CN111420274A - Fixing device and pacing electrode lead thereof - Google Patents

Fixing device and pacing electrode lead thereof Download PDF

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Publication number
CN111420274A
CN111420274A CN202010260905.8A CN202010260905A CN111420274A CN 111420274 A CN111420274 A CN 111420274A CN 202010260905 A CN202010260905 A CN 202010260905A CN 111420274 A CN111420274 A CN 111420274A
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CN
China
Prior art keywords
wing
electrode
fixing device
electrode lead
shaped structure
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Pending
Application number
CN202010260905.8A
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Chinese (zh)
Inventor
秦胜梅
宿燕岗
葛均波
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Zhongshan Hospital Fudan University
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Zhongshan Hospital Fudan University
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Priority to CN202010260905.8A priority Critical patent/CN111420274A/en
Publication of CN111420274A publication Critical patent/CN111420274A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/0563Transvascular endocardial electrode systems specially adapted for defibrillation or cardioversion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (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

The utility model provides a fixing device and pace electrode wire thereof, wherein fixing device includes fixed main part and wing structure, the head end at electrode wire is installed to fixed main part, wing structure set up in fixed main part is last, just wing structure is degradable material, and fixing device is used for pace electrode wire to implant fixed after. The wing-shaped structure and the fixed main body are made of degradable materials and high polymer materials respectively, the wing-shaped structure can be firmly fixed inside the heart at the initial stage of implantation, the wing-shaped structure is degraded and absorbed by a human body after 6-12 months of degradation period, and the head end of the electrode lead is only left with the smooth cylindrical fixed main body, so that the electrode lead is convenient to pull out.

Description

Fixing device and pacing electrode lead thereof
Technical Field
The invention relates to the field of medical instruments, in particular to a fixing device of a pacing electrode lead and the pacing electrode lead.
Background
Implantable cardiac pacemakers are by far the more reliable and effective method of treating bradycardia. Through development for over fifty years, the important function and curative effect of the cardiac pacing technology in the field of cardiovascular disease prevention and treatment are widely accepted worldwide. The pacing electrode lead and the pacemaker form a pacing system which is implanted into the heart to stimulate cardiac muscle cells and restore the normal function of the heart. The pacemaker needs to be replaced after the battery is exhausted for 6-10 years due to the limitation of the service life of the battery, and the electrode lead can be implanted in the heart for a long time if the electrode lead is not damaged, broken, displaced and the like. In reality, with the wide application of pacemakers, the life of patients is prolonged, the electrodes bear bending, friction, stretching and extrusion caused by the motion of human bodies and hearts for a long time, the conditions of pacing threshold rise, lead fracture and insulation layer damage of the electrodes can occur, and the original leads need to be removed and replaced by new electrode leads due to infection.
For the passive pacing electrode lead, the head end fixing structure is generally a wing-shaped integral structure, and can hook tissues such as the trabecula muscularis inside the heart at the initial stage of implantation, so that the fixation is firmer. However, at the later stage of implantation, the neoplasms and the hyperplastic fibrous tissues of the fixed part can be wound on the wings, so that the problem of difficult removal during lead replacement is caused.
Therefore, effective innovation of the existing technology is needed to overcome the above defects.
Disclosure of Invention
The invention aims to provide a fixing device, wherein a fixing main body and a wing-shaped structure in a pacing electrode lead are arranged in a split mode, the wing-shaped structure is made of degradable materials, the electrode fixing cannot be influenced in the early stage of implantation, the wing-shaped structure can be gradually degraded and absorbed by a human body in the later stage of implantation, and the electrode lead is not influenced to be detached and replaced.
In order to achieve the purpose, the invention adopts the following technical scheme:
a fixing device comprises a fixing main body and a wing-shaped structure, wherein the wing-shaped structure is arranged on the fixing main body and made of degradable materials, and the fixing device is used for fixing a pacing electrode lead after implantation;
correspondingly, the degradable material comprises polylactic acid, polyglycolide, polycaprolactone or polycarbonate;
correspondingly, the distance between the wing-shaped structure and the end part of the fixing main body is 2-5 mm;
correspondingly, the number of the wing-shaped structures is 3-5, and the length of each wing-shaped structure is 2-10 mm;
correspondingly, the wing-shaped structure is obliquely arranged on the side surface of the fixing main body, and the angle between the wing-shaped structure and the fixing main body is 30-60 degrees.
A pacing electrode lead comprises a connector end, an electrode body, a ring electrode, a head electrode and the fixing device, wherein one end of the connector end is connected with a pacemaker, the other end of the connector end is connected with the electrode body, the ring electrode and the head electrode are sequentially connected into a continuous lead, and the fixing device is arranged on the electrode body between the ring electrode and the head electrode.
The invention has the beneficial effects that:
the wing-shaped structure and the fixed main body are made of degradable materials and high polymer materials respectively, the wing-shaped structure can be firmly fixed inside the heart at the initial stage of implantation, the wing-shaped structure is degraded and absorbed by a human body after 6-12 months of degradation period, and the head end of the electrode lead is only left with the smooth cylindrical fixed main body, so that the electrode lead is convenient to pull out.
Drawings
FIG. 1 is a schematic structural view of a fixing device according to an embodiment of the present invention;
FIG. 2 is a schematic structural diagram of a pacing electrode lead according to an embodiment of the invention;
in the figure:
1. a fixed body; 2. a wing structure; 3. a connector end; 4. an electrode body; 5. a ring electrode; 6. a head electrode.
Detailed Description
As shown in fig. 1, in an embodiment of the present invention, the fixing device includes a fixing body 1 and wing structures 2, the fixing body 1 is installed at a head end of an electrode lead, the fixing body 1 is usually made of a high polymer material, the wing structures 2 are disposed on the fixing body 1, and the wing structures 2 are made of a degradable material, the degradable material includes, but is not limited to, one or two or more of polylactic acid, polyglycolide, polycaprolactone, or polycarbonate copolymer/blend, considering that the materials used for the fixing body 1 and the wing structures 2 are different, a secondary injection molding method is usually adopted, after the fixing body 1 is injection molded, it is used as an insert, the secondary injection molding is performed on the wing structures 2, the distance from the wing structures 2 to the end of the fixing body 1 is 2-5mm, the number of the wing structures 2 is 3-5, and the length of each wing structure 2 is 2-10mm, the wing-shaped structure 2 is obliquely arranged on the side surface of the fixing main body 1, and the angle between the wing-shaped structure 2 and the fixing main body 1 is 30-60 degrees.
In addition, as shown in fig. 2, the present embodiment also provides a pacing electrode lead, which includes a connector end 3, an electrode body 4, a ring electrode 5, a head electrode 6 and the fixing device, wherein one end of the connector end 3 is connected to the pacemaker, the other end is connected to the electrode body 4, the ring electrode 5 and the head electrode 6 are sequentially connected to form a continuous lead, and the fixing device is disposed on the electrode body 4 between the ring electrode 5 and the head electrode 6. The difference between the electrode lead and the existing pacing electrode lead is that the fixing device of the electrode lead is the fixing device in one embodiment of the invention.
The wing-shaped structure 2 and the fixed main body 1 are made of degradable materials and high polymer materials respectively, at the initial stage of implantation, the wing-shaped structure 2 can be firmly fixed inside the heart, after a degradation period of 6-12 months, the wing-shaped structure 2 is degraded and absorbed by a human body, and the head end of the electrode lead is only left with the smooth cylindrical fixed main body 1, so that the electrode lead is convenient to pull out.
While the foregoing is directed to embodiments of the present invention, it will be understood by those skilled in the art that various changes may be made without departing from the spirit and scope of the invention.

Claims (6)

1. The utility model provides a fixing device, includes fixed main part and wing structure, its characterized in that, the head end at the electrode wire is installed to fixed main part, wing structure set up in fixed main part is last, just wing structure is degradable material.
2. The pacemaker electrode lead fixation device of claim 1, wherein the degradable material comprises polylactic acid, polyglycolide, polycaprolactone or polycarbonate.
3. A fixation device for a pacing electrode lead according to claim 1, characterized in that the wing-like structure is at a distance of 2-5mm from the end of the fixation body.
4. The fixing device for a pacing electrode lead according to claim 1, wherein the number of the wing-like structures is 3-5, and the length of each wing-like structure is 2-10 mm.
5. The fixing device for a pacing electrode lead according to claim 1, wherein the wing-shaped structure is obliquely arranged at the side of the fixing body, and the angle between the wing-shaped structure and the fixing body is 30-60 °.
6. A pacing electrode lead according to a fixing device according to any one of claims 1 to 5, comprising a connector end, an electrode body, a ring electrode, a head electrode and the fixing device, wherein the connector end is connected to a pacemaker at one end and to the electrode body at the other end, the electrode body, the ring electrode and the head electrode are connected in sequence to form a continuous lead, and the fixing device is disposed on the electrode body between the ring electrode and the head electrode.
CN202010260905.8A 2020-04-03 2020-04-03 Fixing device and pacing electrode lead thereof Pending CN111420274A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010260905.8A CN111420274A (en) 2020-04-03 2020-04-03 Fixing device and pacing electrode lead thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202010260905.8A CN111420274A (en) 2020-04-03 2020-04-03 Fixing device and pacing electrode lead thereof

Publications (1)

Publication Number Publication Date
CN111420274A true CN111420274A (en) 2020-07-17

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112156362A (en) * 2020-10-28 2021-01-01 创领心律管理医疗器械(上海)有限公司 Fixing structure and electrode lead

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US20100137927A1 (en) * 2008-12-01 2010-06-03 Tengiz Tkebuchava Multifunctional cardiac pacemaker system
US20120053649A1 (en) * 2010-08-31 2012-03-01 Hon Hai Precision Industry Co., Ltd. Electronic pacemaker and pacemaker electrode
US20120158111A1 (en) * 2010-12-20 2012-06-21 Alexander Khairkhahan Leadless Pacemaker with Radial Fixation Mechanism
CN103110444A (en) * 2013-01-22 2013-05-22 陈平根 Biodegradable fabric body capable of being developed and conveying device
CN104511056A (en) * 2013-09-26 2015-04-15 上海微创医疗器械(集团)有限公司 Bone injury repairing and fixing apparatus and preparation method thereof
CN204601383U (en) * 2015-05-11 2015-09-02 复旦大学附属中山医院 Heart passive Pacing lead Absorbable rod wing fixed structure
CN108187229A (en) * 2018-01-24 2018-06-22 张海军 A kind of controllable wireless heart pacemaker system of multi-electrode pace-making
CN109621199A (en) * 2018-12-25 2019-04-16 创领心律管理医疗器械(上海)有限公司 Electrode cable
CN109907979A (en) * 2019-04-30 2019-06-21 江苏熙美生物科技有限公司 Intradermal needling and preparation method thereof
CN210145307U (en) * 2019-03-26 2020-03-17 复旦大学附属中山医院 Suture-free detachable epicardial temporary pacing lead
CN212817625U (en) * 2020-04-03 2021-03-30 复旦大学附属中山医院 Pace-making electrode lead provided with fixing device

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100137927A1 (en) * 2008-12-01 2010-06-03 Tengiz Tkebuchava Multifunctional cardiac pacemaker system
US20120053649A1 (en) * 2010-08-31 2012-03-01 Hon Hai Precision Industry Co., Ltd. Electronic pacemaker and pacemaker electrode
US20120158111A1 (en) * 2010-12-20 2012-06-21 Alexander Khairkhahan Leadless Pacemaker with Radial Fixation Mechanism
CN103110444A (en) * 2013-01-22 2013-05-22 陈平根 Biodegradable fabric body capable of being developed and conveying device
CN104511056A (en) * 2013-09-26 2015-04-15 上海微创医疗器械(集团)有限公司 Bone injury repairing and fixing apparatus and preparation method thereof
CN204601383U (en) * 2015-05-11 2015-09-02 复旦大学附属中山医院 Heart passive Pacing lead Absorbable rod wing fixed structure
CN108187229A (en) * 2018-01-24 2018-06-22 张海军 A kind of controllable wireless heart pacemaker system of multi-electrode pace-making
CN109621199A (en) * 2018-12-25 2019-04-16 创领心律管理医疗器械(上海)有限公司 Electrode cable
CN210145307U (en) * 2019-03-26 2020-03-17 复旦大学附属中山医院 Suture-free detachable epicardial temporary pacing lead
CN109907979A (en) * 2019-04-30 2019-06-21 江苏熙美生物科技有限公司 Intradermal needling and preparation method thereof
CN212817625U (en) * 2020-04-03 2021-03-30 复旦大学附属中山医院 Pace-making electrode lead provided with fixing device

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刘潇;李彦锋;崔彦君;赵光辉;: "脂肪族聚酯类可生物降解医用高分子材料的研究进展", 化学通报, no. 03, pages 30 - 36 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112156362A (en) * 2020-10-28 2021-01-01 创领心律管理医疗器械(上海)有限公司 Fixing structure and electrode lead
CN112156362B (en) * 2020-10-28 2024-04-26 创领心律管理医疗器械(上海)有限公司 Fixing structure and electrode wire

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Application publication date: 20200717