CA2190530C - Electrophysiology device - Google Patents

Electrophysiology device Download PDF

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Publication number
CA2190530C
CA2190530C CA002190530A CA2190530A CA2190530C CA 2190530 C CA2190530 C CA 2190530C CA 002190530 A CA002190530 A CA 002190530A CA 2190530 A CA2190530 A CA 2190530A CA 2190530 C CA2190530 C CA 2190530C
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CA
Canada
Prior art keywords
fluid
electrode
energy
electrophysiology device
lumen
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
CA002190530A
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French (fr)
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CA2190530A1 (en
Inventor
Daniel Marc La Fontaine
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Boston Scientific Ltd Barbados
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Boston Scientific Ltd Barbados
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Publication date
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Publication of CA2190530A1 publication Critical patent/CA2190530A1/en
Application granted granted Critical
Publication of CA2190530C publication Critical patent/CA2190530C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/44—Applying ionised fluids
    • 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
    • A61B18/1485—Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00065—Material properties porous
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00392—Transmyocardial revascularisation
    • 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
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/1253—Generators therefor characterised by the output polarity monopolar
    • 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
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • A61B2218/003—Irrigation using a spray or a foam

Abstract

An ablation and mapping catheter is disclosed which incorporates a fluid ele ctrode for contacting tissue. The fluid emerges along t he length of the catheter to generate a linear lesion in the cardiac tissue.</S DOAB>

Description

ELECTROPHYSIOLOGY DEVICE
1. Field of the Invention The present invention related to electrophysiology and more particularly to a device and method of operation for an ablation instrument.
2. Backaround Art Arrhythmias can be treated in a number of ways. The traditional treatment has been the systemic administration of anti-arrythmia drugs. However there is a narrow difference between a therapeutic dose and a toxic dose of the most effective drugs. In many instances the drugs induce bradycardia and the patient may receive a heart pacemaker to treat this induced condition.
Another approach is to treat the arrythmia with electrical stimulation of the ventricle to interrupt the arrythmia and convert the heart to normal sinus rhythm. This process may be performed with an implanted device.
A third approach is ablation. Many arrhythmias result from accessory electrical pathways which participate in the generation and continuation of tacky-arrhythmias. It is possible to destroy these accessory pathways by selectively ablating the offending tissue. The application of heat or other energy disrupts and injures the tissue and slows down or prevents the conduction of electrical impulses. The principle benefits of ablation therapies flow from the fact that no implantable device is required nor is a prolonged and expensive drug therapy =aa~ui=-ed. Thus the patient experiences an improved qualify of =ife at a educed overall cost.
The principal problems related to ablation stem from the requirement to localize the conduction disturbances and then to deliver the ablation energy to the same selected conduction site. This is exceedingly difficult to do given the constant motion of the heart.
The energy densities used for radio-frequency ablation are sufficient to "boil" the blood and cause tissue to adhere to the catheter tip. Therefore these therapies must be delivered with care. Therefore there exists a continuing need to improve the ability to deliver ablation energy to heart tissue.
SUMMARY
The present invention is a catheter system that can be used for contact mapping and for the delivery of radio-frequency energy along a segment of the catheter which forms a "linear" lesion in the tissue. The catheter relies on a fluid electrode to conduct the RF energy to the tissue. The fluid electrode is preferably a normal saline solution delivered from a pump or the like under the control of the physician. A porus dielectric surface helps to direct the fluid electrode into contact with the tissue.
More specifically, the invention is concerned with an electrophysiology device for treating tissue by energy delivered from an energy source, comprising:
an elongate catheter body having a lumen for carrying fluid and having a distal end and a proximal end, said catheter body having an axis;
at least one electrode site located proximate said distal end;
at least one wire for connection to said at least one electrode site 18 and to said energy source;

2a a plurality of apertures extending along said axis and communicating with said lumen;
a source of electrolyte fluid in fluid communication with said lumen;
wherein energy from said energy source is directed by said at least one wire from said energy source to said at least one electrode site, and energy is coupled to said electrolyte fluid at said at least one electrode site and communicated to said tissue through said plurality of apertures to create at least one linear lesion.
BRIEF DESCRIPTION OF THE DRAWINGS
The various figures of the drawing set forth an illustrative and exemplary form of the invention.
Throughout the various figures identical reference numerals refer to identical structures, wherein:
FIG. 1 is a view of the invention with the distal tip enlarged to clarify certain details of construction;
FIG. 2 is an enlarged view of the distal portion of the invention;
FIG. 3 is a view of an alternative embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 shows the electrophysiology device 10 as part of system. The system includes an energy source 20, a fluid pump 28 coupled to a fluid source 24 through an appropriate tube 26. The fluid pump 28 draws fluid from the fluid source and forces fluid through the central fluid lumen 40 of the catheter 32_ A Y-shaped manifold 12 couples the energy source 20 and the fluid system to the catheter 32.
The energy source 20 is coupled to the electrode 38 through a wire 22. This wire 22 passes through a sheath 30 and terminates at a connection 50 located on an electrode 38. The RF energy exits the distal open end 52 of the catheter 32 and passes through the heart tissue 11 as indicated by arrow 13. RF
current passing through the heart tissue 11 is collected at the exterior of the patient through a patient pad 21 and is returned to the energy source 20 through return path wire 23 completing the electrical circuit.
Experimental work has been performed with an energy source delivering approximately 50 Watts of power delivered into 100 Ohms at about 500 Ki~iz.
The RF energy is confined and directed by a fluid f lowing through the fluid lumen 40 of catheter 32 tube. In general, a reservoir or fluid source 24 is provided to store an electrolyte fluid shown in the figure by arrow 54. In practice the electrolyte is a saline solution formed by the addition of 35 G of NaCl to 100 ml of water. This balanced saline works well but higher ionic concentrations may be more effective for some applications where the additional salinity is well tolerated. A modest flow of electrolyte 54 is induced by pump 28 to direct fluid flow against the cardiac tissue 11. In use, the moving saline forms a fluid electrode to assist in the delivery c. energy to the tissue 11.
FIG. 2 shows a detail of the distal end of the catheter 32. The drawing shows that the fluid 54 receives the RF energy by passing over the interior of electrode 38. This electrode 38 is located a short distance from the open end 52 of the catheter 32. In general, it is desirable to have a short.path length from the electrode 38 to the tissue 11. But it is also desirable to locate the electrode 38 a sufficient distance from the tissue 11 to prevent adhesions and the like from contaminating the surface of the electrode 38.
The catheter shown in FIG. 2 is particularly effective in making relatively isolated lesions in part because the fluid exits the catheter "axially" at the very distal tip of the catheter 32 body.
FIG. 3 shows a catheter 16 that is adapted to generate a "linear" lesion 14 which extends along the length of the active zone 15 of the catheter 16. In this construction a number of electrodes typified by electrode 18 are aligned along the length of the catheter body 25. The electrodes are coupled to the energy source or other switching structures through wires typified by wire 37. The catheter body 25 has an axis 36. The central lumen 27 of the catheter body 25 is coupled to the fluid source 28 (not shown). The fluid as it moves into the active zone 15 connects to the energy source 20 (not shown) and exits from the catheter body 25 "radially" by migrating through several holes typified by hole 29. A porous sheath 34 overlays the hole pattern and helps to regulate the passage of fluid from the lumen 27. The porus sheath 34 places a porus surface proximate the tissue 11. The multiple electrode sites permit the catheter to be quite flexible over the length of the distal segment. If each electrode set is independently accessible through separate connections for mapping studies then the 219~~~p WO 95134346 PCTlUS95107576 catheter 16 may be used.for mapping when the central lumen 27 is filled with-a dielectric fluid. Once the ectopic-site-has been located the central lumen may be quickly filled with the non-dielectric, electrolyte 5 saline solution to perform ablation. In general, the presence of. saline in the lumen will partially 'short"
out the electrodes and during ablation the electrode will be connected-in parallel to carry the RF currents.
It is also possible to use the individual sets of electrodes to "focus' energy along the length of the active zone-even in the presence of saline, especially if-the salt concentration is low. It should be appreciated that if dielectric tubas were provided to-each electrode site then multiple spot ablation could be performed at selected sites. However, it is believed that the ability to generate a linear connected lesion will prove more effective at removing accessory pathways.
SUBSTITUTE SHEET (RULE 26)

Claims (7)

WHAT IS CLAIMED IS:
1. An electrophysiology device for treating tissue by energy delivered from an energy source, comprising:
an elongate catheter body (25) having a lumen (27) for carrying fluid and having a distal end (31) and a proximal end (33), said catheter body (25) having an axis (36);
at least one electrode site (18) located proximate said distal end (31);
at least one wire (37) for connection to said at least one electrode site (18) and to said energy source (20);
a plurality of apertures (29) extending along said axis (36) and communicating with said lumen (27);
a source (24) of electrolyte fluid (54) in fluid communication with said lumen (27);
wherein energy from said energy source (24) is directed by said at least one wire (37) from said energy source (20) to said at least one electrode site (18), and energy is coupled to said electrolyte fluid (54) at said at least one electrode site (18) and communicated to said tissue through said plurality of apertures (29) to create at least one linear lesion.
2. The electrophysiology device of claim 1 further comprising a porous sheath (34) covering said plurality of apertures (29) for permitting the exit of fluid from said lumen (27).
3. The electrophysiology device of claim 1 or 2, wherein said at least one electrode site (18) comprises a plurality of electrode sites.
4. The electrophysiology device of claim 1 or 2, wherein said distal end (31) is closed.
5. The electrophysiology device of claim 1 or 2, wherein each of said plurality of apertures (29) is perpendicular to said axis (36).
6. The electrophysiology device of claim 3, further comprising a plurality of wires (37) respectively connected between said plurality of electrode sites (18) and said energy source (24), so that said electrode sites (18) are independently accessible.
7. The electrophysiology device of claim 1 or 2, wherein the plurality of apertures (29) is aligned.
CA002190530A 1994-06-14 1995-06-14 Electrophysiology device Expired - Fee Related CA2190530C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/259,663 1994-06-14
US08/259,663 US5676693A (en) 1992-11-13 1994-06-14 Electrophysiology device
PCT/US1995/007576 WO1995034346A1 (en) 1994-06-14 1995-06-14 Electrophysiology device

Publications (2)

Publication Number Publication Date
CA2190530A1 CA2190530A1 (en) 1995-12-21
CA2190530C true CA2190530C (en) 2007-03-27

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Family Applications (1)

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CA002190530A Expired - Fee Related CA2190530C (en) 1994-06-14 1995-06-14 Electrophysiology device

Country Status (6)

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US (1) US5676693A (en)
EP (1) EP0765178B1 (en)
JP (1) JP3710478B2 (en)
CA (1) CA2190530C (en)
DE (1) DE69513396T2 (en)
WO (1) WO1995034346A1 (en)

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