Improved transvenous cardiac pacing catheter

Abstract

The embodiments described herein relate to a self-positioning, rapidly deploying, low profile transvenous electrode system for sequentially pacing both the atria and ventricles of the heart in a "dual chamber" mode, and a method for deploying the same.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Patent Application No. 17 / 153,875, entitled Transvenous Intracardiac Pacing Catheter, filed on January 20, 2021, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The embodiments described herein generally relate to medical devices that provide cardiac pacing functions, and more particularly, to a transvenous two - chamber sequential pacing catheter that can be temporarily and easily inserted, and systems and methods for atrioventricular pacing to achieve AV synchronization. <C

Background Art

[0003] During or after certain medical procedures or conditions such as open - heart surgery, heart attacks, some infectious diseases, electrolyte disorders, cardiac trauma, or other problems, it is necessary to temporarily pace the heart. The only available temporary pacing catheters do not pace the heart in atrioventricular (AV) synchronization (only the right ventricle is paced).

[0004] Establishing and maintaining AV synchronization in a patient is important for achieving optimal cardiovascular hemodynamics. With AV synchronization, in a normal heart, the stroke volume is estimated to increase by 50% and the cardiac index can increase by 25% to 30%.

[0005] After open - heart surgery, pacing is performed using epicardial wires that are lightly sutured to the epicardium before closing the chest wall. When these epicardial wires are no longer needed, these pacing wires are pulled through the skin. Pulling on the pacing wires represents a risk of life - threatening cardiac tamponade and can also pose risks of infection, myocardial damage, ventricular arrhythmia, and perforation.

[0006] Existing temporary pacing catheters are also difficult to position precisely, and in the case of balloon positioning, complications often occur, including the catheter moving to and blocking the right ventricular outflow tract and pulmonary artery.

[0007] Existing pacing catheter leads can also move (dislodge) at critical points during pacing or certain procedures such as rapid pacing. Therefore, patient mobility (walking) is restricted when temporary pacing is being performed. Restricted walking is known to lead to longer hospital stays and higher medical costs in certain scenarios.

[0008] Therefore, there is a need for an AV sequential pacing catheter that is easy to insert and position in the right heart chamber to replace currently available temporary catheters / leads. [Overview of the project]

[0009] Embodiments described herein relate to an insertable atrioventricular sequential pacing catheter that facilitates insertion and positioning in the right heart chamber.

[0010] This disclosure relates to an improved transvenous intracardiac pacing catheter, and more particularly to an apparatus, method, and system for establishing and maintaining atrioventricular (AV) synchronization in a patient by providing an insertable atrioventricular sequential pacing catheter system having an inner catheter, an outer catheter, and a connector assembly. In a preferred embodiment, the inner catheter incorporates a set of seven nitinol PTFE heat-shrinkable wires having radiopaque tips. Four of the wires are leads for the atria, two for the ventricles, and one forms a capped distal tip. The wires are incorporated into a seven-lumen extrusion and fitted into the correct position using a fixation device. In a preferred embodiment, the outer catheter is a multidurometer coil-reinforced catheter having a Luer hub and a radiopaque tip. In a preferred embodiment, the connector assembly attaches the wires to a plug for connection to a pulse transmitting unit. [Brief explanation of the drawing]

[0011] [Figure 1] This is a schematic diagram of one embodiment of the device, showing an atrial lead, a ventricular lead, a retractable sheath, a composite hub and terminal connection section, a movable deployment mechanism, and an external lead terminal according to the present invention. [Figure 2] This is a schematic diagram of another embodiment of the device, showing an atrial lead, a ventricular lead, a retractable sheath, a hub, an independent terminal connector, a movable deployment mechanism, and an external lead terminal according to the present invention. [Figure 3] This is a schematic diagram of an embodiment of a two-inner-sheath (double-lumen) external movable catheter sheath that accommodates two inner sheaths, one inner sheath having a ventricular lead and the other inner sheath having an atrial lead, according to the present invention. [Figure 4] This is a schematic diagram of a seven-inner-sheath (multi-lumen) embodiment showing an outer movable catheter sheath that houses seven inner-sheaths, each inner-sheath having its own lead, providing three ventricular leads and four atrial leads, according to the present invention. [Figure 5] This is a schematic cross-sectional view of a seven-inner-sheath (multi-lumen) embodiment showing an outer movable catheter sheath according to the present invention, which houses seven inner sheaths, each inner sheath having its own lead, and providing three ventricular leads and four atrial leads. [Figure 6] This is a schematic diagram showing a cross-section of a human heart, in which multiple electrodes inserted into the ventricles and atria according to the present invention are in contact with the walls of the cardiac chambers and the pacer. [Figure 7] This is a chart of the acute first phase in human trials and is useful in supporting embodiments of the present invention. Figure 5 shows an exemplary trial of a sample of 10 patients, although it is not necessarily a specific indication. Figure 5 shows that, according to the present invention, the procedure time can take an average of 24 minutes for device positioning and deployment, RV pacing, A synchronization, AV pacing, performing left-sided diagnosis, and RV pacing, A pacing, AV pacing synchronization, and device removal. [Figure 8] This is an example of a chart of data from one embodiment of the present invention, taken from a procedure for recording a non-limiting preferred embodiment. Figure 8 shows the recorded impedance, threshold, and current for the subject and lead. This demonstrates that, according to the present invention, delivery is safe with or without fluorescence guidance, pacing is successful, lead contact and retention to cardiac tissue are excellent, and there are no adverse events or adverse events at discharge. [Figure 9] This figure shows one embodiment of a device introduced into a patient's jugular vein according to the present invention, and illustrates an embodiment in which the guidewire is removed and the transvenous two-lumen sequential pacing device is introduced into a movable catheter sheath. [Figure 10] This figure shows one embodiment of a transvenous two-lobe sequential pacing device deployed in the heart, as shown in the fluorescence fluoroscopy image, according to the present invention. [Figure 11] This is a diagram of one embodiment of a transvenous two-lobe sequential pacing device deployed in the heart, as shown in the fluorescence fluoroscopy image, according to the present invention. [Figure 12] This is a diagram of one embodiment of a transvenous two-lobe sequential pacing device deployed inside the heart, as shown in the cutout diagram into the heart according to the present invention. [Figure 13] This is a diagram of one embodiment of a transvenous two-chamber sequential pacing device deployed inside the heart, having a ventricular lead deployed into the ventricle from a movable inner sheath, according to the present invention. [Figure 14] This is a diagram of one embodiment of a transvenous two-chamber sequential pacing device deployed inside the heart, in which the atrial lead is deployed into the atrium from a movable inner sheath, while the ventricular lead is already deployed into the ventricle. [Figure 15] This figure shows how an abnormal cardiac rhythm can be detected using a transvenous two-lobe sequential pacing device deployed inside the heart according to the present invention. [Figure 16] This figure shows how a transvenous two-lobe sequential pacing device deployed within the heart, according to the present invention, can deliver electrical stimulation to the atria. [Figure 17] This figure shows how a transvenous two-lobe sequential pacing device deployed within the heart, according to the present invention, can deliver electrical stimulation to the ventricles. [Figure 18] This figure shows how a transvenous two-lobe sequential pacing device deployed inside the heart, according to the present invention, can sense a corrected, normal cardiac rhythm. [Figure 19] This figure shows how the device according to the present invention is removed after it has been deployed inside the heart. [Figure 20] This is a diagram of an embodiment of the present invention, showing only the ventricle. [Modes for carrying out the invention]

[0012] The disclosed embodiments relate to a self-positioning, rapid-deploying, thin transvenous electrode system for sequentially pacing both the atria and ventricles of the heart in a "two-chamber" mode, comprising a plurality of insulated wires bundled together to form at least two rows of aligned leads. The invention provides an emergency pacemaker that paces and senses both the atrial and ventricular chambers and provides "two-chamber" control of the heart using leads that can be safely and easily inserted into the heart in an emergency. "Two-chamber" pacing refers to continuously monitoring spontaneous cardiac activity in both the atria and ventricles, interpreting detected events according to a specific, acceptable algorithm, and stimulating the chambers as needed to maintain a physiologically appropriate rhythm. Importantly, the device can be deployed with or without fluoroscopic leads. In one embodiment, the self-positioning feature makes it possible to use the device without the extensive training and expert experience that has historically been required for pacing devices.

[0013] In some embodiments of the present invention, the device comprises three ventricular leads and four atrial leads made of shape memory material. Two of the three ventricular leads are bent at 90 degrees from the central axis lead and are 180 degrees apart from each other. The four atrial leads are bent at 90 degrees from the central axis (x-axis) within the y-axis plane and are 90 degrees apart from each adjacent lead.

[0014] In some embodiments of the present invention, both sets of leads are attached and housed inside an elongated, e.g., 8Fr (1 mm) tubular and flexible elongated, e.g., 35 cm, retention sheath and function as a guide and delivery system during insertion and removal of the electrode system. Each wire is individually surrounded by electrical insulation.

[0015] In some embodiments of the present invention, the bundle of insulated wires can be arranged in either a parallel configuration or a helical configuration. To fit various sizes of heart cavities, the leads are manufactured with various lengths and appropriate distances between electrodes.

[0016] In some embodiments of the present invention, the electrode system is constructed by assembling a plurality of insulated superelastic wires. The insulating material separates each wire from one another, but the wires are bundled together as a single cable-like structure. At the proximal end, the electrodes are connected to an external pacemaker. At the distal end, the individual wires inserted into the heart contact either atrial tissue or ventricular tissue. The distal ends of the individual wires may include spherical electrode contacts that contact atrial or ventricular tissue.

[0017] In some embodiments of the present invention, each of the wires has a memory, The leads are pre-formed to a specific curvature but possess sufficient elasticity to be housed within the sheath before being placed in the cardiac chambers. Both sets of ventricular and atrial leads are contained within a single elongated, flexible retaining sheath, which serves as a guide and delivery system during the insertion and removal of the electrode system. Therefore, the ventricular electrodes, which may be pacemaker sensors or stimulators, are first released after the retaining sheath has been successfully inserted into the right ventricle. At this point, the sheath retracts, allowing the ventricular wires to deviate from the sheath and, due to the pre-formed shape of each wire having memory, spread out to individually contact the endocardial surface. The leads spread outward and engage with the ventricular tissue and chamber wall. If a mechanical parallel wire configuration is selected within the sheath, the wires may be released and in contact within the same plane. Otherwise, the wires may be staggered within the ventricular chambers. If a helical wire configuration is selected within the sheath, the wires stagger upon release to cover various points on the cardiac chamber wall. Ideal wires for this configuration are described in U.S. Patent No. 6,137,060 and U.S. Patent No. 3,699,886.

[0018] By continuing to retract the sheath, the atrial wire and electrodes, which also have memory, can be dislodged from the sheath and move outward toward the atrial tissue for engagement.

[0019] As described above, in some embodiments of the present invention, the distal end of each wire may have a spherical conductive ball tip to provide high current density and sensitivity. For the physician to effectively introduce the device transvenously, the sheath must first be fully extended forward to cover all wires except the distal electrode, which may protrude beyond the sheath while introducing the sheath with the conduction leads into the heart. The path of the sheath with leads during insertion is through the subclavian or jugular vein, passing through the atria into the ventricles. Once the electrode system reaches the apex of the right ventricle, the operator slowly begins to withdraw the sheath, releasing each wire individually until all necessary contact points are formed.

[0020] In some embodiments of the present invention, the sheath is slowly retracted and the wires are released, so each wire is made of a superelastic or shape-retaining material such as Nitinol®.

[0021] Each wire is pre-shaped with the appropriate orientation so that when a medical professional, such as a cardiologist, emergency medical technician, surgical staff, or outpatient staff, pulls back the sheath, the wire fan faces outward and makes electrical contact until the wire tip contacts the inner wall of each heart chamber. Memory within the wire holds it in place within the heart chamber. The ball-shaped tip of each wire and the selected highly flexible material minimize endocardial trauma while allowing a sufficiently large surface area for electrical conduction.

[0022] polymer Any device and / or its components may be made from any suitable biocompatible material or combination of materials. For example, the outer chassis and / or its components may be made from biocompatible materials, metals, metal alloys, polymer-coated metals, etc. Suitable biocompatible materials, metals and / or metal alloys may include polymers, copolymers, ceramics, glass, aluminum, aluminum alloys, stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, nickel-titanium alloys (e.g., Nitinol®), etc. Furthermore, either the chassis or any component may be covered with a suitable polymer coating, such as natural or synthetic rubber, polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), translute styrene-isoprene butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-polylactic acid (DLPLA), polylactic acid-coglycolic acid (PLGA), etc.

[0023] For the electrode system within the sheath to navigate the blood vessels freely, it must have a very smooth surface. Sufficient flexibility must be achieved with a material that does not rupture or break prematurely. The insulating material used to insulate each individual wire is of the type used in the manufacture of existing pacing leads. Furthermore, the sheath material used is a thermoplastic elastomer similar to that used in the manufacture of catheters and may be braided for additional strength.

[0024] In one non-limiting embodiment, the electrode system according to the present invention may be designed primarily for emergency temporary use, such that the described lead has passive fixation. However, in another non-limiting embodiment, the present invention can be used as part of a permanently implanted pacemaker system, such that the electrode is implanted in cardiac tissue or actively attached to the endocardium by one of many means available for active fixation.

[0025] Some biocompatible synthetic materials include, for example, polyester, polyurethane, and polytetrafluoroethylene (PTFE) (e.g., Teflon). When thin and durable synthetic materials are desired (e.g., for covers), synthetic polymer materials such as expanded PTFE or polyester may be used. Other suitable materials may include, depending on the context, elastomers, thermoplastic resins, polyurethanes, thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, polyether ether ketones (PEEK), silicone-polycarbonate urethanes, polypropylene, polyethylene, low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefins, polyethylene glycol, polyether sulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylon), PTFE, elongated PTFE, expanded PTFE, siloxane polymers and / or oligomers, and / or polylactones, as well as block copolymers using these.

[0026] radiopaque material Barium sulfate. Barium sulfate (BaSO4) is a radiopaque material widely used in medical formulations and is a common filler used with medical polymers.

[0027] This is an inexpensive material, costing about $2 / lb, and its white color can be altered by adding colorants.

[0028] Barium sulfate, with a specific gravity of 4.5, is generally used in addition amounts of 20–40% by weight. While 20% barium sulfate compounds are typical for general medical device applications, some physicians prefer higher radiopaqueness than that can be provided by the load. For example, 40% compounds are standard in striped tubing.

[0029] A 20 wt% barium sulfate load is equivalent to approximately 5.8 vol% and 40 wt% is equivalent to 14 vol%. When the barium content exceeds approximately 20 vol%, the compound begins to exhibit a loss of tensile strength and other mechanical properties of the base polymer. Therefore, it is best to incorporate the lowest possible level of radioactive material for each application, and excessive use of these fillers is not recommended.

[0030] Bismuth. Bismuth compounds, which are quite expensive at $20-$30 / lb (depending on the selected chemical salt), are also twice as dense. The specific gravity of yellow bismuth trioxide (Bi2O3) is 8.9, the specific gravity of bismuth tricarbonate (Bi2O2CO3) is 8.0, and the specific gravity of bismuth oxychloride (BiOCl) is 7.7. Due to density, a 40% bismuth compound contains only about half the volume of a 40% barium sulfate compound. Bismuth is commonly used whenever a high level of radiopaqueness is required, as it produces brighter, sharper, and higher-contrast images on X-ray film or fluoroscopy than barium.

[0031] Compared to barium, higher loadings are possible: even a 60% bismuth compound can maintain the same base polymer mechanical properties as a 40% barium sulfate compound. A 20% wt% bismuth loading corresponds to 3% by volume, and a 40% wt% loading corresponds to 7.6% by volume. Bismuth is sensitive to formulation and must be handled gently with a low-shear mix, which is recommended for optimal results. Bismuth provides a high level of radiopaqueness.

[0032] Tungsten. Tungsten(W), a fine metal powder with a specific gravity of 19.35, is more than twice as dense as bismuth and can offer a high attenuation coefficient at a cost of approximately $20 / lb. A 60% tungsten load has roughly the same volume ratio as a 40% bismuth compound. Devices can be made highly radiopaque with relatively low loads of tungsten while maintaining good mechanical properties. Due to its density, tungsten is commonly chosen as a filler for ultrathin-walled devices.

[0033] A 50 wt% tungsten load corresponds to only 5.4 vol% and an 80 wt% load represents 18.5 vol%. Tungsten is black and cannot be altered by colorants. Tungsten is abrasive and can accelerate wear on extruders and other processing equipment. Equipment loaded with high amounts of tungsten exhibits surface roughness. This material oxidizes in the presence of oxygen and heat and is highly flammable, so care must be taken to ensure it is dry. In elastomers, barium sulfate mixes better than tungsten or bismuth compounds.

[0034] Considerations regarding formulation Newer X-ray equipment generally operates at higher energy levels than older equipment, typically at 80–125 kVp compared to 60–80 kVp for older equipment. Higher energy radiation increases photon transmission and may require a higher level of radiopaqueness to provide the desired attenuation. Therefore, equipment fabricated with barium sulfate compounds may not appear bright in newer machines where bismuth compounds are a better choice for radiopaque fillers. However, blending these materials can often be the best solution, especially for multipurpose formulations used across a wide range of energy levels. A mixture of barium, which attenuates easily at low energy levels, and bismuth, which attenuates at high energy levels, often works well.

[0035] Formulating radiopaque materials involves considering the attenuation of the device, the tensile strength and elongation of the polymer, and other mechanical properties. Fillers, antioxidants, stabilizers, and colorants may also be included along with the metal fillers.

[0036] The present invention may be used in emergency rooms, post-cardiac surgery, during or after minimally invasive cardiac surgery or implant procedures such as valve repair or replacement, intensive care units, bedside, cardiac catheterization laboratories, ambulances, battlefields, and other emergency situations where patients with heart block or other life-threatening arrhythmias may be found.

[0037] independent claim In a preferred embodiment, the present invention relates to a self-positioning, rapidly deployable, thin transvenous electrode system for cardiac pacing,

[0038] A pulse generator capable of providing sensing and stimulation to the ventricles or atria; A pacemaker comprising a plurality of insulated wires bundled together to form a distal set of three ventricular leads arranged in a first inner sheath and a proximal set of four atrial leads arranged in a second inner sheath, wherein the first and second inner sheaths comprise a plurality of insulated wires arranged in an outer movable catheter sheath, the outer movable catheter sheath being movable from the first and second inner sheaths once inserted into the heart to deploy the first inner sheath into the ventricle and the second inner sheath into the atrium, and the outer movable catheter sheath being completely removed from the atrium and ventricle when a transvenous electrode system is engaged. The first medial sheath is movable to expose the distal set of three ventricular leads to the ventricles, and the second medial sheath is movable to expose the four atrial leads to the atria. The first inner sheath and the second inner sheath are each formed from a polymer, which is doped with a radiopaque material to form a radiopaque polymer sheath, or is labeled with at least one radiopaque marker element. Each of the ventricular lead and the atrial lead comprises a proximal body, a distal end, and a tip. The proximal main body is made from radiopaque polymer-coated copper wire. The distal end is made from a shape memory material selected from stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy, and mixtures thereof. The tip is made from a shape memory material and a radiopaque material selected from barium-containing compounds, bismuth-containing compounds, steel compounds, tungsten-containing compounds, and mixtures thereof. Two of the three ventricular leads are set in a shape that is spread at a 90-degree angle, and these two ventricular leads are offset from each other by 180 degrees, and one of the three ventricular leads is a central axis lead. Each of the four atrial leads is shaped at a 90-degree angle in the expanded configuration, and the four atrial leads are each 90 degrees apart from each other. The movable catheter sheath consists of a distal and a proximal section, and is equipped with distance markers every 10 cm along its entire length. The distal portion of the movable catheter sheath is 5 cm long, has a pitch coil of 0.010 inches, and has a biocompatible polymer cover. The proximal portion of the movable catheter sheath is 30 cm long, has a pitch coil of 0.020 inches, and has a biocompatible polymer cover. The proximal end of the proximal portion is equipped with a hub element, a Touhy-Borst access connector with a side port, an actuator dial that enables molding and control of the movable catheter sheath, an deployment stop section, and a cable junction housing. The atrial and ventricular lead terminals extend from the cable junction housing to the pacemaker. The pacemaker is equipped with computer program instructions readable by the processor to provide functions selected from a group consisting of diagnostic functions, sensor operation, stimulation signals, programs for individual leads for sensing, programs to reduce oversensing of ventricular leads due to T waves or other noise or attenuation or interference signals, programs to reduce oversensing of atrial leads due to R waves, programs to minimize crosstalk, and programs to adjust sensing and stimulation for each lead. The atrial lead is shaped to sense and stimulate the SA nodal region and AV nodal region of the heart, and the ventricular lead is shaped to sense and stimulate the bundle of His region, the Apex-Purkinje fiber region, and the Free-wall Purkinje region. The system is provided in which each of the ventricular leads is connected to a ventricular sensor or stimulator in the pacemaker, and each of the atrial leads is connected to an atrial sensor or stimulator in the pacemaker.

[0039] Ventricles only In another preferred embodiment, the present invention relates to a self-positioning, rapidly deployable, thin transvenous electrode system for cardiac pacing, A pulse generator capable of providing sensing and stimulation to the ventricles; A pacemaker comprising a pair of insulated wires for forming a first ventricular lead and a second ventricular lead, wherein the first ventricular lead and the second ventricular lead are positioned within an externally movable catheter sheath, The external movable catheter sheath is movable away from the first and second ventricular leads, and once inserted into the heart to deploy the first and second ventricular leads into the ventricles, the external movable catheter sheath is completely detached from the ventricles when the transvenous electrode system is engaged. Each of the first and second ventricular leads comprises a proximal body, a distal end, and a tip, the proximal body being made from radiopaque polymer-coated copper wire. The distal end is made from a shape memory material selected from stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy, and mixtures thereof. The tip is made from a shape memory material and a radiopaque material selected from barium-containing compounds, bismuth-containing compounds, steel compounds, tungsten-containing compounds, and mixtures thereof, and the two ventricular leads are offset 180 degrees from each other. The movable catheter sheath has a diameter of approximately 1.3 mm or 4 French, consists of a distal and proximal section, and is equipped with distance markers every 10 cm along its entire length. The distal portion of the aforementioned movable catheter sheath has a length of 5 cm, a pitch coil of 0.010 inches, and has a biocompatible polymer cover. The proximal portion of the movable catheter sheath is 30 cm long, has a pitch coil of 0.020 inches, has a biocompatible polymer cover, and at the proximal end of the proximal portion, is a hub element, a Touhy-Borst access connector with a side port, an actuator dial that enables molding and control of the movable catheter sheath, a deployment stopper, and a cable connection housing. The atrial and ventricular lead terminals extend from the cable junction housing to the pacemaker. A pacemaker is equipped with computer program instructions readable by a processor to provide functions selected from a group consisting of diagnostic functions, sensor operation, stimulation signals, programs for individual leads for sensing, programs to reduce oversensing of ventricular leads due to T waves or other noise or attenuation or interference signals, programs to minimize crosstalk, and programs to tailor sensing and stimulation for each lead. The ventricular lead is shaped to sense and stimulate the bundle of His region and the free-wall Purkinje region. Each of the ventricular leads is connected to a ventricular sensor or stimulator within the pacemaker, providing a system.

[0040] Independent covering Any embodiment of this specification, including a ventricular embodiment, may include a (first) ventricular lead being positioned within a (first) movable inner sheath, a (second) ventricular lead being positioned within a (second) movable inner sheath, and each inner sheath being made from a polymer, the polymer being doped with an radiopaque material or labeled with at least one radiopaque marker element to form a radiopaque polymer sheath.

[0041] Bundled covering In any embodiment of this specification, the first inner sheath may be a set of three independently movable inner sheaths, with each of the three ventricular leads having its own movable sheath, and the second inner sheath may be a set of four independently movable inner sheaths, with each of the four atrial leads having its own movable sheath.

[0042] Variation Any of the two-chamber embodiments described herein may include two consecutive pulse generators capable of providing sensing and stimulation to the ventricles and atria in order to sequentially pace both the atria and ventricles of the heart in a "two-chamber" mode.

[0043] Any embodiment of the present invention may have a configuration in which the atria are spaced 90 degrees apart from each other around the Y axis, and the ventricles are arranged in a plane perpendicular to the central X axis, and may include four atrial wires and three ventricular wires.

[0044] In any embodiment of the present invention, the atrial lead and ventricular lead may be provided with non-insulated wires at specific positions. In any embodiment of the present invention, the copper body portion is braided or joined to the distal end portion, and the distal end portion may be made of steel or a NiTi alloy. In any embodiment of the present invention, the eyelet shape setting may be performed simultaneously with the shape setting of the regenerated portion of the lead. In any embodiment of the present invention, shape setting may be performed more quickly by changing the wire cross-section.

[0045] In any embodiment of the present invention, the tip of the electrode may be an eyelet rather than a ball, and the tip portion may be a composite of a shape memory material and a radiopaque material. In any embodiment of the present invention, the radiopaque material may be tungsten, barium, and / or bismuth compounds. In particular, bismuth exhibits brighter emission under X-rays. Examples of bismuth compounds include Bi2O3, Bi2O2CO3, and BiOCl. Barium sulfate is well blended with polymer coatings such as polyimide. Barium radiopaque polymers can be used as catheter sheaths / jackets, eyelets, RO bands, and other electrode and sheath components.

[0046] In any embodiment of the present invention, the polymer may be polyimide, or the polymer may be silicone + lubricant, or it may be made from PebaSlix 35D, or it may be made from Pebax 72D, etc. In any embodiment of the present invention, the sheath may be configured to provide a 90-degree curve over a 2.5-inch diameter bend, and may also be configured to provide a hockey stick bend at an angle of 45 degrees ± 5 degrees.

[0047] Computer program In another preferred embodiment, the present invention includes a processor-executable computer program instruction for performing one or more of the following functions: a function that enables the present invention to increase the signal-to-noise ratio (SNR) of the sensing function by reducing the sensitivity of certain leads and increasing the sensitivity of other leads during a depolarization cycle (PQRST); a function that enables the present invention to provide a certain level of precision to the stimulating function by reducing or increasing the stimulation signal to one or more leads to more accurately deliver stimulation to the AV nodule, SA nodule, apex, or other cardiac tissue; and a function that enables the function to continue without removing the entire device from the patient by programming leads so that the sensing leads do not need to share the function of the impact / stimulation leads and bypassing damaged or degraded leads.

[0048] method In another preferred embodiment, the present invention relates to a computer implementation method for rapidly deploying a cardiac pacing device to a patient's heart, (i) the step of supplying a transvenous double lumen system as described in the claim and specified herein; (ii) Accessing the patient's jugular vein and advancing the catheter sheath to the right ventricle of the patient's heart under the guidance of ultrasound or other non-fluorescence imaging; (iii) The step of drawing the external movable catheter sheath to the first position, exposing the first inner sheath and the second inner sheath; (iv) The first inner sheath is pulled out to the second position, exposing the ventricular lead and connecting it to the ventricular tissue; (iv) The second inner sheath is pulled out to the third position, exposing the atrial lead and connecting it to the atrial tissue; (v) A step of performing diagnostic tests using computer program instructions that can be executed on the processor to identify the patient's cardiac pattern and verify the operation of the system; (vi) A step of executing an appropriate cardiac pacing routine as treatment of the Patent's cardiac pattern using computer program instructions that can be executed on the processor; (vii) Provide a method including the step of removing the catheter sheath and allowing the system to be placed in the patient, wherein steps (i) to (vii) are performed within 60 minutes.

[0049] In another preferred embodiment, the present invention provides that steps (i) to (vii) are carried out within 30 minutes. In another preferred embodiment, the present invention provides a low-cost, safe, and reliable transvenous electrode system for emergency use of cardiac block to pace both the atrial and ventricular chambers of the heart of a patient having cardiac block. In another preferred embodiment, the present invention provides an emergency cardiac pacemaker that requires only a small incision to insert leads that provide two-chamber (sequential) pacing and sensing for the atria and ventricles of the heart. In another preferred embodiment, the present invention provides an emergency pacemaker that avoids the problems of single-chamber ventricular pacing, so that the present invention provides atrial-ventricular synchronization.

[0050] definition The terms used herein are for the sole purpose of describing specific embodiments and are not intended to limit the scope of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Nothing in this disclosure should be construed as an acknowledgment that the embodiments described herein do not have prior rights to such disclosure by prior art.

[0051] As used herein, the singular forms "a," "an," and "the" are intended to include both singular and plural forms unless the context explicitly indicates otherwise. With regard to substantially any use of plural and / or singular terms herein, those skilled in the art can convert from plural to singular and / or singular to plural as appropriate to the context and / or use. Various singular / plural substitutions may be explicitly stated herein for clarity.

[0052] In general, the terms used herein, and in particular in the appended claims (e.g., the body of the appended claims), are intended to be “open” terms (for example, “including” should be interpreted as “including but not limited to,” and “having” should be interpreted as “having at least,” etc.). Similarly, the terms “comprises” and / or “comprising,” as used herein, specify the presence of a described feature, integer (or part thereof), step, operation, element, and / or component, but do not exclude the presence or addition of one or more other features, integers (or parts thereof), steps, operations, elements, components, and / or groups thereof. As used herein, “comprises” means “including but not limited.”

[0053] As used herein, the term “and / or” includes any combination of one or more of the related enumerated items. It should be understood that substantially any disjunctive word and / or phrase presenting two or more alternative terms, whether in the detailed description, claims, or drawings, is intended to be understood as construing the possibility of including one of the terms, either of the terms, or both. For example, the phrase “A or B” is understood to include the possibilities of “A” or “B” or “A and B.”

[0054] All scopes disclosed herein also encompass all possible sub-scopes and combinations thereof unless otherwise specified. The listed scopes should be recognized as sufficiently descriptive and enable that the same scope may be broken down into at least equal parts unless otherwise specified. As will be understood by those skilled in the art, the scope includes individual components.

[0055] The embodiments and / or various features or advantageous details thereof described herein are better described with reference to the non-limiting embodiments shown in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments herein. Similar numbers refer to similar elements throughout.

[0056] The examples and / or embodiments described herein are intended solely to facilitate understanding of the structure, function, and / or aspects of the embodiments, to facilitate understanding of the methods by which the embodiments can be carried out, and / or to further enable those skilled in the art to carry out the embodiments described herein. Similarly, methods and / or ways of using the embodiments described herein are provided only as examples and not as limitations. Specific uses described herein are not provided to exclude other uses unless the context specifically indicates otherwise.

[0057] Cardiac electrophysiology The cardiac electrical conduction system uses nodular myocytes and Purkinje cells to maintain synchronization between the atria and ventricles.

[0058] The electrical current is initially initiated in the sinoatrial (SA) node, the heart's natural pacemaker, located in the upper part of the right atrium. The SA node is composed of nodular myocytes. In a normal resting adult heart, the SA node begins to fire at 60–100 impulses per minute, and these impulses cause electrical stimulation and subsequent atrial contraction. The sinoatrial (SA) node, located at the upper end of the septum, generates synchronous neural-mediated signals for cardiac pacing.

[0059] These signals then travel across the atria to the atrioventricular node, located near the septal leaflet of the tricuspid valve. The AV node is also composed of nodules that regulate these incoming electrical impulses.

[0060] After a slight delay allowing the atria to contract and the ventricles to fill completely, the AV (atrioventricular) node relays impulses to the Purkinje cells within the ventricles, which are first conducted through the bundle of His extending along the septum, then split into the right bundle branch to conduct impulses to the right ventricle, and the left bundle branch to conduct impulses to the left ventricle, causing ventricular contraction.

[0061] In a healthy heart, the signal from the AV node to the free wall of the left ventricle is rapid, ensuring that the free wall and septum contract synchronously. For example, the impulse signal can reach the free wall in approximately 70–90 milliseconds. In patients with conduction abnormalities, this timing is significantly delayed (more than 150 milliseconds), which can result in asynchronous contractions.

[0062] In some patients, the conduction pathway through Purkinje fibers may be blocked. The location of the block may be highly localized (as in the case of so-called "left fascicular branch block" or LBBB) or may involve an enlarged area of ​​dysfunctional tissue (which may result from infarction). In such cases, all or part of the free wall of the left ventricle is relaxed while the septum is contracting. In addition to contributing to asynchronous contraction, the contractile force of the free wall is weakened. To address asynchronous contractions, CHF patients may be treated with left ventricular cardiac pacing. Such pacing involves stimulating the septal muscle in sync with stimulating the muscle of the free wall of the left ventricle. The infarcted tissue does not respond to such stimulation, but the non-infarcted tissue contracts, thereby increasing the output of the left ventricle.

[0063] drawing Referring now to Figure 1, this is a schematic diagram of one embodiment of the device according to the present invention, showing an atrial lead, a ventricular lead, a retractable sheath, a connection part combining a hub and terminals, a movable deployment mechanism, and an external lead terminal.

[0064] Referring to Figure 1, the distal central radiopaque lead 101 is shown as one of a three-part set of ventricular leads. Ventricular leads 102 and 103 are shown bent at a 90-degree angle from the central axis of lead 101 and positioned 180 degrees opposite each other, with lead 102 facing lead 103 180 degrees in the y-axis plane. In a preferred embodiment, the ventricular lead is formed from 0.010 inches of Nitinol. Lead 101 extends 6 cm axially from the distal radiopaque band. Leads 102 and 103 curve away from the central lead and extend 4 cm away from the central axis, respectively.

[0065] Atrial leads 104, 105, 106, and 107 are bent 90 degrees away from the central axis and are bent 90 degrees from each other in the y-plane. Each atrial lead extends 4 cm away from the central axis.

[0066] In a preferred embodiment, the movable catheter sheath consists of a distal portion 109 having a length of 5 cm and a pitch coil of 0.010 inches, the distal portion being made from PebaSlix 35D. The movable catheter sheath also consists of a proximal portion 113 having a length of 30 cm and a pitch coil of 0.020 inches. In a preferred embodiment, the proximal portion is made from Pebax 72D. The sheath is configured to exhibit a 90-degree curve over a 2.5-inch diameter bend and also to exhibit a hockey stick bend at an angle of 45 degrees ± 5 degrees. The sheath has OS markers 110, 111, 112 positioned every 10 cm along its length from the distal tip 108.

[0067] At the proximal end, the sheath is equipped with a Touhy-Borst access connector having an adhesive hub 114 and a side port 115. An actuator dial 116 is located at the proximal end of the sheath and allows for the molding and control of the sheath. A red deployment stop 117 connects the last 20 cm 118 of the sheath to the cable joint housing 119.

[0068] Programmable Reeds The atrial lead terminals 120, 121 and the ventricular lead terminals 122, 123 are It can be connected to and operated from an external unit such as an ICD, pacer, diagnostic, or other unit, allowing for individual lead programming to improve sensor operation, stimulation signals, and sensing; avoidance of oversensing of ventricular leads due to T waves or other noise or attenuation or interference signals; avoidance of oversensing of atrial leads due to R waves; avoidance of crosstalk; or customization of sensing and stimulation on a per-lead basis.

[0069] Within the scope of the present invention, it is also conceivable to use digital signal processing in combination with the use of multiple leads. To utilize a multiple lead architecture, multiple input multiple output (MIMO), single input multiple output (SIMO), single input single output (SISO), and multiple input single output (MISO) can be programmed within the control unit. For example, by reducing the sensitivity of a particular lead and increasing the sensitivity of other leads during a depolarization cycle (PQRST), the present invention can increase the signal-to-noise ratio (SNR) in the sensing function. Similarly, by reducing or increasing the stimulation signal to one or more leads, the present invention enables more precise stimulation to be delivered to the AV nodule, SA nodule, apex, or other cardiac tissue, providing a level of precision in stimulation functions that was previously unavailable to physicians. Likewise, unlike conventional devices, the availability of multiple programmable leads means that sensing leads do not need to share the function of the impact / stimulation lead. Furthermore, it is possible to bypass damaged or degraded leads, allowing the device to continue functioning without the need to remove the entire device from the patient, thereby extending the lifespan of devices implanted using the technology of the present invention.

[0070] As is common with implantable pulse generators, the device may be programmable to achieve either conventional bipolar or unipolar stimulation, or to achieve the stimulation of the present invention via an external programming device, or it may be automatically controlled by the device. The selection may be based on user preference or driven by physiological factors such as the width of the patient's QRS complex or the conduction interval between stimuli to distant regions within the heart. Furthermore, switching between the pacing of the present invention and conventional pacing may also be determined by the proportion of pacing, prioritizing the higher proportion achieved by the pacing of the present invention. Moreover, switching from conventional pacing to the pacing of the present invention may be used when conventional pacing cannot achieve high-power levels of myocardial depolarization, such as when an exit block is present or when the pacing electrode is located in infarcted myocardium. This automatic determination may be achieved by deploying any automatic capture detection technique present in the prior art. Furthermore, a wireless network-enabled switching function for treatment optimization may also be implemented in the present invention. In such cases, physiological data of a specific patient is collected by the implantable device and transmitted to a remote server / monitor via a wireless communication network.

[0071] The present invention can also be extended to defibrillation therapy in which high-energy pulses having various waveforms are delivered via an electrode system to treat tachycardia and fibrillation (both atrium and ventricle). Compared to conventional defibrillation configurations, the present invention is thought to achieve a lower defibrillation threshold due to a better distribution of the electric field and to cause a higher voltage gradient in at least certain parts of the heart. Furthermore, the present invention can be used to perform anti-tachyarrhythmic pacing, which uses a faster pace than conventional pacing pulse sequences to terminate certain tachyarrhythmias. The present invention is thought to be advantageous due to its ability to cover a wider range of electric fields and to capture specific conductive systems within the heart (both atrium and ventricle).

[0072] Figure 2 is a schematic diagram of another embodiment of the device, showing atrial leads 104, 105, 106, 107, ventricular leads 101, 102, 103, retractable sheaths 109, 113, hub 114, independent terminal connector 119, and movable deployment mechanism 116, as well as external lead terminals 120, 121, 122, 123 according to the present invention. Figure 2 also shows a deployment stop 117 and a segment 118 20 cm from the terminal connector 119.

[0073] Figure 3 is a schematic diagram of an embodiment of two inner sheaths according to the present invention, showing an outer movable catheter sheath 301 that houses two inner sheaths 302, 303, one inner sheath 303 having a ventricular lead and the other inner sheath 302 having an atrial lead. The eyelet tip 305 is made of a radiopaque material and is configured / formed, for example, as a loop, to have a larger surface area than the point cross-section of the wire lead. In a preferred embodiment, the eyelet tip range is 0.2 to 1.0 mm. The copper wire body 306 of the wire lead extends the length of the catheter from the pacemaker to the distal shape memory section 307. The shape memory section 307 is attached to the copper wire 306 by joining, braiding, welding, etc.

[0074] Figure 4 is a schematic diagram of a seven-inner sheath (multi-lumen) embodiment according to the present invention, showing an outer movable catheter sheath 401 that houses seven inner sheaths, each inner sheath 404 having its own lead, providing three ventricular leads 403 and four atrial leads 402. The eyelet tip 405 is made of a radiopaque material and is configured / formed, for example, as a loop, to have a larger surface area than the point cross-section of the wire lead. In a preferred embodiment, the eyelet tip range is 0.2 to 1.0 mm. The copper wire body 406 of the wire lead extends the length of the catheter from the pacemaker to the distal shape memory section 407. The shape memory section 407 is attached to the copper wire 406 by joining, braiding, welding, etc.

[0075] Figure 5 is a schematic cross-sectional view of an embodiment 501 of a seven-inner-sheath (multi-lumen) outer movable catheter sheath 501 according to the present invention, which houses seven inner sheaths 502, 503, each inner sheath having its own lead, and providing three ventricular leads and four atrial leads.

[0076] Referring here to Figure 6, an external pacemaker 14 is shown connected to a bundle of insulated wire conductors wound around a sheath 12. Specifically, as illustrated, the pacemaker 14 is connected to a bundle of seven insulated wires, of which three wires 20, 22, and 26 are placed in the ventricles, and four wires 30, 32, 34, and 36 are placed in the atria 28. The wires are inserted into the ventricles and then bundled within the sheath 12, which is pulled backward, exposing three ventricular leads that contact the ventricular wall due to the retained curved memory of each wire. As the sheath 12 is further retracted into the atria, four additional electrodes 30, 32, 34, and 36 that contact the wall of the atrial cavity 28 according to the present invention are shown.

[0077] As shown in the drawings, the disclosed invention is a thin transvenous electrode system for sequentially pacing both the atria and ventricles of the heart in a two-chamber mode. As shown in the drawings, a plurality of insulated wires, which are conductive and encased in an electrical insulator, are shown. The wires are bundled together into a set of two separate inline leads. Each wire has memory and is resilient. During manufacturing, each wire is preformed with a specific curvature and length such that the electrode end of the wire engages with the chamber wall for electrical pulse transmission when placed in a cardiac chamber, atrium or ventricle. In a preferred embodiment, the device comprises three ventricular leads and four atrial leads fabricated from a shape memory material. Two of the three ventricular leads are bent at 90 degrees from the central axis lead and are 180 degrees apart from each other. The four atrial leads are bent at 90 degrees from the central axis (x axis) in the y-axis plane and are 90 degrees apart from each adjacent lead.

[0078] Both sets of leads may also be mounted and housed inside an elongated, tubular, flexible, elongated retaining sheath, for example, 35 cm long, of which 8Fr (8 / 3 = 2.66 mm), which serves as a guide and delivery system during insertion and removal of the electrode system.

[0079] Each wire in the ventricle may be of varying shapes and lengths, such that, once the sheath is removed, each wire expands by memory and has sufficient elasticity to contact the inner wall of the ventricle, with the electrode point positioned coplanar with the ventricular wall. Each wire has a certain amount of elasticity, which secures the wire against the wall during pacing at the illustrated position. The four wires used in the atria also have pre-formed curvature and length such that, once the sheath is removed, the wires expand elastically against the atrial wall as shown in the figure, with the electrode point positioned at the end of each wire against the wall tissue. The elasticity of each wire secures the electrode against the atrial wall during pacing.

[0080] The external pacemaker 14 provides electrical pulses for sequential pacing. The pacemaker 14 includes two continuous pulse generators 16 and 18 connected to the proximal end of the wire to supply continuous pulses to both the ventricles and atria via the wire. The external pacemaker itself is a conventional operation.

[0081] pulse generator The term “pulse generator” is intended to include pacemakers, converter defibrillators, and cardiac resynchronization therapy (CRT), all of which are publicly known in the art. It will be understood that the prior art includes numerous examples of cardiac leads, electrodes, mounting mechanisms, conductors, and / or connector pins for placement within the cardiac chambers. The pulse generator includes internal circuitry for generating electrical impulses that are applied to electrodes after they are connected to a lead pulse generator. Such circuitry may also include sensing and amplification circuits so that the electrodes can be used as sensing electrodes to detect and report the patient's electrophysiology.

[0082] The lead is introduced into the vascular system through a small incision and can advance through the vascular system to its position in the right atrium (RA) and right ventricle. Such advancement is typically performed by electrophysiological examination, in which lead advancement can be visualized by fluoroscopy. The pulse generator may be equipped with a battery as its power source. The pulse generator circuit controls the parameters of the signal coupled to the electrodes. These parameters may include, for example, pulse amplitude, timing, and pulse duration. The internal circuitry further includes circuit logic that allows the pulse generator to be reprogrammed so that a physician can change the pacing parameters according to the needs of a particular patient. Such programming may be influenced by inputting programming instructions to the pulse generator via wireless transmission from an external programmer. Most commonly, the electrodes are connected to electrical ground by the circuitry. In a preferred embodiment, the pulse generator may be external and may be coupled to the electrodes by transcutaneous leads or wireless transmission.

[0083] Electrode lead The wire conductors and electrodes, which are leads, are manufactured in various lengths and are elastically curved as described above at the approximate distance between the electrodes to form the configuration or pattern shown in the figure. In a preferred embodiment, the lead is established within the ventricle and within the atrium. The wires may have memory markings, and their pre-formed curvatures are flexible enough to be bundled into a small sheath before being placed in the cardiac chambers. Both wire sets may be housed inside a single cylindrical flexible retaining sheath, which serves as a guide and delivery system during insertion and removal of the electrode system.

[0084] The ventricular electrodes may also be pacemaker sensors, or the stimulator may be released first after the retaining sheath has been successfully inserted into the right ventricle. The sheath may be retracted to expand the electrodes and wires into contact with the endocardial surface. Once the sheath is removed and engages with the ventricular tissue and cavity wall, the wires expand outward. If a parallel configuration of wires is chosen, the wires can be released and brought into contact on the same plane within the ventricular cavity, and they can be arranged in an alternating pattern. By continuing to pull the sheath, the atrial wire can be dislodged from the sheath, advanced towards the atrial tissue, and engaged with the atrial wall. Once electrodes are positioned within the ventricular and atrium chambers, sequential pacing can be initiated within the atria and ventricles in a two-chamber mode, providing an emergency pacemaker that paces and senses both the atrial and ventricular chambers and provides two-chamber control of the heart.

[0085] Dual-chamber pacing refers to the continuous monitoring of spontaneous cardiac activity in both the atria and ventricles, interpreting detected events according to specific, accepted algorithms, and stimulating the cardiac chambers as needed to maintain a physiologically appropriate rhythm.

[0086] Figure 7 is a chart of the acute first phase in a human trial and is useful in supporting embodiments of the present invention. Figure 7 shows an exemplary trial of a sample of 10 patients, although it does not necessarily represent a specific indication. Figure 7 shows that the average procedure time for device positioning and deployment, RV pacing, AV pacing synchronization, left-sided diagnosis, RV pacing, A pacing, AV pacing synchronization, and device removal was 24 minutes.

[0087] Figure 8 is an example chart of data in one embodiment of the present invention from a procedure for recording a non-limiting preferred embodiment. Figure 8 shows the recorded impedance, threshold, and current for the subject and lead. This demonstrates safe delivery with or without fluoroscopy guidance, successful pacing, excellent contact and retention of the lead to cardiac tissue, and no adverse or significant adverse events upon discharge.

[0088] Figures 9A, 9B, and 9C are sequence diagrams of one embodiment. Figure 9A shows the device being introduced into the patient's jugular vein using a guidewire 901 and an introducer 902. A Luer 903 is shown connected near the hub 904, and the external delivery catheter 905 accesses the jugular vein. Figure 9B shows the removal of the guidewire 901. Figure 9C shows the introduction of the transvenous two-lumen sequential pacing device into the delivery catheter 905, which includes a movable catheter sheath 906. Figure 10 shows one embodiment of a transvenous two-lobe sequential pacing device deployed into the heart using a mobile catheter 906, as shown in the fluorescence fluoroscopy image. Figure 11 shows one embodiment of a transvenous two-lobe sequential pacing device deployed into the heart using a movable catheter 906, as shown in the fluoroscopic image. Figure 12 shows one embodiment of a transvenous two-lobe sequential pacing device deployed into the heart using a movable catheter 906, as shown in the notch diagram into the heart. Figure 13 shows one embodiment of a transvenous two-chamber sequential pacing device deployed in the heart, with ventricular leads 907, 908, and 909 deployed into the ventricles from a movable inner sheath. Figure 14 shows one embodiment of a transvenous two-lobe sequential pacing device deployed in the heart, with atrial leads 910, 911, 912, and 913 deployed into the atria from a movable inner sheath, and ventricular leads already deployed into the ventricles. Figure 15 illustrates how a transvenous two-lobe sequential pacing device deployed inside the heart can detect abnormal heart rhythms. Figure 16 illustrates how a transvenous two-lobe sequential pacing device deployed within the heart can deliver electrical stimulation to the atria. Figure 17 illustrates how a transvenous two-lobe sequential pacing device deployed within the viscera can deliver electrical stimulation to the ventricles. Figure 18 illustrates how a transvenous two-lobe sequential pacing device deployed within the heart can sense a corrected, normal cardiac rhythm. Figure 19 shows how the device is removed after it has been deployed into the heart. Here, in one embodiment, the leads may be removed simply by pulling them. In another embodiment, the sheath may be reintroduced to collect the leads before removal. Figure 20 shows a ventricular-only embodiment of the present invention. Figure 20 shows a catheter 2001 having internally positioned unipolar leads 2002, 2003. In non-limiting embodiments, leads 2002, 2003 are shown having an optional radiopaque insulating cover 2004. A conventional temporary pacemaker 2005 is attached to the leads via the brachial vein to provide a dual ventricular lead for pacing to the right ventricle. In non-limiting preferred embodiments, the catheter is 4 French size, or 4 / 3 mm (1.33 mm) in diameter. Leads 2002, 2003 may have a radiopaque eyelet tip, and in the aforementioned non-limiting embodiments, may have a proximal portion made of copper with a distal portion made of steel or nickel-titanium (NiTi) alloy.

[0089] legal equivalent As will be apparent to those skilled in the art, many modifications and variations can be made without departing from the spirit and scope of this disclosure. In addition to those enumerated herein, functionally equivalent methods and apparatus within the scope of this disclosure will be apparent to those skilled in the art from the foregoing description. Such modifications and variations are intended to be included within the appended claims. This disclosure should be limited only by the terminology of the appended claims, encompassing the entire scope of equivalents to which such claims are granted. It should be understood that this disclosure is not limited to any particular method, reagent, compound, composition or biological system, and is naturally subject to change. It should also be understood that the terminology used herein is intended solely to describe a particular embodiment and is not intended to limit it.

[0090] While various embodiments have been described above, it should be understood that these are presented only as examples and not as limitations. If the above methods indicate specific events occurring in a particular order, the order of those events may be changed. Furthermore, some of the events may be executed simultaneously in parallel processing if possible, or they may be executed sequentially as described above.

[0091] Where the schematic diagrams and / or embodiments described above show specific components arranged in a particular orientation or position, the arrangement of the components may be modified. Although embodiments have been specifically shown and described, it will be understood that various modifications of form and detail are possible. Any part of the apparatus and / or method described herein may be combined in any combination, except for mutually exclusive combinations.

[0092] The embodiments described herein may include various combinations and / or partial combinations of the functions, components, and / or features of the different embodiments described herein. Various of the features and functions disclosed above and other features and functions, or their substitutes, may be combined with many other different systems or applications. Various currently unforeseen or unexpected substitutes, modifications, variations, or improvements may be made later by those skilled in the art, each of which is intended to be incorporated into the disclosed embodiments.

Claims

1. An electrode system connectable to a pacemaker or pulse generator for sequentially pacing the atria and ventricles of the heart, A first set of three ventricular leads, each of the three ventricular leads having a proximal end connected to a distal end and a tip connected to the distal end, the proximal end having an insulating coating made of polymer, silicone or silicone copolymer, the distal end and the tip being made of a shape memory material, each of the distal end and tip of the three ventricular leads having elasticity and a shape for contacting the inner wall of the ventricle, and each of the proximal ends of the three ventricular leads having a terminal for connection to the pacemaker or pulse generator, A second set of four atrial leads, each of which has a proximal end connected to a distal end and a tip connected to the distal end, the proximal end having an insulating coating made of polymer, silicone or silicone copolymer, the distal end and the tip being made of shape memory material, each of the distal end and tip of the four atrial leads having elasticity and a shape for contacting the inner wall of the atrium, and each of the proximal ends of the four atrial leads having a terminal for connection to the pacemaker or pulse generator, An externally movable catheter sheath having a proximal and distal portion, wherein the externally movable catheter sheath has a covering portion, and the first set of three ventricular leads and the second set of four atrial leads are positioned entirely inside the externally movable catheter sheath, the externally movable catheter sheath has a retracted position of the first sheath, the first set of three ventricular leads extends from the distal portion of the externally movable catheter sheath, and the second set of four atrial leads remains positioned entirely inside the externally movable catheter sheath, the externally movable catheter sheath has a retracted position of the second sheath, and both the first set of three ventricular leads and the second set of four atrial leads are positioned inside the externally movable catheter sheath extending from the distal portion of the externally movable catheter sheath, When connected to the pacemaker or pulse generator, the first set of three ventricular leads and the second set of four atrial leads synchronously pace the ventricles and atria of the heart. The catheter further comprises a first inner sheath including the first set of three ventricular leads and a second inner sheath including the second set of four atrial leads, wherein the first and second inner sheaths are positioned within the outer movable catheter sheath, and the retracted position of the first sheath is such that the first inner sheath extends from the distal end of the outer movable catheter sheath to the first set of three ventricular leads and contacts the inner wall of the ventricle. An electrode system in which the retracted position of the second sheath is such that the second inner sheath, including the second set of four atrial leads, extends from the distal end of the second inner sheath to contact the inner wall of the atrium.

2. The proximal portions of the three ventricular leads and the four atrial leads include radiopaque polymer-coated copper wires. The tip is coated with a radiopaque material selected from barium-containing compounds, bismuth-containing compounds, steel compounds, tungsten-containing compounds, and mixtures thereof, and of the three ventricular leads, two of the ventricular leads branch off from each other at 180 degrees in the axial direction. The external movable catheter sheath has a diameter of 1.3 mm (4 French), and the external movable catheter sheath is equipped with distance markers every 10 cm along its entire length. The distal portion of the aforementioned externally movable catheter sheath is 5 cm in length and has a biocompatible polymer cover. The proximal portion of the external movable catheter sheath is 30 cm in length and has a biocompatible polymer cover. The proximal end of the external movable catheter sheath is equipped with a hub element, a Touhy-Borst access connector with a side port, and a cable connection housing. The electrode system according to claim 1, wherein the atrial lead terminals and ventricular lead terminals extend from a cable junction housing for connection to a pacemaker or pulse generator.

3. The electrode system according to claim 1, wherein the first inner sheath and the second inner sheath are labeled with at least one radiopaque marker element.

4. The electrode system according to claim 1, wherein two of the three ventricular leads are heat-treated to retain their bending angle, and the two of the three ventricular leads branch out axially from each other to contact different locations on the inner wall of the ventricle.

5. The electrode system according to claim 4, wherein each of the four atrial leads is heat-treated to retain a bending angle, and the four atrial leads branch out axially from one another to contact different locations on the inner wall of the atrium.

6. The tips of the three ventricular leads and the four atrial leads have a radiopaque coating and a non-traumatic shape. The electrode system according to claim 1, wherein the tip is not attachable to the inner wall of the ventricle or the inner wall of the atrium, but is formed to make non-traumatic contact with the inner wall of the ventricle and the inner wall of the atrium.

7. The electrode system according to claim 1, wherein the external movable catheter sheath comprises seven internal sheaths, each of which houses one of the first set of four atrial leads and the second set of three ventricular leads.

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