Levin N W, Yang P M, Hatch D A, Dubrow A J, Caraiani N S, Ing T S, Gandhi V C, Alto A, Davila S M, Prosl F R, Polaschegg H D, Megerman J
Renal Research Institute and Beth Israel Medical Center, New York, New York; Hines VA Hospital, Hines, Illinois; Biolink Corporation, Middleboro, Massachusetts, USA.
Kidney Int. 1998 Nov;54(5):1739-45. doi: 10.1046/j.1523-1755.1998.00128.x.
A new subcutaneous device (DIALOCKtrade mark) provides vascular access to patients who currently require hemodialysis (HD). The device consists of a port-like valve, implanted subcutaneously below the clavicle, which provides a linear flow passage to two catheters placed in the right atrium via the internal or external jugular vein. The valve is accessed percutaneously with needle-cannulas that functionally convert the device to twin catheters for connecting the patient to the HD lines.
The device was implanted in 10 outpatients under local anesthesia. Patients used the device during dialysis 3 times/week, and data were collected on blood flow, pressures, adverse events and patient and nurse satisfaction.
The device was used for HD almost immediately (median 3 days after implantation) and functioned successfully for more than nine months (mean +/- SD 7.3 +/- 1.5) in all but one patient who died of unrelated causes after one month; there were >800 dialysis sessions total. Blood flows over 300 ml/min were consistently achieved (average 326 +/- 40) with venous and arterial pressures of 200 +/- 44 and -246 +/- 29 mm Hg, respectively. After 66 patient-months, condition of the needle puncture sites remained satisfactory. Five systemic infections occurred in four patients, producing 2.3 bacteremic episodes per 1000 patient-days. All resolved without the need for device removal. There were no infections at the puncture sites. Two patients required fibrin sheath stripping of their catheters, one whose heparin lock was not changed for 23 days (for reasons unrelated to the device). Patient and nurse acceptance was excellent.
The device represents a positive improvement in the area of HD access.
一种新型皮下装置（DIALOCK商标）为目前需要血液透析（HD）的患者提供血管通路。该装置由一个类似端口的瓣膜组成，植入锁骨下方的皮下，通过颈内静脉或颈外静脉为置于右心房的两根导管提供线性流动通道。通过针式套管经皮进入瓣膜，该套管在功能上将装置转换为双导管，以便将患者与血液透析管路相连。
在局部麻醉下为10名门诊患者植入该装置。患者每周进行3次透析时使用该装置，并收集有关血流量、压力、不良事件以及患者和护士满意度的数据。
除一名患者在植入后一个月死于无关原因外，该装置几乎在植入后立即（中位数为3天）用于血液透析，并成功运行了九个多月（平均±标准差为7.3±1.5）；总共进行了超过800次透析治疗。始终能实现超过300 ml/min的血流量（平均为326±40），静脉压和动脉压分别为200±44和-246±29 mmHg。在66个患者月后，针刺部位情况仍令人满意。4名患者发生了5次全身感染，每1000患者日产生2.3次菌血症发作。所有感染均自行缓解，无需移除装置。穿刺部位未发生感染。两名患者需要对其导管进行纤维蛋白鞘剥离，其中一名患者的肝素锁23天未更换（与该装置无关）。患者和护士的接受度很高。
该装置代表了血液透析通路领域的一项积极改进。
