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Three-dimensional Medical Printing and Associated Legal Issues in Plastic Surgery: A Scoping Review
(2023)
Three-dimensional printing (3DP) represents an emerging field of surgery. 3DP can facilitate the plastic surgeon’s workflow, including preoperative planning, intraoperative assistance, and postoperative follow-up. The broad clinical application spectrum stands in contrast to the paucity of research on the legal framework of 3DP. This imbalance poses a potential risk for medical malpractice lawsuits. To address this knowledge gap, we aimed to summarize the current body of legal literature on medical 3DP in the US legal system. By combining the promising clinical use of 3DP with its current legal regulations, plastic surgeons can enhance patient safety and outcomes.
"Topographic Shift": a new digital approach to evaluating topographic changes of the female breast
(2021)
Purpose
To assess precise topographic changes of the breast, objective documentation and evaluation of pre- and postoperative results are crucial. New technologies for mapping the body using digital, three-dimensional surface measurements have offered novel ways to numerically assess the female breast. Due to the lack of clear demarcation points of the breast contour, the selection of landmarks on the breast is highly dependent on the examiner, and, therefore, is prone to error when conducting before-after comparisons of the same breast. This study describes an alternative to volumetric measurements, focusing on topographic changes of the female breast, based on three-dimensional scans.
Method
The study was designed as an interventional prospective study of 10 female volunteers who had planned on having aesthetic breast augmentation with anatomical, textured implants. Three dimensional scans of the breasts were performed intraoperatively, first without and then with breast implants. The topographic change was determined as the mean distance between two three-dimensional layers before and after augmentation. This mean distance is defined as the Topographic Shift. Results The mean implant volume was 283 cc (SD = 68.6 cc, range = 210-395 cc). The mean Topographic Shift was 7.4 mm (SD = 1.9 mm, range = 4.8-10.7 mm). The mean Topographic Shifts per quadrant were: I: 8.0 mm (SD = 3.3 mm); II: 9.2 mm (SD = 3.1 mm); III: 6.9 mm (SD = 3.5 mm); IV: 1.9 mm (SD = 4.3 mm).
Conclusion
The Topographic Shift, describing the mean distance between two three-dimensional layers (for example before and after a volume changing therapy), is a new approach that can be used for assessing topographic changes of a body area. It was found that anatomical, textured breast implants cause a topographic change, particularly on the upper breast, in quadrant II, the decollete.
Purpose
Congenital breast asymmetry is a serious gynecological malformation for affected patients. The condition hits young women in puberty and is associated with socio-esthetic handicap, depression, and psychosexual problems. Surgical treatment is usually early in the patient's lifetime, so a long-term sustainable solution is important. Although postoperative outcome has been evaluated in several studies before, this study is the first to analyze which objective parameters have the greatest influence on subjective satisfaction with long-term results.
Methods
Thirty-four patients diagnosed with congenital breast asymmetry that underwent either lipofilling or implant therapy between the years of 2008 to 2019 were examined. On average, our collective comprised patients seven years after surgery. Data were mainly gathered through manual measurements, patient-reported outcome measures (Breast Q™), and breast volumetry based on 3D scans (Vectra® H2, Canfield Scientific).
Results
Among all analyzed parameters, only areolar diameter correlated significantly negatively with the subjective outcome satisfaction of the patient. Regarding the subjective assessment of postoperative satisfaction with similarity of the breasts, again the mean areolar diameter, but also the difference in areolar diameter and breast volume between the right and left breasts correlated significantly negatively.
Conclusion
Areolar diameter was revealed as being a significant factor influencing subjective long-term satisfaction in breast asymmetry patients. Moreover, 3D volumetry proves to be an effective tool to substantiate subjective patient assessments. Our findings may lead to further improvements to surgical planning and will be expanded in further studies.
PURPOSE:
The purpose of this study was to find a suitable method of labelling cartilage samples for the measurement of distraction distances in biomechanical testing.
METHODS:
Samples of bovine cartilage were labelled using five different methods: hydroquinone and silver nitrate (AgNO3), potassium permanganate (KMnO4) with sodium thiosulphate (Na2S2O3), India ink, heat, and laser energy. After the labelling, we analysed the cartilage samples with regard to cytotoxity by histochemical staining with ethidiumbromide homodimer (EthD-1) and calcein AM. Furthermore, we tested cartilages labelled with India ink and heat in a T-peel test configuration to analyse possible changes in the mechanical behaviour between marked and unlabelled samples.
RESULTS:
Only the labelling methods with Indian ink or a heated needle showed acceptable results in the cytotoxity test with regard to labelling persistence, accuracy, and the influence on consistency and viability of the chondrocytes. In the biomechanical T-peel configuration, heat-labelled samples collapsed significantly earlier than unlabelled samples.
CONCLUSION:
Labelling bovine cartilage samples with Indian ink in biomechanical testing is a reliable, accurate, inexpensive, and easy-to-perform method. This labelling method influenced neither the biomechanical behaviour nor the viability of the tissue compared to untreated bovine cartilage.
Vitamin C is an essential nutrient for humans and is involved in a plethora of health-related functions. Several studies have shown a connection between vitamin C intake and an improved resistance to infections that involves the immune system. However, the body cannot store vitamin C and both the elevated oral intake, and the intravenous application have certain disadvantages. In this study, we wanted to show a new formulation for the liposomal packaging of vitamin C. Using freeze etching electron microscopy, we show the formed liposomes. With a novel approach of post-processing procedures of real-time sonography that combines enhancement effects by contrast-like ultrasound with a transducer, we wanted to demonstrate the elevated intestinal vitamin C resorption on four participants. With the method presented in this study, it is possible to make use of the liposomal packaging of vitamin C with simple household materials and equipment for intake elevation. For the first time, we show the enhanced resorption of ingested liposomes using microbubble enhanced ultrasound imaging.
Background:
Lipofilling is one of the most often performed surgical procedures in plastic and reconstructive surgery. Lipoaspirates provide a ready source of stem cells and secreted factors that contribute to neoangiogenesis and fat graft survival. However, the regulations about the enrichment of these beneficial cells and factors are ambiguous. In this study, the authors tested whether a combination of centrifugation and homogenization allowed the enrichment of viable stem cells in lipoaspirates through the selective removal of tumescent solution, blood, and released lipids without significantly affecting the cell secretome.
Methods:
Human lipoaspirate was harvested from six different patients using water jet–assisted liposuction. Lipoaspirate was homogenized by first centrifugation (3584 rpm for 2 minutes), shear strain (10 times intersyringe processing), and second centrifugation (3584 rpm for 2 minutes). Stem cell enrichment was shown by cell counting after stem cell isolation. Lipoaspirate from different processing steps (unprocessed, after first centrifugation, after homogenization, after second centrifugation) was incubated in serum-free cell culture medium for mass spectrometric analysis of secreted proteins.
Results:
Lipoaspirate homogenization leads to a significant 2.6 ± 1.75-fold enrichment attributable to volume reduction without reducing the viability of the stem cells. Protein composition of the secretome did not change significantly after tissue homogenization. Considering the enrichment effects, there were no significant differences in the protein concentration of the 83 proteins found in all processing steps.
Conclusions:
Stem cells can be enriched mechanically without significantly affecting the composition of secreted proteins. Shear-assisted enrichment of lipoaspirate constitutes no substantial manipulation of the cells’ secretome.
The good availability and the large content of adult stem cells in adipose tissue has made it one of the most interesting tissues in regenerative medicine. Although lipofilling is one of the most frequent procedures in plastic surgery, the method still struggles with high absorption rates and volume losses of up to 70%. Therefore, many efforts have been made to optimize liposuction and to process the harvested tissue in order to increase fat graft retention. Because of their immunomodulatory properties, their cytokine secretory activity, and their differentiation potential, enrichment with adipose tissue-derived stem cells was identified as a promising tool to promote transplant survival. Here, we review the important parameters for lipofilling optimization. Finally, we present a new method for the enrichment of lipoaspirate with adipose tissue-derived stem cells and discuss the parameters that contribute to fat graft survival.
Digital nerve lesions result in a loss of tactile sensation reflected by an anesthetic area (AA) at the radial or ulnar aspect of the respective digit. Yet, available tools to monitor the recovery of tactile sense have been criticized for their lack of validity. However, the precise quantification of AA dynamics by three-dimensional (3-D) imaging could serve as an accurate surrogate to monitor recovery following digital nerve repair.
For validation, AAs were marked on digits of healthy volunteers to simulate the AA of an impaired cutaneous innervation. Three dimensional models were composed from raw images that had been acquired with a 3-D camera (Vectra H2) to precisely quantify relative AA for each digit (3-D models, n= 80). Operator properties varied regarding individual experience in 3-D imaging and image processing. Additionally, the concept was applied in a clinical case study.
Images taken by experienced photographers were rated better quality (p< 0.001) and needed less processing time (p= 0.020). Quantification of the relative AA was neither altered significantly by experience levels of the photographer (p= 0.425) nor the image assembler (p= 0.749).
The proposed concept allows precise and reliable surface quantification of digits and can be performed consistently without relevant distortion by lack of examiner experience. Routine 3-D imaging of the AA has the great potential to provide visual evidence of various returning states of sensation and to convert sensory nerve recovery into a metric variable with high responsiveness to temporal progress.
We present the Regensburg Breast Shape Model (RBSM) – a 3D statistical shape model of the female breast built from 110 breast scans, and the first ever publicly available. Together with the model, a fully automated, pairwise surface registration pipeline used to establish correspondence among 3D breast scans is introduced. Our method is computationally efficient and requires only four landmarks to guide the registration process. In order to weaken the strong coupling between breast and thorax, we propose to minimize the variance outside the breast region as much as possible. To achieve this goal, a novel concept called breast probability masks (BPMs) is introduced. A BPM assigns probabilities to each point of a 3D breast scan, telling how likely it is that a particular point belongs to the breast area. During registration, we use BPMs to align the template to the target as accurately as possible inside the breast region and only roughly outside. This simple yet effective strategy significantly reduces the unwanted variance outside the breast region, leading to better statistical shape models in which breast shapes are quite well decoupled from the thorax. The RBSM is thus able to produce a variety of different breast shapes as independently as possible from the shape of the thorax. Our systematic experimental evaluation reveals a generalization ability of 0.17 mm and a specificity of 2.8 mm for the RBSM. Ultimately, our model is seen as a first step towards combining physically motivated deformable models of the breast and statistical approaches in order to enable more realistic surgical outcome simulation.
We present the Regensburg Breast Shape Model (RBSM)—a 3D statistical shape model of the female breast built from 110 breast scans acquired in a standing position, and the first publicly available. Together with the model, a fully automated, pairwise surface registration pipeline used to establish dense correspondence among 3D breast scans is introduced. Our method is computationally efficient and requires only four landmarks to guide the registration process. A major challenge when modeling female breasts from surface-only 3D breast scans is the non-separability of breast and thorax. In order to weaken the strong coupling between breast and surrounding areas, we propose to minimize the variance outside the breast region as much as possible. To achieve this goal, a novel concept called breast probability masks (BPMs) is introduced. A BPM assigns probabilities to each point of a 3D breast scan, telling how likely it is that a particular point belongs to the breast area. During registration, we use BPMs to align the template to the target as accurately as possible inside the breast region and only roughly outside. This simple yet effective strategy significantly reduces the unwanted variance outside the breast region, leading to better statistical shape models in which breast shapes are quite well decoupled from the thorax. The RBSM is thus able to produce a variety of different breast shapes as independently as possible from the shape of the thorax. Our systematic experimental evaluation reveals a generalization ability of 0.17 mm and a specificity of 2.8 mm. To underline the expressiveness of the proposed model, we finally demonstrate in two showcase applications how the RBSM can be used for surgical outcome simulation and the prediction of a missing breast from the remaining one. Our model is available at https://www.rbsm.re-mic.de/.