Reference to Related Application This application is a continuation-in-part of U.S. Patent Application No.

08/515,379, filed August 15, 1995, entitled "Multiple Antenna Ablation Apparatus", incorporated herein by reference.

BACKGROUND QF THE INVENTION Field of the Invention This invention relates generally to an ablation apparatus with an internally cooled electrode, and more particularly to an electrode with a closed looped cooling device positioned in an electrode lumen, and an electrode sidewall port isolated from a cooling medium flowing through the closed looped cooling device

Description of the Related Art

Current open procedures for treatment of tumors are extremely disruptive and cause a great deal of damage to healthy tissue. During the surgical procedure, the physician must exercise care in not cutting the tumor in a manner that creates seeding of the tumor, resulting in metastasis. In recent years, development of products has been directed with an emphasis on minimizing the traumatic nature of traditional surgical procedures.

There has been a relatively significant amount of activity in the area of hyperthermia as a tool for treatment of tumors. It is known that elevating the temperature of tumors is helpful in the treatment and management of cancerous tissues. The mechanisms of selective cancer cell eradication by hyperthermia are not completely understood However, four cellular effects of hyperthermia on cancerous tissue have been proposed, (i) changes in cell or nuclear membrane permeability or fluidity, (ii) cytopiasmic lysomal disintegration, causing release of

digestive enzymes, (iii) protein thermal damage affecting cell respiration and the synthesis of DNA or RNA and (iv) potential excitation of immunologic systems Treatment methods for applying heat to tumors include the use of direct contact radio-frequency (RF) applicators, microwave radiation, inductively coupled RF fields, ultrasound, and a variety of simple thermal conduction techniques

Among the problems associated with all of these procedures is the requirement that highly localized heat be produced at depths of several centimeters beneath the surface of the skin

Attempts to use interstitial local hyperthermia have not proven to be very successful Results have often produced nonuniform temperatures throughout the tumor It is believed that tumor mass reduction by hyperthermia is related to thermal dose Thermal dose is the minimum effective temperature applied throughout the tumor mass for a defined period of time Because blood flow is the major mechanism of heat loss for tumors being heated, and blood flow varies throughout the tumor, more even heating of tumor tissue is needed to ensure effective treatment

The same is true for ablation of the tumor itself through the use of RF energy Different methods have been utilized for the RF ablation of masses such as tumors Instead of heating the tumor it is ablated through the application of energy This process has been difficult to achieve due to a variety of factors including, (i) positioning of the RF ablation electrodes to effectively ablate all of the mass, (ii) introduction of the RF ablation electrodes to the tumor site and (iii) controlled delivery and monitoring of RF energy to achieve successful ablation without damage to non-tumor tissue RF ablation electrodes tend to impede out when used at higher power levels The tissue adjacent to the electrode surface tends to char There have been numerous cooled electrodes Examples of cooled electrodes are found in U S Patents Nos 4,290,435, 4,140,130, 4,881,543, 5,334,193, 5,342,357, 5,348,554, 5,423,81 1, 5,423,807, 5,437,662, and 5,462,521

There is a need for an ablation apparatus with a closed loop cooling device positioned in an electrode lumen. There is a further need for an ablation apparatus with a closed loop cooling device positioned in an electrode lumen, and an electrode sidewall port isolated from the closed loop cooling device and suitable for the introduction of probes and/or infusion solutions into a selected tissue site.

SUMMARY OF THE TNVENTTON Accordingly, it is an object of the invention to provide an ablation apparatus and method with an ablation electrode that does not impede out. Another object of the invention is to provide an ablation apparatus and method with a cooled ablation electrode.

Yet another object of the invention is to provide an ablation apparatus and method with a closed loop cooled ablation electrode.

A further object of the invention is to provide an ablation apparatus and method with a closed loop cooled ablation electrode and an electrode sidewall port that is isolated from a cooling medium flowing through the ablation electrode.

Still another object of the invention is to provide an ablation apparatus and method with a closed loop cooled ablation electrode, an electrode sidewall port isolated from a cooling medium flowing through the ablation electrode and a probe with a sensor that is advanced in and out of the sideport.

Another object of the invention is to provide an ablation apparatus and method with a closed loop cooled ablation electrode, an electrode sidewall port isolated from a cooling medium flowing through the ablation electrode and an infusion medium introduced into a selected tissue site through the sidewall port.

These and other objectives are achieved in an ablation apparatus that has a handpiece, an electrode extending from a handpiece distal end, a probe, a thermal sensor and an energy source. The electrode includes a distal end, a lumen, a cooling medium inlet conduit and a cooling medium exit conduit. Both conduits extend through the electrode lumen to an electrode distal end. A

sidewall port, isolated from a cooling medium flowing in the inlet and outlet conduits, is formed in the electrode. The probe is at least partially positioned in the electrode lumen and configured to be advanced and retracted in and out of the sidewall port. The thermal sensor is supported by the probe. The electrode is coupled to an energy source.

The present invention is also a method for creating an ablation volume in a selected tissue mass. An ablation device is provided that has a handpiece, an electrode, a probe and a thermal sensor supported by the probe. The electrode includes a distal end, a lumen, a cooling medium inlet conduit coupled to a cooling medium outlet conduit which both extend through the electrode lumen to the electrode's distal end. A sidewall port is formed in a sidewall of the electrode and is isolated from a cooling medium flowing through the electrode. The electrode is inserted into the selected tissue mass. A distal end of the probe is advanced from the aperture into the selected tissue. At least a portion of an electrode ablation surface is cooled. Electromagnetic energy is delivered from the electrode to the selected tissue mass. Temperature is measured at a site in the selected tissue mass, and an ablation volume is created.

As electromagnetic energy, including but not limited to RF, is delivered to the selected tissue site, the tissue interface adjacent to the electrode can begin to char and conductivity through the tissue decreases. With a cooling medium the tissue interface remains at a temperature suitable for the delivery of electromagnetic energy to the periphery of the desired ablation site. While a cooling medium is flowing through the electrode, one or more probes, with associated sensors, are deployed into the desired ablation site. The ablation is monitored and controlled. Sensors can be positioned not only at the distal ends of the probes but also at intermediate positions. This permits monitoring of the ablation process between the electrode and the periphery of the targeted ablation volume.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a cross-sectional view of the ablation apparatus of the present invention illustrating an electrode with a lumen, a cooling medium inlet conduit, a cooling medium outlet conduit and two probes extending from sidewall ports formed in the lumen.

Figure 2 is a cross-sectional view of the closed loop distal end of the two cooling medium conduits of Figure 1.

Figure 3 is a cross-sectional view of another embodiment of the closed loop distal end of the two cooling medium conduits. Figure 4 is a cross-sectional of Figure 1 taken along the lines 4-4.

Figure 5 illustrates the creation of a 4 cm spherical ablation volume, with one sensor positioned at the periphery of the ablation volume, and a second sensor positioned on the probe midpoint between the electrode and the distal end of the probe. Figure 6 is a perspective view of the ablation apparatus of the present invention illustrating two probes extending from a distal end of the electrode.

Figure 7 is a perspective view of the distal end of the electrode of the present invention with probes extending from a distal end of an insulation sleeve.

Figure 8 is a perspective view of the ablation apparatus of the present invention illustrating the deployment of four probes from the electrode.

Figure 9 is a block diagram illustrating a feedback system useful ton control the temperature of energy delivering electrodes.

Figure 10 illustrates a circuit useful to implement the feedback system of Figure 9.

DETAILED DESCRIPTION

As shown in Figure 1, an ablation apparatus 10 includes a handpiece 11, an electrode 12, a cooling medium inlet conduit 16, a cooling medium outlet conduit 16 and a cap 18, with tapered distal end, that create a closed loop cooling system. A variety of different cooling mediums can be used including

but not limited to gas, cooled air, refrigerated air, compressed air, freon, water, alcohol, saline and the like A first sidewall port 20 is formed in a sidewall of electrode 12 A second sidewall port 22 may also be included First and second sidewall ports can be windows formed in electrode 12 which create a mechanical weak spot in electrode 12 A first probe 24 is positioned in an electrode lumen and capable of being advanced and retracted in and out of first sidewall port 20 An optional second probe 26 is also positioned in the electrode lumen and is capable of being advanced and retracted to a selected tissue ablation side through second sidewall port 22 Electrode 12 has an exterior ablation energy delivery surface which delivers electromagnetic energy to the selected tissue ablation mass, and may have a tapered or sharpened distal end For the ablation of tumors, electrode 12 can have an exterior ablation energy delivery surface length of 0 25 inches or less, and an outer diameter for electrode 12 of about 0 072 inches or less. Each probe 24 and 26 can be formed of a variety of materials, including but not limited to stainless steel, shaped memory metals and the like. The size of probes 24 and 26 vary depending on the medical application For the treatment of tumors, probes 24 and 26 have a length extending from the sidewall ports into tissue of 3 cm or less A first sensor 28 can be supported by probe 24 on an interior or exterior surface First sensor 28 is preferably positioned at a distal end of probe 24 A second sensor 30 may be positioned on probe 24 somewhere intermediate between an exterior surface of electrode 12 and the distal end of probe 24 Preferably, second sensor 30 is located at a position where it can sense temperature at a midpoint in a selected tissue ablation volume Second sensor 30 is useful to determine if probe 24 has encountered an obstruction, such as a blood vessel, to the ablation process If first sensor 28 measures a higher , emperature than second sensor 30, then this can indicate that second sensor 30 is close to a circulatory vessel When this occurs, ablation energy is carried away by the vessel Similarly, second probe 26 can also include one or more

sensors A third sensor 32 can be positioned at an exterior surface of electrode 12

Sensors 28, 30 and 32 permit accurate measurement of temperature at a tissue site in order to determine, (i) the extent of ablation, (ii) the amount of ablation, (iii) whether or not further ablation is needed and (iv) the boundary or periphery of the ablated mass Further, sensors 28, 30 and 32 prevent non- targeted tissue from being destroyed or ablated

Sensors 28, 30 and 32 are of conventional design, including but not limited to thermistors, thermocouples, resistive wires, and the like Suitable thermal sensors 24 include a T type thermocouple with copper constantene, J type, E type, K type, fiber optics, resistive wires, thermocouple IR detectors, and the like Sensors 28, 30 and 32 need not be thermal sensors

Sensors 28, 30 and 32 measure temperature and/or impedance to permit monitoring and a desired level of ablation to be achieved without destroying too much tissue This reduces damage to tissue surrounding the targeted mass to be ablated By monitoring the temperature at various points within the interior of the selected tissue mass, a determination of the selected tissue mass periphery can be made, as well as a determination of when ablation is complete If at any time sensor 28, 30 or 32 determines that a desired ablation temperature is exceeded, then an appropπate feedback signal is received at energy source 34 which then regulates the amount of energy delivered to electrode 12, as more fully explained hereafter

Electrode 12 is coupled to an electromagnetic energy source 34 by wiring, soldering, connection to a common couplet, and the like Electrode 12 can be independently coupled to electromagnetic energy source 34 from probes

24 and 26 Electrode 12, and probes 24 and 26 may be multiplexed so that when energy is delivered to electrode 12 it is not delivered to probes 24 and 26 Electromagnetic energy power source can be an RF source, microwave source, shortwave source, and the like

Electrode 12 is constructed to be rigid enough so that it can be introduced percutaneously or laparoscopically through tissue without an introducer. The actual length of electrode 12 depends on the location of the selected tissue mass to be ablated, its distance from the skin, its accessibility as well as whether or not the physician chooses a laparoscopic, percutaneous or other procedure. Suitable lengths include but are not limited to 17.5 cm, 25.0 cm. and 30.0 cm Electrode 12, can be introduced through a guide to the selected tissue ablation site.

An insulation sleeve 38 can be positioned in a surrounding relationship to an exterior surface of electrode 12. Insulation sleeve 38 can be moveable along electrode's 12 exterior surface in order to provide a variable length ablation energy delivery surface.

In one embodiment, insulation sleeve 38 can comprise a polyimide material. A sensor may be positioned on top of polyimide insulation sleeve 38. Polyamide insulation sleeve 18 is semi-rigid. The sensor can lay down substantially along the entire length of polyimide insulation sleeve 38. Handpiece 11 can serve the function of a handpiece and include markings to show the length of insulation sleeve 38 and the length of electrode's 12 exposed ablation energy delivery surface. Referring now to Figure 2, cap 18 is illustrated as creating a closed loop cooling medium flow channel. Cap 18 is secured to the distal ends of conduits 14 and 16 by a variety of means, including but not limited to welding, soldering, application of an epoxy, and the like. Cap 18 can have a step which is secured to the distal end of electrode 12 by soldering, welding, press sit and the like. Instead of cap 18, a "U joint can be formed at the distal ends of conduits 16 and

18, as shown in Figure 3.

Referring to Figure 4, only a portion of electrode has an interface with cooling medium inlet conduit 14. However, the diameters of cooling medium inlet conduit 14 and electrode 12 are dimensioned so that a tissue interface formed adjacent to the exterior surface of electrode 12 does not become

sufficiently desiccated and charred to prevent the transfer of energy through the selected tissue ablation site to the periphery of the site.

The creation of a 4 cm diameter spherical ablation is illustrated in Figure 5. A 4 cm ablation energy delivery surface of electrode 12 is exposed. First sidewall port 20 is positioned 2 cm from a distal end of electrode 12. First probe

24 is advanced from electrode lumen with its distal end positioned at the periphery of the spherical ablation area. First sensor 28 is positioned at the distal end of first probe 24 and determines when the ablation has reached the periphery of the desired ablation area. Second sensor 30 is positioned midpoint on first probe 24 to monitor the transfer of electromagnetic energy through the desired ablation area, and determine if there are any obstructions to the ablation process at that position. Once the ablation is completed, first probe 24 is retracted back into the lumen of electrode 12.

Electromagnetic energy delivered by electrode 12 causes the electrode/tissue interface at the electrode ablation delivery surface to heat, and return the heat to electrode 12. As more heat is applied and returned, the charring effect electrode 12 increases. This can result in a loss of electromagnetic energy conductivity through the selected tissue site. The inclusion of cooling with electrode 12 does not affect the effective delivery of electromagnetic energy to the selected tissue ablation site. Cooling permits the entire selected tissue ablation site to be ablated while reducing or eliminating the heating of the electrode/tissue interface tissue.

In Figure 6, probes 24 and 26 are each deployed out of the distal end of electrode 12 and introduced into the selected tissue mass. Probes 24 and 26 form a plane.

As shown in Figure 7 insulation sleeve 38 can include one or more lumens for receiving secondary probes 24, 26 as well as additional probes which are deployed out of a distal end of insulation sleeve 38. Figure 8 illustrates four probes introduced out of different sidewall ports formed in the body of electrode 12. Some or all of the probes provide an anchoring function.

Figure 9 illustrates a block diagram of a temperature/impedance feedback system that can be used to control cooling medium flow rate through electrode 12. Electromagnetic energy is delivered to electrode 12 by energy source 34, and applied to tissue. A monitor 42 ascertains tissue impedance, based on the energy delivered to tissue, and compares the measured impedance value to a set value, if the measured impedance exceeds the set value a disabling signal 44 is transmitted to energy source 34, ceasing further delivery of energy to electrode 12. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. During the application of energy to tissue sensor 46 measures the temperature of tissue and/or electrode 12. A comparator 48 receives a signal representative of the measured temperature and compares this value to a pre-set signal representative of the desired temperature. Comparator 48 sends a signal to a flow regulator 50 representing a need for a higher cooling medium flow rate, if the tissue temperature is too high, or to maintain the flow rate if the temperature has not exceeded the desired temperature.

An output 52 from temperature comparator 48 can be input to energy source 34 to regulate the amount of power delivered by power source 32. Output 54 from impedance monitor 106 can be input to flow regulator 50 to regulate fluid flow and thus control temperature of the tissue. Referring now to Figure 10, energy source 34 is coupled to electrode 12, to apply a biologically safe voltage to the selected tissue site. In the embodiment illustrated in Figure 10, ablation apparatus 10 is represented as a bipolar ablation device having an energy delivering electrode 12 and a ground electrode 56. Both electrodes 12 and 56 are connected to a primary side of transformer windings 58 and 60. The common primary winding 58, 60 is magnetically coupled with a transformer core to secondary windings 58' and 60'.

The primary windings 58 of the first transformer t, couple the output voltage of ablation apparatus 10 to the secondary windings 58'. The primary windings 60 of the second transformer t ₂ couple the output current of ablation apparatus 10 to the secondary windings 60'.

Measuring circuits determine the root mean square (RMS) values or magnitudes of the current and voltage. These values, represented as voltages, are inputted to a diving circuit D to geometrically calculate, by dividing the RMS voltage value by the RMS current value, the impedance of the tissue site at sensor 46.

The output voltage of the divider circuit D is presented at the positive (+) input terminal of comparator A. A voltage source V ₀ supplies a voltage across the variable resistor R^ thus allowing one to manually adjust the voltage presented at the negative input of comparator A. This voltage represents a maximum impedance value beyond which power will not be applied to electrode

12 Specifically, once the tissue is heated to a temperature corresponding to an impedance value greater than the maximum cut-off impedance, energy source 34 stops supplying energy to electrode 12 Comparator A can be of any of a commercially available type that is able to control the amplitude or pulse width modulation of energy source 34.

The flow rate of cooling medium can be controlled based on the tissue impedance, as represented by signal 62, or based on tissue temperature, as represented by signal 64 In one embodiment, the switch S is activated to allow the impedance signal 62 to enter the positive (+) input terminal of comparator A This signal along with the reference voltage applied to the negative (-) input terminal actuates comparator A to produce an output signal. If the selected tissue ablation site is heated to a biologically damaging temperature, the tissue impedance will exceed a selected impedance value seen at the negative (-) input terminal, thereby generating disabling signal 44 to disable energy source 34, ceasing the power supplied to electrode 12

The output signal of comparator A can be communicated to a pump 66. If the temperature of the selected tissue ablation site is too high, despite the tissue impedance falling within acceptable limits, pump 66 adjusts the rate of cooling medium flow applied to electrode 12 to decrease the temperature of electrode 12. The output signal of comparator A may either disable energy

source's 34 energy output, depending on the tissue temperature as reflected by its impedance, or cool electrode 12 or perform both operations simultaneously.

The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that the scope of the invention be defined by the following claims and their equivalents.

What is claimed is: