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Terumo Corporation

Contact information

Address: 2-44-1 Hatagaya, Shibuya-ku, Tokyo, 151-0072 Japan

About

The Akutsu and Kolff collection is stored at Terumo Corporation, Tokyo, Japan. Terumo is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

The Akutsu and Kolff collection has about 100 items and has the following characteristics.

  • The collection includes important artificial hearts in history from the first artificial heart implanted in a dog in the world (1958) to artificial hearts implanted in patients for a bridge to transplantation (second case, 1981) and for permanent use (first case, 1982).
  • The collection includes almost all types of artificial hearts developed by Dr. Tetsuzo Akutsu and Dr. Willem Kolff (who are called fathers of artificial organs and artificial hearts).
  • The collection includes molds and casts of artificial hearts as well as artificial hearts. We can understand how artificial hearts were fabricated.
  • We can learn the whole history of artificial hearts by viewing the Akutsu and Kolff Collection

Items developed by Kolff and his associates (ver. 5)

K1. Mushroom artificial heart (1968)
Soft Shell Mushroom Artificial Heart in National Museum of American History
Date made: 1968, Maker: Kolff Laboratory, Place made: United States: Utah, Salt Lake City
(https://americanhistory.si.edu/collections/search/object/nmah_875472)

The soft-shell mushroom heart has an actively opening and closing mushroom inflow valve. An air sac around the stem of the mushroom expels the blood from the ventricle during systole.

Soft shell mushroom heart (Int J Artif Organs 13(7), 1990, pp. 396-403).

When air pressure is applied, the mitral valve “pops up” and occludes the inflow opening to the left ventricle. With continued air pressure, the stem of the mushroom inflates and drives the blood out of the left ventricle. If enough blood is not available during diastole to fill the ventricle, the soft ventricular walls will collapse inward. Even when a “non-thinking” reciprocating pump is driving this ventricle, undue suction to the natural atrium is avoided by the inward collapse of the ventricular wall.
(W.J. Kolff, The invention of the artificial heart, Int J Artif Organs 13(7), 1990, pp. 396-403)

 

Mushroom artificial heart (K001)

K001 Mushroom artificial heart

(Reference: Kolff, Soft shell mushroom shaped heart, United States Patent 3,641,591, Feb. 15, 1972)

K2. Latex artificial hearts (1969)
The Kolff laboratory tried to produce a latex artificial heart at the end of the 1960 but stopped after a fire in 1973. Latex cannot be glued, so all parts of a latex heart must be dipped in one session, then cured. The team used a polypropylene (Epolene) mold on which the various parts were held together with needles through the center of the tricuspid semilunar valve. Others could be held in place by a specially designed contraption.

Latex artificial hearts 1969 (K002)

K002 Latex artificial hearts
Latex artificial heart (K003)

K003 Latex artificial heart

Epolene molds used making the latex artificial heart (K004)

K004 Epolene molds used making the latex artificial heart

(Reference: Thomas R. Kessler, J. L. Foote, J. D. Andrade, and W. J. Kolff, Methods to construct artificial organs, Trans. Amer. Soc. Artif. Int. Organs, 17: 36-41, 1971.)

K3. Kwan-Gett Prosthetic heart with hemispheric ventricles (1970)
The Kwan-Gett ventricle was made by the layering of Silastic. It was the first to be pumped by a diaphragm. During systole, diaphragm displacement is maximized, but does not touch with the housing. The device had a base of aluminum around which the moving diaphragm and the housing were wired to prevent air leakage.

Schematic cross section of one ventricle. The hemispherical diaphragm is shown in its maximally distended position. There is always a clearance between the diaphragm and housing. The inflow valve is not shown (ASAIO Trans. 14 (1970) 409-415).

Development of the “Kwan-Gett heat”
From the mid-1960s, the sac-type TAH made of Silastic began to be used, but there was concern that its rubbing against the ventricular walls might cause hemolysis during systole. In response to this concern, Kwan-Gett designed an original diaphragm-type TAH (the Kwan-Gett heart) that apportioned some space between the diaphragm and the housing during systole/diastole. In fact, it was designed so the diaphragm and the housing never touched, even at maximum blood displacement. This improvement allowed the University of Utah to keep calves alive for eight days in 1971, two weeks in 1972 (a world record at the time) and 25 days in 1973.

Kwan-Gett Silastic ventricle, about 1970 (K005)

K005 Kwan-Gett Silastic ventricle. The calf survived for 14 hours in 1972.

Silastic ventricles 1974 (K006)

K006 Silastic ventricles 1974

(Reference: Clifford Kwan-Gett, H. H. J. Zwart, A. C. Kralios, T. Kessler, K. Backman, and W. J. Kolff, A prosthetic heart with hemispherical ventricles designed for low hemolytic action, Trans. Amer. Soc. Artif. Int. Organs, vol. 14 (1970) 409-415,)

K4. Segmented polyurethane artificial hearts and LVADs made by solution casting (1975)
In 1975 the Kolff Laboratory developed a fabrication method to make a seamless diaphragm housing junction for an artificial heart using a solution casting of segmented polyurethane.
The housing was placed over a concave diaphragm mold, which corresponds to the shape of the blood diaphragm. This was tapered to be continuous with the inside of the housing. Urethane was poured through the openings which form the inflow and outflow tracts and circulate to coat the housing and steel mold; then assembly was inverted, and the excess was allowed to drain out. This operation was repeated until the desired thickness of diaphragm was formed. After curing and removal, the ventricle and diaphragm formed an integral unit whose blood surface had no interruption.
(Reference: Don B. Olsen, Felix Unger, Hartmut Oster, John Lawson, Thomas Kessler, Jack Kolff, W. J. Kolff, Thrombus generation within the artificial heart, J. Thorac. Cardiovasc. Surg. 70(2): 248-255, 1975.
T .R. Kessler, A. B. Pons, R. K. Jarvik, J. H. Lawson, K. J. Rezzeca, and W. J. Kolff, Elimination of prediction sites for thrombus formation in the total artificial heart-before and after, Trans. Am. Soc. Artif. Intern. Organs 14: 532-536, 1978) )

 

 

LVADs 1969/1981/1983 (K007)

K007 LVADs 1969/1981/1983

Hollow copper mold for solution casting (K008)

K008 Hollow copper mold for solution casting

Lycra Spandex roll (K009)

K009 Lycra Spandex roll. Lycra Spandex roll (produced by Ethicon Corp. under a license from Dupont) is basically the same as Biomer and can be purchased in a large spool.

Pulsating artificial atrium
An extracorporeal left/right ventricular assist device (L/RVAD) has a high inflow resistance resulting from too long cannulas circulating blood through the ventricle. Usually a high vacuum (up to 60 mmHg) is applied during the diastole of the ventricle. Higher vacuum applied might cause additional problems, such as the atrium wall being sucked to the tip of the uptake cannulas. The L/RVAD was operated with short cannulas that can be fixed outside the chest, in which case a pulsating atrium was provided (below figure).
The pulsating artificial atrium was a modified 20 cc ventricle without valves. It had a blood chamber and an air chamber separated with a diaphragm. The air chamber was connected to a pulse-driven system used to pulse the atrium through the diaphragm.
The active atrium converts a stop flow, stop flow situation into a more continuous flow in the uptake cannula and an extra valve is not needed. The air pressure to drive the atrium should not be more than 10 mmHg .

A sketch of the left ventricular assist device. with a pulsating artificial atrium. The ventricle and atrium are driven alternately.

(Reference: Soft Artificial Ventricles for Infants and Adults, With or Without a Clamshell, L. S. Yu, F. Versteeg, M. Kinoshita, B. Yuan, N. Bishop, T. Torgerson, S. Topaz, AND W. J. Kolff
ASAIO Transactions 1990; 36: M238-M242.)

 

 

 

 

Complete 1979 LVAD with tubes (K010)

K010 Complete 1979 LVAD with tubes

Plaster cast of the left side of a human chest with 1979 LVAD. Mold, polyurethane part, and black PVC vacuum-formed part under it (K011)

K011 Plaster cast of the left side of a human chest with 1979 LVAD. Mold, polyurethane part, and black PVC vacuum-formed part under it.

1979 LVAD pumping membrane (K012)

K012 1979 LVAD pumping membrane

Plaster cast of 1980 LVAD (K013)

K013 Plaster cast of 1980 LVAD

1980 LVAD with a round ventricle and round atrium (K014)

K014 1980 LVAD with a round ventricle and round atrium

K5. Jarvik-7 artificial heart: first implantation in a human for permanent use (1982)
The Jarvik-7 total artificial heart is the culmination of 20 years of developmental research. The heart consists of two approximately spherical ventricles with anatomic transitions to the great vessels and atria. Each ventricle is pneumatically powered. The ventricles are constructed of a smooth blood surface made of segmented polyurethane. Each ventricle has a stroke volume of 100 mL. The cardiac valves consist of Bjork-Shiley devices.

Jarvik-7 heart with all connections complete. Right and left ventricles held together by Velcro patches.
(Drawn by Netter, Reproduced from W. C. DeVries and L. D. Joyce, CZDA)

The Jarvik-7 heart first implanted in a huma for permanent use (K015)

K015 The Jarvik-7 heart first implanted in a huma for permanent use

Cast of a Jarvik-7 blood chamber 1983 (K016)

K016 Cast of a Jarvik-7 blood chamber 1983

(Reference: L. D. Joyce, W. C. DeVries, W. L. Hastings, D. B. Olsen, R. K. Jarvis, and w. J. Kolff, Response of the human body to the first permanent implant of the Jarvik-7 total artificial heart, Trans Am Soc Artif Intern Organs 19: 81-87 , 1983.
W. C. Devries, J. L. Anderson, L. D. Joyce, F. L. Anderson, E. H. Hammond, R. K. Jarvik, W. J. Kolff, Clinical use of the total artificial heart, N. Engl. J. Med, 310(5): 273-278, 1984.)

K6. Artificial ventricles and valves made by vacuum forming (1983)
Kolff’s group has recently developed an artificial heart fabricated using a vacuum forming technique. The pump consists of a vacuum-forming soft housing, diaphragm, tricuspid outflow valves and biflap inflow valves. All components are welded together by radio-frequency heat sealing. The advantages of this technique are reliability, speed, and suitability for mass production, resulting in lower expenses than the existing TAHs and VADs made by solution casting. The soft ventricle also provides the following features, easy handling for the surgeon, eliminating the quick connect system, and the employment of a polyurethane valve, which is less thrombogenic.

Extracorporeal LVAD with tricuspid semilunar valves in the inflow and outflow line, 1988 (K017)

K017 Extracorporeal LVAD with tricuspid semilunar valves in the inflow and outflow line.

 

 

Infant artificial heart and molds for atria, aorta, and rings (K018)

K018 Infant artificial heart and molds for atria, aorta, and rings (1988-11)

Vacuum-formed polyurethane ventricles (K019)

K019 Vacuum-formed polyurethane ventricles. Left is used as a total artificial heart and right is used as an LVAD.

 

 

 

Vacuum-formed extracorporeal LVAD (K020)

K020 Vacuum-formed extracorporeal LVAD

Radiofrequency external / internal weld (1993-1-29) (K021)

K021 Radiofrequency external / internal weld (1993-1-29)

 

 

 

Vacuum-forming for monoport LVAD (1991-8-11) (K022)

K022 Vacuum-forming for monoport LVAD (1991-8-11)

Vacuum-formed polyurethane ventricle used as a total artificial heart (K023)

K023 Vacuum-formed polyurethane ventricle used as a total artificial heart.

Dummy vacuum formed TAHs and parts 1983 (K024)

K024 Dummy vacuum formed TAHs and parts 1983

Dummies for trial (K025)

K025 Dummies for trial. Used by surgeons to test fit inside the chest and determine what shape they want to use.

(Reference: G.M. Pantaloa, B.Y. Chalnq, D.N. Bishop, P.A. Perklns, L.S. Yu, J. Jansen, P.A. Socha, J.D. Marks, J.B. Riebman, G.L. Burns, W.J. Kolff, G. Hansen, W. Wildevuur, D. Wurzel , L. Brownstein, J. Kolff, Development of smaller artificial ventricles and valves made by vacuum forming, Int J Artif Organs 11(5): 373-380, 1988.)

K7. Philadelphia-type blood pump (1986)
Philadelphia-type blood pumps are vacuum-formed ventricles with a continuous intima and blood diaphragm.

Philadelphia 1986 (K026)

K026 Philadelphia 1986

(Reference: D. Wurzel, J. Kolff, W. Missfeldt, W. Wildevuur, G. Hansen, L. Brownstein, J. Riebman, R. De Paulis, and W. J. Kolff, Development of the Philadelphia Heart System, Artif Organs 12(5):410-422, 1988.)

K8. Clamshell artificial heart (1988)
This ventricle is extremely soft and pliable for easy insertion. “Quick connector” to the atria and aorta are not necessary. The soft ventricles were made by vacuum forming, after which the pieces were welded together by radiofrequency heat sealing. A rigid clamshell can be pushed and slipped over the soft heart to prevent deformation of the ventricle. This Clamshell artificial heart can be used with a pneumatic driver or any other drive system.

The 60-cc soft left ventricle with clamshell. The clamshell is pushed and slipped over the ventricle through the drive line (ASAIO Trans 1990; 36: M238-M242).

 

 

Clamshell artificial heart with soft ventricles and molds (K027) (K028)

K027 Blood sac

K028 Mold for blood sac of Clamshell pump

Clamshell heart (K029)(1988-7-30)

K029 Clamshell heart (1988-7-30)

(Reference: L. S. Yu, F. Versteeg, M. Kinoshita, B Yuan, N. Bishop, T. Torgerson, S. Topaz, W. J. Kolff, Soft artificial ventricles for infants and adults, with or without a Clamshell, ASAIO Trans 1990; 36: M238-M242.)

K9. Muscle-powered LVAD (1991)
Combination of initial pneumatic power with skeletal muscle-powered LVADs. It has been proven in more than 600 clinical applications of cardiomyopathy that skeletal muscle can be converted by electric “burst” stimulation to contract regularly for years, like a heart muscle. This is combined with initial pneumatic power so that circulation can be supported immediately when the patient is on the operating table. After 6-8 weeks, the muscle is trained, and the pneumatic power can be discontinued.

Muscle-powered LVAD that has a pump sac inside so that it can also be driven with compressed air. In this case, it is connected to the root of the aorta for counterpulsation (Artificial Heart 4, Springer (Tokyo), 1993, pp. 3-11).

Muscle-powered LVAD (K030)

K030 Muscle-powered LVAD

(Reference: Willem J. Kolff & Larry W. Stephenson, Total Artificial Hearts, LVADs or Nothing? And Muscle and Air-Powered LVADs, in T. Akutsu and H. Koyanagi (ed.) Heart Replacement, Artificial Heart 4, Springer (Tokyo), 1993, pp. 3-11)

K10. Skin button for air drive lines (1991)
A skin button produced by Topaz that allows the passage of artificial heart drivelines through the skin. It is equipped with a flange and Dacron velour to prevent the propagation of infection along the driveline.

Cross-section double lumen skin bottom (ASAIO Trans 1991; 37: M222-M223)

Skin button for air-drive-lines (K031)

K031 Skin button for air drive lines

(Reference: P. A. Topaz, S. R. Topaz, W. J. Kolff, Molded Double Lumen Silicone Skin Button for Drivelines to an Artificial Heart, ASAIO Trans 1991; 37: M222-M223.)

List of Kolff’s Items

K1. Mushroom artificial heart (1968)
K001 Mushroom artificial heart

K2. Latex artificial hearts (1969)
K002 Latex artificial hearts 1969
K003 Latex artificial heart
K004 Epolene molds used making the latex artificial heart

K3. Kwan-Gett Prosthetic heart with hemispheric ventricles (1970)
K005 Kwan-Gett Silastic ventricle, about 1970
K006 Silastic ventricles 1974

K4. Segmented polyurethane artificial hearts and LVADs made by solution casting (1975)
K007 LVADs 1969/1981/1983
K008 Hollow copper mold for solution casting
K009 Lycra Spandex roll
K010 Complete 1979 LVAD with tubes
K011 Plaster cast of the left side of a human chest with 1979 LVAD. Mold,
polyurethane part and black PVC vacuum-formed part under it
K012 1979 LVAD pumping membrane
K013 Plaster cast of 1980 LVAD
K014 1980 LVAD with a round ventricle and round atrium

K5. Jarvik-7 artificial heart: first implantation in a human for permanent use (1982)
K015 The Jarvik-7 heart: first implanted in a huma for permanent use
K016 Cast of a Jarvik-7 blood chamber 1983

K6. Artificial ventricles and valves made by vacuum forming (1983)
K017 Extracorporeal LVAD with tricuspid semilunar valves in the inflow and outflow
line, 1988.
K018 Infant artificial heart and molds for atria, aorta, and rings
K019 Vacuum-formed polyurethane ventricles
K020 Vacuum-formed extracorporeal LVAD
K021 Radiofrequency external / internal weld (1993-1-29)
K022 Vacuum-forming for monoport LVAD
K023 Vacuum-formed polyurethane ventricle used as a total artificial heart
K024 Dummy vacuum formed TAHs and parts 1983
K025 Dummies for trial

K7. Philadelphia-type blood pump (1986)
K026 Philadelphia 1986

K8. Clamshell artificial heart (1988)
K027 Blood sac
K028 Mold for blood sac of Clamshell pump
K029 Clamshell heart

K9. Muscle-powered LVAD (1991)
K030 Muscle-powered LVAD

K10. Skin button for air drive lines (1991)
K031 Skin button for air-drive-lines

List of Akutsu and Kolff’s items (ver. 5)

Items developed by Drs. Tetsuzo Akutsu and Willem Johan Kolff at Cleveland Clinic (1957 to 1964)

AK1. First artificial heart (1957)
A001 Copper mold for the left ventricle (1957)
A002 Copper mold for the right atrium and upper/lower vena cava (1957)
A003 Mold and solution cast ventricle inside, about 1960

AK2 Magneto-hydraulic artificial heart (1959)
A004 Magneto-hydraulic artificial heart

AK3. Thermoplastic polyurethane (Estane, Trademark of Goodrich, Akron, Ohio) (about 1960)
A005 Thermoplastic polyurethane (Estane)
A006 Plaster casts of artificial heart

AK4. Electromotor-driven pendulum-type artificial heart (1961)
A007 Electromotor-driven pendulum-type artificial heart

AK5. Pneumatically driven Silastic sac-type artificial heart for use in calves (1963)
A008 Metal mold for a Silastic artificial heart made in February 1960
A009 First Silastic artificial heart (1964)
A010 Cerroture casts of a Silastic artificial heart including atria, pulmonary artery and aorta

Items developed by Akutsu and his associates at Manimonides Medical Center (1964 to 1966) and University of Mississippi (1966 to 1974)

A6. Air-driven sac-type heart for use in dogs (1965)
A011 A pair of ventricles (1966)
A012 A pair of ventricular casts (1966)
A013 Right ventricle of the Silastic artificial heart
A014 Left ventricle of the Silastic artificial heart
A015 Silastic artificial heart (1966-4-25)

A7. V-shaped and U-shaped series-type assist device (1969-1971)
A016 V-shaped series-type assist device (left), U-shaped series-type assist device (right), and polyethylene cast of the U-shaped device (center).

A8. Six-chambered, air-driven, peristatic bypass type assist device (1974)
A017 Peristatic bypass-type assist device (right) and its polyethylene cast (left)

A9. Pneumatically driven silastic sac-type artificial heart for use in calves (1973)
A018 A pair of ventricles (1968)
A019 Left side of the heart (1969-7-18)
A020 Left side of the heart (1970-1-22)
A021 Right side of the heart (1970-11-11)
A022 Left side of the heart (1970) Bicuspid outlet valve and monomembrane inlet valve
A023 Left side of the heart (1973-2-13)
A024 Right side of the heart (1973-2-8)
A025 Left side of the heart (1974-8-15)
A026 Right side of the heart (1974-8-15)
A027 A Completed pair of the hearts (1974-4-11)
A028 A pair of flexible parts for each side of the heart
A029 Housing made of fiberglass and resin
A030 Housing cast covered with Silastic
A031 Original plaster casts of the heart and its polyethylene cast
A032 Mold for left atrium

Items developed by Dr. T. Akutsu and his associates at Texas Heart Institute (1974-1981)

A10. Pneumatically driven diaphragm-type pump fabricated of segmented polyurethane for use in a human (1975)
A033 Akutsu heart model III made on April 2, 1980 (1981)
A034 Right ventricle made of Silastic
A035 Right ventricles: one is made of Silastic (left) and the other is made of segmented polyurethane (right).
A036 Completed pair of ventricles with wavy base made of segmented polyurethane and their plaster casts (1979)
A037 Plaster casts of both ventricles and a wavy-shaped baseplate
A038 Wavy base of the ventricle, its plaster cast and Silastic RTV mold (August 10, 1975)
A039 Plaster casts of a right ventricle (June 1976)
A040 A plaster cast of a left ventricle
A041 A plaster cast of a right ventricle
A042 Plaster casts of a pair of ventricles for “Akutsu Model Ⅲ”; made on May 20, 1981, for clinical use. Left is a right ventricle and right is a left ventricle.
A043 Plaster cast of a left ventricle made on May 28, 1981 for clinical use.
A044 A pair of ventricles made of segmented polyurethane. Left is a left ventricle and right is a right ventricle.
A045 Completed ventricles made of Avcothane. Left is a right pump and right is a left pump.

 

AK11 Artificial valves and valve rings including their molds materials, etc. (A046) (A047) (A048)

Items developed by Drs. Tetsuzo Akutsu and Willem Johan Kolff at Cleveland Clinic (1957 to 1964)

AK1. First artificial heart (1957)
Development of the first artificial heart
In 1957, Tetsuzo Akutsu joined the Kolff Laboratory at the Cleveland Clinic in the United States and began a pioneering artificial heart project. Under Dr. Kolff, he developed the world’s first artificial heart (the Akutsu heart) in December 1957 and implanted it in a dog in January 1958, a truly ground-breaking medical event in artificial heart research.
Made of polyethylene chloride (PVC), this model maintained the circulation of the dog for 1.5 hours. It used two-ventricles contained in one common housing with built-in tricuspid semilunar-type valves and was driven by compressed air.

Akutsu molds 1957 (A001 and A002)
Two copper molds for the first artificial heart (one for the left ventricle and the other for the right atrium and upper/lower vena cava) made by Akutsu in 1957. These were salvaged from a fire in the Kolff Laboratory at the University of Utah in 1973.

A001 Copper mold for the left ventricle (70 mm long and 40 mm wide)

A002 Copper mold for the right atrium and upper/lower vena cava (30.5 mm in diameter for the right atrium and 16 mm in diameter for the vena cava)

Mold and solution cast ventricle inside, about 1960 (A003)

A003 Mold and solution cast ventricle inside

(Reference: T. Akutsu, W. Kolff, Permanent substitutes for hearts and valves, Trans. Amer. Soc. Artif. Intern. Organs 4:230-232, 1958.)

Make a pump
First, a wax cast was made by pouring heat-melted wax into a plaster mold (refer to A003). A paint containing silver powder was applied to the wax cast. This was dried, and then copper plated. When the thickness of the plating reached about 1 mm, the whole was put in boiling water and the wax melted away.
After applying a silicone coating to the inner surface of the copper mold (refer to A001 and A002) thus made, pour in polyvinyl chloride paste, hang it upside down, and when the excess paste has completely flowed down, place it in a dry oven at 160-200 degrees Celsius and bake for a dozen minutes.
Of course, a single coating does not provide sufficient thickness, so coating and baking were repeated as many times as necessary based on the data obtained in the basic experiments. When it reaches the desired thickness, it can be peeled off from the copper mold and pulled out.)
(Reference: Tetsuzo Akutsu, Heart development life, KODANSHA (Tokyo), 1966, pp. 42)


The first total artificial heart which WJ Kolff and T Akutsu made in 1957. The first artificial heart implanted in a dog, which maintained total circulation of the dog for 90 min. This heart was lost on May 5, 1973, when the Artificial Organ Research Center in Utah burned down. (Y Nose, Artif Organs 33(5):389–402, 2009)


The first artificial heart in the western world, used in Cleveland, in 1957. This artificial heart was made of polyvinyl chloride made by Tet Akutsu in Dr. Kolff’s Laboratory, according to the technique of Dr. Selwyn McCabe. Two ventricles are held in one housing. All the valves are of the tricuspid semilunar type. Atrial and artificial vessels are not attached. (Willem J. Kolff and Larry W. Stephenson, Total artificial hearts, LVADs or nothing? and muscle and air-powered LVADs, in T. Akutsu and H. Koyanagi eds., Heart Replacement: Artificial Heart 4, Springer-Verlag, Tokyo, 1993, pp. 3-11.)

AK2 Magneto-hydraulic artificial heart (1959) (A004)
Five electromagnetic solenoids were arranged in a rosette, and each pushed a diaphragm inward, forcing hydraulic fluid to compress the clear polyurethane pumping chamber on either side. The dog lived for 3 hours and 20 minutes. This was the first electrically powered artificial heart implanted in an animal.

A004 Magneto-hydraulic artificial heart

 

 

 

 

 

 

 

 

X-ray image of the magneto-hydraulic artificial heart

 

 

 

The first mechanically actuated total artificial heart (TAH) in the world. (A) This heart was designed and made by Mr. S. Harry Norton of TRW, Inc. in Cleveland with Dr. Kolff. The pumping chambers, heart valve, and connecting conduits were made by Akutsu. (B) This TAH was implanted in a dog on January 12, 1959 by Akutsu and kept him alive for 90 min. This pump was lost by fire when the Artificial Organ Research Center in Utah burned down on May 5, 1973 (Y Nose, Artif Organs 33(5):389–402, 2009).

Cross-sectional view of the pump.

 

When the solenoids are energized, the magnets pull in the armatures and diaphragms. The diaphragms force the oil under them out through holes in the top of the magnet case. This oil, now under pressure, exerts pressure against the blood sacs, which forces the blood out through the valves and into the lungs and body.
The gears shown in both drawing and X-ray image are for only one purpose, to ensure that the magnets work in unison. Without the gears and racks, the freest magnet would be pulled in by the current, and the others would be forced out by the pressure of oil on the diaphragm.

(Reference: W. J. Kolff, T. Akutsu, B. Dreyer and H. Norton, Artificial heart in the chest and use of polyurethane for making hearts, valves and aortas, Trans. Amer. Soc. Artif. Intern. Organs 5:298, 1959.)
(S. Harry Norton, Report on Artificial Heart Work, Artif. Organs 17(2): 111- 146, 1993)

AK3. Thermoplastic polyurethane (Estane, Trademark of Goodrich, Akron, Ohio) (about 1960) (A005)
Thermoplastic polyurethane (Estane) was used to make artificial hearts instead of polyvinyl chloride (PVC). The sac-type artificial heart made of polyurethane kept a dog alive for 27 hours, breaking standing one-day record.
Polyurethane foam and crystals of NaCl were mixed in a solution of DMAC (Dimethylethanamide) .
Dip valves or tubes; dry; dissolve out the NaCl crystals in water. These were made of Estane VC, which disintegrated with age.

A005 Thermoplastic polyurethane (Estane)

Use of polyurethane
On one occasion a gentleman who learned about our research in the newspaper visited the institute. He was an engineer at Goodrich, a company that makes tires for cars in the town of Akron, 30 miles from Cleveland. He suggested using a recently developed polyester-type polyurethane material and offered to offer it free of charge.)
(Reference: Tetsuzo Akutsu, Heart development life, KODANSHA(Tokyo), 1996, pp. 53)

Plaster casts of artificial heart (A006)

A006 Plaster casts of artificial heart. The casts were coated with polyurethane.

AK4. Electromotor-driven pendulum-type artificial heart (1961) (A007)
In a pendulum type of mechanical heart, a small motor swings on pivot within a rigid housing, compressing each ventricle alternately. This pendulum heart was put in 3 dogs.　　Survival time ranged from 4 1/2 hours to 6 1/2 hours.

A007 Electromotor-driven pendulum-type artificial heart

The pendulum heart has a small electromotor inside which swings back and forth, alternately compressing the left and the right chamber.

(Reference: Tetsuzo Akutsu, Wolfgang Seidel, Velimir Mirkovitch, John Feller and Willem J. Kolff, An electromotor-driven pendulum-type artificial heart inside the chest, Trans. Amer. Soc. Artif. Intern. Organs 7:347, 1961.)

AK5. Pneumatically driven Silastic sac-type artificial heart for use in calves (1963)
Metal mold for a Silastic artificial heart made in February 1960 (A008)

A008 Metal mold for a Silastic artificial heart made in February 1960

 

First Silastic artificial heart (1964) (A009)
Silicone rubber came into use.
Silicone rubber, also known as Silastic, a trade name of Dow Corning, was introduced around 1960 as the first biomedical material and was praised for the antithrombogenicity. In 1964, a calf survived 31 hours with a sac-type artificial heart made of Silastic, which was air-driven by the NASA automatic control-drive system.

 

A009 Left: The right side of the heart consisting of vena cava, right atrium, right ventricle, and pulmonary artery.
Right: The left side of the component with a ball valve in the inflow side. This side consists of left atrium, left ventricle and aorta (180 mm long and 80 mm wide).
The calf survived for 31 hours in 1964.

Cerroture casts of a Silastic artificial heart including atria, pulmonary artery, and aorta(A010)
These casts are made of Cerrotrue, a metal alloy with a low melting point. Two Silastic ball valves are enclosed in the mold, which is then layered with Silastic. When the assembly is heated, the inner mold melts and flows out, leaving the valves in position.

A010 Cerroture casts of a Silastic artificial heart including atria, pulmonary artery, and aorta

(Reference: Tetsuzo Akutsu, Velimir Mirkovitch, Stephen R. Topaz and Willem J. Kolff, Silastic sac type of artificial heart and its use in calves, Trans. Amer. Soc. Artif. Intern. Organs 9:281, 1963.)

Initial methods of artificial heart fabrication
1. Using silicone rubber (Silastic)
1) An original cast of plaster, wood or wax is made.
2) The original cast is pressed into RTV (room temperature vulcanizing) silicone rubber to produce a mold.
3) Next, the second cast is made by pouring either melted Cerrotrue (a metal alloy) or polyethylene (which has a lower melting point than silicone rubber) inside the mold and curing it at room temperature.
4) Sheets of silicone rubber are wrapped around the casts with the valves inserted in position.
5) The assembly is the heated and vulcanized causing the inner cast to melt. The silicone rubber will retain its given shape with the valves in position.

2. Using PVC resin or a solution of natural rubber or polyurethane
1) A metal or epoxy resin (heated or unheated) mold is dipped in the solution.
2) The PVC molds are heated, or natural rubber molds are dipped in coagulant to form the blood pump.

 

Items developed by Akutsu and his associates at Manimonides Medical Center (1964 to 1966) and University of Mississippi (1966 to 1974)

Akutsu moved from the Cleveland Clinic to Maimodenas Medical Center in 1964. In Maimodenas, Akutsu was engaged in developing a series type of VADs as well as TAH. The first clinical application of Akutsu’s VAD was made in 1966 with Dr. Kantrowitz.

A6. Air-driven sac-type heart for use in dogs (1965)
A pair of ventricles (A011) and their casts(A012) (1966)

A011 A pair of ventricles

A012 A pair of ventricular casts

 

Silastic artificial hearts: right ventricle (A013) and left ventricle (A014)

A013 Right ventricle of the Silastic artificial heart

A014 Left ventricle of the Silastic artificial heart

Silastic artificial heart (1966-4-25)(A015)

 

A015 Silastic artificial heart (1966-4-25)
(Reference: T. Akutsu, P. A. Chaptal, G. Agrawal, and A. Kantrowitz, Compact prosthetic total heart, Trans. Amer. Soc. Artif. Int. Organs, 12:288, 1966)

A7. V-shaped and U-shaped series-type assist device (1969-1971)(A016)

A016 V-shaped series-type assist device (left), U-shaped series-type assist device (right), and polyethylene cast of the U-shaped device (center). Height of the devices is 150 mm.

U-shaped series-type assist device.

The Dacron cuff at the right will be connected to the ascending aorta by end-to-end anastomosis, and that at the left to the descending aorta by end-to-side anastomosis. The two Silastic tubes are compressed air lines, one for the pumping chamber and the other for the tube-type valve chamber.

(Reference: Tetsuzo Akutsu, Hiroyuki Takagi, Wan Fa Cheng, and James D. Hardy, Complete ventricular atrialization by an implantable heart support device, J Thorac Cardiovasc Surg 56; 421, 1968)

A8. Six-chambered, air-driven, peristatic bypass type assist device (1974)(A017)

A017 Peristatic bypass-type assist device (right) and its polyethylene cast (left)

 

Peristatic bypass type ventricular assist device

The device consists of six chambers which work in a peristatic fashion, being driven by compressed air. Therefore, each chamber works as a valve as the peristaltic movement proceeds. The cross-sectional area of all chambers is the same, and the inside of the pump is essentially a single Silastic tube. The outside of the tube is divided into six sections with six rigid housings. The six housings, made of fiberglass-resin, are completely covered with Silastic.

(References: Hisateru Takano, Hiroyuki Takagi, Tetsuzo Akutsu, Charles A. Farish, Acute hemodynamic studies of a modified peristaltic bypass type of heart assist device, J Thorac Cardiovasc Surg 60(6) 796-804, 1970.
H Takano, H Takagi, C A Farish, T Akutsu, Peristaltic bypass type of heart assist device. I. Acute hemodynamic studies Surgery 68(4):676-84. 1970.)

A9. Pneumatically driven silastic sac-type artificial heart for use in calves (1973)

Model 1971
Air-driven sac-type artificial heart with two new types of valves: monomembrane inlet valve and bicuspid outlet valve.

“Model 1971” set two world records
Three years after having moved to the University of Mississippi (1969), Akutsu’s team kept a sheep alive 55 hours, breaking the two-day record. Nevertheless, all research groups were perturbed by serious problems such as thrombus formation. In the 1971 meeting of the American Society for Artificial Internal Organs, participants raised the question, “Can we survive a 100-hour survival time with TAH?” (M. Klain, G. L. Mrava, K. Tajima, K. Schriber, J. Webb, H. Ogawa, J. Opplt, and Y. Nose, Can we achieve over 100 hours’ survival with a total mechanical heart? Trans. Amer. Soc. Artif. Intern. Organs 17:437-448, 1971).
Under this environment, Akutsu’s team succeeded in keeping a calf alive for a record ten days in April of the same year. This news changed the pessimistic mood among the researchers. The Silastic artificial heart Akutsu used was named “Model 1971” and went on to record survival times of 14 days (1972) and 25 days (1973, another world record).

 

Monomembrane inlet valve Bicuspid outlet valve

(Reference: T. Akutsu, Design criteria for artificial heart valves, JTCS 60: 34-45, 1970)

 

A pair of ventricles (1968) (A018)

A018 Left: left side pump (110 mm long and 55 mm wide)(1968-1-19) and Right: right side pump (100 long and 110 mm wide)(1968-1-18).

Left side of the heart (1969-7-18) (A019)

A019 Left side of the heart (130 mm long and 80 mm wide).

Left side of the heart (1970-1-22) (A020) and right side of the heart (1970-11-11) (A021)

 

A020 Left side of the heart (125 mm long and 80 mm wide)

 

A021 Right side of the heart

 

Left side of the heart (1970) (A022)

 

A022 Bicuspid outlet valve (1970)

 

A022 Monomembrane inlet valve (1970)

 

Left side of the heart (1973-2-13) (A023) and right side of the heart (1973-2-8) (A024)

 

A024 Right side of the heart A023 Left side of the heart

Left side of the heart (1974-8-15) (A025) and right side of the heart (1974-8-15) (A026)

 

A026 Right side of the heart A025 Left side of the heart

 

A Completed pair of the hearts (1974-4-11) (A027)

A027 A Completed pair of the hearts (1974-4-11)

A pair of flexible parts for each side of the heart (A028)

A028 Left: Right side of the heart, right: Left side of the heart

Housing made of fiberglass and resin (A029) and Cast covered with Silastic (A030)
The housing was made separately from fiberglass and epoxy resin and covered completely 0.0254 mm Silastic sheet. Assembly of the Silastic sac (A028) and the housing (A030) was accomplished by applying both Silastic glue and Dacron sutures along the upper edge of the ventricle.

 

A029 Housing made of fiberglass and epoxy resin A030 Housing cast covered with Silastic

(Reference: T. Akutsu, Artificial heart, Igaku Shoin (Tokyo), 1975, pp. 43)

Original plaster casts of the heart and its polyethylene cast (A031)

A031 Original plaster casts of the heart and its polyethylene casts

 

 

Mold for left atrium (A032)

A032 Mold for left atrium

 

Polyethylene casts of all six parts made from Silastic RTV molds. On the left are the left side components-left atrium, left ventricle, and aorta-and on the right are the right atrium, right ventricle, and pulmonary artery.

 

A combined three-piece polyethylene cast of the left heart ready for layering is at the left. The thin stainless rods attached to each chamber are for side tubes. The completed flexible part of the left heart made of silicone rubber is reinforced with Dacron mesh is shown at right.
(Reference: T. Akutsu, Artificial heart, Igaku Shoin (Tokyo), 1975, pp. 42)

Items developed by Dr. T. Akutsu and his associates at Texas Heart Institute (1974-1981)

A10. Pneumatically driven diaphragm-type pump fabricated of segmented polyurethane for use in a human (1975)

Akutsu heart model III made on April 2, 1980 (1981)(A033)

A033 Akutsu model III

 

Dr. Cooley (right) and Dr. Akutsu (left) at the Texas Heart Institute during a TAH implantation surgery in July 1981.

 

Dr. Akutsu was featured in LIFE magazine after the second clinical use of a TAH using the “Akutsu Model III” that he developed.

“Akutsu Model Ⅲ” is an air-driven, diaphragm-type pump made of Avcothane. The largest one stroke volume of each ventricle was about 80ml. Four Bjork-Shiley valves were built-in. This artificial heart was implanted in a human for the bridge to heart transplantation in 1981 (second case in the world).

(References: Kevin Cheng, James W. Meador, Miguel A. Serrato, Tetsuzo Akutsu, The design and fabrication of a new total artificial heart, Tex Heart Inst J 4(1): 7-17, 1977.
Denton A. Cooley, Tetsuzo Akutsu, John C. Norman, Miguel A. Serrato, Howard Frazier, Total artificial heart in two-staged cardiac transplantation, Tex Heart Inst J 8(3): 305-319, 1981.)

In February of 1975, our laboratories deviated from a Silastic (Trademark of Dow Corning, Midland, Michigan) sac-type TAH to a diaphragm-type pump fabricated of Avcothane (Trademark of AVCO Corp., Everett, Massachusetts).
(Reference: Kevin Cheng, James W. Meador, Miguel A. Serrato, and Tetsuzo Akutsu, The design and fabrication of a new total artificial heart, Cardiovascular Diseases, Bulletin of the Texas Heart Institute, 4(1): 7-17, 1977)

Right ventricle made of Silastic (A034)

A034 Right ventricle made of Silastic

Right ventricles: one is made of Silastic (left), and the other is made of segmented
polyurethane (right) (A035)

A035 Right ventricles: one is made of Silastic (left), and the other is made of segmented polyurethane (right).

Completed pair of ventricles with wavy base made of segmented polyurethane (1979) (A036)

A036 Completed pair of ventricles with wavy base made of segmented polyurethane (1979)

 

Plaster casts of both ventricles and a wavy-shaped baseplate (A037)

A037 Plaster casts of a right ventricle (left), a left ventricle (right) and a baseplate (center). The right ventricle is 98 mm long and 70 mm wide.

(Reference: Kevin Cheng, James W. Meador, Miguel A. Serrato, and Tetsuzo Akutsu, The design and fabrication of a new total artificial heart, Cardiovascular Diseases, Bulletin of the Texas Heart Institute, 4(1): 7-17, 1977)

 

Wavy base of the ventricle, its plaster cast and Silastic RTV mold (August 10, 1975) (A038)

A038 Wavy base of the ventricle, its plaster cast and Silastic RTV mold (August 10, 1975)

Plaster casts of a right ventricle (June 1976) (A039)

 

A039 Plaster cast of the base (left) is 110 mm long and 80 mm wide.

 

Plaster casts of a pair of ventricles (A040) (A041)

A041 A plaster cast of right ventricle A040 A plaster cast of left ventricle

Plaster casts of a pair of ventricles for “Akutsu Model Ⅲ”; made on May 20, 1981,
for clinical use (A042)

A042 Plaster casts of a pair of ventricles for “Akutsu Model Ⅲ”; made on May 20, 1981, for clinical use. Left is a right ventricle and right is a left ventricle.

Plaster casts of a pair of ventricles made on May 28, 1981, for clinical use (A043)

A043 A plaster cast of right ventricle (left) and a plaster cast of left ventricle (right) made on May 28 1981 for clinical use.

A pair of ventricles made of segmented polyurethane (A044)

A044 A pair of ventricles made of segmented polyurethane. Left is a left ventricle and right is a right ventricle.

Completed of ventricles made of Avcothane (A045 )

A045 Completed pair of ventricles made of Avcothane. Left is a right pump and right is a left pump. Diameter of a baseplate is 60 mm.

AK11. Artificial valves and valve rings including their molds materials, etc. (A046) (A047) (A048)

A046 Artificial valves and valve rings including their molds materials, etc.

A047 Artificial valves and valve rings including their molds materials, etc.

A048 Artificial valves and valve rings including their molds materials, etc.

A large number of artificial valves and valve rings have been developed since the inception of the artificial heart project. The collection here contains those made not only by Cleveland Clinic but also by the University of Utah.

(Reference: Tetsuzo Akutsu, Design criteria for artificial heart valves, J. Thorac. Cardiovasc. Surg. 60(1): 34-45, 1970)