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平台和套管设计改进用于脊髓治疗药物的输送。

Platform and cannula design improvements for spinal cord therapeutics delivery.

机构信息

Department of Neurosurgery, Emory University School of Medicine, Atlanta, Georgia 30322, USA.

出版信息

Neurosurgery. 2011 Dec;69(2 Suppl Operative):ons147-54; discussion ons155. doi: 10.1227/NEU.0b013e3182195680.

DOI:10.1227/NEU.0b013e3182195680
PMID:21471842
Abstract

BACKGROUND

Only recently have data been published attempting to validate a technology and technique suitable for targeted delivery of biological payloads to the human spinal cord.

OBJECTIVE

To characterize the development and evolution of a spine-stabilized microinjection platform as a vehicle for biologics delivery to the cervical and thoracolumbar spine on the basis of preclinical experience in both non-Good Laboratory Practice (GLP) experimental series and GLP studies.

METHODS

Our laboratory completed > 100 cervical and lumbar porcine microinjection procedures between July 2004 and June 2010. This included both non-GLP- and GLP-adherent survival series to validate the safety and accuracy achievable with intraspinal microinjection. During this time, 3 different microinjection platforms, injection stages, and cannula designs were tested.

RESULTS

Repetitive technological improvements reduced incision length, decreased procedural complexity, and simplified ventral horn targeting and accuracy. These changes reduced procedural invasiveness and the likelihood of neurological morbidity while improving targeting accuracy. In part as a result of these technological improvements and procedural modifications, we have safely progressed from single unilateral microinjections to multiple bilateral injections without long-term neurological sequelae.

CONCLUSION

Technological and procedural refinements have significantly enhanced the capabilities of intraspinal microinjection-based biologics delivery. Reductions in procedural invasiveness and the capability to deliver sequential biological payloads effectively have broadened the flexibility of intraspinal microinjection to a widened array of intrinsic spinal cord pathologies. These advances have laid the groundwork for clinical translation of spinal cord microinjections.

摘要

背景

直到最近,才发表了一些数据,试图验证一种适合将生物有效载荷靶向递送到人体脊髓的技术和技术。

目的

根据非良好实验室规范 (GLP) 实验系列和 GLP 研究中的临床前经验,描述脊柱稳定微注射平台的开发和演变,作为生物递送到颈和胸腰椎的载体。

方法

我们的实验室在 2004 年 7 月至 2010 年 6 月期间完成了 > 100 例颈椎和腰椎猪微注射程序。这包括非 GLP 和 GLP 符合的存活系列,以验证椎管内微注射可实现的安全性和准确性。在此期间,测试了 3 种不同的微注射平台、注射台和套管设计。

结果

重复的技术改进减少了切口长度,降低了程序复杂性,并简化了腹角靶向和准确性。这些变化降低了程序的侵袭性和神经发病率的可能性,同时提高了靶向准确性。部分由于这些技术改进和程序修改,我们已经从单侧单次微注射安全地进展到双侧多次注射,而没有长期的神经后遗症。

结论

技术和程序的改进显著增强了基于脊髓内微注射的生物有效载荷传递的能力。程序侵袭性的降低和连续生物有效载荷传递的能力有效地拓宽了脊髓内微注射的灵活性,适用于更广泛的内在脊髓病理。这些进展为脊髓内微注射的临床转化奠定了基础。

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