Kidney failure and initial treatment approaches
Acute and chronic kidney failure can lead to death if left untreated. It is a disease as old as humanity itself. In ancient Rome and later in the Middle Ages, treatments included hot baths, sweating, varicose veins and enemas.
The first scientific descriptions of various treatments date back to the 19th century and came from the Scottish chemist Thomas Graham, who became known as the “Father of Dialysis”. He was well ahead of his time when he indicated the potential use of osmosis and dialysis to purify the blood. Then followed many attempts to achieve today’s standard of dialysis.
The term hemodialysis today describes a process in which the blood of patients with kidney disease is cleansed outside the body.
The first historical description of such a process dates back to 1913. Abel, Rowntree and Turner “dialyzed” anesthetized animals, whose blood passed through semipermeable membrane tubes made of Collodion, a membrane material based on cellulose. It is no longer clear today if Abel and his co-workers had intended to use this technique for treating kidney failure from the beginning. However, the Abelian Vivi diffusion apparatus undoubtedly represents the essential elements still used in dialysis today.
Vividiffusionmachine, Abel & Co., 1913
First dialysis in humans
The German physician Georg Haas performed the first human dialysis in 1924. In the years leading up to 1928, Haas dialyzed six more patients, none of whom survived. The reasons for this were probably the already very critical state of health for these patients and the insufficient efficiency of dialysis. But Haas was the first to use heparin as an anticoagulant, which is still used today.
Dr. Haas performing dialysis on a patient at the University of Giessen.
In the autumn of 1945, the Dutchman Willem Kolff succeeded in giving a 67-year-old patient with acute renal failure dialysis for a week with a “drum kidney” that he had developed. The patient was later discharged with normal kidney function and represented the first important breakthrough in the treatment of patients with kidney disease.
Accute dialysis during the Korean War (1952).
Nils Alwall’s modified dialyzer
In 1947, the Swede Nils Alwall published a scientific article on a modified dialyzer that could perform the necessary combination of dialysis and ultrafiltration better than was the case with the Kolff kidney. The membranes used in this dialyzer were cellophane hoses that could be subjected to higher pressures due to their location between two metal support grids. The entire membrane arrangement was placed in a tightly fitting cylinder so that different pressure conditions could be generated.
Cellophane is a plastic that was invented in 1908 by the Swiss Jacques E. Brandenberger. It is a thin, transparent material made from regenerated cellulose. Cellophane is very permeable to water vapor. The material is based on biological raw materials, compostable and biodegradable. It can be used in separation techniques that facilitate the flow of small molecules in solution based on differential diffusion. Nowadays, dialyzers made of fully synthetic polysulfone are used, a plastic that is characterized by particularly good cleaning performance and patient tolerance.
Nils Alwall with an early model of the Kiil dialyzer, 1946.
Despite this extensive technical development, it was difficult during the first years of dialysis to access the amount of blood required for treatment. For this purpose, glass needles were inserted into appropriate blood vessels of the patient. This procedure and the fact that the needles could not remain in the patient’s vessels for a long time, made it impossible to adequately care for and keep people who required regular dialysis alive.
The breakthrough in this area was achieved in 1960 in the United States by Belding Scribner. The vascular access, later known as the “Scribner Shunt”, enabled relatively easy access to the patient’s blood vessels for a period of several months. Two needles made of Teflon were surgically inserted into the appropriate blood vessels of the patient. The ends of the two cannulas were connected to each other outside the body – hence the name “shunt”. The shunt was opened during dialysis and connected to the dialyzer. This enabled for the first time dialysis treatment of chronically ill kidney patients.
The breakthrough that was crucial for access to blood through dialysis came in 1966 through the work of Michael Brescia and James Cimino. These connected an arm artery surgically to a vein. The vein was not adjusted to the high arterial blood pressure and was greatly enlarged. Needles could then be inserted into this vein under the skin, allowing repeated blood access. This technique reduced the risk of infection and allowed dialysis treatment for several years. The so-called arterio-venous fistula (AV fistula) is still the preferred method of blood access for dialysis patients. Some AV fistulas were created on dialysis patients over 30 years ago and are still used today.
The development made it possible to treat patients with chronic kidney failure for a long time. In the spring of 1960, Clyde Shields received a shunt, making him the first chronically ill hemodialysis patient. Shields survived the next eleven years thanks to dialysis; he died in 1971 of a heart disease.
Based on this success, the world’s first chronic hemodialysis program was established in Seattle in the following years. For many developments and inventions from Scribner’s working group, no patent protection was sought during these years to support the rapid spread of these life-sustaining techniques.
The work of continuous improvement has progressed since then and thanks to the progress, a lot of data and experience could be collected and analyzed. The possibilities of computerization have made it easier to monitor and handle the machines.
Today, the challenge is not primarily of a technical nature, rather the large number of patients who need and will need dialysis, the complications that result from several years of treatment and also poverty.
AMB’s contribution to dialysis
Various plastics such as former cellophane or now polysulfones have been important in creating membranes in the dialysis process. But for a complete dialysis machine several functional parts are needed and for many of these different plastics are needed.
AMB injection molds several different parts for dialysis machines for hemodialysis in different plastic materials. Some of these are surface treated for electromagnetic shielding. In addition, we buy cabling and other parts to then assemble complete functional units such as blood pump rotors, filter holders and heparin pumps. As these are medical devices, it is important to follow the special rules that apply to their manufacture. AMB has for many years been certified according to ISO 14385, which is a standard for quality management intended for medical technology classification, which describes how to handle and issue equipment suitable for use in healthcare.
Baxter Gambro AK96 dialysis machine