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The invention relates to a device for resecting tissue, in particular a device for high-frequency surgical removal of a tissue section according to the preamble of claim 1, and a corresponding method.
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In a tissue resection, certain tissue parts of an organ or a tumor are surgically removed. The tissue resection can be done by means of high-frequency surgery. In high-frequency surgery, an alternating current is passed through the tissue, so that it is specifically damaged in places with high current density. The current can be introduced into the tissue via two closely adjacent electrodes (so-called bipolar technique) or via an electrode on the tissue to be resected and a (large-area) remote electrode (so-called monopolar technique). For example, in laparoscopic hysterectomy (LSH), the cervix at the transition to the uterus (isthmus) is severed with the aid of a monopolar tick after sealing the afferent blood vessels with bipolar grasping forceps and subsequently severing them.
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As an alternative to the tick, systems using a sling in conjunction with bipolar high frequency surgery technique to sever tissue are also currently being used.
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The LiNA Bipolar Loop System (trade name) and the LiNA Gold Loop System (trade name) of LiNA MEDICAL (company name) each have a tube with an outer diameter of 5 mm, from which a diamond-shaped wire loop can be extended. The gold loop system is only monopolar. In the bipolar system, both wire ends are separated distally by means of an insulating body, so that both wire segments can be energized individually. This achieves a bipolar effect. By pulling the loop under simultaneous RF application, a cutting and at the same time coagulating effect is achieved in the area of the non-insulated wire.
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The PKS-Bill system (trade name) of OLYMPUS (company name) is similar in principle. In contrast to the two systems above, in this case the loop has the shape of a hexagonal rhombus. A forceps with monopolar HF connection is used for power dissipation and replaces the neutral electrode.
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The Medsys Lap Loop system (trade name) is also similar to the former systems. Here, however, the sling must be hooked intracorporeally to the distal end of the instrument. The instrument is reusable.
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Furthermore, the following systems of the applicant Aragon Surgical (company name) are known in the art.
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In
WO 2006/124590 A2 discloses a method and apparatus for a surgical procedure in which two energy-conducting elements on opposite sides are pressed against a tissue and energy is passed through the elements so that sufficient energy for coagulating and closing tissue flows for a sufficient period of time; such that the tissue is cut through the tissue along a plane.
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In
WO 1999/018869 A1 describe a method and a system for the resection of tissue. A pair of electrodes is placed on opposite sides of the tissue. A high frequency current is passed through the electrodes to cause necrosis in the tissue therebetween. Thereafter, the tissue can be removed with minimal or total absence of bleeding.
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In
US Pat. No. 7 641 651 B2 An electrocautery device having a first and a second electrode is described. The electrodes can be clamped together, and a high frequency current can be passed through the clamped together electrodes, so that blood vessels are pressed and interrupted.
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The previous solutions in the prior art, however, have the disadvantage that the coagulation effect due to a lack of depth and surface effect is not sufficient to safely seal larger vessels from about 0.5 mm. As a result, tissue bleeding occurs immediately after severing, in part also during the course, and must be specifically treated. This is time consuming, can lead to unwanted coagulation of healthy tissue in the environment and carries a certain postoperative risk of rebleeding. The advantage of the conventional technique is thus almost completely canceled out.
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Furthermore, the bipolar cutting performance is lower compared to the monopolar technique. The separation process is thus time-consuming and often has to be interrupted by measures for acute hemostasis. This "reworking" negates the fundamental advantages of bipolar technology.
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Regardless, it has often been a problem, the sling over the tissue to be separated (for example, the uterus) and evert then place correctly (for example in the area of the cervix). Therefore, in the prior art, there is the idea to open the loop unilaterally, then lead the loop with its open end ahead of the tissue to be separated and hang on the opposite side again. In this case, however, the difficulty arises that the free end can catch on patient tissue and possibly injure. In principle, this problem can also occur if the free end is correspondingly rounded.
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The object of the invention is therefore to provide a system and to provide a method that can be cut quickly and without major relevant bleeding with easy handling and larger blooded tissue quantities. This system should be adapted to the conditions of the laparoscopic or thoracoscopic procedure.
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This object is achieved by the device for high-frequency surgical removal of a tissue section according to claim 1 and a corresponding method according to claim 10. Preferred embodiments of the invention are the subject of the respective subclaims.
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According to a first, optionally individually claimable aspect of the present invention, a (carrier) band of a soft / flexible thermostable material, preferably plastic, is used for the severing of tissue. On the tape / several electrical conductors are / are arranged, which can preferably be energized individually, so that they can be passed through a current through the adjacent tissue. One end of the band is preferably provided with a fixed loop or eyelet through which the other end of the band is threaded. The band can thus be pulled together like a sling. This makes it possible to apply the carrier band particularly well laparoscopically or throrakoskopisch.
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The inventive device for high-frequency surgical removal of
a tissue section with
an RF generator for generating an RF voltage and
An electrically conductive (flexible) loop for enclosing the tissue section so that an electrical current flows from the loop into the tissue section also has the following technical features:
- - The electrically conductive loop has at least two electrical outer conductor on the insulating carrier tape.
- The outer conductors are arranged on a surface of the insulating carrier tape (longitudinal and / or circumferential spacing) such that they extend in the longitudinal direction of the carrier tape and have a substantially constant (longitudinal and / or circumferential) distance from one another.
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Preferred embodiments of the device according to the invention have as one or, if technically possible and meaningful, several of the following features:
- - The electrically conductive loop also has a center conductor, which extends in the longitudinal direction of the carrier tape and has a substantially constant distance from the two outer conductors;
- A switching device is provided for energizing the conductors, so that in a first time interval a current flows through the at least two outer conductors and in a second time interval a current flows through the center conductor;
- - The at least two outer conductor and / or the center conductor are partially isolated and are energized alternately;
- - A traction device is provided which is connected to the center conductor, so that upon actuation of the traction device of the center conductor is pressed into the fabric section;
- - A draft tube is provided for the loop for receiving the loop, so that the loop is retractable;
- - The draft tube is divided into at least a first shaft and a second shaft, so that a conductor portion in front of the tissue section is electrically isolated from a conductor portion to the tissue section;
- - An impedance detection means is provided for detecting a resistance of the tissue and for controlling an RF power of the RF generator in dependence on the resistance;
- - The loop has a loop through which the tape is pulled, so that the loop is narrowed by a simple train.
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According to another aspect of the present invention, which may be claimed independently or in combination with at least one of the above features, the device for high frequency surgical removal of a tissue section has a (support) band of a soft / flexible thermostable material, preferably plastic. On the tape / several electrical conductors are / are arranged, which can preferably be energized individually, so that they can be passed through a current through the adjacent tissue. One end of the band is preferably provided with a fixed loop or eyelet through which the other end of the band is threaded. The band can thus be pulled together like a sling.
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However, the loop is openable in the eyelet region and / or on the end region of the carrier tape opposite the eyelet region, resulting in an elongate carrier tape section with a free end. However, according to the invention, this elongated carrier tape section resulting in the loop-open state does not extend straight but is arcuate, ie precambered in a single direction. This is achieved by the strip according to this further aspect, which is preferably made of a plastic preformed during the manufacturing process, ie preformed. When the tape is then fed out of a draft tube, it automatically bends around the curve and can thus easily be picked up on the other side after enclosing the fabric piece to be separated. This eliminates or simplifies a difficult step of everting or enclosing. Alternatively, however, it is also possible to provide a preformed / permanently bent guide aid, for example in the form of a preformed tube, which is additionally accommodated in the draft tube and can be advanced from it. In this case, the guide aid encloses arcuately the tissue part to be separated and thus forms a curved channel at least partially around the tissue part along which the opened loop portion can be advanced. As soon as the loop portion is returned to the eyelet, the guide aid can be withdrawn into the feed tube and the loop can be closed.
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The inventive method for high-frequency surgical removal of a tissue section with a high-frequency surgical device comprises the steps:
Generating an RF voltage with an RF generator and
Enclosing the tissue section with a loop such that upon closure of the circuit and activation of the RF generator, electrical current flows from the loop into the tissue section,
wherein the electrically conductive loop comprises at least two electrical outer conductors on an insulating carrier tape and the outer conductors are disposed on a surface of the insulating carrier tape so as to extend in the longitudinal direction of the carrier tape and have a substantially constant distance from each other.
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Preferred embodiments of the method according to the invention have one or - if technically possible and reasonable - several of the following features:
- - Energizing the conductor by a switching device, so that in a first time interval, a current flows through the at least two outer conductors and in a second time interval, a current through a center conductor;
- - Actuating a pulling device which is connected to the center conductor, so that the center conductor is pressed into the fabric section;
- Detecting a resistance of the tissue by an impedance detection device and controlling an RF power of the RF generator in dependence on the resistance.
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The system and method of the invention has i.a. the following advantages. Due to the fixed loop through which the other end is pulled through, the actual separation process is preceded by a broad, deep-acting bipolar coagulation. As a result, the previously described bleeding are largely excluded. In addition, when the band is tightened, a surface pressure is generated which, in combination with the action of heat, causes hemostasis. The separation between coagulation and incision makes the process safer, more effective and faster, significantly reducing the risk of postoperative bleeding.
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If required, an impedance measurement can also be made so that the power input can be individually controlled.
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Overall, with the system according to the invention thus an efficient, safe and fast resection can be performed with profound hemostasis. This significantly reduces the time and effort required for dissection, dissection and haemostasis in laparoscopic hysterectomy and other, primarily laparoscopic or thoracoscopic procedures where larger amounts of tissue are deposited.
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Further features and advantages of the invention will become apparent from the following description of preferred embodiments of the invention, reference being made to the accompanying drawings.
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1 shows a first embodiment (purely monopolar) of the device according to the invention,
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2A and 2 B show an embodiment (bipolar or quasi-monopolar) of the loop according to the invention with two alternative current paths in cross-section,
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3 shows in cross section the loop according to the invention 2A . 2 B under mechanical tension,
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4 shows a further embodiment of the loop according to the invention with possible current paths in cross section,
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5 and 5a show further (alternative) embodiments of the loop according to the invention with a plurality of outer conductors and possible current paths in a perspective view,
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6 shows the loop according to the invention with a draft tube when enclosing a tissue section,
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7 shows an embodiment of the draft tube according to the invention,
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8th shows an embodiment of the method according to the invention for applying the device according to the invention and
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9 and 9a show in principle the preformed shape of a carrier tape in the case of an open loop.
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The drawing is not to scale. Identical or equivalent elements are designated by the same reference numerals, unless otherwise stated.
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In 1 is a tissue section 1 shown at the with 2 to be severed designated point. In the illustration, the tissue section 1 a uterus and the cut surface 2 the cervix. To the cervix 2 becomes an electrically conductive sling 3 placed to high-frequency surgical cutting of the cervix. This is the noose 3 with an HF generator 4 connected, which generates a high-frequency current of appropriate strength. An output of the HF generator 4 is with the noose 3 connected, and another output of the RF generator 4 is connected in the illustrated circuit with neutral electrode potential. Accordingly, the tissue section to be resected is 1 or the main fabric (not shown) also connected to neutral electrode potential. The current density at the loop 3 is relatively high, so it is in the vicinity of the noose 3 ie in the cut surface 2 comes to the desired sclerotherapy of the tissue.
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The electric sling 3 includes in 1 at least two outer conductors 7 and a center conductor 9 on an insulating carrier tape 5 are arranged. In other words, the carrier tape has 5 a certain bandwidth, with the outer conductors 7 in width distance on the carrier tape 5 are arranged and the center conductor is placed in the width direction between them.
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This ladder 7 and 9 be via a switching device 8th temporarily or permanently with the HF generator 4 connected. This will be explained further below.
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In 2A and 2 B is the noose 3 shown at two alternative current paths. In the loop according to the invention 3 are the leaders 7 and 9 on a surface 6 of the insulating carrier tape 5 arranged so that they can come into contact with the tissue area 2 , By using a carrier tape 5 It is achieved that the plurality of conductors can be handled as a loop and the conductors substantially keep a predetermined distance from each other. The individual ladder 7 and 9 can be energized in different ways as explained below.
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In 2A become only two outer conductors 7 used. The center conductor 9 is not used. The two outer conductors 7 be with the two outputs of the HF generator 4 connected so that through the adjacent tissue 2 a current flows between them. In this case would be different than in 1 the connection in the direction of the neutral electrode potential of the tissue section 1 omitted. The current flow between the two outer conductors 7 in this circuit is indicated by two double arrows in 2A indicated.
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An alternative current flow results, although the center conductor 9 is energized. This one is in 2 B shown. If, for example, the center conductor 9 with one pole of the HF generator 4 is connected and the two outer conductors 7 with the other pole of the HF generator 4 connected, the current is shared by the center conductor 9 on and flows through the adjacent tissue 2 to the two outer conductors 7 , This is in 2 B indicated by two single arrows, that of the center conductor 9 out.
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The timing of the energization of the outer and middle conductors 7 respectively. 9 can be chosen freely depending on the application. The ladder 7 . 9 be through the switching device 8th preferably briefly energized alternately, ie first bipolar acting, followed by quasi monopolar, then again bipolar etc.
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3 shows the carrier tape 5 with the two outer conductors 7 and the center conductor 9 when (slowly) contracting. How out 3 apparently the forces act to contract the band 5 priority to the middle conductor 9 , which is used in particular as a quasi-monopolar wire electrode. The ribbon 5 is so flexible in this embodiment that when contracting the center conductor 9 becomes prominent and thus enhances the cutting effect. That is, when contraction of the tape 5 hurries the center conductor 9 opposite the two outer conductors 7 radially inward and acting as a kind of mechanical cutting wire on the tissue.
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The loop according to the invention 3 with two outer conductors 7 and a center conductor 9 on a surface facing the tissue 6 a carrier tape 5 can be supplemented in their structure. In 4 is a band 5 shown in cross-section (width direction), on its surface facing the tissue 6 on both sides of the middle conductor 9 three outer conductors each 7 are arranged in width spacing (transverse). This allows different current paths between the outer conductors 7 of which four exemplify in 4 are indicated by single arrows.
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In 5 is an embodiment of the sling 3 shown at the tape 5 with respect to the tissue contact surface maximum in the band width direction (circumferential direction) spaced outer conductor 7 which are segmented in the band longitudinal direction and alternately energized act as bipolar electrodes. "Segmented" here means that every outer conductor 7 in tape longitudinal direction, sections open on the tape surface 6 Occurs and sections of tape surface 6 is covered. When energizing the outer conductor 7 different schemes are possible. For example, the outer conductors 7 be controlled in series, as in 4 is indicated. Alternatively, the outer conductors 7 on the circular shape of the noose 3 be driven, as it is in 5 is shown, wherein the current flow is indicated by single arrows. In addition, the outer conductor can 7 also cross-energized. That is, a first outer conductor 7 acts with a longitudinally offset opposite outer conductor 7 consecutive (crosswise) together. Alternatively, it is also possible that the band 5 with respect to the tissue contact surface maximum in the band width direction (circumferential direction) spaced outer conductor 7 has, which form quasi two longitudinal lines (corresponding to 5 ), of which, however, (only) an outer conductor longitudinal line in the longitudinal direction of the band is subdivided into individual spaced-apart outer conductor segments which, when energized alternately, interact as bipolar electrodes with the opposite outer conductor longitudinal line. In other words, acts in this way, each individual outer conductor segment with the opposite outer conductor longitudinal line in the most direct way (in the circumferential direction) together (through the current arrows in 5a shown).
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In addition, it is conceivable the sling 3 energize diagonally. This is in 6 shown. In the case of diagonal energization, only one in each row is randomly or randomized 6 eight outer conductors 7 occupied, which are labeled "2", "3", ... "8". The remaining seven outer conductors 7 act as antipole. The flow of current is greatest on the path of least resistance, so that the coagulation effect is greater polnah. Due to the circulating current supply to the outer conductors 7 Ultimately, however, a complete coagulation in the tissue area arises again 2 ,
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Furthermore, in this embodiment, the impedance can be measured and the necessary power for coagulation can be optimally metered via a feedback to the device.
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The loop 3 gets into a draft tube 10 retracted and then ejected intracorporeally via a (not shown) pusher. The intake pipe 10 will be more detailed by 7 explains in which the draft tube 10 shown in cross section. The intake pipe 10 to 7 is in a first shaft 11 and a second shaft 12 divided. In the first bay 11 there is a first ladder section 13 , and in the second shaft 12 there is a second conductor section 14 the noose 3 , This division of the draft tube 10 serves to insulate the individual segmented electrodes. That in the respective shaft 11 and 12 remaining lumens can be used for smoke extraction because the smoke is not negligible and often causes unwanted interruptions.
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The handle on the draft tube 10 can be designed so that the sling 3 is manually tightened by the surgeon. Alternatively, however, it is also possible to provide a mechanical device (not shown) for the controlled pulling in of the loop. Such a mechanical device may be spring-driven or equipped with threaded spindle or servomotors.
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The embodiment of the sling 3 in 6 is characterized in particular by a loop 3a at its end, below the draft tube 10 is shown and through which the flexible insulating tape 5 is pulled. The ribbon 5 , preferably made of a thermostable plastic material, which comprises two bipolar conductors, can be tightened thanks to the loop similar to a lasso, so that the loop 3 narrowed by simple pull. The additionally embedded monopolar energetic center conductor 9 takes over the cutting function in a combination of mechanical and monopolar cutting, as already described above.
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The embodiments described above can be used for the monopolar as well as the bipolar surgical procedure. In short, in the embodiments, a quasi-monopolar technique using the bipolar electrodes is used as a quasi-neutral electrode. In addition, a combination of the previously described monopolar, bipolar and quasi-monopolar techniques is conceivable. In the case of the monoplanar technique, alternatively, a transvaginal introduced counter electrode or as in the prior art a forceps with monopolar RF connection can be used.
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The following is based on 8th the method for operating the device described above with multipolar loops (sealing tapes) explained. One such method for high frequency surgical removal of a tissue section 1 Having a high frequency surgical device has the following steps.
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In one step 16 becomes an RF current with the RF generator 4 generated. In step 15 becomes the tissue section 1 with the noose 3 enclosed, allowing an electric current from the sling 3 in the tissue section 1 can flow. The electrically conductive sling 3 comprises at least two electrical outer conductors 7 on an insulating carrier tape 5 , The outer conductors 7 are on a surface 6 of the insulating carrier tape 5 arranged and extend in the longitudinal direction of the carrier tape 5 , This ensures that the outer conductor 7 a substantially constant distance in the width / circumferential direction of the band 5 have each other. With this structure, the flow of current through the tissue is substantially defined, so that reproducible conditions can be produced with each procedure.
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In an (optional) step 17 becomes the leader 9 by a switching device 8th energized, so that in a first time interval, a current through the at least two outer conductors and in a second time interval, a current through a center conductor 9 flows.
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In another (optional) step 18 a pulling device is operated, which is connected to the center conductor 9 connected so that the center conductor 9 in the tissue area 2 is pressed / pulled.
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Detecting a Resistance of the Fabric (Step 19 ) through an impedance detector (not shown) then enables in step 20 the control of the RF power of the HF generator 4 depending on the resistance of the tissue.
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For those skilled in the art, it will be apparent from the above description of the device that in multi-stranded embodiment of the loop 3 inter alia, an intermittent energizing of the individual conductors with mutual sealing and cutting phases and specially adapting HF operating modes is made possible.
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By parallel or mutual energization of one or more bipolar configured loops 3 The fabric can be easily sealed during the procedure. When measuring the impedance of all transition lines between "2", "3", ... "8", the sealing process can also be controlled with impedance control.
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In bipolar configuration of the outer conductor 7 Special operating modes are possible for cutting with the "cutting wire". Thus, a controlled cut can be performed by using a spark control. The multipolar loops 3 can be targeted together or switched to a counter electrode.
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In classical monopolar configuration with separate neutral electrode as counter electrode, special operating modes are also possible for cutting with the "cut wire".
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Finally, mixed forms of the bipolar and monopolar configuration described above are conceivable and possible. The impedance information for process control can also be used during the cut.
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As already indicated above, it is necessary in the present device that the loop 3 must be placed around a tissue part of the patient to be separated before the noose 3 is drawn. For example, if the tissue part to be separated is a uterus, it is necessary to have the extended loop 3 To pull over the uterus, but adjacent structures could possibly be trapped with and then accidentally separated with. To avoid such a situation, it may be provided according to the invention that the carrier tape 5 formed noose 3 can be opened.
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Specifically in this particular case has the carrier tape 5 according to the 9 and 9a In the loop area for this purpose, an interface at which it can be separated and closed again under the contact closure of the conductors thereon. For example, the in 5 only in principle represented interface a hook 21 be that at the free end of the noose 3 forming carrier tape 5 arranged / trained. In turn, at the distal end of the draft tube 10 a hooked loop 22 be formed / molded, in which the carrier tape 5 can be hung to close a mechanical / electrical contact.
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This makes it possible in principle, the carrier tape 5 after opening the sling 3 to its interface (for example, the hook 21 ) to guide it lengthwise around the part of tissue to be separated and then the loop 3 at the interface of the carrier tape 5 to close again. In order to facilitate this entrainment, it is provided according to a first variant of the invention, that the carrier tape 5 itself is preformed, ie the carrier tape 5 has in its relaxed (constructional) state in its longitudinal extent a curvature corresponding to a single-directional arc.
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Will therefore the carrier tape 5 with the sling open 3 from the draft tube 10 With its now free end forward, this takes out of the draft tube 10 projecting Trägerbandstück independently the preformed arch shape. This may cause the carrier tape 5 easier to be guided around the tissue part to be separated.
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According to a second variant of the present invention is a guide 24 provided with a longitudinal course (optional) preformed in accordance with the above description. Such a guide 24 For example, could be an additional intermediate tube, which is the carrier tape 5 longitudinally displaceable absorbs and which in the draft tube 10 also introduced longitudinally displaceable.
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Is therefore the intermediate tube / guide 24 from the draft tube 10 advanced, takes the intermediate tube / guide 24 in the protruding section automatically the preformed arcuate / curved longitudinal course. As soon as the intermediate tube / guide 24 around the tissue part to be separated, the carrier tape can 5 within the intermediate tube / guide 24 be postponed. In this way, the tissue part to be separated is looped around without risk.
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Finally, the carrier tape 5 only at the above interface (hook 21 - eyelet 22 ) linked to the noose 3 close.
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LIST OF REFERENCE NUMBERS
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- 1
- Tissue section, uterus
- 2
- Cut surface, cervix
- 3
- electrically conductive sling
- 3a
- Loop / eyelet
- 4
- RF generator
- 5
- insulating carrier tape
- 6
- Surface of the insulating carrier tape
- 7
- electrical outer conductor
- 8th
- Switching device for applying power to the conductors
- 9
- center conductor
- 10
- draft tube
- 11
- first shaft
- 12
- second shaft
- 13
- first ladder section of the sling
- 14
- second conductor section of the loop
- 15
- Enclosing the tissue section with a loop so that an electrical current flows from the loop into the tissue section,
- 16
- Generating an RF current with an RF generator
- 17
- Energizing the conductors with current through a switching device so that in a first time interval a current flows through the at least two outer conductors and in a second time interval a current flows through a central conductor
- 18
- Actuating a pulling device connected to the center conductor so that the center conductor is pressed into the tissue section
- 19
- Detecting a resistance of the tissue by an impedance detection device
- 20
- Controlling an RF power of the RF generator in dependence on the resistance.
- 21
- Interface (hook)
- 22
- eyelet
- 24
- Accession assistance
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QUOTES INCLUDE IN THE DESCRIPTION
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This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.
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Cited patent literature
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- WO 2006/124590 A2 [0008]
- WO 1999/018869 A1 [0009]
- US 7641651 B2 [0010]