Biocompatibility of silicon-based electrode arrays implanted in feline cortical tissue

The passive biocompatibility of silicon-based electrode arrays was studied in feline cortical tissue. Three types of arrays were used: uncoated, coated with polyimide, and coated with polyimide over an adhesion promoter. Fifteen arrays were implanted for 24 h to determine early tissue reaction to the implantation procedure, and twelve arrays were implanted for 6 months to determine structural and material biocompatibility. Edema and hemorrhage were present around the short-term implants, but involved less than 6% of the total area of the tissue covered by the array. With chronic implants, leukocytes were rarely present and macrophages were found around roughly one-third of the tracks. Remnants of foreign material from the electrodes could be identified in less than 10% of the tracks. Gliosis was found around all tracks, forming an annulus between 20 and 40 microns thick. A capsule was not always present, and never exceeded a thickness of 9 microns. These results suggest that the implantation procedure produces limited amounts of tissue damage, and that the arrays are biocompatible. However, the arrays insulated with polyimide over a primer had significantly greater involvement of macrophages, gliosis, and capsule formation than uncoated arrays and arrays insulated with polyimide without printer, perhaps indicating a reaction to aluminum oxide in the primer.     

The use of grommets for flexible hinge toe implants. A case report

The postmortem examination of bilateral first metatarsophalangeal flexible hinge toe implants in a 66-year-old woman with rheumatoid arthritis is reported. The prosthesis had been inserted with grommets in 1 joint and without grommets in the other 2.5 years before her death. The implants were removed, and the bone/implant interfaces were examined microscopically by hematoxylin eosin stains and an electron probe microanalyzer. Surfaces of the implants were examined by scanning electron microscopy. Silicone particles within the fibrous tissue at the bone/implant interface, and a tear and significant scuffing of the implant surface, were detected in the joint without grommets. Such changes were not detected in the joint with grommets. These findings suggest that grommets may improve implant durability and preventing silicone synovitis.     

Microgrooved subcutaneous implants in the goat

We investigated the behavior of microgrooved implants in soft tissue using polystyrene implantable disks, either smooth or microgrooved (1-10 microm) on both sides. The implants were placed subcutaneously in a goat for 1, 4, or 12 weeks. Light and transmission electron microscopy showed that fibrous capsule formation around the implants was fairly uniform. After 1 week the implants were covered with a fibrous capsule about 80 microm thick. The collagen matrix was loose, and many inflammatory cells were present. After 4 weeks the matrix was more dense and contained many newly formed blood vessels. At the implant surface a layer of inflammatory cells about 10 microm thick had accumulated. Finally, after 12 weeks the matrix had densified. One cellular layer of inflammatory cells was present at the implant surface. We carried out histomorphometric measurements of capsule thickness, inflammatory layer thickness, and the number of blood vessels. Capsule thickness appeared not to decrease with time. Further, these measurements showed that there were no differences in tissue reaction between smooth and microgrooved implants. On the basis of our observations, we suggest that 1 microm deep and 1-10 microm wide microgrooves do not influence tissue response around polystyrene implants in soft tissue.     

Activation of periprosthetic connective tissue in aseptic loosening of total hip replacements

In aseptic loosening of initially well inserted total hip prostheses, implant wear debris and cyclic mechanical loading lead to a foreign body type of chronic inflammatory reaction, then to osteolysis, and finally to loosening of the implant. In the present work the reactive and adaptive changes of the periprosthetic tissues and pseudojoint were characterized by analysis of the local cell proliferation. Immunohistochemical demonstration of proliferating cells was performed by application of affinity purified rabbit antihuman Ki-67 antibodies to periprosthetic tissues obtained from revision operations for loose total hip prostheses. The fibrous areas and, in particular, the cell rich, vascular areas of the interface tissue (between implant and bone) and the pseudocapsule around aseptically loosened implants contained higher numbers of proliferating cells than the tissues around well fixed implants. In addition, the pseudosynovial lining occasionally contained some Ki-67 positive proliferating cells. Somewhat surprisingly, proliferating vascular endothelial cells were relatively rare. These findings suggest that reactive (interface tissues) and adaptive (pseudojoint and capsule formed around the artificial joint) tissue changes in loosening total hip prostheses comprise proliferation of local fibroblastlike cells. It is concluded that periprosthetic tissues of the loosened total hip prosthesis represent activated mesenchymal tissue.     

Behavior of FRP Jacketed Concrete Columns under Eccentric Loading

This paper describes a study on the behavior of fiber-reinforced polymer (FRP) jacketed square concrete columns subjected to eccentric loading. The effect of strain gradient on the behavior of concrete columns confined by the FRP jacket was investigated through experimental and numerical analysis methods. Nine (108 × 108 × 305 mm) square concrete column stubs with zero, one, and two plies of unidirectional carbon FRP fabric were tested under axial compressive loading. In addition to the FRP jacket thickness, the effects of various eccentricities were examined. The nonlinear finite-element analysis results were compared and validated against the experimental test results. The results show that the FRP jacket can greatly enhance the strength and ductility of concrete columns under eccentric loading and that the strain gradient reduces the retrofit efficiency of the FRP jacket for concrete columns. Therefore, a smaller enhancement factor should be used in designing FRP-jacketed columns under eccentric loading. Furthermore, the nonlinear finite-element models established in this study can be used as templates for future research work on FRP-confined concrete columns.     

Effect of cisplatin chemotherapy on extracortical tissue formation in canine diaphyseal segmental replacement

The reconstruction of large bone and joint defects after the resection of malignant tumors remains a major challenge. Chemotherapy has significantly lowered the risk of metastasic disease, but complications associated with reconstructive techniques continue to result in late morbidity. In the present study, biomechanical torsion testing, gait analysis, and histomorphometric and scanning electron microscopic evaluations of 24 dogs were used to examine the effects of preoperative and postoperative administration of cisplatin on the biologic fixation of a porous-coated segmental replacement prosthesis. The chemotherapy consisted of four cycles of cisplatin administered at a dosage of 75 mg/m2 preoperatively or postoperatively. The healing was enhanced by use of an autogenous corticocancellous bone graft. The graft was placed evenly around the prosthesis and the adjacent femoral cortex. Mechanical analyses of torsional stiffness, yield strength, and maximum strength revealed no statistically significant differences between the groups at 12 weeks. Such lack of difference was mainly due to the penetration of highly organized fibrous tissue into the porous surface; this provided strong fixation of the implant to bone even in the absence of bone ingrowth. Although bone ingrowth into the prostheses was not affected, electron microscopic, histomorphometric, and radiologic analyses showed a clear difference in the formation of new bone around the prosthesis. Preoperative chemotherapy did not alter the formation of new bone, but specimens from animals treated postoperatively with cisplatin showed significantly less bone graft resorption and less new bone formation. Hence, the effect of cisplatin administration caused only a temporary delay, not a permanent effect, on extracortical capsule formation. The formation of extracortical bone and soft tissue might prevent debris-incised osteolysis and, therefore, prevent late complications by forming a tight capsule around the bone-prosthetic interface.     

Preliminary evaluation of a hydrogel core-and-skirt keratoprosthesis in the rabbit cornea

BACKGROUND: We developed a core-and-skirt keratoprosthesis, with both components made from poly(2-hydroxyethyl methacrylate) (PHEMA) hydrogels. The identical chemical nature of both spongy skirt and transparent core assures a permanent union between them. We have previously shown that PHEMA sponges, within a certain range of pore size, can support cellular invasion and neovascularization when implanted into the rabbit cornea. The present study is the first to evaluate the behavior of the whole prosthesis after implantation into the rabbit cornea. METHODS: Hydrogel keratoprostheses were inserted intrastromally into the corneas of seven rabbits and histologically examined by light microscopy in five eyes enucleated at 8, 12, and 14 weeks. RESULTS: None of the implants extruded over this period. Both clinical and histopathologic examination showed that the keratoprostheses were well tolerated by the host tissue. The porous skirt was fully integrated into the stroma by fibrovascular invasion, and no capsule formed around the implants. Stromal melting anterior to the implant occurred in two cases, but this did not affect the fixation of the keratoprostheses. CONCLUSIONS: This study indicates that our keratoprosthesis can prevent extrusion in the short term when inserted into an intrastromal pocket of the rabbit eye.     

Rupture of silicone gel filled testicular prosthesis: causes, diagnostic modalities and treatment of a rare event

PURPOSE: Rupture of the envelope of silicone gel filled testicular prostheses is rare and alleged to be unlikely without intraoperative needle puncture. We observed that it may be caused by chronic intermittent trauma or a single acute increase of pressure, and report diagnostic and therapeutic modalities. MATERIALS AND METHODS: Four cases treated by us during the last 10 years are presented. One patient had testicular implants for Klinefelter's syndrome, whereas the other 3 had been treated for female-to-male transsexualism. Diagnosis was confirmed by ultrasonography and magnetic resonance imaging. The fibrous capsule surrounding the ruptured prosthesis was left intact to allow en bloc surgical extirpation. Histological evaluation of the resected specimen was performed. RESULTS: Rupture of silicone gel filled testicular implants may be caused by acute or chronic pressure without intraoperative needle puncture. CONCLUSIONS: Magnetic resonance imaging offers superior diagnostic accuracy and should be regarded the gold standard in the evaluation of implant rupture. Ultrasonography is an acceptable alternative. In cases when gross symptoms of scrotal inflammation are lacking replacement of implants is facilitated by the fibrous capsule that forms around any prosthesis. Transcapsular migration of silicone particles was observed even when the fibrous capsule was intact.     

Sonography of the knee in normal and abused infants

Histometric evaluations as a function of time were performed with zirconium implants during the healing period in 10 Wistar rats. The implants (7 mm x 1 mm x 0.1 mm) were placed in the right tibia of the animals. Five rats were killed after 14 days and the remainder were sacrificed 30 days after implantation. The tibiae were resected, radiographed, and embedded in poly(methyl methacrylate). Three cross-sections were obtained transverse to the major axis of each tibia. Osseointegrated tissue thickness, percentage of direct bone-to-implant contact, and osseointegrated tissue volume were evaluated for each specimen. Bone formation was observed on the surface of the implanted strip that was in contact with tibia marrow. This method is proposed for the evaluation of the first stage of healing of bone in contact with different implant materials subjected to various surface treatment.     

HLA-A towards a high-resolution DNA typing

PURPOSE: This study assessed the soft tissue changes produced by the placement of hard tissue replacement (HTR) polymer chin implants for augmentation genioplasty and evaluated the dimensional stability as well as any bony changes associated with the implants. PATIENTS AND METHODS: The study group consisted of 18 patients (3 males, 15 females) with an average follow-up of 21.5 months (range, 12 to 44 months). All implants were placed through an intraoral incision and stabilized to the symphysis with a single 2.0-mm diameter titanium screw. Preoperative, postoperative, and long-term cephalometric radiographs were analyzed for changes in soft tissue thickness in the chin region, implant stability, and the presence of bone resorption. RESULTS: The net hard tissue chin augmentation achieved averaged 6.0 mm (range, 4.5 to 9 mm). Average preoperative soft tissue thickness was 12.1 mm (range, 11 to 14.5 mm) and postoperatively it was 10.6 mm (range, 10 to 13.5 mm). The average increase in soft tissue projection was 77.6% (range, 71.4% to 83.3%) of the implant thickness. There was no radiographic evidence of implant migration or bony resorption beneath the implant. CONCLUSIONS: HTR implants appear to be a predictable means of augmenting the chin, providing the desired aesthetic change, without causing resorption of underlying bone.     

Molecular advances in pancreatic cancer

The purpose of this study was to quantify in vivo the three-dimensional motion patterns of the sacroiliac joint during passive manipulations as the opinions about the extent of motion of this joint are varied. 12 sacroiliac joints of 6 patients with clinically and radiologically normal joints were investigated. All patients were treated with an external fixator for diagnostic purposes of low back pain unrelated of this study. The motion of the sacroiliac joint was measured continuously with a three-dimensional goniometric system, which was mounted at the end of Schanz screws implanted in S1 and the ilium. All measurements showed relatively small rotation angles around the three main axis to the body between the ilium and the sacrum (< 2 degrees) and very small translations between the screw entry points into the bones (< 1 mm). The maximum rotation angle in the sagittal plane was 1.3 degrees on the right joint and 1.6 degrees on the left joint for flexion plus extension. It is questionable whether this motion can be quantified during manual manipulation. Extension of the hip always produced the largest motion in the sacroiliac joint.     

Cement-mantle thickness affects cement strains in total hip replacement

Bone cement is commonly used to affix femoral implants to the bone during total hip reconstruction. Previous studies suggest that the expected life of a cemented femoral implant may depend on the thickness of the cement mantle surrounding the implant and the implant geometry. The purpose of this study was to determine whether different cement-mantle thicknesses and femoral stem sizes affected strain patterns in the bone cement around cemented femoral stems. Two different sizes of cobalt-chromium stems were cemented into composite femora with varying cement-mantle thickness. Strain gages were embedded in the cement mantle and the implanted stems were loaded axially and under conditions simulating walking and standing. An increase in stem size with the same cement-mantle thickness (approximately 2.2 mm) caused a 65% decrease in proximal medial cement strains. Increasing cement mantle thickness from 2.4 to 3.7 mm caused substantial strain reductions in the distal cement (40-49%). We conclude that increased cement-mantle thickness around femoral stems may increase the fatigue life of a bone-implant system by reducing peak strains within the cement.     

Diagnosis and therapy of the rupture of both cruciate ligaments, the medial collateral ligament and abscission of both menisci in a ram. A case report

This report describes the case history of a 1.5-year-old ram admitted to the Clinic for Food Animals and Horses, University of Berne, Switzerland, because of an acute severe lameness of the left rear limb. Clinical and radiographic examination revealed disruption of the stifle joint with rupture of both cruciate ligaments, the medial collateral ligament, and disruption of both menisci from their attachments. The ruptured ligaments were replaced by synthetic ligament prostheses. Long-term examination at 12 months after implantation revealed slight instability of the stifle joint, caused by degeneration of the medial meniscus, and signs of arthrosis deformans. The new formed periarticular connective tissue contributed to the stability of the stifle joint, so that a good functional result was achieved. Necropsy findings at 14 months after implantation confirmed that the synthetic ligament prostheses were intact and the medial meniscus was detached from its insertion and incorporated into the joint capsule. At microscopic examination of the synthetic band prosthesis, ingrowth of collagen and fibrous tissue was evident.     

Breast prostheses and their complications

In the past few years silicone breast implants have been a highly charged and controversial topic for psychologic, health and politico-legal reasons for patients and for surgical, medical and research concern for professionals. Both sides are interested in knowing about the complications encountered with these implants on one hand and to find the ideal device needed for mammary reconstruction on the other. Indeed silicone does not fulfill the characteristics initially expected for a synthetic soft-tissue substitute. The local cellular response leads to the formation of a capsule around the implant with frequently unsatisfying cosmetic results. The well described leakage occurring through the silicone envelope allows the silicone gel to diffuse to multiple anatomic areas in the body. Scientific works demonstrated that silicone gel acts as a potent immunologic adjuvant and can induce antibodies to silicone surface-associated antigens. Breast implanted women who present with systemic clinical symptoms can be included either in the group of well defined connective tissue diseases or in the atypical connective tissue disease-like syndrome. The largest epidemiologic studies have shown reassuring evidence against large hazards but have documented a low but statistically significant risk of connective-tissue diseases in women with silicone gel filled implants. Practitioners must manage these patients with the awareness that reliable objective tests to identify the useful problem are not yet available.     

Recording properties and biocompatibility of chronically implanted polymer-based intrafascicular electrodes

We implanted polymer-based longitudinal intrafascicular electrodes (polyLIFEs) in feline dorsal rootlets acutely and for periods of two to six months to evaluate their electrical properties and biocompatibility. A total of 38 implanted electrodes were analyzed. Some 25 of the 38 electrodes were implanted with an insulative flexible polymer cuff, which was required for recording of afferent activity in situ. Electrode impedances remained stable for the duration of the experiments. The distributions of axons were measured at three levels of the implanted rootlets: the implant level, 1-2 mm proximal to the implant with respect to the cell body, and 1-2 mm distal to the implant with respect to the cell body. Similar measurements were made in five samples of fascicles neighboring an implant and six samples of control tissue from animals in which no implants were placed. The polyLIFEs demonstrated a high degree of biocompatibility, as no adverse effects on axon size were observed in either the implanted fascicle or neighboring neural tissue. However, the insulative cuffs were found to be a source of compression, resulting in necrosis of the neural tissue.     

Metal release in patients who have had a primary total hip arthroplasty. A prospective, controlled, longitudinal study

There is an increasing recognition that, in the long term, total joint replacement may be associated with adverse local and remote tissue responses that are mediated by the degradation products of prosthetic materials. Particular interest has centered on the metal-degradation products of total joint replacements because of the known toxicities of the metal elements that make up the alloys used in the implants. We measured the concentrations of titanium, aluminum, cobalt, and chromium in the serum and the concentration of chromium in the urine of seventy-five patients during a three-year prospective, longitudinal study. Twenty patients had had a so-called hybrid total hip replacement (insertion of a modular cobalt-alloy femoral stem and head with cement and a titanium acetabular cup without cement), fifteen had had insertion of an extensively porous-coated cobalt-alloy stem with a cobalt-alloy head and a titanium-alloy socket without cement, and twenty had had insertion of a proximally porous-coated titanium-alloy stem with a cobalt-alloy head and a titanium socket without cement. The remaining twenty patients did not have an implant and served as controls. The results of our study showed that, thirty-six months postoperatively, patients who have a well functioning prosthesis with components containing titanium have as much as a threefold increase in the concentration of titanium in the serum and those who have a well functioning prosthesis with cobalt-alloy components have as much as a fivefold and an eightfold increase in the concentrations of chromium in the serum and urine, respectively. The predominant source of the disseminated chromium-degradation products is probably the modular head-neck junction and may be a function of the geometry of the coupling. Passive dissolution of extensively porous-coated cobalt-alloy stems was not found to be a dominant mode of metal release. CLINICAL RELEVANCE: Increased concentrations of circulating metal-degradation products derived from orthopaedic implants may have deleterious biological effects over the long term that warrant investigation. This is a particularly timely concern because of recent clinical trends, including the reintroduction of metal-on-metal bearing surfaces and the increasing popularity of extensively porous-coated devices with large surface areas of exposed metal. Accurate monitoring of the concentrations of metal in the serum and urine after total hip replacement also can provide insights into the mechanisms of metal release. Our findings suggest that fretting corrosion at the head-neck coupling is an important source of metal release that can lead to increased concentrations of chromium in the serum. Determinations of the concentrations of metal in the serum and urine may be useful in the diagnosis of patients who are symptomatic after a total joint replacement as increased levels are indicative of at least one mode of mechanical dysfunction (for example, fretting corrosion) of the device.     

CAD/CAM (computer-aided design/computer-aided manufacturing) titanium implants for cranial and craniofacial defect reconstruction

The reconstruction of craniofacial bone defects with intraoperatively modeled prosthesis restricts the choice of material and its biocompatibility and the prediction of the esthetic result. A prolonged duration of the surgical procedure and an increased stress on the patient are consequences. In contrast, modern industrial CAD/CAM-systems allow the prefabrication of titanium prosthesis: An individual computer-based 3D model of the bony defect is generated after acquisition, transfer and evaluation of helical CT data. Basing on these data the individual prosthesis-shape is designed using freeform surfaces geometries and fabricated by a numerically controlled milling machine. The conical margins of this prosthesis-geometry are generated by the borders of the defect with a minimal gap of 0.25 mm, and the surface contours by considering the non-affected neighbouring contours with a constant thickness of 1.5 mm. Individual osteosynthesis-microplates for fixation are integrated in design and manufacturing if screw-holes cannot be integrated in the thin margins of the implants. The radiological and clinical results of 17 patients after reconstruction of craniofacial bone defects with CAD/CAM titanium implants were good. Complications were not observed.     

Hinge bending within the cytokine receptor superfamily revealed by the 2.4 A crystal structure of the extracellular domain of rabbit tissue factor

Tissue factor (TF), a member of the cytokine receptor superfamily, is the obligate cofactor of coagulation factor VIIa (FVIIa), and has a pivotal role in initiating the extrinsic pathway of blood coagulation through formation of the TF x FVIIa complex. The crystal structure of the extracellular portion of rabbit TF has been solved at 2.35 A resolution and refined to a crystallographic R-value of 19.1% (free R-value, 27.7%). Like the human homologue, the extracellular portion consists of two fibronectin type III domains connected by a short alpha-helical segment. Unexpectedly, the two molecules in the crystallographic asymmetric unit differ in their relative domain-domain orientation, revealing unsuspected hinge motion consisting of a rotation of about 12.7 degrees around an axis intersecting the linker segment at residue 106. Superposition of rabbit tissue factor with free and bound human tissue factor allows for the detection of an identical, albeit smaller, hinge motion in human TF induced upon binding of FVIIa. This raises the possibility that a very similar hinge axis may be present in other members of the cytokine receptor superfamily.     

Experimental bone replacement with resorbable calcium phosphate ceramic (author's transl)

Compact cylindrical implants (5 x 15.5 mm) of seven calcium phosphate ceramics of different formulations that had been implanted for 6 weeks without fixation in the tibia of dogs were examined histologically. The tissue compatibility of the implant turned out to be dependent on the mineralogical and chemical composition of the material: the ceramic material was biocompatible at a CaO/P2O5 ratio between 2:1 and 4:1, the optimum ratio being about 3:1 (tricalcium phosphate). In addition, cylindrical tetracalcium phosphate implatns with an entirely porous structure were implanted in the same manner. After 6 months, they were resorbed to a minor extent. Implants of different calcium phosphate mixtures, on the other hand, were resorbed to a large extend after the same time. The ceramic material was replaced by mineralised bone tissue which had formed directly on the ceramic implant as well as within the pores. There were no foreign body reactions. Investigations with segment-shaped implants which were implanted in the tibia of dogs and fixed with AO-plates or splints extra-cutaneously for about 8-10 weeks, provided information abouth the maximum stress that can be borne by the implants. While implants with a porosity of 75 percent did not sustain the stress after the fixation had been removed, those with a porosity of 45 percent could be subjected to physiological stress after removal of the splints.     

Tissue response to suture materials implanted subcutaneously in a rabbit model

We compared the tissue response to a nonabsorbable monofilamented suture made of expanded polytetrafluoroethylene (ePTFE), which has recently been introduced for use in plastic surgery, with the response to 10 other commercially available absorbable sutures and nonabsorbable monofilamented and multifilamented sutures. The sutures were used to secure a patch of ePTFE implanted in the dorsum of adult New Zealand White rabbits. At 30, 60, and 120 days after implantation, the tissue response to the sutures was assessed with respect to the number of foreign-body giant cells present, the thickness of the fibrous capsule that developed, and the general inflammatory response (n = 4 for each suture for each time period). Analysis of variance revealed that specific suture type was significantly associated with foreign-body giant cell count and fibrous capsule thickness. Tevdek had a significantly higher value for mean number of foreign-body giant cells. Silk and Tevdek had significantly thicker fibrous capsules, and ePTFE suture had a significantly thinner capsule. Absorbable sutures and nonabsorbable multifilamented sutures evoked a more extensive tissue response than monofilamented sutures; the differences between nonabsorbable monofilamented and nonabsorbable multifilamented sutures were significant for capsule thickness. In general, suture made of ePTFE produced a minimal tissue response. It should be a good choice for use in facial plastic surgery, in which excellent functional and aesthetic results are critical.