Electrocatheter for inducing vessel stenosis having two arrays of diverging electrodes

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ELECTROCATHETER FOR INDUCING VESSEL STENOSYS HAVING TWO ARRAYS OF DIVERGING ELECTRODES ot tPOQin ntnonb "ijus πηταπο nrmupbN 7\y

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This application is acoparrifarion-in-partofco-pending appiicanox serial no. 08/927,251J51ed on September ll&lt;T997 and applicatioxrferial no. 08/958,766 fiWon October 26,1997^

BACKGROUND OF THE INVENTION 5 The invention relates generally to a method and apparatus for applying energy to shrink a hollow anatomical structure, such as a fallopian tube or a vein, including, but not limited to, superficial and perforator veins, hemorrhoids, and esophageal varices, and more particularly, to a method and apparatus using an electrode device having multiple leads for applying radio 10 frequency (RF) energy, microwave energy, or thermal energy.

The human venous system of the lower limbs consists essentially of the superficial venous system and the deep venous system with perforating veins connecting the two systems. The superficial system includes the long or great saphenous vein and the short saphenous vein. The deep venous system 15 includes the anterior and posterior tibial veins which unite to form the popliteal vein, which in turn becomes the femoral vein when joined by the short saphenous vein.

The venous system contains numerous one-way valves for directing blood flow back to the heart Venous valves are usually bicuspid valves, with 20 each cusp forming a sack or reservoir for blood which, under retrograde blood pressure, forces the free surfaces of the cusps together to prevent retrograde flow of the biood and allows only antegrade blood flow to foe heart When an incompetent valve is in foe flow path, foe valve is unable to close because the cusps do not form a proper seal and retrograde flow of foe biood cannot be 25 stopped. When a venous valve fails, increased strain and pressure occur within the lower venous sections and overlying tissues, sometimes leading to additional valvular failure. Two venous conditions which often result from

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2 valve failure are varicose veins and more symptomatic chronic venous insufficiency.

The varicose vein condition includes dilation and tortuosity of die superficial veins of the lower limbs, resulting in unsighdy discoloration, pain, 5 swelling, and possibly ulceration. Varicose veins often involve incompetence of one or more venous valves, which allow reflux of blood within the superficial system. This can also worsen deep venous reflux and perforator reflux. Current treatments of vein insufficiency include surgical procedures such as vein stripping, ligation, and occasionally, vein-segment transplant. 10 Chronic venous insufficiency involves an aggravated condition of varicose veins which may be caused by degenerative weakness in the vein valve segment, or by hydrodynamic forces acting on the tissues of the body, such as the legs, ankles, and feet. As the valves in die veins flail, the hydrostatic pressure increases on the next venous valves down, causing those 15 veins to dilate. As this continues, more venous valves will eventually fail. As they fail, the effective height of the column of blood above the feet and ankles grows, and the weight and hydrostatic pressure exerted on die tissues of the ankle and foot increases. When the weight of that column reaches a critical point as a result of the valve failures, ulcerations of the ankle begin to form, 20 which start deep and eventually come to the surface. These ulcerations do not heal easily because of poor venous circulation due to valvular incompetence in the deep venous system and other vein systems.

Other related venous conditions include dilated hemorrhoids and esophageal varices. Pressure and dilation of the hemorrhoid venous plexus 25 may cause internal hemorrhoids to dilate and/or prolapse and be forced through the anal opening. If a hemorrhoid remains prolapsed, considerable discomfort, including itching and bleeding, may result. The venous return from these prolapsed hemorrhoids becomes obstructed by the anal sphincters, which gives rise to a strangulated hemorrhoid. Thromboses result where the 30 blood within the prolapsed vein becomes clotted. This extremely painful condition can cause edema and inflammation.

Varicose veins called esophageal varices can form in the venous system with submucosa of the lower esophagus, and bleeding can occur from the dilated veins. Bleeding or hemorrhaging may result from esophageal varices, which can be difficult to stop and, if untreated, could develop into a life 5 threatening condition. Such varices erode easily, and lead to a massive gastrointestinal hemorrhage.

Ligation of a fallopian tube (tubal ligation) for sterilization or other purposes is typically performed by laparoscopy. A doctor severs the fallopian tube or tubes and ties foe ends. External cauterization or damps may also be 10 used. General or regional anesthetic must be used. All of the above are performed from outside foe fallopian tube.

Hemorrhoids and esophageal varices may be alleviated by intra-luminal ligation. As used herein, “ligation” or “intra-luminal ligation” comprises foe ocdusion, collapse, or closure of a lumen or hollow anatomical structure by 15 foe application of energy from within foe lumen or structure. As used herein, “ligation” or “intra-luminal ligation” indudes electro-ligation. In foe case of fallopian tube ligation, it would be desirable to perform foe ligation from within foe fallopian tube itself (intra-fallopian tube) to avoid foe trauma assodated with external methods. 20 Ligation involves foe cauterization or coagulation of a lumen using energy such as that applied through an electrode device. An electrode device is introduced into foe lumen and positioned so that it contacts foe lumen wall. Once properly positioned, RF energy is applied to the wall by foe dectrode device thereby causing foe lumen to shrink in cross-sectional diameter. In foe 25 case of a vein, a reduction in cross-sectional diameter of foe vein, for example from 5 mm (0.2 in) to 1 mm (0.04 in), significantly reduces foe flow of blood through a lumen and results in an effective ocdusion. Although not required for effective ocdusion or ligation, foe vein wall may completely collapse thereby resulting in a full-lumen obstruction that blocks foe flow of blood 30 through the vein. Likewise, a fallopian tube may collapse sufficient to effect a sterilization of the patient. 4

One apparatus for performing ligation includes a tubular shaft having an electrode device attached at the distal tip. Running through the shaft, from the distal end to the proximal end, are electrical leads. At the proximal end of the shaft, the leads terminate at an electrical connector, while at the distal end 5 of the shaft the leads are connected to the electrode device. The electrical connector provides the interface between the leads and a power source, typically an RF generator. The RF generator operates under the guidance of a control device, usually a microprocessor.

The ligation apparatus may be operated in either a monopolar or 10 bipolar configuration. In the monopolar configuration, the electrode device consists of an electrode that is either positively or negatively charged. A return path for the current passing through the electrode is provided externally from the body, as for example by placing the patient in physical contact with a large low-impedance pad. The current flows from the ligation device through the 15 patient to the low impedance pad. In a bipolar configuration, the electrode device consists of a pair of oppositely charged electrodes of approximately equal size, separated from each other, such as by a dielectric material or by a spatial relationship. Accordingly, in the bipolar mode, the return path for current is provided by an electrode or electrodes of the electrode device itself. 20 The current flows from one electrode, through the tissue, and returns by way of the oppositely charged electrode.

To protect against tissue damage; Le., charring, due to cauterization caused by overheating, a temperature sensing device is attached to the electrode device. The temperature sensing device may be a thermocouple that 25 monitors the temperature of the venous tissue. The thermocouple interfaces with the RF generator and the controller through the shaft and provides electrical signals to the controller which monitors the temperature and adjusts the energy applied to the tissue through the electrode device accordingly.

The overall effectiveness of an ligation apparatus is largely dependent- 30 on the electrode device contained within the apparatus. Monopolar and bipolar electrode devices that comprise solid devices having a fixed shape and 5 size can limit the effectiveness of the ligating apparatus for several reasons. Firstly, a fixed-size electrode device typically contacts the vein wall at only one point on the circumference or inner diameter of foe vein wall. As a result, the application of RF energy is highly concentrated within the contacting venous 5 tissue, while the flow of RF current through the remainder of the venous tissue is disproportionately weak. Accordingly, the regions of the vein wall near the point of contact collapse at a faster rate then other regions of the vein wall, resulting in non-uniform shrinkage of the vein lumen which can result in inadequacy of the overall strength of the occlusion and the lumen may 10 eventually reopen. To avoid an inadequate occlusion, RF energy must be applied for an extended period of time so that the current flows through the tissue generating thermal energy including through the tissue not in contact with the electrode to cause that tissue to shrink sufficiently also. Extended applications of energy have a greater possibility of increasing the temperature 15 of the blood to an unacceptable level and may result in a significant amount of heat-induced coagulum forming on the electrode and in the vein which is not desirable. This can be prevented by exsanguination of the vein prior to the treatment, and through the use of temperature regulated power delivery.

Secondly, foe effectiveness of an ligating apparatus having a fixed-size 20 electrode device is limited to certain sized veins. An attempt to ligate a vein having a diameter that is substantially greater than foe electrode device can result in not only non-uniform heating of foe vein wall as just described, but also insufficient shrinkage of foe vein diameter. The greater the diameter of the vein relative to foe diameter of the electrode device, the weaker the energy 25 applied to the vein wail at points distant from foe point of electrode contact. Accordingly the vein wall is likely to not completely collapse prior to foe venous tissue becoming over cauterized at the point of electrode contact.

While coagulation as such may initially occlude foe vein, such occlusion may only be temporary in chat the coagulated blood may eventually dissolve 30 recanalizing foe vein. One solution for this inadequacy is an apparatus having interchangeable electrode devices with various diameters. Another solution 6

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would be to have a set of catheters having different sizes so that one with the correct size for the diameter of the target vein will be at hand when needed. Such solutions, however, are both economically inefficient and can be tedious to use. It would be desirable to have a single catheter device that is usable 5 with a large range of sizes of lumina.

Although described above in terms of a vein, the concepts are generally applicable to other hollow anatomical structures in the body as well. For consideration of avoiding unnecessary repetition, the above description has been generally confined to veins. 10 Hence those skilled in the art have recognized a need for an expandable electrode device and a method capable of more evenly distributing RF energy along a circumferential band of a wall of the target anatomical structure where the wall is greater in diameter than the electrode device, and thereby provide more predictable and effective occlusion of anatomical structures while 15 minimizing the formation of heat-induced coagulum. Such device and method should be applicable to the ligation of ail the veins in the body, including but not limited to perforator and superficial veins, as well as hemorrhoids, esophageal varices, and also fallopian tubes. The invention fulfills these needs and others.

20 SUMMARY OF THE INVENTION

Briefly, and in general terms, the present invention provides an apparatus and method for applying energy along a generally circumferential band of the wall of a hollow anatomical structure, such as a vein, fallopian tube, hemorrhoid, or esophageal varix. The application of energy in 25 accordance with this apparatus and method results in a more uniform and predictable shrinkage of the structure.

In a first aspect, an apparatus for applying energy to a hollow anatomical structure comprises a catheter having a shaft with a working end at which energy is applied to the structure, a first plurality of expandable 30 electrode leads mounted at the working end of the catheter, each lead having an electrode, a second plurality of expandable electrode leads mounted at the 7 working end of the catheter separate from and longitudinally spaced apart from the first plurality and longitudinally spaced apart from the first plurality, each lead having an electrode, wherein electrodes of the first and second pluralities each have an expanded position at which the electrode is located 5 outward from the catheter shaft and a contracted position at which the electrode is located nearer the shaft, and a deployment device mounted to the catheter, the deployment device having a first position at which selected electrodes are in the contracted position and a second position at which electrodes are in the expanded position. In more detailed aspects, the 10 electrode leads of the first plurality are formed such that they are urged outwardly from the catheter shaft, wherein the deployment device comprises a movable sheath having a first position at which the sheath surrounds the first plurality of electrode leads over at least a portion thereof and confines the surrounded leads to a contracted position, the movable sheath having a second 15 position at which the first and second pluralities are permitted to expand outwardly. Further, the electrode leads of the second plurality are formed such that they are urged outwardly from the catheter shaft. The movable sheath at its first position also surrounds the second plurality of electrode leads over at least a portion thereof and confines the surrounded leads to a 20 contracted position.

In further aspects, each of the electrode leads of the first and second pluralities is formed with an outward bend that tends to expand the distal portion of each lead outwardly with the second plurality of electrode leads mounted to the catheter proximal to the first plurality, the movable sheath at 25 its first position in relation to die electrode leads is distal to the bends of the first and second pluralities of electrode leads thereby retaining the first and second pluralities in contracted configurations. The movable sheath at its second position is proximal to the bends of the first and second pluralities thereby permitting the first and second pluralities to expand outwardly. 30 In yet further detailed aspects, the electrode leads are mounted at the working end in a cantilever arrangement. Each of the electrode leads of the first and second pluralities are disposed in relation to the working end such that when in the expanded position, the electrodes of the leads form a substantially symmetric arrangement of substantially evenly-spaced electrodes. Each electrode lead is formed of an electrically conductive material insulated 5 along its length, and each electrode lead includes an outwardly-feeing portion at which no insulation is present thereby forming the electrode. The electrode leads are formed of a material having a strength selected such that when the sheath is in its second position, the leads are strong enough to move into apposition with the hollow anatomical structure, and the leads have a strength 10 such that they permit the hollow anatomical structure to shrink but remain in apposition with the shrinking structure.

The first plurality of electrode leads are mounted to a first electrically-conductive mounting ring to which the electrodes of those leads are electrically inter-connected. The second plurality of electrode leads are mounted co a 15 second electrically-conductive mounting ring to which the electrodes of those leads are electrically inter-connected. A third electrically-conductive mounting ring is provided to which alternating electrode leads of a selected one of the pluralities of electrode leads are connected thereby resulting in adjacent leads of the selected plurality being connected to different mounting rings. A power 20 source is connected to the electrodes and a controller controls the power source. A switch is connected to the controller, the switch having a first position at which the controller applies different polarities to foe mounting rings, and a second position at which the controller applies foe same polarity to foe mounting rings. 25 In yet another aspect, a power source is connected to the electrodes, a controller controls the power source, and a temperature sensor is mounted to an electrode lead, foe temperature sensor providing temperature signals to the controller wherein foe controller controls the power source in response to the v temperature signals. 30 In further aspects, foe controller is adapted to switch the electrical polarity of foe leads as selected including controlling foe output of the power 9 source to the electrode leads such that adjacent electrodes of the first plurality of leads are of opposite polarities while maintaining the polarity of the second plurality of electrodes so that they are electrically neutral, switching the polarity of the electrodes of the first plurality of leads so that they are all of the 5 same polarity upon collapse of the hollow anatomical structure around the first plurality of leads, and controlling the power source so that the electrodes of the second plurality of leads are of opposite polarity relative to the electrodes of the first plurality of leads upon performing the step of switching the polarity of the electrodes. The controller is further adapted to, in more detailed 10 aspects, control the power source so that adjacent electrodes of the first plurality are of opposite polarity, control the power source so that adjacent electrodes of the second plurality are of opposite polarity, and control the power source so that the polarities of the electrodes of the second plurality are selected so that opposite polarities are longitudinally aligned with the 15 electrodes of the first plurality. In yet further aspects, the apparatus further comprises a backplate located at a surface of the patient wherein the controller is further adapted to control the energy applied to one of the pluralities of electrode leads so that die electrodes are of a first polarity and control the energy applied to the backplate so that it is a second polarity. 20 In another aspect, the deployment device comprises a movable sheath and an alignment device positioned inside the sheath, the alignment device maintaining separation between the electrode leads wherein movement of the sheath and alignment device in relation to each other controls whether the electrode leads are expanded or contracted. 25 In accordance with other method aspects of the invention, there is provided the steps of introducing into the hollow anatomical structure a catheter having a shaft and a working end with a first plurality of electrode leads disposed at foe working end and a second plurality of electrode leads disposed at foe working end spaced longitudinally apart from foe first 30 plurality, each lead having an electrode connected to a power source, expanding leads of the first plurality outwardly from foe working end of foe 10 catheter wherein the electrodes of the first plurality move away from each other and into contact with the inner wail, and expanding the leads of the second plurality outwardly from the working end of the catheter, wherein the electrodes of the second plurality move away from each other and into contact with the inner wall at positions spaced apart longitudinally from the contact points on the inner wall of the first plurality. Further, in another aspect, the method comprises the step of applying energy to the inner wall from electrodes of the electrode leads to collapse the hollow anatomical structure to effectively occlude the hollow anatomical structure. A more detailed aspect includes the step of moving a sheath and the first and second pluralities of electrodes in relation to each other to selectively expand the electrode leads outwardly or contract the electrode leads.

The method further comprises the step of moving the catheter in the hollow anatomical structure while continuing to apply energy to the hollow anatomical structure by the electrodes. Additionally, the step of compressing the hollow anatomical structure to a desired size before and/or during the step of applying energy is provided. Further steps comprise compressing the hollow anatomical structure with a tourniquet or elastic bandage before and/or during the step of applying energy and monitoring the hollow anatomical structure through an ultrasound window formed in the tourniquet or bandage. More detailed aspects of the method comprise exsanguinating the hollow anatomical structure before and/or during the step of applying energy, by delivering fluid to displace blood from the anatomical structure, or by compressing the hollow anatomical structure.

In addition, there are provided the steps of controlling the energy applied to the electrodes of the first plurality of leads so that they have a first polarity and controlling the energy applied to the electrodes of the second plurality of leads so that they have a second polarity different from the first polarity. In another aspect, provided are the steps of controlling the power source so that adjacent electrodes of the first plurality of leads are of opposite polarity while maintaining the polarity of the second plurality of electrodes so 11 that they are electrically neutral, switching the polarity of the electrodes of the first plurality of leads so that they are all of the same polarity upon collapse of the hollow anatomical structure around the first plurality of leads, and controlling the power source so that the electrodes of the second plurality of leads are of opposite polarity relative to the electrodes of the first plurality of leads upon performing the step of switching the polarity of the electrodes.

Further aspects include applying a backplate to a surface of the patient, controlling the energy applied to one of the pluralities of electrode leads so that die electrodes are of a first polarity, and controlling the energy applied to the backplate so that it is a second polarity. In another aspect, the method comprises the steps of controlling the power source so that adjacent electrodes of the first plurality are of opposite polarity, controlling the power source so that adjacent electrodes of the second plurality are of opposite polarity, and controlling the power source so that the polarities of the electrodes of the second plurality are selected so that opposite polarities are longitudinally aligned with the electrodes of the first plurality.

In yet further detailed aspects, a method comprises the steps of sensing the temperature at an electrode lead and controlling the application of power to the electrode leads in response to the temperature sensed at the lead. Additionally, there is provided the step of flushing the hollow anatomical structure with fluid before the step of applying energy.

Further aspects include introducing a catheter having first and second pluralities of longitudinally, spaced-apart expandable electrode leads into a vein, introducing the catheter into a fallopian tube, introducing the catheter into a hemorrhoid, or introducing the catheter into an esophageal varix.

These and other aspects and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, embodiments of the invention. 12 BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1 is a diagram of an energy application system with a partial cutaway view of a catheter showing both the working end which includes a plurality of outwardly expandable electrodes for applying energy to tissue and 5 the connecting end which is connected to a power source controlled by a microprocessor controller for controlling the energy applied to the electrodes of the working end; FIG. 2 is a cross-sectional view of the working end of a first embodiment of a catheter in accordance with aspects of the invention 10 depicting the electrodes in a fully expanded position; FIG. 2a is an end view of the working end of the first embodiment of the catheter taken along line 2a-2a of FIG. 2; FIG. 3 is a cross-sectional view of foe working end of foe first embodiment depicting foe electrodes in a fully retracted position; IS FIG. 4 is a cross-sectional view of foe working end of a second catheter in accordance with principles of foe invention depicting foe electrodes in a fully expanded position; FIG. 4a is an end view of foe second embodiment of foe invention taken along line 4a-4a of FIG. 4; 20 FIG. 5 is a cross-sectional view of the working end of foe second embodiment of foe catheter of FIG. 4 depicting foe electrodes in a fully retracted position; FIG. 6 is a cross-sectional view of an anatomical structure containing foe catheter of FIG. 2 with foe electrodes in apposition with foe anatomical 25 structure; FIG. 6a is an end view of foe anatomical structure containing foe catheter taken along line 6a-6a of FIG. 6; FIGS. 7a through 7c are cross-sectional views of foe anatomical structure containing a catheter in accordance with foe first embodiment of foe 30 invention and depicting the anatomical structure at various stages of ligation; 13 FIG. 8 is a cross-sectional view of an anatomical structure containing a catheter in accordance with the second embodiment of the invention as depicted in FIG 4; FIG. 8a is an end view of the anatomical structure containing the 5 catheter taken along line 8a-8a of FIG. 8; FIGS. 9a and 9b are cross-sectional views of the anatomical structure containing the catheter in accordance with the second embodiment of the invention and depicting the anatomical structure at various stages of ligation; FIG. 10 is a cross-sectional view of the working end of a third 10 embodiment of a catheter in accordance with the invention depicting the electrodes in a fully retracted position; FIG. 10a is an end view of the working end of the third embodiment of the catheter taken along line lOa-lOa of FIG. 10; FIG. 11 is a cross-sectional view of the working end of the third 15 embodiment depicting the electrodes in a fully expanded position; FIG. 12 is a cross-sectional view of an anatomical structure containing the catheter of FIG. 10 with the electrodes in apposition with the anatomical structure; FIG. 13 is a cross-sectional view of the anatomical structure containing 20 the catheter of FIG. 10 where the anatomical structure is being ligated by the application of energy from the electrodes; FIG. 14 is a cross-sectional view of an anatomical structure containing the catheter of FIG. 10 with the electrodes in apposition with the anatomical structure where external compression is being applied co reduce the diameter 25 of the hollow structure before the application of energy from the electrodes to ligate the structure; FIG. 15 is a side view of another embodiment of an electrode catheter having a balloon and a coaxial fluid channel; FIG. 16 is a view of the balloon and catheter of FIG. 15 showing the 30 balloon inflation ports formed in an inflation sheath of the catheter, also showing the inflation lumen that communicates with the inflation ports; 14 FIG. 17 is a cross-sectional view of an anatomical structure containing another embodiment of the catheter having a balloon located proximal to bowable arms with electrodes, the portion of the catheter distal to the balloon having perfusion holes; FIG. 18 is a side view of another embodiment of an electrode catheter having a covering spanning the splayed leads of the electrodes extended out the catheter, FIG. 19 is a side view of another embodiment of an electrode catheter having a balloon and a coaxial fluid channel located proximal to expandable leads, the balloon having openings for receiving blood to maintain deployment of the balloon; FIG. 20 is a side view of another embodiment of an electrode catheter having a balloon and a coaxial fluid channel located proximal to expandable leads, foe balloon having openings for receiving blood to maintain deployment of foe balloon; FIG. 21 is a partial cross-sectional side view of another embodiment of an electrode catheter having an expandable section; FIG. 22 is a partial cross-sectional side view of foe embodiment of an electrode catheter of FIG. 21 in an expanded condition; FIG. 23 is a side view of an embodiment of an electrode catheter having two pluralities of longitudinally-separated expandable electrodes in a retracted condition; FIG. 24 is a side view of foe embodiment of foe electrode catheter of FIG. 23 with both pluralities of the electrodes in expanded configurations; FIG. 25 is a partial cross-sectional view of foe embodiment of an electrode catheter of FIG 23; FIG. 26 is a side view of another embodiment of an electrode catheter having two pluralities of longitudinally-separated expandable electrodes in a retracted condition; 15 FIG. 27 is a side view of another embodiment of an electrode catheter having two pluralities of longitudinally-separated expandable elecirodes in a retracted condition; FIG. 28 is a side view of another embodiment of an electrode catheter 5 having two pluralities of longitudinally-separated expandable electrodes in a retracted condition; FIG. 29 is a view of a catheter used in a method in accordance with the invention to treat a hemorrhoid; FIG. 30 is a view of a catheter used in a method in accordance with the 10 invention to treat an esophageal varix; and FIG. 31 is a view of a catheter used in a method in accordance with the invention for ligating a fallopian tube.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Turning now to the drawings with more particularity wherein like 15 reference numerals indicate like or corresponding elements among the figures, shown in FIG. 1 is a catheter 10 for applying energy to an anatomical structure such as a vein. The catheter 10 includes an outer sheath 12 having a distal orifice 14 at its working end 15. The connector end 17 of the outer sheath 12 is attached to a handle 16 that includes an electrical connector 18 for 20 interfacing with a power source 22, typically an RF generator, and a microprocessor controller 23. The power source 22 and microprocessor 23 are usually contained in one unit. The controller 23 controls the power source 22 in response to external commands and data from a sensor, such as a thermocouple, located at an intraluminal venous treatment site. In another 25 embodiment, the user can select a constant power output so that automated temperature control is not present and the user can manually adjust the power output in view of the temperature on a display readout The catheter 10 includes an expandable electrode device 24 (partially shown) that moves in and out of the outer sheath 12 by way of the distal orifice 14. The electrode 30 device includes a plurality of electrodes which can be expanded by moving the 16 electrodes within the shaft, or by moving the outer shaft relative to foe electrodes. Although FIG. 1 illustrates a plurality of electrodes surrounding a single central electrode, different electrode configurations will be described for the catheter. 5 Contained within the outer sheath 12 is an inner sheath 28 or inner member. A fluid port 21 communicates with the interior of the outer sheath 12. The catheter 10 can be periodically flushed out with saline through foe port 21. The flushing fluid can travel between foe outer sheath and foe inner sheath. The port also allows for the delivery of drug therapies. Flushing out 10 the catheter prevents foe buildup of biological fluid, such as blood, within foe catheter 10. The treatment area of foe hollow anatomical structure such as a vein can be flushed with a fluid such as saline, or a dielectric fluid, in order to evacuate blood from foe treatment area of foe vein so as to prevent foe formation of coagulum or thrombosis. The use of a dielectric fluid can 15 minimize unintended heating effects away from the treatment area. The dielectric fluid prevents the current of RF energy from flowing away from foe vein wall.

In one embodiment, foe catheter 10 includes a lumen which begins at the distal tip of the outer sheath 12 and runs substantially along foe axis of the 20 outer sheath 12 before terminating at foe guide-wire port 20 of the handle 16. A guide wire can be introduced through foe lumen of foe catheter 10 for use in guiding foe catheter to foe desired treatment site. Where foe catheter is sized to treat smaller veins, foe outer diameter of foe catheter may not allow for a fluid flush between foe outer sheath 12 and foe inner sheath 28. However, a 25 fluid flush can be introduced through foe lumen for the guide wire in such an embodiment.

Referring now to FIGS. 2, 2a, 3, 4,4a and 5, the outer sheath 12 includes a shell 44 and a tip portion 46. To provide an atraumatic tip for the catheter 10 as it is manipulated through foe vein, the tip 46 is preferably 30 tapered inward at its distal end or is “nosecone” shaped. The tip 46, however, can have other shapes that facilitate tracking of foe catheter 10 over a guide 17 wire and through the bends in the venous vascular system. The noseconeshaped tip 46 can, for example, be fabricated from a polymer having a soft durometer, such as 70 Shore A. The shell 44 comprises a biocompatible material having a low coefficient of friction. In one configuration, the outer 5 sheath 12 is sized to fit within a venous lumen and for example may be between 5 and 9 French, which corresponds to a diameter of between 1.7 mm (0.07 in) and 3.0 mm (1.2 in), or other sizes as appropriate.

The electrode device 24 contains a number of leads, including insulated primary leads 30 and, in some embodiments, a secondary lead 31. Preferably, 10 the leads are connected to the power source 22 (FIG. 1) such that the polarity of the leads may be switched as desired. Alternately, a microprocessor controller can be used to switch the polarity, as well as control other characteristics of the power for the electrode device. Thus the electrode device can operate in either a bipolar or a monopolar configuration. When adjacent 15 primary leads 30 have opposite polarity the electrode device 24 operates as a bipolar electrode device. When the primary leads 30 are commonly charged the electrode device 24 can operate as a monopolar electrode device. When the primary leads 30 are commonly charged, and a secondary lead 31 has an opposite polarity, the electrode device 24 operates as a bipolar electrode 20 device. The embodiment of foe invention shown in FIGS. 2 and 3 depict an electrode device 24 having four primary leads 30 and a secondary lead 31, while foe embodiment of foe invention shown in FIGS. 4 and 5 depict an electrode device 24 having only four primary leads. The invention is not limited to four primary leads 30; more or fewer leads may be used in either 25 embodiment. The number of leads can be dependent on foe size or diameter of foe hollow anatomical structure co be treated. The apposed electrodes should be kept within a certain distance of one another. Larger vessels may require more primary leads to ensure proper current density and proper heat distribution. 30 The insulation on each of the leads 30, 31 may be removed at the distal end 32, 33 to expose the conductive wire. In the first configuration as shown 18 in FIGS. 2, 2a, and 3, each electrode 34 has a hemispherical shape. In a second configuration, the electrode can have either a generally spherical shape or a spoon shape. As shown in FIGS. 4, 4a and 5, the electrodes have a spoon shape which can be combined to form a sphere or other shape so as to 5 minimize its profile when the vein collapses. The electrodes 34 are either integrally formed at the distal end 32, soldered, or otherwise formed co the distal end of each primary lead 30. It is to be understood that when the distal end 32 is referred to as acting as an electrode, this is not limited to where the electrode 34 is integrally formed at the distal end 32. For example, the distal 10 end can apply energy to the surrounding tissue where there is an electrode integrally formed at the distal end, or where an electrode is separately soldered to the distal end, or where there is another energy delivery device located at the distal end. The electrode 34 typically has a diameter greater than foe diameter of foe primary lead 30. For example, the primary lead 30 15 may have a diameter ranging from 0.18 mm (0.007 in.) to 0.28 mm (0.011 in.), while the electrode 34 has a diameter of 0.36 mm (0.014 in.) co 0.51 mm (0.020 in.). The primary leads 30 and foe electrodes 34 are preferably made from a biologically-compatible material such as stainless steel. The insulation surrounding the primary leads 30 generally has a thickness of between 0.03 20 mm (0.001 in.) and 0.06 mm (0.0025 in.), resulting in a combined lead- insulation diameter of between 0.23 mm (0.009 in.) and 0.41 mm (0.016 in.). In an alternate configuration, as shown in FIGS. 2 and 3, each primary lead 30 is strip-shaped with a width from 0.76 mm (0.03 in.) to 1.0 mm (0.04 in) and a thickness of approximately 0.13 mm (0.005 in.), while the secondary lead 31 25 is typically tubular-shaped. It should be noted that these dimensions are provided for illustrative purposes, and not by way of limitation. A hemispherical electrode 34 is shaped at foe distal end, as for example, by sanding down a sixteenth-inch (1.6 mm) diameter sphere which is soldered to foe distal end 32 of foe primary lead 30. The electrodes can also be 30 constructed by stamping the desired shape or configuration from foe conductive lead. The electrode is integral with foe lead, and foe remainder of -z 19 the lead is insulated. The distal end 33 of the secondary lead 31 preferably includes a generally spherically-shaped electrode 35.

An alignment device 36 arranges the leads 30, 31 such that they are mounted to the catheter at oniy their proximal ends and so that separation is 5 maintained between the leads within, and distal to the alignment device. The leads can form cantilevers when mounted on the alignment device. A preferred configuration of the alignment device 36 includes a plurality of off-center, axially-aligned lumina 38 which are substantially symmetrically positioned relative to the axis of the alignment device 36. The alignment 10 device 36 is formed, for example, by extruding the plurality of axially-aligned lumina 38 through a solid cylinder composed of a dielectric material, such as polyamide. Each lead 30 passes through an individual off-center lumen 38 and exits out the rear of the alignment device 36. The alignment device 36 may further include a central lumen 48 that may be aligned with the axis. In 15 some embodiments the central lumen 48 is used for accepting a guide wire or for the delivery or perfusion of medicant and cooling solution to the treatment area during application of RF energy. In other embodiments, the central lumen 48 may be used for the secondary lead 31. The alignment device 36 may also further include an auxiliary lumen 47 for additional leads, such as 20 the leads of a thermocouple used as a temperature sensor. The alignment device 36 comprises a dielectric material to prevent or minimize any coupling effect the leads 30, 31 may have with each other and, if present, the guide wire. The length of the alignment device is, for example, 12.5 nun (0.5 in.) to 19.0 mm (0.75 in.) in one embodiment However, these dimensions are 25 provided for purposes of illustration and not by way of limitation.

In the embodiment of the invention shown in FIGS. 2, 2a and 3, the inner sheath 28 is attached to the alignment device 36 and extends beyond the > rear 37 of the alignment device. Preferably, the inner sheath 28 completely surrounds the exterior wall of the alignment device 36 and is mounted to it by 30 adhesive or press fit or in other manner such that it remains in a fixed position relative to the inner sheath. The inner sheath and alignment device can act as 20 an inner member relative to the outer sheath. The inner sheath 28 comprises a biocompatibie material with a low coefficient of friction. The inner sheath 28 provides a pathway for foe interconnection between foe leads 30,31 and foe electrical connector 18 (FIG. 1). This interconnection may occur in any of 5 several ways. The leads 30,31 themselves may be continuous and run foe entire length of foe inner sheath 28. In the alternative (not shown), foe positively charged leads 30,31 may couple with a common positively charged conductor housed in foe inner sheath 28. Likewise, foe negatively charged leads 30, 31 may couple with a common negative conductor. Preferably, foe 10 leads 30, 31 are connected to a conductor that allows for foe polarity of foe leads to be switched. The conductor may comprise, for example, a 36 gauge copper lead with a polyurethane coating. The coupling may occur at any point within foe inner sheath 28. To reduce foe amount of wire contained in foe catheter, it is advantageous to couple foe leads 30, 31 at the point where foe 15 leads exit foe rear 37 of foe alignment device 36. To add further stability to foe electrode device 24, it is preferred that bonding material 40 surround foe leads 30,31 at foe front end of foe alignment device 36. In this embodiment, foe leads 30, 31 exit through foe distal orifice 14 as foe outer sheath 12 is retracted backwards over foe alignment device 36. The inwardly tapered tip 20 46 impedes foe retracting movement of foe outer sheath 12 to prevent foe exposure of foe alignment device 36. FIG. 3 shows foe leads 30 and 31 in foe retracted position where all leads are within the nosecone-shaped tip portion 46 and the outer shell 44.

The alignment device 36 has been moved relative to foe outer shell 44. The 25 soft nosecone provides an atraumatic tip for when the catheter is maneuvered through foe tortuous venous system. The electrode at the distal end of the secondary lead 31 can be sized to approximately foe same size as foe opening formed in foe nosecone 46. The nosecone forms a closed atraumatic tip together with the electrode of foe secondary lead when foe alignment device is 30 retracted into the outer sheath of the catheter. This can present an atraumatic 21 tip even where the nosecone is not constructed from a material having a soft durometer.

Referring now to FIGS. 4 and 5, in another embodiment, the alignment device 36 is attached to the outer sheath 12 and thereby remains immobile in 5 relation to it. The inner sheath 28 is movably positioned at the rear of the alignment device 36 and again provides a pathway for the interconnection between the primary leads 30 and the electrical connector 18 (FIG. 1). In some embodiments the inner sheath 28 contains a guide-wire tube 49 that runs the entire length of the inner sheath. The guide-wire tube 49 is aligned to 10 communicate with the central lumen 48 of the alignment device 36 at one end and with the guide-wire port 20 (FIG. 1) at the other end. The primary leads 30 may be continuous and nm the entire length of the inner sheath 28 or they may be coupled to common leads as previously described. The primary leads 30 are secured to the front end 27 of the inner sheath 28, as for example with 15 a potting material 50, so that the movement of the inner sheath 28 results in a corresponding movement of die primary leads 30 through the lumina 38 of the alignment device 36. In this embodiment, die primary leads 30 are not secured to the alignment device 36 and in essence are free-floating leads in the axial direction. The primary leads 30 travel through the alignment device 36 20 and exit through the distal orifice 14 as the front end of the inner sheath 28 is moved toward the rear 37 of the alignment device 36.

In the above embodiments, the primary leads 30 are formed, e. g., arced -or bent, to move away from each other and thereby avoid contact. The “distal portion” of the primary leads 30 is the portion of the lead which extends from 25 the front end of the alignment device 36 when foe leads are fully extended through the distal orifice 14. It is preferred that foe distal portions 42 are formed to move radially outward from each other relative to foe axis of the alignment device 36 and form a symmetrical arrangement. This is shown in both foe embodiments of FIG. 2a and FIG. 4a. The degree of arc or bend in 30 the primary leads 30 may be any that is sufficient to radially expand the leads as they exit the outer sheath 12 through the distal orifice 14. It is essential 22 that the degree of die arc or bend be sufficient to provide enough force so that the primary leads 30 expand through blood and the electrodes 34 come in apposition with die vein wall. The electrodes are preferably partially embedded in the vein wall to assure full contact. The rounded portion of the 5 electrode is embedded into the vein wall to achieve full surface apposition so that the entire uninsulated surface area of the electrode is in contact with venous tissue for effective current distribution. The surface area of the electrodes in contact with the venous tissue preferably is sufficient to avoid a high current density which may lead to spot heating of foe venous tissue. The 10 heating effect is preferably distributed along a circumferential band of foe vein. The apposed electrodes should be spaced no more than 4 or 5 millimeters from one another along foe circumference of foe vein. Thus, foe electrode arrangement is related to foe size or diameter of foe vein heing treated. Other properties of foe primary leads 30, such as lead shape and 15 insulation thickness, affect the push force of foe lead and foe degree of arc or bend must be adjusted to compensate for these factors. For example, in one configuration of foe electrode device 24, a wire having a diameter of between 0.18 mm (0.007 in) and 0.28 mm (0.011 in) with a total insulation thickness of between 0.05 mm (0.002 in) to 0.13 mm (0.005 in) is arced or bent at an 20 acute angle to proride sufficient apposition with the anatomical structure. It is to be understood that these dimensions are provided for illustrative purposes, and not by way of limitation.

Other techniques for expanding foe leads outwardly once they have been extended from foe working end of foe catheter may be possible. For 25 example, the leads may be straight but are mounted in foe alignment device at ah angle such that they are normally directed outward.

For increased appositionai force, it is preferred that the primary leads 30 be strip-shaped, that is rectangular in cross section, with dimensions, for example, of a width from 0.76 mm (0.030 in.) to 1.0 mm (0.039 in) and a 30 thickness of approximately 0.13 mm (0.005 in.). The rectangular cross section provides increased resistance to bending in the width dimension but allows 23 bending more freely in the thickness dimension. This strip-shaped configuration of the primary leads 30 is shown in FIGS. 2,2a, and 3 and provides for increased stability in the lateral direction while allowing the necessary bending in the radial direction. In FIGS. 2, 2a, and 3, each primary 5 lead comprises a rectangular cross section mounted in relation to the catheter such that the thinner dimension of the rectangular cross section is aligned with the direction of expansion of the lead. The leads are less likely to bend sideways when expanded outward, and a uniform spacing between leads is more assured. Uniform spacing promotes uniform heating around the venous 10 tissue which is in apposition with the electrodes at the distal ends of die leads. The length of che distal portion of the leads 30 also affects the configuration of the electrode device 24. The maximum distance between two mutually opposed electrodes 34; Le., the effective diameter of the electrode device 24, is affected by the bend degree and length of the distal portion 42. 15 The longer the length of the distal portion 42 the greater die diameter of the electrode device 24. Accordingly, by changing the distal portion 42 length and arc or bend degree, the catheter 10 can be configured for use in differently sized anatomical structures.

Different numbers of leads 30,31 can be employed witii the catheter. 20 The number of leads 30, 31 is limited by the diameter of the alignment device 36 and the number of lumina 36, 38,47 that can be extruded through the alignment device. In a bipolar configuration, an even number of primary leads 30 are preferably available to form a number of oppositely charged electrode pairs. The electrodes in apposition with the anatomical structure should be 25 maintained within a certain distance of each other. In a monopolar configuration, any number of commonly charged leads 30 can be present. In the monopolar mode, distribution of RF energy through the anatomical tissue is obtained by creating a return path for current through the tissue by providing a return device at a point external from the tissue, such as a large 30 metal pad. 24

Now referring again co FIG. 1, an actuator 25 controls the extension of the electrode device 24 through the distal orifice 14. The actuator 25 may take the form of a switch, lever, threaded control knob, or other suitable mechanism, and is preferably one that can provide fine control over foe 5 movement of the outer sheath 12 or the inner sheath 28, as the case may be.

In one embodiment of the invention, the actuator 25 (FIG. 1) interfaces with the outer sheath 12 (FIG. 2, 2a and 3) to move it back and forth relative to the inner sheath 28. In another embodiment the actuator 25 (FIG. 1) interfaces with the inner sheath 28 (FIGS. 4,4a and 5) to move it back and forth relative 10 to the outer sheath 12. The relative position between the outer sheath and inner sheath is thus controlled, but other control approaches may be used.

Referring again to FIGS. 2,2a, 3, 4,4a and 5, the catheter 10 includes a temperature sensor 26, such as a thermocouple. The temperature sensor 26 is mounted in place on an electrode 34 so that the sensor 26 is nearly or is 15 substantially flush with the exposed surface of the electrode 34. The sensor 26 is shown in the drawings as protruding from the electrodes for clarity of illustration only. The sensor 26 senses the temperature of the portion of the anatomical tissue that is in apposition with die exposed electrode surface. Monitoring the temperature of the anatomical tissue provides a good 20 indication of when shrinkage of the tissue is ready to begin. A temperature sensor 26 placed on the electrode facing the anatomical tissue provides an indication of when shrinkage occurs (70° C or higher) and when significant amounts of heat-induced coagulum may begin to form on the electrodes. Therefore maintaining the temperature above 70 degrees Centigrade produces 25 a therapeutic shrinkage of the anatomical structure. Application of the RF energy from the electrodes 34 is halted or reduced when the monitored temperature reaches or exceeds the specific temperature that was selected by the operator, typically the temperature at which anatomical tissue begins to cauterize. The temperature sensor 26 interfaces with foe controller 23 (FIG. 30 1) through a pair of sensor leads 45 which preferably nm through foe auxiliary lumen 47 and then through foe inner sheath 28. The signals from foe 25 temperature sensor 26 are provided to the controller 23 which controls the magnitude of KF energy supplied to the electrodes 34 in accordance with the selected temperature criteria and the monitored temperature. Other techniques such as impedance monitoring, and ultrasonic pulse echoing can be 5 utilized in an automated system which shuts down or regulates the application of RF energy from the electrodes to the venous section when sufficient shrinkage of the vein is detected and to avoid overheating the vein.

Impedance can be used to detect the onset of coagulum formation.

Referring now to FIGS. 6, 6a and 7a through 7c, in the operation of one 10 embodiment of the catheter 10, the catheter is inserted into a hollow anatomical structure, such as a vein 52. The catheter is similar to the embodiment discussed in connection with FIGS. 2 and 3. The catheter 10 further includes an external sheath 60 through which a fluid can be delivered to the treatment site. In this embodiment, the fluid port (not shown) 15 communicates with the interior of foe external sheath 60, and fluid is delivered from between foe external sheath 60 and the outer sheath 12. The external sheath 60 surrounds foe outer sheath 12 to form a coaxial channel through which fluid may be flushed.

Fluoroscopy, ultrasound, an angioscope imaging technique, or other 20 technique may be used to direct foe specific placement of the catheter and confirm foe position in the vein. The actuator (not shown) is then operated to shift the outer sheath relative to foe inner sheath by either retracting the outer sheath 12’backward or advancing the inner sheath 28 forward to expose the leads 30, 31 through foe distal orifice 14. As the leads 30, 31 exit foe distal 25 orifice 14, foe primary leads 30 expand radially outward relative to foe axis of the alignment device 36, while foe secondary lead 31 remains substantially linear. The primary leads 30 continue to move outward until apposition with foe vein wall 54 occurs and foe outward movement of the primary leads 30 is impeded. The primary leads 30 contact the vein along a generally 30 circumferential band of foe vein wall 54. This outward movement of foe primary ieads 30 occurs in a substantially symmetrical fashion. As a result, foe 26 primary-lead electrodes 34 are substantially evenly spaced along the circumferential band of the vein wall 54. The central-lead electrode 35 is suspended within the vein 52 without contacting the vein wail 54.

When the electrodes 34 are positioned at the treatment site of the vein, 5 the power supply 22 is activated to provide suitable RF energy. One suitable frequency is 510 kHz. One criterion used in selecting the frequency of the energy to be applied is the control desired over the spread, including the depth, of the thermal effect in the venous tissue. Another criterion is compatibility with filter circuits for eliminating RF noise from thermocouple 10 signals.

In bipolar operation, the primary leads 30 are initially charged such that adjacent leads are oppositely charged while the secondary lead is electrically neutral. These multiple pairs of oppositely charged leads 30 form active electrode pairs to produce an RF field between them. Thus, discrete RF fields 15 are set up along the circumferential band of the vein wall 54. These discrete fields form a symmetrical RF field pattern along the entire circumferential band of foe vein wall 54, as adjacent electrodes 34 of opposite polarity produce RF fields between each other. A uniform, temperature distribution can be achieved along foe vein wall being treated. 20 The RF energy is converted within foe adjacent venous tissue into heat, and this thermal effect causes foe venous tissue to shrink, reducing foe diameter of the vein. A uniform temperature distribution along foe vein wall being treated avoids foe formation of hot spots in the treatment area while promoting controlled uniform reduction in vein diameter. The thermal effect 25 produces structural transfiguration of the collagen fibrils in the vein. The collagen fibrils shorten and thicken in cross-section in response to foe heat from foe thermal effect. As shown in FIG 7a, foe energy causes foe vein wall 54 to collapse around the primary-lead electrodes 34. The wall 54 continues to collapse until further collapse is impeded by foe electrodes 34. The 30 electrodes are pressed farther and farther together by the shrinking vein wall 54 until they touch and at that point, further collapse or ligation of the wall 54 27 is impeded. Upon collapse of the vein wail 54 around the primary-lead electrodes 34, the polarity of the primary-lead electrodes is switched so that all primary-lead electrodes are commonly charged. The switching of polarity for the leads need not be instantaneous. The application of RF energy can be 5 ceased, the polarity switched, and then RF energy is applied again at the switched polarity. The secondary-lead electrode 35 is then charged so that its polarity is opposite that of the primary-lead electrodes 34. The RF field is set up between the primary-lead electrodes 34 and the secondary-lead electrode 35. 10 The catheter 10 is then pulled back while energy is applied to the electrode device. As shown in FIG. 7b, while die catheter 10 is being pulled back, the primary-lead electrodes 34 remain in apposition with the vein wall 54 while the secondary-lead electrode 35 comes in contact with die portion of the vein wall previously collapsed by the primary-lead electrodes 34. 15 Accordingly, RF energy passes through the vein wall 54 between the primary-lead electrodes 34 and the secondary-lead electrode 35 and the vein wall continues to collapse around die secondary-lead electrode 35 as the catheter 10 is being retracted. As shown in FIG. 7c, ligation in accordance with this method results in an occlusion along a length of the vein 52. A lengthy 20 occlusion, as opposed to an acute occlusion, is stronger and less susceptible to recanaiization. A similar result is achieved when the catheter 10 having both primary and secondary leads is operated in a monopolar manner in a monopolar operation, the secondary-lead electrode 35 remains neutral, while the primary 25 leads 30 are commonly charged and act in conjunction with an independent electrical device, such as a large low-impedance return pad (not shown) placed in external contact with the body, to form a series of discrete RF fields. These RF fields are substantially evenly spaced around the circumference of the vein and travel along the axial length of the vein wall causing the vein wail 30 to collapse around the primary-lead electrodes. Upon collapse of the vein wail, foe secondary-lead elecnode is charged to have foe same polarity as that of the 28 primary-lead electrodes. The electrode device is retracted and the vein wail collapses as described in the bipolar operation.

In either bipolar or monopolar operation the application of RF energy is substantially symmetrically distributed through the vein wall, regardless of the 5 diameter of the vein 52. This symmetrical distribution of RF energy increases the predictability and uniformity of the shrinkage and the strength of foe occlusion. Furthermore, the uniform distribution of energy allows for foe application of RF energy for a short duration and thereby reduces or avoids the formation of heat-induced coagulum on foe electrodes 34. The leads, 10 including foe non-convex outer portion of the electrode, are insulated to further prevent heating of foe surrounding blood.

Fluid can be delivered before and during RF heating of foe vein being treated through a coaxial channel formed between the external sheath 60 and foe outer sheath 12. It is to be understood that another lumen can be formed 15 in the catheter to deliver fluid to foe treatment site. The delivered fluid displaces or exsanguinates blood from foe vein so as to avoid heating and coagulation of blood. Fluid can continue to be delivered during RF treatment to prevent blood from circulating back to foe treatment site. The delivery of a dielectric fluid increases the surrounding impedance so that RF energy is 20 directed into the tissue of the vein wall.

Referring now to FIGS. 8, 8a, 9a and 9b, in foe operation of an alternate embodiment of foe catheter 10 that may be used with a guide wire 53. As in the previous embodiment, the catheter 10 is inserted into a hollow anatomical structure, such as a vein 52. The guide wire 53 is advanced past 25 foe point where energy application is desired. The catheter 10 is then inserted over foe guide wire 53 by way of the central lumen 48 and the guide wire tube 49 (FIG. 4) and is advanced over the guide wire through the vein to foe desired point. The guide wire 53 is typically pulled back or removed before RF energy is applied to the electrode device 24.

The actuator 25 (FIG. 1) is then manipulated to either retract foe outer sheath 12 backward, or advance foe inner sheath 28 forward to expose foe 30 29 leads 30 through the distal orifice 14. The leads 30 exit foe distal orifice 14 and expand radially outward relative to foe axis of the alignment device 36. The leads 30 continue to move outward until apposition with the vein wall 54 occurs. The leads 30 contact the vein along a generally circumferential band 5 of foe vein wall 54. This outward movement of foe leads occurs in a substantially symmetrical fashion. As a result, foe electrodes 34 are substantially evenly spaced along foe circumferential band of foe vein wall 54. Alternately, foe electrodes can be spaced apart in a staggered fashion such that foe electrodes do not lie along the same plane. For example, adjacent 10 electrodes can extend different lengths from foe catheter so that a smaller cross-sectional profile is achieved when foe electrodes are collapsed toward one another.

When foe electrodes 34 are positioned at foe treatment site of foe vein, foe power supply 22 is activated to provide suitable RF energy co foe 15 electrodes 34 so that foe catheter 10 operates in either a bipolar or monopolar manner as previously described. As shown in FIGS. 9a and 9b, foe energy causes foe vein wall 54 to collapse around foe electrodes 34 causing foe leads to substantially straighten and foe electrodes to cluster around each other.

The wall 54 continues to collapse until further collapse is impeded by foe 20 electrodes 34 (FIG. 9b). At this point foe application of energy may cease.

The electrodes can be configured to form a shape with a reduced profile when collapsed together. The electrodes can also be configured and insulated to continue applying RF energy after fanning a reduced profile shape by the collapse of foe vein wall. The catheter 10 can be pulled back to ligate foe 25 adjacent venous segment. If a temperature sensor 26 is included, the application of energy may cease prior to complete collapse if foe temperature of the venous tissue rises above an acceptable level as defined by foe controller 23.

Where the catheter includes a fluid delivery lumen (not shown), fluid 30 can be delivered before and during RF heating of foe vein being treated. The fluid can displace blood from the treatment area in the vein to avoid the 30 coagulation of blood. The fluid can be a dielectric medium. The fluid can include an anticoagulant such as heparin which can chemically discourage the coagulation of blood at the treatment site.

After completing the procedure for a selected venous section, the 5 actuator mechanism causes the primary leads co return to the interior of the outer sheath 12. Either the outer sheath or the inner sheath is moved to change the position of the two elements relative to one another. Once the leads 30 are within the outer sheath 12, the catheter 10 may be moved to another venous section where the ligation process is repeated. Upon treatment 10 of all venous sites, the catheter 10 is removed from the vasculature. The access point of the vein is then sutured closed, or local pressure is applied until bleeding is controlled.

Another embodiment of the catheter is illustrated in FIG. 10. The inner member or sheath 28 is contained within the outer sheath 12. The inner 15 sheath is preferably constructed from a flexible polymer such as polyimide, polyethylene, or nylon, and can travel the entire length of the catheter. The majority of the catheter should be flexible so as to navigate the tortuous paths of the venous system. A hypotube having a flared distal end 39 and a circular cross-sectional shape is attached over the distal end of the inner sheath 28. 20 The hypotube is preferably no more than about two to three centimeters in length. The hypotube acts as part of the conductive secondary lead 31. An uninsulated conductive electrode sphere 35 is slipped over ±e hypotube. The flared distal end of the hypotube prevents the electrode sphere from moving beyond the distal end of the hypotube. The sphere is permanently affixed to 25 the hypotube, such as by soldering the sphere both front and back on the hypotube. The majority or the entire surface of the spherical electrode 35 remains uninsulated. The remainder of the hypotube is preferably insulated so that the sphere-shaped distal end can act as the electrode. For example, the hypotube can be covered with an insulating material such as a coating of 30 parylene. The interior lumen of the hypotube is lined by the inner sheath 28 31 which is attached to the haired distal end of the hypotube by adhesive such as epoxy.

Surrounding the secondary lead 31 and sphere-shaped electrode 35 are a plurality of primary leads 30 which preferably have a flat rectangular strip 5 shape and can act as arms. As illustrated in FIG. 11, the plurality of primary leads are preferably connected to common conductive rings 62. This configuration maintains foe position of foe plurality of primary leads, while reducing foe number of internal electrical connections. The rings 62 are attached to the inner sheath 28. The position of the rings and the primary 10 leads relative to foe outer sheath follows that of the inner sheath. As earlier described, the hypotube of foe secondary lead 31 is also attached to foe inner sheath 28. Two separate conductive rings can be used so that the polarity of different primary leads can be controlled separately. For example, adjacent primary leads can be connected to one of foe two separate conductive rings so 15 that foe adjacent leads can be switched to have either opposite polarities or foe same polarity. The rings are preferable spaced closely together, but remain electrically isolated from one another along the inner sheath. Both foe rings and the hypotube are coupled with foe inner sheath, and foe primary leads 30 that are connected to foe rings move together with and secondary lead while 20 remaining electrically isolated from one another. Epoxy or another suitable adhesive can be used to attach the rings to foe inner sheath. The primary leads from the respective rings each alternate with each other along the circumference of foe inner sheath. The insulation along the underside of foe leads prevents an electrical short between foe rings. 25 The ring and primary leads are attached together to act as cantilevers where foe ring forms the base and foe rectangular primary leads operate as foe cantilever arms. The leads 30 are connected to the ring and are formed to have an arc or bend such that the leads act as arms which tend to spring outwardly away from the catheter and toward the surrounding venous tissue. 30 Insulation along foe underside of the leads and the rings prevents unintended electrical coupling between foe leads and the opposing rings. Alternately, the 32 leads are formed straight and connected to the ring at an angle, such that the leads tend to expand or spring radially outward from the ring. The angle at which the leads are attached to the ring should be sufficient to force the primary distal ends and electrodes 34 through blood and into apposition with 5 the vein wall. Other properties of the primary leads 30, such as lead shape and insulation thickness, affect the push force of the lead and the degree of arc or bend must be adjusted to compensate for these factors. The rectangular cross section of the leads 30 can provide increased stability in the lateral direction while allowing the necessary bending in the radial direction. The 10 leads 30 are less likely to bend sideways when expanded outward, and a uniform spacing between leads is more assured. Uniform spacing between the leads 30 and the distal ends promotes uniform heating around the vein by the electrodes 34.

The distal ends of the primary leads 30 are uninsulated to act as 15 electrodes 34 having a spoon or hemispherical shape. The leads can be stamped to produce an integral shaped electrode at the distal end of the lead. The uninsulated outer portion of the distal end electrode 34 which is to come into apposition with the wall of the anatomical structure is preferably rounded and convex. The flattened or non-convex inner portion of the distal end is 20 insulated to minimize any unintended thermal effect, such as on the surrounding blood in a vein. The distal end electrodes 34 are configured such that when the distal ends are forced toward the inner sheath 12, as shown in FIG. 10a, the distal ends combine to form a substantially spherical shape with a profile smaller than the profile for die spherical electrode 35 at foe 25 secondary distal end.

The outer sheath 12 can slide over and surround the primary and secondary leads 30,31. The outer sheath 12 includes an orifice which is dimensioned to have approximately the same size as the spherical electrode 35 at foe secondary distal end which functions as an electrode. A close or snug fit 30 between the electrode 35 at the secondary distal end and the orifice of the outer sheath 12 is achieved. This configuration provides an atraumatic tip for 33 the catheter. The electrode 35 secondary distal end is preferably slightly larger chan the orifice. The inner diameter of the outer sheath 12 is approximately the same as the reduced profile of the combined primary distal end electrodes 34. The diameter of the reduced profile of the combined primary distal end 5 electrodes 34 is preferably less than the inner diameter of the outer sheath. A fluid port (not shown) can communicate with the interior of the outer sheath 12 so that fluid can be flushed between the outer sheath 12 and the inner sheath 28. Alternately, a fluid port can communicate with a central lumen 48 in the hypotube which can also accept a guide wire. As previously 10 stated, the catheter 10 can be periodically flushed with saline which can prevent ±e buildup of biological fluid, such as blood, within the catheter 10. A guide wire can be introduced through the lumen 48 for use in guiding the catheter to the desired treatment site. As previously described, a fluid can be flushed or delivered though the lumen as well. If a central lumen is not 15 desired, the lumen of the hypotube can be filled with solder.

Preferably, the primary leads 30 and the connecting rings are connected to a power source 22 such that the polarity of the leads may be switched as desired. This allows for the electrode device 24 to operate in either a bipolar or a monopolar configuration. When adjacent primary leads 30 have opposite 20 polarity, a bipolar electrode operation is available. When the primary leads 30 are commonly charged a monopolar electrode operation is available in combination with a large return electrode pad placed in contact with the patient. When the primary leads 30 are commonly charged, and a secondary lead 31 has an opposite polarity, a bipolar electrode operation is available. 25 More or fewer leads may be used. The number of leads can be dependent on the size or diameter ofthe hollow anatomical structure to be treated.

Although not shown, it is to be understood that the catheter 10 can include a temperature sensor, such as a thermocouple, mounted in place on trie distal end or electrode 34 so that the sensor is substantially flush with the 30 exposed surface of the electrode 34. The sensor senses the temperature of the portion of the anatomical tissue that is in apposition with trie exposed

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34 electrode surface. Application of the RF energy from the electrodes 34 is halted or reduced when the monitored temperature teaches or exceeds the specific temperature that was selected by the operator, such as the temperature at which anatomical tissue begins to cauterize. Other techniques 5 such as impedance monitoring, and ultrasonic pulse echoing can be utilized in an automated system which shuts down or regulates the application of RF energy from the electrodes to foe venous section when sufficient shrinkage of foe vein is detected and to avoid overheating foe vein.

Referring now to FIGS. 12 through 14, in foe operation of one 10 embodiment of the catheter 10, foe catheter is inserted into a hollow anatomical structure, such as a vein. Fluoroscopy, ultrasound, an angioscope imaging technique, or another technique may be used to direct and confirm foe specific placement of foe catheter in foe vein. The actuator is then operated to retract foe outer sheath 12 to expose foe leads 30,31. As foe 15 outer sheath no longer restrains foe leads, foe primary leads 30 move outward relative to the axis defined by foe outer sheath, while foe secondary lead 31 remains substantially linear along foe axis defined by foe outer sheath. The primary leads 30 continue to move outward until foe distal end electrode 34 of foe primary leads are placed in apposition with foe vein wall 54 occurs and foe 20 outward movement of foe primary leads 30 is impeded. The primary leads 30 contact foe vein along a generally circumferential area of foe vein wall 54.

This outward movement of foe primary leads 30 occurs in a substantially symmetrical fashion so that foe primary distal end electrodes 34 are substantially evenly spaced. The central-lead electrode 35 is suspended within 25 foe vein without contacting the vein wall 54.

When foe electrodes 34 are positioned at foe treatment site of foe vein, foe power supply 22 is activated to provide suitable RF energy. In a bipolar operation, the primary leads 30 are initially charged such that adjacent leads are oppositely charged while foe secondary lead is electrically neutral. These 30 multiple pairs of oppositely charged leads 30 form active electrode pairs to produce an RF field between them, and form a symmetrical RF field pattern 35 along a circumferential band of the vein wall to achieve a uniform temperature distribution along the vein wall being treated.

The RF energy produces a thermal effect which causes the venous tissue to shrink, reducing the diameter of foe vein. As shown in FIG 13, the energy 5 causes the vein wall 54 to collapse until further collapse is impeded by foe electrodes 34. The electrodes are pressed closer together by the shrinking vein wall. The electrodes 34 are pressed together to assume a reduced profile shape which is sufficiently small so that the vein is effectively ligated. Upon collapse of foe vein wall 54 around foe primary-lead electrodes 34, the polarity 10 of the primary-lead electrodes is switched so that all of the primary-lead electrodes are commonly charged. The secondary-lead electrode 35 is then charged so that its polarity is opposite that of the primary-lead electrodes 34. Where the primary electrodes 34 and the secondary electrode 35 are spaced sufficiently close together, when foe vein wall collapses around the primary 15 lead electrodes, foe electrode at foe distal end of foe secondary lead can also come into contact with the a portion of foe vein wall so that an RF field is created between the primary electrodes 34 and foe secondary electrode 35.

The catheter 10 is pulled back to ensure apposition between foe electrodes at the distal ends of the leads and the vein wall. When foe catheter 20 10 is being pulled back, foe primary-lead electrodes 34 remain in apposition ^with the vein wall 54 while foe secondary-lead electrode 35 comes in contact ; with foe portion of the vein wall previously collapsed by the primary-lead electrodes 34. RF energy passes through foe venous tissue between the primary-lead electrodes 34 and foe secondary-lead electrode 35. Ligation as 25 the catheter is being retracted produces a lengthy occlusion which is stronger and less susceptible to recanalization than an acute point occlusion.

In a monopolar operation, the secondary-lead electrode 35 remains neutral, while the primary leads 30 are commonly charged and act in conjunction with an independent electrical device, such as a large low- 30 impedance return pad (not shown) placed in external contact with the body, to form RF fields substantially evenly spaced around the circumference of foe 36 vein. The thermal effect produced by those RF fields along the axial length of the vein wall causes the vein wall to collapse around the primary-lead electrodes. Upon collapse ofthe vein wall, the secondary-lead electrode is charged to have the same polarity as chat of the primary-lead electrodes. The 5 electrode device is retracted as described in the bipolar operation.

In either bipolar or monopolar operation the application of RF energy is substantially symmetrically distributed through the vein wall. As previously described, foe electrodes should be spaced no more than 4 or 5 millimeters apart along foe circumference of the vein, which defines foe target vein 10 diameter for a designed electrode catheter. Where the electrodes are substantially evenly spaced in a substantially symmetrical arrangement, and foe spacing between the electrodes is maintained, a symmetrical distribution of RF energy increases foe predictability and uniformity of foe shrinkage and foe strength of the occlusion. 15 As shown in FIG. 14, after foe electrodes 34 come into apposition with the vein wall (FIG. 12), and before foe energy is applied to ligate foe vein (FIG. 13), an external tourniquet, such as an elastic compressive wrap or an inflatable bladder with a window transparent to ultrasound, is used to compress the anatomy, such as a leg, surrounding the structure to reduce the 20 diameter of the vein. Although the compressive force being applied by foe tourniquet may effectively ligate the vein, or otherwise occlude the vein by flattening the vein, for certain veins, this compressive force will not folly occlude foe vein. A fixed diameter electrode catheter in this instance would not be effective. The electrodes 34 which are expanded outward by the 25 formed leads 30 can accommodate this situation.

The reduction in vein diameter assists in pre-shaping foe vein to prepare foe vein to be molded to a ligated, state. The use of an external tourniquet also exsanguinates the vein and blood is forced away from foe treatment site. Coagulation of blood during treatment can be avoided by this 30 procedure. Energy is applied from foe electrodes to the exsanguinated vein, 37

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and the vein is molded to a sufficiently reduced diameter to achieve ligation. The external tourniquet can remain in place to facilitate healing.

The catheter can be pulled back during the application of RF energy to ligate an extensive section of a vein. In doing so, instead of a single point 5 where the diameter of the vein has been reduced, an extensive section of the vein has been painted by foe RF energy from foe catheter. Retracting foe catheter in this manner produces a lengthy occlusion which is less susceptible to recanalization. The combined use of foe primary and secondary electrodes can effectively produce a reduced diameter along an extensive length of the 10 vein. The catheter can be moved while foe tourniquet is compressing foe vein, of after foe tourniquet is removed.

Where the catheter includes a fluid delivery lumen, fluid can be delivered to foe vein before RF energy is applied to foe vein. The delivered fluid displaces blood from foe treatment site to ensure that blood is not present 15 at foe treatment site, even after the tourniquet compresses foe vein.

Where foe tourniquet is an inflatable bladder with a window transparent to ultrasound, an ultrasound transducer is used to monitor foe flattening or reduction of the vein diameter from foe compressive force being applied by the inflating bladder. The window can be formed from 20 polyurethane, or a stand-off of gel contained between a polyurethane pouch. A gel can be applied to the window to facilitate ultrasound imaging of foe vein by the transducer. Ultrasound visualization through foe window allows foe operator to locate the desired venous treatment area, and to determine when foe vein has been effectively ligated or occluded. Ultrasound visualization 25 assists in monitoring any pre-shaping of foe vein in preparation of being molded into a ligated state by foe thermal effect produced by the RF energy from the electrodes.

After completing the procedure for a selected venous section, foe actuator causes foe leads 30 to return to foe interior of foe outer sheath 12. 30 Once the leads 30 are within foe outer sheath 12, foe catheter 10 may be moved to another venous section where foe ligation process is repeated. 38

In another embodiment, as illustrated in FIG. 15, a balloon 64 is located on the catheter, and can be inflated through ports 66 to occlude the vein. The inflated balloon obstructs blood flow and facilitates the infusion of a high-impedance fluid to the vein in order to reduce the occurrence of coagulation 5 by directing the energy into the vein wall. The inflation of die balloon to occlude the vein before the application of energy can obviate the use of die tourniquet to occlude the vein. Furthermore, this also allows the vein to be occluded even for the deep veins where a compressive tourniquet may not be able to compress the vein to occlusion. It is to be understood that other 10 mechanisms can be used to expand the diameter of the catheter to create an impermeable barrier that occludes the vein.

Fluid 61 can be delivered after inflation of the balloon 64 and before the RF heating of the vein being treated through a coaxial channel 62 fonned between the external sheath 60 and the outer sheath 12. It is to be understood 15 that another lumen can be formed in the catheter to deliver fluid to the treatment site. For example, the lumen through which the guide wire is passed may be used for the delivery of fluid. The delivered fluid displaces or exsanguinates the remaining blood from the treatment area of the vein so as to avoid heating and coagulation of blood. Fluid can continue to be delivered 20 during RF treatment to prevent blood from circulating back to the treatment site. The delivery of a high-dielectric fluid increases the surrounding impedance so that RF energy is directed into the tissue of the vein wall. Less energy is used because the energy is directed to the target; i.e., the vein wall, rather than being dissipated in the blood. Therefore, the vein wall can reach 25 the desired temperature more rapidly than in the case where energy is permitted to reach the blood, which has a cooling effect. Additionally, blood clotting is avoided with this approach, because the blood has been replaced with another fluid such as deionized water mixed with heparin to displace blood and prevent the formation of blood dots. 30 A partial cross-sectional view of this embodiment is shown in FIG. 16, where an inflation sheath 70 surrounds the external sheath 60 to provide a 39 coaxial inflation lumen 72 for the balloon 64. The inflation lumen 72 is in fluid communication with the ports 66. Saline or any other suitable fluid can be used to inflate the balloon.

As shown in the FIG. 17, in one embodiment, the balloon 64 can be 5 used in combination with bowable members or arms 76 having electrodes, where perfusion holes 78 are formed in the catheter between the balloon 64 and the bowable arms 76. The balloon 64 in this embodiment is inflated through a balloon inflation lumen 72 (as shown in FIG. 16). The use of bowable arms for treating veins is discussed in U.S. patent application serial 10 no. 08/610,911, which is hereby incorporated fay reference. The aims can be constructed so as to spring radially outward from the catheter, yet offer little resistance in moving back toward the catheter as foe vein diameter is diminished to occlusion. An anti-coagulant or saline or a high-impedance fluid can be introduced or flushed through foe perfusion holes 78 in foe catheter. 15 As discussed earlier, foe high-impedance fluid forces blood away from foe venous treatment area and prevents foe energy from being dissipated in a more conductive medium such as blood.

As shown in FIG. 18, in another embodiment, a flexible covering 80 is wrapped around or inside foe leads 30 of foe electrodes 34 to prevent blood 20 flow in foe vein. The covering 80 spans foe area between the splayed leads along the circumference of the catheter when foe leads are extended out foe opening, such that the webbed covering blocks blood flow within foe vein.

The covering may be thought of as webbing or an umbrella to keep blood on one side away from foe electrodes. When the electrodes come into apposition 25 with foe vein wall, then foe gap, if any, between foe electrodes 34 and foe covering 80 should be eliminated or otherwise minimized. The covering 80 should be impermeable to fluid. Suitable materials include PET and nylon. Elastomeric materials are also suitable as the leads will need to move close together as they are retracted, and interference with foe movement of foe 30 leads as the vein diameter is reduced by the application of energy is preferably minimized. Although this embodiment is illustrated with only primary leads, it 40 is to be understood that this embodiment is not so limited and that a secondary lead may be included with the catheter as well without affecting the use of the covering.

As with the balloon disclosed earlier, the covering occludes the vein 5 before the application of energy, such that the need for an external compressive tourniquet is not required to stop blood flow. Furthermore, this also allows the vein to be occluded even for the deep veins where a compressive tourniquet may not be able to compress the vein to occlusion. A high-impedance fluid such as deionized water, or an anti-coagulant such as 10 heparin or saline, or both, or heparin with deionized water may be infused or flushed through a central lumen (not shown) similar to that shown in FIG. 4 as numeral 48 or to that shown in FIGS. 10 and 11 before the application of energy as well. The electrodes extend through the shaft lumen which also acts as a conduit for the fluid being flushed through a central lumen 48 (not 15 shown). A sclerosing fluid may also be delivered to the venous treatment site to enhance the dlectro-ligation effect from the application of RF energy. The sclerosing fluid may be added in addition to, or in substitution of, the previously discussed fluids.

In the embodiment shown in FIG. 19, a covering 80 having a parachute 20 shape can be oriented so that blood becomes trapped by the concave portion of the covering 80 and the volume of the blood maintains the deployment of the covering. In this example, the covering is a balloon having openings 84 which allow blood to gather in the balloon, and expand the balloon. The covering 80 can be permanently attached to the catheter shaft. The catheter can still be 25 moved along the vein, even with the balloon in an inflated state.

In the embodiment shown in FIG. 20, the covering 80 is coupled to an outer cannula 82 surrounding the catheter shaft and connected to an actuation mechanism or lever. The outer cannula 82 can be slid along the longitudinal axis of the catheter to allow one end of the parachute covering 80 to be moved 30 axially along the catheter shaft. During insertion of the catheter, the movable end of the covering is pulled away from the connecting end of the catheter to 41 collapse the covering against the catheter. After the catheter is delivered to the venous treatment site, foe cannula 82 is slid toward the working end to deploy the covering 80 which then fills with blood entering through foe openings 84, thereby occluding the vein. The covering expands as it fills with 5 blood, and when the covering comes into contact with the vein wail, the vein is occluded. Fluid, as before, can be infused either through perfusion holes 78 or a coaxial channel 48 (not shown).

In foe embodiment shown in foe cross-sectional view of FIG. 21,,the catheter 10 includes an expandable section having a skeleton 90 disposed 10 along a portion of foe working end of foe catheter. The skeleton 90 is more flexible than the surrounding shaft of foe catheter, and can be constructed from a metal or polymer braid. A flexible membrane 92 covers foe skeleton 90, with the ends of foe membrane attached to foe shaft of foe catheter adjacent the skeleton. The membrane is preferably constructed from an 15 elastomeric material. As shown in FIG. 22, when foe tip of foe connecting end is moved toward the working end of foe catheter, or vice versa, foe skeleton 90 is deformed and forces foe membrane 92 out into contact with the vein wall. This embodiment does not require a separate lumen to provide an inflation fluid to a balloon. The skeleton 90 is preferably resilient so that it returns to 20 its original shape once foe working end and connecting end are no longer being forced toward one another. Mechanisms for moving foe connecting end toward foe working end of foe catheter for expanding foe diameter of a catheter are also discussed in U.S. patent application serial no. 08/610,911, which has been incorporated by reference. Although foe expandable section 25 may be controlled separately from the extension of foe electrode, foe expandable section can be controlled by foe same mechanism which extends the electrodes away from foe catheter.

As illustrated in FIGS. 23 and 24, another embodiment of an expandable electrode catheter 98 includes two sets of expandable electrode 30 leads 100 and 102, although additional sets of electrode leads may be possible. The electrodes 104 of this embodiment are similar to foe electrodes of the 42 embodiment illustrated in FIG. 2 having electrodes with a spoon-shaped contact area. Other shapes for the electrode may be used, such as ellipses, rounded, ovals, race tracks, and others. Although only one electrode is indicated by numeral 104 in FIGS. 23 and 24, this is for purposes of clarity in 5 the drawings only. All electrodes are meant to be indicated by numeral 104. While each set of electrode leads may include as few as two electrode leads, the illustrated embodiment includes six electrode leads per set, although more than six electrode leads may be used as well.

In the embodiment shown in FIGS. 23 and 24, the sets of electrode 10 leads 100 and 102 are longitudinally separated from each other. Thus, the electrodes within each set of electrode leads are separated from one another radially and each of those electrodes is also separated from every electrode in the other set longitudinally, due to the longitudinal separation. There therefore exists radial separation and longitudinal separation of electrodes at 15 the working end 105 of the catheter 98 in the arrangement shown in FIGS. 23 and 24.

With the configuration of electrode leads presented in FIGS. 23 and 24, greater flexibility exists in establishing current flows through the tissue of a patient. As in previous embodiments, the electrodes expand outwardly into 20 contact with patient tissue. Where all the electrodes of a first set of electrode leads have die same polarity, there may be an odd number of electrodes in the seq or an even number. All electrodes in the set may be connected to a common connection point, such as the conducting ring 62 shown in FIG. 11. A single conductor from the connecting end of the catheter may power all 25 electrodes of the set by a single connection to that conducting ring. All electrodes of a second set of electrode leads may also be commonly connected at a respective conducting ring but to a different electrical potential than foe first set. Because two different electrical potentials exist at foe working end of the catheter, energy will flow through the patient tissue between those sets of 30 electrode leads and a bipolar arrangement will exist. Thus, a length of patient 43 tissue, at least as long as the distance between the first and second sets of electrode leads, will receive the energy. A monopolar arrangement may also be established if desired by setting all electrodes of ail electrode leads to the same electrical potential and 5 establishing a different electrical potential outside the patient, such as at a . "backplate” in contact with the skin of the patient at a selected location.

Energy from the working end 105 of the catheter will then flow through the patient to the return provided by the backplate.

In another arrangement in polarizing or controlling the electrical 10 potential at the electrodes, the electrodes in the first set of electrode leads may be individually controlled so that there are electrode pairs of differing potentials in the set of leads. This would establish a bipolar approach within the first set of leads itself. If the electrodes of the second set of leads are likewise connected for different potentials among themselves, they too would 15 provide a bipolar approach in their own set and currents would flow through patient tissue between the electrodes in each set of leads. If the electrodes having a first polarity in the first set are aligned with the electrodes having a different polarity in the second set of leads, energy would not only flow between the bipolar electrodes within the set but would also flow to the 20 electrodes in the other set resulting in two bipolar arrangements at the single working end of the catheter. Patient tissue of a length at least as great as foe distance between foe first and second sets of electrode leads will receive energy as well as patient tissue between electrodes within each set of leads itself. 25 A further arrangement coupled with foe bipolar approach just described would be to also use a backplate at a different electrical potential to provide further control over the energy flow through foe patient’s tissue. In this case, energy would flow between foe electrodes within each set of leads, between elecrtodes in different sets of leads, and between electrodes and the backplate. 30 In yet a further arrangement, each of the electrodes may be individually connected to a power source (22, FIG. 1) and the electrical potential at each 44 electrode can be individually controlled (23, FIG. 1). This arrangement may yield even more precise control over the current densities through patient tissue. As an example, where less current flow is desired between certain electrodes of a set of leads but more current flow is desired between those 5 electrodes and electrodes of a second set of leads, the potential between the electrodes of the same set may be reduced but the potential between those electrodes and the electrodes of the second set of leads may be increased resulting in the desired current flow densities. In the case where a backpiate is also used, the electrodes may be controlled so that energy flows between such 10 electrodes and the backpiate. Because each electrode is individually controlled, the level of energy it imparts to the tissue at its location is controllable.

One factor that could affect the number of electrodes per set of electrode leads is the diameter of the vein being treated. The design of the 15 contact pad for the electrode leads could also affect the desired number of electrodes for a given procedure.

In this embodiment, the electrode leads 100,102 are formed to expand outwardly into apposition with the target tissue, yet as the target tissue shrinks, the electrodes maintain contact with that tissue and are moved 20 inwardly by that tissue. Because of this arrangement, the leads compensate for variations in the diameter of the vein. They are therefore capable of maintaining apposition with the tissue whether or not compression of the vein or anatomical structure exists, such as by use of a pressure cuff or tourniquet

The tip 106 of the electrode catheter 98 should have a hemispherical or 25 another atraumatic shape. The tip 106 may be electrically neutral, and may be fabricated from a polymer or it may be fabricated of stainless steel. Because the tip 106 has a rounded shape and is located at the distal extreme of the catheter, it may perform a guiding function when introducing the catheter to the patient. 30 The double set of expandable electrodes can be used to ligate veins or other hollow anatomical structures in a manner similar to that previously 45

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described. The outer sheath 108 can be pulled back to allow the electrode to expand outwardly from the catheter and into apposition with the wall of the lumen being treated. The two secs of electrodes 100 and 102 apply energy to the lumen to cause it to shrink to a reduced diameter. The catheter can be 5 moved or pulled back while the energy is being applied to treat an extended area of the lumen. When the desired area of the lumen or vein is treated (e.g., ligated) energy is no longer provided to the electrodes, and the outer sheath 108 is pushed forward to force the expanded electrodes back to an unexpanded condition. The catheter can then be removed from the patient, or 10 another section of the vein can be treated.

The description of the component parts discussed above are for a catheter to be used in a vein ranging in size from 3 mm (0.12 in) to 10 mm (0.39 in) in diameter. It is to be understood that these dimensions do not limit the scope of the invention and are merely exemplary in nature. The 15 dimensions of the component parts may be changed to configure a catheter 10 that may used in various-sized veins or other anatomical structures.

Referring now to FIG. 25, there is shown a partial cross-section view of the catheter of FIGS. 23 and 24. Two pluralities of electrodes 100 and 102 are shown with the electrodes of the first plurality 100 being indicated by numeral 20 104 and the electrodes of the second plurality 102 being indicated by numeral 150. Each electrode is formed from an electrically-conductive electrode lead 152 and 154 respectively that is electrically insulated along its length except at its distal end at which point no insulation exists thus forming the electrode. Each lead has an outward bend (not shown). An inner tube 156 includes a 25 lumen 158 through which fluid may flow for flush or other purposes, or through which a guide wire may be positioned. A hypotube 160 is positioned over the inner tube and layers of insulation 162 are mounted over the hypotube. The first plurality 100 of electrode leads 152 extend proximaily to a first mounting ring 164 to which all are connected. The second plurality 102 30 of electrode leads 154 extend proximaily to a second mounting ring 166 to which all are connected. The rings 164 and 166 are mounted over the 46 hypotube insulation so that no electrical conduction path exists between the ° two. Wire conductors 168 and 170 extend from foe proximal end of the catheter to each ring so that all electrode leads connected to a particular ring are interconnected electrically. 5 Alternate arrangements are possible and in one, alternating electrodes of a particular plurality are connected to two different rings. Each ring is separately connected to the power source and the polarities of the rings may therefore be made different to establish a bipolar approach within the plurality. One electrode may be a"+" polarity while the two adjacent 10 electrodes may be apolarity. In this case then, there would be a total of three rings for all electrodes. In another arrangement, both pluralities would have two rings for its respective electrodes with alternating electrodes connected to different rings so that bipolar approaches within each plurality may be established. In this case, there would exist a total of four rings for the 15 two pluralities of electrodes.

An outer movable sheath 172 when slid in the distal direction to the point shown in FIG. 25 will cause the electrode leads to contract to the position shown. When slid in the proximal direction a sufficient distance, foe sheath 172 acts as a deployment device in that it will move past the bend (not 20 shown) in each of the electrode leads of the second plurality 102 permitting all electrode leads to expand outwardly as shown in FIG. 24.

The electrode leads are formed of stainless steel in this embodiment and with foe thin insulation layer and foe outward bend, have enough strength to automatically move outwardly through blood flow (in a venous application) 25 and into apposition with the inner wall of the target tissue. As the inner wall shrinks due to the application of heat by foe electrodes, foe inner wall will force foe electrode leads toward their contracted position but the electrodes will automatically stay in apposition with the inner wall during the entire ligation process due co their outward bends and the material of which they are 30 formed. 47

Other embodiments of electrode catheters having two pluralities of longitudinally-separated expandable electrodes are illustrated in FIGS. 26, 27, and 28. These embodiments are similar to the embodiment of the electrode catheter described in connection with FIGS. 23- 25. The 5 configuration of the dp 106 for the embodiments of the electrode catheters illustrated in FIGS. 26-28 are different. The electrode catheter illustrated in FIG. 26 includes a tip 106 having a radius which matches, or is slightly less than, the inner radius of the collapsed electrodes 100. The electrodes 100 collapse one the molded tip 106. The electrode catheter illustrated in FIG. 27 10 includes a tip 106 having a rounded and cut shape. The radius of the rounded and cut tip matches the inner radius of the collapsed electrodes 100, and the electrodes 100 collapse behind the cut of the tip 106. The electrode catheter illustrated in FIG. 28 includes a tip 106 having a more hemispherical shape than the tip illustrated in FIG. 27. 15 Referring now to FIG. 29, when treating the veins of the lower hemorrhoidal region, the access site is prepared. A guide wire 120 is passed into the vein, and advanced through to the venous treatment site.

Alternatively, the catheter may be inserted into the vein directly and manipulated wi±out a guide wire. The guide wire can be advanced 20 retrograde to the venous treatment site. Several intravenous paths may be taken to the hemorrhoidal treatment site, and it is to be understood that other access sites can be used to treat either internal or external hemorrhoids. A partial cross-sectional view of the venous system leading to the hemorrhoidal region is shown in FIG. 29. Hemorrhoids are generally defined 25 as internal or external depending on whether they are formed above or below the dentate line DL, respectively. Internal hemorrhoids 1H are commonly formed when the smaller veins draining to the superior hemorrhoidal vein SHV or the middle hemorrhoidal vein MHV become dilated. External hemorrhoids are commonly formed when the smaller veins draining to the inferior 30 hemorrhoidal vein IHV become dilated. 48

One method of delivering the catheter 122 and guide wire 120 is to introduce the guide wire 120 into the external iliac vein El on the side opposite to the dilated veins of the hemorrhoid. The guide wire is steered across the bifurcated branch of the inferior vena cava IVC to the inferior iliac vein Π. The 5 guide wire is then maneuvered into either the middle hemorrhoidal vein MHV to treat internal hemorrhoids, or the pudendal vein PV and then the inferior hemorrhoidal vein IHV to treat external hemorrhoids. The guide wire 120 is deployed and maneuvered into the middle hemorrhoidal vein MHV to treat an internal hemorrhoid. The guide wire 120 is maneuvered through the venous 10 system until it reaches the dilated veins of the hemorrhoid. The catheter 122 is then delivered to the venous treatment site over the guide wire 120, as shown in FIG. 29. The working end 124 of die catheter 122 includes a plurality of leads and electrodes for applying RF energy once properly positioned at the venous treatment site to ligate or occlude ±e vein. The 15 catheter should be flexible to allow tracking of the catheter over the guide wire and through bends in the venous vascular system. Fluoroscopy, x-ray, ultrasound, or a similar imaging technique could be used to direct rite specific placement of the catheter and to confirm position within the vein.

Another method of delivering the catheter and guide wire is to 20 introduce the guide wire into the superior hemorrhoidal vein and maneuver the guide wire through the superior hemorrhoidal vein SHV to the hemorrhoidal region. The guide wire is maneuvered into position, and the catheter is then delivered over the guide wire to the venous treatment site for the internal hemorrhoid. The venous treatment site is within the lumen of a 25 dilated vein, and the electrode leads expand away from the body of the catheter to come into apposition with the wall of the dilated vein.

When the electrode leads of the catheter 122 are positioned at the venous treatment site, an RF generator is activated to provide suitable RF energy to cause heating of the surrounding venous tissue. The energy emitted 30 from the electrodes is convened within the venous tissue into heat. As

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49 previously discussed, the application of energy causes the vein to collapse and become effectively occluded or ligated.

In another anatomical region, varicose veins called esophageal varices &amp;#973;. can form in foe venous system along the submucosa of foe lower esophagus, and bleeding can occur from foe swollen veins. When treating the veins of the lower esophageal region, foe access site is prepared, and a guide wire 120 is passed into foe vein and advanced through to foe venous treatment site. The guide wire can be deployed and manipulated so as to reach foe treatment site for treating the esophageal varices. The venous treatment site is preferably within foe lumen of a dilated vein. The wire is advanced to foe venous treatment site which is to be repaired. Preferably, foe guide wire and catheter are advanced antegrade to the esophageal treatment site. Alternatively, foe catheter may be inserted into foe vein directly and manipulated without a guide wire. Fluoroscopy, x-ray, ultrasound, or a similar imaging technique could be used to direct foe specific placement of foe catheter and to confirm position within the vein. A properly sized catheter 122 delivers foe electrode leads to the site of venous dysfunction along foe esophageal varix. The electrodes apply RF energy or other forms of energy at a suitable power or frequency to cause the vein to collapse and become effectively occluded or ligated.

As shown in FIG. 30, in a partial view of foe venous system leading to the esophageal region, foe catheter 122 is advanced over foe guide wire 120 to a dilated section of the vein. One method of delivering the catheter and guide wire is to introduce foe guide wire through foe superior mesenteric vein SMV to foe portal vein PV and coronary vein CV which branches and leads to foe lower esophagus E to form the esophageal veins EV. As an alternate route, foe guide wire could be introduced into the inferior mesenteric vein, and routed through the splenic vein SV, the portal vein PV, and the coronary vein CV to arrive at the esophageal varix to be treated.

Referring now to FIG. 31, ligation of a fallopian tube is shown. A guide wire 120 has been located in the fallopian tube F and foe catheter 122 is also

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50 positioned in the fallopian tube F through the fallopian tube ostium 126. The shaft of the catheter has been introduced through the uterus U with an endoscope 128. The working end of the catheter may now be energized as described above to perform an intra-fallopian tube ligation. The second 5 fallopian tube may then also be ligated in the same manner.

Prior to or during the application of energy to the hollow anatomical structure, the structure may be compressed or pre-sized. Additionally, the lumen may be exsanguinated by compression or by a fluid flush. One method for compressing the lumen of the fallopian tube by external means is with 10 pnuemoperitoneum. In a further feature, the lumen, particularly the lumen of a fallopian tube, may be compressed by the application of negative pressure through the catheter. For example, in the open end catheter such as that shown in FIG. 25, a negative pressure may be applied to the lumen at that open end. If desired, an inflatable balloon may be mounted to the shaft of the 15 catheter proximal to the orifice through which the negative pressure is applied to assist in its application to the lumen. Other arrangements are possible, such as the use of ports in the wall of the catheter through which negative pressure may be applied.

Although described above as positively charged, negatively charged, or 20 as a first polarity, opposite polarity, or as a positive conductor or negative conductor, these terms are used for purposes of illustration only. These terms are generally meant co refer to different electrode potentials and are not meant to indicate that any particular voltage is positive or negative. Furthermore, other types of energy such as light energy from fiber optics or microwaves can 25 be used to create a thermal effect in the hollow anatomical structure undergoing treatment. While the particular hollow anatomical structure may be a vein (e.g., varicose veins, hemorrhoids, esophageal varices, etc.) or a fallopian tube, it is to be understood that other anatomical structures can be ligated using the system disclosed herein. 30 While several particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made

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51 without departing from the spirit and scope of die invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.