WO2018112767A1 - 一种心脏起搏电流提供导线及单元、装置 - Google Patents

一种心脏起搏电流提供导线及单元、装置 Download PDF

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Publication number
WO2018112767A1
WO2018112767A1 PCT/CN2016/111169 CN2016111169W WO2018112767A1 WO 2018112767 A1 WO2018112767 A1 WO 2018112767A1 CN 2016111169 W CN2016111169 W CN 2016111169W WO 2018112767 A1 WO2018112767 A1 WO 2018112767A1
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Prior art keywords
cardiac pacing
pacing current
conductive core
wire
needle
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PCT/CN2016/111169
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English (en)
French (fr)
Inventor
于淑萍
张�浩
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南京心湃医疗科技有限公司
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Priority to EP16924896.0A priority Critical patent/EP3560549A4/en
Priority to PCT/CN2016/111169 priority patent/WO2018112767A1/zh
Priority to US16/470,973 priority patent/US20200188656A1/en
Publication of WO2018112767A1 publication Critical patent/WO2018112767A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/059—Anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/0595—Temporary leads
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium
    • C22C23/04—Alloys based on magnesium with zinc or cadmium as the next major constituent
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01B—CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B1/00—Conductors or conductive bodies characterised by the conductive materials; Selection of materials as conductors
    • H01B1/02—Conductors or conductive bodies characterised by the conductive materials; Selection of materials as conductors mainly consisting of metals or alloys
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01B—CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES
    • H01B3/00—Insulators or insulating bodies characterised by the insulating materials; Selection of materials for their insulating or dielectric properties
    • H01B3/18—Insulators or insulating bodies characterised by the insulating materials; Selection of materials for their insulating or dielectric properties mainly consisting of organic substances
    • H01B3/30—Insulators or insulating bodies characterised by the insulating materials; Selection of materials for their insulating or dielectric properties mainly consisting of organic substances plastics; resins; waxes
    • H01B3/42—Insulators or insulating bodies characterised by the insulating materials; Selection of materials for their insulating or dielectric properties mainly consisting of organic substances plastics; resins; waxes polyesters; polyethers; polyacetals
    • H01B3/421—Polyesters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/0592—Introducing the lead through the pericardium with a needle
    • 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
    • A61N1/37512—Pacemakers

Definitions

  • the invention relates to the field of cardiac pacing and belongs to the field of medical instruments.
  • the existing temporary cardiac pacing leads are made of non-degradable medical polymer material and stainless steel guide wire. After the patient's heart rhythm returns to normal, there is no need to continue pacing treatment, but the temporary pacing lead remains permanently in the patient. In the body, it is clearly visible during routine chest X examinations such as physical examinations and pre-marital medical examinations, which seriously affects the patient's life.
  • the invention solves the problem that the above-mentioned wire is not degradable, and proposes a degradable cardiac pacing current to provide a wire.
  • the wire of the invention is implanted in the body, it is externally passed through chemical and electrochemical reaction with the tissue fluid. In-sequence degradation, degradation products can be absorbed by the human body or discharged as urine in the form of metabolites, without surgical removal, thus effectively solving the above problems.
  • the degradable pacing lead of the present invention can be directly anchored to the epicardium without manual knotting, which not only shortens the operation time but also reduces the damage to the myocardium.
  • a cardiac pacing current provides a wire with one end fixed to the epicardium and myocardial tissue, and the other end Connecting with a cardiac pacemaker placed outside the heart disease patient provides a pacing current for the heart of the patient, and is characterized by comprising: a conductive core; an insulating film covering the conductive core, wherein the conductive core is made of a magnesium alloy, The mass composition percentage of the magnesium alloy is: 4.5-5.5% of zinc, 0.8-1.2% of manganese, 0.8-1.2% of calcium, the balance is magnesium, and the insulating film is composed of polylactic acid (PLA), polyglycolic acid (PGA), poly A copolymer of at least one of lactone (PCL), polydioxanone (PDS), polyhydroxyalkanoate (PHA) or at least two of the above.
  • PHA polylactic acid
  • PGA polyglycolic acid
  • PDS polydioxanone
  • PHA polyhydroxyalkanoate
  • the cardiac pacing current provided by the present invention provides a wire, and may also have the feature that the conductive core is a single magnesium alloy wire or is formed by weaving a plurality of magnesium alloy wires.
  • the present invention also provides a cardiac pacing current providing unit for providing a pacing current to a heart of a patient, comprising: a wire; a needle disposed at one end of the wire for fixing the wire to the heart through the cardiac muscle The outer membrane and the myocardial tissue; and the connecting electrode are disposed at the other end of the lead and connected to the cardiac pacemaker, wherein the lead provides a lead for the cardiac pacing current described above.
  • the cardiac pacing current supply unit provided by the present invention may further have the feature that the utility model further comprises: a retaining member disposed at an end of one end of the wire connected to the needle, the material of the retaining member and The material of the insulating film or the conductive core is the same. After the anti-dropping member guides the conductive core through the epicardium and the myocardium, the pull-back wire can tightly anchor the anti-dropping member on the epicardium to avoid slippage.
  • the cardiac pacing current providing unit provided by the present invention may further have a feature in which the retaining member is a barb or a triangular block that gradually tapers toward the needle.
  • the cardiac pacing current providing unit provided by the present invention may further have the feature that the barb is a flexible protruding strip formed by the boring straight line portion or welded and bonded.
  • the length is 2-10 mm and the thickness is 0.1-1 mm.
  • the cardiac pacing current supply unit provided by the present invention may further have the feature that the barb is formed by cutting a conductive core or by processing the same magnesium alloy material as the conductive core. It is then soldered or bonded to a conductive core.
  • the cardiac pacing current supply unit provided by the present invention may further have the feature that the needle is a semi-circular needle, and the tail end thereof has a card slot for engaging and fixing the conductive core, and the barb An arcuate barb that bends toward the needle.
  • the cardiac pacing current providing unit provided by the present invention may further have the feature that the connecting electrode is a straight needle provided with a recess for directly penetrating the chest wall to expose the outside body, and the recess is convenient for the Straight needle cut or broken.
  • the present invention also provides a cardiac pacing current providing device, comprising: at least one cardiac pacing current providing unit and a cardiac pacemaker connected to the cardiac pacing current providing unit, wherein the cardiac pacing current is provided
  • the unit is the above-described cardiac pacing current supply unit.
  • the cardiac pacing current provides a wire. Since the conductive core of the wire is a human body degradable magnesium alloy material and the insulating film is a human body degradable organic polymer material, the wire can be fixed after being implanted in the body. The time is degraded from the outside to the inside: the outer insulating film is first degraded into a non-toxic normal human metabolite, and then the magnesium alloy of the conductive core is in contact with the tissue fluid and degraded into a soluble electrolyte by a hydrolysis reaction. Some of the above degradation products are absorbed and utilized by the human body, and the other part is excreted with urine through the urinary system.
  • FIG. 1 is a schematic structural view of a cardiac pacing current supply unit according to Embodiment 1 of the present invention.
  • FIG. 2 is a schematic structural view of a needle according to Embodiment 1 of the present invention, wherein a is a schematic view of a barb, b is an enlarged schematic view of a needle and a bare conductive core connected through a card slot, and c is a barb schematic obtained by cutting. d is a barbed schematic obtained by a welding method;
  • FIG. 3 is a cross-sectional view showing the structure of a cardiac pacing current supply lead composed of a single magnesium alloy conductive core and an insulating film according to Embodiment 1 of the present invention
  • FIG. 4 is a schematic view of an anchoring method according to Embodiment 1 of the present invention, where a is a schematic view of a needle passing through the epicardium and the myocardium, and b is a schematic view of the barbed anchored to the epicardium after pulling back the wire;
  • FIG. 5 is a schematic structural view of a triangular block according to Embodiment 2 of the present invention, wherein a is a schematic view of a triangular wedge block, and b is a schematic view of a wedge block having a rear recess;
  • Figure 6 is a cross-sectional view showing the structure of a conductor of a cardiac pacing current composed of a conductive core woven by a plurality of magnesium alloy guide wires and an insulating film in a second embodiment of the present invention
  • FIG. 7 is a schematic view of an anchoring method according to a second embodiment of the present invention, where a is a schematic diagram of a triangular block passing through the epicardium and the myocardium, and b is a schematic view of the triangular block being tightly anchored to the epicardium after the wire is pulled back.
  • the cardiac pacing current providing device includes two cardiac pacing current supply units 100 and a cardiac pacemaker connected to the cardiac pacing current supply unit.
  • the pacemaker is placed outside the heart of a patient to provide pacing current to the patient's heart.
  • One end of the degradable cardiac pacing unit 100 provided in this embodiment is anchored on the epicardium, and the other end is Connected to an external pacemaker.
  • Fig. 1 is a view showing the configuration of a cardiac pacing current supply unit according to a first embodiment of the present invention.
  • the degradable cardiac pacing unit 100 includes a sequentially connected needle 10, a cardiac pacing current supply lead 20, a retaining member 30, and a connecting electrode 40.
  • FIG. 2 is a schematic structural view of a needle according to Embodiment 1 of the present invention, wherein a is a schematic view of a barb, b is an enlarged schematic view of a needle and a bare conductive core connected through a card slot, and c is a barb schematic obtained by cutting. d is a barbed schematic obtained by a welding method.
  • the needle 10 is used to pass through the epicardium and myocardial tissue, and is located at the front end, which is a semi-circular stainless steel medical needle having a tail end for occlusion.
  • the fixed card slot 11 is as shown in Fig. 2(b).
  • the cardiac pacing current provides a wire 20 including a conductive core 21 and an insulating film 22 covering the conductive core.
  • the detachment preventing member 30, which is a barb 31 in the present embodiment, has a curved line shape which is curved toward the needle 10 as shown in Fig. 2(a).
  • the bare conductive core 21 and the barb 31 are made of a demagnetizable magnesium alloy material in the human body.
  • the barb 31 is formed by cutting a bare conductive core 21 by a cutter, and such a processing method is relatively quick and suitable for rapid mass production.
  • the processed barbs are as long as 2-10 mm in length and 0.1-1.0 mm in thickness.
  • the barbs 31 may also be degradable magnesium alloy wires welded or bonded to the bare conductive core 21.
  • Fig. 3 is a cross-sectional view showing the structure of a cardiac pacing current supply lead 20 composed of a single magnesium alloy conductive core and an insulating film according to the first embodiment of the present invention.
  • the cardiac pacing current provides a lead 20, as shown in Figures 1 and 3, including a degradable conductive core in the human body. 21 and a degradable insulating film 22 covering the conductive core.
  • the material of the conductive core 21 is a degradable magnesium alloy in the human body.
  • the mass composition percentage of the magnesium alloy is: 4.5% of zinc, 0.8% of manganese, 0.8% of calcium, 0.5% of ⁇ , and the balance is 96.4% of magnesium.
  • the materials of the bare conductive core 21 and the barb 31 are the same, and both are the same magnesium alloy wire.
  • the insulating film 22 is a copolymer of medical grade polylactic acid PLA and polydioxanone PDS, which coats the entire conductive core 21.
  • the connecting electrode 40 is a straight needle provided with a recess 41 for directly penetrating the chest wall to expose the outside, and the recess 41 facilitates the cutting or breaking of the straight needle.
  • connection electrode 40 is made of stainless steel, and the left end of the drawing is connected to the conductive core 21 exposing the insulating mold 22, and the right end is a tip end.
  • a is a schematic view of the needle passing through the epicardium E and the myocardium M
  • b is a schematic view of the barbed wire being fixed to the epicardium after pulling back the wire.
  • the needle 11 When used surgically, the needle 11 is used to guide the barb on the wire through the epicardium and myocardial tissue of the atrium or ventricle, as shown in Fig. 4(a). Then, the semi-circular stainless steel medical needle is cut off, and the wire is pulled back so that the barb 31 is tightly fixed on the epicardium to avoid slippage, and the knot fixation is not required in the conventional operation, which shortens the operation time and reduces the time. Damage to the heart muscle.
  • the tip end of the connecting electrode 40 is used to guide the wire tail portion through the chest wall to be exposed to the outside, and a part of the connecting electrode 40 is removed from the recess 41, and the remaining portion is used as a metal electrode to be connected to the external cardiac pacemaker.
  • the pacing pulse current from the pacemaker is pacing through the connection electrode 40, the cardiac pacing current supply lead 20 and the barb 31 into the atria or ventricular muscle.
  • the insulating film disposed on the outer layer of the conductive core 21 has good biocompatibility and initial mechanical properties, and under the action of the tissue fluid in the human body, it will hydrolyze or hydrolyze into carbon dioxide in a set time.
  • Non-toxic human normal metabolites such as water, excreted with urine.
  • the outer covering of the insulating film of the conductive core is degraded, the conductive core of the metal is exposed to the weakly acidic (pH 6.7) tissue fluid.
  • the potential of each metal in the magnesium alloy is different, and electrochemical occurs. Degradation causes the metal to decompose into metal ions and dissolve in the tissue fluid; on the other hand, it forms a soluble electrolyte by hydrolysis reaction with water in the tissue fluid.
  • the insulating film is a degradable organic polymer material in the human body, and can be used at a certain time after use.
  • the insulating film disposed on the outer layer is first degraded into a non-toxic small molecule of a normal human metabolite, and the magnesium alloy of the inner core is hydrolyzed to form a soluble electrolyte.
  • the above-mentioned degraded organic small molecules, metal ions and soluble electrolytes are partially absorbed and utilized by the human body, and the other part is excreted with urine through the urinary system.
  • the barb in the embodiment has the function of preventing slippage, the barb is passed through the epicardium and the myocardial tissue under the guidance of the needle during use, and pulling back the wire can fix the barb on the epicardium, which is effective not only effective Prevents the wire from coming out of the myocardial tissue, and does not require manual knotting during the operation, which shortens the operation time and reduces the damage to the myocardium.
  • the connecting electrode is a straight needle provided with an annular recess, it is convenient to fold the straight needle from the recess after piercing the chest wall to expose the body, and the tail end can be directly connected to the positive or negative electrode of the external cardiac pacemaker. It further facilitates the operation of the doctor during surgery and shortens the operation time.
  • FIG. 5 is a schematic structural view of a triangular block according to Embodiment 2 of the present invention, wherein a is a schematic diagram of a triangular wedge block, and b is a schematic diagram of a wedge block having a rear recess.
  • Fig. 6 is a cross-sectional view showing the structure of a conductor of a cardiac pacing current composed of a conductive core woven by a plurality of magnesium alloy guide wires and an insulating film in a second embodiment of the present invention.
  • the embodiment provides a conductive core 21 ′ woven by using three magnesium alloy wires instead of the barb 31 corresponding to the first embodiment, and the wire of the single magnesium alloy wire conductive core 21 in the embodiment is replaced by the triangular block 32 . .
  • the needle 10' and the bare conductive core 21 and the triangular block 32 which is disposed on the segment of the conductive core 21 and which gradually tapers toward the needle 10'.
  • the bare conductive core 21' is made of a demagnetizable magnesium alloy material in the human body.
  • the mass composition percentage of the magnesium alloy is: 5.5% zinc, 1.2% manganese, 1.2% calcium, ⁇ 2%, and the balance is 90.1% magnesium.
  • the material of the triangular block 32 is also a degradable material, which is the same as the material of the insulating film.
  • the triangular block 32 is disposed around the bare conductive core 21 with the tip facing the needle needle 10'. As shown in FIGS. 5(a) and (b), the triangular block may be a triangular block as shown in (a) or a triangular block having a concave rear portion as shown in (b).
  • the conductive core 21' is formed by braiding or stranding three magnesium alloy wires of the same composition as the bare conductive core 21.
  • the insulating film 22' is a copolymer of medical grade polylactic acid PLA and polyglycolic acid PGA, which coats the entire conductive core 21'.
  • Figure 7 is a schematic view showing the anchoring method of the second embodiment of the present invention, wherein a is a triangular block passing through the epicardium and Schematic diagram of the myocardium, b is a schematic diagram of the triangular block tightly anchored to the epicardium after the wire is pulled back.
  • the cardiac pacing current supply unit since the triangular block on the needle in the embodiment has the anti-off function, no knotting is required during the operation, the operation time is shortened, and the damage to the myocardium is reduced.
  • the conductive core is a braided structure of three alloy wires, the strength is higher.

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Abstract

一种心脏起搏电流提供导线，包括：导电芯；绝缘膜，包覆导电芯，其中，导电芯由镁合金制成，该镁合金的质量组成百分比为：锌4.5-5.5％，锰0.8-1.2％，钙0.8-1.2％，余量为镁，绝缘膜由聚乳酸（PLA）、聚羟基乙酸（PGA）、聚已内酯（PCL）、聚二恶烷酮（PDS）、聚羟基脂肪酸酯（PHA）中的任意一种或上述至少两种的共聚物制成。还提供一种包含该导线的心脏起搏电流提供单元，为患者的心脏提供起搏电流，包括：导线；缝针，以及和心脏起搏器相连的连接电极，该导线在降解后体内没有导线的残留物，也不会产生金属伪影，使得患者免除了再次手术取出的必要，减轻了手术给患者造成的精神、身体和经济上的多重负担，具有很强的临床应用价值。

Description

一种心脏起搏电流提供导线及单元、装置 技术领域
本发明涉及心脏起搏领域，属于医疗器械领域。
背景技术
对于短暂性心动过缓的患者(如心脏直视手术后心动过缓)，往往需要通过外科手术的方式植入临时性心脏起搏导线，用于在术后早期提高心率和心输出量，加快术后康复过程。
然而，现有的临时性心脏起搏导线均采用不可降解的医用高分子材料和不锈钢导丝制成，患者心律恢复正常后无需继续起搏治疗，然而临时性起搏导线却永久性存留在患者体内，在工作体检、婚前体检等的常规胸部X检查时清晰可见，给患者的生活造成严重影响。
此外，现有的临时性心脏起搏导线需采用通过手工打结的方法固定在心肌中，不仅操作繁琐而且会造成不同程度的心肌损伤。
发明内容
本发明为解决上述的导线不可降解的问题，提出了一种可降解的心脏起搏电流提供导线，本发明的导线在植入体内后，通过其与组织液的化学、电化学反应而由外到内顺序降解，降解产物可被人体吸收利用或以代谢产物形式随尿液排出，无需手术取出，从而有效解决了上述问题。
此外，本发明的可降解起搏导线可直接锚定在心外膜上，无需手工打结固定，不仅缩短了手术时间，还减少了对心肌的损伤。
一种心脏起搏电流提供导线，其一端固定在心外膜及心肌组织上，另一端 与置于心脏病患者体外的心脏起搏器相连接为患者的心脏提供起搏电流，其特征在于，包括：导电芯；绝缘膜，包覆导电芯，其中，导电芯由镁合金制成，该镁合金的质量组成百分比为：锌4.5-5.5％，锰0.8-1.2％，钙0.8-1.2％，余量为镁，绝缘膜由聚乳酸(PLA)、聚羟基乙酸(PGA)、聚已内酯(PCL)、聚二恶烷酮(PDS)、聚羟基脂肪酸酯(PHA)中的任意一种或上述至少两种的共聚物制成。
本发明提供的心脏起搏电流提供导线，还可以具有这样的特征，其特征在于：其中，导电芯为单根的镁合金丝或由多根镁合金丝编织形成。
本发明还提供一种心脏起搏电流提供单元，为患者的心脏提供起搏电流，其特征在于，包括：导线；缝针，设置在导线的一端，用于穿过心脏心肌而将导线固定在心外膜及心肌组织上；以及连接电极，设置在导线的另一端，和心脏起搏器相连，其中，导线为上述的心脏起搏电流提供导线。
本发明提供的心脏起搏电流提供单元，还可以具有这样的特征，其特征在于还包括：防脱件，设置在导线上与缝针相连接的一端的端部，该防脱件的材料与绝缘膜或导电芯的材料相同，在防脱件引导导电芯穿过心外膜及心肌后，回拉导线可使防脱件紧密锚定在心外膜上而避免滑脱。
本发明提供的心脏起搏电流提供单元，还可以具有这样的特征，其特征在于：其中，防脱件为倒刺或朝向缝针方向逐渐缩小的三角形块。
本发明提供的心脏起搏电流提供单元，还可以具有这样的特征，其特征在于：其中，倒刺为柔性的凸起条，该凸起条通过劈削直线段部分形成或被焊接、粘结在导电芯上，长度为2-10mm，厚度为0.1-1mm。
本发明提供的心脏起搏电流提供单元，还可以具有这样的特征，其特征在于：其中，倒刺通过切削导电芯形成，或采用与导电芯相同的镁合金材料加工 而成然后焊接或粘合在导电芯上。
本发明提供的心脏起搏电流提供单元，还可以具有这样的特征，其特征在于：其中，缝针为呈半圆形的缝针，且其尾端具有咬合固定导电芯的卡槽，倒刺为朝向缝针弯曲的弧形倒刺。
本发明提供的心脏起搏电流提供单元，还可以具有这样的特征，其特征在于：其中，连接电极为设置有凹陷的直针，该直针用于直接扎穿胸壁而露出体外，凹陷便于该直针剪除或折断。
本发明还提供一种心脏起搏电流提供装置，其特征在于，包括：至少一个心脏起搏电流提供单元和与该心脏起搏电流提供单元连接的心脏起搏器，其中，心脏起搏电流提供单元为上述的心脏起搏电流提供单元。
发明作用与效果
根据本发明提供的心脏起搏电流提供导线，由于该导线的导电芯为人体可降解的镁合金材料、绝缘膜为人体可降解的有机高分子材料，因此该导线在植入体内后可在一定的时间内，由外到内顺序降解：外层的绝缘膜首先降解为无毒的人体正常代谢产物，之后导电芯的镁合金与组织液接触，通过水解反应降解成可溶性的电解质。上述降解产物一部分被人体吸收和利用，另一部分则通过泌尿系统随尿液排出体外。因此降解后体内没有导线的残留物，也不会产生金属伪影，使得患者免除了再次手术取出的必要，减轻了手术给患者造成的精神、身体和经济上的多重负担，具有很强的临床应用价值。
附图说明
图1是本发明的实施例一的心脏起搏电流提供单元的结构示意图；
图2是本发明实施例一的缝针的结构示意图，a是倒刺的示意图，b是缝针与裸露的导电芯通过卡槽连接的放大示意图，c是通过切削加工得到的倒刺示意图，d是通过焊接方法得到的倒刺示意图；
图3是本发明实施例一的由单根镁合金导电芯和绝缘膜构成的心脏起搏电流提供导线的结构剖面图；
图4是本发明的实施例一的锚定方法的示意图，a是缝针穿过心外膜及心肌的示意图，b是回拉导线后倒刺锚定在心外膜的示意图；
图5是本发明的实施例二的三角形块的结构示意图，a是三角形的楔形块示意图，b是后部凹陷的楔形块示意图；
图6为本发明的实施例二中的多根镁合金导丝编织而成的导电芯以及绝缘膜构成的心脏起搏电流提供导线的结构剖面图；以及
图7是本发明的实施例二的锚定方法的示意图，a是三角形块穿过心外膜及心肌的示意图，b是回拉导线后三角形块紧密锚定在心外膜的示意图。
具体实施方式
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，以下实施例结合附图对本发明的可降解心脏起搏导线的结构、原理、使用步骤、技术效果作具体阐述。
实施例一
本实施例提供的心脏起搏电流提供装置，包括两个心脏起搏电流提供单元100和与该心脏起搏电流提供单元连接的心脏起搏器。心脏起搏器置于心脏病患者体外，为患者的心脏提供起搏电流。
本实施例提供的可降解心脏起搏单元100的一端锚定在心外膜上，另一端 与体外的心脏起搏器连接。
图1是本发明的实施例一的心脏起搏电流提供单元的结构示意图。
如图1所示，可降解心脏起搏单元100包括顺次连接的缝针10、心脏起搏电流提供导线20、防脱件30以及连接电极40。
图2是本发明实施例一的缝针的结构示意图，a是倒刺的示意图，b是缝针与裸露的导电芯通过卡槽连接的放大示意图，c是通过切削加工得到的倒刺示意图，d是通过焊接方法得到的倒刺示意图。
如图2(a)、(b)所示，缝针10用以穿过心外膜及心肌组织，位于前端，为半圆形的不锈钢医用缝针，该缝针的尾端具有用于咬合固定的卡槽11，如图2(b)所示。
心脏起搏电流提供导线20，包括导电芯21和包覆导电芯的绝缘膜22。
防脱件30，在本实施例中为倒刺31，如图2(a)所示，倒刺31呈朝向缝针10弯曲的弧形线状。
该裸露的导电芯21和倒刺31采用人体内可降解的镁合金材料制作。
如图2(c)所示，倒刺31是通过刀具切削加工裸露的导电芯21形成的，这样的加工方法比较快捷，适于快速大量的制作。为了保证倒刺的强度，加工的倒刺即图中的凸起条长度为2-10mm，厚度为0.1-1.0mm。
如图2(d)所示，倒刺31也可以是焊接或粘结在裸露的导电芯21上的可降解镁合金丝。
下面结合附图3对导线的具体结构做说明。
图3是本发明实施例一的由单根镁合金导电芯和绝缘膜构成的心脏起搏电流提供导线20的结构剖面图。
心脏起搏电流提供导线20，如图1和3所示，包括人体内可降解的导电芯 21和包覆该导电芯的可降解的绝缘膜22。
导电芯21的材料为人体内可降解的镁合金，该镁合金的质量组成百分比为：锌4.5％，锰0.8％，钙0.8％，锶0.5％，余量为镁96.4％。本实施例中上述裸露的导电芯21、倒刺31的材料相同，两者是同一根镁合金丝。
绝缘膜22为医用级别的聚乳酸PLA和聚二恶烷酮PDS的共聚物，该共聚物将整个导电芯21包覆住。
如图1所示，连接电极40为设置有凹陷41的直针，该直针用于直接扎穿胸壁而露出体外，凹陷41便于该直针剪除或折断。
连接电极40为不锈钢材质，图示的左端和露出绝缘模22的导电芯21连接，右边为尖端。
图4是倒刺固定在心外膜的过程示意图，a是缝针穿过心外膜E及心肌M的示意图，b是回拉导线后倒刺固定在心外膜的示意图。
下面结合附图4对本实施例的导线的使用方法详细介绍如下：
手术使用时，用缝针11引导导线上的倒刺穿过心房或心室的心外膜及心肌组织，如图4(a)所示。然后，将半圆形的不锈钢医用缝针剪掉，再回拉导线使得倒刺31紧密固定在心外膜上而避免滑脱，而无需常规手术中的打结固定，缩短了手术时间，同时减少了对心肌的损伤。
然后，利用连接电极40的尖端引导导线刺尾部穿过胸壁而露出体外，并从凹陷41处折除部分的连接电极40，剩下的部分作为金属电极，与体外的心脏起搏器连接。
在使用时，起搏器发出的起搏脉冲电流通过连接电极40、心脏起搏电流提供导线20和倒刺31进入到心房或心室肌进行起搏。
上述实施例的起搏导线的降解过程如下：
首先，设置在导电芯21外层的绝缘膜具有良好的生物相容性和初始力学性能，在人体内组织液的作用下，它将在设定的时间内发生水解或酶解反应变成二氧化碳和水等无毒的人体正常代谢产物，并随尿液排出体外。当外层包覆导电芯的绝缘膜降解后，金属的导电芯暴露在呈弱酸性(pH为6.7)的组织液中，一方面，镁合金中的各个金属的电位是不同的，会发生电化学降解，使得金属降解为金属离子而溶解于组织液中；另一方面，通过与组织液中的水发生水解反应形成可溶性的电解质。
实施例的作用和有益效果
根据本实施例所提供的心脏起搏电流提供单元100，由于该导线的导电芯材料为人体内可降解的镁合金而绝缘膜是人体内可降解的有机高分子材料，使用后可在一定的时间内，设置在外层的绝缘膜首先降解为无毒的人体正常代谢产物小分子，内芯的镁合金发生水解反应形成可溶性的电解质。而上述降解的有机小分子、金属离子以及可溶性电解质一部分被人体吸收和利用，另一部分则通过泌尿系统随尿液排出体外。因此降解后体内没有导线的残留物，也不会产生金属伪影，使得患者免除了再次手术取出的必要，减轻了手术给患者造成的精神、身体和经济上的多重负担，具有很强的临床应用价值。
进一步地，由于本实施例中的倒刺具有防止滑脱的作用，使用时倒刺在缝针引导下穿过心外膜和心肌组织，回拉导线可使倒刺固定在心外膜上，不仅有效防止导线在心肌组织中脱出，而且在手术过程中无需手工打结固定，缩短了手术时间、减少了对心肌的损伤。
更进一步地，由于连接电极为设置有环形凹陷的直针，这样便于在刺穿胸壁而露出体外后从凹陷处折除直针，其尾端可以直接与体外心脏起搏器的正极或负极相连，进一步方便了医生手术时的操作，缩短了手术时间。
实施例二
本实施例中，和实施例一中相同的结构给予相同的编号。
图5是本发明的实施例二的三角形块的结构示意图，a是三角形的楔形块示意图，b是后部凹陷的楔形块示意图。
图6为本发明的实施例二中的多根镁合金导丝编织而成的导电芯以及绝缘膜构成的心脏起搏电流提供导线的结构剖面图。
本实施例提供一种使用三角形块32对应的代替实施例一中的倒刺31，使用三根镁合金丝编织而成的导电芯21’来代替实施例中单根镁合金丝导电芯21的导线。
如图5所示，缝针10’与裸露的导电芯21和设置在该段导电芯21上的朝向缝针10’方向逐渐缩小的三角形块32。该裸露的导电芯21’采用人体内可降解的镁合金材料制作。该镁合金的质量组成百分比为：锌5.5％，锰1.2％，钙1.2％，锶2％，余量为镁90.1％。而三角形块32的材料也是可降解材料，和绝缘膜的材料相同。
三角形块32围绕裸露的导电芯21设置，尖端朝向缝针缝针10’。如图5(a)和(b)所示，该三角形块可以为如图(a)所示的三角形块或是图(b)所示的后部有凹陷的三角形块。
如图6所示，导电芯21’由三根和裸露的导电芯21同样成分的镁合金丝编织或绞合而成。
绝缘膜22’为医用级别的聚乳酸PLA和聚羟基乙酸PGA的共聚物，该共聚物将整个导电芯21’包覆住。
图7是本发明的实施例二的锚定方法的示意图，a是三角形块穿过心外膜及 心肌的示意图，b是回拉导线后三角形块紧密锚定在心外膜的示意图。
如图7(a)、(b)所示，在缝针缝针10’引导裸露的导电芯21’穿过心肌M和心外膜E后，三角形块32固定在心外膜上，从而免于常规手术中的打结固定。
实施例的作用和有益效果
根据本实施例所示提供的心脏起搏电流提供单元，由于本实施例中缝针上的三角形块具有防脱作用，在手术过程中无需打结固定，缩短手术时间，减少对心肌的损伤。
更进一步地，由于导电芯为三根合金丝的编织结构，强度更高。

Claims (10)

  1. 一种心脏起搏电流提供导线，其一端固定在心外膜及心肌组织上，另一端与置于心脏病患者体外的心脏起搏器相连接为所述患者的心脏提供起搏电流，其特征在于，包括：
    导电芯；
    绝缘膜，包覆所述导电芯，
    其中，所述导电芯由镁合金制成，该镁合金的质量组成百分比为：锌4.5-5.5％，锰0.8-1.2％，钙0.8-1.2％，余量为镁，
    所述绝缘膜由聚乳酸(PLA)、聚羟基乙酸(PGA)、聚已内酯(PCL)、聚二恶烷酮(PDS)、聚羟基脂肪酸酯(PHA)中的任意一种或上述至少两种的共聚物制成。
  2. 根据权利要求1所述的心脏起搏电流提供导线，其特征在于：
    其中，所述导电芯为单根的镁合金丝或由多根镁合金丝编织形成。
  3. 一种心脏起搏电流提供单元，为患者的心脏提供起搏电流，其特征在于，包括：
    导线；
    缝针，设置在所述导线的一端，用于穿过心脏心肌而将所述导线固定在心外膜及心肌组织上；以及
    连接电极，设置在所述导线的另一端，和所述心脏起搏器相连，
    其中，所述导线为权利要求1-2中任意一种所述的心脏起搏电流 提供导线。
  4. 根据权利要求3所述的心脏起搏电流提供单元，其特征在于，还包括：
    防脱件，设置在所述导线上与所述缝针相连接的一端的端部，该防脱件的材料与所述绝缘膜或所述导电芯的材料相同，
    在所述防脱件引导所述导电芯穿过心外膜及心肌后，回拉所述导线可使所述防脱件紧密锚定在心外膜上而避免滑脱。
  5. 根据权利要求3所述的心脏起搏电流提供单元，其特征在于：
    其中，所述防脱件为倒刺或朝向所述缝针方向逐渐缩小的三角形块。
  6. 根据权利要求5所述的心脏起搏电流提供单元，其特征在于：
    其中，所述倒刺为柔性的凸起条，该凸起条通过劈削所述直线段部分形成或被焊接、粘结在所述导电芯上，长度为2-10mm，厚度为0.1-1mm。
  7. 根据权利要求5所述的心脏起搏电流提供单元，其特征在于：
    其中，所述倒刺通过切削所述导电芯形成，或采用与所述导电芯相同的镁合金材料加工而成然后焊接或粘合在所述导电芯上。
  8. 根据权利要求4所述的心脏起搏电流提供单元，其特征在于：
    其中，所述缝针为呈半圆形的缝针，且其尾端具有咬合固定所述导电芯的卡槽，
    所述倒刺为朝向所述缝针弯曲的弧形倒刺。
  9. 根据权利要求3所述的心脏起搏电流提供单元，其特征在于：
    其中，所述连接电极为设置有凹陷的直针，该直针用于直接扎穿胸壁而露出体外，所述凹陷便于该直针剪除或折断。
  10. 一种心脏起搏电流提供装置，其特征在于，包括：
    至少一个心脏起搏电流提供单元和与该心脏起搏电流提供单元连接的心脏起搏器，
    其中，所述心脏起搏电流提供单元为权利要求3-9中任意一项所述的心脏起搏电流提供单元。
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