Long-term in vivo biostability of poly(dimethylsiloxane)/poly(hexamethylene oxide) mixed macrodiol-based polyurethane elastomers

Simmons, Anne; Hyvarinen, Jari; Odell, Ross A.; Martin, Darren J.; Gunatillake, Pathiraja A.; Noble, Kathryn R.; Poole-Warren, Laura A.

doi:10.1016/j.biomaterials.2004.01.004

Cited by 176 publications

(158 citation statements)

References 38 publications

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“…1 The Dynesys TM system is composed of pedicle screws and set screws, universal spacers and cords different positions were taken at each depth. At each position, the PCU sample was placed on the ATR cell to detect surface chemistry in a thin surface region (1-5 lm) [8,10]. Because the surface chemistry of polyurethanes may vary in the open-air environment, [11] spectra of the bulk spacer samples were recorded immediately after cutting.…”

Section: Atr-ftir and Gpc Analyses Of Pcu Spacersmentioning

confidence: 99%

In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study

Shen¹,

Zhang²,

Koettig

et al. 2011

Eur Spine J

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The Dynesys System for stabilizing the lumbar spine was first surgically implanted in Europe in 1994. In 2003, a prospective, randomized, investigational device exemption clinical trial of the system for non-fusion dynamic stabilization began. Polycarbonate urethane (PCU) and polyethylene terephthalate (PET) components explanted from four patients who had participated in the study were analyzed for biostability. Components had been implanted 9-19 months. The explanted components were visually inspected and digitally photographed. Scanning electron microscopy was used to analyze the surface of the spacers. The chemical and molecular properties of the retrieved spacers and cords were quantitatively compared with lot-matched, shelf-aged, components that had not been implanted using attenuated total reflection Fourier transform infrared (FTIR) and gel permeation chromatography (GPC). FTIR analyses suggested that the explanted spacers exhibited slight surface chemical changes but were chemically unchanged below the surface and in the center. New peaks that could be attributed to biodegradation of PCU were not observed. The spectral analyses for the cords revealed that the PET cords were chemically unchanged at both the surface and the interior. Peaks associated with the PET biodegradation were not detected. GPC results did not identify changes to the distributions of molecular weights that might be attributed to biodegradation of either PCU spacers or PET cords. The explanted condition of the retrieved components demonstrated the biostability of both PCU spacers and PET cords that had been in vivo for up to 19 months.

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Section: Atr-ftir and Gpc Analyses Of Pcu Spacersmentioning

confidence: 99%

In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study

Shen¹,

Zhang²,

Koettig

et al. 2011

Eur Spine J

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“…[1][2][3][4][5] Resistant polyurethanes have been used as longterm implant materials, including catheters, 6 artificial heart valves, 7 wound dressings, angioplasty balloons, ventricular assist devices, and pacing lead insulation. 8 Recently, investigators have designed biodegradable polyurethanes for applications such as artificial skin, 9 bone graft substitutes, 10 drug delivery systems, 11 and porous scaffolds for regenerating damaged tissues.…”

Section: Introductionmentioning

confidence: 99%

Manufacturing of biodegradable polyurethane scaffolds based on polycaprolactone using a phase separation method: physical properties and in vitro assay

Asefnejad¹,

Khorasani²,

Behnamghader³

et al. 2011

IJN

163

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Background Biodegradable polyurethanes have found widespread use in soft tissue engineering due to their suitable mechanical properties and biocompatibility. Methods In this study, polyurethane samples were synthesized from polycaprolactone, hexamethylene diisocyanate, and a copolymer of 1,4-butanediol as a chain extender. Polyurethane scaffolds were fabricated by a combination of liquid–liquid phase separation and salt leaching techniques. The effect of the NCO:OH ratio on porosity content and pore morphology was investigated. Results Scanning electron micrographs demonstrated that the scaffolds had a regular distribution of interconnected pores, with pore diameters of 50–300 μm, and porosities of 64%–83%. It was observed that, by increasing the NCO:OH ratio, the average pore size, compressive strength, and compressive modulus increased. L929 fibroblast and chondrocytes were cultured on the scaffolds, and all samples exhibited suitable cell attachment and growth, with a high level of biocompatibility. Conclusion These biodegradable polyurethane scaffolds demonstrate potential for soft tissue engineering applications.

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“…Thermo plastic polyurethane (TPU) elastomers are flexible biomaterials that have many end use applications, owing to its combination of excellent bio-stability, bio-compatibility, processability and desirable mechanical properties such as abrasion resistance, toughness, flexibility, durability and tensile strength [1]. TPUs are often referred to as segmented block copolymers as they consist of a hard and soft phase which either mix or segregate due to their immiscibility and produce phase mixed or phase separated morphologies.…”

Section: Introductionmentioning

confidence: 99%

The influence of electron-beam irradiation on the chemical and the structural properties of medical-grade polyurethane

Shin

Lee

2015

Journal of the Korean Physical Society

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Thermo plastic polyurethane (TPU) provides excellent bio-compatibility, flexibility and good irradiation resistance; however, extremely high irradiation doses can alter the structure and function of macromolecules, resulting in oxidation, chain scission and cross-linking. In this study, the effects of e-beam irradiation on the medical grade thermo plastic polyurethane were studied. The changes in the chain length and their distribution as well as the changes in molecular structure were studied. The GPC (Gel Permeation Chromatography) results show that the oxidative decomposition is followed by a decrease in molecular mass together with an increase in polydispersity. This indicates a very inhomogeneous degradation, which is a consequence of the specific course and of the intensity of oxidative degradation. This was confirmed by means of mechanical property measurements. Overall, this study demonstrated that the medical grade TPU was affected by radiation exposure, particularly at high irradiation doses.PACS numbers: 61.82.Pv

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Long-term in vivo biostability of poly(dimethylsiloxane)/poly(hexamethylene oxide) mixed macrodiol-based polyurethane elastomers

Cited by 176 publications

References 38 publications

In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study

In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study

Manufacturing of biodegradable polyurethane scaffolds based on polycaprolactone using a phase separation method: physical properties and in vitro assay

The influence of electron-beam irradiation on the chemical and the structural properties of medical-grade polyurethane

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