a patient's blood does not recognize when it leaves or enters the body during surgery.
It is a pleasure to be a part of your program today. As a person who has spent many years in the field observing open heart
procedures, I have an appreciation and respect for the men and women in this audience who operate the heart lung systems.
Your skills and training contribute greatly to the quality of life of people who undergo open-heart surgery, which is still
considered the gold standard surgical treatment for heart disease.

cardiopulmonary bypass
/pumps

Three types of pumps are currently in use: the roller, centrifugal, and ventricular pumps. Only the roller and
centrifugal pumps currently are in wide use.
roller pumps

Roller pumps have been the most commonly used pumps for cardiopulmonary bypass for the past 30 years. A roller
pump consists of a length of tubing located inside a curved raceway at the outer perimeter of rollers mounted on the
ends of rotating arms (usually two, 180 degrees apart). The system is arranged so that one roller is compressing the
tubing at all times. Flow of blood is induced by compressing the tubing, thereby pushing the blood ahead of the moving
roller. Flow rate depends upon the size of the tubing, length of the track, and rotation rate of the rollers (revolutions per
minute) . For a given pump and type and size of tubing, flow is proportional to pump speed (revolutions per minute). In
vitro calibration curves must be constructed and checked periodically. This is done by measuring the output of the
pump over a measured period of time at various pump settings in a mock circulation, preferably using blood.
Silastic rubber, latex rubber, and polyvinyl chloride (e.g., Tygon) tubing have been used in the raceway. The latter type
is favored by many surgeons because it is an integral part of the circuit, is durable, and associated with acceptable rates
of hemolysis. It does get stiff during hypothermia and is subject to release of particulate material (spallation). Latex
rubber was associated with greater hemolysis, while Silastic rubber had less hemolysis when the pump was completely
occlusive (see below), and is said to resist fracture over long periods of time. Spallation refers to the release of microparticles of plastic from the inner walls of tubing due to compression by roller-pumps. Silicone releases more particles
than polyvinylchloride (PVC), while new formulations of PVC that release even less are being developed.
The degree of compression ("occlusiveness") of the tubing by the rollers can be adjusted and appears to be critical.
Excessive compression aggravates hemolysis and tubing wear, while too little occlusion may also aggravate hemolysis
but, more importantly, compromises forward output. Although there is some disagreement, most surgeons believe that
the least hemolysis occurs when compression is adjusted to be barely non-occlusive. This is accomplished by holding
the outflow line vertically so the top of the fluid (blood or asanguinous) is about 60 to 75 cm (24 to 30 inches) above the
pump, and then gradually decreasing the occlusiveness until the fluid level falls at a rate of 1 cm every 5 sec to 1
cm/min. The tighter setting assures more accurate forward flow, makes the roller pump relatively insensitive to
afterload, and may not be associated with more hemolysis.
Complications associated with roller pumps include malocclusion (with the consequences noted above), miscalibration,
fracture of the pump tubing, "run away" or loss of power, spallation, and pumping of gross air. If the outflow becomes

occluded, pressure in the line will progressively rise until the tubing or connections break. If inflow becomes limited,
the roller pumps will develop high negative pressures producing cavitation (micro-bubbles).
centrifugal pumps

Centrifugal pumps consist of a fanned impeller (Sarns and Aries) or a nest of smooth plastic cones that sit inside a
plastic housing. The impellers or cones are magnetically coupled with an electric motor and, when rotated rapidly,
generate a pressure differential that may cause the movement of blood. Unlike roller pumps, they are totally nonocclusive and afterload-dependent, i.e., an increase in downstream resistance decreases forward flow delivered to the
patient. This has both favorable and unfavorable consequences. Flow is not determined by rotational rate alone, and,
therefore, a flow meter must be incorporated in the arterial outflow to quantitate pump flow. Furthermore, when the
pump is connected to the patient's arterial system but is not running, blood will flow backward through the pump and
out of the patient unless the arterial line is clamped. This can cause exsanguination of the patient or aspiration of air into
the arterial line (e.g., from around the purse-string sutures). Thus, whenever the centrifugal pump is not running, the
arterial line must be clamped. Kolff et al have described a check valve to prevent this problem. On the other hand, if the
arterial line becomes occluded, these pumps will not generate excessive pressure (the maximum is only about 700 to
900 mm Hg) and will not rupture the arterial line. Likewise, they will not generate as much negative pressure (and,
hence, as much cavitation and microembolus production-the maximum is only about-400 to-500 mm Hg) as a roller
pump if inflow becomes occluded.
Another reputed advantage of centrifugal pumps over roller pumps is less risk of passing massive air emboli into the
arterial line. This is because they will become "deprimed" and stop pumping if more than 32 to 52 ml of air is
introduced into the circuit (but they will pass smaller but still potentially lethal quantities of air). Centrifugal pumps are
associated with greater preservation of platelets and leukocytes, decreased complement activation, reduced microbubble
transmission, and less hemolysis and loss of clottable fibrinogen when compared to conventional roller pumps.
Centrifugal pumps may also require less anticoagulation. On the other hand, roller pumps are simpler, cheaper, have a
lower prime volume, and are easier to prime and deair, produce a predictable output that is independent of afterload,
and are capable of generating greater degrees of pulsatile flow. For these reasons, centrifugal pumps are generally
reserved for temporary extracorporeal assist devices and left heart bypass, whereas roller pumps are used for operative

cardiopulmonary bypass. However, some have recently argued for the superiority of centrifugal pumps in pediatric
cardiac surgery.
Several types of centrifugal pumps are commercially available, including the BioMedicus Bio-pump, Sarns Delphin,
and Aries Lifestream 2000 pumps. Leschinsky et al. have analyzed the development of centrifugal pumps and made
suggestions for future improvements. Qian et al. described one such promising new impeller-type
pump. Compared with the BioMedicus pump, which employs the nested cones constrained vortex
principle, the Sarns and Aries pumps utilize a finned (fanned) impeller. The Sarns pump is said to be
more efficient (fewer revolutions per minute to generate the same flow), require less prime volume
(48 versus 80 ml), and to be easier to debubble at the start of the case. It also takes less air to deprime
[i.e., 32 versus 52 ml to stop output], generates less negative and positive pressures, is capable of
generating a modest pulsatile flow when optimized in the pulsatile mode, and has a stronger outer chamber
(polycarbonate versus acrylic).
Pacheco et al. compared the BioMedicus, Sarns, and Aires pumps regarding depriming volumes and microembolus
generation (when inflow was occluded). At a flow of 4 liters/min none generated micro-bubbles, but at 6 liters/min the
Bio-pump generated the most and the Delphin the least. The deprime volumes were about 50 ml for the Lifestream
(Aries), 40 ml for the Bio-pump (BioMedicus), and 30 ml for the Delphin (Sarns). Whether any of these features
influence clinical outcome is unknown.
Methods available to generate pulsatile flow during cardiopulmonary bypass include an indwelling intra-aortic balloon
pump, an extracorporeal "balloon" [e.g., Pulsatile Assist Device], ventricular-type pneumatic or hydraulic pumps [e.g.,
Keele pump, Polystan pulsatile pump], modified roller pumps [e.g., Sarns and Stockert, and modified centrifugal pumps
[e.g., Sarns). Even conventional roller pumps produce some pulsatile flow. The Sarns centrifugal pulsatile pump
produces a much lower pulse pressure amplitude than pulsatile roller pumps, but more than conventional roller pumps.
Wright has compared the hydraulic power outputs of various pulsatile pumps and analyzed the factors that affect the
hydraulic power output of one type of pulsatile roller pump (Stockert). The marked differences in pulsatile power
output with different pumps and bypass configurations might explain the dichotomy of results of comparative studies of
pulsatile and nonpulsatile perfusion. Factors that favor maximal transfer of pulsatile power into the patient, besides
optimal control settings on the pump, include use of a wide, stiff arterial line, large arterial cannula (224 F or 6.5 mm),
and not having a micro-filter or membrane oxygenator between the pulsatile pump and the patient. Three types of

hollow fiber membrane oxygenators (Sarns 16310, Bentley CM 50, Bard HF 4000) and a micro-arterial line filter (Pall
Ultipore) had less damping effect than three flat-sheet membrane oxygenators (Cobe CML, SciMed SM35, and Shiley
M200). For optimal transfer of pulsatile energy in a circuit employing a membrane oxygenator, a two-pump system
with a simple re-circulation line is necessary. The pump perfusing the membrane oxygenator must run slightly faster
than the pulsatile pump that perfuses the patient. This adds significantly to the complexity (and possibly to the risk of
complications) of the circuit.
Ventricular-type pumps, while potentially more powerful, are rather cumbersome and have not been well accepted. The
Pulsatile Assist Device exposes the patient to risk of air embolization. Patient factors, such as vascular tone and
impedance, anesthetic state, and physiologic autoregulation, also influence the physiologic impact of pulsatile bypass.

sarns 9000

INTRA AORTIC BALLOON PUMPS

Intra-Aortic Balloon Shock Box