[go: up one dir, main page]

WO2000018470A1 - A fast bedside temporary pacemaker and method of using it - Google Patents

A fast bedside temporary pacemaker and method of using it Download PDF

Info

Publication number
WO2000018470A1
WO2000018470A1 PCT/CN1999/000151 CN9900151W WO0018470A1 WO 2000018470 A1 WO2000018470 A1 WO 2000018470A1 CN 9900151 W CN9900151 W CN 9900151W WO 0018470 A1 WO0018470 A1 WO 0018470A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaped
pole
electrode
distal end
sheath
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN1999/000151
Other languages
French (fr)
Chinese (zh)
Inventor
Kunshen Liu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to AU57262/99A priority Critical patent/AU5726299A/en
Publication of WO2000018470A1 publication Critical patent/WO2000018470A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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

Definitions

  • the present invention relates to a medical device, and more particularly to a device for rapid bedside temporary cardiac pacing without X-ray guidance and a method of using the same.
  • Temporary cardiac pacing is an emergency treatment technique for critical illnesses such as severe sinus bradycardia, sinus atrial block, sinus arrest, atrioventricular block, ventricular arrest, etc. These conditions can be seen in acute myocarditis, cardiomyopathy, myocardial infarction, drug poisoning or improper application.
  • the concept of temporary cardiac pacing means that the pacemaker itself is placed outside the body, and only the pacing electrode catheter is inserted into the heart cavity through the vein to make contact with the endocardium; or in vitro non-invasive cardiac pacing, the pacing pulse generator and electrode pads are placed Non-invasive cardiac pacing in vitro, such as Zoll's. At present, there are many methods and approaches for temporary cardiac pacing.
  • transendocardial pacing and non-invasive non-invasive cardiac pacing are the most versatile, reliable, and widely accepted methods.
  • the advantages of Zo l l non-invasive cardiac pacing in vitro are simple, non-invasive, easy to learn, and can be used for pacing after the electrode pads are attached to critically ill patients. Therefore, it is suitable for universal application.
  • this method can not be tolerated in awake patients, and some patients are not effective. It is only applicable to patients who are critically ill and can only maintain a short pacing time.
  • Transvenous endocardial pacing is a widely accepted method of pacing by doctors and patients. Pacing therapy can be maintained for a long time. The effect is reliable and widely accepted.
  • Patients can carry an external pacemaker around the ward.
  • the electrode catheter displacement rate in the method is high, and the incidence of ventricular perforation is about 5%-8%.
  • the infection and pulmonary embolism are higher than the supraclavicular approach when the femoral vein approach is used.
  • Transvenous endocardial pacing without X-ray guidance is difficult, especially when using the femoral vein approach.
  • Atrioventricular double-chamber physiological temporary cardiac pacing usually uses two electrode catheters of the atrium and ventricle, which are completed under the guidance of X-rays. The operation steps are cumbersome and require skilled techniques. Atrioventricular dual-chamber physiological cardiac pacing using a single electrode catheter has emerged, but the pacing function is limited to
  • the purpose of the present invention is to overcome the above-mentioned shortcomings and deficiencies of the prior art, and to provide a double-chamber physiological temporary cardiac lift device that is simple, safe, and reliable, and can be quickly completed by the bed without X-ray guidance. Instructions.
  • a rapid bedside temporary cardiac pacing device which includes: a T-shaped introduction sheath 1 and a prosthetic catheter 2 inserted into the inner channel 51 of the J-shaped introduction sheath 1 And quadrupole elastic soft electrode 4,
  • the J-shaped introduction sheath 1 has a circular tube shape, and has a distal end 5, a body part 10, and a proximal end 8, and a hemostatic valve 9 is installed in the inner hole of the proximal end 8, and the distal end of the J-shaped introduction sheath 5 has a J-shaped elbow section 6,
  • the inner channel 51 is the insertion channel of the prosthetic catheter 2 and the quadrupole elastic soft electrode 4, the prosthetic catheter 2 can be inserted into the J-shaped introduction sheath 1; it has a softer tube body
  • the quadrupole elastic soft electrode 4 of 41 has a straight circular tube shape, which is soft as a whole, and has a distal end 23, a body portion 41 and a proximal end
  • the cable binding block 34 is connected with a cable plug 33 that is connected to an external double-chamber temporary pacemaker.
  • the steel wire 20 is inserted into the central cavity 24, and the J-shaped plastic wire is ready for use.
  • the central cavity 24 has an insertion hole at the proximal end and no exit hole at the distal end.
  • the distal end 5 of the tubular J-shaped introduction sheath is blunt and smooth, and the long axis of the distal end of the J-shaped elbow of the J-shaped introduction sheath 1 is connected to the long axis of the J-shaped introduction sheath body, forming an arc angle of 120 °-160 °, Its purpose When the J-shaped elbow is introduced into the high right atrium through the right superior clavicle vein, it will not damage the blood vessels and myocardium. When the J-shaped elbow is twisted in vitro to point to the tricuspid valve, it can be inserted into its internal channel 51 The distal electrode 23 of the quadrupole flexible soft electrode 4 is directly introduced into the right ventricle for pacing.
  • the J-shaped introduction sheath 1 made of plastic is marked with a length mark 101 for reference during insertion, and the proximal end 8 of the J-shaped introduction sheath is marked with a direction mark 102 pointed by the J-shaped elbow.
  • a length mark 101 for reference during insertion
  • the proximal end 8 of the J-shaped introduction sheath is marked with a direction mark 102 pointed by the J-shaped elbow.
  • the proximal end of the J-shaped introducer sheath is equipped with a hemostatic valve 9 in the inner hole.
  • the hemostatic valve is an elastic valve.
  • the central hole allows the four-pole flexible soft electrode 4 and the prosthetic catheter 1 to pass. When it is removed, the central hole of the hemostatic valve 9 is closed. , It plays a role in stopping bleeding and preventing air from entering the blood circulation.
  • the tubular body catheter 2 is a straight round tube, the distal end 12 is blunt and smooth, the tube body portion 11 is soft, and the proximal end 15 is provided with an inner hole 14 inserted into a syringe or a guide wire, and the center of the inner hole is a central cavity 13 Into the hole, the central cavity 13 can be guided by a guide wire from the proximal end to the distal end; the prosthesis catheter is suitable for fitting in the inner channel 51 of the J-shaped introduction sheath 1, and the distal end 12 of the prosthesis catheter 2 can be introduced into the distal end of the sheath 1 from the J-shape.
  • the end 5 protrudes, the purpose of which is that the prosthetic catheter 1 can fill the space in the inner channel 51 of the J-shaped introduction sheath 1, and the distal end 12 of the prosthetic catheter 2 is blunt to prevent damage to the vessel wall and myocardium during insertion.
  • the distal end 23 of the quadrupole flexible soft electrode 4 is the cathode 23, and the second pole 26 is adjacent to the cathode 23 for ventricular pacing; the third pole 27 and the fourth pole 28 are adjacent to the atrial pacing and are located far from the distal end. 23 distance is within the range of 10-20cm.
  • the four-pole elastic soft electrode 4 has the above-mentioned coaxial double-layered spiral coil structure, and there is an insulating layer 25 between the coaxial double-layered spiral coils.
  • the inner coil layer 22 forms a central cavity 24, and is connected to the distal cathode.
  • the outer coil layer 32 is composed of three insulated guide wires 29, 30, 31, and the three insulated guide wires are respectively connected to the second pole 26 , the third pole, and the fourth pole 28;
  • the second pole 26, the third pole 27 and the fourth electrode 28 is a ring electrode, the insulating outer coil layer of wire wrapped around the insulating layer parallel to each other, isolated from each other, the first insulating section wire 29 connected to the second electrode 26, ring electrode and the third electrode 27, Pass under 4 poles 28;
  • the second insulated guide wire 30 is connected to the third pole 27 and pass under the ring electrode 4 pole 28;
  • the ring electrodes 27 and 28 are insulated from the guide wire passing under them;
  • the outer coil layer 32 is external
  • the sheath 36 is covered, and the outer sheath protrudes to form a toothed fixed wing 35 near the distal cathode 23.
  • the outer sheath layer 36 is made of a biocompatible material such as silicone rubber, polyurethane or other suitable plastic. Insulating layer 25 and toothed fixed wings 35; Four-pole flexible soft electrode has four tail cables 33, which are respectively connected to the inner coil layer and the distal cathode 23 and the outer coil layer 2nd, 3rd, 4th, and 4 cables Extends from the proximal cable collection block 34, and connects to the two-chamber temporary pacemaker. Wire end.
  • the four-pole flexible soft electrode 4 body 41 is marked with a length mark 41 for accurate positioning and reference during insertion.
  • the purpose is to accurately estimate the positions of the distal electrode 23, the third pole 27, and the fourth pole 28 during the insertion process.
  • the distal end 23 of the quadrupole flexible soft electrode 4 has a toothed fixed wing 35, the purpose of which is to enable the distal end 23 of the electrode to be anchored in the myocardial trabeculae to prevent electrode displacement.
  • the quadrupole flexible soft electrode 1 is provided with a straight shaped steel wire 20, which is slightly shorter than the axial length of the mated central cavity 24. The purpose is to enable the distal end of the quadrupole flexible soft electrode 1 to be inserted into the ventricle. Keep the soft end without damaging the myocardium.
  • the four-pole flexible soft electrode 1 is equipped with J-shaped plastic wire 21, the distal end of the J-shaped plastic wire is a J-shaped elbow section, and the distal end of the J-shaped elbow is a soft end.
  • the purpose is to make the J-shaped elbow easily inserted into the center Cavity 24, and does not damage the inner coil layer 22; a mildly curved curve section near the proximal end of the J-shaped elbow section is intended to adapt to the anatomically curved curve of the venous access, which is beneficial to the third electrode Pole and 4th pole abut the right atrium wall.
  • a method for using a rapid bedside temporary cardiac pacing device is characterized in that: The right internal jugular vein or right subclavian vein is punctured from the right supraclavicular route, and the guide wire is sent from the venous approach after puncturing. The venous approach is widened with a thick dilator, and then it is withdrawn.
  • the characteristics are: The J-shaped guide sheath with the prosthetic catheter is inserted along the guide wire until the distal J-shaped elbow section of the J-shaped introducer sheath is introduced into the entrance of the high right superior atrial vena cava, and then the prosthetic catheter is removed together with the guide wire.
  • the invention adopts a J-shaped introduction sheath to introduce an electrode catheter, which can quickly, simply, safely and reliably complete bedside emergency ventricular pacing at the bedside or the scene of the disease without X-ray guidance, which is very useful for the rescue of critically ill patients;
  • the present invention adopts a quadrupole flexible soft electrode, which can prevent electrode displacement and prevent myocardial and vascular damage; meanwhile, a dual-chamber physiological temporary cardiac pacing can be quickly, simply, safely, and reliably realized at the bedside or at the scene of the disease. Salvage of critically ill patients and preventive cardiac pacing are very useful.
  • the invention is suitable for popularization because of its simplicity and ease of learning.
  • the present invention adopts a ⁇ -shaped introduction sheath with a J-shaped elbow section at its distal end.
  • the J-shaped elbow is not made at the distal end of the catheter, but at the distal end of the J-shaped introducer sheath. Therefore, the electrode of the present invention does not need to be J-shaped at the distal end.
  • the straight electrode leaves the J-shaped introduction sheath and the distal end will directly point to the three
  • the cuspid valve is easily accessible to the apex of the right ventricle (see Figure 1).
  • the venous approach selected by the present invention conforms to the shortest and straightest path from the tricuspid valve port and the right ventricular apex. Therefore, the standard-compliant approach is only the superior supraclavicular vein approach. Therefore, the J-shaped introduction sheath must have a certain hardness and Elastic and able to withstand blood temperature Keep the original shape, can twist outside the body and point to the front left 45 of the body. Pointing to the tricuspid valve. In order to cooperate with the use of this set of instruments, the puncture method we used is: The venous approach of the J-shaped introducer sheath is inserted by venipuncture and widened with a dilator.
  • the supraclavicular vein puncture was performed using the Yof fa method to puncture the right subclavian vein or the Jernigan method to puncture the right internal jugular vein.
  • the anatomical relationship of this approach is shown in Figures 1 and 2.
  • the right internal jugular vein and the right subclavian vein merge into an innominate vein, and the intersection point forms a vein angle.
  • the puncture point, the venous angle, the superior vena cava, and the right atrium wall form an arc that curves toward the right side of the body.
  • the tricuspid valve and right ventricle are located just to the left anterior side of the entrance to the superior superior atrial vena cava.
  • the long axis of the tricuspid valve and right ventricle is approximately 1 35 ° from the long axis of the superior vena cava.
  • the puncture needle uses a fixed puncture direction, that is, 45 ° inward from the sagittal plane and 15 ° forward from the coronal plane.
  • Hepatic nerve Yof fa method
  • the Jernigan method is similar when puncturing the internal jugular vein.
  • the internal jugular vein is just outside the internal carotid artery below the neck.
  • the needle is inserted behind the sternocleidomastoid muscle bundle.
  • the puncture needle must first enter the internal jugular vein. There is also only cervical fascia in the pathway. This is the basis for ensuring the safe operation of this law.
  • subclavian artery injury, hemothorax, pneumothorax, and phrenic nerve injury can be avoided.
  • the insertion depth of the J-shaped introduction sheath should be 1/10 of the patient's length, and then the J-shaped elbow of the J-shaped introduction sheath is twisted outside the body to point to the tricuspid valve, which is the same as the sagittal plane. 45 ° angle, pointing to the front left of the body.
  • this specially made straight pacing electrode can be inserted into the right ventricle through a J-shaped introducer sheath ( Figure 1).
  • Special four-pole flexible soft electrode with fixed wings near the distal end. Its purpose is to improve the fixing performance of the electrode and prevent myocardial damage and perforation.
  • the electrode becomes straight and helps The J-shaped sheath is inserted directly into the right ventricular apex.
  • the electrode becomes soft, which can prevent the electrode from damaging the myocardium.
  • the quadrupole flexible soft electrode is designed to sense and pace the atrial and ventricular dual heart chambers in order to obtain dual-chamber physiological cardiac pacing without X-ray guidance at the bedside.
  • a straight shaped wire is inserted into its central cavity It can be inserted through a J-shaped sheath and directly into the right ventricle for pacing.
  • a J-shaped shaped wire can be used at the distal end.
  • the 3rd and 4th poles of the electrode can be pressed to the right atrium side wall, and the atrioventricular dual-chamber physiological cardiac pacing and sensing can occur immediately.
  • FIG. 1 is a schematic diagram of an approach of inserting a J-shaped introduction sheath and an electrode according to the present invention
  • FIG. 2 is a schematic diagram of a single-electrode atrioventricular dual-chamber physiological cardiac pacing
  • FIG. 3 is a plan view of a J-shaped introduction sheath of the present invention.
  • FIG. 4 is an enlarged perspective view of a J-shaped introduction sheath of the present invention.
  • FIG. 5 is a sectional view of a J-shaped introduction sheath structure of the present invention.
  • FIG. 6 is a cross-sectional view of a J-shaped introduction sheath of the present invention.
  • FIG. 7 is an external view of a prosthesis catheter of the present invention.
  • FIG. 8 is a cross-sectional view of the internal structure of the prosthesis catheter of the present invention.
  • FIG. 9 is a plan view of a J-shaped introducer according to the present invention.
  • the J-shaped introducer is formed by assembling a J-shaped introducer sheath and a prosthetic catheter together;
  • FIG. 10 is an external perspective view of a coarse dilator of the present invention.
  • FIG. 11 is an external view of a quadrupole flexible soft electrode according to the present invention.
  • FIG. 12 is an internal structure diagram of a quadrupole elastic soft electrode according to the present invention.
  • FIG. 13 is a cross-sectional view of the internal structure of a quadrupole flexible soft electrode according to the present invention.
  • Fig. 14 is an external view of a J-shaped plastic wire according to the present invention.
  • the curved money between arrows A and B in Figure 1 that is, the curve from the puncture point to the side wall of the right atrium, is an arc that spreads to the right side of the patient's body.
  • This curve shows an approach in which the guide wire and the J-shaped introduction sheath 1 are inserted.
  • the curve between arrow A and arrow C shows the J-shaped elbow 6 turns of the J-shaped introduction sheath 1 Direction and the way to insert the electrode.
  • the J-shaped elbow 6 shaped into the sheath 1 is introduced into the upper cavity static entrance of the high right atrium, and then twisted to point to the right ventricle and the tricuspid valve.
  • the long axis of the right ventricle and the tricuspid valve is 45 to the sagittal plane.
  • Arrow D and dot indicate the puncture direction and puncture point of Jernigan's method.
  • the curve between arrow D and arrow B is similar to the curve between arrow A and arrow B, which indicates that the guide wire is inserted when the internal jugular vein is punctured by Jernigan's method and: [the approach when introduced into sheath 1.
  • Figure 2 shows that the electrode was inserted through the right supraclavicular approach, and the distal end of the electrode was anchored at the right ventricular apex.
  • the third and fourth poles 27 and 28 of the electrode were pressed toward the high right atrium wall.
  • FIGS 3 to 6 are illustrations of the J-shaped introduction sheath, which can introduce the electrode from the outside into the right ventricular apex, and its distal end 5 has a: [formed by the long axis of the distal end of the elbow and the long axis of the J-shaped introduction sheath 120 °-160 ° J-shaped elbow section 6 with curved corners.
  • the distal end 5 is round and blunt, and the side view is slightly oblique.
  • the proximal end 8 has a V-shaped handle 7. In the central cavity of the proximal end 8, there is a sleeve-type hemostatic valve 9 for hemostasis and preventing air from entering.
  • the J-shaped introducer sheath was then peeled from the electrode.
  • the J-shaped introduction sheath has an inner diameter of 6 to 8Fr and an outer diameter of 8 to 12Fr. It is 5cm from the distal end and is marked with a length mark 101.
  • Proximal end 8 should be marked with a J-bend pointing 102.
  • the J-shaped introducer sheath should be stiff and flexible, and made of polyethylene or other plastic suitable for the body.
  • FIG. 7 and FIG. 8 are diagrams of the prosthetic catheter 2.
  • the prosthetic catheter 2 is suitable for being filled in the channel 51 inside the J-shaped introduction sheath 1 to fill the space. It has a softer body 11, a blunt and rounded distal end I 2 that when inserted into the J-shaped introducer sheath, it protrudes from the distal end 5 of the helical introducer sheath 3 to 5 cm.
  • the prosthesis catheter has a central lumen 13 for inserting a guide wire, and a proximal end 15 having an inner port 14 for connecting a syringe or introducing a guide wire.
  • the prosthetic catheter is adapted to be inserted into a J-shaped intrathecal channel 51.
  • FIG. 10 is a schematic diagram of a coarse dilator. It is used to widen the venous approach of the J-shaped introducer sheath 1, and its outer diameter is slightly larger than the outer diameter of the J-shaped introducer sheath 1.
  • the proximal end 17 has a handle 16 attached to the syringe, the central lumen 18 can be fed with a guide wire, and the distal end 19 is tapered and tapered for widening the access to the vein.
  • Figures 11 to 13 are diagrams of the four-pole elastic soft electrode 4, which is provided with a straight shaped steel wire 20 inserted in its central cavity 24, and a JT shaped shaped steel wire 21 is ready for use. It has a coaxial double coil structure. It has an inner spring coil layer 22 whose wires are connected to the distal cathode 23. The coil 22 surrounds the central cavity 24 and can be inserted into the shaped wire 20. The inner coil layer 22 is covered by an insulating layer 25 made of silicone rubber, polyurethane, or other body-friendly plastic.
  • the second pole 26, the third pole 27, and the fourth pole 28 are ring electrodes, which are respectively connected to the guide wires 29, 30, and 31 of the outer insulation layer.
  • the insulating guide wires 29, 30, 31 are wound in parallel and isolated from each other around the insulating layer 25 to form an outer coil layer 32.
  • the guide wire 29 is connected to the second pole 26 and passes under the third pole 27 and the fourth pole 28.
  • the guide wire 30 is connected to the third pole 27 and passes under the fourth pole 28.
  • the ring electrode is connected to the guide wires 29 and 30 passing below. insulation.
  • the distal cathode 23 is close to the second pole 26; the third pole 27 and the fourth pole 28 are close to each other and within a range of 10 to 20 cm from the far end.
  • Four tail cables 33 are branched from the cable connection block 34 and are connected to the four connectors of the external double-chamber temporary pacemaker.
  • the outer sheath protrudes near the distal cathode 23 to form a small toothed fixed wing 35.
  • the electrode is provided with a length mark at a fixed position away from the distal end 23 to facilitate the insertion of the electrode.
  • the J-shaped plastic wire 2 1 is a J-shaped elbow at the distal end and a soft end 211 at the distal end of the J-shaped elbow to facilitate insertion into the central cavity. Inside, near the J-shaped elbow section is an arc-shaped lightly curved section consistent with the direction of the J-shaped elbow.
  • the specific operation method and implementation process of the present invention are as follows: the patient is to lie flat, without a pillow or placing a small pillow between 7 and 8 cm in height between the scapula.
  • the jugular vein pressure of the patient is low, the head is lowered and the foot is high. Identify its location.
  • this part is not clear, put your hand on the patient's forehead and ask her to resist neck flexion, which can expose the sternocleidomastoid muscle angle. The area is clean and draped.
  • the center of the sag at 1 cm below the angle of the sternocleidomastoid muscle is the puncture point, where a local anesthesia is made, and a small skin incision is made with a Noll blade to cut through the skin and subcutaneous tissue.
  • the syringe syringe When the dark red blood was sucked into the syringe, the syringe syringe was removed, and a drop of blood dripped out, indicating that the puncture needle has entered the subclavian vein, and the average penetration depth of the puncture needle is about 2 to 4 cm.
  • the J-end of the guide wire is fed into about 30 cm through the puncture needle, and the wire is pulled back and forth. If there is no resistance, it indicates that it has entered the central venous system.
  • the thick dilator is inserted along the guide wire to widen the venous approach.
  • the coarse dilator is removed, the J-shaped sheath is inserted into the prosthetic catheter, and the guide wire is inserted along the guide.
  • the distal elbow of the J-shaped introducer sheath should continue to point to the right side of the body until: The T-elbow reaches the entrance of the high right superior atrial vena cava. Insert the J-shaped sheath into the patient's length 1
  • the prosthetic catheter is then removed along with the guide wire.
  • J-shaped introduction sheath The r-shaped elbow is twisted outside the body and points to the front left 45 of the patient's body. Pointing to the tricuspid valve.
  • the external dual-chamber pacemaker has been preset in the VV1 (or DDD) pacing state: that is, the ventricular stimulation amplitude is 3V, the pacing heart rate is greater than the patient's own ventricular rate, 20 bpm, and the sensitivity is 3 to 5 mv.
  • the quadrupole flexible soft electrode cable has been connected to the dual-chamber pacemaker and inserted from the J-shaped lead into the sheath until the continuous right ventricular cardiac pacing wave group appears on the ECG monitor screen.
  • the electrode insertion depth should generally be within the range of 1/10 + 10-15 cm of the patient's length. If the insertion length is less than this length, there should be a clear anchoring feeling. If the pacing parameters are determined to be acceptable, the pacing site can be accepted. .
  • the AV delay is 150 ms
  • the atrial sensory sensitivity is 0.1-0.5 mv
  • the atrial stimulation amplitude is 3 V.
  • Atrioventricular double-chamber pacing steps are summarized as follows (continued from Article 5)

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (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

A fast bedside temporary pacemaker and method of using it are disclosed, the pacemaker comprising a J-shape lead-in sheath and a false body conduit and four elastic soft electrodes which are matched with an inner passage inside the lead-in sheath, the J-shape lead-in sheath having a J-shape elbow section at the far end and a wire combining section at the electrode near end having a central cavity into which elastic wire can be plugged.

Description

一种快速床边临时心脏起搏装置及其使用方法 所属领域 本发明涉及一种医疗器械, 特别是一种在无 X线指引下用于快速床 边临时心脏起搏的装置及其使用方法。  FIELD OF THE INVENTION The present invention relates to a medical device, and more particularly to a device for rapid bedside temporary cardiac pacing without X-ray guidance and a method of using the same.

背景技术 Background technique

临时心脏起搏是对诸如下列危重急症的急诊处理技术, 例如重度窦 性心动过緩, 窦房阻滞、 窦性停搏、 房室传导阻滞、 心室停搏等。 这些 情况可见于急性心肌炎、 心肌病、 心肌梗塞、 药物中毒或应用失当等。 临时心脏起搏的概念是指起搏器本身置于体外, 仅仅起搏电极导管经静 脉插入心腔与心内膜接触; 或者采用体外无创心脏起搏, 起搏脉沖发生 器和电极片均置于体外, 例如 Zo l l氏体外无创心脏起搏。 目前, 临时心 脏起搏有许多方法和入路。 其中, 经静脉心内膜起搏和 Zo l l氏体外无创 心脏起搏是最通用、 可靠和广为接受的方法。 Zo l l氏体外无创心脏起搏 的优点为简单、 无创、 易学、 可在危重患者贴好电极片后待用起搏。 因 此, 适合普及应用。 然而, 该方法在清醒患者不能耐受, 部分患者无效, 仅适用于垂危卧床的病人, 并且只能维持起搏较短的时间。 而经静脉心 内膜起搏是医患广为接受的起搏方法, 起搏治疗可以维持较长时间, 疗 效可靠并广为接受, 病人可随身携带体外起搏器在病房周围活动, 但该 方法中的电极导管移位率较高, 心室穿孔发生率大约 5 % - 8 % , 感染和 肺动脉栓塞在采用股静脉途径时高于锁骨上途径。 无 X线指引下经静脉 心内膜起搏是困难的, 尤其在采用股静脉途径时更加困难。  Temporary cardiac pacing is an emergency treatment technique for critical illnesses such as severe sinus bradycardia, sinus atrial block, sinus arrest, atrioventricular block, ventricular arrest, etc. These conditions can be seen in acute myocarditis, cardiomyopathy, myocardial infarction, drug poisoning or improper application. The concept of temporary cardiac pacing means that the pacemaker itself is placed outside the body, and only the pacing electrode catheter is inserted into the heart cavity through the vein to make contact with the endocardium; or in vitro non-invasive cardiac pacing, the pacing pulse generator and electrode pads are placed Non-invasive cardiac pacing in vitro, such as Zoll's. At present, there are many methods and approaches for temporary cardiac pacing. Among them, transendocardial pacing and non-invasive non-invasive cardiac pacing are the most versatile, reliable, and widely accepted methods. The advantages of Zo l l non-invasive cardiac pacing in vitro are simple, non-invasive, easy to learn, and can be used for pacing after the electrode pads are attached to critically ill patients. Therefore, it is suitable for universal application. However, this method can not be tolerated in awake patients, and some patients are not effective. It is only applicable to patients who are critically ill and can only maintain a short pacing time. Transvenous endocardial pacing is a widely accepted method of pacing by doctors and patients. Pacing therapy can be maintained for a long time. The effect is reliable and widely accepted. Patients can carry an external pacemaker around the ward. The electrode catheter displacement rate in the method is high, and the incidence of ventricular perforation is about 5%-8%. The infection and pulmonary embolism are higher than the supraclavicular approach when the femoral vein approach is used. Transvenous endocardial pacing without X-ray guidance is difficult, especially when using the femoral vein approach.

目前, 所有紧急临时心脏起搏方法和入路均有缺陷。 插入标准起搏 电极导管进行经静脉临时心脏起搏, 在大多数情况下需要娴熟的导管操 作技术和 X线显象指向。 经胸壁穿刺心肌或心内膜起搏是危险的、 疗效 不可靠。 漂浮电极导管心脏起搏疗效同样不可靠, 为了进入耙心腔, 需 要顶端附有气囊的电极导管和压力监测设备, 或记录单极心内膜心电图 指引。 Currently, all emergency temporary cardiac pacing methods and approaches are flawed. Insert a standard pacing electrode catheter for transvenous temporary cardiac pacing, and in most cases requires skilled catheterization Pointing technique and X-ray imaging. Transthoracic puncture of the myocardium or endocardium is dangerous and unreliable. The effect of floating electrode catheter for cardiac pacing is also unreliable. In order to access the heart cavity, an electrode catheter with a balloon attached to the top and a pressure monitoring device are needed, or a unipolar endocardial ECG guide is recorded.

房室双腔生理性临时心脏起搏, 通常采用心房心室两根电极导管, 在 X线指引下操作完成, 操作步骤烦瑣, 并且需要娴熟的技术。 采用单 支电极导管进行房室双腔生理性心脏起搏虽已出现, 但起搏功能仅限于 Atrioventricular double-chamber physiological temporary cardiac pacing usually uses two electrode catheters of the atrium and ventricle, which are completed under the guidance of X-rays. The operation steps are cumbersome and require skilled techniques. Atrioventricular dual-chamber physiological cardiac pacing using a single electrode catheter has emerged, but the pacing function is limited to

VDD, 实际的 DDD功能并未实现。 VDD, the actual DDD function is not implemented.

发明内容 Summary of the Invention

本发明的目的就在于克服现有技术的上述缺点和不足, 而提供一种 操作简单、 安全可靠、 无需 X线指引即可在床边快速完成的房室双腔生 理性临时心脏起装置及其使用方法。  The purpose of the present invention is to overcome the above-mentioned shortcomings and deficiencies of the prior art, and to provide a double-chamber physiological temporary cardiac lift device that is simple, safe, and reliable, and can be quickly completed by the bed without X-ray guidance. Instructions.

本发明的目的是通过下面的技术方案实现的: 一种快速床边临时心 脏起搏装置, 它有: T形导入鞘 1和与 J形导入鞘 1内通道 51相插配的假体导 管 2和四极弹性软电极 4 , J形导入鞘 1呈圓管状, 具有远端 5、 体部 10和 近端 8 , 近端 8的内孔中装有止血阀 9, J形导入鞘的远端 5有一 J形弯头段 6, 内通道 51为假体导管 2和四极弹性软电极 4的插入通道, 假体导管 2可 插配在 J形导入鞘 1内; 具有较软的管体部 41的四极弹性软电极 4呈直形 圓管状, 整体柔软, 具有远端 23, 体部 41和近端 34; 其轴向全长设有插 装塑形钢丝的中心孔腔 24 , 四极弹性软电极 4的远端为阴极 23 , 近端附 有电缆结合块 34 , 电缆结合块 34上连引有与体外双腔临时心脏起搏器相 插接的电缆插头 33, 直形塑形钢丝 20插配在中心孔腔 24中, J形塑形钢 丝备而待用, 中心孔腔 24在近端有插入孔, 远端无出孔。 The object of the present invention is achieved by the following technical solution: A rapid bedside temporary cardiac pacing device, which includes: a T-shaped introduction sheath 1 and a prosthetic catheter 2 inserted into the inner channel 51 of the J-shaped introduction sheath 1 And quadrupole elastic soft electrode 4, the J-shaped introduction sheath 1 has a circular tube shape, and has a distal end 5, a body part 10, and a proximal end 8, and a hemostatic valve 9 is installed in the inner hole of the proximal end 8, and the distal end of the J-shaped introduction sheath 5 has a J-shaped elbow section 6, the inner channel 51 is the insertion channel of the prosthetic catheter 2 and the quadrupole elastic soft electrode 4, the prosthetic catheter 2 can be inserted into the J-shaped introduction sheath 1; it has a softer tube body The quadrupole elastic soft electrode 4 of 41 has a straight circular tube shape, which is soft as a whole, and has a distal end 23, a body portion 41 and a proximal end 3 4 ; The distal end of the extremely flexible soft electrode 4 is the cathode 23, and a cable binding block 34 is attached at the proximal end. The cable binding block 34 is connected with a cable plug 33 that is connected to an external double-chamber temporary pacemaker. The steel wire 20 is inserted into the central cavity 24, and the J-shaped plastic wire is ready for use. The central cavity 24 has an insertion hole at the proximal end and no exit hole at the distal end.

管状 J形导入鞘的远端 5为钝而圓滑状, J"形导入鞘 1的 J形弯头 远端长轴与 ; [形导入鞘体部长轴形成 120° - 160° 的弧形角, 其目的 是将 J 形弯头段由右锁骨上静脉途径导入高右房时, 不会损伤血管和 心肌, J 形弯头在体外被扭动指向三尖瓣时, 可将在其内通道 51 内插 入的四极弹性软电极 4远端电极 23, 直接导入右心室起搏。 The distal end 5 of the tubular J-shaped introduction sheath is blunt and smooth, and the long axis of the distal end of the J-shaped elbow of the J-shaped introduction sheath 1 is connected to the long axis of the J-shaped introduction sheath body, forming an arc angle of 120 °-160 °, Its purpose When the J-shaped elbow is introduced into the high right atrium through the right superior clavicle vein, it will not damage the blood vessels and myocardium. When the J-shaped elbow is twisted in vitro to point to the tricuspid valve, it can be inserted into its internal channel 51 The distal electrode 23 of the quadrupole flexible soft electrode 4 is directly introduced into the right ventricle for pacing.

J形导入鞘 1近端 8处有一 V形柄 7, 在 J形导入鞘 1管体部轴向全长两侧 或某种薄弱结构, 以便在起搏步骤完成后将 J形导入鞘 1从四极弹性软电 极 4上撕脱。  There is a V-shaped shank 7 at the proximal end 8 of the J-shaped introducer sheath 1 at both sides of the axial length of the body of the J-shaped introducer sheath 1 or some kind of weak structure so that the J-shaped introducer sheath 1 can be removed from The four-pole elastic soft electrode 4 is peeled off.

由塑料制成的 J 形导入鞘 1 管体段上标有供插入时参照的长度标 记 101, 在 J形导入鞘近端 8标有 J形弯头指向的方向标记 102, 其目 的在于插入时准确了解 J形弯头到达部位及弯头指向。  The J-shaped introduction sheath 1 made of plastic is marked with a length mark 101 for reference during insertion, and the proximal end 8 of the J-shaped introduction sheath is marked with a direction mark 102 pointed by the J-shaped elbow. Accurately understand where the J-bend reaches and where the elbow is pointing.

J形导入鞘近端 8 内孔装有止血阀 9 , 止血阀为弹性活阀, 中心孔 可允许四极弹性软电极 4 和假体导管 1 通过, 当将其取出时止血阀 9 中心孔关闭, 则起到止血和防止空气进入血循环的作用。  The proximal end of the J-shaped introducer sheath is equipped with a hemostatic valve 9 in the inner hole. The hemostatic valve is an elastic valve. The central hole allows the four-pole flexible soft electrode 4 and the prosthetic catheter 1 to pass. When it is removed, the central hole of the hemostatic valve 9 is closed. , It plays a role in stopping bleeding and preventing air from entering the blood circulation.

管状 £体导管 2 为直形圓管状, 远端 12钝而圓滑, 管体部 11 柔 软, 近端 15设有与注射器针筒或引导钢丝插装的内孔 14, 内孔中心为 中心腔 13 入孔, 中心腔 13 由近端至远端可通过引导钢丝; 假体导管 适合装配在 J形导入鞘 1 内通道 51 内, 假体导管 2远端 12, 可从 J形 导入鞘 1 的远端 5伸出, 其目的在于假体导管 1可填充 J形导入鞘 1 的内通道 51 内的空间, 假体导管 2远端 12 圓钝可防止插入过程中损 伤血管壁和心肌。  The tubular body catheter 2 is a straight round tube, the distal end 12 is blunt and smooth, the tube body portion 11 is soft, and the proximal end 15 is provided with an inner hole 14 inserted into a syringe or a guide wire, and the center of the inner hole is a central cavity 13 Into the hole, the central cavity 13 can be guided by a guide wire from the proximal end to the distal end; the prosthesis catheter is suitable for fitting in the inner channel 51 of the J-shaped introduction sheath 1, and the distal end 12 of the prosthesis catheter 2 can be introduced into the distal end of the sheath 1 from the J-shape. The end 5 protrudes, the purpose of which is that the prosthetic catheter 1 can fill the space in the inner channel 51 of the J-shaped introduction sheath 1, and the distal end 12 of the prosthetic catheter 2 is blunt to prevent damage to the vessel wall and myocardium during insertion.

四极弹性软电极 4远端 23为阴极 23, 第 2极 26与阴极 23邻近, 用于心室起搏; 第 3极 27和第 4极 28邻近, 用于心房起搏, 且位于 距远端 23距离为 10—20cm范围内。  The distal end 23 of the quadrupole flexible soft electrode 4 is the cathode 23, and the second pole 26 is adjacent to the cathode 23 for ventricular pacing; the third pole 27 and the fourth pole 28 are adjacent to the atrial pacing and are located far from the distal end. 23 distance is within the range of 10-20cm.

四极弹性软电极 4具有上述的同轴双层螺旋线圏结构, 在同轴双层 螺旋线圈之间有一绝缘层 25, 内线圈层 22形成中心腔 24, 并与远端阴极 23连接, 其外线圈层 32由三条绝缘导丝 29、 30、 31组成, 三条绝缘导丝 分别与第 226、 第 3极 、 第 4极 28连接; 第 2极 26、 第 3极 27和第 4极 28 为环形电极, 外线圈层的绝缘导丝围绕绝缘层互相平行缠绕,彼此隔离, 第 1条绝缘导丝 29连接第 2极 26, 并在环形电极第 3极 27、 第 4极 28下面通 过; 第 2条绝缘导丝 30连接第 3极 27, 并在环形电极第 4极 28下面通过; 环形电极 27和 28与其下面通过的导丝互相绝缘; 外线圈层 32由外鞘 36覆 盖, 靠近远端阴极 23处外鞘突出形成齿状固定翼 35, 由生物相容性材料 硅橡胶、 聚氨酯或其它相宜的塑料制成外鞘层 36、 同轴双层螺旋线圈间 的绝缘层 25和齿状固定翼 35 ; 四极弹性软电极具有四条尾部电缆 33 , 分 别连接内线圈层及远端阴极 23和外线圈层第 2极、 第 3极、 第 4极, 4条电 缆从近端电缆集合块 34伸出, 分别连接双腔临时心脏起搏器的接线端。 The four-pole elastic soft electrode 4 has the above-mentioned coaxial double-layered spiral coil structure, and there is an insulating layer 25 between the coaxial double-layered spiral coils. The inner coil layer 22 forms a central cavity 24, and is connected to the distal cathode. 23, the outer coil layer 32 is composed of three insulated guide wires 29, 30, 31, and the three insulated guide wires are respectively connected to the second pole 26 , the third pole, and the fourth pole 28; the second pole 26, the third pole 27 and the fourth electrode 28 is a ring electrode, the insulating outer coil layer of wire wrapped around the insulating layer parallel to each other, isolated from each other, the first insulating section wire 29 connected to the second electrode 26, ring electrode and the third electrode 27, Pass under 4 poles 28; the second insulated guide wire 30 is connected to the third pole 27 and pass under the ring electrode 4 pole 28; the ring electrodes 27 and 28 are insulated from the guide wire passing under them; the outer coil layer 32 is external The sheath 36 is covered, and the outer sheath protrudes to form a toothed fixed wing 35 near the distal cathode 23. The outer sheath layer 36 is made of a biocompatible material such as silicone rubber, polyurethane or other suitable plastic. Insulating layer 25 and toothed fixed wings 35; Four-pole flexible soft electrode has four tail cables 33, which are respectively connected to the inner coil layer and the distal cathode 23 and the outer coil layer 2nd, 3rd, 4th, and 4 cables Extends from the proximal cable collection block 34, and connects to the two-chamber temporary pacemaker. Wire end.

四极弹性软电极 4体部 41标有供插入时准确定位参照的长度标志 41 , 其目的在于插入过程中准确估价电极远端 23和第 3极 27、 第 4极 28所处的位置。  The four-pole flexible soft electrode 4 body 41 is marked with a length mark 41 for accurate positioning and reference during insertion. The purpose is to accurately estimate the positions of the distal electrode 23, the third pole 27, and the fourth pole 28 during the insertion process.

四极弹性软电极 4远端 23具有齿状固定翼 35 , 其目的在于使电极 远端 23能够锚在心肌肌小梁内防止电极移位。  The distal end 23 of the quadrupole flexible soft electrode 4 has a toothed fixed wing 35, the purpose of which is to enable the distal end 23 of the electrode to be anchored in the myocardial trabeculae to prevent electrode displacement.

四极弹性软电极 1 配有直形塑形钢丝 20, 其长度比插配的中心腔 24轴向全长略短, 其目的在于, 使四极弹性软电极 1 的远端在插入心 室时, 保持软端, 不致损伤心肌。  The quadrupole flexible soft electrode 1 is provided with a straight shaped steel wire 20, which is slightly shorter than the axial length of the mated central cavity 24. The purpose is to enable the distal end of the quadrupole flexible soft electrode 1 to be inserted into the ventricle. Keep the soft end without damaging the myocardium.

四极弹性软电极 1 配有 J形塑形钢丝 21 , J形塑形钢丝远端为 J 形弯头段, J形弯头远端为软端, 其目的在于使 J形弯头容易插入中心 腔 24, 并且不会损伤内线圈层 22 ; 靠近 J形弯头段近端为一轻度弧形 弯曲段, 其目的在于适应解剖学上静脉入路的弧形弯曲, 有利于使电 极第 3极和第 4极贴靠右心房侧壁。  The four-pole flexible soft electrode 1 is equipped with J-shaped plastic wire 21, the distal end of the J-shaped plastic wire is a J-shaped elbow section, and the distal end of the J-shaped elbow is a soft end. The purpose is to make the J-shaped elbow easily inserted into the center Cavity 24, and does not damage the inner coil layer 22; a mildly curved curve section near the proximal end of the J-shaped elbow section is intended to adapt to the anatomically curved curve of the venous access, which is beneficial to the third electrode Pole and 4th pole abut the right atrium wall.

一种快速床边临时心脏起搏装置的使用方法, 其特征在于: 从右锁骨上途径穿刺右颈内静脉或右锁骨下静脉, 将引导钢丝从穿 刺后的静脉入路送入, 用粗扩张器扩宽静脉入路, 然后将其抽出, 其特 征在于: 将内装有假体导管的 J形导入鞘顺引导钢丝插入, 直至 J形导入 鞘的远端 J形弯头段被导入高右房上腔静脉入口处, 然后再将假体导管 连同引导钢丝一起移除, 并在体外将 J形导入鞘的 J形弯头段扭动指向患 者的三尖瓣口, 把四极弹性软电极从 J形导入鞘内通道插入, 直至出现 连续右室起搏并认定起搏位置合格为止, 将插装在四极弹性软电极中心 孔腔中的直形塑形钢丝抽出, 电极继续向前推送到设定长度, 再将 J形 塑形钢丝插入四极弹性软电极中心孔腔中, 使四极弹性软电极的第 3极 第 4极贴靠右心房侧壁直至房室双腔感知和起搏出现并认定合格为止。 A method for using a rapid bedside temporary cardiac pacing device is characterized in that: The right internal jugular vein or right subclavian vein is punctured from the right supraclavicular route, and the guide wire is sent from the venous approach after puncturing. The venous approach is widened with a thick dilator, and then it is withdrawn. The characteristics are: The J-shaped guide sheath with the prosthetic catheter is inserted along the guide wire until the distal J-shaped elbow section of the J-shaped introducer sheath is introduced into the entrance of the high right superior atrial vena cava, and then the prosthetic catheter is removed together with the guide wire. And twist the J-shaped elbow section of the J-shaped introducer sheath into the tricuspid valve mouth of the patient in vitro, insert the quadrupole elastic soft electrode from the J-shaped introducer into the sheath channel until continuous right ventricular pacing occurs and it is determined that Until the stroke position is qualified, the straight shaped wire inserted in the central cavity of the quadrupole flexible soft electrode is pulled out, the electrode continues to be pushed forward to the set length, and the J-shaped wire is inserted into the center of the quadrupole flexible soft electrode. In the cavity, the third pole and the fourth pole of the quadrupole elastic soft electrode are brought into abutment with the right atrium side wall until the atrioventricular dual-chamber sensing and pacing appear and are qualified.

由上可见, 本发明的优点和效杲如下:  As can be seen from the above, the advantages and effects of the present invention are as follows:

本发明采用 J形导入鞘导入电极导管, 可在床边或发病现场、 不需 X线指引、 迅速、 简单、 安全、 可靠地完成床边紧急心室起搏, 对于垂 危重症患者抢救十分有用; 同时本发明采用四极弹性软电极, 可防止 电极移位、 防止心肌和血管损伤; 同时迅速、 简单、 安全、 可靠地在 床边或发病现场实现了房室双腔生理性临时心脏起搏, 对挽救垂危患 者的病情和预防性心脏起搏十分有益。 本发明因简单易学适于普及。  The invention adopts a J-shaped introduction sheath to introduce an electrode catheter, which can quickly, simply, safely and reliably complete bedside emergency ventricular pacing at the bedside or the scene of the disease without X-ray guidance, which is very useful for the rescue of critically ill patients; The present invention adopts a quadrupole flexible soft electrode, which can prevent electrode displacement and prevent myocardial and vascular damage; meanwhile, a dual-chamber physiological temporary cardiac pacing can be quickly, simply, safely, and reliably realized at the bedside or at the scene of the disease. Salvage of critically ill patients and preventive cardiac pacing are very useful. The invention is suitable for popularization because of its simplicity and ease of learning.

下面对技术方案作进一步解释。  The technical solution is further explained below.

本发明采用了一种: Γ形导入鞘, 在其远端有一 J形弯头段。 这样, J 形弯头不是做在导管远端, 而是做在 J形导入鞘远端。 因此, 本发明的 电极并不需要在远端做成 J形, 当 J形导入鞘的 J形弯头在体外指向三尖 瓣口时, 直形电极离开 J形导入鞘远端将直接指向三尖瓣, 并易进入右 室心尖部的心腔(参见图 1 )。 本发明所选择的静脉入路符合距三尖瓣口 和右室心尖部路径最短、 较直, 因此, 符合标准的入路只有右锁骨上静 脉途径, 因此要求 J形导入鞘必须有一定硬度和弹性, 并且在血温中能 保持原形, 能在体外扭动并指向身体左前 45。 , 即指向三尖瓣。 为了配 合此套器械的使用, 我们所采用的穿刺方法是: J形导入鞘插入的静脉 入路采用静脉穿刺, 并用扩张器扩宽。 经锁骨上静脉穿刺采用 Yof fa氏 法穿刺右锁骨下静脉或采用 Jerni gan法穿刺右颈内静脉。 这条入路的解 剖学关系如图 1和图 2所示。 右颈内静脉和右锁骨下静脉汇合成无名静 脉, 交点形成一个静脉角。 穿刺点、 静脉角、 上腔静脉和右房侧壁形成 一奈向身体右侧弯曲的弧线。 三尖瓣和右室恰处于高右房上腔静脉入口 的左前侧, 三尖瓣和右室长轴与上腔静脉长轴约呈 1 35 ° 角。 在静脉入 路处没有重要组织和器官, 穿刺针到达静脉仅仅经由颈部筋膜组织。 穿 刺针采用一个固定的穿刺方向, 即与矢状面呈 45° 角向内, 与冠状面呈 15° 角向前, 这样随穿刺针向前推入, 则远离了锁骨下动脉、 颈部胸膜 和膈神经 (Yof fa氏法)。 采用 Jern i gan氏法穿刺颈内静脉时与此类似。 颈内静脉在颈部下方恰处于颈内动脉外侧, 采用胸锁乳突肌束后方进 针, 穿刺针必先进入颈内静脉。 在通路上也仅仅有有颈部筋膜。 这是保 征本法安全操作的基础。 按着这种固定穿刺方向即可避免出现锁骨下动 脉损伤、 血胸、 气胸、 膈神经损伤等。 根据我们测量结果及经验, J形 导入鞘插入深度应为患者身长的 1 / 1 0 , 然后 J形导入鞘的 J形弯头在体 外被扭动指向三尖瓣, 也就是与矢状面呈 45 ° 角, 指向身体左前。 此时 这种特制的直形起搏电极可以经由 J形导入鞘插入并直达右室 (图 1 )。 上述设想在临床验证中得到了完全实现。 特制的四极弹性软电极, 靠近 远端处附有固定翼, 其作用旨在改善电极的固定性能, 并防止心肌损伤 和穿孔, 当直形塑形钢丝插入时, 电极变挺直, 有助于经由 J形导入鞘 直插右室心尖部, 当直形塑形钢丝撤除时, 电极变软, 可防止电极损伤 心肌。 四极弹性软电极旨在感知和起搏心房和心室双心腔, 以便在床边 无 X线指引下获得双腔生理性心脏起搏。 直形塑形钢丝插入其中心腔后 可经 J形导入鞘插入并直达右室起搏, 当电极远端锚在肌小梁内时, 在 撤除 J形导入鞘和直形塑形钢丝后, 可用远端呈 J形的塑形钢丝插入其中 心腔, 可将该电极的第 3极和第 4极压向右心房侧壁, 房室双腔生理性心 脏起搏和感知便可即刻发生。 The present invention adopts a Γ-shaped introduction sheath with a J-shaped elbow section at its distal end. In this way, the J-shaped elbow is not made at the distal end of the catheter, but at the distal end of the J-shaped introducer sheath. Therefore, the electrode of the present invention does not need to be J-shaped at the distal end. When the J-shaped elbow of the J-shaped introduction sheath points to the tricuspid valve in vitro, the straight electrode leaves the J-shaped introduction sheath and the distal end will directly point to the three The cuspid valve is easily accessible to the apex of the right ventricle (see Figure 1). The venous approach selected by the present invention conforms to the shortest and straightest path from the tricuspid valve port and the right ventricular apex. Therefore, the standard-compliant approach is only the superior supraclavicular vein approach. Therefore, the J-shaped introduction sheath must have a certain hardness and Elastic and able to withstand blood temperature Keep the original shape, can twist outside the body and point to the front left 45 of the body. Pointing to the tricuspid valve. In order to cooperate with the use of this set of instruments, the puncture method we used is: The venous approach of the J-shaped introducer sheath is inserted by venipuncture and widened with a dilator. The supraclavicular vein puncture was performed using the Yof fa method to puncture the right subclavian vein or the Jernigan method to puncture the right internal jugular vein. The anatomical relationship of this approach is shown in Figures 1 and 2. The right internal jugular vein and the right subclavian vein merge into an innominate vein, and the intersection point forms a vein angle. The puncture point, the venous angle, the superior vena cava, and the right atrium wall form an arc that curves toward the right side of the body. The tricuspid valve and right ventricle are located just to the left anterior side of the entrance to the superior superior atrial vena cava. The long axis of the tricuspid valve and right ventricle is approximately 1 35 ° from the long axis of the superior vena cava. There are no important tissues and organs at the venous approach, the puncture needle reaches the vein only through the cervical fascial tissue. The puncture needle uses a fixed puncture direction, that is, 45 ° inward from the sagittal plane and 15 ° forward from the coronal plane. When the puncture needle is pushed forward, it is far away from the subclavian artery and cervical pleura. Hepatic nerve (Yof fa method). The Jernigan method is similar when puncturing the internal jugular vein. The internal jugular vein is just outside the internal carotid artery below the neck. The needle is inserted behind the sternocleidomastoid muscle bundle. The puncture needle must first enter the internal jugular vein. There is also only cervical fascia in the pathway. This is the basis for ensuring the safe operation of this law. By following this fixed puncture direction, subclavian artery injury, hemothorax, pneumothorax, and phrenic nerve injury can be avoided. According to our measurement results and experience, the insertion depth of the J-shaped introduction sheath should be 1/10 of the patient's length, and then the J-shaped elbow of the J-shaped introduction sheath is twisted outside the body to point to the tricuspid valve, which is the same as the sagittal plane. 45 ° angle, pointing to the front left of the body. At this time, this specially made straight pacing electrode can be inserted into the right ventricle through a J-shaped introducer sheath (Figure 1). The above assumptions have been fully realized in clinical validation. Special four-pole flexible soft electrode with fixed wings near the distal end. Its purpose is to improve the fixing performance of the electrode and prevent myocardial damage and perforation. When the straight shaped wire is inserted, the electrode becomes straight and helps The J-shaped sheath is inserted directly into the right ventricular apex. When the straight shaped wire is removed, the electrode becomes soft, which can prevent the electrode from damaging the myocardium. The quadrupole flexible soft electrode is designed to sense and pace the atrial and ventricular dual heart chambers in order to obtain dual-chamber physiological cardiac pacing without X-ray guidance at the bedside. After a straight shaped wire is inserted into its central cavity It can be inserted through a J-shaped sheath and directly into the right ventricle for pacing. When the distal end of the electrode is anchored in the muscle trabecula, after the J-shaped sheath and the straight shaped steel wire are removed, a J-shaped shaped wire can be used at the distal end. When inserted into its central cavity, the 3rd and 4th poles of the electrode can be pressed to the right atrium side wall, and the atrioventricular dual-chamber physiological cardiac pacing and sensing can occur immediately.

附图简要说明 Brief description of the drawings

图 1为本发明插入 J形导入鞘和电极的入路图解;  FIG. 1 is a schematic diagram of an approach of inserting a J-shaped introduction sheath and an electrode according to the present invention; FIG.

图 2为实现单电极房室双腔生理性心脏起搏示意图;  FIG. 2 is a schematic diagram of a single-electrode atrioventricular dual-chamber physiological cardiac pacing;

图 3为本发明 J形导入鞘的平面图;  3 is a plan view of a J-shaped introduction sheath of the present invention;

图 4为本发明 J形导入鞘立体放大图;  4 is an enlarged perspective view of a J-shaped introduction sheath of the present invention;

图 5为本发明 J形导入鞘结构剖面图;  5 is a sectional view of a J-shaped introduction sheath structure of the present invention;

图 6为本发明 J形导入鞘横截面图;  6 is a cross-sectional view of a J-shaped introduction sheath of the present invention;

图 7为本发明假体导管外观图;  7 is an external view of a prosthesis catheter of the present invention;

图 8为本发明假体导管内部结构剖面图;  8 is a cross-sectional view of the internal structure of the prosthesis catheter of the present invention;

图 9为本发明 J形导入器的平面图; J形导入器是由 J形导入鞘和假体 导管装配在一起形成的;  9 is a plan view of a J-shaped introducer according to the present invention; the J-shaped introducer is formed by assembling a J-shaped introducer sheath and a prosthetic catheter together;

图 1 0为本发明粗扩张器的外形立体图;  FIG. 10 is an external perspective view of a coarse dilator of the present invention;

图 11为本发明四极弹性软电极外形图;  11 is an external view of a quadrupole flexible soft electrode according to the present invention;

图 12为本发明四极弹性软电极内部结构图;  FIG. 12 is an internal structure diagram of a quadrupole elastic soft electrode according to the present invention; FIG.

图 1 3为本发明四极弹性软电极内部结构剖面图;  FIG. 13 is a cross-sectional view of the internal structure of a quadrupole flexible soft electrode according to the present invention;

图 14为本发明 J形塑形钢丝外形图。  Fig. 14 is an external view of a J-shaped plastic wire according to the present invention.

最佳实施方式 Best practice

下面将结合附图 1 - 14对本发明的具体结构进行详细说明:  The specific structure of the present invention will be described in detail below with reference to the accompanying drawings 1 to 14:

图 1中的箭头 A和箭头 B之间的曲钱, 即穿刺点到右房侧壁之间的曲 线, 呈向患者身体右侧展开的弧线。 该曲线表示插入引导钢丝和 J形导 入鞘 1的入路。 箭头 A和箭头 C之间的曲线表示 J形导入鞘 1的 J形弯头 6转 向的方向和插入电极的入路。 形导入鞘 1的 J形弯头 6被导入高右房的上 腔静^入口处, 然后被扭动指向右室和三尖瓣, 右室和三尖瓣长轴与矢 状面呈 45。 角, 与横截面呈 45。 角。 箭头 D和圆点表示 Jernigan氏法穿 刺方向和穿刺点。 箭头 D和箭头 B之间的曲线与箭头 A和箭头 B之间曲线相 似, 表示采用 Jernigan氏法穿刺颈内静脉时插入引导钢丝和: [形导入鞘 1 时的入路。 The curved money between arrows A and B in Figure 1, that is, the curve from the puncture point to the side wall of the right atrium, is an arc that spreads to the right side of the patient's body. This curve shows an approach in which the guide wire and the J-shaped introduction sheath 1 are inserted. The curve between arrow A and arrow C shows the J-shaped elbow 6 turns of the J-shaped introduction sheath 1 Direction and the way to insert the electrode. The J-shaped elbow 6 shaped into the sheath 1 is introduced into the upper cavity static entrance of the high right atrium, and then twisted to point to the right ventricle and the tricuspid valve. The long axis of the right ventricle and the tricuspid valve is 45 to the sagittal plane. Angle, with a cross section of 45. angle. Arrow D and dot indicate the puncture direction and puncture point of Jernigan's method. The curve between arrow D and arrow B is similar to the curve between arrow A and arrow B, which indicates that the guide wire is inserted when the internal jugular vein is punctured by Jernigan's method and: [the approach when introduced into sheath 1.

图 2表示电极由右锁骨上途径插入, 电极远端锚在右室心尖部, 当 插入 J形塑形钢丝时, 电极的第 3极 27和第 4极 28被压向高右房侧壁。  Figure 2 shows that the electrode was inserted through the right supraclavicular approach, and the distal end of the electrode was anchored at the right ventricular apex. When the J-shaped wire was inserted, the third and fourth poles 27 and 28 of the electrode were pressed toward the high right atrium wall.

图 3 ~ 6为 J形导入鞘图解, 它可将电极自体外导入右室心尖部, 它 的远端 5具有一个由: [形弯头远端长轴与 J形导入鞘体部长轴形 成的 120° - 160° 弧形弯角的 J形弯头段 6。 远端 5圓钝, 侧面观略呈 斜形, 近端 8有一个 V形柄 7, 在近端 8中心腔内孔中有一套筒式止血阀 9, 用于止血和防止进入空气。 在 J形导入鞘体部侧壁和 V形柄 7体部与之相 连的侧壁有双侧对称的纵形凹槽或双侧对称的纵形间断切开线 10, 用于 起搏过程完成后将 J形导入鞘从电极上撕脱。 J形导入鞘内径为 6 ~8Fr, 外径为 8 ~ 12Fr, 自远端 5起, 在 15cm以上, 标有长度标志 101。 近端 8应 标出 J形弯头的指向 102。 J形导入鞘应该较硬、 有弹性, 由聚乙烯或其 它对身休适宜的塑料制成。  Figures 3 to 6 are illustrations of the J-shaped introduction sheath, which can introduce the electrode from the outside into the right ventricular apex, and its distal end 5 has a: [formed by the long axis of the distal end of the elbow and the long axis of the J-shaped introduction sheath 120 °-160 ° J-shaped elbow section 6 with curved corners. The distal end 5 is round and blunt, and the side view is slightly oblique. The proximal end 8 has a V-shaped handle 7. In the central cavity of the proximal end 8, there is a sleeve-type hemostatic valve 9 for hemostasis and preventing air from entering. There are bilaterally symmetrical longitudinal grooves or bilaterally symmetrical vertical discontinuous incision lines 10 on the side wall of the J-shaped introduction sheath body and the side wall of the V-shaped handle 7 for the completion of the pacing process. The J-shaped introducer sheath was then peeled from the electrode. The J-shaped introduction sheath has an inner diameter of 6 to 8Fr and an outer diameter of 8 to 12Fr. It is 5cm from the distal end and is marked with a length mark 101. Proximal end 8 should be marked with a J-bend pointing 102. The J-shaped introducer sheath should be stiff and flexible, and made of polyethylene or other plastic suitable for the body.

图 7、 图 8为假体导管 2图解, 假体导管 2适合装入 J形导入鞘 1内通道 51内填满空间。 它具有较软的体部 11, 钝而圓滑的远端 I2当装入 J形导 入鞘时, 它从: ί形导入鞘远端 5伸出 3 ~ 5厘米。 假体导管有一中心腔 13可 插入引导钢丝, 近端 15有内口 14可接连注射器针筒或导入引导钢丝。 假 体导管适合装入 J形导入鞘内通道 51中。 它的钝而圓滑的远端 12和较软 的体部 11具有当插入时疏忽, 未将引导钢丝充分送入足够长度时, 可免 于血管壁和心 损伤。 图 10为粗扩张器示意图。 它用于扩宽 J形导入鞘 1的静脉入路, 其外 径比 J形导入鞘 1外径略粗。 近端 17附有柄 16, 可连接注射器, 中心腔 18 可送入引导钢丝, 远端 19为逐渐变细的锥形, 以用于扩宽静脉入口。 FIG. 7 and FIG. 8 are diagrams of the prosthetic catheter 2. The prosthetic catheter 2 is suitable for being filled in the channel 51 inside the J-shaped introduction sheath 1 to fill the space. It has a softer body 11, a blunt and rounded distal end I 2 that when inserted into the J-shaped introducer sheath, it protrudes from the distal end 5 of the helical introducer sheath 3 to 5 cm. The prosthesis catheter has a central lumen 13 for inserting a guide wire, and a proximal end 15 having an inner port 14 for connecting a syringe or introducing a guide wire. The prosthetic catheter is adapted to be inserted into a J-shaped intrathecal channel 51. Its blunt and rounded distal end 12 and softer body 11 are negligent when inserted, and the guide wire is not fully fed into a sufficient length to prevent damage to the vessel wall and heart. Figure 10 is a schematic diagram of a coarse dilator. It is used to widen the venous approach of the J-shaped introducer sheath 1, and its outer diameter is slightly larger than the outer diameter of the J-shaped introducer sheath 1. The proximal end 17 has a handle 16 attached to the syringe, the central lumen 18 can be fed with a guide wire, and the distal end 19 is tapered and tapered for widening the access to the vein.

图 11 ~ 13为四极弹性软电极 4的图解, 它配有直形塑形钢丝 20插在 其中心腔 24内, JT形塑形钢丝 21备而待用。 它具有同轴的双线圈结构。 它有一个内弹簧线圈层 22 , 其导线与远端阴极 23相连。 该线圈 22围成中 心腔 24 , 可插入塑形钢丝 20。 由硅橡胶、 聚氨脂、 或其它对身体适宜的 塑料制成的绝缘层 25覆盖内线圈层 22。 第 2极 26 , 第 3极 27和第四极 28为 环形电极, 分别与外包绝缘层的导丝 29、 30、 31相连。 绝缘导丝 29 , 30、 31平行并且相互隔离地围绕绝缘层 25缠绕, 组成外线圈层 32。 导丝 29连 接第 2极 26, 在第 3极 27和第 4极 28下通过, 导丝 30连接第 3极 27 , 在第 4 极 28下通过, 环形电极与下面通过的导丝 29、 30绝缘。 远端阴极 23和第 2极 26接近; 第 3极 27和第 4极 28接近, 并处于距远端 10 ~ 20cm范围内。 四条尾部电缆 33从电缆结合块 34分出, 连接体外双腔临时心脏起搏器的 四个接头。 靠近远端阴极 23处外鞘突出形成小的齿状固定翼 35。 电极在 离开远端 23的固定位置设有长度标志, 以方便电极插入, J形塑形钢丝 2 1远端为 J形弯头, J形弯头远端为软端 211, 以方便插入中心腔内, 在靠 近 J形弯头段为一段与 J形弯头方向一致的弧形轻度弯曲段。  Figures 11 to 13 are diagrams of the four-pole elastic soft electrode 4, which is provided with a straight shaped steel wire 20 inserted in its central cavity 24, and a JT shaped shaped steel wire 21 is ready for use. It has a coaxial double coil structure. It has an inner spring coil layer 22 whose wires are connected to the distal cathode 23. The coil 22 surrounds the central cavity 24 and can be inserted into the shaped wire 20. The inner coil layer 22 is covered by an insulating layer 25 made of silicone rubber, polyurethane, or other body-friendly plastic. The second pole 26, the third pole 27, and the fourth pole 28 are ring electrodes, which are respectively connected to the guide wires 29, 30, and 31 of the outer insulation layer. The insulating guide wires 29, 30, 31 are wound in parallel and isolated from each other around the insulating layer 25 to form an outer coil layer 32. The guide wire 29 is connected to the second pole 26 and passes under the third pole 27 and the fourth pole 28. The guide wire 30 is connected to the third pole 27 and passes under the fourth pole 28. The ring electrode is connected to the guide wires 29 and 30 passing below. insulation. The distal cathode 23 is close to the second pole 26; the third pole 27 and the fourth pole 28 are close to each other and within a range of 10 to 20 cm from the far end. Four tail cables 33 are branched from the cable connection block 34 and are connected to the four connectors of the external double-chamber temporary pacemaker. The outer sheath protrudes near the distal cathode 23 to form a small toothed fixed wing 35. The electrode is provided with a length mark at a fixed position away from the distal end 23 to facilitate the insertion of the electrode. The J-shaped plastic wire 2 1 is a J-shaped elbow at the distal end and a soft end 211 at the distal end of the J-shaped elbow to facilitate insertion into the central cavity. Inside, near the J-shaped elbow section is an arc-shaped lightly curved section consistent with the direction of the J-shaped elbow.

本发明具体操作方法及实施过程如下:病人要平卧,不用枕头或将 7 ~ 8厘米高的小枕放在肩胛骨间, 当病人颈静脉压低时采用头低足高位。 确其部位。 当该部位不明确时, 将手置于患者前额部, 嘱其抗阻力屈颈, 可使胸锁乳突肌角明显暴露。 该部位皮肤清洁、 铺巾。 当病人平卧时, 胸锁乳突肌角下 1厘米处的陷窝中心为穿刺点, 在该处局麻, 用 No l l刀 片作一小的皮肤切口, 切透皮肤及皮下组织。 用带注射器的穿刺针按固 定方向穿刺, 即与矢状面呈 45° 角向内, 与冠状面呈 15° 角向前(Yof fa氏经锁骨上锁骨下静脉穿刺法)。 当暗红色血液吸入针筒, 取掉注射 器针筒, 血一滴滴滴出时, 表明穿刺针己进入锁骨下静脉, 穿刺针平均 刺入深度约 2 ~ 4厘米。 引导钢丝的 J端通过穿刺针送入约 30厘米, 钢丝 来回拉动, 若无阻力, 表明已进入中心静脉系统。 粗扩张器顺引导钢丝 插入, 以扩宽静脉入路, 移去粗扩张器, J形导入鞘内装入假体导管, 然后顺引导钢丝插入。 J形导入鞘远端弯头应持续指向身体右侧, 直到: T 形弯头到达高右房上腔静脉入口处。 J形导入鞘插入长度约为患者身长 1The specific operation method and implementation process of the present invention are as follows: the patient is to lie flat, without a pillow or placing a small pillow between 7 and 8 cm in height between the scapula. When the jugular vein pressure of the patient is low, the head is lowered and the foot is high. Identify its location. When this part is not clear, put your hand on the patient's forehead and ask her to resist neck flexion, which can expose the sternocleidomastoid muscle angle. The area is clean and draped. When the patient is lying supine, the center of the sag at 1 cm below the angle of the sternocleidomastoid muscle is the puncture point, where a local anesthesia is made, and a small skin incision is made with a Noll blade to cut through the skin and subcutaneous tissue. Press firmly with a puncture needle with a syringe Orientation puncture, that is, 45 ° inward from the sagittal plane and 15 ° forward from the coronal plane (Yof fa's transclavicular subclavian vein puncture method). When the dark red blood was sucked into the syringe, the syringe syringe was removed, and a drop of blood dripped out, indicating that the puncture needle has entered the subclavian vein, and the average penetration depth of the puncture needle is about 2 to 4 cm. The J-end of the guide wire is fed into about 30 cm through the puncture needle, and the wire is pulled back and forth. If there is no resistance, it indicates that it has entered the central venous system. The thick dilator is inserted along the guide wire to widen the venous approach. The coarse dilator is removed, the J-shaped sheath is inserted into the prosthetic catheter, and the guide wire is inserted along the guide. The distal elbow of the J-shaped introducer sheath should continue to point to the right side of the body until: The T-elbow reaches the entrance of the high right superior atrial vena cava. Insert the J-shaped sheath into the patient's length 1

/ιο。 然后将假体导管连同引导钢丝一起移除。 J形导入鞘的: r形弯头在 体外被扭动指向患者身体左前 45。 , 即指向三尖瓣。 体外双腔心脏起搏 器已预置于 VV1 (或 DDD )起搏状态: 即心室刺激幅度 3V, 起搏心率大于 患者自身心室率 2 0 bpm, 敏感度 3 ~ 5mv。 四极弹性软电极电缆已和双 腔起搏器相连, 从 J形导入鞘内插入, 直至连续右室心脏起搏波群出现 在心电监视屏上, 这时清晰感知电极与心室内膜接触时的 "碰撞感"。 然后直形塑形钢丝回撤 10 ~ 15厘米, 并应体会电极远端锚泊感, 电极向 前推送 3 ~ 5厘米, 观察病人深吸气、 咳嗽或改换体位时是否起搏信号能 全部夺获心室, 并观察起搏阈值和感知灵敏度。 这时电极插入深度一般 应在患者身长 1 / 10+10 - 15厘米范围内, 若插入少于此长度, 则应有明 显锚泊感, 若认定起搏参数合格, 则该起搏部位可被接受。 之后, 用一 支 25 - 30厘米金属或塑料尺放在电极和 J形导入鞘下面做支持物, 以保 持电极在体内部分不移位, 然后从体内移除 J形导入鞘。 右室起搏步骤 总结如下: / ιο. The prosthetic catheter is then removed along with the guide wire. J-shaped introduction sheath: The r-shaped elbow is twisted outside the body and points to the front left 45 of the patient's body. Pointing to the tricuspid valve. The external dual-chamber pacemaker has been preset in the VV1 (or DDD) pacing state: that is, the ventricular stimulation amplitude is 3V, the pacing heart rate is greater than the patient's own ventricular rate, 20 bpm, and the sensitivity is 3 to 5 mv. The quadrupole flexible soft electrode cable has been connected to the dual-chamber pacemaker and inserted from the J-shaped lead into the sheath until the continuous right ventricular cardiac pacing wave group appears on the ECG monitor screen. At this time, it is clearly sensed when the electrode is in contact with the ventricular membrane. "Collision". Then the straight shaped wire retracts 10 to 15 cm, and you should feel the anchoring feeling at the distal end of the electrode. Push the electrode 3 to 5 cm forward. Observe whether the pacing signal can be captured when the patient inhales deeply, coughs or changes position. Ventricle, and observe pacing threshold and perceived sensitivity. At this time, the electrode insertion depth should generally be within the range of 1/10 + 10-15 cm of the patient's length. If the insertion length is less than this length, there should be a clear anchoring feeling. If the pacing parameters are determined to be acceptable, the pacing site can be accepted. . After that, a 25-30 cm metal or plastic ruler is placed under the electrode and the J-shaped introducer sheath as a support to keep the electrode from moving in the body, and then the J-shaped introducer sheath is removed from the body. The right ventricular pacing steps are summarized as follows:

1.采用 Yof fa氏法穿刺右锁骨下静脉或采用 Jernigan氏法穿刺右颈 内静脉;  1.Use the Yof fa method to puncture the right subclavian vein or the Jernigan's method to puncture the right internal jugular vein;

2.送入引导钢丝并扩宽静脉入路; 3. J形导入鞘的 J形弯头被导入高右房上腔静脉人口处; 2. Feed the guide wire and widen the venous approach; 3. The J-shaped elbow of the J-shaped introduction sheath is introduced into the high right superior atrial vena cava population;

4. J形导入鞘的 J形弯头在体外扭动指向三尖瓣口;  4. The J-shaped elbow of the J-shaped introduction sheath points to the tricuspid orifice in vitro;

5.将四极弹性电极从 J形导入鞘内插入, 直至出现连续右室起搏并 认定起搏位置合格;  5. Insert the quadrupole elastic electrode from the J-shaped lead into the sheath until continuous right ventricular pacing occurs and the pacing position is determined to be qualified;

将直形塑形钢丝拔除, 电极继续向前推送至设定长度, 即患者身长 1 / 1 0加上电极远端至第 4极距离, 将起搏模式调至 DDD , 并调好起搏参 数, 如 AV延迟 150 ms, 心房感知敏感度 0. 1 - 0. 5mv , 心房刺激幅度 3V。 将 J形塑形钢丝插入电极中心腔内, 轻轻上下移动使第 3、 第 4极贴靠右 心房侧壁, 之后房室双腔感知和起搏即可发生。 房室双腔起搏步骤总结 如下 (接第 5条)  Unplug the straight shaped wire and push the electrode forward to the set length, that is, the patient's length is 1/10 plus the distance from the distal end of the electrode to the 4th pole. Adjust the pacing mode to DDD and adjust the pacing parameters. For example, the AV delay is 150 ms, the atrial sensory sensitivity is 0.1-0.5 mv, and the atrial stimulation amplitude is 3 V. Insert the J-shaped wire into the center cavity of the electrode, and move it up and down gently to make the 3rd and 4th poles abut the right atrium side wall, and then the two-chamber sensing and pacing of the atrium can occur. Atrioventricular double-chamber pacing steps are summarized as follows (continued from Article 5)

6.直形塑形钢丝拔除, 电极继续向前推送至设定的深度;  6. The straight shaped wire is pulled out, and the electrode continues to be pushed forward to the set depth;

7.插入 J形塑形钢丝, 使第 3、 第 4极贴靠右心房侧壁, 直至房室双 腔感知和起搏出现。  7. Insert the J-shaped plastic wire, and place the 3rd and 4th poles against the side wall of the right atrium until the atrioventricular double-chamber sensing and pacing appear.

8.按病人实际情况重新设置起搏模式和参数。  8. Reset the pacing mode and parameters according to the actual situation of the patient.

Claims

权利要求 Rights request 1、 一种快速床边临时心脏起搏装置, 它有 J形导入鞘( 1 )和与其 内通道( 51 )相插配的假体导管 ( 2 )和四极弹性软电极( 4 )其特征在 于: 1. A rapid bedside temporary cardiac pacing device, which has a J-shaped introduction sheath (1), a prosthetic catheter (2) inserted into its inner channel (51), and a quadrupole flexible soft electrode (4). Lies in: ( a ) J 形导入鞘 (1 )呈圓管状, 具有远端 (5)、 体部 (10 )和近 端 (8 ), 近端 (8 ) 内孔中装有止血阀 (9), 体部 (10 ) 呈直管状, 远 端 ( 5 )有一 J形弯头段( 6 ), 内通道 ( 51 ) 为假体导管 ( 2 )和四极弹 性软电极( 4 ) 的插入通道, 假体导管 ( 2 )可插配在 J 形导入鞘( 1 ) 内;  (a) The J-shaped introduction sheath (1) has a circular tube shape, and has a distal end (5), a body part (10), and a proximal end (8). The proximal end (8) is provided with a hemostatic valve (9) in the inner hole. The part (10) has a straight tube shape, the distal end (5) has a J-shaped elbow section (6), the inner channel (51) is the insertion channel of the prosthetic catheter (2) and the quadrupole flexible soft electrode (4), and the prosthesis The catheter (2) can be inserted into the J-shaped introduction sheath (1); ( b )四极弹性软电极(4 )呈直形圓管状,整体柔软,具有远端(23 ), 体部 (41 ) 和近端 (34 ); 远端 (23 ) 为阴极, 近端 (34 ) 附有电缆结 合块 ( 34 ), 电缆结合块 ( 34 )连引出与体外双腔临时心脏起搏器相插 接的 4 条电缆插头 (33 ), 电极轴向全长设有抽装塑形钢丝的中心孔腔 (b) the quadrupole flexible soft electrode (4) has a straight circular tube shape, is soft as a whole, and has a distal end (23), a body (41) and a proximal end (34); the distal end (23) is a cathode and the proximal end ( 34) Attached with a cable combination block (34), the cable combination block (34) leads out 4 cable plugs (33) that are connected to the external double-chamber temporary pacemaker, and the electrode is provided with a drawing plastic in the axial length. Central cavity ( 24 ), 直形塑形钢丝 (20 )插配在中心孔腔(24 ) 中, J 形塑形钢丝 ( 21 )备而待用, 中心孔腔( 24 )在近端有插入孔 ( 24 ), 远端 ( 23 ) 无出孔。 (24), the straight shaped steel wire (20) is inserted into the central cavity (24), the J shaped plastic wire (21) is ready for use, and the central cavity (24) has an insertion hole (24) at the proximal end ), The distal end (23) has no holes. 2、 按照权利要求 1 所述的一种快速床边临时心脏起搏装置, 其特 征在于: J形导入鞘 ( 1 ) 的远端 ( 5 ) 为钝而圓滑状, J形导入鞘( 1 ) 的 J形弯头段( 6 ) 呈 120° ~ 160。 由 J形弯头远端长轴与导入鞘体部 长轴形成的弧形弯角。  2. A rapid bedside temporary cardiac pacing device according to claim 1, characterized in that: the distal end (5) of the J-shaped introduction sheath (1) is blunt and smooth, and the J-shaped introduction sheath (1) The J-shaped elbow section (6) is 120 ° ~ 160. An arc-shaped bend formed by the long axis of the distal end of the J-shaped elbow and the long axis of the sheath. 3、 按照权利要求 1 或 2 所述的一种快速床边临时心脏起搏装置, 其特征在于: J形导入鞘近端 ( 8 )处有一 V形柄( 7 ), 在 J形导入鞘 ( 1 )管体轴向全长两侧及 V形柄( 7 )体部与之相连的的两侧开设有供 撕脱用间断切开线或纵向凹槽(10)或薄弱线。 3. A rapid bedside temporary cardiac pacing device according to claim 1 or 2, characterized in that: a V-shaped handle (7) is provided at the proximal end (8) of the J-shaped introduction sheath, and the J-shaped introduction sheath is (1) Both sides of the axial length of the pipe body and the two sides connected to the V-shaped handle (7) of the body are provided with discontinuous incision lines or longitudinal grooves (10) or weak lines for tearing. 4、 按照权利要求 1 所述的一种快速床边临时心脏起搏装置, 其特 征在于: 与 J形导入鞘( 1 ) 内通道( 51 )相插配的假体导管 ( 2 )呈直 形圆管状, 远端 (12 )钝而圓滑, 体部 (11 ) 柔软, 其近端 (15)设有 连接注射器针筒或引导钢丝插装的内孔 (14), 中心腔(13 )可插入引 导钢丝, 当假体导管 (2)插配在 J 形导入鞘内通道(51 )后, 假体导 管远端 (12 )从: [形导入鞘远端 (5 )伸出。  4. A rapid bedside temporary cardiac pacing device according to claim 1, characterized in that: the prosthesis catheter (2) inserted into the inner channel (51) of the J-shaped introduction sheath (1) is straight. The tube is round, the distal end (12) is blunt and smooth, and the body (11) is soft. The proximal end (15) is provided with an inner hole (14) for connecting a syringe or a guide wire, and the central cavity (13) can be inserted With the guide wire, after the prosthetic catheter (2) is fitted in the J-shaped introduction sheath channel (51), the distal end (12) of the prosthetic catheter protrudes from: [the distal end of the shaped introduction sheath (5). 5、 按照权利要求 1或 2 所述的一种快速床边临时心脏起搏装置, 其特征在于: J 形导入鞘管 (1 ) 管体段上标刻有供插入时参照的长度 标记( 101 ),在 J形导入鞘近端( 7 )标出 J形弯头指向的方向标记( 102 )。  5. A rapid bedside temporary cardiac pacing device according to claim 1 or 2, characterized in that: the body section of the J-shaped introduction sheath (1) is marked with a length mark (101 for reference when inserting) ), At the proximal end (7) of the J-shaped introduction sheath, mark the direction mark (102) pointed by the J-shaped elbow. 6、 按照权利要求 1 所述的一种快速床边临时心脏起搏装置, 其特 征在于: 四极弹性软电极( 4 )具有同轴双层螺旋线圏结构, 在同轴双 层螺旋线圈之间有一绝缘层 (25 ), 内线圈层 (22 ) 形成中心腔(24), 并与远端阴极(23)连接, 其外线圈层 (32 ) 由三条外涂绝缘材料的绝 缘导丝 (29 )、 ( 30)、 ( 31 )组成, 3 条绝缘导丝分别与第 2 极(26)、 第 3极( 27 )、 第 4极( 28 )连接; 第 2极、 第 3极和第 4极均为环形 电极, 外线圈层( 32 )的绝缘导丝围绕绝缘层互相平行缠绕, 彼此隔离; 第 1条绝缘导丝( 29 )连接第 2极( 26 ), 并在环形电极第 3极( 27 ) 和第 4极( 28 ) 下面通过; 第 1条绝缘导丝 ( 30 ) 连接第 3极( 27 ), 并在环形电极第 4极(28 )下面通过; 第 3条绝缘导丝连接第 4极(28 ), 环形电极(27)、 (28 ) 与其下面通过的导丝 (29 ) ( 30 ) 互相绝缘; 外 线圏层 (32 ) 由外鞘(36 )覆盖; 靠近远端阴极(23 ) 处由覆盖内线圈 层 (22 ) 的外鞘突出形成齿状固定翼(35 ), 用于锚住电极远端, 由生 物相容性材料硅橡胶、 聚氨酯或其它对身体相宜的塑料制成外鞘层、 同 轴双层螺旋线圈的绝缘层和齿状固定翼; 四极弹性软电极具有四条尾部 电缆(33 ), 分别连接内线圈层 (22 )远极阴极(23 )和外线圈层第 2 极( 26 ), 第 3极( 27 )和第 4极( 28 ); 四条尾部电缆从近端电缆结合 块(34 )分出, 分别连接双腔临时心脏起搏器的相应接线端。 6. A rapid bedside temporary cardiac pacing device according to claim 1, characterized in that: the four-pole elastic soft electrode (4) has a coaxial double-layer spiral coil structure, There is an insulating layer (25) in between, the inner coil layer (22) forms the central cavity (24), and is connected to the distal cathode (23), and the outer coil layer (32) is composed of three insulating guide wires (29) coated with insulating material ), (30), (31), and 3 insulated guide wires are connected to the 2nd pole (26), the 3rd pole (27), and the 4th pole (28) respectively; the 2nd pole, the 3rd pole, and the 4th pole The poles are ring electrodes, and the insulating guide wires of the outer coil layer (32) are wound around the insulation layer in parallel with each other and isolated from each other; the first insulating guide wire (29) is connected to the second pole (26), and the ring electrode is at the third pole (27) and the fourth pole (28) pass through; the first insulation guide wire (30) is connected to the third pole ( 27 ), and passes under the ring electrode fourth pole (28); the third insulation guide wire is connected The fourth pole (28), the ring electrodes (27), (28) and the guide wire ( 2 9) (30) passing below are insulated from each other; The wire coil layer (32) is covered by an outer sheath (36); the outer sheath covering the inner coil layer (22) protrudes to form a toothed fixed wing (35) near the distal cathode (23), and is used to anchor the distal end of the electrode , Made of biocompatible material silicon rubber, polyurethane or other body-friendly plastic, made of outer sheath, coaxial double-layer spiral coil insulation and toothed fixed wings; four-pole flexible soft electrode with four tail cables (33 ), Connect the inner coil layer (22) far pole cathode (23) and outer coil layer 2 (26), 3 (27) and 4 (28) respectively; four tail cables from the proximal cable combination block (34) Divided, respectively connected to the corresponding terminals of the dual-chamber temporary pacemaker. 7、 按照权利要求 1 所述的一种快速床边临时心脏起搏装置, 其特 征在于: 四极弹性软电极( 4 ) 第 2极( 26 ) 与远端阴极( 23 )相邻近, 第 3极( 27 ) 与第 4极( 28 )相邻近, 且位于距远端 10 ~ 20cm范围内, 四极弹性软电极体部( 41 )标有供插入时准确定位的参照长度标记( 41 )0 7. A rapid bedside temporary cardiac pacing device according to claim 1, characterized in that: the quadrupole flexible soft electrode (4), the second pole (26) is adjacent to the distal cathode (23), the first The 3 pole (27) is adjacent to the 4 pole (28) and is located within a range of 10 to 20 cm from the distal end. The quadrupole flexible soft electrode body (41) is marked with a reference length mark (41) for accurate positioning during insertion. ) 0 8、 按照权利要求 1 所述的一种快速床边临时心脏起搏装置, 其特 征在于: 四极弹性软电极(4 )配有两种塑形钢丝, 直形塑形钢丝 (20 ) 为直丝状, 长度短于插入塑形钢丝的中心孔腔(24 ) 的轴向全长; J 形 塑形钢丝 ( 21 )远端有一 J形弯头段, 弯头段远端为软端 ( 211 ), 紧接 J形弯头段的近端有一轻度弧形弯曲段。 8. A rapid bedside temporary cardiac pacing device according to claim 1, characterized in that: the four-pole elastic soft electrode (4) is provided with two shaped steel wires, and the straight shaped steel wire (20) is straight. Filament-shaped, shorter than the axial total length of the central cavity (24) into which the shaped steel wire is inserted; the J-shaped shaped steel wire (21) has a J-shaped elbow at the distal end, and the soft end (211) ), There is a slightly curved curved section near the proximal end of the J-shaped elbow section. 9、 一种如权利要求 1 所述的快速床边临时心脏起搏装置的使用方 法, 其特征在于: 从右锁骨上途径穿刺右颈内静脉或右锁骨下静脉, 将 引导钢丝从穿刺后的静脉入路送入, 用粗扩张器扩宽静脉入路, 然后将 其抽出, 将内装有假体导管 ( 2 ) 的: r形导入鞘( 1 )顺引导钢丝插入, 直至 J .形导入鞘( 1 ) 的远端 ( 5 ) J 形弯头段( 6 )被导入高右房上腔 静脉入口处, 然后再将假体导管 (2 )连同引导钢丝一起移除, 并在体 外将 J形导入鞘( 1 ) 的 J形弯头段( 6 )扭动指向患者的三尖瓣口, 把 四极弹性软电极(4 ) 与调好起搏参数的体外双腔临时心脏起搏器连接, 然后将四极弹性软电极( 4 )从 J形导入鞘 ( 1 ) 内通道( 51 ) 内插入, 直至出现连续右室起搏, 并认定起搏位置合格为止, 然后将 J形导入鞘 ( 1 )从体内撤出, 将插装在四极弹性软电极(4 ) 中心孔腔(24) 中的 直形塑形钢丝 (20)抽出, 电极继续向前推送到设定长度, 再将 J形塑 形钢丝 (21 ) 插入四极弹性软电极(4 ) 中心孔腔(24 ) 中, 使四极弹 性软电极( 4 ) 的第 3极( 27 ) 第 4极( 28 ) 贴靠右心房侧壁直至房室 双腔感知和起搏出现并认定合格为止。 9. A method for using a rapid bedside temporary cardiac pacing device according to claim 1, characterized in that: the right internal jugular vein or the right subclavian vein is punctured from the right supraclavicular route, and the guide wire is guided from the punctured Intravenous approach, use a wide dilator to widen the venous approach, then withdraw it, and insert the prosthesis catheter (2): r-shaped introduction sheath (1) into the guide wire until the J-shaped introduction sheath The distal end (1) (5) of the J-shaped elbow (6) is introduced into the entrance of the high right superior atrial vena cava, and then the prosthetic catheter (2) is removed along with the guide wire and placed in the body The J-shaped elbow section (6) of the J-shaped introduction sheath (1) is twisted toward the tricuspid valve mouth of the patient, and the quadrupole flexible soft electrode (4) and the external double-lumen temporary heart with adjusted pacing parameters are started. Connect the pacemaker, then insert the quadrupole flexible soft electrode (4) from the J-shape into the inner channel (51) of the sheath (1) until continuous right ventricular pacing occurs and it is determined that the pacing position is qualified, and then the J-shape The introduction sheath (1) is withdrawn from the body, and the straight shaped steel wire (20) inserted in the central cavity (24) of the quadrupole flexible soft electrode (4) is pulled out, and the electrode continues to be pushed forward to a set length, Then insert the J-shaped plastic wire (21) into the central cavity (24) of the four-pole flexible soft electrode (4), so that the third pole (27) and the fourth pole (28) of the four-pole flexible soft electrode (4) are pasted. Lean on the right atrium wall until atrioventricular dual-chamber sensing and pacing appears and is deemed eligible.
PCT/CN1999/000151 1998-09-28 1999-09-22 A fast bedside temporary pacemaker and method of using it Ceased WO2000018470A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU57262/99A AU5726299A (en) 1998-09-28 1999-09-22 A fast bedside temporary pacemaker and method of using it

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN98119015.4 1998-09-28
CN98119015 1998-09-28

Publications (1)

Publication Number Publication Date
WO2000018470A1 true WO2000018470A1 (en) 2000-04-06

Family

ID=5226214

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN1999/000151 Ceased WO2000018470A1 (en) 1998-09-28 1999-09-22 A fast bedside temporary pacemaker and method of using it

Country Status (3)

Country Link
CN (1) CN1127990C (en)
AU (1) AU5726299A (en)
WO (1) WO2000018470A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115253070A (en) * 2022-09-02 2022-11-01 首都医科大学附属北京安贞医院 Bedside TVTP electrode catheter
CN120713607A (en) * 2025-08-21 2025-09-30 上海交通大学医学院附属仁济医院 A device for segmented removal of cardiac pacing electrodes via the inferior vena cava

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10207104B2 (en) 2012-12-31 2019-02-19 Shanghai Microport Medical (Group) Co., Ltd. Cardiac electrical lead
US10828499B2 (en) 2017-05-05 2020-11-10 Pacesetter, Inc. Implant delivery and retrieval systems and methods
US10765872B2 (en) * 2017-05-05 2020-09-08 Pacesetter, Inc. Implant delivery and retrieval systems and methods
CN111265259B (en) * 2020-03-20 2024-10-29 江苏省人民医院(南京医科大学第一附属医院) Device for interventional therapy of adult congenital heart disease under guidance of ultrasonic cardiogram
CN115721854B (en) * 2021-08-30 2024-03-26 深圳市先健心康医疗电子有限公司 Electrode catheter structure and pacing electrode catheter device
CN115869542A (en) * 2021-09-29 2023-03-31 创领心律管理医疗器械(上海)有限公司 Medical electrode lead assembly and cardiac pacing system
CN118873834B (en) * 2024-07-09 2025-02-07 中国人民解放军总医院第二医学中心 Shaping floating heart temporary pacing electrode

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2078178U (en) * 1990-12-13 1991-06-05 秦明医学仪器有限公司 Guide-pipe electrode of caridio-activator
CN2102760U (en) * 1990-08-27 1992-04-29 广西钦州地区医院 Adjustable zigzag esophagus pacemaker cardiover electrode conduit
CN1157177A (en) * 1995-11-30 1997-08-20 惠普公司 Systems and methods for controlling transcutaneous cardiac pacing using electrical nerve stimulation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2102760U (en) * 1990-08-27 1992-04-29 广西钦州地区医院 Adjustable zigzag esophagus pacemaker cardiover electrode conduit
CN2078178U (en) * 1990-12-13 1991-06-05 秦明医学仪器有限公司 Guide-pipe electrode of caridio-activator
CN1157177A (en) * 1995-11-30 1997-08-20 惠普公司 Systems and methods for controlling transcutaneous cardiac pacing using electrical nerve stimulation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115253070A (en) * 2022-09-02 2022-11-01 首都医科大学附属北京安贞医院 Bedside TVTP electrode catheter
CN115253070B (en) * 2022-09-02 2023-01-24 首都医科大学附属北京安贞医院 Bedside TVTP lead
CN120713607A (en) * 2025-08-21 2025-09-30 上海交通大学医学院附属仁济医院 A device for segmented removal of cardiac pacing electrodes via the inferior vena cava
CN120713607B (en) * 2025-08-21 2025-11-14 上海交通大学医学院附属仁济医院 Segmented pulling device for heart pacing electrode from inferior vena cava approach

Also Published As

Publication number Publication date
AU5726299A (en) 2000-04-17
CN1127990C (en) 2003-11-19
CN1319027A (en) 2001-10-24

Similar Documents

Publication Publication Date Title
EP2526997B1 (en) Bundle of His stimulation system
US5571161A (en) Apparatus and method for implanting electrical leads in the heart
EP2291212B1 (en) Delivery catheter including side port and electrodes
US10369356B2 (en) Transcoronary sinus pacing system, LV summit pacing, early mitral closure pacing, and methods therefor
US6544270B1 (en) Multi-lumen cardiac catheter and system
EP2092955B1 (en) Leads for pacing and/or sensing the heart from within the coronary veins
US5827296A (en) Medical electrical lead
US20090259283A1 (en) Sheathed lead for pacing or defibrillation
US20020161423A1 (en) System and method for positioning an implantable medical device within a body
JPH07178183A (en) Sheath introducer
US11577075B1 (en) Transcoronary sinus pacing of his bundle
CN105056397A (en) Implantable nerve electrical stimulation electrode assembly and application method thereof
US11648397B1 (en) Transcoronary sinus pacing of posteroseptal left ventricular base
US4401127A (en) Stable electrodes for endocardial pacing
US4357947A (en) Electrode and method for endocardial atrial pacing
Belott A variation on the introducer technique for unlimited access to the subclavian vein
WO2000018470A1 (en) A fast bedside temporary pacemaker and method of using it
US20060089693A1 (en) Delivery system and method using pulmonary artery for placement of RV leads
US7672735B2 (en) Two-part implantable cardiac lead
US4552157A (en) Open curve, atrial "J" electrode
CN111184947B (en) Cerclage pacemaker lead
US8750996B2 (en) Medical implantable lead
BR202016023782Y1 (en) INTRAMUSCULAR ELECTRODE FOR ELECTRICAL DIAPHRAGM STIMULATION

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 99811141.4

Country of ref document: CN

AK Designated states

Kind code of ref document: A1

Designated state(s): AE AL AM AT AU AZ BA BB BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase