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WO2009067695A1 - Procédés et système pour occlure des vaisseaux pendant une ablation cardiaque - Google Patents

Procédés et système pour occlure des vaisseaux pendant une ablation cardiaque Download PDF

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Publication number
WO2009067695A1
WO2009067695A1 PCT/US2008/084406 US2008084406W WO2009067695A1 WO 2009067695 A1 WO2009067695 A1 WO 2009067695A1 US 2008084406 W US2008084406 W US 2008084406W WO 2009067695 A1 WO2009067695 A1 WO 2009067695A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
balloon
accordance
myocardium
occlusion
Prior art date
Application number
PCT/US2008/084406
Other languages
English (en)
Inventor
James V. Kauphusman
Andre D'avila
Vivek Y. Reddy
Original Assignee
St. Jude Medical, Atrial Fibrillation Division, 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 St. Jude Medical, Atrial Fibrillation Division, Inc. filed Critical St. Jude Medical, Atrial Fibrillation Division, Inc.
Publication of WO2009067695A1 publication Critical patent/WO2009067695A1/fr
Priority to US12/785,140 priority Critical patent/US9572583B2/en
Priority to US12/785,227 priority patent/US9717501B2/en
Priority to US15/634,904 priority patent/US10758238B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00797—Temperature measured by multiple temperature sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0237—Characteristics of handpieces or probes with a thermoelectric element in the probe for cooling purposes
    • A61B2018/0243—Characteristics of handpieces or probes with a thermoelectric element in the probe for cooling purposes cooling of the hot side of the junction, e.g. heat sink
    • A61B2018/025—Characteristics of handpieces or probes with a thermoelectric element in the probe for cooling purposes cooling of the hot side of the junction, e.g. heat sink by circulating liquid
    • 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]

Definitions

  • the field of the invention relates generally to cardiac ablation, and, more particularly, to vascular occlusion during cardiac ablation.
  • Atrial fibrillation is a form of arrhythmia and results from disorganized electrical activity in the heart muscle, or myocardium. As a result of abnormalities in the heart's electrical activity, the heart does not beat effectively and it is not able to pump the blood out properly.
  • a method for ablating a portion of the myocardium.
  • the method includes inserting an occlusion catheter into a vessel on a heart, occluding the vessel using the occlusion catheter, inserting an ablation catheter into a chamber of the heart, positioning the ablation catheter against the myocardium, and ablating a portion of the myocardium while the vessel is occluded.
  • a method for ablating a portion of the atrial myocardium.
  • the method includes inserting a balloon catheter into a coronary sinus, inserting an ablation catheter into a left atrium of a heart, and ablating a portion of the atrial myocardium while a balloon on the balloon catheter is expanded.
  • an occlusion catheter in a further aspect, includes a catheter body including a tubular member having a distal portion and a bend located in the distal portion.
  • the occlusion catheter also includes a balloon located proximal of the bend and configured to contact an inner surface of the coronary sinus when positioned therewithin.
  • a plurality of marker bands are positioned on the catheter body and a plurality of electrodes also are positioned on the catheter body.
  • a method for creating a bidirectional mitral isthmus block in a heart.
  • the method includes inserting an occlusion catheter into a coronary sinus of the heart, inserting an ablation catheter into a left atrium of the heart, expanding a balloon on the occlusion catheter, and ablating a portion of the myocardium to create a bi-directional isthmus block while the balloon is expanded.
  • Figure 1 is a schematic view of a coronary sinus occlusion system in accordance with one embodiment of the invention.
  • Figure 2 is a schematic view of an alternative balloon to be used with the catheter shown in Figure 1.
  • Figure 3 is a schematic view of a further alternative balloon to be used with the catheter shown in Figure 1.
  • Figure 4 is a schematic view of a further alternative balloon to be used with the catheter shown in Figure 1.
  • Figure 5 is a schematic view of a further alternative balloon to be used with an alternative catheter.
  • the invention set forth below in detail is a method and system to create ablation lines in the myocardium.
  • an occlusion catheter Prior to initiation of the ablation, an occlusion catheter is positioned within a vessel, such as the coronary sinus, to completely or substantially prevent blood flow therethrough during the ablation procedure. Endocardial ablation is then initiated while the coronary sinus is occluded. It has been found that ablation lines, or lesions, extending completely through the myocardium (i.e., transmural lesions) that are created near the coronary sinus after it has been occluded are formed more easily than if the coronary sinus were not occluded.
  • occlusion of the coronary sinus during the creation of a mitral isthmus ablation line occurs with less power than would be used without occlusion of the coronary sinus and/or the time for creation of the ablation line is shorter.
  • FIG. 1 illustrates a coronary sinus occlusion system 100 in accordance with one embodiment of the invention.
  • System 100 includes a catheter 102 having a distal end 104 and a proximal end (not shown).
  • Catheter 102 has a tubular body with a passageway extending therethrough.
  • a balloon 106 is located near distal end 104.
  • balloon 106 is a polyurethane balloon located 1.5 cm from distal end 104. It should be recognized that balloon 106 could be manufactured from other materials and could be located closer or further from distal end 104 than 1.5 cm.
  • balloon 106 is manufactured from an elastomeric material such as silicone. As shown in Figure 1, balloon 106 has a substantially cylindrical shape.
  • Catheter 102 also includes a plurality of spaced apart marker bands 108 located under balloon 106.
  • catheter 102 includes two marker bands 108 manufactured from a radio-opaque material, as known in the art, to allow for fluoroscopic visualization of catheter 102.
  • marker bands 108 are located on catheter 102 at locations other than under balloon 106.
  • Catheter 102 includes a bend 110 located between balloon 106 and distal end 104. Bend 110 facilitates cannulization of the coronary sinus by allowing easier access to the coronary sinus opening. In one embodiment, bend 110 is between 25 and 75 degrees, and more particularly between 30 and 60 degrees, and more particularly still, is about 45 degrees. In one embodiment, bend 110 is located within 4 centimeters of distal end 104, and more particularly is located within 2 centimeters of distal end 104, and more particularly still, is located about 1.5 centimeters from distal end 104. In addition, catheter 102 is curved proximally of bend 110. This curvature further facilitates cannulization of the coronary sinus as well as proper placement of balloon 106 within the coronary sinus.
  • Catheter 102 also includes a pair of electrodes 112, 114.
  • a first electrode 112 is located on catheter 102 proximally of balloon 106 and a second electrode 114 is located on catheter 102 distally of balloon 106. Electrodes 112 and 114 are utilized to detect the presence and absence of errant electrical signals in the myocardium (wall of the heart).
  • Each electrode 112, 114 is connected to a lead (not shown) that extends along catheter 102. In one embodiment, each electrode is a ring electrode.
  • FIG. 2 illustrates an alternative balloon 130 suitable for use with catheter 102.
  • Balloon 130 is similar to balloon 106 except that balloon 130 includes a temperature sensing array 132 having multiple sensors 134 positioned such that accurate temperature readings can be obtained of adjacent tissue.
  • Sensors 134 are positioned at a first end 136 and/or a second end 138 of balloon 130, at a middle 140 of balloon 130, or at any location along balloon 130.
  • sensors 134 are miniature T-type thermocouples, thermistors, or any other type of sensor that can be utilized to sense temperature of adjacent tissue.
  • sensors 134 are disposed against an interior surface 142 of balloon 130, an exterior surface 144 of balloon 130 and/or within balloon 130 and spaced apart from interior surface 142 of balloon 130.
  • catheter 102 is curved and, accordingly, includes an inner curvature.
  • Array 132 is located at the inner curvature to facilitate positioning of thermocouple array 132 in the area of the mitral isthmus ablation line.
  • a marker is positioned proximate array 132 to facilitate accurate orientation of balloon 130 with regard to the atrial portion of the coronary sinus.
  • four sensors 134 are arranged in an array that is 2 mm wide by 6 mm long, with 2 mm spacing between sensors. Leads (not shown) extend from each sensor 134 along catheter 102 to a multiple channel data logger (not shown) connected to a standard computer (not shown) via an RS 232 serial link (not shown).
  • FIG 3 illustrates a further alternative balloon 150 suitable for use with catheter 102.
  • Balloon 150 has a rounded frusto-conical shape that tapers from a proximal end 152 to a distal end 154. In one embodiment, the taper is about a 7 degree included angle.
  • Catheter 102 includes an inflation port (not shown) that is used to supply fluid to balloons 106, 130 and 150.
  • the inflation fluid is a gas such as air or CO 2 .
  • the inflation fluid is a liquid such as saline or water.
  • FIG 4 illustrates an alternative balloon 160 positioned on catheter 102.
  • Balloon 160 includes a plurality of passageways 162 extending from a proximal end 164 of balloon 160 to a distal end 166 of balloon 160. Passageways 162 permit blood to flow therethrough while balloon 160 is inflated and contacting an interior surface of the vessel into which catheter 102 has been positioned. Passageways 162 are configured such that blood flow will be spaced from the vessel wall thus permitting a fluid gap to be located between the flowing blood and the vessel wall.
  • the fluid filling balloon 160 is, in one embodiment, a gas such as one of air and CO 2 .
  • the fluid is a liquid such as water or saline.
  • FIG. 5 illustrates a further alternative balloon 180 positioned on catheter 182.
  • a passageway 184 extends through a distal portion 186 of catheter 182.
  • Passageway 184 includes a first opening 188 at a position proximal of a proximal end 190 of balloon 180 and a second opening 192 at a position distal of a distal end 194 of balloon 180.
  • blood is permitted to flow through passageway 184 when balloon 180 is expanded and contacting an interior surface of the vessel into which catheter 182 has been positioned.
  • a sheath containing the occlusion catheter is inserted into one of the femoral artery and the internal jugular.
  • the sheath is an 8Fr, Fast Cath R , available from St. Jude Medical, Minnetonka, MN.
  • the sheath is manipulated through the vascular system so that it enters a chamber of the heart, such as the left atrium.
  • the occlusion catheter is extended distally from the sheath until the balloon on the catheter is distal of the distal end of the introducer sheath.
  • the catheter is manipulated to allow a distal tip of the catheter to enter the vessel to be occluded.
  • the extended catheter is inserted into the vessel such that the balloon is at least partially within the vessel.
  • the vessel is the coronary sinus and the balloon is completely contained within the vessel and located adjacent to, and/or overlying, a portion of the myocardium to be ablated.
  • a pair of marker bands is included on the catheter. These marker bands allow accurate placement of the catheter within the vessel to be occluded.
  • an ablation catheter is then manipulated through the vascular system so that the ablation catheter enters a chamber of the heart, such as the left atrium.
  • the ablation catheter also includes diagnostic capability used to map relevant geometries and/or electrical activity within the chamber.
  • geometries include one or more of the left atrial appendage, the right superior pulmonary vein, the inferior pulmonary trunk, and the left atrial body.
  • the above described mapping is performed using a separate mapping system coupled to a mapping and/or therapy delivery catheter.
  • An exemplary mapping system includes the EnSite NavX, available from St. Jude Medical, St. Paul MN.
  • the ablation catheter is then utilized to ablate portions of the myocardium.
  • the ablation energy and delivery technology includes, by way of example and without limitation one or more of the following: cryogenic, radiofrequency (RF), laser, ultrasound (including high intensity focused ultrasound, or HIFU) and microwave.
  • ablation lesions are created on the atrial myocardium overlying the coronary sinus. The ablation lesions extend through the myocardium and prevent errant electrical signals from passing across the portion of the myocardium that has been ablated.
  • an ablation lesion is created that extends from proximate the left inferior pulmonary vein to proximate the mitral valve. Such an ablation lesion is sometimes referred to as a mitral isthmus line.
  • a gas filled balloon is located within the portion of the coronary sinus that is adjacent to, and/or overlies this portion of the myocardium, and thus heat is not removed from the myocardium as efficiently as when blood is flowing through the coronary sinus.
  • the absence of blood flow thus allows more efficient and relatively rapid ablation of this portion of the myocardium.
  • ablating within the coronary sinus is not used when the above described coronary sinus occlusion catheter is used.
  • the number of ablation lesions created when the above described coronary sinus occlusion catheter is used is less than when the coronary sinus occlusion catheter is not used.
  • the occlusion catheter located on the occlusion catheter is a pair of electrodes. These electrodes are utilized to determine whether errant electrical signals are passing through the portion of the myocardium being monitored. In one embodiment, the occlusion catheter is used to monitor these signals before, during, and/or after the ablation procedure, and to gather information so that a determination can be made as to whether the ablation procedure has stopped the errant electrical signals.
  • the occlusion system includes an introducer sheath utilized to position the occlusion catheter at the coronary sinus.
  • the catheter extends through the introducer sheath and, upon arrival at the coronary sinus, is extended distally beyond a distal end of the introducer sheath.
  • the sheath is a steerable sheath that can be manipulated through the use of wires or other means to bend or curve as it passes through the vascular system, thus bending or curving the catheter therewithin.
  • Transeptal access was obtained under fluoroscopic guidance with a Daig SL-I sheath (available from St. Jude Medical, St. Paul, MN).
  • a quadripolar electrode, placed in the right coronary cusp, was used as a reference for the electroanatomical mapping system (EnSite NavX, St. Jude Medical, St. Paul, MN).
  • EnSite NavX St. Jude Medical, St. Paul, MN
  • Separate geometries and associated electrical activity of the left atrial appendage, the right superior pulmonary vein, the inferior pulmonary trunk, and the left atrial body were acquired using a circular mapping catheter.
  • proximal and distal were created over the atrial myocardium overlying the coronary sinus.
  • the proximal line was placed more between the inferior border of the inferior pulmonary vein trunk and the mitral annulus.
  • the distal line was located between the inferior border of the left atrial appendage and the mitral annulus.
  • the coronary sinus was completely occluded with the coronary sinus occlusion balloon during RF ablation for one of the lines.
  • the coronary sinus occlusion balloon was positioned with the center of the balloon under the ablation line.
  • the coronary sinus balloon was then inflated with approximately 5 mis of air and occlusion of the coronary sinus and the great cardiac vein was confirmed by contrast injection through the catheter internal lumen.
  • the position of the line that was created during coronary sinus occlusion was alternated between swine.
  • the coronary sinus balloon was removed during RF application for the ablation line without occlusion to prevent blood flow limitation. Biophysical parameters of each RF application were continuously recorded in the electrophysiology recording system.
  • the coronary sinus was opened posteriorly through its free wall for inspection of possible dissection and to assess transmurality of each line.
  • Ablation lines were also examined and photographed longitudinally with a macro camera (Nikon D50, Micro Nikkor 60mm f2.8, Nikon Corporation, Melville, New York, USA) to assess transmurality and for off-line measurements.
  • Ablation lesion characteristics were measured using custom software written with the Matlab programming language (Mathworks).
  • a total of 18 endocardial ablation lines were placed over the coronary sinus for the nine swine used in the study (i.e. a proximal and distal line for each swine).
  • the occlusion balloon could not be properly positioned and therefore two lines were placed without coronary sinus occlusion. Therefore, eight ablation lines were placed during coronary sinus balloon occlusion and 10 lines were placed without coronary sinus occlusion. All lines were identified at necropsy. However, at post mortem examination, one of the proximal ablation lines was found to be located within the left atrial appendage superior to the coronary sinus and therefore, this line was not included in the data analysis.
  • Catheter temperature and mean power were not significantly different when coronary sinus occlusion was compared to no-occlusion.
  • impedance drop was not different between these two conditions.

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Abstract

L'invention concerne un procédé pour pratiquer l'ablation sur une partie du myocarde. Le procédé comprend l'insertion d'un cathéter d'occlusion dans un vaisseau du cœur, l'occlusion du vaisseau en utilisant le cathéter d'occlusion, l'insertion d'un cathéter d'ablation dans une chambre du cœur, le positionnement du cathéter d'ablation contre le myocarde, et l'ablation d'une partie du myocarde pendant l'occlusion du vaisseau. Le système comprend un cathéter d'occlusion comportant un corps de cathéter incluant un organe tubulaire ayant une partie distale et un coude situé dans la partie distale, un ballonnet situé à proximité du coude et configuré pour venir en contact avec une surface interne du sinus coronarien une fois positionné à l'intérieur, une pluralité de bandes marqueuses positionnées sur le corps de cathéter, et une pluralité d'électrodes positionnées sur le corps de cathéter.
PCT/US2008/084406 2007-11-21 2008-11-21 Procédés et système pour occlure des vaisseaux pendant une ablation cardiaque WO2009067695A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US12/785,140 US9572583B2 (en) 2007-11-21 2010-05-21 Methods and systems for occluding vessels during cardiac ablation
US12/785,227 US9717501B2 (en) 2007-11-21 2010-05-21 Methods and systems for occluding vessels during cardiac ablation including optional electroanatomical guidance
US15/634,904 US10758238B2 (en) 2007-11-21 2017-06-27 Method and systems for occluding vessels during cardiac ablation including optional electroanatomical guidance

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US98980707P 2007-11-21 2007-11-21
US60/989,807 2007-11-21

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/785,227 Continuation-In-Part US9717501B2 (en) 2007-11-21 2010-05-21 Methods and systems for occluding vessels during cardiac ablation including optional electroanatomical guidance
US12/785,140 Continuation-In-Part US9572583B2 (en) 2007-11-21 2010-05-21 Methods and systems for occluding vessels during cardiac ablation

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WO2009067695A1 true WO2009067695A1 (fr) 2009-05-28

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US10933221B2 (en) 2015-11-09 2021-03-02 Kalila Medical, Inc. Steering assemblies for medical devices, and methods of use
US11052226B2 (en) 2015-04-24 2021-07-06 Kalila Medical, Inc. Steerable medical devices, systems, and methods of use
US12290302B2 (en) 2011-09-30 2025-05-06 Covidien Lp Energy delivery device and methods of use

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Cited By (32)

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US10209727B2 (en) 2008-03-26 2019-02-19 Zonit Structured Solutions, Llc Power distribution systems and methodology
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US8323241B2 (en) 2009-06-24 2012-12-04 Shifamed Holdings, Llc Steerable medical delivery devices and methods of use
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