KR102137740B1 - Pacemaker lead for cerclage pacing - Google Patents

Abstract

The present invention relates to a circle large cardiac pacemaker lead, and more particularly, to a cardiac pacemaker lead that moves along the coronary vein to reach the ventricular septum, and is capable of efficient electrical transmission close to his bundle, and includes a stylet. Therefore, it is related to a circle large pacemaker lead with improved pushability for easy movement in the body.
Circle large cardiac pacemaker lead according to the present invention includes a fixed tip that gradually decreases in diameter toward the distal end, and a plurality of bipolar electrodes in contact with the myocardium on the outer circumferential surface, through which a guide wire is inserted through which a guide wire can be inserted. Formed lead fixing portion; A lead body portion formed to extend to the lead fixing portion, having a stylet insertion hole therein, and including a fixing portion formed in a curved shape to be fixed to the inner wall of the coronary vein; And a stylet inserted into the stylet insertion hole and allowing the circle large pacemaker lead to be easily moved in the body. It includes.

Description

Circle large lead pacemaker{Pacemaker lead for cerclage pacing}

The present invention relates to a circle large cardiac pacemaker lead, and more particularly, to a cardiac pacemaker lead that moves along the coronary vein to reach the ventricular septum, which is close to a heath (His bundle) and enables efficient electrical transmission, and includes a stylet. Therefore, it is related to a circle large pacemaker lead with improved pushability for easy movement in the body.

Since the first artificial pacemaker (Pacemaker) was introduced in 1958 by Furman and Rovinson et al., cardiac pacemakers have been used as a major treatment for patients with bradycardia arrhythmia. Recently, an artificial pacemaker has been used as a major treatment for arrhythmia diseases such as complete atrioventricular blockage, high atrioventricular blockade, and symptomatic sinus dysfunction syndrome. Heart rhythm therapy is a treatment method that artificially creates an electrical stimulation by artificial pacemakers because the electrical stimulation of the heart cannot flow.

1 is a diagram of a cardiac conduction system. Referring to FIG. 1, the heart conduction system is formed through Purkinje Fibers, which is divided into Right bundle and Left bundle in the ventricular heath (His bundle) through the Atrioventricular Node from the Sinoatial Node in the atrium.

In electrocardiography, QRS waves are generated by the depolarization process of the ventricular muscle, and the first downward wave following the P wave is called the Q wave, the first upward wave is the R wave, and the downward wave following the R wave is called the S wave. The width of the QRS refers to the time during which electricity is conducted from the heath to the entire ventricle. In normal, the width of the QRS wave is within about 0.12 seconds (about 90 ms), and within 0.12 seconds (120 ms) or more It suggests evangelism disorder. When the electric conduction time is long, the QRS width is widened, and when the electric conduction time is short, the QRS width is narrowed. The wide QRS has a side effect that causes ventricular desynchronization, in which ventricular movement cannot be unified, leading to loss of ventricular function.

That is, if an electrical stimulation is applied to a place close to the heath located in the ventricular septum, the electrical conduction time is shortened and a narrow QRS can be obtained, thereby effectively transmitting the electrical stimulation.

However, it is difficult to accurately locate his bundle located within the ventricular septum during the procedure, and even if a heist bundle is found and the pacemaker lead is fixed to the heater, the pacing threshold is high and the battery life of the pacemaker is shortened. .

Accordingly, various methods have been studied to find the position of the pacemaker lead that replaces the heath. Thesis JACC Vol. 69, No. 25, 2017 June 27, p3099-3114 (Non-Patent Document 1) summarized various methods for the position of fixing the pacemaker lead developed in the related art. FIG. 2 is a diagram published in the above paper and shows various positions in which a pacemaker lead developed in the related art is fixed.

First, the method of fixation to the right ventricle attachment (RVA) is QRS measured at about 172ms, showing a wider QRS than the heath's QRS, leading to heart failure (HF), atrial fibrillation, and the patient's condition. It showed worse results.

The method in which the pacemaker lead is fixed to the right ventricular outlet (RVOT) or right ventricular septum (RV septal) has achieved a superior value to the right ventricle attachment (RVA) with a QRS value of about 165 ms, but the right ventricular attachment (RVA) fixation method Likewise, heart attack and atrial fibrillation occur, and only about 66% of patients have succeeded in the procedure, showing difficulty in the procedure.

As an alternative, studies were conducted on how to fix the lead to the left ventricle (LV). The method of fixing the lead to the left ventricle is a method of fixing to the left ventricle outer membrane and a method of fixing to the left ventricle inner membrane, and when the lead is fixed to the inner membrane than the left ventricle membrane, it exhibits excellent physiological electrical activation (narrow QRS), enabling efficient electric delivery. It was shown. However, the method of fixing the lead to the left ventricle lining has a difficult problem because the lead penetrates into the left ventricle through a thin membrane between the right and left atrium.

U.S. Patent Publication (US2010/0298841) and U.S. Patent Publication (US 2013/0231728) filed for a method of forcing the lead of the pacemaker to directly penetrate the left ventricle into the left ventricle and forcibly position the lead of the pacemaker into the ventricular septum. This is a method of stimulating the left ventricular septum (LV septum) rather than the right ventricular septum (RV septum), which can implement narrower QRS (145 ms) than stimulating the right ventricular septum (RV septum) and has the effect of replacing CRT treatment. However, the method of these patents is a highly invasive method that causes an artificial ventricular septal defect between the left ventricle and the right ventricle, and the risk of tearing surrounding tissue during the procedure is very high, and the risk of embolism caused by air or thrombus is also very high. high. In addition, it poses a number of risks and limitations, such as accessibility limited to the middle or apex side rather than the base of the ventricle, which is a desirable site.

According to a recent study, the patents of the above patents were obtained by rotating the screw from the right ventricle septum (RV septum) to the left ventricle septum (LV septum) using a screw-shaped lead without drilling from the right ventricle to the left ventricle. Methods to compensate for the shortcomings were studied. However, this also has a high possibility of damaging other tissues such as tricuspid valves, and the disadvantage that it is difficult to move near the heath remains.

Therefore, it is necessary to study the pacemaker leads that can effectively deliver electrical stimuli similar to His bundle and safely and conveniently deliver electrical stimuli.

US 20100298841 A1 (2010.11.25) US 20130231728 A1 (2013.09.05)

'The Continued Search for Physiological Pacing', Journal of the American Colllege of Cardiology, Vol.69 No.25, May 3 2017

The problem to be solved by the present invention is to provide a pacemaker lead fixed to a basal ventricular septum close to his bundle to effectively deliver electrical stimulation to the heart.

In addition, an object of the present invention is to provide a pacemaker lead that can find the optimal electrical conduction position according to the patient without measuring the lead by measuring the electrocardiogram at various positions of the ventricular septum.

In addition, another object of the present invention is to provide a pacemaker lead that does not require another device and simply moves the pacemaker lead into the body, and the fixed position does not change with the movement of the heart.

The objects of the present invention are not limited to the objects mentioned above, and other objects not mentioned will be clearly understood by those skilled in the art from the following description.

In order to achieve the above object, the present invention is a large circle heart pacemaker lead according to the present invention, having a shape in which a diameter gradually decreases toward the distal end, and a fixed tip fixed after piercing the myocardium, and a plurality of heart muscles in contact with the outer peripheral surface An electrode and a lead fixing portion having a guide wire insertion hole through which a guide wire can be inserted; It is formed to be extended to the lead fixing portion, a stylet insertion hole is formed inside, and when a stylet is inserted into the stylet insertion hole, it is linearly expanded by a stylet and when the stylet is removed from the stylet insertion hole. A lead body portion formed with a fixed portion of a flexible material to be fixed in close contact with the inner wall of the coronary vein; And a stylet inserted into the stylet insertion hole and allowing the circle large pacemaker lead to be easily moved in the body. It includes.

One end of the guide wire insertion hole is characterized in that it is formed on the distal end of the fixing tip and the other end is formed on the side of the lead body.

Another preferred guide wire insertion hole of the present invention is characterized in that one end of the guide wire insertion hole is formed at the distal end of the fixing tip and the other end is formed on the side of the lead fixing portion.

Another preferred guide wire insertion hole of the present invention is characterized in that it is formed at the distal end of the fixing tip and the other end is formed at the proximal end of the lead body portion.

The lead fixing part is characterized in that it is formed of 2 to 5.5 French sizes (Fr) to be easily pierced and fixed by the myocardium, and the electrode includes two or more bipolar electrodes, and the distance between each electrode is 2 to 10 mm. It is characterized in that it is possible to individually measure the electrical signal of the electrode and to transmit electricity.

In addition, the distal end of the stylet insertion hole is formed to be closed, and the stylet insertion hole is located on the same extension line as the guide wire insertion hole formed in the fixing tip.

The fixing part is characterized in that the stylet is flexible so as to be linearly stretched when inserted into the stylet insertion hole, and has elasticity to restore the original shape that is bent when the stylet is removed. It is characterized by including a plurality of flexible wires on the side wall to improve the fixing force.

In addition, the stylet is characterized in that it is configured to have a stronger rigidity from the distal portion to the proximal portion, and the stylet is characterized in that the diameter becomes smaller toward the distal end.

The present invention is fixed to the base ventricular septum close to the heath (His bundle) is possible for efficient electrical conduction.

In addition, the present invention can identify the electrical stimulation at various locations including a plurality of electrodes, and can change the location of transmitting the electrical stimulation according to the patient without requiring reoperation.

In addition, according to the present invention, the stylet is inserted into the lid body portion, and is easily moved into the blood vessel without requiring any other device when moving in the body.

In addition, the lead fixing portion of the present invention can be easily pierced and inserted into the ventricular septum, including a fixing team having a taper shape of 4Fr and gradually reducing the diameter of the end.

In addition, the present invention can stably insert and fix pacemaker leads without damaging other tissues in the heart.

1 is a diagram of a cardiac conduction system.
2 is a view showing a position where a heart pacemaker studied in the related art is fixed.
3 is a view showing a position in which the lead according to the invention is fixed to the ventricular septum.
4A is a perspective cross-sectional view of a lead according to a preferred embodiment of the present invention.
4B is a perspective cross-sectional view showing that the fixing portion is deformed by removing a stylet from a lid according to a preferred embodiment of the present invention.
Figure 4c is a view showing a state in which the body portion of the lid is fixed to the coronary vein according to a preferred embodiment of the present invention.
Figure 4d is a cross-sectional view of the lid body portion according to a preferred embodiment of the present invention.
5A is a perspective cross-sectional view showing another fixing part according to a preferred embodiment of the present invention.
5B is a cross-sectional view showing another fixing part according to a preferred embodiment of the present invention.
6 is a perspective cross-sectional view showing a guide wire insertion through hole according to another preferred embodiment of the present invention.
7A is a perspective cross-sectional view showing a guide wire insertion through hole according to another preferred embodiment of the present invention.
7B is a cross-sectional view of a lid body portion according to another preferred embodiment of the present invention.
8 is a flow chart of a method using a lid according to a preferred embodiment of the present invention
9A is a photograph showing a pressuized septal venogram when a coronary vein is blocked using a balloon catheter.
9B is a photograph showing a balloon catheter.
10 is a flow chart showing a method of treatment using a lead according to a preferred embodiment of the present invention
11 is a schematic diagram of a path in which a guide wire is inserted in an experiment using a pacemaker lead according to the present invention.
12 is an X-ray photograph showing the appearance of a lead inserted in the path of 1.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

3 is a view showing a position in which the lead according to the invention is fixed to the ventricular septum.

Lead according to the present invention is to insert the pacemaker lead in the same path as the path to enter the body in the'tissue protector for mitral valve circle large procedure' invented by the inventor of Korea Patent Registration No. 10-1536172, the relative vein , Coronary vein, interstitial vein is inserted into the body to reach the ventricular septum. Therefore, it is called'Circlage pacemaker lead'.

The lead according to the present invention is inserted into the coronary vein as described above and moves along the coronary vein to reach the ventricular septum where the lead end is fixed between the heath (His bundle, HBP) and the left ventricular septum (LV septum). Basal interventricular septum, the red circle in FIG. 3.

When the pacemaker lead is fixed to a heath (His bundle), narrow QRS can be obtained to effectively reduce the electrical conduction time, so it is possible to effectively deliver electricity, but to accurately grasp the position of the heath located within the ventricular septum during the procedure It is difficult, and even if the pacemaker lead is fixed to the heath, there is a disadvantage in that the battery life of the pacemaker is shortened due to a high pacing threshold.

When the pacemaker lead is fixed to the LV ventricle (LV septum), it is possible to implement a narrower QRS than to stimulate the right ventricle septum (RV septum), and has the effect of replacing CRT treatment, but it is very effective to enter the left ventricle from the right ventricle. It is an invasive treatment and is a great way to damage other tissues, such as tricuspid valves.

The part in which the lead according to the present invention is fixed (indicated by a red circle) is closer to the heath (His bundle) than the left ventricular septum (LV septum), and has better electrical conduction efficiency, and is located in the left ventricle septum (LV septum) As described above, the lead can be fixed without perforating the ventricular septum from the right ventricle to the left ventricle, and the lead can be fixed without damaging other tissues such as the tricuspid valve.

In addition, although the heat (His bundle) is difficult to find a position during the procedure, the lead according to the present invention can be easily fixed by entering and fixing along the coronary vein.

As described above, the circle large pacemaker lead according to the present invention compensates for the disadvantages of a device in which the lead end developed in the prior art is fixed to the heath and a device fixed to the left ventricular septum (LV septum), and includes both advantages of the conventional two devices. It is an invention.

4A is a perspective cross-sectional view of a lead according to a preferred embodiment of the present invention.

Referring to Figure 4a, the lead 100 according to a preferred embodiment of the present invention includes a lead fixing portion 110 and the lead body portion 120.

The lid 100 is formed of a single catheter or a cylindrical tube, and the material is made of a soft, soft rubber material, a synthetic resin material, or a mixture of polyurethane and silicone.

The lead fixing part 110 is inserted into the myocardium and fixed and transmits electrical stimulation. A guide wire insertion through hole 116 through which the guide wire 200 can be inserted is formed.

The lead fixing part 110 includes a fixing tip 112 whose diameter gradually decreases toward the distal end, and a plurality of electrodes 114 coupled to the outer circumferential surface of the lead fixing part 110 to contact the myocardium.

The fixing tip 112 is formed in a form that is easily inserted through the myocardium, and according to a preferred embodiment of the present invention, the diameter gradually decreases toward the distal end, that is, it is formed in a tapered form. Is done.

In addition, the lead fixing portion 110 has a size of 2 to 5.5 French size (Fr), characterized in that it is formed to be thin to easily penetrate the myocardium. It is preferably formed of 4 French sizes (Fr), and may be formed of 5.1 French sizes (Fr) and 5.2 French sizes (Fr), of course.

The electrode 114 is a bipolar electrode and is coupled to the outer circumferential surface of the lead fixing part 110 and provided with a plurality. The plurality of electrodes 114 are respectively coupled to one end of the plurality of electrode lines 118, and the other ends of the plurality of electrode lines 118 are respectively connected to a pacemaker. The plurality of the electrodes 114 is characterized in that it is possible to measure the electrical signals individually and to deliver individual electrical stimuli.

For example, if the lead fixing unit 110 includes five electrodes, the signals of the five electrodes are measured to find the optimal position according to the patient, and the positive and negative electrodes or the negative electrodes are respectively applied to the first and third electrodes. And the stimulation of the anode, or the stimulation of the anode and the cathode or the cathode and the anode to the electrodes 4 and 5, respectively.

Lead 100 according to the present invention is possible to select the electrode at a position suitable for the patient and transmit electricity as shown in the above example.

A plurality of the electrode wires 118 may be inserted in a straight line on the side walls of the lead body portion 120, and a plurality of the electrode wires 118 may be spirally inserted on the side walls of the lead body portion 120. Yes, of course.

A plurality of the electrodes 114 are installed at intervals of 2 to 10 mm, and more preferably, they are installed at intervals of 2 to 3 mm.

Since the lead 100 according to the present invention includes a plurality of bipolar electrodes 114, it senses a different optimal electrical signal transmission position depending on the patient and delivers electricity to an electrode close to the detected position, thereby more efficiently transmitting electrical stimulation. It is possible to adjust the position of the electric delivery according to the patient without reoperation to change the position of the lead.

One end of the guide wire insertion hole 116 is formed at the distal end of the fixing tip 112 and the other end is formed on the side of the lead body portion 120, the guide wire 200 is the It is inserted into one end of the guide wire insertion through hole 116 formed on the fixing tip 112 to escape to the other end of the guide wire insertion through hole 116 formed on the side surface of the lead body portion 120.

Therefore, it is characterized in that the guide wire 200 can be inserted and removed faster than the guide wire 200 passes through the entire lead body portion 120 and exits.

The guide wire 200 may be made of synthetic resin such as nylon or a metal (stainless steel, nylon coated on metal) wire, and a wire made by twisting a plurality of fine wires may be used, and preferably has a diameter of 0.014 inches. The guide wire of is used.

The guide wire 200 is also to provide a path through which the lid 100 moves in the body, and is inserted into the lead fixing portion 110 to push force when the lead fixing portion 110 moves in the body. ).

The lead body portion 120 is formed to extend from the proximal end of the lead fixing portion 110 and is formed to have a larger diameter than the lead fixing portion 110. Since the lead body portion 120 is located in a coronary vein having a relatively large inner diameter of the vessel, it is possible to have a larger diameter than the lead fixing portion 110. The lead body part 120 includes a fixing part 122 and a stylet insertion hole 124.

A stylet insertion hole 124 into which the stylet 300 is inserted is formed inside the lead body 120, and the stylet insertion hole 124 is closed at the distal end to allow the guide wire insertion hole ( 116).

The distal end of the stylet insertion hole 124 is formed to be positioned on the same vertical line as the distal end of the guide wire insertion hole 116, as shown, the stylet insertion hole is a guide formed on the fixing tip It is located on the same extension line as the wire insertion hole.
Of course, a portion of the stylet insertion hole 124 and the guide wire insertion hole 116 may be formed in parallel within the lead body portion 120.

delete

Therefore, after inserting the stylet 300 into the stylet insertion hole 124, the operator pushes the lid 100 so that the lid 100 does not bend when the lid 100 moves in the body.

The stylet 300 is intended to provide additional rigidity for direction adjustment when a catheter, lid, etc. is moved to a desired position in the body. The stylet 300 may be made of the same material as the guide wire 200, and is the same thickness as the guide wire 200 or thicker than the guide wire 200.

The stylet 300 is formed to have stronger rigidity from the distal portion to the proximal portion, the distal portion is a material that moves more flexibly than the proximal portion so that it can be easily moved along the curved blood vessels in the body, and the proximal portion receives the force pushed by the operator It is made of a solid material to help.

Therefore, the lead 100 formed of a flexible material does not easily move in a desired direction when the operator moves in the body or in a blood vessel, and thus requires another device to assist the movement, but the lead 100 according to the present invention is the style Since the stylet 300 is inserted into the insertion hole 124 to improve the pushability of the lead 100, no other device is required and can be easily inserted into the coronary vein to move toward the ventricular septum.

4B is a perspective cross-sectional view showing that the fixing portion is deformed by removing a stylet from a lid according to a preferred embodiment of the present invention.

The lead body portion 120 is a fixed portion 122 is formed in a portion located in the coronary vein. The fixing portion 122 is formed by bending one side of the lead body portion 120 in a spiral, wavy, or the like, and heating it with heat. Although shown in FIG. 4B as a wave shape, it is of course possible to deform in various forms to press the inner wall of the coronary vein.

The lead body portion 120 is a fixed portion 122 is formed in a portion located in the coronary vein. The fixing portion 122 is formed by bending one side of the lead body portion 120 in a spiral, wavy, or the like, and heating it with heat. Although shown in FIG. 4B as a wave shape (sine wave shape), it is of course possible to deform in various forms to press the inner wall of the coronary vein.

Since the fixing portion 122 is formed by heating one side of the flexible lead body portion 120 with heat, a portion bent in a spiral (coil-shaped) or wavy (sine-wave) shape is expanded according to the movement of the heart. Since it has an elastic force to be restored, it is possible to absorb the impact applied to the lead fixing portion 110.

The fixing part 122 is ductile so that the stylet 300 expands linearly when inserted into the stylet insertion hole 124, and when the stylet 300 is removed, it is restored to its original curved shape. It has elasticity.

Therefore, by inserting the stylet 300 into the lead body portion 120 where the fixing portion 122 is formed, the linear lead 100 is prepared outside the body and then enters the body, and the lead fixing portion 110 ) Is fixed to the ventricular septum and then, when the stylet 300 is removed from the body, the fixing part 122 is restored to its original curved shape and fixed to the coronary vein.

Figure 4d is a cross-sectional view of the lid body portion according to a preferred embodiment of the present invention.

As illustrated in FIG. 4D, the stylet insertion hole 124 is formed inside the lead body 120. The stylet 300 is inserted into the stylet insertion hole 124, and the electrode wire 118 is inserted on a side wall of the lead body 120.

5A is a perspective cross-sectional view showing another fixing part according to a preferred embodiment of the present invention, and FIG. 5B is a cross-sectional view showing another fixing part according to a preferred embodiment of the present invention.

5A and 5B, another fixing part 122 according to a preferred embodiment of the present invention includes a reinforcing material 123. The reinforcing material 123 is formed of a flexible wire and may include one or a plurality.

When the fixing part 122 is fixed to the coronary vein, the fixing force is reinforced, and the fixing part 122 is bent to contact the coronary vein and the movement of the lid 100 according to the heartbeat when the lead 100 is fixed. It is intended to minimize.

Since the reinforcing material 123 is a flexible wire, when the stylet 300 is inserted into the stylet insertion hole 124, the fixing part 122 is unfolded in a straight line, and when the stylet 300 is removed, it is again It is the same that is deformed to bend.

Since the reinforcing material 123 is a flexible wire, when the stylet 300 is inserted into the stylet insertion hole 124, the fixing part 122 is linearly unfolded, and when the stylet 300 is removed, again It is the same that is deformed to bend.

Referring to FIG. 6, in another preferred embodiment of the present invention, a guide wire insertion hole 116 is formed at one end of the distal end of the fixing tip 112 and the other end is formed at a side of the lead fixing unit 110. do.

Referring to FIG. 6, in another preferred embodiment of the present invention, a guide wire insertion hole 116 is formed at one end of the distal end of the fixing tip 112 and the other end is formed at a side of the lead fixing unit 110. do. That is, the guide wire 200 is a structure that is inserted into the distal end of the lead fixing part (strictly speaking, the distal end of the fixing tip) and comes out to the side of the lead fixing part 110.

The other end of the guide wire insertion through hole 116 is formed distal to the point where the electrode 114 is coupled (ie, as shown, the guide wire insertion through hole does not have the inside of the electrode 114), the style Let insertion hole 124 is formed to extend to the inside of the lead fixing portion 110, preferably the same vertical line as the other end of the guide wire insertion hole 116 (guide wire insertion hole formed on the side of the lead fixing portion) At one end of the stylet insertion hole 124 is formed. As shown, the extension line of the stylet insertion hole passes through the end of the fixing tip, which is one end of the guide wire insertion hole. That is, the stylet insertion hole is located on the same extension line as the guide wire insertion hole formed on the fixing tip. Therefore, the stylet 300 is inserted into the stylet insertion hole 124 formed up to the lead fixing part 110 to improve the pushability of the lead 100. In addition, in the case of FIG. 6, the guide wire 200 can be inserted into the guide wire 200 faster and can be removed faster than the shape in which the guide wire 200 passes through the entire lead body portion 120. to be.

7A is a perspective cross-sectional view showing a guide wire insertion through hole according to another preferred embodiment of the present invention.

One end of the guide wire insertion hole 116 is formed at the distal end of the fixing tip 112 and the other end is formed at the proximal end of the lead body portion 120.

Therefore, according to the guide wire insertion through hole 116 according to another preferred embodiment of the present invention, when the guide wire 200 is inserted into the guide wire through hole 116, one side of the guide wire 200 is the lead It comes out to the proximal end of the body portion 120.

7B is a cross-sectional view of a lid body portion according to another preferred embodiment of the present invention. 7B is a cross-section of the lead body portion 120, the lead body portion 120 according to another preferred embodiment of the present invention includes the stylet insertion hole 124 and the guide wire insertion hole 116 therein. It is formed in parallel, the electrode line 118 on the side wall is coupled along the side wall of the lead body portion 120.

8 is a flow chart of a method using a lead according to a preferred embodiment of the present invention.

Referring to FIG. 8, a method of performing a procedure using a circle large heart pacemaker lead according to the present invention, first, a balloon catheter 400 is inserted into the body to check the septal vein. The balloon catheter (ballon tipped guiding catheter 400) is a catheter with a balloon (balloon) formed on the upper side as shown in FIG. 9B, and is inserted through a relative vein and a coronary vein to inflate the balloon by injecting air from outside. Coronary veins are blocked. Accordingly, the flow of blood in the coronary vein is blocked to increase the pressure of the coronary vein, and the coronary vein swells. Thereafter, by contrasting the pressurized venogram (see FIG. 9A ), a septal vein located in the ventricular septum is found.

Instead of the balloon catheter 400, a catheter (not shown) with a tip coupled to one side is also possible. The tip refers to a tube having a diameter similar to the inner diameter of the vessel, thereby preventing the coronary vein and increasing the pressure of the coronary vein.

Next, the guide wire 200 is inserted into the relative vein, coronary vein, and the identified septal vein. At this time, if there is no septal vein, or if the operator does not have a septal vein in a desired position, the myocardium can be perforated by inserting a millet plant. The fabric mill is optional and is not required.

The lead 100 of the present invention is inserted along the inserted guide wire 200.

10 is a flowchart illustrating a method of using a lid according to a preferred embodiment of the present invention, and the procedure will be described later with reference to FIG. 10.

First, the lead 100 according to the present invention prepared outside the body is shown, and the lead 100 is shown before the stylet 300 is inserted into the lead 100. It is prepared in a curved form with a mold. Next, by inserting the stylet 300 into the lid 100 outside the body, the fixing part 300 is prepared in an unfolded state. The prepared lead 100 is inserted into the body along the guide wire 200 first inserted into the body.

Next, the lead 100 prepared in a straight line is inserted into the body to move along the coronary vein. The lid 100 according to the present invention includes the stylet 300, thereby improving the pushability of the lid 100.

Finally, the lead 100 is moved along the guide wire 200, the lead fixing unit 110 is fixed to the ventricular septum at the ventricular septum and the stylet 300 is removed. The government 122 is fixed to the coronary vein in a curved form, such as a wave shape, a spiral, or the like, as in the original state.

Accordingly, the lead 100 has an advantage that does not fluctuate in a fixed position once. In addition, since the lead 100 includes a plurality of electrodes 114, it is possible to grasp an appropriate location for electric transmission according to a patient and efficiently transmit electricity without re-surgery of moving the location of the lead 100.

11 is a schematic diagram of a path in which a guide wire is inserted in an experiment using a pacemaker lead according to the present invention, and shows a path through which the guide wire is inserted into the septal vein along the coronary vein and penetrates the ventricular septum.

In this experiment, the lead according to the present invention was inserted along the path in which the guide wire 200 was inserted.

FIG. 12 is a photograph showing a state in which the lead according to the present invention is inserted and fixed to the base ventricular septum, and is an X-ray photograph showing the state of the lead inserted in the first path of FIG. 11.

Referring to FIG. 12, four bipolar electrodes were coupled to a pacemaker lead according to the present invention, and the spacing between the electrodes was set to 2 mm to be combined. This was fixed to the base ventricular septum by inserting it into the relative vein, coronary vein, and septal vein along the guide wire inserted through the 1st path of FIG. 11.

What will be described later is to compare the electrical conduction efficiency when the lead according to the preferred embodiment of the present invention is fixed to the base ventricular septum, and the electrical conduction efficiency when the lead is fixed at a previously fixed lead fixing position.

Previously studied lead fixation positions include RV apical pacing, RV septal pacing, LV epicardial pacing, LV endocardial pacing, and left ventricle as mentioned in the background art. There are LV apical pacing and LV near apical pacing.

First, as shown in the photograph of FIG. 12A, two electrodes are selected from the four electrodes of the lead inserted into the body along the guide wire inserted in the direction of 1 and fixed to the intra septal pacing (2, 3 electrodes) Or 2,4 electrode or 1,3 electrode or 1,4 electrode) to transfer the electrical stimulation and measure the QRS value. According to the conventional method, the lead was inserted and the electrical stimulation was delivered to measure the QRS value. [Table 1] shows the QRS values tested.

Location QRS (unit: msec) Self rhythm 83 RV septal pacing 93 RV apical pacing 165 Intra septal pacing (2, 3 electrodes) 75 Intra septal pacing (1, 3 electrodes) 75 Intra septal pacing (2, 4 electrodes) 75 Intra septal pacing (1,4 electrodes) 75

Referring to [Table 1], when the lead was fixed to the base ventricular septum in one direction, both narrow QRS values were obtained, and excellent results were compared with those of the comparative example. When the position of the electrode was located within the ventricular septum, a narrow QRS value without relatively large difference was shown regardless of which two of the four electrodes were selected, which was superior to the QRS when inserted by the conventional method. . However, when the electrode moved near the right ventricular inner membrane or left ventricle outer membrane, the QRS showed a longer lengthening phenomenon, and this fact was interpreted as the ideal location for fixing the electrode within the chamber.

Therefore, when using the lead according to the present invention is fixed to the base ventricular septum close to the heath (His bundle) to enable efficient electrical conduction, it is possible to check the electrical stimulation of several locations, including multiple electrodes, other tissues in the heart The cardiac pacemaker leads can be inserted and fixed stably without damaging them.

Although the embodiments of the present invention have been described with reference to the above and the accompanying drawings, those skilled in the art to which the present invention pertains can implement the present invention in other specific forms without changing its technical spirit or essential features. You will understand that there is. Therefore, it should be understood that the above-described embodiments are illustrative in all respects and not restrictive.

100: lead
110: lead fixing part
112: fixed tip
114: electrode
116: Insertion of guide wire
118: electrode wire
120: lead body
122: fixing part
123: reinforcement
124: Stylelet insertion hole
200: guide wire
300: stylet
400: balloon catheter

Claims (16)

In the circle large pacemaker lead,
It has a shape that gradually decreases in diameter as it goes toward the distal end, and a fixed tip that is fixed after being inserted through the myocardium, one or more electrodes in contact with the myocardium on the outer circumferential surface, and a guide wire insertion hole through which a guide wire can be inserted. Is formed, the guide wire insertion hole is connected to pass through the end of the fixing tip, the fixing tip is a lead fixing portion that is inserted and fixed through the myocardium along the guide wire;
It is formed to be extended to the lead fixing portion, a stylet insertion hole through which a stylet can be inserted is formed inside, and the distal end of the stylet insertion hole is blocked, and the stylet is inserted into the stylet insertion hole. A lead body portion of a flexible material that is linearly expanded by a stylet upon insertion; And
A stylet inserted into the stylet insertion hole and imparting pushability so that the circle large pacemaker lead can be easily moved in the body;
Circle large pacemaker lead comprising a. According to claim 1,
One end of the guide wire insertion hole is formed on the distal end of the fixing tip, the other end is formed on the side of the lead body portion circle large heart rate lead. According to claim 1,
One end of the guide wire insertion hole is formed at the distal end of the fixing tip and the other end is formed on the side of the lead fixing portion circle large heart rate lead. According to claim 1,
One end of the guide wire insertion hole is formed at the distal end of the fixing tip and the other end is formed at the proximal end of the lead body portion circle large cardiac pacemaker lead. According to claim 1,
The lead fixing portion is a large large heart pacemaker lead, characterized in that it is formed in a size of 2 to 5.5 French (Fr) in order to easily pierce and fix the myocardium. According to claim 1,
The electrode includes two or more bipolar electrodes, and the distance between each electrode is 2 to 10 mm, and the electrode is a circle large heart pacemaker lead, which is capable of measuring electrical signals individually and transmitting electricity to the proximal part. According to claim 1,
The stylet insertion hole is a circle large cardiac pacemaker lead, characterized in that it is located on the same extension line as the guide wire insertion hole formed in the fixing tip. According to claim 1,
When the stylet is inserted into the stylet insertion hole, the lead body part is linearly unfolded by the stylet and restored to its original shape when the stylet is removed from the stylet insertion hole so that it is fixed to the inner wall of the coronary vein. Circle large cardiac pacemaker lead, characterized in that a fixed portion having a curved shape is formed. The method of claim 8,
The fixing portion comprises a reinforcement consisting of a plurality of flexible wires on the side wall, a circle large pacemaker lead, characterized in that to improve the fixing force. According to claim 1,
The stylet has a stronger stiffness from the distal portion to the proximal portion, and the distal portion is a material that moves more flexibly than the proximal portion so that it can be easily moved along the curved blood vessels in the body. Circle large pacemaker lead, characterized in that formed. According to claim 1,
The stylet is a large circle pacemaker lead, characterized in that the diameter becomes smaller toward the distal end.

The method of claim 8,
The fixed portion has a large or sine wave shaped circle large pacemaker lead. In the circle large pacemaker lead,
A fixed tip having a shape that gradually decreases in diameter as it goes toward the distal end, which is fixed after being inserted through the myocardium;
One or more electrodes in contact with the myocardium on the outer peripheral surface;
A guide wire insertion hole through which a guide wire can be inserted is formed,
The guide wire insertion hole is connected so as to pass through the end of the fixed tip, the fixed tip is inserted through the myocardium along the guide wire is inserted into the circle large heart pacemaker lead. The method of claim 13,
One end of the guide wire insertion hole is formed on the distal end of the fixing tip, the other end is formed on the side of the lead or proximal end of the lead, large heart pacemaker lead. The method of claim 13,
The lead is a large large heart pacemaker lead, characterized in that it is formed in a size of 2 to 5.5 French (Fr) in order to easily pierce and fix the myocardium. The method of claim 13,
The electrode includes two or more bipolar electrodes, and the distance between each electrode is 2 to 10 mm, and the electrode is a circle large heart pacemaker lead, which is capable of measuring electrical signals individually and transmitting electricity to the proximal part.

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