Ultrasound-guided Interventional Cryoneedle System for Enhanced Tumor Chemoablati

描述(由申请人提供)： 化学消融包括通过针(或针状系统)将细胞毒性化学剂直接应用于靶病变以摧毁它。这种方法已经引起了临床的兴趣，因为它是一种治疗肿瘤的微创替代疗法，它具有最大限度地减少组织创伤、提高局部疗效、减少副作用和全身毒性的潜力，但与现有给药技术相关的几个障碍阻碍了它的更广泛应用。因此，必须开发一种方法来可靠地将全部剂量的活化剂(S)注射到病变中，实时监测和控制活化剂(S)在靶区内的分布，并评估化疗后的损害程度。将设计一种混合冷却和可展开的注射针系统，其中包含热传感器，并与手持振动机制相结合。[注：以下内容包含专有/特权信息，即Critical Care Innovation，Inc.要求不得向政府以外的人员发布，但用于审查和评估目的除外]。该装置将被用来测试这样一种假设，即冷却探头/注射针组件与现有的振动定位装置相结合，将允许增强针在目标肿瘤内的定位以及向肿瘤输送化疗药物而不出现回流的可视化。此外，对探头内冷却剂的控制将不同地影响组织与针系统的粘连以及化疗药物在周围组织中的分布和保持。该设备将被集成到配备彩色血流多普勒功能的笔记本电脑超声成像仪中，并将开发必要的软件，以允许对将发生药物输送的设备尖端周围的热场进行计算重建。将在模体和体外组织中进行一系列实验，以评估整个系统在成像、热分析和控制药剂(S)的注射和分布方面的性能。一旦完全开发，集成的超声引导、冷冻辅助注射系统(称为CryoCool“)将允许用解剖图像覆盖计算的热场，最终改善肿瘤的实时化学消融。这种新设备将解决由于操作员缺乏经验、超声图像引导不准确以及在提供安全和可预测的治疗剂量沉积方面的不可靠性而导致的现有结果差异。与公共卫生相关：30%到35%的实体肿瘤是不能手术的，这代表着每年大约100万新的癌症患者中的30万到35万(根据2004年美国癌症协会公司的监测研究)。目前，介入技术被探索作为姑息或治疗环境下手术的替代方法；化学消融就是这样一种技术，它包括通过针直接将细胞毒性化学制剂应用于靶病变，以摧毁它。化学消融术具有减少组织创伤、提高局部疗效、减少副作用和全身毒性的潜力，但为了充分发挥这项技术的潜力，开发新的化学消融器势在必行。

DESCRIPTION (provided by applicant): Chemoablation consists of applying a cytotoxic chemical agent via a needle (or needle-like system) directly to a target lesion in order to destroy it. This approach has gained clinical interest because it is a minimally invasive alternative treatment for tumors and it has the potential to minimize tissue trauma, increase local efficacy, and decrease side effects and systemic toxicity, but several obstacles related to the existing delivery techniques hinder its more widespread use. Thus, a methodology must be developed to reliably inject the full dose of active agent(s) into a lesion, to monitor and control the distribution of the agent(s) within the target in real-time, and to assess the extent of damage following the chemo-injection. A hybrid cooling and deployable injection needle system incorporating thermal sensors will be designed and combined with a handheld vibratory mechanism. [Note: The following contains proprietary/privileged information that Critical Care Innovations, Inc. requests not be released to persons outside the Government, except for purposes of review and evaluation]. The device will be used to test the hypothesis that a cooling probe/injection needle assembly combined with an existing vibratory locating device will allow enhanced visualization of both the positioning of the needle within the targeted tumor as well as the delivery of a chemotherapeutic agent to the tumor without backflow. Furthermore, control of the coolant within the probe will differentially influence the adherence of tissue to the needle system as well as the distribution and retention of the chemotherapeutic agent throughout the surrounding tissue. The device will be integrated into a laptop-based ultrasound imager equipped with color-flow Doppler capability, and the necessary software will be developed to allow for computational reconstruction of the thermal fields around the device tip where drug delivery will occur. A series of experiments in phantoms and in vitro tissues will be conducted to evaluate the whole system's performance in imaging, thermal analysis, and controlling the agent(s) injection and distribution. Once fully developed, the integrated ultrasound-guided, cryo-assisted injection system (known as CryoCool") will allow for an overlay of the computed thermal fields with anatomic images, ultimately improving real-time chemoablation of tumors. Such a new device will address existing outcome variability due to operators' inexperience, inaccurate ultrasonic image guidance, and unreliability in providing safe and predictable therapeutic dose deposition. PUBLIC HEALTH RELEVANCE: Between 30 and 35% of solid tumors are inoperable, which represents 300,000 to 350,000 of the approximate 1 million new cancer patients a year (according to the 2004 American Cancer Society, Inc. Surveillance Research). Interventional techniques are currently explored as alternatives to surgery in the palliative or curative settings; chemoablation is such a technique and consists of applying a cytotoxic chemical agent via a needle directly to a target lesion in order to destroy it. Chemoablation is of interest because it has the potential to minimize tissue trauma, increase local efficacy, and decrease side effects and systemic toxicity, but the development of new chemoablative devices is imperative in order to exploit the full potential of this technique.