CN112274777A - Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side - Google Patents

Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side Download PDF

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Publication number
CN112274777A
CN112274777A CN202011210848.9A CN202011210848A CN112274777A CN 112274777 A CN112274777 A CN 112274777A CN 202011210848 A CN202011210848 A CN 202011210848A CN 112274777 A CN112274777 A CN 112274777A
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China
Prior art keywords
pulse generator
pacing
bundle branch
delivery
left bundle
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Pending
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CN202011210848.9A
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Chinese (zh)
Inventor
梁义秀
宿燕岗
汪菁峰
葛均波
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Zhongshan Hospital Fudan University
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Zhongshan Hospital Fudan University
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Priority to CN202011210848.9A priority Critical patent/CN112274777A/en
Publication of CN112274777A publication Critical patent/CN112274777A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • A61N1/3702Physiological parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37205Microstimulators, e.g. implantable through a cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/37512Pacemakers

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

Abstract

The utility model provides a do not have lead pacing system that realizes left bundle branch pacing at ventricular interval left ventricle side, relates to the surgical instruments field, includes: a pulse generator; and a delivery system for delivering the pulse generator such that the pulse generator screws into the myocardium and contacts the left bundle branch.

Description

Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side
Technical Field
The invention relates to the field of surgical instruments, in particular to a leadless pacing system for realizing left bundle branch pacing on the left ventricle side of a ventricular septum.
Background
The electrode lead currently used to achieve left bundle branch pacing is the lead of a conventional cardiac pacemaker, and is used by implanting the lead along the vein to the right ventricle after puncturing the left or right subclavian vein. The head end of the lead is a spiral structure and can be screwed into the ventricular septum to reach the myocardium of the left bundle branch or the left bundle branch region, and the tail end of the lead is connected with the pulse generator. The disadvantages of this system and technique are: 1) in the operation, the guide wire needs to be repeatedly screwed in and out to find the left bundle branch, so that the time is consumed, and the infection risk in the operation is increased; 2) the right bundle branch is damaged in the process of screwing in the lead in the operation; 3) damaging the right bundle of coronary artery septal branch in the process of screwing in the guide wire in the operation; 4) The lead tip is very close to the ventricular septum left ventricle, which may cause perforation of the ventricular septum after surgery, directly affecting pacing parameters and requiring re-surgery. It is an urgent problem to develop a system or device that can conveniently screw a pulse generator into the myocardium and contact the left bundle branch.
Disclosure of Invention
It is an object of the present invention to provide a leadless pacing system for pacing a left bundle branch on the left ventricular side of a ventricular septum to solve the above problems.
The embodiment of the invention is realized by the following steps:
in one aspect of the embodiments of the present invention, there is provided a leadless pacing system for implementing left bundle branch pacing on the left ventricle side of a ventricular septum, including: a pulse generator; and a delivery system for delivering the pulse generator such that the pulse generator screws into the myocardium and contacts the left bundle branch.
Optionally, the head of the pulse generator has a spiral structure with a conductive function capable of pacing the left bundle branch it contacts.
Optionally, the delivery system comprises an introducer, a delivery sheath and a delivery catheter. The delivery sheath is bendable for delivering the pulse generator to the target area; the head end of the delivery catheter is connected with the pulse generator, the tail end of the delivery catheter is connected with the control handle, and the mapping electrode is contained in the delivery catheter.
Optionally, the tail end of the pulse generator is provided with a T-shaped buckle, and the pulse generator is clamped with the delivery conduit through the T-shaped buckle.
Optionally, the tail end of the delivery sheath is connected with a button which is arranged on the operating handle and used for adjusting the bending degree of the delivery system; the tail end of the delivery catheter is connected with the control handle, a second button for rotating and screwing the head end of the pulse generator into the myocardium and a third button for releasing the connection of the delivery catheter and the T-shaped buckle at the tail end of the pulse generator are arranged on the delivery catheter.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.
FIG. 1 is a schematic diagram of an embodiment of a pulse generator according to the present application;
FIG. 2 is a schematic view of the structure of an introducer (inner band dilator) of the present application;
fig. 3 is a schematic structural diagram of an embodiment of a delivery system according to the present application.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships that the products of the present invention are conventionally placed in use, and are only used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
Furthermore, the terms "horizontal", "vertical" and the like do not imply that the components are required to be absolutely horizontal or pendant, but rather may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Referring to fig. 1 to fig. 3, the present embodiment provides a leadless pacing system for pacing a left bundle branch at a left ventricle side of a ventricular septum, including: a pulse generator 1; and a delivery system for delivering the pulse generator 1 such that the pulse generator 1 is screwed into the myocardium and contacts the left bundle branch.
As described above, the leadless pacing system for pacing a left bundle branch on the left ventricle side of a ventricular septum according to the present embodiment can more easily screw the pulse generator 1 into the myocardium and contact the left bundle branch by the delivery system. The left bundle branch is a conduction path located in the ventricle, and when some reasons cause delayed or blocked activation of the left bundle branch conduction, the right ventricle passes into the left ventricle through the ventricular septum, resulting in obvious delayed activation of the left ventricle, which is called as left bundle branch conduction block. The occurrence of left bundle branch block is very rare in the normal population, and when left bundle branch block occurs, most patients are suggested to suffer from organic heart diseases, such as left ventricular hypertrophy and ischemia, left ventricular dilation leading to left bundle branch rupture, and the like. Diagnosis can be by electrocardiogram. This explanation is not intended to be exhaustive, as the invention can only be applied to patients with left bundle branch block.
Further, the head end of the pulse generator 1 has a spiral structure 11. Wherein the pulse generator 1 contains circuitry and a battery for eventual pacing in the heart chamber. A pulse generator 1 delivery system for delivering a pulse generator 1 to the left bundle branch or left bundle branch region on the left ventricular side of the ventricular septum.
In detail, the pulse generator 1 comprises an electric circuit and a lithium battery, housed in a metal casing. The head end of the shell is used as the cathode of the pacing circuit, is spiral and can be screwed into the cardiac muscle clockwise; the tail end of the shell is used as an anode of the pacing circuit, is made into a T-shaped buckle and can be firmly clamped with a mapping catheter in a delivery system.
The spiral structure 11 at the head end of the pulse generator 1 can be screwed into cardiac muscle and contacts the left bundle branch to be used as the cathode of the pacing circuit;
a circuit 14 in the pulse generator 1 for processing the sensing signal and emitting the pulse signal;
a battery 15 in the pulse generator 1;
the tail end of the pulse generator 1, which is used as the anode of the pacing circuit, is a T-shaped buckle 13 and can be firmly buckled with the conveying catheter 3 in the delivery system;
a guidewire 12 within the delivery catheter 3 is connected to the electrophysiology system through the trailing end of the delivery system for mapping potentials.
Further, the delivery system comprises an introducer 5, a delivery sheath 4 and a delivery catheter 3, the head end of the delivery catheter 3 is connected with the pulse generator 1, the tail ends of the delivery sheath 4 and the delivery catheter 3 are connected with a control handle, the inner sheath 3 is internally provided with a mapping electrode 31, and the pulse generator 1 and the delivery catheter 3 are both arranged inside the delivery sheath 4.
The tail end of the pulse generator 1 is provided with a T-shaped buckle, and the pulse generator 1 is clamped with the conveying conduit 3 through the T-shaped buckle 13.
The operating handle is provided with a first button 31 for adjusting the bending degree of the delivery sheath 4, a second button 32 for rotating the delivery catheter 3 and screwing the head end of the pulse generator 1 into the myocardium, and a third button 33 for releasing the T-shaped buckle connection between the delivery catheter 3 and the tail end of the pulse generator 1.
In detail, the delivery system comprises an introducer 5, a delivery sheath 4 and a delivery catheter 3. Wherein the head end of the transmission catheter 3 is connected and firmly clamped with the T-shaped buckle at the tail end of the pulse generator 1, the transmission catheter 3 contains a lead, and the lead is connected with the connector on the handle at the tail end and can be further connected with an electrophysiological system for mapping potential. The handle is provided with 3 buttons which are respectively used for adjusting the delivery sheath 4, rotating the delivery sheath 4, screwing the head end of the pulse generator 1 into the myocardium and releasing the connection of the delivery sheath 4 and the T-shaped buckle at the tail end of the pulse generator 1.
The tail end of the pulse generator 1 is used as the anode of the pacing circuit and is a T-shaped buckle which can be firmly buckled with a conveying catheter 3 in a delivery system; the first button 21 is used to adjust the camber of the delivery system; the second button 22 is used for rotating the delivery sheath 4 and screwing the head end of the pulse generator 1 into the myocardium; the third button 23 is used for releasing the connection between the delivery sheath 4 and the T-shaped buckle at the tail end of the pulse generator 1; the handle is operated.
One method of use of the present application is as follows:
1) the femoral artery is punctured, heparinized and activated clotting time monitored, the guidewire is fed through the femoral artery over the aortic valve, the introducer 5 (containing dilator 51) of the delivery system is fed along the guidewire, the dilator 51 is withdrawn, then the delivery sheath 4 is fed along the guidewire over the aortic valve, then the guidewire is withdrawn, and then the delivery catheter 3 is fed along the delivery sheath 4 to the left ventricle.
2) The curvature of the transmission sheath 4 is controlled and adjusted, so that the head end of the pulse generator 1 can walk on the left ventricle side of the ventricular septum, and the left bundle branch potential can be searched and mapped.
3) After the left bundle branch potential is marked, the top of the delivery catheter 3 is pressed towards the ventricular septum and fixed with little force, the left bundle branch potential is determined to still exist, the head end of the pulse generator 1 is controlled to be screwed into the ventricular septum myocardium, and the pacing threshold, the sensing and the impedance are tested;
4) the delivery catheter 3 is manipulated to release the T-clip connection to the tail end of the pulse generator 1 and the delivery catheter 3, delivery sheath 4 and introducer 5 are withdrawn.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (5)

1. A leadless pacing system for implementing left bundle branch pacing on the left ventricular side of a ventricular septum, comprising:
a pulse generator; and
a delivery system for delivering the pulse generator such that the pulse generator screws into the myocardium and contacts the left bundle branch.
2. The leadless pacing system for pacing a left bundle branch on the left ventricular side of a ventricular septum of claim 1, wherein the tip of the pulse generator has a helical structure with a conductive function capable of pacing a left bundle branch that it contacts.
3. The leadless pacing system for pacing a left bundle branch on the left ventricular side of a ventricular septum of claim 2, wherein the delivery system comprises an introducer, a delivery sheath and a delivery catheter, the delivery sheath being bendable for delivering the pulse generator to a target area; the head end of the delivery catheter is connected with the pulse generator, the tail end of the delivery catheter is connected with the control handle, and the mapping electrode is contained in the delivery catheter.
4. The leadless pacing system for pacing a left bundle branch on the ventricular side of a ventricular septum of claim 3, wherein the trailing end of the pulse generator has a T-shaped snap, by which the pulse generator snaps with the delivery catheter.
5. The leadless pacing system for pacing a left bundle branch on the left ventricular side of a ventricular septum of claim 4, wherein the delivery sheath trailing end connection manipulating handle has a button for adjusting the curvature of the delivery system; the tail end of the delivery catheter is connected with the control handle, a second button for rotating and screwing the head end of the pulse generator into the myocardium and a third button for releasing the connection of the delivery catheter and the T-shaped buckle at the tail end of the pulse generator are arranged on the delivery catheter.
CN202011210848.9A 2020-11-03 2020-11-03 Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side Pending CN112274777A (en)

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CN202011210848.9A CN112274777A (en) 2020-11-03 2020-11-03 Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side

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CN202011210848.9A CN112274777A (en) 2020-11-03 2020-11-03 Leadless pacing system for realizing left bundle branch pacing at ventricular septum left ventricle side

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023056867A1 (en) * 2021-10-08 2023-04-13 中国医学科学院阜外医院 Leadless left-bundle-branch pacemaker

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108079437A (en) * 2016-11-21 2018-05-29 创领心律管理医疗器械(上海)有限公司 Pacemaker and its fixing means and transport system
CN109498983A (en) * 2018-12-29 2019-03-22 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker
CN109568793A (en) * 2018-12-25 2019-04-05 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker and without conducting wire pacing system
CN110382042A (en) * 2017-03-03 2019-10-25 美敦力公司 For determining the standard of the local organization delay near pacing electrode
CN111246910A (en) * 2017-10-17 2020-06-05 美敦力公司 Leadless pacing device for bundle and branch pacing

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108079437A (en) * 2016-11-21 2018-05-29 创领心律管理医疗器械(上海)有限公司 Pacemaker and its fixing means and transport system
CN110382042A (en) * 2017-03-03 2019-10-25 美敦力公司 For determining the standard of the local organization delay near pacing electrode
CN111246910A (en) * 2017-10-17 2020-06-05 美敦力公司 Leadless pacing device for bundle and branch pacing
CN109568793A (en) * 2018-12-25 2019-04-05 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker and without conducting wire pacing system
CN109498983A (en) * 2018-12-29 2019-03-22 创领心律管理医疗器械(上海)有限公司 Without conducting wire pacemaker

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023056867A1 (en) * 2021-10-08 2023-04-13 中国医学科学院阜外医院 Leadless left-bundle-branch pacemaker

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