Zugl.: Giessen, Universiẗat, Diss., 2008.

Classified for decades as a “least risk medical device,” surgical staplers have been recently associated with at least 41,000 injuries and 360 deaths in the last ten years (FDA Letter to Healthcare Providers, 2019). This shocking development has generated calls for a broad investigation into the errors involved in surgical stapler use and reform of the regulatory protocol for medical devices. Current regulatory infrastructure and framework operate with understandings that combine risk inherent to the device and that which is born by the operator (FDA Classification Call, 2019). This thesis explores the aforementioned classification error and its adverse outcomes from an epistemological standpoint. Social epistemic analysis is applied to FDA regulation and to the comparison of two scenarios in reference to the current status-quo classification and to the proposed risk reclassification of surgical staples. Expert versus novice error avoidance surgical performance capabilities are discussed under these two different classificatory scenarios and epistemic social roles.

京都大学 / 0048 / 新制・課程博士 / 博士(医学) / 甲第22345号 / 医博第4586号 / 新制||医||1042(附属図書館) / 京都大学大学院医学研究科医学専攻 / (主査)教授 上本 伸二, 教授 妹尾 浩, 教授 小西 靖彦 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DGAM

Background: The use of stapling equipment for intestinal surgery in cats is rarely reported, and appropriate staple sizes for cat intestine are unknown. Objective: To determine staple cartridge sizes for thoracoabdominal (TA) and endoscopic gastrointestinal anastomosis (EndoGIA) that will simultaneously prevent leakage of small intestinal contents while also allowing for sufficient vascular permeability past the staple lines for intestinal healing. Methods: Two sizes of EndoGIA cartridges (2.0/2.5/3.0mm and 3.0/3.5/4.0mm) and two sizes of TA cartridges (2.5mm and 3.5mm), applied in a transverse manner across fresh cadaveric cat jejunum, were evaluated via intestinal burst pressure testing for maximum intraluminal pressure prior to leaking, and via infusion of an intravascular dye at normal arterial pressures to determine percentage of vascular patency past the staple lines. Vascular patency was compared not only from pre-and post-staple segments of the same intestinal sample, but also EndoGIA vascular patency was evaluated against TA vascular patency. Results: Two cats met study criteria. All samples had intraluminal burst pressures over twice the chosen minimum (of 30mmHg). Vascular patency post- staple line ranged from 0-90.8%, with the most consistently high numbers noted with the TA 3.5mm cartridges. No EndoGIA cartridge had a post- staple line vascular patency higher than 31.1%, and no intravascular dye was noted in any post- staple line sample in the EndoGIA 2.0/2.5/3.0mm group. Conclusions: While statistical analysis of the dataset was unable to be performed due to low numbers of samples for comparison, both intestinal intraluminal burst pressure trends and intravascular dye patterns suggested both the TA 3.5mm cartridge and (to a lesser extent) the 3.0/3.5/4.0mm EndoGIA cartridge could provide the ideal combination of intraluminal seal without restriction of vascular access for healing. The intravascular dye infusion technique, developed during this research, shows promise as a future instrument to determine vascular patterns around intestinal implants in cadaveric cat specimens. / Master of Science / Despite the regularity of feline small intestinal surgery, few reports exist of stapled anastomoses in cats, in part due to stapler size limitations. However, the recently developed endoscopic gastrointestinal anastomosis (EndoGIA) stapler shows promise as a future surgical tool for cats because it fits into cat intestine. In dogs, 3.5mm staples are often chosen for intestinal surgery; however, dog intestine is considerably thicker than cat intestine. The study goal was to evaluate not only intestinal burst pressures (the pressure at which repaired intestine leaks), but also the ability of fluids to flow through blood vessels that cross the staple lines of four stapler cartridge types from two staple lineages (EndoGIA 2.0/2.5/3.0mm, EndoGIA 3.0/3.5/4.0mm, TA 2.5mm, and TA 3.5mm). The central hypothesis was twofold. First, smaller stapler cartridge sizes (the EndoGIA 2.0/2.5/3.0mm and TA 2.5mm) would have higher intraluminal burst pressures when compared to the larger sizes (the EndoGIA 3.0/3.5/4.0mm). Second, larger stapler cartridges (the EndoGIA 3.0/3.5/4.0mm and the TA 3.5mm) would allow for increased flow of fluids in blood vessels past the stapler lines compared to the smaller cartridges (the EndoGIA 2.0/2.5/3.0mm and the TA 2.5mm). Two cats were included in the study. Trends in the data suggested that all components of the hypothesis might be proven with further data. However, due to the low number of cats acquired during the study period, the hypotheses could not be verified with statistics. The dye infusion technique to evaluate flow of fluids in blood vessels, developed during this research, shows promise as a future instrument to determine vascular patterns around intestinal implants. Future research should focus on acquiring more cats to have the ability able to perform statistical analyses (and prove the hypothesis), before proceeding with additional related studies.