Sources of Medical Technology Universities and Industry (1995) / Chapter Skim
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4 FROM THE SCALPEL TO THE SCOPE: ENDOSCOPIC INNOVATIONS IN GASTROENTEROLOGY, GYNECOLOGY, AND SURGERY
4 FROM THE SCALPEL TO THE SCOPE: ENDOSCOPIC INNOVATIONS IN GASTROENTEROLOGY, GYNECOLOGY, AND SURGERY
Pages 67-96
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From page 67... ...
The central technological component in minimally invasive therapy is the endoscope: a slender rigid or flexible tube through which images can be transmitted, either to the eyepiece or, nowadays mostly, onto a videoscreen. A variety of accessory technologies, such as miniaturized forceps, electrocautery devices, and lasers, can then be moved through the operative channel of the endoscope, or through an alternative instrument inserted in the human body, to undertake the necessary therapeutic interventions.
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From page 68... ...
Minimally invasive therapy may obviate the need for major opensurgery procedures. In terms of health outcomes, it appears to offer the following advantages: elimination of the need for general anesthesia, the absence of the sequelae of open surgery procedures, minute scars, short hospital stays or outpatient treatment, and a much more rapid return to normal activity.
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From page 69... ...
The more widespread application of endoscopic procedures required major improvements in lighting, optics, and photographic capabilities. This meant that the evolution of endoscopic techniques was essentially interdisciplinary and interinstitutional in nature; that is, it required the medical profession to create alliances with scientists and engineers with expertise in optics, electronics, and more recently-optoelectronics.
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From page 70... ...
Whereas we explore how some of these changes in the broader environment have influenced and shaped the conditions surrounding medical R&D in the past, the current changes in the incentive environments remains an important topic for further exploration. FIBER OPTICS AND GASTROINTESTINAL ENDOSCOPY Beginning in the 1920s, the field of gastrointestinal endoscopy in Europe and the United States was dominated by a single individual, Rudolf Schindler.
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From page 71... ...
Fiber optics make it possible to transmit both light and images along a curved path through the use of bundles of long thin fibers of optical glass. The basic science underlying light transmission had been first expounded by the great Dutch scientist Christiaan Huygens in the seventeenth century.
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From page 72... ...
These papers laid down the principles of coherent image transmission by means of fiber optics. Van Heel presented the concept of the coated glass fiber, although he discussed only the possibility of plastic coatings, which later turned out to be unsatisfactory.
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From page 73... ...
The fiber glass available at that time was inadequate and there was no commercially available apparatus for forming the fiber bundles. Fortunately, through lIirschowitz's connection with someone at the Corning Corporation in Midland, Michigan, they were given access to a supply of optical glass rods.
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From page 74... ...
8671. It should be particularly noted, then, that the academic/medical trio at the University of Michigan not only solved a critical technological problem with respect to the new devicethe cladding of the glass fiber but they were also instrumental in teaching the industrial firm how to solve some complicated manufacturing problems-the making of the fiber-optic bundles.
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From page 75... ...
During the 1960s, AO licensed the technology to the Olympus Corporation of Japan and to Machida Instrument Company, which were already producing semirigid endoscopes. The Japanese firms, in particular Olympus, had also developed a gastrocamera even before the introduction of the fiberscope.
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From page 76... ...
The extremely sharp curvature of the sigmoid colon rendered it inaccessible to examination with a rigid, lens-and-prism endoscope. Before fiber optics, proctosigmoidoscopes could inspect only 25-30 cm of the proctosigmoid.
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From page 77... ...
Gastroenterologists in Japan and also in Germany began experimental animal work to test the endoscope as a therapeutic tool in the common bile duct. Because in the early 1970s surgical intervention in the case of recurrent or retained common duct stones carried a significantly high mortality risk, there was a clear need for a safer procedure.
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From page 78... ...
In this prototype the optical fiber bundle was replaced by a charge couple device (CCD) , a kind of microprocessor chip, at the distal tip of the endoscope.
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From page 79... ...
In the early 1950s, Palmer and colleagues at a few other European centers started to collaborate with two newly established endoscope manufacturers (the German optics companies Richard Wolf and Karl Storz) to develop clinically useful gynecological laparoscopes.
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From page 80... ...
In the area of gastroenterology, the need for a flexible endoscope focused R&D efforts on fiber optics as a means of image transmission. In the area of gynecology, and other medical fields that use rigid endoscopes, the major improvement in optics was the introduction of the rod-lens system by the earlier mentioned optical physicist Hopkins, now at the University of Reading (British patent no.
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From page 81... ...
or nitrous oxygen, which reduced air emboli (Semm, 1987~. The improved illumination provided by fiber optics and the Hopkins lens system permitted advances in the documentation of endoscopic images to occur.
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From page 82... ...
Eder Instrument Company and KLI (later to become Cabot Medical) and the German Winter & IBE entered the market.
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From page 83... ...
These instruments played a vital role in the development and further popularization of gynecological laparoscopy. Through Storz's ability to create close collaborations with Semm as well as the physicist Hopkins, this firm became the leading manufacturer in gynecological laparoscopes, holding 40 percent of the world market.
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From page 84... ...
Existing leading manufacturers of rigid endoscopes, such as Storz and Wolf, focused on meeting this demand, but these new requirements opened opportunities for new firms to enter the laparoscopy/arthroscopy arena. Stryker, a firm with a history in medical video imaging, entered the endoscopy field and became very strong in the manufacturing of arthroscopes.
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From page 85... ...
Moreover, gastroenterologists, as described earlier, also successfully developed endoscopic removal of bile duct stones, as surgical intervention in the case of recurrent or retained common duct stones carried a significantly high mortality risk. Finally, 1OAt the end of the nineteenth century, surgeons first introduced cholecystostomy for stones in the gallbladder, and choledocholithotomy for stones in the bile duct.
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From page 86... ...
Because CO2 energy cannot be transmitted through endoscope fiber optics, CO2 lasers were not useful. Laser companies, such as Coherent, Trimedyne, and Laserscope, developed argon, dual wave-length KTP, and contact yttrium-aluminum-garnet (YAG)
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From page 87... ...
To accommodate the burgeoning demand, industry built commercial training TABLE 4-1 Top 12 Laparoscopic or Endoscopic Procedures by Volume, 1991 Procedure Specialist 1991 Esophagogastroduodenoscopy Gastroenterologist 582,000 Colonoscopy Gastroenterologist 272,000 Proctosigmoidoscopy Gastroenterologist 240,000 Gastroenterologic biopsy Gastroenterologist 240,000 Tubal ligation Gynecologist 177,000 Cholecystectomy General surgeon 127,000 Uterine a&esiolysis Gynecologist 120,000 Gastroenterologic polypectomy Gastroenterologist 64,000 Transurethral prostatectomy Urologist 53,000 Gynecologic polypectomy Gynecologist 64,000 Herniorrhaphy General surgeon/urologist 45,000 Appendectomy General surgeon 42,000 SOURCE: Biomedical Business International, 1991.
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From page 88... ...
, hospital length of stay, and recovery period that resulted from the laparoscopic approach (Perissat and Vitale, 1991~. For example, hospital length of stay decreased from four to six days to an overnight or ambulatory procedure; and return to work or normal activity decreased even more dramatically, from four to six weeks to less than one week (Southern Surgeons Club, 1991~.
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From page 89... ...
Furthermore, the ongoing conversion of other traditionally open surgical procedures, such as hernia repair, vagotomy, appendectomies, colon surgery, and bowel resection, to laparoscopic procedures is leading to the demand for new instrumentation. Bowel resection, for example, requires larger instruments to be passed through the laparoscope which, in rum, requires large operating channels.
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From page 90... ...
SOME CONCLUDING OBSERVATIONS AND SPECULATIONS First, some brief observations about the nature of the interdisciplinary relationship in endoscopy. This chapter indicates that endoscopic innovation has indeed been highly dependent on scientific and engineering advances that are generated outside of the medical sector, such as fiber optics, color television, and charge couple devices.
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From page 91... ...
In sum, fiber optics, a major medical innovation, not only came into the world through medical instrumentation, but the medical world itself made significant contributions to the advancement of that technology. As Kapany observes: "From a historical viewpoint, the very origin of fiber optics is intimately linked with its application in medicine." Given the inherently interdisciplinary nature of endoscopic innovation, it is not surprising that close interactions between user clinicians and industrial firms, often in academic medical centers, were found to be crucial to the successful development of medical technology.
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From page 92... ...
By contrast, recent generations of surgeons had little training in endoscopic procedures, and, as described above, laparoscopy was in many ways contrary to the culture of surgery. Indeed, for many decades surgeons were not particularly interested in the adoption of surgical laparoscopy.
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From page 93... ...
Commercial success or failure turns upon considerations of a very different sort than those we have considered so far. For example, many of the original rigid GI endoscope manufacturers failed to make the discontinuous leap to a world of fiber optics and were driven out of the industry.
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From page 94... ...
1994. Minimally invasive surgery.
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From page 95... ...
1954. A flexible fiberscope, using static scanning.
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From page 96... ...
La Presse Me'dicale 64:9799. Southern Surgeons Club.
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