Search

Purpose The posterior superior alveolar (PSA) block injection is one of many techniques used to provide profound anesthesia for invasive dental procedures. This technique has a high success rate but is not without complication risks. The purpose of this study was to determine if pulpal anesthesia of the maxillary second molar could be achieved using a reduced needle depth of 10mm or 5mm compared to the traditional needle depth of 16mm. Methods Sixty participants were asked to participate in three sessions. Each session started with a pre neural response test, followed by one randomized needle depth PSA injection, and ending with a post neural response test. The neural response test consisted of two parts, a cold refrigerant and a dental probe, on the buccal and interproximal surface of the maxillary second molar. After receiving a positive neural response, each participant received a posterior superior alveolar block injection using a short (21mm), 27-gauge dental needle with a randomized needle penetration depth of 16mm, 10mm, or 5mm. A post neural response test consisting of the same two parts as the pre-test was conducted on the maxillary second molar to evaluate for profound anesthesia. Results Positive neural responses were obtained from 100% of the participants (n=167) during the pre-tests. Study results demonstrated an 85% success rate at the traditional 16mm needle depth and a 93% and 92% success rates for the reduced needle depths of 10mm and 5mm, respectively. Pulpal anesthesia of the maxillary second molar had been achieved at all three needle depths with no statistically significant difference in the rate of success. Furthermore, there were no adverse events observed. Conclusion The reduced needle depth technique showed promise in achieving desired results of pulpal anesthesia with a reduced risk for complications associated with the PSA block injection. Additional studies are recommended to achieve evidence-based support for this reduced needle depth technique., (Copyright © 2024 The American Dental Hygienists’ Association.)

Objective: to map scientific evidence regarding the use of local pressure devices in pain relief during injection procedures in patients., Methods: scoping review, following the recommendations of the JBI Manual for Evidence Synthesis and PRISMA-ScR, with searches conducted in the PubMed, EMBASE, CINAHL, LILACS, and PsycINFO databases, without temporal restrictions and with a cutoff date of March 2023., Results: a total of 1,514 studies were identified, with 20 articles included in the final sample. The ShotBlocker® device was utilized during subcutaneous and intramuscular injections in children and adults, proving beneficial in reducing pain, anxiety, and fear associated with the procedure., Final Considerations: the ShotBlocker® is a low-cost, easy-to-use device that can enhance nursing clinical practice during painful procedures. However, studies involving the Brazilian Pikluc® device are scarce. Further research involving both local pressure devices is recommended.

Direct and precise monitoring of intracranial physiology holds immense importance in delineating injuries, prognostication and averting disease 1 . Wired clinical instruments that use percutaneous leads are accurate but are susceptible to infection, patient mobility constraints and potential surgical complications during removal 2 . Wireless implantable devices provide greater operational freedom but include issues such as limited detection range, poor degradation and difficulty in size reduction in the human body 3 . Here we present an injectable, bioresorbable and wireless metastructured hydrogel (metagel) sensor for ultrasonic monitoring of intracranial signals. The metagel sensors are cubes 2 × 2 × 2 mm 3  in size that encompass both biodegradable and stimulus-responsive hydrogels and periodically aligned air columns with a specific acoustic reflection spectrum. Implanted into intracranial space with a puncture needle, the metagel deforms in response to physiological environmental changes, causing peak frequency shifts of reflected ultrasound waves that can be wirelessly measured by an external ultrasound probe. The metagel sensor can independently detect intracranial pressure, temperature, pH and flow rate, realize a detection depth of 10 cm and almost fully degrade within 18 weeks. Animal experiments on rats and pigs indicate promising multiparametric sensing performances on a par with conventional non-resorbable wired clinical benchmarks., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)

Objective: Local drug delivery aims to minimize systemic toxicity by preventing off-target effects; however, injection parameters influencing depot formation of injectable gels have yet to be thoroughly studied. We explored the effects of needle characteristics, injection depth, rate, volume, and polymer concentration on gel ethanol distribution in both tissue and phantoms., Methods: The polymer ethyl cellulose (EC) was added to ethanol to form an injectable gel to ablate cervical precancer and cancer. Tissue mimicking phantoms composed of 1% agarose dissolved in deionized water were used to establish overall trends between various injection parameters and the resulting gel distribution. Additional experiments were performed in excised swine cervices with a CT-imageable injectate formulation, which enabled visualization of the distribution without tissue sectioning., Results: Needle type and injection rate had minimal impact on gel distribution, while needle depths ≥13 mm yielded significantly larger distributions. Needle gauge and EC concentration impacted injection pressure with maximum gel distribution achieved when the pressure was 70-250 kPa. Injection volumes ≤3 mL of 6% EC-ethanol minimized fluid leakage away from the injection site. Results guided the development of a speculum-compatible hand-held injector to deliver gel ethanol into the cervix., Conclusion: Needle depth, gauge, and polymer concentration are critical to consider when delivering injectable gels., Significance: This study addressed key questions related to the impact of injection-based parameters on gel distribution at a scale relevant to human applications including: 1) how best to deliver EC-ethanol into the cervix and 2) general insights about injection protocols relevant to the delivery of injectable gels in tissue.

Introduction: Real-world data evaluating patients' injection experiences using the latest devices/formulations of the long-acting (LA) somatostatin analogs (SSAs) lanreotide Autogel/Depot (LAN; Somatuline®) and octreotide LA release (OCT; Sandostatin®) are limited., Methods: PRESTO 2 was a 2020/2021 e-survey comparing injection experience of adults with neuroendocrine tumors (NETs) or acromegaly treated with LAN prefilled syringe versus OCT syringe for > 3 months in Canada, Ireland, the UK and the USA (planned sample size, 304)., Primary Endpoint: the proportion of patients with injection-site pain lasting > 2 days after their most recent injection, analyzed using a multivariate logistic regression model. Secondary endpoints included interference with daily life due to injection-site pain and technical injection problems in patients with current SSA use for ≥ 6 months., Results: There were 304 respondents (acromegaly, n = 85; NETs, n = 219; LAN, n = 168; OCT, n = 136; 69.2% female; mean age, 59.6 years). Fewer patients had injection-site pain lasting > 2 days after the most recent injection with LAN (6.0%) than OCT (22.8%); the odds of pain lasting > 2 days were significantly lower for LAN than OCT, adjusted for disease subgroup and occurrence of injection-site reactions (odds ratio [95% confidence interval]: 0.13 [0.06-0.30]; p < 0.0001). Injection-site pain interfered with daily life "a little bit" or "quite a bit" in 37.2% and 3.8% (LAN) versus 52.5% and 7.5% (OCT) of patients, respectively. Among patients with ≥ 6 months' experience with current SSA (92.4% of patients), technical injection problems never occurred in 76.8% (LAN) and 42.9% (OCT) of patients., Conclusions: Compared with OCT, significantly fewer patients using LAN had injection-site pain lasting > 2 days after their most recent injection. Also, fewer LAN-treated patients experienced technical problems during injection. These findings demonstrate the importance of injection modality for overall LA SSA injection experience for patients with acromegaly or NETs., (© 2022. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)

During intraocular lens (IOL) implantation it is not uncommon for the injector's nozzle-tip to get damaged. However, the damage has not been systematically described or evaluated using an objective scale. In this study we developed our own system-the Heidelberg Score for IOL Injector Damage ("HeiScore"), which was used to grade 60 injectors from four generations of injector models (Monarch III D, AcrySert C, UltraSert, AutonoMe) made by the same manufacturer. (Alcon Laboratories Inc.) HeiScore has six grades of nozzle-tip damage: no damage (which was graded 0); slight scratches (1), deep scratches (2), extensions (3), cracks (4) and bursts (graded number 5). The score for each injector model was the sum of all grades (total number), and we could compare the four injector models. The injectors showed varying damage profiles, from "no damage" to "crack". A tendency of a lower damage score in the newer generations of IOL injectors was noted. However, a statistically significant difference was observed only between Monarch III D and AutonoMe. The "Heidelberg Score for IOL Injector Damage" could efficiently and effectively evaluate the damage to IOL injector systems, which might help manufacturers optimize the positioning of the IOL in the injector during pre-loading., (© 2022. The Author(s).)

Background and Objective: The main objective of this prospective, open, uncontrolled pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in 10 patients with refractory chronic rhinosinusitis with nasal polyposis (CRSwNP) using a novel injection tool, the MultiGuide ® ., Material and Methods: A one-month baseline period was followed by bilateral injections of 25 U BTA in the SPG and a follow-up of 12 weeks. The primary outcome was adverse events (AE), and the main efficacy outcome was a 50% reduction in visual analogue scale (VAS) symptoms for nasal obstruction and rhinorrhea in months 2 and 3 post-treatment compared to baseline., Results: We registered 13 AEs, none of which were serious, however, one patient experienced diplopia which moderately affected his daily activities. The symptoms slowly improved and resolved 4 weeks after injection. Five patients were treatment responders with at least 50% median reduction in the nasal obstruction, and four were treatment responders concerning rhinorrhea., Conclusions: Injection of BTA toward the SPG using the MultiGuide ® in patients with CRSwNP appears to be safe but with a potential for moderately disabling side effects. The study indicates a beneficial effect on nasal obstruction.

BACKGROUND: Pegfilgrastim is available as a prefilled syringe (PFS) and an on-body injector (OBI). Whether the administration method of pegfilgrastim affects the effectiveness and health care resources has not been evaluated in the setting of routine care. OBJECTIVE: To compare real-world clinical and economic outcomes between PFS and OBI methods of administration. METHODS: This was a retrospective observational study in patients diagnosed with breast cancer or non-Hodgkin lymphoma who received myelosuppressive chemotherapy and prophylactic use of pegfilgrastim via PFS or OBI between January 1, 2017, and May 31, 2018, according to MarketScan research databases. A propensity score was used to match the PFS cohort 1:1 to the OBI cohort. Outcomes were compared among the matched cohorts using a generalized linear model and generalized estimating equations with log-link function. RESULTS: 3,152 patients were identified. After matching, the final sample included 2,170 patients, representing 1,085 in each cohort. The incidence of febrile neutropenia (FN) in the first chemotherapy cycle was 1.01% for OBI (95% CI = 0.56-1.82) vs 1.48% for PFS (95% CI = 0.91-2.39; P = 0.336). In all chemotherapy cycles (total cycles = 7,467), the FN incidence was 0.91% for OBI (95% CI = 0.64-1.30) vs 1.22% for PFS (95% CI = 0.90-1.64; P = 0.214). There was no statistically significant difference in adjusted per-member per-month all-cause total cost health care resource utilization (HCRU) for hospitalizations, emergency department visits, and pharmacy claims. CONCLUSIONS: In a matched cohort of patients representing real-world utilization, there was no statistically or clinically meaningful difference in FN incidence between OBI and PFS methods of pegfilgrastim administration. There was no difference in total HCRU or total costs. OBI and PFS methods of administration are both indicated for patients requiring prophylactic pegfilgrastim, which is important considering that biosimilar PFS options are now available. DISCLOSURES: This study was funded by Sandoz, Inc. Wang, Li, and K. Campbell are employees of Sandoz, Inc. Schroader and D. Campbell are employees of Xcenda, which was contracted by Sandoz, Inc., to provide study and manuscript development. McBride reports receiving payment from Sandoz, Inc., as a consultant, unrelated to this study; Coherus for advisory board and speaker engagements; and Pfizer for advisory board participation during the time of this study.

Purpose: This study aims to determine laryngeal dimension in relation to all three transcutaneous injection laryngoplasty (TIL) approaches (thyrohyoid, transthyroid and cricothyroid) using three-dimensionally reconstructed Computed Tomography (CT) scan and compare the measurements between sex, age group and ethnicity., Methods: CT scans of the neck of two hundred patients were analysed by two groups of raters. For thyrohyoid approach, mean distance from the superior border of the thyroid cartilage to the laryngeal cavity (THd) and mean angle from the superior border of the thyroid cartilage to mid-true cords (THa) were measured. For transthyroid approach, mean distance from mid-thyroid cartilage to mid-true cords (TTd) and Hounsfield unit (HU) at mid-thyroid cartilage (TTc) were measured. For cricothyroid approach, mean distance from the inferior border of the thyroid cartilage to the laryngeal cavity (CTd) and mean angle from the inferior border of the thyroid cartilage to mid-true cords (CTa) were measured., Results: There were statistically significant differences between males and females for all measurements except for CTa (p < 0.0001). No significant difference across age groups and ethnicities were found for all three approaches (p > 0.05). There was a significant fair positive correlation between age and TTc (p = 0.0002). For all measurements obtained, there were moderate to excellent inter-group consistency and intra-rater reliability., Conclusion: This study demonstrated a significant sex dimorphism that may influence the three TIL approaches except for needle angulation in the cricothyroid approach. The knowledge of laryngeal dimension is important to increase success in TIL procedure., (© 2021. Springer-Verlag France SAS, part of Springer Nature.)

Background: Despite its life-saving potential in anaphylaxis, self-injectable epinephrine (SIE) is frequently not administered by caregivers prior to arrival in the emergency department (ED). Prescriptions from the ED often go unfilled which may contribute to the failure to receive SIE when needed., Objective: To determine the prescription filling rate and accessibility of SIE devices among families discharged from the Pediatric ED with an SIE prescription., Methods: A phone survey was administered to parents of children <18 years of age prescribed SIE in the pediatric ED over 12 months. The survey inquired if they own an SIE device, the device's expiration date as confirmation, and details of their child's allergy. Variables were analyzed for association with owning SIE, having SIE accessible when prompted, and having unexpired SIE accessible., Results: 170 children received prescriptions for SIE and 100 (59%) completed the survey. Eighty-four of 100 (84%) had filled the initial SIE prescription. Sixty-five of 100 (65%) had proof of having SIE, of which 29% (19/65) were expired. Only 46% (46/100) of all respondents had an accessible unexpired SIE. Patients with food allergies and those who'd visited an allergist after their ED visit had higher odds of having unexpired accessible devices., Conclusion: A majority of patients prescribed SIE from the ED fill their prescription; however, less than half have unexpired SIE readily available despite high rates of recurrent anaphylactic emergencies. Focusing on post-discharge planning, particularly follow-up, may prevent children with allergies from being left dangerously unprepared., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: To investigate the therapy of stress urinary incontinence in a preclinical setting cells were injected into the urethrae of minipigs; however, cells injected by William's needle were frequently misplaced or lost; thus, we investigated if needle-free cell injections using a novel waterjet technology facilitates precise injections in the urethral sphincter complex., Materials and Methods: Porcine adipose tissue-derived stromal cells (pADSCs) were isolated from boars, expanded, labelled, and injected in the sphincter of female pigs by waterjet employing two different protocols. After incubation for 15 min or 3 days, the urethrae of the pigs were examined. Injected cells were visualised by imaging and fluorescence microscopy of tissue sections. DNA of injected male cells was verified by polymerase chain reaction (PCR) of the sex-determining region (SRY) gene. Cell injections by William's needle served as controls., Results: The new waterjet technology delivered pADSCs faster and with better on-site precision than the needle injections. Bleeding during or after waterjet injection or other adverse effects, such as swelling or urinary retention, were not observed. Morphologically intact pADSCs were detected in the urethrae of all pigs treated by waterjet. SRY-PCR of chromosomal DNA and detection of recombinant green fluorescent protein verified the injection of viable cells. In contrast, three of four pigs injected by William's needle displayed no or misplaced cells., Conclusion: Transurethral injection of viable pADSCs by waterjet is a simple, fast, precise, and yet gentle new technology. This is the first proof-of-principle concept study providing evidence that a waterjet injects intact cells exactly in the tissue targeted in a preclinical in vivo situation. To further explore the clinical potential of the waterjet technology longer follow-up, as well as incontinence models have to be studied., (© 2020 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

Single-cell and in situ cell-based operation with nanopipette approach offers a possibility to elucidate the intracellular processes and may aid the improvement of therapy efficiency and precision. We present here a photo-responsive hydrogel-nanopipette hybrid system that can achieve single-cell operation with high spatial/temporal resolution and negligible cell damage. This strategy overcomes long-time obstacles in nanopipette single-cell studies as high electric potential (ca. 1000 mV) or organic solvent is always used during operations, which would inevitably impose disturbance and damage to targeted cells. The light-triggered system promotes a potential-free, non-invasive single-cell injection, resulting in a well-retained cell viability (90 % survival rate). Moreover, the photo-driven injection enables a precisely dose-controllable single-cell drug delivery. Significantly reduced lethal doses of doxorubicin (163-217 fg cell -1 ) are demonstrated in corresponding cell lines., (© 2020 Wiley-VCH GmbH.)

Anaphylaxis is a life-threatening allergic reaction involving multiple organ systems that can result in significant morbidity and mortality if left untreated. Epinephrine is the mainstay of treatment. Most episodes of anaphylaxis resolve after a single dose of epinephrine, but biphasic and protracted courses of anaphylaxis are well described. The need for additional doses of epinephrine poses a significant challenge in the wilderness setting, because patients and providers may only carry a single autoinjector. Prior work has demonstrated successful disassembly of various brands of epinephrine autoinjectors to retrieve additional drug product for repeat dosing. We describe 2 techniques to retrieve additional doses of epinephrine from Adrenaclick-style epinephrine autoinjectors. The techniques described are off-label and are not approved by the manufacturer or the Food and Drug Administration. Wilderness providers should familiarize themselves with techniques for retrieval of additional epinephrine from various autoinjectors in light of significant differences in product design., (Copyright © 2020 Wilderness Medical Society. All rights reserved.)

Purpose of Review: Infant anaphylaxis has been increasing in incidence; however, significant gaps in the literature remain. The aim of this article is to review the most recent literature pertaining to infant anaphylaxis and discuss recent findings related to epidemiology, diagnosis, management, and prevention., Recent Findings: There is no accurate report of the incidence and prevalence of anaphylaxis in infancy. Food is the most common trigger for infant anaphylaxis reported. The diagnosis of anaphylaxis in infants is often missed, and, even when the diagnosis is made, epinephrine continues to be under-utilized. An epinephrine autoinjector with a shorter needle and lower dose is now available for infants. Concise criteria specifically focusing on infant anaphylaxis is needed to streamline its diagnosis and management. Diagnosis is underrecognized in infants leading to improper treatment. When the diagnosis is made, epinephrine continues to be under-utilized and under-prescribed in infants.

Background: Epinephrine autoinjector (EAI) is prescribed to prevent a fatal outcome in the case of a repeated anaphylactic reactions. We wanted to determine how adult patients who received their first prescription as part of an urgent treatment of an anaphylactic reaction or at their family physician were instructed on the use of EAI., Methods: Nurses assessing patients' knowledge asked the patient to demonstrate how to use the EAI training device. Patients who performed the critical steps correctly in 1 min were labelled as competent., Results: Forty-one patients (24% women, 46 ± 5 years) came for the allergy examination 116 ± 145 days after receiving a prescription for EAI. When prescribing, the doctor or nurse explained the instructions for the use of EAI to 63.4% patients, and 31.7 patients practiced the use of EAI using a training device. At the pharmacy, 22% received explanation and 7% also practiced using a training device. Fifty-four percent of patients were able to effectively administer EAI adrenaline within 1 min. Higher education level was associated with sufficient knowledge about the use of EAI (p = 0.026). At the time of the visit to the allergy specialist clinic, 61% of patients had EAI with them. The shelf life of EAI was known to 63% of patients., Conclusions: The activities to increase the prescription rate of EAI immediately after treatment of anaphylactic episode are not sufficient to prevent severe outcome after the repeated episodes of anaphylaxis as nearly a half of patients are not able to use EAI correctly., (© 2021 S. Karger AG, Basel.)

Background: Growth hormone (GH) treatment preference and adherence are affected by delivery device convenience, injection-site pain, confidence in correct dose administration, and device satisfaction. This survey investigated if switching device to NordiFlex® improved treatment experience in pediatric patients in South Korea., Design and Methods: Patients aged 4-≤18 years were surveyed. Participants were NordiFlex® users who previously used NordiLet®/other devices. Participants compared preference, self-reported adherence, satisfaction, perceived ease of use, and device subjective benefits (across four domains: ease of use, self-efficacy, minimal disruption of daily life, positive feelings about injections ) of NordiFlex® vs. previous device., Results: Ninety-four patients were enrolled, of which 91.5% previously used NordiLet®. Significantly more patients preferred, and were more satisfied with NordiFlex® vs. previous device; mean score: 0.65 (95% confidence interval [CI]:0.41;0.88) and 0.61 (95% CI:0.36;0.85), respectively. Participants reported greater perceived ease of use (0.49 [95% CI:0.26;0.72]) and fewer missed injections (0.20 [95% CI:0.06;0.34], with NordiFlex® vs. previous device. Bivariate analysis showed significant associations between preference for NordiFlex® and higher scores on self-efficacy, ease of use, minimal disruption of daily life , and positive feelings about injection (all p < 0.001)., Conclusion: These results suggest that improvements in device features could be associated with improved treatment experience.

In this study we present a kinematic approach for modeling needle insertion into soft tissues. The kinematic approach allows the presentation of the problem as Dirichlet-type (i.e. driven by enforced motion of boundaries) and therefore weakly sensitive to unknown properties of the tissues and needle-tissue interaction. The parameters used in the kinematic approach are straightforward to determine from images. Our method uses Meshless Total Lagrangian Explicit Dynamics (MTLED) method to compute soft tissue deformations. The proposed scheme was validated against experiments of needle insertion into silicone gel samples. We also present a simulation of needle insertion into the brain demonstrating the method's insensitivity to assumed mechanical properties of tissue., Competing Interests: The authors have declared that no competing interests exist.

The advent of tools enabling the direct manipulation of microglia has furthered our understanding of their role in health and disease. Here, we present a detailed protocol allowing for microglia turnover in adult CX 3 CR 1 creERT2 × iDTR or CX 3 CR 1 creERT2 × iDTR × tdTomato flox mice, either in a brain-wide or region-specific manner, and their subsequent isolation for downstream applications. This protocol may be used to explore microglia biology and their putative region-specific heterogeneous functional diversity, expanding our understanding of their importance in various neuroinflammatory conditions. For complete details on the use and execution of this protocol, please refer to Willis et al. (2020)., Competing Interests: The authors declare no competing interests., (© 2020 The Author(s).)

In rodent models, tail vein injections are important methods for intravenous administration of experimental agents. Tail vein injections typically involve warming of the animal to promote vasodilation, which aids in both the identification of the blood vessels and positioning of the needle into the vessel lumen while securely restraining the animal. Although tail vein injections are common procedures in many protocols and are not considered highly technical if performed correctly, accurate and consistent injections are crucial to obtain reproducible results and minimize variability. Conventional methods for inducing vasodilation prior to tail vein injections generally depend on the use of a heat source such as a heat lamp, electrical/rechargeable heat pads, or pre-heated water at 37 °C. Despite being readily accessible in a standard laboratory setting, these tools evidently suffer from poor/limited thermo-regulatory capacity. Similarly, although various forms of restraining devices are commercially available, they must be used carefully to avoid trauma to the animals. These limitations of the current methods create unnecessary variables in experiments or result in varying outcomes between experiments and/or laboratories. In this article, we demonstrate an improved protocol using an innovative device that combines an independent, thermally regulated, warming device with an adjustable restraining unit into one system for efficient streamlined tail vein injection. The example we use is an intravenous model of fungal bloodstream infection that results in sepsis. The warming apparatus consists of a heat-reflective acrylic box installed with an adjustable automatic thermostat to maintain the internal temperature at a pre-set threshold. Likewise, the width and height of the cone restraining apparatus can be adjusted to safely accommodate various rodent sizes. With the advanced and versatile features of the device, the technique shown here could become a useful tool across a range of research areas involving rodent models that employ tail vein injections.

Background: Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties., Methods: A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted. Patient feedback obtained from two focus groups was used to inform initial instrument development. The pilot instrument was then administered in a multicenter, open-label, phase 3 clinical study in which patients self-injected certolizumab pegol using an e-Device, to gather evidence of its psychometric qualities. Exit interviews were conducted with a sub-sample of patients enrolled in the study to confirm the appropriateness and clarity of the items included and cognitively debrief the instrument. Confirmatory factor analysis (CFA) was conducted on all items, and each domain's internal consistency was measured using Cronbach's ɑ., Results: The literature searches identified several e-Device-specific concepts related to device features, device function, side effects/reactions/pain, confidence, and interference/convenience in daily life. Seven existing PRO instruments were identified. The Self-Injection Assessment Questionnaire (SIAQ), containing pre- and post-injection questionnaire modules, was selected as most suitable and adapted using feedback from 19 patients in the two focus groups to form the pilot Assessment of Self-Injection (ASI) questionnaire. CFA resulted in some changes to the grouping of items in the post-injection module domains following psychometric evaluation of the ASI. Internal consistency was satisfactory for all pre- and post-injection domains (ɑ > 0.8). Cognitive debriefing results from 12 patient exit interviews confirmed the ASI's appropriateness and clarity., Conclusions: The ASI was developed iteratively with patient input and was evaluated in its intended clinical context of use. Psychometric analyses indicated promising cross-sectional results; the ASI was well understood and considered relevant by patients self-injecting using the e-Device, suggesting that it could be used in real-world settings to aid with clinical decision making., Trial Registration: NCT03357471.

Objective: To evaluate the location of transferred embryos under various parameters during embryo transfer in in vitro fertilization (IVF) by applying an in vitro experimental model for embryo transfer (ET)., Methods: Mock ET simulations were conducted with a laboratory model of the uterine cavity. The transfer catheter was loaded with a sequence of air and liquid volumes, including development-arrested embryos donated by patients. The transfer procedure was recorded using a digital video camera. An orthogonal design, including three independent variables (uterine orientation, distance of the catheter tip to the fundus, and injection speed) and one dependent variable (final embryo position), was applied., Results: The uterine cavity was divided into six regions. The distribution of the transferred matter within the uterine cavity varied according to the uterine orientation. Medium speed-injected embryos were mostly found in the static region while fast- and slow-speed injected embryos were mostly found in the fundal region and the cervical-left region, respectively. The possibility of embryo separation from the air bubble increased from 11.1% in slow injection cases to 29.6% and 48.1% in medium and fast injection cases, respectively., Conclusion: The experimental model provides a new method for investigating ET procedures. Fast injection of embryos into a retroverted uterus may be more likely to result in embryo separation from the air bubble., Competing Interests: The authors have declared that no competing interests exist.

OBJECTIVE. The purpose of this study was to determine the capability of a newly developed antireflux valve for a multiuse contrast agent injection system. MATERIALS AND METHODS. Multiuse contrast agent injection systems require an antireflux valve to eliminate the risk of cross-patient blood contamination. An electrically actuated antireflux valve developed for this purpose can control risk of contamination because it is under forced control and surveillance. In this study, the injection system was connected to a pulsatile circulation system that reproduced an aortic flow environment in vitro. The transvalvular pressure difference was measured, and flow dynamics during valve opening and closing were visualized by high-speed flow visualization. A total of 30 injection conditions were tested, which included two catheters (6- and 2-French diameter), five contrast agent concentrations (100%, 90%, 50%, 10%, and 0%), and a wide range of flow rates (0.1-25.0 mL/s). RESULTS. The transvalvular pressure difference and flow dynamics during valve opening and closing were characterized. Just before valve opening, a minimum transvalvular pressure difference of 0.20 MPa (1500 mm Hg) was confirmed. The positive pressure difference prevented regurgitation during valve opening. During valve closing, the front of the backflow was monitored continuously, and we confirmed that the front failed to reach the valve before complete closure. CONCLUSION. This study provided proof of concept for an electrically actuated antireflux valve to be used in a multiuse contrast agent injection system.

Objective: Two similarly designed studies compared user experiences with a second-generation extra-thin-wall, 5-bevel 32 G × 4 mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs., Methods: Adults (18-75 years old) with type 1 or type 2 diabetes and ≥3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies. The investigational 32 G PN was compared with three 33-34 G × 3.5-4 mm PNs in Study 1 and one 34 G × 4 mm PN in Study 2. Participants completed 12 abdominal injections of 0.3 mL sterile saline using insulin pens in 6 pairs, each comprising one investigational 32 G PN and one comparator PN in random order. After each injection pair, participants compared injection pain via relative 150 mm visual analog scale (VAS) and perceived dose delivery force via relative 5 point Likert scale. Adjusted models tested injection pain scores (primary endpoint) for noninferiority and, if met, then for superiority. ClinicalTrials.gov identifiers: NCT03878758 and NCT03878745., Results: The investigational 32 G PN met noninferiority as well as superiority criteria for less injection pain vs. each comparator ( p < .01), with adjusted mean relative VAS scores 9.1-17.6 in Study 1 ( n  = 154) and 7.3 in Study 2 ( n  = 55). The investigational 32 G PN was also superior vs. each comparator PN in requiring less relative perceived force to deliver the dose ( p < .01)., Conclusions: The investigational 32 G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.

Injection laryngoplasty (IL) has been used to treat various types of glottal insufficiency. The precise volume and location of the injected materials impact the outcomes. However, exactly how increasing volumes of material are distributed is unknown. In fact, the amount of IL material required to medialize a vocal cord tends to be determined empirically. Thus, the goal of this study was to investigate the pattern of IL material distribution by checking serial micro-computed tomography (MCT) and pressure changes during ILs. This experimental study used 10 excised canine larynges. Experimental devices included the IL syringe, pressure sensor, infusion pump, fixed frame, and monitoring system. We injected calcium hydroxyapatite in the thyroarytenoid muscle; whenever 0.1 mL of material was injected, we obtained an MCT scan while simultaneously measuring the pressure. After the experiments, we performed histologic analyses. MCT analyses showed that materials initially expanded centrifugally and then expanded in all directions within the muscle. The pressure initially increased rapidly but then remained relatively constant until the point at which the materials expanded in multiple directions. Histologic analyses showed that the IL material tended to expand within the epimysium of the thyroarytenoid muscle. However, in some cases, the MCT revealed that there were leakages to the surrounding space with a corresponding pressure drop. If the IL material passes through the epimysium, leakage can occur in the surrounding space, which can account for the reduction in resistance during ILs., Competing Interests: The authors have declared that no competing interests exist.

Aims: The purpose of this report is to describe a new instrument designed for the injection of therapeutic agents directly into the bone marrow cavity as well as to aspirate bone marrow specimens for the diagnostic purposes., Methods: The instrument consists of three parts: the needle, stilette and an adjustable guard. The overall length of the needle is 76 mm and has uniform external diameter except for the distal penetrating segment, which is sharp but short and safe to use on the sternum. The proximal end of the needle is fitted with a plastic T-bar handle, which is ergonomically designed for firm grip and easy manoeuvrability., Results: The instrument has been designed to obtain bone marrow aspirate specimens as well as to inject therapeutic agents into the posterior ilium., Conclusions: The rationale for the intramedullary injection of therapeutic agents for the treatment of patients with leukaemia, lymphoma and other haematological and non-haematological malignant disorders is described. In an emergency when intravenous therapy becomes difficult due to collapsed veins, this instrument may be used for direct intramarrow infusion of blood and blood products., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Small-bore needles reduce the complications associated with soft tissue filler injection. Gel particles must be sized appropriately to pass through fine-bore needles with an acceptable extrusion force. However, most soft tissue filler particles are larger than the inner diameter of the needle. The authors hypothesized that the physical properties of these particles change as the gel passes through the needle., Objective: The authors aimed to investigate whether the predesigned physical and rheological properties of the filler change after passage through the small-bore needle., Methods and Materials: Particle sizes of 4 hyaluronic acid (HA) fillers were analyzed using a particle size analyzer. Five soft tissue fillers with different particle sizes were subjected to rheological characterization. All tests were performed using fillers with and without a 30-G needle., Results: Monophasic HA fillers with smaller particle sizes exhibited small changes between particle sizes but no differences in rheological properties. Biphasic HA fillers with larger particle sizes exhibited remarkable changes in particle size and rheological properties. Calcium fillers exhibited changes in rheological properties., Conclusion: Injection through small-bore needles can alter the physical properties and rheological equilibrium of soft tissue fillers. The authors suggest avoiding small-bore needles as they may affect the rheological equilibrium and clinical performance of fillers.

Background: Injectable fillers have become an integral part of facial rejuvenation, but vascular occlusion is a dreaded complication of such injections., Objective: To determine the force required by the fingertip onto the plunger of the syringe to cause retrograde migration., Methods: In this cadaver study, twelve 2-cm arterial segments and 4 fillers were tested. Injection pressure required to force a column of filler for 1 cm was measured. Five oculoplastics specialists were subsequently recruited and asked to inject the filler at a typical injection pressure., Results: The nonhyaluronic acid filler required significantly more pressure to cause propagation of the material compared with all other fillers (p < .01). None of the other fillers differed significantly from each other. Typical injection pressures generated by experienced injectors were significantly lower than that required to cause propagation of filler at the desired velocity and significantly lower than mean arterial pressure. Measured pressure required to cause filler propagation was well within the normal range of the finger strength that can be generated by humans., Conclusion: Typical injection pressures from fingertip to plunger are lower than required to cause propagation of filler intravascularly.

The injection of laboratory animals with pathogenic microorganisms poses a significant safety risk because of the potential for injury by accidental needlestick. This is especially true for researchers using invertebrate models of disease due to the required precision and accuracy of the injection. The restraint of the greater wax moth larvae (Galleria mellonella) is often achieved by grasping a larva firmly between finger and thumb. Needle resistant gloves or forceps can be used to reduce the risk of a needlestick but can result in animal injury, a loss of throughput, and inconsistencies in experimental data. Restraint devices are commonly used for the manipulation of small mammals, and in this manuscript, we describe the construction of two devices that can be used to entrap and restrain G. mellonella larvae prior to injection with pathogenic microbes. These devices reduce the manual handling of larvae and provide an engineering control to protect against accidental needlestick injury while maintaining a high rate of injection., Competing Interests: The authors have declared that no competing interests exist.

The design of surgical needles used in biopsy procedures have remained fairly standard despite the increase in complexity of surgeries. Higher needle insertion forces and deflection can increase tissue damage and decrease biopsy sample integrity. To overcome these drawbacks, we present a novel bioinspired approach to reduce insertion forces and minimize needle-tip deflection. It is well known from the literature, design of bioinspired surgical needles results in decreasing insertion forces and needle-tip deflection from the needle insertion path. This technical note studies the influence of vibration on bioinspired needle to further reduce insertion forces and needle-tip deflection. Bioinspired needle geometrical parameters such as barb shapes and geometries were analyzed to determine the best design parameters. Static and dynamic (vibration) needle insertion tests were performed to determine the maximum insertion forces and to estimate needle-tip deflection. Our results show that introducing vibration on the bioinspired needle insertion can reduce the maximum insertion force by up to 50%. It was also found that the needle-tip deflection is decreased by 47%.

This study was performed to investigate the user perception of a cordless, motorized electronically controlled delivery system for botulinum toxin type A. Forty-six post-graduate students of varying experience levels of botulinum toxin injections and four members of the faculty from the MSc programme in Esthetic Medicine at Queen Mary University London participated in a demonstration of a motorized injection device. Thereafter, they performed a number of injections on a high fidelity silicone simulation model before completing a nine-item questionnaire. The more experienced injectors tended to appreciate the accuracy of the device more than the less experienced participants. Seventy-eight percent of participants said the device improved accuracy, particularly when administering small doses. Eighty-four percent leaned toward a favorable general view of the device. Forty-seven percent would possibly consider purchasing the device. Sixty-one percent would consider recommending the device to a colleague. The main advantage of the motorized injection device was the improved accuracy enabling delivery of small and precise doses. This may open up the possibility of new approaches to botulinum toxin treatments.

Objective: The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment., Research Design and Methods: Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session., Results: Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective., Conclusions: The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

The aim of this study was to compare the efficacy and safety of cap-assisted endoscopic injection sclerotherapy (EIS) versus direct EIS in the management of esophageal variceal bleeding in patients with cirrhosis.This retrospective study included patients with cirrhosis and esophageal variceal bleeding who underwent EIS with or without the use of a transparent cap at Shandong Provincial Hospital between December 2014 and April 2017. Patients were divided into two groups: Group A (EIS with transparent cap, n = 50) and Group B (direct EIS, n = 45). Data collected included patients' demographics, procedure details, and rates of variceal eradication, variceal rebleeding, variceal recurrence, and survival during the follow-up period. All data were expressed as mean ± SD. Quantitative variables were compared with Student t test; qualitative variables were compared with the Fisher exact test or chi-square test. P values less than .05 were considered significant.The mean follow-up duration was similar in both groups (16.3 ± 10.2 mo in Group A and 15.5 ± 9.5 mo in Group B). The volume of sclerosant (64.86 ± 10.62 vs 104.73 ± 21.25 ml, P = .044), mean number of sessions (2.37 ± 1.15 vs 5.70 ± 1.57, P = .042), time required to perform endoscopic treatment (6.57 ± 1.50 vs 11.22 ± 2.29 minutes, P = .049), and time to initial esophageal varices eradication (5.43 ± 1.38 vs 8.93 ± 1.5 wk, P = .041) were significantly smaller in the cap-assisted EIS group than in the direct EIS group. The probability of variceal recurrence and rebleeding was significantly higher in the direct EIS group than in the cap-assisted EIS group (14% versus 35.6% and 20% versus 40%). Only 22 patients (44%) developed complications in the cap-assisted group versus 30 patients (66.7%) in the EIS group (P = .039). The probability of survival was similar in both groups (86% versus 75.6%, P = .133).Modified EIS with the use of a transparent cap resulted in lower rates of esophageal variceal recurrence, rebleeding, and complications, compared with direct EIS.

Safety critical events in robotic applications can often be characterized by forces between the robot end-effector and the environment. One application in which safe interaction between the robot and environment is critical is in the area of medical robots. In this paper, we propose a novel Compact Form Dynamic Linearization Model-Free Prediction (CFDL-MFP) technique to predict future values of any time-series sensor data, such as interaction forces. Existing time series forecasting methods have high computational times which motivates the development of a novel technique. Using Autoregressive Integrated Moving Average (ARIMA) forecasting as benchmark, the performance of the proposed model was evaluated in terms of accuracy, computation efficiency, and stability on various force profiles. The proposed algorithm was 11% more accurate than ARIMA and maximum computation time of CFDL-MFP was 4ms, compared to ARIMA (7390ms). Furthermore, we evaluate the model in the special case of predicting needle buckling events, before they occur, by using only axial force and needle-tip position data. The model was evaluated experimentally for robustness with steerable needle insertions into different tissues including gelatin and biological tissue. For a needle insertion velocity of 2.5mm/s, the proposed algorithm was able to predict needle buckling 2.03s sooner than human detections. In biological tissue, no false positive or false negative buckling detections occurred and the rates were low in artificial tissue. The proposed forecasting model can be used to ensure safe robot interactions with delicate environments by predicting adverse force-based events before they occur., Competing Interests: The authors have declared that no competing interests exist.

Objective: To assess the impact of piston-based vs peristaltic injection system technology and contrast media viscosity on achievable iodine delivery rates (IDRs) and vascular enhancement in a pre-clinical study., Methods: Four injectors were tested: MEDRAD ® Centargo, MEDRAD ® Stellant, CT Exprès ® , and CT motion ™ using five contrast media [iopromide (300 and 370 mgI ml -1 ), iodixanol 320 mgI ml -1 , iohexol 350 mgI ml -1 , iomeprol 400 mgI ml -1 ]. Three experiments were performed evaluating achievable IDR and corresponding enhancement in a circulation phantom., Results: Experiment I: Centargo provided the highest achievable IDRs with all tested contrast media ( p < 0.05). Iopromide 370 yielded the highest IDR with an 18G catheter (3.15 gI/s); iopromide 300 yielded the highest IDR with 20G (2.70 gI/s) and 22G (1.65 gI/s) catheters ( p < 0.05).Experiment II: with higher achievable IDRs, piston-based injectors provided significantly higher peak vascular enhancement (up to 48% increase) than the peristaltic injectors with programmed IDRs from 1.8 to 2.4 gI/s ( p < 0.05).Experiment III: with programmed IDRs ( e.g. 1.5 gI/s) achievable by all injection systems, Centargo, with sharper measured bolus shape, provided significant increases in enhancement of 34-73 HU in the pulmonary artery with iopromide 370 ( p < 0.05)., Conclusion: The tested piston-based injection systems combined with low viscosity contrast media provide higher achievable IDRs and higher peak vascular enhancement than the tested peristaltic-based injectors. With equivalent IDRs, Centargo provides higher peak vascular enhancement due to improved bolus shape., Advances in Knowledge: This paper introduces a new parameter to compare expected performance among contrast media: the concentration/viscosity ratio. Additionally, it demonstrates previously unexplored impacts of bolus shape on vascular enhancement.

Background: It can be hypothesized that safety during soft tissue filler injection could be enhanced if the product could be positioned between the periosteum and the bone surface i.e. subperiosteal., Aim: This study investigated the feasibilityof subperiosteal injections., Patients/methods: We analysed 126 injection procedures performed in seven Caucasian body donors (4 males, 3 females) with a mean age of 75.29 ± 4.95 years [range: 70 - 87] and a mean body mass index of 23.53 ± 3.96 kg/m 2 [range: 16.46 - 32.23]. The injection procedures were performed in the forehead, scalp, zygomatic arch and the mandible bilaterally. Injection procedures were conducted using 25G, 27G and 30G sharp-tip needles (TSK Laboratory, Tochigi, Japan) and at various angles from the bone surface measured with a goniometer: 90 degrees (perpendicular), 45 degrees and 10 degrees (as tangential as possible to bone surface)., Results: Cadaveric dissections of the injection sites showed that no product was located deep to the periosteum in any of the investigated regions. This indicates that all performed injection procedures positioned the product superficial to the periosteum (100%) with a zero-success rate of subperiosteal injections., Conclusion: In the setting of this cadaveric investigation, despite varying needle size and injection angle, subperiosteal injection could not be achieved. This indicates that the product can spread uncontrolled into more superficial layers yielding an increased risk for adverse aesthetic and vascular events., (© 2019 Wiley Periodicals, Inc.)

Background: Dermal fillers for lip augmentation can be injected using various techniques. Although all seem to provide acceptable results, it is not clear which technique is safer, less painful, and provides greater patient comfort., Objective: To compare patients' self-reported pain intensity during the injection of hyaluronic acid dermal filler for lip augmentation, with 2 different techniques, anterograde versus retrograde., Methods and Materials: Prospective, single-center, within-subject, single-blinded, randomized controlled trial. All subjects received injections in the lip with hyaluronic acid-based filler, each side using the anterograde or retrograde injection technique. An automated motorized injection device was used to ensure a homogeneous deposition flow of the product injected and reduce operator bias. Pain intensity was self-assessed using a 100-mm visual analog scale. Presence and severity of bruising were recorded., Results: Forty-four women (mean age 30.3 years) were randomized. Mean self-reported pain score was 53.1% lower with the anterograde technique than with the retrograde (p < .0001). The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique., Conclusion: This study demonstrated that the anterograde technique was less painful, and led to fewer bruising and site reactions than the retrograde technique when using an automated device., Level of Evidence: I.

Background: A needle or a cannula can be safely used during filler injection procedures to correct a sunken upper eyelid. To date, there are no precise injection points recommended that are based on an anatomical study., Objective: This study systematically investigated the vascular pattern and depth of forehead arteries at the periorbital area of upper eyelid., Methods: Twenty cadavers were dissected in this study. Additional data were obtained from 30 healthy volunteers using Doppler ultrasound imaging with high-frequency probe., Results: The ophthalmic artery divided into two opposite primary branches: the superior and inferior orbitoglabellar arteries running along the orbital rim. After the supratrochlear artery arose from the superior orbitoglabellar artery at the medial eyebrow, the supraorbital artery either divided from this artery near the supraorbital foramen or emerged as an individual artery from the supraorbital notch. The inferior orbitoglabellar artery gave off the radix artery superior to the medial canthal tendon. The radix artery divided into two opposite branches: the dorsal nasal artery going to the nose and the paracentral artery going to the glabella. Ultrasound imaging revealed a subcorrugator space that a cannula can safely pass through. At the supraorbital foramen/notch, the supraorbital artery traveled very close to the bone. Based on the anatomical data collected, the following injection points for a needle and a cannula technique are recommended., Conclusion: Correction of a sunken upper eyelid is a dangerous procedure which should be performed only by experienced physicians. However, with precise anatomical knowledge and correct techniques, optimal outcomes can be safely achieved., (© 2019 Wiley Periodicals, Inc.)

Aims: In a recent preclinical study, we noticed that injection of cells in the urethral sphincter by needle through a cystoscope under visual control frequently yielded in misplacement or loss of cells. We, therefore, investigated if a needle-free waterjet device delivers viable cells under defined settings, including injection volume and pressure, fluid velocity and transportation media, precisely through the urothelium and connective tissue close to the sphincter muscle without full penetration of the sphincter apparatus., Methods: Mesenchymal stromal cells (MSCs) were prepared for needle-free waterjet injections. Upon injections into liquids cell viability and yield were investigated by trypan blue dye exclusion. Upon injection into cadaveric urethral tissue samples, cells were isolated from the urethrae and expanded to prove that this novel method delivered viable cells into the tissue. MSC injections by William's needle served as controls., Results: Waterjet injections of MSCs into isotonic cell culture medium resulted in equal or better yields of viable cells when compared with needle injections. Upon injection in urethral tissue samples, the waterjet technology facilitated fast and precise injections of viable cells through urothelial, mucosal and submucosal layers to reach the sphincter muscle. By controlling the injection pressure, loss of cells due to insufficient thrust or unintended full penetration was avoided., Conclusions: Needle-free waterjet injections deliver cells in the urethra faster and more precisely when compared with needle injections without compromising their viability. This is the first proof-of-concept study providing evidence that a waterjet transports viable cells precisely into the targeted tissue., (© 2109 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.)

Background : The recent development of high-volume subcutaneous drug delivery using handheld autoinjectors has resulted in longer injection durations. However, the usability of long injections has been neglected. This study aimed to investigate the effects of injection duration on users' ability to apply injections while holding the device against the skin at the injection site. Methods : Thirty-two participants among patients, caregivers, and health-care professionals simulated three injections with different injection durations to evaluate usability and user's force. Linear and quantile regression were then applied to determine the impact of the injection duration on response variables related to user's force. Results : A significant negative effect of injection time was found on both the minimum and mean user's force applied. Initial empirical evidence was also determined on the negative association being more pronounced for users exerting lower force to hold the device against the skin. Conclusions : The results that are subject to future clinical validation suggest the feasibility of injections lasting up to approximately 30 s using handheld autoinjectors. The participants of the simulated use study successfully applied long-duration injections regardless of disease states, age, or visual and dexterity impairments.

Purpose: To compare the MEDRAD Stellant and MEDRAD Stellant FLEX computed tomography contrast media injection systems in terms of radiologic technologists' ability to visually identify air in the syringes at various distances and under different lighting conditions, as well as the ease of cleaning contrast media spills on the injector faces., Methods: Ten experienced radiologic technologists performed 104 tests (52 per injector) in normal light and in ambient light conditions. The tests were randomized for the radiologic technologists' distance from the injector at 2 ft (61 cm), 8 ft (244 cm), and 16 ft (488 cm). In addition, the authors tested the cleaning efficiency of the Stellant injector face with raised buttons and the Stellant FLEX injector face with buttons on a flush surface by applying a mixture of contrast media and invisible ultraviolet ink. Radiologic technologists followed 2 cleaning protocols: a quick clean (5 seconds) and a full clean (1 minute). Residual contrast mixture was measured., Results: The Stellant FLEX injector had an overall higher rate of correct air identification than did the Stellant injector, 97.5% vs 86.9%, respectively ( P < .001), with improvement seen at greater distances. The rates for the Stellant FLEX injector remained stable for all distances (99.4%-93.9%; P < .003). A similar result was seen with ambient lighting: The visibility of air in the Stellant FLEX injector remained stable ( P < .001). During cleaning, the Stellant FLEX injector required less time to reach a greater level of cleanliness and showed less contrast mixture residue, especially after the quick clean procedure (16% and 59%, respectively; P < .001)., Discussion: Injector manufacturers provide various technologies to assist radiologic technologists in visualizing the presence of air in a syringe. The Stellant injector features clear syringes with FluiDots as an air identification technology. The Stellant FLEX injector incorporates an added feature called Beacon technology . This study's results are highly clinically relevant because unintentional iatrogenic air injection occurs in clinical practice and can, in rare cases, severely harm patients., Conclusion: Radiologic technologists showed an improved ability to identify air in the syringes in the Stellant FLEX system. In addition, radiologic technologists were confident about their identification, specifically at greater distances and in ambient lighting conditions. The Stellant FLEX injector face also enabled quicker and more efficient cleaning., (© 2020 American Society of Radiologic Technologists.)

Background: Adalimumab is administered via a pre-filled syringe or spring-loaded pen. In a previous study in Crohn's disease, higher drug levels were observed in syringe users. The aim of this study was to evaluate the impact of delivery device on adalimumab drug levels in patients with Crohn's disease., Methods: Consecutive Crohn's disease patients treated with maintenance adalimumab [40 mg fortnightly] were recruited from five centres. The first recorded drug level with matched clinical and biochemical markers of disease activity was compared between pen and syringe users., Results: Of 218 patients, 64% used pen, with a median faecal calprotectin 110 μg/g and serum C-reactive protein 4 mg/L. In comparison to pen, syringe users had higher albumin [39 vs 42 g/L; p = 0.016], lower Harvey-Bradshaw Index [2 vs 1; p = 0.017], and higher rates of concomitant immunomodulation [54% vs 71%; p = 0.014]. Drug levels were equivalent between pen and syringe users [median 5.3 vs 5.2 μg/ml; p = 0.584], even after controlling for disease activity and immunomodulation. Syringe users at Alfred Health had higher drug levels than pen [6.1 vs 4.5 μg/ml; p = 0.039]; a greater proportion achieved therapeutic levels [75% vs 44%; p = 0.045]. A higher proportion of pen users from Saint-Étienne had therapeutic levels [79% vs 42%; p = 0.027], yet no significant difference in drug levels [7.9 vs 4.5 μg/ml; p = 0.119]., Conclusions: Delivery device does not appear to significantly affect adalimumab drug levels. Given differences between study sites, studies evaluating administration education and technique are warranted., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

DNA vaccination can be applied to the treatment of various infectious diseases and cancers; however, technical difficulties have hindered the development of an effective delivery method. The efficacy of a DNA vaccine depends on optimal antigen expression by the injected plasmid DNA. The pyro-drive jet injector (PJI) is a novel system that allows for adjustment of injection depth and may, thus, provide a targeted delivery approach for various therapeutic or preventative compounds. Herein, we investigated its potential for use in delivering DNA vaccines. This study evaluated the optimal ignition powder dosage, as well as its delivery effectiveness in both rat and mouse models, while comparing the results of the PJI with that of a needle syringe delivery system. We found that the PJI effectively delivered plasmid DNA to intradermal regions in both rats and mice. Further, it efficiently transfected plasmid DNA directly into the nuclei, resulting in higher protein expression than that achieved via needle syringe injection. Moreover, results from animal ovalbumin (OVA) antigen induction models revealed that animals receiving OVA expression plasmids (pOVA) via PJI exhibited dose-dependent (10 μg, 60 μg, and 120 μg) production of anti-OVA antibodies; while only low titers (< 1/100) of OVA antibodies were detected when 120 μg of pOVA was injected via needle syringe. Thus, PJI is an effective, novel method for delivery of plasmid DNA into epidermal and dermal cells suggesting its promise as a tool for DNA vaccination.

Objective: We describe the novel use of injectable carboxymethylcellulose to close a persistent bronchopleural fistula (BPF) in a neonate who underwent an ex utero intrapartum treatment (EXIT) after aborted fetoscopy., Methods: In this case, a patient with laryngeal atresia underwent fetoscopy that was halted after concern for instruments within the mediastinum, and thus ultimately required an EXIT to establish an airway. Bilateral pneumothoraces and eventually multiple BPF were identified that continued to persist despite multiple attempts at removal of chest tubes over a four-week period. We look at the role of endoscopy and a substance often used in the larynx to help close a persistent BPF., Results: At initial bronchoscopy, no BPF was identified, but at subsequent evaluation due to persistent pneumothorax, we used increased positive end expiratory pressure to help reveal the fistula. Given the bronchial location of the fistula, traditional laryngeal instruments could not be used, requiring the use of urologic cystoscopy needles to assist in accessing these challenging locations. At postoperative day 2 from the injection, the chest tube was removed and did not require replacement., Conclusion: There are many methods to help treat BPF. The endoscopic injection of carboxymethylcellulose adds a technique to the pediatric otolaryngologist's armamentarium., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: To determine the influence of needle gauge, syringe volume, and syringe size on needle tract leakage after injection in porcine jejunum., Study Design: Ex vivo experiment., Sample Population: Three hundred sixty jejunal segments from 20 feedlot pigs., Methods: Fresh porcine intestines were divided into 5-cm or 10-cm segments and randomly assigned to the one of nine treatment groups: 25-gauge, 22-gauge, and 20-gauge needles attached to full 12-mL, half-full 20-mL, and full 20-mL syringes (n = 20/group). The jejunal segments were occluded with Rochester-Carmalt forceps prior to injection of diluted India ink. Injection time and leakage were noted by a blinded observer. Multivariate analysis was used with segment size, needle gauge, volume infused, time to inject per milliliter, and syringe size as variables., Results: Leakage occurred in 36% of 5-cm and 15% of 10-cm segments and was immediate without palpation in 33.8% and 11% of segments, respectively. Protective effects were seen for 22-gauge needles in both 5-cm (P = .002) and 10-cm (P = .001) segments, whereas injection of 20 mL had a higher odds ratio of leakage compared with injection of 10 mL and 12 mL in 5-cm segments (P = .003)., Conclusion: Injections with 22-gauge needles reduced the frequency of leakage, while 20 mL instilled in 5-cm segments increased the frequency of leakage in intact segments of porcine jejunum., Clinical Significance: Injection with a smaller syringe size attached to a 22-gauge needle through a 10-cm segment of small intestine may lower the frequency of leakage from the injection site, but influence on the detection of surgical site leakage remains unknown., (© 2019 The American College of Veterinary Surgeons.)

Purpose of Review: Summarize the current thinking concerning the clinically relevant aspects of nerve anatomy and best injection sites for nerve blocks., Recent Findings: The widespread use of ultrasound in regional anesthesia has changed the practice of regional anesthesia and created new possibilities. Among them is the ability to identify fascial planes, and this has become the basis for a new group of blocks, the fascial plane blocks. In this kind of blocks, the target for injection is the plane itself and not a nerve in particular. transversus abdominis plane, pectoralis muscles, erector spinae plane blocks are some examples of fascial blocks. Because injecting into a fascial plane is not controversial, these blocks are not included in our discussion of optimal placement of the needle.To determine optimal needle placement, it is important to have a clear definition of what constitutes intraneural. Although, there is almost universal agreement that the violation of the epineurium defines the intraneural concept, the literature include several studies where this assessment is erroneous.Although intentional intraneural injection is still considered objectionable, some literature suggests that injecting intraneurally, especially if extrafascicular, may be benign. This evidence is limited and anecdotal., Summary: It is necessary to have a better understanding of what intraneural injection is when dealing with any type of nerve blocks, be that single nerve, plexuses, or the sciatic nerve. Perineural injections provide successful anesthesia without putting the nerve integrity at risk. That practice is supported by years of experience and common sense. Currently, there is no evidence to support any kind of intraneural injections, intrafascicular or extrafascicular.