WO2016024710A1 - Method, apparatus, and catheter for placing end of lead of pacemaker, having passed through coronary sinus, inside intermediate or cacuminal inter-ventricular septum - Google Patents

Abstract

The present invention relates to a method, an apparatus, and a catheter for placing an end of a lead of a pacemaker, having passed through a coronary sinus, inside an intermediate or cacuminal inter-ventricular septum and, more specifically, to a method, an apparatus, and a catheter for placing an end of a lead of a pacemaker, having passed through a coronary sinus, inside an intermediate or cacuminal inter-ventricular septum in an effort to more effectively transfer an electrical stimulus in a pacemaker therapy for the heart that is used for a patient having an arrhythmia disease of the heart. An apparatus for placing an end of a lead of a pacemaker, according to an exemplary embodiment of the present invention, comprises a surgical wire, a capture catheter, and a pacemaker lead. A method for placing an end of a lead of a pacemaker, having passed through a coronary sinus, inside an intermediate or cacuminal inter-ventricular septum, according to the present invention, comprises: a step of introducing a surgical wire through a superior vena cava and the coronary sinus, passing the surgical wire through the intermediate or cacuminal inter-ventricular septum, and then guiding the surgical wire toward the superior vena cava or inferior vena cava; and a step of placing the end of the lead inside the inter-ventricular septum by inserting the lead of the pacemaker along the surgical wire.

Description

A method, apparatus, and catheter for positioning the lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum

The present invention relates to a method, apparatus, and catheter for positioning a lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum, and more particularly in cardiac pacemaker treatment used in patients with cardiac arrhythmias. As part of a method for more effectively delivering electrical stimulation, the present invention relates to a method, an apparatus, and a catheter for positioning a lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum.

Since the introduction of artificial pacemakers for the first time in 1958 by Furman and Rovinson et al., Cardiac pacemakers have been used as the main treatment for patients with bradycardia. Recently, the pacemaker has been used as a major treatment for arrhythmia diseases such as complete atrioventricular block, high atrioventricular block, and symptomatic dysfunction syndrome. Cardiac pacemaker treatment is a treatment method in which the electrical stimulation of the heart does not flow normally and artificially creates the electrical stimulation by an artificial pacemaker.

1 is a diagram of a conduction system of the heart, (A) is a flow chart of the conduction system, (B) shows the waveform of the electrocardiogram, and (C) illustrates the relationship between the conduction process and the waveform. Drawing.

Referring to Figure 1, the conduction system of the heart (conduction) through the bundle branch at the ventricular heat through the Atrioventricular (AV) node from the Sinoatial (SA) node in the atrium through the conduciton pathways It is transmitted throughout the ventricles. The transmission of stimuli in the ventricles is via the His-Purkinje system.

In ECG, QRS-complex (QRS wave) is caused by the depolarization process of ventricular muscle, and the first down wave following P wave is called Q wave, the first up wave is R wave, and the down wave following R is called S wave. Attach. The width of the QRS means the time when electricity is conducted from the heat to the entire ventricle.In the normal state, the width of the QRS wave is within about 0.12 seconds (about 90ms or less), and in the case of more than 0.12 seconds (120ms), each block, etc. Suggests ventricular conduction disorder.

The pacemaker is composed of a generator and a lead. The main body supplies power, and a computer is included in it to grasp the electrical state of the heart coming through the induction wire, and to provide electricity or to rest when necessary. The guide line transfers electricity generated from the body to the heart.

2 shows the pacemaker treatment currently being performed.

In the treatment of conventional pacemakers, the electrical stimulation of the ventricle inserts and fixes the tip of the pacemaker lead to the apex of the right ventricle (RV apex) and gives electrical stimulation. This is called "right ventricular apical pacing, RVAP".

As in RVAP, the electrical stimulation in the right ventricular attachment (RV apex) does not become an electrical stimulus through the conduction system, a special tissue structure for the rapid delivery of electrical stimuli in the ventricles, and delivers relatively slow electrical stimuli. The stimulus is transmitted through myocardial cells in the ventricles, which slows the time for all electrical stimulation to spread throughout the ventricles. This means that the width of the QRS on the ECG becomes wider, which is called a wide QRS. That is, the QRS through the RVAP is about 160ms, which is considerably later than about 90ms in the normal case.

Wide QRS has a side effect that causes ventricular dessynchonization in which ventricular movement is not unified, leading to loss of ventricular function. In order to overcome these side effects, efforts are being made to obtain narrower QRS by applying electrical stimulation near the conduction system located in the ventricular septum.

A representative method is to apply an electrical stimulus around the conduction system by placing the lead end of the pacemaker in the right ventricular basal septum. This is called "right ventricular septal pacing, RVSP." The most frequently used site for RVSP is the ventricular septal region of the right ventricular outflow tract (RVOT).

RVSP theoretically compensates for the shortcomings of RVAP, but to actually perform the procedure, it is not easy to position the pacemaker lead precisely in the ventricular septum around the RVOT, or the lead is missing or repositioned. The procedure itself is difficult to use because of its limitations. Another consideration is that the RVSP places the end of the lead in the ventricular septum but is fixed to the outer wall rather than the inside of the ventricular septum, which stimulates the inner wall of the left ventricle or in the middle of the ventricular septum. It is known to be less effective than the method.

Another approach to obtaining a narrower QRS is in the case of a wider electrocardiogram QRS in a heart failure patient with ventricular dysfunction, with one lead placed on the right ventricular attachment (RV apex) using two leads. Stimulation is applied, and the other lead electrostimulates 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 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 groundbreaking treatment when there is a problem such as left bundle branch block (LBBB) in a heart failure patient. However, the CRT treatment has the disadvantage of using two leads to stimulate the ventricle to obtain a narrower QRS.

Therapeutic methods to date have been able to obtain a narrower QRS, theoretically, if the electrical stimulation to the ventricles can be applied directly to the ventricular septum where the conduction system of the ventricle is located, and also the direction of delivery of the electrical stimulation. This physiological electrical stimulation can overcome the problems with RVAP and can be expected to be effective in some patients who need CRT.

Recent studies have reported that direct electrical stimulation of the ventricular septum can compensate for the shortcomings of RVAP, and can also be helpful in ventricular dysfunction that requires CRT in animal experiments. Several attempts have been made to direct electrical stimulation within the ventricular septum (US 2010/0298841) and US 2013/0231728, which lead the pacemaker to the left ventricle in the right ventricle. It is directed to a method of forcing a cardiac pacemaker's lead into the ventricular septum by drilling directly into it. These patented methods are highly invasive, causing artificial ventricular septal defects between the left and right ventricle, and have a high risk of tearing the surrounding tissue during the procedure and a high risk of embolism from air or blood clots. . There are also many risks and limitations, such as being accessible only in the medial or apex side of the ventricle, which is the preferred site.

Therefore, it is necessary to obtain a narrow QRS by applying electrical stimulation directly to the conduction system of the ventricle and to study a safer and easier method.

As part of the results of this study, the present inventor proposed a method for placing a pacemaker lead inside the ventricular septum (Korean application number: 10-2014-092789). This method involves placing the pacemaker lead in the ventricular septum of the basal part of the ventricular septum, but in some studies, the pacemaker lead is placed in the ventricular septum of the apical part of the ventricle. It is posted that positioning is more advantageous.

The present invention has been made to solve the above problems, and an object of the present invention is to direct electrical stimulation to an intermediate or attached ventricular septum in which a cardiac conduction system is located to deliver electrical stimulation more effectively in the treatment of a pacemaker. A method, apparatus, and catheter are provided for placing a lead tip of a pacemaker that has passed through a coronary sinus in a mid- or attached ventricular septum at the same time as it provides safety.

The present invention has been made to achieve the above object, and according to a preferred embodiment of the present invention, a coronary tube in the mid to apical interventricular septum in which the cardiac conduction system is located for delivering an effective electrical stimulation Devices for locating the lead ends of the pacemakers that have passed through the venous sinus include: a surgical wire connected to the relative vein (SVC), coronary sinus (CS), AIV, ventricular septum, right ventricle, right atrium, and relative vein or inferior vena cava; A capture catheter inserted through a relative vein or inferior vena cava to capture the surgical wire located in the right ventricle; And a pacemaker lead inserted along the surgical wire and having an end inserted into the apical interventricular septum tissue.

According to a preferred embodiment, there is a through-hole through which the treatment wire passes, and the frontal vein and AIV (anterior interventricular vein) located in the ventricular septum are easily blocked to prevent coronary sinuses. It further comprises a balloon tipped guiding catheter formed with a balloon (bloon) that can be inflated by blowing air.

According to a preferred embodiment of the present invention, a method of positioning the lead end of a cardiac pacemaker through the coronary sinus in an intermediate or attached ventricular septum where the cardiac conduction system is located to deliver an effective electrical stimulation is provided. Inserting through vein, coronary sinus (CS) and anterior interventricular vein (AIV); ii) placing the procedure wire through the intermediate or attached apical interventricular septum to the right ventricle of the heart; iii) inserting the capture catheter inserted into the relative vein or inferior vena cava into the right ventricle via the right atrium; iv) capturing the procedure wire with the capture means of the capture catheter and then pulling the procedure wire captured with the capture catheter toward the relative vein or inferior vena cava; And v) inserting the lead of the pacemaker along the surgical wire while holding both ends of the surgical wire to position the tip of the lead within the attached ventricular septum.

As described above, the present invention of the present invention is a method for positioning the lead end of a cardiac pacemaker passing through the coronary sinus in the mid to apical interventricular septum, the apparatus is coronary sinus (CS) and AIV A method of locating and stimulating the pacemaker lead into the medial or attached ventricular septum via an anterior interventricular vein, (1) overcoming the disadvantages of wider QRS pacing due to conventional RVAP, and (2) patients requiring conventional CRTs. In patients with narrower QRS only by septal pacing, the present invention has the advantage of expecting a treatment effect with only one lead without using two leads.

Further, according to the present invention, a high-risk and non-physiological procedure for artificially opening the left ventricle and the low-pressure right ventricle, which are responsible for high pressure arterial blood, as in the conventional methods US 2010/0298841 A1, US 2013/0231728 A1, etc. Without using the method, the procedure can be accompanied by placing the pacemaker lead into the ventricular septal tissue through a relatively simple procedure within the flow of the vein using the most naturally formed route along the path of the septal vein. The advantage is that the risks present can be minimized.

In addition, the catheter and surgical wire for capturing the right ventricle from the right atrium, avoiding tissues (leaflet, subvavular structure, modulator band, etc.) of the heart compared to the method proposed by the present inventor first Since it can pass through, there is an advantage that can prevent damage to the tissue in the heart as described above.

1 is a diagram of a conduction system of the heart, (A) is a flow chart of the conduction system, (B) shows the waveform of the electrocardiogram, and (C) illustrates the relationship between the conduction process and the waveform. Drawing.

2 shows a pacemaker treatment presently being performed.

3 is a flow chart of a method for positioning the lead end of a pacemaker that has passed through a coronary sinus in an attached ventricular septum, in accordance with a preferred embodiment of the present invention.

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

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

7 is a cross-sectional schematic diagram of a dual type perforated catheter according to a preferred embodiment of the present invention, where (A) the length of the first and second tubes is the same, (B) is the length of the first and second tubes Shows a different case.

8 and 9 are a partial cutaway view showing the process of puncturing the ventricular septum using a dual-type puncture catheter, according to a preferred embodiment of the present invention, Figure 8 is a direction of the support wire is the RVIT direction, 9 illustrates a case in which the advancing direction of the support wire is in 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.

11 illustrates an example of a capture catheter, in accordance with a preferred embodiment of the present invention.

12 is a schematic diagram showing an unfolded state of the capturing means (mesh) of the capture catheter in the heart according to a preferred embodiment of the present invention.

Methods, devices, and catheters for positioning the lead tip of a pacemaker within the mid to apical interventricular septum of the present invention are directed to coronary and anterior interventricular vein to deliver electrical stimulation more effectively in the treatment of pacemakers. A method, device and catheter for positioning the lead end of a pacemaker in an intermediate or attached ventricular septum after passage That is, the method and apparatus for positioning the lead end of the pacemaker in the intermediate or attached ventricular septum so that direct electrical stimulation can be given at the intermediate or attached ventricular septum where the heart's conduction system is located.

In the case of RVSP described above, the end of the pacemaker lead is located in the ventricular septum, but it is fixed to the outer wall instead of the inside of the ventricular septum to stimulate the stimulus, which is theoretically a conduction system located inside the ventricular septum. The electrical stimulation delivery scheme for is less effective when delivering electrical stimulation in the intra-septal.

The present inventors have developed a method and apparatus for positioning the lead end of a pacemaker in an intermediate or attached ventricular septum using a surgical wire that passes through a relative vein, coronary sinus, ventricular septum, or inferior vena cava (or relative 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 the surgical wire through the relative vein, coronary venous sinus (CS) and an anterior interventricular vein (AIV); ii) placing the procedure wire through the mid to apical interventricular septum into the right ventricle of the heart; iii) inserting a capture catheter inserted into a relative vein or inferior vena cava into the right ventricle via the right atrium, and capturing the procedure wire with the capture means of the capture catheter; iv) pulling the procedure wire captured with the capture catheter toward the relative vein or inferior vena cava; And v) holding the ends of the procedure wire, inserting the leads of the pacemaker along the procedure wire to position the ends of the leads in the intermediate or attached ventricular septum.

In other words, the procedure wire is introduced through the relative vein and the coronary venous sinus, and placed in the right ventricle through the intermediate or attached ventricular septum, and then guided back to the relative vein or the inferior vena cava; And inserting a lead of the pacemaker along the surgical wire to position the end of the lead in the intermediate or attached ventricular septum.

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

3 is a flow chart of a method by which the lead end of a pacemaker may be located within the ventricular septum, in accordance with a preferred embodiment of the present invention. The method of the present invention will be described with reference to FIG. 3.

Referring to FIG. 3, first, i) inserting a surgical wire through a relative vein, coronary venous sinus (CS) and an anterior interventricular vein (AIV) (S10).

The "intervention wire" is inserted through the relative vein, coronary sinus and AIV, passes through the medial or attached ventricular septum, then is led to the inferior vena cava (or relative vein), where both sides are fixed by the operator. The pacemaker lead is inserted through the coronary sinus and inserted into the intermediate or attached ventricular septum. Preferably, about 0.014 '' surgical wire is used for the surgical wire. The intervention wire serves as a guide for the pacemaker lead and is also referred to as a "pacemaker lead guide wire."

The procedure wire is routed through the appropriate ventricular basal vein (septal vein) and the anterior interventricular vein (AIV) to the intermediate or attached ventricular septum. However, it is true that the septal vanes and AIV are generally difficult for the operator to identify. This requires a balloon catheter with a through hole through which the treatment wire passes. Balloon catheter (balloon tipped guiding catheter) is a catheter with a balloon (balloon) formed on the tip (top), inserted through the relative vein, coronary sinus, and then inflated by blowing air from the outside to prevent coronary sinus. As a result, the flow of blood in the coronary sinus is blocked, so that the pressure of the coronary sinus increases, and the coronary sinus expands. Then, by imaging the pressurized venogram, the septal vein and ventricular septal veins located in the ventricular septum are pounded out.

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

4 and 5, the relative vein is connected to the coronary sinus (CS), and the coronary vein (CS) is connected to the anterior interventricular vein (AIV) through a great cardiac vein (GCV). Therefore, the surgical wire in the present invention is inserted into the relative vein, coronary vein, GCV (great cardiac vein), AIV (anterior interventricular vein). The surgical wire inserted into the AIV is pierced to the right ventricle with a mid to apical interventricular septum. In Figure 5, the circle represents the position of the end of the surgical wire, that is, the position of the ventricular septum in which the surgical wire is bent.

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

Intervention wire is inserted into the septal vane and AIV through the aperture of the balloon catheter, and then passes through the mid to apical interventricular septum by external force.

That is, the next step is ii) placing the procedure wire in the right ventricle by passing the procedure wire through an intermediate or attached ventricular septum (S20).

After the procedure wire passes through the intermediate or attached ventricular septum, the balloon catheter is pulled out and removed, and the tip of the procedure wire is located in the intermediate or attached right ventricle.

On the other hand, if it is difficult to bend the ventricular septum with only a surgical wire, a separate ventricular septal puncture catheter is required. The ventricular septal puncture catheter is a dual puncture catheter consisting of two tubes each having two wires inserted therein.

That is, in the general case, without the need for a separate ventricular septal perforation catheter, the end of the procedure wire is pointed, so that the procedure wire can directly orient the mid to apical interventricular septum, but the procedure wire An exceptional ventricular septal puncture catheter is necessary in cases where it is difficult to penetrate the septum alone.

7 shows a dual puncture catheter with two lumens.

7 is a cross-sectional schematic diagram of a dual type perforated catheter according to a preferred embodiment of the present invention, where (A) the length of the first and second tubes is the same, (B) is the length of the first and second tubes 8 and 9 illustrate a partial cardiac incision showing a process of puncturing the ventricular septum using a dual puncture catheter, and FIG. 8 illustrates a case in which the support wire is in the RVIT direction. Shows the case where the advancing direction of the support wire is the RV epicardial vein direction.

First, referring to FIG. 7, a dual puncture catheter having two lumens includes a first tube into which a support wire is inserted and a second tube into which a surgical wire is inserted. The first tube 11 and the second tube 12 of the perforated catheter are in close contact with each other and fixedly coupled to each other. The two tubes may be formed in close contact or may be divided into two spaces by a membrane in one tube. . The length of the 1st pipe | tube 11 and the 2nd pipe | tube 12 may be the same, or may differ. Fig. 7A shows the case where the lengths of the first pipe and the second pipe are the same, and (B) shows the case where the lengths of the first pipe and the second pipe are different. When it is not necessary to lengthen the length of a support wire compared with a procedure wire, as shown in FIG. 7B, a 1st pipe | tube is formed shorter and the length of a 1st pipe | tube and a 2nd pipe | tube are formed differently.

The support wire 21 inserted into the first tube 11 serves to support when the surgical wire 22 inserted into the second tube 12 punctures the mid to apical interventricular septum. That is, 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 intermediate or attached ventricular septum. As described above, the surgical wire 22 penetrates into the ventricular septum and is connected to a relative vein or inferior vena cava, which serves to guide or support the lead of the pacemaker later.

The support wire serves as a support, and the surgical wire serves to penetrate the intermediate or attached ventricular septum, so that the support wire is often softer than the surgical wire.

A puncture catheter is formed with a radiopaque marker 14. The radiopaque marker 14 detects the position of the puncture catheter (the position of the end of the surgical wire) through the imaging device, and helps the surgical wire 22 to puncture the ventricular septum. That is, a radiopaque marker 14 is formed to impart ease of intermediate or attached ventricular septal perforation.

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

8 and 9, the puncture process will be described. After the puncture catheter is inserted into the coronary sinus, the support wire 21 is inserted into the first tube 11 of the puncture catheter. Alternatively, the support wire may be entered first and the perforated catheter may be entered, or the support wire may be inserted into the perforated catheter while being inserted.

In general, the support wire 21 moves in various paths according to the characteristics of the wire and the shape of the septal vein, such as the right ventricular inflow tract (RVIT) direction (septal vein) according to the direction in which the coronary sinus is connected. do. The procedure wire may easily exit to the desired right ventricular outlet, such as RVIT, without the aid of another instrument (another wire or other catheter), but in most cases it does not lead to the desired outlet. In other words, the ideal wire exit varies from patient to patient. If it is difficult to penetrate the middle or attached ventricular septum with only the procedure wire, the use of a support wire makes the procedure very easy. A dual lumen catheter is very useful for this purpose. .

After inserting the support wire 21, the perforated catheter is sent to the appropriate location of the intermediate or attached ventricular septum, and the surgical wire 22 is inserted into the second tube 12 of the perforated catheter. The position at which the procedure wire exits, that is, the position of the end of the second tube, can be confirmed by the radiopaque marker 14 through the imaging device, and is a "ventricular septal penetration start point".

Whether the support wire 21 is inserted in the right ventricular inflow tract (RVIT) direction (septal vein) or in the right ventricular epicardial vein (RV epicardial vein) direction is performed by the operator. It is relatively easy to know the location of the and wires together. Therefore, the operator 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 passing through the ventricular septum is directed to the right ventricle. Preferably, the end of the surgical wire is formed to have a pointed shape or a rigid property, so that the perforation of the ventricular septum is more easily performed. This leads the procedure wire to the right ventricle, which then removes the puncture catheter and support wire.

In various ways as described above, an interventional wire is placed in the intermediate or attached right ventricle through a mid to 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. The red line shown in FIG. 10 represents a path through which the procedure wire passes. In other words, the procedure wire passes through the relative vein, coronary sinus, GCV (great cadiac vein), AIV (anterior interventricular vein), and then penetrates the mid or apical interventricular septum to the middle or attached right ventricle. It is located at.

Next, ii) inserting the capture catheter capturing the surgical wire located in the right ventricle into the relative or inferior vena cava (30). That is, a step of inserting a capture catheter to capture the surgical wire through the relative vein or inferior vena cava into the right ventricle.

In the present invention, since the procedure wire passes through the intermediate or attached ventricular septum to the appended right ventricle, the cardiac tissue located in the right ventricle when the capture catheter is inserted into the right ventricle from the relative vein or inferior vena cava into the right ventricle (three thousand valves) Damage to leaflets, subvavular structures, modulator bands, and the like. That is, upon insertion of the capture catheter, the capture catheter can be directed towards the procedure wire located in the middle or attached right ventricle without damaging the tissue in the right ventricle of the heart.

"A capture catheter is a catheter for capturing a surgical wire located in the middle or attached right ventricle, and can be called a" wire induction device "in the sense that guides the surgical wire to a relative vein or an inferior vena cava. have.

11 is a diagram illustrating an example of a capture catheter, according to a preferred embodiment of the present invention.

The capture catheter is a means (capture means) for capturing a procedure wire, and preferably a mesh is formed. Mesh is a concept that includes not only a narrow grid structure but also a straight basket type. In other words, as shown in Fig. 11, the basket type will be referred to as one type of mesh, and as shown in Fig. 12, the lattice structure will also be referred to as one type of mesh.

The mesh is narrowed from the relative or inferior vena cava until it enters the right ventricle through the right atrium, then unfolds in the right ventricle, inserts an intervention wire into the mesh net, and then narrows the mesh again. The procedure wire will be captured. In other words, the mesh net is expanded or narrowed by external manipulation, and when unfolded, the surgical wire should be able to easily pass through the mesh net, and when it is narrowed, the mesh net should be sized to hold the surgical wire tightly. When the procedure wire passes through the mesh net, the mesh net is narrowed again by external operation means. At this time, the surgical wire is captured to the mesh.

 Whether the procedure wire has passed through the mesh network may be confirmed using an existing imaging apparatus. Preferably, as shown in Figure 12 by forming a radiopaque marker (radiopaque marker) on the top or bottom of the mesh, it can be easily confirmed through the imaging device.

Looking at the structure in more detail with reference to Figure 11, the capture catheter is composed of an outer catheter (outer catheter), the central (central bar), the mesh (mesh). The mesh net is fixed to the central body with the upper part collected and the lower part is fixed to the external catheter in the collected state. The centrosome has a structure inserted into an external catheter.

In a capture catheter located in the right ventricle, if a force is pushed out of the body to push the outer catheter, the outer catheter will rise along the central body, thus unfolding the mesh network. The process wire is then retracted back to some extent and then pushed forward again into the mesh net. Then, when the external catheter is lowered again, the mesh net narrows and the mesh net captures the procedure wire.

12 is a schematic diagram showing an unfolded state of the capturing means (mesh) of the capture catheter in the heart according to the preferred embodiment of the present invention.

After passing through the relative vein, coronary sinus, or AIV, the surgical wire penetrating the intermediate or attached ventricular septum is placed in the middle or attached right ventricle, and the catheter inserted through the relative vein or inferior vena cava is in the right ventricle. It will unfold. The mesh net can be lowered to the attachment of the right ventricle, making it easier to capture the procedure wire located in the middle or attached right ventricle.

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

Next, iii) extracting the capture catheter into the inferior vena cava, and extracting the surgical wire captured by the capture catheter toward the relative vein or inferior vena cava (S40).

When the surgical catheter is captured by the capture catheter and the capture catheter is pulled toward the relative vein or inferior vena cava, the surgical wire also exits to the relative or inferior vena cava. The capture catheter is completely pulled out of the body, and the surgical wire is also pulled out of the body.

Accordingly, the procedure wire is located at one end outside the upper part of the body and passes through the relative vein, coronary sinus, AIV, intermediate or attached ventricular septum, right ventricle, right atrium, inferior vena cava (or relative vein) and the other end of the body. It will be located outside of.

The capture catheter can be inserted through the relative vein or the inferior vena cava, more preferably in the inferior vena cava. When the cardiac pacemaker lead is inserted later, the treatment wire serves not only as a guide but also as a support. In this case, it is preferable that one end of the procedure wire is located at the top and the other is located at the bottom, rather than all the ends of the procedure wire are located at the top. It is because it is more preferable as a support role.

Finally, iv) while holding both ends of the procedure wire, inserting the pacemaker lead along the procedure wire to position the end of the pacemaker lead within the intermediate or attached apical interventricular septum (S50). )to be.

A through hole (inner diameter) is formed inside the lead of the pacemaker so that the procedure wire can be inserted. The upper and lower ends of the surgical wire extend out of the body, passing through the pacemaker lead along the surgical wire through the relative vein, coronary sinus and AIV, while the operator grasps both ends of the surgical wire. And placed in the middle or attached ventricular septum.

The operator inserts the pacemaker lead while holding both ends of the procedure wire, thereby securing sufficient support for safely inserting the lead tip of the pacemaker into the ventricular septal tissue.

Preferably, the end of the pacemaker lead has a sharp shape so as to easily penetrate the ventricular septal tissue, and a locking jaw (hook) is formed so that it is not easily separated after being inserted into the ventricular septal tissue.

As described above, according to the present invention, by placing the lead end of the pacemaker in the tissue in the middle or attached ventricular septum, it is possible to deliver a direct and effective electrical stimulation to the conduction system of the heart to obtain a narrow QRS In addition, since the surgical wire serves as a support, the lead of the pacemaker may be stably and easily inserted into the tissue of the intermediate or attached ventricular septum.

The above description is merely illustrative of the technical idea of the present invention, and those skilled in the art to which the present invention pertains may make various modifications and changes without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are not intended to limit the technical spirit of the present invention, but are intended to explain, and the scope of the technical spirit of the present invention is not limited by these embodiments. The protection scope of the present invention should be interpreted by the claims below, and all technical ideas within the equivalent scope should be interpreted as being included in the scope of the present invention.

The present invention relates to a method, apparatus, and catheter for positioning a lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum, and more particularly in cardiac pacemaker treatment used in patients with cardiac arrhythmias. As part of a method for more effectively delivering electrical stimulation, it is available in the field of methods, devices, and catheter to locate the lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum.

Claims (32)

1. A device for positioning the lead end of a cardiac pacemaker that has passed through a coronary sinus in the mid or apical interventricular septum in which the cardiac conduction system is located to deliver an effective electrical stimulation.

   Surgical wires connected to relative vein (SVC), coronary venous sinus (CS), AIV, ventricular septum, right ventricle, right atrium, and relative vein or inferior vena cava;

   A capture catheter inserted through a relative vein or inferior vena cava to capture the surgical wire located in the right ventricle;

   And a pacemaker lead inserted along the surgical wire such that an end is inserted into the mid to apical interventricular septum tissue.
2. The method of claim 1,

   There is a through hole through which the treatment wire passes,

   An inflatable catheter with a balloon that can be blown from the outside to inflate the volume so that it can easily locate sepal veins and anterior interventricular veins located in the ventricular septum by blocking coronary sinuses. (balloon tipped guiding catheter) further comprises.
3. The method of claim 1,

   To puncture the middle or attached ventricular septum,

   A first pipe through which the support wire passes and is supported;

   And a dual puncture catheter comprising a second tube through which a surgical wire for puncturing the intermediate or attached ventricular septum is formed and fixed in close contact with the side of the first tube.
4. The method of claim 1,

   The capture catheter is

   Apparatus characterized in that the mesh is formed as a capture means for capturing the surgical wire.
5. The method of claim 1,

   The capture catheter is

   Centrosomes;

   An external catheter inserted into the central body and movable up and down;

   And an upper portion of the mesh net fixed to the central body and a lower portion of the mesh mesh fixed to the outer catheter.
6. The method according to claim 4 or 5,

   And said mesh network has a lattice structure or a straight structure.
7. The method of claim 1,

   The inside of the pacemaker lead is formed with a through hole in which the surgical wire is inserted,

   The end of the pacemaker lead is characterized in that it has a pointed shape to easily penetrate the ventricular septal tissue.
8. In a catheter used to position the lead end of the pacemaker through the coronary sinus in the mid or apical interventricular septum where the heart conduction system is located to deliver an effective electrical stimulation.

   There is a through hole through which the treatment wire passes,

   Balloon catheter, characterized in that to prevent the coronary sinus is located in the ventricular septum (septal vein) and AIV, easy to find a balloon (bloon) to inflate the volume by blowing air from the outside.
9. In a ventricular septal puncture catheter used to position the lead end of a cardiac pacemaker that has passed through a coronary sinus in the mid or apical interventricular septum where the heart conduction system is located to deliver an effective electrical stimulation.

   A first pipe through which the support wire passes;

   And a second tube through which a surgical wire for puncturing the ventricular septum passes through and is fixed to the side of the first tube and passes through the ventricular septum.
10. The method of claim 9,

    And a radiopaque marker formed on the catheter to determine the position of the end of the second tube located in the coronary sinus.
11. The method of claim 9,

    The end of the second tube is a dual-type perforated catheter, characterized in that the inclined guide portion is formed to be inclined to enter the ventricular septum to the exit wire obliquely.
12. The method of claim 9,

    Dual end perforated catheter, characterized in that the end of the surgical wire has a pointed shape to penetrate the ventricular septum.
13. The method of claim 9,

    Dual perforated catheter, characterized in that the front is formed with a balloon that can blow up from the outside to inflate the volume so as to easily detect septal veins and AIV located in the ventricular septum .
14. A capture catheter, which is used to position the lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum where the cardiac conduction system is located to deliver an effective electrical stimulation.

    As a catheter for drawing the surgical wire which flows through the relative vein and coronary vein and located in the right ventricle into the inferior vena cava,

    The catheter is inserted into the inferior vena cava is inserted into the right ventricle through the right atrium to capture (capture) the surgical wire (capture).
15. The method of claim 14,

    The capture catheter is a capture catheter, characterized in that the mesh network is formed to be expanded or narrowed by an external operation.
16. The method of claim 14,

    The capture catheter is

    Centrosomes;

    An external catheter inserted into the central body and movable up and down;

    And an upper portion of the mesh net fixed to the central body and a lower portion of the mesh mesh fixed to the outer catheter.
17. The method according to claim 15 or 16,

    The mesh network has a grating structure or a straight catheter, characterized in that the capture catheter.
18. The method according to claim 15 or 16,

    When the mesh net is unfolded, the surgical wire passes easily, but when narrowed, the capture catheter can hold the surgical wire tightly.
19. The method of claim 14,

    And a radiopaque marker formed on a surface of the capture catheter so as to be visually identified through an imaging device.
20. In the pacemaker lead, which is used to position the lead end of the pacemaker through the coronary sinus in the mid or apical interventricular septum, where the heart conduction system is located to deliver an effective electrical stimulation.

    Lead of the cardiac pacemaker, characterized in that the through-hole through which the surgical wire is inserted to be inserted along the surgical wire passing through the relative venous, coronary sinus and penetrating the ventricular septum.
21. The method of claim 20,

    The end of the pacemaker lead is a lead of the atrial synchronizer, characterized in that it has a pointed shape so as to easily penetrate the middle or attached ventricular septum tissue.
22. The method of claim 20,

    The end of the pacemaker lead is a lead of the atrial synchronizer, characterized in that the locking jaw is formed so as not to be easily separated after being inserted into the ventricular septum tissue.
23. A method of positioning a lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum where the cardiac conduction system is located to deliver an effective electrical stimulation,

    i) inserting the procedure wire through a relative vein, coronary sinus (CS) and an anterior interventricular vein (AIV);

    ii) placing the procedure wire through the mid to apical interventricular septum into the right ventricle of the heart;

    iii) inserting the capture catheter inserted into the relative vein or inferior vena cava into the right ventricle via the right atrium;

    iv) capturing the procedure wire with the capture means of the capture catheter and then pulling the procedure wire captured with the capture catheter toward the relative vein or inferior vena cava; And

    v) holding the ends of the procedure wire, inserting the leads of the pacemaker along the procedure wire, thereby positioning the ends of the leads in the intermediate or attached ventricular septum.
24. The method of claim 23, wherein

    In step i),

    Using a balloon tipped guiding catheter with a balloon on the front,

    Infusing the balloon catheter passed through the coronary sinus from the outside to inflate the balloon to prevent coronary sinus and contrast, thereby finding the septal (septal vein) and AIV located in the ventricular septum.
25. The method of claim 23, wherein

    In step ii),

    And perforating the intermediate or attached ventricular septum with a puncture catheter to pass the procedure wire through the intermediate or attached ventricular septum.
26. The method of claim 23, wherein

    The perforated catheter

    A first pipe through which the support wire passes;

    And a second tube through which a surgical wire passing through the ventricular septum is fixed and formed to be in close contact with the side surface of the first tube.
27. The method of claim 23, wherein

    The capture catheter is a capture means characterized in that the mesh network is formed to expand or narrow by an external operation.
28. The method of claim 23, wherein

    The capture catheter is

    Centrosomes;

    An external catheter inserted into the central body and movable up and down;

    And an upper portion fixed to the central body and a lower mesh portion fixed to the outer catheter.
29. The method of claim 27 or 28,

    And the mesh network has a lattice structure or a straight structure.
30. The method of claim 27 or 28,

    The mesh net is easily passed through the treatment wire when it is unfolded, when the narrowing method characterized in that it can hold the treatment wire tight.
31. The method of claim 23, wherein

    The inside of the pacemaker lead is formed with a through hole in which the surgical wire is inserted,

    The end of the pacemaker lead is characterized in that it has a pointed shape to easily penetrate the ventricular septal tissue.
32. A method of positioning a lead end of a pacemaker that has passed through a coronary sinus in an intermediate or attached ventricular septum to deliver an effective electrical stimulation,

    Introducing the surgical wire through the relative vein and the coronary sinus and passing it through the intermediate or attached ventricular septum, and then inducing it back into the relative vein or inferior vena cava; And

    And inserting the lead of the pacemaker along the procedure wire to position the end of the lead within the intermediate or attached ventricular septum.

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