RESUMEN
A trachea is a tubular structure composed of smooth muscle that is reinforced with cartilage rings. Some diseases can cause sagging in smooth muscle and cartilaginous tissue. The end result is reduction (narrowing) of the trachea diameter. A solution to this problem is the use of tracheal stents, which are small tubular devices made of silicone. One is inserted into the trachea to prevent or correct its constriction. The purpose of tracheal stent use is to maintain cartilage support that would otherwise be lost in the airway. Current tracheal stent models present limitations in terms of shape and characteristics of the silicone used in their production. One of the most important is the large thickness of the wall, which makes its placement difficult; this mainly applies to pediatric patients. The wall thickness of the stent is closely related to the mechanical properties of the material. This study aims to test the reinforcement of silicone with three kinds of fibers, and then stents that were produced using fiber with the best compressive strength characteristics. Silicone samples were reinforced with polypropylene (PP), polyamide (PA), and carbon fiber (CF) at concentrations of 2% and 4% (vol%), which then underwent tensile strength and Shore A hardness testing. Samples with fiber showed good characteristics; surface analyses were carried out and they were used to produce stents with an internal diameter of 11 or 13mm and a length of 50mm. Stents underwent compression tests for qualitative evaluation. Samples with 2% and 4% CF blends showed the best mechanical performance, and they were used to produce stents. These samples presented similar compressive strengths at low deformation, but stents with a 4% CF blend exhibited improved compressive strength at deformations greater than 30-50% of their diameter (P ≤ 0.05). The addition of 2% and 4% CF blends conferred greater mechanical strength and resistance to the silicone matrix. This is particularly true at low deformation, which is the condition where the stent is used when implanted. In the finite element compression strength tests, the stent composite showed greater compression strength with the addition of fiber, and the results were in accordance with mechanical compression tests performed on the stents. In vivo tests showed that, after 30 days of post-implantation in sheep trachea, an inflammatory process occurred in the region of the trachea in contact with the stent composite and with the stent without fiber (WF). This response is a common process during the first few days of implantation.
Asunto(s)
Materiales Biocompatibles/química , Bronquios/patología , Siliconas/química , Stents , Tráquea/patología , Animales , Carbono/química , Fuerza Compresiva , Análisis de Elementos Finitos , Dureza , Ensayo de Materiales , Movimiento (Física) , Nylons/química , Polipropilenos/química , Ovinos , Estrés Mecánico , Propiedades de Superficie , Resistencia a la TracciónRESUMEN
OBJECTIVE: To describe the development of a silicone stent and perform in vivo testing for biocompatibility/applicability in the normal canine trachea. METHODS: Four different densities were tested in order to obtain the silicone prototypes. The pressure required for compression considering a contact area of 1 cm(2), and a 30% reduction in diameter was calculated for each density. The best density was 70-75 Shore A hardness. Powdered barium sulfate was added to the silicone to make the stent radiopaque and easily identifiable in radiological imaging. This novel stent presents a corrugated external surface with discontinuous and protruding arcs resembling the tracheobronchial rings (for intercalation and fixation in the lumen of the lower airways), a highly polished inner surface and smooth extremities (to prevent friction-related damage). The prototype considered most appropriate in terms of rigidity and flexibility was bronchoscopically implanted in normal canine tracheas. After eight weeks, the animals were euthanized, and the tracheas were removed for anatomopathological analysis. RESULTS: There were no postimplantation complications, and none had to be removed. After eight weeks, the devices were found to be well-positioned. Histopathology revealed a well-preserved epithelial basal membrane, foci of denuded epithelium, mild submucosal inflammatory infiltrate with scattered granulation tissue, vascular neoformation, and no microorganisms. CONCLUSIONS: The stent developed proved resistant to mechanical stress, biocompatible in the canine trachea and well-preserved at the study endpoint.
Asunto(s)
Materiales Biocompatibles , Implantes Experimentales , Stents , Estenosis Traqueal/terapia , Animales , Fuerza Compresiva , Modelos Animales de Enfermedad , Perros , Ensayo de Materiales , Diseño de Prótesis , Siliconas , Estrés Mecánico , Tráquea/anatomía & histologíaRESUMEN
OBJETIVO: Descrever o desenvolvimento de uma órtese de silicone e os testes in vivo de compatibilidade e aplicabilidade na traquéia canina normal. MÉTODOS: Quatro densidades de silicone foram testadas para a obtenção de protótipos. Para cada densidade, foi calculada a pressão exigida para causar a compressão, considerando-se uma área de contato de 1 cm² e uma redução de 30 por cento no diâmetro. A densidade selecionada foi 70-75 Shore A hardness. Adicionou-se sulfato de bário em pó ao silicone para tornar a órtese desenvolvida radiopaca e facilmente identificável ao exame radiológico. A órtese desenvolvida apresenta superfície externa corrugada com arcos salientes e descontínuos, semelhantes aos anéis traqueobrônquicos, para intercalação e fixação nas vias aéreas inferiores, superfície interna polida e extremidades lisas que evitam o dano por fricção. O protótipo considerado como sendo o mais adequado em termos de rigidez e flexibilidade foi implantado broncoscopicamente em traquéias caninas normais. Os animais foram sacrificados após oito semanas, e a traquéia foi removida para análise anatomopatológica. RESULTADOS: Não houve complicações após a implantação das órteses. Nenhuma precisou ser removida, e todas estavam bem posicionadas ao final de oito semanas. O estudo histopatológico mostrou que a membrana basal epitelial foi preservada. Foram observados pontos focais de desnudamento epitelial, leve infiltrado inflamatório sob a mucosa e, mais raramente, tecido de granulação com neoformação vascular e ausência de microorganismos. CONCLUSÕES: A órtese desenvolvida mostrou resistência aos esforços mecânicos e biocompatibilidade, não provocando reação tecidual adversa na traquéia canina, além de permanecer íntegra ao final do experimento.
OBJECTIVE: To describe the development of a silicone stent and perform in vivo testing for biocompatibility/applicability in the normal canine trachea. METHODS: Four different densities were tested in order to obtain the silicone prototypes. The pressure required for compression considering a contact area of 1 cm2, and a 30 percent reduction in diameter was calculated for each density. The best density was 70-75 Shore A hardness. Powdered barium sulfate was added to the silicone to make the stent radiopaque and easily identifiable in radiological imaging. This novel stent presents a corrugated external surface with discontinuous and protruding arcs resembling the tracheobronchial rings (for intercalation and fixation in the lumen of the lower airways), a highly polished inner surface and smooth extremities (to prevent friction-related damage). The prototype considered most appropriate in terms of rigidity and flexibility was bronchoscopically implanted in normal canine tracheas. After eight weeks, the animals were euthanized, and the tracheas were removed for anatomopathological analysis. RESULTS: There were no postimplantation complications, and none had to be removed. After eight weeks, the devices were found to be well-positioned. Histopathology revealed a well-preserved epithelial basal membrane, foci of denuded epithelium, mild submucosal inflammatory infiltrate with scattered granulation tissue, vascular neoformation, and no microorganisms. CONCLUSIONS: The stent developed proved resistant to mechanical stress, biocompatible in the canine trachea and well-preserved at the study endpoint.