Improved transvenous cardiac pacing catheter

Abstract

The present invention provides an insertable atrioventricular sequential pacing catheter that facilitates insertion and positioning of the catheter in the right heart chamber. [Solution] The improved transvenous intracardiac pacing catheter establishes and maintains 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 104, 105, 106, and 107 for the atria, two are for the ventricles 102 and 103, and one forms a distal tip with a cap. The wires are incorporated into a seven-lumen extrusion and fitted into the correct position using a fixation device.

Description

Technical Field

[0004] , , , , , , ,

[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. The embodiments described herein generally relate to medical devices that provide cardiac pacing functionality, and more particularly, to a transvenous two - chamber sequential pacing catheter that is temporarily and easily insertable, and systems and methods for atrioventricular pacing to achieve AV synchronization.

[0002]

Background Art

[0003] During or after certain medical procedures or conditions such as open - heart surgery, heart attacks, some infections, 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 with 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 increases by 25% to 30%.

[0005] After open - heart surgery, before closing the chest, epicardial wires are lightly sutured to the epicardium to pace Pacing is performed. When these epicardial wires are no longer needed, these pacing wires are removed. The wire is pulled out through the skin. Pulling on the pacing wire can be fatal. This indicates the risk of cardiac tamponade, as well as the risk of infection, myocardial injury, ventricular arrhythmias, and perforation. It can bring about.

[0006] Existing temporary pacing catheters are also difficult to position precisely, In the case of Lune positioning, the catheter is moved to block the right ventricular outflow tract and pulmonary artery. Complications, including the following, frequently occur.

[0007] Existing pacing catheter leads also perform pacing or rapid pacing. It may move (leave) at critical points during certain procedures. Therefore, temporary pacing When this is being done, the patient's movement (walking) is restricted. When walking is restricted, certain It is known that scenarios that involve longer hospital stays result in higher medical costs.

[0008] Therefore, in order to replace the currently available temporary catheter / lead, insertion and Furthermore, there is a need for an AV sequential pacing catheter that allows for easy positioning of the catheter into the right chamber of the heart. . [Overview of the project]

[0009] The embodiments described herein are insertable, which facilitates insertion and positioning of the heart into the right heart chamber. Regarding sequential pacing catheters for the atrioventricular system.

[0010] This disclosure relates to an improved transvenous intracardiac pacing catheter, and in particular to an internal catheter. Insertable atrioventricular sequential pacing with a catheter, external catheter, and connector assembly. By providing a catheter system, we establish and maintain atrioventricular (AV) synchronization in patients. The present invention relates to apparatus, methods, and systems for the following: In a preferred embodiment, the internal catheter is A set of seven nitinol PTFE heat shrink wires with radiopaque tips. It is embedded. Of the wires, four are leads for the atria, two are for the ventricles, and one is This forms a distal tip with a cap. The wire is incorporated into a 7-lumen extrusion molding process. The catheter is fitted into the correct position using a fixing device. In a preferred embodiment, the outer catheter is Coil reinforcement catheter for multidurometer having a lure hub and radiopaque tip It is a connector. In a preferred embodiment, the connector assembly is connected to the pulse transmitting unit. I'm attaching the wire to the plug to connect it. [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] Schematic cross-sectional view of an embodiment of seven inner sheaths (multiple lumens) showing an outer movable catheter sheath according to the invention that houses seven inner sheaths, each inner sheath having its own lead, providing three ventricular leads and four atrial leads. [Figure 6] Schematic view showing a cross-section of a human heart, in which a plurality of electrodes inserted into the ventricles and atria according to the invention are in contact with the walls of the heart cavities and the pacer. [Figure 7] Chart of the acute first phase in a human trial, useful for supporting embodiments of the invention. FIG. 5 shows an exemplary test of a sample of 10 patients, although not necessarily a specific indication. FIG. 5 shows that according to the invention, the treatment time can take an average of 24 minutes for device positioning and deployment, RV pacing, A synchronization, AV pacing, execution of left-sided diagnostics, and RV pacing, A pacing, synchronization of AV pacing, and removal of the device. [Figure 8] An example of a chart of data in one embodiment of the invention from the procedure for documenting non-limiting preferred embodiments. FIG. 8 shows the recorded impedance, threshold, and current for the subject and leads. This shows that according to the invention, delivery is safe with or without a fluoroscopic guide, pacing is successful, lead contact and retention with respect to heart tissue is excellent, and there are no adverse events or adverse events at discharge. [Figure 9] A view showing an embodiment of a device introduced into the jugular vein of a patient according to the invention, in which the guide wire is removed and an embodiment in which a transvenous two-chamber sequential pacing device is introduced into a movable catheter sheath. [Figure 10] A view showing an embodiment of a transvenous two-chamber sequential pacing device deployed within the heart as shown in a fluoroscopic image according to the invention. [Figure 11] A view of an embodiment of a transvenous two-chamber sequential pacing device deployed within the heart as shown in a fluoroscopic image according to the 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 form at least two rows of aligned sets of leads. The atria and ventricles of the heart in a "two-chamber" mode, which includes multiple insulated wires bundled together for this purpose. Regarding a self-positioning, rapidly deployable, thin transvenous electrode system for sequential pacing of both. This invention provides pacing and sensing of both the atrial and ventricular cavities, and enables safe operation in emergencies. Emergency pacemakers that provide "two-chamber" control of the heart using a lead that can be fully and easily inserted into the heart. The manufacturer provides the "two-chamber" pacing. The system continuously monitors spontaneous activity and resolves detected events according to a specific, acceptable algorithm. This refers to stimulating the cardiac chambers as needed to maintain a physiologically appropriate rhythm. Importantly, the apparatus can be deployed with or without fluorescence fluoroscopy guidance. One embodiment Therefore, the self-positioning function allows for the extensive training that has historically been required for pacing devices. This also makes it possible to use the device without the need for expert experience.

[0013] In some embodiments of the present invention, the device comprises three ventricular receptacles made from shape memory material. It has a diaphragm and four atrial leads. Two of the three ventricular leads are central axis leads. They are bent at a 90-degree angle and are 180 degrees apart from each other. The four atrial leads are parallel to the y-axis. Within the plane, it is bent at a 90-degree angle from the central axis (x-axis), and each lead is 90 degrees from the adjacent lead. They are far apart.

[0014] In some embodiments of the present invention, both sets of leads are elongated, for example, 8Fr(1m) A tubular, flexible, elongated structure of m, for example, is mounted and housed inside a retaining sheath of 35 cm. It functions as a guide and delivery system during the insertion and removal of the electrode system. Each wire is individually enclosed by electrical insulation.

[0015] In some embodiments of the present invention, the bundle of insulated wires is arranged in either a parallel or spiral configuration. They can be arranged in any of the following ways. To accommodate various sizes of heart chambers, the leads are of various lengths and It is manufactured with the appropriate distance between electrodes.

[0016] In some embodiments of the present invention, the electrode system is assembled from multiple insulated superelastic wires. It is constructed by [doing something]. The insulating material separates each wire from one another, but the wires are single It is attached in a bundle as a cable-like structure. At the proximal end, the electrode is attached to the external pacemaker. It connects to the atrial or ventricular tissue. At the distal end, the individual wires inserted into the heart connect to the atrial or ventricular tissue. It comes into contact with either of the following. The distal end of each wire comes into contact with the atrial or ventricular tissue. It may include a shaped electrode contact.

[0017] In some embodiments of the present invention, each wire has a memory, Although pre-formed to a specific curvature, it is housed within the sheath before being placed in the cardiac chamber. It has sufficient elasticity to be used. Both sets of leads for the ventricle and atrial are attached to the electrode system. A single, elongated, flexible retainer that serves as a guide and delivery system during insertion and removal of the device. Because it is contained within the sheath, a ventricular electrode can be a pacemaker sensor or stimulator. The retaining sheath is first released after it has been successfully inserted into the right ventricle. At this point, the sheath The wire retracts, allowing the ventricular wire to disengage from the sheath, and each wire retains memory. Due to their pre-formed shape, they spread out to individually contact the endocardial surface. The leads are on the outside. It spreads out and engages with the ventricular tissue and cavity wall. A mechanical parallel wire configuration is selected within the sheath. If selected, the wires are released and can come into contact within the same plane. Otherwise, the wires They can be arranged alternately within the ventricular cavity. If the helical configuration of the wire is selected within the sheath, When released, the yaws stagger each other, covering various points on the heart chamber walls. The ideal yaw for this configuration Ya is in accordance with U.S. Patent No. 6,137,060 and U.S. Patent No. 3,699,886. It is stated.

[0018] As the sheath continues to retract, it also has memory, and when it deviates from the sheath, engagement occurs. This allows the atrial wire and electrodes to protrude outward toward the atrial tissue.

[0019] As described above, in some embodiments of the present invention, the distal end of each wire is a high current It may have a spherical conductive ball tip to provide density and sensitivity. To effectively deliver the electrode transvenously, the sheath contains all wires except for the distal electrode. The distal electrode must first be fully extended forward to cover the distal electrode, which has a conductive lead. The sheath may protrude beyond the sheath while being introduced into the heart. The pathway is subclavian or jugular vein, passing through the atria and entering the ventricle. The electrode system is on the right side. Once the apex of the ventricle is reached, the operator slowly begins to pull the sheath back, and in this way the entire Release each wire individually until the necessary contact points are formed.

[0020] In some embodiments of the present invention, the sheath is slowly pulled back and the wire is released. Therefore, each wire is made of a superelastic or shape-retaining material such as Nitinol (trademark). To be manufactured.

[0021] Each wire is used by healthcare professionals, such as cardiologists, emergency medical technicians, surgical staff, and outpatients. When staff members pull back the sheath, the wire tip will contact the inner wall of each heart chamber. The fan is pre-molded in the correct orientation so that it faces outward and makes electrical contact. The memory inside the wire holds it in place in the designated position within the heart chamber. Furthermore, the selection of highly flexible materials allows for a sufficiently large surface area for electrical conductivity. While minimizing trauma to the endocardium,

[0022] polymer Any device and / or its components may be made of any suitable biocompatible material or material It can be made from a combination of these. For example, the outer chassis and / or its components are raw It can be made from biocompatible materials, metals, metal alloys, polymer-coated metals, etc. Suitable biocompatible materials, metals and / or metal alloys include polymers, copolymers, and ceramics. Glass, aluminum, aluminum alloy, stainless steel (e.g., 316L stainless steel) Stainless steel), cobalt-chromium (Co-Cr) alloy, nickel-titanium alloy (for example, Ni Examples include tinol (registered trademark). Furthermore, any chassis or component These may also be covered with an appropriate polymer coating, such as natural or synthetic rubber, polyethylene. Polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), trans-lyu Translute styrene-isoprene butadiene (SIBS) copolymer, Polylactic acid, polyester, polylactide, D-lactic acid polylactic acid (DLPLA), polylactic acid-co - Glycolic acid (PLGA) is one example.

[0023] For the electrode system inside the sheath to navigate freely through blood vessels, a very smooth surface is necessary. It must have the following characteristics: It must be made of a material that does not break or fray prematurely, and which achieves sufficient flexibility. It must be. The insulating material used to insulate each individual wire is already This is the type used in the manufacture of existing pacing leads. Furthermore, the type used The material is a thermoplastic elastomer similar to that used in the manufacture of catheters. It can be braided for added strength.

[0024] In one non-limiting embodiment, the electrode system according to the present invention is such that the described leads are received It may be designed primarily for emergency temporary use, having dynamic locking. However, another non In a limited context, the present invention relates to electrodes being implanted in cardiac tissue or used for active fixation. Permanently attached to the endocardium by one of many possible means It can be used as part of an implanted pacemaker system.

[0025] Some biocompatible synthetic materials include, for example, polyester, polyurethane, and poly Examples include tetrafluoroethylene (PTFE) (e.g., Teflon). If a durable synthetic material is intended (for example, in the case of a cover), expanded PTFE or Synthetic polymer materials such as polyester may be used in some cases. Other suitable materials Depending on the case, elastomer, thermoplastic resin, polyurethane, thermoplastic polycarbonate Polyurethane, polyether urethane, segmented polyether urethane, silicone Polyether urethane, polyether ether ketone (PEEK), silicone-polycarbonate Polyurethane, polypropylene, polyethylene, low-density polyethylene (LDPE) High-density polyethylene (HDPE), ultra-high-density polyethylene (UHDPE), polyolefin Polyethylene glycol, polyethersulfone, polysulfone, polyvinyl pyro Lydone, polyvinyl chloride, other fluoropolymers, polyester, polyethylene terephthalate PET (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycosylglycerides Poly(D,L-lactide / glycolide) copolymer (PDLA), Recon polyester, polyamide (nylon), PTFE, elongated PTFE, expanded PT FE, siloxane polymers and / or oligomers, and / or polylactones, Furthermore, block copolymers that use this can be cited as examples.

[0026] radiopaque material Barium sulfate. Barium sulfate (BaSO4) is a radioactive substance widely used in medical preparations. It is a permeable material and a common filler used in conjunction with medical polymers.

[0027] This is an inexpensive material, costing about $2 / lb, and can be made white by adding colorants. It can be changed.

[0028] Barium sulfate, with a specific gravity of 4.5, is generally used in amounts of 20-40% by weight. 0% barium sulfate compounds are typical for general medical device applications, but some physicians believe that... A higher degree of radiopaqueness than that can be provided by the loading is preferred. For example, a 40% compound is standard.

[0029] A 20% by weight barium sulfate load is equivalent to approximately 5.8% by volume, and 40% by weight is equivalent to 14% by volume. This corresponds to a percentage. When the barium content exceeds approximately 20% by volume, the compound moves in the base poly The material begins to show a loss of tensile strength and other mechanical properties. Therefore, depending on the application, It is best to incorporate radioactive materials at a certain level, and to avoid excessive use of these fillers. This is not recommended.

[0030] Bismuth. A fairly expensive bismuth compound (selected) at $20-$30 / lb. Depending on the chemical salt, the density is also doubled. Bismuth trioxide (Bi2O3) exhibits a yellow color. The specific gravity is 8.9, while the specific gravity of bismuth carbonate (Bi2O2CO3) is 8.0; The specific gravity of bismuth chloride (BiOCl) is 7.7. Due to its density, 40% bismuth compound The substance contains only about half the volume of a 40% barium sulfate compound. Bismuth is barium Brighter, sharper, and higher-contrast images than those produced by microscopy are produced on X-ray film or fluoroscopy. Therefore, it is commonly used whenever a high level of radiopaqueness is required. .

[0031] Compared to barium, higher loadings are possible: even with a 60% bismuth compound, 4 It can maintain the same base polymer mechanical properties as a 0% barium sulfate compound. 20% by weight of A load of SMAS corresponds to 3 volume%, and a load of 40 wt% corresponds to 7.6 volume%. Mass is sensitive to formulation and should be gently handled with a low-shear mixture, which is recommended for optimal results. It must be done. Bismuth provides a high level of radiopaqueness.

[0032] Tungsten. Tungsten (W), a fine metal powder with a specific gravity of 19.35, is used in Bismarck. It has more than twice the density of [another material] and can offer a high damping coefficient at a cost of approximately $20 / lb. A 60% tungsten load has approximately the same volume ratio as a 40% bismuth compound. This configuration allows for a high degree of radiopaqueness with a relatively low load of tungsten, and exhibits good mechanical properties. It is possible to maintain its properties. Due to its density, tungsten is usually used in ultra-thin wall devices. It is selected as a filler for chairs.

[0033] A 50% tungsten load is equivalent to only 5.4% by volume, and an 80% load is This represents 18.5% by volume. Tungsten is black and cannot be altered by colorants. Stainless steel is abrasive and can accelerate wear on extruders and other processing equipment. The device loaded with tungsten exhibits surface roughness. This material is susceptible to oxygen and heat. It causes oxidation in the presence of ella and is highly flammable, so care must be taken to prevent it from drying out. In stomers, barium sulfate mixes better than tungsten or bismuth compounds. ru.

[0034] Considerations regarding formulation Newer X-ray equipment generally operates at higher energy levels than older X-ray equipment, and typically... In terms of operation, it operates at 80-125kVp, compared to the 60-80kVp of older X-ray machines. High-energy radiation increases the transmission of photons and provides the desired attenuation. A certain level of radiopaqueness may be required. Therefore, it is manufactured using barium sulfate compounds. The developed apparatus is a new machine in which bismuth compounds are a better choice for radiopaque fillers. Then it may not appear bright. However, blending these materials is especially broad For multipurpose formulations used across a range of energy levels, often the best This could be a solution. Barium decays easily at low energy levels, while it decays at high energy levels. A mixture with bismuth often works well.

[0035] Incorporating radiopaque materials improves the attenuation of the device, the tensile strength and elongation of the polymer, and This includes considering other mechanical properties, as well as fillers, antioxidants, stabilizers, and colorants. It may also be included together with metal fillers.

[0036] This invention relates to the emergency room, post-heart surgery, minimally invasive cardiac surgery such as valve repair or replacement, or in During or after plant procedures, in the intensive care unit, at the bedside, in the cardiac catheterization lab, in the ambulance, In the battlefield, and in other places where patients with heart block or other life-threatening arrhythmias may be found. It can be used in emergency situations.

[0037] independent claim In a preferred embodiment, the present invention relates to a self-positioning rapid deployment thin film for cardiac pacing. A transvenous electrode system of the type,

[0038] A pulse generator capable of providing sensing and stimulation to the ventricles or atria; The distal set of three ventricular leads positioned within the first medial sheath, and the second medial sheath Multiple bundled together to form a proximal set of four atrial leads positioned within An insulated wire, wherein the first inner sheath and the second inner sheath are externally movable catheter A pacemaker with multiple insulated wires arranged within a sheath, and an externally movable catheter - The ventricular sheath deploys the first medial sheath into the ventricle and the second medial sheath into the atrium. Once inserted into the heart, it can move through the first and second inner sheaths. The externally movable catheter sheath is capable of engaging the transvenous electrode system with the atrium. and completely removed from the ventricle, The first inner sheath is movable to expose the distal set of the three ventricular leads to the ventricles. The second inner sheath is movable to expose the four atrial leads to the atria. can be, The first inner sheath and the second inner sheath are each formed from a polymer, and the polymer - is doped with a radiopaque material to form a radiopaque polymer sheath, or 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 of stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy, and made from shape memory materials selected from mixtures thereof, The tip is made of a shape memory material, a barium-containing compound, a bismuth-containing compound, a steel compound, and Made from radiopaque materials selected from ngsten-containing compounds and mixtures thereof. Manufactured, Two of the three ventricular leads are set in a shape that is spread at a 90-degree angle, and the two said The ventricular leads are offset 180 degrees from each other, and one of the three ventricular leads is central It is a shaft lead, Each of the four atrial leads is shaped at a 90-degree angle in the expanded configuration, and the four atria The leads are each 90 degrees apart from each other. The movable catheter sheath consists of a distal and a proximal section, and is 10 cm along its entire length. Each has a distance marker, The distal end of the movable catheter sheath is 5 cm long and has a pitch coil of 0.010 It is in inches and has a biocompatible polymer cover. The proximal portion of the movable catheter sheath is 30 cm long and has a pitch coil of 0.02 It is 0 inches in diameter and has a biocompatible polymer cover, with a hub element at the proximal end of the proximal part, and Touhy-Borst access connector with idport, movable catheter sheath Actuator dial, deployment stop unit, and cable connection that enable molding and control. Equipped with a joint housing, the atrial lead terminals and ventricular lead terminals are connected to the cable joint housing. It extends from the ring to the pacemaker, and the pacemaker has diagnostic functions, sensor operation, Stimulus signals, programs for individual leads for sensing, T-waves or other noise or This is a program designed to reduce oversensing of ventricular leads due to attenuation or interference signals, R wave A program to reduce oversensing of atrial leads and minimize crosstalk. A program for doing so, as well as a program for adjusting sensing and stimulation for each lead. To provide a function selected from the group consisting of the above, a processor reads a con It is equipped with computer program instructions, The atrial lead is designed to sense and stimulate the SA nodal region and AV nodal region of the heart. The ventricular lead is shaped to include the His bundle region, the Apex-Purkinje fiber region, and Shaped to sense and stimulate the free-wall Purkinje region, Each of the ventricular leads is connected to a ventricular sensor or stimulator within the pacemaker. Each of the atrial leads is connected to an atrial sensor or stimulator within the pacemaker. It provides a system that is connected to it.

[0039] Ventricles only In another preferred embodiment, the present invention relates to a self-positioning rapid development for cardiac pacing. A thin, open transvenous electrode system, A pulse generator capable of providing sensing and stimulation to the ventricles; A pair of insulated wires for forming the first and second ventricular leads. The first ventricular lead and the second ventricular lead are located within the externally movable catheter sheath. It is equipped with a pacemaker with an insulated wire, located in The externally movable catheter sheath is movable from the first and second ventricular leads. Yes, the first and second ventricular leads are temporarily inserted into the heart to deploy them into the ventricles. When this occurs, the external movable catheter sheath engages with the transvenous electrode system, ventricular Completely removed from, Each of the first and second ventricular leads comprises a proximal body, a distal end, and a tip. The proximal main body is made from a radiopaque polymer-coated copper wire. The distal end is made of stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy, and made from shape memory materials selected from mixtures thereof, The tip is made of a shape memory material, a barium-containing compound, a bismuth-containing compound, a steel compound, and Made from radiopaque materials selected from ngsten-containing compounds and mixtures thereof. The two ventricular leads were then offset 180 degrees from each other. The movable catheter sheath has a diameter of approximately 1.3 mm or 4 French, and the distal portion is It consists of a proximal part and has distance markers every 10 cm along its entire length. The distal portion of the aforementioned movable catheter sheath has a length of 5 cm and a pitch coil of 0.0 It is 10 inches in size and has a biocompatible polymer cover. The proximal portion of the movable catheter sheath is 30 cm long and has a pitch coil of 0.02 It is 0 inches in diameter and has a biocompatible polymer cover, with a hub element at the proximal end of the proximal part, and Touhy-Borst access connector equipped with an access port, the movable catheter Actuator dial, deployment stop unit, and cable that enable molding and control of the cable Equipped with a joint housing, The atrial and ventricular lead terminals are connected to the pacemaker via the cable junction housing. It extends to - Pacemakers have individual leads for diagnostic functions, sensor operation, stimulus signals, and sensing. Programs, ventricular leads with T waves or other noise, attenuation, or interference signals Programs to reduce oversensing, programs to minimize crosstalk Select from a group consisting of a m, and a program for adjusting sensing and stimulation for each lead. To provide the selected function, a computer program readable by the processor It is equipped with a command, The ventricular lead senses the bundle of His region and the free-wall Purkinje region. Shaped to stimulate, Each of the ventricular leads is connected to a ventricular sensor or stimulator within the pacemaker. We provide a system that is currently in place.

[0040] Independent covering In any embodiment of this specification, including the ventricular embodiment, the (first) ventricular lead is (the (1) is located within the movable inner sheath, and the (second) ventricular lead is located within the (second) movable inner sheath. They are placed inside, and the inner sheaths are each made from polymers, and the polymers are radiopaque. The polymer sheath is doped with a radiopaque material, or less This may also include being labeled with another radiopaque marker element.

[0041] Bundled covering In any embodiment of this specification, the first inner sheath has three independently movable inner It is a set of side sheaths, with each of the three ventricular leads having its own movable sheath, and anterior The second inner sheath is a set of four independently movable inner sheaths, and the four atrial rings Each of the components may have its own movable sheath.

[0042] Variation In any of the dual-chamber embodiments described herein, the pacemaker operates in "dual-chamber" mode on the heart. To sequentially pace both the atria and ventricles, sensing and stimulating are provided to the ventricles and atria. It may be equipped with two consecutive pulse generators that can provide the necessary power.

[0043] In all embodiments of the present invention, the atria are spaced 90 degrees apart from each other with respect to the Y axis. The ventricles are arranged in a plane perpendicular to the central X-axis, with four atrial wires and three ventricular wires. It may be equipped with Ya.

[0044] In any embodiment of the present invention, the atrial lead and ventricular lead are in a specific position with non-insulated wires. They may be equipped with earplugs. In all embodiments of the present invention, the copper body portion is braided or joined to the distal end portion. The distal end portion may be made of steel or NiTi alloy. In any embodiment of the present invention, the eyelet shape setting is the shape setting of the regenerated portion of the lead. These may be executed simultaneously. In any embodiment of the present invention, the shape setting can be further improved by changing the wire cross-section. It may run faster.

[0045] In all embodiments of the present invention, the tip of the electrode is an eyelet, not a ball, and the tip The portion may be a composite of shape memory material and radiopaque material. In all embodiments of the present invention, the radiopaque material is tungsten, barium, and It may be bi / or a bismuth compound. In particular, bismuth emits brighter light under X-rays. It exhibits light. Examples of bismuth compounds include Bi2O3, Bi2O2CO3, and BiOCl. One example is barium sulfate, which has excellent properties for blending with polymer coatings such as polyimide. Barium-irresistible polymers are used for catheter sheaths / jackets and eyelets. It can be used as an RO band, as well as for other electrode and sheath portions.

[0046] In all embodiments of the present invention, the polymer is polyimide, or the polymer is It is silicone + lubricant, made from PebaSlix 35D, Peb In some cases, it may be manufactured from an ax 72D. In any embodiment of the present invention, the sheath is 90 inches across a bend with a diameter of 2.5 inches. It is configured to provide a curve of degree, with a hockey stick bend of 45 degrees ± 5 degrees. It may also be configured to provide...

[0047] Computer program In another preferred embodiment, the present invention relates to a specific reapplication during a depolarization cycle (PQRST). By reducing the sensitivity of one lead and increasing the sensitivity of other leads, the present invention provides the aforementioned sensing function A function that allows increasing the SNR, reducing the stimulus signal to one or more leads, By increasing this, the present invention can more accurately target the AV nodule, SA nodule, apex, or other A function that provides stimulation to cardiac tissue, enabling a certain level of precision in the stimulating function. The program is designed so that the sensing lead does not need to share the function of the impact / stimulation lead. By removing and bypassing damaged or deteriorated leads, the entire device can be removed from the patient. A function that allows the function to continue without needing to be removed, a function that performs one or more functions. Includes computer program instructions that can be executed by a processor.

[0048] method In another preferred embodiment, the present invention rapidly deploys a cardiac pacing device to a patient's heart. A computer implementation method for doing so, (i) to supply the transvenous double lumen system described in the claim and specified herein. Steps; (ii) Access the patient's jugular vein and insert a catheter under the guidance of ultrasound or other non-fluorescence imaging. Steps to advance the telcystic to the right ventricle of the patient's heart; (iii) Pull out the external movable catheter sheath to the first position, and the first internal sheath The step of exposing the second inner sheath; (iv) Pull out the first inner sheath to the second position, expose the ventricular lead, and assemble the ventricular assembly. Steps to connect the weave; (iv) Pull out the second inner sheath to the third position, expose the atrial lead, and assemble the atrial assembly. Steps to connect the weave; (v) Use computer program instructions that can be executed on the processor to perform diagnostic tests A step to perform the following: identify the patient's cardiac pattern and verify the system's operation; (vi) Using computer program instructions that can be executed on a processor, patent Execute an appropriate cardiac pacing routine as a treatment for the (Patent) cardiac pattern. Step; (vii) Remove the catheter sheath and allow the system to be left in the patient. We provide a method that includes the steps (i) to (vii) to be completed within 60 minutes. It will be implemented.

[0049] In another preferred embodiment, the present invention allows steps (i) to (vii) to take no more than 30 minutes. It provides that the work will be carried out on a set schedule. In another preferred embodiment, the present invention relates to the atrial cavity of the heart of a patient having a heart block and Low-cost, safe, and reliable emergency pacing for both the heart and ventricular chambers. This provides a transvenous electrode system for use in cardiac block. In another preferred embodiment, the present invention provides a two-chamber (sequential) ventricular palpation system for the atria and ventricles of the heart. Emergency We provide cardiac pacemakers. In another preferred embodiment, the present invention provides atrial-ventricular synchronization, To provide an emergency pacemaker that avoids problems with chamber-ventricular pacing.

[0050] definition The terms used herein are for the sole purpose of describing specific embodiments and patent This is not intended to limit the scope of the claims. Unless otherwise defined, this All technical and scientific terms used in this specification are generally understood by those skilled in the art. It has the same meaning as "to do". Anything in this disclosure is not subject to prior art. This should be interpreted as an acknowledgment that the invention does not have any prior rights to such disclosure. isn't it.

[0051] As used herein, the singular forms "a," "an," and "the" are used only when the context is clear. Unless otherwise specified, this is intended to include both singular and plural forms. Regarding the use of substantially any plural and / or singular terms in writing, by persons skilled in the art If applicable, change from plural to singular, and / or to suit the context and / or use. "Ta" can be converted from singular to plural. Various singular / plural substitutions are used for clarity. This may be explicitly stated herein.

[0052] Generally, this specification, and in particular the appended claims (e.g., the body of the appended claims) The terminology used in ) is generally intended to be "open" terminology (e.g., "contains" The term "including" means "to include but not limited to." It should be interpreted as "having but not limited to," and "possessing The term "having" means "to have at least (having at least) It should be interpreted as "t)" etc. Similarly, "comprises The terms "and / or "comprising" are used herein. If so, the described features, integers (or parts thereof), steps, actions, elements, and / or Or it specifies the existence of a component, but one or more other features, integers (or parts thereof), status Eliminate the presence or addition of pp, actions, elements, components, and / or groups thereof. It does not mean that. As used herein, the term "includes" means "includes, but not limited to." It means "not done."

[0053] As used herein, the term "and / or" refers to the relevant enumerated item. Includes any combination of one or more of the eyes. Detailed description, claims, Or substantially any disjunction that presents two or more alternative terms, regardless of whether it is in a drawing or not. A typical word and / or phrase may contain one of the terms, either of the terms, or both of the terms. It should be understood that this is intended to mean possibility. For example, "A or B" The phrase is understood to include the possibility of "A" or "B" or "A and B".

[0054] All scope disclosed herein also includes, unless otherwise specified, all of its contents. Includes possible subranges and combinations of subranges. The listed ranges are not specifically specified. Unless otherwise specified, it is necessary to adequately explain and enable that the same range can be decomposed into at least equal parts. It should be recognized that, as understood by those skilled in the art, the scope includes individual components. .

[0055] Embodiments of this specification, and / or various features or their advantageous details, are shown in the attached figures. More specifically described with reference to the non-limiting embodiments shown in the following description. To avoid unnecessarily obscuring the embodiments described herein, well-known components and processing techniques are used. The explanation of the technique will be omitted. Similar numbers refer to the same elements throughout.

[0056] The examples and / or embodiments described herein are merely examples of the structure, function, and / or embodiments of the embodiments. Alternatively, to facilitate understanding of the embodiments, or to facilitate understanding of the methods by which the embodiments can be carried out. This will allow a person skilled in the art to further implement the embodiments described herein. It is intended to do so. Similarly, the methods and / or methods of using the embodiments described herein. The methods described herein are provided only as examples and not as limitations. Unless otherwise specified in the context, this is not intended to exclude other uses.

[0057] Cardiac electrophysiology The cardiac electrical conduction system maintains the synchronization of the atria and ventricles through the use of nodular muscle cells and pull cells. Use Kinye cells.

[0058] The current first reaches the SA node, the heart's natural pacemaker, located in the upper part of the right atrium. SA nodules are composed of nodular myocytes. In a normal resting adult heart, SA The nodule begins to be excited (firing) with 60-100 impulses / min, and the impulses are It causes electrical impulses and subsequent atrial contractions. The sinoatrial node, located at the upper end of the septum, is the heart's periapical tract. Generates a synchronous neural-mediated signal for racing.

[0059] These signals then cross the atria to the atrioventricular node, which is located near the septal leaflet of the tricuspid valve. It moves. The AV node is also composed of nodes that regulate incoming electrical impulses. To arrange.

[0060] After a slight delay allowing the atria to contract and the ventricles to complete filling, the AV node, It relays impulses to Purkinje cells in the ventricle, first passing through the bundle of His that extends along the septum. The impulse is then conducted, and then split into the right bundle branch, which conducts the impulse to the right ventricle, while the left bundle branch... It conducts an impulse to the left ventricle, causing ventricular contraction.

[0061] In a healthy heart, the signal flow from the AV node to the free wall of the left ventricle is rapid, and the free wall This ensures that the interseptum contracts synchronously. For example, the stimulus signal is approximately 70-90 milliseconds. It can then flow into the free wall. In patients with conduction abnormalities, this timing is significantly delayed (15 (More than 0 milliseconds) may result in asynchronous stuttering.

[0062] In some patients, the conduction pathway through Purkinje fibers may be blocked. The location can be highly localized (as in the case of a so-called "left bundle bifurcation block" or LBBB). It may include an enlarged area of ​​dysfunctional tissue (which may result from infarction). In this case, while the septum is contracting, all or part of the free wall of the left ventricle is relaxed. In addition to contributing to peritoneal 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 the stimulation applied to the muscle of the free wall of the left ventricle. This involves applying stimulation to the infarcted tissue. Infarcted tissue does not respond to such stimulation, but infarcted The tissue that is not contracting will contract, thereby increasing the output of the left ventricle.

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

[0064] Referring to Figure 1, the distal central radiopaque lead 101 is the ventricular lead. It is shown as one of a three-part set. Ventricular leads 102 and 103 are leads 101 is shown bent at a 90-degree angle from its central axis, and is positioned 180 degrees opposite to each other. As shown, lead 102 is 180 degrees opposite lead 103 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. Notes 102 and 103 are bent away from the central lead, each 4 cm away from the central axis. It persists.

[0065] Atrial leads 104, 105, 106, and 107 are bent 90 degrees away from the central axis. They are bent at 90 degrees from each other in the y-axis plane. The atrial leads are each on the central axis It extends 4 cm away from the other end.

[0066] The movable catheter sheath is 5 cm long, and the pitch coil is 0.010 inches. In a preferred embodiment comprising a distal portion 109, the distal portion is PebaSlix 3 It is made from 5D. The movable catheter sheath is also 30 cm long and has a pitch of It consists of a proximal portion 113 with a length of 0.020 inches. In a preferred embodiment, The proximal portion is made from Pebax 72D. The sheath has a 2.5-inch diameter curved section. A hockey stick designed to exhibit a 90-degree curve across its length, with an angle of 45 degrees ± 5 degrees. It is also configured to show the curved portion. The sheath extends from the distal tip 108 along its length 1 It has OS markers 110, 111, and 112 placed at 0cm intervals.

[0067] At the proximal end, the sheath has an adhesive hub 114 and a side port 115. It has a Borst access connector. The actuator dial 116 is sheathed Located at the proximal end, it enables the shaping and control of the sheath. The red deployment stopper 117 is The last 20 cm of the sheath, 118, is connected to the cable joint housing 119.

[0068] Programmable Reeds The atrial lead terminals 120, 121 and the ventricular lead terminals 122, 123 are Programming individual leads to improve sensor operation, stimulus signals, and sensing. Avoid oversensing of ventricular leads due to T waves or other noise, attenuation, or interference signals. This avoids excessive sensing of atrial leads due to the R wave, prevents crosstalk, or leads ICDs, pacers, diagnostics, or other units that can customize sensing and stimulating. It can be connected to external units such as these and operated from there.

[0069] Within the scope of this invention, digital signal processing is used in combination with the use of multiple leads. This is also a possibility. (Multiple lead architecture) To utilize hitecture, multi-input multi-output (MIMO), single Input multi-output (SIMO), single input single output (SISO), and multi-input A single force output (MISO) can be programmed within the control unit. For example, a depolarization cyanotype During a curl (PQRST), the sensitivity of a specific reed is reduced, while the sensitivity of other reeds is increased. By doing so, the present invention can increase the SNR in the sensing function. Similarly, one or more Lee By reducing or increasing the stimulus signal to the heart, the present invention relates to the AV nodule, SA nodule, and heart By delivering stimulation more precisely to the apex or other cardiac tissue, it becomes possible to access previously unreachable areas for doctors. It enables a certain level of precision in the stimulation function. Similarly, it differs from conventional devices. Therefore, the availability of multiple programmable leads means that the sensing leads can detect impact / stimulation. There is no need to share the function of the lead. Furthermore, damaged or deteriorated lead It is possible to pass through the system, and it can continue to function without having to remove the entire device from the patient. This extends the lifespan of devices implanted using the technology of the present invention.

[0070] As is typical with implantable pulse generators, the device uses conventional bipolar or bipolar or To achieve either unipolar stimulation or via an external programming device, the present invention It may be possible to program the device to achieve the desired stimulation, or it may be automatically controlled by the device. This is possible. The choice may be based on user preference, or on the patient's QRS complex. This can be driven by physiological factors such as the conduction interval between stimuli to distant regions within the heart. Furthermore, switching between the pacing of the present invention and conventional pacing is performed using the pacing of the present invention. Prioritizing a higher percentage of Single's pace, the decision can also be made based on the pacing percentage. Furthermore, Switching from conventional pacing to the pacing of the present invention occurs when an exit block is present. In conventional pacing, such as when the pacing electrode is located in the infarcted myocardium, the myocardium may not be able to decompress. This can be used when polarization cannot be performed at a high power level. This automatic determination is not present in the conventional technology. This can be achieved by deploying any automatic capture and detection technology. Furthermore, wireless technology for treatment optimization. Network-enabled switching functionality can also be implemented in this invention. In such cases, a specific patient Physiological data is collected by an implantable device and remotely transmitted via a wireless communication network. It is sent to the server / monitor.

[0071] The present invention also involves the delivery of high-energy pulses having various waveforms through an electrode system. This can also be extended to defibrillation therapy to treat tachycardia and fibrillation (both atrial and ventricular). The invention, compared to conventional defibrillation configurations, is due to a better distribution of the electric field. A lower defibrillation threshold can be achieved, and a higher voltage gradient can be drawn in at least certain parts of the heart. It is thought that this will cause it. Furthermore, the present invention is faster than conventional pacing pulse sequences. To perform anti-tachyarrhythmic pacing using a fast pace to stop certain tachyarrhythmias It can be used for the following. The present invention covers a wider range of electric fields and within the heart (both atria and ventricles) This is considered advantageous due to its ability to capture special conductive systems.

[0072] Figure 2 shows the atrial leads 104, 105, 106, 107 and the ventricular lead 101 according to the present invention. , 102, 103, retractable sheath 109, 113, hub 114, independent terminal connection part 11 9, and movable deployment mechanism 116, and external lead terminals 120, 121, 122, 1 Figure 2 is a schematic diagram of another embodiment of the apparatus, showing 23. Figure 2 also shows the deployment stop unit 117 and This shows a segment 118 20 cm from the terminal connection section 119.

[0073] Figure 3 shows the present invention in which one inner sheath 303 has a ventricular lead and the other inner sheath Outer movable type housing two inner sheaths 302, 303, with sheath 302 having an atrial lead. This is a schematic diagram of two inner sheath embodiments showing catheter sheath 301. The tip portion 305 is made of a radiopaque material and is larger than the point cross-section of the wire lead. They are configured / formed, for example, as loops, to have a surface area. In a preferred embodiment, The eyelet tip range is 0.2 to 1.0 mm. The copper wire body of the wire lead 3 06 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, or other means.

[0074] Figure 4 shows the present invention in which each inner sheath 404 has its own lead and three ventricular leads An outer sheath housing seven inner sheaths provides lead 403 and four atrial leads 402. Schematic diagram of a movable catheter sheath 401, with seven inner sheaths (multiple lumens). This is a diagram. The eyelet tip 405 is made of a radiopaque material, and the wire lead It is constructed / formed, for example, as a loop, to have a larger surface area than a point cross-section. In a specific embodiment, the tip of the eyelet has a range of 0.2 to 1.0 mm. Wire lead The copper wire body 406 extends from the pacemaker to the distal shape memory section 407 of the catheter. The length is extended. The shape memory section 407 is formed by joining, braiding, welding, etc., to the copper wire 406 It can be attached.

[0075] Figure 5 shows the present invention, which houses seven inner sheaths 502, 503, and each inner sheath is It has its own lead and provides three ventricular leads and four atrial leads. Cross-section of Embodiment 501 of the catheter sheath 501, which has seven inner sheaths (multiple lumens). This is a schematic diagram.

[0076] Referring to Figure 6, the outer wire connected to the bundle of conductive materials wound around the sheath 12 A pacemaker 14 is shown. Specifically, as shown in the figure, pacemaker 14 is connected to a bundle of seven insulated wires, three of which wires 20, 22, and 26 are core They are placed inside the room, and four of the wires, 30, 32, 34, and 36, are placed inside the atrium 28. The wire is inserted into the ventricle and then bundled within the sheath 12, which is pulled backward. Three wires are bent and in contact with the ventricular wall due to the curved memory held by each wire. The ventricular lead is exposed. As the sheath 12 is further drawn into the atrium, the atrial cavity according to the present invention Four additional electrodes 30, 32, 34, and 36 that contact the wall of 28 are shown.

[0077] As shown in the drawings, the disclosed invention relates to both the atria and ventricles of the heart in a two-chamber mode. This is a thin transvenous electrode system for sequential pacing of the body. As shown in the drawing. The diagram shows multiple insulated wires, which are conductive and encased in an electrical insulator. These are bundled together into a set of two separate inline leads. Each wire is memory It has elasticity. During manufacturing, each wire is placed within the cardiac chamber, atrium, or ventricle. The electrode ends of the wire engage with the heart chamber wall for electrical pulse transmission, with a specific curvature. It is pre-formed to a specified length. In a preferred embodiment, the device is made from a shape memory material. It has three ventricular leads and four atrial leads. The four hearts are bent at a 90-degree angle from the central axis lead and are 180 degrees apart from each other. The cluster leads are bent at a 90-degree angle from the central axis (x-axis) in the y-plane, and each is adjacent to It is 90 degrees away from the lead.

[0078] Both sets of leads also provide guidance and delivery during insertion and removal of the electrode system. A slender, flexible tubular structure, such as 8Fr (8 / 3 = 2.66 mm), that functions as a stem. It may be mounted and housed inside a long, slender retaining sheath, for example, 35 cm in length.

[0079] Each wire in the ventricle expands due to memory once the sheath is removed. As shown in the diagram, the electrode point is coplane with the ventricular wall, and is in contact with the inner wall of the ventricle. They may be of various shapes and lengths so as to have elasticity over a certain distance. It has a certain amount of elasticity and secures the wire to the wall during pacing at the position shown in the diagram. The four wires used in the atria also, once the sheath is removed, the wires are as shown in the diagram. The wires expand elastically against the atrial wall, with electrode points positioned at the ends of each wire against the wall tissue. The curvature and length are predetermined so as to be. The elasticity of each wire allows for pacing. Inside, electrodes are fixed to the wall of the atrium.

[0080] The external pacemaker 14 provides electrical pulses for sequential pacing. Car 14 delivers continuous pulses to both the ventricles and atria via wires. To that end, the wire is equipped with two continuous pulse generators 16 and 18 connected to the proximal end. Yes, it exists. The external pacemaker itself is operated using conventional methods.

[0081] pulse generator The term "pulse generator" is used in relation to pacemakers, converter defibrillators, and heart This is intended to include resynchronization therapy (CRT), all of which are publicly known in the art. ru. Conventional technology includes cardiac leads, electrodes, mounting mechanisms, and conductors for placement within the cardiac chambers of the heart. It will be understood that this includes numerous examples of names and / or connector pins. The pulse generator has an electrical impulse applied to the electrode after it is connected to the lead pulse generator. It is equipped with an internal circuit for generating electricity. Furthermore, such a circuit is used to... To enable the use of electrodes as sensing electrodes to detect and report physiological processes, detection and amplification It may also be equipped with a wide circuit.

[0082] The lead is introduced into the vascular system through a small incision and travels through the vascular system to the right atrium and right heart It can advance to that position indoors. Such advancement typically involves the advance of the lead being fluorescently transmitted. It is performed using electrophysiological tests that can be visualized visually. 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 allows doctors to change pacing parameters according to the specific needs of each patient. Furthermore, it includes circuit logic that allows for the reprogramming of the pulse generator. Such programming involves transmitting a programmer to the pulse generator wirelessly from an external programmer. It can be affected by entering programming instructions. Most commonly, electronically The poles are connected to electrical ground by the circuit. In a preferred embodiment, the pulse generator may be external, and may be a transcutaneous lead or wireless. The electrodes may be coupled by transmission.

[0083] Electrode lead The wire conductors and electrodes, known as leads, are manufactured in various lengths, and the approximate distance between the electrodes is As described above, it bends elastically to form a configuration or pattern as shown in the figure. In a preferred embodiment, the lead is established within the ventricle and within the atrium. The wire may have markings, and their pre-formed curvature is used when it is placed inside the heart chamber. It is elastic enough to be bundled into a small sheath beforehand. Both wire sets are electrode systems A single cylindrical flexible retainer that serves as a guide and delivery system during insertion and removal of the system. It may be housed inside a sheath.

[0084] The ventricular electrode may also be a pacemaker sensor, or the retaining sheath may fit well in the right ventricle. The stimulator is first released after insertion. The sheath is retracted, and the electrodes and wires are... It can be expanded and brought into contact with the endocardial surface. The sheath can be removed and it can come into contact with the ventricular tissue and cavity wall. When joined, the wire expands outwards. When a parallel wire configuration is selected, the wires are released and made to contact on the same plane within the ventricular cavity. They can be arranged in an alternating pattern. By continuing to pull the sheath, the atrial wire will slip out of the sheath and move towards the atrial tissue. It can then advance and engage the electrode with the atrial wall. Once electrodes are placed in the ventricular and atrium chambers, both the atrial and ventricular chambers are paced. It senses and provides a two-chamber emergency pacemaker that offers two-chamber control of the heart. Pacing can be initiated sequentially within the ventricles.

[0085] Dual-chamber pacing is a method of continuously monitoring the spontaneous activity of the heart in both the atria and ventricles. This refers to interpreting detected events according to a specific accepted algorithm. To maintain a physiologically appropriate rhythm, the cardiac chambers are stimulated as needed.

[0086] Figure 7 is a chart of the acute first phase in human trials, supporting the embodiments of the present invention. It is useful for this purpose. Figure 7 shows the results for 10 patients, although this does not necessarily represent a specific indication. An exemplary test of the sample is shown. Figure 7 shows the positioning and deployment of the device, pacing of the RV, and A V-pacing synchronization, left-side diagnosis, RV pacing, A pacing, AV pacing The synchronization of the device and the procedure time required for device removal average 24 minutes. .

[0087] Figure 8 shows a procedure from which a non-limiting preferred embodiment is recorded in one embodiment of the present invention. This is an example of a data chart. Figure 8 shows the recorded input for subjects and leads. It shows the pedance, threshold, and current. This is safe with or without a fluorescence fluoroscopy guide. It demonstrates smooth delivery, successful pacing, and excellent lead contact and retention with cardiac tissue, and is discharged. There were no adverse events or significant adverse events at the time of discharge.

[0088] Figures 9A, 9B, and 9C are sequence diagrams of one embodiment. Figure 9A shows a guide wire. The device is shown being introduced into the patient's jugular vein using Ya 901 and introducer 902. - 903 is shown connected near hub 904, and the external delivery catheter 905 is in the neck Accessing the vein. Figure 9B shows the removal of guidewire 901. Figure 9C shows the movable Delivery catheter 9 of a transvenous two-lobe sequential pacing device equipped with a catheter sheath 906. This indicates its introduction into 05. Figure 10 shows the intracardiac use of a mobile catheter 906, as shown in the fluorescence fluoroscopy image. This is a diagram of one embodiment of a transvenous two-lobe sequential pacing device deployed. Figure 11 shows the fluoroscopic image of the mobile catheter 906 being deployed into the heart. This is a diagram of one embodiment of a transvenous two-lobe sequential pacing device. Figure 12 shows the notch into the heart, as indicated by the movable catheter 906 being used inside the heart. This is a diagram of one embodiment of a transvenous two-lobe sequential pacing device deployed. Figure 13 shows one embodiment of a transvenous two-lobe sequential pacing device deployed in the heart. The ventricular leads 907, 908, and 909 are extended into the ventricles from the movable endothelial sheath. Figure 14 shows one embodiment of a transvenous two-lobe sequential pacing device deployed in the heart. The atrial leads 910, 911, 912, and 913 are deployed into the atrium from the movable endothelial sheath. The ventricular lead has already been deployed inside the ventricle. Figure 15 shows how the transvenous two-lobe sequential pacing device deployed inside the heart works. This diagram shows how abnormal heart rhythms can be detected. Figure 16 shows how the transvenous two-lobe sequential pacing device deployed inside the heart works. This figure shows a method for applying electrical stimulation to the atria. Figure 17 shows how the transvenous two-lumen sequential pacing device deployed inside the viscera works. This figure shows a method for delivering electrical stimulation to the ventricles. Figure 18 shows how the transvenous two-lobe sequential pacing device deployed inside the heart works. This figure shows whether it is possible to detect a normal heart rhythm that has been corrected in this way. Figure 19 shows how the device is removed after it has been deployed inside the heart. In one embodiment, the lead may be removed simply by pulling it. In the application configuration, the sheath may be reintroduced to collect the leads before removal. Figure 20 is a diagram of an embodiment of the ventricle only according to the present invention. Figure 20 shows a unipolar arranged inside. Catheter 2001 equipped with sex leads 2002 and 2003 is shown. Non-restrictive implementation. In this configuration, leads 2002 and 2003, each equipped with an optional radiopaque insulating cover 2004, is shown. A conventional temporary pacemaker 2005 is attached to a lead via the superior vena cava to provide a right ventricular lead. In a non-limiting preferred embodiment, the catheter is of 4 French size, or has a diameter of 4 / 3 mm (1 .33 mm). The leads 2002, 2003 may comprise a radiopaque eyelet tip and, in the aforementioned non-limiting embodiment, may comprise a proximal portion made of copper with a distal portion made of steel or nickel titanium ( NiTi) alloy.

[0089] Legal equivalents As will be apparent to those skilled in the art, many modifications and variations can be made without departing from the spirit and scope thereof. In addition to those listed herein, functional equivalents of the methods and apparatuses within the scope of the present 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 scope of the appended claims. The present disclosure should be limited only by the terms of the appended claims, and such claims are accompanied by the full scope of equivalents to which rights are granted. It is understood that the present disclosure is not limited to a particular method, reagent, compound, composition or biological system and, of course, can vary. The terms used herein are for the purpose of describing particular embodiments only and are not intended to

[0090] limit. It should be understood that the various embodiments described above are presented by way of example only and not by way of limitation. Where the above methods show specific events occurring The order of events can be changed. Furthermore, some events can be processed in parallel if possible. They can be executed simultaneously, or sequentially as described above.

[0091] The above schematic diagram and / or embodiment is a specific configuration in which the embodiment is positioned in a particular orientation or location. When showing elements, the arrangement of the components may be changed. Embodiments have been specifically shown and described. However, it will be understood that various changes in form and details may be made. Apparatus described herein and / or any part of the method, except for mutually exclusive combinations, It can be combined with other things.

[0092] The embodiments described herein include the functions, components, and / or different embodiments described herein. This may include various combinations and / or partial combinations of features disclosed above. The various features and functions, or their substitutes, are different from many other different ones. It can be combined with various systems or applications. Various currently unforeseen or unexpected alternatives Modifications, alterations, or improvements may be made later by those skilled in the art, each of which is also disclosed. It is intended to be included in the embodiments.

Claims

1. A self-positioning, rapidly deployable, thin transvenous electrode system for cardiac pacing, A pulse generator capable of providing sensing and stimulation to the ventricle or atrium. The distal set of three ventricular leads positioned within the first medial sheath, and the second medial sheath Multiple bundled together to form a proximal set of four atrial leads positioned within An insulated wire wherein the first inner sheath and the second inner sheath are externally movable. A pacemaker comprising multiple insulated wires arranged within a tether sheath, and the outside The side-movable catheter sheath has the first inner sheath facing the ventricle and the second inner sheath facing the ventricle. Once inserted into the heart in order to deploy into the atrium, the first inner sheath and The outer movable catheter sheath is movable from the second inner sheath, and the outer movable catheter sheath is static The pulse electrode system is completely detached from the atrium and ventricle when engaged. The first inner sheath exposes the distal set of the three ventricular leads to the ventricle. It is movable in such a way that the second inner sheath exposes the four atrial leads to the atrium. It is possible to move it so that it can be released. The first inner sheath and the second inner sheath are each formed from a polymer. The polymer 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 has a proximal body, a distal end, and a tip. Prepare, The aforementioned proximal body portion is made from a radiopaque polymer-coated copper wire. The distal end is made of stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy. Made from gold and shape memory materials selected from mixtures thereof, The aforementioned tip portion is made of a shape memory material, a barium-containing compound, a bismuth-containing compound, and a steel compound. , radiopaque materials selected from tungsten-containing compounds and mixtures thereof, etc. They were made, Two of the three ventricular leads are set in a shape that is spread at a 90-degree angle, The two ventricular leads are offset 180 degrees from each other, and one of the three ventricular leads One is a central axis lead, Each of the four atrial leads is shaped at a 90-degree angle in the expanded configuration, The two atrial leads are spaced 90 degrees apart from each other, and the movable catheter sheath is far It consists of a pit and a proximal part, 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 and a pitch coil of 0.0 It is 10 inches in size and has a biocompatible polymer cover. The proximal portion of the aforementioned movable catheter sheath has a length of 30 cm and a pitch coil of 0. It is 0.20 inches in diameter, has a biocompatible polymer cover, and has a hub element at the proximal end of the proximal portion. , Touhy-Borst access connector with side port, the movable catheter Actuator dial, deployment stop unit, and case that enable molding and control of the sheath. Equipped with a cable joint housing, The atrial lead terminals and ventricular lead terminals are located from the cable connection housing to the page It extends to the pacemaker, which has diagnostic functions, sensor operation, and stimulus signals. Programs for individual leads for sensing, T-wave or other noise or attenuation Alternatively, a program to reduce the oversensing of the ventricular lead due to interference signals, using the R wave A program to reduce the oversensing of the atrial lead and minimize crosstalk. A program for doing so, as well as a program for adjusting sensing and stimulation for each lead. To provide a function selected from the group consisting of the above, a processor reads a con It is equipped with computer program instructions, The atrial lead senses and stimulates the SA nodal region and AV nodal region of the heart. The ventricular lead is shaped in such a way that it includes the His bundle region, the Apex-Purkinje fiber region, and shaped to sense and stimulate the Free-wall Purkinje region, Each of the ventricular leads is connected to a ventricular sensor or stimulator within the pacemaker. Each of the atrial leads is connected to an atrial sensor or stimulator within the pacemaker. A system that is connected to it.

2. The aforementioned pacemaker sequentially paces both the atria and ventricles of the heart in "two-chamber" mode. It includes two consecutive pulse generators capable of providing sensing and stimulation to the ventricles and atria. The system described in claim 1.

3. The pacemaker performs digital signal processing of the ventricular and atrial leads. Includes computer program instructions executable by a processor for the purpose of, the digital Signal processing includes multi-input, multi-output (MIMO), single-input multi-output (SIMO), and single-input single-output. A selected from the group consisting of (SISO) and multi-input single-output (MISO), according to claim 1. The system described.

4. The computer program instructions that can be executed by the processor are depolarization cycles ( During PQRST, the sensitivity of a specific reed is reduced while the sensitivity of other reeds is increased. Therefore, the present invention provides a function that enables the SNR of the sensing function to be increased, one or more By reducing or increasing the stimulus signal to the AV node, the present invention more accurately achieves the aforementioned AV node. , providing stimulation to the SA nodule, apex, or other cardiac tissues to achieve a certain level of precision in stimulating function. The ability to provide this functionality requires that the sensing lead share the functionality of the shock / stimulation lead. Program the leads to avoid this and bypass damaged or degraded leads. This allows the device to continue functioning without the need to remove the entire device from the patient. By providing one or more functions, the lifespan of the implanted device using the technology of the present invention is extended. The system according to claim 2, which extends.

5. The first inner sheath is a set of three independently movable inner sheaths, and the three Each of the ventricular leads has its own movable sheath, and the second inner sheath has four A set of independently movable inner sheaths, each of the four atrial leads, The system according to claim 1, having a movable sheath.

6. This was a computer-implemented method for rapidly deploying a cardiac pacing device to a patient's heart. hand, (i) the step of supplying the system according to claim 1; (ii) Access the patient's jugular vein and, under ultrasound or other non-fluorescence imaging, Steps include advancing the tetrahedron sheath to the right ventricle of the patient's heart; (iii) Pull out the outer movable catheter sheath to the first position, and the first inner sheath Steps to expose the second inner sheath; (iv) Pull out the first inner sheath to the second position, expose the ventricular lead, and assemble the ventricular assembly. Steps to connect the weave; (iv) Pull out the second inner sheath to the third position, expose the atrial lead, and assemble the atrial assembly. Steps to connect the weave; (v) Diagnostic tests using computer program instructions that can be executed on the processor. A step of performing the following to identify the patient's cardiac pattern and verify the operation of the system; (vi) Using computer program instructions that can be executed on a processor, patent Execute an appropriate cardiac pacing routine as a treatment for the cardiac pattern of (patent). Step; (vii) Remove the catheter sheath and enable the system to be left in the patient. A method that includes the steps of

7. The step that performs steps (i) to (iv) is The method according to claim 6, which is carried out within 60 minutes.

8. Steps (i) through (iv) must be completed within 30 minutes. The method described in item 6.

9. 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 pair of insulated wires for forming the first and second ventricular leads. The first ventricular lead and the second ventricular lead are located within the externally movable catheter sheath. It is equipped with a pacemaker with an insulated wire, located in The external movable catheter sheath is movable from the first and second ventricular leads. Yes, the first ventricular lead and the second ventricular lead are deployed to the ventricle in the heart. Once inserted, the external movable catheter sheath engages with the transvenous electrode system. When this happens, it is completely removed from the ventricle. Each of the first and second ventricular leads comprises a proximal body, a distal end, and a tip. picture, The aforementioned proximal body portion is made from a radiopaque polymer-coated copper wire. The distal end is made of stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy. Made from gold and shape memory materials selected from mixtures thereof, The aforementioned tip portion is made of a shape memory material, a barium-containing compound, a bismuth-containing compound, and a steel compound. From radiopaque materials selected from tungsten-containing compounds and mixtures thereof The two ventricular leads were fabricated and offset 180 degrees from each other. The aforementioned movable catheter sheath has a diameter of approximately 1.3 mm or 4 French, and the distal part It consists of a proximal portion 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 and a pitch coil of 0.0 It is 10 inches in size and has a biocompatible polymer cover. The proximal portion of the aforementioned movable catheter sheath is 30 cm in length and 0.020 inches It has a pitch coil, and the biocompatible polymer cover at the proximal end of the proximal part is a hub element, side Touhy-Borst access connector with port, forming a movable catheter sheath. Actuator dials, deployment stop units, and cable connectors that enable shaping and control. Equipped with a woofer, The atrial and ventricular lead terminals are connected to the pacemaker via the cable junction housing. It extends to - Pacemakers have individual leads for diagnostic functions, sensor operation, stimulus signals, and sensing. Programs, ventricular leads with T-wave or other noise, attenuation, or interference signals Programs to reduce oversensing, programs to minimize crosstalk Select from a group consisting of a m, and a program for adjusting sensing and stimulation for each lead. To provide the selected function, a computer program readable by the processor It is equipped with a command, The ventricular lead senses the bundle of His region and the Free-Wall Purkinje region. Shaped to stimulate, Each of the ventricular leads is connected to a ventricular sensor or stimulator within the pacemaker. A system that is in place.

10. The first ventricular lead is positioned within the first movable inner sheath, and the second ventricular lead It is located within the second movable inner sheath. The first inner sheath and the second inner sheath are each formed from a polymer. The polymer is doped with a radiopaque material to form a radiopaque polymer sheath. Claim 9, which is either or is labeled with at least one radiopaque marker element. The system described.

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