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Duan, et al.

















           Figure 9. Verification of blocking effect of the trial-produced sample of bronchial blocker infants only in the concave 3D printing model.

           infant bronchus. One of the approaches to solving this issue   and less likely to fall off at the minimum cost for infant
           is computer  measurements  in  2D or 3D reconstruction   patients. These studies are not feasible in animal studies
           of the infant’s normal CT scan airway [24,25] . This method   that work with rhesus monkeys , and in clinical trials
                                                                                          [36]
           is comparatively  reliable  in measuring long distances,   that do not meet ethical requirements .
                                                                                              [37]
           such as incisor teeth to glottis (T-G) and glottis to carina
           (G-C). Nonetheless, when measuring small  anatomical   5. Conclusion
           structures, such as the distance from the opening of the   3D printing can assist in the design of medical devices
           RUL to the carina (LD) and the inner diameter of the right   or consumables suitable for special populations such as
           main bronchus (TD), the measurement error tends to be   infants. By measuring the parameters obtained from the
           relatively  larger. High-precision  3D printing  based  on   3D printed convex models, we determined that the infant’s
           CT scanning DICOM files and repeated measurement of   BB adopts a soft low-pressure inflatable cuff with a LD of
           3D printed models can provide more realistic measured   6 mm and a TD of 5 mm and has the adaptability of 25%
           values [26-28] . However, 3D printing in every case would be   expansion to adapt to the individual differences of different
           expensive and environmentally unfriendly .          infants. In addition, the barycenter of the BB should be
                                              [29]
               The findings of this study, illustrated in Figure 5, showed   120 mm away from the distal end of the catheter, so that the
           that airway CT measurement parameters of infants were   barycenter of the catheter should be in the infant’s airway
           linearly fitted according to the age in days and body weight,   as far as possible to facilitate the manipulation, and it is not
           accompanied by normal distribution and linear relationship.   easy to shift or fall off due to gravity during the operation.
           As shown in Table 1, goodness-of-fit test and linear fitting   We have obtained a Chinese utility patent authorization
           were conducted according to the age in days, which have a   (ZL  201820428821.9).  We  tested  the  effectiveness  of
           better linear fitting degree [30-32] . At the same time, it was also   the right bronchial occlusion using concave 3D printed
           proven that TD (R  = 0.23) and LD (R  = 0.19) of imaging   models. The test results indicate that the anticipated design
                                          2
                          2
           measurements did not reach the corresponding linear fitting   requirements are satisfied. However, this research has the
           degree with G-C (R  = 0.47), suggesting that imaging   following limitations, which need to be addressed in future
                            2
           measurements may have larger measurement errors in these   studies: (i) We were unable to measure the thickness of the
           two small measurement parameters. The next step was to   infant’s tracheobronchial walls with the use of the current
           extract typical cases according to the age of the day for 3D   facilities and technology; (ii) although the designs of infant
           printing to obtain more accurate measurement values.  BB and intravascular catheter share overlapping material
               Seven typical cases were selected for 3D printing.   requirements, the safety of infant BB still needs to be
           The growth and development rate of infants from birth to   carefully evaluated in the next clinical study.
           120 days is swift , and then progressively slows down.
                         [33]
           Therefore, in the selection of typical cases in this study,   Acknowledgments
           the interval of the first 4 months was 30 days, and the
           patients of 180, 240, and 360 days were selected for 3D   The author would like to many thanks to Ethics expert
           printing after 6 months (Figure 6).                 Professor Yongli Guo and Statistics expert Ping Chu for
               Convex and concave 3D models were printed for   their guidance.
           each typical case (Figure 6) [34,35] . Convex was used for   Funding
           precise measurement of infant airway parameters and the
           concave was used for validation of samples. As shown in   This work was supported by Beijing Municipal Science
           Figures 7-9, the objective was to design a BB with a more   &  Technology  Commission  (No. Z191100007619052
           suitable  anatomical  structure  that  is simpler  to operate   & Z201100005420027 to Xin Zhao), Beijing Hospitals

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