Medical Devices-Evidence and Research最新文献

Lumbar fusion is commonly performed to alleviate chronic low back and leg pain secondary to disc degeneration, spondylolisthesis with or without concomitant lumbar spinal stenosis, or chronic lumbar instability. However, the risk of iatrogenic injury during traditional anterior, posterior, and transforaminal open fusion surgery is significant. The axial lumbar interbody fusion (AxiaLIF) system is a minimally invasive fusion device that accesses the lumbar (L4-S1) intervertebral disc spaces via a reproducible presacral approach that avoids critical neurovascular and musculoligamentous structures. Since the AxiaLIF system received marketing clearance from the US Food and Drug Administration in 2004, clinical studies of this device have reported high fusion rates without implant subsidence, significant improvements in pain and function, and low complication rates. This paper describes the design and approach of this lumbar fusion system, details the indications for use, and summarizes the clinical experience with the AxiaLIF system to date.

Background: This was a randomized, assessor-blind, controlled comparison of a soya oil- based medical device shampoo with a medicinal permethrin lotion in an alcohol vehicle for treatment of head louse infestation to generate data suitable for a regulatory submission to achieve reimbursable status for the shampoo product.

Methods: We treated 91 children and adults, divided between two sites, on two occasions 9 days apart. Participants washed their hair and towel-dried it before treatment. The shampoo was used twice for 30 minutes each time. The lotion was used for 30 minutes followed by rinsing. Assessments were made by dry detection combing on days 2, 9, 11, and 14 after the first treatment. According to present knowledge, this combing technique does not influence the overall head louse populations or outcome of treatment.

Results: The soya oil shampoo was significantly (P < 0.01) more effective than the lotion for both intention to treat (62.2% versus 34.8% successful treatment) and per-protocol (74.3% versus 36.8% success) groups. Post-treatment assessments showed the necessity for repeat treatment, but that a 9-day interval was too long because if eggs hatched after the first treatment, the lice could grow old enough to lay eggs before the second treatment.

Conclusion: The soya oil-based shampoo was more effective than the permethrin lotion, more cosmetically acceptable, and less irritant.

Background and purpose: THE ELECTRO SENSOR COMPLEX (ESC) IS SOFTWARE THAT COMBINES THREE DEVICES USING BIOELECTRICAL IMPEDANCE, GALVANIC SKIN RESPONSE, AND SPECTROPHOTOMETRY: (1) ES-BC (Electro Sensor-Body Composition; LD Technology, Miami, FL) to assess body composition, (2) EIS-GS (Electro Interstitial Scan-Galvanic Skin; LD Technology) to predict autonomic nervous system activity, and (3) ES Oxi (Electro Sensor Oxi; LD Technology) to assess cardiac output. The objective of this study was to compare each to a standardized assessment: ES-BC to dual-energy X-ray absorptiometry (DXA), EIS-GS to heart rate variability, and ES Oxi to BioZ Dx Diagnostic System (BioZ Dx; SonoSite Inc, Bothell, WA).

Patients and methods: The study was conducted in two waves. Fifty subjects were assessed for body composition and autonomic nervous system activity. Fifty-one subjects were assessed for cardiac output.

Results: We found adequate relative and absolute agreement between ES-BC and DXA for fat mass (r = 0.97, P < 0.001) with ES-BC overestimating fat mass by 0.1 kg and for body fat percentage (r = 0.92, P < 0.001) with overestimation of fat percentage by 0.4%. For autonomic nervous system activity, we found marginal relative agreement between EIS-GS and heart rate variability by using EIS-GS as the predictor in a linear regression equation (adjusted R(2) = 0.56, P = 0.03). For cardiac output, adequate relative and absolute agreement was found between ES Oxi and BioZ Dx at baseline (r = 0.60, P < 0.001), after the first exercise stage (r = 0.79, P < 0.001), and after the second exercise stage (r = 0.86, P < 0.001). Absolute agreement was found at baseline and after both bouts of exercise; ES Oxi overestimated baseline and stage 1 exercise cardiac output by 0.3 L/minute and 0.1 L/minute, respectively, but exactly estimated stage 2 exercise cardiac output.

Conclusion: ES-BC and ES Oxi accurately assessed body composition and cardiac output compared to standardized instruments, whereas EIS-GS showed marginal predictive ability for autonomic nervous system activity. The ESC software managing the three devices would be useful to help detect complications related to metabolic syndrome, diabetes, and cardiovascular disease and to noninvasively and rapidly manage treatment follow-up.

Hyaluronic acid (HA), in linear or cross-linked form, is a common component of cosmetics, personal care products, combination medical products, and medical devices. In all cases, the ability of the HA solution or gel to wet surfaces and/or disrupt and lubricate interfaces is a limiting feature of its mechanism of action. We synthesized ferric ion-cross-linked networks of HA based on an adhesion barrier, varied the degree of cross-linking, and performed wetting goniometry, viscometry, and dynamic mechanical analysis. As cross-linking increases, so do contact angle, viscosity, storage modulus, and loss modulus; thus, wetting and lubrication are compromised. These findings have implications in medical device materials, such as adhesion barriers and mucosal drug delivery vehicles.

The Spanner™ stent was first used in patients to relieve bladder outlet obstruction (BOO), and has recently been used in patients following transurethral microwave thermotherapy and men unfit for surgical intervention. We review the current literature on the role of the Spanner stent in treating prostatic obstruction compared to previously reported cases involving the use of temporary stents. The Spanner stent has been found to be successful in treating patients with bladder outlet obstruction from benign prostatic hyperplasia and following high-energy transurethral microwave thermotherapy (TUMT). Patients with the Spanner stent had an increase in peak flow rate and a decrease in post void residual and International Prostate Symptom Scores. In patients treated with TUMT, quality of life measures indicate that the Spanner stent shows increased ease of bladder drainage, decreased leakage, and no adverse effect on daily activities. In patients unfit for surgery, however, there was increased retention and pain requiring stent removal in 63% of cases. The Spanner stent offers ease of insertion with a decrease in voiding symptoms in selected patients. Based on limited data, the Spanner stent has been recommended as a treatment option for men with BOO following TUMT. However, it is not a good treatment option for men unfit for surgery based on an increased incidence of urinary retention and dysuria. The Spanner stent is the only currently approved temporary stent and, based on a literature review, it does not offer significant advantage over previously used temporary stents. It is notable that most researchers have not evaluated the role of detrusor function on the outcomes.

Pediatric peripheral venipuncture and intravenous cannulation are difficult. However, successful venipuncture and intravenous cannulation are absolutely required for pediatric clinical risk management. This study assessed the success rate of venipuncture and intravenous cannulation when transmitted light was applied to the pediatric dorsum manus. The subjects included 100 young children who were scheduled for dental treatment or oral surgery under general anesthesia. Anesthesia was induced, and insertion of an intravenous catheter into the dorsum manus was attempted with or without using transmitted light. The patients were evaluated to determine whether the venipuncture was successful, and whether the intravenous cannulation of the external catheter was successful. The success rate of venipuncture was 100% when transmitted light was used, and 83% when the transmitted light was not used (P = 0.000016). In addition, the success rate of intravenous cannulation was 88% when transmitted light was used, and 55% when the transmitted light was not used (P = 0.0000002). The shape of the vein in the dorsum manus can be clearly recognized when transmitted light is used. The use of light significantly increased the success rate of intravenous cannulation, because it allowed direct confirmation of the direction to push the intravenous catheter forward. The use of transmitted light allows for more successful venipuncture and intravenous cannulation in young children.

A colonoscopy add-on device has been developed to reduce intubation time without modification of the current colonoscope and peripheral devices. One of the main purposes of the system is to minimize trauma caused by the distal tip of the colonoscope. The detachable sensory fixture at the end of the distal tip measures the distance between the distal tip and the colon wall in three directions, and the actuation system attached at the base of the colonoscope controls the distal tip by rotating two dial knobs. The device controls the distal tip to minimize contact between the distal tip and the colon wall, and the distal tip ideally points out the next possible lumen. A compatibility test of the infrared sensory system was carried out, and the design of the actuation system was accomplished. The system is integrated and controlled by a microprocessor. The device was tested in a silicon colon and porcine intestine. The results showed that a colonoscopist successfully reached the cecum with the aid of the colonoscopy add-on device without significant contact between the colon wall and the distal tip. The colonoscopy aid device was very helpful for the novice colonoscopist.

Background: Cellulose masks obtained from natural sources such as bacteria are of interest as cosmetic devices for the treatment of dry skin because they not only improve hydration of the skin, but have low toxicity and are biodegradable. The aims of this study were to determine the in vivo effects of a cellulose mask obtained from Acetobacter xylinum on skin characteristics and to evaluate user satisfaction with the product.

Methods: Thirty healthy Thai volunteers aged 21-40 years participated in the study. The volunteers were randomly separated into a control group and an experimental group. For the control group, volunteers were assigned to apply moist towels to the face for 25 minutes. For the experimental group, the volunteers were assigned to apply the masks, ie, translucent patches which could be fitted onto the face for the same period. The following week, the groups were changed over to the alternative treatment. Skin moisture, sebum, elasticity, texture, dullness, and desquamation levels were assessed using a system used for routine skin counseling before applying the trial product and five minutes after its removal. Degree of satisfaction with use of the cellulose mask was investigated using a five-point rating scale.

Results: The cellulose mask increased moisture levels in the skin significantly more than moist towels (P < 0.05) after a single application. No obvious effects on other skin characteristics were found. The cellulose mask product rated around 4/5 on the satisfaction rating scale.

Conclusions: A single application of the trial cellulose mask enhanced moisture uptake by facial skin. Users also reported being satisfied with the trial product.

The Respimat(®) Soft Mist™ Inhaler (SMI) (Boehringer Ingelheim International GmbH, Ingelheim, Germany) was developed in response to the need for a pocket-sized device that can generate a single-breath, inhalable aerosol from a drug solution using a patient-independent, reproducible, and environmentally friendly energy supply. This paper describes the design and evolution of this innovative device from a laboratory concept model and the challenges that were overcome during its development and scaleup to mass production. A key technical breakthrough was the uniblock, a component combining filters and nozzles and made of silicon and glass, through which drug solution is forced using mechanical power. This allows two converging jets of solution to collide at a controlled angle, generating a fine aerosol of inhalable droplets. The mechanical energy comes from a spring which is tensioned by twisting the base of the device before use. Additional features of the Respimat(®) SMI include a dose indicator and a lockout mechanism to avoid the problems of tailing-off of dose size seen with pressurized metered dose inhalers. The Respimat(®) SMI aerosol cloud has a unique range of technical properties. The high fine particle fraction allied with the low velocity and long generation time of the aerosol translate into a higher fraction of the emitted dose being deposited in the lungs compared with aerosols from pressurized metered dose inhalers and dry powder inhalers. These advantages are realized in clinical trials in adults and children with obstructive lung diseases, which have shown that the efficacy and safety of a pressurized metered dose inhaler formulation of a combination bronchodilator can be matched by a Respimat(®) SMI formulation containing only one half or one quarter of the dose delivered by a pressurized metered dose inhaler. Patient satisfaction with the Respimat(®) SMI is high, and the long duration of the spray is of potential benefit to patients who have difficulty in coordinating inhalation with drug release.

The use of elastomeric diffusers (EDs) has grown together with the expansion of home care. In these devices, the fill volume of the drug reservoir and the flow rate are preset and cannot be modified. The elastomer, which makes up the reservoir walls, is what makes the infusate flow due to the pressure it exerts. The purpose of this work was to quantify, under standardized experimental conditions and following recommended conditions of use, the mechanical performances of the 2 commonly used elastomers (silicone and polyisoprene) and their impact on infusion flow rate consistency. Results show that they exhibit different mechanical performances which leads to concerns regarding the use of these devices for some intravenous (IV) therapies.