Ricerca di Marketing a supporto del lancio di due dispositivi medicali: i casi Virusolve+ e Santec Laser Smooth™ (Fotona) di Santec Srl

L’obiettivo principale del presente lavoro di tesi magistrale è applicare la ricerca di marketing ad un caso concreto, proposto dall’azienda Santec Srl, al fine di raccogliere informazioni necessarie alla definizione della strategia aziendale. L’azienda Santec Srl, opera nel settore dei dispositivi medicali e sta lanciando sul mercato italiano due prodotti innovativi: il primo è una salvietta ad elevato potere disinfettante in grado di eliminare in pochi minuti virus, batteri e funghi; il secondo è un sistema laser a stato solido utilizzabile a scopo terapeutico in ambito ginecologico

The SSSA-MyHand: a dexterous lightweight myoelectric hand prosthesis

The replacement of a missing hand by a prosthesis is one of the most fascinating challenges in rehabilitation engineering. State of art prostheses are curtailed by the physical features of the hand, like poor functionality and excessive weight. Here we present a new multi-grasp hand aimed at overcoming such limitations. The SSSA-MyHand builds around a novel transmission mechanism that implements a semi-independent actuation of the abduction/adduction of the thumb and of the flexion/extension of the index, by means of a single actuator. Thus, with only three electric motors the hand is capable to perform most of the grasps and gestures useful in activities of daily living, akin commercial prostheses with up to six actuators, albeit it is as lightweight as conventional 1-Degrees of Freedom prostheses. The hand integrates position and force sensors and an embedded controller that implements automatic grasps and allows inter-operability with different human-machine interfaces. We present the requirements, the design rationale of the first prototype and the evaluation of its performance. The weight (478 g), force (31 N maximum force at the thumb fingertip) and speed of the hand (closing time: <370 ms), make this new design an interesting alternative to clinically available multi-grasp prostheses

Pectus excavatum and heritable disorders of the connective tissue

Pectus excavatum, the most frequent congenital chest wall deformity, may be rarely observed as a sole deformity or as a sign of an underlying connective tissue disorder. To date, only few studies have described correlations between this deformity and heritable connective tissue disorders such as Marfan, Ehlers-Danlos, Poland, MASS (Mitral valve prolapse, not progressive Aortic enlargement, Skeletal and Skin alterations) phenotype among others. When concurring with connective tissue disorder, cardiopulmonary and vascular involvement may be associated to the thoracic defect. Ruling out the concomitance of pectus excavatum and connective tissue disorders, therefore, may have a direct implication both on surgical outcome and long term prognosis. In this review we focused on biological bases of connective tissue disorders which may be relevant to the pathogenesis of pectus excavatum, portraying surgical and clinical implication of their concurrence

Towards a CAD-based automatic procedure for patient specific cutting guides to assist sternal osteotomies in pectus arcuatum surgical correction

Abstract Pectus Arcuatum, a rare congenital chest wall deformity, is characterized by the protrusion and early ossification of sternal angle thus configuring as a mixed form of excavatum and carinatum features. Surgical correction of pectus arcuatum always includes one or more horizontal sternal osteotomies, consisting in performing a V-shaped horizontal cutting of the sternum (resection prism) by means of an oscillating power saw. The angle between the saw and the sternal body in the V-shaped cut is determined according to the peculiarity of the specific sternal arch. The choice of the right angle, decided by the surgeon on the basis of her/his experience, is crucial for a successful intervention. The availability of a patient-specific surgical guide conveying the correct cutting angles can considerably improve the chances of success and, at the same time, reduce the intervention time. The present paper aims to propose a new CAD-based approach to design and produce custom-made surgical guides, manufactured by using additive manufacturing techniques, to assist the sternal osteotomy. Starting from CT images, the procedure allows to determine correct resection prism and to shape the surgical guide accordingly taking into account additive manufacturing capabilities. Virtually tested against three case studies the procedure demonstrated its effectiveness. Highlights Patient-specific surgical guide improves the chances of success in sternal osteotomy. A CAD-based approach to design and produce custom-made surgical guides is proposed. The proposed framework entails both a series of automatic and user-guided tasks

The Role of DNA Amplification and Cultural Growth in Complicated Acute Appendicitis

Bacterial growth of peritoneal fluid specimens obtained during surgical procedures for acute appendicitis may be useful to optimize further antibiotic therapy in complicated cases. DNA amplification represents a fast technique to detect microbial sequences. We aimed to compare the potential of DNA amplification versus traditional bacterial growth culture highlighting advantages and drawbacks in a surgical setting. Peritoneal fluid specimens were collected during surgery from 36 children who underwent appendectomy between May and December 2012. Real-time polymerase chain reaction (RT-PCR) and cultures were performed on each sample. RT-PCR showed an amplification of 16S in 18/36 samples, <em>Escherichia coli</em> (in 7 cases), <em>Pseudomonas aeruginosa</em> (3), <em>Fusobacterium necrophorum</em> (3), <em>Adenovirus</em> (2), <em>E.coli</em> (1), <em>Klebsiella pneumoniae</em> (1), <em>Serratia marcescens/Enterobacter cloacae</em> (1). Bacterial growth was instead observed only in four patients (3 <em>E.coli</em> and 1 <em>P.aeruginosa</em> and <em>Bacteroides ovatus</em>). Preoperative C-reactive protein and inflammation degree, the most reliable indicators of bacterial translocation, were elevated as expected. DNA amplification was a quick and useful method to detect pathogens and it was even more valuable in detecting aggressive pathogens such as anaerobes, difficult to preserve in biological cultures; its drawbacks were the lack of biological growths and of antibiograms. In our pilot study RT-PCR and cultures did not influence the way patients were treated

Development of a porcine acellular bladder matrix for tissue-engineered bladder reconstruction

PURPOSE: Enterocystoplasty is adopted for patients requiring bladder augmentation, but significant long-term complications highlight need for alternatives. We established a protocol for creating a natural-derived bladder extracellular matrix (BEM) for developing tissue-engineered bladder, and investigated its structural and functional characteristics. METHODS: Porcine bladders were de-cellularised with a dynamic detergent-enzymatic treatment using peristaltic infusion. Samples and fresh controls were evaluated using histological staining, ultrastructure (electron microscopy), collagen, glycosaminoglycans and DNA quantification and biomechanical testing. Compliance and angiogenic properties (Chicken chorioallantoic membrane [CAM] assay) were evaluated. T test compared stiffness and glycosaminoglycans, collagen and DNA quantity. p value of < 0.05 was regarded as significant. RESULTS: Histological evaluation demonstrated absence of cells with preservation of tissue matrix architecture (collagen and elastin). DNA was 0.01 μg/mg, significantly reduced compared to fresh tissue 0.13 μg/mg (p < 0.01). BEM had increased tensile strength (0.259 ± 0.022 vs 0.116 ± 0.006, respectively, p < 0.0001) and stiffness (0.00075 ± 0.00016 vs 0.00726 ± 0.00216, p = 0.011). CAM assay showed significantly increased number of convergent allantoic vessels after 6 days compared to day 1 (p < 0.01). Urodynamic studies showed that BEM maintains or increases capacity and compliance. CONCLUSION: Dynamic detergent-enzymatic treatment produces a BEM which retains structural characteristics, increases strength and stiffness and is more compliant than native tissue. Furthermore, BEM shows angiogenic potential. These data suggest the use of BEM for development of tissue-engineered bladder for patients requiring bladder augmentation

Testicular germ cells tumors in adolescents and young adults: Management and outcomes from a single-center experience.

Objective: To investigate and compare the effectiveness of active surveillance versus post-surgical active treatment, in patients with testicular germ cells tumor (TGCT). Materials and methods: We retrospectively analyzed 52 patients who underwent surgery for TGCT from January 2009 to December 2014. All the patients were divided into two age groups: the Group A included children-adolescents from 18 months to 21 years old, while the Group B comprised young adults from 22 to 39 years old. Clinical, histopathological, therapeutic and follow-up data were collected. Results: Overall, 22 patients (42,3%) were enrolled in the Group A and 30 patients (57.7%) were categorized in the Group B. Inguinal orchiectomy was performed in all patients. Retroperitoneal lymphadenectomy was performed in 4 patients (7.7%). Post-surgical management differed based on clinical stage, resulting in active surveillance or adjuvant therapy. After an average 7 years follow-up period (range: 3.5-9.0 years), the overall survival rate is 100%. The relapse risk is significantly higher for the patients in the Group B, displaying a recurrence free-survival rate of 72% versus 95% (Group A); 11 relapses (21.1%) were recorded 2 years after surgery. Of these, 3 recurrences (12.0%) occurred in patients undergoing an active surveillance approach, while 8 (29.6%) in patients subjected to an active treatment. Conclusions: The excellent prognosis in both age groups confirms the high curability of this neoplasia. The active surveillance could represent an optimal option for low recurrence risk tumors. However, post-surgical treatments should be taken into consideration for TGCT with high risk factors, including tumor size, lymphovascular and rete testis invasion

Targeting SIRT1 Rescues Age- and Obesity-Induced Microvascular Dysfunction in Ex Vivo Human Vessels

ackground: Experimental evidence suggests a key role of SIRT1 (silent information regulator 1) in age- and metabolic-related vascular dysfunction. Whether these effects hold true in the human microvasculature is unknown. We aimed to investigate the SIRT1 role in very early stages of age- and obesity-related microvascular dysfunction in humans. Methods: Ninety-five subjects undergoing elective laparoscopic surgery were recruited and stratified based on their body mass index status (above or below 30 kg/m2) and age (above or below 40 years) in 4 groups: Young Nonobese, Young Obese, Old Nonobese, and Old Obese. We measured small resistance arteries' endothelial function by pressurized micromyography before and after incubation with a SIRT1 agonist (SRT1720) and a mitochondria reactive oxygen species (mtROS) scavenger (MitoTEMPO). We assessed vascular levels of mtROS and nitric oxide availability by confocal microscopy and vascular gene expression of SIRT1 and mitochondrial proteins by qPCR. Chromatin immunoprecipitation assay was employed to investigate SIRT1-dependent epigenetic regulation of mitochondrial proteins. Results: Compared with Young Nonobese, obese and older patients showed lower vascular expression of SIRT1 and antioxidant proteins (FOXO3 [forkhead box protein O3] and SOD2) and higher expression of pro-oxidant and aging mitochondria proteins p66Shc and Arginase II. Old Obese, Young Obese and Old Nonobese groups endothelial dysfunction was rescued by SRT1720. The restoration was comparable to the one obtained with mitoTEMPO. These effects were explained by SIRT1-dependent chromatin changes leading to reduced p66Shc expression and upregulation of proteins involved in mitochondria respiratory chain. Conclusions: SIRT1 is a novel central modulator of the earliest microvascular damage induced by age and obesity. Through a complex epigenetic control mainly involving p66Shc and Arginase II, it influences mtROS levels, NO availability, and the expression of proteins of the mitochondria respiratory chain. Therapeutic modulation of SIRT1 restores obesity- and age-related endothelial dysfunction. Early targeting of SIRT1 might represent a crucial strategy to prevent age- and obesity-related microvascular dysfunction. Keywords: aging; endothelial cells; microcirculation; mitochondria; obesity; sirtuin

Activation of Regulatory T Cells during Inflammatory Response Is Not an Exclusive Property of Stem Cells

BACKGROUND: Sepsis and systemic-inflammatory-response-syndrome (SIRS) remain major causes for fatalities on intensive care units despite up-to-date therapy. It is well accepted that stem cells have immunomodulatory properties during inflammation and sepsis, including the activation of regulatory T cells and the attenuation of distant organ damage. Evidence from recent work suggests that these properties may not be exclusively attributed to stem cells. This study was designed to evaluate the immunomodulatory potency of cellular treatment during acute inflammation in a model of sublethal endotoxemia and to investigate the hypothesis that immunomodulations by cellular treatment during inflammatory response is not stem cell specific. METHODOLOGY/PRINCIPAL FINDINGS: Endotoxemia was induced via intra-peritoneal injection of lipopolysaccharide (LPS) in wild type mice (C3H/HeN). Mice were treated with either vital or homogenized amniotic fluid stem cells (AFS) and sacrificed for specimen collection 24 h after LPS injection. Endpoints were plasma cytokine levels (BD™ Cytometric Bead Arrays), T cell subpopulations (flow-cytometry) and pulmonary neutrophil influx (immunohistochemistry). To define stem cell specific effects, treatment with either vital or homogenized human-embryonic-kidney-cells (HEK) was investigated in a second subset of experiments. Mice treated with homogenized AFS cells showed significantly increased percentages of regulatory T cells and Interleukin-2 as well as decreased amounts of pulmonary neutrophils compared to saline-treated controls. These results could be reproduced in mice treated with vital HEK cells. No further differences were observed between plasma cytokine levels of endotoxemic mice. CONCLUSIONS/SIGNIFICANCE: The results revealed that both AFS and HEK cells modulate cellular immune response and distant organ damage during sublethal endotoxemia. The observed effects support the hypothesis, that immunomodulations are not exclusive attributes of stem cells