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- Description
- This is one of the early versions of the St. Jude Medical (SJM) artificial heart valve, a bi-leaflet valve made of pyrolytic carbon. There are four pivot points, and the edges of the donut are not as rounded as later models. A white Dacron sewing ring surrounds the valve. The first surgical implant with a SJM heart valve was carried out in October 1977.
- The SJM valve was the first all carbon valve in clinical use. All St. Jude valves would be made with pyrolytic carbon, a material and coating recognized for its biocompatibility and thromboresistance. The SJM valve quickly became the 'gold standard' for subsequent valves.
- St. Jude Medical was founded by Manuel "Manny" Villafaña in 1976, in St. Paul, Minnesota, U.S.A. The model for its popular bi-leaflet valve was developed at the University of Minnesota in 1972 by Dr. Demetre Nicoloff (1934-2003). It differed from previous valves because it was made of pyrolytic carbon, a material that was very durable and could last many years in the body. Dr. Jack Bokros, founder of OnX Life Technologies Inc., is the doctor who developed this material. Manny Villafaña is a businessman whose first company was Cardiac Pacemakers, Inc.
- In an interview for the Smithsonian, Villafaña identified this valve as the first St. Jude valve, "serial number one," made of pyrolytic carbon, January 20, 1977. The interview clip is available online as "Manny Villafana's "No. 1" St. Jude Heart Valve."
- Location
- Currently not on view
- date made
- ca 1976
- maker
- St. Jude Medical
- ID Number
- 2015.0031.02
- catalog number
- 2015.0031.02
- accession number
- 2015.0031
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- Description (Brief)
- Also called the toilet plunger valve because of its remarkable resemblance to the inner workings of a toilet, this valve was designed by Christiaan Barnard of the University of Cape Town, South Africa. This valve had been implanted and eventually explanted. Notice the worn and discolored cloth suture, and the wear of the silicone disc. The valve has a low profile and the principal causes of death with this valve were thromboembolism.
- Dr. Barnard (1922-2001) was inspired by the way in which the water tank in a toilet functions, and he saw similarities with the human heart. Due to the tiny metal ring which held the 'plunger' in place, clotting occurred. In spite of that, this valve was implanted in humans. In an interview donor Manny Villafana explained, "you've gotta understand that there was no answer (a workable artificial heart valve) and everyone was looking for an answer." This is why the valve was used, in spite of thrombosis and thromboembolism. These issues led to its eventual discontinuation.
- Barnard is best known for the dramatic headline grabbing first human-to-human heart transplant in 1967.
- Location
- Currently not on view
- date made
- 1965
- ID Number
- 2015.0031.19
- catalog number
- 2015.0031.19
- accession number
- 2015.0031
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- Description (Brief)
- Give-away items such as pens and paperwights are popular ways for companies to advertise their products. This plastic mechanical pen bears the Medtronic Inc. logo. It is white, blue, and black plastic with red print. It was used as a giveaway for advertising. There is a cap for the eraser end and the pencil works by twisting one end to expose the graphite. "MEDTRONIC INC. / 3055 Old Highway 8 / Minneapolis, Minn. 55418 U. S. A. / Phone (612) 781-6855"
- Location
- Currently not on view
- maker
- Medtronic
- ID Number
- 2015.0031.60
- catalog number
- 2015.0031.60
- accession number
- 2015.0031
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- Description (Brief)
- This is an open-cage, non-tilting disc valve with four metal struts, designed by Dr. Denton Cooley and Dr. Robert Bloodwell. It has a low-profile design to prevent protrusion of the cage into the ventricle, which might lead to arrhythmia. The suture is made of Dacron cloth impregnated with silicon to prevent postoperative thromboembolism. The bare cage legs are made of titanium and the disc is made of silicone rubber. This valve was used from April 1967 until it was discontinued October 1968. Hospital mortality with this valve was 13% for 160 patients. The cumulative morality rate was 31%. Thromboembolic complications occurred in 51 patients (32%). Other issues included leakage, cerebral embolism, respiratory insufficiency, and sepsis. These figures contributed to a change in valve design to reduce emboli.
- Cutter Laboratories was a family-owned pharmaceutical company founded by Edward Ahern Cutter in 1897. It was located in Berkeley, California.
- Denton Cooley (1920-) has been involved with heart surgery since its beginnings in the 1940s and 1950s. He interned for Dr. Alfred Blalock (1899-1964) and Dr. Helen Taussig (1898-1986), the first doctors to correct malformations of the heart by reconstructing the valves (Blalock-Taussig Operation.) Dr. Cooley considered this operation a breakthrough, referring to this period as "the dawn of heart surgery." After receiving his medical degree in 1944 from Johns Hopkins University he moved back to Texas to start his career at Baylor College in Houston. Dr. Robert Bloodwell (1932-2013) attended Baylor School of Medicine and was trained at Johns Hopkins University. In 1968 Cooley and Bloodwell assisted one another in carrying out the first heart transplant in Houston, Texas.
- Location
- Currently not on view
- date made
- 1967-1968
- maker
- Cutter Laboratories, Inc.
- ID Number
- 2015.0031.06
- catalog number
- 2015.0031.06
- accession number
- 2015.0031
- serial number
- 881T
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- Description (Brief)
- This single heart leaflet or cusp was used to replace or supplement a compromised natural leaflet. One, two or three leaflets could be surgically implanted. The leaflets were made of polypropylene mesh and impregnated with silicone rubber. Charles A. Hufnagel, MD, the inventor believed polypropylene leaflets would be a better design solution than the ball and cage model because it provided better dynamics. He acknowledged that only a few of these leaflets worked well, "those leaflets were the only leaflets, I think, that really lasted for any significant length of time." The single leaflets were later used to develop a trileaflet valve which looked similar to a natural human valve.
- Dr. Charles Hufnagel, (1916-1989) graduated in 1941 from Harvard Medical School. While a resident at Boston’ Children’s Hospital he worked with pioneer cardiac surgeon Dr. Robert Gross. In 1950 he left the Peter Bent Brigham Hospital in Boston to becoame the Director of Georgetown University Medical Research laboratory. In September 1952, he implanted the first artificial heart valve which consisted of a ball of plastic inside a chambered tube. Hufnagel also made significant contributions to the development of the modern heart-lung machine.
- Location
- Currently not on view
- date made
- ca. 1960
- maker
- Brunswick Manufacturing Company
- ID Number
- 2015.0031.09
- catalog number
- 2015.0031.09
- accession number
- 2015.0031
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- Description (Brief)
- This is an open cage, sutureless ball valve developed by Harry Cromie, an engineer, and Dr. George Magovern, MD. It uses an open cage design to lower chances of thrombosis. Its components include a Dacron ring and a silicone rubber poppet with barium sulphate (to make the valve radiopaque). There are titanium struts but no legs below the orifice. This valve differs from earlier valves because it can be implanted without sutures. Suturing valves in place often took forty-five minutes to an hour. The patients were sick before surgery, and they were often sick afterwards because of the time their hearts spent hooked up to heart-lung machine. Prolonged clamping of the aorta also caused injury. The longer the procedure, the higher the risk of irreparable heart damage and patient death. With a 90% patient mortality rate, Dr. Magovern was inspired to design something that would save time, and thus, patient's lives. He and Cromie collaborated in the latter's basement to develop a valve that would clamp into place with small teeth. They developed a claw like fixation device that did not require any sewing, and took approximately three to four minutes to attach. The ring has an upper and lower set of curved, pointed metal teeth. These hooks allowed for rapid fixation when time was most critical. The implantation of this valve required a special devicean insertion and removal instrumentthat would rotate and engage the fixation pins with the aorta. After the inserting tool is removed, the rubber poppet is placed into the cage. With sutureless valves, there was an increased risk of perivalvular regurgitation (leaking) and postoperative thromboembolism. The production of these valves ceased in 1980. Magovern said, "I wouldn't say I was particularly skillful, but I was fast."
- Dr. George Magovern (1924-2013) trained at George Washington University and helped to establish Allegheny General Hospital in Pittsburgh, Pennsylvania. Harry Cromie is an engineer. They both went on to found Surgitool, Incorporated, which at the time became the leading U.S. company for heart-valve design.
- Location
- Currently not on view
- date made
- after 1962
- maker
- Surgitool, Inc.
- ID Number
- 2015.0031.45
- catalog number
- 2015.0031.45
- accession number
- 2015.0031
-
- Location
- Currently not on view
- date made
- 1970
- 1983
- maker
- American Edwards Laboratories
- ID Number
- 2015.0031.16
- catalog number
- 2015.0031.16
- accession number
- 2015.0031
- model number
- 6120
- serial number
- AI 8064
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- Description (Brief)
- This trileaflet valve which looks similar to a natural human heart valve was developed by Charles Hufnagel, MD. It is coated in hepacone, silicone rubber impregnated with heparin, and is a size 5 with a diameter of 33mm. Hufnagel believed the trileaflet design would prove to be superior to the ball and cage heart valve because it provided better dynamics. The base of the valve was designed to fit the shape of the aorta when implanted. The leaflets or cusps were made of polypropylene and coated with silicone rubber at high pressure. A 1975 study of patients who had received this prostheses determined that the Hufnagel trileaflet valve was not durable enough to withstand constant blood flow. In a majority of cases, patients died due to prosthetic degeneration or thrombosis. Other problems included aortic regurgitation and stenosis. The Hufnagel tri-leaflet valve was distributed by Codman and Shurtleff, Inc. of Randolph, Massachusetts and manufactured by Heyer-Schulte Corporation.
- Location
- Currently not on view
- date made
- after 1967
- distributor
- Codman & Shurtleff, Inc.
- ID Number
- 2015.0031.11
- catalog number
- 2015.0031.11
- accession number
- 2015.0031
- serial number
- 850
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- Description (Brief)
- This is an early prototype of a curvilinear-shaped artificial heart valve developed by pioneering heart surgeon Dr. Charles Hufnagel (1916-1989) and his team at the Georgetown University.
- The materials used to fabricate this prostethic were polypropylene cloth, metal frame and metal leaflets polypropylene coated in silicone. Because the silicone rubber proved to be less flexible than desired, their design was not used extensively.
- Location
- Currently not on view
- maker
- Hufnagel, Charles A.
- ID Number
- MG.M-11582.09
- catalog number
- M-11582.09
- accession number
- 267860
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- Description
- The Schimert-Cutter valve also known as the "Toilet Seat" valve dates to 1967/1968. It is 29 mm in diameter with serial number 656R. According to donor Manuel “Manny” Villafaña, this valve was never implanted and never went into production because it does not always close properly, a significant structural issue.
- Dr. George Schimert (1918-2000) was born in Switzerland, grew up in Budapest, Hungary, and received his medical degrees from Pazmany Peter University in Hungary, and Freidrich Wilhelm University in Germany. Cutter Laboratories founded by Edward Ahern Cutter in 1897 was a family-owned pharmaceutical company located in Berkeley, California.
- Location
- Currently not on view
- date made
- ca 1967
- maker
- Cutter Laboratories, Inc.
- ID Number
- 2015.0031.47
- catalog number
- 2015.0031.47
- accession number
- 2015.0031
- serial number
- 656R
-
- Description (Brief)
- This Björk-Shiley 60-degree mitral Convexo-Concave heart valve has a tilting carbon disk and a Teflon fabric suture ring. The valve ran into problems when the weld joint fractured. This problem was resolved with a free-floating disk.
- Location
- Currently not on view
- date made
- ca 1980
- maker
- Shiley Incorporated
- ID Number
- 1985.0439.04
- accession number
- 1985.0439
- catalog number
- 1985.0439.04
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- Description (Brief)
- This 23mm Carpentier-Edwards Perimount Magna aortic heart valve is a tri-leaflet design. The frame or stent is made from Eligiloy, a strong and durable alloy, and tissue from bovine pericardium. The silicone rubber sewing ring is covered with polyester woven fabric.
- The valve is housed in a sealed round plastic jar in a sterilized solution. Two pages of product literature, implant patient registration, plus the jar are housed in a square pliable plastic box.
- Location
- Currently not on view
- date made
- ca 2004
- maker
- Edwards Lifesciences LLC
- ID Number
- 2006.0003.01
- serial number
- KG6368
- catalog number
- 2006.0003.01
- accession number
- 2006.0003
-
- Description (Brief)
- This valve was developed by Dr. Carl Goosen of the University of Cape Town, South Africa. One issue with this valve was its thick orifice. When the orifice is thick, the opening gets smaller. This means less blood will go through, creating more work for the heart. The ball at the top (added to prevent a piece from falling out) is not durable and runs the risk of wearing out and breaking. This valve was never implanted but was tested on animals. Dr. Goosen worked with colleague Dr. Christian Barnard (1922-2001) to design a new heart valve prosthesis.
- Location
- Currently not on view
- date made
- after 1960
- ID Number
- 2015.0031.21
- catalog number
- 2015.0031.21
- accession number
- 2015.0031
-
- Description (Brief)
- This is a St. Jude Medical demonstation mechanical 23mm bi-valve aortic artificial heart valve. The leaflets are made of graphite and coated with pyrolytic carbon. A white polyester cuff or sewing ring is implanted by sewing it into the patient's tissue.
- Location
- Currently not on view
- maker
- St. Jude Medical
- ID Number
- 2005.0275.07
- model number
- 23ahpj-505
- serial number
- 0544dt31
- catalog number
- 2005.0275.07
- accession number
- 2005.0275
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- Description (Brief)
- This is a Lillehei-Kaster tilting-disc valve made of pyrolytic carbon. Approximately 17,500 of these valves were distributed. It is made of titanium and pyrolite-coated graphite. It has a low embolic rate, good hemodynamics, and low hemolysis. The angular opening of tilting disc valve reduces damage to the blood cells. The white plastic holder attached to the valve is used to position the valve during the implantation procedure.
- Tilting disc valves were first introduced by Lillehei-Kaster in 1969. Robert Kaster (1934-2014) received an engineering degree from the University of Minnesota (1951). He later worked at Cornell Medical School as a biological engineer. He became interested in designing prostheses while working in Dr. C. Walton Lillehei's laboratory. It was there that he designed the tilting disc valve. The disc is held in place by two side struts. Kaster also worked with another valve creator, Dr. Jack Bokros, to develop the disc. Lillehei-Kaster valves were produced by Medical Incorporated in Minneapolis. These valves demonstrated high durability due to their pyrolyte composition and had "essentially no valve failures."
- Dr. C. Walton Lillehei (1918-1999) a pioneering surgeon was named the "father of open heart surgery" by the American Heart Association. He earned his undergraduate, medical degree, and doctorate in surgery degrees from University of Minnesota. He became a medical school professor for the university and trained other heart doctors, such as Christiaan Barnard of Cape Town, South Africa, who performed the world’s first heart transplant. Lillehei and a colleague, Dr. Richard Wall, resolved the issue of circulating blood during surgery by developing a successful heart-lung machine, called a helix reservoir bubble oxygenator. He also helped to develop one of the first successful pacemakers in 1957, and contributed to the design of the successful and widely used St. Jude Medical valve. During the 1960s, Dr. Lillehei was president of the American College of Cardiology and in 1975, he became director of medical affairs at St. Jude Medical Incorporated.
- Location
- Currently not on view
- date made
- 1970
- ID Number
- 2015.0031.25
- catalog number
- 2015.0031.25
- accession number
- 2015.0031
- serial number
- C-100-1025
-
- Location
- Currently not on view
- date made
- 1996
- ID Number
- 2015.0031.39
- catalog number
- 2015.0031.39
- accession number
- 2015.0031
-
- Description (Brief)
- This single heart leaflet or cusp was used to replace or supplement a compromised natural leaflet. One, two or three leaflets could be surgically implanted. The leaflets were made of polypropylene mesh and impregnated with silicone rubber. Charles A. Hufnagel, MD, the inventor believed polypropylene leaflets would be a better design solution than the ball and cage model because it provided better dynamics. He acknowledged that only a few of these leaflets worked well, "those leaflets were the only leaflets, I think, that really lasted for any significant length of time." The single leaflets were later used to develop a trileaflet valve which looked similar to a natural human valve.
- Dr. Charles Hufnagel, (1916-1989) graduated in 1941 from Harvard Medical School. While a resident at Boston’ Children’s Hospital he worked with pioneer cardiac surgeon Dr. Robert Gross. In 1950 he left the Peter Bent Brigham Hospital in Boston to becoame the Director of Georgetown University Medical Research laboratory. In September 1952, he implanted the first artificial heart valve which consisted of a ball of plastic inside a chambered tube. Hufnagel also made significant contributions to the development of the modern heart-lung machine.
- Location
- Currently not on view
- date made
- ca 1960
- maker
- Brunswick Manufacturing Company
- ID Number
- 2015.0031.08
- catalog number
- 2015.0031.08
- accession number
- 2015.0031
-
- Description
- A normal human heart has four chambers. Each chamber has a valve: the tricuspid, the mitral, the aortic, and the pulmonary. As the heart muscle contacts, the mitral and tricuspid valves close and the pulmonary and aortic valves open, directing blood to flow in one direction. When one or more valves do not work properly, they might need to be repaired or replaced.
- The causes of heart valve malfunction are numerous, and can include congenital malformation or acquired heart disease. Artificial heart valves were the first mechanical replacements of a natural organism in a human.
- Pioneering heart surgeon Dr. Charles Hufnagel (1916-1989) began working on the developed of artificial heart valves in 1947, and the first clinical implantation occurred in 1952. The patient's natural valve was left in place and the mechanical valve was placed in the descending aorta, aiding the damaged valve.
- Many artificial heart valves were developed in the early 1960s. This Magovern-Cromie caged ball valve was first implanted in a patient in 1962. It was developed by Dr. George Magovern of the University of Pittsburgh and engineer Harry Cromie. The struts and the small hooks are made of titanium. The hooks at the base of the valve replaced the need for sutures and shortened the time of the operation. Thousands of Magovern-Cromie artificial valves were manufactured and implanted until production ceased in 1980.
- Location
- Currently not on view
- date made
- ca 1963
- maker
- Codding, D. D.
- ID Number
- 1981.0731.02
- accession number
- 1981.0731
- catalog number
- 1981.0731.02
-
- Description (Brief)
- This double caged ball valve for aortic valve replacement was developed by Edward Smeloff M.D. The struts at the top and bottom of the valve remain open and unconnected to the lower surface area. It has a titanium skeleton with a silastic ball and cloth suture. Its advantages are long term durability and good hemodynamics. The disadvantages are a high embolic rate and the need to take an anticoagulant. This valve is a size T, with serial number 534A. A 1975 study on 200 patients who received this implant yielded a hospital mortality rate of 22% and a thromboembolic complication rate of 15%. Another study of 134 patients with a mean age of 54 years and aortic stenosis as the dominant issue yielded an 85% survival rate of 5 years and a 75% survival rate of eight years. Its main structural problem is that of ball variance, but it has an advantage over disc valves with a lower rate of thrombotic stenosis.
- Edward Smeloff (1925-2012) worked with the engineering department at Sacramento State College to develop a mechanical heart. The Smelloff-Cutter valve was the result of this effort. The valve was manufactured by Cutter Laboratories, a family-owned pharmaceutical company in Berkeley, California founded by Edward Ahern Cutter in 1897.
- Location
- Currently not on view
- date made
- ca 1966
- maker
- Cutter Laboratories, Inc.
- ID Number
- 2015.0031.22
- catalog number
- 2015.0031.22
- accession number
- 2015.0031
- serial number
- 534A
-
- Description
- This is a type 1 Kay-Shiley non-tilting disc valve, the most common type of Kay-Shiley valve. It has four vertical struts form two parallel bars made of Stellite, and the disc is made of a radiolucent silicone rubber. It was first used in 1965. Dr. Viking Bjork (1918-2009) implanted Kay-Shiley aortic valves in 60 patients, but results were disappointing. There were incidences of thromoembolism, sudden death, disc wear (particularly the edges), the narrowing of the artery, valvular leaks, disc cocking, and disc variance. Another weakness of this design is that it only took a small amount of thrombus to interfere with disc mobility. In contrast, there is another case of a woman who received a Kay-Shiley mitral implant and went 299 months without valve dysfunction. The accompanying label reads, "KAYSHILEY #7 Heart Valve"
- In 1956, Dr. Earle B. Kay (1911-2000) of St. Vincent Charity Hospital in Cleveland, Ohio helped to perform open-heart surgery using his own heart-lung machine, the Kay-Cross Disc Oxygenator. Donald Shiley (1920-2010), an engineer, was one of the co-inventors of the Bjork–Shiley artificial heart valve. He graduated from the University of Portland in 1951, where he studied engineering. Later, he established his own company, Shiley Laboratories. His first valve was developed with heart-surgeon Dr. Earle Kay, and it was the first disc valve.
- Location
- Currently not on view
- date made
- after 1965
- maker
- Shiley Incorporated
- ID Number
- 2015.0031.44
- catalog number
- 2015.0031.44
- accession number
- 2015.0031
- serial number
- 7K527
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