BACKGROUND: The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. OBJECTIVE: To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences. METHODS: The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved. RESULTS: Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported. CONCLUSION: As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious.

• MeSH
• bezpečnost pacientů MeSH
• časové faktory MeSH
• design vybavení MeSH
• kardiostimulátor škodlivé účinky   MeSH
• lidé MeSH
• management nemoci * MeSH
• následné studie MeSH
• odstranění implantátu metody   MeSH
• retrospektivní studie MeSH
• selhání zařízení MeSH
• senioři MeSH
• srdeční arytmie terapie   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

INTRODUCTION: We developed a new portable device called "VEPpeak" for the examination of visual evoked potentials (VEPs) to extend VEP examination beyond specialized electrophysiological laboratories and to simplify the use of this objective, noninvasive, and low-cost method for diagnostics of visual and central nervous system dysfunctions. METHODS: VEPpeak consists of a plastic headset with a total weight of 390 g containing four EEG amplifiers, an A/D converter, a control unit, and a visual LED stimulator built in the front, vertically adjustable peak. The device is powered and controlled via USB connection from a standard PC/notebook using custom software for visual stimuli generation and for VEP recording and processing. Up to four electrodes can be placed at any scalp location or in combination with two dry electrodes incorporated into the headset. External visual stimulators, such as a tablet, can be used with synchronization. Feasibility and validation studies were conducted with 86 healthy subjects and 76 neuro-ophthalmological patients including 67 who were during the same session also tested with a conventional VEP system. RESULTS: VEPpeak recordings to standard (pattern-reversal) and non-standard (motion-onset, red-green alternation) were robust and repeatable and obtained also in immobilized patients. Good comparability of results was achieved between VEPpeak and standard examination. Some systematic differences in peak latencies and amplitudes are consistent with differences in stimulus characteristics of the two compared systems. DISCUSSION: VEPpeak provides an inexpensive system for clinical use requiring portability. In addition to ISCEV standard VEP protocols, free choice of stimuli and bio-signal recordings make the device universal for many electrophysiological purposes.

• MeSH
• elektrody MeSH
• elektroretinografie MeSH
• lidé MeSH
• světelná stimulace MeSH
• zrakové evokované potenciály * MeSH
• zrakové korové centrum * fyziologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

Článek shrnuje výsledky disertační práce, která představuje nový přístup v navrhování kompenzačních pomůcek z hlediska mechanického řešení a netradičního designu. Práce byla řešena pro konkrétního pacienta s vrozeným postižením horních končetin zvaným fokomélie. Řešení vzniklo na základě osobních konzultací a schůzek na specializovaném pracovišti, kde byla pro našeho pacienta vyrobena kompenzační pomůcka na míru, avšak způsobem a z dílů určených pro jiný druh postižení. Jak se ukázalo, používání této pomůcky je spojeno s celou řadou problémů, a proto se ve výsledku toto řešení ukázalo jako nevyhovující. Díky ní však bylo možné problémy blíže specifikovat, odhalit důležité zákonitosti a poukázat na nutnost vývoje zcela nové a unikátní pomůcky speciálně pro pacienty postižené fokomélií. Práce vychází z těchto nabytých zjištění a z rešeršních poznatků z oblasti ortotiky, protetiky, kompenzačních pomůcek a protetického vybavení. Následně byl proveden kompletní redesign, jehož cílem bylo odstranit všechny zjištěné problémy. Výsledkem předkládané práce je koncept jedinečné pomůcky pro osoby se specifickým vrozeným postižením horních končetin, která nese pracovní označení 4TE.

This article summarizes the results of the project which deals with a new approach to designing ortho-prosthetic devices in terms of mechanical solution and innovative design. The work was addressed to a specific patient with congenital malformation of upper limbs called phocomelia. A custom-made compensatory aid was designed on the basis of personal consultations and meetings at specialized workplace; however the aid was built in a way and from parts for other kind of disability. As it turned out, the use of this device is associated with many complications, and therefore as a result, this solution proved as unsatisfactory. Nevertheless, thanks to this compensation aid, it was possible to specify the problems, to reveal important patterns and highlight the needs for development of entirely new and unique aid designed for patients with phocomelia disability. The work is based on these findings and knowledge acquired from bibliographic search in the field of orthotics, prosthetics, assistive devices and prosthetic equipment. A complete redesign was done with the aim to eliminate all detected problems. The presented result is a unique tool for people with specific congenital disability of upper limbs, with working label 4TE.

• Klíčová slova
• ortoprotetika, handicap, kompenzační pomůcka, design, vrozené postižení horní končetiny, fokomélie, 4TE,
• MeSH
• dítě MeSH
• ektromelie * MeSH
• lidé MeSH
• paže MeSH
• postižené děti MeSH
• postižení MeSH
• protézy - design * metody   přístrojové vybavení   MeSH
• umělé končetiny * normy   MeSH
• vrozené deformity horní končetiny MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• kazuistiky MeSH

PURPOSE: To compare the efficacy and safety of anterior capsulotomy creation with a new selective laser device (CAPSULaser) with those of manual capsulotomies. SETTING: GEMINI Eye Clinic, Zlin, Czech Republic. DESIGN: Prospective case series. METHODS: Patients were placed in cohorts based on age and cataract grade and randomly allocated to have laser capsulotomy or manual continuous curvilinear capsulorhexis (CCC). The anterior capsule was stained with microfiltered trypan blue 0.4%. The anterior capsulotomy was created with the laser device focused on the anterior capsule through a custom patient interface lens. Intraoperative video analysis with the use of an intraocular ruler and postoperative examinations were used to assess safety and efficacy (accuracy of capsulotomy size, circularity, centration). RESULTS: No intraoperative complications occurred in the laser group or the manual group. All capsulotomies in the laser group were free-floating with no tags or tears. The mean capsulotomy diameter was 5.03 mm overall (range 4.8 to 5.2 mm, laser group; 4.4 to 5.8 mm, manual group). In the laser group, all the capsulotomies were within 0.1 mm ± 0.1 (SD) of the target. The circularity accuracy was greater than 99.0% ± 1.0%; the mean centration of the capsulotomy in relation to the intraocular lens (IOL) was 0.1 ± 0.1 mm. All parameters were statistically significant (P < .01). The IOL-capsulotomy overlap was 360 degrees in all laser cases. CONCLUSIONS: Selective laser capsulotomy using a new proprietary trypan blue formulation was safe and effective in cataract surgery. The sizing, circularity, and centration of the laser capsulotomy were more accurate than those of the manual CCC, resulting in consistent 360-degree IOL coverage.

• MeSH
• barvicí látky aplikace a dávkování   MeSH
• capsulorhexis metody   MeSH
• dospělí MeSH
• fakoemulzifikace * metody   MeSH
• implantace nitrooční čočky * MeSH
• katarakta komplikace   MeSH
• laserová terapie škodlivé účinky   přístrojové vybavení   MeSH
• lidé středního věku MeSH
• lidé MeSH
• přední pouzdro oční čočky chirurgie   MeSH
• prospektivní studie MeSH
• pseudofakie patofyziologie   MeSH
• senioři MeSH
• trypanová modř aplikace a dávkování   MeSH
• výsledek terapie MeSH
• zraková ostrost fyziologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

BACKGROUND: The Heartmate 3 (HM3) is a Conformiteé Européenne mark-approved left ventricular (LV) assist device (LVAD) with fully magnetically levitated rotor and features consisting of a wide range operational speeds, wide flow paths, and artificial pulse. We performed a hemodynamic-echocardiographic speed optimization evaluation in HM3-implanted patients to achieve optimal LV- and right ventricular (RV) shape. METHODS AND RESULTS: Sixteen HM3 patients underwent pump speed ramp tests with right heart catheterization. Three-dimensional echocardiographic (3DE) LV and RV datasets (Philips) were acquired, and volumetric (Tomtec) and shape (custom software) analyses were performed (LV: sphericity, conicity; RV: septal and free-wall curvatures). Data were recorded at up to 13 speed settings. Speed changes were in 100-rpm steps, starting at 4600 rpm and ramping up to 6200 rpm. 3DE was feasible in 50% of the patients. Mean original speed was 5306 ± 148 rpm. LV end-diastolic (ED) diameter (-0.15 ± 0.09 cm/100 rpm) and volumes (ED: 269 ± 109 mL to 175 ± 90 mL; end-systolic [ES]: 234 ± 111 mL to 146 ± 81 mL) progressively decreased as the shape became less spherical and more conical; RV volumes initially remained stable, but at higher speeds increased (ED: from 148 ± 64 mL to 181 ± 92 mL; ES: 113 ± 63 mL to 130 ± 69 mL). On average, the RV septum became less convex (bulging toward the LV) at the highest speeds. CONCLUSIONS: LV and RV shape changes were noted in HM3-supported patients. Although a LV volumetric decrease and shape improvement was consistently noted, RV volumes grew in response to increase in speed above a certain point. A next concern would be whether understanding of morphologic and function changes in LV and RV during LVAD speed change assessed with the use of 3DE helps to optimize LVAD speed settings and improve clinical outcomes.

• MeSH
• echokardiografie trojrozměrná trendy   MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetoterapie metody   trendy   MeSH
• podpůrné srdeční systémy trendy   MeSH
• prospektivní studie MeSH
• senioři MeSH
• srdeční katetrizace metody   trendy   MeSH
• srdeční komory diagnostické zobrazování   chirurgie   MeSH
• srdeční selhání diagnostické zobrazování   terapie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH

OBJECTIVES: The purpose of our study was to compare the complication rate and the outcomes of custom-made spacers (C-spacers) and prefabricated articular spacers (P-spacers) in the treatment of periprosthetic infection. PATIENTS AND METHODS: In this retrospective study, 78 patients (44 females, 34 males; mean age: 68.5±9.48 years; range, 47 to 82 years) with articular spacers implanted in our institution were analyzed between January 2009 and December 2019. We recorded implant results as per mechanical complications, infection control, the interval from surgery to definitive hip replacement, and the rate of achieving recovery of joint function after stage two arthroplasty. RESULTS: There were 29 revised spacers; 18 of them were C-spacers and 11 were P-spacers (p=0.0383). A total of 16 dislocations were recorded, of which six were dislocations of C-spacers, and 10 were dislocations of P-spacers (p=0.0082). Additionally, we registered four spacer breakages, all of which occurred in C-spacers (p=0.295). C-spacers failed early, at an mean interval of 2.2 weeks after implantation, and P-spacers failed later, with an mean of 9.3 weeks after implantation (p=0.0187). A total of nine reinfection complications of spacers were registered; only one infection of P-spacers, and eight infections related to C-spacers (p=0.2583). Definitive revision total hip arthroplasty (rTHA) after spacer explantation and successful treatment of the infection occurred in 63 cases out of 78 patients. Definitive rTHA occurred after the use of C-spacers in 41 (78%) patients and after the use of C-spacers in 22 (84%) patients (p=0.7816). C-spacers had a mean interval from spacer implantation to definitive rTHA of 6.56±6.03 months, and P-spacers had a mean interval of 4±1.93 months (p=0.0164). CONCLUSION: Custom-made spacers were shown to have lower mechanical complication rates than prefabricated ones but more infection complications. Prefabricated spacers had more dislocations and fewer breakages. Custom-made spacer mechanical failures occurred earlier compared to prefabricated ones.

• MeSH
• dislokace kloubu * MeSH
• kontrola infekce MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhrada kyčelního kloubu * škodlivé účinky   MeSH
• odstranění implantátu škodlivé účinky   MeSH
• retrospektivní studie MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

Objective: Medical device development, from the product's conception to release to market, is very complex and relies significantly on the application of exact processes. This paper aims to provide an analysis and summary of current research in the field of medical device development methodologies, discuss its phases, and evaluate the associated legislative and risk aspects. Methods: The literature search was conducted to detect peer-reviewed studies in Scopus, Web of Science, and Science Direct, on content published between 2007 and November 2019. Based on exclusion and inclusion criteria, 13 papers were included in the first session and 11 were included in the second session. Thus, a total of 24 papers were analyzed. Most of the publications originated in the United States (7 out of 24). Results: The medical device development process comprises one to seven stages. Six studies also contain a model of the medical device development process for all stages or for just some of the stages. These studies specifically describe the concept stage during which all uncertainties, such as the clinical need definition, customer requirements/needs, finances, reimbursement strategy, team selection, and legal aspects, must be considered. Conclusion: The crucial factor in healthcare safety is the stability of factors over a long production time. Good manufacturing practices cannot be tested on individual batches of products; they must be inherently built into the manufacturing process. The key issues that must be addressed in the future are the consistency in the classification of devices throughout the EU and globally, and the transparency of approval processes.

• Publikační typ
• systematický přehled MeSH

The authors implemented medialization thyroplasty with a customized silicone implant in a total of 43 operations (36 patients) in 1999-2003. In 5 of these patients, the medialization thyroplasty was combined with cricothyroid subluxation (3 cases) or adduction of arytenoid cartilage (3 cases). One patient received medialization thyroplasty, cricothyroid subluxation and adduction of arytenoid cartilage. Postoperatively 36 patients reported substantial reduction of their complaints, 5 patients found their voice improved and only 2 patients (5.6%) stated that their voice had not changed. The subjective evaluation was consistent with the findings of laryngoscopy and the preoperative and postoperative phonation parameters (maximum phonation time, maximum sound pressure level, jitter and shimmer). Average maximum phonation time was 6.5 s before surgery and 12.5 s after surgery. Maximum vocal sound pressure level was, on average, about 4 dB higher after surgery. Jitter was reduced from 5.3 to 3.7% and shimmer from 32.3 to 18.6%. The differences between presurgical and postsurgical parameters in our study were all statistically significant, indicating voice improvement. Medialization thyroplasty with a silicone implant was proven to be a successful and safe surgical method for the treatment of vocal fold paralysis. Copyright 2008 S. Karger AG, Basel.

• MeSH
• arytenoidní chrupavka chirurgie   MeSH
• cartilago cricoidea chirurgie   MeSH
• design vybavení MeSH
• dospělí MeSH
• financování organizované MeSH
• hlasové řasy chirurgie   MeSH
• implantace protézy metody   MeSH
• kvalita hlasu MeSH
• laryngektomie škodlivé účinky   MeSH
• lidé MeSH
• nemoci bloudivého nervu komplikace   MeSH
• nervus laryngeus recurrens MeSH
• ochrnutí hlasivek etiologie   chirurgie   MeSH
• poranění krku komplikace   MeSH
• poranění nervus laryngeus recurrens MeSH
• poruchy hlasu etiologie   chirurgie   MeSH
• protézy a implantáty MeSH
• retrospektivní studie MeSH
• silikonové elastomery MeSH
• spokojenost pacientů MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• hodnotící studie MeSH

BACKGROUND: Electroporation is an effective technique for genetic manipulation of cells, both in vitro and in vivo. In utero electroporation (IUE) is a special case, which represents a fine application of this technique to genetically modify specific tissues of embryos during prenatal development. Commercially available electroporators are expensive and not fully customizable. We have designed and produced an inexpensive, open-design, and customizable electroporator optimized for safe IUE. We introduce NeuroPorator. METHOD: We used off-the-shelf electrical parts, a single-board microcontroller, and a cheap data logger to build an open-design electroporator. We included a safety circuit to limit the applied electrical current to protect the embryos. We added full documentation, design files, and assembly instructions. RESULT: NeuroPorator output is on par with commercially available devices. Furthermore, the adjustable current limiter protects both the embryos and the uterus from overcurrent damage. A built-in data acquisition module provides real-time visualization and recordings of the actual voltage/current pulses applied to each embryo. Function of NeuroPorator has been demonstrated by inducing focal cortical dysplasia in mice. SIGNIFICANCE AND CONCLUSION: The simple and fully open design enables quick and cheap construction of the device and facilitates further customization. The features of NeuroPorator can accelerate the IUE technique implementation in any laboratory and speed up its learning curve.

• MeSH
• design vybavení MeSH
• elektroporace * metody   přístrojové vybavení   MeSH
• embryo savčí MeSH
• myši MeSH
• technika přenosu genů * přístrojové vybavení   MeSH
• těhotenství MeSH
• uterus MeSH
• zvířata MeSH
• Check Tag
• myši MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

This paper presents a newly-designed and realized Invasive Blood Pressure (IBP) device for the simulation on patient's monitors. This device shows improvements and presents extended features with respect to a first prototype presented by the authors and similar systems available in the state-of-the-art. A peculiarity of the presented device is that all implemented features can be customized from the developer and from the point of view of the end user. The realized device has been tested, and its performances in terms of accuracy and of the back-loop measurement of the output for the blood pressure regulation utilization have been described. In particular, an accuracy of ±1 mmHg at 25 °C, on a range from -30 to 300 mmHg, was evaluated under different test conditions. The designed device is an ideal tool for testing IBP modules, for zero setting, and for calibrations. The implemented extended features, like the generation of custom waveforms and the Universal Serial Bus (USB) connectivity, allow use of this device in a wide range of applications, from research to equipment maintenance in clinical environments to educational purposes. Moreover, the presented device represents an innovation, both in terms of technology and methodologies: It allows quick and efficient tests to verify the proper functioning of IBP module of patients' monitors. With this innovative device, tests can be performed directly in the field and faster procedures can be implemented by the clinical maintenance personnel. This device is an open source project and all materials, hardware, and software are fully available for interested developers or researchers.

• MeSH
• design vybavení MeSH
• kalibrace MeSH
• krevní tlak fyziologie   MeSH
• lidé MeSH
• měření krevního tlaku přístrojové vybavení   metody   MeSH
• monitorování fyziologických funkcí přístrojové vybavení   metody   MeSH
• monitory krevního tlaku * MeSH
• software MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH