重新思考肥胖的人类因素:开发人类软组织的模拟和物理测试模型,以研究自动注射器激活性能
Eric Linvill1, Chung Tsai2, Paolo Ravaynia2
1SHL Medical AB, Nacka Strand, Sweden; and eric.linvill@shl-medical.com.
PDA journal of pharmaceutical science and technology
|August 23, 2024
概括
自动注射器激活测试需要改进. 标准化方法无法代表肥胖患者中发现的软组织,这可能导致更高的激活力,并在现实世界中影响设备性能.
科学领域:
- 生物医学工程 生物医学工程
- 医疗器械开发 医疗器械开发
- 人类因素工程 人类因素工程
背景情况:
- 标准化自喷器激活测试 (ISO 11608-1) 使用硬表面,这可能不会准确地反映在软人体组织上的性能.
- 肥胖患者往往有较软的注射部位,这是由于独特的人类测量和粘弹性特性.
- 这些软组织特性可以显著增加自喷器激活力,这是目前测试中通常不考虑的因素.
研究的目的:
- 开发自动注射器的先进软组织模拟和物理测试方法.
- 提高自动注射器激活测试的准确性和相关性.
- 确保在不同患者群体中可靠的设备性能,包括那些注射部位较软的患者.
主要方法:
- 开发新的软组织模拟模型.
- 实施先进的物理测试协议,以模仿真实世界的注射场景.
- 对模拟软组织,具有不同的粘弹性质的自我注射力进行评估.
主要成果:
- 开发的方法成功模拟了软注射部位的粘弹性特性.
- 测试显示,与硬表面相比,模拟软组织上的自喷器激活力显著更高.
- 新的方法提供了对自动注射器性能更现实的评估.
结论:
- 目前的标准化自喷器测试不足以预测软注射点的性能.
- 先进的模拟和物理测试对于为所有患者类型开发可靠的自喷器至关重要.
- 这项研究通过结合现实的软组织相互作用来推进自喷器设计.
相关概念视频
01:09Clearance Models: Physiological Models
Drug clearance is a critical pharmacokinetic process involving the irreversible removal of drugs from the body through various organs over a specified time period. Physiological models are indispensable in determining organ-specific clearance, defined by the proportion of the drug eliminated per unit of time from the organ's blood volume.
The organ's clearance rate depends on the blood flow to the organ and the extraction ratio (E). The extraction ratio describes the organ's proficiency in drug...
The organ's clearance rate depends on the blood flow to the organ and the extraction ratio (E). The extraction ratio describes the organ's proficiency in drug...
01:15Model Approaches for Pharmacokinetic Data: Physiological Models
Physiological models in pharmacokinetics are instrumental in understanding the distribution and elimination of drugs within the body. These models describe the drug concentration within target organs, influenced by factors such as drug uptake, tissue volume, and blood flow. Drug uptake is governed by the partition coefficient, which signifies the drug concentration ratio in tissue to that in the blood. The blood flow rate to a specific tissue is expressed as Qt, and the rate of change in tissue...