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.     

Needle-free jet injection of DNA and protein vaccine of the far-eastern subtype of tick-borne encephalitis virus induces protective immunity in mice

Tick-borne encephalitis virus (TBEV) causes severe encephalitis in humans. It is endemic in one area of Japan; however no commercial vaccine is available in that country. In this Japan-based study, the efficacy of subviral particles (SPs) of TBEV administered by needle-free injector was evaluated as a vaccine candidate. Inoculation with SP-encoding DNA by needle-free injector induced neutralizing antibodies more efficiently than when administered by needle and syringe, and mice vaccinated with one dose by needle-free injector survived challenge with a lethal dose of TBEV. These results suggest that SP vaccines delivered by needle-free injector can protect against TBEV infection.     

Dynamics of a relativistic electron beam in the vicinity of a spherical injecting body in space plasma

The dynamics of a relativistic electron beam in the vicinity of an injector in the form of a spherical conducting body in a space plasma is considered. An equation describing the radial evolution of a steady electron beam with a self-similar density profile in the electric field of the injector is formulated. A method for calculating the radial evolution of a relativistic electron beam in the vicinity of an injector is developed. The method is based on the numerical integration of a set of ordinary differential equations for the beam radius and field potential in the space charge region under the relevant boundary conditions at the injector surface. Results are presented from numerical simulations of the radial dynamics of an electron beam in the vicinity of a spherical screen system for neutralizing the electric charge carried away by the beam. The numerical results show that the electric field of the injector hastens the beam expansion.     

Blood glucose and free insulin levels after the administration of insulin by conventional syringe or jet injector in insulin treated type 2 diabetics

The levels of blood glucose and free insulin were compared in 20 diabetic subjects (type 2) receiving one dose of a combination of fast-acting and intermediary-acting insulins in the morning by means of a needle syringe or a jet injector (SICIM, Italy), using minimum possible injecting power. A shift to the left in the free insulin profile, consequential to different pharmacokinetic characteristics of insulin when administered by means of a jet injector, was observed, although no significant differences were seen for free insulin levels. Statistically significantly higher blood glucose values (P less than 0.05) were recorded 6 and 9 h after insulin administration by means of a jet injector, as well as statistically significant higher MBG values (P less than 0.05), thus indicating a faster and shorter effect achieved in comparison to that produced by the syringe injected insulin. Conclusions: 1. When switching the method of insulin administration in patients from needle syringe to jet injections the power of the jet injector should be increased (it can be set in three different levels). If that is not possible, because of patient skin characteristics then the dose of intermediary acting insulin should be slightly increased. 2. No local or general side-effects were registered using minimum injecting power of jet injector. 3. The results of the controlled poll have shown that this method of insulin administration is less painful and simpler for patients. The great majority of the patients would like to possess a jet injector.     

Automated lab-scale production of PVA/PEG-enzyme immobilisates

Entrapment of biocatalysts by cryogelation is a gentle method to extend the scope of biocatalysis. To foster the use of this versatile method we devised an automated injector for the production of PVA/PEG beads. The device consists of a thermostated reservoir connected to a programmable injector nozzle and an agitated receiving bath for the droplets. This lab-scale production unit yields up to 1500 beads with immobilized enzyme per minute with a narrow size distribution and good roundness.     

Scalable Fluidic Injector Arrays for Viral Targeting of Intact 3-D Brain Circuits

Our understanding of neural circuits--how they mediate the computations that subserve sensation, thought, emotion, and action, and how they are corrupted in neurological and psychiatric disorders--would be greatly facilitated by a technology for rapidly targeting genes to complex 3-dimensional neural circuits, enabling fast creation of "circuit-level transgenics." We have recently developed methods in which viruses encoding for light-sensitive proteins can sensitize specific cell types to millisecond-timescale activation and silencing in the intact brain. We here present the design and implementation of an injector array capable of delivering viruses (or other fluids) to dozens of defined points within the 3-dimensional structure of the brain (Figure. 1A, 1B). The injector array comprises one or more displacement pumps that each drive a set of syringes, each of which feeds into a polyimide/fused-silica capillary via a high-pressure-tolerant connector. The capillaries are sized, and then inserted into, desired locations specified by custom-milling a stereotactic positioning board, thus allowing viruses or other reagents to be delivered to the desired set of brain regions. To use the device, the surgeon first fills the fluidic subsystem entirely with oil, backfills the capillaries with the virus, inserts the device into the brain, and infuses reagents slowly (<0.1 microliters/min). The parallel nature of the injector array facilitates rapid, accurate, and robust labeling of entire neural circuits with viral payloads such as optical sensitizers to enable light-activation and silencing of defined brain circuits. Along with other technologies, such as optical fiber arrays for light delivery to desired sets of brain regions, we hope to create a toolbox that enables the systematic probing of causal neural functions in the intact brain. This technology may not only open up such systematic approaches to circuit-focused neuroscience in mammals, and facilitate labeling of brain regions in large animals such as non-human primates, but may also open up a clinical translational path for cell-specific optical control prosthetics, whose precision may enable improved treatment of intractable brain disorders. Finally, such devices as described here may facilitate precisely-timed fluidic delivery of other payloads, such as stem cells and pharmacological agents, to 3-dimensional structures, in an easily user-customizable fashion.     

Radiolucent prosthetic gel.

The successful use of silicone breast implants is complicated by their interference with mammography. We have evaluated clinically available implant filling materials and found that a new Bio-Oncotic gel approximates the radiolucency of normal breast tissue. Silicone implants completely obscure areas of the breast in mammography. Recently proposed as a filler material, peanut oil is significantly more radiolucent than normal tissue. Physiologic saline solution compares favorably as a tissue-density-simulating substance. However, saline's lack of lubricating properties results in leakage, making it less than optimal. Bio-Oncotic gel is biologically compatible. We conclude that this gel is the most appropriate filler for breast prostheses. Clinical studies are indicated.     

Analysis of the soft-tissue response to components used in the manufacture of breast implants: rat animal model.

The implant-tissue response to the silicone gel mammary prosthesis requires a more thorough evaluation in light of recent concerns related to human connective-tissue diseases, contracture, infection, and neoplasia. The silicone prosthesis is not a homogeneous implant but is a milieu of various silicone chemistries. Silicone polymer precursors and prosthesis components (silicone shells, shells extracted of their low-molecular-weight components, silica-free silicone, silicone oil, fumed silica, and silicone extract) were implanted subcutaneously using a nonhemorrhagic technique into the backs of Lew/SsN rats (n = 90), two implants per rat, for periods of 7, 14, 28, 56, and 90 days for a total of 6 implants per material per time period. Histologic analysis was performed on specimens from the harvested soft tissue. The intensity of the cellular and capsular response was lowest for the silicone oil and increased as the material's molecular weight increased and material compliance decreased. Fumed silica elicited the most highly reactive cellular response. From this study it is apparent that the polymer's molecular weight influences its migration, encapsulation, and intensity of cellular response. Further, the silicone extract distillate elicited a highly intense cellular response with pronounced lymphocyte invasion. The human relevance of this work awaits further correlation with implant retrieval and in vivo performance.     

Microbial response to reinjection of produced water in an oil reservoir

The microbial response to produced water reinjection (PWRI) in a North Sea oil field was investigated by a combination of cultivation and culture-independent molecular phylogenetic techniques. Special emphasise was put on the relationship between sulphate-reducing bacteria (SRB) and nitrate-reducing bacteria (NRB), and results were used to evaluate the possibility of nitrate treatment as a souring management tool during PWRI. Samples were collected by reversing the flow of the injection water, which provided samples from around the injection area. The backflowed samples were compared to produced water from the same platform and to backflowed samples from a biocide-treated seawater injector, which was the previous injection water treatment of the PWRI well. Results showed that reinjection of produced water promoted growth of thermophilic SRB. Thermophilic fatty acid oxidising NRB and potential nitrate-reducing sulphide-oxidising bacteria were also found. The finding of thermophilic NRB makes nitrate treatment during PWRI possible, although higher nitrate concentration will be necessary to compensate for the increased SRB activity.     

Microinjection into Xenopus oocytes: a precise semi-automatic instrument and optimal parameters for injection of mRNAs

A new apparatus for the injection of Xenopus oocytes is described which provides semi-automatic cell handling together with highly accurate and reproducible volume delivery. Using the system requires very little skill, yet it gives 6.3% average reproducibility in the 5 to 70 nl volume range. The instrument uses a fixed injector system driven by an Inchworm piezoelectric positioner or, in a low-cost version, by a Rainin EDP-2 battery-operated motorized pipette. A movable, vacuum-operated oocyte holder minimizes lateral movement of the oocyte during injection. Oocytes injected with the system show better survival and enhanced expression of mRNA compared with those injected with a widely used type of manual injector (Coleman, 1984).     

Possibility of using the BI-3 jet injector for gamma globulin administration]

The results of weighing glass flasks before and after "shooting" preparations varying in viscosity into these flasks from type BI-3 jet injectors indicated that the ejected dose of gamma globulin corresponded to the preset value. Studies carried out by means of radioisotyope technique with the use of Tc99m showed that the intramuscular injection of gamma globulin with type BI-3 jet injector resulted in 75% of the preset dose penetrating the body. For this reason in mass vaccination against Botkin's disease the dose of the preparation in the injector should be increased by 1/3.     

Assay of ezlopitant, a substance P receptor antagonist, and metabolites in biological matrices by gas chromatography with mass spectrometric detection: simultaneous analysis of a benzyl alcohol and alkene

A method for the analysis of the substance P antagonist ezlopitant and two active metabolites in serum using solid-phase extraction followed by GC–MS analysis is described. The linear dynamic range was 1.0 to 100 ng/ml and precision and accuracy over this range were within 15%. Upon injection of reconstituted sample extracts into the hot injector port of the gas chromatograph, the benzyl alcohol metabolite undergoes a small amount of spontaneous dehydration to the alkene metabolite. We have incorporated an additional hexadeuterated internal standard of the benzyl alcohol into the assay to permit measurement of the extent of dehydration in each sample. This novel approach should be generally applicable to the simultaneous determination of benzyl alcohols and corresponding alkenes by GC–MS when the possibility exists that the alcohol can undergo spontaneous dehydration to the alkene in the injector port of GC instrumentation.     

口腔种植材料表面特性与生物膜形成研究进展

人类口腔环境为微生物提供了适宜生存的条件,多种微生物在牙齿表面形成了由基质包裹相互粘附的口腔生物膜,口腔生物膜是口腔微生物生存、代谢和致病的基础。随着1965年Brnemark种植体在临床上的成功应用,种植相关材料周围致病菌导致的种植体周围炎成为种植修复最常见的并发症之一,影响种植修复的远期效果。种植体周围炎引起了许多关注,并且口腔种植材料表面的特性和口腔生物膜的形成密切相关。本文就种植材料及天然牙齿表面的生物膜形成、种植材料表面特性对口腔生物膜及细菌粘附的影响因素、增强种植材料抗菌性能的方法以及未来的研究方向等作一综述。     

Multiscale design and multiobjective optimization of orthopedic hip implants with functionally graded cellular material

Revision surgeries of total hip arthroplasty are often caused by a deficient structural compatibility of the implant. Two main culprits, among others, are bone-implant interface instability and bone resorption. To address these issues, in this paper we propose a novel type of implant, which, in contrast to current hip replacement implants made of either a fully solid or a foam material, consists of a lattice microstructure with nonhomogeneous distribution of material properties. A methodology based on multiscale mechanics and design optimization is introduced to synthesize a graded cellular implant that can minimize concurrently bone resorption and implant interface failure. The procedure is applied to the design of a 2D left implanted femur with optimized gradients of relative density. To assess the manufacturability of the graded cellular microstructure, a proof-of-concept is fabricated by using rapid prototyping. The results from the analysis are used to compare the optimized cellular implant with a fully dense titanium implant and a homogeneous foam implant with a relative density of 50%. The bone resorption and the maximum value of interface stress of the cellular implant are found to be over 70% and 50% less than the titanium implant while being 53% and 65% less than the foam implant.     

Mandibular matrix implant system: a method to restore skeletal support to the lower face

Disharmony between the skeletal support and the softtissue envelope is a common cause of aesthetic concerns regarding the lower face. A loss of volume or a genetically small mandible affects the aesthetics and function of the mouth, chin, and neck. Because of the limitations of correcting such problems with current implants made of silicone or porous polyethylene, the author developed an implant system and a method of restoring the entire volume of the mandible called the mandibular matrix implant system. This implant system is made of high-density porous polyethylene and is composed of an articulated wraparound geniomandibular implant and a wraparound gonial angle implant. A prejowl implant can be integrated in the system as an addition or as a replacement for a chin implant. This implant system has different sizes and projections, and it can be modified by carving to fit the requirements of most patients. Carving is done using an appropriate sizer. This implant system is indicated for use in patients with a congenitally small mandible, edentulous patients, and patients requesting facial enhancement. The mandibular matrix implant system is implanted either during a single procedure or simultaneously with a facial rejuvenation. The extended geniomandibular implant is introduced through an anterior oral sulcus incision or a submental incision. The mandibular angle implant is introduced through a retromolar incision. The posterior end of the chin implant overlaps the anterior end of the gonial implant, and screw fixation of each chin component helps to stabilize the entire system. Antibiotics, irrigation, and closure of the incisions are performed before any additional operative procedure. The complete system has been used in 13 patients; one additional patient had the complete system plus an overlapping additional left prejowl implant for correction of asymmetry. Complications were manageable; these included one mandibular angle implant displacement and one infection. The implant displacement required a reoperation to reset the implant. The infection was treated with irrigation and closed system suction; the implant was salvaged. The satisfaction of patients has been high, and the author can now solve aesthetic problems that in the past were considered unsolvable.     

Design of a gas chromatograph with parallel radioactivity and mass spectrometric detection : Application to the identification of the major metabolite of d-limonene associated with α2u-globulin

A Perkin Elmer 3920 gas chromatograph, equipped with a versatile inlet system (i.e. an injector/trap), was interfaced to a radioactivity detector and a mass-selective detector (H/P 5970B) to identify ¹⁴C-labeled compounds. The use of a pre-trap as a demountable, programmable-temperature injector, in conjunction with the injector/trap, allowed the introduction of 0.5-ml samples of rat kidney cytosol extracts to 0.32 mm I.D. capillary columns. The instrumentation greatly facilitated the identification of the major radiolabeled metabolite of d-limonene associated with the male rat-specific protein α2u-globulin as 1,2-cis-d-limonene oxide.     

Biocompatibility of radiolucent breast implants

Current implants for breast augmentation containing silicone gel, saline, or both are radiopaque on mammographic examination and can totally obscure microcalcifications and soft-tissue masses. The effect of these implants on the detection of early breast cancers in patients who have undergone augmentation mammaplasty remains unproven and controversial. Implants filled with medium-chain triglycerides (peanut oil) are radiolucent on mammographic examination and allow visualization of both soft-tissue masses and microcalcifications. To investigate the biocompatibility of radiolucent implants, 10 cc of sterile, nonpyrogenic peanut oil was injected subcutaneously into rats using silicone gel as a control. Twenty-one rabbits had two 125-cc silicone shell implants inserted on either side of the chest wall. The right-sided shell was filled with 125 cc of sterile saline, and the left-sided shell was filled with 125 cc of sterile, nonpyrogenic peanut oil. Results were determined by both histologic and radiographic examination. Rats injected with peanut oil equivalent to 7 percent of their body weight rapidly absorbed the freely injected oil without detriment. Histologic examination of the lungs, liver, kidneys, and tissues adjacent to the injection sites demonstrated no abnormalities. There was no evidence of allergic, toxic, inflammatory, or neoplastic response. Eighteen of 21 rabbits survived more than 3 months. Radiographs showed the oil-filled implants to be radiolucent, whereas the saline-filled controls obscured the surrounding soft and bony tissues. Histologic examination demonstrated a fibrous capsule surrounding both types of implants. Histologic examination of the lungs, liver, and kidneys showed no significant abnormalities. These and previous studies have shown peanut oil to be biocompatible when freely injected either intramuscularly or subcutaneously. This study demonstrates that a radiolucent, peanut oil-filled implant is biocompatible in animals and that further long-term studies for its use in humans are merited.     

Patient acceptance of adequately filled breast implants using the tilt test

Adequate fill of any breast implant, regardless of shell characteristics, shape, or filler material, is important to prevent implant shell wrinkling, folding, or collapse that could potentially decrease the life of the implant. Implant shell life is a major factor that affects reoperation rates. The greater the necessity of reoperations, regardless of implant type, the greater the rate of local complications, necessitating additional surgery with additional risks and costs to patients. Palpable shell folding, visible wrinkling or rippling, palpable shifts of filler material, sloshing, and compromised aesthetic results can result from an under-filled implant. Any of these complications can necessitate reoperations with increased risks and costs to patients. This is a study of 609 consecutive patients from January of 1993 to December of 1998 who were given detailed preoperative informed consent and a choice of implant shape and type and who chose the increased firmness associated with an implant that is adequately filled to pass the tilt test. This study addresses two questions: (1) Will patients accept the increased firmness of an implant that is filled to pass the tilt test? and (2) Is adequate fill by the tilt test useful clinically to help reduce the incidence of postoperative rippling, wrinkling, and spontaneous deflation in saline implants? Patients were followed by postoperative examinations and questionnaires. No patient requested implant replacement to a softer implant postoperatively, and no reoperations were performed for visible rippling or wrinkling. The spontaneous deflation rate over this 6-year period was 9 of 1218 implants, or 0.739 percent. If patients will accept more firmness with an adequately filled implant, regardless of the filler material, surgeons might worry less about recommending an adequately filled implant to patients, and manufacturers might feel more comfortable producing adequately filled implants and redefining fill volumes for underfilled implants. More adequately filled implants could potentially reduce risks of reoperations by reducing premature shell failure and shell wrinkling complications.     

High-tech hip implant for wireless temperature measurements in vivo

When walking long distances, hip prostheses heat up due to friction. The influence of articulating materials and lubricating properties of synovia on the final temperatures, as well as any potential biological consequences, are unknown. Such knowledge is essential for optimizing implant materials, identifying patients who are possibly at risk of implant loosening, and proving the concepts of current joint simulators. An instrumented hip implant with telemetric data transfer was developed to measure the implant temperatures in vivo. A clinical study with 100 patients is planned to measure the implant temperatures for different combinations of head and cup materials during walking. This study will answer the question of whether patients with synovia with poor lubricating properties may be at risk for thermally induced bone necrosis and subsequent implant failure. The study will also deliver the different friction properties of various implant materials and prove the significance of wear simulator tests. A clinically successful titanium hip endoprosthesis was modified to house the electronics inside its hollow neck. The electronics are powered by an external induction coil fixed around the joint. A temperature sensor inside the implant triggers a timer circuit, which produces an inductive pulse train with temperature-dependent intervals. This signal is detected by a giant magnetoresistive sensor fixed near the external energy coil. The implant temperature is measured with an accuracy of 0.1°C in a range between 20°C and 58°C and at a sampling rate of 2-10 Hz. This rate could be considerably increased for measuring other data, such as implant strain or vibration. The employed technique of transmitting data from inside of a closed titanium implant by low frequency magnetic pulses eliminates the need to use an electrical feedthrough and an antenna outside of the implant. It enables the design of mechanically safe and simple instrumented implants.     

Finite element analysis of an additional implant for intramedullary nailing]

In the surgical treatment of fractured femurs, the fracture is bridged by a medullary nail fixed in the bone with interlocking screws. Failure of bone substance in the region of the interlocking screws is the most common complication in the treatment of osteoporotic bone. With the aim of preventing this complication, an additional implant was developed. A finite element analysis of an ideal bone/implant system was carried out to investigate the role of the additional implant. Three defined finite element models were generated, and the associated stress situations compared. The first model is a standard fixation without the additional implant. In the second model, the additional implant is integrated within the bone/implant system. The third model uses a modified form of the additional implant. The results show that both additional implants reduce the stresses occurring, both in the bone substance and at the screws. The modified form of the additional implant proved to be the most favorable version. In the case of the original additional implant, the negative effect of the sharp edges of the thread was demonstrable.