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PubMed2001

[Effect of crystallization and branch on fine structure of orthorhombic in polyethylene].

The CH2 rocking bands are used as a probe to monitor the crystalline behavior of polyethylene segments in a series of poly (ethylene-octene) copolymers. High resolution and cryogenic FTIR spectra reveal that different composition and/or crystalline condition of the copolymers result in significant variation on the CH2 rocking bands including the change in peak position, band width and A730/A720. We conclude that side chain in the copolymer can influence the structure of the orthorhombic polyethylene crystallite although they can not enter the crystal lattice.

Crystallization↗
PubMed1990

Scanning electron microscopy analysis of polyethylene oxide hydrogels for blood contact.

Hydrogels are a class of synthetic material, composed of a polymer-water matrix and have been proposed as tissue substitutes and drug delivery vehicles. Polyethylene oxide (PEO) hydrogels were synthesized and used to produce coated wires and conduits for baboon blood compatibility studies. Blood-material interactions were studied both by Scanning Electron Microscopy (SEM) and 111In labeled platelet deposition. SEM processing modifications were first evaluated in order to reduce shrinkage and surface distortion incurred during sample preparation of these high water content materials. Pretreatment with 1% tannic acid reduced bulk shrinkage associated with critical point drying by 10-20%. This effect is small, nevertheless, it prevented major sample disruption. Coated guidewires were exposed to baboon blood for one hour in the inferior vena cava and conduits were placed for either 30 or 60 minutes in an ex vivo femoral arteriovenous shunt. Reference materials included Gore-tex, polyethylene and silica-free polydimethyl siloxane (PDMS). In the guidewire studies, 111In labeled platelet levels were highest on Gore-tex (6568.97 platelets/1000 microns 2) and large thrombotic deposits were well visualized by SEM. Formulations containing PEO had low levels of platelet deposition and little evidence of platelet activation was noted by SEM. Shunt studies demonstrated that materials of high PEO content and molecular weight had the lowest levels of platelet deposition. After 60 minutes of blood flow, mean platelet deposition on PDMS and Gore-tex was 50 and 1000 fold higher than on a network composed of 65% PEO 20,000 (p less than 0.05). SEM confirmed these findings.

Analysis of Variance↗
PubMed1998

The use of high-density polyethylene implants in facial deformities.

OBJECTIVE: To determine the usefulness of porous high-density polyethylene implants (Medpor) in a variety of facial skeletal deformities and subcutaneous defects, excluding those associated with acute maxillofacial trauma. DESIGN: Case series. SETTING: Academic tertiary care referral center in Baltimore, Md. PATIENTS: Thirty-four patients (age range, 20-74 years) with facial deformities requiring skeletal defect reconstruction or augmentation (38 cases), treated between January 1, 1992, and January 1, 1997. Follow-up ranged from 6 months to 40 months. MAIN OUTCOME MEASURES: Age, type and origin of the deformity treated, type of treatment, and complications. RESULTS: Types of deformities and defects treated include 7 patients with orbital defects (secondary traumatic or oncologic deformities), 8 with temporal fossa defects, 8 with frontocranial defects, 4 with maxillary or malar defects, 7 with calvarial bone graft donor site defects, 2 with microtia, and 2 with chin deficiency. Forty implants were placed. Complications included implant exposure in 4 patients and inappropriate augmentation in 1 patient (chin implantation). CONCLUSIONS: High-density polyethylene implants offer an excellent alternative to autogenous and other alloplastic materials in reconstruction of many facial defects and deformities. Advantages include its versatility and relatively ideal pore size that allows for excellent soft tissue ingrowth and coverage. Disadvantages include its rigid nature and difficulty in contouring to the surface of complex skeletal structures.

Adult↗
PubMed1985

Porous polyethylene in reconstructive head and neck surgery.

Porous polyethylene is a thermoplastic synthetic with a pore size ranging from about 100 micron to 200 micron. In addition to other materials, it is used for alloplastic replacement of auditory ossicles. Experimental and clinical experience in our department in recent years has shown that porous polyethylene, due to its good formability, tissue tolerance, and stability is suitable for use in reconstruction of other cartilaginous and bony structures. Therefore, it has been used successfully in reconstruction of the outer ear, in repairing defects of the facial skull, and in rebasing paralyzed vocal folds. Its use in the inner nose to replace the cartilaginous septum or rebase the mucosa in ozena, however, cannot be recommended. The suitability of the material for alloplastic tracheal replacement is investigated experimentally.

Ear, External↗
PubMed1991

Polyethylene oxide gel. A new intranasal dressing after septorhinoplasty.

The purpose of intranasal dressings after septorhinoplasty is to absorb secretions, stop bleeding, act as an internal splint, discourage adhesions, and facilitate nasal hygiene. The ideal dressing should conform to the irregularities of the nasal cavity and resist adherence to the wounds of the nasal lining so it can be easily removed. It should be nonirritating, antiseptic, and economical. The failure of previously reported dressings in one or more of these requirements led us to evaluate a new alternative. Polyethylene oxide gel (Vigilon) was identified as a potential improvement and investigated in 48 patients over 17 months. There were no significant complications. Polyethylene oxide gel appears superior to previously described dressings, primarily because of comfort for the patient at removal.

Bandages↗
PubMed1996

Characterization of submicron polyethylene wear debris from synovial-fluid samples of revised knee replacements using a light-scattering technique.

The objectives of this study were to determine whether submicron-sized ultra-high-molecular-weight polyethylene (UHMWPE) wear debris was present in synovial fluid surrounding knee implants, and to report on the utility of a light-scattering technique for the in situ analysis of submicron-sized wear debris. The measured light-scattering coefficients of the implant synovial fluid samples were significantly larger than the coefficients of the control samples (p < 0.0001). The enhanced light scattering was attributed to the presence of submicron UHMWPE particles. This is consistent with light-scattering considerations and a Raman spectroscopy survey of synovial fluid. The mean particle volume fraction of UHMWPE was 1.11 x 10(-5) cm3/mL for the six implant samples, with mean particle diameters in the range of 200-300 nm. The UHMWPE volume fractions were found to differ by a factor of 2 between the osteolytic and nonosteolytic cases. The current findings warrant further work to determine the role of submicron polyethylene debris in the wear mechanisms of biomaterials and in the development of osteolysis following total knee replacement.

Adult↗
PubMed1997

Separation and characterization of polyethylene wear debris from synovial fluid and tissue samples of revised knee replacements.

A study was made of in vivo-generated polyethylene wear particles as separated from synovial fluid samples and from tissue samples surrounding total knee arthroplasty. A comparison of particle size and morphology between the two particle groups was made to assess any effects of selective tissue capture, and macrophage encapsulation and digestion. In addition, a Raman spectroscopy technique was evaluated that enables positive identification of individual wear particles. The particles of the same size range found in the synovial fluid and tissue samples exhibited a comparable morphology. Notably, submicron-sized debris was present in both the synovial fluid and tissue samples surrounding knees with osteolysis. The novel micro-Raman analysis of individual particles was successful in the categorizing of wear debris as polyethylene or nonpolyethylene.

Aged↗
PubMed1998

Influence of sterilization by gamma irradiation and of thermal annealing on creep of hydroxyapatite-reinforced polyethylene composites.

Sterilization of medical devices by gamma (gamma)-irradiation is common. The effect of irradiation on a bone replacement material, HAPEX (hydroxyapatite-reinforced polyethylene composite), was investigated. Unfilled and hydroxyapatite-filled polyethylene at 0.20 and 0.40 filler volume fractions were gamma-irradiated at 2.5 Mrad, and the modified properties were studied by differential scanning calorimetery, isochronous experiments, and creep tests. The effect of thermal annealing of the samples from 140 degrees C also was examined. The results suggest that both irradiation and annealing increase creep resistance of the materials. These are associated with the formation of crosslinks and an increase in crystallinity, respectively.

Biocompatible Materials↗
PubMed1998

Adhesion of Staphylococcus epidermidis and transposon mutant strains to hydrophobic polyethylene.

Staphylococcus epidermidis capsular polysaccharide adhesin (PS/A) and slime were studied as possible mediators of bacterial adhesion to NHLBI polyethylene (PE) under dynamic flow. This putative interaction was examined by quantifying the adhesion of M187 (PS/A+, slime+) parent strain and isogenic transposon mutant strain sn3 (PS/A-, slime-) to polyethylene (PE) under a range of physiologic shear stress conditions in both phosphate-buffered saline (PBS) and 1% platelet poor plasma (PPP). No significant differences in adhesion were noted between the M187 and sn3 strains in either test medium. However, adhesion of both strains in 1% PPP was decreased 75-95% compared to adhesion in PBS. In PBS, adhesion was shear stress dependent from 0-15 dyne/cm2, after which adhesion was comparatively shear stress independent. Adhesion in 1% PPP was independent of shear stress. Epifluorescent imaging of both strains labeled for slime confirmed the presence of slime on the surface of M187 and suggested that PS/A and slime promote the formation of large aggregates, as aggregates were totally absent in the images of the sn3 strain. The results suggest that PS/A and slime do not mediate S. epidermidis adhesion to bare PE or PE with adsorbed plasma proteins, but may be necessary for intercellular adhesion, which is important for biofilm formation.

Bacterial Adhesion↗
PubMed1998

Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax.

Although bone wax is effective at achieving hemostasis, it is nonresorbable, causes a foreign body reaction, and inhibits osteogenesis. We report development of a polyethylene glycol/microfibrillar collagen composite (PEG/MFC) that has inherent hemostatic qualities, is biodegradable, and is compatible with bone repair. PEG/MFC composite (n = 42) was placed in 5 mm cranial defects in New Zealand white rabbits. Hemostasis and healing were compared to unfilled defects (n = 32) and defects filled with standard bone wax (n = 10). Both PEG/MFC and bone wax handled well and stopped bleeding. The polyethylene glycol component was resorbed by 8 h, and the microfibrillar collagen was resorbed over 2 months, eliciting only a minor inflammatory response during the first month. Defects filled with the PEG/MFC composite showed similar amounts of bony regeneration as did unfilled control defects. At 4 weeks, healing bone accounted for 43 +/- 13% in those treated with PEG/MFC and 47 +/- 19% defect area in untreated holes. In contrast, less than 1% of the area was bone in defects filled with bone wax (p < 0.05). PEG/MFC composite provided excellent bony hemostasis and did not inhibit bone growth.

Animals↗
PubMed1998

Improved local delivery of TGF-beta2 by binding to injectable fibrillar collagen via difunctional polyethylene glycol.

To overcome rapid diffusion and clearance from the implant site and to increase stability, recombinant transforming growth factor beta2 (TGF-beta2) was covalently bound to injectable bovine dermal fibrillar collagen (FC) and its activity compared to admixed TGF-beta2. Covalent binding was achieved in a two-step procedure: First, TGF-beta2 was reacted with the difunctional polyethylene glycol (PEG) linker, and then the PEG-attached TGF-beta2 (PEG-TGF-beta2) was bound to the fibrillar collagen (FC-PEG-TGF-beta2). Initial binding of TGF-beta2 to difunctional succinimidyl glutarate (D-SG-PEG) or succinimidyl propionate polyethylene glycol (D-SE-PEG) linkers was completed after reacting for 8 or 10 min as monitored by reverse-phase high-performance liquid chromatography. After reaction with injectable fibrillar collagen, extraction of unbound PEG-TGF-beta2 and Western blot analysis, using a TGF-beta specific antibody, demonstrated that at least 85% of the TGF-beta2 was bound to the fibrillar collagen. The activity of PEG-TGF-beta2 was fully stable in phosphate-buffered saline at 4 degrees C and 37 degrees C for at least up to 4 weeks. Unmodified TGF-beta2 mixed with fibrillar collagen was completely inactivated after 1 week of incubation, as measured by the mink lung epithelial cell (Mv1Lu) growth inhibition assay. Formulations of FC-PEG-TGF-beta2 containing 40 microg/ mL TGF-beta2 were implanted subcutaneously into rats and analyzed after days 7, 21, and 42. All TGF-beta2-containing formulations showed the TGF-beta typical fibroblastic response at the day 7 time point. Covalent binding of TGF-beta2 to collagen with both difunctional PEG crosslinkers resulted in a significantly stronger and longer-lasting TGF-beta2 response than that observed with admixed formulations of collagen and TGF-beta. The TGF-beta response with FC-PEG-TGF-beta2 lasted up to day 42 but was not seen after day 7 for TGF-beta2 admixed to FC. These findings clearly demonstrate that TGF-beta2 remains fully active after being covalently bound to collagen via difunctional PEG. In addition, covalent binding potentiates and prolongs in vivo TGF-beta responses and stabilizes the TGF-beta in vitro. Results suggest that this method of formulation could be useful to stabilize and deliver similar peptide growth factors or biologically active agents.

Animals↗
PubMed1999

Multitechnique characterization of articular surfaces of retrieved ultrahigh molecular weight polyethylene acetabular sockets.

The articular surfaces of 10 retrieved ultrahigh molecular weight polyethylene acetabular sockets were studied by optical microscopy, X-ray fluorescence spectrometry, multiple internal reflectance FTIR spectroscopy, scanning electron microscopy, and wavelength dispersive X-ray microanalysis. The results revealed characteristic wear patterns including polishing, scratching, pitting, cratering, folding, shredding, burnishing, cracking, embedding of particles, and development of acquired biofilms with various degrees of mineralization. The biofilms formed were mainly of proteinaceous origin, and mineralized regions were composed of calcium phosphates with carbonate impurities. The crystallinity of the polyethylene at the articular surfaces was enhanced compared to the bulk, which was possibly due to the cold work produced in vivo. The mineralized regions were classified into two groups based on the grey levels of the backscattered images obtained. The high-contrast regions that were mainly composed of Ca and P with traces of Al and Si were associated with bone fragments; the low-contrast regions composed of K, Na, Ca, Mg, Si, Al, Fe, Cl, and P were associated with acquired biofilm calcification, which implies the active engagement of biofilms in the long term performance of acetabular sockets in vivo.

Aged↗
PubMed1995

The use of polyethylene glycol-modified interleukin-2 (PEG-IL-2) in the treatment of patients with metastatic renal cell carcinoma and melanoma. A phase I study and a randomized prospective study comparing IL-2 alone versus IL-2 combined with PEG-IL-2.

BACKGROUND: Conjugation of polyethylene glycol to recombinant human interleukin-2 (IL-2) results in a compound, polyethylene glycol-modified IL-2 (PEG-IL-2) that retains the in vitro and in vivo activity of IL-2, but exhibits a markedly prolonged circulating half-life. In mice, one dose of PEG-IL-2 results in tumor regression comparable to that achieved with multiple bolus doses of IL-2. Based on these preclinical studies, a Phase I study with PEG-IL-2 was undertaken in patients with metastatic renal cell carcinoma (RCC) and melanoma. Then, to exploit the higher peak levels attained with IL-2 and the improved trough levels of PEG-IL-2, a combination regimen beginning with bolus IL-2 followed by low dose maintenance PEG-IL-2 was devised and tested for efficacy. METHODS: Patients with measurable metastatic melanoma or RCC were entered in a Phase I dose escalation trial of PEG-IL-2 given once a week by intravenous bolus. This trial then was repeated using a twice-a-week schedule. After determining the maximum tolerated dose (MTD) and a safe outpatient regimen for PEG-IL-2, a hybrid regimen combining an initial high dose IL-2 cycle followed by chronic maintenance with weekly PEG-IL-2 was devised. This regimen was compared with a standard regimen consisting of two cycles of high dose unconjugated IL-2 in a randomized prospective clinical trial. RESULTS: When given by intravenous bolus once a week, the MTD of PEG-IL-2 was 12 million IU/m2, with toxicities similar to those of unconjugated IL-2. A twice-a-week schedule was less well tolerated. Of 28 patients given 32 treatment courses at varied dose levels, there were two partial responses and one minor response. A total of 124 patients with metastatic melanoma or RCC were randomized to either standard unconjugated IL-2 therapy or the hybrid regimen. There was no treatment-related mortality in either arm, and the use of PEG-IL-2 resulted in a significant decrease in the need for intensive-care-unit care. The response rates (partial response and complete response) for patients with RCC and melanoma were 19% and 15%, respectively, for IL-2 alone and 17% and 11%, respectively, for the IL-2 and PEG-IL-2 combination. CONCLUSIONS: The combination of high dose IL-2 followed by PEG-IL-2 is a well tolerated regimen with significant activity against RCC and melanoma, but it shows no significant increase in antitumor activity compared with high dose IL-2 alone.

Adult↗
PubMed2002

Adeno-associated virus-mediated osteoprotegerin gene transfer protects against particulate polyethylene-induced osteolysis in a murine model.

OBJECTIVE: Osteoprotegerin (OPG), a natural negative regulator of osteoclastogenesis and bone resorption, may be a potential therapeutic agent for treatment of osteolysis-associated prosthetic joint loosening. Using an in vivo adeno-associated virus (AAV)-mediated gene transfer technique, this study was designed to evaluate the protective effects of OPG transgene against orthopedic wear debris-induced bone loss in a murine model of osteolysis. METHODS: Bone tissue was implanted into established pouches on BALB/c mice, followed by the introduction of ultra-high-molecular-weight polyethylene (UHMWPE) particles to provoke inflammation and osteolysis. The viruses encoding human OPG gene (rAAV-hOPG) or beta-galactosidase marker gene (rAAV-LacZ) were injected into the air pouches, and the tissue was harvested 7 days after viral infection for histologic and molecular analyses. RESULTS: Successful transgene expression was confirmed by the detection of OPG by enzyme-linked immunosorbent assay and positive X-Gal staining of pouch tissue (LacZ). Real-time polymerase chain reaction indicated significant diminishment of messenger RNA expression of osteoclast markers in OPG-transduced pouches compared with rAAV-LacZ-transduced pouches. The transduction and expression of OPG also markedly decreased the gene copies of the biologic receptor activator of nuclear factor kappaB. The expression of OPG in the bone-implanted pouch reduced bone calcium release by a mean of 39% compared with the calcium release in the other 2 groups. Computerized image analysis revealed that expression of OPG significantly protected against bone collagen loss. CONCLUSION: OPG gene transfer mediated by rAAV effectively protects against particulate polyethylene-induced bone resorption in this experimental model. Data suggest that gene transfer using rAAV-OPG may be a feasible and effective therapeutic candidate to treat or prevent wear debris-associated osteolysis and aseptic loosening.

Animals↗
PubMed1982

Specificity in systemic lupus erythematosus of antibodies to double-stranded DNA measured with the polyethylene glycol precipitation assay.

Recently, a new radioimmunoassay--the polyethylene glycol (PEG) assay--was introduced to measure antibodies to double-stranded (ds) DNA. In this method, polyethylene glycol precipitation of formed 3H-DNA/antiDNA complexes is used instead of the ammonium sulfate precipitation used in the Farr assay. In contrast to the Farr assay, with which only high-avidity antibodies to dsDNA are detected, the PEG assay also reportedly measures anti-dsDNA of relatively low avidity. We studied whether this gain in antibody measurement results in loss of specificity for systemic lupus erythematosus. When the PEG assay was applied to a selected panel of 440 sera from patients with various well-defined autoimmune diseases and to a group of 197 normal human control sera, matched sex and age to the patients, the method was found to be fairly specific for systemic lupus erythematosus, although the sera from some patients with myasthenia gravis and some with autoimmune liver disease were also found positive. Screening of 352 additional serum specimens, sent to our laboratory for diagnostic reasons, revealed that, with the PEG assay, an extra population of relatively low-avidity antibodies to dsDNA--missed by the Farr assay--was detected. Upon clinical evaluation, we found that the patients in whom such antibodies were detected generally fulfilled a number of the preliminary criteria of the American Rheumatism Association for systemic lupus erythematosus, but that this diagnosis often was not made. We claim that the presence of low-avidity antiDNA characterizes a milder form of the disease in which patients often show only a single clinical feature of the disease. We conclude that results of the PEG assay add valuable diagnostic and clinical information to results obtained by the Farr assay.

Antibody Specificity↗
PubMed1988

Comparative study of shortwave heating patterns in phantoms with polyethylene and silk partitions.

Specific absorption rate (SAR) and effective depths of heating patterns induced by a shortwave, pancake diathermy applicator in fat-muscle phantom are measured. Midplane partitions of polyethylene and silk screen with and without contact chemicals are used. Thermographically obtained SAR data show nearly the same value for silk-screen partitions with and without contact chemicals and slightly lower values with polyethylene partitions, provided that the partition midplanes are tightly pressed against each other. Thermometry data indicate that for low-power exposures the major error in thermographic measurements obtained after termination of heating is due to thermal diffusion and not evaporative cooling in the opened midplane of the phantom.

Diathermy↗
PubMed2004

ULTRAMINE: a high-capacity polyethylene-imine-based polymer and its application as a scavenger resin.

The synthesis of a novel high-loading polyethylene-imine resin (ULTRAMINE) is described, and its application as a scavenger resin in various acylation reactions is demonstrated. The inverse suspension polymerization technique was used for the synthesis of well-defined spherical polymer beads. Polymer beads with different cross-linking densities were synthesized according to the degree of acryloylation of the polyethylene-imine polymer. The resin was characterized by various spectroscopic techniques. The size, shape, and morphological features of the resin were demonstrated by microscopy. The resin showed excellent swelling properties in both polar and nonpolar solvents. The chemical stability of the resin in various reagents and solvents was investigated and monitored by IR spectroscopy. The mechanical stability of the beads was determined by a single-bead compressive experiment. The ULTRAMINE beads can be used as an excellent scavenger for excess acylating reagent, as demonstrated for a variety of reactions. ULTRAMINE-red resin was derived from ULTRAMINE through exhaustive reduction of the amide carbonyl groups to yield an all-amine resin.

Imines↗
PubMed2003

A Phase I-II trial of polyethylene glycol-conjugated L-asparaginase in patients with multiple myeloma.

BACKGROUND: Multiple myeloma remains an incurable disease. New agents are needed to improve therapy for patients with this disease. Previous investigators evaluated in vitro sensitivity of myeloma cells to polyethylene glycol-conjugated L-asparaginase (PEG-L-asparaginase) using the human tumor clonogenic assay. Of the 19 myeloma samples evaluated, 63% were inhibited at 0.075 IU/mL, and 74% were inhibited at 0.75 IU/mL. PEG-L-asparaginase is a form of Escherichia coli-derived L-asparaginase that is bound covalently to polyethylene glycol. Compared with the native form, it has a longer half-life and is less likely to cause allergic reactions. METHODS: The authors conducted a Phase I-II trial using PEG-L-asparaginase as a single agent in patients with recurrent and/or refractory multiple myeloma. RESULTS: Twenty-two patients received a median of two doses of PEG-L-asparaginase. In the 17 patients who are evaluable for response, a complete response was observed in one patient after four doses, and stable disease was observed in eight patients. Progression of disease was the reason for termination from study in the remaining eight patients. The median survival was 31.7 months, with four patients who were alive at 72 months after the start of therapy. Grade 3-4 toxicity was noted by the PEG-L-asparaginase 2000 mg/m(2) level. Severe allergic reactions were noted only at the highest dose level. CONCLUSIONS: Current data suggest that the maximal tolerated dose for single agent PEG-L-asparaginase in relapse/refractory multiple myeloma patients is 1000 mg/m(2) every 4 weeks. We could not identify any correlation between dose, plasma level and response. In this advanced group of patients we noted stable disease and/or response in 52% of evaluable patients. PEG-L-asparaginase has lower tolerance when used in the standard dosage as a single agent in this group of patients. We therefore recommend further studying of PEG-L-asparaginase dose of 1000 mg/m(2) on alternate weeks with steroids and/or other immune modulators.

Adult↗