The 50th anniversary of long-term central venous catheters

The American Journal of Surgery 213 (2017) 837e848

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The American Journal of Surgery journal homepage: www.americanjournalofsurgery.com

Review

Between the lines: The 50th anniversary of long-term central venous catheters Kenneth W. Gow, MD a, *, 1, David Tapper, MD a, 2, Robert O. Hickman, MD b a b

Division of General and Thoracic Surgery, Seattle Children's Hospital and the University of Washington, Seattle, WA, USA Division of Nephrology, Seattle Children's Hospital and the University of Washington, Seattle, WA, USA

a r t i c l e i n f o

a b s t r a c t

Article history: Received 5 January 2017 Received in revised form 26 January 2017 Accepted 15 March 2017

Background: Tunneled central venous catheters (CVC) were developed five decades ago. Since then, several clinician-inventors have created a variety of catheters with different functions. Indeed, many catheters have been named after their inventor. Many have wondered who the inventors were of each catheter, and what specifically inspired their inventions. Many of these compelling stories have yet to be told. Data source: A literature review of common catheters and personal communication with inventors. Only first person accounts from inventors or those close to the invention were used. Conclusions: CVCs are now essential devices that have saved countless lives. Though the inventors have earned the honor of naming their catheters, it may be reasonable to consider more consistent terminology to describe these catheters to avoid confusion. © 2017 Elsevier Inc. All rights reserved.

Keywords: Catheter Tunneled Central Venous Review

Introduction The tunneled central venous catheter (CVC) celebrates its 50th anniversary in 2017. It goes without saying that the tunneled CVC has been one of the most crucial important advances in medicine in our lifetime. After the first catheter was created and the concept of long-term central venous access was accepted, many modifications to the catheter have lead to additional uses which have benefited innumerable patients with life-saving therapy, including chemotherapy, bone marrow transplantation, and hemodialysis amongst countless other uses (Fig. 1). While these catheters are all considered commonplace now, their design and usage have evolved over several generations of practitioners. Added to this, many catheters have been named after the original inventor of the device. As a result, an entire generation has passed which may have little to no knowledge of the difference between these common but differently named catheters. This review aims to answer commonly asked

* Corresponding author. 4800 Sand Point Way NE, Seattle, WA, 98105, USA. E-mail address: [email protected] (K.W. Gow). 1 Financial disclosure e has been a consultant for Bard. 2 Please note that the original draft was composed by David Tapper and Robert O. Hickman. David Tapper passed away in 2002 prior to the update but due to his key contribution to this review article, he is posthumously listed as one of the authors to give him the appropriate credit. http://dx.doi.org/10.1016/j.amjsurg.2017.03.021 0002-9610/© 2017 Elsevier Inc. All rights reserved.

questions and to clarify misconceptions about tunneled CVCs, from personal accounts of the inventors themselves (Table 1). How did we get to this point and why would one need a central line? Although fascination with human blood probably began with the first human, the story of vascular access must properly begin with bloodletting which is described in ancient Egyptian and Arabic texts; the Old Testament contains veiled references to blood transfusion,1 but it remained for William Harvey and his students to begin scientific investigations of blood volume and blood pressure. These studies depended on crude metal tubes used as cannulae.2,3 Several reports of blood transfusion appeared in the early 1600s with results ranging from “no ill effect” to “very effective.” Robert Boyle and Sir Christopher Wren introduced more sophisticated cannulae crafted from the quill of a bird's feather1,4,5 and by the late 1600s they had performed animal experiments involving the injection of intravenous narcotics, and the popular press was publishing reports (and cartoons) detailing animal-to-human blood transfusion. By 1697, religious and secular opposition to the practice of “xeno-transfusion” culminated in a ban on all transfusion for most of Europe. Bloodletting, however, continued to flourish. In 1733, Stephen Hales, an English clergyman, described experiments on animal physiology including

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K.W. Gow et al. / The American Journal of Surgery 213 (2017) 837e848

Fig. 1. A timeline indicating when each tunneled central venous catheter was developed and the inventor.

Table 1 Common commercial long term central venous catheters. Type of Catheter

Inventor(s)

Main use

Key distinguishing feature

Broviac

Groshong

LeRoy E Groshong, Ronald J. Brawn

Leonard

Arnold S. Leonard

Implantable venous access port Hemodialysis

William D. Ensminger, Elton M. Tucker, John E. Niederhuber Sakharam D. Mahurkar, Geoffrey Martin Stephen R. Ash, Tim Schweikert David C. Hohn

Fluid administration, hyperalimentation, chemotherapy, infusion therapy Fluid administration, hyperalimentation, chemotherapy, infusion therapy Fluid administration, hyperalimentation, chemotherapy, infusion therapy Fluid administration, hyperalimentation, chemotherapy, infusion therapy Chemotherapy, infusion therapy

Tunneled catheter held into the tract by a fabric cuff.

Hickman

Beldig H Scribner, Robert C. Atkins, John W. Broviac Robert O. Hickman, James R. Sisley

Split Hemodialysis Hohn Peripherally inserted central catheter

Verne L. Hoshal Jr.

Hemodialysis, Pheresis Hemodialysis, Pheresis Fluid administration, hyperalimentation, chemotherapy, infusion therapy Fluid administration, hyperalimentation, chemotherapy, infusion therapy

measurements of the “force of blood” which essentially were the first descriptions of blood pressure.3,6 It would be another 150 years before observations and studies on the massive fluid and electrolyte losses of cholera patients stimulated the investigation of intravenous fluid therapy. In 1831, William O'Shaughnessy coined the term “black blood” to describe the result of severe physiologic salt and water depletion.5,7 Thomas Latta used the pandemic of cholera in the 1880s to demonstrate that fluid replacement was the necessary and sufficient treatment, concluding that “one third of is moribund patients were restored to the world”.5,8 Intravenous infusion therapy was still not universally accepted in the 1800s, perhaps due to well-meaning but ill-fated infusions of non-sterile water, cow's milk, albumin, and various salt concentrations.9 One can imagine a significant mortality rate from such interventions related to infection, air embolus, hemolysis, hyponatremia, and anaphylaxis. However, as early as 1885, the French physiologist Claude Bernard was performing sophisticated studies of cardiac catheterization in animals,5 later describing myocardial perforation as its first complication. The same era saw the development of the first “hypodermic” needle and syringe. In the early 1900s Karl Lansteiner described the ABO system of blood types; sodium citrate was introduced as an anti-coagulant; and sterile needles, tubing, and continuous intravenous fluid infusions became

Similar to a Broviac but larger in size Valved tip to reduce clot formation Double lumen catheter allowing administration of incompatible solutions simultaneously Subcutaneous port allows easier daily management for patients Able to achieve high flows for withdrawal and reinfusion Separate tips have more side holes to increase flow rates Does not require tunneling; inserted into central veins Does not require tunneling; inserted into peripheral veins

commonplace. Soon thereafter, the “catheter through the needle” became the first long-term intravenous device, followed by the safer, more comfortable, and more durable “cannula over the needle”.5 However, all of the aforementioned experimentation was via peripheral vascular access, which provided adequate entry of substances into the body for short periods of time. Administration of long-term (>6 weeks) therapy was more challenging due to the limited number of peripheral veins, and the risks of phlebitis, thrombosis, and pain. This gave rise to an interest in use of central veins e veins in close proximity to the heart e because it was suspected that central veins might better tolerate the administration of substances which otherwise might irritate peripheral veins. Central veins are marked by a more rapid dilution of administered fluid or drugs due to higher blood flow in the superior and inferior cava, and in the heart itself. The challenge was in how to place and maintain a long-term catheter successfully into these vessels. Who created the first central line? Stanley J. Dudrick is the first individual to have described the concept and the steps involved in the creation of what today is considered a standard tunneled CVC.10 The problem he was given at


University of Pennsylvania by his mentor Jonathan E. Rhoads, Chair of Surgery, was to develop a means by which patients could be provided nutrition via the intravenous route.11 After developing the initial formulation with the assistance of Harry Vars, the Department's biochemist, Dudrick trialed this on his own peripheral vein with poor results.10 Inspired by this failure, he determined that central venous access would be necessary. His solution was based on the technique described by Robert Aubaniac, a French Army surgeon, in which the subclavian vein was punctured percutaneously to gain access to the large central veins where high blood flow generally prevented clotting and ensured unimpeded blood flow. To devise a long-term catheter, Dudrick tried every plastic tubing available. All medical-grade catheters or infusion tubing were tested by placing them subcutaneously in dogs and rats. All led to an inflammatory response which rendered them undesirable as an intravenous infusion catheter with the assumption that the inflammation induced would be thrombogenic and lead to thrombophlebitis.12 Ultimately, a simple roll of polyvinyl tubing was obtained from a local hardware store, which worked with minimal inflammatory response.12 By 1967, Dudrick had established that animals could be kept alive via parenteral nutrition. In July 1967, a female infant with near total small bowel atresia was born at the Children's Hospital of Philadelphia. Surgeons there had heard of Dudrick's work on animals and asked him to help.10 After many discussions it was decided to try the new catheter technique. The polyvinyl catheter was inserted via a cut-down into her right external jugular vein and advanced into her superior vena cava, while the proximal end was passed subcutaneously behind her right ear to emerge through the parietal scalp. This tunnel was used to reduce the chances of infection. The girl was sustained on TPN for 22 months and achieved a maximum weight of 18.5 lbs. Although, sadly, she did eventually die, this was nevertheless considered a success at demonstrating the effectiveness of the tunneled central line and TPN. Dudrick submitted this report, and three weeks later it was published in the Journal of the American Medical Association.13 Dudrick would then continue to make refinements to the catheter. First, he used silicone rubber that he mixed with barium to create an inert substance that was radiopaque.10 Then, to reduce dislodgement, he added a Dacron® cuff that the patient would grow into. All of the key attributes of tunneled CVCs are found in Dudrick's work: a subcutaneous tunnel,

Fig. 2. Dr. Stanley J. Dudrick (courtesy of Dr. Stanley J. Dudrick).

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silastic material, and indwelling cuff. For this accomplishment, Dudrick has been honored by numerous societies and associations. He is currently Professor of Surgery Emeritus, Yale School of Medicine (Fig. 2). Who made the first commercial central line? Within the Beldig H. Scribner (Fig. 3) laboratory at the University of Washington (UW), the goal was to treat chronic renal failure patients successfully. Scribner would eventually come to work with many key figures including Wayne Everett Quinton (Fig. 4), who came from the Boeing Airplane Company in 1949 and would serve ten years at the University of Washington running the medical instrument shop.14 Together, they devised the ScribnerQuinton shunt, which was a Teflon shunt designed to connect a forearm artery and with a vein, and which served as the access for dialysis.15 Another influential figure was Henry Tenckhoff, who would develop a long-term catheter for peritoneal dialysis (PD).16 One issue, however, that arose from caring for these renal failure patients was the concurrent and critical need to support their nutritional requirements.17 Initially, Scribner attempted infusion of TPN through their Scribner-Quinton shunt; however, the concentrated TPN solutions were not tolerated in the peripheral veins, thereby forcing interest in accessing central circulation. The first version of their CVC was described in 1970 and consisted of a piece of Teflon-bonded silicon rubber. The Teflon was the portion in the subclavian vein and the silicon rubber was in the subcutaneous tunnel. A Dacron cuff which was “adapted” from the Tenckhoff PD catheter allowed a fibroblastic in-growth anchoring the catheter in place.17 They successfully used this catheter in 6 patients with renal failure. While the original work was done by Robert C. Atkins,18 the catheter later became known as the Broviac catheter, because it was John Walter Broviac, an internal medical resident, who was tasked with the job of going around the hospital putting the catheters into patients.19 It would appear that the solutions for the development of the tunneled CVC were similar to those that Dudrick created; however, these two centers apparently were doing this work in parallel. After the creation of this catheter, James R Sisley, a medical

Fig. 3. Dr. Belding H. Scriber (courtesy of UW Medicine).

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Fig. 5. Dr. Robert O. Hickman (courtesy of the Division of Nephrology, Seattle Children's Hospital).

Fig. 4. Wayne Quinton (courtesy of Northwest Kidney Centers, Seattle, WA).

engineer working in the Scribner lab, went to a New York-based company to see if they could market it. After a year, the catheter sent it back because the company felt it wasn't commercially feasible as there would be no market for them.20 Sisley would eventually take things into his own hands to form Evermed (Medina, WA) in 1980 to manufacture these catheters. The company was eventually purchased by Davol, Inc, a subsidiary of Bard in 1984, and it continues to make catheters to this day. Broviac, the busy resident, currently works as a nephrologist in Lansing, Michigan. After Quinton's decade at the University of Washington, he would launch Quinton Instrument Company in 1961, creating many devices including the first lightweight cardiac treadmill, as well as working on a hemodialysis catheter (see below). It was Quinton's collaboration with physicians that gave birth to the field of bioengineering, and, in fact, the University of Washington honored this pioneer and visionary innovator with the title, “Father of Biomedical Engineering” in 2005. He would design some 40 gadgets at the UW before his passing in 2015.

a nephrologist, who created a catheter with a primary role in nonnephrology situations, as well as the fact that later on, Hickman would indeed help in the development of a hemodialysis catheter which was more in line with his clinical training. Hickman would go on to personally place in tens of thousands of tunneled CVCs,20 many of which bore his name. Hickman now is retired from clinical practice but has remained in Seattle where he trained and worked. The endowed chair of Pediatric Nephrology at Seattle Children's Hospital bears his name. What is a Groshong catheter and who was he? Most catheters tips are merely horizontally-cut ends akin to the end of a straw. As such, they are an open lumen, which allows delivery of fluids and medications. However, it also becomes a site where blood may collect and form a clot, which may eventually shorten the life of the catheter. LeRoy E. Groshong (Fig. 6), a surgical oncologist in Oregon, identified this as one possible area of

What is the difference between a Hickman and a Broviac? Also working within the Scribner lab at the University of Washington was Robert O Hickman (Fig. 5), a pediatric nephrology fellow.21 Hickman had recently moved from Salt Lake City, UT where he had completed his internship and pediatrics training. One day when caring for patients on the floor, he was asked by bone marrow transplant nurses to create a catheter that could be utilized for their patients.20,22 Hickman and Jim Sisley worked together to modify the Broviac, creating the Hickman catheter.20 The difference between a Broviac and Hickman catheter comes down to the Hickman simply being a larger-bore catheter than the Broviac.23 The Broviac was originally a 6.5 Fr whereas the Hickman catheter was 9.6 Fr.20 So the difference between the two is not in the use of the catheter, the number of lumens, or the manufacturer as some have believed. Some of confusion may lie in the fact that Hickman is

Fig. 6. Dr. LeRoy E. Groshong (resident Roster, 1949e1950, courtesy of the Oregon Health & Sciences University Historical Collections & Archives).


needed improvement, and, along with Ronald J. Brawn developed a close-ended catheter tip with a valve in 1978. The Groshong valve allows infusion but would also close off after use to minimize clot formation. This catheter is also unique in that it is the only catheter made from pure silicone without with the addition of barium sulfate, a substance required to make it radiopaque, but which can also make it less elastic, less flexible, and more fragile.24 Instead, the radio-opaque particles in the catheter are concentrated into radiopaque strips, rather than spread over the entire catheter surface. It is thought that the full-surface coverage of these particles is associated with surface roughness, and that this roughness may be one of the causes for increased thrombogenicity.24 Also, it is a clear catheter, thereby allowing visual inspection for clots in the internal lumen.24 Groshong and Brawn formed the Catheter Technology Corporation to manufacture and market the Groshong Catheter, and this company was purchased by Davol in 1989. Groshong died in 2003 but in his lifetime, he held patents not only for the valve that continues to bear his name but for several other devices as well.

Who invented the first double lumen tunneled central line? The first catheters were single lumen catheters and for most purposes, they sufficed. However, with the introduction of more incompatible drugs, there arose a need to administer fluids at different rates, and thus the need for the creation of a catheter that had two lumens. Bone marrow transplantation was one such instance of need. While a “Fig. 8” double lumen catheter existed, clots would form within, and the overall dimensions were large.25 Arnold S. Leonard (Fig. 7), a pediatric surgeon at the University of Minnesota worked with engineers from Bard Inc. to create a 10 Fr double lumen tunneled CVC that still maintained a cylindrical shape. The key was the development of a viable wall separating the two lumens. Also, in 1990 Leonard and his group described a specific insertion technique that continues to be the common method still in use to this day.26 The Leonard catheter continues to be sold

Fig. 7. Dr. Arnold S. Leonard (courtesy of Dr. Arnold S. Leonard).

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and is usually the standard catheter used for children and adults requiring intensive chemotherapeutic regimens and/or bone marrow transplantation. Dr. Leonard is currently Professor Emeritus at the University of Minnesota, and chair of the Arnold S. Leonard Cancer Research Fund, and continues to be active in research and the education of surgical trainees.

Who invented the implantable venous access port? And who developed the needle used for it? Almost all tunneled central lines are similar in terms of the catheter being visible externally and then being tunneled before it reaches the vein. However, the exposed portion of the catheter poses challenges in terms of maintenance, including the potential for infection, dislodgment (despite the cuff), and the need for dressing changes. These issues are particularly magnified when they are used in children who are less likely to understand the catheter, more likely to cause breakage and dislodgement, and their pediatric stature presupposes a short distance to the vein. It was with these limitations in mind that William D. Ensminger (Fig. 8), a medical oncologist, set forth to create a tunneled CVC that would be fully contained under the skin. When Ensminger moved to the University of Michigan in 1979 to begin practice, he came to meet with the Elton M. Tucker, President of Metal Bellows Corporation (Sharon, MA) who made the hepatic artery infusion pumps that were implantable. Ensminger asked whether this could be repurposed into a separate device for infusions into veins. After a few months of work, Tucker sent Ensminger what would be the first implantable venous access port: a titanium device with a silicone rubber septum and a catheter made of silastic. Ensminger collaborated with John E. Niederhuber, a surgeon at the University of Michigan, who inserted the prototype into dogs to test its viability. During this time of trouble-shooting, it became clear that heparin would need to be infused into the port to prevent clot formation in between infusions. Also, they noted that the larger catheters were more effective than the smaller-sized catheters. Finally, as the Huber side needle (see Huber Needle design below) had been used for the hepatic artery chemotherapy pumps, Ensminger and Niederhuber similarly used it for their new design to avoid the coring out of the rubber septum.27

Fig. 8. Dr. William D. Ensminger (courtesy of Dr. William D. Ensminger).

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Ensminger arranged to purchase these devices directly from the Metal Bellows Corporation. Ray Shamie, the CEO of Metal Bellows Corporation, sensing the emerging market, developed a side company that manufactured these implantable venous access ports called Infusaid Corp. (Norwood, MA). The group proceeded to start placing these devices into breast cancer patients. After the first handful had been placed in, Ensminger realized there was great potential. However, at around the same time, the Federal Drug Administration (FDA) was beginning to become more stringent about the rules surrounding implantable devices. When Ensminger received word of the new rules, he became concerned about the ramifications. He contacted the lawyers of Infusaid Corp. who advised him to send the ports back, along with the data from the patients in whom the ports had already been inserted. Fortunately, Infusaid Corp. received approval to sell the device in 1982 and they referred to it as the Infusaport (Fig. 9). It was then in 1982 that Ensminger presented his initial clinical experience at the American Society of Clinical Oncology as a poster. This generated strong interest on the part of early adopters around the country.27 Later that year, two papers were published documenting the first patients use of implantable venous access ports.28,29 This is where the story of the port takes an interesting turn. In the midst of the success of the port clinically, the key personnel with whom Ensminger worked at Infusaid Corp. had a falling out with Elton Tucker moving on to work with another company, Pharmacia, and developed a port for their company. To market the device, a new name had to be created, and Ensminger suggested the term Port-a-cath. In hindsight, one would have thought that Infusaid Corp., with the first approved device, should have protected their research and development of a potential high-demand device with patent protection. As it turns out, Tucker, who was charged with doing just that, failed to ask the attorneys of the company to protect their investment. The short and long term ramifications of this are significant. However, as Ensminger points out, the very fact that many companies were able to rapidly manufacture this device without concern for a patent probably allowed more patients to be treated.27 Perhaps because of this, multiple companies have developed ports for the marketplace, each with slightly different variations: materials of the body of the port; type of catheter; number of lumens; and shape of the port. But

Fig. 9. First implantable venous access port was the Infusaport (Courtesy of Dr. William D. Ensminger).

they all essentially share a similar construct with a reservoir connected to a catheter, and a silicone septum through which a specialized needle is inserted to access the reservoir. Ensminger is currently Emeritus Professor at the University of Michigan. John Niederhuber served as the chief operating officer for the National Cancer Institute (NCI) from 2006 to 2010, and is currently the Chief Executive Office of the Inova Translational Medicine Institute, and an Adjunct Professor of Oncology and Surgery at Johns Hopkins University School of Medicine. Elton M. Tucker continued to invent and patent various medical devices. The needle used for implantable venous access port access needs to be a type that does not allow “coring out” of the silicone septum, otherwise fluid will leak out of the reservoir and thereby shorten the life of the device. The needle used to access the implantable venous access port is called a Huber type needle. It is a non-coring type needle with a side hole, different from the typical needle where the opening of the needle is at the tip end of the needle itself. The Huber needle is named after Ralph L. Huber (Fig. 10), who was trained as a dentist at the University of Oregon Dental School and practiced dentistry in Seattle for 30 years. He was not only a dentist but a prolific inventor with several patents to his name. He invented this non-coring needle in 1946 primarily to reduce trauma when injecting local anesthetics for dental procedures. In his patent, he notes that the Huber point is a continuation of his earlier needles.30 The lack of recognition of Huber and his needle likely is due to the fact that, while he patented the needle, he did not write any papers demonstrating and elucidating the needle's usage. In fact, there is no mention of Huber in the medical literature and, until recently, he was essentially forgotten.31 Like many inventors, it appears he was satisfied with his devices just being used, and used successfully. Probably due to his low profile, as well as his affiliation with the military, he offered many of his inventions to the US Army during World War II. Ultimately, when the implantable venous access port was invented 36 years later, the Huber needle was perfectly suited for access, it was an item that could be used “off the self.” This side end needle was also the inspiration for the Tuohy needle which is used for insertion of epidural catheters.31,32 Huber died in 1953.

Fig. 10. Ralph L. Huber, DMD (courtesy of the Seattle times, 1944).


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Who invented the hemodialysis catheter? Peter Robert Uldall (Fig. 11), a UK trained nephrologist,33 was the Director of Hemodialysis at the Toronto Western Hospital. During the early 1970's, arteriovenous shunts of subsequent generations following the Scribner-Quinton shunt were used as the vascular access for hemodialysis. Uldall recognized then that there was need for a temporary method of vascular access which did not destroy blood vessels or restrict activities, and could be used repeatedly and for extended periods at different times in the same patient.34 Uldall collaborated with Geoffrey S. Martin of Vas-Cath of Canada to create a single lumen catheter design with an alternating blood flow to support hemodialysis,35 and in 1978, they used it successfully on patients.36 This approach was better as it preserved blood vessels and avoided the problem of repeated vein puncture for each dialysis. However, Uldall recognized the limitations of even this improved approach, and set forth to develop a double-lumen catheter.37 Uldall would sketch out a “tube in a tube” and Vas-cath would create a 12 Fr catheter with a 7 Fr catheter inside.35 Since Vas-cath was based in Canada, they formed an agreement with Shiley (run by Donald Shiley) to enter the US market.33,35 Uldall would later dissolve his ties with Vas-cath, and partner instead with Sorensen (based in Salt Lake City), and then Cook.38 Sadly, Uldall died prematurely in 1995.39 Martin would then modify the design of the double lumen due to clotting issues, filing a patent in the early 1980s. At this same time, Martin started working with an India-trained nephrologist from Chicago (Sakharam D. Mahurkar). Vas-cath was eventually sold to Bard Access in 1994 and the staff moved from Toronto to Salt Lake City with Martin staying on for the first year of transition.35 Born and educated in Indian, Sakharam D. Mahurkar was a nephrologist and inventor (Fig. 12). Before Uldall's catheter had really enjoyed wide-spread sales, Muhurkar had designed and patented a hemodialysis catheter (Fig. 13). Along the way, Mahurkar collaborated with Geoffrey Martin to help design the tip.35 Eventually the Mahurkar design would be manufactured and sold by the

Fig. 11. Dr. Peter Robert Uldall (from deVeber GA. Appreciation: Peter Robert Uldall MB, BS, MD, FRCP, FRCP© 1935e1995. Nephrol Dial Transplant 1996; 11:902-3, by permission of Oxford University Press).33

Fig. 12. Dr. Sakharam D. Mahurkar (courtesy of Dr. Sakharam Mahurkar).

Quinton Instruments Company (Fig. 14). As the market was taking off, multiple disputes arose about who held the patent for the hemodialysis catheter. Dr. Uldall testified that he immediately recognized that the Mahurkar catheter was superior to his own.40 Uldall said that when Dr. Muhurkar first privately showed him some of his earlier prototype catheters, Dr. Uldall was doubtful they would work because he felt that the inlet holes on the side of the catheter - intended to allow for the passage of blood into the inlet lumen - would become blocked by adhesion to the side of the blood vessel. In fact this proved not to be the case. He also recognized the superiority of the double-“D” tubing over his own design, but such an efficient structure for this kind of catheter had not occurred to him. Testifying, Dr. Uldall made it clear that Dr. Mahurkar solved this problem with Mahurkar's own device, and that this achievement was recognized through the rapid adoption of catheters of this type. Unlike prior catheters, which have two coaxial circularshaped lumens, Mahurkar's construction allowed for both efficient blood flow and minimal insertion trauma to the patient.41 The patent for the Double Lumen Hemodialysis Catheter was granted to Mahurkar in 1979. Quinton eventually introduced Mahurkar's catheters to the market for widespread commercialization in April 1983. Interestingly, Mahurkar would encounter legal issues from there on out, having disputes on the original design which he initially lost to the Vas-cath (Martin) and Gambro companies of Canada before the decision was reversed. Notably, Mahurkar would obtain a declaration from Stephen R. Ash, which went towards the reversal of that first decision. Thereafter, for the next decade, Mahurkar would seek and win legal disputes with multiple other companies (including Shiley, Arrow, Kendall, Cook, Impra, C. R. Bard, Davol, Neostart, Strato, Medical Components Inc.), which developed catheters violating the patents he held. Mahurkar retired from clinical practice in 1995, and died in 2012. Stephen R. Ash, who helped Mahurkar above, was a Nephrologist in Indiana, and also studied and produced a hemodialysis catheter (Fig. 15). He had looked at the Tesio catheters, invented by Franco Tesio42 whereby two catheters were used, one for inflow and the other for outflow, a configuration which could achieve excellent blood flow from all directions around the tip, so that occlusion by a vein wall or sheath or clot was less likely.43 However, the Tesio was unpopular because it required two insertions, two tunnels, and two external connectors. Ash sought to design a single-body catheter with separate tips. Ash would create a

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Fig. 13. Page 1 of 9 of the patent for Dr. Mahurkar's hemodialysis catheter. This patent would become the centerpiece of multiple legal proceedings (courtesy of Dr. Sakharam Mahurkar).


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Fig. 14. Advertisement by Quinton Instrument Co. for the Mahurkar hemodialysis catheter (courtesy of Dr. Sakharam Mahurkar).

prototype by gluing a double-D lumen of a single-body catheter to two Tesio tips. He worked with a Medical Components (MedComp) engineer Tim Schweikert to develop the catheter, which was released in 2000 and has had great ongoing success.44 Schwikert would eventually become president of MedComp. Ash currently is Chairman of the Board of Directors and Director of R&D at HemoCleanse, Inc. as well as Ash Access Technology, Inc. What is a Hohn catheter? David C. Hohn trained in surgical oncology at UCSF and joined

the faculty in 1978 (Fig. 16). As a junior faculty, one of his tasks was to undertake the Venous Access Service. At that time all the types of catheters continued to be the cuffed and tunneled catheters, as well as the recently-introduced implantable venous access ports, which were all still being inserted in the operating room. After inserting many such catheters, Hohn started wondered. “Why do you need a cuff?”; “Why do you need to tunnel the device?”; “Why does the catheter need to be this big?” He got standard off-the-shelf catheters and started to create a single non-tunneled silastic catheter. Also, as he had been watching the radiologist inserting many tubes over a wire, he became intrigued at incorporating this into a new

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Houston, TX and started using his catheter, which was quickly accepted as they had an outpatient center that was perfectly suited for insertion. They found that the rates of infection, thrombosis, and stenosis were low, perhaps a result of the smaller size of the catheter. Further, with an easy change over a guidewire, the venous access site could be maintained in the face of possible line sepsis an important advantage in patients who may have limited venous access sites. Further, the hospital system intended to minimize the need for physician involvement and had created a system to allow IV teams to perform many of the tasks needed for insertion. Hohn would later design a double lumen version of his catheter which also worked well. The design was a double D design, but there was a legal challenge on this from Mahurkar though the judge found no infringement on the hemodialysis catheter design. Since 1997, Hohn has been at Roswell Park Cancer Center in Buffalo, NY, active in health policy and working on various committees for stem cell research and promotion of cancer education with respect to case managers and billing.45 Who invented the peripherally inserted central catheter?

Fig. 15. Dr. Stephen R. Ash (courtesy of Dr. Stephen R. Ash).

design. After fashioning a mock design, it was successfully tested in animals and in autopsy patients. He refined the design by adding a winged hub to make it easier to grasp.45 In having established a “new catheter” and knowing of possible patent issues since he was part of the staff at UCSF, he disclosed the new design with the technology transfer offices at UCSF. However, the university believed that since the catheter was made from off the shelf items, it was not a “new” design per se. Also, they believed that there was likely a limited market for the device, so they allowed Hohn to hold on to the intellectual property of the product. With permission in hand, he chose to “shop” the idea to companies. Bard/Davol helped with the final designs and helped get it into the market. The device was first shown at the American Society of Clinical Oncology Meeting in 1987. The main feature of this catheter was the avoidance of a trip to the OR. It was quickly adopted by ICU's and for outpatient oncology practices.45 In 1987, Hohn moved to MD Anderson Cancer Center in

Fig. 16. Dr. David C. Hohn (courtesy of Dr. David C. Hohn).

Verne L. Hoshal Jr. (Fig. 17), was a surgical resident at Saint Joseph Mercy Health System in the late 1960s and noticed reactions between the existing polyethylene catheters placed into the subclavian veins.46e48 He performed animal studies that demonstrated the reactions. He presented this work at scientific meetings in October 1972, and Tommy Thompson, an inventor with Vicra Division, Travenol Labs, Dallas, TX saw his work. Hoshal was convinced that the right material to use was silastic which he obtained from the local Dow Corning company in Midland, Michigan. His studies in animals showed less reaction. Thompson went to work creating many prototypes that he refined with direct input from Hoshal.49 As part of this tinkering, delivery using a hand crank was developed. At the time, the company had created a subclavian inserted catheter called the Centrasil®. This was modified into a longer device, which they would later call the Intrasil®. After getting IRB approval at St. Joseph's Hospital, Hoshal would use this

Fig. 17. Dr. Verne L. Hoshal, Jr. (courtesy of Dr. Verne L. Hoshal, Jr.).


new device on patients and wrote about his first experiences.50 While remarkable at this time for its simplicity and lower thrombotic rate, the peripherally inserted central catheter (PICC) really took off when Thompson and Baxter gave a grant to MD Anderson (Houston, TX) to develop a PICC team. Millie Lawson, RN was the lead nurse on the project and it is widely believed that her development of this team, along with “getting the word out” about how patients could benefit from PICCs, is why we know about this important catheter to this day.51e53 Having grassroots adoption and empowering the nurses who would be caring for these patients and catheters anyway was the key. Hickman said that if he was the “father of central lines,” then Millie Lawson must be considered the “mother of central lines” due to her key role in helping many centers develop PICC teams.54 Other companies would later develop PICC catheters: the Per-QCath by Gesco (San Antonio, TX, later acquired by C. R. Bard, Inc, Salt Lake City, UT); L-cath by Luther Medical Products (Tunsin, CA, later acquired by Becton Dickenson, Franklin Lakes, NJ)55; and C-PICS by Cook Biotech Inc. (West Lafayette, IN). Currently, it is estimated that over 1 million PICCs are inserted in the US annually.56 Tommy Thompson passed away after having his hand in product development in further companies. Millie Lawson has also passed but not before she spread the word about catheters across the US and popularized the technique with many PICC teams that can trace their origins to her driving force. Conclusion These first person accounts shed a fascinating light on fifty years of vision, dedication, innovation, and invention. There is no doubt that innumerable patients have benefited from central venous catheters. In honor of their accomplishments, many of the inventors have had their names attached to the devices they created. Going forward, since most of the original catheters designs have been modified in size, number of lumen, and newer materialswe would advocate using more generic terms for these catheters such as tunneled central venous catheter, implantable venous access port, and peripherally inserted central catheter. We would posit that a better way to honor this array of brilliant inventors is through their stories and the winding, compelling history of catheter development. References 1. Payne J, Stewart G, Meyer H, et al. The history of vascular access. Nephrology. 1998;4:247e253. 2. Nicholl C. Circulation: William Harvey's Revolutionary Idea by Thomas Wright Review; 2012. http://www.guardian.co.uk/books/2012/jun/06/circulationwilliam-harvey-thomas-wright-review (Accessed June 6, 2012). 3. Sette P, Dorizzi RM, Azzini AM. Vascular access: an historical perspective from Sir William Harvey to the 1956 nobel prize to Andre F. Cournand, Werner Forssmann, and Dickinson W. Richards. J Vasc Access. 2012;13:137e144. 4. Wren Dagnino J. Boyle, and the origins of intravenous injections and the royal society of London. Anesthesiol. 2009;111:923e924. 5. Rivera AM, Strauss KW, van Zundert A, et al. The history of peripheral intravenous catheters: how little plastic tubes revolutionized medicine. Acta Anaesthesiol Belg. 2005;56 d:271e282. 6. Nossaman BD, Scruggs BA, Nossaman VE, et al. History of right heart catheterization: 100 years of experimentation and methodology development. Cardiol Rev. 2010;18:94e101. 7. Cosnett JE. Dr. William Brooke O'Shaughnessy. Old Limerick J. Winter 1992;1992:13e16. 8. Foex BA. How the cholera epidemic of 1831 resulted in a new technique for fluid resuscitation. Emerg Med J. 2003;20:316e318. 9. Cosnett JE. The origins of intravenous fluid therapy. Lancet. 1989;1:768e771. 10. Gosche JR. Oral History Project: Stanley J Dudrick. Pediatrric History Center American Academy of Pediatrics; 2007. 11. Fuchshuber PR. VE10-Subject-oriented Symposium II: Heroes in Surgery: Our Legacy - Stanley Dudrick, MD: The Father of Intravenous Feeding. American College of Surgeons Video Library; 2014. 12. Dudrick SJ. History of parenteral nutrition. J Am Coll Nutr. 2009;28:243e251.

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