SBIR Phase I: A novel 3D printed biodegradable mesh delivering active pharmaceutical ingredients in a sustained and localized manner

SBIR 第一阶段：一种新型 3D 打印可生物降解网，以持续和局部的方式提供活性药物成分

• 批准号: 2052049
• 负责人: Khatija Ali
• 金额: $ 25.6万
• 依托单位: BIOSAPIEN INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2052049&HistoricalAwards=false
• 关键词: SBIR; Phase; novel; 3D; printed

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to establish a proof-of-concept for an oncological medical device that will be used as an adjunct treatment for pancreatic cancer (PC). PC is one of the lethal forms of cancer and is the second leading cause of cancer-related death in the US. Chemotherapy is the first-line standard treatment for cancer therapy. The medications used during chemotherapy are administered through an intravenous infusion (IV), pill, or injection. Once these medications enter the bloodstream, they destroy the cancerous cells and the healthy cells. The most common side effects for patients are nausea, vomiting, hair loss, and decreased immunity leading to a low quality of life. Our prototype aims to reduce chemotherapy side effects and the need for in-hospital chemotherapy administration, significantly reducing healthcare costs. The proposed innovative technology offers an alternative to direct surgical resection in the sensitive areas surrounding the pancreas. This treatment will extend the number of patients who can benefit from surgery and increase the overall success of surgeries primarily by preventing local relapse. This Small Business Innovation Research Phase I project will lay the essential foundation for understanding the medical device product's physical and chemical characteristics. Pancreatic cancer (PC) is a "silent" disease because it is diagnosed at a much later stage when cancer has already metastasized. One of the significant challenges associated with PC treatment is the standard administration techniques (e.g., intravenous injection, oral administration) cannot efficiently deliver a therapeutic concentration of the drug to the tumor site because of the pancreas' anatomy. The innovative technology used in this prototype device will render it as an implantable, biodegradable, drug-eluting product allowing for spatio-temporal control and delivery of various active pharmaceutical ingredients (APIs) directly to the tumor site. Further, reductions in global toxicity and access to traditionally unresectable areas may enable higher concentrations of chemotherapeutic agents than could be tolerated by systemic administration, significantly altering the treatment landscape. This project will address the following four technical challenges related to the formulation and physical characteristics of the prototype, which will determine its release profile and the 3D printing mechanism, and its impact on the device's quality. The research and development routes that are being pursued include (1) assessment of prototype mechanical profile, starting with one API of interest (2) assessment of different polymer compositions and how they impact the flow of the printing material and resolution; (3) testing the use of fluorophores during the formulation of the prototype (4) assessment of different properties of the print material (e.g., pressure, print-head type, temperature, and viscosity) on the quality of the prototype.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小型企业创新研究（SBIR）I期项目的更广泛影响是为将用作胰腺癌（PC）辅助治疗的肿瘤医疗器械建立概念验证。PC是致命的癌症形式之一，是美国癌症相关死亡的第二大原因。化疗是癌症治疗的一线标准治疗。化疗期间使用的药物通过静脉输注（IV），药丸或注射给药。一旦这些药物进入血液，它们就会破坏癌细胞和健康细胞。患者最常见的副作用是恶心，呕吐，脱发和免疫力下降，导致生活质量低下。我们的原型旨在减少化疗副作用和住院化疗管理的需要，显着降低医疗成本。这项创新技术为胰腺周围敏感区域的直接手术切除提供了一种替代方案。这种治疗将扩大可以从手术中受益的患者数量，并主要通过防止局部复发来增加手术的总体成功率。该小型企业创新研究第一阶段项目将为理解医疗器械产品的物理和化学特性奠定必要的基础。胰腺癌（PC）是一种“沉默”的疾病，因为它是在癌症已经转移的后期诊断的。与PC治疗相关的重大挑战之一是标准给药技术（例如，静脉内注射、口服给药）由于胰腺的解剖结构而不能有效地将治疗浓度的药物递送到肿瘤部位。该原型装置中使用的创新技术将使其成为一种可植入的，可生物降解的药物洗脱产品，允许时空控制和将各种活性药物成分（API）直接输送到肿瘤部位。此外，整体毒性的降低和进入传统上不可切除的区域可以使化疗剂的浓度高于全身给药所能耐受的浓度，从而显著改变治疗前景。该项目将解决与原型的配方和物理特性相关的以下四个技术挑战，这将决定其释放曲线和3D打印机制，以及其对设备质量的影响。正在进行的研究和开发路线包括（1）评估原型机械轮廓，从一个感兴趣的API开始（2）评估不同的聚合物组合物以及它们如何影响打印材料的流动和分辨率;（3）测试在原型的配制期间荧光团的使用;（4）评估打印材料的不同性质（例如，该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。