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可运输、便携式、可穿戴及(部分)可植入式血液透析系统:技术与技术就绪水平比较

Transportable, portable, wearable and (partially) implantable haemodialysis systems: comparison of technologies and readiness levels.

作者信息

Wieringa Fokko P, Bolhuis Dian, Søndergaard Henning, Ash Stephen R, Cummins Cian, Gerritsen Karin G F, Vollenbroek Jeroen, Irmak Tugrul

机构信息

IMEC the Netherlands - Health Research, Eindhoven, The Netherlands.

UMC Utrecht - Nephrology Dept, Utrecht, The Netherlands.

出版信息

Clin Kidney J. 2024 Aug 24;17(9):sfae259. doi: 10.1093/ckj/sfae259. eCollection 2024 Sep.

Abstract

BACKGROUND

Dialysis modalities and their various treatment schedules result from complex compromises ('trade-offs') between medical, financial, technological, ergonomic, and ecological factors. This study targets summarizing the mutual influence of these trade-offs on (trans)portable, wearable, or even (partially) implantable haemodialysis (HD) systems, identify what systems are in development, and how they might improve quality of life (QoL) for patients with kidney failure.

METHODS

HD as defined by international standard IEC 60601-2-16 was applied on a PUBMED database query regarding (trans)portable, wearable, and (partly) implantable HD systems. Out of 159 search results, 24 were included and scanned for specific HD devices and/or HD systems in development. Additional information about weight, size, and development status was collected by the internet and/or contacting manufacturers. International airplane hand baggage criteria formed the boundary between transportable and portable. Technology readiness levels (TRLs) were assigned by combining TRL scales from the European Union and NATO medical staff.

RESULTS

The query revealed 13 devices/projects: seven transportable (six TRL9, one TRL5); two portable (one TRL6-7, one TRL4); two wearable (one TRL6, one frozen); and two partly implantable (one TRL4-5, one TRL2-3).

DISCUSSION

Three main categories of technical approaches were distinguished: single-pass, dialysate regenerating, and implantable HD filter with extracorporeal dialysate regeneration (in climbing order of mobility).

CONCLUSIONS

Kidneys facilitate mobility by excreting strongly concentrated waste solutes with minimal water loss. Mimicking this kidney function can increase HD system mobility. Dialysate-regenerating HD systems are enablers for portability/wearability and, combined with durable implantable HD filters (once available), they may enable HD without needles or intravascular catheters. However, lack of funding severely hampers progress.

摘要

背景

透析方式及其各种治疗方案是医学、经济、技术、人体工程学和生态因素之间复杂权衡(“取舍”)的结果。本研究旨在总结这些权衡对(可)移动、可穿戴甚至(部分)植入式血液透析(HD)系统的相互影响,确定哪些系统正在研发中,以及它们如何改善肾衰竭患者的生活质量(QoL)。

方法

根据国际标准IEC 60601-2-16定义的血液透析应用于关于(可)移动、可穿戴和(部分)植入式血液透析系统的PUBMED数据库查询。在159个搜索结果中,纳入了24个并扫描正在研发的特定血液透析设备和/或血液透析系统。通过互联网和/或联系制造商收集了有关重量、尺寸和研发状态的其他信息。国际航空手提行李标准构成了可移动和便携式之间的界限。技术就绪水平(TRL)是通过结合欧盟和北约医务人员的TRL量表来确定的。

结果

该查询揭示了13种设备/项目:7种可移动的(6种TRL9,1种TRL5);2种便携式的(1种TRL6-7,1种TRL4);2种可穿戴的(1种TRL6,1种停滞);以及2种部分植入式的(1种TRL4-5,1种TRL2-3)。

讨论

区分了三种主要的技术方法类别:单程、透析液再生和具有体外透析液再生功能的植入式血液透析过滤器(按移动性递增顺序排列)。

结论

肾脏通过以最小的水分流失排出高度浓缩的废物溶质来促进移动性。模仿这种肾脏功能可以提高血液透析系统的移动性。透析液再生血液透析系统是实现便携性/可穿戴性的关键,并且与耐用的植入式血液透析过滤器(一旦可用)相结合,它们可能实现无需针头或血管内导管的血液透析。然而,资金短缺严重阻碍了进展。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c66f/11411285/edef0447a0ee/sfae259fig1.jpg

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