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PubMedDate not supplied

Plaster of Paris: thermal properties and biocompatibility. A study on an alternative implant material for ear surgery.

There is no single technique for reconstruction of the canal wall following radical mastoidectomy. Autograft tissues may be unsuitable because of resorption and limited availability. An ideal foreign implant material should be bone-like in quality, non-ototoxic, readily available and malleable. Plaster of Paris, a degradable ceramic powder of CaSO4, may be regarded as a bone mineral. But a certain amount of heat develops during its solidifying process and may present a risk for injury to the facial nerve and the labyrinth. We studied the temperature rise with respect to added solution, to volume, and to surroundings, and investigated its biocompatibility when implanted in soft tissue in guinea pigs. The investigations suggested no risk of thermal injury and the biocompatibility was excellent. Hence plaster of Paris may constitute an alternative implant material for mastoid obliteration and reconstruction of the canal wall in ear surgery.

Animals↗

PubMed1987

Biocompatible surfaces prepared by immobilized heparin or hyaluronate.

Artificial surfaces modified with immobilized heparin or hyaluronate were evaluated as possible approaches to improve biocompatibility. The heparin surface was highly thromboresistant in contact with blood, as manifested by minimal cell adhesion and a pronounced capacity to inactivate coagulation enzymes such as thrombin and factor Xa. The hyaluronate coating also reduced cell adhesion, but this coating seemed to be less effective than the heparin surface. Outgrowth of human macrophages was not affected by the hyaluronate coating, nor did it display any capacity to inactivate coagulation enzymes. It is concluded that the heparin surface exhibits a high degree of biocompatibility in contact with blood and cell culture, which should make it an interesting candidate for use in the ear compartment.

Biocompatible Materials↗

PubMed1991

[Studies on biocompatibility of apatite-silicone composite material and investigation of its clinical application].

As reconstructive and prosthetic material of the bone or soft tissue, the author developed a hydroxyapatite composite with silicone (HA-Si composite and studied its biocompatibility to the bone and investigated its clinical application. Si and HA-Si composite containing 30wt%, 50wt%, 70wt% of HA particles were implanted into the rabbit femurs and 2, 4, 12 weeks after, the histological observation was performed. On the surface of the Si fibrous tissue was formed directly, but with the composite, of with the higher HA content, new trabecula were formed from the cortical bone 2 weeks after and the bone developed and contacted the surface directly 4 weeks after and then progressed along the surface. Twelve weeks after the remodeling of the bone progressed and the lamellar structure was recognized. In the bone marrow region new bone formation was observed along the composite and the lamellar structure was recognized. The 70wt% composite showed a good affinity like hydroxyapatite. This composite had elasticity and good handling and biocompatibility to the bone, and it was suggested to be potentially useful for implantation. The 70wt% composite was applied in the clinical cases: mandibular reconstruction (8 cases), additional implantation for deformity of the face (3 cases), alveolar ridge augmentation (3 cases) and supporting of the retention of facial prosthesis (2 cases). The results in the cases of mandibular reconstruction were not satisfactory, however those in the other cases were good so far now. Therefore it was considered that the 70wt% HA-Si composite could be useful in the statical condition.

Adolescent↗

PubMed1993

[In vitro study on biocompatibility of zirconium and titanium].

The purpose of this study is to evaluate the biocompatibility of zirconium compared with titanium by the in vitro study using human osteosarcoma cell line (HOS). Various characteristics of the HOS cells cultured on zirconium (99.9%) and titanium (99.9%) discs were investigated. On the colony formation of the HOS cells, there were no differences between the zirconium and titanium in colony size and number. Good proliferation of the HOS cells was observed on the zirconium as well as on the titanium. Morphological observation of the HOS cells by SEM revealed that the cells on the zirconium as well as on the titanium were flat and polygonal in shape with radial pseudopods. Collagen fibers and calcified substances were observed in the matrix of the HOS cells by TEM on the zirconium as well as on the titanium. The calcium of the HOS cell layer was stained well by Dahl's method. Analysis of the HOS cell layer by the Fourier transform infrared spectroscopy indicated that the HOS cells formed the same matrices including the apatite on the zirconium as on the titanium. Measurements of the zirconium and titanium elution into the human saliva indicated that the elution of zirconium was less than that of titanium. These results suggest that zirconium possesses as excellent biocompatibility as titanium.

Biocompatible Materials↗

PubMed2002

Effect of biocompatibility of hemodialysis membranes on mortality in acute renal failure: a meta-analysis.

BACKGROUND: The effect of biocompatibility of hemodialysis membranes on mortality in acute renal failure (ARF) has been a subject of intense debate, with some, but not all studies reporting a lower risk of death among patients with ARF dialyzed with biocompatible membranes (BCM) compared to bioincompatible membranes (BICM). OBJECTIVES: We performed a meta-analysis of group data extracted from previously published studies of controlled clinical trials to assess the impact of BCM on the mortality among patients with ARF who required intermittent hemodialysis (IHD). METHODS: BCM and BICM were defined as synthetic and cellulose-derived membranes (cuprophan and cellulose acetate), respectively. All controlled clinical trials comparing the effect of BCM to BICM on clinical outcomes in the setting of ARF were included. Original articles as well as abstracts were included. Data in Tables, Figures, and text were independently extracted by 2 of the authors. Risk ratios (RR) for mortality were combined using the random-effects model. RESULTS: Seven studies with a total of 722 patients met the inclusion criteria. One hundred seventy-two (45%) of 384 patients died in the BCM group, compared with 156 (46%) of 338 patients in the BICM group. The RRs for mortality ranged from 0.56-1.28. Overall, the pooled RR for mortality was 0.92 (95% CI = 0.76-1.13) in favor of the BCM group. However, the test for heterogeneity in RR among studies was significant (chi2 = 8.6, p < 0.05). One study accounted for this significance, and once removed from the model, the RR for mortality was 0.94 (95% CI = 0.79-1.12), and the test for heterogeneity among studies lost its significance. Subgroup analyses comparing BCM to cuprophan membranes revealed that the RR for mortality was 0.82 (95% CI = 0.62 - 1.08) in favor of the BCM group, whereas in the subgroup of studies comparing BCM to cellulose acetate, the RR for mortality was 1.11 (95% CI = 0.87-1.44) in favor of the BCM group. CONCLUSION: This metaanalysis demonstrates that the use of BCM does not significantly affect mortality among patients with ARF who require IHD. However, subgroup analyses suggest that cellulose acetate membranes may offer a survival advantage when compared with synthetic membranes, which, in turn, may be more beneficial than cuprophan membranes. Available evidence does not permit a recommendation for or against the use of BCM in ARF. Large trials and pooled analyses of individual patient-level data will be required to assess sources of variability among studies and non-fatal outcomes of ARF.

Acute Kidney Injury↗

PubMed1996

Symposium "Implantable Materials in Facial Aesthetic and Reconstructive Surgery: Biocompatibility and Clinical Applications". American Society of Maxillofacial Surgeons. Montreal, Quebec, October 6, 1995.

On October 6, 1995, the American Society of Maxillofacial Surgeons sponsored a 1-day symposium entitled "Implantable Materials in Facial Aesthetic and Reconstructive Surgery: Biocompatibility and Clinical Applications." The symposium examined issues relating to the biocompatibility and clinical role of alloplastic materials commonly used for facial bone and soft-tissue replacement and augmentation. It provided a forum for the interaction of basic scientists, clinicians, and manufacturers. Clinical and laboratory data concerning a variety of implantable materials were presented and discussed. The program consisted of three parts. The first session was designed to provide historical and scientific background as well as perspective on legal issues surrounding the use of implantable biomaterials. The second session involved the presentation of clinical data on bone and bone substitutes for augmentation of the facial skeleton. The third session was devoted to clinical reports of bone and bone substitutes used for the reconstruction of cranial vault and cranial base skull defects.

Biocompatible Materials↗

PubMed1999

Biocompatibility testing of a new bioabsorbable X-ray positive SR-PLA 96/4 urethral stent.

PURPOSE: Recently a first X-ray-positive bioabsorbable urethral stent was developed by our group. The stent is made from self-reinforced poly-L,D-lactic acid (SR-PLA 96/4) blended with barium sulfate. The aim of this study was to evaluate the biocompatibility properties of the new stent materials. MATERIALS AND METHODS: Rods made from pure SR-PLA 96/4 and SR-PLA 96/4 blended with barium sulfate were inserted into the dorsal muscles of a rabbit. Rods made from latex and silicone were used as positive and negative controls. To evaluate the long-term effect of BASO4 after the bioabsorption of the polymer, fast degrading SR-PGA (self-reinforced polyglycolic acid) and SR-PLA + BASO4 rods were used as controls. Urethral stents made from SR-PLA 96/4 and X-ray-positive SR-PLA 96/4 stents were inserted cystoscopically into the rabbit urethra. Metal stents were used as controls. The animals were sacrificed after 1 week, 1 month or 6 months. RESULTS: In the muscle implantation samples acute tissue reactions due to operative trauma were seen in all specimens at 1 week. After 6 months chronic inflammatory changes and foreign body reaction were seen only in the positive controls. The stent worked well in the rabbit urethra, its biocompatibility was good and there was less encrustation than in the metal stents. CONCLUSIONS: This first X-ray-positive bioabsorbable urethral stent showed no toxic tissue effects.

Absorbable Implants↗

PubMed1999

Hard, soft tissue and in vitro cell response to porous nickel-titanium: a biocompatibility evaluation.

Porous nickel-titanium (NiTi) alloys have demonstrated bone attachment as well as tissue ingrowth in the past. However, very few studies have compared porous NiTi soft and hard tissue reactions, and in vitro cell response. We therefore have evaluated the general muscle and bone reaction to porous nickel-titanium. The latter material was implanted in rabbit tibias and back muscle, and assessed after three, six and twelve weeks of implantation. Porous NiTi specimens did not cause any adverse effect regardless of both implantation site and post-surgery recovery time. Muscle tissue exhibited thin tightly adherent fibrous capsules with fibers penetrating into implant pores. We observed that attachment strength of the soft tissue to the porous implant seemed to increase with post-implantation time. Bone tissue demonstrated good healing of the osteotomy. There was bone remodeling characterized by osteoclastic and osteoblastic activity in the cortex. This general good in vivo biocompatibility with muscle and bone tissue corresponded very well with the in vitro cell culture results we obtained. Fibroblasts seeded on porous nickel-titanium sheets managed to grow into the pores and all around specimen edges showing an another interesting cytocompatibility behavior. These results indicate good biocompatibility acceptance of porous nickel-titanium and are very promising towards eventual NiTi medical device approbation.

Adipose Tissue↗

PubMedDate not supplied

Biocompatibility of an adhesive system and 2-hydroxyethylmethacrylate.

The aim of the study was to evaluate the biocompatibility of an adhesive system and a resin component when implanted into connective tissue of rats. Forty sponges embedded in both materials: Scotchbond MP (SBMP/ 3M-Group A) and 2-hydroxyethylmethacrylate (HEMA-Group B), were implanted into dorsal connective tissue of 20 animals. After 7, 15, 30, or 60 days of the implantation, the animals were sacrificed; implant sites were excised and immersed for 24 hours in Kamovisky's fixative. The samples were processed under routine histologic technique, being stained with H & E. Histological evaluation showed that both materials promoted at 7 days intense inflammatory response with predominance of neutrophils and macrophages. The intense connective reaction was replaced for fibroblastic proliferation associated with macrophages and foreign body giant cells over time. The persistent moderate inflammatory reaction adjacent to scattered fragments of materials was greater to HEMA than to the SBMP. Both experimental materials did not show acceptable biocompatibility with connective tissue of rats in spite of allowing an evident connective tissue healing.

Animals↗

PubMed2000

[Evaluation for biocompatibility of poly-(3-hydroxypropyl)-DL-aspartamide].

To evaluate the biocompatibility of poly-(3-hydroxypropyl)-DL-aspartamide(PHPA), we utilized the laboratory methods, including subcutaneous implantation, histological examination, blood biochemical and micronucleus test. Histological examination revealed a nonspecific foreign body reaction around the PHPA and a slight inflammation around the small blood vessels of the liver on the 13th day, but all these reactions diminished or disappeared gradually after 34 days of implantation. The structures and functions of liver and kidney were normal. The results indicate that PHPA possesses a good nature in biocompatibility.

Alanine Transaminase↗

PubMed2000

Evaluation of the biocompatibility of two new diamond-like stent coatings (Dylyn) in a porcine coronary stent model.

UNLABELLED: Hydrogenated diamond-like carbon films (DLC, a-C:H), deposited using plasma-assisted or ion beam-assisted techniques, offer great potential as self-lubricating coatings in many tribological applications. Additionally, studies on biocompatibility have shown that DLC is an inert, impervious hydrocarbon with properties suitable for use in the biomedical field. One particular class of modified DLC coatings are diamond-like nanocomposite coatings (DLN or Dylyn , Bekaert, Kortrijk, Belgium), which offer promising solutions for many industrial applications. In this study, the biocompatibility of two diamond-like stent coatings are evaluated in a porcine coronary stent model. METHODS: Either coated or non-coated stents were randomly implanted in two coronary arteries of 20 pigs so that each group contained 13 stented arteries. Pigs underwent a control angiogram at 6 weeks and were then sacrificed. Quantitative coronary analysis before, immediately after stent implantation, and at 6 weeks was performed using the semi-automated Polytron 1000 system (Siemens, Erlangen, Germany). Morphometry was performed using a computerized morphometric program. Angiographic analysis showed similar baseline selected arteries and post-stenting diameters. At 6-week follow-up, there was no significant difference in minimal stent diameter. Histopathology revealed a similar injury score in the 3 groups. Inflammation was significantly increased in the DLN-DLC coating group. Thrombus formation was significantly decreased in both coated stent groups. Neointimal hyperplasia was decreased in both coated stent groups; however, the difference with the non-coated stents was not statistically significant. Area stenosis was lower in the DLN-coated stent group than in the control group (41 +/- 17% vs. 54 +/- 15%; p = 0.06). CONCLUSION: The results indicate that the diamond-like nanocomposite stent coatings are compatible, resulting in decreased thrombogenicity and decreased neointimal hyperplasia. Covering this coating with another diamond-like carbon film (DLC) resulted in an increased inflammatory reaction and no additional advantage compared to the single-layer diamond-like nanocomposite coating.

Animals↗

PubMed2000

Heparin-free DALI LDL-apheresis in hyperlipidemic patients: efficacy, safety and biocompatibility.

BACKGROUND AND AIM OF STUDY: In routine DALI apheresis--the first technique for direct adsorption of lipoproteins from whole blood--heparin plus citrate (ACD-A) is used as anticoagulation regimen. However, recently several publications have warned of heparin-induced thrombocytopenia as a rare but potentially life-threatening complication of heparin administration (HIT type 2). The aim of the present study was therefore to test the efficacy and biocompatibility of DALI using a heparin-free anticoagulation regimen consisting exclusively of citrate. METHODS: Four symptomatic hypercholesterolemic patients on regular DALI apheresis were switched to the heparin-free protocol for two sessions each. Two of the patients were on oral anticoagulation using phenprocoumon. In the weekly sessions, 1.3 patient blood volumes were processed at a blood flow rate of 60 ml/min using ACD-A at a ratio of 1:20 (v/v) during adsorber priming and the session. RESULTS: Clinically, all sessions were essentially uneventful. Uncorrected lipoprotein reductions amounted to 65% for LDL-C, 62% for Lp(a), 53% for VLDL-C, 24% for HDL-C, 17% for triglycerides and 19% for fibrinogen. Cell counts remained virtually constant. No signs of hemolysis or clotting could be detected. Thromboplastin time (Quick) was slightly prolonged and partial thromboplastin time (PTT) moderately elevated in all patients. In contrast, whole blood coagulation time acc. to Lee-White and activated clotting times were increased only in orally anticoagulated patients. Biocompatibility in terms of complement, leukocyte and thrombocyte activation was excellent. Bradykinin activation was moderate peaking at 3038 pg/ml in the efferent line. Systemic thrombin-antithrombin complex (TAT) reflected perfect anticoagulation in orally anticoagulated patients and adequate anticoagulation in the patients without phenprocoumon. CONCLUSION: In this pilot study, heparin-free DALI apheresis was safe and effective and may thus be performed in LDL-apheresis dependent patients who suffer from heparin intolerance.

Adsorption↗

PubMed2000

[Study on the biocompatibility and toxicology of biomaterials--poly(epsilon-caprolactone)].

Four observation indexes were selected to evaluate the biocompatibility and toxicology of biodegradable materials poly(epsilon-caprolactone)(PCL), which is synthesized in our laboratory using Ti(OBu)4 as an initiator. The results showed that PCL films had a mild inflammatory reaction in the early days of planting and after 3 months the inflammation basically disappeared. We conclude that PCL material possesses good biocompatibility and has a good developmental prospect.

Animals↗

PubMed2001

[Progress in the studies on the evaluation of biocompatibility of biomaterials].

Biocompatibility remains the central theme for biomaterials applications in medicine. It generally refers to the compatibility between the biomaterials and the receptor, including tissue-compatibility and blood-compatibility. The definition of the biocompatibility has been greatly changed in recent years; it is now accepted as involving two principle areas, one is the principle of 'biosafety', the second is the principle of 'biofunctionality'.

Biocompatible Materials↗

PubMed2001

[Biocompatibility of HA/TCP biphasic ceramics with co-cultured human osteoblasts in vitro].

The biocompatibility of HA/TCP ceramic was evaluated by investigation of attachment and growth of osteoblasts on biomaterial, as well as monitoring the effects of biomaterial on expression of functional phenotypes of co-cultured osteoblasts in vitro. When co-cultured with HA/TCP ceramics, osteoblasts firstly attached to the surface of HA/TCP disk, then attached to notches and grew into the micropores of biomaterial during further culture period. At last, the ceramics were almost packed with osteoblasts. Additionally, osteoblasts co-cultured with HA/TCP were similar to osteoblasts cultured under normal condition in osteoblastic phenotypes; the secreted lots of collagen type I, possess strong activity of Alkaline Phosphatase and mineralized extracellular matrix. The fact that osteoblasts could grow well on HA/TCP ceramics and the biomaterial did not affect their physiological function suggest that HA/TCP ceramic is biocompatible with human osteoblasts.

Biocompatible Materials↗

PubMed2002

Rabbit muscle and urethral in situ biocompatibility properties of the self-reinforced L-lactide-glycolic acid copolymer 80: 20 spiral stent.

PURPOSE: A new type of self-reinforced L-lactide-glycolic acid copolymer, molar ratio 80:20, stent was developed. We evaluated the tissue biocompatibility properties of the new material. MATERIALS AND METHODS: Rods made of self-reinforced L-lactide-glycolic acid copolymer were inserted into rabbit dorsal muscles and rods of latex or polyvinylchloride and silicone served as positive and negative controls, respectively. Urethral stents of self-reinforced L-lactide-glycolic acid copolymer and steel were inserted in situ via cystoscopy into the rabbit prostatic urethra. The animals were sacrificed after 2 weeks, 1, 2 and 3 months, respectively. In situ histological analysis was done. Tissue reactions around the implantation types were analyzed histologically and scored semiquantitatively. In addition, macroscopic analysis was done of the urethral in situ stents. RESULTS: In rabbit muscle implantation test tissue reaction to the self-reinforced L-lactide-glycolic acid copolymer stent resembled that of negative control silicone. Less than moderate chronic inflammatory changes gradually subsided after 2 weeks. Foreign materials in the tissue and the reaction to these materials began to disappear after 1 month and at 3 months were completely absent. All rabbits fitted with the stent voided normally postoperatively. Self-reinforced L-lactide-glycolic acid copolymer stents were soft, partially fragmented and easily disintegrated when touched at 2 months, and were almost completely degraded at 3 months. The material did not encroach into the urethral wall macroscopically or microscopically. No calcification on the self-reinforced L-lactide-glycolic acid copolymer stents or bladder stone formation was seen. CONCLUSIONS: The new self-reinforced L-lactide-glycolic acid copolymer 80:20 material is safe, highly biocompatible and suited for future clinical use. It is most appropriate for preventing postoperative urinary retention after most minimally invasive thermal treatments for benign prostatic hyperplasia.

Animals↗

PubMed2002

Surface, corrosion and biocompatibility aspects of Nitinol as an implant material.

The present review surveys studies on physical-chemical properties and biological response of living tissues to NiTi (Nitinol) carried out recently, aiming at an understanding of the place of this material among the implant alloys in use. Advantages of shape memory and superelasticity are analyzed in respect to functionality of implants in the body. Various approaches to surface treatment, sterilization procedures, and resulting surface conditions are analyzed. A review of corrosion studies conducted both on wrought and as-cast alloys using potentiodynamic and potentiostatic techniques in various corrosive media and in actual body fluids is also given. The parameters of localized and galvanic corrosion are presented. The corrosion behavior is analyzed with respect to alloy composition, phase state, surface treatment, and strain and compared to that of conventional implant alloys. Biocompatibility of porous Nitinol, Ni release and its effect on living cells are analyzed based on understanding of the surface conditions and corrosion behavior. Additionally, the paper offers a brief overview of the comparative toxicity of metals, components of commonly used medical alloys, indicating that the biocompatibility profile of Nitinol is conducive to present in vivo applications.

3T3 Cells↗

PubMed2002

Biocompatibility of electrochemically activated aqueous solutions: an animal study.

The purpose of the study was to evaluate the biocompatibility of electrochemically activated aqueous solutions on experimental animals. Nine rabbits were subjected to acute eye irritation/corrosion tests, nine rabbits to acute dermal irritation/corrosion and 30 rats to acute oral toxicity (LD50) tests. No significant negative effects were noted. Considering the relatively high levels of exposure of the animals to the solutions and the low levels in the anticipated real clinical situation it is argued that these solutions are indeed biocompatible.

Administration, Cutaneous↗