KEYWORDS: Tissues, Thermal modeling, Medical device development, Animal model studies, Instrument modeling, Liver, Photography, Thermal effects, Uterus, Medical devices, In vivo imaging
Expansions in minimally invasive medical devices and technologies with thermal mechanisms of action are continuing to advance the practice of medicine. These expansions have led to an increasing need for appropriate animal models to validate and quantify device performance. The planning of these studies should take into consideration a variety of parameters, including the appropriate animal model (test system - ex vivo or in vivo; species; tissue type), treatment conditions (test conditions), predicate device selection (as appropriate, control article), study timing (Day 0 acute to more than Day 90 chronic survival studies), and methods of tissue analysis (tissue dissection - staining methods). These considerations are discussed and illustrated using the fresh extirpated porcine longissimus muscle model for endometrial ablation.
Penetrating thermal tissue damage/spread is an important aspect of many electrosurgical devices and correlates with effective tissue cutting, hemostasis, preservation of adjacent critical structures and tissue healing. This study compared the thermal damage/spread associated with the PhotonBlade, Valleylab Pencil, Valleylab EDGE Coated Pencil, PlasmaBlade 3.0S and PlasmaBlade 4.0, when performing a single pass dynamic tissue cut in fresh extirpated porcine longissimus muscle. These devices were used in a fashion that emulated their use in the clinical setting. Each device’s thermal damage/spread, at Minimum, Median and Maximum power input settings, was assessed with nitroblue tetrazolium viability staining in the WVU Pathology Laboratory for Translational Medicine. The thermal damage/spread associated with the PhotonBlade was compared with the other devices tested based on the individual treatment results (n=179 cuts combined). In summary, the PhotonBlade overall demonstrated the least penetrating thermal tissue damage/spread, followed by the PlasmaBlade 4.0, then Valleylab Pencil and PlasmaBlade 3.0S and then Valleylab EDGE Coated Pencil in order of increasing thermal damage/spread depths.
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