WO1997013547A1 - Dispositif permettant de traiter l'arythmie cardiaque par chauffage ou refroidissement - Google Patents

Dispositif permettant de traiter l'arythmie cardiaque par chauffage ou refroidissement Download PDF

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Publication number
WO1997013547A1
WO1997013547A1 PCT/US1996/016273 US9616273W WO9713547A1 WO 1997013547 A1 WO1997013547 A1 WO 1997013547A1 US 9616273 W US9616273 W US 9616273W WO 9713547 A1 WO9713547 A1 WO 9713547A1
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WO
WIPO (PCT)
Prior art keywords
arrhythmia
temperature
tissue
cardiac
catheter
Prior art date
Application number
PCT/US1996/016273
Other languages
English (en)
Inventor
Stanislao F. Obino
Paul J. Buscemi
Original Assignee
Pharmatarget, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pharmatarget, Inc. filed Critical Pharmatarget, Inc.
Priority to AU74383/96A priority Critical patent/AU7438396A/en
Publication of WO1997013547A1 publication Critical patent/WO1997013547A1/fr

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Classifications

    • 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
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3622—Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/28—Apparatus for applying thermoelectric currents

Definitions

  • the present invention relates generally to the field of implantable medical devices for heart rhythm management.
  • the invention pertains to both apparatus and methods for treating cardiac arrhythmias.
  • Tissue sites associated with myocardial infarction and anatomic accessory pathways may each create or participate in so-called re-entrant circuits which may provoke and sustain tachy arrhythmia.
  • Typical methods for terminating a ⁇ -hythmias include both anti tachy pacemakers which deliver electrical stimulation at a specific site in the heart and ablation therapies.
  • RF radio frequency
  • a radio frequency (RF) probe is placed into direct contact with the tissue site and RF electrical energy is delivered to the site to create a lesion.
  • lesions are typically electrically inactive and serve to interrupt the re-entrant circuit.
  • Implantable pharmacological defibrillating devices which combine electrical stimulation with endocardial drug delivery, are also known in the art. For example, see Cammilli et al..
  • Catheters used for temperature ablation of endocardial tissue are known in the art. For example, see Milder et al.. U.S. Pat. No.'s 5.281.213: 5,281,215, and 5,423,807, which teach catheters with cooling systems and cryogenic mapping techniques. Nardella. U.S. Pat. No. 5,334,193 teaches fluid-cooled ablation catheters with temperature monitoring capability for treatment of cardiac arrhythmia. Also, Had. U.S. Pat. No. 5,139,496, teaches ultrasonic freeze ablation catheters for treatment of arrhythmia. Typically, the tip ofthe catheter is cooled below the freezing point to ablate the tissue. However, these devices cause permanent tissue damage as a method for treatment.
  • the device includes a thermal catheter for insertion into a chamber ofthe heart. Both atrial and ventricular locations are contemplated within the scope of the invention.
  • the catheter contains both a sensor electrode for detecting arrhythmic activity and a Peltier device or the like for altering the temperature of heart tissue.
  • the catheter may raise or lower the temperature from the ambient state.
  • heart tissue may be either heated or cooled depending on the desired therapeutic strategy.
  • the catheter also contains a lumen structures for infusing a drug directly into the circulatory system from a reservoir contained in the device.
  • the device provides a method for temporary, non-ablative and non-damaging temperature manipulation ofthe endocardial environment, resulting in inhibition of cardiac arrhythmias.
  • dosage requirements of pharmaceutical agents may also be altered and perhaps reduced.
  • the combined temperature and drug therapy may serve to quickly terminate and then prevent further arrhythmia.
  • the invention may be used in conjunction with other heart rhythm management technologies, such as conventional pacemaker rhythm management protocols.
  • FIG. 1 is a schematic view ofthe overall system using the device.
  • FIG. 2 is a schematic view of a thermal catheter.
  • FIG. 3 is a schematic view of an alternate thermal catheter.
  • arrhythmia is used to include a variety cardiac rhythm disturbances, including atrial tachycardia and atrial fibrillation.
  • non-ablative as used herein is used to describe the absence of prolonged or permanent tissue damage which results from temperature change.
  • FIG.l shows a therapy generator 7 coupled to a thermal catheter 2.
  • the thermal catheter 2 is depicted located within the atria of a heart 1, and the distal tip 4 ofthe thermal catheter is in contact with the wall ofthe atrium at the target tissue site.
  • the thermal catheter 2 is formed into a "J-shape", and the catheter body 3 may have multiple thermal treatment sites to contact a large portion ofthe heart wall.
  • Other lead configurations may be used in the ventricular chamber ofthe heart, and both chambers may be treated as well.
  • the thermal catheter 2 is coupled to the therapy generator 7.
  • the therapy generator 7 will have a can 8, which is coupled to a connector block 16.
  • the thermal treatment catheter 2 will connect to the connector block 16, and suitable electrical and hydraulic connections will be made with the circuit module 12 and reservoir 9 and pump 17 located within the can 8.
  • a suitable battery 10 is provided to power the circuit module 12 and to power the thermal catheter 2 system and the drug infusion system.
  • the circuit module 12 may be made using conventional pacemaker technologies and may include a sense amplifier 13 coupled to the sensing electrode 5 or sensing electrode 6.
  • Computer logic 11 is supplied to interpret the signal generated by the sense amplifier 13. In general, the computer logic 11 will activate either the thermal treatment generator 15 or the reservoir pump 17 or both in response to the detection of an arrhythmia.
  • Atrial or ventricular rate may be used as a threshold parameter, as well as rate acceleration. If both atrial and ventricular catheters are used, then dissociation between the electrical activity between chambers may be used to indicate a treatable arrhythmia.
  • a suitable control signal is issued through connection 14 to the thermal generator 15.
  • the thermal generator in turn couples power through a suitable connection 20 to the thermal catheter 2. It is preferable to use Peltier devices which are semiconductor devices which can either cool or heat depending on applied polarity.
  • the therapy generator monitors the rhythm ofthe heart and alters the temperature of target site tissues so that the conduction velocity of electrical impulses in that target tissue interrupts the arrhythmia in that tissue.
  • the thermal catheter can deliver either "hot” or "cold” therapy. Either approach affects conduction velocities of cardiac cells. Reducing or increasing temperature will depend upon the desired therapeutic strategy. Tissue conduction is generally known to be caused by the transmission of ions either through cellular membranes and along fibers in cardiac tissue. Changes in temperature are generally known in the pharmaceutical field as having profound effects on chemical reaction rates.
  • a 10° C drop in temperature can effect a rate decrease of 50 percent. While such linear relationships are not expected in the use of this invention, it is expected that lowering the temperature ofthe tissue results in slowed transmission of ionic currents which will become too slow to allow propagation in the re-entrant circuits. In the case of increasing temperature, the increase should cause a depletion of ions in a localized area so that currents are again lowered.
  • the temperature is modified to a point sufficient to terminate arrhythmia, as in the case of cooling, or sufficient to terminate arrhythmia or effectuate therapeutic rates, as in the case of heating.
  • the temperature may be increased above or decreased below ambient temperature according to need, provided no tissue damage occurs as a result.
  • the phrase “sufficient to terminate arrhythmic activity” means that the temperature is reduced to between about 10° C to 35° C, preferably in the range of about 25° C to 35° C, more preferably to about 30° C. While it is recognized that temperatures between about 10° to 30° C are possible, such temperatures are not necessary in order to be effective for the purposes ofthe invention.
  • the phrase “sufficient to terminate arrhythmic activity” means that the temperature is increased up to no greater than approximately 50° C, preferably up to about 45° C.
  • Either temperature modification may last up to approximately 1 minute, although it is preferred that the duration be for about 5 to 10 seconds.
  • Both the "cold” and “hot” therapy are accomplished by the “chilling” and “warming”, respectively, ofthe blood immediately surrounding the thermal catheter and the target tissue site itself.
  • the thermal treatment may be used alone or in conjunction with drug infusion or other therapy.
  • drug infusion is used in conjunction with heat treatment, the phrase "sufficient to increase the reaction rate of a drug” indicates the temperature parameter as used to describe heat treatment alone, provided the temperature used does not significantly alter the therapeutic properties ofthe infused drug.
  • the logic 11 issues a signal through connection 19 to the pump 17, which pumps the contents from the reservoir 9 into the lumen 27 ofthe thermal catheter through a suitable connection 18.
  • the infusion system for drug delivery can be that of any mechanical and/or electrical system capable of delivering a dosage ofthe drug into the heart.
  • Such system can consist of a rotary electric pump, a linear electromagnetic pump, an elastic mechanical system, or hydropneumatic system.
  • Classes of anti a ⁇ hythmic drugs which may be used in accordance with the invention include sodium channel blockers, beta blockers, calcium channel blockers.
  • sodium channel blockers include quinidine, procainamide, disopyramide, lidocaine, tocainide, mexiletine, phenytoin, flecainide, and moricizine.
  • beta blockers include propranolol, acebutolol, esmolol, sotalol, amiodarone, bretylium.
  • Examples of calcium channel blockers include verapamil.
  • Selection of drug to be used will depend upon the desired treatment strategy and that other anti arrhythmic drugs not specifically mentioned are also suitable for practicing the invention. Increasing temperature of localized tissue will improve the effectiveness of many such pharmaceutical agents. Accordingly, lower concentrations and more systematically tolerable dosages ofthe selected drug can be used.
  • FIG.2 shows a schematic view of an illustrative cooling version ofthe thermal catheter 2 designed for ventricular or atrial use.
  • the catheter body 3 may be made of silicone rubber or another biocompatible material.
  • the distal tip 4 includes an active fixation screw 21 which is thermally connected to the cooling/heating device 22.
  • the cooling device may be a Peltier device or other electrically powered device.
  • phase change cooling may be used as well, although electrical cooling is illustrated for simplicity of implementation.
  • the Peltier device is in thermal contact with the active fixation tip.
  • a J- shaped configuration is shown where the cross-section ofthe body ofthe catheter may be asymmetrical or oval-shaped to cause the body 3 to conform to the wall ofthe heart. In this instance, it is desirable to locate the Peltier device off-center within the body so that they lie in close proximity to the cardiac wall.
  • a ring electrode 5 may be positioned near the distal tip electrode 4 to monitor heart rhythm.
  • a separate lumen 23 terminating in a port 24 may be provided as well so as to deliver drugs from the reservoir 9 to the circulatory system.
  • FIG.3 is a schematic view of an illustrative cooling/heating version ofthe thermal catheter 2 for ventricular use.
  • multiple Peltier elements depicted as cooling/heating element 25, cooling/heating element 26, and cooling/heating element 27, are located along the length of catheter body 3.
  • a distal section of tines 28 may be used to trap the catheter in the trabaculae ofthe ventricle ofthe heart.
  • the catheter body may also have a drug delivery lumen 23 and a drug delivery port 24 along the body 3 proximal ofthe distal tip electrode.
  • the distal tip electrode 6 is shown coupled to a conductor 29 to monitor cardiac rhythm.
  • the catheter Since the catheter is located within a beating heart, the general construction must be flexible and mechanically robust. It is to be expected that conventional pacemaker lead technologies and construction techniques may be used to create a suitable thermal treatment catheter 2.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif (7) pour le traitement des arythmies cardiaques qui détecte l'apparition d'une arythmie et modifie la température du tissu endocardiaque, sans porter une atteinte de caractère permanent du site tissulaire. Le dispositif comprend un cathéter thermique (2) inséré dans le coeur (1), comprenant une électrode de détection (5, 6) et un moyen pour régler la température à l'extrémité distale du cathéter. Le cathéter thermique peut soit refroidir, soit chauffer le tissu, et le dispositif peut également comporter un moyen d'injection d'un médicament.
PCT/US1996/016273 1995-10-12 1996-10-11 Dispositif permettant de traiter l'arythmie cardiaque par chauffage ou refroidissement WO1997013547A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU74383/96A AU7438396A (en) 1995-10-12 1996-10-11 Device for treating cardiac arrhythmia by heating or cooling

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US526895P 1995-10-12 1995-10-12
US60/005,268 1995-10-12

Publications (1)

Publication Number Publication Date
WO1997013547A1 true WO1997013547A1 (fr) 1997-04-17

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PCT/US1996/016273 WO1997013547A1 (fr) 1995-10-12 1996-10-11 Dispositif permettant de traiter l'arythmie cardiaque par chauffage ou refroidissement

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AU (1) AU7438396A (fr)
WO (1) WO1997013547A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004062481A2 (fr) * 2003-01-10 2004-07-29 M.D. Morton M. Mower Rupture de circuits de rentree par refroidissement de tissus cardiaques
US8447399B2 (en) 1996-08-19 2013-05-21 Mr3 Medical, Llc System and method for managing detrimental cardiac remodeling

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4003379A (en) * 1974-04-23 1977-01-18 Ellinwood Jr Everett H Apparatus and method for implanted self-powered medication dispensing
US5154169A (en) * 1990-03-16 1992-10-13 Nippon Zeon Co., Ltd. Pacing unit with catheter holder
EP0598616A2 (fr) * 1992-11-19 1994-05-25 Siemens Aktiengesellschaft Système et méthode de prévention de concurrence auriculaire entre la détection et la stimulation dans un stimulateur cardiaque double chambre
EP0655260A2 (fr) * 1993-10-05 1995-05-31 SORIN BIOMEDICA CARDIO S.p.A. Dispositif et méthode de détermination du fonctionnement du myocarde
US5423807A (en) * 1992-04-16 1995-06-13 Implemed, Inc. Cryogenic mapping and ablation catheter
WO1996005767A1 (fr) * 1994-08-19 1996-02-29 Novoste Corporation Procedes et appareil utilises dans des operations relatives a l'electrophysiologie du coeur

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4003379A (en) * 1974-04-23 1977-01-18 Ellinwood Jr Everett H Apparatus and method for implanted self-powered medication dispensing
US5154169A (en) * 1990-03-16 1992-10-13 Nippon Zeon Co., Ltd. Pacing unit with catheter holder
US5423807A (en) * 1992-04-16 1995-06-13 Implemed, Inc. Cryogenic mapping and ablation catheter
EP0598616A2 (fr) * 1992-11-19 1994-05-25 Siemens Aktiengesellschaft Système et méthode de prévention de concurrence auriculaire entre la détection et la stimulation dans un stimulateur cardiaque double chambre
EP0655260A2 (fr) * 1993-10-05 1995-05-31 SORIN BIOMEDICA CARDIO S.p.A. Dispositif et méthode de détermination du fonctionnement du myocarde
WO1996005767A1 (fr) * 1994-08-19 1996-02-29 Novoste Corporation Procedes et appareil utilises dans des operations relatives a l'electrophysiologie du coeur

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8447399B2 (en) 1996-08-19 2013-05-21 Mr3 Medical, Llc System and method for managing detrimental cardiac remodeling
WO2004062481A2 (fr) * 2003-01-10 2004-07-29 M.D. Morton M. Mower Rupture de circuits de rentree par refroidissement de tissus cardiaques
WO2004062481A3 (fr) * 2003-01-10 2005-01-13 M D Morton M Mower Rupture de circuits de rentree par refroidissement de tissus cardiaques

Also Published As

Publication number Publication date
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