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PubMed2006

Design and development of mechanical embolic protection devices.

Carotid angioplasty and stenting (CAS) is rapidly becoming an acceptable alternative to carotid endarterectomy in many patients. Much of the success of CAS is credited to advances in equipment dedicated to this minimally invasive approach. Lower profile delivery systems, tapered stent designs and most importantly, development of mechanical cerebral embolic protection devices (EPDs) have contributed to a reduction in periprocedural neurological complications that now rival results of carotid endarterectomy. Despite a lack of level one evidence in support of EPDs, a meta-analysis as well as two recent institutional reports of CAS with and without EPDs suggest a reduced stroke risk when a mechanical protection device is incorporated as part of the procedure. Since the original description by Theron and colleagues, embolic protection systems are markedly improved in ease of use and effectiveness. The three primary groups of EPDs are distal balloon occlusion, distal filtration and proximal occlusion. Although the ideal EPD has yet to materialize, this review provides insight into current design systems and the accompanying strengths and weaknesses of each.

Biomechanical Phenomena↗
PubMed1998

Atopic dermatitis, conjunctivitis, and hand dermatitis among Swedish dental personnel, including use of personal protective devices.

A previous study on dental personnel in northern Sweden show that dentists had a significantly higher prevalence of self-reported and physician-diagnosed atopic dermatitis and conjunctivitis, compared to chair assistants and referents (Lönnroth & Shahnavaz 1998). Further, significantly more male dentists reported experience of hand dermatitis compared to male referents. To compare the prevalence among dental personnel working in other geographical areas of Sweden, and survey the use of personal protective equipment, a questionnaire study was conducted during 1997, which included all dentists and his/her chair assistants, working in general private and public dental care in Sweden. A total of 7384 dental personnel were included in the study, 4293 dentists (54.7% male and 45.3% female), and 3090 chair assistants. Logistic regression was used for analysing data. Results show that significantly more dentists reported symptoms of atopic dermatitis, conjunctivitis, and hand dermatitis, and had been diagnosed by a physician, compared to chair assistants. However, they did not report more sick-leave due to symptoms, compared to chair assistants. More female used protective devices, than male, and more chair assistants than dentists. Significantly more dental personnel in public dental care used protective devices, than in private dental care. Use of gloves, and face mask, decreased with increasing age but, use of eye protection, mainly in form of prescription spectacles, increased. The prevalence of hand dermatitis decreased significantly with increasing age but, more for female (p < 0.0001), than for male (p = 0.01).

Adult↗
PubMedDate not supplied

A review of needle-protective devices to prevent sharps injuries.

The risk of occupational transmission of blood-borne pathogens via sharp devices remains a significant hazard to both healthcare and ancillary workers. Previously, education, training, universal precautions and hepatitis B vaccination have been implemented in an attempt to reduce the risk. However, the most recent preventive strategy is needle-protective devices. These have been developed from conventional products but incorporate a safety mechanism that, when activated, covers the needletip and thus assists in the prevention of needlestick injuries and potential seroconversion to blood-borne pathogens. To date, a number of studies have been undertaken to evaluate these products, the majority of which show these devices to be safe and reliable in addition to potentially reducing associated needlestick injuries. However, to encourage the introduction of these devices in the UK, further studies are needed to either support or refute initial findings and to encourage the evaluation and subsequent implementation of needle-protective devices.

Accidents, Occupational↗
PubMed1996

A Method for Response Time Measurement of Electrosensitive Protective Devices.

A great step toward the improvement of safety at work was made when electrosensitive protective devices (ESPDs) were applied to the protection of press and robot-assisted manufacturing system operators. The way the device is mounted is crucial. The parameters of ESPD mounting that ensure safe distance from the controlled dangerous zone are response time, sensitivity, and the dimensions of the detection zone. The proposed experimental procedure of response time measurement is realized in two steps, with a test piece penetrating the detection zone twice. In the first step, low-speed penetration (at a speed vm) enables the detection zone border to be localized. In the second step of measurement, the probe is injected at a high speed Vd. The actuator rod position is measured and when it is equal to the value L registered by the earlier measurements, counting time begins as well as the monitoring of the state of the equipment under test (EUT) output relays. After the state changes, time tp is registered. The experimental procedure is realized on a special experimental stand. Because the stand has been constructed for certification purposes, the design satisfies the requirements imposed by Polski Komitet Normalizacyjny (PKN, 1995). The experimental results prove the measurement error to be smaller than ± 0.6 ms.

certification↗
PubMed2005

The SPIDER Embolic Protection Device performance evaluation in the carotid artery during percutaneous transluminal angioplasty and or stenting.

Recently completed studies have compared carotid endarterectomy with carotid artery stenting, a nonsurgical method of improving blood flow in the carotid arteries. Embolic protection devices can prevent particles dislodged during carotid artery stenting from causing stroke or death. An ev3 Inc.-sponsored trial (PROTECT) evaluated the performance requirements of the SPIDER Embolic Protection Device in the carotid artery for CE Marking. Patients who were candidates for percutaneous transluminal angioplasty (PTA) and or stenting were enrolled. Performance was assessed by determining the incidence of major adverse neurological events (MANE) through 30 days post-procedure in 74 patients, along with the successful placement and recovery rates of the filter. MANE was defined as stroke or death. There were a total of 5 MANE events reported in 5 patients, 1 major stroke and 4 minor strokes. There were no deaths. The total MANE event rate was 6.8% (5 of 73). The overall SAE rate was 8.2% (6 of 73). An SAE was defined as an event that resulted in the hospitalization or prolongation of hospitalization due to potential disability, or due to danger of life that resulted in an intervention or that was terminal. Technical success of the SPIDER device was defined as placement of the filter at the distal edge of the lesion in the carotid artery, placement of the recovery catheter and successful retrieval of the filter with the recovery catheter. An inability to place or retrieve the filter was concluded to be a system failure. The SPIDER device was successfully placed in the carotid artery and retrieved with an overall successful placement rate of 88.1% (74 of 84), and a retrieval rate of 98.6% (73 of 74). In conclusion, the PROTECT Trial demonstrated that the performance of the SPIDER device in the carotid artery complied with the relevant Product Directives for CE Marking. The incidence of MANE was low and comparable to what has been reported in recently published literature.

Aged↗
PubMed1987

Measurement of the attenuation characteristics of nonlinear hearing protective devices using the auditory brain stem response.

The purpose of this study was to determine the feasibility of using the auditory brain stem response (ABR) as a method of measuring the attenuation characteristics of nonlinear hearing protective devices. Sound field ABRs were recorded from seven normal hearing subjects with and without hearing protection. Three hearing protectors (two nonlinear and one linear) were evaluated. Test stimuli, consisting of 4000-Hz tone pips, were presented in a sound field. Linearity and the amount of attenuation for each hearing protector were derived by comparing the protected and unprotected latency-intensity functions for wave I of the ABR. Results indicate that the ABR may be used effectively to measure the attenuation characteristics of linear and nonlinear hearing protectors for high-frequency impulse-type stimuli.

Adult↗
PubMed2005

Early experience in the application of distal protection devices in treatment of peripheral vascular disease of the lower extremities.

The objectives of this study were to reduce the risk of showering distal vessels with thromboemboli created during percutaneous interventions of the arteries in the lower extremities. Distal protection devices have been used in coronary and carotid interventions. Hence, using similar techniques, these filters and occlusion balloons were advanced past the targeted lesions and distally into femoral and popliteal arteries. Once opened, these devices allowed standard angioplasty and stent placement and captured the dislodged thromboemboli. Five cases were performed with the distal protection devices. One case used the distal occlusion balloon and four with the filter system. All five passed the lesion and were deployed. All five devices were retrieved without incident and were retrieved with substantial debris. There were no adverse events. The use of distal protection to treat high-risk or unstable lesions in the lower extremities shows great promise. Further case will be needed to evaluate the device for feasibility and safety.

Aged↗
PubMed1978

[Selection of suitable individual respiratory protective devices in relation to workroom environment].

Adopting individual respiratory protective equipments, even if in those limited situations in which they are justified, must be consequent to a selection related with the nature of the pollutants to which the operator is, or may be, exposed, with the peculiarity of the workroom environment and, lastly, with the degree of security to be achieved. This statement is not to be neglected even if all respiratory protective equipments are fit to meet the suggestions of qualified standard making institutions. The same is to be considered of capital importance in Italy where the lack of legislation as far as omologation is concerned, allows products not fit to guarantee the request for security which are, consequently, not only superfluous, but dangerous for wearers. For these reasons it has been considered useful to illustrate the characteristics and proper application-fields of the most widely spread respiratory protective equipments referring, as far as possible, to the recommendations being prepared on the matter by the CEN (European Committee for Standardization).

Air Pollutants↗
PubMed1991

Psychological effects on prolonged use of respiratory protective devices in children.

In the study of psychological effects of prolonged use of a respiratory protective device (RPD), forty 7-10-year-olds, fifty 12-15-year-olds and twenty-eight 17-20-year-olds participated as subjects. Subjects in the experimental groups wore a full-face mask provided for civil defence in Sweden, and subjects in the control groups wore a filtering facepiece consisting of a tissue material covering the nose and mouth. Subjects in both groups tended to terminate at the same time, implying that breathing resistance may not be an important obstacle to prolonged wear of the full-face mask. In the experimental groups 97% wore the mask for at least 1.5 h, 77% for at least 2.5 h and 54% for the full 6-h session. About 50% of subjects in the younger age groups terminated in the interval between 1.5 to 3.5 h, whereas the corresponding figure in the older age group was about 30%. Boredom may have played an important role for decisions to terminate, perhaps in part because the mask interfered with speech communication. Discomfort due to pressure on the nose, the chin and the forehead was also reported, more frequently by the older than by the younger subjects.

Adolescent↗
PubMed2002

Embolic protection devices.

The limiting factor in coronary artery bypass surgery is the relatively rapid progression of atheromatous disease in the saphenous vein grafts. Greater than one-half of these vein grafts will fail by 10 years, and the risks associated with repeat coronary artery bypass surgery are significantly greater than that of the initial surgery. Yet, catheter-based interventional treatment of saphenous vein grafts is hindered by distal embolization of friable lipidrich plaque. This is one mechanism responsible for reduced antegrade flow (i.e., "no-reflow" phenomenon), including spasm of the distal microcirculation and platelet clumping. This complication increases the risk of a major adverse clinical event (i.e., myocardial infarction or late mortality). Distal protection devices are designed to provide protection of the distal microcirculation during percutaneous intervention. One device type is a balloon occlusive system that temporarily occludes the distal vessel during the intervention followed by the aspiration of liberated atheromatous and thrombotic material before it reaches the arteriolar and capillary bed. The other device type is a nonocclusive, filter-based system that preserves coronary blood flow through tiny pores, as low as 100 microns. Atheromatous and thrombotic material is trapped in the filter-based systems and then removed with the retrieval of the device through a retrieval catheter. This article discusses the current distal protective devices.

Angioplasty, Balloon, Coronary↗
PubMed1976

[Possibilities of the biophysical evaluation of the efficiency of vibration protection devices for the hands].

The possibility of quantitative assessment of the efficiency of hand vibratory-protective devices using a physiological parameter--the loss of vibrosensitivity in the right-hand fingers depending on the intensity of vibration effect--is discussed. The results of the experiments prove that in case of vibration effect at frequency 31--500 Hz, the changes in vibrosensitivity threshold might be employed as an experimental method of assaying the efficiency whenever it exceeds two decibels.

Biomechanical Phenomena↗
PubMed1985

Individual factors in the choice of respiratory protective devices.

Federal regulations recognize the need to determine whether individuals are physically able to perform their job while wearing respirators. A variety of safety and workplace factors should also be considered at the time that a respiratory protective device is evaluated for use by a particular worker. In most negative pressure respirators, inspiratory resistance constitutes the major load on the respiratory system. In normals, the major load to the cardiovascular system occurs with heavy, self-contained respirators. In the absence of objective guidelines for the use of respirators by impaired workers, careful examination and conservative clinical judgement, and the willingness to re-assess choices must form the basis of respirator selection.

Humans↗
PubMed2006

An experience with angioplasty and stenting of carotid artery stenosis with embolic protection devices.

BACKGROUND: Carotid artery stenting has recently been recommended as an alternative to carotid endarterectomy by some clinicians. OBJECTIVE: To evaluate success rate, as well as in-hospital and 30-day adverse events in our first experience in Iran for carotid artery stenting with protection devices. METHODS: From December 2003 through July 2004, we performed 12 consecutive (9 males and 3 females) carotid artery stenting procedures. The patients had a mean age of 62 (range: 46 - 78) years. Indications for carotid artery stenting included primary lesions in all patients, stenosis > or =50% in symptomatic, and stenosis > or =80% in asymptomatic patients. RESULTS: Carotid artery stenting was technically successful in all 12 patients. The mean +/- SD severity of stenosis before carotid artery stenting was 85 +/- 14% as compared with 15 +/- 10% after the procedure. No periprocedural death occurred. No in-hospital or 30-day minor or major stroke/death was observed. CONCLUSION: Percutaneous stenting of the carotid artery stenosis, when a cerebral protection device is used, is feasible and effective but not without technical difficulties and potential complications. We, therefore, recommend carotid artery stenting for patients who are at high risk for undergoing carotid endarterectomy. Nevertheless, a long-learning curve may be needed for anyone who wishes to start this technique.

Aged↗
PubMed1995

Respiratory protection devices.

OSHA authority and responsibility have led to the requirement that health care workers potentially exposed to patients with active tuberculosis in situations where engineering controls are not feasible for protection must utilize personal protective equipment at least equivalent to HEPA respirators. ICPs generally believe that this approach is unnecessarily conservative and imposes undue burdens on patient care. The arguments on both sides of this controversy have some merit. Reported cases of tuberculosis and skin-test conversions among health care workers since 1988 and the absence of a demonstrated safe level of exposure have led many to the conclusion that HEPA respirators are justified. On the other side, tuberculosis currently is not a major problem in some areas of the country, and many believe that less stringent personal protective devices (e.g., DM respirators) may provide protection equivalent to HEPA filters--at least in terms of preventing infection if not in terms of filtration efficiency. They believe that the lesser discomfort and lower cost associated with DM respirators justify the argument for a more flexible standard. Perhaps additional research can help to resolve the remaining controversy. Definitive answers are unlikely to surface quickly, however, and it is likely that the controversy and confusion will continue for at least awhile longer.

Health Personnel↗
PubMed2003

High-concentration ethylene-vinyl alcohol copolymer and endovascular treatment of experimental aneurysms: feasibility of embolization without protection devices at the neck.

BACKGROUND AND PURPOSE: Coiling of intracranial aneurysms is both safe and effective but may be followed by recurrences. The purpose of this study was to assess the feasibility of endovascular treatment of aneurysms with high-concentration ethylene-vinyl alcohol copolymer (HCEVOH), without the use of protection devices at the neck. METHODS: Wide-necked bifurcation aneurysms with a high propensity for recurrences were constructed in 22 dogs. HCEVOH embolization was performed with a dedicated high-pressure microcatheter in 12 animals. Angiographic results at 3 and 12 weeks and pathologic results at 12 weeks were compared with those of a separate group of 10 animals treated with platinum coils. We used a qualitative scoring system to grade angiographic results, neointima formation, and recanalization at the neck. RESULTS: Intraaneurysmal HCEVOH injections could be performed without carotid emboli and without a protection device in 11 of 12 animals. Fragments detached upon traction of the microcatheters at the end of the procedure on two occasions. Immediate and late angiographic results were not significantly different between the two groups (P =.807), with a tendency for angiographic recurrences at 3 months (angiographic scores were significantly worse in both groups at 12 weeks as compared with T0 [P <.02]). A complete occlusion, including the neck, even at the cost of protrusion of material at the level of the branches, is necessary to decrease risks of recurrences. Neointima formation at the surface of the embolic agent was complete at the neck of aneurysms treated with HCEVOH. The neointimal score was significantly improved with HCEVOH as compared with coil embolization (P =.03). CONCLUSION: HCEVOH embolization of aneurysms without neck protection is feasible. It does not, however, eliminate recurrences in an experimental wide-necked aneurysm model.

Animals↗
PubMed2002

Prospective comparative study of two cerebral protection devices in carotid angioplasty and stenting.

BACKGROUND: The aim of the study was to compare two of the available cerebral protection devices (CPD) PercuSurge, balloon type (group A) and Angioguard, filter type (group B) used in carotid stenting and angioplasty (CAS). METHODS: From September 1999 to February 2001, 26 consecutive patients undergoing CAS were alternatively assigned to group A and B. Postoperative disabling stroke and neurological mortality, nondisabling stroke, TIA and non-neurological mortality were examined. CPD features included time required, ease of handling, device rupture or malfunctioning, radiopaque markers evidence, abnormal major mobility of the opened system. RESULTS: RNCR was 0 and TIAs were not observed in either group. Four patients (3 in group A and 1 in group B) showed drowsiness in the immediate postoperative period. Perioperative carotid occlusion and surgical conversion were observed in 1 case of group A. Average time calculated from the beginning of set-up to complete removal was 46 min in group A versus 31 min in group B. Abnormal major mobility of the opened system was very often observed during endovascular maneuvers with both devices. CONCLUSIONS: CAS may protect against postoperative procedure-related neurological events. Common and specific disadvantages were observed in both systems showing they were not close enough to the ideal device.

Aged↗
PubMed1991

[Hygienic assessment of protective effects of overalls and individual protective devices used in the production of ampicillin trihydrate and its dosage form, ampicillin sodium salt].

The working clothes and individual protective devices recommended by the industrial Rules for the production of ampicillin trihydrate and its medicinal derivatives such as natrium salt ampicillin, do not provide adequate protection of the skin and respiratory mucous from antibiotic contamination. The use of the overalls in combination with the pressurized helmet (designed and produced at the 'Sintez' enterprise) which provided air supply for breathing and, partially, under the overalls, significantly decreased contamination of the body. At the stages of manual handling of the finished products, adequate protection was attained by using the protective paste produced at the 'Altaivitamine' enterprise.

Air Pollutants, Occupational↗