WO2002038064A1 - Apparatus and method for intrabodily treatment - Google Patents

Apparatus and method for intrabodily treatment Download PDF

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Publication number
WO2002038064A1
WO2002038064A1 PCT/IL2000/000735 IL0000735W WO0238064A1 WO 2002038064 A1 WO2002038064 A1 WO 2002038064A1 IL 0000735 W IL0000735 W IL 0000735W WO 0238064 A1 WO0238064 A1 WO 0238064A1
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WO
WIPO (PCT)
Prior art keywords
tissue
catheter
treatment
line
treatments
Prior art date
Application number
PCT/IL2000/000735
Other languages
French (fr)
Inventor
Pinhas Gilboa
Original Assignee
Super Dimension Ltd.
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 Super Dimension Ltd. filed Critical Super Dimension Ltd.
Priority to AU2001212971A priority Critical patent/AU2001212971A1/en
Priority to EP00974760A priority patent/EP1280470A1/en
Priority to PCT/IL2000/000735 priority patent/WO2002038064A1/en
Publication of WO2002038064A1 publication Critical patent/WO2002038064A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2051Electromagnetic tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2201/00Properties
    • C08L2201/12Shape memory

Definitions

  • the present invention relates to an apparatus and method for intrabodily applying a continuous treatment at a plurality of locations along a line and, more particularly, to an apparatus and method for applying ablation at a plurality of locations along a line.
  • Atrial fibrillation is, in many cases, treated by ablating atrial tissue at a plurality of locations along a line so as to form a closed loop of ablation across the atrium. In other cases, it is treated by ablating the pulmonary vein tissue at a plurality of locations along a line, so as to form a closed loop of ablation across the vein.
  • PCT/IL99/00512 filed September 23, 1999, which is incorporated by reference as if fully set forth herein, teaches how to mark and ablate a series of points of ablation in order to create a continues line of ablation. According to PCT/IL99/00512 this is effected by a steerable catheter having a tip adapted to ablate a single point.
  • each individual point of ablation the parameters of the process, such as current, voltage, and temperature are monitored, thus the quality of each ablation point is determined. It often occurs that an electrode of the multiple electrodes is not properly contacted with the endocardium, and as a result insufficient ablation occurs, forming a gap along the line of ablation. Leaving such a gap unablated may cause the entire procedure to fail due to hampering the electrophysiological activity of the heart.
  • the prior art fails to teach a method, device or system with which location information pertaining to locations of successful and unsuccessful treatment can be determined, so as to enable the treating physician to precisely retreat a location of unsuccessful treatment, so as to avoid gap formation.
  • a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue
  • the catheter apparatus comprising (a) a catheter having at least one active site for applying the treatments at the adjacent locations along the line of treatment; (b) a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
  • a method for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue comprising the steps of (a) inserting into the body a catheter apparatus having a catheter including at least one active site for applying the treatments at the adjacent locations along the line of treatment, the catheter including a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue, the catheter further including an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations, and at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied; (b) using the positioning mechanism, sequentially guiding the single active site of the catheter along, or positioning the plurality of active sites, of
  • the catheter further includes at least one quality monitoring mechanism for monitoring a quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue, the method further comprising the step of using the quality monitoring mechanism for monitoring the quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue.
  • the at least one position sensing mechanism serves for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, whereas said at least one quality monitoring mechanism serves for determining whether a quality thereof is under or above a predetermined threshold.
  • each of the at least one active site includes an ablation electrode.
  • each of the at least one active site includes an applicator of a substance.
  • the substance is selected from the group consisting of a nucleic acid encoding a growth factor, a growth factor, and a cell expressing a growth factor.
  • each of the at least one active site is designed for executing a purpose selected from the group consisting of injecting a substance into the tissue, dispersing a substance onto the tissue, bombarding the tissue with a substance, puncturing the tissue, drilling into the tissue, marking the tissue and attaching an object to the tissue.
  • each of the at least one active site is designed to transmit energy to the tissue.
  • the energy is selected from the group consisting of radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy and nuclear energy.
  • each of the at least one active site is designed to absorb energy from the tissue.
  • the energy is thermal energy.
  • the catheter has the single active site for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting a guiding element; (ii) the positioning mechanism serves for sequentially guiding the single active site of the catheter along the line of treatment in contact with the tissue, the positioning mechanism includes the guiding element; and (iii) the at least one position sensing mechanism is located at the single active site.
  • the catheter has the plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting the activating mechanism; (ii) the activating mechanism is insertable into the hollow of the catheter, the activating mechanism includes an activating element for activating at least one active site of the plurality of active sites at a time; and (iii) the at least one position sensing mechanism is located at the activating element of the activating mechanism.
  • the catheter has the plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a terminal portion having a shape memory, the plurality of active sites are arranged along the terminal portion; and (ii) the at least one position sensing mechanism is located at the terminal portion.
  • the terminal portion is extendible from and retractable into a sleeve.
  • a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue
  • the catheter apparatus comprising (a) a catheter having an active site for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a longitudinal hollow being adapted for accepting a guiding element; (b) the guiding element for sequentially guiding the active site of the catheter along the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the active site of the catheter to apply the treatments to the tissue at the adjacent locations; and (d) a position sensing mechanism being at the active site for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
  • a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue
  • the catheter apparatus comprising (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting an activating mechanism; (b) a positioning mechanism for positioning the plurality of active sites at the line of treatment in contact with the tissue; (c) the activating mechanism being insertable into the hollow of the catheter, the activating mechanism including an activating element for activating at least one active site of the plurality of active sites at a time; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, the at least one position sensing mechanism being located at the activating element of the activating mechanism.
  • a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue
  • the catheter apparatus comprising (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a terminal portion having a shape memory, the plurality of active sites being arranged along the terminal portion, the shape memory serving as a positioning mechanism for positioning the plurality of active sites of the catheter at the line of treatment in contact with the tissue (b) an activating mechanism for timely activating the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism being located at the terminal portion for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
  • the present invention successfully addresses the shortcomings of the presently known configurations by providing an apparatus and method for intrabodily applying medical treatment at a plurality of locations along a line and while monitoring quality wise and position wise the effectiveness of treatment applied to each of the locations, so as to enable the identification and position of gaps is treatment, so as to retreated such gaps.
  • Implementation of the method and apparatus of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof.
  • several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof.
  • selected steps of the invention could be implemented as a chip or a circuit.
  • selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system.
  • selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.
  • FIG. 1 is a schematic partially cross sectional depiction of an ablating catheter according to one configuration of the present invention
  • FIG. 2 is a schematic cross sectional depiction of an ablating catheter according to another configuration of the present invention
  • FIGs. 3a-b are perspective views of an ablating catheter according to yet another configuration of the present invention in a retracted and extended form.
  • the present invention is of an apparatus and method which can be intrabodily applying medical treatment at a plurality of locations along a line of treatment. Specifically, the present invention can be used to perform a line of adjacent ablations, while monitoring gap formation during the process.
  • a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue.
  • the catheter apparatus according to the present invention can be realized by several configurations which are further described in context with the drawings in the Examples section that follows. However, the following description is applicable to all of these configurations.
  • the catheter apparatus includes a catheter which has at least one active site for applying treatments at adjacent locations along a line of treatment.
  • the catheter apparatus further includes a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue.
  • the catheter apparatus further includes an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations.
  • the catheter apparatus according to any of its configurations, further includes, at least one position sensing mechanism which serves for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
  • the catheter further includes at least one quality monitoring mechanism for monitoring a quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue.
  • quality monitoring mechanism can include, for example, thermistor(s), thermocouple(s), resistivity sensor(s), capacitance sensor(s), electric field sensor(s), magnetic sensor(s), radiation sensor(s), acoustic sensor(s) and the like.
  • a method for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue is effected by implementing the following method steps, in which, in a first step a catheter apparatus as described herein is inserted into the body of the patient. In a second step of the method according to this aspect of the invention the positioning mechanism is used to sequentially guide the single active site of the catheter along, or position the plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue.
  • the activating mechanism is used to timely activate the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations, while at the same time the at least one position sensing mechanism is used to determine the position of at least one location of the adjacent locations along the line of treatment of the tissue in which the medical treatments have been applied.
  • the at least one position sensing mechanism serves for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, whereas said at least one quality monitoring mechanism serves for determining whether a quality thereof is under or above a predetermined threshold.
  • the apparatus according to the present invention provides information of locations in which treatment has been successful and of locations in which treatment has failed. Hence, information pertaining to the location of gaps in the line of treatment becomes readily available, so as to enable retreating such gaps so as to obtain a desired continuous line of treatment, having no gaps left therein.
  • the single or plurality of active sites includes an ablation electrode.
  • the single or the plurality of active sites includes an applicator of a substance, such an applicator, can be, for example, an injector, a dispenser, or a bombardment device.
  • the substance applied to the tissue in this case can be, for example, a nucleic acid encoding, for example, a growth factor, a protein, such as a growth factor, and a cell expressing a protein such as a growth factor, so as to effect gene therapy, revascularization, such as myocardial revascularization, or to accelerate/decelerate cell growth and/or differentiation.
  • each of the single or the plurality of active sites are each designed for executing a purpose, such as injecting a substance into the tissue, dispersing a substance onto the tissue, bombarding the tissue with a substance, puncturing the tissue, drilling into the tissue, marking the tissue and attaching an object, such as a medical device or an anchor thereof, to the tissue. Puncturing and drilling the tissue can be effected mechanically, or, for example, via laser radiation at a wavelength absorbable be the treated tissue.
  • Application of laser radiation intrabodily via a catheter is known in the art. Applying a catheter with a mechanically operated implement such as a drill is also known in the art. Disposing an object in the body via a catheter is also known in the art.
  • Marking the tissue can be effected by a dye, e.g., X-ray visible dye, so as to serve as intrabody feducial mark.
  • a dye e.g., X-ray visible dye
  • each of the single or plurality of active sites is designed to transmit energy, such as, but not limited to, radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy or nuclear energy, to the tissue.
  • energy such as, but not limited to, radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy or nuclear energy.
  • the single or plurality of active sites are designed to absorb energy, such as thermal energy, from the tissue, so as to effect cryo treatment.
  • the position sensing mechanism which serve according to the present for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied is well known in the art and can be realized in several configurations as is further described in PCT/IL99/00512, which is incorporated herein by reference, referred to therein as a locating sensor of a locating system.
  • a locating system is understood to include an extracorporeal unit which defines a reference frame of coordinates and by interacting with the locating sensor serves to determine the position thereof in for example six degrees of freedom with respect thereto.
  • the catheter has a single active site which serves for applying the treatments at the adjacent locations along the line of treatment.
  • the catheter is formed with a longitudinal hollow adapted for accepting a guiding element.
  • the positioning mechanism serves for sequentially guiding the single active site of the catheter along the line of treatment in contact with the tissue.
  • the positioning mechanism includes the guiding element, whereas the catheter is blindly guided along the guiding element. Measures to ensure an appropriate configuration of the guiding element while in the body, as is known in the art, are taken, so as to ensure that the active sites are indeed contacted with the tissue to be treated.
  • the at least one position sensing mechanism is located at the single active site.
  • Activation of the active site is performed in a manner similar to that of conventional steerable catheters.
  • the active site is activated by the activating mechanism, its position determined by the position sensing mechanism, whereas the quality of treatment is preferably monitored in situ.
  • corrective measures can be taken either immediately, by slightly repositioning the guiding element and the active site and repeating treatment, or thereafter by using a steerable catheter as is described for example in PCT/IL99/00512.
  • This configuration can thus be described to include (a) a catheter having an active site for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a longitudinal hollow being adapted for accepting a guiding element; (b) the guiding element for sequentially guiding the active site of the catheter along the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the active site of the catheter to apply the treatments to the tissue at the adjacent locations; and (d) a position sensing mechanism being at the active site for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
  • the catheter has a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment.
  • the catheter is formed with a longitudinal hollow adapted for accepting the activating mechanism.
  • the activating mechanism is insertable into the hollow of the catheter.
  • the activating mechanism includes an activating element for activating at least one active site of the plurality of active sites at a time, whereas the at least one position sensing mechanism is located at the activating element of the activating mechanism.
  • the activating mechanism can include, for example, magnetic contacts which activate an active site which they contact.
  • the positioning mechanism is realized in this case by ensuring an appropriate configuration of the catheter while in the body, as is known in the art and is further described in the patents listed in the background section, so as to ensure that the active sites are indeed contacted with the tissue to be treated.
  • the active sites are sequentially activated by sliding the activating mechanism in the hollow so as to sequentially activate the active sites.
  • the position of each activated site is determined by the position sensing mechanism, whereas the quality of treatment is preferably monitored in situ.
  • corrective measures can be taken either immediately, by slightly repositioning the catheter and a respective active site and repeating treatment, or thereafter by using a steerable catheter as is described for example in PCT/IL99/00512.
  • This configuration can thus be described to include (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting an activating mechanism; (b) a positioning mechanism for positioning the plurality of active sites at the line of treatment in contact with the tissue; (c) the activating mechanism being insertable into the hollow of the catheter, the activating mechanism including an activating element for activating at least one active site of the plurality of active sites at a time; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, the at least one position sensing mechanism being located at the activating element of the activating mechanism.
  • the catheter has the plurality of active sites for applying the treatments at the adjacent locations along the line of treatment.
  • the catheter is formed with a curved (e.g., open loop) terminal portion having a shape memory, whereas the plurality of active sites are arranged along the terminal portion.
  • the shape memory serves as a positioning mechanism.
  • the at least one position sensing mechanism is located at the terminal portion.
  • the terminal portion is preferably extendible from and retractable into a sleeve. It retains its shape while ejected due to the shape memory it has.
  • the activating mechanism is realized in this case similar to the activating mechanism of the multi electrode catheter described in the patents cited in the Background section
  • This configuration can thus be described to include (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a terminal portion having a shape memory, the plurality of active sites being arranged along the terminal portion, the shape memory serving as a positioning mechanism for positioning the plurality of active sites of the catheter at the line of treatment in contact with the tissue (b) an activating mechanism for timely activating the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism being located at the terminal portion for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
  • This configuration is particularly advantageous for ablating a continuous loop across the pulmonary vein.
  • the present invention enables applying medical treatment at a plurality of locations along a line, while monitoring quality wise and position wise the effectiveness of treatment applied to each of the locations, so as to enable the identification and position of gaps is treatment, so as to retreated such gaps. If the exact location of each center point of treatment, e.g., ablation, is recorded as a point of interest, as this term is defined in PCT/IL99/00512, than a steerable catheter as, for example, described in PCT IL99/00512, may later be used to fill in the gaps.
  • Figure 1 shows a guided ablation catheter.
  • a guiding element or wire 100 is placed along the endocardium at a desirable placement.
  • a catheter 110 having a lumen or hollow 115, may slide along wire 100, and placed at any desire location along wire 100.
  • a position sensor 130 and an ablation electrode 120 are placed at the tip of the catheter.
  • a thermistor (not shown) may also be incorporated with electrode 120 for measuring the temperature of tissue being ablated in situ.
  • a conductor 135 carries the sensed signal from the position sensor 130 to a locating system 140.
  • a conductor 125 carries an ablation RF signal from an RF generator 150 to electrode 120.
  • FIG. 2 shows a catheter apparatus in which constant distance between points of ablation is mechanically forced.
  • Ablation ring electrodes are spaced along a hollow catheter 200 in equal distances. Only three such electrodes are shown in the drawing: 210, 212 and 214, however about 30 or more can be realized.
  • Each of the electrodes is concave so as to have larger diameter at its center.
  • Each of the electrode is transiently connectable to an RF generator via a conductor 224 which is engaged by a tube 220 slideable along the hollow of catheter 200.
  • electrode 212 is connected to the RF generator.
  • the outer diameter of tube 220 is smaller than the inner diameter of catheter 200 so as to allow tube 220 to slide within catheter 200.
  • a positioning sensor 230 is located at the tip of tube 220.
  • Positioning sensor 230 is connected to a positioning system via a conductor 232.
  • a plurality of electrical spring contacts 222 concentrically arranged around the tip of tube 220 connect one of the ablation electrodes to conductor 224 at a time.
  • a thermistor may also be incorporating into the tip of the tube. While sliding tube 220 along catheter 200 it is slightly captured by the concave structure of each of the ring electrodes, for instance ring 212, and electrically connects the respective electrode to the RF generator. Hence, by supplying RF energy to conductor 224 the tissue in contact with the respective electrode is ablated. At the same time, the location of positioning sensor 230 is measured for recording the exact location of the point of ablation associate with the respective electrode.
  • the quality of the ablation is assessed and recorded as described above.
  • stepwise advancing tube 220 within catheter 200 a continuous line of ablation may be formed and the location of gaps monitored.
  • the recorded data may later be used to direct a steerable catheter to fill in gaps in the line of ablation by apparatus and methods described in, for example, PCT/IL99/00512.
  • a third configuration of the present invention is describes in Figures 3a-b.
  • This configuration is suitable to perform ablation of particular shape, for instance a circular ablation of the inner walls of a pulmonary vein.
  • a multiple-electrode catheter 310 has a memory shape of a specific desired active shape, for instance a circle.
  • Ablation electrodes 330 are spaced along the active shape at distances shorter than the size of an average spot of ablation. Each such electrode 330 may be incorporated with a thermistor for measuring the temperature during ablation.
  • Each such electrode 330 is connected via an individual conductor 332 to an RF generator.
  • a positioning sensor 340 is located at a location along the catheter. The catheter is inserted into a hollow guiding tube or sleeve 300.
  • catheter 310 While fully retracted into guiding tube 300, catheter 310 is forced into the lumen of tube 300 as is shown in Figure 3b. While extended, as is shown in Figure 3a, catheter 310 acquires its active memorized shape.
  • the active portion of catheter 310 is located against a portion of tissue to be ablated, for instance a wall of a pulmonary vein. This can be done by, for example, using the measured coordinates of positioning sensor 340, tube 300 and catheter 310 to a point of interest previously defined using the method and apparatus described in PCT/IL99/00512.
  • electrophysiology signals may be measured between the electrodes to identify an electrophysiology malfunction pathway to be ablated. Then, RF ablation signal can be conducted to appropriate ablation rings.
  • the location of each of electrodes 330 can be determined in a three-dimensional space. Hence, the location of each ablated spot as well as the quality of ablation at that spot may be recorded. The recorded data may later be used to direct a steerable catheter to fill in gaps in the line of ablation by apparatus and methods described in, for example, PCT/IL99/00512.

Abstract

A catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue. The catheter apparatus comprises (a) a catheter having at least one active site for applying the treatments at the adjacent locations along the line of treatment; (b) a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.

Description

APPARATUS AND METHOD FOR LNTRABODILY TREATMENT
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to an apparatus and method for intrabodily applying a continuous treatment at a plurality of locations along a line and, more particularly, to an apparatus and method for applying ablation at a plurality of locations along a line.
Atrial fibrillation is, in many cases, treated by ablating atrial tissue at a plurality of locations along a line so as to form a closed loop of ablation across the atrium. In other cases, it is treated by ablating the pulmonary vein tissue at a plurality of locations along a line, so as to form a closed loop of ablation across the vein.
PCT/IL99/00512, filed September 23, 1999, which is incorporated by reference as if fully set forth herein, teaches how to mark and ablate a series of points of ablation in order to create a continues line of ablation. According to PCT/IL99/00512 this is effected by a steerable catheter having a tip adapted to ablate a single point.
U.S. Pat. Nos. 5,842,984; 5,555,883; 5,893,885; 5,433,198 and 5,341,807, which are incorporated by reference as if fully set forth herein, teach multiple-electrode catheters designed to ablate a tissue at a plurality of locations along a line of a predetermined configuration. In some cases, this configuration is monitored by sensors adapted at determining the shape or bend of the portion of the catheter carrying the multiple electrodes. These multiple-electrode catheters are therefore design to enable positioning of the electrodes thereof in close contact with the endocardium tissue, whereas ablation is performed in a controlled manner, typically one electrode at a time. In each individual point of ablation the parameters of the process, such as current, voltage, and temperature are monitored, thus the quality of each ablation point is determined. It often occurs that an electrode of the multiple electrodes is not properly contacted with the endocardium, and as a result insufficient ablation occurs, forming a gap along the line of ablation. Leaving such a gap unablated may cause the entire procedure to fail due to hampering the electrophysiological activity of the heart.
The prior art, however, fails to teach a method, device or system with which location information pertaining to locations of successful and unsuccessful treatment can be determined, so as to enable the treating physician to precisely retreat a location of unsuccessful treatment, so as to avoid gap formation.
There is thus a widely recognized need for, and it would be highly advantageous to have, apparatus and method for intrabodily applying medical treatment at a plurality of locations along a line, which are devoid of the above limitations.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising (a) a catheter having at least one active site for applying the treatments at the adjacent locations along the line of treatment; (b) a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
According to another aspect of the present invention there is provided a method for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the method comprising the steps of (a) inserting into the body a catheter apparatus having a catheter including at least one active site for applying the treatments at the adjacent locations along the line of treatment, the catheter including a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue, the catheter further including an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations, and at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied; (b) using the positioning mechanism, sequentially guiding the single active site of the catheter along, or positioning the plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue; (c) using the activating mechanism, timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) using the at least one position sensing mechanism, determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
According to further features in preferred embodiments of the invention described below, the catheter further includes at least one quality monitoring mechanism for monitoring a quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue, the method further comprising the step of using the quality monitoring mechanism for monitoring the quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue.
According to still further features in the described preferred embodiments the at least one position sensing mechanism serves for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, whereas said at least one quality monitoring mechanism serves for determining whether a quality thereof is under or above a predetermined threshold.
According to still further features in the described preferred embodiments each of the at least one active site includes an ablation electrode.
According to still further features in the described preferred embodiments each of the at least one active site includes an applicator of a substance. According to still further features in the described preferred embodiments the substance is selected from the group consisting of a nucleic acid encoding a growth factor, a growth factor, and a cell expressing a growth factor.
According to still further features in the described preferred embodiments each of the at least one active site is designed for executing a purpose selected from the group consisting of injecting a substance into the tissue, dispersing a substance onto the tissue, bombarding the tissue with a substance, puncturing the tissue, drilling into the tissue, marking the tissue and attaching an object to the tissue. According to still further features in the described preferred embodiments each of the at least one active site is designed to transmit energy to the tissue.
According to still further features in the described preferred embodiments the energy is selected from the group consisting of radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy and nuclear energy.
According to still further features in the described preferred embodiments each of the at least one active site is designed to absorb energy from the tissue.
According to still further features in the described preferred embodiments the energy is thermal energy.
According to still further features in the described preferred embodiments (i) the catheter has the single active site for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting a guiding element; (ii) the positioning mechanism serves for sequentially guiding the single active site of the catheter along the line of treatment in contact with the tissue, the positioning mechanism includes the guiding element; and (iii) the at least one position sensing mechanism is located at the single active site.
According to still further features in the described preferred embodiments (i) the catheter has the plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting the activating mechanism; (ii) the activating mechanism is insertable into the hollow of the catheter, the activating mechanism includes an activating element for activating at least one active site of the plurality of active sites at a time; and (iii) the at least one position sensing mechanism is located at the activating element of the activating mechanism.
According to still further features in the described preferred embodiments (i) the catheter has the plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a terminal portion having a shape memory, the plurality of active sites are arranged along the terminal portion; and (ii) the at least one position sensing mechanism is located at the terminal portion. According to still further features in the described preferred embodiments the terminal portion is extendible from and retractable into a sleeve.
According to an additional aspect of the present invention there is provided a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising (a) a catheter having an active site for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a longitudinal hollow being adapted for accepting a guiding element; (b) the guiding element for sequentially guiding the active site of the catheter along the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the active site of the catheter to apply the treatments to the tissue at the adjacent locations; and (d) a position sensing mechanism being at the active site for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
According to a further aspect of the present invention there is provided a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting an activating mechanism; (b) a positioning mechanism for positioning the plurality of active sites at the line of treatment in contact with the tissue; (c) the activating mechanism being insertable into the hollow of the catheter, the activating mechanism including an activating element for activating at least one active site of the plurality of active sites at a time; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, the at least one position sensing mechanism being located at the activating element of the activating mechanism. According to yet a further aspect of the present invention there is provided a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a terminal portion having a shape memory, the plurality of active sites being arranged along the terminal portion, the shape memory serving as a positioning mechanism for positioning the plurality of active sites of the catheter at the line of treatment in contact with the tissue (b) an activating mechanism for timely activating the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism being located at the terminal portion for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
The present invention successfully addresses the shortcomings of the presently known configurations by providing an apparatus and method for intrabodily applying medical treatment at a plurality of locations along a line and while monitoring quality wise and position wise the effectiveness of treatment applied to each of the locations, so as to enable the identification and position of gaps is treatment, so as to retreated such gaps. Implementation of the method and apparatus of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. In the drawings:
FIG. 1 is a schematic partially cross sectional depiction of an ablating catheter according to one configuration of the present invention; FIG. 2 is a schematic cross sectional depiction of an ablating catheter according to another configuration of the present invention; and FIGs. 3a-b are perspective views of an ablating catheter according to yet another configuration of the present invention in a retracted and extended form.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is of an apparatus and method which can be intrabodily applying medical treatment at a plurality of locations along a line of treatment. Specifically, the present invention can be used to perform a line of adjacent ablations, while monitoring gap formation during the process.
The principles and operation of an apparatus and method according to the present invention may be better understood with reference to the drawings and accompanying descriptions. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Thus, according to one aspect of the present invention there is provided a catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue. The catheter apparatus according to the present invention can be realized by several configurations which are further described in context with the drawings in the Examples section that follows. However, the following description is applicable to all of these configurations.
Thus, the catheter apparatus according to the present invention includes a catheter which has at least one active site for applying treatments at adjacent locations along a line of treatment. The catheter apparatus further includes a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue. The catheter apparatus further includes an activating mechanism for timely activating the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations. Finally, the catheter apparatus, according to any of its configurations, further includes, at least one position sensing mechanism which serves for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied.
Thus, according to preferred embodiments of the invention, the catheter further includes at least one quality monitoring mechanism for monitoring a quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue. Depending on the type of treatment applied such quality monitoring mechanism can include, for example, thermistor(s), thermocouple(s), resistivity sensor(s), capacitance sensor(s), electric field sensor(s), magnetic sensor(s), radiation sensor(s), acoustic sensor(s) and the like.
According to another aspect of the present invention there is provided a method for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue. The method according to this aspect of the present invention is effected by implementing the following method steps, in which, in a first step a catheter apparatus as described herein is inserted into the body of the patient. In a second step of the method according to this aspect of the invention the positioning mechanism is used to sequentially guide the single active site of the catheter along, or position the plurality of active sites, of the at least one active site of the catheter, at, the line of treatment in contact with the tissue. Then, the activating mechanism is used to timely activate the single active site or the plurality of active sites to apply the treatments to the tissue at the adjacent locations, while at the same time the at least one position sensing mechanism is used to determine the position of at least one location of the adjacent locations along the line of treatment of the tissue in which the medical treatments have been applied.
According to preferred embodiments of the invention the at least one position sensing mechanism serves for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, whereas said at least one quality monitoring mechanism serves for determining whether a quality thereof is under or above a predetermined threshold. Thus, the apparatus according to the present invention provides information of locations in which treatment has been successful and of locations in which treatment has failed. Hence, information pertaining to the location of gaps in the line of treatment becomes readily available, so as to enable retreating such gaps so as to obtain a desired continuous line of treatment, having no gaps left therein.
According to preferred embodiments of the present invention, the single or plurality of active sites includes an ablation electrode. Alternatively, the single or the plurality of active sites includes an applicator of a substance, such an applicator, can be, for example, an injector, a dispenser, or a bombardment device. The substance applied to the tissue in this case, can be, for example, a nucleic acid encoding, for example, a growth factor, a protein, such as a growth factor, and a cell expressing a protein such as a growth factor, so as to effect gene therapy, revascularization, such as myocardial revascularization, or to accelerate/decelerate cell growth and/or differentiation.
According to preferred embodiments each of the single or the plurality of active sites are each designed for executing a purpose, such as injecting a substance into the tissue, dispersing a substance onto the tissue, bombarding the tissue with a substance, puncturing the tissue, drilling into the tissue, marking the tissue and attaching an object, such as a medical device or an anchor thereof, to the tissue. Puncturing and drilling the tissue can be effected mechanically, or, for example, via laser radiation at a wavelength absorbable be the treated tissue. Application of laser radiation intrabodily via a catheter is known in the art. Applying a catheter with a mechanically operated implement such as a drill is also known in the art. Disposing an object in the body via a catheter is also known in the art. Marking the tissue can be effected by a dye, e.g., X-ray visible dye, so as to serve as intrabody feducial mark. According to preferred embodiments of the invention each of the single or plurality of active sites is designed to transmit energy, such as, but not limited to, radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy or nuclear energy, to the tissue. Application of these classes of energy to a tissue is known in the art. Alternatively, the single or plurality of active sites are designed to absorb energy, such as thermal energy, from the tissue, so as to effect cryo treatment.
The position sensing mechanism which serve according to the present for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied is well known in the art and can be realized in several configurations as is further described in PCT/IL99/00512, which is incorporated herein by reference, referred to therein as a locating sensor of a locating system. Such a locating system is understood to include an extracorporeal unit which defines a reference frame of coordinates and by interacting with the locating sensor serves to determine the position thereof in for example six degrees of freedom with respect thereto.
So far, embodiments which are common to all of the configurations of the catheter apparatus according to the present invention have been described. All of these embodiments were practiced in one way or another before and their accommodation into the catheter apparatus of the present invention is considered to be with the skills of the ordinary artisan. The following descriptions relate to several configurations of the present invention, each of these configurations is further detailed and exemplified in the Examples section that follows.
Thus, according to one configuration of the catheter apparatus of the present invention, the catheter has a single active site which serves for applying the treatments at the adjacent locations along the line of treatment. According to this configuration, the catheter is formed with a longitudinal hollow adapted for accepting a guiding element. According to this configuration, the positioning mechanism serves for sequentially guiding the single active site of the catheter along the line of treatment in contact with the tissue. The positioning mechanism includes the guiding element, whereas the catheter is blindly guided along the guiding element. Measures to ensure an appropriate configuration of the guiding element while in the body, as is known in the art, are taken, so as to ensure that the active sites are indeed contacted with the tissue to be treated. The at least one position sensing mechanism is located at the single active site. Activation of the active site is performed in a manner similar to that of conventional steerable catheters. Thus, while the active site is guided along the guiding element to the locations to be treated, the active site is activated by the activating mechanism, its position determined by the position sensing mechanism, whereas the quality of treatment is preferably monitored in situ. Thus, should a treatment applied at a specific location of the adjacent location fail and gap is formed, corrective measures can be taken either immediately, by slightly repositioning the guiding element and the active site and repeating treatment, or thereafter by using a steerable catheter as is described for example in PCT/IL99/00512.
This configuration can thus be described to include (a) a catheter having an active site for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a longitudinal hollow being adapted for accepting a guiding element; (b) the guiding element for sequentially guiding the active site of the catheter along the line of treatment in contact with the tissue; (c) an activating mechanism for timely activating the active site of the catheter to apply the treatments to the tissue at the adjacent locations; and (d) a position sensing mechanism being at the active site for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied. According to another configuration of the catheter apparatus of the present invention the catheter has a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment. In addition, the catheter is formed with a longitudinal hollow adapted for accepting the activating mechanism. Thus, the activating mechanism is insertable into the hollow of the catheter. The activating mechanism includes an activating element for activating at least one active site of the plurality of active sites at a time, whereas the at least one position sensing mechanism is located at the activating element of the activating mechanism. The activating mechanism, can include, for example, magnetic contacts which activate an active site which they contact. The positioning mechanism is realized in this case by ensuring an appropriate configuration of the catheter while in the body, as is known in the art and is further described in the patents listed in the background section, so as to ensure that the active sites are indeed contacted with the tissue to be treated. Thus, while the active sites are positioned along the line of treatment at the locations to be treated, the active sites are sequentially activated by sliding the activating mechanism in the hollow so as to sequentially activate the active sites. The position of each activated site is determined by the position sensing mechanism, whereas the quality of treatment is preferably monitored in situ. Thus, should a treatment applied at a specific location of the adjacent locations fail, and gap is formed, corrective measures can be taken either immediately, by slightly repositioning the catheter and a respective active site and repeating treatment, or thereafter by using a steerable catheter as is described for example in PCT/IL99/00512.
This configuration can thus be described to include (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter is formed with a longitudinal hollow adapted for accepting an activating mechanism; (b) a positioning mechanism for positioning the plurality of active sites at the line of treatment in contact with the tissue; (c) the activating mechanism being insertable into the hollow of the catheter, the activating mechanism including an activating element for activating at least one active site of the plurality of active sites at a time; and (d) at least one position sensing mechanism for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied, the at least one position sensing mechanism being located at the activating element of the activating mechanism.
According to yet another configuration of the catheter apparatus of the present invention the catheter has the plurality of active sites for applying the treatments at the adjacent locations along the line of treatment. The catheter is formed with a curved (e.g., open loop) terminal portion having a shape memory, whereas the plurality of active sites are arranged along the terminal portion. The shape memory serves as a positioning mechanism. The at least one position sensing mechanism is located at the terminal portion. The terminal portion is preferably extendible from and retractable into a sleeve. It retains its shape while ejected due to the shape memory it has. The activating mechanism is realized in this case similar to the activating mechanism of the multi electrode catheter described in the patents cited in the Background section This configuration can thus be described to include (a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, the catheter being formed with a terminal portion having a shape memory, the plurality of active sites being arranged along the terminal portion, the shape memory serving as a positioning mechanism for positioning the plurality of active sites of the catheter at the line of treatment in contact with the tissue (b) an activating mechanism for timely activating the plurality of active sites to apply the treatments to the tissue at the adjacent locations; and (d) at least one position sensing mechanism being located at the terminal portion for determining positions of at least one location of the adjacent locations along the line of treatment of the tissue in which the treatments have been applied. This configuration is particularly advantageous for ablating a continuous loop across the pulmonary vein.
Thus, the present invention enables applying medical treatment at a plurality of locations along a line, while monitoring quality wise and position wise the effectiveness of treatment applied to each of the locations, so as to enable the identification and position of gaps is treatment, so as to retreated such gaps. If the exact location of each center point of treatment, e.g., ablation, is recorded as a point of interest, as this term is defined in PCT/IL99/00512, than a steerable catheter as, for example, described in PCT IL99/00512, may later be used to fill in the gaps.
Additional objects, advantages, and novel features of the present invention will become apparent to one ordinarily skilled in the art upon examination of the following examples, which are not intended to be limiting. Additionally, each of the various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below finds experimental support in the following examples.
EXAMPLES Reference is now made to the following examples, which together with the above descriptions, illustrate the invention in a non limiting fashion. Several configurations are applicable in performing ablation of continues pattern while recording the location of ablation points.
EXAMPLE 1
Figure 1 shows a guided ablation catheter. A guiding element or wire 100 is placed along the endocardium at a desirable placement. A catheter 110, having a lumen or hollow 115, may slide along wire 100, and placed at any desire location along wire 100. A position sensor 130 and an ablation electrode 120 are placed at the tip of the catheter. A thermistor (not shown) may also be incorporated with electrode 120 for measuring the temperature of tissue being ablated in situ. A conductor 135 carries the sensed signal from the position sensor 130 to a locating system 140. A conductor 125 carries an ablation RF signal from an RF generator 150 to electrode 120. While effecting ablation of a first location, its position is determined and recorded using sensor 130 and system 140, while the RF signal is supplied to electrode 120 via generator 150. The quality of ablation is assessed, and recorded. While sliding the tip of catheter 110 to the next location to be ablated, the distance between the first location and the current location is measured using sensor 130 and system 140. The tip may preferably located at a distance less than the average size of a single ablation, and is securely held in position while ablating, recording position and monitoring ablation quality as described above. This process is repeated until a full line of ablation is performed. The recorded data may later be used to direct a steerable catheter to fill in gaps in the line of ablation by apparatus and methods described in, for example, PCT/IL99/00512.
EXAMPLE 2 Figure 2 shows a catheter apparatus in which constant distance between points of ablation is mechanically forced. Ablation ring electrodes are spaced along a hollow catheter 200 in equal distances. Only three such electrodes are shown in the drawing: 210, 212 and 214, however about 30 or more can be realized. Each of the electrodes is concave so as to have larger diameter at its center. Each of the electrode is transiently connectable to an RF generator via a conductor 224 which is engaged by a tube 220 slideable along the hollow of catheter 200. In the drawing electrode 212 is connected to the RF generator. The outer diameter of tube 220 is smaller than the inner diameter of catheter 200 so as to allow tube 220 to slide within catheter 200. A positioning sensor 230 is located at the tip of tube 220. Positioning sensor 230 is connected to a positioning system via a conductor 232. A plurality of electrical spring contacts 222 concentrically arranged around the tip of tube 220 connect one of the ablation electrodes to conductor 224 at a time. Optionally a thermistor may also be incorporating into the tip of the tube. While sliding tube 220 along catheter 200 it is slightly captured by the concave structure of each of the ring electrodes, for instance ring 212, and electrically connects the respective electrode to the RF generator. Hence, by supplying RF energy to conductor 224 the tissue in contact with the respective electrode is ablated. At the same time, the location of positioning sensor 230 is measured for recording the exact location of the point of ablation associate with the respective electrode. Furthermore, the quality of the ablation is assessed and recorded as described above. Thus, by stepwise advancing tube 220 within catheter 200 a continuous line of ablation may be formed and the location of gaps monitored. The recorded data may later be used to direct a steerable catheter to fill in gaps in the line of ablation by apparatus and methods described in, for example, PCT/IL99/00512. EXAMPLE 3
A third configuration of the present invention is describes in Figures 3a-b. This configuration is suitable to perform ablation of particular shape, for instance a circular ablation of the inner walls of a pulmonary vein. A multiple-electrode catheter 310 has a memory shape of a specific desired active shape, for instance a circle. Ablation electrodes 330 are spaced along the active shape at distances shorter than the size of an average spot of ablation. Each such electrode 330 may be incorporated with a thermistor for measuring the temperature during ablation. Each such electrode 330 is connected via an individual conductor 332 to an RF generator. A positioning sensor 340 is located at a location along the catheter. The catheter is inserted into a hollow guiding tube or sleeve 300. While fully retracted into guiding tube 300, catheter 310 is forced into the lumen of tube 300 as is shown in Figure 3b. While extended, as is shown in Figure 3a, catheter 310 acquires its active memorized shape. The active portion of catheter 310 is located against a portion of tissue to be ablated, for instance a wall of a pulmonary vein. This can be done by, for example, using the measured coordinates of positioning sensor 340, tube 300 and catheter 310 to a point of interest previously defined using the method and apparatus described in PCT/IL99/00512. If necessary, electrophysiology signals may be measured between the electrodes to identify an electrophysiology malfunction pathway to be ablated. Then, RF ablation signal can be conducted to appropriate ablation rings. Since the geometric of the active portion of catheter 310 is predetermined by its memory, while acquiring the position data of the position sensor in six degrees of freedom, the location of each of electrodes 330 can be determined in a three-dimensional space. Hence, the location of each ablated spot as well as the quality of ablation at that spot may be recorded. The recorded data may later be used to direct a steerable catheter to fill in gaps in the line of ablation by apparatus and methods described in, for example, PCT/IL99/00512. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising:
(a) a catheter having at least one active site for applying the treatments at the adjacent locations along the line of treatment;
(b) a positioning mechanism for sequentially guiding a single active site of said catheter along, or for positioning a plurality of active sites, of said at least one active site of said catheter, at, the line of treatment in contact with the tissue;
(c) an activating mechanism for timely activating said single active site or said plurality of active sites to apply said treatments to the tissue at said adjacent locations; and
(d) at least one position sensing mechanism for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied.
2. The catheter apparatus of claim 1, further comprising:
(e) at least one quality monitoring mechanism for monitoring a quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue.
3. The catheter apparatus of claim 2, wherein said at least one position sensing mechanism serves for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied, whereas said at least one quality monitoring mechanism serves for determining whether a quality thereof is under or above a predetermined threshold.
4. The catheter apparatus of claim 1, wherein each of said at least one active site includes an ablation electrode.
5. The catheter apparatus of claim 1, wherein each of said at least one active site includes an applicator of a substance.
6. The catheter apparatus of claim 1, wherein said substance is selected from the group consisting of a nucleic acid encoding a growth factor, a growth factor, and a cell expressing a growth factor.
7. The catheter apparatus of claim 1, wherein each of said at least one active site is designed for executing a purpose selected from the group consisting of injecting a substance into the tissue, dispersing a substance onto the tissue, bombarding the tissue with a substance, puncturing the tissue, drilling into the tissue, marking the tissue and attaching an object to the tissue.
8. The catheter apparatus of claim 1, wherein each of said at least one active site is designed to transmit energy to the tissue.
9. The catheter apparatus of claim 8, wherein said energy is selected from the group consisting of radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy and nuclear energy.
10. The catheter apparatus of claim 1, wherein each of said at least one active site is designed to absorb energy from the tissue.
11. The catheter apparatus of claim 10, wherein said energy is thermal energy.
12. The catheter apparatus of claim 1, wherein:
(i) said catheter has said single active site for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a longitudinal hollow adapted for accepting a guiding element;
(ii) said positioning mechanism serves for sequentially guiding said single active site of said catheter along the line of treatment in contact with the tissue, said positioning mechanism includes said guiding element; and
(iii) said at least one position sensing mechanism is located at said single active site.
13. The catheter apparatus of claim 1 , wherein:
(i) said catheter has said plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a longitudinal hollow adapted for accepting said activating mechanism; (ii) said activating mechanism is insertable into said hollow of said catheter, said activating mechanism includes an activating element for activating at least one active site of said plurality of active sites at a time; and
(iii) said at least one position sensing mechanism is located at said activating element of said activating mechanism.
14. The catheter apparatus of claim 1, wherein:
(i) said catheter has said plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a terminal portion having a shape memory, said plurality of active sites are arranged along said terminal portion; and
(ii) said at least one position sensing mechanism is located at said terminal portion.
15. A method for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the method comprising the steps of:
(a) inserting into the body a catheter apparatus having a catheter including at least one active site for applying the treatments at the adjacent locations along the line of treatment, said catheter including a positioning mechanism for sequentially guiding a single active site of said catheter along, or for positioning a plurality of active sites, of said at least one active site of said catheter, at, the line of treatment in contact with the tissue, said catheter further including an activating mechanism for timely activating said single active site or said plurality of active sites to apply said treatments to the tissue at said adjacent locations, and at least one position sensing mechanism for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied;
(b) using said positioning mechanism, sequentially guiding said single active site of said catheter along, or positioning said plurality of active sites, of said at least one active site of said catheter, at, the line of treatment in contact with the tissue;
(c) using said activating mechanism, timely activating said single active site or said plurality of active sites to apply said treatments to the tissue at said adjacent locations; and
(d) using said at least one position sensing mechanism, determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied.
16. The method of claim 15, wherein said catheter further includes at least one quality monitoring mechanism for monitoring a quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue, the method further comprising the step of using said quality monitoring mechanism for monitoring said quality of the treatments applied at each of the adjacent locations along the line of treatment of the tissue.
17. The method of claim 16, wherein said at least one position sensing mechanism serves for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied, whereas said at least one quality monitoring mechanism serves for determining whether a quality thereof is under or above a predetermined threshold.
18. The method of claim 15, wherein each of said at least one active site includes an ablation electrode.
19. The method of claim 15, wherein each of said at least one active site includes an applicator of a substance.
20. The method of claim 15, wherein said substance is selected from the group consisting of a nucleic acid encoding a growth factor, a growth factor, and a cell expressing a growth factor.
21. The method of claim 15, wherein each of said at least one active site is designed for executing a purpose selected from the group consisting of injecting a substance into the tissue, dispersing a substance onto the tissue, bombarding the tissue with a substance, puncturing the tissue, drilling into the tissue, marking the tissue and attaching an object to the tissue.
22. The method of claim 15, wherein each of said at least one active site is designed to transmit energy to the tissue.
23. The method of claim 22, wherein said energy is selected from the group consisting of radio-frequency energy, electromagnetic energy, magnetic energy, electric energy, mechanic energy, acoustic energy, thermal energy and nuclear energy.
24. The method of claim 15, wherein each of said at least one active site is designed to absorb energy from the tissue.
25. The method of claim 24, wherein said energy is thermal energy.
26. The method of claim 15, wherein:
(i) said catheter has said single active site for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a longitudinal hollow adapted for accepting a guiding element;
(ii) said positioning mechanism serves for sequentially guiding said single active site of said catheter along the line of treatment in contact with the tissue, said positioning mechanism includes said guiding element; and
(iii) said at least one position sensing mechanism is located at said single active site.
27. The method of claim 15, wherein:
(i) said catheter has said plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a longitudinal hollow adapted for accepting said activating mechanism; (ii) said activating mechanism is insertable into said hollow of said catheter, said activating mechanism includes an activating element for activating at least one active site of said plurality of active sites at a time; and (iii) said at least one position sensing mechanism is located at said activating element of said activating mechanism.
28. The method of claim 15, wherein:
(i) said catheter has said plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a terminal portion having a shape memory, said plurality of active sites are arranged along said terminal portion; and
(ii) said at least one position sensing mechanism is located at said terminal portion.
29. A catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising:
(a) a catheter having an active site for applying the treatments at the adjacent locations along the line of treatment, said catheter being formed with a longitudinal hollow being adapted for accepting a guiding element; (b) said guiding element for sequentially guiding said active site of said catheter along the line of treatment in contact with the tissue;
(c) an activating mechanism for timely activating said active site of said catheter to apply said treatments to the tissue at said adjacent locations; and
(d) a position sensing mechanism being at said active site for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied.
30. A catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising:
(a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, said catheter is formed with a longitudinal hollow adapted for accepting an activating mechanism;
(b) a positioning mechanism for positioning said plurality of active sites at the line of treatment in contact with the tissue;
(c) said activating mechanism being insertable into said hollow of said catheter, said activating mechanism including an activating element for activating at least one active site of said plurality of active sites at a time; and
(d) at least one position sensing mechanism for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied, said at least one position sensing mechanism being located at said activating element of said activating mechanism.
31. A catheter apparatus for intrabodily applying treatments at a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment of the tissue, the catheter apparatus comprising:
(a) a catheter having a plurality of active sites for applying the treatments at the adjacent locations along the line of treatment, said catheter being formed with a terminal portion having a shape memory, said plurality of active sites being arranged along said terminal portion, said shape memory serving as a positioning mechanism for positioning said plurality of active sites of said catheter at said line of treatment in contact with the tissue
(b) an activating mechanism for timely activating said plurality of active sites to apply said treatments to the tissue at said adjacent locations; and
(d) at least one position sensing mechanism being located at said terminal portion for determining positions of at least one location of said adjacent locations along the line of treatment of the tissue in which said treatments have been applied.
32. The catheter apparatus of claim 31, wherein said terminal portion is extendible from and retractable into a sleeve.
PCT/IL2000/000735 2000-11-09 2000-11-09 Apparatus and method for intrabodily treatment WO2002038064A1 (en)

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PCT/IL2000/000735 WO2002038064A1 (en) 2000-11-09 2000-11-09 Apparatus and method for intrabodily treatment

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WO2007063443A2 (en) * 2005-12-02 2007-06-07 Koninklijke Philips Electronics, N.V. Automating the ablation procedure to minimize the need for manual intervention
EP2332476A1 (en) * 2009-12-11 2011-06-15 Biosense Webster (Israel), Ltd Pre-formed curved ablation catheter

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Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005120375A2 (en) * 2004-06-02 2005-12-22 Medtronic, Inc. Loop ablation apparatus and method
WO2005120375A3 (en) * 2004-06-02 2006-04-27 Medtronic Inc Loop ablation apparatus and method
WO2007063443A2 (en) * 2005-12-02 2007-06-07 Koninklijke Philips Electronics, N.V. Automating the ablation procedure to minimize the need for manual intervention
WO2007063443A3 (en) * 2005-12-02 2007-11-01 Koninkl Philips Electronics Nv Automating the ablation procedure to minimize the need for manual intervention
JP2009517161A (en) * 2005-12-02 2009-04-30 コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ Method and apparatus for automating ablation procedures and minimizing the need for human hand intervention
EP2332476A1 (en) * 2009-12-11 2011-06-15 Biosense Webster (Israel), Ltd Pre-formed curved ablation catheter
CN102090924A (en) * 2009-12-11 2011-06-15 韦伯斯特生物官能(以色列)有限公司 Pre-formed curved ablation catheter
US8926589B2 (en) 2009-12-11 2015-01-06 Biosense Webster (Israel) Ltd. Pre-formed curved ablation catheter
AU2010241461B2 (en) * 2009-12-11 2016-02-25 Biosense Webster (Israel), Ltd. Pre-formed curved ablation catheter
US9439727B2 (en) 2009-12-11 2016-09-13 Biosense Webster (Israel) Ltd. Pre-formed curved ablation catheter
EP3219280A1 (en) * 2009-12-11 2017-09-20 Biosense Webster (Israel) Ltd. Pre-formed curved ablation catheter
EP3219281A1 (en) * 2009-12-11 2017-09-20 Biosense Webster (Israel), Ltd. Pre-formed curved ablation catheter
US9861438B2 (en) 2009-12-11 2018-01-09 Biosense Webster (Israel), Ltd. Pre-formed curved ablation catheter

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