BACKGROUND

Technical field

[0001] The embodiments herein are generally related to the field of cardiac electrophysiology. The embodiments herein are particularly related to a diagnostic cardiac electrophysiology catheter used for pacing and recording cardiac signals. The embodiments herein are more particularly related to an electrophysiological catheter capable of recording and pacing in multiple chambers of a heart simultaneously.

Description of the related art

[0002] In the last decades, advances in the field of electrophysiology study (EPS) have increased exponentially. Electrophysiology study is a test conducted to identify abnormal heart rhythms called arrhythmias. The abnormal heart rhythms occur due to many reasons. Typically, the proper functioning of a heart relies on electrical signals and muscle contractions. These electrical signal travels through the heart in a regular pattern. Any abnormality in cardiac conduction system causes the heart to beat in an irregular pattern.

[0003] The irregular pattern or abnormal heart rhythms are monitored by recording the electrical signals from the heart during EPS. In order to record the electrical signals, an electrophysiology catheter (EP catheter) is inserted into blood vessels and advanced into the heart. The EP catheter is capable of sending the electrical signals to the heart for recording electrical activities of the heart. Currently, multiple EP catheters are used to pace into different parts of the heart and record the electrical signals during EPS. Most of EPS operations are performed by placing three to five EP catheters inside the heart for recording the electrical signals. The main three EP catheters are inserted via veins into the heart to record the electrical signals from atrium, ventricle and His bundle. Further, extra EP catheters are inserted for recording coronary sinus signal and ablation catheter for ablating arrhythmia substrate zone.

[0004] However, there are many risks and problems involved in using the multiple EP catheters for recording the electrical signals. For each EP catheter, a separate venous access is obtained and separate sheaths are placed in the veins. The separate venous access causes discomfort in a patient because of multiple venous punctures made. The multiple venous punctures cause possible vascular injury, thereby creating infection, bleeding and bruising at the site of venous access. Sometimes, the blood clots are formed inside the blood vessels because of venous occlusion by multiple catheters. Further, a separate venous access during EPS is a time consuming and tiring process. Further, maneuvering the ablation catheter becomes difficult in the presence of multiple EP catheters. Furthermore, the use of multiple EP catheters is costly as the EP catheters once used is disposed after the EPS.

[0005] Currently, the two types of EP catheters are designed. The two types of EP catheters include simple curve catheters and steerable catheters. The simple curve catheters are used for sensing and pacing through different chambers of the heart. However, a plurality of single curve catheters is required for sensing and pacing through different chambers of the heart. The steerable catheters are used for sensing and pacing within coronary sinus and mapping. However, the steerable catheter uses a relatively expensive steerable technology for advancing into the heart of a patient.

[0006] Hence, there is a need for an EP catheter capable of reducing the risks and problems of EPS by pacing through a plurality of chambers and recording the electrical signals simultaneously. Further, there is a need for reducing the cost involved in using the disposable catheter by using a single EP catheter for recording the electrical signals from the plurality of chambers of the heart. Furthermore, there is a need for an EP catheter capable of advancing through the cardiac chambers without using relatively expensive steerable technology.

[0007] The above-mentioned shortcomings, disadvantages, and problems are addressed herein and which will be understood by reading and studying the following specification.

OBJECTS OF THE EMBODIMENTS HEREIN

[0008] The primary object of the embodiments herein is to provide Dual

Chamber Multisite Electrophysiology (EP) Catheter for interventional cardiac electrophysiology study (EPS)

[0009] Another object of the embodiments herein is to provide an EP catheter capable of simultaneously pacing through the plurality of chambers to record the electrical signals from each chamber.

[0010] Yet another object of the embodiments herein is to provide a single

EP catheter capable of sensing and pacing in right ventricle, right atrium and near the

His bundle.

[0011] Yet another object of the embodiments herein is to enable a medical professional to perform EPS by a single venous access and a single sheet for application.

[0012] Yet another object of the embodiments herein is to provide an EP catheter containing a plurality of electric dipoles for sensing and pacing at a desired location in the heart.

[0013] Yet another object of the embodiments herein is to provide an EP catheter enabling a user to perform EPS by a single venous access, thereby reducing a discomfort of the patients caused by a plurality of vascular access.

[0014] Yet another object of the embodiments herein is to provide a method for reducing a total time required for performing an EPS

[0015] Yet another object of the embodiments herein is to provide a method of performing EPS by a single vascular access, thereby reducing a vascular complication caused due to a plurality of vascular access.

[0016] Yet another object of the embodiments herein is to provide a method of EPS for placing an EP catheter in the desired location by simple traction, advancement and rotational maneuvers.

[0017] Yet another object of the embodiments herein is to provide a method of EPS for placing an EP catheter in the desired location by traction and advancement of the guiding wire inside a lumen.

[0018] Yet another object of the embodiments herein is to provide a method of reducing the cost of EPS by reducing the number of required EP sheets and EP catheters.

[0019] Yet another object of the embodiments herein is to provide a method of EPS for facilitating a mapping of maneuvers by providing more space for EP catheter while mapping.

[0020] These and other objects and advantages of the embodiments herein will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. SUMMARY

[0021] The various embodiments herein provide a Dual Chamber Multisite Electrophysiology (EP) catheter used for interventional cardiac Electrophysiology Study (EPS). The EP catheter is designed for pacing and recording an electrical signal at desired optimum locations in dual chambers of a heart simultaneously. The EP catheter enables a medical practitioner to perform EPS with ease by reducing the complications and a discomfort of a patient.

[0022] According to an embodiment herein, an Electrophysiology (EP) catheter for pacing and recording the electrical signals from a plurality of chambers of a heart simultaneously is disclosed. The EP catheter comprises an internal lumen, a catheter body, a plurality of electric dipoles and a cable. The internal lumen is configured to allow a guide wire to pass through for the EP catheter to a ventricle in the heart of a patient. The catheter body is configured for recording electrical signals. The catheter body comprising two consecutive curves is inserted into the heart using traction advancing manoeuvres up to an apex of a ventricle. The plurality of electric dipoles are embedded on the catheter body and is configured to stimulate heart muscles and record the electrical signals from desired optimal locations in the plurality of chambers of the heart. The plurality of electric dipoles are placed at the desired optimal location in the plurality of chambers using fine tuning and traction advancing manoeuvres. The cable is configured to connect the plurality of electric dipoles to an EP monitoring system via an electrical junction box. The EP monitoring system enables a medical practitioner to observe the electrical signals recorded from the heart of the patient.

[0023] According to an embodiment herein, the EP catheter enables the recording electrical signals from atrium, ventricle and His bundle simultaneously.

[0024] According to an embodiment herein, the two consecutive curves of the catheter body comprises a first distal curve configured to take a shape of the ventricle and a second distal curve configured to take shape of the atrium upon insertion in to the heart of the patient.

[0025] According to an embodiment herein, the two consecutive curves of the catheter body are designed at a flexible angle to fit with an angle between the ventricle and the atrium.

[0026] According to an embodiment herein, the two consecutive curves of the catheter body are designed at a flexible angle such that the catheter body is placed close to the His bundle position.

[0027] According to an embodiment herein, the EP catheter comprises a long straight shaft positioned at a proximal end of the EP catheter.

[0028] According to an embodiment herein, the angle between the second distal curve and the long straight shaft is similar to the angle between right atrial wall and vena cava.

[0029] According to an embodiment herein, the cable comprises a plurality of wires for connecting each electrical dipole to the electrical junction box via an electric circuit.

[0030] According to an embodiment herein, the electrical junction box enables the medical practitioner to activate the electric dipoles to stimulate heart muscles and record the electrical signals.

[0031] According to an embodiment herein, the internal lumen allows the guide wire to pass through the EP catheter for straightening the catheter body to pass through a vein of the patient.

[0032] According to an embodiment herein, the plurality of electrical dipoles are connected to an electric circuit sited (situated) in the catheter body of the EP catheter.

[0033] According to an embodiment herein, the EP catheter comprises a nonelectrical conducting body.

[0034] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating the preferred embodiments and numerous specific details thereof, are given by way of an illustration and not of a limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The other objects, features, and advantages will be apparent to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0036] FIG. 1 illustrates a schematic representation or a side view of an EP catheter indicating the shape before advancing a guide wire, according to one embodiment herein.

[0037] FIG. 2 illustrates a side view of an EP catheter indicating the shape after advancing the guide wire, according to one embodiment herein.

[0038] FIG. 3 A illustrates a side view of an EP catheter placed at desired position in a heart after inserting the catheter through a vein that connecting to the heart via inferior vena cava (for example a groin vein) of a patient, according to one embodiment herein.

[0039] FIG. 3B illustrates a side view of an EP catheter placed at a desired position in a heart after inserting the catheter through a vein that connecting to the heart via superior vena cava (for example a wrist vein) of a patient, according to one embodiment herein.

[0040] Although the specific features of the embodiments herein are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the embodiments herein.

DETAILED DESCRIPTION OF THE INVENTION

[0041] In the following detailed description, a reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.

[0042] The various embodiments herein provide a Dual Chamber Multisite Electrophysiology (EP) catheter used for interventional cardiac electrophysiology study (EPS). The EP catheter is designed for pacing and recording an electrical signal at a desired point in the dual chambers of a heart simultaneously. The EP catheter enables the pacing and recording of the electrical signals in an atrium, a ventricle and His bundle all at the same time. Further, the EP catheters are advanced into the desired points of dual chambers of the heart using simple traction, advancement and rotational manoeuvres.

[0043] According to an embodiment herein, an Electrophysiology (EP) catheter for pacing and recording the electrical signals from a plurality of chambers of a heart simultaneously is disclosed. The EP catheter comprises an internal lumen, a catheter body, a plurality of electric dipoles and a cable. The internal lumen is configured to allow a guide wire to pass through for the EP catheter to a ventricle in the heart of a patient. The catheter body is configured for recording electrical signals. The catheter body comprising two consecutive curves is inserted into the heart using traction advancing manoeuvres up to an apex of a ventricle. The plurality of electric dipoles are embedded on the catheter body and is configured to stimulate heart muscles and record the electrical signals from desired optimal locations in the plurality of chambers of the heart. The plurality of electric dipoles are placed at the desired optimal location in the plurality of chambers using fine tuning and traction advancing manoeuvres. The cable is configured to connect the plurality of electric dipoles to an EP monitoring system via an electrical junction box. The EP monitoring system enables a medical practitioner to observe the electrical signals recorded from the heart of the patient.

[0044] According to an embodiment herein, the EP catheter enables the recording electrical signals from atrium, ventricle and His bundle simultaneously.

[0045] According to an embodiment herein, the two consecutive curves of the catheter body comprises a first distal curve configured to take a shape of the ventricle and a second distal curve configured to take shape of the atrium upon insertion in to the heart of the patient.

[0046] According to an embodiment herein, the two consecutive curves of the catheter body are designed at a flexible angle to fit with the angle between the ventricle and the atrium.

[0047] According to an embodiment herein, the two consecutive curves of the catheter body are designed at a flexible angle such that the catheter body is placed close to the His bundle position.

[0048] According to an embodiment herein, the EP catheter comprises a long straight shaft at a proximal end of the EP catheter.

[0049] According to an embodiment herein, the angle between the second distal curve and the long straight shaft is similar to an angle of right atrial wall and vena cava.

[0050] According to an embodiment herein, the cable comprises a plurality of wires for connecting each electrical dipole to the electrical junction box via an electric circuit.

[0051] According to an embodiment herein, the electrical junction box enables the medical practitioner to activate the electric dipoles to stimulate heart muscles and record the electrical signals.

[0052] According to an embodiment herein, the internal lumen allows the guide wire to pass through the EP catheter for straightening the catheter body to pass through a vein of the patient.

[0053] According to an embodiment herein, the plurality of electrical dipoles are connected to an electric circuit sited (situated) in the catheter body of the EP catheter.

[0054] According to an embodiment herein, the EP catheter comprises a nonelectrical conducting body.

[0055] FIG. 1 illustrates a side view of an EP catheter before advancing a guide wire, according to one embodiment herein. FIG.1 further indicates the shape of the EP catheter before advancing a guide wire. The EP catheter 100 comprises a catheter body 102, an internal lumen 104, and a cable 106. A plurality of electric dipoles 1 10a, 110b . . . 1 1 On is embedded on the catheter body for stimulating the heart muscles and recording the electrical signals.

[0056] A distal end of the catheter body 102 of the EP catheter 100 is inserted into the patient' s heart. The catheter body 102 is inserted into the patient' s body via the venous access, usually at groin or wrist of the patient. The shape of the catheter body 102 is designed according to the walls of a ventricle and an atrium. For example, the shape of the EP catheter for pacing and recording the electrical signals from the right atrium, the right ventricle and His bundle is designed to take or conform to the shape of the walls of right ventricle and right atrium.

[0057] The catheter body 102 comprises two consecutive curves. The consecutive curves includes a first distal curve 1 14a in the shape of a ventricle and a second distal curve 1 14b in the shape of the corresponding atrium. The consecutive curves of the catheter body 102 are designed such that an angle between the consecutive curves is flexible to fit an angle between the ventricle and the atrium. Further, the angle between the consecutive curves of the catheter body 102 is designed such that the catheter body 102 is placed close to the His bundle position after a complete insertion of the EP catheter 100 into the heart of the patient. The shape of the EP catheter 100 and the two consecutive curves are designed with different lengths and angles for insertion from specific roots such as groin, wrist, or shoulder.

[0058] Further, the catheter body 102comprises a long straight shaft 1 14c at a proximal end of the EP catheter 100. The angle between the second distal curve 1 14b and the long straight shaft 1 14c is designed such that the angle is similar to the angle of right atrial wall and vena cava. The catheter body 102 comprises an electric circuit for connecting the plurality of electric dipoles 1 10a, 1 10b . . . 1 1 On to the electrical junction box 108.

[0059] The catheter body 102 further comprises a plurality of electrical dipoles 1 10a, 1 10b . . . HOn for sensing the electrical signals at the desired locations in the dual chambers. For example, the catheter body comprises three to five electrical dipoles for sensing the electrical signals. Each electrical dipole among the plurality of electrical dipoles 1 10a, 1 10b. . . HOn comprises two electrodes. One of the electrodes acts as a positive pole and the other electrode acts as a negative pole. The plurality of electrical dipoles 1 10a, 1 10b . . . HOn are designed to record the electrical signals and transmit the electrical signals to an electrical junction box 108 via the cable 106.

[0060] The cable 106 comprises a plurality of wires corresponding to each electric dipole. The plurality of wires in the cable is connected to the plurality of electrical dipoles 1 10a, 1 10b . . . HOn with the electrical junction box 108 via the electric circuit in the catheter body 102. The electrical junction box 108 enables the medical practitioner to record the electrical signal from the heart using any electric dipole among the plurality of electrical dipoles 1 10a, 1 10b . . . 1 1 On. The electrical junction box 108 is further designed to connect the plurality of wires to an EP monitoring system, thereby enabling the medical practitioner to perform the EPS for identifying any abnormal heart rhythm.

[0061] FIG. 2 illustrates a side view of an EP catheter after advancing the guide wire, according to one embodiment herein. FIG.2 further indicates the shape of the EP catheter before advancing a guide wire. The EP catheter 100 shown in FIG. 1 is advanced into heart of a patient using a guide wire 202. The EP catheter 100 is inserted into the patient' s body by following a procedure. Initially, an insertion point on the patient' s body is identified. The insertion point is usually a vein at the groin or wrist of the patient. For example, the insertion point is a femoral vein at the groin of the patient. Once the insertion point is identified, a venous puncture is made in the vein. After puncture, a standard vascular sheet placed in the vein. The EP catheter 100 is inserted into the patient' s body via the sheath. Prior to the insertion of EP catheter 100 via the sheath, the guide wire 202 is inserted into the EP catheter 100.

[0062] The guide wire 202 is a stiff wire capable of straightening and advancing the EP catheter 100 up to the heart of the patient through the vein. The guide wire 202 is inserted via the internal lumen 104 for straightening the EP catheter 100. The guide wire 202 is inserted up to the distal end of the EP catheter 100, thereby straightening the consecutive curves of the EP catheter 100. Further, the EP catheter 100 is pushed into the venous puncture via the sheath. The location of the EP catheter 100 in the vein is identified using navigational techniques. The EP catheter 100 is pushed through the vein using the guide wire 202 until the distal end of EP catheter 100 touches the atrium. Once the tip of the distal end touches the atrium, the guide wire 202 is withdrawn. Further, the EP catheter 100 is advanced through the atrioventricular valve into the ventricle for pacing and recording the electrical signals in the heart.

[0063] The EP catheter 100 is advanced through the atrium and to the corresponding ventricle using traction advancing manoeuvres. The EP catheter 100 is advanced through the heart of the patient until the tip of the distal end is placed near the ventricular apex. Further, the EP catheter 100 is placed at the desired optimal location in the heart by using fine rotation and traction advancing manoeuvers. Once the EP catheter 100 is placed in the desired optimal location, the electrical signals from atrium, ventricle, and His signal are recorded.

[0064] FIG. 3A illustrates a side view of an EP catheter placed at desired position in a heart by inserting through a vein that connecting to the heart via inferior vena cava (for example a groin vein) of a patient, according to one embodiment herein. FIG. 3B illustrates a side view of an EP catheter placed at a desired position in a heart by inserting through a vein that connecting to the heart via superior vena cava (for example a wrist vein) of a patient, according to one embodiment herein. With respect to FIG. 3A-3B, the EP catheter inserted into the dual chambers including the right atrium 302 and right ventricle 304 is explained. The first distal curve 1 14a of the catheter body 102 takes the shape of the right ventricle 304 and the second distal curve 1 14b takes the shape of right atrium 302 up on insertion. The angle between the first distal curve 1 14a and the second distal curve 1 14b is similar to the angle between the right ventricle 304 and right atrium 302. As shown in the FIG. 3, a first electric dipole 1 10a at the distal end of the EP catheter 100 is placed at the apex of the right ventricle 304. A second electric dipole 1 10b and a third electric dipole 1 10c are placed at atrioventricular node (AV node) 306 located between the atrium and ventricle. Further a fourth electric dipole 1 lOd and a fifth electric dipole 1 lOe are placed along the wall of right atrium 302.

[0065] Each electric dipole among the plurality of electric dipoles 1 10a, 1 10b . . . 1 10e is connected to an EP monitoring system via a cable and an electrical junction box. The location of each electric dipole is viewed in the EP monitoring system and each electric dipole is advanced to a desired optimal location using fine tuning and traction advancing manoeuvres. Once the plurality of electric dipoles 1 10a, 1 10b . . . HOe of the EP catheter 100 is located at the desired optimal locations, the electric signal from the chambers in the heart is recorded.

[0066] The medical practitioner is enabled to send the electric pulses through the plurality of electric dipoles 1 10a, 1 10b . . . 1 1 Oe to make the heart beat at different speeds. Further the electric signal produced from the heart is picked up and recorded by the plurality of electric dipoles 1 10a, 1 10b . . . 1 lOe. The first electric dipole 1 10a placed at the apex of the right ventricle 304 is designed to record the electrical signal produced from the right ventricle 304. The second electric dipole 1 10b and the third electric dipole 1 10c are placed at atrioventricular node (AV node) 306 to record the electrical signals from the His bundle. Further, the fourth electric dipole HOd and the fifth electric dipole HOe are placed along the walls of right atrium 302 to measure the electrical signals from the right atrium. The process is called EPS.

[0067] EPS enables the medical practitioner to find the mechanism of an abnormal variation in the heart rhythm (arrhythmia). The medical practitioners are therefore enabled to identify the type and location of arrhythmias for judging appropriate therapy for the patient.

[0068] According to one embodiment herein, the EP catheter 100 is manufactured using a non-electrical conducting material. The dimensions of the EP catheter are manufactured in different sizes according to the need of individual cases. According to one embodiment, the length of an EP catheter is about 1 meter and the diagonal dimension of the EP catheter is about 2-2.5 millimetres (5-8 French). Further, the guide wire is designed with a diagonal diameter of about 1 millimeter.

[0069] Therefore, the EP catheter enables the identification of abnormal rhythm sequence from atrium, ventricle and His bundle simultaneously using a single venous access. Since a single EP catheter is used for measuring the electrical signals from the dual chambers of the heart, the discomfort of the patient is greatly reduced compared to the multiple vascular access performed in the currently routine EPS. Further, multiple vascular accesses are avoided to reduce the vascular complications.

[0070] The insertion of a single EP catheter for recording the electric signal from the dual chambers reduces the total time required for EPS. Further, the cost involved in using the multiple catheters and multiple sheaths are considerably reduced. The use of a single catheter enables an easy mapping of ablation catheter using different mapping manoeuvres.

[0071] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such as specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments.

[0072] It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modifications. However, all such modifications are deemed to be within the scope of the claims.