Untitled record

Background of the Invention

These This invention relates to a catheter-based system for positioning an electrode for applying energy to a vein intraluminally to shrink to the liquid flow dynamics to change and the ability of Venous valves and the proper function the vein recover by means of a minimally invasive procedure.

the human venous system of the lower limbs consists essentially from the superficial venous System and the deep venous system, said perforating veins connecting the two systems. The superficial System includes the long or great saphenous vein and the short Saphenous vein. The deep system includes the front and rear Tibial veins, which unite to Knievene, which in turn the femoral vein is when they are combined with the short saphenous vein.

the venous contains system numerous one-way valves for directing blood flow back to the heart. Venous flaps are usually bicuspid valves, each leaflet a bag or a reservoir Blood forms the under pressure that forces three surfaces of the leaflets together, a backward to prevent flow of blood and to a forward flow to the heart to allow. If the flow path in the backward flow Full toward a dysfunctional Flap is, the valve can not close because form the leaflets no proper seal and the rearward Blood flow can not be stopped.

Inoperative flaps can in venous System gets Venendilatation. The separation of the valve leaflets the venous valves in the commissure may occur as a result. The leaflets be through the dilation of the vein and the accompanying increase in vein diameter, to the leaflets pull, stretched. An extension of the leaflets of venous flap allows loose papers to fold on itself and to open the door. This prolapse can backflow allow blood in the vein. Ultimately failed venous flap, the pressure on the lower venous Sections and above increased underlying tissues is. Two venous Diseases that often a involve Venendilatation, are varicose veins and chronic venous insufficiency.

the Varicosity closes Dilation and tortuosity of the superficial veins of the lower extremities a, which, in unsightly discoloration Pain and ulcers result. Varicose veins often involve the inoperability of one or more venous Flaps reflux the blood from the deep venous system to the superficial System, or reflux within the superficial permit system. Current treatments include those invasive, open surgical procedures as Venenexhairese, sclerotherapy and sometimes vein grafting, venous valvuloplasty and implantation of various prosthetic devices a. The removal of Varicose veins from the body can be an annoying, time-consuming his procedure that a painful and slow healing process has. Complications, scarring, and the loss of the vein for future cardiac and other by-pass procedures may also occur. In addition to the complications and risks of invasive, open surgery can remain varicose veins or recur, particularly when the flap problem is not corrected. Because of the long, arduous and troublesome Nature of the surgical procedure, the treatment of several vein sections the physical endurance of the physician exceed and therefore the make overall treatment of varicosity unusable.

Chronic venous Insufficiency (CVI) is a problem caused by hydrodynamic forces is that, on the body tissue particularly the legs, ankles and feet, acts. If the veins due to the increased Pressure dilate, fail the flaps in the veins. This leads to a increase Pressure on the next Flap and the next lower Vein segment, resulting in that these veins dilate and if this goes on, fail the valves in the veins eventually all. If they fail to grow the effective height the column of blood above the Fussen and ankles and the weight and hydrostatic pressure exerted on the tissue the ankle and the foot exercised is to take. If the weight of this column a critical point achieved by the veins fail to ulcers ankle begin to make that start deep and eventually come to the surface. These ulcers not heal easily, since the weight of the blood that they caused, still applies and they have the tendency to increase the ulcer.

Chronic venous Insufficiency is frequently from hypertension of the lower extremities in the deep, perforating and often superficial Veins and, in discoloration, Pain, swelling and ulceration result. Existing treatments for chronic venous insufficiency are frequently less than ideal. These treatments include the increase the legs, external compression veins with elastic support stockings and surgical repair by transplantation <?page 3?>of vein sections with healthy valves from the arm into the leg. These processes a different efficacy. Furthermore, the invasive Surgery their attendant complications with life and cost risks. Similarly require relieving therapies from the patient great changes lifestyle. For example, ulcers will occur again if the Patient does not continue, continuously to be entire life to raise the legs and to use the support stockings.

Because of the time-consuming and invasive nature of the current surgical Forms of treatment, such as vein grafts, typically only one flap while treated each procedure. This limits the ability of the physician a strong, people suffering from chronic venous insufficiency patients completely to treat. However, any invasive surgery has its accompanying complications with life and cost risk.

the Setting of vascular Lumen by attaching a surgical suture around it, cauterization or coagulation using electrical energy from a Electrode was used as an alternative to or Venenexhairese surgical removal of such veins used. Abbindeprozeduren conclude However, the lumen from and destroy essentially their functional abilities. For example, it is known to introduce an electrode into the leg of a patient and the electrode to the outside the position to be treated for varicose veins lying. By a small stab incision is a probe through the subcutaneous layer forced between the fascia and the skin, and then to the different to be destroyed Veins. Electrodes at the outer end the probe to be positioned adjacent to the veins. After correctly Positioning is applied an alternating current of 500 kilohertz, to destroy the adjacent varicose veins. The veins lose Function, it flow therethrough to allow blood and can no longer be use. For example, would a setting of the saphenous vein this unavailable for withdrawal in other surgical procedures, such as coronary bypass operations do. Abbindetechniken that the venous lumen functionally destroy would inadequate for corrective procedures restoring and maintaining the function of the vein appear.

hemorrhoids are dilated veins in and around the anus and the lower rectum around. Dilation can be of an increased Pressure in the Hämorrhoidalvene originate. constipation including the frequent Strain to pass hard stool, increases the pressure in hemorrhoidal veins and is a conventional reason for Hemorrhoids. Other contributory factors include pregnancy, low-fiber food and obesity in. If the Hämorrhoidalvene by the increased pressure further is, can the venous valves of Hämorrhoidalvene begin to fail and to become inoperable. This can the dilation of Hämorrhoidalvene worse, since a reflux is made possible by the blood in the vein through the open, inoperative door. The vein can eventually a bag-like bulging form if the condition is allowed to stop. hemorrhoids are generally classified as either internal or external, dependent of their location relative to the dentate line. The dentate line can be easily identified as the dividing line between the pink Mucosa that forms the anoderm. The dentate line separates the internal and external Hämorridensystem. Internal hemorrhoids are in the anus the dentate Line locates. External hemorrhoids are below the dentate Line locates. Both can extending from the anus.

strain or irritation caused by passing stool, can the sensitive surface an internal Hämorride hurt and lead to bleeding. If the pressure and dilation of Hämorrhoidalvene persists can the internal hemorrhoids collapse and by the anal opening are forced. If a Hämorrhoidalvene remains collapses, can considerable Malaise, including Itching and bleeding, occur. The blood supply to these prolapsed hemorrhoids can through the sphincter are cut off, which leads to a strangled Hämorride. thrombosis can arise where the blood clots within the prolapsed vein. This extremely painful State can edema and inflammation cause.

increased pressure in the portal venous system may also lead to an increase in pressure of the upper Hämorrhoidalvene (SHV) lead, which increased to a Diameter of Hämorride leads. The portal venous system allows the venous drainage of the Intestinalgeweben to the liver and may be hypertensive when the liver cirrhotic is.

The Treatment process for Hemorrhoids include invasive Surgery to remove the Hämorride, Bonding with an elastic ring, sclerotherapy and the application of ointments and suppositories on. The surgical removal of large and heavy hemorrhoids as hemorrhoidectomy known. This surgical procedure can in both internal and external hemorrhoids be used. However, such a surgical procedure involved typically a long recovery period, along with the associated Risks and costs of invasive surgery.

Internal hemorrhoids can by gum<?page 4?>bandabbindung be treated with a Abbinder is inserted through an area in the anal canal. The Hämorride is grasped with tweezers in Ligator and held in position. includes The Ligator a cylinder which is pushed up and one or more rubber bands around the basis of Hämorride dismisses. A typical diameter for the rubber band is a millimeter. The belt intersecting the blood circulation to the Hämorride and from the Hämorride begins wegzuschrumpfen. Provided that the elastic band at its space remains, falls the Hämorride typically within seven to ten days.

sclerotherapy, another form of treatment for Hemorrhoids, involves injecting a solution such as sodium morrhuate or Phenol oil, submucoulär in the areolar tissue around the Hämorrhoidalvene, an inflammation and cause scarring to eliminate the Hämorride. Other external Treatments call incineration or coagulation forth to the Hämorride to destroy. at the Infrarotkoagulation can be applied infrared light to a small combustion gewebszerstörende around the base of Hämorride to cause to cut off the blood supply to the Hämorride. electrocoagulation, sometimes referred to as bipolar diathermy, can in a similar way be used. In laser therapy, also known as vaporization known generates a laser beam has a superficial burn, to the to seal blood vessels and Hämorride keep in a non-prolapsed position.

The previous treatments for hemorrhoids involvierend external ligation or excision of Hämorride can do not affect the underlying causes, the original to the Hämorridenleiden led. Therefore, the disease may recur.

varicose veins, oesophageal called Varices, can in venous forming system along the submucosa of the lower esophagus and bleeding from the dilated veins can occur. blood flows from the portal venous system through the veins surrounding the esophagus, to the heart back. In contrast to other veins, such as the saphenous vein in the lower leg, have the esophagus surrounding veins typically no flaps to blood back to the heart bring to. The venous pressure in these oesophageal Vein is relatively high and blood can without the help of venous valves back flow to the heart.

oesophageal varices can resulting from portal hypertension and other abnormalities in the portal venous system, as Cirrhosis. Bleeding or bleeding that will be hard to stop can, can of oesophageal Varices caused and could, if left untreated, to life-threatening conditions develop. Such varices can easy to erode and to massive gastrointestinal bleeding to lead.

The Treatment of oesophageal varices closes portal-caval shunts, endoscopic variceale ligation, sclerotherapy and electrocoagulation of an electrode within the esophagus a, as from a Tamponadehilfsmittel. involved The portal shunt the surgical connection of two veins, the portal vein and the inferior vena cava, to relieve pressure in the vein, the blood in the Liver performs. Although effective in preventing recurrent bleeding of Varices, there still exist the associated risks and complications of such invasive surgery, including encephalopathy and postshunt hepatic failure, for the portal shunt surgery.

The endoscopic variceale ligation is analogous to rubber band ligation in the treatment of hemorrhoids. The oesophageal Varices with elastic bands ensnared to eradicate the varices. An endoscope into the patient imported and is to be treated to the oesophageal Varize fitting placed. The varix is ​​drawn into a drum, which is attached to the tip of the endoscope. An on the drum mounted elastic band is then released through the varicose vein. Endoscopic Varizenligation can not complete fibrosis the inner wall of the esophagus reach and a recurrence of varicose veins may result. Other complications include Bleeding from the elastic bands induced ulcers and oesophageal Blocking due to a blockage of the lumen by unset oesophageal Varices a.

at Sclerotherapy is a solution, such as sodium morrhuate or ethanolamine, submucosal tissue in the injected, which is around the varicose veins in the esophagus to treat inflammation and to cause scarring, to complete the vein and to reduce the probability of bleeding. sclerotherapy however, ulcers produce to the oesophageal cause constrictions can.

electrocoagulation has also been used to oesophageal to treat varicose veins. A Tamponadehilfsmittel with a metallized surface is into the esophagus brought in. The metallized surface is mucosal the Membrane of the esophagus contacted. An electric current is then applied to the metallized surface applied to cause thrombosis formation of oesophageal varices.

<patcit><text>EP 0,205,851</text></patcit> discloses a Catheter comprising at least one lumen, closed at the front End for the local treatment of internal &lt;?page 5?&gt;Body structures, in particular Stenoses. at least the catheter comprises an opening in the catheter wall, which is arranged in a treatment section at the front end and extending from the lumen to the outer wall the catheter extends. The catheter further comprises an extendible and expandable member in the treatment section of the catheter end is arranged with at least one electrically conducting zone, the one part of the extension This part forms. The electrically conducting zone on the outer surface of this portion of the catheter disposed.

The previous treatments for oesophageal Varices typically involve the external coagulation or desolation the veins and need frequently several treatment sessions. Treating such treatments the varicose vein does not directly and can not access the underlying affect root causes that originally rise to the oesophageal Varices gave.

It there is a need for a system to treat dilated veins like these that in varicose veins resulting from venous or Insufficiency, the continuity, the the veins on venous receives function and yet restores the competence flaps concerned. There is also a need to treat dilated hemorrhoidal vein to venous Pressure on the hemorrhoidal reducing region. Such treatment should the functional patency maintained the vein and the expertise the flap in question at the origin of the hemorrhoids, and within the Hämorride could restore. There is a need, the dilated treat veins to the oesophageal lead varices and venous Pressure on the oesophageal reducing region of the portal venous system, without de attendant risks of invasive surgery. Furthermore, a need exists for a less invasive Procedure available to provide that more venous Ask can handle easily. The need exists, River pictures, and dynamics with restoring pressure and sections dilated veins to a normal or reduced diameter to shrink. Where bleeding, there is a need, hemostasis to achieve in bleeding varices and the recurrence of bleeding to minimize.

Summary of the Invention

In shortly and generally expressed provides the use of the present invention, a less invasive and faster method willing to address the underlying problems of varicose veins and venous solve insufficiency and uses a novel repair system, including a Catheter for placement of an electrode for application of radio frequency energy.

According to the present Invention is an apparatus provided to apply power, around the diameter of a vein to reduce claimed in Claim first

the Method of using the apparatus of the present invention closes the steps of: introducing a catheter having a functional end and means for heating, located at the end of function to treat a site in a vein; Positioning the means for heating at the treatment site in the vein; Application of energy from the means for heating, to the treatment site heat controllable and shrinkage causing the vein; and terminating the energy emission from the Means for heating, after sufficient shrinkage of the has occurred vein, thus, as to its competence flaps is restored, or so that the vein remains consistent, to the function as a blood channel to execute on. The procedure is a minimally invasive procedure that the need for open surgical Procedure for venous Repair eliminated, including venous Valvuloplasty and transplantation an arm vein in the leg.

On Apparatus brings to radiant energy to the shrinkage of a vein to cause. The heating unit may include RF electrodes to heat the vein and to shrink. Feedback control systems can be used to control the application of energy, to the venous to heat tissue to control the amount of shrinkage.

characteristics of the present invention include the recovery the competence of the venous valves, the normalization of the flow pattern dynamics with, and pressure and the reduction of portions of dilated Varicose veins to a normal diameter for cosmetic purposes. The treated veins remain patent and can continue to function and blood back to the heart.

A Procedure is to restore the venous valve competence through controllable shrinkage of otherwise dilated lumen of a vein to the desired Diameter.

On Another advantage is the control or adjusting the effective Diameter of the catheter or of the electrode configuration to the amount of the circumferential shrinkage to control which of the vein wall is experienced. A retractable element to the functional end the catheter is located adjacent to, can the effective diameter increase of the catheter and limit the shrinkage of the vein.

&lt;?page 6?&gt;

Advantageous there is provided a catheter electrode radiofrequency field generated around the circumference of the catheter, the vein wall circumferentially and to shrink around while the longitudinal contraction is minimized when the catheter electrode intraluminally within the vein is positioned.

On Field can be generated at a certain frequency around the catheter in order to minimize coagulation within the vein and to the catching spread of heating within the venous tissue.

The venous valve leaflets be by minimizing the heating effect on the venous valves protected by selective positioning of the electrodes within the vein.

Preferably is coolant delivered to the blood stream in order to reduce the likelihood that the blood is heated to the point of coagulation.

Preferably the shrinkage of the vein over prevents the end of the catheter.

Advantageous the electrodes are held in sequencer to the venous tissue in order to ensure that the heat for venous Tissue is delivered to and not to the blood through the Vein moves.

The flexible elements are radially by Outside diffracted to maintain contact with the vein tissue. The flexible Elements are conductive, longitudinal Electrodes covers substantially with an insulating film are, in addition to the Part which is to reach in sequencer to the venous tissue.

In another arrangement is a balloon on one side of the catheter with electrodes on the opposite localized page. Inflating the balloon moves the electrodes in sequencer with the vein wall on the opposite side.

On Advantage of the use of the apparatus according to the present invention It is a procedure available questions to which more venous Ask can handle easily.

On Advantage of the present invention is that no foreign object or no prosthesis after the treatment in the vasculature remains.

in the Method of using the apparatus according to the present invention, contains the step of positioning the heating device at the treatment site preferably further comprising the step of placing the heater adjacent to the venous valve at the treatment site to the venous valve competence restore.

Advantageous closes the step of positioning the heating device continues to Step of aligning the heater to complete a circumferential to achieve shrinkage of the vein and an axial shortening to minimize.

Advantageous closes the step of positioning the heating apparatus further comprises the Step of moving the heater in sequencer with the vein wall at a treatment site.

Advantageous closes the step of positioning further comprises the step of increasing a effective diameter of the catheter to the heater bring in sequencer with the vein wall; and the step of applying includes energy further comprising the step of reducing the effective diameter of the catheter in a controlled manner, so that the serial connection of made with the vein wall remains, while the vein wall shrinks, to a diameter of the vein is achieved, which restores the venous function.

Advantageous the method further comprises the step of limiting the Shrinkage of a vein up to a diameter by the heating device is defined. Preferably, the method further comprises the Step of moving the heater radially away from the catheter with a flexible element to the heater in sequencer with the vein bring to. Preferably closes the step of applying energy further comprises the step of checking the energy of a heating device in order the depth of heating to control at the treatment site of the vein.

Advantageous the method further comprises the step of determining the degree of shrinkage the vein.

Advantageous the method further comprises the step of determining the degree of shrinkage the vein using fluoroscopy.

Advantageous the method further comprises the step of determining the degree of shrinkage the vein using ultrasound.

These be and other aspects and advantages of the present invention become apparent from the following more detailed description, when they are viewed in conjunction with the accompanying drawings, way of example the principles of the invention illustrate.

&lt;?page 7?&gt;

Brief Description of Drawings

<figref idrefs="S54">1</figref> shows a cross section of a dilated vein in the lower extremity, the incompetent having venous valves, which using the present invention are to be treated;

<figref idrefs="S55">2</figref> shows a representative View of a venous portion of <figref idrefs="S54">1</figref> taken along lines 2-2 of to be treated using the present invention;

<figref idrefs="S55">3</figref> shows a partial cross section of a catheter having electrodes, the antegrade a venous Treatment site is administered;

<figref idrefs="S55">4</figref> shows a partial cross-sectional view of a venous portion of <figref idrefs="S55">2</figref> after the treatment using the present invention;

<figref idrefs="S56">5</figref> shows a partial cross section of the catheter and the vein in the <figref idrefs="S55">3</figref> shown are, the venous to another Treatment site to be administered;

<figref idrefs="S56">6</figref> shows a partial cross section of a catheter retrograde laterally flexed to a venous Treatment site is administered;

<figref idrefs="S57">7</figref> shows a partial cross-section of an arrangement of the catheter which a bulbous tip and ring electrodes to treat a dilated vein according to the present Invention.

<figref idrefs="S58">8th</figref> shows a partial cross-section of an arrangement of the catheter which a flush Tip at the end of function and ring electrodes to treat a dilated vein;

<figref idrefs="S58">9</figref> shows a partial cross-section of an arrangement of the catheter which a cap electrode has to treat a dilated vein;

<figref idrefs="S58">10</figref> shows a partial cross-sectional view of another arrangement of the catheter, a cap electrode and a balloon for centering the placement comprising the electrode within the vein to be treated;

<figref idrefs="S59">11a</figref>. <figref idrefs="S59">11b</figref> and <figref idrefs="S59">11c</figref> show partial cross sections of other assemblies the catheter has a flexible tip, which flexed laterally is a sequencer between the electrodes of the catheter and the vein wall to effect;

<figref idrefs="S60">12a</figref>. <figref idrefs="S60">12b</figref> and <figref>12c</figref> are side or top views in partial cross-section of another arrangement of the catheter, of a balloon on one side of the catheter and longitudinal Electrodes on the other side on the functional end of the catheter having to the electrodes in a anreihenden contact with the bring vein wall;

<figref idrefs="S61">13</figref> shows an embodiment the catheter has flexible electrodes, the outwardly bent are to the effective diameter of the functional end of the catheter according to the invention to enlarge;

<figref idrefs="S61">14</figref> shows another arrangement of the catheter, the balloon a and a flexible The element with electrodes away bent to the effective Diameter to increase the functional end of the catheter;

<figref idrefs="S61">15a</figref> shows a cross section of an arrangement of Catheter in <figref idrefs="S61">14</figref> As shown, the four equally far distributed electrodes;

<figref idrefs="S61">15b</figref> shows a cross section of an arrangement of Catheter in <figref idrefs="S61">14</figref> As shown, the four electrodes which are preferably distributed to two pairs of electrodes to give;

<figref idrefs="S56">16</figref> shows a partial cross-sectional view of another arrangement of the catheter, comprises of four equidistant distributed electrodes and the retrograde to a venous Treatment site is administered;

<figref idrefs="S62">17</figref> shows a partial cross-sectional view of another arrangement of an over-the-wire Balloon catheter, the four equidistant distributed electrodes on the surface having the balloon

<figref idrefs="S62">18</figref> shows a cross-section taken along lines 18-18 of the over-the-wire balloon catheter out <figref idrefs="S62">17</figref>;

<figref idrefs="S62">19</figref> shows a partial cross-sectional view of another arrangement of the catheter, comprising the electrodes, which are located within the balloon portion;

<figref idrefs="S63">20</figref> is a side view of one embodiment a catheter having flexible electrodes according to the invention coupled, with a block diagram of a heat treatment system;

<figref idrefs="S63">21</figref> is a partial side view of the functional end of the catheter, the in <figref idrefs="S63">20</figref> is illustrated and it has electrodes, the away are bent to the effective diameter of the end function Catheter according to the present Invention to increase;

<figref idrefs="S63">22</figref> is a cross-section taken along lines 22-22 of the electrode for the in <figref idrefs="S63">21</figref> illustrated &lt;?page 8?&gt;Catheter;

<figref idrefs="S64">23</figref> is a cross-section taken along lines 23-23 in <figref idrefs="S63">20</figref> and shows a catheter which four equidistant distributed electrodes according to the present Invention comprises;

<figref idrefs="S64">24</figref> is a cross section of another embodiment of the in <figref idrefs="S64">23</figref> shown Catheter, this embodiment has four electrodes, the present according to the Invention are preferably distributed, to two pairs of electrodes result;

<figref idrefs="S64">25</figref> is a cross section of another embodiment of the in <figref idrefs="S64">23</figref> shown Catheter, this embodiment has two pairs of opposed Electrodes according to the present Invention;

<figref idrefs="S65">26</figref> is a cross section of the catheter taken along lines 26-26 in <figref idrefs="S63">20</figref>;

<figref idrefs="S65">27</figref> is a partial side view of the functional end of another arrangement a catheter having a balloon and a flexible element with having electrodes;

<figref idrefs="S65">28</figref> is a cross section of the catheter taken along lines 28-28 in <figref idrefs="S65">26</figref>;

<figref idrefs="S66">29</figref> shows a partial cross section of the venous system of the Hämorrhoidregion, which are treated using the present invention should;

<figref idrefs="S67">30a</figref>. <figref idrefs="S67">30b</figref> and <figref idrefs="S67">30c</figref> are side views of an embodiment of the catheter, a venous Treatment site within a dilated vein according to the present Invention addresses;

<figref idrefs="S68">31</figref> shows a partial profile view of the anatomical region of oesophageal Region, including a vein being treated using the present invention shall be;

<figref idrefs="S69">32a</figref>. <figref idrefs="S69">32b</figref> and <figref idrefs="S69">32c</figref> are side views of an embodiment of the catheter, constructed and within a venous treatment site a dilated vein for treatment using the present Invention is administered.

Detailed description the embodiments

As shown in the exemplary drawings, the present invention relates to the intravenous treatment vein using a catheter to at least one electrode a venous bringing treatment site. As used herein, are similar reference numbers similar elements in the various embodiments of the present, designate to be discussed invention. In addition, unless otherwise indicated, the term functional end to the direction toward the treatment site in the patient and the term connecting end refers to the direction of the treatment site away in the patient. The invention is related The treatment of venous Systems of the lower extremities to be discribed. It is understood, however, that the invention is not limited and can be used, veins in other areas of the body, such as hemorrhoids, oesophageal Varices and venous Drainage impotence of the penis to treat intraluminal. furthermore it should be understood that although the invention as RF energy from the electrode is described using also other forms of energy, such as Microwaves, ultrasound, direct current, circulating heated fluid, bright light and lasers can be used, and that of a Resistive coil or curie point element generated thermal energy can also be used.

On partial cross-section of a dilated vein of the lower limb, the incompetent Flaps has, in <figref idrefs="S54">1</figref> shown. These veins are frequently in Muscle arranged. Veins have valves and in bicupsidale a normal, competent flap forms each leaflet a Bag or a reservoir for Blood, wherein each leaflet forms a sack or reservoir for blood the under pressure, the three surfaces of the leaflets together forcing a reverse flow to prevent blood and to a forward flow to the heart to allow. The leading out of the top of the vein Arrow represents the forward Blood flow back to the Heart. The venous valves prevent the backward flow during the Blood forward through the vein lumen and back pressed to the heart is.

If an incompetent valve in reverse River meets, the flap can not be closed in a position that Leaflets do not seal properly and backward-looking blood flow can occur. Incompetent flaps from stretching of dilated Veins originate. If the valves fail, is an increased pressure on the lower Veins and exercised the bottom flaps of the veins, which in turn failure these bottom flaps worse. A cross-sectional view of a dilated vein taken along lines 2-2 of <figref idrefs="S54">1</figref> is in <figref idrefs="S55">2</figref> shown. The leaflet can at the junction due to the thinning and stretching of the vein wall by making the leaflets ready separation.

&lt;?page 9?&gt;

the A method of using the present invention for the minimally invasive treatment of venous insufficiency can be measured using a catheter <figref>10</figref> be performed, to electrodes <figref>12</figref> to bring to the venous treatment site restore the competency of a vein. An array of catheter <figref>10</figref>To the electrodes <figref>12</figref> to the venous treatment site bring, is in <figref idrefs="S55">3</figref> shown. electrodes<figref>12</figref> two RF ring electrode <figref>14</figref> and <figref>16</figref> be that at the end of function <figref>11</figref> of catheter <figref>10</figref> are localized. These and other arrangements the catheter <figref>10</figref> are described in more detail later. furthermore is considered the method with any suitable apparatus to Using the application of radiant energy, thermal energy, or other forms of energy to the vein tissue in the repair or heating reconfiguration of incompetent veins and shrink, the venous restore function or flaps competence. A special Discussion is made to the treatment of varicose veins and incompetent are aligned in the legs, although the method of the present is the invention well suited to treat veins in other areas of the body.

at the treatment of veins of the lower limbs, the patient is typically placed on a treatment table, with drooping Feet to to fill the veins of the leg. The patient's leg is pretreated with antiseptic solution. percutaneous insertion is introduced into the vein using the well known Seldinger technique introduced to gain access to the saphenous vein or the deep venous system. Alternatively, a venous cut are used to gain access to the vein to be treated. The Procedure for repair of incompetent veins can by a qualified Physician with or without fluoroscopic or ultrasonic observation, or conducted direct visualization will. Furthermore, could the doctor palpate the treatment site to the location of the to determine the catheter and the treatment site during the procedure, when the superficial Venous system is treated.

Of the catheter <figref>10</figref> could after introduction by the insertion aid run within the vein and advanced through this to the venous treatment site will. The wire is advanced antegrade venous treatment site, such as the height the next incompetent veins site to be repaired. catheter is then introduced the wire and guided up through the leg through the vein to the level the vein section where rear-facing Flow occurs. In any case, the catheter brings<figref>10</figref> the electrodes <figref>12</figref> to the venous treatment site. Fluoroscopy, x-ray, Ultrasonic or similar Visualization technology can are then used to determine the specific placement of the catheter and confirmation the position within the vein to direct. X-ray contrast material can be injected through or around the catheter to the incompetent identify venous sections to be repaired.

From antegrade approach from the catheter can be pushed through the venous valve, so that the electrodes on the flap of the incompetent vein under are positioned, to be treated. catheter<figref>10</figref> is moving antegrade through the venous valves, as in <figref idrefs="S55">3</figref> shown, and is positioned so that the electrodes <figref>12</figref> in the vicinity of a dilated portion of the are to be treated vein. electrodes can are positioned so that they have the incompetent venous valve protrude. When the electrode<figref>12</figref> the catheter <figref>10</figref> at the venous Treatment site are positioned, the RF generator is activated, to a suitable RF energy to provide, preferably at a chosen Frequency from a range of 250 kHz to 350 MHz. A suitable Frequency is 40 MHz. One criterion for the selection of the applied Frequency is the minimization of coagulation in the vein. Another one Criterion is controlling the spread and the depth of the thermal Effect in the tissues. The extent of Heating or the depth of penetration into the tissue takes generally with lower frequencies, and decreases as the frequency elevated. A microprocessor may be used to provide a frequency for the treatment different vein according to the above select criteria. For example, the microprocessor may be a table stored in memory lock in, at certain frequencies for the treatment of varicose veins and venous diameters according to the criteria for the Minimization of coagulation with the control of the spread and the associating depth of the heating effect. Of the electrode emitted energy is converted into heat within the vein tissue. When the temperature of the venous tissue increases, the venous tissue begins to shrink. The shrinkage in part through dehydration and structural transfiguration of the collagen fibers in the Vein. Although the collagen while this process is compressed, the collagen nevertheless retains some elasticity at. When RF energy in the vicinity the locus of the dilated vein and venous valve is applied, , the shrinkage of the vein flaps expertise by reduction restore the dilation, the proper functioning the venous valve prevented.

the end of Life <figref>11</figref> the catheter <figref>10</figref> near the electrodes <figref>12</figref> limited physically, the extent of Shrinkage. The functional end<figref>11</figref> is preferably sufficiently dimensioned or magnification&lt;?page 10?&gt;ßert to prevent the complete ligation of the vein. Other measures, as an inflatable balloon, can be used to the amount of shrinkage the vein mechanically limiting.

The Venendilatation is reduced after the application of RF energy from the electrode <figref>12</figref> the surrounding venous tissue is heated, to cause shrinkage. RF energy is no longer applied, after sufficient shrinkage of the vein has taken place, to alleviate the dilation of the vein near the valve, the venous function restore or flaps competence. Sufficient shrinkage can by fluoroscopy, external ultrasound scanning, intravascular ultrasound scanning, Impedance monitoring, Temperature monitoring, direct visualization using a angioscope or any suitable method can be detected. For example, the catheter<figref>10</figref> configured be x-ray contrast media provide to a visualization under fluoroscopy to allow the condition of the vein and the relationship of the catheter to the treatment area the vein during the shrinkage process to judge. As an alternative to Fluoroscopy, can external ultrasound techniques such as B-scanning using certain Ultrasound signals from different angles, or intravascular ultrasound be used to provide a multidimensional view of the vein shrinkage to obtain at the treatment site, which the recognition of unequal Shrinkage in the vein improves. A Angioscope can also be used to the extent and Prior veins shrink to directly visualize and determine.

After treatment should the joint and the valve leaflets the venous valves are closer to one another, with little distance or incident, indicating a restoration of the valve competence. A cross-section the venous valve after treatment with RF energy is in <figref idrefs="S55">4</figref> shown. The flaps competence can by contrast injection or Doppler probe measurement be determined.

A considerable shrinkage can be achieved very quickly, depending on the specific treatment conditions. Since the shrinkage with may proceed quite a rapid rate, the RF energy preferably applied to low levels. As previously discussed, the frequency of the RF energy is selected to minimize the coagulation and the spread of the heating effect at the treatment site to control. The properties of the treatment site, such as temperature, can be monitored are to a feedback control for the RF energy available to provide, in order to minimize coagulation. Other techniques, as impedance monitoring and ultrasonic pulse echo, can be used in an automated system, the application of the RF off power from the electrodes to the venous section, when sufficient shrinkage of the vein is detected and to an overheating and to avoid a cauterization of the vein. Monitoring these values ​​in an automated feedback control system for RF Energy may also be used to the spread, including the Depth catching the heating effect. In all cases, the application of RF energy is controlled so that the venous tissue is sufficiently shrunk to restore the competence of the venous valve and receive.

After Treatment of venous section, the in <figref idrefs="S55">3</figref> shown is, the catheter is <figref>10</figref> to the next lower venous valve emotional, suffering from insufficiency, as in <figref idrefs="S56">5</figref> shown. electrode <figref>12</figref> may as previously in connection with <figref idrefs="S55">3</figref> discussed the Venous valve are placed. However, an alternative placement the electrode <figref>12</figref> be used. For example, as in<figref idrefs="S56">5</figref> shown, is the electrode <figref>12</figref> just below or retrograde to the Leaflets of venous valve positioned. The placement of Electrode under the flap, when RF energy is applied, can advantageous in minimizing the effect of local RF heating the thin his leaflet of the venous valve, while still shrinking the vein is achieved, to restore venous function or flaps competence.

If the catheter having a fluid delivery lumen is provided, a cooling liquid through the delivery lumen during administered of RF heating to the bloodstream of the treated vein will. The administered coolant minimizes any heating effect on the blood and reduced the risk of heating the blood to the point of coagulation. The liquid can through openings along the side of the catheter near the operative end and the Electrodes are formed, are administered.

While the The method previously described as the flaps competence restoring was, it is not limited thereto. A contiguous axial section of a dilated vein may by application treated by RF energy along the dilated Veneabschnitts , even if the section is far-reaching. The dilated vein is under the controlled application of RF energy according to the present shrunk invention on a normal diameter and reduced. Such a treatment can in the cosmetic treatment of varicose veins be used. Furthermore, a thickening of the vein currency&lt;?page 11?&gt;rend the Treatment occur, the chance of recurrence of varicose veins and venous can reduce insufficiency.

Of the catheter <figref>10</figref> can be repositioned as many venous sections and valves as necessary to to treat. RF energy is applied to each venous section, the is to be repaired, until all of the desired venous sections repaired are and the flaps were made competent. Several incompetent Flaps and insufficient or dilated veins portions during a be treated and repaired single minimally invasive procedure. If desired is, a second insertion in the extremity introduced a patient be, either to reach the deep or superficial venous system, which also still needs to be addressed. The catheter can are then used to determine the incompetent venous sections in the other treat venous system.

Instead of the antegrade approach, as in <figref idrefs="S55">3</figref> and <figref idrefs="S56">5</figref> shown, the catheter electrodes by a retrograde direction from venous to the Treatment site bring. catheter<figref>10</figref> is by the Skin and inserted into a vein in a retrograde direction. Of the catheter <figref>10</figref> , the vein above and adjacent to the penetrate treated incompetent vein segment. electrodes preceded pushed until contact with the leaflets of Veneklappe by fluoroscopy, ultrasound, or other Detection method is observed. The catheter is then easily withdrawn, to allow the treatment of dilated veins section. electrodes be enabled to deliver RF energy to the venous tissue and Vein to shrink. The shrinkage of the vein can be limited, to prevent ligation and the continued operation of the vein to allow. The outer diameter of the catheter or a pull-out element can be controlled be to increase the size of the vein shrinkage limiting.

A specific delivery of RF energy to the separating joints of the venous valves can be effective in restoring the be venous function and valve competence. catheter<figref>10</figref> can be configured to position the electrode within the vein and applied the electrodes to be repaired vein segment allow. The catheter is capable of bent, twisted or otherwise be moved to proper placement to allow the electrode. Alternatively, a permanent bend are formed near the functional end of the catheter, which is then can be rotated and twisted in order to achieve the desired aim. Manipulation of function end of the catheter allows a preferable character Heating along the vein wall being treated, if desired, where the electrodes closer are placed to one side of the vein wall.

The electrodes <figref>12</figref> on a curved catheter as in <figref idrefs="S56">6</figref> shown, can in close concern to the vein walls placed near the junction in a retrograde approach be. The catheter can also be manipulated, the electrodes in a close baying at the junctions of the venous valve to place to a local shrinkage near the junctions reach out to because any separation of the junctions a Venendilatation treat and venous function and the flaps competence restore. After treatment of one end of the flaps juncture the catheter can then be moved around the electrodes in the vicinity of the joint to place at the opposite end of the flap. Therefore, according to selective application of RF energy to a side of the vein wall the catheter to be rotated 180 degrees to provide energy to the other apply side of the vein wall to the restoration of venous function drive. Alternatively, an asymmetric balloon, such as in<figref>12</figref> shown, or other such positioning element be used to connect the electrodes to the venous section to be treated bay them. The balloon may be deflated, and then inflated, a easier movement and repositioning of the catheter to allow.

After Treatment of a portion of the vein, the catheter to the next level the next Portion of the vein to be repaired are moved. The same procedure would then for each subsequent instance the veins are repeated repair. Treatment may take several Times are repeated until a sufficient vein shrinkage achieved is to the venous restore function and valve competence, while Vein throughout remains. After treatment of the incompetent vein segments is the containing electrode catheter is removed from the vein.

A Placement of the catheter <figref>10</figref> with electrodes <figref>12</figref> at the end of Life <figref>11</figref>, The local heating of the surrounding venous tissue caused as described and shrinkage of the vein, as shown in <figref idrefs="S55">3</figref> and <figref idrefs="S56">5</figref>Is detailed in <figref idrefs="S57">7</figref> shown. electrodes <figref>12</figref> include two ring electrodes <figref>14</figref> and <figref>16</figref> on. The Endringelektrode <figref>14</figref> can act as an active electrode and ring electrode <figref>16</figref> may act as the return electrode or vice versa. The Endringelektrode<figref>14</figref> is preferably the top of the function end of the catheter is removed, the plastic may consist or another non-conductive material. The by the ring electrodes <figref>14</figref> and &lt;?page 12?&gt;<figref>16</figref> generated RF field should not be the end of the catheter rich. The inert non-conductive tip the functional end of the catheter helps by limiting the extent and the formation of the RF field, the shrinkage beyond the end to avoid the catheter. This non-conductive tip acts as a schrumpfungslimitierender mandrel to a shrinking of the veins to a diameter of less than to prevent the catheter tip, and can 2 to 25 mm the electrode <figref>14</figref> transcend. Both electrodes<figref>14</figref> and <figref>16</figref> are preferably made of stainless steel. An insulator material<figref>18</figref> is located between the end electrode and the ring electrode. Of the catheter <figref>10</figref> and electrode <figref>12</figref> should be made Materials to be prepared, a visualization under fluoroscopy X-ray, allow ultrasound or other imaging techniques. For example , the catheter <figref>10</figref> be configured an X-ray contrast medium to administer to allow visualization by fluoroscopy. In the vein injected contrast media can be used to the Condition of the vein and the ratio the catheter to the treatment area of ​​the vein by phlebography while the shrinking process to determine.

Of the catheter <figref>10</figref> closes a stranded, twisted center conductors <figref>20</figref>, surrounded by an insulating layer <figref>22</figref> one that EXQUISITE ugsweise TFE Teflon^® produced is. A silver-coated copper screen<figref>24</figref> surrounds the insulated center conductor and provides flexible catheter shaft and twistable properties. A sheath<figref>26</figref> covers the copper screen <figref>24</figref> from. The vagina<figref>26</figref> is preferably selected from an electrically lofted, biocompatible material with a low friction coefficient, such as Teflon^®. manufactured. The center conductor<figref>20</figref> is to a power source <figref>64</figref>. such as the RF generator, connected to receive RF energy to the electrodes to deliver.

While the electrodes <figref>12</figref> were described as ring electrodes, others can Electrode configurations and arrangements be used. For example, equidistant distributed longitudinal electrodes are used, an omnidirectional and circumferential shrinkage available to questions and the longitudinal contraction the vein to minimize. The electrodes form a circumferential RF Field around the electrode.

It is understandable, that even though a bipolar arrangement will be described, also a monopolar arrangement can be used. In a monopolar Application is an inner electrode such as a grid or wire electrode, in a hollow of the body the patient introduced. An outer electrode with a much larger surface area than the inner electrode is placed on the outer surface of the patient's body, near the treatment site. For example, an external metal plate to the skin over the inner electrode placed through the region to be treated. The electrodes are connected to an RF generator, the electric one Field within the patient's body generated. Since the surface the inner electrode is much smaller than that of the outer electrode, is the Density of the electric field around the inner electrode around a lot higher. The electric field reaches its highest density between the two Electrode in the region in the vicinity of the inner electrode. The increased Density of the field to the inner electrode around allows a local Heating of the tissue surrounding the inner electrode. The degree of heating may depend be factors such as the impedance of the dielectric constant and of the treated tissue.

The Endringelektrode <figref>14</figref> and ring electrode <figref>16</figref> are preferably between sensors <figref>60</figref>For measurement the values ​​of impedance, localized. When measuring the impedance as later in more detail will be described, the region between the electrodes often the most relevant data. It is understandable, that the sensors <figref>60</figref> can be used to other values ​​including temperature and to measure ultrasonic signals. Furthermore, the positioning the sensors <figref>60</figref> on catheter <figref>10</figref> vary, depending on the measured value. If, for example, the temperature is measured is, it may be desirable, placing the sensor at or immediately adjacent to the electrode. The temperature sensor, the temperature of the tissue around the electrode Measure around. If echo signals from pulsed ultrasound measured be able the sensors between the electrodes or at the tip of the catheter to be placed. In the measurement of pulse-echo ultrasonic signals the catheter is preferably rotated to an image of the environment surrounding the catheter and sensors to dissolve.

The sensors <figref>60</figref> measure parameters which can be used, the extent of to determine vein shrinkage. For example, the sensors can<figref>60</figref> sensor electrodes be that the impedance of the venous tissue which is in contact with the terminal electrode <figref>14</figref> and of the ring electrode <figref>16</figref> stands, measure. A constant RF power is from the active terminal electrode <figref>14</figref> the return electrode <figref>16</figref> emitted. The impedance can continue directly between the electrodes <figref>14</figref> and <figref>16</figref> measured will. The voltage across the electrodes is measured by the sensor electrodes to the Impedance of the volume to be detected between the electrodes. The measured Voltage is proportional to the impedance Z between the electrodes, wherein Z = V / I, and the current I is constant. The impedance changes as a function of the diameter of the vein, as with decrease in Vein diameter there Weni&lt;?page 13?&gt;ger blood and less conductivity are. If the volume decreases due to the shrinkage, the amount the conductive Volume between the electrodes decreases and the increased impedance causes a corresponding Increase in the measured voltage. This technique allows the vein shrinkage to measure in relative terms. The signals of the sensor electrodes can in a monitor or microprocessor <figref>62</figref> be conducted the control signals to the RF generator <figref>64</figref> could send to the application of RF energy to the electrodes according to the measured relative impedance control. Alternatively, the shown signals of the sensor electrodes visually on a monitor in order to allow manual control by the physician.

In an alternative arrangement may the sensors <figref>60</figref> Instead, temperature sensors such as thermistors, be. The temperature sensors may be on be included in the catheter near the electrodes on the functional end, to the temperature which the electrodes and the treated venous portion surrounds to monitor. The application of RF energy from the electrodes can be stopped, when the monitored Temperature reaches the specific temperature or above, in the vein tissue begins to shrink. The signals from the Temperature sensors can to microprocessor <figref>62</figref> are led to the use of RF energy to the electrodes in accordance with the monitored catching temperature.

Instead of Sensor electrodes or thermistors includes another arrangement Ultrasonic Piezoelectric Elements, which as sensors <figref>30</figref> pulsed ultrasonic waves emit. The piezoelectric elements with a Pulse-Echo Manner is operated to the distance to the vein wall by the catheter shaft to measure from. Again, would the signals of the pulse-echo to the microprocessor <figref>63</figref> be conducted or in a monitor to allow manual control, and the application of RF energy would according to the calculated Distance between the catheter and the vein wall controlled will.

the end of Life <figref>11</figref> the catheter <figref>10</figref>, as in <figref idrefs="S57">7</figref> shown, is rounded to an atraumatic tip available to provide that any accidental Injury minimized while the catheter is manipulated into the vein. The functional end<figref>11</figref> the catheter <figref>10</figref> can enlarged dimensions have that the extent local vein shrinkage limited. An enlarged atraumatic tip , by using a bulbous shape as the function end <figref>11</figref> reached will. different sized function ends <figref>11</figref> and electrodes <figref>12</figref> can separate from the catheter <figref>10</figref> for later Assembling with the shaft of the catheter <figref>10</figref> getting produced, so that a single catheter shaft ends function used may be, having a variety of diameters. A functional end having a specific size or Form could then with catheter <figref>10</figref> be used, depending on the type of treated Vein. For example, certain larger veins have a diameter from seven to eight millimeters (mm), while others only veins have a diameter of 2 to 3.5 mm. Alternatively, the end of Life <figref>11</figref> and the ring electrode <figref>14</figref> and <figref>16</figref> flush with the shaft of the catheter to complete, as in <figref idrefs="S58">8th</figref> shown. Other methods, such as monitoring the extent shrinkage by fluoroscopy can be used to the extent of catching shrinkage. In other respects, the configuration the catheter in <figref idrefs="S58">8th</figref> similar to that in <figref idrefs="S57">7</figref>, as previously discussed.

A Another arrangement of the catheter <figref>10</figref> includes a end electrode <figref>14</figref> a, which is a hood electrode, the on top of the functional end <figref>11</figref> the catheter <figref>10</figref> educated is. As in<figref idrefs="S58">9</figref> shown, the terminal electrode <figref>14</figref> preferably made of stainless steel. The terminal electrode<figref>14</figref> acts as the active electrode and the ring electrode <figref>16</figref> acts as the return electrode. The cap electrode <figref>14</figref> the catheter <figref>10</figref> is rounded, in order to provide an atraumatic tip available to any injury to minimize the surrounding venous tissue, while the catheter through the Vein is manipulated. The outer diameter (OD) of the electrodes <figref>14</figref> and <figref>16</figref> is in a sample size <figref>7</figref> French, or about 2.3 mm. Alternatively, the cap electrode and the function end <figref>11</figref> the catheter <figref>10</figref> enlarged dimensions have from the rest of the catheter. The electrodes and the function end conclude essentially as described in <figref idrefs="S58">9</figref> shown flush with the remainder of the catheter from. The Schirmungsscheide<figref>26</figref> covering the silver-coated copper screen <figref>24</figref> the catheter and the sheath is flush with the outer diameter of the ring electrode <figref>16</figref>, An insulation tube<figref>18</figref> is between the End electrode and the ring electrode located. At the end of function the catheter is a filling with solder <figref>28</figref> in between the center conductor <figref>20</figref> and the terminal electrode <figref>14</figref> educated. The center conductor <figref>20</figref> is of the annular electrode <figref>16</figref> by means of isolation <figref>22</figref> isolated. The end cap in<figref idrefs="S58">9</figref> limited not the shrinkage of the vein adjacent to the tip of the catheter and it may therefore allow the vein to shrink completely, if desired.

In another arrangement, an inflatable balloon <figref>40</figref>. coaxially about the shielded stock is placed, the catheter <figref>10</figref> and electrodes <figref>14</figref> and <figref>16</figref> within the vein lumen center to a unwanted electrode contact with the venous lumen to avoid the otherwise in an uneven heating of parts cause of venous lumen could. As in <figref idrefs="S58">10</figref> shown, &lt;?page 14?&gt;the balloon <figref>40</figref> at the electrode <figref>16</figref> fitting located, for closer Connection end of the catheter is located. The balloon<figref>40</figref> is preferably extensible and flexible and made of an elastic prepared material, such as latex, the intermediate diameter to disposal can provide. The balloon can with saline or other conductive Solutions are filled.

As combined with <figref idrefs="S56">6</figref> discussed, it may be desirable be selective baying between the electrodes and the venous tissue at the treatment location to maintain it. An array of catheter <figref>10</figref>, Shown in <figref idrefs="S59">11a</figref>. <figref idrefs="S59">11b</figref> and <figref idrefs="S59">11c</figref>. is capable, by a shaft deflection wire <figref>29</figref> bent to become. The catheter contains a silver-plated copper screen <figref>24</figref> and an outer insulating layer. electrodes <figref>12</figref> can four surrounding distributed its longitudinal electrodes, as previously discussed. <figref idrefs="S59">11a</figref> and <figref idrefs="S59">11c</figref> show only two of the four longitudinal electrodes. catheter<figref>10</figref> contains further a stiffening sheath <figref>25</figref>Arranged around the catheter shaft is formed around, except for the function of the catheter tip. A central hollow wire lumen <figref>27</figref> runs through the Length of the catheter. The shaft deflection wire <figref>29</figref> has a stiff bend is formed near its end function and is determined by the wire lumen <figref>27</figref> of Catheter pressed. The end of the wire <figref>29</figref> after stiff flexure, which extends through the tip of the functional end of the catheter is preferably flexible and pliable. The stiffening sheathing<figref>25</figref> prevented that the catheter shaft through the shaft bending wire <figref>29</figref> bent is, until the bending wire reaches the functional end of the catheter. The deflection in the deflection wire <figref>29</figref> moves the function end <figref>11</figref> of Catheter to a site. The electrodes can then selectively in baying be placed at the specific, to be treated vein tissue. A contrast medium can also be carried to the treatment site the lumen <figref>27</figref> be administered. Further, a cooling liquid or liquid to the treatment site through the lumen <figref>27</figref> to be brought. side openings <figref>30</figref> for the lumen can the functional end near the electrodes <figref>12</figref> are made to the contrast agent and the cooling liquid to administer. Alternatively the lumen <figref>27</figref> at the top of the functional end of the catheter be closed to allow that an injection of contrast agent or coolant from the side openings <figref>30</figref> is forced. Lock in the lumen <figref>27</figref> at the tip further allows the bending wire <figref>29</figref> stiff can be made without Concern that the stiffer wire extends through the catheter.

A Another arrangement uses an asymmetric balloon <figref>40</figref>. around the electrodes <figref>12</figref> the function end <figref>11</figref> the catheter to bend to one side. electrodes<figref>12</figref> are a Pair of longitudinal electrodes located on one side of the catheter are. As in<figref idrefs="S60">12a</figref> and <figref idrefs="S60">12b</figref> shown, the balloon <figref>40</figref> on the opposite side of the catheter localized. When the balloon<figref>40</figref> is inflated, the opposed Side of the functional end <figref>11</figref>Which receives the longitudinal electrodes, moved in sequencer with the treated vein tissue. After treatment of the dilated venous section, the balloon can be deflated and the catheter removed from the vasculature. It should be noted, that other mechanisms for bending of the functional end of the catheter can be used. For example, a flexible Aktuierungsdraht on one side of catheter are used to perform a function similar to that of the asymmetric balloon. The catheter further includes the sheathing <figref>26</figref>, The shield <figref>24</figref> and TFE insulation <figref>22</figref> and is similar in its construction to the previously discussed Embodiments.

In one embodiment of the present invention as shown in <figref idrefs="S61">13</figref> shown, closes the catheter <figref>10</figref> flexible electrodes <figref>12</figref> in the Form of four conductive, elongate Elements a. The flexible electrodes<figref>12</figref> are similar to longitudinal electrodes around the circumference of the catheter are formed, but are not attached to the catheter. catheter itself can for the procedure by a sheath of a suitable size to fit. For example, a 9 French Vagina that about a diameter of 3 mm, are used. The functional end<figref>11</figref> of catheter includes a movable top <figref>31</figref> one that manually by a Durchmesseraktuator <figref>33</figref>. which is located at the connecting end of the catheter, controlled is. The movable top<figref>31</figref> is the Durchmesseraktuator <figref>33</figref> by means of a central wire (not shown) defined by the Catheter runs. The Durchmesseraktuator <figref>33</figref> can on the connecting end threaded the catheter be. maneuvering the actuator <figref>33</figref> in and out of the connecting end of the catheter also causes a corresponding movement in the mobile tip <figref>31</figref> the functional end of the catheter. When the movable tip <figref>31</figref> by Durchmesseraktuator <figref>33</figref> in Direction of the connecting end is drawn, the electrodes are <figref>12</figref> after Outside bent. The flexible electrodes<figref>12</figref> preferably extend from to treat veins up to 8 mm. When the movable top<figref>31</figref> by means of the Diameteraktuators <figref>33</figref> is pushed out, the bendable electrodes <figref>12</figref> retreated to the shaft of the catheter. A permanent contact of the electrode with the vein wall can maintain will.

the extent of Shrinkage can by means of the effective diameter of the catheter and electrode combination can be controlled. The electric&lt;?page 15?&gt;the <figref>12</figref> can radially outwardly bent As part of the effective diameter of the catheter to in Baying coming with the vein wall. When RF energy applied is, the vein begins on the effective diameter of the catheter herunterzuschrumpfen. The effective diameter of the catheter is lowered under control of the doctor, to the amount of shrinkage to control. If the effective diameter is decreased, keep the electrodes in the serial connection to the venous tissue. As previously, the extent of monitored vein shrinkage by fluoroscopy or any suitable method will. After shrinkage of the vein to the desired Diameter is the application of RF energy from the electrodes set. The desired Diameter, the final be effective diameter of the catheter, the curved by the electrodes <figref>12</figref> is defined.

The electrodes <figref>12</figref> can be made of spring steel or nitinol, so that the electrodes <figref>12</figref> inclined were harnessed, back to a reduced diameter profile. When the entire length of is flexible longitudinal electrode conductive, can insulation <figref>35</figref> on the large part the electrode surface to disposal will be provided, to prevent any unwanted heating effects. The ends of the electrodes are isolated from each other to the formation to prevent variable field densities at the ends, especially when increasing the effective diameter, which even greater inequalities field could generate between the ends and the curved central section. The insulation <figref>35</figref> may polyimide or other type insulating his film. Along the trailing side of the electrode away from the vein wall to disposal Asked insulation <figref>35</figref> continues to prevent the heating of the blood flowing in the vein, which also reduce the likelihood of coagulation should. The remaining exposed surface of the electrode is preferably the surface, the venous wall during the Baying contacted. The heating effect is then along the Vein wall focused. The exposed surface of the electrode should be as be great as possible, while an integrated Distance between exposed portions of the electrode along of the periphery of the effective diameter is maintained. The larger the exposed surface of the electrodes during the shrinkage are bayed against the vein wall, the greater the surface the vein wall, the electrical of the field generated by the electrodes Field is affected.

A Another arrangement of the catheter <figref>10</figref>, as in <figref idrefs="S61">14</figref> shown, closes flexible, elongated elements <figref>32</figref> on, one end of the function end <figref>11</figref> anchored the catheter is and the other end slidably connected to the catheter in the direction the connecting end is connected. The catheter in<figref idrefs="S61">14</figref> shown is similar to that in <figref idrefs="S61">13</figref> is shown, with the exception that, instead of the elongate acting elements as electrode itself, the electrodes <figref>12</figref> on the elongate elements <figref>32</figref> are localized. The elongate elements<figref>32</figref> preferably include a flat central region <figref>34</figref> for the electrodes <figref>12</figref> on. The central region <figref>34</figref> remains substantially flat, while the elongate elements <figref>32</figref> outward are deflected and bent. The substantially flat central region allows a more uniform Contact with the vein wall. The flat portion creates a larger surface area, by a contact between the electrode <figref>12</figref> on the elongated Element and the vein wall to ensure. It is understandable, that the flat portion <figref>34</figref> not centrally on the elongated member <figref>32</figref> localized have to be. The flat portion should be located so that it the first region is contacting the vein wall. The elongate elements <figref>32</figref>, in the <figref idrefs="S61">14</figref> shown are designated by the sliding shell <figref>36</figref> connected, along the exterior of the Catheter shaft is formed. When the electrode<figref>12</figref> radially outwardly and moves inward be, is the sliding shell <figref>36</figref> to and from the Functional end back and moved away.

Of the Balloon can between the catheter shaft and the elongate element <figref>32</figref> be located. A manual manipulation the sliding cover is in this arrangement is not necessary, and the sheath must be no substantial distance along the move the catheter. The balloon<figref>40</figref> is inflated and comes with the elongate elements <figref>32</figref> in Contact. When the balloon<figref>40</figref> is further inflated, be the electrodes <figref>12</figref> in a radial direction is moved outward, while the elongate Elements by the expanding balloon <figref>40</figref> distracted and be bent. The balloon is preferably using a nonconductive fluid inflated, particularly when the elongate members, the electrodes contain or when the elongated Elements themselves are conductive to act as electrodes. If the correct diameter for the electrode has been reached, stops the inflating of the balloon and the application of RF energy starts. The balloon<figref>40</figref> covers a larger surface area of ​​the venous Treatment site and adjusts the correct electrode placement relative to the vein wall safe while he extent of Vein shrinkage controlled. A more precise control over the shape and the extent of the balloon may also be possible using of bendable elements. When RF energy is applied, begins Vein down to shrink. The effective diameter of the catheter is reduced under the control of the physician to the amount of shrinkage to control. If the effective diameter is decreased, keep the electrodes the Anrei&lt;?page 16?&gt;hung in to the vein tissue. The Application of RF energy is terminated after the vein to the desired Diameter was shrunk, the final effective diameter is defined by the diameter of the balloon <figref>40</figref> and the deflected elongate elements <figref>32</figref> is defined. The balloon<figref>40</figref> becomes then discharged to a minimal profile. The elongate elements<figref>32</figref> are preferably made of spring steel or nitinol, so that the elongated Elements have a bias to a reduced diameter profile to return, when the balloon is deflated.

A Cross-sectional view of the electrode <figref>12</figref> out <figref idrefs="S61">14</figref> along lines 15-15 is in <figref idrefs="S61">15a</figref> shown. In the four-electrode configuration, it is a preferred arrangement, the electrodes <figref>12</figref> equidistant along the circumference to have the catheter. The polarity of each electrode is preferably opposite to the polarity of the directly adjacent electrode. Therefore, would the alternate Electrodes, a uniform RF field along the circumference of catheter be generated. In another arrangement, as shown in<figref idrefs="S61">15b</figref> shown, would two effective pairs of active electrodes of opposite polarity formed along the periphery of the catheter when adjacent electrodes closer together would zoom moves. During a still formed RF field along the entire circumference of the catheter would, would be that RF field most between the nearest neighbor Electrodes of opposite polarity. The shrinkage of the vein would be concentrated, where the RF field most would.

In a with to the combined <figref idrefs="S61">14</figref> discussed alternative arrangement, the outer sheath can <figref>36</figref> along the length extending the catheter, to allow the operator or doctor, the effective electrode diameter mechanically during catching energy use of RF, so a separate balloon <figref>40</figref> not necessary is. A movement of the sliding shell in the direction of functional end <figref>11</figref> of Catheter causes the electrodes to be distracted and radially outward to an increased bend diameter. The outer shell<figref>36</figref> can a preset distance to be moved, to cause the electrodes to bow to a known diameter outward. On Away Bow the electrodes placed the electrodes also in sequencer with the veins to be treated tissue. A displacement of the outer shell,<figref>36</figref> in Direction of the connection end of the catheter pulls the electrodes before introducing or retraction in or out from the vein and pushes it against the catheter. Movement of the casing controls the diameter of the catheter formation for a proper treatment venous lumen with different diameters and for making available locations of varying degrees of vein shrinkage. For example, the electrodes could in contact contacted with the vein tissue and the effective diameter mechanically be reduced to control the shrinkage, while RF Energy would be applied.

In another arrangement instead of the outer casing, the ends the elongate Elements attached otherwise to the outer shell would, slidably located within the longitudinal slots or channels, which are arranged along the circumference of the catheter. The ends the bendable elements would within these channels slide toward the functional end, while the elements away distracted or would bent, and would recede toward the connection end in order to their original back configuration.

In an alternative arrangement could the electrodes and the elongate Elements by a single wire mesh or a shielded Electrode to be replaced, preferably when RF energy in a monopolar configuration is administered. As previously could the Balloon the grid electrode radially outwardly expand, in sequencer with the vein wall. The balloon can also the extent of vein shrinkage check.

On alternative method for changing the effective diameter of the catheter in <figref idrefs="S61">13</figref> and <figref idrefs="S61">14</figref> is it, the electrodes <figref>12</figref> in direct contact with the vein wall to move. When the electrodes emit RF energy, shrinks the vein wall and presses the electrodes inward in the direction of the catheter. The vein shrinkage directly reduces the effective diameter instead of the active Control of the physician, eliminating the need for ongoing fine mechanical adjustments of the effective diameter is eliminated. On Mechanism such as a push rod or a balloon fixed diameter can be involved to a more radial contraction of the electrodes to prevent at a specific effective diameter, whereby the extent of is controlled and limited vein shrinkage. This has the advantage of Maintenance of the serial connection of the electrodes to the venous tissue, so that the tissue heated more is than the surrounding blood, without the physician constantly effective must adjust diameter of the catheter, while RF energy applied is.

Other Elements that are controllable expandable or extendable, can be used, the shrinkage of the vein to limit to a desired size. For example can mandrels from the sides of the catheter herausgescho&lt;?page 17?&gt;be ben a diameter limit for shrinkage the vein portion to define. As another example, a bendable, conducting deflection wire in one side of the catheter be localized in order to achieve the serial connection with the vein wall. Furthermore, and the non-expandable Catheter shaft and the electrodes, which in <figref idrefs="S57">7</figref> shown are to be used to the extent of vein shrinkage during limiting procedure. The vein would only fixed on the Diameter of the catheter without shrinking.

Other methods may be used with the catheter to maintain a sequencer. For example, a pressure cuff can be used to external exert pressure on the leg, in order to compress the treatment site, so that the vein wall comes into contact with the electrodes. The serial connection of the electrodes would with the vein tissue maintained by the applied external pressure. Such external compression can be used when the superficial Veins are treated. Other than the aforementioned mechanical processes can also be used to determine the size of the veins shrink to check. Such non-mechanical methods include Controlling the time and temperature of the venous RF treatment a.

the Functional end of the catheter <figref>10</figref> could be constructed, a having diffraction near the end function as in <figref>11</figref> shown, so that the catheter can be rotated to a stirring effect to produce within the vein to a more uniform heating of the vein tissue for a still more elevated to achieve shrinkage. Instead of a permanent diffraction can the catheter also be produced, a controllable diffraction near the end function available deliver. For example, the diffraction of a metal can be manufactured with shape memory be manipulated by a system of wires, a rotatable shielding or a permanent flexion of the catheter.

On Another method for controlling the heat transfer to a more uniform To achieve heating, the use of an external tourniquet, to reduce the blood flow and the vein around the catheter to venous compress treatment site. By the reduction of blood flow, either by external compression or through an intravenous inflated occlusive Balloon, the influence of the blood flow through the vein, the heat is may carry away from the treatment site is minimized. The heat transfer to the venous tissue during the procedure is less affected by the blood flow and the shrinkage rate the vein would are therefore more predictable. Sufficient pressure can also by the external tourniquet be prepared to cause the vein in baying engages with the electrodes.

In another arrangement, as shown in <figref idrefs="S56">16</figref> shown, an occlusive Zentrierungsballon <figref>40</figref> used to create a stagnant pool of blood in the vicinity the venous withhold treatment site. A single-occlusive balloon <figref>40</figref> can be used in connection with the venous valve are to retain an accumulation of blood that are heated is, the electrodes <figref>12</figref> between the venous valve and the occluding balloon <figref>40</figref> are localized. Two closing balloons (Not shown) can are formed at each end of the electrodes to a stationary collection of blood on the venous off to generate the treatment site of the venous valve. Such Arrangement insulates the venous valve, if treatment of the flap is not desirable. The closing Balloon can also be used within the electrode to center of the vein lumen.

Although not limited to the arrangement of the occlusive balloon, shown in <figref idrefs="S56">16</figref>. limited, the catheter can <figref>10</figref> further electrodes <figref>12</figref> contain, the round in a longitudinal way around the circumference of catheter are arranged. This arrangement is similar to the embodiments, with in connection <figref idrefs="S61">13</figref> and <figref idrefs="S61">14</figref> disclosed and have been described, however, the electrodes in this case are fixed to the catheter and do not bend outwards. These Arrangement with a fixed diameter that allows a RF field along the Circumference of the catheter is produced. Such an arrangement may be a allow shrinkage round and elongated contraction of the vein avoid. The particular positioning and orientation of the longitudinal Electrodes is preferably as shown in <figref idrefs="S61">15a</figref> shown.

A Arrangement with expandable balloon, as in <figref idrefs="S62">17</figref> shown, contains the four longitudinal electrodes <figref>12</figref>, Which in a longitudinal Type around the periphery of the balloon <figref>40</figref> the catheter <figref>10</figref> around are arranged. This arrangement is similar to the embodiments, with in connection <figref idrefs="S61">13</figref> and <figref idrefs="S61">14</figref> disclosed and described, to allow a shrinkage completely, and elongated Contraction of the vein to be minimized. The special positioning and orientation of the longitudinal electrode is preferably equidistant as in <figref idrefs="S61">15a</figref> shown. The in <figref idrefs="S62">17</figref> The catheter shown is an over-the-wire type, wherein the catheter via a guidewire <figref>42</figref> by a guide wire lumen <figref>52</figref> runs. Of the catheter <figref>10</figref> further includes the braided shielding <figref>24</figref>. the guide wire lumen <figref>52</figref> surrounds. A Umflechtungsröhre <figref>54</figref> is to the braid <figref>24</figref> educated. The lumen<figref>56</figref>&lt;?page 18?&gt;for the balloon <figref>40</figref> and the balloon tube <figref>55</figref>. surrounded the Umflechtungsröhre. The Umflechtungsröhre forms a sealing barrier in the guidewire lumen <figref>52</figref> leaking inflation fluid from the balloon lumen. The exterior of the Catheter includes a restraint tube <figref>57</figref>. which leads the <figref>20</figref> considers that the electrodes <figref>12</figref> connect to a RF generator. On Cross-section of the shaft of the catheter <figref>10</figref> taken along lines <figref>18-18</figref> in <figref idrefs="S62">17</figref>. is in <figref idrefs="S62">18</figref> shown.

In another arrangement, the electrodes under the balloon <figref>40</figref> of catheter <figref>10</figref> localized. This arrangement, they in<figref idrefs="S62">19</figref> shown is and the similar to that in the <figref idrefs="S62">17</figref> and <figref idrefs="S62">18</figref> is shown, allows the conductive heating of the vein tissue. The in<figref idrefs="S62">19</figref> shown Catheter is of over-the-wire type in which the catheter over the previously introduced guidewire <figref>42</figref> runs. This Balloon is inflated and expands into contact with the to reach venous tissue. As previously discussed, can the inflated balloon <figref>40</figref> be used to determine the size of the shrinkage of the vein to the outer diameter the inflated balloon <figref>40</figref> to control or restrict. Of the effective diameter, by means of selective inflation and Deflation of the balloon <figref>40</figref> to be controlled. The inflator the balloon <figref>40</figref> is preferably a conductive liquid, such as saline, so that a significant amount of RF energy still on the surrounding venous tissue is transferred. However, the inflating absorb a certain amount of RF energy, which then in heat is converted. This diffusion of the RF energy could be a greater control over the Shrinkage of the vein available put. Alternatively, could a heating coil or a Curie point element in place of the electrodes <figref>12</figref> be used, around the inflator to heat directly, which in turn the heat would conductively transferred to the vein tissue.

A embodiment the catheter <figref>10</figref> of the present invention with electrodes <figref>12</figref> at the end of Life <figref>11</figref>What a local heating of the surrounding causes venous tissue and the shrinkage of the vein is in <figref idrefs="S63">20</figref> shown. catheter <figref>10</figref> includes electrodes <figref>12</figref> in the Form of four conductive, elongate Elements outside to can be bent. The curved electrodes are along the circumference of catheter formed, but not fixed to the catheter. The catheter itself is by for the procedure suitable dimensioned sheath inserted. To the Example, a 7 French sheath, a diameter of about 2.3 millimeters (mm) has to be used. The vagina is made of a biocompatible material having a low friction coefficient. The functional end <figref>11</figref> the catheter includes a tip <figref>15</figref>. which is attached to one end of each electrode and the other End of each electrode is connected to the sliding shell <figref>36</figref> connected, along the exterior of the Catheter shaft is formed. extends the outer shell along the length down the catheter to allow the physician, the effective electrode diameter directly and mechanically during catching the application of RF energy. When the shiftable jacket <figref>36</figref> in response to a Kontrollaktuator <figref>33</figref> forward and is moved away from the operative end, the electrodes <figref>12</figref> radially outwardly, respectively inwards forced. The summit<figref>15</figref> remains essentially stationary, while the sliding sheath is moved. A retraction of the sheath<figref>36</figref> in Direction of the connection end of the catheter pulls the electrode before the introduction or removal into or out of the vein back and flattens it against the catheter from. Moving the sheath<figref>36</figref> forward towards the functional end of the catheter causes deflection and radial Turn Away of the electrodes to an elevated Diameter. The contact area of ​​the electrodes is bent outward, while the opposite ends of the longitudinal electrode closer to each other be moved. The outer shell may be moved a preset distance, in order to achieve that the electrodes to bow to a known diameter outward. A Away Bow the electrode brings the electrodes in sequencer with the to treated vein tissue. By manipulating the displaced Jacket to the effective diameter of the catheter defines through the radial Diffracting the electrodes to adapt, the contact between the Electrodes and the vein wall can be maintained during the Vein shrinks. The Kontrollaktuator<figref>33</figref> is a switch, Lever-wound control knob or any other suitable Mechanism, preferably one which precise control over the movement the sliding sheath allowed. By using the Kontrollaktuators, to move the displaceable sheath, the effective Diameter of the electrode for the treatment of venous lumen with different Diameters are controlled, and by different amounts of vein shrinkage to enable.

The tip <figref>15</figref> has a peak-like shape or may be any shape in that movement of the catheter over the guide wire and through the bends in venous vascular System allows. The spike-shaped Tip can be made of a polymer having a low hardness, such as 70 Shore A, are prepared. Alternatively, the tip of a Spring may be manufactured with a thin layer of polyethylene shrink tubing is covered.

the extent of Shrinkage is &lt;?page 19?&gt;the effective diameter of catheter and electrode combination controlled. electrodes<figref>12</figref> will radially outwards bent, as part of the effective diameter of the catheter so that they reach baying with the vein wall. After Contact with the vein tissue and the effective diameter could mechanically be reduced to control the shrinkage, while RF energy would be applied. electrodes <figref>12</figref> are preferably used as bipolar electrodes operated. When RF energy is applied to the electrodes, generates an RF field around the effective diameter of the catheter, which is defined by means of the diffracted electrodes, and the vein is heated and begins to shrink. The effective diameter the catheter is reduced under the control of the physician to the extent of catching shrinkage. If the effective diameter is decreased, remain the electrodes in baying to the vein tissue. The extent of vein shrinkage monitored by means of fluoroscopy, or any other suitable method. After the shrinkage of the vein to the desired diameter, the application is of RF energy from the electrodes <figref>12</figref> set. The desired diameter the vein is the effective final diameter of the catheter, such as by the deflected electrode <figref>12</figref> defined.

The electrodes <figref>12</figref> have an elongated shape and can be made of stainless steel, spring steel, or nitinol are produced, so that the electrodes <figref>12</figref> have a bias to return a reduced diameter profile. electrodes are rounded wires, a bending of the catheter to enable the function end, while this through the thin venous Vasculature is brought. The diameter of the electrodes is preferably between about 0:12 to 0:35 mm (approximately 0005-0015 inch), but can be up to 0.7 mm (about 12:03 Inches). Other shapes, including rectangular wires relatively large, flat surfaces can for contacting the vein wall be used. Such rectangular wires have widths in the range of 0.12 mm to 1.2 mm (0.005 to 0.05 inches) and preferably between 0.35mm to 0.7 mm (0.012 and 0.030 inch) to four to eight electrodes to allow the catheter shaft.

The whole length the bendable longitudinal electrode is conductive and insulation <figref>35</figref> is the Majority of the electrode surface made available, as in <figref idrefs="S63">21</figref> and <figref idrefs="S63">22</figref> shown, To avoid any unwanted heating effects. Only a lower portion of the conductive surface is exposed to as the to act electrode. The heating effect is greater when the electrodes closer are together, since the electric field density (power density) at this Point is the greatest. The ends of the electrodes are isolated from each other to the generation To avoid electric field densities which are larger at the ends, compared with those around the center of the electrode. When the effective Diameter increases, could larger field inequalities between the ends and the bent outwards midsections are generated when no insulation would be present. The insulation <figref>35</figref> may polyimide, parylene or other type be of insulating material. isolation<figref>35</figref>Along of the sides and the rear side of the electrode opposite from the vein wall is mounted, continues to prevent the heating of blood flowing in the veins, which also reduce the likelihood of coagulation should. When the wire has a rectangular shape, would the exposed area, which acts functionally as an electrode, then only one side of this wire occupy. As in<figref idrefs="S63">22</figref> shown, the isolation <figref>35</figref>Surrounding the electrode, further the peripheral edges of the exposed side of the electrode cover, to increase blood flow further unwanted heating effects to isolate.

Of the exposed area of ​​the electrode is preferably the area that the vein during baying contacted directly. The heating effect is then focused in the vein wall. The exposed surface area the electrode should be as large as possible his while a stable Distance between the exposed areas of the electrode along of the periphery of the effective diameter is maintained. The larger the exposed surface area of the electrodes during the shrinkage is bayed to the vein wall, the greater the surface area the vein wall, the electrodes through the generated from the electrical Field is concerned. The exposed surface area for the electrode may be substantially flat in order to uniform contact with the vein wall to improve and to control the diameter of the vein.

On sensor <figref>60</figref> and a small thermocouple for measuring the Temperature is applied to the electrode <figref>12</figref> appropriate. Like in the Cross-sectional view in <figref idrefs="S63">22</figref> shown is the temperature sensor <figref>60</figref> through a Hole in the electrode soldered, so that the sensor is substantially flush with the exposed surface of Electrode closes. The sensor can detect the temperature of the vein wall, which with in baying the exposed electrode surface is measured accurately. The wiring to the sensor is on the opposite Side of the electrode attached to it is isolated.

A Cross-sectional view of the electrode <figref>12</figref> out <figref idrefs="S63">20</figref> along lines 23-23 in <figref idrefs="S64">23</figref> shown. In the four-electrode configuration, it is a preferred embodiment, the electrodes <figref>12</figref> equally far along the to have the circumference of the catheter. Although the catheter described&lt;?page 20?&gt;ben was to have a four-electrode configuration, it is understandable that the catheter may include a different number of electrodes, for example, six, eight or more bendable electrode to the gap between to reduce the electrodes and to reduce the amount of current, is necessary to heat the vein tissue. The polarity of each Electrode is preferably opposite to the polarity of the direct adjacent electrodes to a in all directions and circumferential Shrinkage of the vein to allow. Therefore would by the alternating electrodes a relatively uniform RF Field is generated along the circumference of the catheter. In another embodiment, as in <figref idrefs="S64">24</figref> shown, two would effective pairs of active electrodes of opposite polarity along the circumference of the catheter formed when the adjacent electrodes closer together would move. While generates an RF field still along the entire circumference of the catheter would, would be that RF field most between the closest adjacent electrodes of opposite polarity. shrinkage the vein would concentrated where the RF field would be strongest.

In Alternatively, may the RF field using two pairs of electrodes, which are arranged such that they are insulated from each other, directed be focused. For example, as in<figref idrefs="S64">25</figref> shown, would be the positive electrode adjacent each pair of electrodes and no field is along the periphery of the effective diameter between the two pairs of electrodes formed. Opposite RF fields by made of two pairs of electrodes to two discrete heating zones to produce along the circumference. These heating zones may be aligned be, a heating isolated areas within the veins (ie not rotating) to cause to a treatment to the specific orient toward the range of variceal bleeding of the vein. Specific or isolated occurrences of variceal bleeding can by means of forward Application of RF energy are treated to the vein.

the Functional end of the catheter further comprises a guide wire lumen <figref>39</figref>. about the guidewire <figref>13</figref> take. The tip of the guidewire <figref>13</figref> is preferably rounded. The guidewire lumen<figref>39</figref> is preferably insulated to avoid any coupling effects or minimize the electrodes, the <figref>12</figref> onto the guide wire might have. The guidewire can be removed before the application of RF energy to the electrodes will. A cross-sectional view of the catheter<figref>10</figref> along lines 26-26 in <figref idrefs="S63">20</figref> is in <figref idrefs="S65">26</figref> shown. The guidewire <figref>13</figref> becomes centrally within a guidewire lumen <figref>38</figref> localized shown. The guidewire lumen <figref>38</figref> is surrounded by a layer of insulating material <figref>22</figref>Which in turn surrounded by a copper screen <figref>24</figref> for strength and rigidity, and to permit a flexible rotation ability of the catheter. An insulating sheath<figref>26</figref> covers the copper shielding <figref>24</figref> and contains also the conductive connections <figref>20</figref> to the electrodes. In a bipolar arrangement, the conductive connections <figref>20</figref> a opposite polarity. In an over-the-rail type catheter guidewire is on the outside of the catheter until it reaches the functional end of the catheter, whereupon the guidewire merges into the guide wire lumen. the Guidewire lumen <figref>39</figref> is preferably within the insulation material <figref>22</figref> localized, about the guidewire <figref>13</figref> electric from the electrode <figref>12</figref> isolate. The guidewire lumen may also include administration of a medicament or perfusion or a cooling liquid while the application of RF energy to allow the treatment area.

A Another arrangement of the catheter <figref>10</figref>, as in <figref idrefs="S65">27</figref> shown, closes bendable elongated members <figref>32</figref> on, with one end in the end function <figref>11</figref> anchored the catheter are and connected me to the other end slidably connected to the catheter are, in the direction of the connection end. The in<figref idrefs="S65">27</figref> shown Catheter is similar for the in <figref idrefs="S63">20</figref> shown, with the exception that instead of elongate Elements, which act independently as an electrode, the electrode <figref>12</figref> on the elongate elements <figref>32</figref> are localized. The elongate elements<figref>32</figref> preferably include a flat central region and for the electrodes <figref>12</figref> on. The central region is substantially flat, while the elongate members <figref>32</figref> distracted and outwardly be bent. The substantially flat central region Allowed a more uniform Contact with the vein wall. The flat portion provides a larger surface area forth to the contact between the electrode <figref>12</figref> on the elongated Element and the vein wall to ensure. It is understood that the flat area not central to the elongate member <figref>32</figref> localized have to be. The flat area should be localized to the to be the first region contacting the vein wall. The elongate elements<figref>32</figref> at the Functional end of the catheter is connected to a moving point, which is manually controlled by a Durchmesseraktuator, the is located at the connection end of the catheter. The movable tip <figref>17</figref> is the Durchmesseraktuator a Aktuierungsdraht <figref>37</figref> connected, the centrally through the catheter running, as in <figref idrefs="S65">28</figref> shown. The Durchmesseraktuator can be wound on the connecting end of the catheter. Maneuver of Durchmesseraktuators in and out of the connection end of the Catheter also caused over the Aktuierungsdraht a korrespondie&lt;?page 21?&gt;Rende movement in the mobile Tip at the function end of the catheter. When the movable top<figref>17</figref> by the Durchmesseraktuator <figref>33</figref> in the direction of the connection end is pulled, the electrodes are <figref>12</figref> bent outwardly. The flexible electrodes <figref>12</figref> stretch of preferably, to veins to treat up to a diameter of ten mm or more. When the movable top <figref>17</figref> by means of Aktuierungsdrahts <figref>37</figref> is pushed forward, are the flexible electrodes <figref>12</figref> then to stem the Catheter withdrawn. A contact of the electrode with the vein wall can maintain are while the vein shrinks.

In one embodiment the balloon <figref>40</figref> between the catheter shaft and the elongate member <figref>32</figref> localized. The manual manipulation of a sliding sheath or a movable tip is not necessary in this embodiment, and the sliding sheath, if used, needs to to move any significant distance along the catheter. Of the balloon <figref>40</figref> can either be made of elastic material such as latex or not resilient material. The balloon<figref>40</figref> becomes inflated and comes with the elongate elements <figref>32</figref> in contact. When the balloon<figref>40</figref> continue is inflated, the electrodes <figref>12</figref> in a radial direction outward moved while the elongate Elements by the expanding balloon <figref>40</figref> distracted and be bent. The balloon is preferably using a nonconductive fluid inflated, particularly when the elongate members electrodes contain or when the elongate Element itself is conductive to act as an electrode. If the correct diameter for the Electrodes is reached, stops the inflating of the balloon and the Application of RF energy starts.

Of the balloon <figref>40</figref> covers a larger surface area of ​​the venous Treatment site and adjusts the correct electrode placement relative to the vein wall safe while he extent of Vein shrinkage controlled. A more precise control over the shape and the extent of the balloon may also be possible using of bendable elements. The balloon may also be used, to the effective diameter of the catheter at the end to function check. When RF energy is applied, the vein begins to shrink down to the effective diameter of the catheter. The effective diameter of the catheter is under the control the doctor reduced to control the amount of shrinkage. If the effective diameter is decreased, keeping the electrodes baying in to the vein tissue. The application of RF energy from the electrode <figref>12</figref> is terminated after the vein on the desired Diameter was shrunk, the final effective diameter is defined by the diameter of the balloon <figref>40</figref> and the deflected elongated elements <figref>32</figref> is defined. The balloon<figref>40</figref> becomes then discharged to a minimal profile. The elongate elements<figref>32</figref> can from Spring steel or Nitinol be made, so that the elongated elements <figref>32</figref> have a bias to a reduced return diameter profile, when the balloon is deflated.

In Alternatively, are the ends of the elongate Elements instead slidably disposed within the longitudinal slots or channels localized, which are arranged along the circumference of the catheter. would the ends of flexible elements within these channels toward the Functional end slide while the elements away would be deflected or bent, and would recede toward the connection end in order to their original back configuration.

In an alternative arrangement could the electrodes and the elongate Elements by a single wire mesh or a shielded Electrode to be replaced, preferably when RF energy in a monopolar configuration is administered. As previously could the Balloon the grid electrode radially outwardly expand, in sequencer with the vein wall. The balloon can also the extent of vein shrinkage check.

On alternative method for changing the effective diameter of the catheter to the electrodes is in direct moving contact with the vein wall or deflect and then to allow the vein wall to change the effective diameter. If The electrodes emit RF energy, shrinks the vein wall and presses the electrodes inward in the direction of the catheter. The vein shrinkage directly reduces the effective diameter instead of the active Control of the physician, eliminating the need for ongoing fine mechanical adjustments to the effective diameter is eliminated. On Mechanism such as a push rod or a balloon fixed diameter can be involved to a more radial contraction of the electrodes to prevent at a specific effective diameter, whereby the extent of is controlled and limited vein shrinkage. This has the advantage maintaining the baying of the electrodes to the venous tissue, so that the fabric is stronger is heated than the surrounding blood, continuously without the physician must adjust the effective diameter of the catheter during RF Energy is applied.

the A method of using the present invention for the minimally invasive treatment of venous insufficiency can be measured using a running catheter be at least &lt;?page 22?&gt;an electrode on the functional end of the catheter to a venous treatment site bring to the proper function a vein to Hämorrhoidalregion leads, restore. An over-the-wire or rail-guided catheters can be used one or more electrodes through the tortuous bends of the ven eyelets System to the hemorrhoidal bringing treatment site.

The Electrode applies RF energy at a suitable frequency for the minimum coagulation for to stiffen a sufficient time in order to shrink the vein, and to fix and yet the venous function or flaps competence upright to obtain. This intraluminal approach avoids the risks and Mortality associated with more invasive surgical techniques such Hömorrhoidektomie are while the return flow of blood is significantly reduced in the areas without causing necrosis or to remove the vein tissue.

at treating veins of the lower Hämorrhoidalregion is the access point prepared and a percutaneous introducer is inserted into the vein. The Procedure for repair of incompetent veins can by a qualified Doctor with fluoroscopic or ultrasonic observation, or conducted direct visualization will. A guidewire is in the vein by the insertion imported and shifted to the venous treatment site. Alternatively, the catheter can be inserted directly into the vein and without a guidewire be manipulated. Preferably, the guidewire has a federgewundene Tip. The guidewire is retrograde venous advanced treatment site, such as the incompetent vein location, which is very distally located, should be repaired. Various intravenous ways can for hemorrhoidal Treatment site are taken.

A partially cross-sectional view of the venous system to Hämorrhoidalregion leads, is in <figref idrefs="S66">29</figref> shown. hemorrhoids are generally defined as internal or external depending on if she or under the serrated line (DL) are formed. Internal hemorrhoids are usually formed, if smaller veins in the upper Hämorrhoidalvene SHV or average Hämmorhoidalvene MHV lead, be dilated. External hemorrhoids are usually formed when the smaller veins, the lower in the Hämorrhoidalvene IHV lead, be dilated.

On Methods of administering the catheter <figref>10</figref> and guidewire <figref>13</figref>. it is the guidewire <figref>13</figref> in the external Iliacvene EI on the side opposite to the dilated Vein of Hämorride introduce. The guidewire is the forked branch of the lower vein cava IVC to the lower Iliacvene II controlled. The guidewire is either in the middle Hämorrhoidalvene MHV for treatment internal hemorrhoids or Pudendalvene PV and lower Hämorrhoidalvene IHV to treat external hemorrhoids maneuvered. The guidewire is inserted and maneuvered into the middle Hämmorhoidalvene MHV, to internal hemorrhoids to treat. The guidewire<figref>13</figref> becomes through the venous System maneuvered until it reaches the dilated veins of the Hämorride. catheter <figref>10</figref> is then over the guidewire <figref>13</figref> at venous brought treatment site, such as in <figref idrefs="S66">29</figref> shown. The functional end <figref>11</figref> the catheter <figref>10</figref> includes a or more electrodes for applying an RF power once properly at the venous Treatment site positioned to a shrinkage of the vein to to cause. The functional end of the catheter further includes a flexible tip-shaped Tip a, a tracking of the catheter over the guidewire and through the bends in vascular to enable system. Fluoroscopy, x-rays, Ultrasonic or similar image-representative techniques could be used, the specific placement of the catheter to conduct and verify the position within the vein. X-ray contrast media can be injected through or around the catheter to the incompetent identify venous sections to be repaired. This Approach allows the guidewire or catheter advantageous to avoid sharp bends or curves, while he Venous Treatment site is controlled. It is understood that other access points can be used to either internal or external hemorrhoids to treat.

On Another method of administering the catheter and the guide wire is the guidewire in the upper Hämorrhoidalvene introduce and the guidewire through the upper Hömorrhoidalvene SVH to Hämorrhoidalregion to maneuver. The guidewire is brought into position and the catheter is then over the guidewire the venous Treatment site for internal Hämorride brought. venous Treatment site is within the lumen of a dilated vein.

If the electrodes <figref>12</figref> the catheter <figref>10</figref> at the venous treatment site are positioned, an RF generator is activated to provide suitable RF energy to provide, preferably at a low power level and preferably at a selected frequency in the range of 250 kHz to 350 MHz. For example, an appropriate frequency is 510 kHz. Another suitable frequency is 460 kHz. An example of the selection the applied frequency is to control the speed, including &lt;?page 23?&gt;the Depth, the thermal effect in the tissue. Another criterion for the Selection of the applied frequency is the ability of the filter circuits, RF noise to eliminate from the thermocouple signals.

The from the electrodes emitted energy is within the venous tissue converted into heat. When the temperature of the venous tissue increases, the vein tissue begins to shrink. The shrinkage takes place partly by dehydration and the structural transfiguration of the collagen fibers in the vein. Although the collagen is compressed during this process will retain the collagen still some elasticity.

RF Energy can be applied to the dilated venous sections a Hämorride to heat. The dilated vein is under the controlled application RF energy heats the venous tissue to a normal shrunk or reduced diameter. The venous pressure on the lower portions of the veins Hämorride can be lowered because of the decrease of the cross-sectional area of ​​the vein. The flaps competence in the lower venous Sections may also indirectly by lowering the venous pressure be restored. A thickening of the vein occurs during Treatment also on what the likelihood of recurrence the Venendilatation may decrease. The temperature and energy the RF energy can also be controlled in order to shrink the Hämorride both as well as to cause the wall of the adjacent Hämorrhoidalvene Fabric is attached.

Although the application of RF energy the Venendilatation in the vicinity of the formation the Hämorride can shrink the extent of shrinkage can also higher venous sections be included advantageous to effect higher and increased venous pressure the Hämorrhoidalsystem to Reduce. A contiguous axial section of a dilated vein can be accomplished using RF energy can be treated along the dilated vein portion, although this portion is large. For example, hemorrhoids sensitive to pressures the portal system, the hemorrhoids through the upper Hämorrhoidalvene SHV can be transferred. A treatment of the upper Hämorrhoidalvene by general shrinkage along a portion of the extensive vein over the Hämorride can the dilating forces cancel, the elevated from any Press the Portal system arise. Such a treatment may even desirable be, if there is no significant dilation in the upper Hämorrhoidalvene SHV is.

Of the catheter <figref>10</figref> , as in <figref idrefs="S67">30a</figref> shown on the guidewire <figref>13</figref> by the venous System introduced. The summit <figref>15</figref> the functional end <figref>11</figref> the catheter <figref>10</figref> Has the shape of a tip which is flexible enough to slide over the guidewire and through the bends in the venous System. As in<figref idrefs="S67">30b</figref> shown, the catheter is <figref>10</figref> in the dilated venous brought portion which may contain an incompetent valve. The electrodes are then positioned in sequencer with the vein wall, preferably by mechanical bending of the electrodes <figref>12</figref> away from catheter <figref>10</figref>, as in <figref idrefs="S67">30c</figref> shown. The application of RF energy from the electrodes causes Shrinkage of the vein and the effective diameter of the catheter, as by the time away curved electrode defines, is mechanically reduced to the extent of catching vein shrinkage. The curved electrode as in <figref idrefs="S67">30d</figref> shown held in place, to define a specific effective diameter and to a closing to prevent the vein. The catheter can be moved along the length of the dilated vein to be moved to a general contraction to cause, where an extensive dilation is present.

RF Energy is no longer applied after sufficient shrinkage the vein has occurred, to alleviate the dilation of the vein. A considerable shrinkage can be achieved very quickly, dependent of the specific treatment conditions including the energy levels the applied RF energy. The properties of the treatment site, such as temperature can be monitored are to a feedback control for the RF energy available deliver. Other techniques such as impedance monitoring, and ultrasonic pulse echo, can be used in an automated system, the application of the RF off power from the electrodes to the venous section, when sufficient shrinkage of the vein is detected and to an overheating and to avoid a cauterization of the vein. Monitoring these values ​​in an automated feedback control system for RF Energy can also be used, the energy level and catching the heating effect.

A sufficient shrinkage of the vein can fluoroscopy, venography, external ultrasound scanning, intravskulärem ultrasound scanning, impedance monitoring, Temperature monitoring, direct visualization using a angioscope or any suitable method can be detected. For example, the catheter<figref>10</figref> configured be an X-ray contrast media to be administered to allow visualization by fluoroscopy for judging the condition of the vein and the relationship between Catheter and treatment area of ​​the vein during the shrinkage&lt;?page 24?&gt;process. As an alternative to fluoroscopy, external ultrasound techniques such as B-scanning using certain signals from ultrasonic different angles or intravascular ultrasound are used, a multidimensional view of the vein shrinkage at the treatment site to obtain what the recognition of unequal shrinkage in the Vein improved. An angioscope can also be used, to the extent and to visualize the state of vein shrinkage directly and to determine.

If the catheter having a fluid delivery lumen is provided, a cooling liquid through the delivery lumen during the RF heating are given the treated vein into the bloodstream. The liquid may include radio dense contrast material. The administered coolant minimizes any heating effect on the blood and reduced the risk of heating the blood to the point of coagulation. The liquid can through openings be administered, along the side of the catheter near the End of Life and the electrodes are formed.

the end of Life <figref>11</figref> the catheter <figref>10</figref> near the electrodes <figref>12</figref> can be used to the extent of Shrinkage physically limiting. The functional end<figref>11</figref> is preferably of sufficient size or enlarged to Complete sealing to prevent the vein. Other measures, such as an inflatable Balloon can be used are, to the extent of to limit shrinkage of the vein mechanically or catching or to displace blood from the treatment site. Such mechanical means can also be used to the serial connection between the electrodes and the Venous tissue during ensure the treatment.

During the Catheter allows a general shrinkage of the vein, It can also be used to direct the venous valves to treat. The hemorrhoidal veins have Bikupsidalklappen and in a normal and competent flap forms each leaflet a sack or reservoir for blood, the pressurized surfaces the leaflets forces together to a backward flow of blood and to prevent a forward to allow flow to the heart. The arrows from the top the inferior vena cava IVC and the upper Hämorrhoidalvene SHV as in <figref idrefs="S66">29</figref> shown lead out, represent antegrade blood flow back to the heart. The venous valves prevent retrograde flow as blood forward through the vein lumen and back pressed to the heart is. When an incompetent valve does not close the valve leaflets properly and retrograde Blood flow can occur. Incompetent flaps from stretching of dilated Veins originate. If the valves fail, is an increased pressure on the lower Veins and exercised the bottom flaps of the veins, which in turn failure these bottom flaps worse. As a result to hemorrhoids occur or be exacerbated. The leaflets can to the junction due to the thinning and stretching of the vein wall to the leaflets undergo a slight separation. When RF energy applied within the dilated vein near the incompetent venous valve is a contraction of the vein, the flaps competence again produced by reducing the dilation, the proper functioning the venous valve prevented.

at the treatment of venous valves, the electrodes on the catheter is advanced until a contact with the leaflets of venous valve by fluoroscopy, ultrasound, or any other detection method is observed. The catheter is then withdrawn slightly, to allow a treatment of the dilated section of the vein. The electrodes are activated to RF power to the venous tissue deliver and to shrink the vein. The application of RF energy should be controlled to an unwanted heating of the leaflets to avoid. The shrinkage of the vein can be limited to a closing to avoid the vein and a continuous function of the vein to allow. The outer diameter of the catheter or a pull-out element can be controlled be to increase the size of the vein shrinkage to restrict.

After treatment should the joint and the valve leaflets the venous valves are closer to one another, with little distance or incident, indicating a restoration of the valve competence. The flaps competence can be determined by means of contrast injection or Doppler probe measurement will.

To the Example, by a radiopaque contrast agent the catheter lumen can be infused to the flaps competence over Descending to determine venography. It should be noted that a reduction above the Venendilatation means of general contraction in a portion of the portion that contains the incompetent venous valves that could restore valve competence by reduction of venous pressure on the flap and the dilation of the vein, which the necessary span the leaflets reduced. The direct placement of electrodes on a Venous valve can lead to shrinkage of the loose, limp leaves what to prevent prolapse and reflux of blood through the valve leads.

&lt;?page 25?&gt;

Of the catheter <figref>10</figref> can be repositioned within the vein, to treat as many venous sections and valves as necessary. RF Energy is applied to each vein segment, the repaired is to be until all of the desired venous Sections are repaired and the flaps were made competent. Multiple incompetent valves and dilated venous sections can in treated and repaired a single minimally invasive procedure will. If desired, , a second insertion in introduced the patient are to incompetent venous Sections in the other vein system, as the upper Hämorrhiodalvene, to treat.

On Another area of ​​venous Insufficiency, which is suitable, according to the present invention to be treated, involved oesophageal varices. oesophageal Varicose veins called, Varices, can in venous form and circulatory system along the submucosa of the lower esophageal may occur from the swollen veins. properly sized Catheter according to the present Invention will be used to the electrodes of the place of venous Insufficiency along the esophageal bring varices. The endovascular access the catheter is preferably through the upper mesenteric vein or Portal vein available asked to shrink the portal vein branches of which the lower esophagus to lead. Proper positioning of the electrode within the vein can be performed using fluoroscopic confirmed or ultrasonic techniques will. The electrodes apply RF energy or other radiant To shrink energy at a suitable frequency to the vein and the swelling and transmission of high portalvenösem Pressure on the esophagus to reduce surrounding veins, while the function of the vein is maintained. The extent of shrinkage of the vein may be limited by the diameter of the catheter, or the Electrodes themselves can be extended to a predetermined diameter, shrinking the the vein limited to this diameter.

varicose veins, oesophageal called Varices, can in venous can make system along the submucosa of the lower esophagus and bleeding occur from the swollen veins ago. A properly dimensioned catheter <figref>10</figref> is used to the electrodes <figref>12</figref> at the place of venous Dysfunction along the esophageal varices bring to. The endovascular access the catheter is preferably through the upper mesenteric vein or portal vein available asked to shrink the portal vein branches of which the lower esophagus to lead. Proper positioning of the electrode within the vein can be performed using fluoroscopic or confirmed ultrasound techniques will. The electrodes apply RF energy or other forms of energy To shrink the vein at a suitable power or frequency to and the swelling and transmission high portovenous Pressure on the esophagus to reduce surrounding veins, while the function of the vein is maintained. The extent of shrinkage of the vein can be limited by the diameter of the catheter itself, and The catheter or electrodes themselves can to a predetermined diameter be extended, the shrinkage of the vein on this diameter limited.

at treating veins of the lower esophageal region is the preparing access site and a percutaneous insertion is introduced into the vein. The procedure for repair of incompetent veins can range from a qualified physician with or without fluoroscopic or ultrasonic observation be carried out or under direct visualization. A guidewire<figref>13</figref> becomes by the insertion inserted into the vein and venous Treatment site advanced. The wire to the treatment site advanced as the height the most proximal point situated an incompetent vein to be repaired. Preferably, the guide wire and the catheter antegrade for oesophageal Treatment site is advanced. Alternatively, the catheter can directly inserted into the vein be manipulated and without a guide wire will.

As in <figref idrefs="S68">31</figref> in a partial view of the venous system, the for oesophageal leads region shown, the catheter is <figref>10</figref> over the guidewire <figref>13</figref> to a dilated portion of the vein is advanced. A procedure for administration by catheter and guide wire is, the guide wire through the upper mesenteric vein SMV for portal vein PV and Coronalvene CV introduce, the shares and the lower esophagus E leads, the oesophageal to form veins EV. As an alternative route, the guidewire could in the lower mesenteric introduced vein be and the splenic vein SV, the portal vein PV and Coronarvene CV are steered to arrive at the esophageal varix to be treated.

Of the guidewire is used and manipulated to reach the treatment site for the treatment of oesophageal Varices. The venous treatment site is preferably within the lumen of a dilated vein. Of the catheter <figref>10</figref> then to the venous treatment site on the guidewire <figref>13</figref>. as in <figref idrefs="S68">31</figref> shown accommodated. fluoroscopy, X-ray, Ultrasonic or similar imaging technique can be used, the specific placement of the catheter to conduct and the position within the vein &lt;?page 26?&gt;to check. X-ray contrast media can or injected around the catheter to the dilated venous identify sections that are to be treated. bleeding or bleeding of oesophageal Varicose veins may also be identified in this way.

As soon as the dilated venous Section is reached, the one or more electrodes are <figref>12</figref> activated submit to RF energy to the dilated venous section. While the Electrodes are held in the middle of the vein, the electrodes are preferably placed in sequencer to the vein wall. The baying in with the vein tissue located electrodes ensure that the heating effect is emitted in the direction of the venous tissue and not on the moving blood through the vein, and allow control of the shrinkage of the vein. A method to achieve a sequencer, is the electrode away from the body the catheter to bend away. This is in<figref idrefs="S69">32a</figref>. <figref idrefs="S69">32b</figref> and <figref idrefs="S69">32c</figref> shown. The electrodes have an elongated, longitudinal structure having opposed Ends to a fixed or a movable part are attached to the functional end of the catheter. The flexible electrodes be by movement of the outer shell the catheter manipulated while the tip of the catheter remains fixed. Alternatively, a central wire be used to move the tip, while the opposite End of the flexible electrode is held in place.

The one or more electrodes <figref>12</figref> the function end <figref>11</figref> of catheter <figref>10</figref> contact RF energy at once it is properly positioned and venous Treatment site are bayed to a shrinkage of the vein to to cause. An RF generator is activated to an appropriate to deliver RF energy to the electrodes, preferably at a low energy level, and preferably at a selected frequency in a range of 250 kHz to 350 MHz. For example, a suitable frequency 510 kHz. One criterion for the selection of the applied Frequency is controlling the spread including Depth of the thermal effect in the tissue. Another criterion is compatibility with filter circuits which can be used to RF noise to be eliminated from the thermocouple signals.

The from the electrodes emitted energy is within the venous tissue converted into heat. When the temperature of the venous tissue increases, the vein tissue begins to shrink. The shrinkage takes place partly by dehydration and the structural transfiguration of the collagen fibers in the vein. Although the collagen is compressed during this process will retain the collagen still some elasticity.

A considerable shrinkage can be achieved very quickly, depending on the specific treatment conditions, including the diameter the treated vein and the energy level of the applied RF energy. The properties of the treatment site, such as temperature can be monitored are to a feedback control for the RF energy available deliver. Other techniques such as impedance monitoring, and ultrasonic pulse echo, can be used in an automated system, the application of the RF off power from the electrodes to the venous section, when sufficient shrinkage of the vein is detected and to an overheating and to avoid a cauterization of the vein. Monitoring these values ​​in an automated feedback control system for RF Energy can also be used, the heating effect to control.

Sufficient Shrinkage can by fluoroscopy, external ultrasound scanning, intrvaskulärem Ultrasound scanning, impedance monitoring, Temperature monitoring, direct visualization using a angioscope or any suitable be detected procedure. For example, the catheter<figref>10</figref> configured be x-ray contrast media provide to a visualization under fluoroscopy to allow the condition of the vein and the relationship of the catheter to the treatment area the vein during the shrinkage process to judge. As an alternative to fluoroscopy external ultrasound techniques such as B-scanning using certain ultrasonic signals from different angles or intravascular ultrasound be used to provide a multidimensional view of the vein shrinkage to obtain at the treatment site, which the recognition of unequal shrinkage improved in the vein. An angioscope can also be used, to the extent and Prior veins shrink to directly visualize and determine.

the end of Life <figref>11</figref> the catheter <figref>10</figref> near the electrodes <figref>12</figref> limited physically, the extent of Shrinkage. electrodes<figref>12</figref> the function end <figref>11</figref> will outwards bent in sequencer with the vein wall and then during the Application of RF energy slowly inwardly in the direction of the catheter, reduced. The final effective diameter of the electrodes <figref>12</figref> the function end <figref>11</figref> is preferably sufficient to complete the sealing of the To prevent vein. Other systems, such as an inflatable balloon, can be used to the extent of to limit shrinkage in the vein to a desired diameter or catching. RF energy is not more of the electrodes applied after sufficient shrinkage of the vein taken place &lt;?page 27?&gt;Has, to alleviate the dilation of the vein. Methods other than the aforementioned mechanical methods may also be used, to the extent of catching vein shrinkage. Such non-mechanical method conclude controlling the time and temperature of the venous RF treatment on.

Of the dilated venous Section under the controlled application of RF energy according to the present Invention and heated to a normal or reduced diameter shrunk. A contiguous axial section of a dilated vein may by application are treated by RF energy along the dilated venous section, even if the section is extensive. To an extensive vein segment treated, the catheter to the venous portion is moved at intervals, progressively to shrink, or along the extensive section while the application of RF energy back and moved back. Furthermore, a Thickening of the vein while occur during treatment and the likelihood of recurrence reduce a Venendilatation and bleeding.

The Application of RF energy will shrink the dilation of oesophageal Varices and the extent of the shrinkage to other sections the portal venous system may be advantageous to determine the effect of increased venous pressure the oesophageal varices to further reduce. oesophageal veins can sensitive to pressures from its portal system. Treatment of the branches of the portal vein before the esophagus by general shrinkage along a extensive range of vein before the esophagus can the dilating effect on Ösophagealvenen who by elevated pressures caused the portal venous system, reduce.

It is understandable, that other mechanisms may be used to the electrodes in or with the venous to be repaired position or to rows, section without bending or stretching the electrodes from the catheter away itself. The catheter may adapted be distracted, twisted or otherwise moved to proper place to allow the electrode. The catheter may be made to a controllable deflection near the end of function available to put. For example, the deflection of a shape memory metal manufactured, manipulated by a wire system, a rotatable cord or may be a permanent bend in the catheter. manipulation of the functional end of the catheter allows, if desired, the preferred heating along the vein wall being treated, where the electrodes closer are placed to one side of the vein wall. The preferably Heating of the vein may also be used to the hemostasis to accomplish.

It is understandable that even though a bipolar arrangement will be described, also a monopolar arrangement can be used. In a monopolar Arrangement is an internal electrode as a grid or wire electrode in the body the patient introduced. An outer electrode with a much larger surface area than the inner electrode is placed on the outer surface of the patient's body, near the treatment site. For example, an external metal plate to the skin over the inner electrode placed through the region to be treated. Alternatively, a metallized balloon in the esophagus imported and inflated in contact with the mucosal lining of the esophagus come and as inactive return electrode to act. The electrodes are connected to a RF generator, which produces an electrical field within the patient's body. There the surface the inner electrode is much smaller than that of the outer electrode, is the Density of the electric field around the inner electrode around a lot higher. the electric field reaches its highest density between the two Electrode in the region in the vicinity of the inner electrode. The increased Density of the field to the inner electrode around allows a local Heating of the tissue surrounding the inner electrode. The degree of heating may depend be factors such as the impedance of the dielectric constant and of the treated tissue. It is understood that various electrodes different number and configuration may be used to the wished create any heating effect.

As easily can be determined from the present disclosure, , the procedure of the present invention without the need for one longer accomplished hospitalization or post-operative recovery will. The curative restoration of venous function is possible without the need for ongoing changes in lifestyle, such as frequent Lifting the legs, wearing relatively uncomfortable elastic stockings or longer treatment of recurring Venenstauungsgeschwüren. Moreover, the surgical transplantation veins not necessary.

The early treatment a venous disease could more serious complications such as ulceration, thrombophlebitis prevent and thromboembolism. The cost of treatment and complications would because of venous disease significantly reduced. There would no need for an extended hospital stay for this procedure and the need for a subsequent treatment or hospitalization would in view on what currently erforder&lt;?page 28?&gt;is Lich, also reduced. Furthermore, it would minimally allow invasive nature of the disclosed methods the physician more Vein sections in a single procedure and a relatively short to repair or treat time period.

It it should be understood that the type and dimensions of the catheter and the electrodes are selected according to the size of the vein to be treated can. Although the present invention for the treatment of venous insufficiency of the lower limbs, such as varicose veins in the leg, has been described, the present Invention will be used to create a venous insufficiency in other Areas of the body intraluminal treat.

On Another area of ​​venous insufficiency relates to erectile Impotency of the penis. A significant number of all physically-induced Cases of impotence resulting from an excessive outflow of blood from the venous system the penis. Venous drainage impotence can be treated using the present invention. Catheter with a sufficiently small diameter can be used to to ring electrodes by thee dorsal vein of the venous system of the penis, to these venous Outflow path to shrink. Fluoroscopic or ultrasound techniques can are used to the electrode properly within the incompetent positioning vein. RF energy or other radiant energy is applied from the electrodes at a suitable frequency, to shrink the surrounding venous tissue to the excess amount reduce to drain from the penis, while the venous function or Flaps competence is maintained. The extent of shrinkage the vein can be limited by the diameter of the catheter itself are, or the catheter or electrodes themselves can on the appropriate size to be extended. Ligation of these veins should be avoided to ensure proper drainage to allow blood from a swollen penis, penile what for proper Function is needed.

While numerous certain forms of the invention illustrated and described are, it is obvious that a variety of modifications can be made without departing from the scope of the invention. Accordingly, it is not intended that the invention be limited is intended, except as by the appended claims.