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Article(id=1244321226664030589, tenantId=1146029695717560320, journalId=1244284848500682798, issueId=1244321215637209904, articleNumber=null, orderNo=null, doi=10.16156/j.1004-7220.2025.05.024, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1733328000000, receivedDateStr=2024-12-05, revisedDate=1737648000000, revisedDateStr=2025-01-24, acceptedDate=null, acceptedDateStr=null, onlineDate=1774598898807, onlineDateStr=2026-03-27, pubDate=1759248000000, pubDateStr=2025-10-01, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1774598898807, onlineIssueDateStr=2026-03-27, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1774598898807, creator=13701087609, updateTime=1774598898807, updator=13701087609, issue=Issue{id=1244321215637209904, tenantId=1146029695717560320, journalId=1244284848500682798, year='2025', volume='40', issue='5', pageStart='1079', pageEnd='1366', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=null, createTime=1774598896178, creator=13701087609, updateTime=1774599509568, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1244323788452639476, tenantId=1146029695717560320, journalId=1244284848500682798, issueId=1244321215637209904, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1244323788452639477, tenantId=1146029695717560320, journalId=1244284848500682798, issueId=1244321215637209904, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1265, endPage=1271, ext={EN=ArticleExt(id=1244321227037323674, articleId=1244321226664030589, tenantId=1146029695717560320, journalId=1244284848500682798, language=EN, title=Design and Verification of Implantable Central Venous Dialysis Port, columnId=1244321216404767539, journalTitle=Journal of Medical Biomechanics, columnName=Original Articles, runingTitle=null, highlight=null, articleAbstract=
Objective

To design and verify an implantable dialysis port that enables the central venous catheter to no longer be placed on the body surface, and to study the effect of the central venous catheter's structural design on its performance.

Methods

The feasibility of the dialysis port was verified by flow and pressure experiments. Four representative catheter structures were analyzed by finite element method. The recirculation rate, flow rate-pressure ratio and proportion of indwelling particles were recorded, and performance differences were analyzed. An experimental platform was built to verify the simulation conclusion, and the fluid flow direction of the arteriovenous cavity was quantified by the salinity measurement method.

Results

The dialysis port could reach the flow requirement of 300 mL/min under the 45 kPa pressure. The recirculation rate of the measured central venous catheter was between 10.7% and 23.5%, and the residual value of heparin was between 2.3% and 2.8%. The performance of the catheter with bundle mouth, positive position and side hole structure was better.

Conclusions

The implantable dialysis port can potentially cooperate with central venous catheters to establish a new vascular access approach. The structure of the central venous catheter should adopt the design of bundle mouth, positive position and side hole, which has better recirculation rate and heparin locking performance with low flow rate-pressure ratio. This study provides a theoretical and experimental basis for structural design and clinical selection of the central venous catheter.

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目的

设计并验证一种使中心静脉导管不再外置于体表的植入式透析港，并研究中心静脉导管的结构设计对其性能的影响。

方法

通过流量与压强实验验证透析港的可行性。通过有限元方法分析4款代表性的导管结构，记录导管的再循环率、流速压力比和留置粒子占比，分析性能差异。搭建实验平台验证仿真结论，通过盐度测定方法量化动静脉腔液体流向。

结果

透析港能够在45 kPa压强下达到300 mL/min的流量要求。实测中心静脉导管的再循环率为10.7%~23.5%，肝素残留值在2.3%~2.8%之间；其中，束口、正位、侧孔结构的导管表现更优。

结论

植入式透析港可与中心静脉导管相配合，以建立新的血管通路方式。中心静脉导管的结构宜采用束口、正位、侧孔设计，其以低流速压力比换取了较优异的再循环率和肝素锁定性能。研究结果为中心静脉导管的结构设计和临床选用提供理论和实验依据。

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宋成利，教授，博士生导师，E-mail：
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作者贡献声明：

刘洋志负责建模仿真、实验操作、论文撰写；林清晶负责整体方案设计、实验方案设计；高钦贤负责数据评估；宋成利负责指导及论文审校。

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J Vasc Interv Radiol, 2020, 31(7): 1148-1155., articleTitle=Comparison of clinical performance of VectorFlow and Palindrome symmetric-tip dialysis catheters: A multicenter, randomized trial, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1244321230963192467, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, xref=null, ext=[AuthorCompanyExt(id=1244321230971581077, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, companyId=1244321230963192467, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai 200093, China), AuthorCompanyExt(id=1244321230979969686, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, companyId=1244321230963192467, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=上海理工大学　健康科学与工程学院，上海　200093)])], figs=[ArticleFig(id=1244321235560150003, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Fig. 1, caption=Assembly of implantable dialysis port　(a) Overall view, (b) Sectional view, figureFileSmall=xLN5W+i/I2vHDXNc0jZrOw==, figureFileBig=IDZfxsj78dUZuHyfJ21wpg==, tableContent=null), ArticleFig(id=1244321235669201918, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=图1, caption=植入式透析港装配, figureFileSmall=xLN5W+i/I2vHDXNc0jZrOw==, figureFileBig=IDZfxsj78dUZuHyfJ21wpg==, tableContent=null), ArticleFig(id=1244321235937636373, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Fig. 2, caption=Experiment of central venous catheter　(a) Structure model of central venous catheter, (b) Experimental platform, figureFileSmall=uEWJW1fwGSkBmoLcfdcpYA==, figureFileBig=zP7FsS/s4xzRfdwp5LMq0Q==, tableContent=null), ArticleFig(id=1244321236063465501, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=图2, caption=中心静脉导管实验, figureFileSmall=uEWJW1fwGSkBmoLcfdcpYA==, figureFileBig=zP7FsS/s4xzRfdwp5LMq0Q==, tableContent=null), ArticleFig(id=1244321236197683243, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Fig. 3, caption=Measurement data of flow-pressure drop, figureFileSmall=G51OM5x7ImzEN8FFL5DJag==, figureFileBig=PgEzALXilmIAw/f14y7UEA==, tableContent=null), ArticleFig(id=1244321236306735158, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=图3, caption=流量-压强测定数据, figureFileSmall=G51OM5x7ImzEN8FFL5DJag==, figureFileBig=PgEzALXilmIAw/f14y7UEA==, tableContent=null), ArticleFig(id=1244321236466118728, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Fig. 4, caption=Flow velocity cloud diagram corresponding to the four catheter models　(a) Model a, (b) Model b, (c) Model c, (d) Model d, figureFileSmall=lJZvE5tkWkx2Z5p2SjYM5A==, figureFileBig=LGhFUxEIYqXZIpVccMUQ0g==, tableContent=null), ArticleFig(id=1244321237594386517, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=图4, caption=4种导管模型所对应的流速云图, figureFileSmall=lJZvE5tkWkx2Z5p2SjYM5A==, figureFileBig=LGhFUxEIYqXZIpVccMUQ0g==, tableContent=null), ArticleFig(id=1244321237741187167, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Fig. 5, caption=Color diagram of countercurrent flow velocity (single abscissa velocity component)　(a) Model a, (b) Model b, (c) Model c, (d) Model d, figureFileSmall=WyuSF2+wFtSKX4AEwz5H1Q==, figureFileBig=B3pyVPs3/DGyS0pvkvcqNQ==, tableContent=null), ArticleFig(id=1244321237850239083, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=图5, caption=逆流流速显色图（单取横坐标速度分量）, figureFileSmall=WyuSF2+wFtSKX4AEwz5H1Q==, figureFileBig=B3pyVPs3/DGyS0pvkvcqNQ==, tableContent=null), ArticleFig(id=1244321238009622644, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Tab. 1, caption=

Structural characteristics of the catheter

, figureFileSmall=null, figureFileBig=null, tableContent=
模型束口/直口正位/偏位侧孔/通孔
a束口正位侧孔
b直口正位侧孔
c直口偏位通孔
d直口正位通孔
), ArticleFig(id=1244321238139646085, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=表1, caption=

导管结构特征

, figureFileSmall=null, figureFileBig=null, tableContent=
模型束口/直口正位/偏位侧孔/通孔
a束口正位侧孔
b直口正位侧孔
c直口偏位通孔
d直口正位通孔
), ArticleFig(id=1244321238265475214, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Tab. 2, caption=

Flow field data during simulated dialysis

, figureFileSmall=null, figureFileBig=null, tableContent=
模型RR/%动脉腔静脉腔
v/（m·s-1） p/Pa R/% v/（m·s-1） p/Pa R/%
a0.230.58842.290.070.76242.640.31
b0.790.60725.520.080.94117.100.81
c1.260.70875.580.081.10126.770.87
d2.080.66732.720.091.14104.721.09
), ArticleFig(id=1244321238395498648, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=表2, caption=

模拟透析时流场数据

, figureFileSmall=null, figureFileBig=null, tableContent=
模型RR/%动脉腔静脉腔
v/（m·s-1） p/Pa R/% v/（m·s-1） p/Pa R/%
a0.230.58842.290.070.76242.640.31
b0.790.60725.520.080.94117.100.81
c1.260.70875.580.081.10126.770.87
d2.080.66732.720.091.14104.721.09
), ArticleFig(id=1244321238504550558, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Tab. 3, caption=

Data of countercurrent flow field

, figureFileSmall=null, figureFileBig=null, tableContent=
模型逆流距离/mm留置粒子占比/%
a2 33622.02
b5 0076.53
c2 5131.61
d4 7153.38
), ArticleFig(id=1244321238634573993, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=表3, caption=

逆流流场数据

, figureFileSmall=null, figureFileBig=null, tableContent=
模型逆流距离/mm留置粒子占比/%
a2 33622.02
b5 0076.53
c2 5131.61
d4 7153.38
), ArticleFig(id=1244321238747820208, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=EN, label=Tab. 4, caption=

Experimental data of catheter recirculation rate

, figureFileSmall=null, figureFileBig=null, tableContent=
模型动脉腔静脉腔RRRRa模型动脉腔静脉腔RRRRa
Q/（mL·min-1） C/% Q/（mL·min-1） C/% Q/（mL·min-1） C/% Q/（mL·min-1） C/%
a1830.51505.012.2 c1830.71505.017.1 
 1830.51505.710.711.2 1830.81505.717.117.1
 1830.51505.710.7  1830.81505.717.1 
b1830.51505.012.2 d1830.91505.022.0 
 1830.61505.712.812.6 1831.01505.721.422.3
 1830.61505.712.8  1831.11505.723.5 
), ArticleFig(id=1244321238869455033, tenantId=1146029695717560320, journalId=1244284848500682798, articleId=1244321226664030589, language=CN, label=表4, caption=

导管再循环率实验数据

, figureFileSmall=null, figureFileBig=null, tableContent=
模型动脉腔静脉腔RRRRa模型动脉腔静脉腔RRRRa
Q/（mL·min-1） C/% Q/（mL·min-1） C/% Q/（mL·min-1） C/% Q/（mL·min-1） C/%
a1830.51505.012.2 c1830.71505.017.1 
 1830.51505.710.711.2 1830.81505.717.117.1
 1830.51505.710.7  1830.81505.717.1 
b1830.51505.012.2 d1830.91505.022.0 
 1830.61505.712.812.6 1831.01505.721.422.3
 1830.61505.712.8  1831.11505.723.5 
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Data of catheter heparin locking experiment

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导管肝素锁定实验数据

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植入式中心静脉透析港的设计与验证
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刘洋志 , 林清晶 , 高钦贤 , 宋成利
医用生物力学 | 论著 2025,40(5): 1265-1271
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医用生物力学 | 论著 2025, 40(5): 1265-1271
植入式中心静脉透析港的设计与验证
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刘洋志, 林清晶, 高钦贤, 宋成利
作者信息
  • 上海理工大学　健康科学与工程学院，上海　200093

通讯作者:

宋成利，教授，博士生导师，E-mail：
Design and Verification of Implantable Central Venous Dialysis Port
Yangzhi LIU, Qingjing LIN, Qinxian GAO, Chengli SONG
Affiliations
  • School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai 200093, China
出版时间: 2025-10-01 doi: 10.16156/j.1004-7220.2025.05.024
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摘要
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目的

设计并验证一种使中心静脉导管不再外置于体表的植入式透析港，并研究中心静脉导管的结构设计对其性能的影响。

方法

通过流量与压强实验验证透析港的可行性。通过有限元方法分析4款代表性的导管结构，记录导管的再循环率、流速压力比和留置粒子占比，分析性能差异。搭建实验平台验证仿真结论，通过盐度测定方法量化动静脉腔液体流向。

结果

透析港能够在45 kPa压强下达到300 mL/min的流量要求。实测中心静脉导管的再循环率为10.7%~23.5%，肝素残留值在2.3%~2.8%之间；其中，束口、正位、侧孔结构的导管表现更优。

结论

植入式透析港可与中心静脉导管相配合，以建立新的血管通路方式。中心静脉导管的结构宜采用束口、正位、侧孔设计，其以低流速压力比换取了较优异的再循环率和肝素锁定性能。研究结果为中心静脉导管的结构设计和临床选用提供理论和实验依据。

血液透析  /  静脉输液港  /  中心静脉导管  /  有限元分析  /  流体实验
Objective

To design and verify an implantable dialysis port that enables the central venous catheter to no longer be placed on the body surface, and to study the effect of the central venous catheter's structural design on its performance.

Methods

The feasibility of the dialysis port was verified by flow and pressure experiments. Four representative catheter structures were analyzed by finite element method. The recirculation rate, flow rate-pressure ratio and proportion of indwelling particles were recorded, and performance differences were analyzed. An experimental platform was built to verify the simulation conclusion, and the fluid flow direction of the arteriovenous cavity was quantified by the salinity measurement method.

Results

The dialysis port could reach the flow requirement of 300 mL/min under the 45 kPa pressure. The recirculation rate of the measured central venous catheter was between 10.7% and 23.5%, and the residual value of heparin was between 2.3% and 2.8%. The performance of the catheter with bundle mouth, positive position and side hole structure was better.

Conclusions

The implantable dialysis port can potentially cooperate with central venous catheters to establish a new vascular access approach. The structure of the central venous catheter should adopt the design of bundle mouth, positive position and side hole, which has better recirculation rate and heparin locking performance with low flow rate-pressure ratio. This study provides a theoretical and experimental basis for structural design and clinical selection of the central venous catheter.

hemodialysis  /  implantable venous access port  /  central venous catheter  /  finite element analysis  /  fluid experiment
刘洋志, 林清晶, 高钦贤, 宋成利. 植入式中心静脉透析港的设计与验证. 医用生物力学, 2025 , 40 (5) : 1265 -1271 . DOI: 10.16156/j.1004-7220.2025.05.024
Yangzhi LIU, Qingjing LIN, Qinxian GAO, Chengli SONG. Design and Verification of Implantable Central Venous Dialysis Port[J]. Journal of Medical Biomechanics, 2025 , 40 (5) : 1265 -1271 . DOI: 10.16156/j.1004-7220.2025.05.024
正文
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终末期肾病是肾功能衰竭的最后阶段，可选择的治疗方式包括血液透析、腹膜透析和肾移植。截至2019年底，我国接受血液透析超过70万人，接受腹膜透析超过10万人[1]。血液透析作为主要治疗方式，需要建立血管通路[2]。血管通路可由动静脉内瘘、中心静脉导管建立。中心静脉导管因其即插即用、不会永久性损伤血管的特点，较动静脉内瘘具有显著优势[3]。但中心静脉导管作为长期留置于人体静脉的管道，其留置体表的创口容易引发感染，植入体内的管腔会因纤维蛋白鞘、血栓等现象降低导管在透析时的流量，甚至完全阻塞导管使导管失效，需重新手术进行拔管、置管，增加了患者和医护人员的负担[4-5]。本文通过流场分析[6]及实验验证，提出一种将植入式透析港与中心静脉导管相结合的血管通路建立方案，使中心静脉导管不再存在外置体表的结构。
研究表明，中心静脉导管的结构设计对其性能的影响十分显著[7]。目前对中心静脉导管的研究主要集中在透析期间，缺少对植入体内后占据绝大多数时间的非透析期间的相关分析。已有研究指出，衡量中心静脉导管性能时，应增加非透析期间肝素锁定性能的权重[8]。然而，现阶段缺少对非透析期间流场分析的方法和实验。本文分析了中心静脉导管不同的结构设计对其性能的影响，为中心静脉导管的设计和选用提供理论和实验依据。
1　材料与方法
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1.1　植入式透析港
植入式透析港是一种具有独立双腔、可用于血液透析的静脉输液港[9]。植入式透析港的设计目标在于：将原本半植入式的中心静脉导管变为植入式。将中心静脉导管暴露在患者体外的部分经过结构设计后植入患者皮下，透析时通过无损伤针穿刺透析港的穿刺膜即可建立血管通路，使得患者免于频繁穿刺血管，并规避造瘘带来的负面影响。植入式透析港由港座、端盖、穿刺膜、连接件构成，末端连接中心静脉导管。为了便于无损伤针的正确朝向，将端盖设计为倾斜斜面。同时，采用球形液体腔以提高流场性能（见图1）[10]。
1.2　中心静脉导管
中心静脉导管是指经锁骨下静脉、颈内静脉、股静脉穿刺置管，尖端置于上腔静脉或下腔静脉的导管[11]。血液透析用中心静脉导管多为双腔设计，分别与透析机的动脉回路、静脉回路对应。通过手术将中心静脉导管置入人体后，只需穿刺留置在患者体外的动脉腔、静脉腔接头，即可建立血管通路，进行血液透析。在透析结束后，需要分别对动脉腔、静脉腔注入生理盐水或肝素盐水进行冲刷和封管[12]，再关闭止流夹，使管内存在一定压力，以减少静脉血液流动时的血液回流至导管内的现象。
导管性能的衡量参数主要包括再循环率、流速压力比、留置粒子占比[13]。再循环率表示经过净化的血液再次被吸入导管进行二次透析的血液占比，该值越高，透析效率越低。再循环率与导管尖端的结构设计密切相关。Cho等[14]研究表明，束口形状的尖端设计能够降低再循环率。流速压力比表示流场中平均流速与平均压力的比值，高流速压力比表示在流速相同的情况下，流场具有更低的压力。流速越大、压力越小，该比值就越大，流场性能越强[15]。留置粒子占比表示在封管后的一段时间内，管内存留粒子的多少。高留置粒子占比的导管被视作具有更好的肝素锁定性能。
基于以上3个衡量参数，本文设计了4种不同的导管尖端结构[见表1、图2（a）]。使用这4种结构设计，可通过控制变量法分析3种结构特征的差异。
1.3　透析港的流量压强测定
根据《中国血液透析充分性临床实践指南》，常规血液透析的流量为200~300 mL/min[16]，故需测定通过透析港建立通路时所允许的流量及压强能否达到使用要求[17]。使用16 G穿刺针、透析港、ZP200-B54蠕动泵（莘际流体科技（上海）有限公司）、YX-LP01-P500蠕动泵（上海岩骁科技有限公司）、WT3000-1FA恒流泵（保定兰格恒流泵有限公司）等设备搭建实验平台。具支U型管用于模拟中心静脉腔道，通过铁架台固定U型管及中心静脉导管的相对位置。使用3个泵来提供3个独立的流路。其中，恒流泵模拟中心静脉环境；蠕动泵1、2分别连接导管的静脉腔、动脉腔，模拟血液透析时的动静脉环境。测量蠕动泵1通路中的流量及压强[见图2（b）]。
1.4　中心静脉导管的流场分析
流场分析使用ANSYS Workbench 2022 R1计算。将外径5 mm、内径4.2 mm的双D型导管[18]置入内径为20 mm的圆柱体中心，模拟中心静脉环境[19]。设置中心静脉入口和导管动脉腔入口两个入口，以及中心静脉出口和导管静脉腔出口两个出口。人体中心静脉流量为2~3 L/min，内径为18~30 mm。根据公式
计算出中心静脉入口处的流速约为0.2 m/s。根据导管截面积及400 mL/min透析流量计算出导管动脉腔入口流速约为1.09 m/s。式中：v为流速；Qv为流量；A为截面积。
运用离散项捕捉功能，将喷射源的入口设置为导管动脉腔入口，初速度设置为1.09 m/s，方向同截面法向方向一致。将导管静脉腔出口截面的边界条件设置为“捕捉”，中心静脉出口设置为“逃逸”，其余面设置为“反射”，将离散项被截面捕获的比例通过
运算可得再循环率（recirculation rate，RR）。式中：QA和QV分别为动脉腔和静脉腔的流量；CA和CV分别为动脉腔和静脉腔溶液的盐度。
运用瞬态分析模式，将导管的动脉腔、静脉腔均视作入口，使用自定义函数控制入口流速随时间变化的曲线，在一段时间后，4种导管的入口均停止输入，其间中心静脉入口均保持0.2 m/s恒定流速，采集经过相同时间后，管内留置从导管释放粒子的数量。留置的粒子数量越多，认为该导管具有更好的肝素锁定性能。
1.5　中心静脉导管的实验验证
实验测定导管模型的再循环率，通过横向对比不同结构的再循环率是否与流场分析的结论一致，以验证结论的正确性。使用LS10T精密盐度计（广州速为仪器仪表有限公司）配比特定浓度的盐水。利用盐度计可以量化液体中盐分浓度的特性，将静脉腔输出的液体设定为特定浓度的盐水，其余流路采用不含盐分的蒸馏水，统计经过一定时间后，从动脉腔抽取的液体中的盐分浓度，由式（2）进行计算，得出再循环率的数值。
再循环率及肝素锁定性能的实验验证均采用与图2（b）相同的实验平台，用盐度约5%的盐水模拟静脉腔中的血液。需要注意的是，肝素锁定性能实验中的流路3为逆时针方向，且烧杯2中也预先存有盐度约5%的盐水。
2　结果
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2.1　植入式透析港的流量压强测定
在穿刺针刺入透析港穿刺膜后，使用蠕动泵作为动力源，使液体通过穿刺针进入透析港的液体腔，由液体腔流经导管实现输注过程。使用量杯和压力表分别采集1 min内搜集液体的体积及过程中的压强，绘制流量-压强图。结果表明，透析港能够达到200~300 mL/min的血液透析流量要求，且在达到该流量时对应25~45 kPa的压强区间（见图3），满足血液透析流量压强要求[20]。
2.2　中心静脉导管的流场分析
通过CFD-Post对Fluent计算结果进行后处理，绘制4种导管结构的流速云图（见图4）。从导管动脉腔入口处释放最多约60 000个离散项，统计作为出口之一的静脉腔出口处所捕获离散项的数量，记录流场中的平均流速和平均压力，并用两者的比值作为衡量流场流动性能的指标（见表2）。
（1）束口/直口。模型a、b均能够将再循环率控制在1%以下，具备良好的再循环率性能，这与Clark等[21]实验结论相吻合。通过模型a的半圆截面可以看出，束口式设计的静脉腔流体流过导管尖端时会被束口结构改变流动方向，使其略微偏向一侧，从而降低再循环率。但同样由于束口结构的限制，将降低流速并增加压力。表2中的数值可以量化地体现这一点。尽管模型a的再循环率优于模型b，但其动、静脉腔的平均流速均低于模型b，平均压力均高于模型b。该结果提示，模型a用降低流场性能（低流速压力比）的代价换取了高透析效率（同流量下的低再循环率）。考虑再循环率仅影响透析时的效率，而导管的失效形式是蛋白纤维鞘和由血栓引起的腔体阻塞，其与流速和压力相关，因此，本文认为流速压力比性能较好的模型b具有优势，即直口设计优于束口设计。
（2）正位/偏位。通过观察模型c、d的环状截面可以发现，正位/偏位对静脉腔流速分布影响轻微，但对动脉腔流速分布影响显著。模型c偏位使得高流速区分布在动脉腔的一侧，而不是模型d正位的对称分布。在降低再循环率方面，偏向一侧的流动方向较对称分布具有优势；而在流场性能上，对称分布的流动方向允许更高的流速压力比。因此，考虑导管失效形式因素，本文认为流速压力比性能较好的模型d具有优势，即正位设计优于偏位设计。
（3）通孔/侧孔。通过比较模型b、d两者间流速及流场数据可以发现，通孔设计可视作在侧孔设计的基础上将侧孔至导管尖端区域的结构去除，进而提高了流速压力比。虽然同时增大了再循环率，使更多净化过的静脉血被重新吸回了动脉腔，但其获得了更高的流速压力比。因此，本文认为模型d具有最优异的性能，即通孔设计更优。
2.3　肝素锁定性能的流场分析
2.3.1　定性分析
绘制流体迹线，以在横坐标上的速度分量为参数，逆流方向设置为正，且用颜色标出；顺流方向为负，且用白色隐藏（见图5）。
观察模型a、b，作为有侧孔的导管，均在侧孔位置及导管近端产生了逆流区域，束口的结构设计使回流情况有显著缓解。分析原因是束口结构增加了管内液体的压力（顺流时模型a的静脉腔压力相比其余模型高约1倍），使管腔内肝素溶液不易受外环境的影响。
观察模型c、d，作为通孔设计的导管，模型c的偏位会导致在偏位对侧出现大面积回流，且回流是从导管最远端开始，这意味着外环境中的血液会回流至导管近端，而模型d的对称式设计并没有改善此现象，反而形成了两束回流区，血液更容易进入导管。
观察有侧孔的模型a、b与通孔设计的模型c、d，发现有侧孔存在的导管在远端不存在回流，存在两种情况可以解释此现象：①肝素溶液被锁在了管内，形成理想中的肝素锁；②远端肝素全部被冲走，导致该段导管在非透析期间不断被中心静脉血流冲刷，这是导致蛋白纤维鞘和血栓阻塞的直接原因[22]。因此，需通过量化的数值来定量分析分辨此两种情况。
2.3.2　定量分析
在Fluent中输出约280 000个粒子的运动轨迹参数，导入CFD-Post中进行后处理。对其中逆流项的逆流距离进行积分，将所采集的数据汇总于表3。
对比模型a、b数据发现，模型a的留置粒子占比是模型b的3倍多，可推断出模型a远端没有回流区的原因是其束口结构使得肝素被锁在了管内，而直口结构的模型b其远端不能将肝素停留在管内，其侧孔至远端区域的肝素流失，使得该段结构在非透析时不断被血液冲刷。
对比模型c、d数据发现，逆流距离长的模型d，其留置粒子占比却高于模型c，这表明逆流严重并不代表肝素流失更多，因为肝素的逆流距离同样被统计在了逆流距离中。
综上所述，模型a的逆流距离和留置粒子占比均优于其余项目，这与定性分析的结果吻合，视其拥有更优异的性能。
2.4　中心静脉导管的实验验证
将导管再循环率的实验数据汇总于表4。每个样本采用3组有效数据，表4中再循环率根据式（2）求得。由于导管模型均是对称式设计，不必对动、静脉腔进行反接重复实验。结果表明，4种模型再循环率逐渐增大，印证了仿真模拟的结论，即如果为了更好的流速压力比而选择模型c、d这两种导管结构，则将面临更高的再循环率，从而降低透析效率。在平均再循环率上，模型a、b存在明显优势，其较模型c、d的不同之处在于模型a、b采用了侧孔的设计而非通孔，故通孔设计会显著增加再循环率。
2.5　肝素锁定性能的实验验证
将肝素锁定性能的实验数据汇总于表5。模型a的实验后盐度最高，其余3组差异并不明显。模型a的不同之处在于采用了束口设计。此外，由表1数据可知，束口设计使得管内在正向流动时的压力提高约1倍，使管内生理盐水或肝素盐水更稳定地存留在管内，具有更优的长期使用性能。该结果也与Nadolski等[23]临床试验结论一致。
3　结论
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本文设计了一种能够将中心静脉导管完全植入皮下的植入式中心静脉透析港，通过仿真模拟和实验验证的方式，验证透析港的可行性，并分析不同的中心静脉导管结构设计对其性能的影响。本文在仿真模拟前对不同网格划分的同组数据进行计算，将随网格密度增加但结果已基本一致时的网格密度作为本实验的划分标准，确保计算结果收敛。本文在肝素锁定性能实验中，由于在计时结束后抽取残余液体时会将蠕动泵1、2管道中残存的5%盐度的水一同抽出，且该部分盐水占总抽出盐水的大部分，使得各组检测液体的盐度差异变小，不过这一因素只会定量地影响数值，并不会定性地影响结论。
总体来说，对中心静脉导管的研究展现出多元的性能差异，依据不同的衡量标准会得出不同的结论，不存在某一种设计的导管在所有参数上均优于其余类型的导管。具体而言，如以透析时的再循环率衡量结构优劣，则侧孔将优于通孔、束口将优于直口；如以透析时的流速压力比衡量，则通孔将优于侧孔、直口将优于束口；如以非透析时的肝素锁定性能来衡量，侧孔将优于通孔、束口将优于直口。
鉴于此现象，本文将衡量参数的重点放在引起导管失效的血栓阻塞上。由于中心静脉导管在实际使用中，非透析时间远长于透析时间，且肝素保存量的多少直接影响着蛋白纤维鞘和血栓形成的概率，因此将肝素锁定性能优异的束口、正位、侧孔设计定为较优的导管设计。
综上所述，植入式透析港存在与中心静脉导管相配合以建立新的血管通路方式的可能性；束口、正位、侧孔设计的中心静脉导管在透析时的再循环率、非透析时的肝素锁定性能上均优于对照组。本研究结果可为植入式透析港及中心静脉导管的设计和选用提供理论和实验依据。
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doi: 10.16156/j.1004-7220.2025.05.024
  • 接收时间：2024-12-05
  • 首发时间：2026-03-27
  • 出版时间：2025-10-01
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  • 收稿日期：2024-12-05
  • 修回日期：2025-01-24
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    上海理工大学　健康科学与工程学院，上海　200093

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宋成利，教授，博士生导师，E-mail：
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