上下肢康复机器人检验常见问题的讨论

随着我国医疗器械技术的发展,上下肢康复机器人作为一种新型的医疗器械出现在大众面前,很大程度上替代了传统的康复训练,提高了康复训练的效率。但是上下肢康复机器人的出现也伴随着一些问题,文章结合上下肢康复机器人的一些标准及广东省医疗器械质量监督检验所近年来对上下肢康复机器人的检测情况进行探讨,并提出一些问题和建议,以期能够规范上下肢康复机器人的市场和提高上下肢康复机器人的产品质量。     

肢体缺血/再灌注诱发大鼠心脏血红素氧合酶1的表达(英文)

目的　观察后肢体缺血 /再灌注是否诱发心脏血红素氧合酶 1(HO - 1)的表达。方法　在氨基甲酸乙脂麻醉大鼠行后肢体缺血 /再灌注后 ,测量心脏组织中丙二醛的含量和超氧歧化酶 (SOD)的活性 ;并应用Northern和Western杂交方法分别检测HO - 1mRNA和蛋白的表达情况。结果　在肢体缺血 /再灌注过程中 ,心脏中的丙二醛含量增加 ,而超氧歧化酶的活性降低 ;单纯肢体缺血并不引起心脏血红素氧合酶 1mR NA和蛋白表达的变化 ,但缺血 /再灌注增强心脏血红素氧合酶 1mRNA和蛋白表达。结论　肢体缺血 /再灌注不仅提高心脏中丙二醛的含量 ,降低超氧歧化酶的活性 ;而且上调血红素氧合酶 1在心脏的表达。     

急性下肢缺血性疾病的介入治疗

目的 探讨应用介入方法治疗急性下肢缺血性疾病的临床效果及安全性。方法 21例患按基础病因不同分为两组,对无患肢慢性缺血史给予单纯动脉内灌注尿激酶,对存在有患肢慢性缺血史在给予适当尿激酶30万u后,应用超滑导丝通过闭塞段,顺导丝送入球囊导管行PTA术。结果 第1组8例,获得成功,1例于术后第3天死于急性左心功能不全;第2组9例获得成功,3例在发病5日后行截肢术。结论 (1)多种介入方法联合治疗急性下肢缺血临床效果可靠。(2)基础性病因是决定介入方法选择的首要因素。     

Successful 18-h acellular extracorporeal perfusion and replantation of porcine limbs - Histology versus nerve stimulation

The current standard for composite tissue preservation is static cold storage (SCS) and is limited to 6 h until irreversible muscle damage occurs. Extracorporeal perfusion (ECP) is a promising technique for prolonged preservation, however, functional results have been scarcely researched. This article assessed neuromuscular function and compared results to histological alterations to predict muscle damage after ECP. Forelimbs of twelve Dutch landrace pigs were amputated and preserved by 4 h SCS at 4–6 °C (n = 6) or 18 h mid-thermic ECP with University of Wisconsin solution (n = 6). Limbs were replanted and observed for 12 h. Sham surgery was performed on contralateral forelimbs (n = 12). Histology analysis scored four subgroups representing different alterations (higher score equals more damage). Muscle contraction after median nerve stimulation was comparable between ECP, SCS, and sham limbs (P = 0.193). Histology scores were higher in ECP limbs compared to SCS limbs (4.8 vs. 1.5, P = 0.013). This was mainly based on more oedema in these limbs. In-vivo muscle contraction was well preserved after 18 h ECP compared to short SCS, although histology seemed inferior in this group. Histology, therefore, did not correlate to muscle function at 12 h after replantation. This leads to the question whether histology or neuromuscular function is the best predictor for transplant success.     

Post-retrieval functionality testing of PRECICE lengthening nails: The “Sleeper” nail concept

IntroductionPRECICE intramedullary magnetic lengthening nails, introduced in 2011, have changed the landscape of long bone limb lengthening. The implants have a stroke ranging from 5 to 8 cm, but it may be desirable to perform part of the lengthening at one treatment, allow bone healing, leave the implant in place, dormant, and then return one or more years later to re-lengthen with the same implant. We call this the “sleeper” nail concept. This strategy may be gentler for the joints and soft tissues. Would the nail mechanism still be functional one or more years later?MethodsWe tested 102 intact, consecutively explanted nails. Using a “fast magnet,” the male part was lengthened to 5 mm short of its maximum stroke capacity and retracted back to 35 mm (all nails start with the male part exposed 30 mm). The nails passed the test if the male part succeeded in lengthening to 5 mm short of the maximum stroke capacity and back to 35 mm (or only retract in case fully deployed at testing). During our testing, the nails were prevented from reaching their full capacity of lengthening/retraction to avoid jamming the gears. Failure was defined as the inability or partial ability to complete the process.ResultsEighty-six nails (84.3%) performed successfully according to our testing standard. When comparing successful and failed nails in terms of nail type, generation, diameter, length and in vivo interval, there was no statistical significance. Comparing both groups in terms of status at testing (fully deployed or not) showed statistical significance with 9 of the 16 failed nails fully deployed at testing (p < 0.001).ConclusionDormant PRECICE nails can be reactivated for further lengthening. The results imply that full deployment may damage the mechanism, making future re-use by retracting and then re-lengthening unsuccessful. The candidate nails for this purpose should not have any signs of clear damage (bending or breakage) and should not have been fully deployed. However, surgeons and patients should be aware of the need for possible nail exchange if the “sleeper” nail fails to wake up.Level of evidenceLevel IV case series analysis of retrieved surgical implants.     

Impacto del nivel socioeconómico sobre el perfil del paciente amputado de miembro inferior por causa no traumática

IntroductionTo analyse the influence of socioeconomic status on the clinical profile of patients undergoing non-traumatic lower-limb amputation.MethodsRetrospective study of 697 lower-limb amputee patients in an Angiology and Vascular Surgery Department during a 5-year period. Patients were classified according to their socioeconomic status (low, medium and high). We analysed demographic (age and gender) and clinical variables (cause of amputation, comorbidity, cardiovascular risk factors and amputation level).ResultsMean age was 70.5 ± 11.9 years, and the median was 72 years. The low socioeconomic status group presented a higher frequency of amputations in men. Cardiovascular risks factors were more frequent in this socioeconomic group, and the difference was statistically significant for diabetes (85.8% low, 69.3% medium, 65% high; P<.01) and obesity (31.4% low, 22.6% medium, 12.5% high, P<.01). Diabetic retinopathy was the only comorbidity with a significant association with low socioeconomic status (21.1% low, 15.3% medium, 12.5% high, P<.03). Regarding the cause for amputation, there was no difference in terms of socioeconomic status. The low socioeconomic level showed a higher frequency of major amputation, which was a significant difference (63.6% low, 41.2% medium, 55% high, P<.04) and a higher predisposition for this amputation level.ConclusionsThe low socioeconomic status has been shown to determine an unfavourable vascular risk profile in lower-limb non-traumatic amputees and a higher predisposition of a major amputation. This socioeconomic level demonstrates a negative influence on these patients’ diabetes, obesity and diabetic retinopathy.