Ultrasound-guided Interventional Cryoneedle System for Enhanced Tumor Chemoablati

超声引导介入冷冻针系统增强肿瘤化疗

• 批准号: 7749316
• 负责人: Patrick Jean LePivert
• 金额: $ 15.18万
• 依托单位: NUVUE THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-14 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7749316
• 关键词: Address; Adherence; Adverse effects; American Cancer Society; Anatomy; Animals; Cancer Patient; Catheters; Chemical Agents; Clinical; Color; Computer software; Computers; Critical Care; Deposition; Development; Devices; Dose; Drug Delivery Systems; Evaluation; Fresh Tissue; Government; Hybrids; Image; Imagery; In Vitro; Injection of therapeutic agent; Lesion; Life; Liquid substance; Liver; Malignant Neoplasms; Methodology; Modification; Monitor; Movement; Needles; Operative Surgical Procedures; Outcome; Performance; Persons; Phase; Polymers; Positioning Attribute; Research; Series; Site; Solid Neoplasm; System; Techniques; Testing; Therapeutic; Time; Tissues; Toxic effect; Treatment-Related Cancer; Ultrasonography; Work; alternative treatment; base; chemotherapeutic agent; cytotoxic; design; fluid flow; improved; in vivo; innovation; interest; interstitial; laptop; minimally invasive; palliative; pre-clinical; public health relevance; reconstruction; research study; response; sensor; software development; tissue phantom; tissue trauma; tumor; tumor xenograft

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.

描述（由申请人提供）： 化学措施包括通过针（或针状系统）将细胞毒性化学剂直接应用于靶病变，以破坏其。这种方法获得了临床兴趣，因为它是一种对肿瘤的微创替代方法，并且有可能最大程度地减少组织创伤，提高局部功效并降低副作用和全身毒性，但与现有递送技术相关的几种障碍阻碍了其更广泛的使用。因此，必须开发一种方法，以可靠地将活性剂的全剂量注入病变中，以实时监测和控制靶标内药物的分布，并评估化学注射后的损害程度。将设计并结合使用手持振动机制的混合冷却和可部署的注入针头系统。 [注意：以下内容包含专有/特权的信息，即“重症监护创新公司”的请求未向政府以外的人释放，但出于审查和评估的目的除外]。该设备将用于测试以下假设：冷却探针/注射针料与现有的振动定位装置结合使用，将使针头在目标肿瘤内的定位以及将化学治疗剂递送到无反向流量的肿瘤中的可视化。此外，对探针内冷却剂的控制将有所不同地影响组织对针系统的依从性，以及在整个周围组织中化学治疗剂的分布和保留。该设备将集成到配备色流多普勒功能的基于笔记本电脑的超声成像仪中，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。将在幻像和体外组织中进行一系列实验，以评估整个系统在成像，热分析和控制药物注射和分布方面的性能。一旦完全开发，综合的超声引导，冷冻辅助注射系统（称为冷冻机”）将允许与解剖图像进行计算的热场覆盖，最终改善肿瘤的实时化学化。这种新设备将解决由于操作员的不稳定性和不稳定性的超出性图像和预测，并确定了现有的结果，并且可解决现有的结果，并确定了不稳定的图像和范围，并且是不稳定的图像性，并且不及时稳定性范围。沉积。为了破坏靶点病变，这是值得的，因为它有可能最大程度地减少组织创伤，增加局部功效并降低副作用和全身毒性，但是新的化学设备的发展是必要的。