Patent Publication Number: US-2022233206-A1

Title: His bundle-detecting snare catheter

Description:
TECHNICAL FIELD 
     The present invention relates to a HIS-bundle-detecting snare catheter, and more particularly, to a HIS-bundle-detecting snare catheter in which a snare and an electrophysiology (EP) catheter are inserted into a dual lumen catheter including two lumens formed therein, an electrical signal of myocardia is detected to locate a His bundle, and a cerclage wire having passed through the His bundle is captured and safely induced into a human body. 
     BACKGROUND ART 
     A cardiac conduction system is formed from a sinoatial node in an atrium via an atrioventricular node and is divided into a right bundle and a left bundle in a His bundle of a ventricle through Purkinje fibers. 
     In an electrocardiogram, a QRS wave is generated due to a depolarization process of ventricular muscles. Here, an initial downward wave following a P-wave is referred to as a Q wave, an initial upward wave is referred to as an R wave, and a downward wave following the R wave is referred to as an S wave. A width of QRS means time in which electricity is conducted from a His bundle to all ventricles. In a normal case, the width of QRS wave is about 0.12 seconds (about 90 ms). When more than 0.12 seconds (120 ms), intraventricular conduction disturbance is implied. When an electrical conduction time is long, the width of QRS increases. When the electrical conduction time is short, the width of QRS decreases. Wide QRS causes ventricular desynchronization in which ventricular movements are not synchronized such that a ventricular failure is caused. 
     When malfunction of an electricity delivery system itself of the heart occurs or abnormal electricity occurs out of the system and is delivered to another part, arrhythmia occurs. 
     Methods of diagnosing patients with cardiac arrhythmia include electrocardiography, Holter monitoring, an electrophysiological test, and the like. 
     Among them, the electrophysiological test measures and records electrical activity at a variety of parts of the heart while a catheter on which an electrode is mounted is inserted into the heart through blood vessels of an arm or leg or to monitor cardiac responses while electrical stimuli are given to a variety of parts of the heart. Through the electrophysiological test, a cardiac surgeon may locate a precise cause of arrhythmia occurrence, performs treatment of removing the located cause, or treats arrhythmia by installing a pacemaker. 
     As a part of such research, the present inventor has filed applications for a method, device, and catheter for locating an end of a lead of a pacemaker which has passed through sinus coronaries in a ventricular septum which are disclosed in Korean Patent Publication Nos. 10-2016-0011530 and 10-2016-0020887. The published applications have been filed by improving a cerclage wire disclosed in Korean Patent Registration No. 10-1116867 filed by the present inventor and relate to an apparatus configured to more simply fix a pacemaker to the heart in comparison to conventional techniques. 
     The published application discloses a method including introducing a surgical wire through a superior vena cava and a coronary sinus, passing the surgical wire through an intermediate or cacuminal inter-ventricular septum, and then guiding the surgical wire toward the superior vena cava or inferior vena cava and placing an end of a lead of a pacemaker inside the inter-ventricular septum by inserting the lead of the pacemaker along the surgical wire. 
     Here, when the end of the lead of the pacemaker is fixed to a part close to a His bundle located in the inter-ventricular septum and electrical stimuli are applied, an electrical conduction time may be reduced and narrow QRS may be obtained. 
     Accordingly, research on an apparatus configured to induce a lead of a pacemaker to a His bundle so as to allow the lead of the pacemaker to apply electrical stimuli to a part close to the His bundle is necessary. 
     Disclosure 
     Technical Problem 
     The present invention is directed to providing a HIS-bundle-detecting snare catheter configured to install a pacemaker at a place closer to a His bundle in order to increase an arrhythmia treatment effect in which the HIS-bundle-detecting snare catheter configured to insert an electrophysiology (EP) catheter configured to see a position of the His bundle by detecting an electrical signal of myocardia and a snare configured to capture a cerclage wire are inserted simultaneously into a human body so as to capture and move the cerclage wire having passed through the His bundle to the outside of the human body. 
     The present invention is also directed to providing a HIS-bundle-detecting snare catheter configured to easily sense a His bundle and to move a catheter to a desired position so as to capture a cerclage wire having passed through the His bundle. 
     Objects of the present invention are not limited to the above-described objects and other unstated objects of the present invention will be understood clearly by one of ordinary skill in the art from the following descriptions. 
     Technical Solution 
     One aspect of the present invention provides a HIS-bundle-detecting snare catheter including a dual lumen catheter including a first lumen and a second lumen which are formed therein, an electrical-signal-detecting catheter inserted into the first lumen or the second lumen to detect an electrical signal of myocardia, and a snare inserted into the first lumen or the second lumen and including one or more annular wire at a distal part. Here, the electrical-signal-detecting catheter and the snare are inserted into different lumens, respectively. 
     Here, the dual lumen catheter may include a bending portion at the distal part to be bent at a predetermined angle, and the dual lumen catheter may include a position adjustor installed on a proximal part so as to adjust a position of the distal part of the dual lumen catheter when the position adjustor is adjusted. 
     The dual lumen catheter may include a hole formed in a side of the distal part. Also, the hole may be coupled to and communicate with an end of a distal part of the first lumen or the second lumen, and the electrical-signal-detecting catheter or the snare may protrude through the hole. 
     The snare may include a capture portion including one or more annular wires and a body portion having one end coupled to the annular wire and another end passing through the snare lumen and located outside a human body. Also, the other end of the body portion may be pushed or pulled to allow the capture portion of the snare to be inserted into or protrude from the dual lumen catheter. 
     A guide wire may be inserted into the first lumen or the second lumen, and the guide wire may be inserted into the human body in advance of the HIS-bundle-detecting snare catheter to allow the HIS-bundle-detecting snare catheter to easily move to the human body. 
     The HIS-bundle-detecting snare catheter may include a hemostasis valve on an end of a proximal end of the position adjustor to prevent blood flowing into the dual lumen catheter from leaking when the HIS-bundle-detecting snare catheter is inserted into the human body. 
     Advantageous Effects 
     According to the present invention, in a HIS-bundle-detecting snare catheter, an electrical-signal-detecting catheter and a snare are inserted into a dual lumen catheter simultaneously to detect an electrical signal of myocardia so as to allow a cerclage wire to pass through a position of myocardia desired by a user and to easily capture and move the cerclage wire having passed through a His bundle to the inferior vena cava. 
     Also, the HIS-bundle-detecting snare catheter according to the present invention may move a distal part of the dual lumen catheter to a desired position using a position adjustor so that the electrical-signal-detecting catheter and the snare may protrude to be closer to the myocardia. 
    
    
     
       DESCRIPTION OF DRAWINGS 
         FIG. 1  is a perspective view of a HIS-bundle-detecting snare catheter according to a first exemplary embodiment of the present invention. 
         FIG. 2  is a perspective view of a HIS-bundle-detecting snare catheter according to a second exemplary embodiment of the present invention. 
         FIG. 3  is a perspective view of a HIS-bundle-detecting snare catheter according to a third exemplary embodiment of the present invention. 
         FIG. 4  is a perspective view of a HIS-bundle-detecting snare catheter according to a fourth exemplary embodiment of the present invention. 
         FIG. 5  is a flowchart illustrating a method of performing treatment using the HIS-bundle-detecting snare catheter according to the present invention. 
     
    
    
     DESCRIPTION OF REFERENCE NUMERALS 
     
         
         
           
               10 : dual lumen catheter 
               12 : first lumen 
               14 : second lumen 
               20 : snare 
               22 : capture portion 
               24 : body portion 
               30 : electrical-signal-detecting catheter 
               32 : electrode 
               40 : position adjusting device 
               42 : hemostasis valve 
               50 : cerclage wire 
           
         
       
    
     MODES OF THE INVENTION 
     Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the attached drawings. 
     A HIS-bundle-detecting snare catheter according to the present invention is a device configured so that a cerclage wire (treatment wire) inserted into a human body before a lead of a pacemaker passes through a His bundle and is easily induced into inferior vena cava to allow an end of the lead of the pacemaker to be fixed to the His bundle so as to reduce an electrical conducting time and to increase an arrhythmia treatment effect. 
       FIG. 1  is a perspective view of a HIS-bundle-detecting snare catheter according to a first exemplary embodiment of the present invention. Referring to  FIG. 1 , the HIS-bundle-detecting snare catheter according to the first exemplary embodiment of the present invention includes a dual lumen catheter  10 , a snare  20 , and an electrical-signal-detecting catheter  30 . 
     The dual lumen catheter  10  has a cylindrical shape that is an exterior of a general catheter and includes two lumens including a first lumen  12  and a second lumen  14  which are two lumens into which a tool is insertable and are called a dual lumen catheter. 
     The dual lumen catheter  10  may be formed of a synthetic resin material such as a ductile rubber material, a ductile plastic material, and the like which are soft and have high elasticity and restorability. 
     The first lumen  12  and the second lumen  14  may be formed to be parallel at a certain interval, have diameters of 6 Fr (French) or less, and have the same diameters or different diameters. 
     The first lumen  12  and the second lumen  14  have distal ends formed on a distal end of the dual lumen catheter  10  so that the snare  20  or the electrical-signal-detecting catheter  30  are inserted into the dual lumen catheter  10  and protrude from the distal end of the dual lumen catheter  10 . 
     The snare  20  includes a capture portion  22  including one or more annular wires and a body portion  24  having one end coupled to the capture portion  22  and the other end inserted into the first lumen  12  or the second lumen  14 . The snare  20  may employ metal materials (SUS304, nitinol, titanium, and the like) or the like which are insertable into a human body. 
     The capture portion  22  includes one or more annular wires having both ends coupled to one end of the body portion  24  and may include three or four annular wires. The capture portion  22  is formed of a shape memory alloy, an elastic body, or a selfexpandable stent and has a feature of retracting while being inserted into the first lumen  12  or the second lumen  14  and extends while protruding therefrom. 
     In more detail, the snare  20  pushes the body portion  24  while moving according to pushing or pulling one side of the body portion  24  so as to be inserted into the first lumen  12  or the second lumen  14  and protrudes and extends to the outside of the dual lumen catheter  10 . When a cerclage wire  50  having passed through the His bundle is located on the snare  20 , the cerclage wire  50  is captured by pulling the body portion  24  and inserted into the dual lumen catheter  10 . 
     The electrical-signal-detecting catheter  30  includes a plurality of electrodes  32  and may be inserted into the first lumen  12  or the second lumen  14 . Here, the snare  20  and the electrical-signal-detecting catheter  30  may be inserted into different lumens. 
     Accordingly, the snare  20  and the electrical-signal-detecting catheter  30  may be inserted into the dual lumen catheter  10  simultaneously. A position of the His bundle may be detected using the electrical-signal-detecting catheter  30  and the cerclage wire having passed through the His bundle may be captured and withdrawn to inferior vena cava using the snare  20 . 
     The electrodes  32  are configured to detect an electrical signal of myocardia. One or more electrodes  32  may be coupled to an outer circumferential surface of the electrical-signal-detecting catheter  30 . In more detail, the plurality of electrodes  32  formed to have a strand shape are installed to be spaced at certain intervals on the outer circumferential surface of the electrical-signal-detecting catheter  30 . Using the plurality of electrodes  32 , electrical signals at a variety of positions may be detected and the His bundle may be located. 
     The dual lumen catheter  10  includes a position adjustor  40  installed on a proximal part. The position adjustor  40  may rotate in one direction. A distal part of the dual lumen catheter  10  may be moved leftward or rightward and moved to a myocardiac position desired by a practitioner by adjusting the position adjustor  40  so that the snare  20  and the electrical-signal-detecting catheter  30  protrude toward a place near myocardia. 
     The position adjustor  40  is formed by coupling a hemostasis valve  42  to a proximal end to block the proximal end of the position adjustor  40  and prevents blood flowing from the dual lumen catheter  10  into the position adjustor  40  from leaking through the proximal end of the position adjustor  40 . The hemostasis valve  42  may be formed of a silicone material but is not limited thereto. 
       FIG. 2  is a perspective view of a HIS-bundle-detecting snare catheter according to a second exemplary embodiment of the present invention. 
     In the HIS-bundle-detecting snare catheter according to the second exemplary embodiment of the present invention, the dual lumen catheter  10  includes a hole  18  formed in a side of a distal part, and the hole  18  is coupled to and communicates with a distal end of the first lumen  12 . 
     In other words, the distal end of the first lumen  12  is located on a side of the distal part of the dual lumen catheter  10 , and a distal end of the second lumen  14  is located on the distal end of the dual lumen catheter  10 . 
     Accordingly, the snare  20  or the electrical-signal-detecting catheter  30  which is inserted into the first lumen  12  protrudes toward the side of the distal part of the dual lumen catheter  10 . 
       FIG. 3  is a perspective view of a HIS-bundle-detecting snare catheter according to a third exemplary embodiment of the present invention. 
     In the HIS-bundle-detecting snare catheter according to the third exemplary embodiment of the present invention, the dual lumen catheter  10  includes a hole  18  formed in a side of a distal part, and the hole  18  is coupled to and communicates with a distal end of the second lumen  14 . 
     In other words, the distal end of the second lumen  14  is located on a side of the distal part of the dual lumen catheter  10 , and a distal end of the first lumen  12  is located on the distal end of the dual lumen catheter  10 . 
     Accordingly, the snare  20  or the electrical-signal-detecting catheter  30  which is inserted into the second lumen  14  protrudes toward the side of the distal part of the dual lumen catheter  10 . 
       FIG. 4  is a perspective view of a HIS-bundle-detecting snare catheter according to a fourth exemplary embodiment of the present invention. 
     The HIS-bundle-detecting snare catheter according to the fourth exemplary embodiment of the present invention includes a bending portion  16  on a distal part of the dual lumen catheter  10 . The bending portion  16  is formed by bending a distal part of the dual lumen catheter  10  at a certain angle, and the dual lumen catheter  10  includes the bending portion  16  and bends at a certain angle in advance and enters a human body. 
     The dual lumen catheter  10  according to the fourth exemplary embodiment of the present invention includes the bending portion  16  and includes the position adjustor  40  on a proximal part so as to move a distal part of the dual lumen catheter  10  further toward myocardia. The position adjustor  40  is the same as that described above with reference to  FIG. 1  and may move the distal part of the dual lumen catheter  10  leftward or rightward by adjusting the position adjustor  40 . 
     Accordingly, the HIS-bundle-detecting snare catheter according to the present invention may include the dual lumen catheter  10  to move the snare  20  and the electrical-signal-detecting catheter  30  to a position of myocardia desired by a practitioner, may detect an electrical signal of the myocardia to see a position of a His bundle, and may capture and induce the cerclage wire having passed through the His bundle to inferior vena cava. 
       FIG. 5  is a flowchart illustrating a method of performing treatment using the HIS-bundle-detecting snare catheter according to the present invention. 
     First, a guide wire (not shown) is inserted sequentially into a femoral vein, inferior vena cava, the right atrium, and the right ventricle. Next, the dual lumen catheter  10  enters a human body along the guide wire. Here, as the guide wire is inserted into the dual lumen catheter  10 , the guide wire enters the human body along a path through which the guide wire is inserted into the human body. The guide wire is inserted into the first lumen  12  or the second lumen  14  of the dual lumen catheter  10  and it does not matter whether the guide wire is inserted into the first lumen  12  or the second lumen  14 . The dual lumen catheter  10  is inserted sequentially into a femoral vein, inferior vena cava, the right atrium, and the right ventricle which is the same path as that of the guide wire so that a distal part thereof is located in the right atrium. 
     Here, in order to move the distal part of the dual lumen catheter  10  to a position desired by a practitioner, the distal part of the dual lumen catheter  10  may be moved leftward or rightward using the position adjustor  40 . 
     Next, an operation of inserting the electrical-signal-detecting catheter  30  into the dual lumen catheter  10  inserted into the human body is performed. The electrical-signal-detecting catheter  30  may be inserted into the first lumen  12  or the second lumen  14  and may be inserted into the human body to detect an electrical signal of myocardia. Here, the guide wire may be removed from the human body. The electrical-signal-detecting catheter  30  may include a plurality of electrodes to detect electrical signals at a variety of positions of myocardia and may locate a His bundle according to the detected electrical signal. The cerclage wire  50  passes through a position of the His bundle detected using the electrical-signal-detecting catheter  30 . 
     The cerclage wire  50  moves into the human body through superior vein cava and sinus coronaries and passes through the His bundle to guide an end of a lead of a pacemaker to be fixed to the His bundle. Accordingly, when the cerclage wire  50  passes through the His bundle, the end of the lead of the pacemaker which is inserted into the human body along a path of the cerclage wire  50  may be fixed to the His bundle so as to further improve an arrhythmia treatment effect. 
     The snare  20  is inserted into the dual lumen catheter  10  to capture the cerclage wire  50  having passed through the His bundle. When the snare  20  is pushed to protrude from the distal part of the dual lumen catheter  10 , the cerclage wire  50  is located in the capture portion  22  of the snare  20 , and then the snare  20  is pulled and inserted into the dual lumen catheter  10 , the cerclage wire  50  is inserted, with the snare  20 , into the dual lumen catheter  10 . 
     Finally, when the dual lumen catheter  10 , the snare  20 , and the electrical-signal-detecting catheter  30  are removed from the human body through the inferior vena cava, the cerclage wire  50  may move, with the snare  20 , to the inferior vena cava and thus an end thereof may be located outside the human body. 
     Accordingly, in the HIS-bundle-detecting snare catheter according to the present invention, the electrical-signal-detecting catheter and the snare are inserted into the dual lumen catheter simultaneously to detect an electrical signal of myocardia so as to allow the cerclage wire to pass through a position of myocardia desired by the user and to easily capture and move the cerclage wire having passed through the His bundle to the inferior vena cava. 
     Although the embodiments of the present invention have been described above with reference to the attached drawings, it can be understood by one of ordinary skill in the art that the present invention may include other detailed forms without departing from the technical concept or essential features thereof. Therefore, it should be understood that the above-described embodiments are exemplary and not limitative in every aspect.