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Development of an implantable artificial anal sphincter using a shape memory alloy.

BACKGROUND/PURPOSE: The authors created a new artificial anal sphincter using a shape memory alloy (AS-SMA) to treat fecal incontinence and evaluated its validity. METHODS: AS-SMA consists of 2 Ti-Ni plates to sandwich the intestine and generates a pressure of 55 mm Hg at its resting position. With the electric power supply, the 2 metals bend to form an almondlike shape making a maximum gap of 33 mm between each other at the temperature of 55 degrees C. The device was attached to the colostomy in a piglet and was operated several times a day for 1 month. Fecal continence, bowel movements, and general condition of the piglet were recorded. After the experiment, tissue damage around the device was investigated. RESULTS: Fecal continence was obtained while the device was in the resting position. When it was operated, bowel movements were observed. The bowel movements to operations ratio was 82:105 (78%). During the experiment, the animal had neither abdominal distension nor vomiting. At the autopsy, there was mild inflammation and shallow burns around the device. No compression injury was detected. CONCLUSIONS: AS-SMA achieved fecal continence of the colostomy. With reduction of the associated side effects, it would be a potential substitute for an impaired anal sphincter.

Alloys↗

Immersion behavior of RF magnetron-assisted sputtered hydroxyapatite/titanium coatings in simulated body fluid.

The focus of the present study was on the dissolution/degradation behavior of a series of magnetron-sputtered, single-layered HA/Ti coatings on Ti-6Al-4V substrate immersed in SBF. Changes in coating morphology, crystal structure, and adhesion strength with immersion time are characterized. XRD, FTIR, and LVSEM results consistently indicate that highly crystalline monolithic HA coating is very dissolvable in SBF. The monolithic HA coating is largely delaminated in 3 weeks and entirely peeled off the substrate in 7 weeks. The dissolution is even greater for 95HA/5Ti coating, which severely disintegrated in only 1 week. The amorphous-like coatings sputtered from targets comprising 10 vol % or more Ti, however, appeared almost intact, and their adhesion strengths, which were all higher than 60 MPa, did not change much (within 10%) even after 14 weeks of immersion. The coatings from targets comprising roughly 10-50 vol % Ti combine advantages of high and nondeclining adhesion strength, high resistance to SBF attack, and possibly much higher bioactivity (with large amounts of Ca, P, etc., dissolved in the coatings) than that of Ti.

Biocompatible Materials↗

Anti-inflammatory effects of a titanium-peroxy gel: role of oxygen metabolites and apoptosis.

Polymorphonuclear neutrophils (PMN) are among the first inflammatory cells to arrive at an implant interface, where they encounter with the foreign material and may produce reactive oxygen species (ROS). During the interaction between titanium and ROS, titanium-peroxy (Ti-peroxy) compounds may be formed. We used a Ti-peroxy gel, made from titanium and hydrogen peroxide, to study the effects of Ti-peroxy compounds on PMN. In the absence of serum, the Ti-peroxy gel decreased the oxidative response of PMN to yeast and PMA and reduced PMN apoptosis without inducing necrosis. These effects could not be ascribed to the release of hydrogen peroxide from the Ti-peroxy gel, because a steady-state hydrogen peroxide producing system failed to mimic the effects of the gel. The effects were similarly unaffected when PMN were preincubated with beta(2)-integrin antibodies, questioning the involvement of adhesion molecules. Nevertheless, when a filter was used to separate the Ti-peroxy gel from the cells, the gel effect on PMN life span was abolished, pointing to a contact-dependent mechanism. In the presence of serum, the Ti-peroxy gel had no effect on the PMN oxidative response and life span, but appeared rather inert. In summary, this study demonstrates that the Ti-peroxy gel has potentially anti-inflammatory properties through a combined peroxide and physical contact effect, supporting the notion that interactions between titanium and inflammatory cells are responsible for the good performance of titanium in vivo.

Anti-Inflammatory Agents↗

Structure and properties of Ti-7.5Mo-xFe alloys.

The present work is a study of a series of Ti-7.5Mo-xFe alloys, with the focus on the effect of iron addition on the structure and mechanical properties of the alloys. Experimental results indicate that alpha" phase-dominated binary Ti-7.5Mo alloy exhibited a fine, acicular martensitic structure. When 1 wt% or more iron was added, the entire alloy became equi-axed beta phase structure with a grain size decreasing with increasing iron content. A thermal omega phase was formed in the alloys containing iron of roughly between 0.5 and 3 wt%. The largest quantity of omega phase and highest microhardness were found in Ti-7.5Mo-1Fe alloy. The binary Ti 7.5Mo alloy had a lower microhardness, bending strength and modulus than all iron-containing alloys. The largest bending strength was found in Ti-7.5Mo-2Fe alloy. The present alloys with iron contents of about 2-5 wt% seem to have a great potential for use as an implant material.

Alloys↗

Adhesion, apoptosis and cytokine release of human mononuclear cells cultured on degradable poly(urethane urea), polystyrene and titanium in vitro.

Early interactions between materials and mononuclear cells may influence the viability and secretory response of the cells. Such effects may in turn influence the subsequent inflammatory and repair phases around the materials. In the present study, it was examined if mononuclear cells cultured in vitro either unstimulated or stimulated with lipopolysaccharide (LPS) (10ng/ml) revealed differences regarding cell viability and apoptosis. A major interest was to study the influence of different material properties on the parameters of the inflammatory response upon cell adhesion to materials with widely different surface chemical properties but similar surface topography: degradable poly(urethane urea) (PUUR), cell culture treated polystyrene (PS) surfaces, and commercially pure (c.p.) titanium (Ti). Finally, the secretion of the proinflammatory tumor necrosis factor-a (TNF-alpha) and the downregulating interleukin-10 (IL-10) cytokines was examined in the supernatants from 24h mononuclear cell cultures. No differences in cell viability as measured by lactate dehydrogenas (LDH) were observed between the three materials. The number of material-surface adherent cells was higher on PUUR than the more hydrophilic PS and Ti as judged by quantification of material surface-associated DNA, light microscopic morphological examination of DAPI-stained cells and SEM. LPS increased the number of adherent cells, irrespective of the type of material. The lowest number of apoptotic (annexin-V) and necrotic (propidium iodide) mononuclear cells was detected on PUUR. LPS decreased the number of both apoptotic and necrotic cells, irrespective of material. Low TNF-alpha levels were detected in unstimulated conditions, irrespective of material types. A significantly lower amount of TNF-alpha was found with unstimulated cells on PUUR than on Ti. A significantly higher IL-10 level was detected in unstimulated Ti cultures compared with PUUR and PS. Secretion of IL-10 was predominantly stimulated by LPS on PUUR and Ti. The data indicate that material-related differences are expressed in differences in cell adherence, apoptosis and cytokine secretion. Further, degradable PUUR has equal or less cell-activating properties than Ti and PS under in vitro conditions.

Absorbable Implants↗

Sliding wear studies of selected nitride coatings and their potential for long-term use in orthopaedic applications.

In the area of orthopaedic implants, particularly total hip joint replacements, a metal-plastic combination is still the most popular choice consisting of a femoral head fabricated from 316L stainless steel, Ti alloy or Co-Cr alloy in contact with an ultra-high molecular weight polyethylene (UHMWPD) acetabular cup. It is recently considered that wear of the UHMWPE cup is of major concern. Generation of the wear debris can have adverse effects on the body, both localized and systemic. It is envisaged that wear of the prosthetic components, particularly those fabricated from UHMWPE can be reduced through the use of surface coatings. The aim of this investigation was to deposit a selection of refractory element nitride-based coatings (TiN, TiA1N, ZrN) onto 316L stainless steel substrates, using physical vapour deposition (PVD) technology and to study their sliding wear behaviour in contact with both UHMWPE and 316L stainless steel pins, using a pin-on-plate testing rig. Tests were conducted in Ringers solution and Ringers solution plus bone cement particles. The volume of material removed from the pins served as an indication of their wear behaviour. Wear mechanisms were identified using scanning electron microscopy. The results of these findings and the potential for these coatings to be used in orthopaedic applications are discussed.

Alloys↗

[Titanium as an implant material for rods of transpedicular instrumentation of the lumbar spine].

BACKGROUND AND AIM: Titanium alloys are increasingly being used as an implant material in orthopaedics and for spinal instrumentation. In this study a metallographic analysis and mechanical testing were performed to evaluate the resistance of rods of Ti-A16-V4 in particular to tensile forces. METHOD: The surface texture of unprepared Ti-A16-V4 and a rod of the same material for spinal instrumentation were evaluated in a metallographic analysis using light microscopy and electron microscopy. Tensile strength measurements were performed on 2 rods, and the strength of the connection between rod and pedicle screws was tested in 9 cases. An electron microscopic analysis of surface changes of the connections between rod and pedicle screws after loading was performed. RESULTS: The titanium alloy Ti-A16-V4 has a mill-annealed appearance, which has a high resistance to tearing under stress. Titanium rods show high tensile strength before failure under loading. The connection between rod and pedicle screws also as high resistance to tensile loads (> 27 kN) with only little deformation of the connecting surface and no tearing. CONCLUSION: The titanium alloy Ti-A16-V4 is an appropriate material for dorsal spinal instrumentation rods because of its low weight, high biocompability and high tensile strength.

Alloys↗

Response of bone and cartilage cells to biomaterials in vivo and in vitro.

In vivo and in vitro models have been developed to study the bone/material interface. The in vivo model exploits the osteogenesis that accompanies marrow ablation of the rat tibia and uses morphological and biochemical changes in extracellular organelles, called matrix vesicles, as markers of the healing process. Matrix vesicles, which are associated with primary bone formation and calcification, are produced by osteoblasts and are sensitive to cellular and environmental regulation. In bone adjacent to bone-bonding implants, matrix vesicle number increases, as does its alkaline phosphatase activity. In bone adjacent to nonbonding materials, matrix vesicle activity is inhibited. The materials exert systemic effects which can also be studied by use of matrix vesicles. Cell models are needed in order for the specificity of the cellular response to the material to be understood. By the use of culture plates sputter-coated with implant materials, the response of cells can be studied under controlled conditions. Comparison of the response of costochondral chondrocytes at two stages of endochondral development demonstrates that the effects of various materials are surface- and cell-maturation-dependent. Cells cultured on Ti exhibited increased alkaline-phosphatase-specific activity, whereas those cultured on Al2O3 have decreased enzyme activity.

Alkaline Phosphatase↗

Biological performance of calcium phosphate films formed on commercially pure Ti by electron-beam evaporation.

Thin and defect-free calcium phosphate films with a Ca/P ratio of 1.62 were formed by electron-beam evaporation. The as-deposited films had average bonding strengths to the metal implants of 64.8 MPa and the dissolution rates of 47.5 nm/h in isotonic saline solutions. The interface mechanical characteristics and histology of the as-machined, as-blasted, and calcium phosphate coating on the machined surfaces of commercially pure titanium were investigated. After a healing period of 12 weeks, the implants were unscrewed with a torque gauge instrument at the day of sacrifice. The coated sample showed a removal torque of 48.5 Ncm (SD 5.4) compared to 32.3 Ncm (SD 2.91) for the uncoated implant with the same surface roughness, and 47.3 Ncm (SD 5.8) for the grit blasted screw. The histomorphometric analyses of the calcium-phosphate-coated implants revealed a mean of 52.4% (SD 6.3) as the highest bone to implant contact.

Animals↗

[Effect of wear particles on cell-to-cell communication of synoviocyte system in vitro and its significance in aseptic loosening of prosthesis].

OBJECTIVE: To study the biological reason of abnormal fiber proliferation at bone-implant interface of aseptically loosened prosthesis by observing cell-to-cell communication of synoviocyte system in vitro under the stimulation of wear particles. METHODS: The synoviocyte system of normal human hip joint was established in vitro and the change of cell-to-cell communication was monitored by fluorescence redistribution after photobleaching technique (FRAP) and confocal laser scanning microscope (CLSM) after Ti alloy, CoCr alloy or UHMWPE particles suspension (1.5 mg/ml, W/V) was added into the system. RESULTS: Cell-to-cell communication of synoviocyte system significantly decreased under the stimulation of three kinds of particles (P < 0.01). he decreased degree was maximal in UHMWPE group and minimal in Ti alloy group (P < 0.01). The cell-to-cell communication level of fibroblast-like-cells (FCs) was significantly lower than that of macrophage-like-cells (MCs) (P < 0.05). CONCLUSIONS: Besides the effect of cytokines promoting fiber proliferation, the great amount of fibrous granuloma at bone-implant interface which has relations with aseptic loosening may be caused by the decrease of cell-to-cell communication of fibroblast under direct stimulation of wear particles.

Alloys↗

Release and retention of biomolecules in collagen deposited on orthopedic biomaterials.

Delivery of osteotropic biomolecules directly to the bone-implant interface can alter initial interactions between tissue and biomaterial. To this end, type I collagen coatings containing a model biomolecule, lysozyme, were deposited on Co-Cr-Mo and Ti-6Al-4V. Two deposition methods were examined. In the first, lysozyme was deposited concurrently with collagen, while in the second, protein was impregnated into previously deposited collagen coatings. The amount of collagen and the amount of lysozyme loaded into collagen were varied to provide different amounts of weakly and strongly bound protein. Release and retention of lysozyme were monitored over a 7 d period of incubation in physiological saline. For both methods, larger amounts of collagen in the coatings allowed incorporation of more lysozyme. Additionally, loading collagen coatings with greater amounts of lysozyme resulted in release of more protein. During the first 24-96 h of incubation, loosely bound protein was eluted, resulting in release of 2 micrograms to 55 mg (5-75% of the amount available) of enzymatically active lysozyme. This left 25-95% of the protein bound to the collagen-coated biomaterials and, thus, available for later release during degradation of the collagen.

Animals↗

Quantitative analysis of in vivo tissue responses to titanium-oxide- and hydroxyapatite-coated titanium alloy.

We have previously studied a large number of histological specimens of biomaterials and found that regions with and without an intervening fibrous membrane coexisted in many specimens. Therefore, it appears necessary to perform an evaluation of the entire specimen when histologically assessing the affinity of bone for a biomaterial. Accordingly, we performed a quantitative histological evaluation of hydroxyapatite (HAP)- and titanium-oxide(TiO2)-coated Ti-6A1-4V and uncoated Ti-6A1-4V (control) by determining the affinity index. This was defined as the length of bone directly opposed to the implant/the total length of the bone-implant interface X 100%. The test materials were inserted into the distal epiphyseal region of the femurs of adult dogs, and follow-up quantitative histological comparisons were performed from 4 weeks to 96 weeks. The HAP-coated implants had the highest affinity index 4 weeks after insertion, and this superiority was maintained up to 96 weeks. There was a significant difference in affinity index between HAP-coated implants and control implants (P less than 0.001), while TiO2-coated implants showed no significant difference in comparison to the control.

Alloys↗

Tonic immobility and heterophil/lymphocyte responses of the domestic fowl to corticosterone infusion.

The tonic immobility (TI) fear reactions, plasma corticosterone concentrations and heterophil/lymphocyte (H/L) ratios of adults laying hens were measured before and at intervals of 4 and 11 days after the subcutaneous implantation of osmotic minipumps delivering either corticosterone solution (15 micrograms/hr) or only polyethylene glycol vehicle. The dummy pumps exerted no apparent behavioral or endocrine effects, whereas tonic immobility was significantly prolonged and circulating corticosterone concentrations significantly elevated at 4 and 11 days after implantation of the corticosterone minipumps. H/L ratios were significantly elevated from pre-treatment levels in both groups. However, H/L ratios were considerably higher at both post-treatment points among birds receiving corticosterone rather than vehicle. The present findings suggest that chronic elevations of plasma corticosterone not only alter the haematological profile but may also predispose birds to react more fearfully to alarming stimulation.

Animals↗

Successful replacement of the aortic valve, mitral valve and ascending aorta with re-implantation of the coronary arteries.

A 63-year-old man was operated upon with replacement of the aortic valve, mitral valve and ascending aorta with re-implantation of the coronary arteries. A composite graft with a 27 mm Björk-Shiley tilting disc prosthesis was inserted with 3 continuous Prolene sutures in the aortic position. The coronary arteries were thereafter re-implanted in holes made in the graft. A 31 mm Björk-Shiley valve was sutured in the mitral position with about 20 isolated mattress sutures of Ti-Cron. Selective myocardial hypothermia was instituted with Ringer's solution of 4 degrees C. The total perfusion time was 185 min compared with 240 and 275 min in two previously reported, similar cases. We consider that the use of cardioplegia, a composite graft and continuous sutures makes it possible to reduce the operation time in these complex cases. Our patient is in good condition 9 months postoperatively.

Aortic Aneurysm↗

Comparison of two types of synthetic biodegradable barriers for GTR in interproximal infrabony defects: clinical and radiographic 24-month results.

The aim of the present study was to compare the efficacy of guided tissue regeneration (GTR) using two different biodegradable barriers (polylactide acetyltributyl citrate; polydioxanon) in three- and two-walled infrabony defects. The polydioxanon barrier is an experimental GTR membrane that consists of a continuous occlusive barrier with a layer of slings on the side that is meant to face the mucoperiosteal flap. Fifteen patients provided 15 pairs of similar contralateral periodontal defects: 12 predominantly two-walled and 18 predominantly three-walled infrabony defects. Each defect was randomly assigned to treatment with polylactide acetyltributyl citrate (control) or polydioxanon (test) devices. At baseline, 6, 12, 18, and 24 months after surgery, clinical measurements were performed and standardized radiographs obtained (not at 18 months). Both treatments revealed a significant Gingival Index reduction, probing depth reduction, and vertical probing attachment level gain 24 months after surgery. Both treatments showed slight resorption of the crestal alveolar ridge after 24 months, which failed to reach statistical significance. A statistically significant bone gain within the infrabony pockets was measured for both treatment options 24 months postsurgical. Regarding Gingival Index and probing depth reduction as well as vertical probing attachment level and bone gain, there were neither statistically significant nor clinically relevant differences between test and control barriers. The use of both biodegradable barriers in GTR therapy may be recommended.

Absorbable Implants↗

Effects of a modified sandblasting surface treatment on topographic and chemical properties of titanium surface.

A modified sandblasting surface treatment (a noncoating, roughening surface modification of dental implants) has been developed that will overcome the defects of conventional coating techniques. To verify the feasibility and reliability of this method at the chemical and topographic levels, scanning electron microscopy, x-ray diffraction, and a titanium ion releasing test were used; the topography of titanium surface, the embedding of sandblasting particles, nonpollution of heteroelements, and anticorrosiveness of titanium were criteria. Results showed that the rough surface created by sandblast was rather irregular, full of sharp tips and many embedded sandblast particles, and its corrosive rate was increased. These characteristics were modified by oxalic acid attack; the contour of the rough surface became more regular and round, the embedded particles and the heteroelement pollution were thoroughly removed, and the Ti corrosive rate decreased dramatically. Oxalic acid attack modification also created numerous secondary micropores (2.0-micron diameter) on the basis of sandblasted surface macrotexture. This modified sandblasting surface treatment is feasible and reliable to apply to dental implants and does not decrease the biocompatibility of titanium.

Aluminum Oxide↗