Breast cancer rates are rising in low- and middle-income countries (LMICs), yet there is a lack of accessible and cost-effective treatment. As a result, the cancer burden and death rates are highest in LMICs. In an effort to meet this need, our work presents the design and feasibility of a low-cost cryoablation system using widely-available carbon dioxide as the only consumable. This system uses an 8-gauge outer-diameter needle and Joule-Thomson expansion to percutaneously necrose tissue with cryoablation. Bench top experiments characterized temperature dynamics in ultrasound gel demonstrated that isotherms greater than 2 cm were formed. Further, this system was applied to mammary tumors in an in vivo rat model and necrosis was verified by histopathology. Finally, freezing capacity under a large heat load was assessed with an in vivo porcine study, where volumes of necrosis greater than 1.5 cm in diameter confirmed by histopathology were induced in a highly perfused liver after two 7-minute freeze cycles. These results demonstrate the feasibility of a carbon-dioxide based cryoablation system for improving solid tumor treatment options in resource-constrained environments.
34Breast cancer rates are rising in low-and middle-income countries (LMICs), yet 35 there is a lack of accessible and cost-effective treatment. As a result, the cancer burden 36 and death rates are highest in LMICs. In an effort to meet this need, our work presents the 37 design and feasibility of a low-cost cryoablation system using widely-available carbon 38 dioxide as the only consumable. This system uses an 8-gauge outer-diameter needle and 39 Joule-Thomson expansion to percutaneously necrose tissue with cryoablation. Bench top 40 experiments characterized temperature dynamics in ultrasound gel demonstrated that 41 isotherms greater than 2 cm were formed. Further, this system was applied to mammary 42 tumors in an in vivo rat model and necrosis was verified by histopathology. Finally, 43 freezing capacity under a large heat load was assessed with an in vivo porcine study, 44 where volumes of necrosis greater than 1.5 cm in diameter confirmed by histopathology 45 were induced in a highly perfused liver after two 7-minute freeze cycles. These results 46 demonstrate the feasibility of a carbon-dioxide based cryoablation system for improving 47 solid tumor treatment options in resource-constrained environments. 48 49 54 United States [2], the survival rate in low-and middle-income countries (LMICs) can 55 range from 64% in Saudi Arabia to 46% in Uganda to only 12% in The Gambia [3]. 56These rates are typically lower in rural areas of LMICs due to inadequate treatment and 57 long travel times to regional hospitals [4]. The current treatment pattern used in 58 developed countries-surgery, chemotherapy, and radiation therapy-is inefficient, 59 inaccessible, and costly in many LMICs [5,6]. 60Tissue ablation has several advantages over surgical treatments for practical use 61 in LMICs, and previous work has explored the use of cryoablation for treatment of 62 cancers including liver, lung, prostate, and breast cancer [7][8][9][10][11][12]. Cryoablation is a 63 minimally-invasive treatment that is well tolerated with the intrinsic anesthetic properties 64 of cold providing local anesthesia [13]. Moreover, the ice formation can easily be tracked 65 with ultrasound for real-time treatment guidance. These features permit precise and 66 effective cryoablation treatment with a companion ultrasound unit and only a local skin 67 cleaning rather than the current standard of general anesthesia and an operating theater 68 for surgery [9,14]. Importantly, circumventing the requirement for a sterile operating 69 room would enable treatments to be performed at local clinics, which are more accessible 70 to patients as they are more abundant in the rural regions. Further, by virtue of being 71 minimally invasive, cryoablation is known to reduce pain, bleeding, and recovery time 72 when compared with surgical procedures [15]. 73Cryoablation kills breast cancer cells through the formation of intracellular ice 74 crystals, which begin forming at temperatures below -20 °C; however, temperatures 75 below -40 °C are optimal for c...
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