WO2018059426A1 - 弹簧接触式心脏起搏导线 - Google Patents

弹簧接触式心脏起搏导线 Download PDF

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Publication number
WO2018059426A1
WO2018059426A1 PCT/CN2017/103612 CN2017103612W WO2018059426A1 WO 2018059426 A1 WO2018059426 A1 WO 2018059426A1 CN 2017103612 W CN2017103612 W CN 2017103612W WO 2018059426 A1 WO2018059426 A1 WO 2018059426A1
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spring
lead
cardiac pacing
contact type
type cardiac
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PCT/CN2017/103612
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English (en)
French (fr)
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胡秋明
许春雷
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胡秋明
许春雷
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Publication of WO2018059426A1 publication Critical patent/WO2018059426A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3752—Details of casing-lead connections
    • A61N1/3754—Feedthroughs

Definitions

  • the present invention relates to a medical device, and more particularly to a cardiac surgical pacemaker connection device.
  • Postoperative cardiac surgery is prone to slow heart rate, severe patient drugs are difficult to increase heart rate, and even lead to acute congestive heart failure, life-threatening.
  • cardiac surgeons often sew a needle pacing electrode on the patient's heart surface and skin surface during the operation. Once the patient's heart rate is slow, they can The pacing lead is connected to the external pacemaker to control the heart rate of the patient, actively improve the patient's heart rhythm, and prevent postoperative congestive heart failure.
  • the current conventional pacing lead contact ends are mainly spiral plastic wires or flexible metal guide wires.
  • the main problem of the former is that the area of the conductive contact point is too small, and the spiral plastic line may slip out with the beating of the heart, resulting in poor contact.
  • the latter problem mainly lies in the thicker and harder metal wire bundles that are bundled into a bundle, and the damage to the heart is large. The bleeding risk is high, and it is also easy to slip out due to the beating of the heart, resulting in poor contact.
  • the main method of fixing the traditional pacing lead on the surface of the heart is the suture method.
  • Suturing the pacing lead on the beating heart ventricular muscle and removing it in the future has the risk of bleeding.
  • the suture bleeding may cause difficulty in hemostasis and prolong the operation time;
  • the removal of the pacing lead after operation is more dangerous, and it is easy to cause bleeding in the original suture, tamponade, emergency pericardial puncture drainage, and even emergency thoracotomy. Serious death may even occur in patients with heart failure.
  • the invention aims at designing a spring contact type cardiac pacing lead for the deficiency of the conventional pacing lead.
  • the difference between the cardiac pacing lead of the present invention and the conventional pacing lead is that the contact end does not need to be sutured on the surface of the myocardium, but relies on itself.
  • the elasticity of the contact spring coil is directly in contact with the surface of the heart, and the elastic force does not press the heart itself.
  • the spring coil itself can be straightened, and the epicardium can be directly withdrawn from the pericardium when it is taken out. Since the present invention does not need to be sutured to the surface of the heart, it not only effectively reduces the operation time, but also greatly reduces the risk of bleeding during the placement and removal process.
  • the spring coil itself has a certain elasticity and tension. When used as a negative electrode, it ensures that it can effectively contact the surface of the heart, and is closely attached to the surface of the heart by its own tension. In addition, the spring metal coil is rubber-free throughout the process to ensure its effective conductivity. Since the spring coil is a flexible metal, the longitudinal stretching along the pacing lead can straighten the spring coil, which is convenient for the patient to withdraw from the pericardium after the heart rate is restored. When used as a positive electrode, the needle end can be pulled out of the skin and pulled to the spring coil end, the spring coil is straightened, and the knot is fixed. The operation is simple and safe.
  • Figure 1 is a front elevational view of an embodiment of the present invention
  • Figure 3 is a cross-sectional view of the wire portion 2;
  • FIG. 1 A preferred embodiment of the present invention is shown in Fig. 1.
  • the spring contact type cardiac pacing lead of the present embodiment is located between the heart, the skin and the pacemaker.
  • the wire is divided into four parts: the spring lead portion 1; the lead portion 2
  • the whole length is 500 mm and the diameter is 0.5 mm; the lead wire portion 3 and the first connecting portion 4 are pierced.
  • the spring lead portion 1 is connected to the lead portion 2 via the first connecting portion 4, and the other end of the lead portion 2 is connected to the puncture lead portion 3.
  • the spring coil is a flexible metal, the longitudinal stretching along the pacing lead can straighten the spring coil, which is convenient for the patient to withdraw from the pericardium after the heart rate is restored.
  • the needle end When used as a positive electrode, the needle end can be pulled out of the skin, pulled to the spring coil end, the spring coil is straightened, and the knot is fixed. The operation is simple and safe.
  • Figure 3 is a cross-sectional view of the wire portion 2, the inside of the wire portion 2 is 7 strands of conductive wire, the diameter is 0.13mm, 7 strands of conductive wire spirally coiled into a 0.4mm metal wire, outsourcing a 0.1mm thick wire Insulating adhesive, this rubber is medical insulating material, non-toxic and non-degradable.
  • the wire can be a conductive wire.
  • the second connecting portion 6 is 1 mm long and is disposed on the piercing corner pin 5 which is 23 mm away from the end portion of the connecting lead portion 7.
  • the second connecting portion 6 is made of a brittle metal material, and is different from the other parts of the piercing corner pin 5, and the middle portion There is a notch. After the leather is used, the needle is broken directly at this point to remove the needle tip.
  • the cross-sectional shape and size of the second connecting portion 6 is the same as the cross-sectional shape and size of the rear portion of the piercing corner pin 5.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

一种弹簧接触式心脏起搏导线，所述导线位于心脏、皮肤和起搏器之间，包括：弹簧导线部（1）、导线部（2）、穿刺导线部（3）和第一连接部（4）；其中，弹簧导线部（1）通过第一连接部（4）与导线部（2）连接，导线部（2）的另一端与穿刺导线部（3）连接。其中，弹簧导线部（1）为自身有弹力的金属弹簧线圈，弹簧线圈为螺旋锥形，利用弹簧线圈本身的弹力和张力，保证有效的接触心脏表面。

Description

弹簧接触式心脏起搏导线 一、技术领域
本发明涉及一种医疗装置，尤其涉及一种心脏外科起搏器连接装置。
二、背景技术
心脏外科手术术后，尤其是心功能较差和房颤消融术后的患者，容易出现心率慢，严重的患者药物难以提升心率，甚至可导致患者出现急性充血性心衰，危及生命。为了保证患者的术后围手术期心率在安全范围，心脏外科医生常常会在手术过程中，于患者的心脏表面及皮肤表面各缝一针心脏起搏电极，一旦患者心率偏慢，便可将起搏导线连接体外起搏器，控制患者的心率，主动提高患者心律，预防术后充血性心衰的发生。
目前的传统起搏导线接触端主要为螺旋塑料线或柔性金属导丝。前者的主要问题在于导电接触点面积偏小，螺旋塑料线可能随心脏的跳动而滑出，造成接触不良，后者问题主要在于集结成束的金属导丝较粗较硬，对心脏损伤大，出血风险高，同样容易因心脏的跳动而滑出，导致接触不良。
另外，传统起搏导线在心脏表面固定的主要方法为缝合法，在跳动的心脏心室肌肉上缝合起搏导线及将来将其拔除都有出血风险，缝合出血会造成手术止血困难，延长手术时间；而术后拔除起搏导线，更为危险，容易造成原缝合口出血，心包填塞，需要急诊心包穿刺引流，甚至紧急开胸探查，严重的甚至会出现心衰导致患者死亡。
近年来，心脏微创小切口手术普及，案例数逐年增多，传统的起搏导线采用缝合固定，而大多数微创手术无法暴露心室肌，只能暴露较薄的心房肌，缝合固定更是无法应用到这类型的手术患者。由于缺乏无创式的心表起搏导线，微创心外科手术患者术后心率的控制更是一个难以解决的问题。
三、发明内容
本发明针对目前传统起搏导线的不足，设计一种弹簧接触式心脏起搏导线，本发明的心脏起搏导线与传统起搏导线的区别在于其接触端不用缝合在心肌表面，而是依靠自身接触弹簧线圈的弹性直接与心脏表面接触，其弹性力度不会压迫心脏本身，弹簧线圈本身还可以被拉直，心外膜取出时可以从心包内直接抽出。由于本发明无需缝合于心脏表面，不仅有效的降低了手术时间，而且也大大降低了放置和取出过程的出血风险。
为实现本发明的上述目的而采取的优选的技术方案是，一种弹簧接触式心脏起搏导线，位于心脏、皮肤和起搏器之间，所述导线包括：弹簧导线部、导线部、穿刺导线部和第一连接部；其中，弹簧导线部通过第一连接部与导线部连接，导线部的另一端与穿刺导线部连接。其中，弹簧导线部为自身有弹力的金属弹簧线圈，弹簧线圈为螺旋锥形，利用弹簧线圈本身的弹力和张力，保证有效的接触心脏表面。
弹簧线圈本身有一定弹性及张力，作为负极使用时，保证其能有效的接触心脏表面，靠自身张力紧贴于心脏表面，另外弹簧金属线圈全程无橡胶包裹，保证其有效导电性。由于弹簧线圈为柔性金属，沿起搏导线纵向拉伸可使弹簧线圈变直，方便患者心率恢复后将其从心包内抽出。作为正极使用时，可先将角针端穿出皮肤，并拉至弹簧线圈端，拉直弹簧线圈，并打结固定。操作简单安全。
四、附图说明
图1为本发明实施例的正视图；
图2为图1中弹簧导线部1的示意图；
图3为导线部2的横截面视图；
图4为穿刺导线部3的示意图。
五、具体实施方式
本发明优选的一个实施例参见图1，本实施例的弹簧接触式心脏起搏导线位于心脏、皮肤和起搏器之间，所述导线分为四个部分：弹簧导线部1；导线部2，全长为500毫米，直径为0.5毫米；穿刺导线部3和第一连接部4。其中，弹簧导线部1通过第一连接部4与导线部2连接，导线部2的另一端与穿刺导线部3连接。
如图2所示，弹簧导线部1为自身有弹力的金属弹簧线圈，弹簧线圈为螺旋锥形。近端围绕直径为5mm，远端围绕直径为10mm，弹簧线圈无受力高度为5mm，金属弹簧线圈自身的直径为0.4mm。本发明采用质地柔软的金属弹簧线圈作为起搏导线的接触端，弹簧线圈本身有一定弹性及张力，作为负极使用时，保证其能有效的接触心脏表面，靠自身张力紧贴于心脏表面，另外弹簧金属线圈全程无橡胶包裹，保证其有效导电性。由于弹簧线圈为柔性金属，沿起搏导线纵向拉伸可使弹簧线圈变直，方便患者心率恢复后将其从心包内抽出。作为正极使用时，可先将角针端穿出皮肤，拉至弹簧线圈端，拉直弹簧线圈，并打结固定。操作简单安全。
图3为导线部2的横截面视图，导线部2内部为7股导电金属丝，直径均为0.13mm，7股导电金属丝螺旋盘绕汇聚成一股0.4mm的金属导线，外包0.1mm厚的导线绝缘胶，此橡胶为医用绝缘材料，无毒害，不可降解。金属丝可以为导电金属丝。
图4为穿刺导线部3的示意图，如图4所示，穿刺导线部3全长为90mm，包括：穿皮角针5、第二连接部6和连接导线部7，其中穿皮角针5的针尖头部有7mm，为三角锥形状；从7mm开始为三角柱形，截面为面积不变的等边三角形；穿皮角针5从22mm之后形状变为圆柱形，截面尺寸不变。连接导线部7用于将穿皮角针5与导线部2进行连接，连接导线部7长2mm。第二连接部6长1mm，设置在距离连接导线部7端部23mm的穿皮角针5上，所述第二连接部6为脆性金属材质，与穿皮角针5其他部分材质不同，中间有一凹口，穿皮使用完成后，直接在此处将穿皮角针折断，除去针尖。所述第二连接部6的横截面形状和尺寸与穿皮角针5后部的横截面形状和尺寸相同。
本发明的附图只是示出了本发明的一个优选实施例，本领域技术人员可以预料到的变形均落入本发明权利要求的保护范围。

Claims (15)

  1. 一种弹簧接触式心脏起搏导线，位于心脏、皮肤和起搏器之间，所述导线包括：弹簧导线部(1)、导线部(2)、穿刺导线部(3)和第一连接部(4)；其中，弹簧导线部(1)通过第一连接部(4)与导线部(2)连接，导线部(2)的另一端与穿刺导线部(3)连接。
  2. 如权利要求1所述的弹簧接触式心脏起搏导线，其中，弹簧导线部(1)为弹簧线圈。
  3. 如权利要求2所述的弹簧接触式心脏起搏导线，其中，弹簧线圈为金属弹簧线圈。
  4. 如权利要求2或3所述的弹簧接触式心脏起搏导线，其中，弹簧线圈为螺旋锥形。
  5. 如权利要求4所述的弹簧接触式心脏起搏导线，其中导线部(2)内部为多股导电金属丝，螺旋盘绕汇聚成一股金属导线，外包导线绝缘胶。
  6. 如权利要求5所述的弹簧接触式心脏起搏导线，其中导线部(2)内部为7股导电金属丝。
  7. 如权利要求2-6之一所述的弹簧接触式心脏起搏导线，其中所述弹簧线圈无受力高度为5mm。
  8. 如权利要求2-7之一所述的弹簧接触式心脏起搏导线，其中所述弹簧线圈自身的直径为0.4mm。
  9. 如权利要求1-8之一所述的弹簧接触式心脏起搏导线，其中所述弹簧导线部(1)近端围绕直径为5mm，远端围绕直径为10mm。
  10. 如权利要求1-9之一所述的弹簧接触式心脏起搏导线，其中穿刺导线部(3)包括穿皮角针(5)、第二连接部(6)和连接导线部(7)。
  11. 如权利要求10所述的弹簧接触式心脏起搏导线，穿皮角针(5)的后部通过连接导线部(7)与导线部(2)连接。
  12. 如权利要求10或11所述的弹簧接触式心脏起搏导线，其中所述穿皮角针(5)针头部分为三角锥形。
  13. 如权利要求10-12之一所述的弹簧接触式心脏起搏导线，所述第二连接部(6)的横截面形状为圆柱形，与穿皮角针(5)后部形状相同，并且所述第二连接部(6)的尺寸与穿皮角针(5)后部横截面的尺寸也相同。
  14. 如权利要求10-13之一所述的弹簧接触式心脏起搏导线，其中所述穿刺导线部(3)全长为90mm，第二连接部(6)长1mm，连接导线部(7)长2mm,穿皮角针(5)长7mm。
  15. 如权利要求14所述的弹簧接触式心脏起搏导线，其中所述第二连接部(6)设置在距离连接导线部(7)端部23mm的穿皮角针(5)上。
PCT/CN2017/103612 2016-09-30 2017-09-27 弹簧接触式心脏起搏导线 WO2018059426A1 (zh)

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CN106422064B (zh) * 2016-09-30 2024-06-04 胡秋明 弹簧接触式心脏起搏导线
CN108721707B (zh) * 2017-04-25 2021-04-09 北京纳米能源与系统研究所 可降解导线及其制备方法

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