Experimental tissue molding for soft-tissue reconstruction: a preliminary report

Molding of pig omentum to create external structures, such as the ear or penis, was performed using silicone rubber molds. The omentum was mobilized on its gastroepiploic pedicle and brought out through a fascial defect. The molds containing the omentum were placed beneath the skin and panniculus carnosus for 4 weeks. Split-thickness skin grafts were placed on both surfaces of the mold, and a series of synthetic materials was placed within the omentum to provide structural support. When an appropriate amount of tissue had been placed within the device, omentum took on the contour of the mold. Excessive pressure associated with swelling resulted in necrosis, while an inadequate amount of tissue gave poor contour. Omentum molded without any support material rapidly lost its contour once removed from the mold. Omentum molded in combination with a synthetic material maintained its shape up to 1 month after mold removal in a limited number of animals. This model was designed to create structures with the fine detail of a prosthesis using autologous tissue. This "prosthesis" made from living tissue could then be transferred secondarily to its recipient area by microvascular technique.     

Development of Biotechnology Products in Pre-filled Syringes: Technical Considerations and Approaches

A monoclonal antibody (mAb) product development case study is presented to address some of the issues faced during developing a pre-filled syringe (PFS) product for a biotherapeutic. In particular, issues involving incompatibility with silicone oil and a stability-based approach for selection of PFS barrel and tip cap components have been discussed. Silicone spiking studies followed by exposure to agitation stress or accelerated temperature conditions were used to check for incompatibilities of the mAb with silicone oil, a necessary product contact material in PFS. In addition, screening studies to compare various closure materials as well as syringe barrel processing methods were used to select the optimum closure materials as well as the correct syringe processing method. Results indicate that the model mAb formulation used was sensitive to high levels of silicone oil especially under accelerated temperature conditions resulting in formation of protein–silicone particles in the solution for samples that were spiked with the silicone oil. Agitation stress did not have any significant impact on the quality attributes tested. Samples stored in syringe barrels that were processed with sprayed-on silicone had higher levels of subvisible particles as compared to those that were processed with the baked-on process. The tip cap comparability study resulted in one tip cap material having superior compatibility among the three that were tested. The quality attribute that was most impacted by the tip cap materials was mAb oxidation. An approach for evaluation of primary packaging components during the development of pre-filled syringe presentations for biotechnology-based compounds has been highlighted.     

In situ evaluation of surface roughness and micromorphology of temporary soft denture liner materials at different time intervals

Objective

To perform an in situ evaluation of surface roughness and micromorphology of two soft liner materials for dentures at different time intervals.

Background

The surface roughness of materials may influence the adhesion of micro‐organisms and inflammation of the mucosal tissues. The in situ evaluation of surface roughness and the micromorphology of soft liner materials over the course of time may present results different from those of in vitro studies, considering the constant presence of saliva and food, the changes in temperature and the pH level in the oral cavity.

Materials and methods

Forty‐eight rectangular specimens of each of the two soft liner materials were fabricated: a silicone‐based material (Mucopren Soft) and an acrylic resin‐based material (Trusoft). The specimens were placed in the dentures of 12 participants (n = 12), and the materials were evaluated for surface roughness and micromorphology at different time intervals: 0, 7, 30 and 60 days. Roughness (Ra) was evaluated by means of a roughness tester. Surface micromorphology was evaluated by scanning electron microscopy.

Results

Analysis of variance for randomised block design and Tukey's test showed that surface roughness values were lower in the groups using the silicone‐based material at all the time intervals (P < .0001). The average surface roughness was higher at time interval 0 than at the other intervals, for both materials (P < .0001). The surface micromorphology showed that the silicone material presented a more regular and smoother surface than the acrylic resin‐based material.

Conclusion

The surface roughness of acrylic resin‐based and silicone‐based denture soft liner materials decreased after 7 days of evaluation, leading to a smoother surface over time. The silicone‐based material showed lower roughness values and a smoother surface than the acrylic resin‐based material, thereby making it preferred when selecting more appropriate material, due its tendency to promote less biofilm build‐up.     

A Method for Processing Light Microscopy Sections for Oriented Ultramicrotomy

A simple technique is described for processing optical microscopy sections attached to glass slides for ultramicrotomy in any desired plane. A silicone rubber mold with a central orifice is clamped onto the slide so that the orifice overlies the section. Routine processing and embedding procedures are carried out in the well formed by the orifice.     

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications.     

Multi-Scale Compliant Foot Designs and Fabrication for Use with a Spider-Inspired Climbing Robot

Climbing robots are of potential use for surveillance, inspection and exploration in different environments. In particular, the use of climbing robots for space exploration can allow scientists to explore environments too challenging for traditional wheeled designs. To adhere to surfaces, biomimetic dry adhesives based on gecko feet have been proposed. These biomimetic dry adhesives work by using multi-scale compliant mechanisms to make intimate contact with different surfaces and adhere by using Van der Waals forces. Fabrication of these adhesives has frequently been challenging however, due to the difficulty in combining macro, micro and nanoscale compliance. We present an all polymer foot design for use with a hexapod climbing robot and a fabrication method to improve reliability and yield. A high strength, low-modulus silicone, TC-5005, is used to form the foot base and microscale fibres in one piece by using a two part mold. A macroscale foot design is produced using a 3D printer to produce a base mold, while lithographic definition of microscale fibres in a thick photoresist forms the ＇hairs＇ of the polymer foot. The adhesion of the silicone fibres by themselves or attached to the macro foot is examined to determine best strategies for placement and removal of feet to maximize adhesion. Results demonstrate the successful integration of micro and macro compliant feet for use in climbing on a variety of surfaces.     

Immobilization of microbial cells in a mixed matrix of silicone polymer and calcium alginate gel: epoxidation of 1-octene by Nocardia corallina B-276 in organic media.

Immobilization of Nocardia corallina B-276 was examined for production of 1,2-epoxyoctane from 1-octene in the presence of n-hexadecane as the organic solvent. Hydrophobic silicone polymer was the most suitable material for entrapment of the cells. Coentrapment of aqueous reaction medium into the silicone polymer matrix improved the epoxide productivity. It was also effective to immobilize the cells in a mixed matrix composed of silicone polymer and calcium alginate gel involving the reaction medium. In the organic monophase, the amount of epoxide accumulated with the cells immobilized in an almost equivolumetric composite of both materials was 2 and 7 times the amounts in the silicone and alginate single matrices, respectively, and it became larger than with the free cells in the aqueous-organic two-liquid phase after a longer period of batch operation. The use of such an optimized composite matrix enabled us to perform a relatively simple operation of the continuous three-phase bioreactor.     

Variability in the properties of silicone gel breast implants.

Several generations of silicone gel breast implants have been produced by implant manufacturers. The primary material usually viewed as the base material in the manufacture of implants is polydimethylsiloxane. Polymeric reactions are notorious for their variability and nonuniformity. The elastomer used in different types of implants can have vastly different properties. Furthermore, the material properties associated with a particular type of implant can vary considerably from one lot to the next. Considering the various designs, styles, and manufacturing techniques associated with silicone gel implants, knowledge of the original properties of the implants before implantation is important in determining the effects of aging in vivo. This study was conducted to investigate differences in key mechanical and chemical properties of silicone gel breast implant materials. The two types of implants chosen for analysis were Silastic I and Silastic II control implants. Material property data were determined for both types of controls and significant differences were found in their values. Lot-to-lot variability was also investigated and found to be significant.     

Spatial comparison between wall shear stress measures and porcine arterial endothelial permeability

A better understanding of how hemodynamic factors affect the integrity and function of the vascular endothelium is necessary to appreciate more fully how atherosclerosis is initiated and promoted. A novel technique is presented to assess the relation between fluid dynamic variables and the permeability of the endothelium to macromolecules. Fully anesthetized, domestic swine were intravenously injected with the albumin marker Evans blue dye, which was allowed to circulate for 90 min. After the animals were euthanized, silicone casts were made of the abdominal aorta and its iliac branches. Pulsatile flow calculations were subsequently made in computational regions derived from the casts. The distribution of the calculated time-dependent wall shear stress in the external iliac branches was directly compared on a point-by-point basis with the spatially varying in vivo uptake of Evans blue dye in the same arteries. The results indicate that in vivo endothelial permeability to albumin decreases with increasing time-average shear stress over the normal range. Additionally, endothelial permeability increases slightly with oscillatory shear index.     

Precision casting: A new method in museum technology

By employing a version of industrial slush casting to conventional silicone rubber moulds and simultaneously applying internal pressure, accurate epoxy resin casts may be obtained, varying by less than 1.0% from the original. This is made possible by the construction of a machine which rotates the moulds through all axes. When applied to fossil crania these moulding and casting methods not only accurately reproduce the external morphology, but when access permits, simultaneously copy the endocranium. The dimensional accuracy is reproduced throughout for any given measurement. By using a variety of colouring methods these casts also produce replicas which closely approximate the appearance of the original.     

Effect of accelerated ageing and surface sealing on the permanent deformation of auto‐polymerising soft linings

doi: 10.1111/j.1741‐2358.2010.00419.x
Effect of accelerated ageing and surface sealing on the permanent deformation of auto‐polymerising soft linings Purpose: To compare the effects of different ageing methods on the permanent deformation of two permanent soft liners. Materials and methods: The materials selected were auto‐polymerising acrylic resin and silicone‐based reliners. Sealer coating was also evaluated. Sixty specimens of each reliner were manufactured (12.7 mm diameter and 19 mm length). Specimens were randomly distributed into 12 groups (n = 10) and submitted to one of the accelerated ageing processes. Permanent deformation tests were conducted with a mechanical device described within the American Dental Association specification number 18 with a compressive load of 750 gf applied for 30 s. All data were submitted for statistical analysis. Mann–Whitney test compared the effect of the surface sealer on each material and the permanent deformation of the materials in the same ageing group (p = 0.05). Kruskal–Wallis and Dunn tests compared all ageing groups of each material (p = 0.05). Results: The silicone‐based reliner presented a lower permanent deformation than the acrylic resin‐based reliner, regardless of the ageing procedure. The surface sealer coating was effective only for the thermocycled silicone group and the accelerated ageing processes affected only the permanent deformation of the acrylic resin‐based material. Conclusion: The silicone‐based reliner presented superior elastic properties and the thermocycling was more effective in ageing the materials.     

A new species of the conifer Frenelopsis from the Cretaceous of Sudan

Conifer fragments from the Lower Cretaceous of Sudan are preserved as internal and external silica moulds. Low viscosity silicone rubber has been used to prepare casts showing fine epidermal details which enable identification of the plants. One is I'seudofrenelopsis parceramosa (Fontaine) Watson, the other is described as a new species of Frenelopsis Schenk.     

The effect of breast implants on the radiographic detection of microcalcification and soft-tissue masses

Current implants for breast augmentation containing silicone gel, saline, or both can totally obscure mammographic detection of microcalcifications and soft-tissue masses. To investigate the possibility of developing a more radiolucent implant, radiographs were obtained of silicone shells that contained silicone gel, saline, silicone gel and saline, polyurethane-covered silicone gel, gelatin, sunflower oil, and peanut oil. All radiographs were obtained using a Siemens Mammomat by placing the implant over an American College of Radiology mammography phantom. Results were measured by the ability to visualize or resolve the artifacts in the mammography phantom. The silicone shell alone minimally altered artifact resolution. Silicone shells filled with silicone gel, silicone gel and saline, saline alone, polyurethane-covered silicone gel, and gelatin were equal in radiodensity and completely obscured all phantom artifacts. Silicone shells filled with peanut oil and sunflower oil had equal radiodensity and allowed visualization of large microcalcifications and some soft-tissue masses. Current implants used for augmentation mammaplasty can totally obscure mammographic detection of microcalcifications and soft-tissue masses. A more radiolucent breast implant is possible, and further research is needed to define the best filler material and test its biocompatibility.     

Arterial supply and venous drainage of the brain of the black bear (Ursus americanus). II. Intracranial microvasculature

A morphological study of the intracranial microvasculature of the Black bear (Ursus americanus) using vascular casts was undertaken. The object was to provide basic information regarding structural modifications of the microvasculature that might provide insight into the ability to cope with low blood flow states that occur during winter sleep. Vascular casts were prepared from 6 animals. The microvasculature of the brain disclosed characteristic features of the small vessels in mammals, including vascular sphincters of two types and numerous arterial and arteriolar anastomoses.     

Extended Latanoprost Release from Commercial Contact Lenses: In Vitro Studies Using Corneal Models

In this study, we compared, for the first time, the release of a 432 kDa prostaglandin analogue drug, Latanoprost, from commercially available contact lenses using in vitro models with corneal epithelial cells. Conventional polyHEMA-based and silicone hydrogel soft contact lenses were soaked in drug solution ( solution in phosphate buffered saline). The drug release from the contact lens material and its diffusion through three in vitro models was studied. The three in vitro models consisted of a polyethylene terephthalate (PET) membrane without corneal epithelial cells, a PET membrane with a monolayer of human corneal epithelial cells (HCEC), and a PET membrane with stratified HCEC. In the cell-based in vitro corneal epithelium models, a zero order release was obtained with the silicone hydrogel materials (linear for the duration of the experiment) whereby, after 48 hours, between 4 to 6 of latanoprost (an amount well within the range of the prescribed daily dose for glaucoma patients) was released. In the absence of cells, a significantly lower amount of drug, between 0.3 to 0.5 , was released, (). The difference observed in release from the hydrogel lens materials in the presence and absence of cells emphasizes the importance of using an in vitro corneal model that is more representative of the physiological conditions in the eye to more adequately characterize ophthalmic drug delivery materials. Our results demonstrate how in vitro models with corneal epithelial cells may allow better prediction of in vivo release. It also highlights the potential of drug-soaked silicone hydrogel contact lens materials for drug delivery purposes.     

老化和风干处理对蚓粪微生物学性质和结构稳定性的影响

蚓粪水稳性团聚体含量是结构稳定性表征之一,蚓粪中水稳性团聚体含量与其微生物学性质是紧密联系的,并且受到老化时问和有机质等因素的影响。国内将蚓粪水稳性团聚体含量与其微生物学性质联系,并结合施用不同有机物处理的研究很少见报道。研究通过室内短期培养试验,研究了在不同碳氮比有机物施用下蚓粪老化和风干处理对其微生物生物量、微生物活性和结构稳定性变化的影响。研究结果表明蚓粪经过老化处理后真菌数量、微生物生物量碳和微生物活性都显著降低。不同有机物的施用对蚓粪微生物学性质的影响主要表现在施用牛粪的处理中蚓粪细菌数量高于施用秸秆的处理,真菌数量相反。新鲜蚓粪经过老化处理后总的水稳性团聚体含量（〉0．053mm）增加,主要表现在水稳性大型大团聚体（〉2mm）含量增加,且在施用牛粪的处理中达到显著,可能是与牛粪比秸秆能分解产生更多的粘结物质有关。蚓粪的风于处理也显著增加各个处理中总水稳性团聚体含量,且风干后蚓粪中水稳性团聚体主要以微团聚体（0．25～0．053mm）形式存在。施用秸秆的处理中,新鲜蚓粪0．25～0．053mm粒级的水稳性团聚体含量显著高于施用牛粪的处理。经风干后,施用秸秆的处理0．25～0．053mm的水稳性团聚体含量显著低于施用牛粪的处理,而水稳性大型大团聚体含量显著高于施用牛粪的处理。蚓粪的不同粒级水稳性团聚体含量和蚓粪的生物学性质之间存在良好的相关性。     

Thermoresponsive heparin bioconjugate as novel aqueous antithrombogenic coating material

A novel thermoresponsive aqueous antithrombogenic coating material comprising a heparin bioconjugate with a six-branched, star-shaped poly(2-(dimethylaminoethyl)methacrylate) (6B-PDMAEMA), which has both thermoresponsive and cationic characters, was developed to reduce the thrombogenic potential of blood-contacting materials such as synthetic polymers or tissue-engineered tissues in cardiovascular devices. 6B-PDMAEMA with M(n) of ca. 24 kDa was designed as a prototype compound by initiator-transfer agent-terminator (iniferter)-based living radical photopolymerization from hexakis(N,N-diethyldithiocarbamylmethyl)benzene. Bioconjugation of heparin with 6B-PDMAEMA occurred as soon as both aqueous solutions were simply mixed to form particles. The particle size at 25 °C was less than several hundred nanometers in diameter under a heparin/6B-PDMAEMA mixing weight ratio of over 2.5. The particles were very stable because of the prevention of hydrolysis of 6B-PDMAEMA in its bioconjugated form. Because the lower critical solution temperature of the bioconjugate ranges from approximately 20 to 36 °C for the formation of microparticles, the coating could be done in an aqueous solution at low temperatures. The excellent adsorptivity and high durability of the coating above 37 °C was demonstrated on silicone and polyethylene films by surface chemical compositional analysis. Blood coagulation was significantly reduced on the bioconjugate-coated surfaces. Therefore, the thermoresponsive bioconjugate developed here appears to satisfy the initial requirements for a biocompatible aqueous coating material.     

Colour change of soft denture liners after storage in coffee and coke

doi:10.1111/j.1741‐2358.2009.00356.x
Colour change of soft denture liners after storage in coffee and coke This study was to evaluate the colour change of soft denture liners after thermocycling and storage in coffee and coke. Four liners, two silicone‐based (Sofreliner S and Reline GS) and two acrylic resin‐based (Soft Confort and Dentuflex), were evaluated in this study. Ten samples were obtained for each group. After 2000 cycles of thermocycling with baths of 5°C and 55°C, five samples were stored in coffee and the remaining samples in coke. The colour alteration was evaluated in a reflection spectrophotometer before and after thermocycling, and after 1, 3, 24, 48 and 96 h of storage in coffee and coke. Data were submitted to anova and Tukey’s HSD test (α = 0.05). Thermocycling and storage period represented a higher statistically significant influence for the resin liners than for the silicone materials. Coke did not influence the colour stability of the materials during storage. However, the coffee solution generated statistically significant colour alteration in the material Soft Confort. In the comparison between the coffee and coke solutions, there was no statistically significant difference for colour alteration only for the material Dentuflex. The silicone liners presented better colour stability following thermocycling and storage independent of the solution. The coffee solution was a statistically significant factor for colour alteration of the material Soft Confort.     

Microcirculation of the rat omentum studied by means of corrosion casts

A study of the microvasculature of the omentum using corrosion casts was undertaken. The object was to supply information regarding the morphology of the three-dimensional structure of the microvasculature, information which may be valuable in understanding the functions of the omentum. Corrosion casts of rat omenta were prepared and studied. Characteristic glomerular-like capillary beds were identified. Some of these beds were densely and others loosely arranged. Two types of capillaries made up these beds, tortuous and straight capillaries. These beds also showed a planate surface giving the impression that they lie directly under the mesothelium.     

Nanoscale investigation on adhesion of E. coli to surface modified silicone using atomic force microscopy

Bacterial adhesion on biomaterial surfaces is the initial step in establishing infections and leads to the formation of biofilms. In this study, silicone was modified with different biopolymers and silanes, including: heparin, hyaluronan, and self-assembled octadecyltrichlorosilane (OTS), and fluoroalkylsilane (FAS). The aim was to provide a stable and bacteria-resistant surface by varying the degree of hydrophobicity and the surface structure. The adhesion of Escherichia coli (JM 109) on different modified silicone surfaces was investigated by atomic force microscopy (AFM) and scanning electron microscopy (SEM). Mica, an ideal hydrophilic and smooth surface, was employed as a control specimen to study the effect of hydrophobicity and surfaces roughness on bacterial adhesion. AFM probes were coated with E. coli and the force measurements between the bacteria-immobilized tip and various materials surfaces were obtained while approaching to and retracting from the surfaces. A short-range repulsive force was observed between the FAS coated silicone and bacteria. The pull-off force of bacteria to FAS was the smallest among coated surfaces. On the other hand, heparin exhibited a long-range attractive force during approach and required a higher pull-off force in retraction. Both AFM and SEM results indicated that FAS reduced bacterial adhesion whereas heparin enhanced the adhesion compared to pure silicone. The work demonstrates that hydrophobicity cannot be used as a criterion to predict bacterial adhesion. Rather, both the native properties of the individual strain of bacteria and the specific functional structure of the surfaces determine the strength of force interaction, and thus the extent of adhesion.