Percutaneous Lung Nodule Resection With Sealing Of Airways And Blood Vessels In A Chronic Porcine Model
Rick Fischel, MD,Ph.D1, Edward M. Boyle, MD1, Joanna Nathan2.
1Prana Thoracic LLC, Irvine, CA, USA, 2Prana Thoracic LLC, Houston, TX, USA.
BACKGROUND: Lung cancer remains the number one cause of cancer related death and early detection by CT screening has proven to decrease mortality by 20%. We have determined that there is a large unmet need in properly addressing and diagnosing intermediate sized lung nodules in this patient population.
METHODS: Over the course of several years we have designed, developed and built numerous iterations of a prototype device which can delve into tissue over an anchored guide-wire and then seal it using radio-frequency energy (RF) in a 360 degree circular fashion allowing the user to remove a core of tissue. Using our device we operated on acute and chronic pigs under general anesthesia to demonstrate proof of concept and overall safety and sealing efficacy of the technique.
RESULTS: Overall 39 successful lung tissue core sample were removed with some acute animals having more than one core obtained. In each case hemostasis was obtained in the core cavity. Several methods were studied to eliminate air leak if present after coring. These included testing sealants such as bioglue, surgifoam and ablation using innoblative technology as well as autologous blood patch application. After determining that blood patch was successful in each case we proceeded to perform a single core to a depth of 2.5 cm in two chronic pigs who were then sacrificed day 7 after the procedure showing excellent healing of the surgical core area.
CONCLUSIONS: In conclusion, we have developed a novel device capable of percutaneously taking a core of lung tissue to remove nodules up to 1.2 cm while sealing blood vessels and airways using RF energy in a circular fashion and to ligate the distal end of the specimen. The technology has proven to be applicable to a survival animal model with excellent results including complete hemostasis and aerostasis. Further development for human use should help to meet the unmet need for accurately diagnosing and treating small to intermediate sized lung nodules and improving overall survival for lung cancer patients.
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