WO2008024857A2 - Appareil et procédé permettant d'optimiser la thérapie de resynchronisation cardiaque - Google Patents

Appareil et procédé permettant d'optimiser la thérapie de resynchronisation cardiaque Download PDF

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Publication number
WO2008024857A2
WO2008024857A2 PCT/US2007/076543 US2007076543W WO2008024857A2 WO 2008024857 A2 WO2008024857 A2 WO 2008024857A2 US 2007076543 W US2007076543 W US 2007076543W WO 2008024857 A2 WO2008024857 A2 WO 2008024857A2
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pacing
heart
cardiac
endomyocardium
site
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PCT/US2007/076543
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English (en)
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WO2008024857A3 (fr
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Guanggen Cui
Luyi Sen
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The Regents Of The University Of California
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Publication of WO2008024857A3 publication Critical patent/WO2008024857A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Definitions

  • the invention relates to the field of endomyocardium and epicardium biventricular pacing.
  • Congestive heart- failure is the first listed diagnosis in 875,000 hospitalizations and the most common diagnosis in hospital patients over age 65. Almost 5 million Americans have congestive heart failure, a further 550,000 are diagnosed with congestive heart failure annually, and congestive heart failure represented the primary diagnosis for approximately 1 million hospital discharges. Approximately 25% to 40% of congestive heart failure patients do not die of progressive congestive heart failure, but instead die suddenly, often without obvious prior symptoms.
  • Sudden death also known as sudden cardiac arrest, is 6 to 9 times more likely in persons diagnosed with congestive heart failure than in the general population. Sudden death is caused most commonly by ventricular tachycardia (VT) or ventricular fibrillation (VF) in patients with underlying impaired left ventricular (LV) function.
  • VT ventricular tachycardia
  • VF ventricular fibrillation
  • LV left ventricular
  • Cardiac resynchronization therapy is a way of treating heart failure with an implantable device similar to a pacemaker. Basically, it is a heart failure pacemaker that helps both ventricles of the heart beat together again in a more synchronized pattern. This improves the heart's ability to pump blood and oxygen to the body.
  • the heart failure pacemaker is implanted under the skin of the chest and connected to three leads (soft insulated wires) that are inserted through the veins into the heart.
  • the device is battery-powered and delivers small electrical pulses to both ventricles which makes them beat in a synchronized way. These small impulses are usually not felt.
  • Cardiac resynchronization therapy in combination with a complete program of therapy, has proven to improve the quality of life for many patients by reducing symptoms of heart failure, increasing exercise capacity and allowing them to resume many daily activities.
  • ICDs implantable cardioverter defibrillators
  • CRT cardiac resynchronization therapy
  • the implantable cardioverter defibrillator continuously monitors the cardiac rhythm and provides backup bradycardia pacing and anti-tachycardia pacing or shock therapy for life threatening ventricular arrhythmias.
  • Cardiac resynchronization therapy which was developed to provide hemodynamic improvement with restoration of atrioventricular, interventricular, and intraventricular synchrony, can be used in conjunction with defibrillator capabilities (CRT-D).
  • Biventricular pacing could provide a more coordinated pattern of contraction than the dissynchronous ventricular activation which occurs in patients with interventricular conduction defects, which is common in patients with congestive heart failure.
  • the MUSTIC trial which was recently published, demonstrated that biventricular pacing might improve symptoms and quality of life in selected patients with congestive heart failure.
  • up to 30% of the patients are classified as "non-responders" to the current techniques of cardiac resynchronization with or without an implantable cardioverter defibrillator. Discordance between the site of maximal delay and the pacing site can be a potential explanation for the lack of benefit. More than 70% of "non-responders" cases were due inability to find the optimized "responding" pacing site.
  • the site for maximally delayed conduction is different in each patient and may also different in various diseases underlying congestive heart failure.
  • Current practices for cardiac resynchronization, pacing and implantable cardioverter defibrillator are standardized, not individualized and optimized . Most importantly, even though the majority of the patients have a "response", they do not reach the optimized effectiveness of this therapy due to discordance between the site of maximal delay and the pacing site.
  • the illustrated embodiments of the invention establish the concept and applicable methodology for optimized endomyocardium and/or epicardium biventricular pacing.
  • the illustrated embodiments include four components, namely the concept, device and technology for i) evidence-based, ii) optimized, iii) simultaneously evidence-based and/or optimized endomyocardium and/or iv) optimized epimyocardium pacing in cardiac resynchronization.
  • An object of the invention is to introduce a new strategy for personalized and evidence based optimization of cardiac resynchronization applied in percutaneous intervention, open chest or thoracoscopic surgeries. To perform optimized cardiac resynchronization, we disclose three illustrative embodiments.
  • the first embodiment for evidence-based optimized endomyocardium pacing in cardiac resynchronization uses a lantern catheter with 64 or 128, or even more Ag-AgCI plated electrodes made by laser microfabrication and deposition technology.
  • the lantern catheter allows simultaneous, three-dimensional mapping of the entire or substantially all of the endomyocardium MAP.
  • the lantern catheter can be percutaneously inserted through peripheral veins and/or arteries using standardized cardiac intervention. We are able to three dimensionally, real-time map the endomyocardium monophasic action potential in each atrium and/or ventricle.
  • the pattern and/or the magnitude or size of the alteration of the action potential, changes in the action potential duration and/or the site or sites of 90% of the action potential duration (APD 90 ), the slowest action potential repolarization and/or depolarization (dv/dt), and/or other parameters can be determined in each patient. With the standard electrophysiologic system all these parameters can be directly visualized and/or recorded. Most importantly, using this real-time three- dimensional mapping, the site and sites of the myocardium with maximum dispersion of these parameters among 128 or more recording sites can be identified that indicates the pathology of the myocardium, even in an early disease stage. By analyzing the changes of parameters using advanced software, the individualized optimized pacing site(s) can be determined precisely in combination with the analysis of hemodynamic parameters in as short a time as 10 minutes.
  • the lantern catheter can be used for determine the optimized pacing site or the combination of sites using a programmed pacing protocol.
  • the electrodes on the lantern catheter may be platinum plated, and need not be Ag-AgCI plated.
  • the site with the best hemodynamic responses in parameters such as peak amplitude and/or dp/dt of left ventricular (LV) and/or right ventricular (RV) systolic pressure, left ventricular (LV) and/or right ventricular (RV) diastolic pressure, pulse pressure and the like will be determined by pacing individual electrodes or pacing electrodes in sequential combinations.
  • the third embodiment for evidence-based optimized epimyocardium pacing in cardiac is as follows.
  • an elastic mash with 128 or more Ag-AgCI plated electrode array can be used to cover the entire heart.
  • the individualized optimized pacing site(s) can be determined precisely in combination with the analysis of hemodynamic parameters. Especially in the case of coronary artery bypass surgery involving two, three or more vessels, more than three pacing sites may be applied. This mapping system can provide more evidence for the basis of the treatment, and can create a new strategy for the cardiac resynchronization.
  • the fourth embodiment for optimized epimyocardium pacing in cardiac resynchronization is as follows, in most community hospitals, there is no electrophysiologic recording system available. The standard open chest operating room also does not come equipped with an electrophysiologic system. In open chest surgery, an elastic mash with 128 or more platinum plated electrodes array can be used to cover the entire heart.
  • the electrodes on the lantern catheter may be platinum plated, and need not be Ag-AgCI plated.
  • the site with the best hemodynamic responses in parameters such as peak amplitude and/or dp/dt of left ventricular (LV) and/or right ventricular (RV) systolic pressure, left ventricular (LV) and/or right ventricular (RV) diastolic pressure, pulse pressure and the like will be determined by pacing individual electrodes or pacing electrodes in sequential combinations.
  • the illustrated embodiments can be used to the advantage of any patients with an indication for cardiac resynchronization, pacing and/or defibrillation: such as heart failure induced by ischemic cardiomyopathic, myocardities, idiopathic dilated cardiomyopathy, restricted cardiomyopathy, drug induced heart failure, heart ' transplant rejection, surgically related cardiac dysfunction and/or heart failure, congenital heart diseases, or various arrhythmias, such as various right and/or left ventricular bundle branch blocks, intraventricular conduction block, AV block, VT, SVT, AF, Af, various AV block etc. with or without heart failure. In these cases an electrophysiologic system is required.
  • the illustrated embodiments can be further used to the advantage of any patients with an indication for cardiac resynchronization, pacing and/or defibrillation, such as: heart failure induced by ischemic cardiomyopathy, myocardities, idiopathic dilated cardiomyopathy, restricted cardiomyopathy, drug induced heart failure, heart " transplant rejection, operation related cardiac dysfunction and/or heart failure, congenital heart diseases, and/or various arrhythmias, such as: various right and/or left ventricular bundle branch blocks, intraventricular conduction block, AV block, VT, SVT, AF, Af, various AV block etc. with or without heart failure. In these cases an electrophysiologic system is not required.
  • the illustrated embodiments can be further used to the advantage of patients undergoing open chest surgery for coronary artery bypass grafting, heart transplantation, valve repair and/or replacement, aneurysms, various surgeries for congenital heart diseases, assistance device implantation, pacemaker implantation, defibrillation device implantation, and the like.
  • Optimized single or multiple site(s) pacing can improve the cardiac function, shorten the cardiac recovery time with or without a bypass pump, improve the cardiac remodeling, reduce the incidence of arrhythmias, and decrease the incidence of sudden death. In these cases an electrophysiologic system is required.
  • the illustrated embodiments can be further used to the advantage of patients undergoing open chest surgery for coronary artery bypass grafting, heart transplantation, valve repair and/or replacement, aneurysms, various surgeries for congenital heart diseases, assistance device implantation, pacemaker implantation, defibrillation device implantation, and the like.
  • Optimized single or multiple site(s) pacing can improve the cardiac function, shorter the cardiac recovery time with or without bypass pump, improve the cardiac remodeling, reduce the incidence of arrhythmias, decrease the incidence of sudden death. In these cases an electrophysiologic system is not required.
  • the elastic mash with 128 or more Ag-AgCI plated electrodes array can also be inserted into the chest through thoracoscopy without open chest surgery. Thus, epicardium pacing can be applied. The indication of this procedure is the same as described in open chest surgery above. In this case an electrophysiologic system is required.
  • the optimization of the epimyocardium pacing can still be performed using an elastic mesh with 128 or more platinum plated electrode array inserted into the chest through thoracoscopy without open chest surgery.
  • the indication of this procedure is the same as described in open chest surgery above. In this case an electrophysiologic system is not required.
  • the illustrated embodiments of the invention introduce a novel monophasic action potential mapping techniques for evidence-based and/or individualized optimization of cardiac resynchronization, pacing and/or implantable cardioverter defibrillators in percutaneous procedures, thoracoscopic procedures or open chest surgeries.
  • the apparatus and/or methods of the invention to identify the optimized electrode sites without MAP mapping can be practiced in hospitals or operating rooms without an electrophysiologic system for optimized cardiac resynchronization, pacing and/or an implantable cardioverter defibrillator in percutaneous procedures, thoracoscopic procedures or open chest surgeries.
  • the illustrated embodiments of the invention will turn the "non- responders" to responders, and moderate response to optimized response.
  • the illustrated embodiments of the invention are safer, e.g. 5 - 10 times faster and less demanding on physician skill as compared with current interventionist procedures which manually move the electrodes to find the better pacing site or the best combination of sites.
  • the illustrated embodiments of the invention will let us avoid unnecessary use of high energy for cardiac pacing to improve the response. This will avoid scar formation and/or improve the cardiac remodeling.
  • the illustrated embodiments of the invention introduces a novel concept and technique that can help us to understand the unrevealed mechanism of cardiac resynchronization, arrhythmia and/or antiarrhythmia, cardiac remodeling, and similar cardiac functions at a cellular level in patients.
  • the illustrated embodiments of the invention will also help us to improve our understanding of electrophysiology of various cardiac diseases in human and develop new therapeutic strategies, such as low energy multi-site pacing for cardiac resynchronization, pacing and implantable cardioverter defibrillating, high energy-microwave pacing for cardiac resynchronization, and the like.
  • Fig. 1 is a diagrammatic side view of the lantern catheter used in the illustrated embodiments.
  • Fig. 2 is a diagrammatic end view of the lantern catheter used in the illustrated embodiments.
  • Fig. 3a is a side cut-away view of the human heart showing the endovascular placement of the collapsed lantern catheter of Figs. 1 and 2 according to the invention.
  • Fig. 3b is a side cut-away view of the human heart showing the expanded deployment of the lantern catheter of Figs. 1 and 2 according to the invention.
  • Fig. 3c is an image of a MAP-mapping produced by the parameter analysis generated by the computer connected to the cardiac amplifier in Fig. 3b.
  • Fig. 4a is a side perspective view of a segment of the insulated basket wire with electrodes of the lantern catheter.
  • Fig. 4b is a layout of the microfabricated supporting wires for electrical coupling to the electrodes on the basket wire of Fig. 4a.
  • Fig. 4c is a cross section view of the basket wire of Fig. 4a as seen through section lines 4c - 4c of Fig. 4a.
  • Fig. 5a is a diagram showing deployment of another embodiment of the lantern catheter having both an atrial and ventricular basket.
  • Fig. 5b is a side view of the embodiment used in Fig. 5a.
  • Fig. 6 is a diagram showing deployment of another embodiment of the MAP-mapping and pacing device where it is deployed exteriorly to the heart during open-chest operation.
  • Fig. 7a is a side plan view of another embodiment that is the electrode-array mesh for epimyocardium MAP-mapping and pacing which is used to contact the exterior surface of the heart.
  • Fig. 7b is an enlargement of a plan view of a portion of the electrode-array mesh of Fig. 7a shown in an open configuration.
  • Fig. 7c is a side perspective view of the wires of the electrode-array mesh of Figs. 7a and 7b.
  • Fig. 7d is a cross sectional view taken of an electrode ring taken through section lines 7d - 7d of Fig. 7c.
  • Fig. 8 is a diagram of the use of the electrode-array mesh of Figs.
  • the first embodiment for evidence-based optimized endomyocardium pacing in cardiac resynchronization uses a lantern catheter with 64 or 128, or even more Ag-AgCI plated electrodes made by laser microfabrication and deposition technology.
  • the lantern catheter is described in detail in U.S. Patent 6,738,655, which is incorporated herein by reference.
  • the "lantern" catheter generally denoted by reference numeral 10 in Fig, 1 , allows simultaneous, three-dimensional mapping of the entire endomyocardium MAP.
  • Catheter 10 as shown in the diagrammatic side view of FIG. 1 is retained within a protection sheath (not shown) which retains basket 12 in a collapsed condition.
  • Basket 12 is connected to a catheter lead through which insulated copper wires 16 are disposed.
  • Wires 16 are connected to electrodes 24 in basket 12 at their distal ends and to a multichannel amplifier or multiplexer and other appropriate electronics 42 at its proximal end.
  • Central trunk 31 of the catheter supports all of the wires 16 as diagrammatically shown in Fig. 1.
  • Wires 26 are insulated or nonconducting so that they function as mechanical supports for electrodes 24.
  • a plurality of very fine wires 16 are electrically coupled to corresponding electrodes 24, which are therefore selectively and individually accessible for detection and recording through the electronics.
  • Distal tip 22 of basket 12 may be provided with a radioopaque platinum or gold marker 30 to aid in its fluoroscopic detection and visualization, since stainless steel wires 26 and electrodes 24 can be very fine or small and difficult to unambiguously show in a fluoroscopic image.
  • the "lantern" 10 shall collectively denote basket 12 of wires 26 and electrodes 24. Each electrode 24 is preferably made of or plated with Ag/AgCI. Wires 26 are preferably made from stainless steel, which provides the needed degree of resiliency and flexibility. Other alloy choices, gauges and material choices could be made for wires 26 consistent with the teachings of the invention.
  • a central guide wire 46 extends through basket catheter 10 from distal tip 22 to the proximal grounded end 48.
  • a central wire spring or lock 50 bears against a washer 52 to act as a stop for compliant spring 54 which is coaxially positioned around wire 46 and its plastic central wire sheath 58.
  • Sheathed wire 46 is in turn coaxially disposed in a flexible shaft 62 which extends from washer 60 to a stainless steel ring 64 adjacent to the proximal end of basket 12.
  • Central wire sheath 58 is sized and has a surface treatment or material quality, such as a Teflon ® composition, which allows the free telescopic movement of guidewire 46 within it. Washer 60 bears against the distal end of compliant spring 54.
  • Wires 16 are disposed in the concentric coaxial space between shaft 62 and heat shrink tubing 68. Collectively sheath 58, shaft 62, wires 16 and tubing 68 comprise an electrode array tube 66 through which guidewire 46 freely telescopes.
  • Wires 16 extend into ring 64 to be lead along various ones of the basket wires 26 to corresponding electrodes 24, which are mounted wires 26 and connected to a selected one of the wires 16. Basket wires 26 are mounted to ring 64. Wires 26 are covered by a laser-cut microfabricated insulating covering or tube 27. A hole is cut or formed into tube 27 at each location where an electrode 24 is exposed and extends above the level of tube 27 for contact with the myocardium.
  • lock 50 in its collapsed state be forced out of the end of shaft 62 and through spring 54 which abuts shaft 62.
  • Lock 50 is then freed and snaps open by reason of its inherent resiliency to then provide a mechanical stop for the proximal end of spring 54.
  • Lock 50 can be released by insertion into the catheter (not shown) by advancing the catheter over lock 50 and reinserting lock 50 through the inner space of coil spring 54 and/or shaft 62. This will then allow basket 12 to collapse and be withdrawn from the heart chamber.
  • Spring 54 abuts the proximal end of shaft 62 to give basket 12 some flexibility during heart contractions and relaxations during each beat, i.e.
  • Electrodes 24 are spherical or rounded and sized to extend from wires 16 and thereby to provide positive and firm contact with the surrounding heart tissue. This feature in combination with the resilient nature of the basket/spring combination insure continuous and firm or intimate contact between electrodes 24 and the heart tissue, which contact is important to obtain valid readings.
  • Wire 26 is shown in greater detail in Figs. 4a - 4c.
  • the side perspective view of Fig. 4a shows a segment of wire 26 in which a plurality of Ag/AgCi plated conductive electrode rings 70, each carrying an electrode 24, are inset or mounted in longitudinal sequence into or onto insulation tube 27 through which wire 26 is coaxially disposed.
  • a laser-cut microfabricated flexible sheet of wires 16 as shown in Fig. 4b is wrapped around insulation tube 27 to provide electrical connection between 'individual wires 16 and each electrode 24.
  • a sectional view through section lines 4c - 4c of Fig. 4a shows in Fig. 4c a plan view of ring 70.
  • wire 26 has a diameter of about 0.012 inch (0.30mm) and is disposed in a central lumen 72 defined in insulation tube 27 which has a diameter of about 0.014 inch (0.36mm).
  • the outer diameter of insulation tube 27 is approximately 0.020 inch (0.51mm) or less, which matches the inner diameter 74 of ring 70.
  • the height 76 from the base of ring 70 to the top of electrode 24 is approximately 0.035 (0.89mm) ⁇ .002 inch (0.05mm).
  • the upper surface of electrode 24 has a radius of curvature of approximately 0.005 inch (0.1mm).
  • the thickness 78 of ring 70 is approximately 0.002 inch (0.05mm) +.004 inch (0.1mm) or -.002 inch (0.05mm).
  • the first step in the method is the step of placing two lantern catheters 10 with the basket 12 in the closed position in into the atriums 32a, 32b or ventricles 34a, 34b as shown in Fig. 3a.
  • a lantern catheter 10a can be percutaneously or directly placed into venous system, then into the right atrium 32a or further advanced into right ventricle 34a through superior vena cava 36 or inferior vena cava 38.
  • a lantern catheter 10b can be percutaneously or directly inserted into the venous system, then from the right atrium 32a into left atrium 32b using a transseptal approach.
  • the catheter can also be further advanced into left ventricle 34b.
  • another approach is to percutaneously or directly insert the catheter 10b into arterial system, then advance the catheter 10b into the left ventricle 34b retroactively through aorta 40.
  • the second step is to perform real-time three-dimensional endomyocardium monophasic action potential (MAP)-mapping.
  • MAP endomyocardium monophasic action potential
  • the basket 12 on the lantern catheter 10a, 10b will be unfolded and expended to let all electrodes 24 tightly contact the endomyocardium of the atriums 32a, 32b and ventricles 34a, 34b. All 64 or 128, or even, more electrodes 24 are connected to an electrophysiologic amplifier 42. Endomyocardium monophasic action potentials are recorded from all electrodes 24 simultaneously. A computer 44 with software for real-time three-dimensional endomyocardium monophasic action potential- mapping parameter analysis is connected to the amplifier 42. [053] A three-dimensional MAP-map is recorded from both atrium 32a,
  • MAP parameters including action potential amplitude, depolarization dv/dt, repolarization dv/dt, ADP 90 , and the like are recorded.
  • Real-time three-dimensional MAP mapping also allows us to analyzed the dispersion of all MAP parameters among a atrium 32a or 32b and/or a ventricle34a or 34b, two atriums 32a and 32b or two ventricles 34a and 34b, one atrium 32a or 32b and one ventricle34a or 34b, any three chambers, or all four chambers.
  • mapping parameters especially the dispersions of each parameter help the physician to visually localize the maximum and minimum of a parameter at a cardiac site that implicates the pathology of the myocardium and help to identify the optimized pacing spot and the combination of spots.
  • the third step is to perform a comparative programmed test pacing to determine the optimized pacing spots in the heart.
  • Each of the electrodes 24 are programmed to be paced one-by-one or in different combinations using a programmed pacing stimulator.
  • observing the improvement on the real-time three-dimensional MAP-mapping parameters and color imaging, and the hemodynamic parameters are used for verifying the optimal pacing spot or combination of spots.
  • the fourth step is to pace the temporally or permanently placed pacing leads after the optimized pacing spot or spots are identified, and then withdraw the MAP-mapping catheters 10a and 10b.
  • FIG. 5a Another embodiment of lantern catheter 10a is diagrammatically shown in Figs. 5a and 5b.
  • Catheter 10a has a smaller atrium basket 12a and a larger ventricular basket 12b coupled to the same guidewire 46.
  • the details of construction of catheter 10b are illustrated in Fig. 5b and are similar to that described in connection with Fig. 1.
  • the design and construction of atrium basket 12a and ventricular basket 12b is similar except for sizing and except the addition of an atrial double spring 80 and atrial shaft 82.
  • Catheter 10a of Fig. 5b is similar in overall construction and operation to catheter 10 of Fig. 1 with respect to the same referenced elements.
  • Wire 46 is telescopically disposed through ventricular shaft 62 and atrial shaft 82 and is led back to an additional atrial basket lock 50a.
  • Lock 50a operates in a manner similar to lock 50 with respect to an introducing catheter (not shown) to temporarily lock atrial basket 12a in the expanded configuration.
  • Atrial shaft 82 is telescopically disposed inside of ventricular shaft 62 and can be independently advanced on wire 46 to independently expand atrial basket 12a from the expansion of ventricular basket 12b by advancement of ventricular shaft 62.
  • Spring 80 allows for relative movement of baskets 12a and 12b to accommodate a beating heart. [055] After insertion into the atrium 32a and ventricle 34a as shown in
  • lantern catheter 10a is expanded to make every electrode 24, 24a and 24b tightly contact the endomyocardium.
  • Fig. 5a shows a ventricular lantern catheter 10 being inserted into the left ventricle 34b while catheter 10a is inserted into the right atrium 32a and ventricle 34a.
  • Each electrode 24, 24a, 24b is programmed to be serially paced or in a selected combination. The improvement of hemodynamic parameters will be used for identify the optimized pacing spot or spot combinations. Then the temporally or permanent pacing lead(s) are paced and the lantern catheter 10a is withdrawn.
  • epimyocardium MAP-Mapping electrode-array mesh catheter 10b is placed outside of the heart.
  • a real-time three dimensional MAP-mapping analysis is performed to identify the optimal pacing spot or spot combinations.
  • All electrodes 24 on the mesh of catheter 10b are in tight contact with the epicardium. About 128 to 256, or even more electrodes 24 are connected to an electrophysiologic amplifier 42. Epimyocardium monophasic action potentials at each electrode 24 are recorded simultaneously.
  • a computer 44 with software for generating a real-time three-dimensional epimyocardium monophasic action potential-mapping parameter analysis is connected to the amplifier 42.
  • MAP parameters including action potential amplitude, depolarization dv/dt, repolarization dv/dt, ADP 90 , etc.
  • the third step of the method is to perform the comparative programmed test pacing to determine the optimized pacing spots on the heart.
  • Each electrode 24 is programmed to be paced one-by-one or in different combinations using a program stimulator.
  • observing the improvement in the color image of the real-time three dimensional MAP-mapping parameters and the hemodynamic parameters are used to identifying the optimal pacing spot or spots combination.
  • the fourth step of the method is to pace the temporally or permanent pacing leads after the optimized pacing spot or spots are identified, and to withdraw the MAP-mapping catheter 10b.
  • Fig. 7a is a diagram of the mesh basket 12 of catheter 10b shown in a collapsed condition.
  • the mesh basket 12 is comprised of 16 wires 26 forming a cylindrical sock around which is spirally disposed a plurality of electrodes 24 and a spiral elastic fiber 84 which provides a resilient force which tends to keep basket 12 collapsed or at least in a tight contact with the heart tissue.
  • a closing string 86 is provided around the distal end of basket 12 to allow the surgeon to close the distal end to maintain basket 12 tightly wrapped around the heart.
  • Wires 26 are connected to a connecting ring 88 and thence by a multiple wire cable 90 to amplifier 42.
  • Fig. 8 is a diagram which illustrates an embodiment of the method in which optimized endomyocardium pacing is performed with out MAP-mapping.
  • epimyocardium electrode array catheter 10b is not only deployed and used during open heart surgery, but it can also be deployed in vivo using endoscopic and robotic surgery approach using an endoscopic entry tube 94.
  • an epicardium electrode array mesh catheter 10b is deployed using an endoscope.
  • Each electrode 24 is again tightly contacted with the epicardium.
  • each electrode 24 is programmed to be paced serially, or in a selected combination.
  • the improvement of hemodynamic parameters is used to identify the optimized pacing spot or spot combinations with the optional use of an instrument endoscopic entry tube 96. Then the temporally or permanent pacing lead(s) are paced and the lantern catheter 10b is withdrawn.

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Abstract

L'invention concerne un appareil et un procédé de stimulation biventriculaire, comprenant des moyens et des étapes permettant une stimulation endomyocardique i) basée sur des éléments factuels, ii) optimisée, iii) à la fois basée sur des éléments factuels et optimisée et iv) épimyocardique optimisée dans le cadre de la resynchronisation cardiaque. Le potentiel d'action monophasique est déterminé par une optimisation basée sur des éléments factuels et individualisée de la resynchronisation cardiaque, de la stimulation et des dispositifs de défibrillation/cardioversion implantables dans des interventions percutanées, des interventions sous thoracoscopie ou des interventions à thorax ouvert. Les sites d'électrodes optimisés sont identifiés sans détermination de la PAM et sans utiliser de système électrophysiologique pour une resynchronisation cardiaque, une stimulation et un dispositif de défibrillation/cardioversion implantable optimisés dans des interventions percutanées, des interventions sous thoracoscopie ou des interventions à thorax ouvert. L'efficacité de cette thérapie est optimisée chez une majorité de patients atteints d'insuffisance cardiaque, de dysfonctionnement du ventricule gauche (VG) ou du ventricule droit (VD), de cardiomyopathies, d'arythmies, de maladies cardiaques congénitales, chez les patients ayant subi une transplantation cardiaque et/ou chez les patients juste après une intervention à thorax ouvert en vue d'un rétablissement rapide.
PCT/US2007/076543 2006-08-23 2007-08-22 Appareil et procédé permettant d'optimiser la thérapie de resynchronisation cardiaque WO2008024857A2 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014189077A1 (fr) * 2013-05-21 2014-11-27 独立行政法人科学技術振興機構 Sonde multipoint et feuille de contact électronique permettant de la configurer, réseau de sondes multipoint et procédé de fabrication de sonde multipoint
WO2016076485A1 (fr) * 2014-11-11 2016-05-19 서울대학교 산학협력단 Électrode à mailles pour thérapie de resynchronisation cardiaque, et son procédé de fabrication

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US4936857A (en) * 1987-02-23 1990-06-26 Kulik Yaroslav P Prosthetic pericardium
US6522904B1 (en) * 1999-03-30 2003-02-18 Impulse Dynamics N.V. Bipolar sensor for muscle tissue action potential duration estimation
US6738655B1 (en) * 1999-04-05 2004-05-18 The Regents Of The University Of California Endomyocardial monophasic action potential for early detection of myocardium pathology

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4936857A (en) * 1987-02-23 1990-06-26 Kulik Yaroslav P Prosthetic pericardium
US6522904B1 (en) * 1999-03-30 2003-02-18 Impulse Dynamics N.V. Bipolar sensor for muscle tissue action potential duration estimation
US6738655B1 (en) * 1999-04-05 2004-05-18 The Regents Of The University Of California Endomyocardial monophasic action potential for early detection of myocardium pathology

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014189077A1 (fr) * 2013-05-21 2014-11-27 独立行政法人科学技術振興機構 Sonde multipoint et feuille de contact électronique permettant de la configurer, réseau de sondes multipoint et procédé de fabrication de sonde multipoint
JP2014226257A (ja) * 2013-05-21 2014-12-08 独立行政法人科学技術振興機構 多点プローブ及びそれを構成する電子接点シート、多点プローブアレイ並びに多点プローブの製造方法
US10588525B2 (en) 2013-05-21 2020-03-17 Japan Science And Technology Agency Multi-point probe, electronic contact sheet for configuring the same, multi-point probe array, and method of manufacturing the same
WO2016076485A1 (fr) * 2014-11-11 2016-05-19 서울대학교 산학협력단 Électrode à mailles pour thérapie de resynchronisation cardiaque, et son procédé de fabrication
US10874854B2 (en) 2014-11-11 2020-12-29 Seoul National University R&Db Foundation Mesh electrode for cardiac resynchronization therapy, and manufacturing method therefor

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