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Background: We investigated the relationship between the loaded pressure and flow rate in various catheters and the entire infusion line including the catheters, in several infusion solutions and packed red blood cells., Methods: We connected the infusion line and catheter to the infusion solution and used an outer pressure bag or a compressor to pressurize the infusion solution bag to a pressure within the clinical (up to 450 mm Hg) or higher range (up to 1050 mm Hg). We approximated the relationship between the loaded pressure and flow rate in the entire infusion line including the catheter, versus the catheter alone, as a power function and compared the power numbers., Results: In the clinical pressure range of normal saline, the power numbers of the entire infusion line for the 24-, 22-, 20-, and 18-gauge catheters were 0.76, 0.82, 0.81, and 0.86, respectively, while those for the catheter alone were 0.67, 0.63, 0.56, and 0.44, respectively. In the higher pressure range of normal saline, the power numbers of the entire infusion line for the 24-, 22-, 20-, and 18-gauge catheters were 0.68, 0.70, 0.71, and 0.73, respectively, while those for the catheter alone were 0.62, 0.61, 0.59, and 0.58, respectively. As the power number of the entire infusion line was closer to 1.00 than the values of the catheter, the relation between the loaded pressure and the flow rate was more linear in the entire infusion line than that in the catheter. Similar results were obtained using packed red blood cells and 40% glycerin mixture in normal saline., Conclusions: Regardless of the type of infusion solution or transfusion, the pressure-flow relationship in the catheter was nonlinear and not directly proportional. However, within the clinical pressure range (up to 450 mm Hg), the relationship between the flow rate and pressure in the entire infusion line was almost linear and proportional., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 International Anesthesia Research Society.)

Purpose: Infusion of cytotoxic drugs carries the risk of occupational exposure of healthcare workers. Since disconnecting an infusion line is a source of contamination, flushing of tubing after infusion of cytotoxic agents is recommended, but the optimal volume of rinsing solution is unknown. The objective of this study was to assess whether postinfusion line flushing completely eliminates cytotoxics., Methods: Infusions were simulated with 3 cytotoxics (gemcitabine, cytarabine, and paclitaxel) diluted in 5% dextrose injection or 0.9% sodium chloride injection in 250-mL infusion bags. Infusion lines were flushed using 5% dextrose injection or 0.9% sodium chloride solution at 2 different flow rates. The remaining concentration of cytotoxics in the infusion line was measured by a validated high-performance liquid chromatography (HPLC) method after passage of every 10 mL of flushing volume until a total of 100 mL had been flushed through., Results: All cytotoxics remained detectable even after line flushing with 80 mL of flushing solution (a volume 3-fold greater than the dead space volume within the infusion set). Gemcitabine and cytarabine were still quantifiable via HPLC even after flushing with 100 mL of solution. Efficacy of flushing was influenced by the lipophilicity of drugs but not by either the flushing solvent used or the flushing flow rate. After 2-fold dead space volume flushing, the estimated amount of drug remaining in the infusion set was within 0.19% to 0.56% of the prescribed dose for all 3 cytotoxics evaluated., Conclusion: Complete elimination of cytotoxics from an infusion line is an unrealistic objective. Two-fold dead space volume flushing could be considered optimal in terms of administered dose but not from an environmental contamination point of view. Even when flushed, the infusion set should still be considered a source of cytotoxic contamination., (© American Society of Health-System Pharmacists 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Infusion sets with precision flow regulators are frequently used in children undergoing surgery in order to control the perioperative administration of fluids. There are no data about the safety and accuracy of these infusion sets. A study was therefore conducted to compare adjusted and actual flow rates of three different infusion sets with precision flow regulators under standardized conditions., Methods: The study evaluated three different infusion sets with precision flow regulators each at two different static levels. The actual flow rates of 5 infusions were recorded each time for adjusted flow rates of 50 ml/h, 100 ml/h, 150 ml/h, 200 ml/h and 250 ml/h over 1 h. Statistical analysis was performed with Excel (Excel, Microsoft Corporation, Redmond, WA, USA) and SOFA (Paton-Simpson and Associates Ltd., USA). The results are presented as means (standard deviation)., Results: For the adjusted flow rates of 50, 100, 150, 200 and 250 ml/h, actual flow rates were 107 (5.3), 174.8 (6.5), 255.8 (10.2), 312.4 (15.7) and 362.6 (20.2) ml/h for the Frekadrop® infusion set at a static level of 128 cm and 83.8 (4.4), 147.8 (5.5), 197 (12.4), 257.2 (4.97) and 311.6 (17.9) ml/h at a static level of 100 cm, respectively. For the Exadrop® infusion set actual flow rates were 88.6 (6.9), 131.2 (14.1), 224.4 (14.1), 296.6 (27.6) and 330.4 (22.4) ml/h at a static level of 128 cm and 54 (4), 82.4 (10.2), 138.8 (15.7), 209.4 (36.8) and 249 (12) ml/h at a static level of 76 cm, respectively. For the D-Flo infusion set actual flow rates were 95.6 (2.8), 167.6 (29), 217.8 (9.9), 281.6 (10.6) and 396.8 (37.5) ml/h at a static level of 128 cm and 69.2 (4.4), 110.2 (12.6), 169.2 (6), 205.2 (14) and 243 (15.9) ml/h at a static level of 80 cm, respectively., Conclusion: The actual flow rates differed considerably from the adjusted flow rates in the evaluated infusion sets. The flow rates substantially depended on the static level of the infusion. First and foremost, regulation of the administered infusion volume does not seem to be reliable when using an infusion set with a precision flow regulator.

Background: The analgesic benefits of programmed intermittent bolus infusion for thoracic paravertebral block remain unknown., Objective: The aim of this study was to compare the analgesia from intermittent bolus infusion with that of a continuous infusion after thoracic paravertebral block., Design: A randomised controlled study., Setting: A single centre between December 2016 and November 2017. Seventy patients scheduled for video-assisted thoracoscopic surgery were included in the study., Intervention(s): Patients were randomly assigned to receive 0.2% levobupivacaine via continuous infusion (5 ml h, continuous group) or programmed intermittent bolus infusion (15 ml every 3 h, bolus group) after an initial 15-ml bolus injection of 0.2% levobupivacaine., Main Outcome Measures: The main outcome was the amount of rescue fentanyl (per kg of body weight) consumed within 24 h after surgery. Secondary outcomes were postoperative pain scores, plasma levobupivacaine concentrations and the number of dermatomes anaesthetised., Results: There was no significant difference between the continuous and bolus groups in the postoperative consumption of fentanyl (median [interquartile range] 5.5 [4 to 9.5] μg kg versus 6 [3.5 to 9] μg kg respectively, P = 0.45) and postoperative pain scores within 24 h. At 20 h after initiating the infusions, there was no statistically significant difference between the two groups in terms of the plasma levobupivacaine concentration. The number of dermatomes anaesthetised to pinprick and cold testing was significantly greater in the bolus group., Conclusion: Our findings suggest that postoperative pain and opioid usage are similar with either programmed intermittent bolus infusion or continuous infusion after thoracic paravertebral block. Programmed intermittent bolus infusion provides a wider sensory blockade and could benefit patients requiring a wider extent of anaesthesia., Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR; URL: http://umin.ac.jp/ctr/, ID: UMIN000023378).

This document represents the American Society for Parenteral and Enteral Nutrition (ASPEN) clinical guidelines to describe best practices in the selection and care of central venous access devices (CVADs) for the infusion of home parenteral nutrition (HPN) admixtures in adult patients. The guidelines targeted adults >18 years of age in which the intervention or exposure had to include HPN that was administered via a CVAD. Case studies, non-English studies, or studies of CVAD no longer available in the United States were excluded. In total, 564 abstract citations, 350 from Medline and 214 from PubMed/non-MEDLINE databases, were scanned for relevance. Of the 564 citations, 13 studies addressed at least 1 of the 6 guideline-related questions, and none of the studies were prospective and randomized. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria were used to adjust the evidence grade based on assessment of the quality of study design and execution. Recommendations for the CVAD type, composition, or number of lumens to minimize infectious or mechanical complications are based on a limited number of studies and expert opinion of the authors, all very experienced in home infusion therapy. No studies were found that compared best solutions for routine flushing of lumens (eg, heparin versus saline) or for maintaining catheters in situ while treating CVAD mechanical or infectious complications. It is clear that studies to answer these questions are very limited, and further research is needed. These clinical guidelines were approved by the ASPEN Board of Directors., (© 2018 American Society for Parenteral and Enteral Nutrition.)

The technique, feasibility, and results of a new 25-gauge trocar-anterior chamber maintainer (ACM) designed for maintaining intraoperative fluid infusion is described in this prospective interventional analysis. The 25-gauge trocar-ACM with an overall length of the trocar blade of 6.0 mm, cannula length of 4.0 mm, and the cannula tip beveled at 45 degrees to the base was designed and used in all the cases. The dimensions of the sclerotomy wound that comprised of the internal ostium, external ostium, wound length, and the time interval for wound apposition in the postoperative period was analyzed by spectral-domain anterior segment optical coherence tomography., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Disposable medical devices release toxic leachables during their clinical use. Specifically, the individual parts of the infusion sets (the drip chamber, tube, flashball and injection site) are composed of numerous chemical compounds that can reach the patients' systemic circulation and induce local and systemic toxic effects. We aimed to reveal the relative in vitro toxicity of infusion sets from the leading vendors that are used in Israel, and to determine its dependence on their design and storage time/conditions. We found that leachates of the rubber parts were more toxic than those of the other parts of the infusion sets. The measured toxicity was affected by the experimental settings: the cells, medium composition, exposure duration, and the type of assay applied for toxicity assessment. We recommend to use the capillary endothelium cells for in vitro toxicity testing of the infusion sets, and refrain from the use of the MTT test which is insufficiently reliable, and can lead to artefacts and incorrect conclusions. Further investigation is needed to identify the toxic leachables from the individual parts of the infusion sets, and to reveal the risk of their toxicity during the clinical use of the infusion sets., (Copyright © 2015 Elsevier B.V. All rights reserved.)

The purpose of this study was to investigate the feasibility of interventional MRI-guided local agent delivery into pig common bile duct (CBD) walls using a newly designed MR-compatible, needle-integrated balloon catheter system. We first designed a needle-integrated balloon catheter system that comprised of a 22 G MR-compatible Chiba biopsy needle and a conventional 12 mm × 2 cm balloon catheter. Under fluoroscopy guidance, a custom needle-balloon system was positioned in the target CBD via a transcholecystic access. T1-weighted MRI was used to localize and reposition the needle-balloon system in the target. A 0.5 mL mixture of motexafin gadolinium (MGd) and trypan blue dye as well as 5-fluorouracil was delivered into the CBD wall through the needle-balloon system. Post-infusion T1-weighted MRI was obtained and contrast-to-noise ratios (CNRs) of CBD walls of pre- and post-MGd-blue infusions were compared by a paired t-test. In addition, post-infusion x-ray cholangiography was achieved to evaluate the potential injuries of CBDs by the needle-balloon system. Subsequent histologic analysis was performed to correlate and confirm the imaging findings. A post-infusion cholangiogram did not show any extravasation of contrast agent, indicating no procedure-related damage to the CBDs. MRI demonstrated clear enhancement of the target bile duct walls infused with MGd-trypan blue dye with average penetration depth of 4.7 ± 1.2 mm and an average MGd perfusion length of 21 ± 1.5 mm in the bile ducts and their surrounding tissues. The average CNR of the post-infusion bile ducts was significant higher than that of the pre-infusion bile ducts (110.6 ± 22 versus 5.7 ± 2.8, p < 0.0001). Histology depicted the blue dye staining and red fluorescence of MGd through the target CBD walls, which was well correlated with the imaging findings. It is feasible to use the new MR-compatible, needle-integrated balloon catheter system for intrabiliary local agent delivery into CBD walls under MRI guidance, which may open new avenues for efficient management of pancreatobiliary malignancies using MR-guided interventional oncology., (Copyright © 2015 John Wiley & Sons, Ltd.)

Medical devices (MD) for infusion and artificial nutrition are essentially made of plasticized PVC. The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evaluated the migration performance of DEHP, DEHT, DINCH, and TOTM using a model adapted to the clinical use of the MDs. Each PVC tubing sample was immersed in a simulant consisting of a mixture of ethanol/water (50/50v/v) at 40°C and migration tests were carried out after 24h, 72h, and 10 days.DEHP had the highest migration ability, which increased over time. The amount of TOTM released was more than 20 times less than that of DEHP, which makes it an interesting alternative. DEHT is also promising, with a migration level three times smaller than DEHP. However, the migration ability of DINCH was similar to DEHP, with the released amounts equaling 1/8th of the initial amount in the tubing after 24h of contact. Taking into account the available toxicological data, TOTM and DEHT appear to be of particular interest. However, these data should be supplemented and correlated with clinical and toxicological studies on plasticizers and their metabolites., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Syringe pumps offer an alternative route for delivering medicine when the oral route cannot be used. This is particularly important for patients receiving palliative care, for whom a continuous infusion of medication can improve symptom control. This article explains how to administer drugs safely using these devices.

Objective: Drug incompatibilities can jeopardize the safety and effectiveness of intravenous drug therapies, especially in the field of anaesthesia and intensive care. Patients receive many drugs simultaneously through limited venous accesses. This study was designed to confirm the impact of a multilumen infusion device on the occurrence of known physical drug incompatibilities., Study Design: In vitro laboratory work., Methods: Two infusion devices were studied: a standard single-lumen set and a multilumen infusion access device (Edelvaiss Multiline-8, Doran International). Up to six drugs were infused simultaneously: three acidic solutions of midazolam, amiodarone and dobutamine, and three alkaline solutions of furosemide, pantoprazole and amoxicillin/clavulanate. Saline, Ringer' solution and 5% dextrose were used as hydration vehicles with an infusion rate initially set at 100 mL/h and with stepwise decreases of 10 mL/h until precipitation. Two methods were used to highlight physical drug compatibility according to the European Pharmacopoeia: visual inspection of the extension set and an obscured-light sub-visible particle count test of infusions. The lowest infusion rate value for vehicle infusion to satisfy the two tests in all trials is reported for each infusion device., Results: The standard set did not satisfy the test in 82% of the assessed drug combinations. The Edelvaiss Multiline-8 was able to prevent the occurrence of drug incompatibilities in 49% of the drug combinations tested. This device is therefore advantageous, especially when simultaneously infusing two or four incompatible drugs., Conclusions: Infusion device characteristics have an impact on physical drug incompatibilities. Our results confirm that the Edelvaiss Multiline-8 device prevents physical drug incompatibilities under specified conditions., (Copyright © 2015 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.)

Background: Convection-enhanced delivery (CED) is currently the only effective clinical technique to deliver biological therapeutic agents that would otherwise not cross the blood-brain barrier. Despite the promise of CED, several technical problems have limited its effectiveness., New Method: Brain infusions into a large mammal (pig) were performed with a catheter that was fabricated using micro-electro-mechanical systems (MEMS) technology (Olbricht et al., 2010). The performance of the catheter was evaluated for infusions at increasing infusion rates. Magnetic resonance (MR) images were acquired in real time to examine the distribution of infused tracers in the parenchyma., Results: Both backflow and the distribution of CED of infusates into a variety of cytoarchitectures in porcine brain were quantified. Concentration profiles were determined for several MR contrast reagents as well as a fluorescent dye that are the sizes of small molecules, therapeutic proteins and an adeno-associated virus (AAV). The reagents can serve as surrogates for assessing the convective distribution of active molecules. Infusion rates up to 20μL/min were attained without evidence of backflow along the catheter., Comparison With Existing Methods: The device performed well in terms of both backflow and infusion, superior to that of many studies reported in the literature on other catheters. All infused molecules had comparable ratios of distribution to infusion volumes., Conclusions: The catheter described in this report appears able to target tissue structures with precision, deliver therapeutics at high infusion rates, and resist backflow that can compromise the efficacy of CED therapy. The technology allows development of "smart" catheters for future applications., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex procedure used for the treatment of various types of cancer. Specifically, HIPEC has shown success where treatment failure sites (metastases) thrive. A classic example of one such area is the peritoneal surface, which remains a prominent failure site for patients with gynecologic and gastrointestinal cancer. Traditionally, most patients with advanced stages of cancer have undergone palliative procedures as part of their treatment modality or had no surgery at all. With the advent of cytoreductive surgery with HIPEC, patients with peritoneal cancer have shown increased survival rates. Anesthetic complications are common during this procedure with disturbances in hemodynamics, coagulation, and respiratory gas exchange. A knowledge of what to anticipate anesthetically will guide the practitioner to achieve successful management during and after the case. In this case report, a 71-year-old woman was treated for stage Ill peritoneal and ovarian cancer by cytoreductive surgery with HIPEC.

Current parenteral administration of drugs suffers from several drawbacks including the requirement of healthcare personnel to administer the drug, the risk of needle stick injuries that may result in the transmission of blood borne pathogens, and patient discomfort. Prefilled devices have emerged as powerful tools to improve parenteral administration of drugs. There are a number of clinical conditions including treatment of endocrine diseases, neurological disorders, autoimmune diseases and emergency medicine where prefilled devices have made major improvements to patient care. Prefilled devices have become an important set of tools for the medical practitioner due to their ease of use and safety, cost effectiveness and patient convenience. This review provides a comprehensive summary of existing prefilled devices, their current clinical uses and corresponding regulatory processes.

Background: Levodopa is the most effective therapy for Parkinson's disease, but chronic treatment is associated with the development of potentially disabling motor complications. Experimental studies suggest that motor complications are due to non-physiological, intermittent administration of the drug, and can be reduced with continuous delivery. We aimed to assess efficacy and safety of levodopa-carbidopa intestinal gel delivered continuously through an intrajejunal percutaneous tube., Methods: In our 12-week, randomised, double-blind, double-dummy, double-titration trial, we enrolled adults (aged ≥ 30 years) with advanced Parkinson's disease and motor complications at 26 centres in Germany, New Zealand, and the USA. Eligible participants had jejunal placement of a percutaneous gastrojejunostomy tube, and were then randomly allocated (1:1) to treatment with immediate-release oral levodopa-carbidopa plus placebo intestinal gel infusion or levodopa-carbidopa intestinal gel infusion plus oral placebo. Randomisation was stratified by site, with a mixed block size of 2 or 4. The primary endpoint was change from baseline to final visit in motor off-time. We assessed change in motor on-time without troublesome dyskinesia as a prespecified key secondary outcome. We assessed efficacy in a full-analysis set of participants with data for baseline and at least one post-baseline assessment, and imputed missing data with the last observation carried forward approach. We assessed safety in randomly allocated patients who underwent the percutaneous gastrojejunostomy procedure. This study is registered with ClinicalTrials.gov, numbers NCT00660387 and NCT0357994., Findings: From baseline to 12 weeks in the full-analysis set, mean off-time decreased by 4.04 h (SE 0.65) for 35 patients allocated to the levodopa-carbidopa intestinal gel group compared with a decrease of 2.14 h (0.66) for 31 patients allocated to immediate-release oral levodopa-carbidopa (difference -1.91 h [95% CI -3.05 to -0.76]; p=0.0015). Mean on-time without troublesome dyskinesia increased by 4.11 h (SE 0.75) in the intestinal gel group and 2.24 h (0.76) in the immediate-release oral group (difference 1.86 [95% CI 0.56 to 3.17]; p=0.0059). In the safety analyses 35 (95%) of 37 patients allocated to the levodopa-carbidopa intestinal gel group had adverse events (five [14%] serious), as did 34 (100%) of 34 patients allocated to the immediate-release oral levodopa-carbidopa group (seven [21%] serious), mainly associated with the percutaneous gastrojejunostomy tube., Interpretation: Continuous delivery of levodopa-carbidopa with an intestinal gel offers a promising option for control of advanced Parkinson's disease with motor complications. Benefits noted with intestinal gel delivery were of a greater magnitude than were those obtained with medical therapies to date, and our study is, to our knowledge, the first demonstration of the benefit of continuous levodopa delivery in a double-blind controlled study., Funding: AbbVie., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

The free care smart infusion system which has the function of liquid end alarm and automatic stopping has been designed. In addition, the system can send the alarm to the health care staff by Zigbee wireless network. Besides, the database of infusion information has been set up, it can be used for inquiry afterwards.

Objective: Analyzing the performance of microbial barrier of needleless positive pressure closed connectors., Methods: Three kinds of brand needleless positive pressure closed connectors were chosen to do the access of microorganisms test., Results: Positive results were detected in the three experimental groups., Conclusions: So far, lots of the connectors are not qualified strictly on the market, some improvement is required in the structure design and process.

In patients with peritoneal carcinomatosis, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) offers a chance for long term survival in well selected patients. During cytoreductive surgery, all macroscopically visible tumors needs to be resected before HIPEC is performed in the same procedure. The aim of HIPEC is eradication of microscopic tumor cells after radical surgery. Perioperative morbidity and mortality are comparable with other major surgical procedures. Patients with peritoneal carcinomatosis from tumors of the appendix, the colon or primary peritoneal mesothelioma are currently recommended for evaluation of CRS/HIPEC in an interdisciplinary setting.

An important mechanism for postoperative cognitive impairment after cardiac surgery using cardiopulmonary bypass (CPB) is microemboli. One component of the CPB circuit-the cardiotomy-is a major source of gaseous microemboli because it aspirates significant volumes of air with blood from the operative field and intracardiac chambers. Cardiotomies are either integrated within an open hardshell venous reservoir (IC-HSVR) or are a separate canister attached to a softshell collapsible venous reservoir bag (SC-SSVR). The purpose of this study was to compare the Medtronic IC-HSVR (Affinity NT CVR) with Medtronic's SC-SSVR (CB 1351, CBMVR 1600) in terms of relative microbubble transmission during cardiotomy infusion. A recirculating in vitro circuit primed with blood was used to compare the two cardiotomy-reservoir systems with the venous reservoir in the SC-SSVR further assessed in a fully closed or partially open state (SC-SSVR-closed; SC-SSVR-open). Microbubbles were detected using a GAMPT BC100 Doppler system in the outflow line of the venous reservoir. Measurements were taken before (baseline) and after aerated prime was pumped into the cardiotomy while altering pump flow rates (3 L/min; 5 L/min) and reservoir prime volumes (400 mL; 900 mL). Infusing cardiotomy blood into the venous reservoir was associated with an increase in microbubbles and bubble volume transmitted by both cardiotomy-reservoir systems with the magnitude rising with reduced prime volumes. The effect was markedly greater with the IC-HSVR. The IC-HSVR also transmitted larger bubbles, particularly with reduced prime volumes. There was no significant difference in microbubble transmission seen between the SC-SSVR-closed and SC-SSVR-open. The SC-SSVR transmits fewer microbubbles than the IC-HSVR during cardiotomy infusion and should be considered as the preferential system. Because both cardiotomy-reservoir systems transmitted microbubbles during cardiotomy infusion, particularly at the lower venous reservoir volume, it is important to use strategies to minimize cardiotomy microbubble infusion.

The adverse reactions caused by the traditional Chinese medicine has become increasingly aroused great attention. Traditional Chinese medicine injection may produce insoluble particles in the process of production, preparation and infusion, which is one of the reasons caused some adverse drug reactions such as phlebitis, allergic reactions, so it is essential that how to control Chinese medicine injection of insoluble drug particles enter human clinical safety. The author retrieve a large number of paper, from the infusion of particles, analysis traditional Chinese medicine injection and insoluble particles in the liquid compatibility increased occurrence and cause, comparative advantages and disadvantages of the ordinary infusion and precision infusion, which found that using sophisticated filters infusion of traditional Chinese medicine injection control of traditional Chinese medicine injection of insoluble particles enter the blood vessels, thereby reducing the occurrence of adverse drug reactions part of the traditional Chinese medicine injection, is the best, most effective, most secure way of infusion.

Infusate backflow or leak-back along the cannula track can occur during intraparenchymal infusions resulting in non-specific targeting of therapeutic agents. The occurrence of backflow depends on several variables including cannula radius, infusate flow rate, and tip location. In this study, polymer coatings that swell in situ were developed and tested with in vitro hydrogel experiments for backflow reduction. Coatings were applied to the external cannula surface in a dual layer arrangement with a poly(vinyl alcohol) outer layer atop an inner poly(ethylene oxide) and alginate layer. Once these coated cannulas were inserted and allotted an 8-10 min waiting period for hydration, backflow during infusions of 4.0 μl of a macromolecular tracer (Evans Blue labeled albumin) was reduced significantly under flow rates of 0.3-0.6 μl/min, allowing for more effective distribution within targeted regions. Polymer coating thicknesses before and after hydrations were 0.035 and 0.370 mm, respectively. Also, backflow data was fit to a model to estimate the effective local compressive stress caused by the hydrated polymers. After withdrawal of the cannula from the insertion site, the hydrated polymer coatings remained within the cavity left in the hydrogel tissue phantom and formed a seal at the infusion site that prevented further backflow during needle withdrawal. Ex vivo infusions in excised porcine brain tissues also showed significant backflow reduction while also demonstrating the ability to leave a polymer seal in the tissue cavity after cannula removal. Thus, application of these polymers as needle or cannula coatings offers a potentially simple method to improve targeting for local drug delivery.

Background: Two significant limitations of intraperitoneal drug therapy are limited drug distribution and poor penetration into peritoneal nodules. A possible solution is the application of the so-called "therapeutic pneumoperitoneum," taking advantage of the gaseous nature and the pressure of capnoperitoneum during laparoscopy. Our objective was to develop a device able to apply such therapeutic pneumoperitoneum., Methods: The technology presented here is a spraying device and can be introduced through a trocar. It is driven by mechanical pressure and consists of an injector, a line, and a nozzle. An in vivo experimental study was performed in five pigs. A transvaginal cholecystectomy was performed. At the end of the procedure, a standard dose of methylene blue was sprayed/infused into the abdominal cavity for 30 min (4 test animals w/therapeutic pneumoperitoneum (12 mmHg CO(2)) and 1 control animal w/conventional lavage (2 l intra-abdominal volume with extracorporeal circulation)). At the end of the procedure, all animals were autopsied and the peritoneum was analyzed. Outcome criteria were: (1) drug distribution (as assessed by the stained peritoneal surface at autopsy), and (2) diffusion into the peritoneum (presence or not of macroscopic staining of the outer aspect of the peritoneum immediately after surgery)., Results: Stained peritoneal surface was larger after aerosol application compared with peritoneal lavage, and staining more intense. Hidden peritoneal surfaces and the anterior abdominal wall were stained only in the aerosol group. In contrast to peritoneal lavage, the outer aspect of peritoneal membrane was immediately stained after pressurized spraying., Conclusions: This device and the related approach significantly improve both distribution and penetration of a test substance into the peritoneal cavity in a large animal model. This might be a significant progress in treating intraperitoneal disease, in particular peritoneal carcinomatosis.

Intraperitoneal access ports are essential to the delivery of chemotherapy agents into the peritoneal cavity of women with ovarian cancer, but their malfunction and adverse effects are frequently responsible for the failure to complete planned therapy. Complications, such as obstruction of the catheter, infection, leakage, rotation, retraction, and pain, together with bowel and vaginal perforation, cause delays in treatment, patient suffering and the expenditure of medical resources. A wide variety of ports have been used, including vascular access devices and intraperitoneal access devices. This paper reviews the development and use of ports for intraperitoneal chemotherapy, their complications and reported methods of prevention., (© 2011 The Author BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.)

Adjuvant intraperitoneal chemotherapy in ovarian cancer has shown improved survival but limited by catheter-related complications. We present a technique of Veress needle use for intraperitoneal instillation of chemotherapy for 220 procedures in 43 patients with minimal adverse effects all managed conservatively. Our unique technique of paclitaxel instillation is described.

Transtracheal access enables researchers to obtain diagnostic samples from or infuse materials into the lower respiratory tract. This column describes transtracheal aspiration and infusion of horses.

Convection-enhanced delivery (CED) is a rational technique for the direct intracranial administration of a range of therapeutic agents. CED critically depends on the use of a catheter with a narrow outer diameter and low infusion rate. Failure to adhere to these requirements can lead to reflux of infusate along the catheter-brain interface and damage at the catheter-tip. In this study we have tested the hypothesis that the relationship between infusion parameters and infusate distribution, including reflux, is critically dependent on the occurrence of tissue damage. The relationship between catheter outer diameter and the extent of blood-brain barrier disruption and subsequent tissue oedema was evaluated following catheter insertion into the striatum of rats. Three patterns of infusate distribution were observed: (1) Reflux restricted to the traumatised tissue around the catheter site. (2) Distribution in the white matter beyond the area of tissue trauma. (3) Widespread distribution in the striatum, which occurred only with catheters of an outer diameter of 0.35 mm or less. Extensive tissue damage occurred with a 0.2mm outer diameter catheter. This damage was completely prevented by rounding the catheter-tip. Infusions into pig brain demonstrated that high-flow CED could be performed in a large brain in both grey and white matter using a 0.2mm outer diameter catheter, with minimal reflux or MRI-evidence of tissue damage. This study demonstrates that by minimising tissue damage from catheter design and insertion, high flow-rate CED can be utilised to distribute therapeutic agents over large volumes of brain within clinically practical timescales., (Copyright © 2011 Elsevier B.V. All rights reserved.)

The use of medical devices containing highly criticized phthalates including di(2-ethylhexyl) phthalate (DEHP) has been challenged by European directive 2007/47/CE, put into effect in March 2010. New plasticizers are now being used to soften PVC in medical devices: trioctyltrimellitate (TOTM), di-isononyl-cyclohexan-1,2-dicarboxilate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT). To quantify DEHP in nine DEHP-free medical devices made of PVC softened by alternative plasticizers, high performance liquid chromatography analysis with ultraviolet detection at 220 nm wavelength was achieved. An NMR spectroscopy was performed to confirm DEHP presence. Only two medical devices out of the nine tested were truly without DEHP. One of them showed traces of DEHP exceeding the threshold contamination of 0.1% in plastic mass set by REACH regulations. TOTM plasticizer is still incriminated when polyvinyl-chloride (PVC) is contaminated with DEHP. Manufacturers must verify the purity of their raw material, not only on PVC, but also on other soft plastics entering into the composition of medical infusion devices. The clinical consequences of exposure to certain levels of DEHP have not been evaluated. A solution could be to use alternative PVC-free materials., (Copyright © 2011 Elsevier B.V. All rights reserved.)

If users of Nutricia Flocare Infinity or Flocare Infinity+ feeding pumps press the unit's Fill Set key while attempting to address an occlusion alarm, the unit's display may indicate normal device operation even though the unit is not delivering feeding solution. Failure to deliver solution may result in hypoglycemia, which can have severe outcomes for patients who have difficulty maintaining their blood sugar levels. Flocare users should become familiar with the issue and with the guidance offered in the products' instructions for use.

The use of the intrathecal infusion pump for therapeutic treatment and pain management is increasing. For example, one such application is the pain treatment of cancer patients suffering from severe chronic pain, where all other treatment methods have failed. This method is gaining popularity because of its high cure effect with low dosage. In this study, we developed a prototype implantable intrathecal infusion pump and evaluated its mechanical and hydraulic characteristics in vitro to determine how its performance varied under different environmental conditions. The data are reported as means (standard deviations). In the experiments, the prototype pump could control the micro-scale infusion amount, and its performance was affected by ambient temperature and pressure conditions. In a temperature change test, at a constant pressure of 1.0 atm, the minimal amounts of a bolus were 4.44 (1.07), 5.06 (1.17), and 5.54 (0.90) uL for the temperature of 27.5, 36.5, and 42°C, respectively. In a pressure change test, at a constant temperature of 36.5°C, the minimal amounts of a bolus were 5.06 (1.17), 5.94 (0.67), and 6.13 (0.39) uL for pressures of 1.0, 0.9 and 0.8 atm, respectively. These experimental results demonstrate the possibility of using the prototype pump as an implantable microvolumetric infusion device. However, this prototype pump will have to undergo further design enhancement before being clinically feasible for such an application.

We tested a novel neurocatheter in a brain-tissue gel model of drug infusion via convection-enhanced delivery (CED) for the treatment of a variety of neurological diseases. CED is an alternative to systemic administration of agents by intravenous or oral routes, which are often less effective or carry risk of systemic side effects. We investigated two co-axial tube devices, with outer diameters of 1.6 mm and 2.0 mm. Bromophenol blue dye was infused into 400 ml of 0.6% agarose gel at 1 μl/min for 1 h, with/without the inner and outer tubes Luer-locked at the proximal end, with/without the inner tube primed, and with/without the inner tube preloaded into the outer tube upon insertion into the gel. The unlocked, primed, and unloaded configuration produced infusions that resulted in significantly less (p < 0.05) entrapped air escaping into the gel and resulted in no reflux of infusate.

Background: Postoperative pain control is a challenge in patients undergoing TKA due to side effects and technical limitations of current analgesic approaches. Local anesthetic infiltration through continuous infusion pumps has been shown to reduce postoperative pain in previous studies., Questions/purposes: We assessed the effectiveness of intraarticular ropivacaine infusions in reducing pain and postoperative opioid use after TKA and determined whether such infusions accelerate functional recovery of the patient and reduce length of hospital stay., Methods: In a randomized, prospective, double-blind study, two groups were assigned: Group A (n = 25) underwent continuous intraarticular infusion with 300 mL ropivacaine 0.2% at a speed of 5 mL/hour through an elastomeric infusion pump and Group B (n = 25) had an elastomeric pump insertion with 300 mL saline solution at an infusion speed of 5 mL/hour. All patients had the same prosthesis model implanted. Parameters analyzed over the first 3 days, at discharge, and 1 month later included postoperative pain, joint function, opioid use, and length of hospital stay., Results: All patients in Group A showed a decrease in pain intensity measured by a visual analog scale and opioid use in the first 3 days. Mean length of hospital stay was also reduced in Group A (5.72 days) compared to Group B (7.32 days). There were no device-related complications., Conclusions: Use of an infusion pump is effective in treating pain after TKA, reducing postoperative pain and opioid use. It also improves immediate functionality and patient comfort, reducing the mean length of hospital stay, without increasing the risk of complications., Level of Evidence: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Purpose: Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is safe and effective in selected subjects with diabetes. Our aim was to assess surgical experience and complications with CIPII., Methods: We performed a retrospective longitudinal observational cohort study of patients that started with CIPII from 1990 to 2006. Operation free period and complication rate were compared between patients initiating CIPII before 2000 and from 2000 onwards., Results: In 63 patients, 166 re-operations were performed during 381 patient-years. Re-operations were pump replacement due to end-of-battery life (47%), laparoscopic catheter-related procedures (29%) and other interventions (24%). Median operation free period increased from 21 to 78 months from 2000 onwards (p = 0.039). Nineteen percent of patients developed complications. No operation-related mortality was reported., Conclusions: Increased experience together with technical improvements has led to an increase of the operation free period. The absence of procedure-related mortality and a low complication rate makes CIPII feasible for selected patients with diabetes.

Background: Multiaccess infusion sets allow multiple simultaneous infusions but may induce interference in drug delivery resulting from large variations in the delivery rate of potent drugs. In this study, we sought to understand the influence of multiaccess infusion device properties (dead space volume and antireflux valve [ARV]) on drug delivery during multi-infusion therapy., Methods: Infusion sets differing in length, dead space volume, and presence of an ARV were assessed. Three drugs were infused simultaneously through different access points, and their concentrations were obtained using UV spectrophotometric analysis of the effluent. Different infusion configurations were compared by assessing (1) the amount of drug delivered to the patient per unit of time, (2) the mean amount of drug delivered to the patient per unit of time during the steady-state infusion (mass flow rate plateau), and (3) flow change efficiency calculated from the ratio of the area under the experimental instant mass flow rate curve to the area corresponding to theoretical instant mass flow rate curve., Results: Infusion sets with lower dead space volumes offered significantly higher flow change efficiency (53.0% +/- 15.4% with a dead space volume equal to 0.046 mL 5 min after the start of infusion) than infusion sets with higher dead space volume (5.6% +/- 8.2% with a dead space volume equal to 6.16 mL), whatever the flow rate changes. Even in case of large dead space volumes, the presence of an ARV significantly increased the mass flow rate plateau (from 92.4% to 99.3% of the theoretical plateau without and with the presence of an ARV, respectively)., Conclusions: Multi-infusion therapy induces perturbation in drug delivery. These perturbations (lag time, backflow, and bolus) could be reduced by using infusion sets including very low dead space volume and an ARV.

Patients treated with long-term spinal infusion of high doses of morphine develop a granuloma at the location of the catheter tip. Diagnosis is based on a steady increase in intrathecal morphine dosage after a relatively prolonged period of stability, on the gradual development of neurologic signs and symptoms suggesting radicular or spinal cord compression, and on magnetic resonance images. We describe a man with central neuropathic pain after removal of a tumor. The presence of all 3 of the aforementioned diagnostic criteria led to suspicion of a spinal granuloma.

Purpose: To report experiences with a transcutaneous soft tissue-anchored titanium port (T-port) attached to an intestinal tube for gastroduodenal infusion of levodopa/carbidopa in patients with Parkinson disease, and to describe and analyze complications related to the T-port, gastrostomy technique, and intestinal tube placement., Materials and Methods: The T-port implantation and gastrostomy were done under local anesthesia in 15 patients (mean age, 64 years; range, 52-74 y). An intestinal tube (10 F) was attached to the T-port for duodenal/jejunal access. Three versions of the T-port have been tested (generations I-III)., Results: Our experience with T-ports covers 34.5 patient-years (mean, 2.3 y per patient). Maximum duration of use was 4.9 years. The major complications were perforation of the skin by the straight flange (three of five generation I ports), local infections (12 of 15 patients) resulting from leakage of levodopa/carbidopa (five of 11 generation II ports), problems with T-fasteners, and poor hygiene. Hypergranulation tissue was often seen as a result of local inflammation/infection resulting from levodopa/carbidopa leakage, poor hygiene, and/or an overly mobile T-port. The last version of the T-port (generation III), with more optimized implantation and gastrostomy techniques, seemed to considerably improve the results., Conclusions: The initial experience with the T-port system reveals that it may be a useful alternative to presently used gastrojejunostomy tubes. Several improvements of the T-port and placement technique were made. The T-port offers a potential advantage compared with standard techniques from an aesthetic point of view.

This paper describes the principle of detector for pulse and fill-liquid in one body, which is used to detect the body pulse and the number of liquid-drop within one minute when filling liquid. The detector works exactly and rapidly. It makes doctors and nurses disentangle from the annoyed daily grinds.

Objective: To compare the utility of intra-articular analgesia (IA) to that of a continuous interscalene block (CIB) by evaluating the quality of postoperative analgesia, a satisfaction index, and the incidence of complications., Patients and Method: A randomized controlled trial enrolling patients classified as ASA 1 or 2. The IA group received 25 mL of ropivacaine 0.2% plus 2 mg of morphine. The CIB group received a 7-mL/h infusion of bupivacaine 0.0625% plus 1 microg/mL of sufentanil. Postoperative pain was expressed on a visual analog scale (VAS) at 2, 4, 6, 12, 24, and 48 hours. Intravenous morphine was used as a rescue analgesic. Morphine use, incidence of adverse effects, and level of patient satisfaction after 48 hours were recorded., Results: Twenty-three patients were randomized to the IA group and 24 to the CIB group. There were no between-group differences in patient characteristics. VAS scores and morphine use were similar in the 2 groups in the first 12 hours but were lower in the CIB group at 24 and 48 hours. The level of patient satisfaction was higher in the CIB group. There was a higher incidence of nausea and/or vomiting in the IA group at 24 and 48 hours., Conclusions: Postoperative pain in the first 12 hours after shoulder surgery can be adequately managed with either IA or CIB. CIB is more effective than IA between 12 and 48 hours after surgery.

Voriconazole is a novel broad-spectrum antifungal drug, employed in the treatment of invasive fungal infections, and represents an alternative to amphotericin B treatment. The manufacturer recommends that any unused reconstituted product should be stored at 2 masculineC to 8 masculineC, for no more than 24 h, but no recommendations about i.v. infusion solutions are given. Previous works have reported on the stability of voriconazole in polyolefin bags and just one in 5% dextrose polyvinyl chloride (PVC) bags, at a 4 mg.mL-1 concentration. In this work, the stability of voriconazole as an i.v. infusion solution in 0.9% sodium chloride and in 5% dextrose, in PVC bags, at 0.5 mg.mL-1, stored at 4 masculineC and at room temperature, protected from light, was evaluated. These infusion solutions were analyzed for a 21-day period. Chemical stability was evaluated by HPLC assay. Visual inspection was performed and pH of the solutions was measured. No color change or precipitation in the solutions was observed. The drug content remained above 90% for 11 days in 0.9% sodium chloride and for 9 days in 5% dextrose solutions. The i.v. infusion solutions stored at room temperature were not stable. At room temperature, the voriconazole content dropped down to 88.3 and 86.6%, in 0.9% sodium chloride or 5% dextrose solutions, respectively, two days after admixture. Assays performed at the end of the study suggest the sorption of voriconazole by the PVC bags. The results of this study allow cost-effective batch production in the hospital pharmacy.

Covalent modifications of therapeutic proteins are of interest for the biotech industry as they potentially impact the quality of the material. This study focuses on covalent protein modifications by the reducing monosaccharide glucose via the glycation reaction. In particular, we examined (i) to which extent different therapeutic monoclonal antibodies are glycated, (ii) the glycation during storage in sucrose-containing formulation buffers where non-reducing sucrose potentially could hydrolyze into its reducing constituent monosaccharides and (iii) the risk of glycation in the course of short-term incubation in Dextrose infusion bags in simulated administration testing. A boronate affinity chromatography method was employed to detect and quantify glycation products in different antibody formulations. For confirmation and to determine the degree of glycation per molecule, selected samples were analyzed via LC-ESI-MS. We could demonstrate that different antibodies differed drastically regarding the degree of glycation, probably a result of their respective fermentation conditions and protein glycation susceptibility. We also demonstrated that sucrose is a non-critical excipient with respect to glycation when stored long-term at intended storage conditions (2-8 degrees C). Finally, we could show that short-term incubation of antibodies in Dextrose infusion bags might lead to huMAb glycation, suggesting to test on glycated products when considering diluting protein drug products in infusion media containing reducing sugars.

This article will outline the use of continuous subcutaneous infusion pumps, known as syringe drivers, including their benefits and drawbacks in a palliative care context. There have been over 5000 articles published globally describing syringe drivers in the medical and nursing literature within the last decade. Many provide guidance on their use, although much of the data are repetitious, disease or age-group specific, and focused on pragmatic issues to do with clinical application. Several trusts and hospices across the UK are carrying out trials of the recently launched McKinley T34 syringe driver. Therefore, it seems timely to consider their wider use internationally. Globally, practitioners in palliative care are very familiar with their use, although the literature lacks specific guidance and, at times, the information is ambiguous. Having briefly reviewed their benefits, the article considers the limitations of using syringe drivers and comments on some of the lesser known/reported practical and patient-focused drawbacks associated with their use. We conclude by considering why, when so much education and training exists to help practitioners use these devices effectively, so many human errors occur.

The treatment for many neurodegenerative diseases of the central nervous system (CNS) involves the delivery of large molecular weight drugs to the brain. The blood brain barrier, however, prevents many therapeutic molecules from entering the CNS. Despite much effort in studying drug dispersion with animal models, accurate drug targeting in humans remains a challenge. This article proposes an engineering approach for the systematic design of targeted drug delivery into the human brain. The proposed method predicts achievable volumes of distribution for therapeutic agents based on first principles transport and chemical kinetics models as well as accurate reconstruction of the brain geometry from patient-specific diffusion tensor magnetic resonance imaging. The predictive capabilities of the methodology will be demonstrated for invasive intraparenchymal drug administration. A systematic procedure to determine the optimal infusion and catheter design parameters to maximize penetration depth and volumes of distribution in the target area will be discussed. The computational results are validated with agarose gel phantom experiments. The methodology integrates interdisciplinary expertise from medical imaging and engineering. This approach will allow physicians and scientists to design and optimize drug administration in a systematic fashion.