A wireless millimetric magnetoelectric implant for the endovascular stimulation of peripheral nerves.

Implantable bioelectronic devices for the simulation of peripheral nerves could be used to treat disorders that are resistant to traditional pharmacological therapies. However, for many nerve targets, this requires invasive surgeries and the implantation of bulky devices (about a few centimetres in at least one dimension). Here we report the design and in vivo proof-of-concept testing of an endovascular wireless and battery-free millimetric implant for the stimulation of specific peripheral nerves that are difficult to reach via traditional surgeries. The device can be delivered through a percutaneous catheter and leverages magnetoelectric materials to receive data and power through tissue via a digitally programmable 1 mm × 0.8 mm system-on-a-chip. Implantation of the device directly on top of the sciatic nerve in rats and near a femoral artery in pigs (with a stimulation lead introduced into a blood vessel through a catheter) allowed for wireless stimulation of the animals' sciatic and femoral nerves. Minimally invasive magnetoelectric implants may allow for the stimulation of nerves without the need for open surgery or the implantation of battery-powered pulse generators.

The effect of hydroxyapatite on titanium pedicle screw resistance: an electrical model.

BACKGROUND CONTEXT: Intraoperative detection of a pedicle wall breach implicitly reduces surgical risk, but the reliability of intraoperative neuromonitoring has been contested. Hydroxyapatite (HA) has been promulgated to increase pedicle screw resistance and negatively influence the accuracy of electromyography. PURPOSE: The primary purpose of this experiment is to evaluate the effect of HA on pedicle screw electrical resistance using a controlled laboratory model. STUDY DESIGN: Controlled laboratory study. METHODS: Stimulation of pedicle screws was performed in normal saline (0.9% NaCl). The experimental group included 8 HA coated (HAC) pedicle screws and matched manufacturer control pedicle screws without HAC (Ti6Al4V). All screws were stimulated at 5, 10-, 15-, 20-, and 25-mm submersion depths. Circuit current return was recorded, and pedicle screw electrical resistance was calculated according to Ohm's Law. Data were assessed for normality and variance. Mann-Whitney U and Kruskal-Wallis tests compared groups with Bonferroni correction for multiple testing. Effect size is reported with 95% confidence intervals (95CI). p values <.05 were considered significant. RESULTS: Current return was detected for all screws (N=24) following subclinical 8.5 µA stimulation at 5, 10-, 15-, 20-, and 25-mm submersion depths (N=144). The effect estimate of HA on pedicle screw electrical resistance is -0.07 (-0.17 to 0.01 95CI). The estimated effect of HA on pedicle screw electrical resistance did not differ across manufacturers. Electrical resistance values were inversely related to submersion depth. Electrical resistance values were lower in the experimental group at 10 mm (p=.04), 15 mm (p=.04), and 25 mm (p=.02) submersion depths. The HA effect ranged from -0.03 to -0.08 as submersion depth varied. CONCLUSIONS: We found no evidence that HA increased pedicle screw electrical resistance in a matched manufacturer control laboratory model. Electrical stimulation of pedicle screws may be reliable for pedicle breach detection in the presence of HA. Future research should investigate if laboratory findings translate to clinical practice and confirm that electrical stimulation of pedicle screws is a reliable method to detect pedicle breach in the presence of HA.

Technique for Intraoperative Neuromonitoring During Periacetabular Osteotomy After Concomitant Hip Arthroscopy.

Intraoperative neurologic injury during periacetabular osteotomy (PAO) for the treatment of symptomatic acetabular dysplasia is a major complication that can lead to permanent disability and limit the benefit of correcting the acetabular dysplasia. Current literature reflects the evolution of hip-preservation surgery for symptomatic acetabular dysplasia to include hip arthroscopy to address the intra-articular abnormalities, including labral tears, chondral lesions, and femoral cam morphology. A growing number of young hip surgeons and surgeon teams are subscribing to this approach and now performing concomitant hip arthroscopy and PAO. The value of intraoperative neuromonitoring cannot be understated, both in terms of surgeon confidence as well as patient safety, particularly during the learning curve of PAO, with or without hip arthroscopy. We present our current technique for the application of neuromonitoring to allow free mobility of the operative leg and continuous monitoring during PAO. This reproducible technique allows the use of nonsterile neuromonitoring to be used through a sterile conduit, positioned to allow free mobility of the operative extremity and performance of the PAO. We believe this technique provides additional safety benefit and increases awareness regarding neurologic compromise, particularly for the low-volume PAO surgeon or during the procedural learning curve.

The impact of a social norms approach on reducing levels of misperceptions around smokefree hospital entrances amongst patients, staff, and visitors of a NHS hospital: a repeated cross-sectional survey study.

BACKGROUND: Smoking is a cause of avoidable morbidity and mortality. In the United Kingdom (UK) the national smoking ban inside hospital buildings is widely adhered to. There is a perception it has led to smokers congregating around hospital entrances (Selbie D. 2016, It's time for a truly smokefree NHS. Public Health Matters Blog. Public Health England). Efforts to shift social norms and create positive smokefree environments might be strengthened by delivering social norms messages. This study explored the impact of a social norms approach campaign to reduce levels of misperceptions surrounding support for smokefree hospital entrances. METHOD: Repeated cross sectional study design. Staff, patients, and hospital visitors at Pinderfields National Health Service (NHS) Hospital (Wakefield, United Kingdom (UK)) completed a survey before and after implementation of a public health social norms campaign (n = 481 surveyed before; n = 459 surveyed after). The main outcome measure was difference between perceived and reported levels of support for smokefree hospital entrances. RESULTS: There were high levels of support for smokefree hospital entrances. The majority of participants agreed that patients (n = 849, 90% agreed), staff (n = 863, 92% agreed), and visitors (n = 850, 90% agreed) should not smoke in the hospital entrance. Participants underestimated the proportion of others who self-reported keeping the entrance smokefree. Over 90% of respondents reported not smoking in the hospital entrance, but the perception was that between 50 to 75% of hospital staff, patients, and visitors did not smoke in the hospital entrance. The mean percentage of hospital staff, patients, and visitors who respondents thought did not smoke in entrances was higher for respondents responding after, compared to those responding before, the campaign. There was an overall significant effect of time on attitudes towards smoking in the entrances; in all instances the mean percentage of hospital staff, patients, and visitors the participants believed agreed that hospital entrances should be smokefree was higher for those responding after, compared with before, the campaign. CONCLUSIONS: People hold misperceptions of the proportion of people who choose to smoke in the hospital entrance. The social norms approach campaign was associated with a strengthening of positive social norms. Such campaigns should be considered by Trusts as one evidence-based based tactic to denormalise smoking, increase support for smokefree policies.

Attitudes towards smokefree high streets: a survey of local shoppers in a northern UK town.

OBJECTIVE:: As a local authority we wanted to practically determine the perception of the public to smokefree zones in shopping high streets and other local outdoor public places. METHODS:: A survey was carried out by students on a convenience sample of shoppers on a single busy market day in Barnsley. RESULTS:: In all, 142 responses were collected; 28% were smokers and 15% e-cigarette users. The majority (69%) of respondents were not against smokefree high streets, including 68% of smokers; 69% of respondents (including 61% of smokers) were not against all public areas becoming smokefree; 70% of respondents (including 63% of smokers) were not against outdoor seating areas, such as those outside pubs and cafés becoming smokefree. There was a marginal preference that smokefree outdoor zones should be voluntary (42%) rather than enforced (39%). Most respondents believed that people smoking around children was influential in determining whether those children go on to take up smoking when they get older. Most smokers (92%) said they already moderated their smoking behaviour in some way when children were present, including 44% who claimed that when children are around they do not smoke at all. CONCLUSION:: This study gives strength to the argument for local authorities to implement voluntary outdoor smokefree zones in public places such as shopping high streets, as a part of a comprehensive tobacco control plan. Shoppers were generally supportive of smokefree zones and in particular where the rationale for their implementation is to protect children from taking up smoking.

The need for transparency of clinical evidence for medical devices in Europe.

To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device. Defining its content, however, has been delegated to implementing legislation, which is now being considered. From a clinical perspective, it is imperative that all evidence reviewed by notified bodies and regulatory authorities is disclosed-with the exception, if justified, only of technical specifications that are considered confidential or manufacturing details that are protected as intellectual property-and public access to this evidence must be guaranteed by EU law. From ethical and other perspectives, there are no grounds for less clinical evidence being available to health-care professionals about the medical devices that they use than is already available for new pharmaceutical products. Full transparency is needed; without it, informed decisions relating to the use of new medical devices will remain impossible.

NHS patients, staff, and visitor viewpoints of smoking within a hospitals' ground: a qualitative analysis.

BACKGROUND: Smoking is a public health concern and an avoidable cause of morbidity and mortality. Widening tobacco control policies might help shift social norms, the acceptability of exposing others to second-hand smoke, and cultural attitudes towards smoking. This study explored patient, staff, and visitor viewpoints of smoking within the grounds of a National Health Service hospital. METHODS: Analysis of free text responses given as part of a larger repeat cross sectional questionnaire study. Free text qualitative responses analysed using thematic analysis. Pinderfields Hospital, a UK National Health Service hospital in the county of Yorkshire, provides a health service to around half a million people living in the Wakefield and North Kirklees area. Surveys were distributed 10th-18th September and 17th-21st December 2012. Of the n=952 participants who completed an anonymous survey n=306 participants provided a response to the optional free text question. RESULTS: Thematic analysis revealed 5 distinct themes: (1) smoking is a dirty problem; (2) smokers are free to do as they wish; (3) the poor smoker; (4) smoke in our space: the battleground; and (5) no smoking please. Of the n=272 represented by the five themes, generally people accepted that smoking is socially unacceptable but their understanding of smoking behaviours and attitudes towards management and control of smoking differed. There was a strong sense that action is needed to separate the space smokers and non-smokers share. We identified a distinct group of participants that supported a hard line approach and suggested enforcing the no smoking policy through fines and monitoring. CONCLUSIONS: Smoking on hospital grounds remains a contentious issue. Participants acknowledge that smoking is an increasingly unacceptable social behaviour but their understanding and acceptance of smokers vary. There is a strong sense of dislike about the impact of smoke and smokers on the shared hospital environment, with a focus on the hospital entrance. Participants suggest separating smokers and non-smokers and moving smokers away from the hospital entrance with the introduction of smoking shelters. These results suggest a complex narrative that should be investigated further to inform the implementation of the no-smoking policy across hospital settings.