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2006 Conference Presidential Address

Artificial Organs: A New Chapter in Medical History

Ash, Stephen R.

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doi: 10.1097/01.mat.0000248997.25627.39
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Medical researchers are sometimes accused of having a focus that is too narrow, of thinking about their own little problem to the exclusion of everything else. So, OK, the big picture starts with the Milky Way galaxy. Space is blackness, punctuated by glorious and intense points light and heat. Clicking on one point, we see that on earth life exists at interfaces. With the right combination of earth, water, air, heat, and light, life flourishes. With the wrong combinations of these basic elements, such as in the Sahara desert or a polar region, life struggles. In fact, life itself can be defined as an interface with high chemical gradients. Living cells and organisms have internal chemical environments that are greatly different from their environments. The cell contains potassium, phosphate, urea, and other chemicals that are much different from the local environment. In the healthy state, chemical gradients result in high levels of potential and kinetic energy at the cell membranes. In diseases such as kidney failure, toxins build up in the fluid around the cell, the ratio between internal and external chemical levels becomes lower, and kinetic and potential energy at the membrane decreases. When there is equilibrium across the cell membrane, there is no life. Viewed from another aspect, in life the cell also contains chemical order and structure (enthalpy) in macromolecules such as DNA and RNA, as opposed to the disordered environment (entropy). In disease states, chemical structures fall apart and disorder prevails within and outside the cells.

Artificial organs also include interfaces. Most of our man-made organs have membranes. In the artificial kidney, the membranes transfer urea, creatinine, phosphorus, and other toxins across the membranes to dialysate. The artificial lung transfers CO2 and oxygen, and the liver support device transfers nutrients and a variety of toxins across membranes. The artificial pancreas transfers insulin (and maybe glucagon) across membranes in response to glucose, fatty acids, and so forth. Even the artificial heart has interfaces of high pressure to low pressure.

Innovation is also an interface. A patient suffers from disease (or literally a dis-ease). The standard medical therapy is less than effective and creates its own problems. The physician’s dedication turns to frustration. Somewhere, an engineer comes up with a new technology for measuring or affecting a physical process. Science supplies a “paradigm” for understanding the cause and a proper therapy for the disease. The fusion of these various processes, usually by a physician or skilled researcher, results in an innovation in medical therapy. The word paradigm means “pattern” in Greek. The word means the same in Latin. Through the work of Dr. Thomas Kuhn, paradigm began to be understood as a set of assumptions used when viewing reality.1

The two most important questions of science are “What can I know?” and “How can I know it?”1,2 Regarding the first question, the main search is for “the cause and controlling principle of any occurrence.” The question “Why?” is too deep for science, and falls instead in the religion and philosophy departments…sometimes in physics. Regarding the second question, how one pursues a question dictates the answer. As stated by Thomas Kuhn:..“at any point in time, a paradigm, perceived truth, dominates the thinking in any science and tends to freeze progress.”1 However, a good theory or hypothesis encourages predictions. The scientific method tests this prediction and the results often demonstrate in “anomalies” that erode the paradigm. As a result, eventually a new paradigm is created. This happens over and over in the field of artificial organs; pathogenesis of disease becomes much more interesting after a treatment is created and is partially successful.

History of Medicine and Artificial Organs

I decided to try to present the History of Medicine and Artificial Organs in just three slides, with information from John Barry’s excellent book and the Project Bionics Timeline on,3 I’m not sure what compelled me to try to do this, but there is a point to this exercise (I hope). The three slides describe an accelerating course of innovation, the first covering years –400 to 1890, the second 1890 to 1960, and the third 1960 to 2000 (Figures 1, 2, and 3). On the slides, technological improvements are indicated by words perpendicular to the center line and other lines. Branching points in the diagram represent new paradigms.

Figures 1, 2 and 3.:
Timeline of medical development from 400 B.C. to 2000 A.D. Technological improvements are written vertically. Branching points are new paradigms. Source: Project Bionics Timeline.

Years 400 BC to 1890

In 400 BC, the technologic tools that Hippocrates had were his eyes, ears, and brain (Figure 1). About 400 BC, he claimed “theory is the composite memory of things apprehended with sense perceptions.”2 He observed nature but did not probe nature. He decided that there were four humors: blood, phlegm, bile, and black bile. Illness was an internal imbalance between these four humors, or external environmental influences. The idea of four humors conformed pretty well to the four seasons and the four elements earth, air, fire, and water. Examples of humors were separation of blood to clear yellow and red layers on standing and the fact that phlegm in the chest was related to cough. His general conclusion was that we should not interfere with natural processes but rather augment them. Later, the term “laudable pus” was an example of this philosophy. According to Hippocrates, surgery was intrusive and a purely mechanical skill.

About 200 AD, Galen benefited from a technologic innovation called the sword. He was a physician to the gladiators and was able to learn a lot about internal anatomy and the healing process from their wounds. He also dissected animals and generally probed at nature. He remained a theoretician, however, and still believed in four humors, but he believed that humors were not body fluids, were invisible, and were “recognizable only by logic.” Perhaps that was the same as saying that life forces are not visible. He helped establish bloodletting as a therapy (maybe because this was easier than removing phlegm, bile, or black bile). Until the 1800s, bleeding was a common therapy.

Around 1500, four physicians established the modern paradigms of medicine. Fractasorius proposed the radical theory of “contagion” by which illness “passes from one thing to another and is originally caused by infection of the imperceptible particle.” Paracelsus believed that medicine should not be practiced by following old teachings but “by our own observation of nature, experiment, and reasoning thereon.” He was the first to apply the techniques of chemistry to medicine. Vesalius dissected human corpses and defined anatomic relationships as never before seen. He thought that Galen’s logic was flawed. Fabricius demonstrated that with techniques designed for a specific purpose, surgery could actually benefit patients. Not much changed in medical practice for a long time, but a structure of thought was established.

Following the concepts of Fractasorius and with the scientific method, Jenner was able to prove that cowpox vaccination prevented smallpox in 1798. About 400 years earlier, the practice of “variolation” had demonstrated that if fluid from smallpox pustules was applied to small wounds, then a recoverable illness would result rather than a lethal illness. It took Jenner to prove that exposure to one disease could prevent another. Using the techniques of bacterial culture, Henle established the germ theory. Pasteur proved that heating wine prevented illness and that a vaccine prevented anthrax. Lewis proved that vaccination could prevent pneumococcal infection. Establishing the techniques of epidemiology, John Snow proved that cholera was an infectious disease.

Following the concepts of Paracelsus, Bernard demonstrated chemical function of the liver and pancreas. Osler linked diseases and symptoms to chemical levels, establishing the clinical laboratory. With the development of physical chemical techniques, Lavoisier demonstrated oxygen extraction and Starling demonstrated chemical and gas transfer of tissues, including the peritoneum. DNA was isolated in the 1860s. The discovery of electricity was intimately tied to its effects on nerves, and Galvani proved the presence of electricity partly by biologic experiments.

Following the concepts of Vesalius and Fabricius, in 1628, Harvey proved the circulation of blood, often called the single greatest achievement of medicine. Using the microscope, Malpighi demonstrated capillaries. Starling demonstrated how capillaries and the heart worked together. Along the way, surgical techniques improved. John Hunter elevated surgery to scientific study and did model experiments, infecting himself with pus from a case of gonococcal disease to prove the infection hypothesis. ”Don’t think, try” was his motto.

Years 1890 to 1960

By the 1890s, scientific disciplines evolved including immunology, bacteriology, biochemistry and organ chemistry, gas physiology, genetics, electrophysiology, and cardiac physiology. Medical history from 1890 to 1960 was accelerated by numerous technologic innovations (Figure 2). Immunology led to the application of plasmapheresis and globulin therapy. Fleming proved that penicillin could inhibit bacteria, but he never conceived of it as an injectable compound or the clinical use of penicillin and numerous other antibiotics. Lewis proved that a filterable agent called “virus” caused polio and that protective effects could be obtained by immunization in animals. He also proved that the 1918 influenza pandemic was due to a virus, a radical concept at a time when bacteria were just being accepted as a cause of disease. Abel, Rountree, and Turner at Johns Hopkins demonstrated the chemical function of dialysis using rather unstable colloidin membranes and animal models of kidney failure. Haas performed dialysis of humans by using colloidin membranes. Thallheimer performed dialysis of dogs by using cellophane membranes and heparin as anticoagulant. During World War II, Kolff developed the rotating drum artificial kidney with cellophane membranes and heparin anticoagulant. He treated 17 patients with acute renal failure before finally having one patient with renal recovery. Scribner described chronic hemodialysis in the 1950s, and within a few years, Eschbach and Scriber described the benefits of nighttime hemodialysis. Thomas Chang perfected the techniques of encapsulation for cells, sorbents, and enzyme systems.

Von Frey and Gruber developed heart-lung devices, and Jacobi used them for organ perfusion. Gibbon introduced the diaphragm pump for propelling blood, and DeBakey adapted the roller pump for cardiac bypass. Clowes demonstrated a clinically functional membrane oxygenator. Avery proved that DNA carried the genetic information for bacterial transformation. Within 20 years, Watson and Crick proved the double-helix configuration of DNA.

Electrophysiology led to clinical nerve stimulation, and Chardack and Greatbach developed the implanted pacemaker. Demikhov applied extracorporeal assist to animal models. Kolff and Akutsu implanted the artificial heart in the dog, and DeBakey implanted the ventricular assist device and a total heart in humans. Dubose performed an aortic homograft in patients and Hufnagel an aortic valve replacement.

Years 1960 to 2000

The period of 1960 to 2000 also was a time of rapid technologic advances (Figure 3). There are many new technologies not even mentioned in this slide. In the field of Immunology, plasmapheresis applications expanded. Malchesky showed benefits of twin-stage pheresis. Immunosorbents containing Staph protein A and anti-IgG made pheresis more selective and practical. Antibacterial surfaces for catheters were developed, and eventually antibacterial catheter locks were developed. Adsorption therapy proved to be of some benefit in sepsis or systemic inflammatory response syndrome. The benefits of long-term dialysis were proven, and the End-Stage Renal Disease act was passed to provide greater patient access to dialysis. Popovich and Moncrief developed continuous ambulatory peritoneal dialysis for end-stage renal disease therapy. Cycler peritoneal dialysis machines were developed, as were several machines making home dialysis more practical. The benefits of nighttime and daily dialysis became generally accepted. Rohde and Blackshear developed an implantable insulin pump, and pancreatic transplants and bioreactors were tested widely. Extracorporeal treatment for liver failure and drug overdose started with the hemoperfusion columns of Yatzidis. Demetriou and others developed the hepatocyte-based artificial liver. Sorbent dialysis and pheresis devices were applied to treatment of liver failure.

The implantable defibrillator became possible with the work of Schuder, Geddes, and others. Dobelle developed early models of the artificial eye and ear. Portner developed a practical implantable left ventricle assist device. Devries implanted a pneumatic heart with operation for 112 days. Portner also developed an electrical left ventricular assist system. Frazier and Wampler developed an early axial flow left ventricle assist device, the Hemopump, and DeBakey later implanted other versions of this type of pump. Gray and Dowling implanted an electric total heart.

Conclusions and Suggestions From History

As shown in Figure 4, it seems that our speed is faster than we often realize. I think this summary of progress does show that history matters, and we can make some conclusions and suggestions:

Figure 4.:
The way we feel after reviewing medical progress.
  • Paradigms drive our understanding and our therapies for disease—we must choose the most complete paradigm if we will be successful.
  • Paradigms are slow to change—if you wish to disprove one, you must gather lots of proof.
  • Partial improvement of patients with medical therapy may mean that our paradigms are imperfect—always search for new paradigms.
  • New technologies result in better diagnosis and treatment; but the physician has to find them first—learn about new techniques and materials as they arise.
  • Progress in artificial organs always seems painfully slow to us but is fast by historical standards—be patient.
  • It is possible to predict the course of medical science: “I don’t skate to where the puck is, I skate to where it’s going” Wayne Gretsky.
  • However, predictions are difficult because of the breadth of science included in medicine: “It’s dangerous to make predictions, especially about the future” Casey Stengel.

March of Technologic Resources

The field of artificial organs is filled with success stories (Figure 5). Dr. Michael Lysaght provided these photos and the title “Man made Man,” demonstrating successful artificial hearts, pacemakers and defibrillators, heart valves, dialysis machines, oxygenators, artificial hips, biological hip components, and artificial skin.4 The march of technologic resources has changed our concepts of artificial organs. In the “old” model, replacement of organ function has been with organometallic man-made devices. In the near future, living substitute parts with biological components will be used to replace organs and tissues of the body. Eventually, technologies, probably based on stem cells, will allow self-regeneration of deteriorated organs and tissue. Perhaps we won’t be able to regenerate limbs and organs as well as starfish and salamanders, but we might be close.

Figure 5.:
Man-made organ and tissue replacements (Dr. Michael Lysaght, 2006).

How Can We Contribute to Artificial Organs?

Turning to another question, how can we each contribute to artificial organs? I’m 60 years old now, so I’m old enough to give advice but also am less receptive to advice. Here are 10 simple rules that I would give to any young researcher: 1) Know the problem. 2) Know but doubt the paradigm. 3) Train with the best in scientific method. 4) Use the newest tools; model all you can. 5) Focus. 6) Collaborate. 7) Communicate; publish. 8) Be patient. 9) Be careful. 10) Keep balance, a strong family, faith, and humility. I’ll now discuss each of these points somewhat briefly.

1. Know the Problem.

Regarding the first point, to solve any problem you have to intimately understand it. To see where science and society are going, find today’s problems. Assume the role of patient, or a too-tired doctor at the end of a complicated procedure. Find what frustrates them with current devices and medical practice. Then, know that this problem will be solved, some day. If you are a scientist, hang around the clinic. If you are a physician, learn everything about the machines you use and work with engineers and scientists to understand the reasons that the machines are designed as they are. As an example, what are the problems in renal replacement therapy? In my viewpoint, today’s needs scream out for the following:

  • Safe and simple approaches for home dialysis
  • Improving monitoring for nighttime dialysis
  • Machine response to patient physiology
  • Machine response to patient chemistry
  • Wearable artificial kidneys
  • Regenerating or sterilizing all components
  • Replacing hormonal functions….

Maybe some of these seem a “fur piece” from today’s practice, but all are important in making dialysis therapy practical and effective. There are currently three machines being developed specifically for home hemodialysis, and all represent significant improvements over standard machines. The Allient Sorbent Hemodialysis System is the resurrection of the Redy machine and includes pressure-actuated blood pumping (with a two-ventricle pump), automated fluid management, and increased monitoring. The NxStage system utilizes sterile dialysate, a neatly packaged cartridge for all disposables, and increased monitoring. The Aksys machine sterilizes all components including the dialysate, blood tubing, and dialyzer with heat, making setup for daily dialysis simpler. With all these devices, there still is a way to go before home dialysis becomes as simple as peritoneal dialysis cycler therapy. However, we’re getting there. The Renal Assist Device from Renamed includes tubule cells cultured from progenitor cells in adult kidneys. The tubule cells not only reabsorb fluid from the filtrate but also modulate cytokine levels and perform some hormonal functions. Dr. David Humes continues to work to make the device practical for implementation in treatment of patients with acute and chronic kidney disease.

Problems in blood access for hemodialysis portray the following needs:

  • Repeatable blood access of 400 ml/min, not 1000 ml/min, as in fistulas/grafts
  • Arterial access without bleeding risk
  • Access without repeated needle-sticks
  • Catheters with consistent flow, avoiding clotting and sheathing
  • Anticoagulant/antithrombotic catheter locks and solutions

Fistulas are the best current dialysis access. These are created by mobilizing and attaching the cephalic vein, basilic vein, or brachial vein to a neighboring artery. The vein must be transposed if it is too deep to allow ease of needle insertion. Grafts are the next best access, PTFE fashioned in loops or lines and fastened to artery or vein. Stenosis develops near the site of these anastomoses, and sometimes far upstream, for reasons that aren’t clear. A number of devices have been developed to create a sutureless anastomosis between a vein and an artery. These devices have worked pretty well when hooking into a large blood vessel like the aorta, but have had more problems when attaching to a peripheral vessel. Why can’t we create a subcutaneous device with a small tube connecting artery to vein, carrying about 400 ml/min? This would provide just enough flow for successful dialysis, not much more. For access, something at skin level would be ideal, such as is used with the Hemaport. Although this access is connected to a PTFE graft and is somewhat bulky, the concept is sound and patient-friendly.

In central venous catheters for dialysis, the best approach yet is the tunneled, cuffed, dual-lumen catheter. The function and placement of this catheter seems rather simple. Place the arterial (outflow) lumen near the junction of the superior vena cava and the venous (return) lumen within the atrium, and blood flow rate of 400 ml/min is usually obtained. However, life is never as simple as in the pictures. The anatomy of veins of the chest is actually much more complicated, and especially when catheters lead to central vein stenosis the positioning of catheters is much more complicated. As shown by Dr. Gerald Beathard, clots occur within the lumen and at the tip of dialysis catheters and sheaths occur around the catheters, resulting in diminishing flow over time. Biofilm forms on all of the catheters, and when bacteria enter the biofilm and become sessile, they are impossible to eradicate with antibiotics. When portions of the biofilm break off and enter the blood stream, planktonic bacteria cause catheter-related blood stream infection, or CRBSI. The incidence of CRBSI in patients with tunneled dialysis catheters is about 10% per month of use, and patency failure occurs in another 3% per month. To prevent clotting at the tip of the catheter and to hold anticoagulant lock solution, catheters that actively open and close would be ideal. The opening might also break the surrounding sheath, limiting its growth. Antibacterial catheter locks of almost any type can greatly decrease the incidence of CRBSI. However, antiseptic-type compounds are preferable to antibiotics to diminish the onset of bacterial resistance. One such solution in clinical trials is a combination of methylene blue, citrate, and one other compound, called AAT-023. This solution kills all organisms infecting catheters within hours. Heparin, by contrast, kills almost no organisms.

Liver support is a new area of application of dialysis, sorbent, and cell therapy. The problems of treatment of liver failure are greater than for renal failure therapy, partly because the intrinsic clearances of the liver are so much higher than for kidneys. Problems of liver support include:

  • Obtaining blood flow rates and toxin clearances in liters per minute, not milliliters per minute
  • Sorbent removal of toxins without removing vital substances
  • In cell devices, obtaining a mass of at least one tenth of normal liver
  • Supporting metabolic needs of cells (and oxygenation) better than is possible by the plasma of ill patients
  • Creating an intricate structure for cell-blood interaction
  • Reconstructing the relationship of hepatic cells to bile canaliculi, to which toxins should be transferred.

An early attempt at artificial liver support was the BioLogic-DT System, which included a suspension of activated charcoal and cation exchangers and blood on opposite sides of a cellulosic membrane. Selectivity of chemical removal was achieved by the natural function of the charcoal and by preloading with various nutrients and removal of protein-bound toxins was promoted by binding on the dialysate side of the membrane. The system was FDA approved for market for treatment of hepatic encephalopathy and drug overdose in 1996. A slightly more sophisticated approach is the MARS system, which uses albumin on the dialysate side to bind protein-bound toxins as they pass through the membrane. Charcoal and anion exchange columns regenerate the albumin, and a second dialysis membrane removes small molecular toxins. The Prometheus system is more chemically effective because its membrane allows convective passage of albumin (but few globulins). The albumin carries the toxins directly to the filtrate side, for removal by neutral resins. The Impact system creates a plasma filtrate for perfusion over sorbent columns. Although all of these systems have demonstrated beneficial clinical effects, their overall chemical function is small despite their size and complexity and the effort in operation, something like a steam-powered pencil sharpener.

Despite tremendous progress, daunting problems remain for the artificial heart:

  • Miniaturizing the entire system to fit above the diaphragm
  • Creating physiologic responsiveness closer to nature
  • Providing blood-contacting surfaces without thrombosis or fibrosis
  • Minimizing trauma and fibrosis at major vessel interfaces
  • Maintaining pulsatile waveform
  • Insertion with less invasive surgery
  • Mechanical operation 10 years or more

From my overview perspective, these goals seem clear, but difficult, but we are making progress toward solving all of them.

For the artificial lung, the progress has also been great, but problems are formidable:

  • Vascular access, as in chronic dialysis, suited for liters per minute
  • Designs with intricate spacing of gas and blood vessels
  • Gas transfer capable of supporting life
  • Materials capable of long-term contact without clotting
  • Size and design suitable for implantation
  • Hormonal and endocrine effects similar to natural lung

Toward an artificial pancreas or bio-artificial pancreas, work has been ongoing for over 40 years. However, there remain significant problems:

  • Creating a long-term glucose sensor, durable and without need for calibration (same need as 40 years ago)
  • Avoiding sclerotic changes around the sensor, which alter local mass transfer coefficient
  • Creating an intricate relationship of cells and blood for diffusion to carry insulin (and glucagon) to blood
  • Solving blood access problems for a bioreactor
  • Avoiding encapsulation if using cell-containing microcapsules
  • Providing other hormonal functions of the pancreas
  • Implanting major portions or all of the device
  • Solving immunologic problems for xenotransplanted cells
  • In general, how to rebuild rather than merely replace organs.

Regarding the insulin sensor, there are some approaches that promise to simplify the problem. Ultrafiltration of fluid from capillary beds or from blood results in a filtrate that has a concentration of glucose identical to plasma water. Glucose measurement is then performed in an environment that is more in vitro than in vivo. There are physical properties of glucose that can be measured by sensors that would never need recalibration. I hope to speak more about this approach to glucose measurement at next year’s ASAIO meeting.

2-4. Know But Doubt the Paradigm.

Train with the best in scientific method; Use the newest tools; Model all you can.

Returning to our suggestions on “how to contribute” above, we’ve covered “know the problem” pretty thoroughly. Thinking about the paradigm that you’re following is educational and leads to new paradigms. Training with the best is not always easy and usually involves travel. In my case, it was traveling to Utah in 1975 to work with Drs. Kolff, Andrade, Olsen, and Jacobsen. In 3 months, I learned more about how to conduct artificial organ research than I ever expected. One lesson I learned later was the value of mathematical modeling. A good theoretical model sharpens your own thinking. Results of sophisticated techniques like computational flow dynamics, particle velocity measurements, and chemical reaction models save countless hours of frustrating experiments.

5. Focus.

Regarding focus, this is sometimes an easy lesson to forget when we are driven by patient needs and new technology. If we have resources to try to solve a problem, it’s hard not to begin some preliminary work. However, looking back at my own career, I find it amazing that in the space of only about 35 years I “focused” on all of these problems and therapies (with the resulting devices):

  • Kidney failure treatment at home (BioLogic-HD, Allient).
  • Liver failure treatment (Liver Dialysis, PF sorbent pheresis)
  • Sepsis therapy (PF)
  • HIV/AIDS and advanced cancer (Hyperthermia with sorbent dialysis)
  • Blood access for dialysis (SplitCath, IVAD, expandable catheters, new methods of fistula creation…)
  • Catheter infections (silver catheter coating, and Antibacterial/Antithrombotic Solution AAT-023)
  • Peritoneal access for dialysis (LifeCath, Advantage, Sureflow catheters)
  • Peritoneoscopy for catheter placement (Y-Tec System)
  • Peritoneal clearance improvements (Flow-through Peritoneal Dialysis, pressure controlled)
  • Diabetic monitoring (ultrafiltration fibers, glucose sensors)
  • Electronic Medical Records (SmartChart, Velos)
  • Nephrology training issues (IJ Ultrasound and Endovascular models for interventional procedures)

Perhaps a little focus would have helped in my career: there is a fine line between dedication and obsession.

6. Collaborate.

Regarding collaboration, remember that innovation is at the interface of clinical practice and science. We all are searchers for new technology to answer the problems we see in clinical practice. There are researchers with a technology or solution looking for a problem. Find them; plan years of collaboration. Surround yourself with capable people and collaborate with them, with allies, and with outside corporations whenever possible. In my case, the collaboration with David Carr (Chemical Engineering), Janusz Steczko (Biochemistry), Tom Sullivan (Electrical Engineering), Lloyd Brewer (Medical Technology), and Keith Williams (Computer Programming and Electrical Technology) has been invaluable.

7.Communicate; Publish.

Regarding communication, never be afraid to ask for help from others. Use societies like the ASAIO for what they offer—others with your goals and interests. Publish when the data are conclusive, even if the results are unsatisfactory. And remember, none of our artificial, surrogate organs is truly satisfactory.

8. Be Patient.

Regarding patience, I am reminded that it took 20 years to progress from the BioLogic-HD (a home dialysis system) to liver dialysis (for hepatic failure) to the Allient machine for nighttime dialysis. This seemed an eternity to me. However, it took 3 centuries to progress from the first demonstration of arterial blood pressure (in the horse) to catheter-tipped microchip pressure gauges (by companies such as Issys).

9. Be Careful.

Regarding being careful, try every test method, in the lab and in animals, before going to clinical trials. Go to clinicals when the device is ready, and when questions can’t be answered any other way. Plan for device improvements after the first clinical trial. Don’t get caught in the marketing push to bring the first model to market. And remember, even daily medical practice has sneaky surprises. There’s a right way and a wrong way to do anything. Sometimes you have a feeling that something is wrong and sometimes things just happen.

10. Keep Balance, a Strong Family, Faith, and Humility.

Along with your career, keep balance, a strong family, faith, and humility. You’re going to need all the help and support you can get, when things go right and when they go wrong. Support your family’s interests, even if they are doing things you never could or would do. My long-tolerant wife Marianne is a veterinarian and director of biosecurity for the State Board of Animal Health. Our daughter Sarah is a lawyer with the Department of Agriculture, and Emily is a practicing Ophthalmologist. All three love competitive horseback jumping. In none of these could I excel, but that’s the fun of it.

What Is ASAIO?

I wish to thank the Board of ASAIO for electing me President, a true honor, especially in light of my distinguished predecessors. It has been an exciting and productive year for all of us. Regarding ASAIO, we sometimes take our society for granted, since it’s been here for 52 years (one decade for each ring in our logo). People sometimes ask “What is ASAIO?” It really is four things:

  • A premier society to promote knowledge and utilization of artificial organs by “soul mates in an important field” (Bluemle, 1955) with “a way of thinking, an orientation, an attitude” (Depner, 2004).
  • A crossroad of disciplines, the original “interdisciplinary” society. Like artificial organs themselves, combining all fields of science, engineering, and medicine.
  • A unique scientific forum through the Journal, Annual Meeting, and web site, with rigorous science and recognition of new ideas and concepts.
  • The future of organ replacement therapy, solving the current problems of artificial organs and focusing on bioartificial organs, bionics, and cell and genetic therapies.

Accomplishments of ASAIO

At the member’s meeting this year, we presented some remarkable accomplishments of the ASAIO in just the last year:


Attendance up 20%, abstract submissions up 10%, exhibitors increased. Moderated posters expanded (thanks to Dr. Richenbacher and Program Committee). High school program continued (thanks to the NIH and Dr. Phillips).


Submissions up 20%, selectivity increased, impact factor on the rise (thanks to Dr. Zwischenberger).


One hundred new members so far this year.

Web Site

Completely revamped and truly educational, 17 content editors (Dr. Keith Cook is new Editor in Chief).

For Young Innovators

Enrolling members and providing career benefits (thanks to Sonna Patel, Amy Throckmorton, and Dr. Manning).

Project Bionics

Continuing to find and categorize relics, interviewing pioneers, improvements in educational programs and website (thanks to Mark Kurusz, Jean Kantrowitz, Bob Bartlett, and others).

I look forward to seeing all of you at ASAIO in Chicago again next year. Thank you for your attention and a good sense of humor.


1.Kuhn Thomas: The Structure of Scientific Revolutions (1970, 2nd edition, with postscript).Chicago, IL, University of Chicago Press, 1962.
2.Barry John: The Great Influenza. Penguin Group Inc., NY, NY, 2004.
3.Project Bionics Timeline: ASAIO Gold Volume, 2004, ASAIO, Boca Raton, FL (and in Projects Bionic Timeline,
4.Galletti PM, Aebischer P, Lysaght MJ: The dawn of biotechnology in artificial organs. ASAIO J 41: 49–57, 1995.
Copyright © 2006 by the American Society for Artificial Internal Organs