Islet culture, shipping, and infusion device

胰岛培养、运输和输注装置

• 批准号: 6953189
• 负责人: John Wilson
• 金额: $ 51.08万
• 依托单位: WILSON WOLF MANUFACTURING CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6953189
• 关键词: animal tissue; biomedical equipment development; clinical research; consumable /disposable biomedical equipment; gas; growth media; human tissue; injection /infusion; insulin dependent diabetes mellitus; membrane permeability; miniature biomedical equipment; oxygen consumption; packaging material; pancreatic islet transplantation; pancreatic islets; tissue /cell culture

DESCRIPTION (provided by applicant): There exists a need for a single device that can culture, ship, and infuse islet. Flasks and petri dishes are the devices currently used to store islets. They are a weak link in the process because these devices have inherent design limitations that do not allow them to maintain islets at high viability during culture or shipping. The problem is the need to oxygenate islets by a gas/medium interface. The net result is that many devices are required for a single transplant, the process is not compatible with regulatory control, and precious islets are lost due to necrosis. There are no commercially available substitutes that offer a superior alternative. This grant is focuses upon creating a gas permeable device that cultures, ships, and infuses islets at high viability in a manner compatible with regulatory control. This device will be superior to any commercially available alternatives. By eliminating the link between oxygen delivery and a gas/medium interface, a device that allows high density culture at high viability becomes available. The islets are at improved oxygen tension, with extra medium capacity, from culture through shipping. Primary and backup device configurations are proposed. One configuration is based on culturing islets at high density in an extremely easy to use device. A backup device integrates a high amount of surface area to house islets at a wide range of possible densities. Aim 1 determines which configuration will be pursued, and creates its design specifications. Of primary interest is the optimal gas permeable surface area to medium volume ratios that indicate device size and shape. Aim 2 produces small scale prototypes of the device and quantifies the performance relative to the flask using porcine and human islets, and provides design specifications for Aim 3. Aim 3 produces full scale device prototypes and quantifies the performance relative to the flask using porcine and human islets. If the novel device proves superior to the flask, specifications of the device will be delivered to Phase II which will investigate making the device suitable for shipping and infusing islets.

描述（由申请人提供）： 需要一种能够培养、运输和输注胰岛的单一装置。烧瓶和培养皿是目前用于储存胰岛的装置。它们是该过程中的薄弱环节，因为这些装置具有固有的设计限制，不允许它们在培养或运输期间保持胰岛处于高活力。问题是需要通过气体/介质界面来包裹胰岛。最终结果是，单次移植需要许多设备，该过程与监管控制不兼容，并且由于坏死而丢失了宝贵的胰岛。目前还没有市售替代品提供上级替代品。 该补助金的重点是创造一种透气装置，以符合监管控制的方式培养，运输和注入高活力的胰岛。该装置将上级任何市售替代品。通过消除氧气输送和气体/培养基界面之间的联系，可以获得允许以高活力进行高密度培养的装置。从培养到运输，胰岛的氧张力得到改善，具有额外的中等容量。提出了主设备和备份设备配置。一种配置是基于在非常容易使用的装置中以高密度培养胰岛。备用装置集成了大量的表面积，以在广泛的可能密度范围内容纳胰岛。目标1确定将采用哪种配置，并创建其设计规范。主要关注的是指示装置尺寸和形状的最佳气体可渗透表面积与介质体积比。目标2生产了器械的小规模原型，并使用猪和人胰岛量化了相对于培养瓶的性能，并提供了目标3的设计质量标准。目标3生产全尺寸器械原型，并使用猪和人胰岛量化相对于培养瓶的性能。如果新装置被证明上级培养瓶，则该装置的规格将被交付到第II阶段，该阶段将研究使该装置适合于运输和输注胰岛。