Tissue valves are made in bovine and porcine models from the biological tissue of cows and pigs, respectively, as an alternative to mechanical heart valves. This valve is a porcine heart valve manufactured by St. Jude Medical of Minneapolis, Minnesota. Harvested tissue is sewn into a Dacron covered sewing ring, creating leaflets, and then affixed to a polyester covered stent. One advantages of tissue valves is that the patient does not have to rely on anticoagulation medication to prevent blood clots.
This is a prototype of an artificial heart valve invented by pioneering heart surgeon Dr. Charles Hufnagel (1916-1989). Instead of an interior ball to help the blood flow in one direction, this valve has a tri-leaflet insertion. In 1952 Hufnagel and his team at Georgetown University invented and implanted the first successful artificial heart valve in a human. Hufnagel experimented with various materials but settled on polymethylmethacrylate, a hard, clear plastic more popularly known by the trade name of Plexiglas or Lucite.
The museum's collection of Hufnagel valves shows some of the early designs tested when first trying to produce a workable artificial heart valve.
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.
This free floating artificial heart valve was the second type of prosthetic designed by pioneering heart surgeon Dr. Charles Hufnagel (1916-1989) and his team at Georgetown University. It was made of polypropylene. The disk initially received a coating of silicone rubber to ensure it did not make a loud noise. The valve could be implanted in the aortic and mitral and tricuspid valves. First clinically used in 1963, many of these early valves were still in use ten years later.
Hufnagel, invented and implanted the first successful artificial heart valve at Georgetown University Hospital in Washington, D.C. He experimented with various materials, but eventually settled on polymethylmethacrylate, a hard, clear plastic more popularly known by the trade name of Plexiglas or Lucite.
This free floating artificial heart valve was the second type of prosthetic designed by pionerring hear surgeon Dr. Charles Hufnagel (1916-1989), and his team at Georgetown University. It was made of polypropylene while the disk initially received a coating of silicone rubber to ensure it did not make a loud noise. The valve could be implanted in the aortic, mitral, and tricuspid valves. First clinically used in 1963, many of these early valves were still in use ten years later.
Hufnagel, invented and implanted the first successful artificial heart valve at Georgetown University Hospital in Washington, D.C. He experimented with various materials, but eventually settled on polymethylmethacrylate, a hard, clear plastic more popularly known by the trade name of Plexiglas or Lucite.
This is an example of the first artificial heart valve developed by pioneering heart surgeon Dr. Charles Hufnagel. The interior ball was made of hollow methylmethacrylate. The ball made so much noise the wearer could be heard walking down the hall. Hufnagel later replaced the noisy ball with ones coated with silicone. They proved to be considerably quieter.
Hufnagel, invented the plastic implantable heart valve in 1947. The ridged valve was first implanted in a human in 1952 at Georgetown University Hospital in Washington, D.C. Hufnagel experimented with various materials but settled on polymethyl methacrylate, a hard, clear plastic more popularly known by the trade name of Plexiglas or Lucite.
This is a mitral artificial heart valve manufactured by Shiley Incorporated. It has a carbon tilting-disk which opens 60 degrees, retaining struts, and a Teflon fabric suture ring.
Biomedical engineer Donald P. Shiley (1920-2010) and Viking O. Björk (1918-2009) professor of thoracic and cardiovascular surgery at the Karolinska Institute in Stockholm, Sweden, began working on their artificial valve around 1968. They were intent on developing an improved tilting-disk valve that would work in a narrow aortic root. This aortic valve is a spherical-shaped tilting carbon disk with a woven Teflon sewing ring.
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.
This open-caged ball valve has silastic or silicone rubber poppets. This was the first time a valve had cloth-covered struts. The reasoning behind this design was that Dr. Nina Starr Braunwald, one of its creators, believed it would reduce clot formation because tissue infiltrated the fabric. However, fabric covered metal actually increased thrombogenicity, and clots soon covered by endothelial cells yielded a non-thrombogenic surface. According to the donor Manny Villafana, the Braunwald-Cutter Valve is an example of good engineering that failed.
In 1967, Braunwald began work in conjunction with Cutter Laboratories to develop this cloth covered caged ball valve, using Dacron fabric and polypropylene mesh. It had good hemodynamics and was made of polypropylene over titanium, a silastic poppet, and polypropylene mesh. This in one of two Braunwald-Cutter valves (see 2015.0031.36.02 for the second valve) which were previously implanted in people and then explanted. The large valve (shown here) shows wear/variance on the poppet as well as a large crack. The mesh on the struts has worn down or completely come off. The small valve (2015.0031.36.02) also shows wear of the cloth from the struts. Clinical use of the valve began in 1968 and lasted until 1979, when there were a significant number of cases of fabric wear, poppet abrasion, and poppet escape.
Dr. Nina Starr Braunwald (1928-1992) led the surgical team that was the first to implant a prosthetic heart valve which she designed (1960). She received her MD from New York University School of Medicine and was one of the first women to train as a general surgeon at New York's Bellevue Hospital, from 1952 to 1955. She completed her training in general surgery and her residency at Georgetown University Medical Center, with a postdoctoral fellowship in Dr. Charles Hufnagel's surgical laboratory.
From 1958 to 1968 Dr. Braunwald practiced at the National Heart Institute (now the National Heart, Lung and Blood Institute) of the National Institutes of Health (NIH) in Bethesda, Maryland. From 1958 to 1965 she served as the chief of surgery. While at the NIH she developed her caged ball artificial heart valve, the Braunwald-Cutter valve, which was implanted in patients during the late 1960s and early 1970s. In 1972, Dr. Braunwald joined the faculty at Harvard Medical School. She was the first woman to be elected to the American Association for Thoracic Surgery.
This open-caged ball valve has silastic or silicone rubber poppets. This was the first time a valve had cloth-covered struts. The reasoning behind this design was that Dr. Nina Starr Braunwald, one of its creators, believed it would reduce clot formation because tissue infiltrated the fabric. However, fabric covered metal actually increased thrombogenicity, and clots soon covered by endothelial cells yielded a non-thrombogenic surface. According to the donor Manny Villafana, the Braunwald-Cutter Valve is an example of good engineering that failed.
In 1967, Braunwald began work in conjunction with Cutter Laboratories to develop this cloth covered caged ball valve, using Dacron fabric and polypropylene mesh. It had good hemodynamics and was made of polypropylene over titanium, a silastic poppet, and polypropylene mesh. This in one of two Braunwald-Cutter valves (see 2015.0031.36.01 for the second valve) which were previously implanted in people and then explanted. The large valve (2015.0031.36.01) shows wear/variance on the poppet as well as a large crack. The mesh on the struts has worn down or completely come off. The small valve (shown here) also shows wear of the cloth from the struts. Clinical use of the valve began in 1968 and lasted until 1979, when there were a significant number of cases of fabric wear, poppet abrasion, and poppet escape.
Dr. Nina Starr Braunwald (1928-1992) led the surgical team that was the first to implant a prosthetic heart valve which she designed (1960). She received her MD from New York University School of Medicine and was one of the first women to train as a general surgeon at New York's Bellevue Hospital, from 1952 to 1955. She completed her training in general surgery and her residency at Georgetown University Medical Center, with a postdoctoral fellowship in Dr. Charles Hufnagel's surgical laboratory.
From 1958 to 1968 Dr. Braunwald practiced at the National Heart Institute (now the National Heart, Lung and Blood Institute) of the National Institutes of Health (NIH) in Bethesda, Maryland. From 1958 to 1965 she served as the chief of surgery. While at the NIH she developed her caged ball artificial heart valve, the Braunwald-Cutter valve, which was implanted in patients during the late 1960s and early 1970s. In 1972, Dr. Braunwald joined the faculty at Harvard Medical School. She was the first woman to be elected to the American Association for Thoracic Surgery.
This black nylon salesman’s kit containing ATS artificial heart valves belonged to the donor Manuel “Manny” Villafaña. The items contained within the kit include: Villafaña’s business cards, a Hemashield® double velour vascular graft model manufactured by MeadoxMedicals Inc., a pivot design model, 3 demonstration valves one of which is a suture/sewing ring, 2 valve inserters (one aortic, one mitral), 2 standard and AP sizers, 3 tissue anulus plates, 2 plastic models of the bileaflet design, one extra end pieces for valve holders, and 2 metal tools called "Reusable Handles" which have flexible heads and screw into part of mitral/aortic holders for implantation during surgery.
Also included are three ATS Medical pamphlets, which include the CE Mark (Commission European) clinical results, ATS Medical Open Pivot™ Valve, and Scientific Presentations. At the time the pamphlets were printed (1995 -1996) ATS valves were not available in the United States.
ATS Medical was founded in 1992 by Manny Villafaña and acquired by Medtronic Inc. in April 2010.
This valve, designed by doctors Gerald Lemole and Denton Cooley, is one of the rarest concept designs for a heart valve. It is not circular like other artificial heart valves, but rather, oval shaped like the mitral valve itself. This artificial valve has a Dacron fabric ring. It is the only valve the donor Manuel “Manny” Villafaña has seen that is not circular. But, for the valve to work well, it has to be big enough in size. The valve needs something to push the blood through, and this design would not work sufficiently. As a result, it was never implanted. The 'disc' has two prongs that have ball shapes at its ends.
Dr. Denton Cooley’s (b. 1920) career parallels the evolution of heart surgery beginning in the 1940s and 1950s. He was an intern for Dr. Alfred Blalock (1899-1964) and Dr. Helen Taussig (1898-1986), the first doctors to surgically correct malformations of the heart by reconstructing the valves (Blalock-Taussig Operation.) Dr. Cooley considered this breakthrough, "the dawn of heart surgery." He received training at Johns Hopkins University School of Medicine in 1944 and started a practice at Baylor College in Houston, TX. He led the team which implanted the first artificial heart in a human in 1969.
Dr. Gerald Lemole, MD (b. 1937) trained in Houston with Dr. Michael DeBakey and Dr. Denton Cooley. In 1968, he was on the team that carried out the first successful heart transplant in the United States. Lemole is also known to play rock music in the operating room. In 1991, he traveled to Beijing, China, to train surgeons in open-heart surgery and give lectures. He served as chief of cardiothoracic surgery at Temple University Hospital and chief of cardiovascular surgery at Medical Center of Delaware, Christiana Hospital.
The manufacturer, Surgitool Inc., was founded by Harry Cromie and Dr. George Magovern creators of the sutureless Magovern-Cromie Valve.
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.
The Cooley-Cutter heart valve was designed in the 1960s by Denton A. Cooley, MD, in collaboration with Cutter Laboratories and introduced for clinical use in 1971. It was an improvement of the 1967/68 Cooley-Bloodwell-Cutter valve, which had many serious issues. This is a demonstration only, Cooley-Cutter non-tilting Disc Valve made by Cutter Laboratories. Included on the label is, "U.S. Federal Law restricts this device to sale by or on the order of a physician. UNSTERILE - MAY BE AUTOCLAVED." It is comprised of a pyrolytic carbon non-tilting disc with titanium struts and a cloth suture. Non-tilting disc valves were advantageous with regards to limiting regurgitation. They had a low profile design and were easier to implant. Issues with this valve included thromboembolic complications, higher rates of hemolysis, strut wear (due to the hard pyrolytic and soft titanium) and significant turbulence in blood flow. In 1977, there were two reported cases of strut fracture--a failure that can be attributed to the "differential hardness" in the materials being used. This resulted in its being discontinued by 1978. The majority of the Cooley-Cutter valves were implanted at the Texas Heart Institute in Houston.
Dr. Denton Cooley (1920-) has been involved with heart surgery since its beginnings in the 1940s and 1950s. As an intern he worked with 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 breakthrough, "the dawn of heart surgery." He received his training at Johns Hopkins University School of Medicine in 1944, and started a practice at Baylor College in Houston, TX.
The Jyros Bileaflet Heart Valve has a hinge that rotates inside the housing/valve ring. In one study, those who received the implant showed no signs of hinge rotation. Over all the valve had good clinical results, but there were some incidences of thrombosis. It has two pyrolytic carbon leaflets (impregnated with Boron carbide) within carbon housing. In 1992, 100 valves were implanted in patients 33 to 80 years old. 92 patients left the hospital. At that time there were no instances of thromboembolic events. The idea behind rotating hinges is that lack of stasis would mean a lesser likelihood of thromboembolism. In another study of 19 patients, only 50% of valves showed rotation of the leaflets. It was decided that the performance of the valve was successful, irrespective of whether or not the leaflets rotate.
In Russia, the valve was named "Carbonix-1" and was clinically used beginning in 1988. In 1990, the valve was first used in the United States under the trademark, "Jyros." The development of artificial heart valves took place in many countries around the world, and there were many international collaborations.
This blue cardboard display of 3, Gerbode-Seager tri-leaflet valves has a yellow label with black print which reads "EARLY AORTIC PROSTHESES". Handwritten beneath it reads "HISTORY ON BACK". The valves are attached to the board with sewing string. From left to right: Silastic Cusps re-enforced with Dacron Mesh, Gold-coated cusps, and Silastic cusps. On the back is handwritten information about the valve and the doctor who used them.
"used by Dr. Frank Gerbode / in San Francisco / Dr. O'Brien (?) worked with Dr. Gerbode / at his --- in 1963 / on this valve. / Gold plated / thromboemboli occurred / + valve had to be / clinically ceased."
Another label reads, "Approx 20 used at Presbyterian Med. Center San Francisco. Most had trhombo-embolytic complications. There are two pin holes on either side of the display indicating at one time it hung for viewing.
Dr. Frank Gerbode (1907-1984) a native Californian took his undergraduate degree from Stanford University, and received his medical degree from Stanford Medical School. He founded the Medical Research Institute and Heart Research Institute at Presbyterian Hospital-Pacific Medical Center, San Francisco. He performed the first successful open heart surgery on the west coast in 1954 at what was then Presbyterian Hospital. He was the head of the Heart Research division at the Research Institute until his death in 1984. See also Gerbode's Modified Buford Rib Spreader accession 1994.0365.01.
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.