CN116059471A - An implantable central venous dialysis port - Google Patents

Abstract

Translated fromChinese

本发明涉及一种植入式中心静脉透析港，包括港体部分(1)、锁紧卡扣(2)和双腔静脉导管(3)；所述港体部分(1)包括港座(10)、左端盖(11)、右端盖(12)和穿刺膜(13)，所述港座(10)包括底板(100)、港身(101)和连接内管(102)，港身(101)中设有静脉腔(1011)和动脉腔(1012)；所述双腔静脉导管(3)包括导管静脉端(30)和导管动脉端(31)；所述静脉腔(1011)与导管静脉端(30)以及动脉腔(1012)与导管动脉端(31)通过锁紧卡扣(2)对应连通。本发明提供了一种植入式中心静脉透析港，利用完全植入式的港体来替代中心静脉导管进行血液透析，能更好的降低感染率，使用方便且不妨碍患者的日常生活。

The invention relates to an implantable central venous dialysis port, comprising a port body part (1), a locking buckle (2) and a double-caval venous catheter (3); the port body part (1) includes a port seat (10) , left end cover (11), right end cover (12) and puncture film (13), described port seat (10) comprises bottom plate (100), port body (101) and connecting inner pipe (102), port body (101) There is a venous cavity (1011) and an arterial cavity (1012) in the middle; the double-caval catheter (3) includes a catheter venous end (30) and a catheter arterial end (31); the venous cavity (1011) and the catheter venous end (30) and the arterial cavity (1012) communicate with the catheter arterial end (31) correspondingly through the locking buckle (2). The invention provides an implantable central venous dialysis port, which uses a fully implanted port to replace a central venous catheter for hemodialysis, can better reduce the infection rate, is convenient to use and does not hinder the daily life of patients.

Description

Translated fromChinese

一种植入式中心静脉透析港An implantable central venous dialysis port

技术领域technical field

本发明涉及医疗器械技术领域，尤其是涉及一种植入式中心静脉透析港。The invention relates to the technical field of medical devices, in particular to an implantable central venous dialysis port.

背景技术Background technique

血液透析(Hemodialysis，HD)是急慢性肾功能衰竭患者的肾脏替代治疗方式之一。它通过将肾衰竭病人体内的血液引流至体外，经过含有中空纤维膜的透析器，将血液与透析液进行物质交换，清除体内的代谢废物、维持电解质和酸碱平衡，同时清除体内过多的水分，并将净化过的血液重新输入患者体内，从而替代肾脏对于毒素的代谢功能，维持患者生命。Hemodialysis (HD) is one of the renal replacement therapies for patients with acute and chronic renal failure. It drains blood from the body of patients with renal failure to the outside of the body, passes through a dialyzer containing a hollow fiber membrane, exchanges blood with the dialysate, removes metabolic waste in the body, maintains electrolyte and acid-base balance, and removes excessive excess in the body at the same time. Water, and reinfuse the purified blood into the patient's body, thereby replacing the kidney's metabolic function for toxins and maintaining the patient's life.

对于透析患者来说，最重要的就是建立通畅、可长期使用的血管通路。常见的血管通路有：临时性通路、半永久性通路和永久性通路。由于直接用针穿刺患者的临时性通路，仅用于中毒类紧急透析患者，因此不作为常规透析考虑的方式。半永久性通路依赖于对患者植入中心静脉导管，其适用于中长期的透析。因为导管植入于大静脉中，因此透析血流量能够得到充分保证，并且患者可进行微创手术置管，后期透析无穿刺痛苦。但其缺点在于，留置外管在体外影响美观，妨碍患者的日常生活，并容易发生感染。永久性的血管通路通常指建立动静脉内瘘，包括自体动静脉内瘘和移植血管内瘘。动静脉内瘘是长期有效的透析通路，血流量充足，并且不影响患者日常活动。但其并发症也不容忽视，感染、血栓、移植血管动脉瘤等可能会造成内瘘的狭窄与失效，需要重新造瘘才可继续透析，并且由于造瘘将“静脉动脉化”，一定程度上会加大患者的心衰。For dialysis patients, the most important thing is to establish unobstructed and long-term use of vascular access. Common vascular accesses are: temporary access, semi-permanent access and permanent access. Since the temporary access of the patient directly with a needle is only used for toxic emergency dialysis patients, it is not considered as a method for routine dialysis. Semi-permanent access relies on the implantation of a central venous catheter in the patient, which is suitable for medium and long-term dialysis. Because the catheter is implanted in the large vein, the dialysis blood flow can be fully guaranteed, and the patient can undergo minimally invasive surgery to insert the catheter, and there is no puncture pain in the later stage of dialysis. But its disadvantage is that the indwelling external tube affects the appearance outside the body, hinders the daily life of the patient, and is prone to infection. Permanent vascular access usually refers to the establishment of arteriovenous fistula, including autogenous arteriovenous fistula and graft vessel fistula. Arteriovenous fistula is a long-term effective dialysis access with sufficient blood flow and does not affect patients' daily activities. However, its complications cannot be ignored. Infection, thrombus, graft vessel aneurysm, etc. may cause the stenosis and failure of the internal fistula, requiring re-ostomy to continue dialysis, and because the fistula will "arterialize the vein", to a certain extent It will increase the patient's heart failure.

静脉输液港(Port)是一种植入式的输液装置，常用于癌症患者化疗给药和输液。现有的输液港包括输液港座单元、穿刺隔膜和导管，输液港座单元上设置有储液槽，穿刺隔膜覆盖在储液槽的开口处，导管的一端与储液槽连通，另一端则与血管连通，从而使输液港座单元与血管形成通路。植入手术过程中，需将其导管经颈内静脉或锁骨下静脉通向右心房，再将港体埋放在胸部皮下，缝合好皮肤即可。由于其每次穿刺时，钢针仅需垂直穿刺透表皮薄层皮肤进入透析隔膜中，即可形成通路进行化疗给药或输液，因此可以有效保护患者的血管，减轻穿刺痛苦，并且植入式器械不影响美观与患者的日常生活。The intravenous infusion port (Port) is an implanted infusion device, which is often used for chemotherapy administration and infusion in cancer patients. Existing infusion ports include infusion port seat unit, puncture diaphragm and catheter, and the infusion port seat unit is provided with liquid storage tank, and puncture diaphragm covers the opening of liquid storage tank, and one end of catheter communicates with liquid storage tank, and the other end is It communicates with blood vessels, so that the infusion port unit and blood vessels form a pathway. During the implantation operation, the catheter needs to be led to the right atrium through the internal jugular vein or subclavian vein, and then the port body is buried under the skin of the chest, and the skin is sutured. Because each time it is punctured, the steel needle only needs to vertically penetrate the thin layer of epidermis and enter the dialysis diaphragm to form a pathway for chemotherapy administration or infusion, so it can effectively protect the patient's blood vessels and reduce the pain of puncture, and the implantable The device does not affect the aesthetics and the daily life of the patient.

为克服现有的技术缺陷，将静脉输液港引入到血液透析领域，具有重要的技术创新和应用前景。而现有的血液透析输液港仅在原有静脉输液港的基础上将单腔港座改为双腔，单腔导管变为双腔导管，采用绝对的垂直港体腔或水平港体腔进针穿刺方式，未综合考虑内部的血流动力学环境和体外透析针的方便固定。In order to overcome the existing technical defects, introducing the venous infusion port into the field of hemodialysis has important technical innovation and application prospects. However, the existing hemodialysis infusion port only changes the single-lumen port seat into a double-lumen catheter on the basis of the original venous infusion port, and the single-lumen catheter becomes a double-lumen catheter, and the absolute vertical port body cavity or horizontal port body cavity is adopted. , without considering the internal hemodynamic environment and the convenient fixation of extracorporeal dialysis needles.

发明内容Contents of the invention

本发明的目的就是为了克服上述现有技术存在的缺陷而提供一种植入式中心静脉透析港，利用完全植入式的港体来替代中心静脉导管进行血液透析，能更好的降低感染率，使用方便且不妨碍患者的日常生活。The purpose of the present invention is to provide an implantable central venous dialysis port in order to overcome the defects of the above-mentioned prior art, and use a fully implanted port body to replace the central venous catheter for hemodialysis, which can better reduce the infection rate. It is convenient to use and does not interfere with the daily life of patients.

本发明的目的可以通过以下技术方案来实现：The purpose of the present invention can be achieved through the following technical solutions:

一种植入式中心静脉透析港，包括港体部分、锁紧卡扣和双腔静脉导管；An implantable central venous dialysis port, including a port body part, a locking buckle and a double-vena cava catheter;

所述港体部分包括港座、左端盖、右端盖和穿刺膜，所述穿刺膜安装于港座前端，所述左端盖和右端盖对称设置，与港座过盈配合形成密封腔体；The port body part includes a port seat, a left end cover, a right end cover and a puncture membrane, the puncture film is installed at the front end of the port seat, the left end cover and the right end cover are arranged symmetrically, and form a sealed cavity with an interference fit with the port seat;

所述港座包括底板、港身和连接内管，连接内管与双腔静脉导管相连通，港身中设有静脉腔和动脉腔；The port seat includes a bottom plate, a port body and a connecting inner tube, the connecting inner tube communicates with the double-vena cava catheter, and the port body is provided with a venous cavity and an arterial cavity;

所述双腔静脉导管包括导管静脉端和导管动脉端；The double vena cava catheter includes a catheter venous end and a catheter arterial end;

所述静脉腔与导管静脉端以及动脉腔与导管动脉端通过锁紧卡扣对应连通。The venous cavity communicates with the venous end of the catheter, and the arterial cavity communicates with the arterial end of the catheter through locking buckles.

进一步地，所述静脉腔和动脉腔为直径逐渐缩小的锥形腔体，左右对称设置于港身中且不相连通，并与水平面形成60°夹角。Further, the venous cavity and the arterial cavity are tapered cavities with gradually reduced diameters, symmetrically arranged in the port body without communication, and form an included angle of 60° with the horizontal plane.

进一步地，所述穿刺膜包括圆柱和直径逐渐减小的锥形圆台，穿刺膜的穿刺面上设有四个均布的圆形凸起，能够辅助透析港的穿刺区域在体表显型，所述锥形圆台的侧壁与静脉腔和动脉腔的内壁贴合，所述穿刺膜安置于港身中后，静脉腔和动脉腔后端留有储血的空腔。Further, the puncture membrane includes a cylinder and a conical truncated cone whose diameter gradually decreases, and four evenly distributed circular protrusions are arranged on the puncture surface of the puncture membrane, which can assist the puncture area of the dialysis port to be displayed on the body surface, The side wall of the conical frustum is attached to the inner wall of the venous cavity and the arterial cavity, and after the puncture membrane is placed in the port body, there is a cavity for storing blood at the rear ends of the venous cavity and the arterial cavity.

进一步地，所述港座前端面上设有定位键槽，所述穿刺膜两侧设有定位键，用于限制穿刺膜的周向旋转，所述左端盖和右端盖上设有凹槽，穿刺膜通过定位键槽与定位键相配合安装于港座上，定位键槽与凹槽过盈配合形成密封的港体部分腔体。Further, a positioning keyway is provided on the front end surface of the port seat, positioning keys are provided on both sides of the puncture film to limit the circumferential rotation of the puncture film, grooves are provided on the left end cover and the right end cover, and the puncture The membrane is installed on the port seat through the cooperation of the positioning key groove and the positioning key, and the positioning key groove and the groove are interference fit to form a sealed part of the cavity of the port body.

进一步地，所述连接内管为阶梯形管道，连接内管外表面设有第一阶梯和锁紧环，连接内管中间设有通过内管圆心的切槽，切槽两内壁上设有凸起的第一内阶梯和第二内阶梯，用于辅助导管的锁紧。Further, the connecting inner pipe is a ladder-shaped pipe, the outer surface of the connecting inner pipe is provided with a first step and a locking ring, the middle of the connecting inner pipe is provided with a cut groove passing through the center of the inner pipe, and the two inner walls of the cut groove are provided with protrusions. The first inner step and the second inner step are raised to assist in the locking of the catheter.

进一步地，所述连接内管中设有两个D形腔，港身中设有D形弯孔，静脉腔和动脉腔通过D形弯孔与D形腔相连通，所述D形弯孔含两个转角，第一转角为120°，第二转角为90°，D形弯孔的直径小于等于D形腔的直径。Further, two D-shaped cavities are provided in the connecting inner tube, and a D-shaped curved hole is provided in the port body, and the venous cavity and the arterial cavity communicate with the D-shaped cavity through the D-shaped curved hole, and the D-shaped curved hole There are two corners, the first corner is 120°, the second corner is 90°, and the diameter of the D-shaped curved hole is smaller than or equal to the diameter of the D-shaped cavity.

进一步地，所述锁紧卡扣底部设有水平平台，锁紧卡扣包括直径逐渐缩小的喇叭口与拱门状轴，所述拱门状轴内部设有阶梯形通孔，阶梯形通孔内设有楔形内阶梯，所述港座后端面设有定位凹槽，所述锁紧卡扣的端面上设有定位凸台，港座与锁紧卡扣通过定位凹槽与定位凸台之间的配合相连接。Further, the bottom of the locking buckle is provided with a horizontal platform, and the locking buckle includes a bell mouth and an arch-shaped shaft with a gradually reduced diameter. There is a wedge-shaped inner step, the rear end surface of the port seat is provided with a positioning groove, and the end face of the locking buckle is provided with a positioning boss, and the port seat and the locking buckle pass through the gap between the positioning groove and the positioning boss. Mate to connect.

进一步地，所述左端盖的前端面为不完全圆形，内部设有圆形通孔，右侧设有与右端盖重合的配合切面，左端盖端盖轴向为直径逐渐变大的锥形侧壁，所述右端盖与左端盖为完全对称结构。Further, the front end face of the left end cover is incompletely circular, and a circular through hole is provided inside, and a matching cut surface overlapping with the right end cover is provided on the right side, and the axial direction of the end cover of the left end cover has a tapered shape with gradually increasing diameter. The side wall, the right end cover and the left end cover are completely symmetrical structures.

进一步地，所述底板的两斜边夹角为120°，底板上设有五个对称分布的不完全圆形缝合台，每个缝合台上均设有同轴心的缝合孔，方便港体的缝合与固定。Further, the angle between the two hypotenuses of the bottom plate is 120°, five symmetrically distributed incomplete circular suture stations are arranged on the bottom plate, each suture station is provided with coaxial suture holes, which is convenient for the port suturing and fixing.

进一步地，所述港座、左端盖、右端盖和锁紧卡扣采用具有一定硬度且生物相容性良好的聚四氟乙烯材料，所述穿刺膜采用质地软、耐穿刺且生物相容性良好的液态硅胶LSR材料，所述双腔静脉导管采用顺应性、生物相容性良好的聚氨酯材料，双腔静脉导管末端设有带侧孔的倒Z形的螺旋对称尖端，能够保证透析流量的同时减小血液的再循环，并且在操作错误反接透析回路的情况下也保证基本的透析流量。Further, the port seat, the left end cap, the right end cap and the locking buckle are made of polytetrafluoroethylene material with certain hardness and good biocompatibility, and the puncture membrane is made of soft, puncture-resistant and biocompatible Good liquid silicone LSR material, the double-cavity venous catheter is made of polyurethane material with good compliance and biocompatibility, and the end of the double-cavity venous catheter is equipped with an inverted Z-shaped spiral symmetrical tip with a side hole, which can ensure the flow rate of dialysis At the same time, the recirculation of blood is reduced, and the basic dialysis flow rate is also guaranteed in the event of a reversed connection of the dialysis circuit by an operator error.

与现有技术相比，本发明具有以下优点：Compared with the prior art, the present invention has the following advantages:

(1)本发明先将双腔静脉导管由尖端植入人体中心静脉，再将整个港体部分埋置于胸壁皮下囊袋中，通过锁紧卡扣对应将导管静脉端与港体静脉腔相连、导管动脉端与港体动脉腔相连，最后缝合好表皮从而完成植入手术。因此，完全植入式的透析港相比于中心静脉导管，能够能够很好地减少感染，在保证美观的同时不妨碍患者的日常生活，术后通过透析针分别穿刺薄层表皮与表皮下港体的静脉腔与动脉腔形成血液透析回路，能够减轻患者的穿刺痛苦，有效地保护血管。(1) In the present invention, the double-caval catheter is first implanted into the central vein of the human body from the tip, and then the entire port body is partially embedded in the subcutaneous pouch of the chest wall, and the vein end of the catheter is connected to the port body venous cavity by locking buckles correspondingly 1. The arterial end of the catheter is connected to the arterial lumen of the port body, and finally the epidermis is sutured to complete the implantation operation. Therefore, compared with the central venous catheter, the fully implanted dialysis port can reduce infection well, and it can ensure the aesthetics without hindering the daily life of the patient. The body's venous cavity and arterial cavity form a hemodialysis circuit, which can reduce the patient's puncture pain and effectively protect blood vessels.

(2)本发明中植入于人体中心静脉内的导管采用带侧孔的倒Z形的螺旋对称尖端，在保证透析流量的同时减小血液的再循环，并且在操作错误反接透析回路的情况下也保证基本的透析流量。(2) In the present invention, the catheter implanted in the central vein of the human body adopts an inverted Z-shaped spiral symmetrical tip with a side hole, which reduces the recirculation of blood while ensuring the dialysis flow rate, and reverses the connection of the dialysis circuit when the operation is wrong. Under normal circumstances, the basic dialysis flow rate is also guaranteed.

(3)本发明中透析港的各部件都采用生物相容性良好且满足各部件功能需要的材料，在保证器械的安全性、有效性前提下，降低了血栓的发生概率。(3) All components of the dialysis port in the present invention are made of materials with good biocompatibility and meeting the functional requirements of each component, which reduces the occurrence probability of thrombus on the premise of ensuring the safety and effectiveness of the device.

附图说明Description of drawings

图1为本发明整体结构示意图；Fig. 1 is a schematic diagram of the overall structure of the present invention;

图2为本发明整体结构剖面示意图；Fig. 2 is a schematic cross-sectional view of the overall structure of the present invention;

图3为本发明港座的结构示意图；Fig. 3 is the schematic structural view of the port seat of the present invention;

图4为本发明港座的另一种结构示意图；Fig. 4 is another kind of structural schematic diagram of the port seat of the present invention;

图5为本发明港座的前视图；Fig. 5 is the front view of the port seat of the present invention;

图6为本发明港座的后视图；Fig. 6 is the rear view of the port seat of the present invention;

图7为本发明港座剖面结构示意图；Fig. 7 is the schematic diagram of the cross-sectional structure of the port seat of the present invention;

图8为本发明港座另一种剖面结构示意图；Fig. 8 is a schematic diagram of another cross-sectional structure of the port seat of the present invention;

图9为本发明左端盖结构示意图；Fig. 9 is a schematic diagram of the structure of the left end cap of the present invention;

图10为本发明左端盖结构示意图；Fig. 10 is a schematic diagram of the structure of the left end cap of the present invention;

图11为本发明左端盖结构示意图；Fig. 11 is a schematic diagram of the structure of the left end cap of the present invention;

图12为本发明穿刺膜结构示意图；Fig. 12 is a schematic diagram of the structure of the puncture membrane of the present invention;

图13为本发明穿刺膜结构示意图；Figure 13 is a schematic diagram of the structure of the puncture membrane of the present invention;

图14为本发明穿刺膜结构示意图；Figure 14 is a schematic diagram of the structure of the puncture membrane of the present invention;

图15为本发明锁紧卡扣结构示意图；Fig. 15 is a schematic diagram of the structure of the locking buckle of the present invention;

图16为本发明锁紧卡扣结构示意图；Fig. 16 is a schematic diagram of the structure of the locking buckle of the present invention;

图17为本发明锁紧卡扣连接港体部分与导管的剖面结构示意图。Fig. 17 is a schematic cross-sectional structure diagram of the locking buckle connecting the port body and the catheter according to the present invention.

图中：1为港体部分；2为锁紧卡扣；3为双腔静脉导管；10为港座；100为底板；1000为斜边；1001为缝合台；1002为缝合孔；101为港身；1010为定位键槽；1011为静脉腔；1012为动脉腔；1013为第一平台；1014为第二平台；1015为D形弯孔；1016为定位凹槽；102为连接内管；1020为第一阶梯；1021为锁紧环；1022为第一内阶梯；1023为第二内阶梯；1024为D形腔；1025为内管切槽；11为左端盖；110为前端面；111为后端面；112为通孔；113为凹槽；114为锥形侧壁；115为配合切面；12为右端盖；13为穿刺膜；130为圆柱；131为锥形圆台；132为凸键；133为侧壁；134为穿刺面；135为圆形凸起；20为喇叭口；21为拱门形轴；22为端面；23为定位凸台；24为阶梯形通孔；25为楔形内阶梯；30为静脉端；31为动脉端。In the figure: 1 is the port body; 2 is the locking buckle; 3 is the double-caval catheter; 10 is the port seat; 100 is the bottom plate; 1000 is the hypotenuse; 1001 is the suture table; 1010 is the positioning keyway; 1011 is the vein cavity; 1012 is the artery cavity; 1013 is the first platform; 1014 is the second platform; 1015 is a D-shaped curved hole; 1016 is a positioning groove; 1021 is the locking ring; 1022 is the first inner step; 1023 is the second inner step; 1024 is the D-shaped cavity; 1025 is the groove of the inner pipe; 11 is the left end cover; 110 is the front face; End face; 112 is a through hole; 113 is a groove; 114 is a tapered side wall; 115 is a matching cut surface; 12 is a right end cover; 13 is a puncture membrane; 130 is a cylinder; 131 is a conical round table; 132 is a convex key; 133 134 is a puncture surface; 135 is a circular protrusion; 20 is a bell mouth; 21 is an arched shaft; 22 is an end face; 23 is a positioning boss; 24 is a stepped through hole; 25 is a wedge-shaped inner step; 30 is a vein end; 31 is an arterial end.

具体实施方式Detailed ways

下面结合附图和具体实施例对本发明进行详细说明。The present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments.

实施例Example

如图1和图2所示，一种植入式中心静脉透析港，包括港体部分1、锁紧卡扣2和双腔静脉导管3；港体部分1包括港座10、左端盖11、右端盖12和穿刺膜13，穿刺膜13安装于港座10前端，左端盖11和右端盖12对称设置，与港座10过盈配合形成密封腔体。As shown in Figures 1 and 2, an implantable central venous dialysis port includes aport body part 1, a lockingbuckle 2 and a double-cavalvenous catheter 3; theport body part 1 includes aport seat 10, aleft end cover 11, aright end Cover 12 andpuncture membrane 13,puncture membrane 13 is installed on the front end ofport seat 10,left end cap 11 andright end cap 12 are arranged symmetrically, and interference fit withport seat 10 to form a sealed cavity.

如图3至图8所示的港座10，所述港座10包括底板100、港身101和连接内管102，港身101上设有左右对称、与水平面成60°角但不相连通的静脉腔1011和动脉腔1012，静脉腔1011和动脉腔1012通过D型弯孔1015分别与后端连接内管102的两个D形腔1024相通，港座10前端面上设有定位键槽1010，通过与穿刺膜13两侧设有的定位键132相互配合而防止穿刺膜13的转动，定位键槽1010分别与左端盖和右端盖上的凹槽113进行过盈配合，从而实现端盖对港体内部的密封安装。港座后端面设有与锁紧卡扣2上的定位凸台23配合的定位凹槽1016，港座10与锁紧卡扣2通过定位凹槽1016与定位凸台23之间的配合相连接。As shown in Figures 3 to 8, theport seat 10 includes abase plate 100, aport body 101 and a connectinginner pipe 102, and theport body 101 is provided with left-right symmetry, an angle of 60° with the horizontal plane but not connected Thevenous cavity 1011 and thearterial cavity 1012 communicate with the two D-shapedcavities 1024 connected to theinner tube 102 at the rear end respectively through the D-shapedcurved hole 1015, and the front end surface of theport seat 10 is provided with apositioning keyway 1010 , by cooperating with thepositioning keys 132 provided on both sides of thepuncture film 13 to prevent the rotation of thepuncture film 13, the positioningkey grooves 1010 respectively carry out interference fit with thegrooves 113 on the left end cover and the right end cover, so as to realize the alignment of the end cover to the port. Sealed installation inside the body. The rear end surface of the port seat is provided with apositioning groove 1016 that cooperates with thepositioning boss 23 on thelocking buckle 2, and theport seat 10 and thelocking buckle 2 are connected through the cooperation between thepositioning groove 1016 and thepositioning boss 23 .

如图3所示，所述底板100的两斜边1000夹角为120°，底板100上设有五个对称分布的不完全圆形缝合台1001，每个缝合台1001上均设有同轴心的缝合孔1002，方便港体的缝合与固定。As shown in Figure 3, the included angle between the twohypotenuses 1000 of thebase plate 100 is 120°, thebase plate 100 is provided with five symmetrically distributed incompletecircular suture stations 1001, and eachsuture station 1001 is provided with a coaxial Thesuturing hole 1002 in the heart facilitates the suturing and fixing of the port body.

如图8所示，所述静脉腔1011和动脉腔1012为直径逐渐缩小的锥形通孔；所述D形弯孔1015含两个转角，第一转角为120°，第二转角为90°，两D形弯孔1015末端包含于连接内管的D形腔1024中，即D形弯孔的直径小于等于连接内管的D形腔直径。所述连接内管102为阶梯型管道，横截面为D字形，连接内管102外表面设有第一阶梯1020和锁紧环1021，中间有一通过内管圆心的切槽1025，切槽两内壁上设有第一内阶梯1022和第二内阶梯1023，第一内阶梯1022和第二内阶梯1023均为半圆形凸起，用于辅助导管的锁紧。As shown in Figure 8, thevenous cavity 1011 and thearterial cavity 1012 are tapered through holes with gradually reduced diameters; the D-shapedcurved hole 1015 contains two corners, the first corner is 120°, and the second corner is 90° The ends of the two D-shapedcurved holes 1015 are included in the D-shapedcavity 1024 connecting the inner tube, that is, the diameter of the D-shaped curved hole is smaller than or equal to the diameter of the D-shaped cavity connected to the inner tube. The connectinginner pipe 102 is a stepped pipe with a D-shaped cross section. The outer surface of the connectinginner pipe 102 is provided with afirst step 1020 and alocking ring 1021. There is acut groove 1025 passing through the center of the inner pipe in the middle, and the two inner walls of the cut groove There is a firstinner step 1022 and a secondinner step 1023 on the top, both of which are semicircular protrusions for assisting the locking of the catheter.

如图9至图11所示，左端盖11的前端面110为不完全圆形，内部设有圆形通孔112，右侧设有一与右端盖12重合的配合切面115，左端盖11轴向为直径逐渐变大的锥形侧壁114，与港身配合的后端面111设有与港身键槽1010配合的凹槽113。右端盖12与左端盖11为完全对称结构。As shown in Figures 9 to 11, thefront end surface 110 of theleft end cover 11 is incompletely circular, and a circular throughhole 112 is provided inside, and amating cut surface 115 overlapping with theright end cover 12 is provided on the right side, and theleft end cover 11 is axially It is a taperedside wall 114 with gradually larger diameter, and therear end surface 111 matching with the port body is provided with agroove 113 matching with thekey groove 1010 of the port body. Theright end cover 12 and theleft end cover 11 are completely symmetrical structures.

如图12至14所示，穿刺膜13包括圆柱130和直径逐渐减小的锥形圆台131，穿刺膜13上设有与港身键槽1010配合的凸键132，可限制穿刺膜的周向旋转。穿刺面134上设有四个均布的圆形凸起135，能够辅助透析港的穿刺区域在体表显型。如图2所示，锥形圆台131的侧壁133与静脉腔1011和动脉腔1012的内壁贴合，在穿刺膜13安置于港身上后，静脉腔1011和动脉腔1012的腔体后端留有储血的空腔。As shown in Figures 12 to 14, thepuncture membrane 13 includes acylinder 130 and a conicaltruncated cone 131 whose diameter gradually decreases. Thepuncture membrane 13 is provided with aconvex key 132 that cooperates with thekeyway 1010 of the port body, which can limit the circumferential rotation of the puncture membrane. . Thepuncture surface 134 is provided with four evenly distributedcircular protrusions 135, which can assist the puncture area of the dialysis port to be visualized on the body surface. As shown in Figure 2, theside wall 133 of the conicalcircular frustum 131 fits the inner walls of thevenous cavity 1011 and thearterial cavity 1012. After thepuncture membrane 13 is placed on the port body, the rear ends of thevenous cavity 1011 and thearterial cavity 1012 remain There is a cavity for blood storage.

如图15和图16所示的锁紧卡扣2，其端面22设有与港体配合的定位凸台23，锁紧卡扣2外部形状为直径逐渐缩小的喇叭口20与拱门状轴21相连，锁紧卡扣2内部为阶梯型通孔24，含一楔形内阶梯25，卡扣底部呈水平，保证能平稳放置于组织平面上。As shown in Figure 15 and Figure 16, the lockingbuckle 2 has apositioning boss 23 on itsend surface 22 that matches the port body, and the outer shape of the lockingbuckle 2 is abell mouth 20 with a gradually decreasing diameter and anarched shaft 21. Connected, the inside of the lockingbuckle 2 is a stepped throughhole 24, including a wedge-shapedinner step 25, and the bottom of the buckle is horizontal to ensure that it can be placed stably on the tissue plane.

如图17所示，所述双腔静脉导管3的横截面为D字形，导管末端采用带侧孔的倒Z型的螺旋对称尖端，能够保证透析流量的同时减小血液的再循环。As shown in FIG. 17 , the cross section of the double-caval catheter 3 is D-shaped, and the end of the catheter adopts an inverted Z-shaped spiral symmetrical tip with a side hole, which can ensure dialysis flow and reduce blood recirculation.

具体地，所述双腔静脉导管3在安装时，需先套入锁紧卡扣2中，再套入港身的连接内管102上，直到触碰港身的后端面，让连接内管的第一阶梯1020、锁紧环1021、中间切槽的两个内阶梯以及锁紧卡扣的楔形内阶梯25充分将导管进行内外锁死，以保证港体内部的密封性，也防止导管在体内滑脱和扭转。Specifically, when the double-caval catheter 3 is installed, it needs to be inserted into the lockingbuckle 2 first, and then inserted into the connectinginner tube 102 of the port body until it touches the rear end surface of the port body, so that the connecting inner tube can Thefirst step 1020, thelocking ring 1021, the two inner steps of the middle groove, and the wedge-shapedinner step 25 of the locking buckle fully lock the catheter inside and outside, so as to ensure the tightness inside the port body and prevent the catheter from being trapped inside the body. Slip and twist.

具体地，所述港座10、左端盖11、右端盖12和锁紧卡扣2采用具有一定硬度且生物相容性良好的聚四氟乙烯材料。所述穿刺膜13采用质地软、耐穿刺且生物相容性良好的液态硅胶LSR材料。所述双腔静脉导管3采用顺应性、生物相容性良好的聚氨酯材料。这些选材，在保证器械安全性、有效性的前提下，降低了血栓的发生概率。Specifically, theport seat 10 , theleft end cap 11 , theright end cap 12 and thelocking buckle 2 are made of polytetrafluoroethylene material with certain hardness and good biocompatibility. Thepuncture membrane 13 is made of liquid silicone LSR material which is soft, puncture-resistant and has good biocompatibility. The doublevena cava catheter 3 is made of polyurethane material with good compliance and biocompatibility. These selections reduce the probability of thrombus on the premise of ensuring the safety and effectiveness of the device.

在本实施例中，先将双腔静脉导管3由尖端植入人体中心静脉，再将整个港体部分1埋置于胸壁皮下囊袋中，通过锁紧卡扣2对应将导管静脉端30与港体静脉腔1011相连、导管动脉端31与港体动脉腔1012相连，最后缝合好表皮从而完成植入手术。完全植入式的透析港相比于中心静脉导管，能够能够很好地减少感染，在保证美观的同时不妨碍患者的日常生活。术后通过透析针分别穿刺薄层表皮与表皮下港体的静脉腔1011与动脉腔1012形成血液透析回路，能够减轻患者的穿刺痛苦，有效地保护血管。In this embodiment, the double-caval catheter 3 is first implanted into the central vein of the human body from the tip, and then the entireport body part 1 is embedded in the chest wall subcutaneous pouch, and the cathetervenous end 30 is connected to the catheter by locking thebuckle 2 correspondingly. The portbody vein cavity 1011 is connected, the catheterarterial end 31 is connected with the portbody artery cavity 1012, and finally the epidermis is sutured to complete the implantation operation. Compared with the central venous catheter, the fully implanted dialysis port can reduce infection well, and it does not hinder the daily life of patients while ensuring aesthetics. After the operation, thevenous cavity 1011 and thearterial cavity 1012 of the thin layer of epidermis and the subepidermal port body are respectively punctured by a dialysis needle to form a hemodialysis circuit, which can reduce the puncture pain of the patient and effectively protect the blood vessels.

综上所述，本发明提供了一种植入式中心静脉透析港，利用完全植入式的港体来替代中心静脉导管进行血液透析，能更好的降低感染率，使用方便且不妨碍患者的日常生活。In summary, the present invention provides an implantable central venous dialysis port, which uses a fully implanted port body to replace the central venous catheter for hemodialysis, which can better reduce the infection rate, is easy to use, and does not hinder the patient's life. daily life.

Claims (10)

Translated fromChinese

1.一种植入式中心静脉透析港，其特征在于，包括港体部分(1)、锁紧卡扣(2)和双腔静脉导管(3)；1. An implantable central venous dialysis port, characterized in that it comprises a port body part (1), a locking buckle (2) and a double-caval catheter (3);所述港体部分(1)包括港座(10)、左端盖(11)、右端盖(12)和穿刺膜(13)，所述穿刺膜(13)安装于港座(10)前端，所述左端盖(11)和右端盖(12)对称设置，与港座(10)过盈配合形成密封腔体；The port body part (1) includes a port seat (10), a left end cover (11), a right end cover (12) and a puncture film (13), and the puncture film (13) is installed on the front end of the port seat (10), so The left end cover (11) and the right end cover (12) are symmetrically arranged, and form a sealed cavity with an interference fit with the port seat (10);所述港座(10)包括底板(100)、港身(101)和连接内管(102)，连接内管(102)与双腔静脉导管(3)相连通，港身(101)中设有静脉腔(1011)和动脉腔(1012)；Described port seat (10) comprises base plate (100), port body (101) and connecting inner pipe (102), and connecting inner pipe (102) is connected with double-caval catheter (3), and the port body (101) is provided with Has a venous cavity (1011) and an arterial cavity (1012);所述双腔静脉导管(3)包括导管静脉端(30)和导管动脉端(31)；The double vena cava catheter (3) comprises a catheter venous end (30) and a catheter arterial end (31);所述静脉腔(1011)与导管静脉端(30)以及动脉腔(1012)与导管动脉端(31)通过锁紧卡扣(2)对应连通。The venous cavity (1011) communicates with the catheter venous end (30) and the arterial cavity (1012) communicates with the catheter arterial end (31) through the locking buckle (2).2.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述静脉腔(1011)和动脉腔(1012)为直径逐渐缩小的锥形腔体，左右对称设置于港身(101)中，并与水平面形成60°夹角。2. A kind of implantable central venous dialysis port according to claim 1, characterized in that, the venous cavity (1011) and the arterial cavity (1012) are conical cavities whose diameter gradually decreases, and are symmetrically arranged in the port. body (101), and form a 60 ° angle with the horizontal plane.3.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述穿刺膜(13)包括圆柱(130)和直径逐渐减小的锥形圆台(131)，穿刺膜(13)的穿刺面(134)上设有四个均布的圆形凸起(135)，所述锥形圆台(131)的侧壁(133)与静脉腔(1011)和动脉腔(1012)的内壁贴合，所述穿刺膜(13)安置于港身(101)中后，静脉腔(1011)和动脉腔(1012)后端留有储血的空腔。3. A kind of implantable central venous dialysis port according to claim 1, characterized in that, the puncture membrane (13) comprises a cylinder (130) and a tapered cone (131) whose diameter gradually decreases, and the puncture membrane (131) 13) The puncture surface (134) is provided with four evenly distributed circular protrusions (135), and the side wall (133) of the conical conical cone (131) is connected with the venous cavity (1011) and the arterial cavity (1012) After the puncture membrane (13) is placed in the port body (101), blood storage cavities are left at the rear ends of the venous cavity (1011) and the arterial cavity (1012).4.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述港座(10)前端面上设有定位键槽(1010)，所述穿刺膜(13)两侧设有定位键(132)所述左端盖(11)和右端盖(12)上设有凹槽(113)，穿刺膜(13)通过定位键槽(1010)与定位键(132)相配合安装于港座(10)上，定位键槽(1010)与凹槽(113)过盈配合形成密封的港体部分(1)腔体。4. An implantable central venous dialysis port according to claim 1, characterized in that, a positioning keyway (1010) is provided on the front end surface of the port seat (10), and a positioning keyway (1010) is provided on both sides of the puncture membrane (13). There are grooves (113) on the left end cover (11) and the right end cover (12) of the positioning key (132), and the puncture membrane (13) is installed in the port through the positioning key groove (1010) and the positioning key (132). On the seat (10), the positioning keyway (1010) is in interference fit with the groove (113) to form a sealed cavity of the port body part (1).5.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述连接内管(102)为阶梯形管道，连接内管(102)外表面设有第一阶梯(1020)和锁紧环(1021)，连接内管(102)中间设有通过内管圆心的切槽(1025)，切槽(1025)两内壁上设有凸起的第一内阶梯(1022)和第二内阶梯(1023)。5. An implantable central venous dialysis port according to claim 1, characterized in that, the connecting inner tube (102) is a stepped pipeline, and the outer surface of the connecting inner tube (102) is provided with a first step (1020 ) and locking ring (1021), connecting the middle of the inner tube (102) with a slot (1025) passing through the center of the inner tube, the two inner walls of the slot (1025) are provided with a raised first inner step (1022) and Second inner step (1023).6.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述连接内管(102)中设有两个D形腔(1024)，港身(101)中设有D形弯孔(1015)，静脉腔(1011)和动脉腔(1012)通过D形弯孔(1015)与D形腔(1024)相连通，所述D形弯孔(1015)含两个转角，第一转角为120°，第二转角为90°，D形弯孔(1015)的直径小于等于D形腔(1024)的直径。6. An implantable central venous dialysis port according to claim 1, characterized in that two D-shaped cavities (1024) are provided in the connecting inner tube (102), and two D-shaped cavities (1024) are provided in the port body (101). The D-shaped curved hole (1015), the venous cavity (1011) and the arterial cavity (1012) communicate with the D-shaped cavity (1024) through the D-shaped curved hole (1015), and the D-shaped curved hole (1015) contains two corners , the first rotation angle is 120°, the second rotation angle is 90°, and the diameter of the D-shaped curved hole (1015) is less than or equal to the diameter of the D-shaped cavity (1024).7.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述锁紧卡扣(2)底部设有水平平台，锁紧卡扣(2)包括直径逐渐缩小的喇叭口(20)与拱门状轴(21)，所述拱门状轴(21)内部设有阶梯形通孔(24)，阶梯形通孔(24)内设有楔形内阶梯(25)，所述港座(10)后端面设有定位凹槽(1016)，所述锁紧卡扣(2)的端面(22)上设有定位凸台(23)，港座(10)与锁紧卡扣(2)通过定位凹槽(1016)与定位凸台(23)之间的配合相连接。7. An implantable central venous dialysis port according to claim 1, characterized in that, the bottom of the locking buckle (2) is provided with a horizontal platform, and the locking buckle (2) includes a horn whose diameter gradually decreases The mouth (20) and the arch-shaped shaft (21), the inside of the arch-shaped shaft (21) is provided with a stepped through hole (24), and the stepped through hole (24) is provided with a wedge-shaped inner step (25). The rear end surface of the port seat (10) is provided with a positioning groove (1016), and the end face (22) of the locking buckle (2) is provided with a positioning boss (23), and the port seat (10) and the locking buckle (2) It is connected through the cooperation between the positioning groove (1016) and the positioning boss (23).8.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述左端盖(11)的前端面(110)为不完全圆形，内部设有圆形通孔(112)，右侧设有与右端盖(12)重合的配合切面(115)，左端盖(11)端盖轴向为直径逐渐变大的锥形侧壁(114)，所述右端盖(12)与左端盖(11)为完全对称结构。8. An implantable central venous dialysis port according to claim 1, characterized in that, the front end face (110) of the left end cap (11) is incompletely circular, and a circular through hole (112) is arranged inside ), the right side is provided with a matching cut surface (115) overlapping with the right end cover (12), the left end cover (11) end cover is axially a tapered side wall (114) whose diameter gradually increases, and the right end cover (12) It is a completely symmetrical structure with the left end cover (11).9.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述底板(100)的两斜边(1000)夹角为120°，底板(100)上设有五个对称分布的不完全圆形缝合台(1001)，每个缝合台(1001)上均设有同轴心的缝合孔(1002)。9. An implantable central venous dialysis port according to claim 1, characterized in that, the angle between the two hypotenuses (1000) of the base plate (100) is 120°, and the base plate (100) is provided with five Symmetrically distributed incomplete circular suture stations (1001), each suture station (1001) is provided with concentric suture holes (1002).10.根据权利要求1所述的一种植入式中心静脉透析港，其特征在于，所述港座(10)、左端盖(11)、右端盖(12)和锁紧卡扣(2)采用聚四氟乙烯材料，所述穿刺膜(13)采用液态硅胶LSR材料，所述双腔静脉导管(3)采用聚氨酯材料，双腔静脉导管(3)末端设有带侧孔的倒Z形的螺旋对称尖端。10. An implantable central venous dialysis port according to claim 1, characterized in that, the port seat (10), the left end cover (11), the right end cover (12) and the locking buckle (2) adopt Polytetrafluoroethylene material, the puncture membrane (13) is made of liquid silicone LSR material, the double-caval catheter (3) is made of polyurethane material, and the end of the double-caval catheter (3) is provided with an inverted Z-shaped Spiral symmetrical tip.

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