Document Detail

Design and validation of a dynamic flow model simulating encrustation of biomaterials in the urinary tract.
MedLine Citation:
PMID:  12803767     Owner:  NLM     Status:  MEDLINE    
A number of models exist for assessing encrustation on biomaterials employed as devices in the urinary tract. However, static urine models are suitable only for assessment of biomaterials residing in the bladder and the dynamic models available suffer from a number of disadvantages, notably their complexity and limitation to short-term assessment. The dynamic model described herein is a relatively simple design incorporating the ability to assess a large number of biomaterials in replicate fashion and over long periods of time. The biomaterials tested in the dynamic model conform to the urethral catheter and ureteral stent devices that experience urine flow within the urinary tract. The model was initially validated using Percuflex as a test biomaterial. The mass of calcium and magnesium, representing hydroxyapatite and struvite encrustation, respectively, on Percuflex was detected by atomic absorption spectrometry. No significant differences in encrustation levels were detected either between vessels or between biomaterial positions on any mandrel within the vessels, indicating the suitability of the dynamic model for reproducible determination of biomaterial encrustation. The dynamic model was then used to compare the encrustation of biomaterials commonly employed in urinary-tract devices, namely polyurethane, Percuflex and silicone. Calcium and magnesium levels on polyurethane and Percuflex were shown to be statistically similar, whereas silicone exhibited significantly reduced encrustation. When, subsequently, comparisons were made of biomaterial encrustation between the dynamic model and a static model, calcium and magnesium levels arising from the latter model were significantly higher on each of the biomaterials. However, the same rank order of encrustation resistance was observed for the biomaterials in both models, with silicone performing better than polyurethane or Percuflex. The prediction of in-vivo performance based on in-vitro models of encrustation is often difficult, although the model described provides a more accurate method for assessing the potential of novel and existing biomaterials for use in urinary medical devices requiring flow of urine.
Sean P Gorman; Clare P Garvin; Fergus Quigley; David S Jones
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Publication Detail:
Type:  Journal Article; Validation Studies    
Journal Detail:
Title:  The Journal of pharmacy and pharmacology     Volume:  55     ISSN:  0022-3573     ISO Abbreviation:  J. Pharm. Pharmacol.     Publication Date:  2003 Apr 
Date Detail:
Created Date:  2003-06-13     Completed Date:  2003-12-10     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0376363     Medline TA:  J Pharm Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  461-8     Citation Subset:  IM    
Medical Devices Group, School of Pharmacy, The Queen's University of Belfast, Medical Biology Centre, Belfast, BT9 7BL, UK.
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MeSH Terms
Biocompatible Materials*
Calcium / chemistry
Catheters, Indwelling*
Equipment Design
Magnesium / chemistry
Microscopy, Electron, Scanning
Models, Biological*
Prosthesis Failure
Reproducibility of Results
Urinary Catheterization / instrumentation*
Urine / chemistry
Reg. No./Substance:
0/Biocompatible Materials; 0/Polymers; 0/Polyurethanes; 0/Silicones; 0/percuflex TM; 7439-95-4/Magnesium; 7440-70-2/Calcium

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