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Long-term corneal astigmatism related to selected elastic, monofilament, nonabsorbable sutures.

The long-term decay of surgically induced corneal astigmatism following planned extracapsular cataract extraction has been studied in 395 patients who had limbal or scleral pocket incisions of 60 to 140 degrees. Limbal incisions were closed with a full-thickness shoelace closure; scleral pocket incisions, with a new, modified shoelace closure. Suture material was 10-0 nylon, 9-0 nylon, 10-0 polypropylene (Prolene), and 10-0 polyester (Mersilene). The nylon sutures demonstrated clinically significant hydrolysis beginning at five months (10-0) and 12 months (9-0). Because of the adverse hydrolytic effects, 10-0 nylon was eliminated from the scleral pocket closure group. The hydrolysis of 9-0 nylon caused excessive late astigmatic changes in patients who did not heal normally. Prolene and Mersilene showed no tendency toward hydrolysis; however, the elasticity of Prolene produced more against-the-rule change in astigmatism than desired even though it was stable over the long run. I stopped using nylon sutures in cataract (and keratoplasty) wound closures and switched to routine use of Mersilene.

Adult↗

Ultrasound-induced degradation of PLA and PLGA during microsphere processing: influence of formulation variables.

The effect of probe sonication during microsphere processing on the stability of various aliphatic polyesters based on lactic acid (PLA) and lactic/glycolic acid (PLGA) was investigated. The weight average molecular weight (Mw) of the polymers dissolved in dichloromethane (DCM) generally decreased with an increase in duration and/or intensity of the sonication process. The extent of the Mw-reduction was more pronounced with polymers of high initial Mw and high GA content. Polydispersity indices (PD=Mw/Mn) were nearly unchanged indicating that random chain cleavage is the likely degradation mechanism. From the observation that ultrasound-induced polymer degradation slightly increased in the presence of suspended drug particles acting as cavitation nuclei, it can be concluded that the mechanical stress induced by the implosive collapse of cavitation bubbles is at least partly responsible for the observed effects in PLA/ PLGA solutions. The use of ultrasound for the preparation of W/O, O/W and W/O/W emulsions exhibited different effects depending on the formulation and the type of emulsion. The preparation of W/O emulsions generally lead to Mw-changes comparable to those observed for the corresponding polymer solutions. Fatty acid free bovine serum albumin (BSAff) was found to protect PLA and PLGA against ultrasound-induced degradation in W/O-emulsions due to the formation of a semisolid interfacial film. A tremendous effect not only on the polymer Mw, but also on its PD could be observed, when ultrasound was used to emulsify an organic polymer solution or W/O-emulsion in an external aqueous phase. As this last finding was found to have rather important implications on the drug loading efficiency, the hydration, the degradation and the initial release characteristics of the resulting microspheres, it can be concluded that probe sonication can be a rather critical process step during the preparation of microspheres.

Chemistry, Pharmaceutical↗

Preparation and characterization of biodegradable poly-3-hydroxybutyrate-starch blend films.

Bacterial polyesters have attracted much attention as biodegradable biocompatible polymers. Poly-3-hydroxybutyrate, a microbially produced thermoplastic, has similar material properties to polypropylene. Its potential application as biodegradable and biocompatible plastics is well documented. However, due to high cost it is used mainly in biomaterials for medical applications. Materials with useful properties may result from blending bacterial polyhydroxybutyrate (PHB) with other polymers. In this paper, the compatibility of PHB with starch for improved properties and cost reduction is discussed. The thermal and mechanical properties of the blended films were studied by means of thermogravimetry, differential scanning calorimetry and an automated material testing system. The results revealed that blend films had a single glass transition temperature for all the proportions of PHB:starch tested. The nature of all combinations was found to be crystalline. The tensile strength was optimum for the PHB:starch ratio of 0.7:0.3 (wt/wt). The variation in tensile strength, Young's modulus, extension needed to break, thermal stability, glass transition temperature, melting temperature, for the different proportions of PHB:starch are discussed.

Bacteria↗

Comparison of two methods for reconstruction of the posterior cruciate ligament using a computer based method: quantitative evaluation of laxity, three-dimensional kinematics and ligament deformation measurement in cadaver knees.

The aim of this paper is to present a biomechanical comparison of two different methods for reconstruction of the posterior cruciate ligament in cadaver knees. We used an original computer-based method allowing precise calculation of three-dimensional (3D) knee kinematic parameters as well as the estimation of combined graft deformation (elongation-flexion-torsion). After isolated posterior cruciate ligament (PCL) dissection, double bundle and 'over-the-bottom' methods were performed successively on each knee using synthetic polyester ligaments. The effect of pre-tensioning was tested with the 'over-the-bottom' method. antero-posterior (A-P) and rotational laxity as well as 3D kinematics were recorded and analysed. Our computer based method allowed us to show that both reconstruction methods were equivalent in restoring A-P and rotational laxity as well as kinematic curves. Combined deformation of the prostheses was equivalent for both ligaments.

Aged↗

10-16 year results of Leeds-Keio anterior cruciate ligament reconstruction.

Following initial enthusiasm in the late 1980s, the use of artificial ligament substitutes for anterior cruciate ligament (ACL) reconstruction has declined. However, the disadvantages of donor site morbidity for autologous graft and concerns about cross-infection from allogenic material have resulted in a maintained interest in prosthetic ligament substitutes. This study presents the outcome of ACL substitution using the Leeds-Keio (LK) polyester ligament at a mean of 13.3 years (range 10-16 years). Outcome was assessed using the International Knee Documentation Committee score, the Lysholm knee score, Tegner activity scale and American Knee Society Score and laxity by clinical examination and the Stryker Knee Laxity Tester. Standardized radiographs were taken to assess for evidence of degenerative change. The objective scoring tests showed that all patients experienced some degree of symptoms from their knee but functional impairment varied widely. Of the group, 28% were known to have ruptured their LK ligament and 56% had increased laxity compared with their opposite knee but no correlation could be shown between rupture, increased laxity and poor function. Of particular concern, all post-operative knees had radiographic signs of degenerative change compared with a rate of 39% in the contralateral knees.

Adult↗

Tissue engineered cartilage generated from human trachea using DegraPol scaffold.

OBJECTIVE: To date numerous attempts have been undertaken to conquer the challenging problem of reconstructing long segmental tracheal defects, as yet without lasting success. Recently, employing concepts of tissue engineering in animals, cartilage-like constructs were transplanted in vivo. However, both the feasibility of fabricating tracheal replacements and the use of human tracheal chondrocytes (HTC) for tissue engineering are still under investigation. In this study, we optimized isolation and cultivation techniques for human tracheal cartilage, assessing the feasibility of seeding these cells onto a novel, three-dimensional (3-D) polyester-urethane polymer (DegraPol). METHODS: Human tracheal cartilage was harvested from the trachea of lung donors, digested in 0.3% collagenase II, and the condrocytes serially passaged every 7-9 days. Cells were also cultivated over agar plate during the total 6-8 weeks expansion phase. Thereafter, chondrocytes were seeded onto DegraPol (pore sizes 150-200 microm) with a seeding density of 2.4 x 10(7)/ml, and chondrocyte-polymer constructs maintained during in vitro static culture. RESULTS: HTC displayed stable proliferation kinetics in monolayer culture with positive expression of collagen type II. Following polymer seeding, both cellular proliferation and extracellular matrix (ECM) production, as measured by MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) and glycosaminoglycan assays, continued over extended culture. Active growth of HTC on DegraPol was further demonstrated by Alcian blue staining, with the histomorphological appearance of the construct resembling that of native cartilage. Scanning electron microscopy showed chondrocyte growth and ECM synthesis both on the surface and inside the porous scaffold, with a dense cell layer on the surface of the scaffold and a lower cell distribution in the scaffold's interior. CONCLUSIONS: The harvested chondrocytes from human trachea cartilage expand well in vitro and possess the ability to form new cartilage-like tissue when seeded onto DegraPol matrix. However, improved culture conditions are needed to permit cellular growth throughout cell-polymer constructs.

Absorbable Implants↗

Stent-graft therapy for subclavian artery aneurysms and fistulas: single-center mid-term results.

PURPOSE: To evaluate the potential of covered stents to replace surgery in the treatment of subclavian artery aneurysms and traumatic injuries. MATERIALS AND METHODS: Nine patients (five men, four women; age range, 20-83 years; mean, 54 years) with subclavian artery aneurysms (n = 5) or fistulas (n = 4) were treated with stent-grafts. All devices used were custom-made, consisting of polytetrafluoroethylene (PTFE)-covered Palmaz (n = 5), Wallstent (n = 2), Z stents (n = 8), or a polyester-covered Z stent (n = 1). One patient was lost to follow-up after 2 months. All others were followed up with clinical evaluation, computed tomography (CT), and/or ultrasound. RESULTS: All devices were deployed successfully with exclusion of the aneurysms and fistulas. There were two procedure-related complications (22%), consisting of groin pseudoaneurysms requiring surgical repair 3 and 9 days after the procedure. One of those patients required additional oral antibiotic therapy for a postsurgical groin wound infection. One patient developed a stenosis at 12 months, which required angioplasty. The stent-graft thrombosed in one patient because of a kink 2 months after placement, which was successfully treated by thrombolysis and placement of a Wallstent. The primary and secondary patencies are 89% and 100%, respectively, after a mean follow-up of 29 months (2-66 mo). CONCLUSION: Mid-term results of stent-graft therapy of subclavian artery aneurysms and fistulas are encouraging, with low morbidity and excellent clinical outcome.

Adult↗

Repositionable vascular occluder: experimental comparison with standard Gianturco coils.

PURPOSE: To evaluate the efficacy and recanalization rates of a newly designed vascular occlusion device. MATERIALS AND METHODS: The self-expanding vascular occluder was braided from fine nitinol wires and filled with polyester fibers. The device was delivered through a 6-F polyethylene introducing sheath with use of a delivery cable with a microscrew adaptor. Comparison was made between one occlusion plug and two Gianturco coils placed in the corresponding contralateral arterial segment in nine dogs and six pigs. The mean diameter of the targeted vessels was 4.8 mm +/- 0.8. Two animals were killed immediately after occlusion, and the remaining 13 animals underwent follow-up angiography at 1 week and/or 1 month, after which the animals were killed and the vessels were explanted for gross and histopathologic examination. RESULTS: Significantly shorter time-to-occlusion was achieved with the nitinol plug compared with two Gianturco coils (1.73 minutes +/- 1.28 vs 5.73 minutes +/- 6.18; P = .021). The recanalization rate at 1 month was also significantly lower (36.4% vs 81.8%, P = .027). The occlusion time was strongly dependent on the target artery diameter with Gianturco coils (R = .79, P = .0007), and not with the nitinol plug. CONCLUSION: The nitinol vascular occluder appears highly effective and reliable, with one plug resulting in significantly faster and longer lasting occlusions compared with two Gianturco coils. The new device can be repositioned prior to release, therefore allowing optimal positioning.

Alloys↗

Treatment of aortoiliac aneurysms with use of single-piece tapered stent-grafts.

PURPOSE: The authors describe their experience with the use of single-piece, tapered stent-grafts for the treatment of abdominal aortic or aortoiliac aneurysms. MATERIALS AND METHODS: Single-piece, tapered stent-grafts were placed in 15 patients for the treatment of abdominal aortic aneurysms with small distal necks (n = 13), and aortoiliac aneurysms (n = 2). There were 13 men and two women who ranged in age from 59 to 83 years (mean, 71 years). Usual open surgery was considered high risk in all patients because of comorbid medical conditions. The stent-grafts were made of Z stents covered with polytetrafluoroethylene (PTFE). Additional stent-grafts needed to treat perigraft leaks were made of Z stents covered with woven polyester (n = 5), Wallstents covered with PTFE (n = 2), Z stents covered with PTFE (n = 1), and a PTFE-covered Palmaz stent (n = 1). After stent-graft placement, the contralateral iliac artery was occluded by a blocking device composed of either a PTFE-covered Palmaz (n = 1) or Z stent (n = 13), and a femoral-femoral bypass was created. RESULTS: After placement of the stent-grafts, immediate perigraft leaks were observed in eight patients (53%). These were at the proximal (n = 5) or the distal end (n = 3). All, except one, were treated successfully with additional stent-grafts. The one failure was in a patient who developed aortic rupture after balloon dilation, requiring open surgical repair. Second procedures were required in four patients (27%), including three leaks treated successfully with coil embolization and/or a back-up stent-graft, and one stent-graft migration and thrombosis treated by thrombolysis and placement of an additional stent-graft. One patient died of respiratory failure 23 days after placement of the stent-graft. The mean follow-up was 12 months (range, 4-26 months). On the last follow-up, the aneurysms in the 13 living patients remained thrombosed. CONCLUSION: Treatment of aortoiliac aneurysms with use of single-piece, tapered stent-grafts is feasible in selected patients. The morbidity and mortality rates compare favorably with those of the open surgical procedures in a high-risk population. Further improvements in the technique and longer follow-up data are needed before this procedure can be recommended for the treatment of all aortoiliac aneurysms.

Aged↗

Abdominal aortic aneurysm treatment: preliminary results with the Talent stent-graft system.

PURPOSE: To evaluate the treatment of abdominal aortic aneurysm (AAA) with use of the endoluminal Talent stent-graft (TSG). PATIENTS AND METHODS: In 10 men, AAA treatment was attempted with use of the TSG. All patients presented significant surgical risk, with chronic obstructive pulmonary disease and coronary arteriopathy. The mean age was 65.5 years (range, 57-82 years). The mean proximal neck diameter was 25.8 mm (range, 21.6-34 mm). Five of the TSGs were straight tubes and five were bifurcated systems. The main body of the TSG is made of a polyester graft material mounted on a self-expandable nitinol frame. The bifurcated system uses polytetrafluoroethylene (PTFE) material for the legs and extensions mounted on a self-expandable nitinol frame. The bifurcated grafts used a 22 to 27-F introducer and the extensions, a 18-F introducer through a surgical cutdown technique. RESULTS: The TSG system was successfully implanted in nine patients and failed in one because of dislodgment after deployment, which required conversion to surgery. Four leaks occurred initially. One was sealed off with balloon dilation at the end of the procedure, one leak was treated with an additional extension, another leak disappeared spontaneously in 30 days, and the other leak required embolization 4 weeks after discharge. Seven patients were discharged on the third day after the procedure, and two patients were discharged at 1 and 2 weeks, respectively. Blood transfusion was necessary in three patients because of hematoma at the incision site in two patients, which required surgical revision for hemostasis, and because of transoperative bleeding in one patient. Follow-up time ranged from 2 to 15 months. The only death occurred 5 days postoperatively as a consequence of ischemic colitis and multisystem organ failure in the only patient who required surgery. CONCLUSION: Treatment of AAA with the TSG system is effective for aneurysm exclusion. This device seems to provide a good alternative to surgery in patients who are otherwise considered to be at high risk for complications after direct surgical repair, but it is not without risk of complications.

Aged↗

The nitinol vascular occlusion plug: preliminary experimental evaluation in peripheral veins.

PURPOSE: To compare the nitinol occlusion plug with standard stainless steel coils for the occlusion of moderate-size peripheral veins. MATERIALS AND METHODS: The nitinol plug is a braided multilayered vascular occlusion device filled with thrombogenic polyester fibers. It is self-expanding and can be recaptured into its 6-F introducing sheath for repositioning prior to detachment. Ten occlusion procedures were performed in five dogs from a retrograde transjugular venous approach. Five nitinol plugs (diameter: 7.4 mm +/- 0.5) were deployed in five femoropopliteal veins (diameter: 6.5 mm +/- 0.7; mean oversizing 14.6%). Two sequential Gianturco coils (diameter: 7.4 mm +/- 0.9) were deployed in the corresponding contralateral veins (diameter: 6.2 mm +/- 0.8; mean oversizing 19.6%). Follow-up venography was performed at 1 month, following which the animals were killed and the vessels were explanted. RESULTS: Time-to-occlusion was significantly shorter with the nitinol plug as compared to two Gianturco coils (4.2 minutes +/- 3.4 vs 25.6 minutes +/- 14.1, respectively [P < .03]). At 1 month all but one coil-doublet (80%) had recanalized or migrated, compared to only one nitinol occluder (20%, P < .04). Histopathologic examination of plug-occluded veins showed a uniform organized matrix and underlying intimal proliferative response. CONCLUSION: A single nitinol occluder resulted in significantly faster occlusion time and significantly lower recanalization or migration rate than two Gianturco coils, in moderate-size peripheral veins.

Alloys↗

Custom bifurcated stent-graft for abdominal aortic aneurysms: initial experience.

PURPOSE: To describe a custom bifurcated stent-graft for possible treatment of abdominal aortic aneurysm (AAA). MATERIALS AND METHODS: Five male patients (mean age, 76 +/- 6 years), who had AAA (mean diameter, 4.7 +/- 0.4 cm) and who were considered to be at high risk for conventional surgery, were treated with a custom modular bifurcated stent-graft constructed with bifurcated 24-mm x 12-mm (upper body diameter x iliac limb diameter) Cooley Veri-Soft Woven polyester grafts and Gianturco-Rösch Z stents. The stent-graft body was delivered through 20-22-F sheaths, and the contralateral iliac limb was delivered through a 16-F sheath by means of surgical exposure of the common femoral arteries. A flared distal limb extender (12 mm to 14 mm) was created for one patient to accommodate a large common iliac artery. RESULTS: Stent-grafts were successfully deployed without complications in all five patients. There were no proximal or distal leaks. A lumbar-to-inferior mesenteric artery leak was seen in one patient at 24 hours. At 6-month follow-up, all devices were intact, with complete exclusion and shrinkage of the aneurysm in four of five patients. Aneurysm size remained stable in the one patient with a lumbar-to-inferior mesenteric artery leak. CONCLUSION: A custom, bifurcated stent-graft was utilized for endovascular treatment of AAA. Long-term follow-up is necessary for the device.

Aged↗

Localization and characterization of acharan sulfate in the body of the giant African snail Achatina fulica.

Acharan sulfate is a glycosaminoglycan (GAG), having the structure -->4)-2-acetamido-2-deoxy-alpha-D-glucopyranose(1-->4)-2-sulfo-alpha-L-idopyranosyluronic acid (1-->, isolated from the body of the giant African snail Achatina fulica. This GAG represents 3-5% of the dry weight of this snail's soft body tissues. Frozen sections and polyester wax sections of the snail's body were stained by Alcian blue-periodic acid-Schiff's reagent (PAS) to localize acharan sulfate. Alcian blue staining indicated that GAG was mainly secreted into the outer surface of the body from internal granules. A highly mucous material was collected and treated and the acharan sulfate was recovered by ethanol and cetyl pyridinium chloride precipitation. Crude acharan sulfate was purified by DEAE-Sephacel ion-exchange chromatography. Depolymerization of intact mucus and purified acharan sulfate fractions by heparin lyase II (heparitinase I) from Flavobacterium heparinum produced an unsaturated disaccharide as a major product, establishing the repeating unit of acharan sulfate. These results demonstrate that mucus in the granule and secreted to the outside of the body is composed entirely of acharan sulfate.

Alcian Blue↗

[Characteristics and mechanisms of action of leukocyte depletion filters].

Since their creation, leukocyte depletion filters, used to prepare leukocyte-poor red cell or platelet concentrates, have been continuously evoluting: their volume has been reduced and their composition has been modified, polyester fibers have replaced cotton wool or cellulose acetate. In the same way, their capacity to remove leukocytes has increased. The mechanisms of cell separation are still unclear. Through published studies, different factors seem to be implicated, such as wetable surface of the filter, surface tension or charge density of fibers. It was also observed that removal of lymphocytes from red cell concentrates is rather based on trapping in the fiber network, and that removal of granulocytes, monocytes and platelets is partly due to activation and subsequent adhesion to the fibers. There have been few studies of the mechanism of leukocytes depletion from platelets concentrates.

Adsorption↗

Pressure-dependent Fourier transform infrared spectroscopy of a poly (ester urethane).

The effects of hydrostatic pressure upon (1) a segmented poly (ester urethane), (2) a hydrolytically degraded sample of the same polymer, and (3) models for the polyurethane and polyester segments in this polymer have been studied by Fourier transform infrared spectroscopy using high-pressure diamond anvil cells (DACs). The pressure responses of the vibrational frequencies of specific functional groups of the poly (ester urethane) in the 0-100-kbar range are compared with data for individual segment models and the partially degraded sample. The results indicated that the polymer is highly stable in this pressure regime, with no measurable degradation or phase changes. Differences in the pressure dependency of specific infrared bands between the poly (ester urethane) sample and the partially degraded sample are slight and consistent with changes in hydrogen-bonding interactions and shorter chain lengths in the degraded sample.

Diamond↗

Depth profiling of 4-acetamindophenol-doped poly(lactic acid) films using cluster secondary ion mass spectrometry.

The feasibility of using cluster secondary ion mass spectrometry for depth profiling of drug delivery systems is explored. The behavior of various biodegradable polymer films under dynamic SF(5)(+) primary ion bombardment was investigated, including several films doped with model drugs. The SF(5)(+) depth profiles obtained from these biodegradable polymer films showed very little degradation in secondary ion signal as a function of increasing primary ion dose, and it was discovered that the characteristic ion signals for the polymers remained constant for ion doses up to approximately 5 x 10(15) ions/cm(2). These results suggest that the polyester structure of the biodegradable polymers studied here allows for a greater ability to depth profile due to ease of main chain scission. Attempts were also made to depth profile through a series of poly(lactic acid) (PLA) films containing varying concentrations of the drug 4-acetamidophenol. The depth profiles obtained from these films show very little decrease in both the 4-acetamidophenol molecular ion and PLA fragment ion signals as a function of increasing SF(5)(+) primary ion dose. Similar results were obtained with theophylline-doped PLA films. These results show that, in some drug delivery devices, it is possible to monitor the distribution of a drug as a function of depth by using cluster primary ion beams.

Acetaminophen↗

Chloride concentration dependency of the electrogenic activity of halorhodopsin.

The capacitive photoelectric current responses of the halorhodopsins from Halobacterium salinarum (shR) and from Natronobacterium pharaonis (phR) were studied using membrane fragments adsorbed onto a thin polyester film. The electric current of shR was not much affected by ionic strength or cations present in the medium (Na+, K+, Li+, Mg2+, or Ca2+), but was greatly influenced by the Cl- concentration. It increased biphasically as the Cl- concentration increased from 0 to 5 M, then decreased and almost vanished at around 10 or 12 M. Apparent Kd's of about 0.1 and 6 M were deduced for the Kd of Cl- uptake sites. We had to assume a sigmoidal increase of Cl- binding with a Hill coefficient of about 8 at the cytoplasmic, Cl- release site(s). The half-maximum Cl- concentration for the sigmoidal binding was about 7.5 M. The electric current of phR had a maximum around 30 mM Cl- and biphasically decreased at higher Cl- concentrations. The apparent Kd for the Cl- uptake site was 5 mM. The biphasic decrease in the transport activity was explained by assuming a sum of simple hyperbolic type binding (Kd = 0.2 M) and sigmoidally increasing binding with a Hill coefficient of 10 on the cytoplasmic side. The half-maximum concentration of the latter cooperative binding was 5.6 M. This great difference between the apparent affinity of the release site of shR and that of phR can explain the previously reported difference between the Cl- dependency of their photocycles. These results also suggest that there may be multiple Cl- binding sites in the Cl- transport pathway. A simple sequence of Cl- transport steps based on a multiion channel model is proposed.

Adsorption↗

Modification of oligo(poly(ethylene glycol) fumarate) macromer with a GRGD peptide for the preparation of functionalized polymer networks.

A novel macromer, oligo(poly(ethylene glycol) fumarate) (OPF), was synthesized by the reaction between poly(ethylene glycol) (PEG) of molecular weight 1000 (PEG 1.0K) and fumaryl chloride. The oligo(PEG fumarate) (OPF 1.0K) was modified with a peptide known to modulate cellular functions, Gly-Arg-Gly-Asp (GRGD), after being activated with 4-nitrophenyl chloroformate (NPC). The determined yield of the GRGD modification in 0.1 M sodium bicarbonate buffer of pH 8.3 was 83% as determined by NMR measurements. The OPF 1.0K and the OPF 1.0K modified with GRGD were cross-linked with an unsaturated biodegradable polyester, poly(propylene fumarate) (PPF), by photopolymerization. The cross-linked PPF was characterized by Fourier transform infrared (FT-IR) spectroscopy and contact angle measurements. The equilibrium contact angle of water on the cross-linked PPF surface decreased with the incorporation of OPF 1.0K and the OPF 1.0K modified with GRGD. The results suggest that the OPF macromer can be used for the preparation of functionalized networks incorporating cell adhesion specific sequences.

Biopolymers↗