KR20160020887A - Devices and Method of trans-coronary sinus mid to apical interventricular septal pacing in the lead end of the cardiac pacemaker - Google Patents

Devices and Method of trans-coronary sinus mid to apical interventricular septal pacing in the lead end of the cardiac pacemaker Download PDF

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KR20160020887A
KR20160020887A KR1020140106209A KR20140106209A KR20160020887A KR 20160020887 A KR20160020887 A KR 20160020887A KR 1020140106209 A KR1020140106209 A KR 1020140106209A KR 20140106209 A KR20140106209 A KR 20140106209A KR 20160020887 A KR20160020887 A KR 20160020887A
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catheter
wire
vein
lead
coronary sinus
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김준홍
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부산대학교 산학협력단
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Priority to KR1020140106209A priority Critical patent/KR20160020887A/en
Priority to PCT/KR2015/006045 priority patent/WO2016024710A1/en
Publication of KR20160020887A publication Critical patent/KR20160020887A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • 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

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Abstract

The present invention relates to a method, apparatus and catheter for positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum, and more particularly, to a method, apparatus and catheter for use in a pacemaker To a method, apparatus and catheter for positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum as part of a method for delivering electrical stimulation more effectively.
According to a preferred embodiment of the present invention, an apparatus for positioning a lead end of a pacemaker includes a surgical wire, a capture catheter, and a pacemaker lead.
A method of locating the lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum according to the present invention includes passing a surgical wire through a superior vein and a coronary sinus through a middle or attached ventricular septum, And a step of inserting the lead of the pacemaker along the procedure wire to position the end of the lead in the ventricular septum.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and apparatus for positioning a lead end of a cardiac pacemaker through a coronary sinus in a middle or attached ventricular septum,

The present invention relates to a method, apparatus and catheter for positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum, and more particularly, to a method, apparatus and catheter for use in a pacemaker To a method, apparatus and catheter for positioning the lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum as part of a method for delivering electrical stimulation more effectively.

Since the introduction of artificial pacemakers for the first time by Furman and Rovinson in 1958, pacemakers have been used as a major therapy for patients with bradyarrhythmia. Recently, artificial pacemakers have been used as a major treatment for arrhythmia, such as complete atrioventricular block, high-risk atrioventricular block, and symptomatic dysfunctional syndrome. Heart pacemaker therapy is a therapy that artificially induces electrical stimulation by artificial pacemakers because the electrical stimulation of the heart can not flow normally.

1 is a diagram of a conduction system of a heart, wherein (A) is a flowchart of a conduction system, (B) shows a waveform of an electrocardiogram, (C) shows a relationship between a conduction process and a waveform FIG.

Referring to FIG. 1, the conduction conduction of the heart passes through a bundle branch from the sinoatrial (SA) node to the atrioventricular (AV) node in the atrium, from the ventricle's heath in the atrium, Through the ventricles. Delivery of stimuli in the ventricles is via the His-Purkinje system.

In the electrocardiogram, the QRS complex (QRS wave) is generated by the depolarization process of the ventricular muscle. The first downward wave following the P wave is Q wave, the first upward wave is R wave and the downward wave following R is called S wave Stick. The width of the QRS is the time at which electrical conduction from the His to the ventricle is conducted. At normal times, the width of the QRS wave is within about 0.12 seconds (about 90 ms), and when it is over 0.12 seconds (120 ms) Suggesting a disturbance of the ventricular conduction.

A pacemaker consists of a generator and a lead. The main body supplies the power, and the computer also contains a guide wire to identify the electrical state of the card coming in, and to supply electricity or rest if necessary. The lead wire serves to transfer the electricity generated from the main body to the heart.

FIG. 2 shows the currently practiced pacing method.

Currently, electrical stimulation of the ventricle in the treatment of normal pacemakers inserts the end of the pacemaker lead into the apex of the right ventricle (RV apex) and provides electrical stimulation. This is called "right ventricular apical pacing, RVAP".

As in RVAP, electrical stimulation in the RV apex does not result in electrical stimulation through a conduction system, a specialized tissue structure for rapid electrical stimulation in the ventricle, and a relatively slow electrical stimulation Because the stimulus is transmitted through the myocardial cells of the ventricle, all of the electrical stimulation is slowed down in the entire ventricle. This means that the QRS width on ECG is widened, and it is called Wide QRS. That is, the QRS over RVAP is about 160 ms, which is considerably slower than about 90 ms in the normal case.

Wide QRS has the side effect of causing ventricular dyssynchonization, which results in loss of ventricular function, in which movement of the ventricles is not unified. To overcome these side effects, many efforts have been made to obtain narrower QRS by applying electric stimulation near a condution system located in the interventricular septum.

A typical approach is to position the lead of the pacemaker on the right ventricular basal septum and apply electrical stimulation around the conduction system. This is called "right ventricular septal pacing, RVSP". The most common place for RVSP is the ventricular septum of the right ventricular outflow tract (RVOT).

Although RVSP theoretically supplements the disadvantages of RVAP, it is not easy to accurately position the lead of the pacemaker to the ventricular septum around the RVOT, and the lead is lost or the position is changed There is a limitation that the procedure itself can not be used because of difficulties. One of the other considerations is that RVSP is placed on the ventricular septum at the end of the lead but it is fixed to the outer wall of the ventricular septum rather than the inside of the ventricular septum. It stimulates in the middle of the left ventricular endocardium or ventricular septum It is known to be less effective than the method.

Another approach to acquire a narrower QRS is the case of a wide QRS in patients with heart failure with ventricular dysfunction. One lead is placed in the right ventricular apex (RV apex) using two leads, And the other leads electrically stimulate the side of the left ventricle in the left lateral vein. In other words, it is a treatment to secure narrower QRS by applying electrical stimulation to the sides of the right ventricle and the left ventricle simultaneously. This is called "Cardiac Resynchronization Therapy (CRT)".

The CRT treatment is known to be a very effective and epoch-making treatment when there are problems such as left bundle branch block (LBBB) in patients with heart failure. However, the CRT treatment has the disadvantage of requiring two leads to stimulate the ventricles to obtain a narrower QRS.

The current treatment modality can be applied to the ventricular septum in which the conduction system of the ventricle is located when electrical stimulation is applied to the ventricle. Theoretically, narrower QRS can be obtained, This physiological electrical stimulation can overcome the problems that arise in RVAP and can be expected to have a good effect in some patients who require CRT.

Recently, several studies have shown that direct electrical stimulation to the ventricular septum can complement the disadvantages of RVAP, and it can also be helpful in patients with ventricular dysfunction requiring CRT in animal experiments. Several approaches have been attempted to provide direct electrical stimulation in the ventricular septum, such as US Pat. No. US 2010/0298841 and United States Patent (US 2013/0231728), wherein the lead of the pacemaker is in the right ventricle, And then placing the lead of the pacemaker in the ventricular septum forcibly. These methods are highly invasive methods that cause an artificial ventricular septal defect between the left ventricle and the right ventricle. There is a high risk of tearing the surrounding tissue during the procedure, and the risk of embolism due to air or thrombosis is also very high . In addition, there are many risks and limitations, such as the location of the preferred site, not the basal portion of the ventricle, but accessible only to the apex side.

Therefore, it is necessary to investigate a safer and more convenient way to obtain narrow QRS by applying direct electrical stimulation to the conduction system of the ventricle.

As a result of this research, the present inventor has proposed a method of placing a pacemaker lead inside the ventricular septum (Korean Patent Application No. 10-2014-092789). This method involves positioning the pacemaker lead in the ventricular septum of the basal part of the ventricular septum (ventricular septum near the atrium), but in some research papers, the apical part of the ventricle It is more advantageous to place it.

U.S. Published patents (US2010 / 0298841 A1, published November 25, 2010) U.S. Published patents (US 2013/0231728 A1 (published September 5, 2013)

SUMMARY OF THE INVENTION The present invention has been made to solve the above problems, and it is an object of the present invention to provide an electrocardiographic apparatus, an electrocardiogram Device, and catheter for positioning a lead end of a pacemaker through a coronary sinus in a safer, simpler, intermediate, or attached ventricular septum.

In order to achieve the above object, the present invention provides a method for delivering an effective electrical stimulus in accordance with a preferred embodiment of the present invention, the method comprising the steps of: delivering a cardiac conduction system in a middle or apical interventricular septum, The device for positioning the lead end of the pacemaker through the sinus is a surgical wire connected to the superior vein (SVC), the coronary sinus (CS), the AIV, the ventricular septum, the right ventricle, the right atrium, and the superior vein or inferior vein; A capture catheter inserted through a superior vein or an inferior vein to capture a surgical wire positioned in the right ventricle; And a pacemaker lead inserted along the surgical wire and inserted into apical interventricular septum tissue having an end attached thereto.

According to a preferred embodiment, a through hole through which a surgical wire passes is formed. In order to easily detect a septal vein and an anterior interventricular vein (AIV) located in a ventricular septum by blocking a coronary sinus, And further includes a balloon tipped guiding catheter in which a bloon capable of inflating the air is blown.

A method for positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum in which a conduction system of the heart is located for delivering effective electrical stimulation, according to a preferred embodiment of the present invention, comprises the steps of: i) Intravenous, coronary sinus (CS) and anterior interventricular vein (AIV); ii) positioning the surgical wire through the intermediate or attached apical interventricular septum into the right ventricle of the heart; iii) inserting the capture catheter inserted into the superior vein or vein into the right ventricle through the right atrium; Iv) capturing the surgical wire with the capture unit of the capture catheter, and then pulling the surgical wire captured with the capture catheter toward the superior vein or the inferior vein; And inserting a lead of the pacemaker along the procedure wire in a state of holding both ends of the surgical wire, thereby positioning the end of the lead in the attached ventricular septum.

As described above, the present invention provides a method for positioning a lead end of a pacemaker that has passed through a coronary sinus in a middle or apical interventricular septum. The apparatus includes a coronary sinus (CS) (1) overcome the disadvantages of wider QRS pacing due to the conventional RVAP, (2) overcome the disadvantages of conventional RVAP in patients requiring a conventional CRT, In patients with narrower QRS by septal pacing alone, the present invention has the advantage of being able to expect a therapeutic effect with only one lead without using two leads.

Also, according to the present invention, a high-risk and non-physiological procedure for artificially opening the left ventricle for high-pressure arterial blood and the low-pressure right ventricle as in the above-mentioned conventional patents US 2010/0298841 A1 and US 2013/0231728 A1 This procedure can be performed by placing a pacemaker lead in the ventricular septal tissue through a relatively simple procedure in the flow of the vein using the path that is as naturally as possible along the path of the septal vein, There is an advantage that the risk can be minimized.

Compared with the method proposed by the present inventor, the present inventors have succeeded in avoiding the intracardiac tissue (leaflet, subvavular structure, moderator band, etc.) of the heart, It is possible to prevent damage to the tissue in the heart as described above.

1 is a diagram of a conduction system of a heart, wherein (A) is a flowchart of a conduction system, (B) shows a waveform of an electrocardiogram, (C) shows a relationship between a conduction process and a waveform FIG.
Fig. 2 is a view showing a currently practiced pacing method. Fig.
3 is a flowchart of a method for positioning a lead end of a pacemaker through a coronary sinus in an attached ventricular septum according to a preferred embodiment of the present invention.
Figures 4 and 5 are schematic diagrams of anatomical structures of the heart and coronary veins, in accordance with a preferred embodiment of the present invention.
Figure 6 is a photograph of a Pressuized septal venogram when a coronary sinus is obstructed using a balloon catheter, according to a preferred embodiment of the present invention.
FIG. 7 is a schematic cross-sectional view of a dual-type perforated catheter according to a preferred embodiment of the present invention, wherein (A) when the lengths of the first tube and the second tube are the same, Are different from each other.
FIGS. 8 and 9 are partial cutaway views showing a procedure of puncturing a ventricular septum using a dual-type perforated catheter according to a preferred embodiment of the present invention. FIG. 8 is a cross- Fig. 9 shows a case in which the advancing direction of the support wire is the RV epicardial vein direction.
10 is a photograph showing a path through which a surgical wire passes, according to a preferred embodiment of the present invention.
Figure 11 illustrates an example of a capture catheter, in accordance with a preferred embodiment of the present invention.
12 is a schematic diagram showing a state in which the capture means (mesh network) of the capture catheter is deployed in the heart, according to a preferred embodiment of the present invention.

Methods, devices and catheters for locating the lead end of a pacemaker in the mid or apical interventricular septum of the present invention are useful for the treatment of coronary sinus and AIV (anterior interventricular vein ) And then placing the lead end of the pacemaker in the middle or attached ventricular septum. That is, a method and apparatus are provided for placing the lead end of a pacemaker in a middle or attached ventricular septum so as to provide direct electrical stimulation in the middle or attached ventricular septum in which the conduction system of the heart is located.

In the case of the RVSP described above, the end of the lead of the pacemaker is placed in the ventricular septum. However, the conduction system, which is located inside the ventricular septum, is theoretically fixed to the outer wall of the ventricular septum, Is less effective when delivering electrical stimulation in the intra-septal ventricle.

The present inventors have developed a method and apparatus for positioning a lead end of a pacemaker in a middle or attached ventricular septum using a surgical wire passing through a superior vein, a coronary sinus, a ventricular septum, and an inferior vein (or a superior vein).

The method of positioning the lead end of the pacemaker of the present invention in the ventricular septum comprises the steps of: i) inserting a surgical wire through a superior vein, a coronary sinus (CS) and an anterior interventricular vein (AIV); ii) placing the surgical wire through a mid or apical interventricular septum into the right ventricle of the heart; iii) inserting the capture catheter inserted into the superior vein or the inferior vein through the right atrium into the right ventricle, and capturing the surgical wire with the capturing means of the capture catheter; Iv) withdrawing the surgical wire captured with the capture catheter toward the superior vein or the inferior vein; And inserting a lead of the pacemaker along the procedure wire in a state of holding both ends of the surgical wire, thereby positioning the end of the lead in the middle or attached ventricular septum.

In other words, the procedure involves introducing the surgical wire through the superior vein and coronary sinus, passing the middle or attached ventricular septum into the right ventricle, and then directing it to the superior vein or inferior vein; And inserting the lead of the pacemaker along the surgical wire to position the end of the lead in the middle or the inner ventricle of the attached ventricular septum.

Hereinafter, a method of placing the lead end of the pacemaker of the present invention in the ventricular septum will be described in detail with reference to the accompanying drawings.

3 is a flowchart of a method of positioning a lead end of a pacemaker in a ventricular septum according to a preferred embodiment of the present invention. The method of the present invention will be described with reference to Fig.

Referring to FIG. 3, the following steps are performed: (i) inserting a surgical wire through a superior vein, a coronary sinus (CS), and an anterior interventricular vein (S10).

The "intervention wire" is inserted through the superior vein, the coronary sinus and the AIV, through the middle or attached ventricular septum, and then into the inferior vein (or the superior vein), and the two are fixed by the practitioner The lid of the pacemaker is inserted through the coronary sinus and serves as a support for insertion into the middle or attached ventricular septum. Preferably, a surgical wire of about 0.014 " is used as the surgical wire. The intervention wire is also referred to as a "pacemaker lead guide wire " because it serves to guide the pacemaker lead.

The surgical wires are delivered to the middle or attached ventricular septum through a septum vein and anterior interventricular vein (AIV) of the appropriate ventricular basal ganglia. However, it is true that it is generally difficult for practitioners to confirm the presence of Hepvar and AIV. For this purpose, a balloon catheter with a through hole through which the surgical wire passes is needed. A balloon tipped guiding catheter is a catheter with a balloon at the tip of the catheter. The catheter is inserted through the superior vein and the coronary sinus, and air is injected from the outside to inflate the balloon to block the coronary sinus. Thus, the flow of blood flow in the coronary sinus is blocked, the pressure of the coronary sinus increases, and the coronary sinus becomes swollen. Then, by contrasting the pressurized venogram, a septic vein (AV) and AIV located in the ventricular septum are found.

Figures 4 and 5 are schematic diagrams of anatomical structures of the heart and coronary veins, in accordance with a preferred embodiment of the present invention.

Referring to FIGS. 4 and 5, the superior vein is connected to a coronary sinus (CS), and the coronary sinus (CS) is connected to an anterior interventricular vein (AIV) through a GCV (great cardiac vein). Therefore, in the present invention, the surgical wire is inserted into the superior vein and inserted into the coronary sinus, the great cardiac vein (GCV), and the anterior interventricular vein (AIV). The surgical wires inserted into the AIV are guided through the mid or apical interventricular septum and into the right ventricle. In Fig. 5, the circle indicates the position of the end of the surgical wire, that is, the position of the ventricular septum into which the surgical wire is inserted.

Figure 6 is a photograph of a pressuited septal venogram when a coronary sinus is blocked with a balloon catheter, according to a preferred embodiment of the present invention.

An intervention wire is inserted through the through-hole of the balloon catheter into the pleural cavity and the AIV, and then passed through a mid-apical interventricular septum by an external force.

That is, step (ii) is a step (ii) of placing the surgical wire through the middle or attached ventricular septum and placing the surgical wire in the right ventricle (S20).

After the procedure wire has passed the middle or attached ventricular septum, the balloon catheter is pulled out and removed, and the end of the procedure wire is located in the middle or attached right ventricle.

On the other hand, if ventricular septal defects are difficult to achieve with only surgical wires, a separate ventricular septal perforation catheter is needed. A ventricular septal perforation catheter is a dual-type perforated catheter made up of two tubes into which two wires are inserted, respectively.

In other words, in general, there is no need for a separate ventricular septal perforation catheter, and the distal end of the treatment wire is pierced, so that the treatment wire can directly cross the middle or apical interventricular septum. However, The ventricular septal puncture catheter is required in exceptional cases.

Figure 7 shows a dual-type perforated catheter having two lumens.

FIG. 7 is a schematic cross-sectional view of a dual-type perforated catheter according to a preferred embodiment of the present invention, wherein (A) when the lengths of the first tube and the second tube are the same, 8 and 9 are a partial cut-away view showing a procedure of puncturing a ventricular septum using a dual-type puncture catheter. FIG. 8 shows a case where the advancing direction of the support wire is the RVIT direction, Shows the case where the advancing direction of the supporting wire is the RV epicardial vein direction.

First, referring to FIG. 7, a dual-type perforated catheter having two lumens is composed of a first tube into which a support wire is inserted and a second tube into which a treatment wire is inserted. The first tube 11 and the second tube 12 of the puncture catheter are in tight contact with each other and are fixedly coupled to each other. The two tubes may be formed in close contact with each other or may be divided into two spaces by a membrane in one tube . The lengths of the first tube 11 and the second tube 12 may be the same or different. 7A shows a case where the lengths of the first tube and the second tube are the same, and FIG. 7B shows a case where the lengths of the first tube and the second tube are different. When it is not necessary to make the length of the supporting wire longer than that of the surgical wire, the length of the first tube is formed to be shorter than that of the first tube, as shown in FIG. 7B.

The support wire 21 inserted in the first tube 11 is used to support the middle wire 12 when the surgical wire 22 inserted in the second tube 12 punctures the middle or apical interventricular septum The support wire 21 serves as a support for preventing the surgical wire 22 from being pushed back when the surgical wire 22 punctures the middle or attached ventricular septum. As described above, the treatment wire 22 is connected to the superior vein or the vein after passing through the ventricular septum and serves to guide or support the lead of the pacemaker when the lead is inserted.

Because the support wire serves as a support and the surgical wire is used to pass through the middle or attached ventricular septum, it is preferable to use a wire that is relatively more flexible than the surgical wire.

A radiopaque marker 14 is formed in the puncture catheter. The radiopaque marker 14 is for grasping the position of the perforation catheter (position of the end of the surgical wire) through the imaging device and helping the surgical wire 22 to puncture the ventricular septum. That is, the radiopaque marker 14 is formed to provide ease of intermediate or attached ventricular septal perforation.

On the other hand, the second tube end of the puncture catheter, that is, the outlet portion of the second tube, is formed with a slightly inclined guide portion 13. This is to allow the procedure wire 22 to escape from the second tube 12 to puncture the middle or attached ventricular septum.

Referring to FIGS. 8 and 9, the puncturing procedure will be described. After insertion of the puncture catheter into the coronary sinus, the support wire 21 is inserted into the first tube 11 of the puncture catheter. Or the support wire may be inserted first and the puncture catheter may be inserted, or the support wire may be inserted into the puncture catheter.

Generally, the support wire 21 is moved in various directions depending on the characteristics of the wire such as the right ventricular inflow tract (RVIT) direction (septal vein) and the shape of the septal vein depending on the direction in which the coronary sinus is connected. do. In some cases, the procedure wire may easily come out to the desired right ventricular exit, such as RVIT, without the aid of another device (other wire or other catheter), but in most cases it is not directed to the desired exit. That is, there is a difference in ideal wire outlets per patient. The use of a support wire makes it very easy to perform when a single wire is difficult to penetrate the middle or attached ventricular septum. A dual lumen catheter is very useful for this purpose .

After insertion of the support wire 21, the puncture catheter is passed through to the appropriate position of the middle or attached ventricular septum and the procedure wire 22 is inserted into the second tube 12 of the perforation catheter. The position at which the surgical wire exits, i.e., the end position of the second tube, can be identified by a radiopaque marker 14 through the imaging device and is the "ventricular septal perforation start point ".

Whether the support wire 21 was inserted in the right ventricular inflow tract (RVIT) direction (septal vein) or in the right ventricular epicardial vein (RV epicardial vein) was confirmed by the operator performing angiography, And the position of the wire are relatively easy to understand. Therefore, the practitioner grasps the position of the support wire and pushes the procedure wire as shown in FIG. 8 or 9 to puncture the ventricular septum.

The surgical wire that has passed through the ventricular septum is guided into the right ventricle. Preferably, the distal end of the surgical wire is configured to have a pointed shape or to have a rigid nature to facilitate perforation of the ventricular septum. Thereby, the surgical wire is guided to the right ventricle, and then the perforation catheter and support wire are removed.

In a variety of ways as described above, the interventional wire is placed in the middle or attached right ventricle through a mid or apical interventricular septum.

10 is a photograph showing a path through which a surgical wire passes according to a preferred embodiment of the present invention. A red line shown in Fig. 10 represents a path through which the surgical wire passes. In other words, the surgical wire passes through the middle or apical interventricular septum after passing through the superior vein, coronary sinus, GCV (great cadiac vein), and anterior interventricular vein (AIV) .

Next, step (ii) is a step (30) of inserting a capture catheter that captures a surgical wire positioned in the right ventricle into the superior vein or inferior vein. That is, it is a step of inserting a capture catheter for capturing the treatment wire through the superior vein or the superior vein into the inside of the right ventricle.

In the present invention, since the surgical wire is passed through the middle or attached ventricular septum to the attached right ventricle, when the capture catheter is inserted into the right ventricle from the superior vein or the superior vein through the right ventricle, the heart tissue located in the right ventricle Such as leaflets, subvavular structures, moderator bands, etc., of the endothelium can be avoided. That is, upon insertion of the capture catheter, it is possible to send the capture catheter towards a surgical wire positioned in the middle or attached right ventricle without damaging tissue in the cardiac right ventricle.

"Cature catheter " means a catheter for capturing a surgical wire positioned in the middle or attached right ventricle and may also be referred to as a " wire guiding device " in the sense that it directs the surgical wire to the superior vein or inferior vein. have.

11 is a view showing an example of a capture catheter according to a preferred embodiment of the present invention.

The capture catheter is a means (capturing means) for capturing a surgical wire, preferably a mesh mesh. A mesh mesh is a concept that includes a straight basket type as well as a narrow lattice structure. That is, the basket type is also a type of the mesh network as shown in FIG. 11, and the mesh structure is also a form of the mesh network as shown in FIG.

The mesh is narrowed from the superior or inferior vein through the right atrium until it enters the right ventricle. After expanding in the right ventricle, the intervention wire is inserted into the mesh network, And captures the surgical wire. That is, the mesh network is expanded or narrowed by the operation from the outside. When the spread mesh network is expanded, the mesh wire network should be able to easily pass through the mesh network. When the mesh network is narrowed, the mesh network must be sized enough to hold the treatment wire. When the surgical wire passes through the mesh network, the mesh network is narrowed again by an external manipulating means. At this time, the surgical wire is captured in the mesh network.

 Whether or not the surgical wire has passed through the mesh network can be confirmed by using an existing imaging device. Preferably, as shown in FIG. 12, a radiopaque marker may be formed on the upper or lower end of the mesh network, so that the radiopaque marker can be easily confirmed through a video apparatus.

11, the capture catheter is composed of an outer catheter, a central bar, and a mesh mesh. The mesh network is fixed to the central body with the upper part gathered, and the lower part is fixed to the outer catheter with the lower part gathered. The central body has a structure inserted into the external catheter.

In a capture catheter located in the right ventricle, when the external catheter is pushed up by exerting force from the outside of the body, the external catheter will ascend along the centric body, thereby unfolding the mesh network. Then, the procedure wire is moved backward to a certain extent and then pushed forward again, allowing the surgical wire to enter the mesh network. Then, when the external catheter is lowered again, the mesh network is closed, and the mesh network captures the treatment wire.

12 is a schematic diagram showing a state in which a capture means (mesh network) of a capture catheter is deployed in a heart, according to a preferred embodiment of the present invention.

A catheter inserted through the superior or inferior vena cava is placed in the middle or attached right ventricle. The catheter inserted through the superior vein, It will be unfolded. The mesh network can be lowered to the attachment of the right ventricle, making it easier to capture surgical wires located in the middle or attached right ventricle.

In this manner, the procedure wire is captured by the capture catheter.

Next, iii) step (S40) of withdrawing the capture catheter into the inferior vein and pulling the procedure wire captured by the capture catheter toward the superior vein or inferior vein.

When the capture catheter is pulled out toward the superior vein or vein in a state in which the procedure wire is captured by the capture catheter, the procedure wire also exits to the superior vein or the inferior vein. The capture catheter is completely pulled out of the body, and the surgical wire is also pulled out of the body.

Thus, the surgical wire is located at the upper end of the body at one end and passes through the superior vein, the coronary sinus, the AIV, the middle or attached ventricular septum, the right ventricle, the right atrium, the inferior vein (or the superior vein) As shown in FIG.

The capture catheter may be inserted through the superior or inferior vein, more preferably inserted into the inferior vein. When inserting a pacemaker lead at a later time, the surgical wire serves not only as a guide but also as a support. At this time, one end of the surgical wire is positioned on the upper side and the other side is located on the lower side Because it is more desirable as a support.

(Iv) placing the lead of the pacemaker in the middle or the apical interventricular septum along the procedure wire with both ends of the procedure wire being held, S50 )to be.

A through hole (inner diameter) is formed inside the lead of the pneumatic heart so that the treatment wire can be inserted. The upper end and the lower end of the surgical wire are extended to the outside of the body so that the pacemaker lead is passed along the procedure wire through the through hole of the heartbeat lid lead to the superior vein, the coronary sinus and the AIV And placed in the middle or attached ventricular septum.

The practitioner inserts the lead of the pacemaker while holding the both ends of the treatment wire, thereby securing a sufficient supporting force for safely inserting the lead tip of the pacemaker into the ventricular septal tissue.

Preferably, the end of the cardiac catheter lead has a pointed shape so as to easily penetrate the ventricular septal tissue, and a latching jaw is formed so as not to be easily separated after insertion into the ventricular septal tissue.

As described above, according to the present invention, by placing the lead end of the pacemaker in the middle or attached ventricular septal tissue, it is possible to deliver direct and effective electrical stimulation to the conduction system of the heart, thereby achieving narrow QRS And because the surgical wire acts as a support, the pacemaker leads can be stably and easily inserted into the middle or attached ventricular septal tissue.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention may be embodied otherwise without departing from the spirit and scope of the invention. Therefore, the embodiments disclosed in the present invention are not intended to limit the scope of the present invention, but are intended to be illustrative, and the scope of the present invention is not limited by these embodiments. The scope of protection of the present invention should be construed according to the following claims, and all technical ideas within the scope of the claims should be construed as being included in the scope of the present invention.

10: Perforation device
11: 1st pipe
12: Second Hall
13: inclined guide portion
14: radiopaque marker
21: first wire
22: second wire

Claims (32)

An apparatus for positioning a lead end of a pacemaker through a coronary sinus in a mid or apical interventricular septum in which a conduction system of the heart is located to deliver effective electrical stimulation,
(SVC), coronary sinus (CS), AIV, ventricular septum, right ventricle, right atrium, and a superior vein or inferior vein;
A capture catheter inserted through a superior vein or an inferior vein to capture a surgical wire positioned in the right ventricle;
And a pacemaker lead inserted along the surgical wire and inserted into the mid or apical interventricular septum tissue with an intermediate end or an attached end.
The method according to claim 1,
A through hole through which the surgical wire passes is formed inside,
A balloon-shaped catheter with a bloon that can be inflated from the outside by blowing air from the outside is used to easily identify the septal vein and the anterior interventricular vein (AIV) located in the ventricular septum by blocking the coronary sinus. further comprising a balloon tipped guiding catheter.
The method according to claim 1,
In order to perforate the middle or attached ventricular septum,
A first tube for supporting and supporting the supporting wire,
Further comprising a dual-tube perforation catheter including a second tube fixedly attached to a side surface of the first tube and through which a surgical wire penetrating an intermediate or attached ventricular septum is passed.
The method according to claim 1,
The capture catheter
And a mesh network is formed as a capturing means for capturing the surgical wire.
The method according to claim 1,
The capture catheter
Central body;
An external catheter having the central body inserted therein and being movable up and down;
Wherein the upper portion is fixed in a state of being collected in the central body, and the lower portion is fixed to the outer catheter in a gathered state.
The method according to claim 4 or 5,
Wherein the mesh network has a lattice structure or a straight structure.
The method according to claim 1,
A through hole through which the treatment wire is inserted is formed in the inside of the heartbeat lid lead,
Wherein the end of the cardiac pendulum lead has a pointed shape to easily penetrate the ventricular septal tissue.
A catheter for use in positioning a lead end of a pacemaker through a coronary sinus in a mid-apical interventricular septum in which the conduction system of the heart is located to deliver effective electrical stimulation,
A through hole through which the surgical wire passes is formed inside,
Wherein a bloon capable of inflating a volume by blowing air from the outside is formed on the front surface so as to easily find the septal vein and the AIV located in the ventricular septum by blocking the coronary sinus.
A ventricular septal perforation catheter for use in positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached interventricular septum in which the conduction system of the heart is located to deliver effective electrical stimulation,
A first tube for supporting and supporting the support wire;
And a second tube fixedly attached to a side surface of the first tube and through which a procedure wire puncturing the ventricular septum passes.
10. The method of claim 9,
And a radiopaque marker is formed on the catheter so as to grasp the position of the second tube end located in the coronary sinus.
10. The method of claim 9,
And the inclined guide portion is formed at an end of the second tube so that the surgical wire slants out of the diaphragm so that the ventilator can be inserted into the ventricular septum.
10. The method of claim 9,
Wherein the distal end of the surgical wire has a pointed shape so as to penetrate the ventricular septum.
10. The method of claim 9,
A dual-type perforated catheter, characterized in that a bloon capable of inflating the volume by blowing the outside from the outside is formed on the front so that the septal vein and the AIV located in the ventricular septum can be easily found by blocking the coronary sinus. .
A capture catheter for use in positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum in which a conduction system of the heart is located to deliver an effective electrical stimulus,
A catheter for introducing a surgical wire through the superior vein and the coronary sinus and located in the right ventricle,
Wherein the catheter is inserted into the inferior vein and inserted into the right ventricle through the right atrium to capture the surgical wire.
15. The method of claim 14,
Wherein the capture catheter is formed with a mesh net that is unfolded or narrowed by manipulation from the outside.
15. The method of claim 14,
The capture catheter
Central body;
An external catheter having the central body inserted therein and being movable up and down;
Wherein the upper portion is fixed to the central body in a state of being collected, and the lower portion is fixed to the outer catheter in a gathered state.
17. The method according to claim 15 or 16,
Wherein the mesh network has a lattice structure or a straight structure.
17. The method according to claim 15 or 16,
Wherein the mesh wire is easily passed through when the wire mesh is unfolded but can be held tight when the wire mesh is narrowed.
15. The method of claim 14,
Wherein a radiopaque marker is formed on a surface of the capture catheter so as to be visually distinguishable through an imaging device.
A lead of a pacemaker used to position a lead end of a pacemaker through a coronary sinus in a mid or apical interventricular septum in which the conduction system of the heart is located to deliver effective electrical stimulation,
Wherein a through hole for inserting the surgical wire is formed in the inside so as to be inserted along a surgical wire passing through the ventricular septum through the superior vein, the coronary sinus, and the like.
21. The method of claim 20,
Wherein the end of the cardiac pendulum lead has a pointed shape so as to easily penetrate the middle or attached ventricular septal tissue.
21. The method of claim 20,
Wherein the end of the cardiac pendulum lead is formed with a latching jaw so as not to be easily separated after being inserted into the ventricular septal tissue.
A method for positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum in which a conduction system of the heart is located to deliver an effective electrical stimulus,
i) inserting a surgical wire through a superior vein, a coronary sinus (CS) and an anterior interventricular vein (AIV);
ii) placing the surgical wire through a mid or apical interventricular septum into the right ventricle of the heart;
iii) inserting the capture catheter inserted into the superior vein or vein into the right ventricle through the right atrium;
Iv) capturing the surgical wire with the capture unit of the capture catheter, and then pulling the surgical wire captured with the capture catheter toward the superior vein or the inferior vein; And
V) placing the lead of the pacemaker along the procedure wire in a state of holding both ends of the surgical wire, thereby positioning the end of the lead in the middle or attached ventricular septum.
24. The method of claim 23,
In the step i)
Using a balloon tipped guiding catheter with a balloon in the front,
The method comprising the step of injecting air from a balloon catheter passing through the coronary sinus to inflate the balloon to block and visualize the coronary sinus, thereby locating septum vein and AIV located in the ventricular septum.
24. The method of claim 23,
In the step ii)
And puncturing an intermediate or attached ventricular septum using a puncture catheter to pass the treatment wire through the intermediate or attached ventricular septum.
24. The method of claim 23,
The puncture catheter
A first tube for supporting and supporting the support wire;
And a second tube which is tightly fixed to the side surface of the first tube and through which a procedure wire penetrating the ventricular septum passes.
24. The method of claim 23,
Wherein the capture catheter is formed with a mesh net extending or narrowed by an external operation as a capturing means.
24. The method of claim 23,
The capture catheter
Central body;
An external catheter having the central body inserted therein and being movable up and down;
Wherein the upper portion is fixed to the central body in a state of being collected, and the lower portion is fixed to the outer catheter in a gathered state.
29. The method of claim 27 or 28,
Wherein the mesh network has a lattice structure or a straight structure.
29. The method of claim 27 or 28,
Wherein when the mesh network is deployed, the surgical wire is easily passed, but when the mesh network is narrowed, the surgical wire can be held tight.
24. The method of claim 23,
A through hole through which the treatment wire is inserted is formed in the inside of the heartbeat lid lead,
Wherein the end of the cardiac pendulum lead has a pointed shape to easily penetrate the ventricular septal tissue.
A method for positioning a lead end of a pacemaker through a coronary sinus in an intermediate or attached ventricular septum for delivering an effective electrical stimulus,
Introducing the surgical wire through the superior vein and the coronary sinus to pass through the intermediate or attached ventricular septum and then directing it to the superior vein or inferior vein; And
And inserting a lead of the pacemaker along the procedure wire to position the end of the lead within the intermediate or attached ventricular septum.
KR1020140106209A 2014-08-14 2014-08-14 Devices and Method of trans-coronary sinus mid to apical interventricular septal pacing in the lead end of the cardiac pacemaker KR20160020887A (en)

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PCT/KR2015/006045 WO2016024710A1 (en) 2014-08-14 2015-06-16 Method, apparatus, and catheter for placing end of lead of pacemaker, having passed through coronary sinus, inside intermediate or cacuminal inter-ventricular septum

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