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PubMed2004

Utilizing acid pretreatment and electrospinning to improve biocompatibility of poly(glycolic acid) for tissue engineering.

Poly(glycolic acid) (PGA) has a long history as a bioresorbable polymer. Its biocompatibility is widely accepted, yet PGA is often rejected as a soft-tissue scaffold because of fibrous encapsulation. The goal of this study was to improve the soft-tissue biocompatibility of PGA by producing scaffolds composed of small-diameter fibers through electrospinning and subjecting these scaffolds to a concentrated hydrochloric acid (HCL) pretreatment. The theory is that small-diameter fibers will elicit a reduced immune response and HCl treatment will improve cellular interactions. Scaffolds were characterized in terms of fiber diameter and pore area via image-analysis software. Biocompatibility was assessed through a WST-1 cell-proliferation assay (in vitro) with the use of rat cardiac fibroblasts and rat intramuscular implantations (in vivo). Fibers produced ranged in diameter from 0.22 to 0.88 microm with pore areas from 1.84 to 13.22 microm(2). The untreated scaffold composed of 0.88-microm fibers was encapsulated in vivo and supported the lowest rates of cell proliferation. On the contrary, the acid pretreated scaffold with 0.22-microm fibers was incorporated into the surrounding tissue and exhibited proliferation rates that exceeded the control populations on tissue-culture plastic. In conclusion, this study has shown the ability to improve the biocompatibility of PGA through acid pretreatment of scaffolds comprised of submicron fiber diameters.

Animals↗

PubMed1992

Biocompatibility considerations at stimulating electrode interfaces.

The choice of biocompatible stimulating electrodes for various biomedical applications varies with the type of electrode-tissue interface, biomolecules present, electrolyte background, preparation of electrode, interfacial potential, current density, electrode material, porosity, geometry, and inflammatory response. Illustrative examples are given to demonstrate the importance of these parameters. Topics discussed are: A) DC electrodes applied to partially keratinized epithelial membranes; B) Variation of the electrical impedance and biocompatibility of stimulating electrodes with electrode potential and surrounding pH; C) Influence of electrode geometry, porosity and pore size on biocompatibility; D) Body defense mechanisms at the sites of implantable stimulating electrodes; E) Thrombus formation at stimulating electrode interfaces and F) Sterilization of electrodes to ensure biocompatibility.

Animals↗

PubMed2005

Assessing the biocompatibility of NiTi shape memory alloys used for medical applications.

The present paper reviews aspects related to the biocompatibility of NiTi shape memory alloys used for medical applications. These smart metallic materials, which are characterised by outstanding mechanical properties, have been gaining increasing importance over the last two decades in many minimal invasive surgery and diagnostic applications, as well as for other uses, such as in orthodontic appliances. Due to the presence of high amounts of Ni, the cytotoxicity of such alloys is under scrutiny. In this review paper we analyse work published on the biocompatibility of NiTi alloys, considering aspects related to: (1) corrosion properties and the different methods used to test them, as well as specimen surface states; (2) biocompatibility tests in vitro and in vivo; (3) the release of Ni ions. It is shown that NiTi shape memory alloys are generally characterised by good corrosion properties, in most cases superior to those of conventional stainless steel or Co-Cr-Mo-based biomedical materials. The majority of biocompatibility studies suggest that these alloys have low cytotoxicity (both in vitro and in vivo) as well as low genotoxicity. The release of Ni ions depends on the surface state and the surface chemistry. Smooth surfaces with well-controlled structures and chemistries of the outermost protective TiO2 layer lead to negligible release of Ni ions, with concentrations below the normal human daily intake.

Alloys↗

PubMed1994

Determination of drugs by direct injection of plasma into a biocompatible extraction column based on a protein-entrapped hydrophobic phase.

Drugs were determined by direct injection of plasma samples into a biocompatible extraction column. The column is based on particles with a biocompatible external surface and a hydrophobic internal surface. The pores of the particles are small enough to exclude the protein molecules; the drug molecules can penetrate the porous particle and are retained on the hydrophobic internal surface. Biocompatibility of the particles was obtained by reaction of the external surface with the human plasma protein alpha1-acid glycoprotein. The surface within the pores of the particles contains hydrophobic C8 or C18 groups. The biocompatible extraction column was used in a fully automated system for the determination of ibuprofen, naproxen, propranolol, carbamazepine and phenytoin in plasma. No pressure increase was observed during the analysis of several hundred plasma samples. Plasma concentrations of propranolol in the range 4.5-125 ng/ml were determined with a precision (R.S.D.) of 0.75-1.8%. Linear calibration graphs were observed for the five drugs, and correlation coefficients of 1.0000 were obtained for four of the five model compounds.

Biocompatible Materials↗

PubMed1989

A model for biocompatibility and its evaluation.

Concepts of biocompatibility have changed radically in recent years. This paper describes these new concepts and the present knowledge of the components and mediators of biocompatibility and leads to the development of a model for the explanation and rationalization of these phenomena. Of particular importance is the question of the assessment or evaluation of biocompatibility. The paper concludes with comments on the need for a schedule of biocompatibility assessment procedures to take into account this new thinking.

Biocompatible Materials↗

PubMed1996

In vitro swelling studies and preliminary biocompatibility evaluation of acrylamide-based hydrogels.

In this in vitro study, the biocompatibility of acrylamide-based hydrogels such as acrylamide/crotonic and acrylamide/itaconic acid, prepared by using gamma-rays, has been investigated against some biochemical parameters of human serum. The swelling kinetics of acrylamide/crotonic and acrylamide/itaconic acid hydrogels are investigated in distilled water and physiological saline solution and some swelling and diffusion parameters have been calculated. For the analysis of biocompatibility, acrylamide/crotonic and acrylamide/itaconic acid hydrogels are incubated in 10 different human sera for 24 h and their biocompatibilities with some biochemical parameters have been investigated. No significant difference in values before and after the test procedures have been found. It is therefore concluded that acrylamide/crotonic and acrylamide/itaconic acid hydrogels are biocompatible.

Acrylamide↗

PubMed1991

Structural properties and biocompatibility of polymers used in ophthalmology.

The chemico-physical and structural properties and biocompatibility of new polymers used for intraocular lens manufacture are studied. In particular, the vibrational infrared and Raman spectra of fluorinated polymethacrylates are presented and discussed in relation to those of polymethylmethacrylate (PMMA), in order to correlate their structure with their properties and biocompatibility. The thermal analysis points out that the polymers are more stable than polymethylmethacrylate and the biocompatibility tests show that they are as biocompatible as polymethylmethacrylate.

Animals↗

PubMed2004

Changes in hemostasis during pediatric heart surgery: impact of a biocompatible heparin-coated perfusion system.

BACKGROUND: This study describes the response in hemostasis during open-heart surgery with cardiopulmonary bypass (CPB) in children (<== 10 kg) and tests the hypothesis that the use of a biocompatible perfusion system, in comparison with a conventional system, causes less hemostatic activation. METHODS: Prospective, randomized, controlled clinical study. Forty consecutive children <== 10 kg were included and divided into two groups: group bioc. (n = 19) treated with a fully heparin-coated system, centrifugal pump, and a closed circuit, and group conv. (n = 21) treated with an uncoated system, roller pump, and a hard shell venous reservoir. Concentrations of plasma thrombin-antithrombin (TAT), D-dimer, tissue plasminogen activator antigen (t-PA ag), and the complex consisting of tissue plasminogen activator and its inhibitor plasminogen activator inhibitor-1 (t-PA-PAI-1) were measured. RESULTS: The biochemical variables measured increased significantly in both groups during the study period. There was less activation of fibrinolysis during cardiopulmonary bypass (t-PA ag: p = 0.009) in patients treated with the biocompatible perfusion system than in patients treated with the conventional system. A trend in favor of the biocompatible system based on the D-dimer and TAT data (p = 0.07 for both measurements) was observed but no significant intergroup differences regarding these variables or t-PA-PAI-1 were found. CONCLUSIONS: Open-heart surgery with cardiopulmonary bypass in children (<== 10 kg) causes transient activation of the coagulation and fibrinolytic systems. This study demonstrates that the use of a biocompatible perfusion system results in a lower extent of activation of fibrinolysis during CPB than the use of a conventional system.

Anticoagulants↗

PubMed2004

A closed perfusion system with heparin coating and centrifugal pump improves cardiopulmonary bypass biocompatibility in elderly patients.

BACKGROUND: Cardiopulmonary bypass induces a systemic inflammatory and hemostatic activation, which may contribute to postoperative complications. Our aim was to compare the inflammatory response, coagulation, and fibrinolytic activation between two different perfusion systems: one theoretically more biocompatible with a closed-circuit, complete heparin coating, and a centrifugal pump, and one conventional system with uncoated circuit, roller pump, and a hard-shell venous reservoir. METHODS: Forty-one elderly patients (mean age, 73 +/- 1 years, 66% men) undergoing coronary artery bypass grafting or aortic valve replacement were included in a prospective, randomized study. Plasma concentrations of complement factors (C3a, C4d, Bb, and sC5b-9), proinflammatory cytokines (tumor necrosis factor-alpha, interleukin-6, and interleukin-8), granulocyte degradation products (polymorphonuclear elastase), and markers of coagulation (thrombin-antithrombin) and fibrinolysis (D-dimer, tissue plasminogen activator antigen and tissue plasminogen activator-plasminogen activator inhibitor-1 complex) were measured preoperatively, at bypass during rewarming (35 degrees C), 60 minutes after bypass, and on day 1 after surgery. RESULTS: The mean concentrations of C3a (-39%; p = 0.008), Bb (-38%; p < 0.001), sC5b-9 (-70%; p < 0.001), interleukin-8 (-60%; p = 0.009), polymorphonuclear-elastase (-55%; p < 0.003), and tissue plasminogen activator antigen (-51%; p = 0.012) were all significantly lower in the biocompatible group during rewarming. Sixty minutes after bypass, the mean concentrations of sC5b-9 (-39%; p = 0.006) and polymorphonuclear-elastase (-55%; p < 0.001) were lower in the biocompatible group. CONCLUSIONS: The results suggest that a closed perfusion system with a heparin-coated circuit and a centrifugal pump may improve cardiopulmonary bypass biocompatibility in elderly cardiac surgery patients in comparison with a conventional system.

Aged↗

PubMed2006

The influence of implantation site on the biocompatibility and survival of alginate encapsulated pig islets in rats.

This work investigated the impact of implantation sites on the biocompatibility of alginate encapsulated pig islets. Non-diabetic rats were implanted with adult pig islets encapsulated in alginate either intraperitoneally (IP; n=25), subcutaneously (SC; n=37) or under the kidney capsule (KC; n=34). Capsule biocompatibility (retrieval rate, capsule diameter, degree of capsule broken and cellular overgrowth, CD68/CD3 staining) as well as islets viability and functionality were assessed until 30 days after transplantation. Implantation site did not significantly influence the biocompatibility of empty alginate capsules after transplantation (n=48). Most of the empty capsules (>90%) were retrieved after harvesting and were free of cellular overgrowth until day 30 post-transplantation. Three days after implantation, no significant difference for encapsulated pig islets was observed in terms of capsule biocompatibility and islet functionality in peritoneum, KC or subcutaneously. However, between days 5 and 30 after transplantation, explanted capsules from IP demonstrated a higher degree of broken capsules (>13%) and capsules with severe cellular overgrowth (>50%, CD68+ infiltration) than capsules removed from SC and KC (p<0.05). This was associated with a significant reduction of islet viability, insulin content and insulin secretion. In rats, the peritoneum site seems not appropriate for promoting the engraftment of encapsulated pig islets. Kidney subcapsular and subcutaneous spaces represent an interesting alternative.

Alginates↗

PubMed2006

Phase-sensitive polymer-based controlled delivery systems of leuprolide acetate: in vitro release, biocompatibility, and in vivo absorption in rabbits.

Leuprolide acetate (LA) is a synthetic analog of gonadotropin releasing hormone. It is effective in prostate cancer treatment only when its desired concentration in blood is maintained for longer duration. Therefore, the purpose of this study was to investigate the in vitro release, biocompatibility, and in vivo absorption of LA from phase-sensitive polymer delivery systems capable of delivering it at a controlled rate for longer duration. Phase-sensitive formulations were prepared by dissolving dl-polylactic acid (dl-PLA) in a mixture of organic solvents, benzyl benzoate (BB) and benzyl alcohol (BA). LA was incorporated into the polymer solution by homogenization. In vitro release was studied into 15 ml of releasing media contained in a vial which was maintained at 37 degrees C in a reciprocal shaking water bath. The amount of LA in the released samples was analyzed by stability indicating HPLC method. The biocompatibility of polymer formulations was investigated by in vitro 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. In vivo absorption of LA from delivery systems was studied in rabbits. Blood samples were analyzed for LA and testosterone contents by commercially available immunoassay kits. In vitro release studies showed a greater release of LA from formulations containing a greater proportion of BA (hydrophilic fraction) in the solvent mixture. In vitro biocompatibility study showed significantly (p<0.05) higher cell viability in growth media diluted with polymer extract than the control. In vivo absorption of LA and its effect on testosterone level in rabbits from the delivery system showed a sustained plasma level of LA up to 12 weeks which suppressed the testosterone plasma concentration to castration level beginning from 14th day until 90 days. Thus, phase-sensitive polymer delivery systems of LA were biocompatible and delivered LA at a controlled rate both in vitro and in vivo to keep testosterone plasma concentration at a castration level up to 3 months.

Animals↗

PubMed2005

Hydrophilic polymers--biocompatibility testing in vitro.

Biocompatibility is one of the main prerequisites for safe use of medical devices. Estimation of cytotoxicity is a part of the initial evaluation laid down in ISO standards on biological evaluation of medical devices. Hydrophilic polymers (based on 2-hydroxyethyl methacrylate HEMA) doped by addition of selected additives with antioxidant and/or free radical scavenging potential (vitamin C and hindered amine stabilizer N-(2,2,6,6-tetramethylpiperidin-4-yl)methacrylamide) were tested in different in vitro systems (3T3 Balb/c cell culture and a 3D human skin model) for biocompatibility and suitability for use as wound dressings. The results of the 3T3 NRU cytotoxicity test using both the direct and indirect contact approaches and a 3D skin model modified irritation test (EpiDerm) confirmed high biocompatibility and good skin tolerance of both the basic polymers and those enriched with specific additives up to a balanced level. HEMA polymer showed a beneficial effect against cytotoxicity of an irritant (sodium dodecyl sulfate). The in vitro biocompatibility test results were confirmed by human local skin tolerance testing.

Adult↗

PubMed1997

Haemodialyser biocompatibility and erythrocyte structure and function.

There is controversy as to the clinical importance of providing haemodialysis (HD) with biocompatible versus non-biocompatible membranes. The effects of both acute and chronic dialysis with a biocompatible membrane (polyacrylonitrile, PAN) and a non-biocompatible membrane (cuprophane, CU) on the structural and functional properties of human erythrocytes have been examined. All 27 studied HD patients had increased erythrocyte osmotic fragility (OF) compared to controls; a single CU HD decreased mean OF (% lysis) by 13% without altering cell cholesterol. A single PAN HD decreased OF by a significantly greater amount (24%) and was associated with a 20% reduction in cell cholesterol. Chronic PAN HD for 6 months was associated with a sustained reduction in osmotic fragility compared to chronic CU HD (mean lysis 16% vs 45%) with no differences in mean pre-HD cell cholesterol. A single CU HD was associated with increased mean erythrocyte malonyldialdehyde (MDA) and reduced membrane content of spectrin and band 3 and this was significantly different from the effects of PAN. A single CU or PAN HD had no significant action on reduced glutathione (GSH), ankyrin, actin or sodium pump activity. Chronic HD was associated with increased GSH, and decreased ankyrin and band 3 protein compared with controls but the results for CU and PAN were not different. There was a non-significant tendency for higher MDA levels after chronic CU HD compared to PAN. These results indicate that the structural integrity of erythrocytes is improved by PAN HD with respect to CU but this difference cannot easily be ascribed to gross changes in structural proteins, ionic homeostasis or oxidation status.

Acrylic Resins↗

PubMed1996

In vitro models of biocompatibility: a review.

The objectives of this paper were to define in vitro biocompatibility of materials, to discuss some of the issues concerning why conclusions from tissue culture are sometimes different from in vivo biocompatibility, to give highlights of the sequence of the development of these in vitro assays from the early 1950s to their present state of development, and to discuss possible future trends for in vitro testing. In vitro biocompatibility tests were developed to simulate and predict biological reactions to materials when placed into or on tissues in the body. Traditional assays have measured cytotoxicity by means of either an end-stage event, (i.e., permeability of cytoplasmic membranes of dead and dying cells, or some metabolic parameter such as cell division or an enzymatic reaction). In vitro assays for initiation of inflammatory and immune reactions to materials have also begun to appear in the literature. More recently, the concept of dentin barrier tests has been introduced for dental restorative materials. Four models which measure both permeability and biological effects of materials are compared and discussed. Future efforts may be directed toward development of materials which will allow or promote function and differentiation of tissues associated with materials. New analytical procedures and understanding of optimal characteristics of materials should improve our ability to develop more biocompatible materials. Both molecular biology techniques, and altered design of material surfaces may make the materials either more or less reactive to the biological milieu. These trends suggest a greater future role of the biological sciences in the development of biomaterials.

Animals↗

PubMed2003

Long-term biocompatibility, chemistry, and function of microencapsulated pancreatic islets.

Transplantation of encapsulated living cells is a promising approach for the treatment of a wide variety of diseases. Large-scale application of the technique, however, is hampered by insufficient biocompatibility of the capsules. In the present study, we have implemented new as well as previously reported technologies to test biocompatibility issues of immunoisolating microcapsules on the long term (i.e. 2 years) instead of usually reported short time periods. When transplanted empty, the capsules proved to be highly biocompatible not only for short periods (i.e. 1 month) but also on the long term as evidenced by the absence of any significant biological response up to 2 years after implantation in rats. The immunoprotective properties of the capsules were confirmed by prolonged survival of encapsulated islet allografts up to 200 days. The surface of the applied capsule was analyzed and provides new insight in the chemical structure of true biocompatible and immunoprotective capsules applicable for transplantation of encapsulated islets in type I diabetes.

Animals↗

PubMed2001

Comparison of the biocompatibility of 2 foldable intraocular lenses with sharp optic edges.

PURPOSE: To compare the clinical performance of 2 foldable intraocular lenses (IOLs) with sharp optic edges in terms of uveal and capsular biocompatibility. SETTING: Department of Ophthalmology, University Hospital of Vienna, Vienna, Austria. METHODS: Fifty eyes scheduled for cataract surgery were included in this comparative study. A standardized surgical protocol was used, and all operations were performed by 1 experienced surgeon. Two posterior chamber lens types of similar design with a 6.0 mm sharp-edged optic and poly(methyl methacrylate) haptics were used. Twenty-five eyes received an AcrySof acrylic IOL (Alcon), and 25 eyes received a CeeOn 911A silicone IOL (Pharmacia). Relevant data were collected at a 3-year follow-up examination. To evaluate uveal biocompatibility, anterior chamber laser flare and cell measurements and inflammatory cell reactions were monitored. Cellular biocompatibility was investigated by examining anterior capsule opacification (ACO), posterior capsule opacification (PCO), and lens epithelial cell (LEC) ongrowth on the IOL's anterior surface. Factors such as intralenticular glistenings and IOL decentration were also evaluated. RESULTS: Anterior chamber flare and cells and the inflammatory cell reaction were significantly lower in the CeeOn 911A group. There was no statistically significant difference in ACO, PCO, and LEC ongrowth between the 2 groups. The AcrySof lenses showed significantly better centration and a higher density of intralenticular glistening. CONCLUSIONS: The findings show that a sharp-edged optic design is, to date, the most effective method of reducing the rate of PCO. Despite a subclinical foreign-body reaction in the AcrySof group, both lenses had a high degree of capsular and uveal biocompatibility.

Acrylic Resins↗

PubMed2006

Biocompatibility testing of branched and linear polyglycidol.

Polyglycidols are flexible hydrophilic polyethers that are potentially biocompatible polymers based on their similarities to the well-studied poly(ethyleneglycol). Polyglycidols can be prepared as branched or linear polymers by suitable synthetic methods. Biocompatibility testing of these polymers conducted in vitro as well as in vivo are reported here. The in vitro studies included hemocompatibility testing for effects on coagulation (PT and APTT), complement activation, red blood cell aggregation, and whole blood viscosity measurements. In vitro cytotoxicity experiments were also conducted. The results were compared with some of the common biocompatible polymers already in human use. Results from these studies show that polyglycidols are highly biocompatible. Hyperbranched polyglycidols were found to be well tolerated by mice even when injected in high doses.

Animals↗

PubMed2000

Biocompatibility of a cuprophane charcoal-based detoxification device in cirrhotic patients with hepatic encephalopathy.

Extracorporeal detoxification has been proposed to treat patients with hepatic encephalopathy (HE) not responding to standard therapy. To investigate the biocompatibility of a cuprophane charcoal-based detoxification device, a prospective, randomized, controlled study was performed. Of 41 consecutive patients with cirrhosis and HE grade II or III who did not improve with conventional treatment, 20 patients (median age, 56 years; range, 33 to 71 years; 13 men) were randomly assigned to either ongoing conventional treatment or one additional 6-hour treatment with a sorbent suspension dialysis system. Main outcome parameters were physiological function and blood parameters of biocompatibility. In the 10 patients undergoing combined conventional and sorbent suspension dialysis treatment, blood pressure remained unchanged and body temperature and heart rate increased (P: < 0.01). Platelet count decreased (medians, from 75 to 26 g/L; P: < 0.001) and international normalized ratio increased after combined treatment (2.0 to 2.2; P: < 0.001). Three patients developed bleeding complications during treatment or shortly after. Treated patients showed increases in levels of plasma elastase (104 to 586 microg/L; P: = 0.001), tumor necrosis factor-alpha (5.4 to 7.5 pg/mL; P: = 0.04), and interleukin-6 (118 to 139 pg/mL; P: = 0.04), but not interferon-gamma and E-selectin. No changes were observed in the 10 patients treated conventionally. In conclusion, despite technical refinements compared with charcoal hemoperfusion, biocompatibility of sorbent suspension dialysis is still very limited. Clinical complications were apparently caused by blood-membrane interactions and disseminated intravascular coagulation. We suggest further developments in design and appropriate strategies of anticoagulation to improve the biocompatibility of artificial liver support.

Adult↗