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The authors's personal experience using an earlier manufactured polyurethane-covered gel prosthesis is presented. Very long-term follow-up did not validate the author's initial enthusiasm. It is to be hoped that the newer polyurethane-covered implants will give more satisfactory long-term results.
The use of stacked polyurethane-covered mammary implants has proven useful in improving results in the correction of deficiencies of mammary form and projection that can occur in certain cases of congenital and acquired breast deformity. The method has been used in 57 patients (102 breasts). The rate of significant complications, including seroma, rash, infection, hematoma, and capsular contracture, has been low (1 to 6 percent). Polyurethane-covered implants will maintain their position when used in a stacked system because of their unique biophysical characteristics, which include tissue bonding and a high friction coefficient between the implant surfaces.
PURPOSE: To evaluate the results of nasolacrimal polyurethane stent implantation for the treatment of primary acquired nasolacrimal duct obstruction and the effects of obstructed nasolacrimal stent on subsequent dacryocystorhinostomy (DCR). METHODS: This study was designed as a nonrandomized, prospective clinical trial. Stent implantation was attempted in 53 obstructed lacrimal drainage systems of 47 patients. Stent placement was performed in a retrograde fashion through the external nare over a guide wire, which was introduced from the upper punctum. Occluded stents were removed either with nasal endoscopy or during DCR. External DCR surgery with silicone intubation was performed in cases with stent failure. RESULTS: The mean follow-up period was 23.4 months. The success rate of stent implantation was 60.4%, 37.5%, and 31.2% at 6-, 12-, and 18-month follow-up, respectively. Stent obstruction developed in 33 eyes. Twenty underwent external DCR with silicone intubation. During DCR surgery, varying degrees of chronic inflammatory reaction were detected in the lacrimal sac and nasolacrimal duct. The mean follow-up period after DCR was 10.3 months. Epiphora was relieved with DCR in all but one eye. CONCLUSIONS: The success rate of nasolacrimal polyurethane stent implantation for the treatment of primary acquired nasolacrimal duct obstruction is low and may induce inflammation and fibrous tissue formation. Although this may cause further difficulties in subsequent lacrimal surgery, epiphora could be relieved with meticulous technique.
AIMS: As a preventive strategy to inhibit fungal biofilm formation on medical devices, we planned experiments based on polyurethane loading with fluconazole plus pore-former agents in order to obtain a promoted release of the antifungal drug. METHODS AND RESULTS: Different functional groups including carboxyl, hydroxyl, primary and tertiary amino groups, were introduced in polyurethanes. Fluconazole was adsorbed in higher amounts by the most hydrophilic polymers and its release was influenced by the degree of polymer swelling in water. The entrapping in the polymer of polyethylenglycol as a pore former significantly improved the fluconazole release while the entrapping of the higher molecular weight porogen albumin resulted in a controlled drug release and in an improved antifungal activity over time. CONCLUSIONS: Among the tested in vitro models, best results were achieved with an hydrophobic polymer impregnated with 25% (w/w) albumin and fluconazole which inhibited Candida albicans growth and biofilm formation on polymeric surfaces up to 8 days. SIGNIFICANCE AND IMPACT OF THE STUDY: The combined entrapping in polymers of pore formers and an antifungal drug and the consequent controlled release over time is a novel, promising approach in the development of medical devices refractory to fungal colonization.
The pressure-induced calcium deposition in crosslinked polyurethane was studied. Two polyurethane systems, IPDI-PTMG/PPG-TMP and SMDI-PTMG/PPG-TMP were subjected to calcification under induced pressure. Calcium deposition in IPDI polymers was linear with the increase of soft segment (PTMG) content whereas in SMDI polymers the reverse trend was observed. Decreased phase mixing and hydrophilicity in the polymer (SMDI based) having increased soft segment content was attributed to the decreased calcification. The enhanced amount of calcium deposition under pressure indicates the possible influence of pressure on calcification.
Compliance mismatch between a host artery and an implanted graft has been suggested as a contributing factor to a small diameter graft failure. In this study, static compliance and dynamic compliance were defined and measured in vitro and in vivo for canine carotid arteries and 2 types of polyurethane grafts. Based on these compliance values, the circumferential modulus (E[theta]) and longitudinal modulus (Ez) were calculated. It was shown that grafts have constant moduli over a wide range of pressure while the moduli of carotid arteries increase significantly with increasing pressure (dynamic E[theta] from 0.20 to 1.32 MPa). Polyurethane grafts are nearly isotropic, with the modulus almost identical in each direction, while carotid arteries are anisotropic (E[theta]/Ez = 2-3). The dynamic moduli are generally higher than static values and are especially pronounced for arteries. Due to these different inherent characteristics, the compliance of a synthetic graft may match that of the host artery only in the circumferential direction and within a small pressure range. A stated limitation is therefore given for complete compliance matching. The results provide a rationale for identifying the degree of compliance match. These efforts may lead to better designed vascular grafts.
Chronic hemodialysis patients with failed native fistulas and/or synthetic arteriovenous grafts are usually dialyzed via surgically placed silicone jugular catheters such as the PermCath (Quinton, Seattle, WA, U.S.A.). We report a successful experience with the use of double lumen polyurethane central venous catheters placed percutaneously. Catheters with poor flows were replaced over a guidewire at the bedside. Eleven long-term hemodialysis patients failed arteriovenous access, 9 of them having had multiple attempts at fistulas and/or grafts. Seven of these patients had also failed peritoneal dialysis. They were dialyzed with polyurethane catheters for a mean of 681 +/- 280 days (range 282-1150 days), requiring a mean of 3.4 +/- 0.4 new venous punctures and 8.2 +/- 1.5 catheter changes over a guidewire over that period of time. Actuarial patient survival was 50% at 2 years, and mean urea reduction during dialysis was 64.2 +/- 1.7%. The septicemia rate was only 1.2 episodes per 1,000 catheter-days, but about 20% of patients experienced central venous occlusion, attributable to the use of subclavian catheter placement in 82% of the sites. The success of this technique and its elimination of the need for urokinase, radiologic interventions, and surgical placement warrant its consideration as an acceptable form of long-term vascular access, provided jugular placement allows reduced central venous occlusion rates.
A comparison of polyurethane and silicone cardiac pacing leads is presented. In comparing mechanical and electrical properties, friction coefficient and hydrolytic stability, both are highly qualified for use as electrode sheaths. The occurrence of surface cracking of polyurethane leads is examined. Several suggestions are proposed for dealing with the manufacture of new leads, the technique of implantation, and the follow-up required for successful surveillance.
Self-inhibition of bipolar DVI AV-sequential pacemakers has been attributed to electrode malposition, although the potential for self-inhibition due to current leakage has been recognized. Previous cases of current leakages due to insulation defects in bipolar VVI ventricular demand systems have usually presented as abnormal sensing or pacing function without a change to actual unipolar sensing and pacing. This article describes a case of disruption of the insulation of polyurethane bipolar atrial and ventricular leads by silk ligatures, resulting in unipolar atrial and ventricular pacing and self-inhibition of ventricular output of a DVI pulse generator. This case emphasizes the importance of avoiding any application of suture material directly to polyurethane leads. This case also emphasizes the importance of monitoring pacemaker artifact amplitude and axis in patient follow-up.
During a 44-month period, 105 Medtronic model 6972-58 polyurethane-insulated, bipolar ventricular pacing leads were implanted, of which 16 failed clinically at a mean of 20.5 months post-implant. Pacing dysfunction presented as either intermittent or complete loss of sensing and/or capture and, rarely, oversensing . Thirteen of the 16 patients were asymptomatic, and problems were detected in 11 instances during routine telephonic surveillance. At the time of lead replacement, low or widely fluctuating lead resistance values and high current drain were uniformly observed. The single lead capable of total extraction revealed rupture of both internal and external insulation. A brief summary of the currently much-discussed "polyurethane controversy" is presented, and the issue of patient management is discussed.
Polyurethane leads have been implanted in humans since 1977. Because of cases of stress cracking found in 1981, changes in the manufacturing process were made. Subsequent performance was excellent. There remains concern regarding the ability to predict accurately long-term performance. However, the advent of reliable, statistically accurate actuarial data coupled with accelerated tests predictive of human performance has restored confidence in the newer polyurethane lead technology.
During implantation of a bipolar dual chamber pacing system, two polyurethane leads were placed side-by-side through a single left subclavian vein puncture. The costoclavicular space was restrictive at the insertion site, and binding of the leads in this region made positioning difficult. Eleven months later, although pacemaker function remained normal, deterioration of both leads' insulation was noted on routine chest roentgenogram. Sixteen months after implantation, both leads failed. Insertion of polyurethane leads through a tight costoclavicular region should be avoided as subsequent mechanical stressing of the insulation may result in delayed lead failure.
The purpose of the present investigation was to evaluate the use of biodegradable membranes of polylactic acid or polyurethane for obtaining regeneration following treatment of circumferential periodontal defects in monkeys with the "guided tissue regeneration" procedure. Orthodontic elastic bands were placed around selected test and control teeth in 4 monkeys in order to induce breakdown of the periodontal tissues. When the destruction of the supporting tissues had progressed to a level corresponding to approximately half the length of the roots, the elastic bands were removed. After 1 to 8 months, full thickness flaps were raised on the buccal and lingual aspects of both test and control teeth. The exposed root surfaces were scaled and a notch was prepared in the root surface at the level of the reduced bone crest. Membranes of polylactic acid or polyurethane were placed circumferentially around the test teeth, while no membranes were placed around the control teeth. The tissue flaps were then sutured in a coronally displaced position. The surgical procedures and sacrifice of the animals were scheduled to provide observation times of 1, 4 and 8 months. During the healing period, various complications such as recession of the flap margins and exposure or exfoliation of the membranes were noticed. The histological analysis showed that the amount of new connective tissue attachment on test and control teeth did not differ and was restricted to the most apical part of the lesions. The bio-degradable membranes could be identified in a few specimens, and they were always surrounded by an epithelial layer.(ABSTRACT TRUNCATED AT 250 WORDS)
Investigations of respiratory symptoms among workers in a factory producing polyurethane foam included measurement of air pollution with amines and isocyanates and a simultaneous health investigation of the exposed workers. An increased bronchial reactivity to inhaled methacholine was found in the study group compared with two unexposed control groups. This finding, together with visual disturbances in the exposed group, were assumed to be caused mainly by the volatile amines. The concentrations of isocyanates in air were well below 0.005 ppm. The amine concentration was 1000 to 10 000 times higher than the isocyanate concentration. The most volatile amine, N-methylmorpholine, occurred in the air in concentrations higher than 10 ppm. The results indicate that not only the isocyanates but also the amines might well be responsible for respiratory symptoms among exposed workers in polyurethane foam production.
OBJECTIVES: To study the prevalence of symptoms from the eyes and the upper and lower respiratory tract, lung function, and immunological sensitisation towards isocyanates in pipelayers exposed to thermal degradation products from methylene diphenyl diisocyanate (MDI)-based polyurethane (PUR). MATERIAL AND METHODS: 50 presently active and 113 formerly active pipelayers were examined. Also, 65 unexposed workers were investigated for comparison. The one year prevalence of symptoms and smoking history (questionnaire data), lung function (vital capacity (VC) and forced expiratory volume in one second (FEV1), and atopy (positive skin prick tests towards standard allergens) were assessed among pipelayers and controls. For the pipelayers, the presence of work related symptoms and estimates of isocyanate and welding exposure were obtained from an interview. Skin prick tests towards specific isocyanate antigens and determinations of IgE-MDI and IgG-MDI in serum were also performed. RESULTS: The prevalence of episodes (more than once a month) of irritative eye symptoms, congestion of the nose, and soreness or dryness in the throat was much higher among the PUR pipelayers than among the controls. Most of the pipelayers with symptoms reported that these had started and occurred in relation to the PUR welding tasks. Presently active pipelayers with recent high PUR exposure showed a significant reduction of FEV1 compared with the controls. The estimated reduction, adjusted for smoking, was -0.3 l (P = 0.04). There was no confounding effect of ordinary welding. None of the pipelayers showed positive skin prick reactions against the specific isocyanate antigens used, or positive IgE-MDI, and only two had increased IgG-MDI. CONCLUSIONS: The findings indicate that exposure to thermal degradation products from MDI-based polyurethane has adverse effects on the mucous membranes and airways.
AIMS: To describe cause specific mortality and site specific cancer morbidity among workers employed in factories that produce polyurethane foams, and to determine if any part of the experience may be caused by occupation, in particular to investigate any association between respiratory disease (malignant and non-malignant) and exposure to diisocyanates. METHODS: The mortality (1958-98) and cancer morbidity (1971-94) experienced by a cohort of 8288 male and female employees from 11 factories in England and Wales engaged in the manufacture of flexible polyurethane foams were investigated. All employees were employed for at least six months with some period of employment in the period 1958-79. Two analytical approaches were used, indirect standardisation and Poisson regression. RESULTS: Compared with the general population of England and Wales, mortality from lung cancer in female employees was significantly increased (observed (Obs) 35, expected (Exp) 19.4, standardised mortality ratio (SMR) 181). A similar excess was not found for male employees (Obs 134, Exp 125.0, SMR 107). There were no significantly increased cause specific SMRs among the subcohort (n = 1782) with some period of isocyanate exposed employment. No significant positive trends were found between risks of lung cancer or risks of non-malignant diseases of the respiratory system and durations of "lower" or "higher" exposures to diisocyanates. CONCLUSIONS: The study has been unable to link isocyanate exposed employment either with risks of lung cancer or with risks of non-malignant diseases of the respiratory system. The increased SMR for female lung cancer is most likely caused by factors unrelated to the industry under study.
Antegrade placement of polyethylene and polyurethane stents was successfully achieved in 93 of 107 ureters (87 of 101 patients). These materials functioned adequately in 24 of 26 patients with indications for temporary stenting, including fistulas, strictures, and trauma caused by manipulation of calculi. Thirty of 61 patients with malignancy (49.2%) died within 6 months with their original stents in place; 12 survived to undergo elective cystoscopic stent replacement. Fifteen of the 61 patients had premature stent occlusions, which were treated by permanent nephrostomy in nine, replacement of the stent in five, and no further diversion in one patient with lymphoma. Encrustation and stent occlusion are problems during extended use of polyethylene and polyurethane stents. Long-term patency rates with newer stent materials remain to be documented and compared.
PURPOSE: To evaluate the long-term effectiveness of a polyurethane stent in the treatment of obstruction of the lacrimal sac and the nasolacrimal duct. MATERIALS AND METHODS: Fluoroscopically guided placement of a polyurethane nasolacrimal stent was evaluated in 283 obstructed lacrimal systems of 236 patients, with a follow-up period of more than 1 year (range, 52-134 weeks). The obstruction was at the junction between the lacrimal sac and the nasolacrimal duct in 192 systems, at the lacrimal sac in 52, and at the nasolacrimal duct in 39. The causes of obstruction were traumatic in 34 and idiopathic in 249 systems. RESULTS: Stent placement was technically successful in 270 systems (95%). At 7 days after stent placement, 235 (87%) of the 270 systems with successful placement demonstrated complete resolution of epiphora, 27 (10%) had partial resolution, and the remaining eight (3%) had no resolution. There was recurrence in 81 systems due to obstruction of the stent (n = 77) or obstruction of the common canaliculus (n = 4). The recurrence rate was much higher in the systems with obstruction at the lacrimal sac (64%) than in the systems with obstruction at the junction (26%) between the lacrimal sac and nasolacrimal duct or at the nasolacrimal duct (15%). CONCLUSION: Stent placement in the obstructed lacrimal system below the junction between the lacrimal sac and the nasolacrimal duct is valuable as an initial therapy.