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Compodock, a new device for sterile docking.

BACKGROUND: A new device for sterile docking, the Compodock (Fresenius NPBI Transfusion Technology), was developed for connecting PVC tubing for medical use while maintaining sterility. STUDY DESIGN AND METHODS: Sterility of the connections was assessed by welding tubing with a heavy exterior contamination with Bacillus subtilis spores and also by welding in an environment contaminated with aerosols of B. subtilis. Tubing was either dry or liquid-filled ("wet") and had various diameters. Bacterial culture medium was flushed through the welded area and subsequently cultured. Tensile strength was measured, and, under semi-routine conditions, Compodock was tested for user friendliness and speed. RESULTS: None of the cultures of welded tubing with exterior contamination showed growth, neither the dry-dry (n = 434) nor the wet-wet connections (n = 622). Cultures were also negative for welds made in the contaminated environment (dry-dry, 67; wet-wet, 55). Tensile strength complied fully with ISO 3826 standards (that is, a force of 20 newtons [N] for 15 sec), with a mean maximal strength ranging from 73 to 100 N, depending on diameter and content of the tubing. The semi-routine handling was regarded as good: welds were easily opened; there were clear instructions and error warnings; and the processing time averaged 52 seconds. CONCLUSION: The Compodock is able to maintain a functionally closed system, with maintenance of sterility, despite heavy exterior bacterial contamination; tensile strength conformed to ISO standards. Compodock is suitable for routine implementation in the blood bank.

Bacillus subtilis↗

Thermal studies of in-vivo vascular tissue fusion by argon laser.

There are conflicting opinions regarding the mechanism of welding or fusion of vascular tissue by lasers. In this study, we measured the effects of saline irrigation on tissue temperature and fusion produced by argon laser welding of eight femoral and four carotid arteriovenous fistulas. Temperatures were continuously recorded using a digital thermographic camera. Forty 1-cm. welds were performed using powers of 0.50 (n = 24), 0.75 (n = 8), and 1.00 (n = 8) watt (W), with an energy fluence of 1100 J/cm2 per 1 cm segment, and cooling of the anastomotic site by saline irrigation (3 ml/minute). The "success" of fusions was determined by testing integrity of the repairs by exposure to blood flow. At 0.50 and 0.75 W, successful welds were formed when the temperatures were 44.2 +/- 1.6 (n = 28) and 55.0 +/- 3.6 degrees C (n = 20), with maximum temperatures of 47.9 and 59.9 degrees C respectively. At 1 W, the tissue was desiccated and the welds disrupted when exposed to blood flow with temperatures measured at 63.7 +/- 10.0 degrees C (n = 22) and maximum of 88.0 degrees C. Eight welds were also attempted without saline irrigation at 0.25 (n = 4) and 0.50 W (n = 4). At 0.25 W, tissue fusion was achieved but disrupted when exposed to intraluminal pressures with temperatures 50.3 +/- 2.0 degrees C (n = 10) and maximum of 52.6 degrees C. At 0.50 W, the fusion failed after only minimal exposure to the laser energy because of tissue drying and retraction with temperatures measured at greater than 125 degrees C.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Laser-assisted tubal anastomosis.

OBJECTIVE: To determine if laser-assisted anastomosis is superior to microsurgical anastomosis and laser welding for tubal reconstruction. STUDY DESIGN: Sixty uterine tubes from 30 rabbits were transected and then anastomosed with a microsurgical technique, laser welding and laser-assisted anastomosis using a microscope. The rabbits were mated one month postoperatively and examined for implantation sites and adhesion formation three to seven days postpartum. RESULTS: The amount of time required to perform laser-assisted anastomosis as well as laser welding was significantly shorter than for microsurgery. All the tubes withstood the distension pressure of pregnancy with the exception of 1 of the 20 laser-welded tubes, which had 30% of its circumference dehisced. There was no difference in the number of implantation sites per tube between the different groups. The anastomotic sites were well healed and were nonidentifiable except for holding stitches and microsurgical sutures. CONCLUSION: Laser-assisted anastomosis and laser welding took less time to perform than microsurgery. Laser-assisted anastomosis resulted in excellent healing, as did microsurgery. With the protection of serum albumin, laser-assisted anastomosis did not cause any thermal damage, and the anastomotic sites could tolerate the distension pressure of pregnancy and parturition without problems. Laser welding without protection of serum albumin could cause thermal damage and dehiscence. The implantation and pregnancy rates were comparable The implantation and pregnancy rates were comparable with all three types of procedure.

Analysis of Variance↗

Welder's maculopathy?

OBJECTIVE: The aim of this study was to verify or to disprove whether the term 'Welder's maculopathy' or 'Welding arc maculopathy' has to be considered being a justifiable occupational hazard and is to be annexed to the list of occupational diseases. METHODS: Multifocal electroretinography (MERG) and thorough ophthalmologic examinations were performed in a group of 89 welders. The matched control group comprised 81 subjects who had never been exposed to welding. All participants of this study were examined by a specialist of occupational medicine prior to the MERG. RESULTS: Multifocal electroretinography as well as ophthalmological tests did not reveal a significant morphological or functional differences between the welders and the control group. On an average, the welders' visual acuity appeared to be better than that of the control group. This phenomenon could be attributed to the so-called healthy worker effect. CONCLUSION: Welding arc maculopathy seems to be rather a sequel of occupational accidents and negligence of safety regulations. The results of this study indicate that the usual protective measures in professional welding appears to be sufficient in order to prevent an occupational risk of welding arc maculopathy.

Adult↗

Neurologic manifestations in welders with pallidal MRI T1 hyperintensity.

BACKGROUND: Neurologic symptoms have been attributed to manganese fumes generated during welding. Increased T1 MRI signal in the basal ganglia is a biologic marker of manganese accumulation. Recent studies have associated welding and parkinsonism, but generally without MRI corroboration. OBJECTIVE: To characterize the clinical and neuropsychological features of patients with MRI basal ganglia T1 hyperintensity, who were ultimately diagnosed with neurotoxicity from welding fumes. METHODS: The medical records of welders referred to the Department of Neurology with neurologic problems and basal ganglia T1 hyperintensity were reviewed. RESULTS: All eight patients were male career welders with increased T1 basal ganglia signal on MRI of the brain. Several different clinical syndromes were recognized: a parkinsonian syndrome (three patients), a syndrome of multifocal myoclonus and limited cognitive impairment (two patients), a mixed syndrome with vestibular-auditory dysfunction (two patients), and minor subjective cognitive impairment, anxiety, and sleep apnea (one patient). Neuropsychometric testing suggested subcortical or frontal involvement. Inadequate ventilation or lack of personal respiratory protection during welding was a common theme. CONCLUSIONS: Welding without proper protection was associated with syndromes of parkinsonism, multifocal myoclonus, mild cognitive impairment, and vestibular-auditory dysfunction. The MRI T1 hyperintensity in the basal ganglia suggests that these may have been caused by manganese neurotoxicity.

Adult↗

Cancer risk of arc welders exposed to fumes containing chromium and nickel.

A retrospective follow-up study among chromium- and nickel-exposed welders, which took into consideration welding procedures, duration of exposure, and smoking habits, yielded an increased cancer risk in a comparison with an internal reference group of turners, milling cutters, and drillers, as well as in a comparison with the general population of the Federal Republic of Germany. Due to the cohort size (1 224 welders, 1 694 turners) and the fact that the observation period is still too short, confirmed statements as to the target cancer sites cannot yet be made. However, it emerges that welding with coated electrodes shows a higher cancer risk as compared to the other welding processes observed. This finding may be explained by the fact that the share of hexavalent chromium compounds in the welding fumes is greater with coated electrodes than with other processes so that a follow-up study observing the health risks of chromium and nickel fumes separately would be warranted. For the confirmation of a more favorable outcome with gas-shielded welding, a larger investigation group or a longer observation period would be required.

Adolescent↗

An experimental human model of metal fume fever.

OBJECTIVE: To examine the pathogenesis of metal fume fever in humans by studying functional, cellular, and biochemical responses after exposure to zinc welding fume. DESIGN: Clinical experimental study. PARTICIPANTS: We studied 14 welders recruited through public advertisements. INTERVENTIONS: Participants welded galvanized steel. MEASUREMENTS: We measured lung volumes, airflow, diffusing capacity for carbon monoxide, and airway reactivity at baseline as well as either 6 or 20 hours after welding. We carried out bronchoalveolar lavage either 8 hours (early follow-up, 5 participants) or 22 hours (late follow-up, 9 participants) after welding, assaying the fluid for total and differential cell counts and bronchoalveolar lavage supernatant concentrations of interleukin-1 and tumor necrosis factor (TNF). MAIN RESULTS: Changes in pulmonary function and airway reactivity were minimal. Cumulative zinc exposure and polymorphonuclear leukocyte count in bronchoalveolar lavage fluid at late (r = 0.87; P less than 0.01) and early (r = 0.93; P less than 0.05) follow-up were positively correlated. Among the late follow-up group, the mean proportion of polymorphonuclear leukocytes was 37% (range, 19% to 63%), a statistically greater proportion than the 9% (range, 2% to 21%) seen among the early follow-up group (P less than 0.05). We did not detect TNF or more than a trace amount of interleukin-1 in the bronchoalveolar lavage supernatant. CONCLUSIONS: Zinc oxide welding fume was associated with a marked dose-dependent increase in the number of polymorphonuclear leukocytes recovered in bronchoalveolar lavage fluid 22 hours after exposure but was not associated with a clinically significant change in pulmonary function or airway reactivity. Although we did not identify increases in either interleukin-1 or TNF levels in bronchoalveolar lavage fluid, cytokines or a cytokine-like mechanism may mediate the syndrome of metal fume fever.

Adult↗

Amyotrophic lateral sclerosis and occupational history. A pilot case-control study.

OBJECTIVE: To assess the association of a number of occupational and industrial exposures with amyotrophic lateral sclerosis (ALS). DESIGN: A case-control study of ALS cases matched by age and sex to 2 controls each: 1 from a neurologic clinic and 1 from a local community. Exposures were ascertained by questionnaire, and patients were requested before the interview to be to prepared to supply occupational histories. SETTING: Patients with ALS were enrolled at the University of Minnesota ALS Clinic in Minneapolis. PATIENTS: Patients with ALS (n = 25) were from the University of Minnesota ALS clinic, and clinic controls (n = 25) were patients with other neuromuscular diseases from the university's Muscle Disease Clinic, selected on the basis of clinic enrollment date nearest to that of the matched case. Clinic controls were principally patients with myopathies. Community controls (n = 25) were selected from the community using a random-digit-dialing protocol matching on the first 5 digits of the case patient's telephone number. RESULTS: The strongest association with disease was exposure to welding or soldering materials (odds ratio, 5.0) and the welding industry (odds ratio, 5.3). Electric plating showed a high odds ratio of 8 (95% confidence interval, 0.9-72.0), but low statistical significance (P < .07) Several exposures or industries, while not statistically different, showed enough difference that to ignore them might lead to a Type II error, a result of the pilot nature and small sample size. These included paint or pigment manufacturing, the petroleum industry, the printing industry, and shipbuilding. CONCLUSIONS: The association with welding, soldering, and the welding industry is strong and suggests a need for further work. This is despite the small numbers studied, thus making most industrial or occupational exposures too limited to draw conclusions or detect associations. Perhaps the most obvious candidate from the welding, soldering exposure for a common toxin would be lead. Other suggestions of risk were seen for paint or pigment manufacture, shipbuilding, electric plating, and the dairy industry. The degree of association for these, while high, is not statistically significant, and suggests that there may be 1 or more environmental toxins common to those industries that need more precise measurement.

Amyotrophic Lateral Sclerosis↗

Two-layer film as a laser soldering biomaterial.

BACKGROUND AND OBJECTIVES: A two-layer solder was developed to weld at low laser intensity and to provide a new method of measuring solder-tissue temperature. STUDY DESIGN/MATERIALS AND METHODS: A film solder consisted of a white layer (bovine serum albumin (BSA) and distilled water) and a black layer (BSA, carbon black (CB), and distilled water). This two-layer solder was used with a diode laser to weld sections of dog small intestine (lambda = 810 nm, power = 200 +/- 20 mW, radiation dose = 18 +/- 1 J/mg). Sections of intestine were welded only with one-layer black solders as control group. The temperature difference between the external solder surface and the tissue-solder interface was evaluated during welding. RESULTS: The two-layer solder performed welds as strong as the one-layer solder ( approximately 0.12 N) but with less laser intensity on the black layer. The temperature difference between the external surface of the solder and the solder-tissue interface was significantly less for the two-layer solder than for the one-layer solder ( approximately 6 degrees C and approximately 15 degrees C, respectively; P < 0.05). CONCLUSIONS: The two-layer solder appeared to be more efficient at soldering biomaterials than the one-layer solder. Furthermore, the heat diffusion from the black midplane of the two-layer solder decreased the difference in temperature recorded on the solder external surface and on the solder-tissue interface.

Animals↗

Penetration depth into dental casting alloys by Nd:YAG laser.

This study investigated the effect of laser-beam welding conditions [voltage (V) and spot diameter (mm)] on the penetration depth into dental casting alloys. Castings (3.0 mm x 8.0 mm x 50 mm) were prepared from the metals used in this study: commercially pure titanium (CP Ti), Ti-6Al-4V, Ti-6Al-7Nb, cobalt-chromium alloy (Co-Cr) and Type IV gold alloy. Two cast blocks of each metal were butted against one another at the 8.0 x 50-mm surfaces. They were then welded at their interface under the following conditions: voltage of 160-340 V, spot diameter of 0.4-1.6 mm, and pulse duration of 10 ms. After laser welding, the blocks were separated, and the penetration depth into each alloy was measured. The data were analyzed with the use of ANOVA at the p < 0.05 level of significance. The penetration depths were as follows: CP Ti (0.29-6.45 mm), Ti-6Al-4V (0.32-5.24 mm), Ti-6Al-7Nb (0.34-5.65 mm), Co-Cr (0.24-6.15 mm), and Type IV gold alloy (0.12-5.22 mm). The voltage and spot diameter affected the penetration depth into the metals tested. When the voltage increased and the spot diameter decreased, the penetration depth increased for each metal. Selecting suitable conditions for laser welding to obtain sufficient penetration depth for the optimal thickness of the metal is important when welding prostheses.

Dental Alloys↗

Ex vivo evaluation of human fetal membrane closure.

BACKGROUND AND OBJECTIVE: This study compares stress and leak point pressure of human fetal membranes following closure with suture, laser welding, or a new tissue sealant, SynthaSeal. STUDY DESIGN/MATERIALS AND METHODS: Samples of fetal membrane were bisected and repaired with suture, laser welding with albumin solders, or a tissue sealant. Representative tissue samples were assessed by histology. Anastomotic strength was evaluated by tensiometry. Additionally, leak pressure was measured after membrane samples were placed onto an infusion pump/pressure transducer, incised, and repaired as above. RESULTS: Membrane stress was strongest (P<0.001) for the tissue sealant group. Sutured samples were stronger than laser-welded samples. Membrane leak pressure was greatest for the tissue sealant group. The suture group demonstrated a higher leak pressure than the laser-welded group. CONCLUSIONS: Human fetal membranes were not suited for repair with laser welding under the conditions tested. A new tissue sealant, SynthaSeal, may provide a simple, effective method for membrane closure following fetoscopy, amniocentesis, and open fetal surgery.

Anastomosis, Surgical↗

Closure of rabbit ileum enterotomies with the argon and CO2 lasers: bursting pressures and histology.

In this study, we examined short-term strength and histology of experimental argon and CO2 laser-welded and control-sutured enterotomies in a rabbit model. Longitudinal 1.0-cm enterotomies were closed with the argon laser at 0.5 (n = 10) or 1.0 (n = 10) W power and a spot diameter of 2.8 mm resulting in energy fluences of 230 and 450 J/cm2, respectively. Similar enterotomies were closed using the CO2 laser at 0.5 (n = 10) or 1.0 (n = 10) W power and a spot diameter of 1.2 mm, resulting in energy fluences of 1,360 and 2,730 J/cm2. In all closures, continuous wave laser was delivered for 30 seconds. Using a pressure-monitored infusion system with normal saline, the pressure required to burst each weld as well as sutured controls (n = 10) was recorded approximately 1 minute following fusion. Mean bursting pressures for the argon laser at 0.5 W and 1.0 W were 34.1 +/- 19.4 mm Hg (mean +/- SD) and 17.3 +/- 8.3 mm Hg, respectively, and for the CO2 laser were 23.5 +/- 12.0 mm Hg and 31.8 +/- 15.6 mm Hg, respectively. Sutured controls leaked at 45.2 +/- 12.0 mm Hg. With the exception of argon-laser welds at an energy fluence of 450 J/cm2, which were less than sutured repairs, the bursting pressures for welded closures were not significantly different from the sutured controls (Student's t distribution, P less than .05). Histologic examination of both types of welds demonstrated a fibrin and red blood cell coagulum bridging the anastomosis, with some evidence of mild thermal injury at the mucosa.(ABSTRACT TRUNCATED AT 250 WORDS)

Anastomosis, Surgical↗

Primary closure of choledochotomy using CO2 laser: comparison with suture closure.

This study was designed to compare laser welding to suture closure of the common bile duct (CBD). A 12 mm linear choledochotomy was closed in 12 mongrel dogs using tissue welding low-energy CO2 laser. Tissue welding was accomplished at 5.0 w/cm2 for 120 sec. Twelve similar mongrel dogs (control) were treated with CBD closure using 5/0 Vicryl (polyglactin 910, Ethicon, Inc., Somerville, NJ) interrupted simple stitches. All animals were sacrificed at six weeks. Gross and histologic evaluation of the choledochotomy site were performed. There were no statistical differences in parameters of comparison in the two groups. These parameters were pre- and post-treatment measurements of liver function tests, stenosis, and dehiscence. However, it must be noted that there was a 33% (4/12) incidence of dehiscence and death in the CO2 laser welded choledochorrhaphy. This result, although not statistically significant, is clinically significant. We conclude that the tensile strength of CO2 laser welded CBDs must be optimized and that these results are preliminary and still unreliable to recommend for clinical adaptability.

Animals↗

Laser(-assisted) nerve repair. A review.

Over the last decade low power laser irradiation has been used to repair nerves by photothermal welding. Nineteen animal and clinical experimental studies of laser tissue welding of nerves are reviewed. Possible mechanisms of tissue welding are presented, together with the benefits, limitations, and possible future implications of several techniques used in laser nerve repair. The consensus of these studies is that nerve welding has some advantages over standard suture repair. These advantages include less neuroma- und scar formation and shorter repair time. The major disadvantage of laser nerve repair is the initial inferior tensile strength. In the future, use of dyes or proteins could enhance the welding process by reinforcing the union strength, thus may improve the results of this promising technique.

Animals↗

Dismembered nonstented ureteroureterostomy using the carbon dioxide laser in the rabbit: comparison with suture anastomosis.

End-to-end laser welding of transected nonspatulated ureters was compared to conventional spatulated suture anastomosis in 3 kg. rabbits. Nonspatulated sutureless ureteral welding was achieved in 12 rabbits with low energy levels from a carbon dioxide laser. In 12 other rabbits spatulated end-to-end anastomoses were performed with interrupted 7-zero chromic catgut sutures. Patency rate in the welded ureters was 92 per cent, compared to 83 per cent for the suture anastomoses. Histological changes in welded ureters were similar to the sutured ureters. Ureteral welding is achieved in far less time than suture anastomosis.

Animals↗

Low-profile dynamic splints: a solution to the friction problem.

To find a solution to the problem of friction between the nylon fishing line and the outrigger of a low-profile dynamic splint, a jig was manufactured to bend notches in 2.5-mm copper-coated welding rod. This type of outrigger was compared with an adjustable stainless-steel outrigger to determine which of the two types produces the least amount of friction. As one of each type of outrigger was covered with a layer of Teflon paint, four different outriggers were compared with each other: welding rod only, welding rod with Teflon, stainless steel with Teflon, and stainless steel only. Equal traction units were attached to each of the outriggers and the amount of elongation of a 50-mm tension spring was measured when a 300-g weight was hooked onto it. This was compared with the elongation of the same spring when no friction was present. The results show that the Teflon-covered outriggers displayed significantly (on a 5% level) less friction than did the uncovered outriggers. The stainless-steel outrigger with Teflon performed slightly better than the welding-rod outrigger with Teflon. However, there was no significant difference between these two outriggers, and because the welding-rod outrigger is cheaper and more readily available, it is recommended for clinical use.

Equipment Design↗

Laser-assisted fibrinogen bonding of umbilical vein grafts.

Despite success with autologous tissue welding, laser welding of synthetic vascular prostheses has not been possible. The graft material appears inert and fails to allow the collagen breakdown and electrostatic bonding that results in tissue welding. To develop a laser welding system for graft material, we repaired glutaraldehyde-tanned human umbilical cord vein graft incisions using laser-assisted fibrinogen bonding (LAFB) technology. Modified umbilical vein graft was incised transversely (1.2 cm). Incisions were repaired using sutures, laser energy alone, or LAFB. For LAFB, indocyanine green dye was mixed with human fibrinogen and the compound applied with forceps onto the weld site prior to exposure to 808 nm diode laser energy (power density 4.8 W/cm 2). Bursting pressures for sutured repairs (126.6 +/- 23.4 mm Hg) were similar to LAFB anastomoses (111.6 +/- 55.0 mm Hg). No evidence of collateral thermal injury to the graft material was noted. In vivo evaluation of umbilical graft bonding with canine arteries demonstrates that LAFB can reliably reinforce sutured anastomoses. The described system for bonding graft material with laser exposed fibrinogen may allow creation or reinforcement of vascular anastomoses in procedures where use of autologous tissue is not feasible.

Anastomosis, Surgical↗

Laser photoirradiation in digital flexor tendon repair.

This study evaluates tendon coaptation using Nd:YAG laser photoirradiation in an in vivo cockerel model. Using the intervinculum segments of the flexor profundus tendons, experimental transactions were performed. Tendon coaptation was then attempted using laser photoirradiation. Tendons were immediately examined for evidence of stable coaptation. After this assessment, specimens were excised and processed for electron microscopic examination and exposure to trypsin digestion. Despite varying multiple laser parameters, tissue welding was not observed. The subsequent functional and ultrastructural observations of irradiated tendon suggest that these changes are those of simple thermal denaturation. The results of this study suggest that when successful tissue welding has been observed in other tissue types, the mechanism is unlikely to be because of formation of intermolecular collagen bonds as hypothesized. An alternative hypothesis is that laser welding reflects photothermal coagulation of cytoplasmic peptides or nucleic acids liberated at the coaptation interface. This may explain the successful welding of cell-rich tissues such as bowel, vas deferens, and arteries and the observed failure of laser welding in collagen-rich but relatively hypocellular tendon.

Animals↗